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As
filed with the Securities and Exchange Commission on November 6, 2023
Registration
Statement No. 333-258528
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
Post-Effective
Amendment No. 3
to
FORM
S-1
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
RETINALGENIX
TECHNOLOGIES INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
3841 |
|
82-3936890 |
(State
or other jurisdiction of
incorporation or organization) |
|
(Primary
Standard Industrial
Classification Code Number) |
|
(I.R.S.
Employer
Identification Number) |
1450
North McDowell Boulevard, Suite 150
Petaluma,
CA 94954
(415)
578-9583
(Address and telephone number of registrant’s principal executive offices)
Jerry
Katzman
Chief
Executive Officer
RetinalGenix Technologies Inc.
1450
North McDowell Boulevard, Suite 150
Petaluma,
California 94954
(415)
578-9583
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies
to:
Leslie
Marlow, Esq.
Hank Gracin, Esq.
Blank Rome LLP
1271
Avenue of the Americas
New
York, New York 10020
Telephone:
(212) 885-5000
Approximate
date of commencement of proposed sale to the public: From time to time after the effective date of this registration statement.
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933 check the following box: ☒
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement number of the earlier effective registration statement for the same
offering. ☐
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If
this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
Emerging
growth company |
☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act.
The
Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the
Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective
in accordance with Section 8(a) of the Securities Act of 1933, or until the Registration Statement shall become effective on such date
as the Commission, acting pursuant to said Section 8(a), may determine.
EXPLANATORY
NOTE
This
Post-Effective Amendment No. 3 (this “Post-Effective Amendment”) relates to the registration statement on Form S-1 (File
No. 333-258528), initially filed by RetinalGenix Technologies Inc., a Delaware corporation (the “Registrant”), with the Securities
and Exchange Commission (the “SEC”) on August 5, 2021 and declared effective by the SEC on October 7, 2021 (the “Registration
Statement”).
This
Post-Effective Amendment is being filed pursuant to Section 10(a)(3) of the Securities Act of 1933, as amended (the “Securities
Act”) to update the Registration Statement to include, among other things, the audited financial statements of the Registrant as
at and for the year ended December 31, 2022 which was filed with the SEC on March 31, 2023, as part of the Registrant’s Annual
Report on Form 10-K, and the unaudited financial statements of the Registrant as at and for the quarter ended June 30 2023 which was
filed with the SEC on August 14, 2023 as part of Registrant’s Quarterly Report on Form 10-Q.
This
Post-Effective Amendment covers only the resale, from time to time, of up to 1,559,820 shares of common stock, including 1,358,920
outstanding shares of common stock, 181,000 shares of common stock issuable upon exercise of outstanding options and 19,900
shares of common stock issuable upon exercise of outstanding warrants (the “Resale Shares”) owned by the selling stockholders.
The Registrant previously paid to the SEC the entire registration fee relating to the shares of common stock that are the subject of
this Post-Effective Amendment. The Registrant paid a fee of $173.82 in connection with the registration of the Resale Shares of common
stock in connection with the Registration Statement.
The
information in this preliminary prospectus is not complete and may be changed. The selling stockholders may not sell these securities
until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an
offer to sell these securities and it is not soliciting an offer to buy these securities in any state or jurisdiction where the offer
or sale is not permitted.
PRELIMINARY
PROSPECTUS |
SUBJECT
TO COMPLETION |
DATED
NOVEMBER 3, 2023 |
1,559,820
Shares of Common Stock
This
prospectus relates to the sale by the selling stockholders named in this prospectus (the “Selling Stockholders”) of RetinalGenix
Technologies Inc. (the “Company”) of 1,559,820 shares of common stock, par value $0.0001 per share, including 1,358,920
outstanding shares of common stock, 181,000 shares of common stock issuable upon exercise of outstanding options and 19,900
shares of common stock issuable upon exercise of outstanding warrants (collectively, the “Resale Shares”). We will not receive
any of the proceeds from the sale by Selling Stockholders of the Resale Shares. However, we will receive proceeds from the exercise of
the options and warrants if they are exercised for cash by the Selling Stockholders.
The
Selling Stockholders will sell their Resale Shares at prevailing market prices or in privately negotiated transactions. We provide more
information about how a Selling Stockholder may sell its Resale Shares in the section titled “Plan of Distribution” on page
23.
Our
common stock is quoted on the OTCQB under the symbol “RTGN.” The closing price of our common stock on November 1,2023,
as reported by the OTCQB was $4.49 per share.
The
Selling Stockholders and any broker-dealers that participate in the distribution of the securities may be deemed to be “underwriters”
as that term is defined in Section 2(a)(11) of the Securities Act of 1933, as amended.
We
are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and may elect to comply with
certain reduced public company reporting requirements. See the section titled “Implications of Being an Emerging Growth Company.”
Investing
in our securities is highly speculative and involves a high degree of risk. You should carefully consider the risks and uncertainties
described under the heading “Risk Factors” beginning on page 5 of this prospectus before making a decision to purchase our
securities.
NEITHER
THE SECURITIES AND EXCHANGE COMMISSION (“SEC”) NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES
OR PASSED UPON THE ACCURACY OR ADEQUACY OF THE DISCLOSURES IN THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The
date of this prospectus is November 6, 2023.
ABOUT
THIS PROSPECTUS
In
this prospectus, unless the context suggests otherwise, unless otherwise noted, references to “the Company,” “we,”
“us,” and “our” refer to RetinalGenix Technologies Inc., a Delaware corporation.
This
prospectus describes the specific details regarding this offering and the terms and conditions of the securities being offered hereby
and the risks of investing in our securities. You should read this prospectus, any free writing prospectus and the additional information
about us described in the section entitled ‘‘Where You Can Find More Information’’ before making your investment
decision.
Neither
we, nor any of our officers, directors, agents, representatives or underwriters, make any representation to you about the legality of
an investment in our securities. You should not interpret the contents of this prospectus or any free writing prospectus to be legal,
business, investment or tax advice. You should consult with your own advisors for that type of advice and consult with them about the
legal, tax, business, financial and other issues that you should consider before investing in our securities.
ADDITIONAL
INFORMATION
You
should rely only on the information contained in this prospectus and in any accompanying prospectus supplement. No one has been authorized
to provide you with different or additional information. The securities are not being offered in any jurisdiction where the offer is
not permitted. You should not assume that the information in this prospectus or any prospectus supplement is accurate as of any date
other than the date on the front of such documents.
TRADEMARKS
AND TRADE NAMES
This
prospectus includes trademarks which are protected under applicable intellectual property laws and are our property. This prospectus
also contains trademarks, service marks, trade names and/ or copyrights of other companies, which are the property of their respective
owners. Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the ® or TM symbols,
but such references are not intended to indicate, in any way, that the respective owners of the trademarks and trade names will not assert,
to the fullest extent under applicable law, their rights thereto.
INDUSTRY
AND MARKET DATA
Unless
otherwise indicated, information contained in this prospectus concerning our industry and the markets in which we operate, including
market position and market opportunity, is based on information from our management’s estimates, as well as from industry publications
and research, surveys and studies conducted by third parties. The third-party sources from which we have obtained information generally
state that the information contained therein has been obtained from sources believed to be reliable, but we cannot assure you that this
information is accurate or complete. We have not independently verified any of the data from third-party sources nor have we verified
the underlying economic assumptions relied upon by those third parties. Similarly, internal company surveys, industry forecasts and market
research, which we believe to be reliable, based upon management’s knowledge of the industry, have not been verified by any independent
sources. Our internal company surveys are based on data we have collected over the past several years, which we believe to be reliable.
Management estimates are derived from publicly available information, our knowledge of our industry, and assumptions based on such information
and knowledge, which we believe to be reasonable and appropriate. However, assumptions and estimates of our future performance, and the
future performance of our industry, are subject to numerous known and unknown risks and uncertainties, including those described under
the heading “Risk Factors” in this prospectus and those described elsewhere in this prospectus. These and other important
factors could result in our estimates and assumptions being materially different from future results. You should read the information
contained in this prospectus completely and with the understanding that future results may be materially different and worse from what
we expect. See the information included under the heading “Cautionary Note Regarding Forward-Looking Statements.”
TABLE
OF CONTENTS
PROSPECTUS
SUMMARY
The
following summary is qualified in its entirety by, and should be read together with, the more detailed information and financial statements
and related notes thereto appearing elsewhere in this prospectus. Before you decide to invest in our securities, you should read the
entire prospectus carefully, including the risk factors and the financial statements and related notes included in this prospectus.
Business
Overview
We
are an ophthalmic research and development company focused on developing technologies to screen, monitor, diagnose and treat ophthalmic,
optical, and sight-threatening disorders. Our mission is to prevent vision loss and blindness due to diabetic retinopathy and maculopathy
through two devices: (1) Retinal Imaging Screening Device, a portable, retinal imaging system providing a 200-degree field of
view without requiring pupil dilation; and (2) RetinalCamTM, a home monitoring and imaging device offering real-time
communication and alerting system for physicians available 24/7.
To
date, we have devoted substantially all of our resources to organizing, business planning, raising capital, designing and developing
product candidates, and securing manufacturing and sales/distribution partners. We do not have any products approved for sale and have
not generated any revenue from product sales. We have funded our operations primarily through the private placement of common stock.
We
anticipate that we will need an additional $12,000,000 to (i) complete product design and testing for RetinalGenixTM and RetinalCamTM
and submit RetinalGenixTM for FDA clearance (we anticipate that the RetinalCamTM will not require FDA clearance);
(ii) complete the development and expansion of the software tools around the recently acquired DNA/GPS’ genetic mapping technology;
and (iii) build the infrastructure for our sustained growth. We intend to obtain such funds through the sales of our equity and debt
securities and/or through potential strategic partnerships; however, no assurance can be provided that funds will be available to us
on acceptable terms, if at all.
We
do not expect to generate any revenues from product sales unless and until we successfully complete development of RetinalCamTM,
and we do not expect to generate any revenues from product sales unless and until we successfully obtain regulatory clearance for RetinalGenixTM.
In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting,
investor relations, compliance and other expenses.
As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such
time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through
public or private equity offerings, debt financings, strategic partnerships, collaborations and licensing arrangements or other capital
sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms or
at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial
condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant
rights to develop and market our product candidates.
We
have been issuing shares of our common stock pursuant to a private placement raising approximately $3.0 million from the sale of 3,070,500
shares of common stock from 2019 January 2022.
Because
of the numerous risks and uncertainties we are unable to accurately predict the timing or amount of increased expenses or when or if
we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If
we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations
at planned levels and be forced to reduce or terminate our operations.
Acquisition
of DNA/GPS Inc.
On
July 5, 2022, we entered into an Exchange Agreement (the “Exchange Agreement”) with Dr. Lawrence Perich pursuant to which
we acquired all the outstanding shares of DNA/GPS Inc., a pharmacogenetics company based in Tampa, Florida (“DNA/GPS”), in
exchange for the issuance of 2,000,000 shares of our common stock. The acquisition of DNA/GPS combines DNA/GPS’ genetic mapping
capabilities with our retinal imaging capabilities. The combined technology is expected to have the ability to provide diagnoses of systemic
and retinal diseases. We accounted for this transaction as an asset acquisition in the quarter ending September 30, 2022, and recorded
the estimated purchase consideration and related expenses as in process research and development in the accompanying consolidated statement
of operations.
RISK
FACTOR SUMMARY
Our
business is subject to significant risks and uncertainties that make an investment in us speculative and risky. Below we summarize what
we believe are the principal risk factors but these risks are not the only ones we face, and you should carefully review and consider
the full discussion of our risk factors in the section titled “Risk Factors,” together with the other information in this
Registration Statement on Form S-1. If any of the following risks actually occurs (or if any of those listed elsewhere in this Registration
Statement on Form S-1 occur), our business, reputation, financial condition, results of operations, revenue, and future prospects could
be seriously harmed. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also
become important factors that adversely affect our business.
Risk
Related to our Financial Position and Need for Capital
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We
have generated no revenue from commercial sales and our future profitability is uncertain. |
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If
we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development
and you will likely lose your entire investment. |
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Raising
additional capital may cause dilution to our existing stockholders. |
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There
is substantial doubt about our ability to continue as a going concern. |
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We
have incurred net losses every year and expect to continue to incur increased expenses. |
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Failure
to maintain effective internal control over our financial reporting in accordance with Section 404 of Sarbanes-Oxley could cause
our financial reports to be inaccurate. |
Risk
Related to Product Development, Regulatory Approval, Manufacturing and Commercialization
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Our
revenues from sales of our products will be dependent upon pricing and reimbursement guidelines. |
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We
will depend upon our suppliers to provide the components we require. |
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Our
commercial and financial success depends on our products being accepted in the market. |
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We
may face substantial competition in the future. |
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Product
liability lawsuits against us could cause us to incur substantial liabilities. |
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We
are dependent on information technology systems. |
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If
the quality or delivery of our products does not meet our customers’ expectations, our reputation could suffer and ultimately
our sales and operating earnings could be negatively impacted. |
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Failure
to comply with data privacy and security laws could have a material adverse effect on us |
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We
may not be successful in hiring and retaining key employees, including executive officers. |
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Our
management overlaps substantially with the management and our principal stockholder. |
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We
may acquire other businesses that could negatively affect our operating results and dilute our stockholders’ ownership. |
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Our
failure to accurately forecast demand for our products could result in additional costs. |
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If
our facilities were to experience catastrophic loss, our operations would be seriously harmed. |
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Changes
in general economic conditions and geopolitical and other conditions may adversely impact our business and operating results. |
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We
will be dependent upon third parties for the distribution of our products. |
Risk
Related to our Intellectual Property Rights
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Our
intellectual property may not be sufficient to protect our products from competition. |
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We
may become involved in future lawsuits to protect or enforce our patents. |
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We
may not be able to enforce our intellectual property rights throughout the world. |
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Third
parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated
trade secrets. |
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We
may be unable to adequately prevent disclosure of trade secrets and other proprietary information. |
Risks
Relating to Government Regulations
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Our
failure to obtain and maintain FDA clearances or approvals on a timely basis, or at all, would prevent us from commercializing our
products in the U.S., which could severely harm our business. |
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Our
promotional practices will be subject to extensive government scrutiny. |
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Legislative
or regulatory reform of the health care system in the U.S. may adversely impact our business. |
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We
are subject to stringent domestic and foreign medical device regulations. |
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We
will also be subject to stringent government regulation in foreign countries. |
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Failure
by us or our distributors to comply with foreign regulations applicable to the products we design, manufacture, install or distribute
could expose us to enforcement actions or other adverse consequences. |
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We
will be subject to ongoing requirements and inspections. |
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We
could be subject to substantial fines or damages and possible exclusion from participation in federal or state health care programs
if we fail to comply with the laws and regulations applicable to our business. |
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If
we fail to develop and successfully introduce new products our operating results may suffer. |
Risks
Related to Owning our Securities
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Our
stock price may be volatile. |
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Future
sales and issuances of our securities could result in additional dilution. |
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We
have never paid cash dividends and have no plans to pay cash dividends in the future. |
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The
“penny stock” rules of the SEC makes transactions in our stock cumbersome. |
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Certain
of our stockholders control a significant number of shares of our common stock. |
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We
have availed ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our common stock
less attractive to investors. |
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Our
First Amended and Restated Certificate of Incorporation (“Certificate of Incorporation”) and our Bylaws (the “Bylaws”)
and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our
stock price to decline. |
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Financial
reporting obligations of being a public company in the U.S. are expensive and time-consuming. |
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Failure
to maintain effective internal control over our financial reporting in accordance with Section 404 of Sarbanes-Oxley could cause
our financial reports to be inaccurate. |
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Halo Management LLC may contest, and we would need then
to successfully defend, the action taken by our board of directors to rescind the 3,000,000 shares of our Series F Preferred Stock
that was issued to Halo. |
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Our
Certificate of Incorporation and Bylaws provide that the Court of Chancery of the State of Delaware will be the sole and exclusive
forum for substantially all disputes between us and our stockholders, which could limit stockholders’ ability to obtain a favorable
judicial forum for disputes with us or our directors, officers or employees. |
Corporate
Information
We
were incorporated in Delaware on November 17, 2017. Our principal executive offices are located at 1450 North McDowell Boulevard, Suite
150, Petaluma, CA 94954 and our telephone number is (415) 578-9583. Our website address is www.retinalgenix.com. The information
contained on our website is not incorporated by reference into this prospectus, and you should not consider any information contained
on, or that can be accessed through, our website as part of this prospectus or in deciding whether to purchase our securities.
Implications
of Being an Emerging Growth Company
We
qualify as an emerging growth company as defined in the Jumpstart our Business Startups Act of 2012 (“JOBS Act”). As an emerging
growth company, we expect to take advantage of reduced reporting requirements that are otherwise applicable to public companies. These
provisions include, but are not limited to:
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being
permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements,
with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
disclosure in this prospectus; |
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not
being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley”); |
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reduced
disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and |
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exemptions
from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute
payments not previously approved. |
We
may use these provisions until the last day of our fiscal year following the fifth anniversary of the completion of our initial public
offering. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated
filer,” our annual gross revenues exceed $1.235 billion or we issue more than $1.0 billion of non-convertible debt in any three-year
period, we will cease to be an emerging growth company prior to the end of such five-year period.
As
an emerging growth company, we intend to take advantage of an extended transition period for complying with new or revised accounting
standards as permitted by the JOBS Act. To the extent that we continue to qualify as a “smaller reporting company,” as such
term is defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), after we cease
to qualify as an emerging growth company, certain of the exemptions available to us as an emerging growth company may continue to be
available to us as a smaller reporting company, including: (i) not being required to comply with the auditor attestation requirements
of Section 404(b) of the Sarbanes Oxley Act; (ii) scaled executive compensation disclosures; and (iii) the requirement to provide only
two years of audited financial statements, instead of three years.
THE
OFFERING
Common
stock offered by Selling Stockholders: |
|
1,559,820
shares of common stock, par value $0.0001 per
share, which includes 1,358,920 outstanding shares of common stock, 181,000 shares of common stock issuable upon exercise
of outstanding options and 19,900 shares of common stock issuable upon exercise of warrants (collectively, the “Resale Shares”). |
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Offering
price: |
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The
selling stockholders (the “Selling Stockholders”) will sell their Resale Shares at prevailing market prices or in privately
negotiated transactions. See “Plan of Distribution.” |
|
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Common
stock outstanding: |
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17,588,811
shares. |
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Use
of proceeds: |
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We
will not receive any of the proceeds from the sale of the Resale Shares by the Selling Stockholders. Any proceeds received from the
exercise of options or warrants by Selling Stockholders will be used by us for working capital purposes. See “Use of Proceeds.” |
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|
Risk
factors: |
|
An
investment in our securities involves a high degree of risk and could result in a loss of your entire investment. Prior to making
an investment decision, you should carefully consider all of the information in this prospectus and, in particular, you should evaluate
the risk factors set forth under the caption “Risk Factors” beginning on page 5. |
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|
|
OTCQB
Symbol: |
|
RTGN |
The
number of shares of common stock outstanding is based on 17,588,811 shares of common stock issued and outstanding as of November
1, 2023 and excludes as of that date:
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● |
150,000
shares of common stock issuable upon exercise
of warrants with a weighted average exercise price of $1.09 per share; |
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● |
2,660,000
shares
of common stock issuable upon exercise of options with an exercise price of $1.00 per share;
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28,014,540
shares of common stock issuable upon exercise of pre-funded warrants with an exercise price of $0.0001 per share; and |
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4,815,000
shares of common stock reserved for future issuance
under our 2017 Equity Incentive Plan. |
RISK
FACTORS
An
investment in our common stock involves a high degree of risk. You should carefully consider the following risk factors and the other
information in this Registration Statement on Form S-1 before investing in our common stock. Our business and results of operations could
be seriously harmed by any of the following risks. The risks set out below are not the only risks we face. Additional risks and uncertainties
not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition
and/or operating results. If any of the following events occur, our business, financial condition and results of operations could be
materially adversely affected. In such case, the value and trading price of our common stock could decline, and you may lose all or part
of your investment.
Risk
Related to our Financial Position and Need for Capital
We
have generated no revenue from commercial sales to date and our future profitability is uncertain.
We
were incorporated in November 2017 and have a limited operating history, and our business is subject to all of the risks inherent in
the establishment of a new business enterprise. Our likelihood of success must be considered in light of the problems, expenses, difficulties,
complications and delays frequently encountered in connection with development and expansion of a new business enterprise. Since inception,
we have incurred losses and expect to continue to operate at a net loss for at least the next several years. Our net losses for the years
ended December 31, 2022 and December 31, 2021, were $3,913,990 and $2,179,294, respectively, and our accumulated deficit as of December
31, 2022 and December 31, 2021 was $9,018,306 and $5,104,316, respectively. Our net losses for the six months ended June 30, 2023 and
2022, were $862,786 and $734,534, respectively, and our accumulated deficit as of June 30, 2023 was $9,881,092. There can be no assurance
that the products under development by us will be cleared for sale in the U.S. or elsewhere. Furthermore, there can be no assurance that
if such products are cleared they will be successfully commercialized, and the extent of our future losses and the timing of our profitability
are highly uncertain. If we are unable to achieve profitability, we may be unable to continue our operations.
If
we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and
you will likely lose your entire investment.
We
will need to continue to seek capital from time to time to continue development of our products and we cannot provide any assurances
that any revenues they may generate in the future will be sufficient to fund our ongoing operations. We believe that we will need to
raise substantial additional capital to fund our continuing operations and the development and commercialization of our products. We
anticipate that we will need an additional $12,000,000 to (i) complete product design and testing for the RetinalGenixTM and
RetinalCamTM and submit RetinalGenixTM for FDA clearance (we anticipate that the RetinalCamTM will not
require FDA clearance); (ii) complete the development and expansion of the software tools around the recently acquired DNA/GPS’
genetic mapping technology; and (iii) build the infrastructure for our sustained
growth.
Our
business or operations may change in a manner that would consume available funds more rapidly than anticipated and substantial additional
funding may be required to maintain operations, fund expansion, develop new or enhanced products, acquire complementary products, business
or technologies or otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment. In addition,
we may need to accelerate the growth of our sales capabilities and distribution beyond what is currently envisioned, and this would require
additional capital. However, we may not be able to secure funding when we need it or on favorable terms. We may not be able to raise
sufficient funds to commercialize the products we intend to develop.
If
we cannot raise adequate funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development
activities or future operations. We may also be required to obtain funds through arrangements with collaborators, which arrangements
may require us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing, including
rights to certain major geographic markets. This could result in sharing revenues which we might otherwise retain for ourselves. Any
of these actions may harm our business, financial condition and results of operations.
The
amount of capital we may need depends on many factors, including the progress, timing and scope of our product development programs;
the time and cost necessary to obtain regulatory clearance; our ability to enter into and maintain collaborative, licensing and other
commercial relationships; and our partners’ commitment of time and resources to the development and commercialization of our products.
Raising
additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our
products on unfavorable terms to us.
We
may seek additional capital through a variety of means, including through private and public equity offerings and debt financings, collaborations,
strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the
sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms of such financings
may include liquidation or other preferences, anti-dilution rights, conversion and exercise price adjustments and other provisions that
adversely affect the rights of our stockholders, including rights, preferences and privileges that are senior to those of our holders
of common stock in the event of a liquidation. In addition, debt financing, if available, could include covenants limiting or restricting
our ability to take certain actions, such as incurring additional debt, making capital expenditures, or declaring dividends and may require
us to grant security interests in our assets. If we raise additional funds through collaborations, strategic alliances, or marketing,
distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue
streams, or products or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity
or debt financings when needed, we may need to curtail or cease our operations.
There
is substantial doubt about our ability to continue as a going concern.
As
of June 30, 2023, we had cash, of $1,913. In addition, as of June 30, 2023, we had liabilities of $1,776,950. As of the date of this
report, we do not have adequate resources to fund our operations through August 2024 without considering any potential future milestone
payments that we may receive under any new collaborations that we may enter into in the future or any future capital raising transactions.
We will need to raise additional funding to complete the development of its products and commence the market launch, assuming regulatory
approval is obtained. We do not know whether additional financing will be available when needed, whether it will be available on favorable
terms, or if it will be available at all. These factors raise substantial doubt about our ability to continue as a going concern. In
the event that we are unable to obtain additional financing, we may be unable to continue as a going concern. There is no guarantee that
we will be able to secure additional financing. Changes in our operating plans, our existing and anticipated working capital needs, costs
related to legal proceedings we might become subject to in the future, the acceleration or modification of our development activities,
any near-term or future expansion plans, increased expenses, potential acquisitions or other events may further affect our ability to
continue as a going concern. Similarly, the report of our independent registered public accounting firm on our financial statements as
of and for the year ended December 31, 2022 includes an explanatory paragraph indicating that there is substantial doubt about our ability
to continue as a going concern. If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in
us.
Failure
to maintain effective internal control over our financial reporting in accordance with Section 404 of Sarbanes-Oxley could cause our
financial reports to be inaccurate.
We
are required pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, to maintain internal control over financial reporting
and to assess and report on the effectiveness of those controls. This assessment includes disclosure of any material weaknesses identified
by our management in our internal control over financial reporting. Although we prepare our financial statements in accordance with accounting
principles generally accepted in the United States, our internal accounting controls may not meet all standards applicable to companies
with publicly traded securities. If we fail to implement any required improvements to our disclosure controls and procedures, we may
be obligated to report control deficiencies, in which case we could become subject to regulatory sanction or investigation. Further,
such an outcome could damage investor confidence in the accuracy and reliability of our financial statements.
Our
management has concluded that our internal controls over financial reporting were, and continue to be, ineffective, and as of June 30,
2023 as a result of a material weakness in our internal controls due to the lack of segregation of duties. While management is working
to remediate the material weakness, there is no assurance that such changes, when economically feasible and sustainable, will remediate
the identified material weaknesses or that the controls will prevent or detect future material weaknesses. If we are not able to maintain
effective internal control over financial reporting, our financial statements, including related disclosures, may be inaccurate, which
could have a material adverse effect on our business.
Risks
Relating to Our Business
Our
revenues from sales of our products will be dependent upon pricing and reimbursement guidelines, and if pricing and reimbursement levels
are inadequate to achieve profitability, our operations will suffer.
Our
financial success will be dependent on our ability to price our products in a manner acceptable to government and private payors while
still maintaining our profit margins. Numerous factors that may be beyond our control may ultimately impact the pricing of our products
and determine whether we are able to obtain reimbursement or reimbursement at adequate levels from governmental programs and private
insurance. If we are unable to obtain reimbursement or our products are not adequately reimbursed, we will experience reduced sales,
our revenues likely will be adversely affected, and we may not become profitable. Obtaining reimbursement approvals is time consuming,
requires substantial management attention and is expensive. Our business will be materially adversely affected if we do not receive approval
for reimbursement of our products under government programs and from private insurers on a timely or satisfactory basis. If reimbursement
for our products is unavailable, limited in scope or amount, or if pricing is set at unsatisfactory levels, our business may be materially
harmed.
If
our suppliers cannot provide the components we require, our ability to develop and manufacture our products could be harmed.
We
rely on third-party suppliers to provide us with components that will be used in the products we are developing. For example, we rely
on third-party suppliers to provide us with sensors which will be used in both RetinalGeniXTM and RetinalCamTM.
Relying on third-party suppliers makes us vulnerable to component part failures or obsolescence and interruptions in supply including,
but not limited to, as a result of COVID-19, either of which could impair our ability to develop our products in a timely manner. Vendor
lead times to supply us with ordered components vary significantly and as a result of COVID-19 can exceed three months or more. We cannot
be sure that our suppliers will furnish us required components when we need them or be able to provide us with sufficient components
to support the development and manufacture of our products.
Some
of our suppliers may be the only source for a particular component, which makes us vulnerable to significant cost increases or shortage
of supply. We have foreign suppliers for some of our parts in which we are subject to currency exchange rate volatility. Some of our
vendors are small in size and may have difficulty supplying the quantity and quality of materials required for our products as our business
potentially grows. Vendors that are the sole source of certain products may decide to limit or eliminate sales of certain components
due to product liability or other concerns and we might not be able to find a suitable replacement for those products. Our inventory
may run out before we find alternative suppliers and we might be forced to purchase excess inventory, if available, to last until we
are able to qualify an alternate supplier. Any of these events could adversely impact our results of operations.
Our
commercial and financial success depends on our products being accepted in the market, and if not achieved will result in our not being
able to generate revenues to support our operations.
Even
if we are able to obtain favorable reimbursement within the markets that we serve, commercial success of our products will depend, among
other things, on their acceptance by retinal specialists, ophthalmologists, general practitioners, low vision therapists and mobility
experts, hospital purchasing and controlling departments, patients, and other members of the medical community. The degree of market
acceptance of any of our potential products will depend on factors that include:
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cost
of treatment; |
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pricing
and availability of alternative products; |
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the
extent of available third-party coverage or reimbursement; |
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perceived
efficacy of our products relative to other products and medical solutions; and |
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prevalence
and severity of adverse side effects associated with treatment. |
We
may face substantial competition in the future and may not be able to keep pace with the rapid technological changes which may result
from others discovering, developing or commercializing products before or more successfully than we do.
In
general, the development and commercialization of new medical devices is highly competitive and is characterized by extensive research
and development and rapid technological change. Our customers consider many factors including product reliability, product availability,
inventory consignment, price and product services provided by the manufacturer. Market share can shift as a result of technological innovation
and other business factors. Major shifts in industry market share have occurred in connection with product related problems, physician
advisories and safety alerts and quality problems with processes, goods and services, any of which could harm our reputation and have
a material adverse effect on our operations. In addition, our competitors may develop products or other novel technologies that are more
effective, safer or less costly than our products. If we fail to develop new products or enhance our existing products, our business,
financial condition and results of operations may be adversely affected.
Product
liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we
may develop.
We
face an inherent risk of product liability exposure related to our products. Product liability claims may be brought against us by patients,
healthcare providers or others using, administering or selling our products. If we cannot successfully defend ourselves against claims
that our products caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims
may result in:
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decreased
demand for our products; |
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injury
to our reputation and significant negative media attention; |
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significant
costs to defend the related litigation; |
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substantial
monetary awards; |
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loss
of revenue; |
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diversion
of management and scientific resources from our business operations; and |
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the
inability to commercialize any products that we may develop. |
Prior
to commercializing our products, we intend to obtain product liability insurance coverage at a level that we believe is customary for
similarly situated companies and adequate to provide us with insurance coverage for foreseeable risks; however, we may be unable to obtain
such coverage at a reasonable cost, if at all. If we are able to obtain product liability insurance, we may not be able to maintain insurance
coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise and such insurance may not be adequate
to cover all liabilities that we may incur. A successful product liability claim or series of claims brought against us, particularly
if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.
Risk
Related to our Intellectual Property Rights
We
are dependent on information technology systems, including systems from third parties, and if we fail to properly maintain the integrity
of our data or if our products do not operate as intended, our business could be materially and adversely affected.
We
are dependent on information technology systems for our products and infrastructure, and we rely on these information technology systems,
including technology from third-party vendors, to process, transmit and store electronic information in our day-to-day operations. We
continuously monitor, upgrade and expand the systems we operate to improve information systems capabilities. Our information systems
require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and develop or contract new
systems to keep pace with continuing changes in information processing technology, evolving systems and regulatory standards, and the
increasing need to protect patient and customer information. In addition, third parties may attempt to hack into our products or systems
and may obtain data relating to patients or proprietary information. If we fail to protect our information systems and data integrity,
we could lose existing customers; have difficulty attracting new customers; have difficulty preventing, detecting, and controlling fraud;
be subject to regulatory sanctions, fines or penalties; be subject to increases in operating expenses; incur expenses or lose revenue;
or suffer other adverse consequences.
If
the quality or delivery of our products does not meet our customers’ expectations, our reputation could suffer and ultimately our
sales and operating earnings could be negatively impacted.
In
the course of conducting our business, we will need to adequately address quality issues associated with our products, including in our
engineering, design, manufacturing and delivery processes, as well as issues in third-party components included in our products. Because
our products are highly complex, the occurrence of performance issues may increase as we continue to introduce new products and as we
rapidly scale up manufacturing to meet increased demand for our products. There can be no assurance that we will be able to eliminate
or mitigate occurrences of these issues and associated liabilities. In addition, identifying the root cause of performance or quality
issues, particularly those affecting third-party components, may be difficult, which increases the time needed to address quality issues
as they arise and increases the risk that similar problems could recur. Finding solutions to quality issues can be expensive, and we
may incur significant costs or lost revenue in connection with, for example, shipment holds, product recalls and warranty or other service
obligations. In addition, quality issues can impair our relationships with new or existing customers and our reputation as a producer
of high-quality products could suffer, which could adversely affect our business, financial condition or results of operations.
Failure
to comply with data privacy and security laws could have a material adverse effect on our business.
We
are subject to state, federal and foreign laws relating to data privacy and security in the conduct of our business, including state
breach notification laws, the Health Insurance Portability and Accountability Act, as amended by the Health Information Technology for
Economic and Clinical Health Act of 2009 and the California Consumer Privacy Act. These laws affect how we collect and use data of our
employees, consultants, customers and other parties. Furthermore, these laws impose substantial requirements that require the expenditure
of significant funds and employee time to comply, and additional states are enacting new data privacy and security laws, which will require
future expansion of our compliance efforts. We also rely on third parties to host or otherwise process some of this data. Any failure
by a third party to prevent security breaches could have adverse consequences for us. We will need to expend additional resources and
make significant investments to comply with data privacy and security laws. Our failure to comply with these laws or prevent security
breaches of such data could result in significant liability under applicable laws, cause disruption to our business, harm our reputation
and have a material adverse effect on our business.
We
may not be successful in hiring and retaining key employees, including executive officers.
Our
future operations and successes depend in large part upon the strength of our management team. We rely heavily on the continued service
of Jerry Katzman, our President and Chief Executive Officer. Accordingly, if Dr. Katzman terminates his employment with us, such a departure
may have a material adverse effect on our business. Our future success also depends on our ability to identify, attract, hire or engage,
retain and motivate other well-qualified financial, managerial, technical and regulatory personnel. There can be no assurance that these
professionals will be available in the market, or that we will be able to retain existing professionals or to meet or to continue to
meet their compensation requirements. Furthermore, the cost base in relation to such compensation, which may include equity compensation,
may increase significantly, which could have a material adverse effect on us. Failure to establish and maintain an effective management
team and work force could adversely affect our ability to operate, grow and manage our business.
Our
management overlaps substantially with the management and beneficial owners of our principal stockholder, which may give rise to potential
conflicts of interest.
Our
Chief Executive Officer also serves as the Chief Executive Officer of our principal stockholder, Sanovas, Inc. (“Sanovas”).
Accordingly, there may be inherent, albeit non-specific, potential conflicts involved in the participation by members of each company’s
management.
We
may acquire other businesses, form joint ventures or make investments in other companies or technologies that could negatively affect
our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
We
may pursue acquisitions of businesses and assets. We also may pursue strategic alliances and joint ventures that leverage our proprietary
technology and industry experience to expand our offerings or distribution. We have no experience with acquiring other companies other
than our acquisition of DNA/ GPS Inc. and limited experience with forming strategic partnerships. We may not be able to find suitable
partners or acquisition candidates, and we may not be able to complete such transactions on favorable terms, if at all. If we make any
acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown
or contingent liabilities. Any future acquisitions also could result in the incurrence of debt, contingent liabilities or future write-offs
of intangible assets or goodwill, any of which could have a negative impact on our cash flows, financial condition and results of operations.
Integration of an acquired company also may disrupt ongoing operations and require management resources that we would otherwise focus
on developing our existing business. We may experience losses related to investments in other companies, which could harm our financial
condition and results of operations. We may not realize the anticipated benefits of any acquisition, strategic alliance or joint venture.
To
finance any acquisitions or joint ventures, we may choose to issue shares of common stock as consideration, which could dilute the ownership
of our stockholders. Additional funds may not be available on terms that are favorable to us, or at all. If the price of our common stock
is low or volatile, we may not be able to acquire other companies or fund a joint venture project using our stock as consideration.
If
we fail to accurately forecast demand for our products, we could incur additional costs or experience lost sales.
It
will be very important that we accurately predict the demand for our products. If we overestimate the demand for our products, we may
have excess inventory, which would increase our costs. If we underestimate demand for our products, we may have inadequate inventory,
which could delay delivery of our products to our customers and result in the loss of customer sales. Any of these occurrences would
negatively impact our business and operating results.
If
our facilities were to experience catastrophic loss, our operations would be seriously harmed.
Our
facilities could be subject to catastrophic loss such as fire, flood, unpredictable power outages or earthquakes. All of our research
and development activities, our corporate headquarters and other critical business operations are located in California. California can
experience catastrophic wildfires, as well as intermittent power outages. Any such loss at any of our facilities caused by fires, flooding,
power outages or earthquakes could disrupt our operations and may have a material adverse effect on our business.
Changes
in general economic conditions, geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond
our control may adversely impact our business and operating results.
Our
operations and performance depend on global, regional and U.S. economic and geopolitical conditions. General worldwide economic conditions
have experienced significant instability in recent years including the recent global economic uncertainty and financial market conditions.
Russia’s invasion and military attacks on Ukraine have triggered significant sanctions from U.S. and European leaders and financial
markets around the world experienced volatility following the invasion of Ukraine by Russia in February 2022. Resulting changes in U.S.
trade policy could trigger retaliatory actions by Russia, its allies and other affected countries, including China, resulting in a “trade
war.” Furthermore, if other countries, including the U.S., become further involved in the conflict, we could face significant adverse
effects to our business and financial condition.
The
uncertain financial markets, disruptions in supply chains, mobility restraints, and changing priorities as well as volatile asset values
could impact our business in the future. Concerns over medical epidemics, energy costs, geopolitical issues, the mortgage market and
a deteriorating real estate market, unstable global credit markets and financial conditions, and volatile oil prices have led to periods
of significant economic instability, diminished liquidity and credit availability, declines in consumer confidence and discretionary
spending, diminished expectations for the global economy and expectations of slower global economic growth, increased unemployment rates,
and increased credit defaults in recent years. Our general business strategy may be adversely affected by any such economic downturns
(including the current downturn related to the current COVID-19 pandemic), volatile business environments and continued unstable or unpredictable
economic and market conditions. The COVID-19 outbreak and government measures taken in response to the pandemic have also had a significant
impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities
and production have been suspended; and demand for certain goods and services, such as medical services and supplies, have spiked, while
demand for other goods and services, such as travel, have fallen. The future progression of the pandemic and its effects on our business
and operations are uncertain. In addition, the outbreak of a pandemic could disrupt our operations due to absenteeism by infected or
ill members of management or other employees, or absenteeism by members of management and other employees who elect not to come to work
due to the illness affecting others in our office or laboratory facilities, or due to quarantines. Pandemics could also impact members
of our Board of Directors resulting in absenteeism from meetings of the directors or committees of directors, and making it more difficult
to convene the quorums of the full Board of Directors or its committees needed to conduct meetings for the management of our affairs.
Further,
due to increasing inflation, operating costs for many businesses including ours have increased and, in the future, could impact demand
or pricing manufacturing of our devices, foreign exchange rates or employee wages. Inflation rates, particularly in the United States,
have increased recently to levels not seen in years, and increased inflation may result in increases in our operating costs (including
our labor costs), reduced liquidity and limits on our ability to access credit or otherwise raise capital. In addition, the Federal Reserve
has raised, and may again raise, interest rates in response to concerns about inflation, which coupled with reduced government spending
and volatility in financial markets may have the effect of further increasing economic uncertainty and heightening these risks.
Actual
events involving reduced or limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions
or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events
of these kinds, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon
Valley Bank, was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance
Corporation as receiver. Although we did not have any cash or cash equivalent balances on deposit with Silicon Valley Bank, uncertainty
and liquidity concerns in the broader financial services industry remain and the failure of Silicon Valley Bank and its potential near-
and long-term effects on the biotechnology industry and its participants such as our vendors, suppliers, and investors, may also adversely
affect our operations and stock price.
We
are actively monitoring the effects these disruptions and increasing inflation could have on our operations.
These
conditions make it extremely difficult for us to accurately forecast and plan future business activities.
We
will be dependent upon third parties for the distribution of our products, and if such third parties are unable to establish and maintain
effective sales, marketing and distribution capabilities, we will be unable to successfully commercialize our products.
We
intend to use third parties to market and sell our products. We cannot guarantee that we will be able to enter into and maintain any
distribution agreements with third parties on acceptable terms, if at all. If we enter into distribution agreements with third parties,
and such third parties are unable to establish and maintain effective sales, marketing and distribution capabilities, we will be unable
to successfully commercialize our products.
Our
board of directors rescinded the 3,000,000 shares of Series F Preferred Stock issued to Halo Management LLC (“Halo”) and
Halo may dispute such decision.
Halo
was previously issued 3,000,000 shares of our Series F Preferred Stock. See “Description of Business - Legal Proceedings.”
On November 21, 2021, our board of directors rescinded the 3,000,000 shares of Series F Preferred Stock issued to Halo for lack of contract
consideration. Halo may dispute this decision; however, we believe Halo has no basis to dispute such decision, and we are prepared to
vigorously defend our decision. Notwithstanding the foregoing, litigation can be expensive and time consuming and an adverse result in
any litigation proceeding may have a material adverse effect on our business. The cost to us of any litigation or other proceeding, regardless
of its merit, even if resolved in our favor, could be substantial and may result in a diversion of our management’s attention.
Risks
Relating to Intellectual Property
Our
intellectual property may not be sufficient to protect our products from competition, which may negatively affect our business.
We
may be subject to competition despite the existence of intellectual property we license or may, in the future, own. We can give no assurances
that our intellectual property claims will be sufficient to prevent third parties from designing around patents we license, or may in
the future own or developing and commercializing competitive products. The existence of competitive products that avoid our intellectual
property rights could materially adversely affect our operating results and financial condition. Furthermore, limitations, or perceived
limitations, in our intellectual property rights may limit the interest of third parties to partner, collaborate or otherwise transact
with us, if third parties perceive a higher than acceptable risk to commercialization of our products.
We
may elect to sue a third party, or otherwise make a claim, alleging infringement or other violation of patents, trademarks, trade dress,
copyrights, trade secrets, domain names or other intellectual property rights that we license from a third party or may, in the future
own. If we do not prevail in enforcing our intellectual property rights in this type of litigation, we may be subject to:
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paying
monetary damages related to the legal expenses of the third party; |
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facing
additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial
condition and the commercial viability of our product; and |
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restructuring
our company or delaying or terminating select business opportunities, including, but not limited to, research and development and
commercialization activities, due to a potential deterioration of our financial condition or market competitiveness. |
A
third party may also challenge the validity, enforceability or scope of the intellectual property rights that we license or may, in the
future, own, and the result of these challenges may narrow the scope or claims of or invalidate patents that are integral to our products
in the future. There can be no assurance that we will be able to successfully defend our intellectual property rights in an action against
third parties due to the unpredictability of litigation and the high costs associated with intellectual property litigation, among other
factors.
Intellectual
property rights and enforcement may be less extensive in jurisdictions outside of the U.S. Thus, we may not be able to protect our intellectual
property rights and third parties may be able to market competitive products that may use some or all of our intellectual property rights.
Changes
to patent law, including the Leahy-Smith America Invests Act, AIA or Leahy-Smith Act, of 2011 and the Patent Reform Act of 2009 and other
future article of legislation, may substantially change the regulations and procedures surrounding patent applications, issuance of patents,
and prosecution of patents. We can give no assurances that the patents of our licensor can be defended or will protect us against future
intellectual property challenges, particularly as they pertain to changes in patent law and future patent law interpretations.
In
addition, enforcing and maintaining our intellectual property protection depends on compliance with various procedural, document submission,
fee payment and other requirements imposed by the United States Patent and Trademark Office (“USPTO”), courts and foreign
government patent agencies, and patent protection could be reduced or eliminated for non-compliance with these requirements which may
have a material adverse effect on our business.
We
may become involved in future lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time
consuming and unsuccessful.
Competitors
may infringe our future patents or the patents of our licensors. To counter infringement or unauthorized use, we may file infringement
claims, which can be expensive and time consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours
or of our licensors is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the
grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put
one or more of our or our licensors’ patents at risk of being invalidated or interpreted narrowly and could put our or our licensors’
potential patent applications at risk of not issuing.
The
USPTO may initiate interference proceedings to determine the priority of inventions described in or otherwise affecting our future patents
and patent applications or those of our licensors. An unfavorable outcome could require us to cease using the technology or to attempt
to license rights to it from the prevailing party. Our business could be harmed if a prevailing party does not offer us a license on
terms that are acceptable to us. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs
and distraction of our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of
our proprietary rights, particularly in countries where the laws may not protect those rights as fully as in the U.S.
Furthermore,
if we are the target of claims by third parties asserting that our products or intellectual property infringe upon the rights of others,
we may be forced to incur substantial expenses or divert substantial employee resources from our business and, if successful, those claims
could result in our having to pay substantial damages or prevent us from developing one or more of our products. Further, if a patent
infringement suit were brought against us or our licensors, we or they could be forced to stop or delay research, development, manufacturing
or sales of the product that is the subject of the lawsuit.
If
we experience patent infringement claims, or if we elect to avoid potential claims others may assert, we or our licensors may choose
to seek, or be required to seek, a license from the third-party and would most likely be required to pay license fees or royalties or
both. These licenses may not be available on acceptable terms, or at all. Even if we or our licensors were able to obtain a license,
the rights may be non-exclusive, which would give our competitors access to the same intellectual property. Ultimately, we may be prevented
from commercializing a product, or be forced to cease some aspect of our business operations if, as a result of actual or threatened
patent infringement claims, we or our licensors are unable to enter into licenses on acceptable terms. This could harm our business significantly.
The cost to us of any litigation or other proceeding, regardless of its merit, even if resolved in our favor, could be substantial and
may result in a diversion of our management’s attention. Some of our competitors may be able to bear the costs of such litigation
or proceedings more effectively than we can because they may have greater financial resources than us. Uncertainties resulting from the
initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our business.
We
may not be able to enforce our intellectual property rights throughout the world.
The
laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many
companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions.
This could make it difficult for us to stop the infringement of our future patents or those that we license from our licensors, or the
misappropriation of our other intellectual property rights. For example, many foreign countries have compulsory licensing laws under
which a patent owner must grant licenses to third parties. In addition, many countries limit the enforceability of patents against certain
third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit.
Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain
outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection
in such countries.
Proceedings
to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other
aspects of our business. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate. In
addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain
adequate protection for our products and the enforcement of intellectual property.
Third
parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade
secrets.
We
may employ individuals who were previously employed at universities or other medical device companies, including our competitors or potential
competitors. Although we intend to ensure that our employees and consultants do not use the proprietary information or know-how of others
in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently
or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer
or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition
to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against
such claims, litigation could result in substantial costs and result in a diversion of management’s attention.
We
may be unable to adequately prevent disclosure of trade secrets and other proprietary information.
We
rely on trade secrets to protect our proprietary know-how and technological advances, especially where we do not believe patent protection
is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our
employees, consultants, outside scientific collaborators and other advisors to protect our trade secrets and other proprietary information.
However, any party with whom we have executed such an agreement may breach that agreement and disclose our proprietary information, including
our trade secrets. Accordingly, these agreements may not effectively prevent disclosure of confidential information and may not provide
an adequate remedy in the event of unauthorized disclosure of confidential information. Costly and time-consuming litigation could be
necessary to enforce and determine the scope of our proprietary rights. Failure to obtain or maintain trade secret protection could enable
competitors to use our proprietary information to develop products that compete with our products or cause additional, material adverse
effects upon our competitive business position and financial results.
Risks
Relating to Government Regulations
Our
failure to obtain and maintain FDA clearances or approvals on a timely basis, or at all, would prevent us from commercializing our products
in the U.S., which could severely harm our business.
Unless
an exemption applies, each medical device that we market in the U.S. must first undergo premarket review pursuant to the FDCA by receiving
clearance of a 510(k) premarket notification, receiving clearance through the de novo review process, or obtaining approval of
a PMA application. Even if regulatory clearance or approval of a product is granted, the FDA may clear or approve our products only for
limited indications for use. Additionally, the FDA may not grant 510(k) clearance on a timely basis, if at all, for new products or uses
that we propose. The traditional FDA 510(k) clearance process for our products may take between four to nine months. However, in some
cases, the FDA is requiring applicants to provide additional or different information and data for 510(k) clearance than it had previously
required, and that the FDA may not rely on approaches that it had previously accepted to support 510(k) clearance. As a result, FDA 510(k)
clearance may be delayed for our products in some cases.
To
support our product applications to the FDA, we may be required to conduct clinical testing of our products. Such clinical testing must
be conducted in compliance with FDA requirements pertaining to human research. Among other requirements, we must obtain informed consent
from study subjects and approval by institutional review boards before such studies may begin. We must also comply with other FDA requirements
such as monitoring, record-keeping, reporting and the submission of information regarding certain clinical trials to a public database
maintained by the National Institutes of Health. In addition, if the study involves a significant risk device, we are required to obtain
the FDA’s approval of the study under an Investigational Device Exemption. Compliance with these requirements can require significant
time and resources. If the FDA determines that we have not complied with such requirements, the FDA may refuse to consider the data to
support our applications or may initiate enforcement actions. Even if we obtain 510(k) clearance, if safety or effectiveness problems
are identified with our products, we may need to initiate a recall of such devices. Furthermore, our products may be denied 510(k) clearance
and be required to undergo the more burdensome PMA or de novo review processes. The process of obtaining a de novo classification
or PMA approval is much more costly, lengthy and uncertain than the process for obtaining 510(k) clearance. De novo classification
generally takes six months to one year from the time of submission of the de novo request, although it can take longer. Approval
of a PMA generally takes one year from the time of submission of the PMA, but may be longer.
Some
of our products or product features may also be exempted from the 510(k) process and/or other regulatory requirements in accordance with
specific FDA regulations, guidance or policies. If the FDA changes its policy or concludes that our marketing of these products is not
in accordance with its current policy, we may be required to seek clearance or approval of these devices through the 510(k), de novo
or PMA processes.
Our
promotional practices will be subject to extensive government scrutiny. We may be subject to governmental, regulatory and other legal
proceedings relative to advertising, promotion, and marketing that could have a significant negative effect on our business.
We
will be subject to governmental oversight and associated civil and criminal enforcement relating to medical device advertising, promotion,
and marketing, and such enforcement is evolving and intensifying. In the United States, we are subject to potential enforcement from
the FDA, the U.S. Federal Trade Commission, the Department of Justice, the Centers for Medicare & Medicaid Services, other divisions
of the Department of Health and Human Services and state and local governments. Other parties, including private plaintiffs, also are
commonly bringing suit against medical device companies, alleging off-label marketing and other violations. We may be subject to liability
based on the actions of individual employees and contractors carrying out activities on our behalf, including sales representatives who
may interact with healthcare professionals.
Legislative
or regulatory reform of the health care system in the U.S. may adversely impact our business, operations or financial results.
Our
industry is highly regulated and changes in law may adversely impact our business, operations or financial results. In March 2010, the
Patient Protection and Affordable Care Act, and a related reconciliation bill were signed into law. This legislation changes the current
system of healthcare insurance and benefits intended to broaden coverage and control costs. The law also contains provisions that will
affect companies in the medical device industry and other healthcare related industries by imposing additional costs and changes to business
practices. We cannot predict what healthcare reform initiatives may be adopted in the future. These reforms could have an adverse effect
on our ability to obtain timely regulatory approval for new products and on anticipated revenues from our products, both of which may
affect our overall financial condition.
We
are subject to stringent domestic and foreign medical device regulations and any unfavorable regulatory action may materially and adversely
affect our financial condition and business operations.
Our
products, development activities and manufacturing processes are subject to extensive and rigorous regulation by numerous government
agencies, including the FDA and comparable foreign agencies. To varying degrees, each of these agencies monitors and enforces our compliance
with laws and regulations governing the development, testing, manufacturing, labeling, marketing, distribution, and the safety and effectiveness
of our medical devices. The process of obtaining marketing approval or clearance from the FDA and comparable foreign bodies for new products,
or for enhancements, expansion of the indications or modifications to existing products, could:
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in product shortages due to regulatory delays; |
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require
the expenditure of substantial resources; |
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involve
modifications, repairs or replacements of our products; |
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design changes of our products; |
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result
in limitations on the indicated uses of our products; and |
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in our never being granted the regulatory approval we seek. |
Any
of these occurrences that we might experience will cause our operations to suffer, harm our competitive standing and result in further
losses that adversely affect our financial condition.
We
will be subject to ongoing responsibilities under FDA and international regulations, both before and after a product is commercially
released. For example, we are required to comply with the FDA’s Quality System Regulation which mandates that manufacturers of
medical devices adhere to certain quality assurance requirements pertaining, among other things, to validation of manufacturing processes,
controls for purchasing product components and documentation practices. As another example, the Medical Device Reporting regulation requires
us to provide information to the FDA whenever there is evidence that reasonably suggests that a device may have caused or contributed
to a death or serious injury, or that a malfunction occurred which would be likely to cause or contribute to a death or serious injury
upon recurrence. Compliance with applicable regulatory requirements is subject to continual review and is monitored rigorously through
periodic inspections by the FDA. If the FDA were to conclude that we are not in compliance with applicable laws or regulations, or that
any of our medical devices are ineffective or pose an unreasonable health risk, the FDA could ban such medical devices, detain or seize
such medical devices, order a recall, repair, replacement, or refund of such devices, or require us to notify health professionals and
others that the devices present unreasonable risks of substantial harm to the public health. Additionally, the FDA may restrict manufacturing
and impose other operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices and assess
civil or criminal penalties against our officers, employees, or us. Any adverse regulatory action, depending on its magnitude, may restrict
us from effectively manufacturing, marketing and selling our products. In addition, negative publicity and product liability claims resulting
from any adverse regulatory action could have a material adverse effect on our financial condition and results of operations.
We
will also be subject to stringent government regulation in foreign countries, which could delay or prevent our ability to sell our products
in those jurisdictions.
We
intend to pursue market authorizations for our products in foreign countries. For us to market our products in international jurisdictions,
we and our distributors and agents must obtain required regulatory registrations or approvals. The approval procedure varies among countries
and jurisdictions and can involve additional testing, and the time and costs required to obtain approval may differ from that required
to obtain an approval by the FDA. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions,
and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or jurisdictions
or by the FDA. Violations of foreign laws governing use of medical devices may lead to actions against us by the FDA as well as by foreign
authorities. We must also comply with extensive regulations regarding safety, efficacy and quality in those jurisdictions. We may not
be able to obtain all the required regulatory registrations or approvals, or we may be required to incur significant costs in obtaining
or maintaining any regulatory registrations or approvals we receive. Delays in obtaining any registrations or approvals required for
marketing our products, failure to receive these registrations or approvals, or future loss of previously obtained registrations or approvals
would limit our ability to sell our products internationally and may have a material adverse effect on our business.
Failure
by us or our distributors to comply with foreign regulations applicable to the products we design, manufacture, install or distribute
could expose us to enforcement actions or other adverse consequences.
We
may be subject to the European Medical Device Regulation, which was adopted by the European Union (“EU”) as a common legal
framework for all EU member states. These regulations require companies that wish to manufacture and distribute medical devices in EU
member states to meet certain quality system and safety requirements and ongoing product monitoring responsibilities, and obtain a “CE”
marking (i.e., a mandatory conformity marking for certain products sold within the European Economic Area) for their products. Various
penalties exist for non-compliance with the laws implementing the European Medical Device Regulations which, if incurred, could have
a material adverse impact on our business, results of operations and cash flows.
Even
if we obtain clearance or approval to sell our products, we are subject to ongoing requirements and inspections that could lead to the
restriction, suspension or revocation of our clearance.
We,
as well as any potential collaborative partners such as distributors, will be required to adhere to applicable FDA regulations regarding
good manufacturing practice, which include testing, control, and documentation requirements. We are subject to similar regulations in
foreign countries. Even if regulatory clearance of a product is granted, the clearance may be subject to limitations on the indicated
uses for which the product may be marketed or to the conditions of approval or contain requirements for costly post-marketing testing
and surveillance to monitor the safety or efficacy of the product. Ongoing compliance with good manufacturing practice and other applicable
regulatory requirements is strictly enforced in the United States through periodic inspections by state and federal agencies, including
the FDA, and in international jurisdictions by comparable agencies. Failure to comply with these regulatory requirements could result
in, among other things, warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension
of production, failure to obtain pre-market clearance or pre-market approval for devices, withdrawal of approvals previously obtained
and criminal prosecution. The restriction, suspension or revocation of regulatory approvals or any other failure to comply with regulatory
requirements would limit our ability to operate and could increase our costs which may have a material adverse effect on our business.
We
could be subject to substantial fines or damages and possible exclusion from participation in federal or state health care programs if
we fail to comply with the laws and regulations applicable to our business.
We
are subject to stringent laws and regulations at both the federal and state levels governing the participation of durable medical equipment
suppliers in federal and state health care programs. From time to time, the government may seek additional information related to our
claims submissions, and in some instances government contractors may perform audits of payments made to us under Medicare, Medicaid,
and other federal health care programs. These reviews may identify overpayments for which we submit refunds. We believe the frequency
and intensity of government audits and review processes has intensified, and we expect this will continue in the future, due to increased
resources allocated to these activities at both the federal and state Medicaid level, and greater sophistication in data review techniques.
If
we are considered to have violated these laws and regulations, we could be subject to substantial fines, damages, possible exclusion
from participation in federal health care programs such as Medicare and Medicaid and possible recoupment of any overpayments related
to such violations. Failure to comply with applicable laws and regulations, even if inadvertent, could have a material adverse impact
on our business.
If
we fail to develop and successfully introduce new products and applications or fail to improve our existing products, our business prospects
and operating results may suffer.
Our
ability to generate incremental revenue growth will depend, in part, on the successful outcome of research and development activities,
which may include clinical trials that lead to the development of new products and new applications using our products. Our research
and development process is expensive, prolonged, and entails considerable uncertainty. Due to the complexities and uncertainties associated
with ophthalmic research and development, products we are currently developing may not complete the development process or obtain the
regulatory approvals required to market such products successfully. In addition, our research and development process has been slowed
by the impact of COVID-19, and should the COVID-19 economic restrictions worsen, it could delay and disrupt our research and development
processes even further.
Successful
commercialization of new products and new applications will require that we effectively transfer production processes from research and
development to manufacturing and effectively coordinate with our suppliers. In addition, we must successfully sell and achieve market
acceptance of new products and applications and enhanced versions of existing products. The extent of, and rate at which, market acceptance
and penetration are achieved by future products is a function of many variables, which include, among other things, price, safety, efficacy,
reliability, marketing and sales efforts, the development of new applications for these products, the availability of third-party reimbursement
of procedures using our new products, the existence of competing products and general economic conditions affecting purchasing patterns.
Our
ability to market and sell new products is subject to government regulation, including approval or clearance by the FDA and foreign government
agencies. Any failure in our ability to successfully develop and introduce new products or enhanced versions of existing products and
achieve market acceptance of new products and new applications could have a material adverse effect on our operating results and would
cause our net revenues to decline.
Risks
Related to Owning our Securities
Our
stock price may be volatile and you may not be able to resell your shares at or above the purchase price.
The
market price of our common stock is likely to be highly volatile and could fluctuate widely in price in response to various factors,
many of which are beyond our control, including the following:
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our
ability to execute our business plan; |
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changes
in our industry; |
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competitive
pricing pressures; |
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our
ability to obtain working capital financing; |
|
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additions
or departures of key personnel; |
|
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sales
of our common stock; |
|
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operating
results that fall below expectations; |
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regulatory
developments; |
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economic
and other external factors; |
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period-to-period
fluctuations in our financial results; |
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the
public’s response to press releases or other public announcements by us or third parties, including filings with the SEC; |
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changes
in financial estimates or ratings by any securities analysts who follow our common stock, our failure to meet these estimates or
failure of those analysts to initiate or maintain coverage of our common stock; |
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the
development and sustainability of an active trading market for our common stock; |
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any
future sales of our common stock by our officers, directors and significant stockholders; and |
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other
events or factors, many of which may be out of our control, including, but not limited to, pandemics such as COVID-19, war, or other
acts of God. |
In
addition, the securities markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the
operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of
our common stock.
Future
sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders.
We
expect that significant additional capital will be needed in the future to continue our planned operations. We may sell common stock,
convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time.
To the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution.
We
have never paid cash dividends and have no plans to pay cash dividends in the future.
Holders
of shares of our common stock are entitled to receive such dividends as may be declared by our board of directors. To date, we have paid
no cash dividends on our capital stock and we do not expect to pay cash dividends in the foreseeable future. We intend to retain future
earnings, if any, to provide funds for operations of our business. Therefore, any return investors in our capital stock may have will
be in the form of appreciation, if any, in the market value of their shares of common stock.
Our
common stock is subject to the “penny stock” rules of the SEC and the trading market in the securities is limited, which
makes transactions in the stock cumbersome and may reduce the value of an investment in the stock.
Rule
15g-9 under the Exchange Act, establishes the definition of a “penny stock,” for the purposes relevant to us, as any equity
security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject to certain
exceptions. For any transaction involving a penny stock, unless exempt, the rules require: (a) that a broker or dealer approve a person’s
account for transactions in penny stocks; and (b) the broker or dealer receive from the investor a written agreement to the transaction,
setting forth the identity and quantity of the penny stock to be purchased.
In
order to approve a person’s account for transactions in penny stocks, the broker or dealer must: (a) obtain financial information
and investment experience objectives of the person and (b) make a reasonable determination that the transactions in penny stocks are
suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the
risks of transactions in penny stocks.
The
broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to
the penny stock market, which, in highlight form: (a) sets forth the basis on which the broker or dealer made the suitability determination;
and (b) confirms that the broker or dealer received a signed, written agreement from the investor prior to the transaction. Generally,
brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more
difficult for investors to dispose of our common stock and cause a decline in the market value of our common stock.
Disclosure
also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions
payable to both the broker or dealer and the registered representative, current quotations for the securities and the rights and remedies
available to an investor in cases of fraud in penny stock transactions. Finally, monthly statements have to be sent disclosing recent
price information for the penny stock held in the account and information on the limited market in penny stocks.
Because
certain of our stockholders control a significant number of shares of our common stock, they may have effective control over actions
requiring stockholder approval.
As
of November 1, 2023, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially
own approximately 82% of our outstanding shares of common stock. As a result, these stockholders, acting together, would have
the ability to control the outcome of matters submitted to our stockholders for approval, including the election of directors and any
merger, consolidation or sale of all or substantially all of our assets. In addition, these stockholders, acting together, would have
the ability to control the management and affairs of our company. Accordingly, this concentration of ownership might harm the market
price of our common stock by:
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delaying,
deferring or preventing a change in corporate control; |
|
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impeding
a merger, consolidation, takeover or other business combination involving us; or |
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discouraging
a potential acquirer from making a tender offer or otherwise attempting to obtain control of us. |
We
are an “emerging growth company” and will be able to avail ourselves of reduced disclosure requirements applicable to emerging
growth companies, which could make our common stock less attractive to investors.
We
are an “emerging growth company,” as defined in the JOBS Act and we intend to take advantage of certain exemptions from various
reporting requirements that are applicable to other public companies that are not “emerging growth companies” including not
being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations
regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding
advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. In addition,
pursuant to Section 107 of the JOBS Act, as an “emerging growth company” we intend to take advantage of the extended transition
period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. In other words,
an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise
apply to private companies. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions.
If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and
our stock price may be more volatile. We may take advantage of these reporting exemptions until we are no longer an “emerging growth
company.” We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in
which we have total annual gross revenues of $1.235 billion or more; (ii) the last day of our fiscal year following the fifth anniversary
of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous
three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
Our
First Amended and Restated Certificate of Incorporation (“Certificate of Incorporation”) and our Bylaws (the “Bylaws”)
and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock
price to decline.
Our
Certificate of Incorporation and our Bylaws and Delaware law could make it more difficult for a third party to acquire us, even if closing
such a transaction would be beneficial to our stockholders. We are authorized to issue up to 40,000,000 shares of preferred stock. This
preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by our board of directors
without further action by stockholders. The terms of any series of preferred stock may include voting rights (including the right to
vote as a series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions.
The issuance of any preferred stock could materially adversely affect the rights of the holders of our common stock, and therefore, reduce
the value of our common stock. In particular, specific rights granted to future holders of preferred stock could be used to restrict
our ability to merge with, or sell our assets to, a third party and thereby preserve control by the present management.
Provisions
of our Certificate of Incorporation and our Bylaws and Delaware law also could have the effect of discouraging potential acquisition
proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable.
Such provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. In particular, our Certificate
of Incorporation and our Bylaws and Delaware law, as applicable, among other things provide the board of directors with the ability to
alter the bylaws without stockholder approval.
Financial
reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management will be required to
devote substantial time to compliance matters.
As
a publicly traded company we will incur significant additional legal, accounting and other expenses that we did not incur as a private
company. The obligations of being a public company in the U.S. require significant expenditures and will place significant demands on
our management and other personnel, including costs resulting from public company reporting obligations under the Exchange Act and the
rules and regulations regarding corporate governance practices, including those under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street
Reform and Consumer Protection Act. These rules require the establishment and maintenance of effective disclosure and financial controls
and procedures, internal control over financial reporting and changes in corporate governance practices, among many other complex rules
that are often difficult to implement, monitor and maintain compliance with. Moreover, despite recent reforms made possible by the JOBS
Act, the reporting requirements, rules, and regulations will make some activities more time-consuming and costly, particularly after
we are no longer an “emerging growth company.” In addition, we expect these rules and regulations to make it more difficult
and more expensive for us to obtain director and officer liability insurance. Our management and other personnel will need to devote
a substantial amount of time to ensure that we comply with all of these requirements and to keep pace with new regulations, otherwise
we may fall out of compliance and risk becoming subject to litigation, among other potential problems.
Failure
to maintain effective internal control over our financial reporting in accordance with Section 404 of Sarbanes-Oxley could cause our
financial reports to be inaccurate.
We
are required pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, to maintain internal control over financial reporting
and to assess and report on the effectiveness of those controls. This assessment includes disclosure of any material weaknesses identified
by our management in our internal control over financial reporting. Although we prepare our financial statements in accordance with accounting
principles generally accepted in the United States, our internal accounting controls may not meet all standards applicable to companies
with publicly traded securities. If we fail to implement any required improvements to our disclosure controls and procedures, we may
be obligated to report control deficiencies, in which case we could become subject to regulatory sanction or investigation. Further,
such an outcome could damage investor confidence in the accuracy and reliability of our financial statements.
Our
management has concluded that our internal controls over financial reporting were, and continue to be, ineffective, and as of December
31, 2022 as a result of a material weakness in our internal controls due to the lack of segregation of duties. While management is working
to remediate the material weakness, there is no assurance that such changes, when economically feasible and sustainable, will remediate
the identified material weaknesses or that the controls will prevent or detect future material weaknesses. If we are not able to maintain
effective internal control over financial reporting, our financial statements, including related disclosures, may be inaccurate, which
could have a material adverse effect on our business.
Our
Certificate of Incorporation and Bylaws provide that the Court of Chancery of the State of Delaware will be the sole and exclusive forum
for substantially all disputes between us and our stockholders, which could limit stockholders’ ability to obtain a favorable judicial
forum for disputes with us or our directors, officers or employees.
Our
Certificate of Incorporation and Bylaws provide that unless we consent in writing to the selection of an alternative forum, the Court
of Chancery in the State of Delaware is the sole and exclusive forum for: (i) any derivative action or proceeding brought on behalf of
us, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of our Company to
us or our stockholders, (iii) any action asserting a claim against us, our directors, officers or employees arising pursuant to any provision
of the Delaware General Corporation Law (“DGCL”) or our Certificate of Incorporation or Bylaws or (iv) any action asserting
a claim governed by the internal affairs doctrine. This exclusive forum provision would not apply to suits brought to enforce any liability
or duty created by the Securities Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.
To the extent that any such claims may be based upon federal law claims, Section 27 of the Exchange Act creates exclusive federal jurisdiction
over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder.
These
choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes
with us or our directors, officers or other employees and may result in increased costs to our stockholders, which may discourage such
lawsuits against us and our directors, officers and other employees. Alternatively, if a court were to find our choice of forum provisions
contained in our Certificate of Incorporation or Bylaws to be inapplicable or unenforceable in an action, we may incur additional costs
associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange
Act. Any statements in this prospectus about our expectations, beliefs, plans, objectives, assumptions or future events or performance
are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words
or phrases such as “believe,” “will,” “expect,” “anticipate,” “estimate,”
“intend,” “plan” and “would.” For example, statements concerning financial condition, possible or
assumed future results of operations, growth opportunities, industry ranking, plans and objectives of management and market for our common
stock are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown
risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially
from any results, levels of activity, performance or achievements expressed or implied by any forward-looking statement.
Any
forward-looking statements are qualified in their entirety by reference to the risk factors discussed throughout this prospectus. You
should read this prospectus and the documents that we reference herein and have filed as exhibits to the registration statement, of which
this prospectus is part, completely and with the understanding that our actual future results may be materially different from what we
expect. You should assume that the information appearing in this prospectus is accurate as of the date on the front cover of this prospectus
only. Because the risk factors referred to on page 5 of this prospectus could cause actual results or outcomes to differ materially from
those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking
statements. Further, any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to
update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the
occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which factors will
arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors,
may cause actual results to differ materially from those contained in any forward-looking statements. We qualify all of the information
presented in this prospectus, and particularly our forward-looking statements, by these cautionary statements.
USE
OF PROCEEDS
The
Selling Stockholders will receive all of the proceeds from the sale of the Resale Shares offered by them pursuant to this prospectus.
We will not receive any proceeds from the sale of the Resale Shares by the Selling Stockholders covered by this prospectus. However,
we will receive proceeds from the exercise of the options and warrants if they are exercised for cash by the Selling Stockholders, and
will use such proceeds for working capital purposes.
SELLING
STOCKHOLDERS
This
prospectus relates to the resale from time to time by the Selling Stockholders identified herein of up to an aggregate of 1,559,820
shares of common stock, including 1,358,920 outstanding shares of common stock, 181,000 shares of common stock issuable
upon exercise of outstanding options and 19,900 shares of common stock issuable upon exercise of outstanding warrants.
The
transactions by which the Selling Stockholders acquired their securities from us were exempt under the registration provisions of the
Securities Act.
The
Resale Shares are being registered to permit public sales of such securities, and the Selling Stockholders may offer the Resale Shares
for resale from time to time pursuant to this prospectus. The Selling Stockholders may also sell, transfer or otherwise dispose of all
or a portion of their Resale Shares in transactions exempt from the registration requirements of the Securities Act or pursuant to another
effective registration statement covering the sale of such securities.
The
following table sets forth, based on information provided to us by the Selling Stockholders or known to us, the names of the Selling
Stockholders, the nature of any position, office or other material relationship, if any, which the Selling Stockholders have had, within
the past three years, with us or with any of our predecessors or affiliates, and the number of shares of our common stock beneficially
owned by the Selling Stockholders before and after this offering. The number of shares owned are those beneficially owned, as determined
under the rules of the SEC, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under these
rules, beneficial ownership includes any shares of common stock as to which a person has sole or shared voting power or investment power
and any shares of common stock that the person has the right to acquire within 60 days through the exercise of any option, warrant or
right, through conversion of any security or pursuant to the automatic termination of a power of attorney or revocation of a trust, discretionary
account or similar arrangement. Except as otherwise set forth herein, none of the Selling Stockholders are a broker-dealer or an affiliate
of a broker-dealer.
Except
as otherwise noted below, the address for each person or entity listed in the table is c/o RetinalGenix Technologies Inc., 1450 North
McDowell Boulevard, Suite 150, Petaluma, California 94954.
| |
Beneficial Ownership of | | |
Common Stock | | |
Beneficial Ownership | |
| |
Common Stock Prior | | |
Saleable | | |
of Common Stock | |
| |
to the Offering | | |
Pursuant | | |
After the Offering (1) | |
| |
Number of | | |
Percent of | | |
to This | | |
Number of | | |
Percent of | |
Name of Selling Shareholder | |
Shares | | |
Class (2) | | |
Prospectus | | |
Shares | | |
Class (2) | |
Morland G. McManigal Trust (3) | |
| 50,000 | | |
| * | | |
| 5,000 | | |
| 45,000 | | |
| * | |
Christopher Elbers | |
| 34,000 | | |
| * | | |
| 3,400 | | |
| 30,600 | | |
| * | |
David Nissen | |
| 107,500 | | |
| * | | |
| 10,750 | | |
| 96,750 | | |
| * | |
Karl Moll | |
| 45,000 | | |
| * | | |
| 4,500 | | |
| 40,500 | | |
| * | |
Michael Sordelli | |
| 50,000 | | |
| * | | |
| 5,000 | | |
| 45,000 | | |
| * | |
Forge Trust Co. CFBO Philip Petruzzelli (4) | |
| 16,500 | | |
| * | | |
| 1,650 | | |
| 14,850 | | |
| * | |
Forge Trust Co. CFBO (Jeffrey N. Allen) SEP IRA Acct #561009 (5) | |
| 150,001 | | |
| * | | |
| 15,000 | | |
| 135,001 | | |
| * | |
Gary LeBlanc | |
| 50,000 | | |
| * | | |
| 5,000 | | |
| 45,000 | | |
| * | |
James Banister and Michele Banister JT | |
| 25,000 | | |
| * | | |
| 2,500 | | |
| 22,500 | | |
| * | |
Suess & Rapkin Family
Trust (64) | |
| 8,371 | | |
| * | | |
| 837 | | |
| 7,534 | | |
| * | |
William Wilson and Carolyn Wilson JT | |
| 9,000 | | |
| * | | |
| 900 | | |
| 8,100 | | |
| * | |
Steven Hawthorne and Jeanne Hawthorne JT | |
| 15,000 | | |
| * | | |
| 1,500 | | |
| 13,500 | | |
| * | |
Steven M. Nass and Suzanne M. Nass JT | |
| 25,000 | | |
| * | | |
| 2,500 | | |
| 22,500 | | |
| * | |
The Rostad Family Trust (6) | |
| 30,000 | | |
| * | | |
| 3,000 | | |
| 27,000 | | |
| * | |
Richard Waltz and Martha Waltz JT | |
| 5,000 | | |
| * | | |
| 500 | | |
| 4,500 | | |
| * | |
Jeffrey Banister and Milissa Banister JT | |
| 1,000 | (7) | |
| * | | |
| 100 | | |
| 900 | | |
| * | |
Basem Kandah | |
| 5,000 | | |
| * | | |
| 500 | | |
| 4,500 | | |
| * | |
Bill Pelzl and Tracie Pelzl JT | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Theresa D. Gifford Revocable Trust (8) | |
| 50,000 | | |
| * | | |
| 5,000 | | |
| 45,000 | | |
| * | |
David Rodin as Trustee under trust instrument dated March 2, 2010 and Heather Yeckes Rodin as Trustee under trust instrument dated March 1, 2010 (9) | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Lawrence Pabst | |
| 100,000 | | |
| * | | |
| 10,000 | | |
| 90,000 | | |
| * | |
Barbara T. Maddox Revocable Living Trust dated March 13, 2000 (10) | |
| 6,667 | | |
| * | | |
| 666 | | |
| 6,001 | | |
| * | |
Dianne C. DeBoest Revocable Trust, dated January 28, 2013, as amended, Dianne C. DeBoest Grantor (11) | |
| 30,069 | | |
| * | | |
| 3,006 | | |
| 27,063 | | |
| * | |
Survivors Trust of the Hans and Elsie Van Boldrik Trust of 1982 (12) | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Provident Trust Group FBO, Douglas Bertsch ROTH IRA3201389 (13) | |
| 23,333 | | |
| * | | |
| 2,333 | | |
| 21,000 | | |
| * | |
Hayden Hosford | |
| 160,000 | | |
| * | | |
| 16,000 | | |
| 144,000 | | |
| * | |
Mark Manning and Carrie Manning JT | |
| 45,000 | | |
| * | | |
| 4,500 | | |
| 40,500 | | |
| * | |
Nestor Sala II | |
| 20,000 | | |
| * | | |
| 2,000 | | |
| 18,000 | | |
| * | |
The Liza and Steve Trust of 2013 (14) | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Greg Schultz and Diane M. Schultz JT | |
| 15,000 | | |
| * | | |
| 1,500 | | |
| 13,500 | | |
| * | |
The Boston Strong Trust (15) | |
| 165,000 | | |
| * | | |
| 16,500 | | |
| 148,500 | | |
| * | |
Patricia Skovron | |
| 11,670 | | |
| * | | |
| 1,167 | | |
| 10,503 | | |
| * | |
Gary A. Banister and Janice D. Banister Trust dated February 2000 (16) | |
| 50,000 | | |
| * | | |
| 5,000 | | |
| 45,000 | | |
| * | |
Forge Trust Co. CFBO (Monique Slone) (IRA acct# 747130) (17) | |
| 25,000 | | |
| * | | |
| 2,500 | | |
| 22,500 | | |
| * | |
Dana Seymour | |
| 12,850 | | |
| * | | |
| 1,285 | | |
| 11,565 | | |
| * | |
Joseph Caprioni | |
| 20,000 | | |
| * | | |
| 2,000 | | |
| 18,000 | | |
| * | |
Deborah Gisonni and Joseph Prestipino TTEES (18) | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
The Raymond William Kaliski and Carla Daro Kaliski Family Trust (19) | |
| 16,667 | | |
| * | | |
| 1,666 | | |
| 15,001 | | |
| * | |
The Donald and Joan Hansen Trust dated 6-1-1993 (20) | |
| 20,000 | | |
| * | | |
| 2,000 | | |
| 18,000 | | |
| * | |
Nick Moudakis and Andrea Moudakis JT | |
| 25,000 | | |
| * | | |
| 2,500 | | |
| 22,500 | | |
| * | |
The Kinnear Trust dated July 13, 2000 (21) | |
| 15,000 | | |
| * | | |
| 1,500 | | |
| 13,500 | | |
| * | |
Clark W. Nicholls | |
| 5,000 | | |
| * | | |
| 500 | | |
| 4,500 | | |
| * | |
Jillian Ottney Eddy | |
| 5,000 | | |
| * | | |
| 500 | | |
| 4,500 | | |
| * | |
Emad Nimri and Ruba Nimri JT | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Isaac Triscell | |
| 5,000 | | |
| * | | |
| 500 | | |
| 4,500 | | |
| * | |
Kristine Cesena | |
| 13,333 | | |
| * | | |
| 1,333 | | |
| 12,000 | | |
| * | |
Fred Chasalow and Sandra Chasalow JT | |
| 25,000 | | |
| * | | |
| 2,500 | | |
| 22,500 | | |
| * | |
Frank Wang | |
| 600,000 | (23) | |
| 3.46 | % | |
| 60,000 | (23) | |
| 540,000 | | |
| 3.13 | % |
Ahmed Mouhiuddin (63) | |
| 600,000 | (24) | |
| 3.46 | % | |
| 60,000 | (24) | |
| 540,000 | | |
| 3.13 | % |
Holly Sargent | |
| 300,000 | (25) | |
| 1.73 | % | |
| 30,000 | (25) | |
| 270,000 | | |
| 1.56 | % |
Margureite B. McDonald (63) | |
| 100,000 | (26) | |
| * | | |
| 10,000 | (26) | |
| 90,000 | | |
| * | |
Lawrence A. Yannuzzi (63) | |
| 100,000 | (27) | |
| * | | |
| 10,000 | (27) | |
| 90,000 | | |
| * | |
Jack M. Dodick (63) | |
| 100,000 | (28) | |
| * | | |
| 10,000 | (28) | |
| 90,000 | | |
| * | |
William C. Frankmore and Shelby S. Frankmore | |
| 12,500 | (29) | |
| * | | |
| 1,250 | (29) | |
| 11,250 | | |
| * | |
Sheehan Family Trust, December 6, 2008 (30) | |
| 12,500 | (31) | |
| * | | |
| 1,250 | (31) | |
| 11,250 | | |
| * | |
Marcia M. Fenning Trust UA DTD 11/19/73 (23) | |
| 7,500 | | |
| * | | |
| 750 | | |
| 6,750 | | |
| * | |
Barbara Lewicki | |
| 78,580 | | |
| * | | |
| 7,858 | | |
| 70,722 | | |
| * | |
Forge Trust Co (Peter J Migale) (IRA Acct# 705597) (23) | |
| 194,334 | | |
| 1.13 | % | |
| 19,433 | | |
| 174,901 | | |
| 1.0 | % |
Jan and Judith Ann Hervert Trust Dated February 10, 2021 (34) | |
| 15,000 | | |
| * | | |
| 1,500 | | |
| 13,500 | | |
| * | |
Provident Trust Group FBO, Leslie D. Hellewell ROTH IRA110800021 (35) | |
| 15,000 | | |
| * | | |
| 1,500 | | |
| 13,500 | | |
| * | |
Eric P. Werner and Michele A. Werner Revocable Living Trust (36) | |
| 16,672 | | |
| * | | |
| 1,667 | | |
| 15,005 | | |
| * | |
Rick Slyter and Kathy Slyter JT | |
| 6,000 | | |
| * | | |
| 600 | | |
| 5,400 | | |
| * | |
Dennett Kouri, Jr. | |
| 7,500 | | |
| * | | |
| 750 | | |
| 6,750 | | |
| * | |
Karolyn Sowle | |
| 5,000 | | |
| * | | |
| 500 | | |
| 4,500 | | |
| * | |
Frank Anthony Filangeri | |
| 8,000 | | |
| * | | |
| 800 | | |
| 7,200 | | |
| * | |
Lori Rheaume | |
| 15,200 | | |
| * | | |
| 1,520 | | |
| 13,680 | | |
| * | |
Gallagher Family Trust dated May 24, 2004 (37) | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Gloria Morabito | |
| 7,500 | | |
| * | | |
| 750 | | |
| 6,750 | | |
| * | |
Forge Trust Co CFBO (Regina Martinelli) (IRA Acct# 722765) (38) | |
| 5,000 | | |
| * | | |
| 500 | | |
| 4,500 | | |
| * | |
Daniel McCauley | |
| 7,676 | | |
| * | | |
| 767 | | |
| 6,909 | | |
| * | |
Forge Trust Co CFBO (Byron Scott Plumley) (IRA Acct# 842515) (39) | |
| 5,000 | | |
| * | | |
| 500 | | |
| 4,500 | | |
| * | |
Forge Trust Co CFBO (Brad Nelson Whalen) (IRA Acct# 759570) (40) | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Lanier W. Moore II Trustee as His Sole Separate Property | |
| 175,000 | | |
| * | | |
| 17,500 | | |
| 157,500 | | |
| * | |
Amato and Partners (41) | |
| 150,000 | (42) | |
| * | | |
| 15,000 | (43) | |
| 135,000 | | |
| * | |
PDS Trust, dtd 10/18/2000
(43) | |
| 102,500 | | |
| * | | |
| 10,250 | | |
| 92,250 | | |
| * | |
Patricia Sheehan CFBO, Ashley
Godshall (44) | |
| 3,333 | | |
| * | | |
| 333 | | |
| 3,000 | | |
| * | |
Patricia Sheehan CFBO, James
Sanborn (45) | |
| 3,333 | | |
| * | | |
| 333 | | |
| 3,000 | | |
| * | |
Patricia Sheehan CFBO, Lindsay
Doyle (46) | |
| 3,334 | | |
| * | | |
| 333 | | |
| 3,001 | | |
| * | |
Patricia Sheehan CFBO The
Sanborn Revocable Living Trust (47) | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Patricia Sheehan CFBO William
C. Frankmore and Shelby S. Frankmore (48) | |
| 15,000 | | |
| * | | |
| 1,500 | | |
| 13,500 | | |
| * | |
Patricia Sheehan CFBO Sheehan
Family Trust, December 6, 2008 (49) | |
| 20,000 | | |
| * | | |
| 2,000 | | |
| 18,000 | | |
| * | |
Bruce Blakely | |
| 115,000 | (50) | |
| * | | |
| 6,500 | | |
| 58,500 | | |
| * | |
Forge Trust Co CFBO (Bruce
W. Blakely) (ROTH IRA ACCT#613009) (51) | |
| 50,000 | | |
| * | | |
| 5,000 | | |
| 45,000 | | |
| * | |
Charles Dorn | |
| 20,601 | (52) | |
| * | | |
| 2,060 | | |
| 18,541 | | |
| * | |
Provident Trust Group FBO,
Chuck Dorn ROTH IRA3201358 (53) | |
| 7,000 | | |
| * | | |
| 700 | | |
| 6,300 | | |
| * | |
Scott Fenning | |
| 70,000 | (54) | |
| * | | |
| 7,000 | | |
| 63,000 | | |
| * | |
Philip Petruzzelli | |
| 26,500 | (55) | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Hans Van Boldrik | |
| 15,000 | (56) | |
| * | | |
| 1,500 | | |
| 13,500 | | |
| * | |
Renson Revocable Trust (57) | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Fred Chasalow | |
| 65,000 | (58) | |
| * | | |
| 6,500 | | |
| 58,500 | | |
| * | |
Capital Funding Partners,
LLC (59) | |
| 5,897,000 | | |
| 34.1 | % | |
| 589,700 | | |
| 5,307,300 | | |
| 30.7 | % |
Bayern Capital, LLC (60) | |
| 4,666,200 | | |
| 27.0 | % | |
| 466,620 | | |
| 4,199,580 | | |
| 24.3 | % |
Herbert Gould (61) | |
| 315,000 | | |
| * | | |
| 31,500 | | |
| 283,500 | | |
| | |
Lisa Arbisser | |
| 25,000 | | |
| * | | |
| 2,500 | | |
| 22,500 | | |
| * | |
Cynthia Matossian | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Christopher Lanoue | |
| 10,000 | | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| * | |
Alex Hsia (62) | |
| 10,000 | (63) | |
| * | | |
| 1,000 | | |
| 9,000 | | |
| | |
George Coyne | |
| 5,000 | | |
| * | | |
| 500 | | |
| 4,500 | | |
| * | |
Robert Epstein | |
| 25,000 | | |
| * | | |
| 2,500 | | |
| 22,500 | | |
| * | |
Eugene Harrison | |
| 50,000 | | |
| * | | |
| 5,000 | | |
| 45,000 | | |
| * | |
TOTAL | |
| 15,598,224 | | |
| | | |
| 1,559,820 | | |
| 14,038,405 | | |
| | |
*
Less than 1%.
(1)
Assumes that all of the Resale Shares held by the Selling Stockholders covered by this prospectus are sold and that the Selling Stockholders
acquire no additional shares of common stock before the completion of this offering. However, as the Selling Stockholders can offer all,
some, or none of their Resale Shares, no definitive estimate can be given as to the number of Resale Shares that the Selling Stockholders
will ultimately offer or sell under this prospectus.
(2)
Calculated based on 17,588,811 shares of common stock outstanding as of November 1, 2023.
(3)
Morland McManigal is the Trustee of Morland G. McManigal Trust and in such capacity has the right to vote and dispose of the securities
held by such trust.
(4)
Philip Petruzzelli is the Beneficiary of the IRA Services Trust Co. CFBO, Philip Petruzzelli and in such capacity has the right to vote
and dispose of the securities held in such IRA.
(5)
Jeffrey Allen is the Beneficiary of IRA Services Co. CFBO Jeffrey N. Allen SEP IRA561009 and in such capacity has the right to vote and
dispose of the securities held in such IRA.
(6)
Michael Rostad and Sandra Rostad are Co-Trustees of The Rostad Family Trust and in such capacity have the right to vote and dispose of
the securities held by such trust.
(7)
Represents 1,000 shares of common stock
(8)
Marshall Gifford is the Trustee of the Theresa D. Gifford Revocable Trust and in such capacity has the right to vote and dispose of the
securities held by such trust.
(9)
David Rodin is the Trustee under trust instrument dated March 2, 2010 and Heather Yeckes Rodin is Trustee under trust instrument dated
March 1, 2010 and in such capacity have the right to vote and dispose of the securities held by such trust.
(10)
Barbara Maddox is the Trustee of the Barbara T. Maddox Revocable Living Trust dated March 13, 2000 and in such capacity has the right
to vote and dispose of the securities held by such trust.
(11)
Dianne C. DeBoest is the Trustee of the Dianne C. DeBoest Revocable Trust, dated January 28, 2013, as amended, Dianne C. DeBoest Grantor
and in such capacity that has the right to vote and dispose of the securities held by such trust.
(12)
Hans Van Boldrik is the Trustee of the Survivors Trust of the Hans & Elsie Van Boldrik Trust of 1982 and in such capacity has the
right to vote and dispose of the securities held by such trust.
(13)
Douglas Bertsch is the Beneficiary of the Provident Trust Group FBO, Douglas Bertsch ROTH IRA3201389 and in such capacity has the right
to vote and dispose of the securities held in the Roth IRA.
(14)
Steven H. Wilhelm is the Trustee of the Liza and Steve Trust of 2013 and in such capacity has the right to vote and dispose of the securities
held by such trust.
(15)
Dessislava Boneva is the Trustee of The Boston Strong Trust and in such capacity has the right to vote and dispose of the securities
held by such trust.
(16)
Gary Banister is the Trustee of the Gary A. Banister and Janice D. Banister Trust dated February 2000 and in such capacity has the right
to vote and dispose of the securities held by such trust.
(17)
Monique Slone is the Beneficiary of IRA Services Trust Co. CFBO Monique Slone IRA747130 and in such capacity has the right to vote and
dispose of the securities held in such IRA.
(18)
Deborah Gisonni is the Trustee of the Deborah Gisonni & Joseph Prestipino TTEE’s and in such capacity has the right to vote
and dispose of the securities held by such trust.
(19)
Raymond Kaliski is the Trustee of The Raymond William Kaliski and Carla Daro Kaliski Family Trust and in such capacity has the right
to vote and dispose of the securities held by such trust.
(20)
Donald C. Hansen and Joan C. Hansen are the Co-Trustees of The Donald and Joan Hansen Trust dated 6-1-1993 and in such capacity have
the right to vote and dispose of the securities held by such trust.
(21)
John C. Kinnear III & Barbara E. Kinnear are the Co-Trustees of the Kinnear Trust dated July 13, 2000 and in such capacity have the
right to vote and dispose of the securities held by such trust.
(22)
Represents 1,250 shares of common stock issuable
upon exercise of warrants.
(23)
Represents 60,000 shares of common stock issuable upon exercise of options.
(24)
Represents 60,000 shares of common stock issuable upon exercise of options.
(25)
Represents 30,000 shares of common stock issuable upon exercise of options.
(26)
Represents 10,000 shares of common stock issuable upon exercise of options.
(27)
Represents 10,000 shares of common stock issuable upon exercise of options.
(28)
Represents 10,000 shares of common stock issuable upon exercise of options.
(29)
Represents 1,250 shares of common stock issuable upon exercise of warrants.
(30)
Timothy Sheehan is the Trustee of the Sheehan Family Trust, December 6, 2008 and in such capacity has the right to vote and dispose of
the securities held by such trust.
(31)
Represents 1,250 shares of common stock issuable upon exercise of warrants.
(32)
Marcia Fenning is the Trustee of the Marcia M. Fenning Trustee Marcia M. Fenning Trust UA DTD 11/19/73 and in such capacity has the right
to vote and dispose of the securities held by such trust.
(33)
Peter Migale is the Beneficiary of the Forge Trust Co. CFBO Peter J Migale IRA705597 and in such capacity has the right to vote and dispose
of the securities held in such IRA.
(34)
Jan Hervert is the Trustee of the Jan and Judith Ann Hervert Trust Dated February 10, 2021 and in such capacity has the right to vote
and dispose of the securities held by such trust.
(35)
Leslie Hellewell is the Beneficiary of the Provident Trust Group FBO, Leslie D. Hellewell ROTH IRA110800021 and in such capacity has
the right to vote and dispose of the securities held in such Roth IRA.
(36)
Michele Werner is the Trustee of the Eric P. Werner and Michele A. Werner Revocable Living Trust and in such capacity has the right to
vote and dispose of the securities held by such trust.
(37)
Cathy Gallagher is the Trustee of the Gallagher Family Trust dated May 24, 2004 and in such capacity has the right to vote and dispose
of the securities held by such trust.
(38)
Regina Martinelli is the Beneficiary of the Forge Trust Co CFBO Regina Martinelli (IRA acct# 722765) and in such capacity has the right
to vote and dispose of the securities held in such IRA.
(39)
Scott Plumley is the Beneficiary of the Forge Trust Co CFBO (Byron Scott Plumley) (IRA acct# 842515) and in such capacity has the right
to vote and dispose of the securities held in such IRA.
(40)
Brad Whalen is the Beneficiary of the Forge Trust Co CFBO (Brad Nelson Whalen) (IRA759570) and in such capacity has the right to vote
and dispose of the securities held in such IRA.
(41)
Gerald Amato is the President of Amato and Partners
and in such capacity has the right to vote and dispose of the securities held by such entity. The address of Amato and Partners is 100
Park Avenue, 16th Floor, New York, NY 10017.
(42)
Represents 15,000 shares of common stock issuable
upon exercise of warrants.
(43)
Patricia Sheehan is the Trustee of PDS Trust, dtd
10/18/2000 and in such capacity has the right to vote and dispose of the securities held by such trust.
(44)
Patricia Sheehan is the Custodian of Patricia Sheehan
CFBO, Ashley Godshall and in such capacity has the right to vote and dispose of the securities held by such trust.
(45)
Patricia Sheehan is the Custodian of Patricia Sheehan
CFBO, James Sanborn and in such capacity has the right to vote and dispose of the securities held by such trust.
(46)
Patricia Sheehan is the Custodian of Patricia Sheehan
CFBO, Lindsay Doyle and in such capacity has the right to vote and dispose of the securities held by such trust.
(47)
Patricia Sheehan is the Custodian of Patricia Sheehan
CFBO The Sanborn Revocable Living Trust and in such capacity has the right to vote and dispose of the securities held by such trust.
(48)
Patricia Sheehan is the Custodian of Patricia Sheehan
CFBO William C. Frankmore and Shelby S. Frankmore and in such capacity has the right to vote and dispose of the securities held by such
trust.
(49)
Patricia Sheehan is the Custodian of CFBO Sheehan
Family Trust, December 6, 2008 and in such capacity has the right to vote and dispose of the securities held by such trust.
(50)
Represents (i) 65,000 shares of common stock held
by Bruce Blakely and (ii) 50,000 shares of common stock held by IRA Services Trust Co. CFBO Bruce W. Blakely ROTH IRA613009. Bruce Blakely
is the Beneficiary of IRA Services Trust Co. CFBO Bruce W. Blakely ROTH IRA613009 and in such capacity has the right to vote and dispose
of the securities held in such IRA.
(51)
Bruce Blakely is the Beneficiary of IRA Services
Trust Co. CFBO Bruce W. Blakely ROTH IRA613009 and in such capacity has the right to vote and dispose of the securities held in such
IRA.
(52)
Represents (i) 20,601 shares of common stock held
by Charles Dorn and (ii) 7,000 shares of common stock held by Provident Trust Group FBO, Chuck Dorn ROTH IRA3201358. Charles Dorn is
the Beneficiary of Provident Trust Group FBO, Chuck Dorn ROTH IRA3201358 and in such capacity has the right to vote and dispose of the
securities held in such Roth IRA.
(53)
Charles Dorn is the Beneficiary of Provident Trust
Group FBO, Chuck Dorn ROTH IRA3201358 and in such capacity has the right to vote and dispose of the securities held in such Roth IRA.
(54)
Represents (i) 10,000 shares of common stock held
by Scott Fenning and (ii) 60,000 shares of common stock held by Scott & Sharon Fenning.
(55)
Represents (i) 10,000 shares of common stock held
by Philip Petruzzelli and (ii) 16,500 shares of common stock held by IRA Services Trust Co. CFBO, Philip Petruzzelli. Philip Petruzzelli
is the Beneficiary of the IRA Services Trust Co. CFBO, Philip Petruzzelli and in such capacity has the right to vote and dispose of the
securities held in such IRA.
(56)
Represents (i) 5,000 shares of common stock held
by Hans Van Boldrik and (ii) 10,000 shares of common stock held by Survivors Trust of the Hans & Elsie Van Boldrik Trust of 1982.
Hans Van Bolrik is the Trustee of the Survivors Trust of the Hans & Elsie Van Boldrik Trust of 1982 and in such capacity has the
right to vote and dispose of the securities held by such trust.
(57)
Marc Renson is the Trustee of The Renson Revocable
Trust and in such capacity has the right to vote and dispose of the securities held by such trust.
(58)
Represents (i) 40,000 shares of common stock held
by Fred Chasalow and (ii) 25,000 shares of common stock held by Fred Chasalow & Sandra Chasalow.
(59)
Jerry Katzman is the Sole Member of Capital Funding
Partners, LLC and in such capacity has the right to vote and dispose of the securities held by such entity. The address of Capital Funding
Partners, LLC is P.O. Box 24866, Tampa, FL 33623. Jerry Katzman is the Chief Executive Officer and President of the Company and serves
as a member of the board of directors of the Company.
(60)
Steven Bayern is the Manager of Bayern Capital,
LLC and in such capacity has the right to vote and dispose of the securities held by such entity. The address of Bayern Capital, LLC
is 403 East Boardwalk, Suite 601, Long Beach, NY 11561.
(61)
Herbert Gould serves as a member of the board of
directors of the Company.
(62)
Member of the Company’s Medical Advisory Board.
(63)
Represents 1,000 shares of common stock issuable
upon exercise of options.
(64)
Amido Rapkin and James Suess are the Trustees of
Suess & Rapkin Family Trust and in such capacity have the right to vote and dispose of the securities held by such trust.
PLAN
OF DISTRIBUTION
Up
to 1,559,820 shares of common stock are being offered by this prospectus, all of which are being registered for sale for the accounts
of the Selling Stockholders. We will not receive any of the proceeds from the sale by the Selling Stockholders of the Resale Shares.
Any proceeds received from exercise of options or warrants by the Selling Stockholders will be used for working capital purposes. We
will bear all fees and expenses incident to this registration.
The
Selling Stockholders may sell all or a portion of the Resale Shares beneficially owned by them and offered hereby from time to time directly
or through one or more underwriters, broker-dealers or agents. If the Resale Shares are sold through underwriters or broker-dealers,
the Selling Stockholders will be responsible for underwriting discounts or commissions or agent’s commissions. The Selling Stockholders
will sell their Resale Shares at prevailing market prices or in privately negotiated transactions. The Resale Shares may be sold in one
or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of
sale, or at negotiated prices. All sales may be effected in transactions, which may involve crosses or block transactions:
|
● |
on
any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale; |
|
|
|
|
● |
in
the over-the-counter market; |
|
|
|
|
● |
in
transactions otherwise than on these exchanges or systems or in the over-the-counter market; |
|
|
|
|
● |
through
the writing of options, whether such options are listed on an options exchange or otherwise; |
|
|
|
|
● |
ordinary
brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
|
|
|
|
● |
block
trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block
as principal to facilitate the transaction; |
|
|
|
|
● |
purchases
by a broker-dealer as principal and resale by the broker-dealer for its account; |
|
|
|
|
● |
an
exchange distribution in accordance with the rules of the applicable exchange; |
|
|
|
|
● |
privately
negotiated transactions; |
|
|
|
|
● |
settlement
of short sales entered into after the effective date of the registration statement of which this prospectus is a part; |
|
|
|
|
● |
sales
pursuant to Rule 144, Rule 144A or Regulation S under the Securities Act, if available, rather than under this prospectus; |
|
|
|
|
● |
broker-dealers
may agree with the Selling Stockholders to sell a specified number of such securities at a stipulated price per share; |
|
|
|
|
● |
a
combination of any such methods of sale; and |
|
|
|
|
● |
any
other method permitted pursuant to applicable law. |
If
the Selling Stockholders effect such transactions by selling Resale Shares to or through underwriters, broker-dealers or agents, such
underwriters, broker-dealers or agents may receive commissions in the form of discounts, concessions or commissions from the Selling
Stockholders or commissions from purchasers of the Resale Shares for whom they may act as agent or to whom they may sell as principal
(which discounts, concessions or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary
in the types of transactions involved). In connection with sales of the Resale Shares or otherwise, the Selling Stockholders may enter
into hedging transactions with broker-dealers, which may in turn engage in short sales of shares of common stock in the course of hedging
in positions they assume. The Selling Stockholders may also sell shares of common stock short and deliver Resale Shares covered by this
prospectus to close out short positions and to return borrowed common stock in connection with such short sales. The Selling Stockholders
may also loan or pledge common stock to broker-dealers that in turn may sell such shares of common stock.
The
Selling Stockholders may pledge or grant a security interest in some or all of the Resale Shares owned by them and, if they default in
the performance of their secured obligations, the pledgees or secured parties may offer and sell the Resale Shares from time to time
pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities
Act, amending, if necessary, the list of Selling Stockholders to include the pledgee, transferee or other successors in interest as Selling
Stockholders under this prospectus. The Selling Stockholders also may transfer and donate the Resale Shares in other circumstances in
which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this
prospectus.
The
Selling Stockholders and any broker-dealer participating in the distribution of the Resale Shares may be deemed to be “underwriters”
within the meaning of the Securities Act, and any commission paid, or any discounts or concessions allowed to, any such broker-dealer
may be deemed to be underwriting commissions or discounts under the Securities Act. At the time a particular offering of the Resale Shares
is made, a prospectus supplement, if required, will be distributed which will set forth the aggregate amount of Resale Shares being offered
and the terms of the offering, including the name or names of any broker-dealers or agents, any discounts, commissions and other terms
constituting compensation from the Selling Stockholders and any discounts, commissions or concessions allowed or reallowed or paid to
broker-dealers.
Under
the securities laws of some states, the Resale Shares may be sold in such states only through registered or licensed brokers or dealers.
In addition, in some states the Resale Shares may not be sold unless such securities have been registered or qualified for sale in such
state or an exemption from registration or qualification is available and is complied with.
There
can be no assurance that any Selling Stockholders will sell any or all of the Resale Shares registered pursuant to the registration statement,
of which this prospectus forms a part.
The
Selling Stockholders and any other person participating in such distribution will be subject to applicable provisions of the Exchange
Act and the rules and regulations thereunder, including, without limitation, Regulation M of the Exchange Act, which may limit the timing
of purchases and sales of any of the Resale Shares stock by the Selling Stockholders and any other participating person. Regulation M
may also restrict the ability of any person engaged in the distribution of the Resale Shares to engage in market-making activities with
respect to the Resale Shares. All of the foregoing may affect the marketability of the Resale Shares and the ability of any person or
entity to engage in market-making activities with respect to the Resale Shares.
DESCRIPTION
OF SECURITIES
General
Our
authorized capital stock consists of 80,000,000 shares of common stock, par value $0.0001 per share, and 40,000,000 shares of preferred
stock, par value $0.0001 per share.
As
of November 1, 2023, there were 112 record holders of our common stock. As of November 1, 2023, there were 17,588,811
shares of common stock and no shares of preferred stock issued and outstanding.
The
following description of our capital stock is intended as a summary only and is qualified in its entirety by reference to our Certificate
of Incorporation and Bylaws which are filed as exhibits to the registration statement of which this prospectus is a part.
Common
Stock
We
are authorized to issue up to a total of 80,000,000 shares of common stock, par value $0.0001 per share. Holders of our common stock
are entitled to one vote for each share held on all matters submitted to a vote of our stockholders. Holders of our common stock have
no cumulative voting rights, preemptive or conversion rights or other subscription rights. Upon our liquidation, dissolution or winding-up,
holders of our common stock are entitled to share in all assets remaining after payment of all liabilities and the liquidation preferences
of any of our outstanding shares of preferred stock. Subject to preferences that may be applicable to any outstanding shares of preferred
stock, holders of our common stock are entitled to receive dividends, if any, as may be declared from time to time by our board of directors
out of our assets which are legally available.
The
holders of a majority of the shares of our capital stock, represented in person or by proxy, are necessary to constitute a quorum for
the transaction of business at any meeting. If a quorum is present, an action by stockholders entitled to vote on a matter is approved
if the number of votes cast in favor of the action exceeds the number of votes cast in opposition to the action, with the exception of
the election of directors, which requires a plurality of the votes cast.
Preferred
Stock
Our
board of directors will have the authority, without further action by the stockholders, to issue up to 40,000,000 shares of preferred
stock in one or more series and to fix the designations, powers, preferences, privileges, and relative participating, optional, or special
rights as well as the qualifications, limitations, or restrictions of the preferred stock, including dividend rights, conversion rights,
voting rights, terms of redemption, and liquidation preferences, any or all of which may be greater than the rights of the common stock.
Our board of directors, without stockholder approval, will be able to issue preferred stock with voting, conversion, or other rights
that could adversely affect the voting power and other rights of the holders of common stock. Preferred stock could be issued quickly
with terms calculated to delay or prevent a change of control or make removal of management more difficult. Additionally, the issuance
of preferred stock may have the effect of decreasing the market price of our common stock, and may adversely affect the voting and other
rights of the holders of common stock.
Options
Our
2017 Equity Incentive Plan provides for us to issue up to 10,000,000 shares of common stock as restricted shares, incentive stock options,
nonqualified stock options, stock appreciation rights or restricted stock unit awards to our and our subsidiaries’ employees, members
of the board of directors and consultants. As of November 1, 2023, 2,660,000 options to purchase common stock pursuant
to our 2017 Equity Incentive Plan were outstanding. For additional information regarding the terms of the 2017 Equity Incentive Plan,
see “Executive and Director Compensation — 2017 Equity Incentive Plan.”
Warrants
As
of November 1, 2023, warrants to purchase up to 150,000 shares of our common stock were outstanding and pre-funded warrants
to purchase up to 28,014,540 shares of our common stock were outstanding.
Exclusive
Forum
Our
Certificate of Incorporation and Bylaws provide that unless we consent in writing to the selection of an alternative forum, the State
of Delaware is the sole and exclusive forum for: (i) any derivative action or proceeding brought on behalf of us, (ii) any action asserting
a claim of breach of a fiduciary duty owed by any director, officer or other employee of our Company to us or our stockholders, (iii)
any action asserting a claim arising pursuant to any provision of the DGCL of our Certificate of Incorporation or Bylaws or (iv) any
action asserting a claim governed by the internal affairs doctrine.
Anti-Takeover
Provisions of Delaware Law, our Certificate of Incorporation and our Bylaws
Delaware
Law
We
are governed by the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a publicly traded
Delaware corporation from engaging in a business combination with an interested stockholder for a period of three years after the date
of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed
manner. A business combination includes mergers, asset sales or other transactions resulting in a financial benefit to the stockholder.
An interested stockholder is a person who, together with affiliates and associates, owns (or within three years, did own) 15% or more
of the corporation’s voting stock, subject to certain exceptions. The statute could have the effect of delaying, deferring or preventing
a change in control of our Company.
Advance
Notice Requirements for Stockholder Proposals and Director Nominations
Our
Bylaws provide that stockholders seeking to bring business before our annual meeting of stockholders, or to nominate candidates for election
as directors at our annual meeting of stockholders, must provide timely notice of their intent in writing. To be timely, a stockholder’s
notice must be delivered to our secretary at our Company’s principal executive offices not later than the close of business on
the 90th day nor earlier than the close of business on the 120th day prior to the first anniversary of the preceding year’s
annual meeting; provided, however, that in the event the date of the annual meeting is more than 30 days before or more than 60 days
after such anniversary date, or if no annual meeting was held in the preceding year, notice by the stockholder must be delivered not
earlier than the close of business on the 120th day prior to such annual meeting and not later than the 90th day
prior to such annual meeting or the 10th day following the day on which a public announcement of the date of such meeting
is first made by the Company. These provisions may preclude our stockholders from bringing matters before our annual meeting of stockholders
or from making nominations for directors at our annual meeting of stockholders.
Authorized
but Unissued Shares
Our
authorized but unissued shares of common stock and preferred stock are available for future issuance without stockholder approval and
may be utilized for a variety of corporate purposes, including future private or public offerings to raise capital, corporate acquisitions
and employee benefit plans. The existence of authorized but unissued and unreserved common stock and preferred stock could render more
difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or otherwise.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Continental Stock Transfer and Trust at 1 State Street, Floor 30, New York, New
York 10004.
DESCRIPTION
OF BUSINESS
Overview
We
are an ophthalmic research and development company focused on developing technologies to screen, monitor, diagnose and treat ophthalmic,
optical, and sight-threatening disorders. Our mission is to prevent vision loss and blindness due to diabetic retinopathy and maculopathy
through two devices: (1) Retinal Imaging Screening Device, a portable, retinal imaging system providing a 200-degree field of
view without requiring pupil dilation; and (2) RetinalCamTM, a home monitoring and imaging device offering real-time
communication and alerting system for physicians available 24/7.
To
date, we have devoted substantially all of our resources to organizing, business planning, raising capital, designing and developing
product candidates, and securing manufacturing and sales/distribution partners. We do not have any products approved for sale and have
not generated any revenue from product sales. We have funded our operations primarily through the private placement of common stock.
We
anticipate that we will need an additional $12,000,000 to (i) complete product design and testing for RetinalGenixTM and RetinalCamTM
and submit RetinalGenixTM for FDA clearance (we anticipate that the RetinalCamTM will not require FDA clearance);
(ii) complete the development and expansion of the software tools around the recently acquired DNA/GPS’ genetic mapping technology;
and (iii) build the infrastructure for our sustained growth. We intend to obtain such funds through the sales of our equity and debt
securities and/or through potential strategic partnerships; however, no assurance can be provided that funds will be available to us
on acceptable terms, if at all.
We
do not expect to generate any revenues from product sales unless and until we successfully complete development of RetinalCamTM,
and we do not expect to generate any revenues from product sales unless and until we successfully obtain regulatory clearance for RetinalGenixTM.
In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting,
investor relations, compliance and other expenses.
As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such
time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through
public or private equity offerings, debt financings, strategic partnerships, collaborations and licensing arrangements or other capital
sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms or
at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial
condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant
rights to develop and market our product candidates.
We
have been issuing shares of our common stock pursuant to a private placement raising approximately $3.0 million from the sale of 3,010,000
shares of common stock from 2019 through December 31, 2021. An additional 60,500 shares were sold in January 2022 pursuant to this private
placement.
Because
of the numerous risks and uncertainties we are unable to accurately predict the timing or amount of increased expenses or when or if
we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If
we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations
at planned levels and be forced to reduce or terminate our operations.
Our
acquisition of DNA/GPS Inc.
On
July 5, 2022, we entered into an Exchange Agreement (the “Exchange Agreement”) with Dr. Lawrence Perich pursuant to which
we acquired all the outstanding shares of DNA/GPS Inc., a pharmacogenetics company based in Tampa, Florida (“DNA/GPS”), in
exchange for the issuance of 2,000,000 shares of our common stock. The acquisition of DNA/GPS combines DNA/GPS’ genetic mapping
capabilities with our retinal imaging capabilities. The combined technology is expected to have the ability to provide diagnoses of systemic
and retinal diseases. We accounted for this transaction as an asset acquisition in the quarter ending September 30, 2022, and recorded
the estimated purchase consideration and related expenses as in process research and development in the accompanying consolidated statement
of operations.
Recent
Developments
None
Market
Opportunity
Our
devices are being designed initially to detect the earliest stages of diabetic retinopathy to prevent blindness. Diabetic Retinopathy
(“DR”) happens when too much blood sugar (glucose) associated with diabetes damages the blood vessels in the retina. As a
result, the retina does not get enough oxygen and nutrients, and blood vessels can leak blood into the retina. According to the Mayo
Clinic, DR is the leading cause of new cases of blindness in people 20 to 74 years of age in the United States. According to the Centers
for Disease Control and Prevention (“CDC”) 2022 National Diabetes Statistics Report, more than 130 million adults are living
with diabetes or prediabetes in the United States. The American Diabetes Association reports that diabetic retinopathy is the most common
diabetic eye disease and a leading cause of blindness in American adults. The number of individuals with diabetic retinopathy is predicted
to increase by nearly 50% (it’s actually 47.7%) to over 11 million people by 2030. According to the CDC, 34.2 million patients
in the U.S. have diabetic maculopathy with 26.9 million diagnosed and 7.3 million undiagnosed. In addition, 88 million adult Americans
are pre-diabetics of which 84%, or 74 million, are undiagnosed. Diabetic maculopathy effects 500 million patients globally.
Competition
The
ophthalmic medical technology industries utilize rapidly advancing technologies and are characterized by intense competition. There is
a strong emphasis on intellectual property and proprietary products. We face competition from different sources including ophthalmic
medical technology companies, academic institutions, government agencies, and public and private research institutions. For example,
we face competition from Optomed plc. (“Optomed”), Optos plc (“Optos”) and Zeiss with respect to our RetinalGeniXTM
Imaging System. Optos has developed and is currently globally marketing a wide screen imaging system that has a 200-degree field
of view that screens for diabetic retinopathy, and Optomed has developed and is currently globally marketing a wide screen imaging system
that has a 150 degree field of view that screens for diabetic retinopathy. Zeiss has developed and is currently globally marketing a
wide screen imaging system that has a 200-degree field of view that screens for diabetic retinopathy. Although we face competition with
respect to our RetinalGeniXTM Imaging System, we do not believe we face competition with respect to our RetinalCamTM.
Many
of our competitors have significantly greater financial resources and expertise in research and development, medical device development
and obtaining regulatory approvals than us as well as more established distribution networks and relationships with healthcare providers.
Mergers and acquisitions in the ophthalmic medical technology industries may result in even more resources being concentrated among a
smaller number of our competitors. These competitors also compete with us in recruiting and retaining qualified personnel, as well as
in acquiring technologies complementary to our products.
Manufacturing
and Distribution
On
June 24, 2021, we entered into an Amended and Restated Master Services Agreement (“Master Services Agreement”) with ADM Tronics
Unlimited, Inc. (“ADM Tronics”), pursuant to which ADM Tronics will provide us with design, engineer and provide regulatory
services related to RetinalGenixTM and RetinalCamTM.
On
October 8, 2019, we entered into an option exchange agreement (the “Option Exchange Agreement”) with Diopsys, Inc. (“Diopsys”)
pursuant to which we shall issue Diopsys an option to purchase up to 10% of our issued and outstanding shares of common stock and Diopsys
shall issue us an option to purchase up to 10% of the issued and outstanding shares of common stock of Diopsys on the Closing Date (the
“Option Exchange”). “Closing Date” means a date that is within 30 days of the date that all of the contingencies
set forth in the Option Exchange Agreement are satisfied including, but not limited to, approval of a product by the FDA. In addition,
pursuant to the Option Exchange Agreement, upon the closing of the Option Exchange, we shall enter into an exclusive distribution agreement
with Diopsys pursuant to which Diopsys shall act as our exclusive distributor of such product. The agreement was terminated on February
14, 2022.
Intellectual
Property Portfolio
Our
success depends in large part on our ability to protect our proprietary technologies and information, and to operate without infringing
the proprietary rights of third parties. We rely on a combination of patent, trade secret, trademark, and copyright laws, as well as
confidentiality and other agreements, to establish and protect our proprietary rights. In addition to patent protection, we rely on trade
secrets, proprietary know-how, and continuing technological advances to develop and maintain our competitive position. Our goal is to
obtain, maintain and enforce patent protection for our products, preserve our trade secrets, and operate without infringing on the proprietary
rights of other parties.
Sublicense
Agreement with Sanovas Ophthalmology LLC
On
June 24, 2021, we entered into a sublicense agreement (“Sublicense Agreement”) with Sanovas Ophthalmology LLC (“Sanovas
Ophthalmology”), a company for which our Chief Executive Officer is also the managing member, pursuant to which Sanovas Ophthalmology
granted us an exclusive worldwide (“Territory”) license to certain intellectual property, including six patents, two patent
applications, and two trademark applications, licensed to Sanovas Ophthalmology by Sanovas Intellectual Property LLC relating to certain
technologies for eye and ocular visualization and monitoring (“Licensed IP”) for uses related to the screening, examination,
diagnosis, prevention and/or treatment of any eye disease, medical condition or disorder, or any disease, medical condition or disorder
affecting the eye. The Licensed IP which has been issued by the USPTO and relates to methods of use and systems expires on dates ranging
from September 2034 to December 2034, and the Licensed IP which is still pending before the USPTO also relates to methods of use and
systems. Pursuant to the Sublicense Agreement, commencing on the date of the first commercial sale of a Licensed Product (as defined
in the Sublicense Agreement), in each country in the Territory and continuing on a country by country basis until the expiration or termination
of the last Valid Claim (as defined herein) of a licensed patent in such country (the “Royalty End Date”), we shall pay Sanovas
Ophthalmology a royalty equal to a mid-single digit percentage of any Net Sales (as defined in the Sublicense Agreement) of any Licensed
Product. “Valid Claim” means an issued, unexpired patent claim contained in a licensed patent as long as the claim has not
been admitted by Sanovas Intellectual Property, LLC, the owner of the Licensed IP, or otherwise caused to be invalid or unenforceable
through reissue, disclaimer or otherwise, or held invalid or unenforceable by a tribunal or governmental agency of competent jurisdiction
from whose judgment no appeal is allowed or timely taken. The Sublicense Agreement shall continue until the Royalty End Date, unless
earlier terminated pursuant to its terms. The Sublicense Agreement may be terminated by either party if the other party materially breaches
the Sublicense Agreement in a manner that cannot be cured, or materially breaches the Sublicense Agreement in a manner that can be cured,
and such breach remains uncured for more than 30 days after the receipt by the breaching party of notice specifying the breach. Furthermore,
we may terminate the Sublicense Agreement at any time upon 90 days written notice to Sanovas Ophthalmology.
Government
Regulations
Our
business is subject to extensive, complex, and rapidly changing federal and state laws and regulations. Various federal and state agencies
have discretion to issue regulations any interpret and enforce healthcare laws. While we believe we comply in all material respects with
applicable healthcare laws and regulations, these regulations can vary significantly from jurisdiction, and interpretation of existing
laws and regulations may change periodically. Federal and state legislatures also may enact various legislative proposals that could
materially impact certain aspects of our business.
United
States Regulations
In
the U.S., medical devices are subject to regulation by the FDA under the Federal Food, Drug, and Cosmetic Act (the “FDCA”)
and its implementing regulations. The FDCA and regulations govern, among other things, the design, manufacture, storage, recordkeeping,
approval, labeling, promotion, post-approval monitoring and reporting, distribution and import and export of medical devices. Failure
to comply with applicable requirements may subject a device and/or its manufacturer to a variety of administrative and judicial sanctions,
such as FDA refusal to grant requests for 510(k) clearance, de novo classification, or premarket approval of new products or modified
products, issuance of warning letters or untitled letters, mandatory product recalls, import detentions, civil monetary penalties, and/or
judicial sanctions, such as product seizures, injunctions, and criminal prosecution.
The
FDCA classifies medical devices into one of three categories based on the risks associated with the device and the level of control necessary
to provide reasonable assurance of safety and effectiveness. Class I devices are deemed to be low risk and are subject only to the general
regulatory controls. Class II devices are moderate risk. They are subject to general controls and may also be subject to special controls.
Class III devices are generally the highest risk devices. They are required to obtain premarket approval and comply with post-market
conditions of approval in addition to general regulatory controls.
We
believe RetinalGenixTM is a Class II medical device that will require 510(k) clearance from the FDA. In addition, we believe
RetinalCamTM will be considered a Class II exempt medical device because it is non-diagnostic in nature, and therefore, we
do not anticipate needing 510(k) clearance from the FDA to market such product. Pursuant to FDA product classification codes for ophthalmic
cameras under 21 C.F.R. § 886.1120, “PJZ” cameras are prescription devices indicated only for the capture and storage
of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g.,
pediatrics, AMD patients, etc.), cannot contain any type of “diagnostic” or “aid in diagnosis” claims in the
indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet,
visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection
for Ophthalmic Instruments. PJZ cameras also have other design and performance characteristics that are described by FDA in the product
code description.
If
the RetinalGeniXTM were to be classified as a Class II medical device, such classification would require us to submit a premarket
notification submission to FDA prior to marketing. We anticipate the submission will require clinical evidence of safety and efficacy,
generated through a regulated, randomized clinical trial or field evaluation. FDA clearance for ophthalmological devices usually require
about 170 days.
We
intend to launch RetinalCamTM in the fall of 2023 and we intend to apply for 510(k) clearance for RetinalGenixTM
in 2024.
FDA
Pre-Market Authorization and Notification
Under
FDA regulations, all devices, including Class I devices, are subject to general controls, which are the basic authorities of the Medical
Device Amendments that provide the FDA with the means of regulating devices to ensure their safety and effectiveness (e.g., labeling,
facility registration and device listing and adherence to Quality System Regulation (“QSR”) requirements). For Class III
devices, a pre-market approval (“PMA”) application will be required unless the device is a pre-amendment device (on the market
prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) or is exempted from submission
of a PMA. In that case, a 510(k) will be the route to market. A 510(k) clearance will be granted if the submitted information establishes
that the proposed device is substantially equivalent to a legally marketed Class I or II medical device, or to a Class III medical device
for which the FDA has not required a PMA. The FDA may determine that a proposed device is not substantially equivalent to a legally marketed
device or that additional information or data are needed before a substantial equivalence determination can be made. A request for additional
data may require that clinical studies of the device’s safety and efficacy be performed.
While
most Class I and some Class II devices may be marketed without prior FDA authorization, most other medical devices can be legally sold
within the U.S. only if the FDA has: (i) approved a PMA prior to marketing, generally applicable to most Class III devices; (ii) cleared
the device in response to a premarket notification, or 510(k) submission, generally applicable to Class I and II devices; or (iii) authorized
the device to be marketed through the de novo classification process, generally applicable for novel Class I or II devices. PMA
applications, 510(k) premarket notifications, and de novo requests require payment of substantial user fees that are modified
each fiscal year.
Commercial
distribution of a device for which a 510(k) notification is required may begin only after the FDA issues an order finding the device
to be substantially equivalent to a previously cleared device. Even in cases where the FDA grants a 510(k) clearance, it may take the
FDA between four and nine months from the date of submission to grant a 510(k) clearance, but may take longer.
A
“not substantially equivalent” determination, or a request for additional information, could delay the market introduction
of new products that fall into this category and could have a material adverse effect on our business, financial condition and results
of operations. For any of our products that are cleared through the 510(k) process, modifications or enhancements that could significantly
affect the safety or efficacy of the device or that constitute a major change to the intended use of the device will require new 510(k)
submissions.
Any
products manufactured or distributed by us are subject to pervasive and continuing regulation by the FDA, including record keeping requirements
and reporting of adverse experiences with the use of the device. Device manufacturers are required to register their establishments and
list their devices with the FDA and certain state agencies, and are subject to periodic inspections by the FDA and certain state agencies.
The FDCA requires devices to be manufactured to comply with applicable QSR regulations which impose certain procedural and documentation
requirements upon us with respect to design, development, manufacturing and quality assurance activities. The FDA enforces its requirements
by market surveillance and periodic visits, both announced and unannounced, to inspect or re-inspect equipment, facilities, laboratories
and processes to confirm regulatory compliance. These inspections may include the manufacturing facilities of subcontractors. Following
an inspection, the FDA may issue a report, known as a Form 483, listing instances where the manufacturer has failed to comply with applicable
regulations and/or procedures or, if observed violations are sufficiently severe and urgent, a warning letter. If the manufacturer does
not adequately respond to a Form 483 or warning letter, the FDA make take enforcement action against the manufacturer or impose other
sanctions or consequences.
We
are subject to unannounced inspections by the FDA and the Food and Drug Branch of the California Department of Public Health to determine
our compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of our subcontractors.
510(k)
Premarket Notification Pathway
Product
marketing in the U.S. for most Class II and a limited number of Class I devices typically follows the 510(k) premarket notification pathway.
To obtain 510(k) clearance, a manufacturer must submit a premarket notification demonstrating that the proposed device is substantially
equivalent to a legally marketed device, referred to as the “predicate device.” A predicate device may be a previously 510(k)-cleared
device placed in Class I or Class II via a finding of substantial equivalence to a lawfully marketed Class I or Class II device, or a
Class III device that was in commercial distribution before May 28, 1976 and for which the FDA has not yet called for PMA applications,
or a product previously placed in Class I or Class II through the de novo classification process. A finding of “substantial
equivalence” means the FDA must conclude that the proposed device has the same intended use as a predicate device, and it either
has the same technological characteristics, or it has different technological characteristics but submitted information (potentially
including clinical data) shows it is as safe and effective and does not raise different questions of safety and effectiveness as compared
to the predicate device.
The
FDA has a user fee goal to apply no more than 90 calendar review days to 510(k) submissions. During the process, the FDA may issue an
Additional Information request, which stops the clock. The applicant has no more than 180 days to respond (after which the submission
is automatically terminated). Therefore, the total review time could be up to a maximum of 270 days.
After
a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute
a major change in its intended use, requires a new 510(k) clearance or could require a PMA approval or de novo classification.
The FDA requires each manufacturer to make this determination in the first instance, but the FDA can review any such decision. If the
FDA disagrees with a manufacturer’s decision not to seek a new 510(k) clearance for the modified device, the agency may retroactively
require the manufacturer to seek 510(k) clearance, de novo classification, or PMA approval. The FDA also can require the manufacturer
to cease marketing and/or recall the modified device until 510(k) clearance or PMA approval is obtained.
Post-market
Requirements
After
a device is placed on the market, numerous general regulatory controls apply. These include: the QSR, labeling regulations, the medical
device reporting regulations (which require that manufacturers report to the FDA if their device may have caused or contributed to a
death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur),
and reports of corrections and removals regulations (which require manufacturers to report recalls or removals and field corrections
to the FDA if initiated to reduce a risk to health posed by the device or to remedy a violation of the FDCA). Failure to properly identify
reportable events or to file timely reports, as well as failure to address each of the observations to FDA’s satisfaction, can
subject a manufacturer to warning letters, recalls, or other sanctions and penalties.
Labeling
and promotion activities are subject to scrutiny by the FDA and by the Federal Trade Commission. The FDA actively enforces regulations
prohibiting marketing of products for unapproved uses. We and our products are also subject to a variety of state laws and regulations
in those states or localities where our products will be marketed. Any applicable state or local regulations may hinder our ability to
market our products in those states or localities. Manufacturers are also subject to numerous federal, state and local laws relating
to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous
or potentially hazardous substances. We may be required to incur significant costs to comply with such laws and regulations now or in
the future. Such laws or regulations may have a material adverse effect upon our ability to do business.
Advertising,
marketing and promotional activities for devices are also subject to FDA oversight and must comply with the statutory standards of the
FDCA, and the FDA’s implementing regulations. The FDA’s oversight authority review of marketing and promotional activities
encompasses, but is not limited to, direct-to-consumer advertising, healthcare provider-directed advertising and promotion, sales representative
communications to healthcare professionals, promotional programming and promotional activities involving electronic media. The FDA also
regulates industry-sponsored scientific and educational activities that make representations regarding product safety or efficacy in
a promotional context.
Manufacturers
of medical devices are permitted to promote products solely for the uses and indications set forth in the approved or cleared product
labeling. A number of enforcement actions have been taken against manufacturers that promote products for “off-label” uses
(i.e., uses that are not described in the approved or cleared labeling), including actions alleging that claims submitted to government
healthcare programs for reimbursement of products that were promoted for “off-label” uses are fraudulent in violation of
the Federal False Claims Act or other federal and state statutes and that the submission of those claims was caused by off-label promotion.
The failure to comply with prohibitions on “off-label” promotion can result in significant monetary penalties, revocation
or suspension of a company’s business license, suspension of sales of certain products, product recalls, civil or criminal sanctions,
exclusion from participating in federal healthcare programs, or other enforcement actions. In the United States, allegations of such
wrongful conduct could also result in a corporate integrity agreement with the U.S. government that imposes significant administrative
obligations and costs.
Violations
of the FDCA relating to the inappropriate promotion of approved products may lead to investigations alleging violations of federal and
state healthcare fraud and abuse and other laws, as well as state consumer protection laws.
For
a Class II or Class III device meeting certain requirements, the FDA also may require post-market surveillance requirements. Additionally,
the FDA may place conditions on a PMA-approved device that could restrict the distribution or use of the product. In addition, all classes
of devices must comply with quality-control, manufacture, packaging, and labeling procedures under the QSR, and manufacturers are subject
to periodic inspections by the FDA for compliance. Accordingly, manufacturers must continue to expend time, money, and effort in the
areas of production and quality control to maintain compliance with the QSR. The FDA may withdraw product approvals or recommend or require
product recalls if a company fails to comply with regulatory requirements.
Export
of our products is regulated by the FDA and subject to the FDCA, 21 U.S.C. §§381-384f, and other statutes FDA administers,
which greatly expanded the export of approved and unapproved United States medical devices. Some foreign countries require manufacturers
to provide a specific type of FDA export certificate (such as a Certificate to Foreign Government or Certificate of Exportability), which
may require the device manufacturer to certify the device is lawfully marketed in the United States, including in conformance with QSR
requirements, labeling regulations, premarket notification, and other requirements. The FDA will refuse to issue any export certificate
if significant outstanding QSR violations exist.
European
Union Regulations
In
the European Union (“EU”), there are four main medical device classes: I, IIa, IIb and III. Similar to the US classification
system, the EU classification system is a risk-based system, depending on the potential risk associated with the device. In the EU, we
believe the RetinalCamTM would be considered a Class IIa medical device, which would require the grant of a CE marking prior
to launching in the EU. To obtain a CE marking, the device manufacturer must be certified to ISO 13485, and the product must meet certain
harmonized standards for its design, development and testing. If the manufacturer is not self-certifying, outside agencies (known as
Notified Bodies) will be required to test and certify that the device meets the applicable requirements, including clinical evidence
of safe and effective use prior to the product being released for general market introduction.
Other
Healthcare Laws
In
addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws have been applied
to restrict certain general business and marketing practices in the pharmaceutical industry. These laws include anti-kickback, false
claims, transparency and health information privacy laws and other healthcare laws and regulations.
The
federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration
to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service
reimbursable under Medicare, Medicaid, or other federally financed healthcare programs. The Patient Protection and Affordable Care Act
as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA”) amended the intent element of the
federal Anti-Kickback Statute so that a person or entity no longer needs to have actual knowledge of the statute or specific intent to
violate it in order to commit a violation. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers
on the one hand and prescribers, purchasers and formulary managers, among others, on the other. Although there are a number of statutory
exceptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exceptions
and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases or recommendations
may be subject to scrutiny if they do not qualify for an exception or safe harbor. Additionally, the ACA amended the federal Anti-Kickback
Statute such that a violation of that statute can serve as a basis for liability under the federal civil False Claims Act. Federal civil
and criminal false claims laws, including the federal civil False Claims Act, prohibit any person or entity from knowingly presenting,
or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false
statement to have a false claim paid. This includes claims made to programs where the federal government reimburses, such as Medicare
and Medicaid, as well as programs where the federal government is a direct purchaser, such as when it purchases off the Federal Supply
Schedule. Pharmaceutical and medical device companies have been prosecuted under these laws for, among other things, allegedly providing
free product to customers with the expectation that the customers would bill federal programs for the product. In addition, certain marketing
practices, including off-label promotion, may also violate false claims laws. Most states also have statutes or regulations similar to
the federal Anti-Kickback Statute and civil False Claims Act, which apply to items and services reimbursed under Medicaid and other state
programs, or, in several states, apply regardless of the payor.
Other
federal statutes pertaining to healthcare fraud and abuse include the Civil Monetary Penalties Law statute, which prohibits, among other
things, the offer or payment of remuneration to a Medicaid or Medicare beneficiary that the offeror or payor knows or should know is
likely to influence the beneficiary to order or receive a reimbursable item or service from a particular supplier, and the additional
federal criminal statutes created by HIPAA, which prohibit, among other things, knowingly and willfully executing or attempting to execute
a scheme to defraud any healthcare benefit program or obtain by means of false or fraudulent pretenses, representations or promises any
money or property owned by or under the control of any healthcare benefit program in connection with the delivery of or payment for healthcare
benefits, items or services.
Further,
pursuant to the ACA, CMS issued a final rule that requires certain manufacturers of prescription drugs to collect and annually report
information on certain payments or transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists
and chiropractors), certain other health care professionals (such as physicians assistants and nurse practitioners) and teaching hospitals,
as well as ownership and investment interests held by physicians and their immediate family members. The reported data are made available
in searchable form on a public website on an annual basis. Failure to submit required information may result in civil monetary penalties.
Analogous
state and foreign anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare
items or services reimbursed by non- governmental third-party payors, including private insurers, or that apply regardless of payor.
In addition, several states now require prescription drug companies to report certain expenses relating to the marketing and promotion
of drug products and to report gifts and payments to individual healthcare practitioners in these states. Other states prohibit various
marketing-related activities, such as the provision of certain kinds of gifts or meals. Further, certain states require the posting of
information relating to clinical trials and their outcomes. In addition, certain states require medical device companies to implement
compliance programs and/or marketing codes.
Privacy
and Data Protection Laws
Data
privacy and security regulations by both the federal government and the states in which business is conducted may also be applicable.
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and its implementing
regulations, imposes requirements relating to the privacy, security and transmission of individually identifiable health information.
HIPAA requires covered entities to limit the use and disclosure of protected health information to specifically authorized situations
and requires covered entities to implement security measures to protect health information that they maintain in electronic form. Among
other things, HITECH made HIPAA’s security standards directly applicable to business associates, independent contractors or agents
of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered
entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable
to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts
to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.
In
addition, state laws govern the privacy and security of health information in specified circumstances, many of which differ from each
other in significant ways and may not have the same effect, thus complicating compliance efforts. Certain state laws may be more stringent
or broader in scope, or offer greater individual rights, with respect to personal information, and such laws may differ from each other,
all of which may complicate compliance efforts. For example, the CCPA, which increases privacy rights for California residents and imposes
obligations on companies that process their personal information, came into effect on January 1, 2020. Among other things, the CCPA requires
covered companies to provide new disclosures to California consumers about their data collection, use and sharing practices and provide
such consumers new data protection and privacy rights, including the ability to opt out of certain sales of personal information. The
CCPA provides for civil penalties for violations, as well as a private right of action for certain data breaches that result in the loss
of personal information. This private right of action may increase the likelihood of, and risks associated with, data breach litigation.
On November 3, 2020, California voters approved a new privacy law, the CPRA, which significantly modifies the CCPA, including by expanding
consumers’ rights with respect to certain personal information and creating a new state agency to oversee implementation and enforcement
efforts. Many of the CPRA’s provisions will become effective on January 1, 2023. State laws are changing rapidly and there is discussion
in the U.S. of a new comprehensive federal data privacy law.
Healthcare
Reform
Healthcare
reforms that have been adopted, and that may be adopted in the future, have been focused on cost containment in the healthcare system
and could result in reductions in coverage and levels of reimbursement for healthcare products, increases in rebates payable under U.S.
government rebate programs and additional downward pressure on pharmaceutical product prices. On September 9, 2021, the Biden administration
published a wide-ranging list of policy proposals, most of which would need to be carried out by Congress, to reduce drug prices and
drug payment. The Department of Health and Human Services (“HHS”) plan includes, among other reform measures, proposals to
lower prescription drug prices, including by allowing Medicare to negotiate prices and disincentivizing price increases, and to support
market changes that strengthen supply chains, promote biosimilars and generic drugs, and increase price transparency. These initiatives
recently culminated in the enactment of the Inflation Reduction Act (“IRA”) in August 2022, which will, among other things,
allow HHS to negotiate the selling price of certain drugs and biologics that CMS reimburses under Medicare Part B and Part D, although
only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for biologics) can be selected by CMS
for negotiation, with the negotiated price taking effect two years after the selection year. The negotiated prices, which will first
become effective in 2026, will be capped at a statutory ceiling price representing a significant discount from average prices to wholesalers
and direct purchasers. The law will also, beginning in October 2023, penalize drug manufacturers that increase prices of Medicare Part
B and Part D drugs at a rate greater than the rate of inflation. The IRA also extends enhanced subsidies for individuals purchasing health
insurance coverage in ACA marketplaces through plan year 2025. The IRA permits the Secretary of HHS to implement many of these provisions
through guidance, as opposed to regulation, for the initial years. Manufacturers that fail to comply with the IRA may be subject to various
penalties, including civil monetary penalties. These provisions will take effect progressively starting in 2023, although they may be
subject to legal challenges.
Employees-Human
Capital
As
of November 1, 2023, we had no employees. We utilize certain Sanovas’ personnel for our business and are allocated the proportion
of payroll costs applicable to such usage from Sanovas.
Available
Information
Our
website address is www.retinalgenix.com. The contents of, or information accessible through, our website are not part of this Registration
Statement on Form S-1, and our website address is included in this document as an inactive textual reference only. We make our filings
with the SEC, including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments
to those reports, available free of charge on our website as soon as reasonably practicable after we file such reports with, or furnish
such reports to, the SEC. The public may read and copy the materials we file with the SEC at the SEC’s Public Reference Room at
100 F Street, NE, Washington, DC 20549. The public may obtain information on the operation of the Public Reference Room by calling the
SEC at 1-800-SEC-0330. Additionally, the SEC maintains an internet site that contains reports, proxy and information statements and other
information. The address of the SEC’s website is www.sec.gov. The information contained in the SEC’s website is not intended
to be a part of this filing.
Properties
We
do not own or lease any real property or office space. We are allocated a portion of Sanovas’ office and laboratory space in Petaluma
California based upon usage of such space for RetinalGenix projects.
We
believe this arrangement is adequate for our current needs.
Legal
Proceedings
From
time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to
any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have
a material adverse effect on our business, operating results, cash flows or financial condition. Notwithstanding the foregoing, Sanovas,
Inc. (“Sanovas”), the majority stockholder of Sanovas Ophthalmology, LLC which is our majority stockholder, commenced an
action in the Court of Chancery of the State of Delaware against Halo Management LLC (“Halo”) and Lawrence Gerrans seeking
an order declaring that any rights that Halo and/or Mr. Gerrans may have with respect to any equity securities in Sanovas and each of
its affiliated subsidiaries (including, but not limited to, our Company) are void or voidable and may be cancelled.
Pursuant
to the terms of an employment agreement dated January 1, 2012 (the “Effective Date”) by and between Sanovas, the majority
stockholder of Sanovas Ophthalmology, LLC which is our majority stockholder, and Lawrence Gerrans, the then President and Chief Executive
Officer of Sanovas (the “Original Employment Agreement”), in consideration for Mr. Gerrans’ services, Mr. Gerrans was
to receive, among other consideration, the following equity securities: (i) 441,177 shares of restricted common stock of each of the
wholly-owned subsidiaries of Sanovas, as of the Effective Date (the “Affiliate Subsidiaries”), representing 7.5% of the total
equity capital of each such subsidiary issued and outstanding as of the date of grant; and (ii) 5,000 shares of Series F Preferred Stock
of Sanovas and each of the Affiliate Subsidiaries. We were incorporated in Delaware on November 17, 2017, subsequent to the Effective
Date, and as such these shares were never issued by us because we were not an Affiliate Subsidiary of Sanovas. Thereafter, in May 2015,
Mr. Gerrans’ Original Employment Agreement was amended and restated with an effective date of January 1, 2012 (the “Amended
and Restated Employment Agreement”), the same as the Effective Date of the Original Employment Agreement. Pursuant to the Amended
and Restated Employment Agreement, in consideration for Mr. Gerrans’ services, Mr. Gerrans was to receive, among other consideration,
the following equity securities: (i) 7.5% of the total equity capital of each of Sanovas’ Affiliate Subsidiaries as of the Effective
Date or thereafter formed (collectively, the “New Subsidiaries”); and (ii) 5,000 shares of Series F Preferred Stock of Sanovas,
each of the Affiliate Subsidiaries and each of the New Subsidiaries, including our Company. Subsequently, pursuant to a board resolution
dated December 1, 2017 approved by Lawrence Gerrans, our then Chief Executive Officer, President and sole director, in 2018 we issued
27,000,000 shares of our common stock to Sanovas Ophthalmology LLC, and issued 3,000,000 shares of our Series F Preferred Stock to Halo
Management LLC (“Halo”), an entity owned by Mr. Gerrans, for certain enumerated consideration that was purported to have
been provided. Thereafter, and in part based upon the evidence and testimony presented, and verdict and conviction rendered, in the Criminal
Action (discussed below), including, but not limited to, the fact that Mr. Gerrans misled and coerced the board of Sanovas regarding
the terms and need for approval of the Amended and Restated Employment Agreement, our board of directors, acting in concert with the
board of directors of Sanovas, carried out an investigation with respect to actions taken by Mr. Gerrans and have determined that Halo
did not provide us with valid consideration for the Series F Preferred Stock, and we dispute whether any of the shares of the Company
issued to Halo were validly issued.
In
January 2020, a jury in the United States District Court for the Northern District of California found Mr. Gerrans guilty, in a criminal
proceeding (the “Criminal Action”), on 12 felony counts of wire fraud, money laundering, perjury, contempt of court, witness
tampering, and obstruction of justice in connection with his activities as an officer and director of Sanovas. Thereafter, in November
2020, Sanovas commenced an action in the Court of Chancery of the State of Delaware (the “Delaware Action”) against Halo
and Mr. Gerrans seeking an order declaring that any rights that Halo and/or Mr. Gerrans may have with respect to any equity securities
in Sanovas and each of its affiliated subsidiaries (including, but not limited to, our Company) are void or voidable and may be cancelled.
The Delaware Action is currently still pending. We intend to take any and all actions required to assist Sanovas in obtaining a judgement
against Halo and Mr. Gerrans in the Delaware Action declaring any shares issued to them void or voidable.
On
November 21, 2021, our Board of Directors resolved to rescind the 3,000,000 shares of Series F Preferred Stock purported issued to Halo
for lack of contract consideration. We recorded this action into our accounts in the fourth quarter of 2021.We are aware that the management/ownership
of Halo may dispute this decision however, we are prepared to defend our decision in this case. In addition, we reserve the right to
void the shares ab initio and adjust our filings accordingly if necessary.
Corporate
Information
We
were incorporated in Delaware on November 17, 2017. Our principal executive offices are located at 1450 North McDowell Boulevard, Suite
150, Petaluma, CA 94954 and our telephone number is (415) 578-9583. Our website address is www.retinalgenix.com. The information
contained on our website is not incorporated by reference into this prospectus, and you should not consider any information contained
on, or that can be accessed through, our website as part of this prospectus or in deciding whether to purchase our securities.
MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market
Information
Our
common stock is quoted on the OTC Pink tier of the OTC Markets Group, Inc. under the symbol “RTGN.”
Dividend
Policy
We
have not paid any cash dividends on our capital stock and we do not expect to pay cash dividends in the foreseeable future. We intend
to retain future earnings, if any, to provide funds for operations of our business. The decision whether to pay cash dividends on our
common stock will be made by our board of directors, in their discretion, and will depend on our financial condition, results of operations,
capital requirements and other factors that our board of directors considers significant.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You
should read the following discussion of our financial condition and results of operations in conjunction with our financial statements
and notes thereto, as well as the “Risk Factors” and “Description of Business” sections included elsewhere in
this prospectus. The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual
results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these
differences include those discussed below and elsewhere in this prospectus, particularly in “Risk Factors.”
Overview
We
are an ophthalmic research and development company focused on developing technologies to screen, monitor, diagnose and treat ophthalmic,
optical, and sight-threatening disorders. Our mission is to prevent vision loss and blindness due to diabetic retinopathy and maculopathy
through two devices: (1) Retinal Imaging Screening Device, a portable, retinal imaging system providing a 200-degree field of
view without requiring pupil dilation; and (2) RetinalCamTM, a home monitoring and imaging device offering real-time
communication and alerting system for physicians available 24/7.
To
date, we have devoted substantially all of our resources to organizing, business planning, raising capital, designing and developing
product candidates, and securing manufacturing and sales/distribution partners. We do not have any products approved for sale and have
not generated any revenue from product sales. We have funded our operations primarily through the private placement of common stock.
We
anticipate that we will need an additional $12,000,000 to (i) complete product design and testing for RetinalGenixTM and RetinalCamTM
and submit RetinalGenixTM for FDA clearance (we anticipate that the RetinalCamTM will not require FDA clearance);
(ii) complete the development and expansion of the software tools around the recently acquired DNA/GPS’ genetic mapping technology;
and (iii) build the infrastructure for our sustained growth. We intend to obtain such funds through the sales of our equity and debt
securities and/or through potential strategic partnerships; however, no assurance can be provided that funds will be available to us
on acceptable terms, if at all.
We
do not expect to generate any revenues from product sales unless and until we successfully complete development of RetinalCamTM,
and we do not expect to generate any revenues from product sales unless and until we successfully obtain regulatory clearance for RetinalGenixTM.
In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting,
investor relations, compliance and other expenses.
As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such
time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through
public or private equity offerings, debt financings, strategic partnerships, collaborations and licensing arrangements or other capital
sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms or
at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial
condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant
rights to develop and market our product candidates.
We
have been issuing shares of our common stock pursuant to a private placement raising approximately $3.0 million from the sale of 3,010,000
shares of common stock from January 2019 through December 31, 2021. An additional 60,500 shares were sold in January 2022 pursuant
to this private placement.
Because
of the numerous risks and uncertainties we are unable to accurately predict the timing or amount of increased expenses or when or if
we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If
we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations
at planned levels and be forced to reduce or terminate our operations.
On
July 5, 2022, we entered into an Exchange Agreement (the “Exchange Agreement”) with Dr. Lawrence Perich pursuant to which
we acquired all the outstanding shares of DNA/GPS Inc., a pharmacogenetics company based in Tampa, Florida (“DNA/GPS”), in
exchange for the issuance of 2,000,000 shares of our common stock. The acquisition of DNA/GPS combines DNA/GPS’ genetic mapping
capabilities with our retinal imaging capabilities. The combined technology is expected to have the ability to provide diagnoses of systemic
and retinal diseases. We accounted for this transaction as an asset acquisition in the quarter ending September 30, 2022, and recorded
the estimated purchase consideration and related expenses as in process research and development in the accompanying consolidated statement
of operations.
In September 2023, the Company retired $950,086 due to Sanovas through the issuance of 316,695 shares of common
stock to Sanovas Opthalmology, LLC.
Basis
of presentation:
These
accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the
United States of America (“US GAAP”) including all pronouncements of the SEC applicable to annual financial statements.
Components
of Results of Operations
Revenue
We
have not generated any revenue since our inception.
Research
and Development Expenses
Research
and development expenses include personnel costs associated with research and development activities, including third-party contractors
to perform research, product and prototype development, and testing of materials. Research and development expenses are charged to operations
as incurred.
We
accrue for costs incurred by external service providers based on our estimates of services performed and costs incurred. These estimates
include the level of services performed by third parties and other indicators of the services completed.
We
cannot determine with certainty the duration and costs of future clinical trials and product development or if, when or to what extent
we will generate revenue from the commercialization and sale of any product candidate for which we obtain marketing clearance. We may
never succeed in obtaining marketing approval for any product candidate. The duration, costs and timing of product development will depend
on a variety of factors, including:
|
● |
the
scope, rate of progress, expense and results of product development, as well as of any future clinical trials of other product candidates
and other research and development activities that we may conduct; |
|
|
|
|
● |
the
actual probability of success for our product candidates, including their safety and efficacy, early clinical data, competition,
manufacturing capability and commercial viability; |
|
|
|
|
● |
significant
and changing government regulation and regulatory guidance; |
|
● |
the
timing and receipt of any marketing approvals; and |
|
|
|
|
● |
the
expense of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights. |
A
change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change
in the costs and timing associated with the development of that product candidate.
Administrative
Expenses
Administrative
expenses consist primarily of compensation and consulting related expenses. Administrative expenses also include professional fees and
other corporate expenses, including legal fees relating to corporate matters; professional fees for accounting, auditing, tax and consulting
services; insurance costs; travel expenses, marketing activities and other operating costs that are not specifically attributable to
research activities.
We
expect that our administrative expenses will increase in the future as we increase our personnel headcount to support our continued research
activities and development of our product candidates. We also expect increased expenses associated with being a public company, including
costs related to accounting, audit, legal, regulatory and tax-related services associated with compliance with SEC requirements; director
and officer insurance costs; and investor and public relations costs.
Interest
Expense
Interest
expense is the coupon interest rate charged on loans from stockholders.
Results
of Operations
Comparison
of the six months ended June 30, 2023 and 2022
The
following table sets forth key components of our results of operations for the six months ended June 30, 2023 and 2022.
| |
For The Six Months Ended | | |
| | |
| |
| |
June 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
Change | | |
% Change | |
| |
| | |
| | |
| | |
| |
Revenues | |
$ | - | | |
$ | - | | |
| | | |
| | |
Expenses | |
| | | |
| | | |
| | | |
| | |
General and Administrative Expenses | |
| 323,339 | | |
| 328,580 | | |
| (5,241 | ) | |
| -5 | % |
Research and Development | |
| 380,509 | | |
| 292,932 | | |
| 87,577 | | |
| 30 | % |
Stock-based compensation | |
| 157,018 | | |
| 110,102 | | |
| 46,916 | | |
| 43 | % |
Total Expenses | |
| 860,866 | | |
| 731,614 | | |
| 129,252 | | |
| 18 | % |
Interest expense | |
| 1,920 | | |
| 2,920 | | |
| (1,000 | ) | |
| (34 | )% |
Net Loss | |
$ | (862,786 | ) | |
$ | (734,534 | ) | |
| 128,252 | | |
| 17 | % |
Revenues
We
did not recognize revenues for the six months ended June 30, 2023 and 2022.
Research
and Development Expenses
| |
For the six months ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Direct costs | |
$ | 363,849 | | |
$ | 281,432 | |
Allocated costs from Sanovas | |
| 16,660 | | |
| 11,500 | |
Total Research and Development expenses | |
$ | 380,509 | | |
$ | 292,932 | |
Research
and development expenses increased by $87,577, or 30%, to $380,509 for the six months ended June 30, 2023 from $292,932 for the six months
ended June 30, 2022. The increase was primarily the result of an increase in prototype related expense, engineering and technology consultants,
and pilot manufacturing costs.
Comparison
of the quarter ended June 30, 2023 and 2022
The
following table sets forth key components of our results of operations for the three months ended June 30, 2023 and 2022.
| |
For The Three Months Ended | | |
| | |
| |
| |
June 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
Change | | |
% Change | |
Revenues | |
$ | - | | |
$ | - | | |
| | | |
| | |
Expenses | |
| | | |
| | | |
| | | |
| | |
General and Administrative Expenses | |
| 120,097 | | |
| 167,385 | | |
| (47,288 | ) | |
| -28 | % |
Research and Development | |
| 152,577 | | |
| 135,439 | | |
| 17,138 | | |
| 13 | % |
Stock-based compensation | |
| 78,509 | | |
| 55,051 | | |
| 23,458 | | |
| 43 | % |
Total Expenses | |
| 351,183 | | |
| 357,875 | | |
| (6,692 | ) | |
| -2 | % |
Interest expense | |
| 960 | | |
| 1,460 | | |
| (500 | ) | |
| -34 | % |
Net Loss | |
$ | (352,143 | ) | |
$ | (359,335 | ) | |
| (7,192 | ) | |
| -2 | % |
Revenues
We
did not recognize revenues for the three months ended June 30, 2023 and 2022.
Research
and Development Expenses
| |
For the three months ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Direct costs | |
$ | 135,917 | | |
$ | 125,439 | |
Allocated costs from Sanovas | |
| 16,660 | | |
| 10,000 | |
Total Research and Development expenses | |
$ | 152,577 | | |
$ | 135,439 | |
Research
and development expenses increased by $17,138, or 13%, to $152,577 for the three months ended June 30, 2023 from $135,439 for the three
months ended June 30, 2022. The increase was primarily the result of an increase in prototype related expense, engineering and technology
consultants, and pilot manufacturing costs.
Stock
Based Compensation Expenses
Stock-based
compensation expenses increased by $23,458, or 43%, to $78,509 for the three months ended June 30, 2023 from $55,051 for the three months
ended June 30, 2022. The increase was primarily due to the recognition of expense for options issued in mid - 2022, for which expense
was recognized in the second quarter of 2023.
General
and Administrative Expenses
| |
For the three months ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Direct costs | |
$ | (3,653 | ) | |
$ | 69,725 | |
Allocated costs from Sanovas | |
| 123,750 | | |
| 97,660 | |
Total general and administrative expenses | |
$ | 120,097 | | |
$ | 167,385 | |
Administrative
expenses decreased by $47,288 or 28%, to $120,097 for the three months ended June 30, 2023 from $167,385 for the three months ended June
30, 2022. We have no full-time employees and have had limited funding to progress our internal projects. The decrease in general and
administrative expenses was primarily due a lack of funding available to procure services and settlement of amounts owed to certain vendors,
partially offset by an increase in compensation allocated to us from Sanovas from approximately $90,000 to $120,000 during the three
months ended June 30, 2023 and 2022, respectively, due to an increase in Sanovas staff working on our related projects. Administrative
costs consisting of costs related to executives and employees from Sanovas, were allocated based upon the amount of effort spent by such
personnel on our business. Other administrative expenses were slightly higher and related primarily to increased professional fees and
listing related expenses.
Critical
Accounting Estimates
The
preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and related disclosures in the financial statements and accompanying notes. Management bases
it estimates on historical experience and on assumptions believed to be reasonable under the circumstances. The estimation process often
may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls
within that range of reasonable estimates. Estimates are used in areas including, but not limited to: research and development expense
recognition, valuation of stock options, allowances of deferred tax assets, accrued expenses and liabilities, and cash flow assumptions
regarding going concern considerations.
Stock-based
Compensation
Stock-based
compensation represents the cost related to stock-based awards granted to employees. We measure stock-based compensation costs at the
grant date, based on the estimated fair value of the award and recognize the cost (net of estimated forfeitures) over the vesting period.
Forfeitures are estimated on the date of grant and revised if actual or expected forfeiture activity differs materially from the original
estimates. We estimate the fair value of stock options using a Black-Scholes valuation model. The cost is recorded in the consolidated
statements of operations based on the employees’ respective function. The fair value of common stock was determined based upon
the sale of common stock to third parties pursuant to the offering which commenced in 2019, which offering continued through January
2022.
The
risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero-coupon issues with a remaining
term commensurate with the expected term of the award. Management has estimated expected volatility based on similar comparable industry
sector averages. Expected life of the option represents the period of time options are expected to be outstanding. The estimate for dividend
yield is 0% because we have not historically paid and does not intend to pay a dividend on its common stock in the foreseeable future.
Allocated
costs from Sanovas
A
substantial portion of our expenses are costs and expenses paid by Sanovas and costs and expenses allocated to us by Sanovas. We expect
that to continue until we have sufficient resources to build our own team and infrastructure to support our operations. The allocations
our payroll related expenses are based upon the estimated percentage of effort incurred by each employee on operations. Allocation of
non-payroll related expenses are based upon whether the expense related to our operations.
Income
taxes
We
account for income taxes using the asset-and-liability method in accordance with Accounting Standards Codification 740, Income Taxes.
Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial
statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.
Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those
temporary differences are expected to be recovered or settled. The effect on the deferred tax assets and liabilities of a change in tax
rate is recognized in the period that includes the enactment date. A valuation allowance has been recorded for all of the deferred tax
assets.
Recently
Issued and Adopted Accounting Standards
The
following pronouncement may have an impact on the accounting policies of the Company:
In
February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“ASU 2016-02”). ASU 2016-02 requires an
entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require
new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing,
and uncertainty of cash flows arising from leases. The FASB issued ASU No. 2018-10 “Codification Improvements to Topic 842, Leases”
(“ASU 2018-10”), ASU No. 2018-11 “Leases (Topic 842) Targeted Improvements” (“ASU 2018-11”) in July
2018, and ASU No. 2018-20 “Leases (Topic 842) - Narrow Scope Improvements for Lessors” (“ASU 2018-20”) in December
2018. ASU 2018-10 and ASU 2018-20 provide certain amendments that affect narrow aspects of the guidance issued in ASU 2016-02. ASU 2018-11
allows all entities adopting ASU 2016-02 to choose an additional (and optional) transition method of adoption, under which an entity
initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of
retained earnings in the period of adoption. Pursuant to ASU 2019-10 the effective date for ASC 842 was deferred an additional year.
We expect to recognize operating lease right-of-use assets and lease liabilities on the balance sheet upon adoption of this ASU for its
2022 financial period . We do not current have any leases.
A
variety of proposed or otherwise potential accounting standards are currently under study by standard-setting organizations. Due to the
tentative and preliminary nature of those proposed standards, management has not determined whether the implementation of such proposed
standards would be material to our consolidated financial statements.
JOBS
Act
We
are an “emerging growth company,” as defined in Section 2(a) the Securities Act, as modified by the JOBS Act. For as long
as we continue to be an emerging growth company, we also intend to take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies including, but not limited to, reduced disclosure obligations regarding executive compensation
in our periodic reports and proxy statements, exemptions from the requirements of holding a nonbinding advisory stockholder vote on executive
compensation and any golden parachute payments not previously approved, exemption from the requirement of auditor attestation in the
assessment of our internal control over financial reporting and exemption from any requirement that may be adopted by the Public Company
Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional
information about the audit and the financial statements (auditor discussion and analysis). We will remain an emerging growth company
until the earliest of (i) the end of the fiscal year in which the market value of our common stock that is held by non-affiliates exceeds
$700 million as of the end of the second fiscal quarter, (ii) the end of the fiscal year in which we have total annual gross revenues
of $1.325 billion or more during such fiscal year, (iii) the date on which we issue more than $1 billion in non-convertible debt in a
three-year period or (iv) the end of the fiscal year following the fifth anniversary of the date of the first sale of our common stock
pursuant to an effective registration statement filed under the Securities Act.
Trends
and Uncertainties
Increasing
inflation, operating costs for many businesses including ours have increased and, in the future, could impact demand or pricing manufacturing
of our devices, foreign exchange rates or employee wages. Inflation rates, particularly in the United States, have increased recently
to levels not seen in years, and increased inflation may result in increases in our operating costs (including our labor costs), reduced
liquidity and limits on our ability to access credit or otherwise raise capital. In addition, the Federal Reserve has raised, and may
again raise, interest rates in response to concerns about inflation, which coupled with reduced government spending and volatility in
financial markets may have the effect of further increasing economic uncertainty and heightening these risks.
Basis
of presentation:
These
accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States
of America (“US GAAP”) including all pronouncements of the SEC applicable to annual financial statements.
Components
of Results of Operations
Revenue
We
have not generated any revenue since our inception.
Research
and Development Expenses
Research
and development expenses include personnel costs associated with research and development activities, including third-party contractors
to perform research, product and prototype development, and testing of materials. Research and development expenses are charged to operations
as incurred.
We
accrue for costs incurred by external service providers based on our estimates of services performed and costs incurred. These estimates
include the level of services performed by third parties and other indicators of the services completed.
We
cannot determine with certainty the duration and costs of future clinical trials and product development or if, when or to what extent
we will generate revenue from the commercialization and sale of any product candidate for which we obtain marketing clearance. We may
never succeed in obtaining marketing approval for any product candidate. The duration, costs and timing of product development will depend
on a variety of factors, including:
|
● |
the
scope, rate of progress, expense and results of product development, as well as of any future clinical trials of other product candidates
and other research and development activities that we may conduct; |
|
|
|
|
● |
the
actual probability of success for our product candidates, including their safety and efficacy, early clinical data, competition,
manufacturing capability and commercial viability; |
|
|
|
|
● |
significant
and changing government regulation and regulatory guidance; |
|
|
|
|
● |
the
timing and receipt of any marketing approvals; and |
|
|
|
|
● |
the
expense of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights. |
A
change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change
in the costs and timing associated with the development of that product candidate.
Administrative
Expenses
Administrative
expenses consist primarily of compensation and consulting related expenses. Administrative expenses also include professional fees and
other corporate expenses, including legal fees relating to corporate matters; professional fees for accounting, auditing, tax and consulting
services; insurance costs; travel expenses, marketing activities and other operating costs that are not specifically attributable to
research activities.
We
expect that our administrative expenses will increase in the future as we increase our personnel headcount to support our continued research
activities and development of our product candidates. We also expect increased expenses associated with being a public company, including
costs related to accounting, audit, legal, regulatory and tax-related services associated with compliance with SEC requirements; director
and officer insurance costs; and investor and public relations costs.
Interest
Expense
Interest
expense is the coupon interest rate charged on loans from stockholders.
Results
of Operations
Comparison
of the six months ended June 30, 2023 and 2022
The
following table sets forth key components of our results of operations for the six months ended June 30, 2023 and 2022.
| |
For The Six Months Ended | | |
| | |
| |
| |
June 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
Change | | |
% Change | |
Revenues | |
$ | - | | |
$ | - | | |
| | | |
| | |
Expenses | |
| | | |
| | | |
| | | |
| | |
General and Administrative Expenses | |
| 323,339 | | |
| 328,580 | | |
| (5,241 | ) | |
| -5 | % |
Research and Development | |
| 380,509 | | |
| 292,932 | | |
| 87,577 | | |
| 30 | % |
Stock-based compensation | |
| 157,018 | | |
| 110,102 | | |
| 46,916 | | |
| 43 | % |
Total Expenses | |
| 860,866 | | |
| 731,614 | | |
| 129,252 | | |
| 18 | % |
Interest expense | |
| 1,920 | | |
| 2,920 | | |
| (1,000 | ) | |
| (34 | )% |
Net Loss | |
$ | (862,786 | ) | |
$ | (734,534 | ) | |
| 128,252 | | |
| 17 | % |
Comparison
of the years ended December 31, 2022 and 2021
The
following table sets forth key components of our results of operations for the year ended December 31, 2022 and 2021.
| |
For The Years Ended | | |
| | |
| |
| |
December 31, | | |
| | |
| |
| |
2022 | | |
2021 | | |
Change | | |
% Change | |
| |
| | |
| | |
| | |
| |
Revenues | |
$ | - | | |
$ | - | | |
$ | | | |
| | |
Expenses | |
| | | |
| | | |
| | | |
| | |
General and Administrative Expenses | |
| 807,406 | | |
| 1,120,949 | | |
| (313,543 | ) | |
| (28 | )% |
Research and Development | |
| 809,255 | | |
| 747,808 | | |
| 61,447 | | |
| 8 | % |
Acquired In-process research and development | |
| 2,032,889 | | |
| - | | |
| 2,032,889 | | |
| 100 | % |
Stock-based compensation | |
| 259,300 | | |
| 307,918 | | |
| (48,618 | ) | |
| (16 | )% |
Total Expenses | |
| 3,908,850 | | |
| 2,176,675 | | |
| 1,732,175 | | |
| 80 | % |
Interest expense | |
| 5,140 | | |
| 2,619 | | |
| 2,521 | | |
| 96 | % |
Net Loss | |
$ | (3,913,990 | ) | |
$ | (2,179,294 | ) | |
| (1,734,696 | ) | |
| 80 | % |
Revenues
We
did not recognize revenues for the years ended December 31, 2022 and 2021.
Research
and Development Expenses for the years ended December 31, 2022 and 2021
| |
For the years ended | |
| |
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Direct costs | |
$ | 713,801 | | |
$ | 635,108 | |
Allocated costs from Sanovas | |
| 95,454 | | |
| 112,700 | |
Total Research and Development expenses | |
$ | 809,255 | | |
$ | 747,808 | |
Research
and development expenses increased by $61,447, or 8%, to $809,255 for the year ended December 31, 2022 from $747,808 for the year ended
December 31, 2021. The increase was primarily the result of an increase in prototype related expense, engineering and technology consultants,
and pilot manufacturing costs.
Stock
Based Compensation Expenses
Stock
Based Compensation Expenses for the six months ended June 30, 2023 and 2022
Stock-based
compensation expenses increased by $46,916, or 43%, to $157,018 for the six months ended June 30, 2023 from $110,102 for the six months
ended June 30, 2022. The increase was primarily due to the recognition of expense for options issued in mid - 2022, for which expense
was recognized in the first half of 2023.
Stock
Based Compensation Expenses for the year ended December 31, 2022 and 2021
Stock-based
compensation expenses decreased by $48,618, or 16%, to $259,300 for the year ended December 31, 2022 from $307,918 for the year ended
December 31, 2021. The decrease was primarily due to the recognition of expense for fully vested warrants issued in the first quarter
of 2021, which did not re-occur in 2022.
General
and Administrative Expenses
General
and Administrative Expenses for the six months ended June 30, 2023 and 2022
| |
For the six months ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Direct costs | |
$ | 75,839 | | |
$ | 135,089 | |
Allocated costs from Sanovas | |
| 247,500 | | |
| 193,491 | |
Total general and administrative expenses | |
$ | 323,339 | | |
$ | 328,580 | |
Administrative
expenses decreased by $5,241 or 2%, to $323,339 for the six months ended June 30, 2023 from $328,580 for the six months ended June 30,
2022. We have no full-time employees and have had limited funding, therefore the Company has temporarily eliminated as many costs as
possible including professional fees and website and marketing. Administrative costs consisting of costs related to executives and employees
from Sanovas, were allocated based upon the amount of effort spent by such personnel on our business. Marketing and other costs allocated
from Sanovas substantially ceased in 2023. Salaries allocated to the Company from Sanovas increased in 2023 since the majority of time
spent by Sanovas employees were on Company activities as opposed to 2022, when Sanovas had other significant projects ongoing. Other
administrative expenses were lower because of a lack of cash funding for marketing and professional fees and listing related expenses.
General
and Administrative Expenses for the year ended December 31, 2022 and 2021
| |
For the years ended | |
| |
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Direct costs | |
$ | 370,523 | | |
$ | 361,580 | |
Allocated costs from Sanovas | |
| 436,883 | | |
| 759,369 | |
Total general and administrative expenses | |
$ | 807,406 | | |
$ | 1,120,949 | |
Administrative
expenses decreased by $313,543 or 28%, to $807,406 for the year ended December 31, 2022 from $1,120,949 for the year ended December 31,
2021. We have no full-time employees. The decrease in administrative expenses was primarily due to a decrease in compensation allocated
to us from Sanovas from $654,000 to $360,000 during the year ended December 31, 2022 and 2021, respectively due to a total lower quantity
of Sanovas employees in total and an increase in Sanovas staff working on other projects. Administrative costs consisting of costs related
to executives and employees from Sanovas, were allocated based upon the amount of effort spent by such personnel on our business. Other
administrative expenses were lower due to a lack of funding. This decrease was offset by increases corporate travel and entertainment
of approximately $22,000 during the year ended December 31, 2022 as compared to the year ended December 31, 2021 primarily related to
investor meetings.
Acquired
in-process research and development
Acquired
in-process research and development presents the estimated fair value of the acquired technology held by DNA/GPS, Inc. when we acquired
that company in July 2022. The estimated fair value of the transaction was $2,000,000 plus legal fees associated with the transaction
of $32,889 is recorded as acquired in-process research and development costs in the associated consolidated statement of operations.
Liquidity
and Capital Resources
To
date, we have devoted substantially all of our resources to organizing, business planning, raising capital, designing and developing
product candidates, and securing manufacturing and sales/distribution partners. We do not have any products approved for sale and have
not generated any revenue from product sales. We have funded our operations primarily from the sale of common stock, loans and advances
from related parties and by utilizing Sanovas personnel and facilities. During the three months ended June 30, 2023, we received $188,370
of cash advances and allocated services from Sanovas. We have settled a portion of the amounts due to Sanovas through the periodic issuance
of shares of common stock, including 353,432 shares issued in May 2022 in settlement of the amounts due to Sanovas of $353,432 and 586,370
shares issued in November 2022 in settlement of the amounts due to Sanovas of $586,370.
We
anticipate that we will need $12,000,000 in operating capital to (i) complete product design and testing for RetinalGenixTM
and RetinalCamTM and submit RetinalGenixTM for FDA approval (we anticipate that the RetinalCamTM will
not require FDA approval); (ii) complete the development and expansion of the software tools around the recently acquired DNA/GPS’
genetic mapping technology; and (iii) build the infrastructure for our sustained growth. We do not expect to generate any revenues from
product sales unless and until we successfully complete development of RetinalGenixTM and RetinalCamTM and obtain
regulatory approval for RetinalGenixTM. We will also require additional operating capital as a result of us operating as a
public company, including for legal, accounting, investor relations, compliance and other expenses.
As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such
time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through
public or private equity offerings, debt financings, strategic partnerships, collaborations and licensing arrangements or other capital
sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms or
at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial
condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant
rights to develop and market our product candidates.
Because
of the numerous risks and uncertainties, we are unable to accurately predict the timing or amount of increased expenses or when or if
we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If
we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations
at planned levels and be forced to reduce or terminate our operations.
Cash
Flow Activities for the six months ended June 30, 2023 and 2022
The
following table sets forth a summary of our cash flows for the periods presented:
| |
For The Six Months Ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Net cash used in operating activities | |
$ | (201,385 | ) | |
$ | (107,106 | ) |
Net cash provided by financing activities | |
| 203,260 | | |
| 102,186 | |
Net increase (decrease) in cash | |
| 1,875 | | |
| (4,920 | ) |
Cash at beginning of the period | |
| 38 | | |
| 4,947 | |
Cash at end of the period | |
$ | 1,913 | | |
$ | 27 | |
Operating
Activities
Net
cash used in operating activities was $201,385 for the six months ended June 30, 2023 and $107,106 for the six months ended June 30,
2022, the increase was driven by higher R&D costs partially offset by a reduction in costs allocated from Sanovas to us and increases
in accounts payable due to a lack of funding. The cash flow used in operating activities in 2023 was driven by the net loss of $862,786
offset in part by non-cash expenses of $157,018 and an increase in accounts payable and accrued interest payable of $221,593. In addition,
Sanovas billed us for allocated costs and expenses paid on behalf of and allocated to us in the amount of $280,2820 during the six months
ended June 30, 2023, and we received $102,423 of net cash advances from Sanovas, for a net change in cash of $1,875.
Net
cash used in operating activities was $107,106 for the six months ended June 30, 2022, the decrease driven by a reduction in salaries
allocated from Sanovas to the Company and expenditures by third-party consultants and engineers on the prototype development. The cash
flow used in operating activities in 2022 was driven by the net loss of $734,534 offset in part by non-cash stock-based compensation
expense of $110,102 and an increase in accounts payable and accrued interest payable of $91,217. In addition, Sanovas billed us for allocated
costs and expenses paid on behalf of and allocated to us in the amount of $204,991 and we received $221,119 of net cash advances from
Sanovas during the six months ended June 30, 2022.
Financing
Activities
Net
cash provided by financing activities was $203,260 and $102,186 during the six months ended June 30, 2023 and 2022, respectively, attributable
to proceeds from advances from related parties and Sanovas of $203,260 in the six months ended June 30, 2023, and the sale of common
stock of $60,500 and proceeds from advances from related parties of $41,686 in the six months ended June 30, 2022.
Liquidity
and Capital Resources
To
date, we have devoted substantially all of our resources to organizing, business planning, raising capital, designing and developing
product candidates, and securing manufacturing partners. We do not have any products approved for sale and have not generated any revenue
from product sales. We have funded our operations primarily from the sale of common stock, loans and advances from related parties and
by utilizing Sanovas personnel and facilities. During the year ended December 31, 2022, we received $1,225,014 of cash advances and allocated
services from Sanovas. We have settled a portion of the amounts due to Sanovas through the periodic issuance of shares of common stock,
including 353,432 shares of common stock issued in May 2022 in settlement of the amounts due to Sanovas of $353,432 and 586,370 shares
of common stock issued in November 2022 in settlement of the amounts due to Sanovas of $586,370.
We
anticipate that we will need $12,000,000 in operating capital to (i) complete product design and testing for RetinalGenixTM
and RetinalCamTM and submit RetinalGenixTM for FDA approval (we anticipate that the RetinalCamTM will
not require FDA approval); (ii) complete the development and expansion of the software tools around the recently acquired DNA/GPS’
genetic mapping technology; and (iii) build the infrastructure for our sustained growth. We do not expect to generate any revenues from
product sales unless and until we successfully complete development of RetinalGenixTM and RetinalCamTM and obtain
regulatory approval for RetinalGenixTM. We will also require additional operating capital as a result of us operating as a
public company, including for legal, accounting, investor relations, compliance and other expenses.
As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such
time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through
public or private equity offerings, debt financings, strategic partnerships, collaborations and licensing arrangements or other capital
sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms or
at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial
condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant
rights to develop and market our product candidates.
Because
of the numerous risks and uncertainties, we are unable to accurately predict the timing or amount of increased expenses or when or if
we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If
we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations
at planned levels and be forced to reduce or terminate our operations.
Cash
Flow Activities for the year ended December 31, 2022 and 2021
The
following table sets forth a summary of our cash flows for the periods presented:
| |
For The Year Ended | |
| |
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Net cash used in operating activities | |
$ | (199,287 | ) | |
$ | (1,166,971 | ) |
Net cash used in investing activities | |
| (307 | ) | |
| - | |
Net cash provided by financing activities | |
| 194,685 | | |
| 1,169,699 | |
| |
| | | |
| | |
Net (decrease) increase in cash | |
| (4,909 | ) | |
| 2,728 | |
Cash at beginning of the period | |
| 4,947 | | |
| 2,219 | |
Cash at end of the period | |
$ | 38 | | |
$ | 4,947 | |
Operating
Activities
Net
cash used in operating activities was $199,287 for the year ended December 31, 2022 and $1,166,971 for the year ended December 31, 2021,
the decrease driven by a reduction in salaries allocated from Sanovas to the Company and expenditures by third-party consultants and
engineers on the prototype development due to a lack of funding. The cash flow used in operating activities in 2022 was driven by the
net loss of $3,913,990 offset in part by non-cash expenses of $2,259,351 and an increase in accounts payable and accrued interest payable
of $230,338. In addition, Sanovas billed us for allocated costs and expenses paid on behalf of and allocated to us in the amount of $532,337
during the year ended December 31, 2022, and we received $692,677 of net advances from Sanovas, for a net change in cash of $1,225,014.
The
cash flow used in operating activities in 2021 was driven by the net loss of $2,179,294 offset in part by non-cash stock-based compensation
expense of $307,918 and an increase in accounts payable and other current liabilities/assets of $156,257 for the year ended December
31, 2021. In addition, Sanovas billed us for allocated costs and expenses paid on behalf of and allocated to us in the amount of $872,069
during the year ended December 31, 2021, and we paid $323,922 of net advances from Sanovas, for a net change in cash of $548,148.
In
each of the years, 2019-2022, the Company has settled a portion of the amounts due to Sanovas through the issuance of common stock. The
Company issued 939,802 and 390,358 shares of its common stock to offset amounts due to Sanovas for payment of expenses on behalf of the
Company of $939,802 and $390,358 during the years ended December 31, 2022 and 2021, respectively.
Investing
Activities
There
was no cash used in or provided by investing activities for the year ended December 31, 2022 and 2021, except an equipment purchase in
the third quarter of 2022.
Financing
Activities
Net
cash provided by financing activities was $194,685 and $1,169,699 during the year ended December 31, 2022 and 2021, respectively, attributable
primarily to proceeds from the sale of common stock of $60,500 and proceeds from advances from related parties of $109,185 in the year
ended December 31, 2022, and proceeds from the exercise of options and warrants and the sale of common stock of $1,096,699 and shareholder
loans of $73,000 in the year ended December 31, 2021.
Recently
Issued and Adopted Accounting Standards
The
following pronouncement may have an impact on the accounting policies of the Company:
In
February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“ASU 2016-02”). ASU 2016-02 requires an
entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require
new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing,
and uncertainty of cash flows arising from leases. The FASB issued ASU No. 2018-10 “Codification Improvements to Topic 842, Leases”
(“ASU 2018-10”), ASU No. 2018-11 “Leases (Topic 842) Targeted Improvements” (“ASU 2018-11”) in July
2018, and ASU No. 2018-20 “Leases (Topic 842) - Narrow Scope Improvements for Lessors” (“ASU 2018-20”) in December
2018. ASU 2018-10 and ASU 2018-20 provide certain amendments that affect narrow aspects of the guidance issued in ASU 2016-02. ASU 2018-11
allows all entities adopting ASU 2016-02 to choose an additional (and optional) transition method of adoption, under which an entity
initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of
retained earnings in the period of adoption. Pursuant to ASU 2019-10 the effective date for ASC 842 was deferred an additional year.
The Company expects to recognize operating lease right-of-use assets and lease liabilities on the balance sheet upon adoption of this
ASU for its 2022 financial period. The Company is currently evaluating these ASUs and their impact on its consolidated financial statements,
but does not expect it to have a significant impact on its financial statements.
A
variety of proposed or otherwise potential accounting standards are currently under study by standard-setting organizations. Due to the
tentative and preliminary nature of those proposed standards, management has not determined whether the implementation of such proposed
standards would be material to the financial statements of the Company.
JOBS
Act
We
are an “emerging growth company,” as defined in Section 2(a) the Securities Act, as modified by the JOBS Act. For as long
as we continue to be an emerging growth company, we also intend to take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies including, but not limited to, reduced disclosure obligations regarding executive compensation
in our periodic reports and proxy statements, exemptions from the requirements of holding a nonbinding advisory stockholder vote on executive
compensation and any golden parachute payments not previously approved, exemption from the requirement of auditor attestation in the
assessment of our internal control over financial reporting and exemption from any requirement that may be adopted by the Public Company
Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional
information about the audit and the financial statements (auditor discussion and analysis). We will remain an emerging growth company
until the earliest of (i) the end of the fiscal year in which the market value of our common stock that is held by non-affiliates exceeds
$700 million as of the end of the second fiscal quarter, (ii) the end of the fiscal year in which we have total annual gross revenues
of $1.325 billion or more during such fiscal year, (iii) the date on which we issue more than $1 billion in non-convertible debt in a
three-year period or (iv) the end of the fiscal year following the fifth anniversary of the date of the first sale of our common stock
pursuant to an effective registration statement filed under the Securities Act.
MANAGEMENT
Set
forth below is certain information regarding our executive officers and directors. Each of the directors listed below was elected to
our board of directors to serve until our next annual meeting of stockholders or until his or her successor is elected and qualified.
The following table sets forth information regarding the members of our board of directors and our executive officers:
Name |
|
Age |
|
Position |
Jerry
Katzman |
|
70 |
|
Chief
Executive Officer, President and Chairman of the Board |
Herbert
Gould |
|
94 |
|
Director |
Vinay
Mehindru |
|
55 |
|
Director |
Biographies
for the members of our board of directors and our management team are set forth below.
Jerry
Katzman. Jerry Katzman has served as the Company’s Chief Executive Officer and President since December 2018 and Chairman
of the board of directors since August 2018. In addition, since December 2018, he has served as the Chief Executive Officer, President
and Chairman of the board of directors of Sanovas Inc. In 2013, he founded Disruptor Technologies, a marketing and consulting company
and served as founder, Chief Executive Officer and President. Dr. Katzman previously served in various capacities including ophthalmologist
and founder of the Ophthalmology department at Brandon Surgical Group in Brandon, Florida; Founder, President, Chief Medical Officer
and a director of Eye Care International, the national’s largest non-insurance based discount vision network consisting of ophthalmologists,
optometrists, opticians and optical outlets; Chief Medical Officer and director of Amacore Group, Inc., the successor of Eye Care International,
Inc.; Chief Executive Officer and President of Clinical Control Systems, Inc., an electronic medical record development and marketing
firm; and Executive Vice President of Strategic Development of Comprehensive Behavioral Care. Since August 2019, Dr. Katzman has served
as a member of the board of directors of Paradigm Medical Industries, Inc. Dr. Katzman received his bachelor of science in biomedical
engineering from Boston University and his M.D. from Universidad de Guadalajara in Jalisco, Mexico.
We
believe Dr. Katzman is qualified to serve as a member of our board of directors because of his proven track record as a leader within
the ophthalmology field.
Herbert
Gould. Herbert Gould has served as a member of the Company’s board of directors since April 2019. Since 2007, he has served
as a Medical Director of Nutraceutical Delivery Corporation, a drug delivery system company. He previously served in various capacities
including Medical Director of Diamond Vison Laser Center; Teaching Fellow and Assistant Clinical Professor in Ophthalmology at State
University of New York; Associate Clinical Professor at New York Medical College; Instructor at American Academy of Ophthalmology; and
Attending Surgeon at Westchester County Medical Center and New York Eye & Ear Infirmary. Dr. Gould also served as a Flight Surgeon
for the U.S. Air Force. Since January 2019, Dr. Gould has served as a director of Sanovas, Inc., and since August 2019, he has served
as a member of the board of directors of Paradigm Medical Industries, Inc. Dr. Gould received his bachelor of arts from Bowdoin College
and his M.D. from Columbia University. Dr. Gould is a board certified ophthalmologist.
We
believe Dr. Gould is qualified to serve as a member of our board of directors because of his expertise and professional contacts in the
ophthalmology field.
Vinay
Mehindru. Vinay Mehindru has served as a member of the Company’s board of directors since July 2022. Dr. Mehindru, is a multi-talented
top-level executive with over 25 years of healthcare experience. He has been Chief Executive Officer of Exemplary Health, LLC from February
2019 to present. From January 2018 through January 2019 he was President of Advent Health Provider Network and from October 2014 through
December 2017 he was the President of West Florida Health Network. His leadership spans population health and financial performance management.
He has led multiple physician performance enhancement strategies and built stakeholder alliances with clinical and financial integration.
He is currently serving on the board of Sanovas, Inc., SteriView™ Technologies, Inc., Intubation Science™, Inc, SinuGeniX™,
Inc., OtoGeniX™ Inc., PulmoGeniX™ Technologies, Inc. and GastroGeniX™, Inc.
Dr.
Mehindru graduated from medical school in India. At age 27, he served on the faculty of the Cleveland Clinic where he was a top-tier
internal medicine resident and did research in gastroenterology. Dr. Mehindru has a second residency from the University of Florida in
emergency medicine. For 16 years, he had been an instructor teaching difficult airway management for both cardiovascular life support
and pediatric advanced life support.
At
the University of Texas at Dallas, he received an Executive MBA with honors in 2009, earning the Beta Gamma Sigma Award offered only
to the world’s top 5% of business students.
We
believe Dr. Mehindru is qualified to serve as a member of our board of directors because of his expertise healthcare field.
Family
Relationships
There
are no family relationships among our executive officers and directors.
Arrangements
between Officers and Directors
Except
as set forth herein, to our knowledge, there is no arrangement or understanding between any of our officers or directors and any other
person pursuant to which the officer or director was selected to serve as an officer or director.
Involvement
in Certain Legal Proceedings
We
are not aware of any of our directors or officers being involved in any legal proceedings in the past ten years relating to any matters
in bankruptcy, insolvency, criminal proceedings (other than traffic and other minor offenses), or being subject to any of the items set
forth under Item 401(f) of Regulation S-K.
Corporate
Governance
Board
Committees
We
presently do not have an audit committee, compensation committee or nominating and corporate governance committee or committee performing
similar functions, as management believes that we are in an early stage of development to form an audit, compensation, or nominating
committee. We currently do not have an audit committee financial expert for the same reason that we do not have board committees. Currently,
our board of directors acts as our audit, nominating, corporate governance and compensation committees. We intend to appoint persons
to the board of directors and committees of the board of directors as required to meet the corporate governance requirements of a national
securities exchange, although we are not required to comply with these requirements until we are listed on a national securities exchange.
We intend to appoint directors in the future so that we have a majority of our directors who will be independent directors, and of which
at least one director will qualify as an “audit committee financial expert,” prior to a listing on a national securities
exchange.
Medical
Advisory Board
In
2019, the board of directors formed a Medical Advisory Board. The members of such board are Larry Perich, D.O., Jack M. Dodick, M.D.,
Marguerite B. McDonald, M.D., Lawrence A. Yannuzzi, M.D. and Ahmed Mohiuddin, M.D.
Larry
Perich, D.O.
Dr.
Perich, a board-certified Ophthalmologist, has been in practice for the past 39 years in the Tampa Bay Area, developing one of the first
laser refractive centers in SE and 3 ambulatory surgery centers in addition to 6 offices in four counties with 94 employees. He has performed
over 75,000 cataract surgeries in addition to excelling in corneal transplants, glaucoma, and cosmetic surgical procedures.
The
Perich Eye Centers is also one of the largest providers of several Medicare advantage plans in the state of Florida for the past 37 years,
providing eye care to over 120,000 patients annually.
Dr.
Perich is the Program Director for an ophthalmology residency for HCA/USF Bayonet Point, presently training for the past 8 years.
He
graduated from the University of Southern California in 1973, studying Biochemistry and cinema photography. Dr. Perich graduated from
Chicago College of Osteopathic Medicine in 1978, an Internship at Sun Coast Hospital in Largo, Florida, and completed an Ophthalmology
residency at Metropolitan Hospital in Grand Rapids, Michigan in 1983.
Larry
Perich was born in Warren, Ohio to his parents, Pete and Anne, whose careers as a professional photography family, provided the education
for Dr. Perich to excel in the photographic business. He used his skills as an accomplished photojournalist to become the editor /photographer
for the yearbooks for high school, college, and medical school.
Jack
M. Dodick, M.D.
Jack
M. Dodick M.D. is a world-renowned eye surgeon who has devoted his professional life to teaching, innovation, and patient care. He is
currently Professor and formerly, Chairman, Department of Ophthalmology, at the New York University School of Medicine, one of the largest
eye residency training programs in the United States. Prior to that, he served as Chairman, Department of Ophthalmology at the Manhattan,
Eye, Ear and Throat Hospital in New York for over 20 years.
As
a teacher and Departmental Chairman over the past 40 years, he has supervised and participated in training hundreds of eye surgeons who
now practice throughout the United States and abroad. Dr. Dodick was a pioneer in the use of intraocular lens implants following cataract
surgery. He is a past president of the American Society of Cataract and Refractive Surgery, the world’s largest organization of
Cataract and Refractive surgeons.
He
has served as President of numerous other Ophthalmological Societies throughout his career. Dr. Dodick is the author of several publications
and book chapters on the subject of Cataract and Implant surgery and has presented over two hundred lectures on the subject throughout
the world. He has performed eye surgery to teach his techniques in over 20 countries worldwide.
Many
of his students have gone on to render eye care to countless numbers of people worldwide. He has participated in several clinical trials
of devices and drugs related to his field. His innovations include several surgical instruments which bear his name and the first to
publish on a laser-based technology to remove human cataracts which he invented, developed, and received marketing approval from the
FDA.
Marguerite
B. McDonald, M.D.
Dr.
MacDonald has been a legend in ophthalmology since she performed one of the first laser corrections of the human eye in 1994. She also
performed the first wavefront-based laser surgeries in the U.S. Since then she has been globally recognized as an authority in laser
refractive procedures and ocular surface disease. She has given nearly 600 presentations worldwide and published chapters in over 80
textbooks. She is a member of many prestigious ophthalmological societies. In 2012 she became the first person to receive the Visionary
Woman Award from the group Ophthalmic Women Leaders. Dr. McDonald has also been nominated for woman of the year in ophthalmology by her
alma mater, The Vagelos College of Physicians and Surgeons of Columbia University.
Lawrence
A. Yannuzzi, M.D.
Dr.
Yannuzzi is the founder of VRMNY as well as vice-chairman and director of the LuEsther T. Mertz Retinal Research Center of the Manhattan
Eye, Ear & Throat Hospital. He is also the founder and president of The Macula Foundation, Inc., which has distributed several million
dollars to eye research across the country.
Dr.
Yannuzzi has made numerous innovative and lasting contributions in imaging, drug development, and therapeutic modalities. He was the
first to use oral non-steroid anti-inflammatory medication for the treatment of cystoid macular edema and developed an eye drop to treat
this condition.
He
has described new diseases as well as new associations and manifestations of established entities and photosensitization. He has published
over 550 scientific papers and 13 books, which have earned him respect and admiration in the ophthalmic-retinal community.
He
is well recognized as a devoted and excellent educator, a superb clinical diagnostician, and a prolific organizer of retinal meetings
worldwide.
Dr.
Yannuzzi is the recipient of numerous awards, including an honorary doctorate by the University of Ancona, the Michelson Award for Retinal
Vascular Disease, a Distinguished Alumnus Award by Boston University, the Henkind, Gass, and Patz Medals by The Macula Society, the Alcon
Research Award, the Herman Wacker Award of the Club Jules Gonin, the Arthur J. Bedelle Award, the Retinal Research Award and the Gass
Medal of the Retina Society, the Bietti Medal, the Pisart Award from the Lighthouse International, and the Lifetime Achievement Award
by the American Academy of Ophthalmology.
Ahmed
Mohiuddin, M.D.
Dr.
Mohiuddin was the early adopter of telemedicine and established telemedicine programs in India and Dubai. He has been an advisor to several
governments around the world. He is currently the Chairman and CEO New England Heart Center, Director, New England Heart Center Foundation,
Diplomate, American Board of Internal Medicine, Diplomate, American Board of Cardiovascular Diseases, Fellow, American College of Cardiology,
Chief Emeritus of Cardiology, New England Baptist Hospital in Boston, Affiliated with Brigham and Women’s Hospital and Beth Israel
Deaconess Medical Center (both are major Harvard Medical School hospitals).
Dr.
Mohiuddin is an internationally renowned cardiologist seeing patients from many countries such as Greece, Saudi Arabia, all of the Gulf
countries, India, Pakistan, Malaysia, China, and several South American countries.
EXECUTIVE
COMPENSATION
During
the year ended December 31, 2022, our executive officers did not receive any compensation.
Outstanding
Equity Awards at December 31, 2022
As
of December 31, 2022, there were no outstanding equity awards held by any of our executive officers.
Non-Employee
Director Compensation
The
following table sets forth information regarding all forms of compensation that were both earned by and paid to our non-employee directors
during the year ended December 31, 2022.
Name | |
Fees Earned or Paid in Cash ($) | | |
Option Awards(1) | | |
All Other Compensation ($) | | |
Total | |
Herbert Gould | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
Vinay Mehindru | |
$ | — | | |
$ | 287,487 | | |
$ | — | | |
$ | 287,487 | |
(1) |
This
column indicates the aggregate grant date fair value, as determined in accordance with Financial Accounting Standards Board Accounting
Standards Codification Topic 718, Compensation — Stock Compensation (“FASB ASC Topic 718”), of option awards granted
as of their respective grant date. See “Note B, paragraph 7 — Stock-based compensation” of the Notes to Consolidated
Financial Statements contained in this Registration Statement on Form S-1 for an explanation of the assumptions made in valuing these
awards. |
The
aggregate number of option and stock awards outstanding as of December 31, 2022 for each non-employee director was as follows:
Name | |
Option Awards (#) | | |
Stock Awards (#) | |
Herbert Gould | |
| — | | |
| — | |
Vinay Mehindru | |
| 500,000 | | |
| | |
Employment
Agreements
During
the year ended December 31, 2022, we were not a party to any employment agreement.
2017
Equity Incentive Plan
Summary
Our
2017 Equity Incentive Plan (the “2017 Plan”) was adopted by our board of directors on December 1, 2017 and by our stockholders
on December 1, 2017. Having an adequate number of shares available for future equity compensation grants is necessary to promote our
long-term success and the creation of stockholders value by:
|
● |
Enabling
us to continue to attract and retain the services of key service providers who would be eligible to receive grants; |
|
|
|
|
● |
Aligning
participants’ interests with stockholders’ interests through incentives that are based upon the performance of our common
stock; |
|
|
|
|
● |
Motivating
participants, through equity incentive awards, to achieve long-term growth in our business, in addition to short-term financial performance;
and |
|
|
|
|
● |
Providing
a long-term equity incentive program that is competitive as compared to other companies with whom we compete for talent. |
The
2017 Plan permits the discretionary award of options, including non-qualified stock options (“NSOs”) and incentive stock
options (“ISOs”), restricted shares, deferred stock, restricted stock units (“RSUs”), or stock appreciation rights
(“SARs”). The 2017 Plan will remain in effect until the earlier of (i) December 1, 2027 and (ii) the date upon which the
2017 Plan is terminated pursuant to its terms, and in any event subject to the maximum share limit of the 2017 Plan. The 2017 Plan provides
for the reservation of 10,000,000 shares of common stock for issuance thereunder.
Key
Features of the 2017 Plan
Certain
key features of the 2017 Plan are summarized as follows:
|
● |
If
not terminated earlier by our board of directors, the 2017 Plan will terminate on December 1, 2027. |
|
|
|
|
● |
Up
to a maximum aggregate of 10,000,000 shares of common stock may be issued under the 2017 Plan. The maximum aggregate fair market
value with respect to ISOs are exercisable for the first time by such grantee during any calendar year may not exceed $100,000. |
|
|
|
|
● |
The
2017 Plan will generally be administered by a committee (the “Committee”), comprised of two or more directors who may
be appointed by the board from time to time. |
|
|
|
|
● |
Employees,
consultants and board members are eligible to receive awards, provided that the Committee has the discretion to determine (i) who
shall receive any awards, and (ii) the terms and conditions of such awards. |
|
|
|
|
● |
Awards
may consist of ISOs, NQSOs, restricted shares, deferred stock, RSUs and SARs. |
|
|
|
|
● |
Stock
options and SARs may not be granted at a per share exercise price below the fair market value of a share of our common stock on the
date of grant. If stock options or SARs are granted to a ten percent owner, they may not be granted at a per share exercise price
below 110% of the fair market value of a share of our common stock on the date of grant. |
|
|
|
|
● |
The
maximum exercisable term of stock options and SARs may not exceed ten years (five years if the grantee is a ten percent owner). |
Eligibility
to Receive Awards. Employees, consultants and board members of the Company and its subsidiaries are eligible to receive awards
under the 2017 Plan. The Committee determines, in its discretion, the selected participants who will be granted awards under the 2017
Plan.
Shares
Subject to the 2017 Plan. The maximum number of shares of common stock that can be issued under the 2017 Plan is 10,000,000 shares.
The shares underlying forfeited or terminated awards (without payment of consideration), or unexercised awards become available again
for issuance under the 2017 Plan.
Administration
of the 2017 Plan. The 2017 Plan will be administered by the Committee, which shall consist of two or more directors who may be
appointed by the board from time to time Subject to the terms of the 2017 Plan, the Committee has the sole discretion, among other things,
to:
|
● |
Select
the individuals who will receive awards; |
|
|
|
|
● |
Determine
the terms and conditions of awards (including the number of shares to which an award will relate, any option price, grant price or
purchase price, any limitation or restriction, any performance conditions, forfeiture restrictions, any performance goals and/or
vesting schedules and the terms of the grants); |
|
|
|
|
● |
Determine
whether or not specific awards shall be granted in connection with other specific awards, and if so, whether they shall be exercisable
cumulatively with, or alternatively to, such other specific awards and all other matters to be determined in connection with an award; |
|
|
|
|
● |
Offer
to exchange or buy out any previously granted award for a payment of cash, shares or other award; and |
|
|
|
|
● |
Interpret
the provisions of the 2017 Plan and outstanding awards. |
Types
of Awards.
Stock
Options. A stock option is the right to acquire shares at a fixed exercise price over a fixed period of time, not to exceed ten
years from its grant date. The Committee will determine, among other terms and conditions, the number of shares covered by each stock
option and the exercise price of the shares subject to each stock option, but such per share exercise price cannot be less than the fair
market value of a share of our common stock on the date of grant of the stock option. The exercise price of each stock option granted
under the 2017 Plan must be paid in full at the time of exercise, either with cash or through another method approved by the Committee.
Stock options granted under the 2017 Plan may be either ISOs or NQSOs.
SAR.
A SAR is the right to receive, upon exercise, an amount equal to the difference between the fair market value of the shares on the date
of the SAR’s exercise and the aggregate exercise price of the shares covered by the exercised portion of the SAR. The Committee
determines the terms of SARs, including the exercise price (provided that such per share exercise price cannot be less than the fair
market value of a share of our common stock on the date of grant), the vesting and the term of the SAR. Settlement of a SAR may be in
shares of common stock, in cash, or in other property or any combination thereof, as the Committee may determine.
Restricted
Shares. A restricted share award is the grant of shares of our common stock to a selected participant and such shares may be
subject to a substantial risk of forfeiture until specific conditions or goals are met. The restricted shares may be issued with or without
cash consideration being paid by the selected participant as determined by the Committee. The Committee also will determine any other
terms and conditions of an award of restricted shares.
Deferred
Stock. Deferred stock is a right to receive shares at the end of a specified deferral period.
RSUs.
RSUs are the right to receive an amount equal to the fair market value of the shares covered by the RSU at some future date after the
grant. The Committee will determine all of the terms and conditions of an award of RSUs. Payment for vested RSUs may be in shares of
common stock or in cash, or any combination thereof, as the Committee may determine. RSUs represent an unfunded and unsecured obligation
for us, and a holder of a stock unit has no rights other than those of a general creditor.
Limited
Transferability of Awards. Awards granted under the 2017 Plan generally are not transferrable other than by will or by the laws
of descent and distribution. In addition, in the event a holder desires at any time to sell or otherwise transfer all or part of his
shares (the “Offered Shares”) under the 2017 Plan, then such holder shall first give us written notice of such proposed sale
or transfer including the terms of such sale or transfer, and we shall have the right at any time, within 30 days after receipt of such
notice, to elect to purchase all or any portion of the Offered Shares at the price and on the terms set forth in the notice. Furthermore,
in the event the holders of a majority of our voting capital then outstanding determine to sell or otherwise dispose or all or substantially
all of our assets or all or 50% or more of our capital stock to any person (other than to our affiliate(s) or to the Majority Shareholders
(as defined in the 2017 Plan)), or to cause us to merge with or into or consolidate with any person (other than to our affiliate(s) or
to the Majority Shareholders) in a bona fide negotiated transaction, each holder of shares issued under the 2017 Plan shall be obligated
to and shall upon written request of the Majority Shareholders sell, transfer and deliver to the buyer his shares under the 2017 Plan.
Change
in Control. In the event that we are a party to a merger or consolidation or similar transaction (“Corporate Transaction”),
unless an outstanding award under the 2017 Plan is assumed by the surviving company or replaced with an equivalent award granted by the
surviving company in substitution for such outstanding award, such award shall be vested and non-forfeitable and any conditions with
respect to such award shall lapse. If an award becomes exercisable or non-forfeitable, the Committee may (i) permit the grantee to exercise
such award of options or SARs within a reasonable period prior to the consummation of the Corporate Transaction and cancel any outstanding
awards that remain unexercised upon consummation of such transaction or (ii) cancel any or all outstanding awards of options and SARs
in exchange for a payment (in cash, securities or other property) in an amount equal to the amount that the grantee would have received
(net of the option price and/or grant price) if such options and SARs were fully vested and exercised immediately prior to the consummation
of the Corporate Transaction; provided, however, if the option price with respect to any outstanding option or grant price with respect
to any outstanding SAR exceeds the fair market value of the shares immediately prior to the consummation of the Corporate Transaction,
such awards shall be cancelled without any payment to the grantee.
Amendment
and Termination of the 2017 Plan. The board generally may amend or terminate the 2017 Plan at any time and for any reason, except
that it must obtain stockholder approval if required pursuant to federal or state laws or the rules of any stock exchange or quotation
system on which our shares are then listed or quoted.
SECURITY
OWNERSHIP OF
CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The
following table sets forth certain information regarding the beneficial ownership of our capital stock outstanding as of November
1, 2023 by:
|
● |
each
person, or group of affiliated persons, known by us to beneficially own more than 5% of our shares of common stock; |
|
|
|
|
● |
each
of our directors; |
|
|
|
|
● |
each
of our named executive officers; and |
|
|
|
|
● |
all
of our directors and named executive officers as a group. |
The
percentage ownership information is based on 17,588,811 shares of common stock outstanding as of November 1, 2023. The
number of shares owned are those beneficially owned, as determined under the rules of the SEC. Under these rules, beneficial ownership
includes any shares of common stock as to which a person has sole or shared voting power or investment power and any shares of common
stock that the person has the right to acquire within 60 days of November 1, 2023 through the exercise of any option, warrant
or right, through conversion of any security or pursuant to the automatic termination of a power of attorney or revocation of a trust,
discretionary account or similar arrangement. These shares are deemed to be outstanding and beneficially owned by the person holding
such option, warrants or other derivative securities for the purpose of computing the percentage ownership of that person, but they are
not treated as outstanding for the purpose of computing the percentage ownership of any other person. Unless otherwise indicated, the
persons or entities identified in this table have sole voting and investment power with respect to all shares shown as beneficially owned
by them, subject to applicable community property laws.
Beneficial Owner(1) | |
Shares of Common Stock Beneficially Owned | | |
Percentage | |
Directors and Named Executive Officers: | |
| | | |
| | |
Jerry Katzman | |
| 35,168,037 | (3)(4) | |
| 77.1 | %(2) |
Herbert Gould | |
| 315,000 | | |
| 1.8 | % |
Vinay Mehindru | |
| 500,000 | (5) | |
| 2.8 | % |
All Officers and Directors as a Group | |
| 35,983,037 | | |
| 81.9 | % |
5% or Greater Shareholders: | |
| | | |
| | |
Sanovas Ophthalmology, LLC (4) | |
| 29,271,037 | (6) | |
| 64.2 | %(2) |
Bayern Capital, LLC (7) | |
| 4,666,200 | | |
| 26.75 | % |
Capital Funding Partners, LLC (8) | |
| 5,897,000 | | |
| 33.5 | % |
(1) |
The
address of each person is c/o RetinalGenix Technologies Inc., 1450 North McDowell Boulevard, Suite 150, Petaluma, CA 94954 unless
otherwise indicated herein. |
|
|
(2) |
The
calculation is based upon 17,588,811 shares of common stock outstanding on November 1, 2023 and the pre-funded
warrant to purchase 28,014,540 shares of common stock held by Sanovas Ophthalmology LLC. |
|
|
(3) |
Represents
(i) 5,897,000 shares of common stock held by Capital Funding Partners, LLC; (ii) 1,256,497 shares of common stock held by
Sanovas Ophthalmology LLC and (iii) pre-funded warrants to purchase up to 28,014,540 shares of common stock held by Sanovas Ophthalmology.
Jerry Katzman is the Sole Member of Capital Funding Partners, LLC and in such capacity has the right to vote and dispose of the securities
held by such entity. Jerry Katzman is the Manager of Sanovas Ophthalmology and in such capacity has the right to vote and dispose
of the securities held by such entity. |
|
|
(4) |
Jerry
Katzman is the Manager of Sanovas Ophthalmology LLC and in such capacity has the right to vote and dispose of the securities held
by such entity. |
|
|
(5) |
Vinay
Mehindru holds fully-vested options to purchase 500,000 shares of common stock at $1.00 per share. |
|
|
(6) |
Represents
1,256,497 shares of common stock held by Sanovas Ophthalmology LLC and pre-funded warrants held by Sanovas Ophthalmology LLC
to purchase up to 28,014,540 shares of the Company’s common stock. |
|
|
(7) |
Steven
Bayern is the Manager of Bayern Capital, LLC and in such capacity has the right to vote and dispose of the securities held by such
entity. The address of Bayern Capital, LLC is 403 East Boardwalk, Suite 601, Long Beach, NY 11561. |
|
|
(8) |
Jerry
Katzman is the Sole Member of Capital Funding Partners, LLC and in such capacity has the right to vote and dispose of the securities
held by such entity. The address of Capital Funding Partners, LLC is P.O. Box 24866, Tampa, FL 33623. |
Securities
Authorized for Issuance Under Equity Compensation Plans
The
following table shows information regarding our equity compensation plans as of December 31, 2022.
Plan Category | |
Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) | | |
Weighted average exercise price of outstanding options, warrants and rights (b) | | |
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (c) | |
Equity compensation plans approved by security holders (1) | |
| 2,360,000 | (2) | |
$ | 1.00 | | |
| 5,115,000 | |
Equity compensation plans not approved by security holders | |
| - | | |
| - | | |
| - | |
Total | |
| 2,360,000 | | |
| | | |
$ | 5,115,000 | |
(1) |
2017
Equity Incentive Plan. On December 1, 2017, our Board adopted the 2017 Equity Incentive Plan (the “2017 Plan”) was
adopted by our board of directors (the “2017 Plan”). The purpose of our Plan is to advance the best interests of the
company by providing those persons who have a substantial responsibility for our management and growth with additional incentive
and by increasing their proprietary interest in the success of the company, thereby encouraging them to maintain their relationships
with us. Further, the availability and offering of stock options and common stock under the plan supports and increases our ability
to attract and retain individuals of exceptional talent upon whom, in large measure, the sustained progress, growth and profitability
which we depend. The total number of shares available for the grant of either stock options or compensation stock under the plan
is 10,000,000 shares, subject to adjustment. |
Our
Board administers our plan and has full power to grant stock options and common stock, construe and interpret the plan, establish rules
and regulations and perform all other acts, including the delegation of administrative responsibilities, it believes reasonable and proper.
Any decision made, or action taken, by our Board arising out of or in connection with the interpretation and administration of the plan
is final and conclusive.
The
Board, in its absolute discretion, may award common stock to employees of, consultants to, and directors of the company, and such other
persons as the Board or compensation committee may select, and permit holders of common stock options to exercise such options prior
to full vesting therein and hold the common stock issued upon exercise of the option as common stock. Stock options may also be granted
by our Board or compensation committee to non-employee directors of the company or other persons who are performing or who have been
engaged to perform services of special importance to the management, operation or development of the company.
In
the event that our outstanding common stock is changed into or exchanged for a different number or kind of shares or other securities
of the company by reason of merger, consolidation, other reorganization, recapitalization, combination of shares, stock split-up or stock
dividend, prompt, proportionate, equitable, lawful and adequate adjustment shall be made of the aggregate number and kind of shares subject
to stock options which may be granted under the plan.
Our
Board may at any time, and from time to time, suspend or terminate the plan in whole or in part or amend it from time to time in such
respects as our Board may deem appropriate and in our best interest.
CERTAIN
RELATIONSHIPS AND RELATED PARTY TRANSACTIONS AND DIRECTOR INDEPENDENCE
The
following includes a summary of transactions since January 1, 2021 to which we have been a party, including transactions in which the
amount involved in the transaction exceeds the lesser of $120,000 or 1% of the average of our total assets at year-end for the last two
completed fiscal years, and in which any of our directors, executive officers or, to our knowledge, beneficial owners of more than 5%
of our capital stock or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material
interest, other than equity and other compensation, termination, change in control and other arrangements, which are described elsewhere
in this Registration Statement on Form S-1. We are not otherwise a party to a current related party transaction, and no transaction is
currently proposed, in which the amount of the transaction exceeds the lesser of $120,000 or 1% of the average of our total assets at
year-end for the last two completed fiscal years and in which a related person had or will have a direct or indirect material interest.
Transactions
with Sanovas, Inc.
On
June 24, 2021, we entered into a sublicense agreement (“Sublicense Agreement”) with Sanovas Ophthalmology pursuant to which
Sanovas Ophthalmology granted us an exclusive worldwide (“Territory”) license to certain intellectual property licensed to
Sanovas Ophthalmology by Sanovas Intellectual Property LLC relating to certain technologies for eye and ocular visualization and monitoring
(“Licensed IP”) for uses related to the screening, examination, diagnosis, prevention and/or treatment of any eye disease,
medical condition or disorder, or any disease, medical condition or disorder affecting the eye. Pursuant to the Sublicense Agreement,
commencing on the date of the first commercial sale of a Licensed Product (as defined in the Sublicense Agreement), in each country in
the Territory and continuing on a country by country basis until the expiration or termination of the last Valid Claim (as defined in
the Sublicense Agreement) of a licensed patent in such country (the “Royalty End Date”), the Company shall pay Sanovas Ophthalmology
a royalty equal to a mid-single digit percentage of any Net Sales (as defined in the Sublicense Agreement) of any Licensed Product. The
Sublicense Agreement shall continue until the Royalty End Date, unless earlier terminated pursuant to its terms. The Sublicense Agreement
may be terminated by either party if the other party materially breaches the Sublicense Agreement in a manner that cannot be cured, or
materially breaches the Sublicense Agreement in a manner that can be cured and such breach remains uncured for more than 30 days after
the receipt by the breaching party of notice specifying the breach. Furthermore, the Company may terminate the Sublicense Agreement at
any time upon 90 days written notice to Sanovas Ophthalmology. No royalties have been paid through December 31, 2022 under this Sublicense
Agreement.
Commencing
in 2019, Sanovas began paying invoices on behalf of the Company, and began allocating a portion of salaries and infrastructure costs
to the Company. There were no specific terms of repayment. For the years ended December 31, 2022 and 2021, Sanovas allocated an aggregate
of $532,337 and $872,070, respectively to the Company. As of December 31, 2022, the Company owed Sanovas $427,933. For the years ended
December 31, 2022 and 2021, the Company received (paid) $692,677 and ($323,922) from (to) Sanovas, respectively. A portion of the balance
of the payments due to Sanovas have been discharged pursuant to the issuance by the Company of shares of its common stock since 2019.
Specifically, in June 2021, the Company issued 390,358 shares of common stock to Sanovas Ophthalmology LLC to retire the then estimated
debt due from the Company which had a value of $390,358. In May 2022 and November 2022, we issued 353,432 and 586,370 shares of
common stock to discharge $353,432 and $586,370 of debt owed to Sanovas Ophthalmology LLC at a purchase price of $1.00 per share, respectively.
The Company is related to Sanovas through common ownership and management. Included in such allocated costs is approximately $281,000
and $106,000 in costs related to an officer of the Company in the six months ending June 30, 2023 and 2022, respectively.
The
following summarizes the transactions between the Company and Sanovas for the six months ended June 30, 2023 and 2022:
| |
Six months Ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Balance due to ( Sanovas – beginning of year | |
$ | 427,933 | | |
$ | 142,721 | |
| |
| | | |
| | |
Costs paid by Sanovas on the Company’s behalf | |
| - | | |
| 36,289 | |
Costs of Sanovas allocated to the Company | |
| 280,820 | | |
| 168,702 | |
Proceeds from costs charged by Sanovas to the Company, net | |
| 102,423 | | |
| 221,119 | |
Retirement of due to Sanovas through the issuance of shares to Sanovas Ophthalmology | |
| - | | |
| (353,432 | ) |
| |
| | | |
| | |
Balance due to Sanovas - end of period | |
$ | 811,176 | | |
| $ | |
On
December 23, 2018, Sanovas entered into an employment agreement with Dr. Katzman pursuant to which Dr. Katzman serves as the President
and Chief Executive Officer of Sanovas.
Due
to affiliates
From
time to time, an officer of the Company, a shareholder of the Company and affiliates of Sanovas advances funds or paid expenses on behalf
of the Company. There is no formal notes or repayment plan for such advances. At June 30, 2023 and December 31, 2022, the Company had
received $210,022 and $109,185 pursuant to such advances, respectively.
Stockholders’
loans payable
During
2021, the Company borrowed an aggregate of $73,000 from several stockholders pursuant to note agreements bearing interest at 8% per annum
and maturing December 31, 2022. Company has informally extended the maturity date to December 31, 2023. During the year ended December
31, 2022, one of the noteholders exercised outstanding warrants with an aggregate exercise price of $25,000 through the offset of the
note payable due to them from the Company, such that $48,000 remain outstanding at December 31, 2022.
Director
Independence
Although
our common stock is not listed on any national securities exchange, for purposes of independence we use the definition of independence
applied by The Nasdaq Stock Market. Our board of directors has determined that each of Herbert Gould and Vinay Mehindru is “independent”
in accordance with such definition.
LEGAL
MATTERS
Unless
otherwise indicated, Blank Rome LLP, New York, New York, will pass upon the validity of the shares of the Resale Shares to be sold in
this offering.
EXPERTS
The
financial statements of RetinalGenix Technologies Inc. for the years ended December 31, 2022 and December 31, 2021 have been included
herein in reliance upon the reports of Liebman Goldberg & Hymowitz LLP, independent registered public accounting firm, upon the authority
of said firm as experts in accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We
have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the Resale Shares offered hereby.
This prospectus, which constitutes a part of the registration statement, does not contain all of the information set forth in the registration
statement or the exhibits and schedules filed therewith. For further information about us and the Resale Shares offered hereby, we refer
you to the registration statement and the exhibits and schedules filed thereto. Statements contained in this prospectus regarding the
contents of any contract or any other document that is filed as an exhibit to the registration statement are not necessarily complete,
and each such statement is qualified in all respects by reference to the full text of such contract or other document filed as an exhibit
to the registration statement.
You
may read and copy the registration statement of which this prospectus is a part, as well as our reports, proxy statements and other information,
at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for more
information about the operation of the Public Reference Room. The SEC maintains an Internet site that contains reports, proxy and information
statements, and other information regarding issuers that file electronically with the SEC, including RetinalGenix Technologies Inc. The
SEC’s Internet site can be found at http://www.sec.gov. You may also request a copy of these filings, at no cost, by writing us
at RetinalGenix Technologies Inc., 1450 North McDowell Boulevard, Suite 150, Petaluma, California 94954 or telephoning us at (415) 578-9583.
We
are subject to the information and reporting requirements of the Exchange Act, and, in accordance with this law, file periodic reports,
proxy statements and other information with the SEC. These periodic reports, proxy statements and other information are available for
inspection and copying at the SEC’s public reference facilities and the website of the SEC referred to above. You may access these
materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC.
1,559,820
Shares of Common Stock
PROSPECTUS
,
2023
INDEX
TO FINANCIAL STATEMENTS
RetinalGenix
Technologies Inc.
Financial
Statements
TABLE
OF CONTENTS
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and
Stockholders of RetinalGenix Technologies Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of RetinalGenix Technologies Inc. and Subsidiary (the “Company”)
as of December 31, 2022 and 2021, and the related statements of operations, stockholders’ deficit, and cash flows for each of the
years then ended, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements
present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of
its operations and its cash flows for each of the years in the two-year period ended December 31, 2022, in conformity with accounting
principles generally accepted in the United States of America.
Substantial
Doubt about the Company’s Ability to Continue as a Going Concern
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note
A to the financial statements, based on its projections, the Company anticipates that during 2023, it will not have sufficient capital.
Furthermore, the Company’s losses from operations and working capital deficiency raises substantial doubt about its ability to
continue as a going concern. Management’s plans in regard to these matters are also described in Note A. The financial statements do
not include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits,
we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks.
Such
procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits
also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall
presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matters
Critical
audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and
(2) involved our especially challenging, subjective, or complex judgments. We determined that there were no critical audit matters.
/s/
Liebman Goldberg & Hymowitz, LLP
We
have served as the Company’s auditor since 2019.
Garden
City, New York
March
30, 2023
PCAOB
ID No. 473
PART
I — FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS.
RETINALGENIX
TECHNOLOGIES INC.
CONSOLIDATED
BALANCE SHEETS
| |
December 31, 2022 | | |
December 31, 2021 | |
ASSETS | |
| | | |
| | |
Current Assets | |
| | | |
| | |
Cash | |
$ | 38 | | |
$ | 4,947 | |
Total Current Assets | |
| 38 | | |
| 4,947 | |
Equipment, net of accumulated depreciation of $52 | |
| 256 | | |
| - | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 294 | | |
$ | 4,947 | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
Liabilities | |
| | | |
| | |
Current Liabilities | |
| | | |
| | |
Accounts payable and accrued liabilities | |
| 475,480 | | |
| 251,282 | |
Due to Sanovas | |
| 427,933 | | |
| 142,721 | |
Due to related parties | |
| 109,185 | | |
| - | |
Shareholders’ notes payable | |
| 49,000 | | |
| 73,000 | |
Accrued interest payable | |
| 7,759 | | |
| 2,619 | |
Total Liabilities | |
| 1,069,357 | | |
| 469,622 | |
Stockholders’ Deficit: | |
| | | |
| | |
Preferred stock, $0.0001 par value; 40,000,000 shares authorized; Series F preferred stock - 3,000,000 shares designated, 0 issued and outstanding at December 31, 2022 and December 31, 2021 | |
| - | | |
| - | |
Common stock, $0.0001 par value; 80,000,000 shares authorized; 17,272,116 shares issued and outstanding at December 31, 2022 and 14,221,814 shares issued and outstanding at December 31, 2021 | |
| 1,783 | | |
| 1,423 | |
Additional paid in capital | |
| 7,947,460 | | |
| 4,638,218 | |
Accumulated deficit | |
| (9,018,306 | ) | |
| (5,104,316 | ) |
Total Stockholders’ Deficit | |
| (1,069,063 | ) | |
| (464,675 | ) |
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
$ | 294 | | |
$ | 4,947 | |
The
accompanying notes are an integral part of these consolidated financial statements.
RETINALGENIX
TECHNOLOGIES INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
| |
2022 | | |
2021 | |
| |
For The Year Ended | |
| |
December 31, | |
| |
2022 | | |
2021 | |
Operating expenses: | |
| | | |
| | |
General and administrative expenses | |
| 807,406 | | |
| 1,120,949 | |
Research and development | |
| 809,255 | | |
| 747,808 | |
Acquired in-process research and development | |
| 2,032,889 | | |
| - | |
Stock-based compensation | |
| 259,300 | | |
| 307,918 | |
| |
| | | |
| | |
Total Operating expenses | |
| 3,908,850 | | |
| 2,176,675 | |
| |
| | | |
| | |
Interest expense | |
| 5,140 | | |
| 2,619 | |
| |
| | | |
| | |
Net loss | |
$ | (3,913,990 | ) | |
$ | (2,179,294 | ) |
| |
| | | |
| | |
Net loss per share - basic and diluted | |
$ | (0.25 | ) | |
$ | (0.05 | ) |
| |
| | | |
| | |
Weighted average number of common shares outstanding during the period- basic and diluted | |
| 15,584,346 | | |
| 41,246,915 | |
The
accompanying notes are an integral part of these consolidated financial statements.
RETINALGENIX
TECHNOLOGIES INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ DEFICIT
FOR
THE YEARS ENDED DECEMBER 31, 2022 AND 2021
| |
Shares | | |
Par Value | | |
Shares | | |
Par Value | | |
Preferred Stock | | |
Paid-in Capital | | |
Accumulated Deficit | | |
Total | |
| |
Common Stock | | |
Preferred Stock Series F | | |
Subscription Receivable | | |
Additional | | |
| | |
| |
| |
Shares | | |
Par Value | | |
Shares | | |
Par Value | | |
Preferred Stock | | |
Paid-in Capital | | |
Accumulated Deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance as at December 31, 2020 | |
| 40,678,323 | | |
$ | 4,067 | | |
| 3,000,000 | | |
$ | 300 | | |
$ | (300 | ) | |
$ | 2,840,599 | | |
$ | (2,925,022 | ) | |
$ | (80,356 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock purchased by investors | |
| 1,154,173 | | |
| 117 | | |
| | | |
| | | |
| | | |
| 1,083,082 | | |
| | | |
| 1,083,199 | |
Stock based compensation | |
| | | |
| | | |
| | | |
| | | |
| | | |
| 307,918 | | |
| | | |
| 307,918 | |
Exercise of warrants | |
| 13,500 | | |
| 1 | | |
| | | |
| | | |
| | | |
| 13,499 | | |
| | | |
| 13,500 | |
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC | |
| 390,358 | | |
| 39 | | |
| | | |
| | | |
| | | |
| 390,319 | | |
| | | |
| 390,358 | |
Exchange of shares owned by Sanovas Ophthalmology LLC for pre-funded warrants | |
| (28,014,540 | ) | |
| (2,801 | ) | |
| | | |
| | | |
| | | |
| 2,801 | | |
| | | |
| - | |
Recission of preferred stock | |
| | | |
| | | |
| (3,000,000 | ) | |
| (300 | ) | |
| 300 | | |
| | | |
| | | |
| - | |
Net loss | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| (2,179,294 | ) | |
| (2,179,294 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as at December 31, 2021 | |
| 14,221,814 | | |
$ | 1,423 | | |
| - | | |
$ | - | | |
$ | - | | |
$ | 4,638,218 | | |
$ | (5,104,316 | ) | |
$ | (464,675 | ) |
Beginning balance | |
| 14,221,814 | | |
$ | 1,423 | | |
| - | | |
$ | - | | |
$ | - | | |
$ | 4,638,218 | | |
$ | (5,104,316 | ) | |
$ | (464,675 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 259,300 | | |
| - | | |
| 259,300 | |
Stock purchased by investors | |
| 60,500 | | |
| 61 | | |
| - | | |
| - | | |
| - | | |
| 60,439 | | |
| - | | |
| 60,500 | |
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC | |
| 939,802 | | |
| 94 | | |
| - | | |
| - | | |
| - | | |
| 939,708 | | |
| - | | |
| 939,802 | |
Exercise of warrants and options | |
| 50,000 | | |
| 5 | | |
| | | |
| | | |
| | | |
| 49,995 | | |
| | | |
| 50,000 | |
Issuance of shares upon acquisition of in process research and development | |
| 2,000,000 | | |
| 200 | | |
| | | |
| | | |
| | | |
| 1,999,800 | | |
| | | |
| 2,000,000 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,913,990 | ) | |
| (3,913,990 | ) |
Balance as at December 31, 2022 | |
| 17,272,116 | | |
$ | 1,783 | | |
| - | | |
| - | | |
| - | | |
$ | 7,947,460 | | |
$ | (9,018,306 | ) | |
$ | (1,069,063 | ) |
Ending balance | |
| 17,272,116 | | |
$ | 1,783 | | |
| - | | |
| - | | |
| - | | |
$ | 7,947,460 | | |
$ | (9,018,306 | ) | |
$ | (1,069,063 | ) |
The
accompanying notes are an integral part of these consolidated financial statements.
RETINALGENIX
TECHNOLOGIES INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
| |
2022 | | |
2021 | |
| |
For The Years Ended | |
| |
December 31, | |
| |
2022 | | |
2021 | |
Cash Flows From (Used In) Operating Activities | |
| | | |
| | |
Net loss | |
$ | (3,913,990 | ) | |
$ | (2,179,294 | ) |
Adjustments to reconcile net loss to net cash used in operating activities | |
| | | |
| | |
Non-cash items: | |
| | | |
| | |
Stock based compensation expense | |
| 259,300 | | |
| 307,918 | |
Acquired In-process research and development through issuance of common stock | |
| 2,000,000 | | |
| - | |
Depreciation expense | |
| 51 | | |
| - | |
Expenses paid by Sanovas on behalf of Company, net | |
| 1,225,014 | | |
| 548,148 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Increase (decrease) in accounts payable and accrued liabilities | |
| 225,198 | | |
| 109,851 | |
(Increase) decrease in deferred offering costs | |
| - | | |
| 43,787 | |
Increase in accrued interest | |
| 5,140 | | |
| 2,619 | |
Total Adjustments | |
| 3,714,703 | | |
| 1,012,323 | |
Net cash used in operating activities | |
| (199,287 | ) | |
| (1,166,971 | ) |
| |
| | | |
| | |
Cash Flows (Used In) Investing Activities | |
| | | |
| | |
Equipment purchase | |
| (307 | ) | |
| - | |
| |
| | | |
| | |
Cash Flows From (Used In) Financing Activities | |
| | | |
| | |
Proceeds from common stock sold, net of costs | |
| 60,500 | | |
| 1,083,199 | |
Proceeds from exercise of warrants and options | |
| 25,000 | | |
| 13,500 | |
Proceeds from shareholders’ notes payable | |
| - | | |
| 73,000 | |
Advances from related parties | |
| 109,185 | | |
| - | |
Net cash provided by financing activities | |
| 194,685 | | |
| 1,169,699 | |
Net (decrease) increase in cash | |
| (4,909 | ) | |
| 2,728 | |
Cash at beginning of year | |
| 4,947 | | |
| 2,219 | |
Cash at end of year | |
$ | 38 | | |
$ | 4,947 | |
| |
| | | |
| | |
Supplemental information: | |
| | | |
| | |
Retirement of due to Sanovas through the issuance of common stock to Sanovas Ophthalmology LLC (Note C) | |
$ | 939,802 | | |
$ | 390,358 | |
Exchange of common stock by Sanovas Ophthalmology LLC for pre-funded warrants | |
| - | | |
| 2,801 | |
Repayment of shareholders’ note payable through the exercise of warrants | |
| 25,000 | | |
| - | |
The
accompanying notes are an integral part of these consolidated financial statements.
RETINALGENIX
TECHNOLOGIES INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
A – HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN
RetinalGenix
Technologies Inc. (the “Company”), a Delaware corporation, was formed in November 2017 by Sanovas Ophthalmology, LLC (“Sanovas
Ophthalmology”), a majority owned subsidiary of Sanovas Inc. (“Sanovas”), a privately held research and development
incubator. During the years ended December 31, 2022 and December 31, 2021, a substantial portion of the operations of the Company were
conducted by Sanovas, who invoices the Company for costs and expenses paid for on behalf of the Company and costs and expenses allocated
to the Company for services performed on behalf of the Company.
The
Company was formed to develop technologies to diagnose and treat ophthalmic disorders. The Company sublicensed certain technology initially
developed by Sanovas from Sanovas Ophthalmology – See Note C. Since 2018, the Company has been developing its screening device
and home monitoring and physician alert system.
In
October 2021, the Company filed a registration statement on Form S-1 (the “Registration Statement”) with the Securities and
Exchange Commission pursuant to which it registered for resale shares of common stock, including shares of common stock issuable upon
exercise of outstanding options and warrants. The Company did not raise any cash from the resale of the securities offered by the Registration
Statement, and accordingly, the previously deferred offering costs were applied against the proceeds of the shares of common stock sold
in 2021 pursuant to the Company’s previous private offering of securities.
On
October 8, 2019, the Company entered into an option exchange agreement (the “Option Exchange Agreement”) with Diopsys, Inc.
(“Diopsys”) pursuant to which the Company shall issue Diopsys an option to purchase up to 10% of its issued and outstanding
shares of common stock and Diopsys shall grant the Company an option to purchase up to 10% of the issued and outstanding shares of common
stock of Diopsys on the Closing Date (the “Option Exchange”). “Closing Date” means a date that is within 30 days
of the date that all of the contingencies set forth in the Option Exchange Agreement are satisfied including, but not limited to, approval
of a product by the U.S. Food and Drug Administration. In addition, pursuant to the Option Exchange Agreement, upon the closing of the
Option Exchange, the Company shall enter into an exclusive distribution agreement with Diopsys pursuant to which Diopsys shall act as
the Company’s exclusive distributor of such product. On February 14, 2022, the Company entered into a Termination of Option Exchange
Agreement (the “Termination Agreement”) with Diopsys pursuant to which the prior Option Exchange Agreement between the Company
and Diopsys dated October 8, 2019 (the “Option Exchange Agreement”) was terminated effective immediately and of no further
force and effect, and neither party has any past, current or future obligations or liabilities to the other (or any other person or entity)
with respect to any rights, obligations or any of the transactions contemplated in the Option Exchange Agreement. At the time of such
termination, none of the conditions in the Option Exchange Agreement were satisfied and no options thereunder had been issued to either
the Company or Diopsys. In addition, the Exclusive Distribution Agreement to be entered into between the Company and Diopsys and referred
to in the Option Exchange Agreement has not been negotiated and as of the second quarter of 2022, there are no plans to move forward
with Diopsys.
On
December 27, 2021, RetinalGenix Technologies Inc. entered into an exchange agreement (the “Exchange Agreement”) with Sanovas
Ophthalmology pursuant to which the Company exchanged 28,014,540 shares of common stock held by Sanovas Ophthalmology for a pre-funded
warrant (the “Pre-funded Warrant”) to purchase up to an aggregate of 28,014,540 shares of the Company’s common stock.
The Pre-funded Warrant is immediately exercisable at an exercise price of $0.0001 per share and terminates when exercised in full.
On
July 5, 2022, RetinalGenix Technologies Inc. entered into an Exchange Agreement (the “Exchange Agreement”) with Dr. Lawrence
Perich pursuant to which it acquired all the outstanding shares of DNA/GPS Inc., a pharmacogenetics company based in Tampa, Florida (“DNA/GPS”),
in exchange for the issuance of 2,000,000 shares of the Company’s common stock. The acquisition of DNA/GPS combines DNA/GPS’
genetic mapping capabilities with the Company’s retinal imaging capabilities. The combined technology is expected to have the ability
to screen, monitor and provide data to profile trends and create diagnostic markers for systemic and retinal disorders in the cardiovascular,
Alzheimer’s, Parkinson and other diseases. The markers and data analysis are rapid and cost effective, thereby eliminating expensive
diagnostic equipment such as MRI or CT scanning. The results are to confidential to the patient and anonymous for any third party without
permission of the patient. The Company accounted for this transaction as an asset acquisition in 2022. The estimated fair value of the
transaction was $2,000,000 plus legal fees associated with the transaction of $32,889 is recorded as acquired in-process research and
development costs in the associated consolidated statement of operations.
Liquidity
and Going Concern
The
Company has had net losses since inception and has an accumulated deficit of approximately $9,018,000 at December 31, 2022. In addition,
as of December 31, 2022 and December 31 2021, the Company had liabilities of approximately $1,069,000 and $470,000, respectively, the
majority of which is with related parties. The Company has minimal cash at December 31, 2022 and remains dependent on Sanovas for much
of its operations. The Company expects that operating losses and negative cash flows from operations will occur for at least the next
several years, and the Company will need to access additional funds to achieve its strategic goals with respect to the sublicensed technology.
The Company commenced private offerings of shares of its common stock raising net proceeds of approximately $1,083,000 in the year ended
December 31, 2021, and $60,500 in the year ended December 31, 2022 - See Note D. In February 2021, the Company entered into an agreement
with an investment banker to raise funds for the Company which led to the private offering of shares mentioned above. The Company is
in discussions with investment bankers and individual investors with respect to raising additional capital for the Company and potentially
up-listing to the NASDAQ exchange.
Sanovas
has paid a significant portion of the Company’s operating expenses through December 2022, and was owed approximately $428,000 as
of December 31, 2022 by the Company. The Company also issued shares of its common stock to offset amounts due to Sanovas for payment
of expenses on behalf of the Company of $390,358 in June 2021 and $353,432 in May 2022 and $586,370 in November 2022 (see Note C).
As
of the date of this report, the Company does not have adequate resources to fund its operations through April 2024 without considering
any potential future milestone payments that it may receive under any new collaborations that it may enter into in the future or any
future capital raising transactions. The Company will need to raise additional funding to complete the development of its products and
commence the market launch, assuming regulatory approval is obtained. The Company does not know whether additional financing will be
available when needed, whether it will be available on favorable terms, or if it will be available at all. These factors raise substantial
doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
NOTE
B - SIGNIFICANT ACCOUNTING POLICIES
A
summary of significant accounting policies consistently applied in the preparation of the accompanying financial statements is as follows:
1.
Basis of Presentation
The
Company’s financial statements were prepared in accordance with accounting principles generally accepted in the United States of
America (“US GAAP”). As of December 31, 2022, there have been no material changes in the Company’s significant accounting
policies from those that were disclosed in the 2021 Annual Report. The consolidated financial statements include the accounts of the
Company and its wholly owned subsidiary, DNA/GPS, Inc. All intercompany accounts and transactions have been eliminated in consolidation.
2.
Cash Equivalents
For
purpose of the statements of cash flows, the Company considers all short-term investments purchased with a maturity of three months or
less to be cash equivalents.
3.
Offering Costs
Deferred
offering costs are expenses directly related to an expected financing. These costs consisted of legal fees that the Company capitalized.
These costs are offset against the resultant capital raised.
4.
Use of Estimates
In
preparing the Company’s financial statements in conformity with US GAAP, management is required to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial
statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those
estimates.
5.
Income Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future
tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted
tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
date.
The
Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
Topic 740-10 Income Taxes. ASC Topic 740-10 clarifies the accounting for income taxes by prescribing a minimum recognition threshold
a tax position is required to meet before being recognized in the financial statements. It also provides guidance on the recognition,
measurement, and classification of amounts relating to uncertain tax positions, accounting for and disclosure of interest and penalties,
accounting in interim periods and disclosures. The application of that guidance did not result in the recognition of any unrecognized
tax benefits At December 31, 2022 or December 31, 2021. The Company’s policy is to expense any penalties and interest associated
with this topic. At December 31, 2022 and December 31, 2021, there were no amounts accrued for penalties and interest.
6.
Income (Loss) Per Common Share
The
Company computes net income (loss) per share in accordance with ASC 260, Earnings Per Share (“EPS”). Under the provisions
of ASC 260, basic net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number
of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for
the period by the weighted-average number of common and common equivalent shares outstanding during the period. However, common shares
that are considered anti-dilutive are excluded from the computation of diluted EPS. Since the Company had a loss during the year ended
December 31, 2022 and 2021, the basic and diluted net loss per share is the same.
Potentially
dilutive securities not included in the computation of loss per share for the year ended December 31, 2022, include stock options to
purchase 2,360,000 shares of common stock, pre-funded warrant to purchase 28,014,540 shares of common stock, and warrants to purchase
161,500 shares of common stock. Potentially dilutive securities not included in the computation of loss per share for the year ended
December 31, 2021 included 3,000,000 shares of Series F preferred stock, stock options to purchase 1,882,500 shares of common stock,
and warrants to purchase 212,500 shares of common stock. The shares of common stock potentially issuable to Diopsys upon the resolution
of specified contingencies and exercise of stock options are also excluded from the loss per share calculation for the year ended December
31, 2021.
7.
Stock-based compensation:
The
Company recognizes expense for stock-based compensation in accordance with ASC Topic 718, Stock-Based Compensation. For stock-based
awards, the Company calculates the fair value of the award on the date of grant using the Black Scholes option-pricing model. The expense
is recognized over the service period for awards expected to vest. The estimate of stock-based awards that will ultimately vest requires
judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative
adjustment in the period the estimates are revised. Stock options granted to non-employee consultants are revalued at the end of each
reporting period until vested and the changes in their fair value are recorded as adjustments to expense over the related vesting period.
8.
Research and Development costs:
Research
and development costs are expensed as incurred. Costs incurred in obtaining technology licenses outside of business combinations are
charged to research and development expense as acquired in-process research and development if the technology licensed has not reached
technological feasibility and has no alternative future use.
licensed
has not reached technological feasibility and has no alternative future use.
9.
Property and Equipment:
Property
and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives (3
years), once the asset is placed in service. Expenditures for maintenance and repairs, which do not extend the economic useful life of
the related assets, are charged to operations as incurred, and expenditures which extend the economic life are capitalized. When assets
are retired or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and
any gain or loss on disposal is recognized in the statement of operations for the respective period.
The
Company’s long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying
amount of the asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result
from the use of the asset and its eventual disposition are less than its carrying amount.
10.
Recent Accounting Pronouncements:
The
following pronouncement may have an impact on the accounting policies of the Company:
In
February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“ASU 2016-02”). ASU 2016-02 requires
an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require
new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing,
and uncertainty of cash flows arising from leases. The FASB issued ASU No. 2018-10 “Codification Improvements to Topic 842,
Leases” (“ASU 2018-10”), ASU No. 2018-11 “Leases (Topic 842) Targeted Improvements” (“ASU
2018-11”) in July 2018, and ASU No. 2018-20 “Leases (Topic 842) - Narrow Scope Improvements for Lessors” (“ASU
2018-20”) in December 2018. ASU 2018-10 and ASU 2018-20 provide certain amendments that affect narrow aspects of the guidance issued
in ASU 2016-02. ASU 2018-11 allows all entities adopting ASU 2016-02 to choose an additional (and optional) transition method of adoption,
under which an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to
the opening balance of retained earnings in the period of adoption. Pursuant to ASU 2019-10 the effective date for ASC 842 was deferred
an additional year. The Company expects to recognize operating lease right-of-use assets and lease liabilities on the balance sheet upon
adoption of this ASU when it obtains a lease. The Company is currently evaluating these ASUs and their impact on its financial statements,
but does not expect it will have a material effect on the consolidated financial statements.
A
variety of proposed or otherwise potential accounting standards are currently under study by standard-setting organizations. Due to the
tentative and preliminary nature of those proposed standards, management has not determined whether the implementation of such proposed
standards would be material to the financial statements of the Company.
11.
Reclassification:
The
Company reclassified approximately $68,000 of costs incurred during the year ended December 31, 2021 from general and administrative
expense to research and development costs to conform to the current presentation.
NOTE
C - RELATED PARTY TRANSACTIONS
Sanovas
The
Company is related to Sanovas through common ownership and management. Sanovas Ophthalmology is a majority owned subsidiary of Sanovas
and Jerry Katzman, the Company’s Chief Executive Officer, is also a director of Sanovas Ophthalmology and in such capacity has
the right to vote and dispose of the securities held by such entity.
Commencing
in 2019, Sanovas began paying expenses on behalf of the Company, and began allocating a portion of expenses and infrastructure costs
to the Company and other entities where Sanovas was performing shared services. Included in such allocated costs is approximately $344,000
and $391,000 in costs related to an officer of the Company in the year ending December 31, 2022 and 2021, respectively.
The
following summarizes the transactions between the Company and Sanovas for the year ended December 31, 2022 and December 31, 2021:
SCHEDULE
OF RELATED PARTY TRANSACTIONS
| |
| | |
| |
| |
Years Ended | |
| |
December 31, | | |
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Balance due to (from) Sanovas – beginning of year | |
$ | 142,721 | | |
$ | (15,069 | ) |
| |
| | | |
| | |
Costs paid by Sanovas on the Company’s behalf | |
| 79,290 | | |
| 68,073 | |
Costs of Sanovas allocated to the Company | |
| 453,047 | | |
| 803,997 | |
Proceeds from (repayment of) costs charged by Sanovas to the Company, net | |
| 692,677 | | |
| (323,922 | ) |
Retirement of due to Sanovas through the issuance of common stock to Sanovas Ophthalmology | |
| (939,802 | ) | |
| (390,358 | ) |
| |
| | | |
| | |
Balance due to Sanovas - end of year | |
$ | 427,933 | | |
$ | 142,721 | |
The
Company issued 390,358, 353,432 and 586,370 shares of its common stock to offset amounts due to Sanovas for payment of expenses on behalf
of the Company of $390,358 in June 2021 and $353,432 in May 2022 and $586,370 in November 2022, respectively.
Sublicense
On
June 24, 2021, the Company entered into a sublicense agreement (“Sublicense Agreement”) with Sanovas Ophthalmology pursuant
to which Sanovas Ophthalmology granted the Company an exclusive worldwide (“Territory”) license to certain intellectual property
licensed to Sanovas Ophthalmology by Sanovas Intellectual Property LLC relating to certain technologies for eye and ocular visualization
and monitoring (“Licensed IP”) for uses related to the screening, examination, diagnosis, prevention and/or treatment of
any eye disease, medical condition or disorder, or any disease, medical condition or disorder affecting the eye. Pursuant to the Sublicense
Agreement, commencing on the date of the first commercial sale of a Licensed Product (as defined in the Sublicense Agreement), in each
country in the Territory and continuing on a country by country basis until the expiration or termination of the last Valid Claim (as
defined in the Sublicense Agreement) of a licensed patent in such country (the “Royalty End Date”), the Company shall pay
Sanovas Ophthalmology a royalty equal to a mid-single digit percentage of any Net Sales (as defined in the Sublicense Agreement) of any
Licensed Product. The Sublicense Agreement shall continue until the Royalty End Date, unless earlier terminated pursuant to its terms.
The Sublicense Agreement may be terminated by either party if the other party materially breaches the Sublicense Agreement in a manner
that cannot be cured, or materially breaches the Sublicense Agreement in a manner that can be cured and such breach remains uncured for
more than 30 days after the receipt by the breaching party of notice specifying the breach. Furthermore, the Company may terminate the
Sublicense Agreement at any time upon 90 days written notice to Sanovas Ophthalmology. No royalties have been paid through December 31,
2022 under this Sublicense Agreement.
Due
to affiliates
From
time to time, an officer of the Company, a shareholder of the Company and affiliates of Sanovas advances funds or paid expenses on behalf
of the Company. There is no formal notes or repayment plan for such advances. At December 31, 2022, the Company had received $109,185
pursuant to such advances.
Shareholders’
notes payable – See Note G
NOTE
D - COMMON AND PREFERRED STOCK
Pursuant
to the Company’s Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”),
filed with the Delaware Secretary of State on January 8, 2018, the Company is authorized to issue 40,000,000 shares of preferred stock
and 80,000,000 shares of common stock each with a par value of $0.0001 per share. The Company has designated 3,000,000 shares of preferred
stock as Series F preferred stock.
Pursuant
to the terms of an employment agreement dated January 1, 2012 (the “Effective Date”) by and between Sanovas and Lawrence
Gerrans, the then President and Chief Executive Officer of Sanovas (the “Original Employment Agreement”), in consideration
for Mr. Gerrans’ services, Mr. Gerrans was to receive, among other consideration, the following equity securities: (i) 441,177
shares of restricted common stock of each of the wholly-owned subsidiaries of Sanovas, as of the Effective Date (the “Affiliate
Subsidiaries”), representing 7.5% of the total equity capital of each such subsidiary issued and outstanding as of the date of
grant; and (ii) 5,000 shares of Series F preferred stock of Sanovas and each of the Affiliate Subsidiaries. The Company was incorporated
in Delaware on November 17, 2017, subsequent to the Effective Date, and as such these shares were never issued by the Company because
the Company was not an Affiliate Subsidiary of Sanovas. Thereafter, in May 2015, Mr. Gerrans’ Original Employment Agreement was
amended and restated with an effective date of January 1, 2012 (the “Amended and Restated Employment Agreement”), the same
as the Effective Date of the Original Employment Agreement. Pursuant to the Amended and Restated Employment Agreement, in consideration
for Mr. Gerrans’ services, Mr. Gerrans was to receive, among other consideration, the following equity securities: (i) 7.5% of
the total equity capital of each of Sanovas’ Affiliate Subsidiaries as of the Effective Date or thereafter formed (collectively,
the “New Subsidiaries”); and (ii) 5,000 shares of Series F preferred stock of Sanovas, each of the Affiliate Subsidiaries
and each of the New Subsidiaries, including the Company. Subsequently, pursuant to a board resolution dated December 1, 2017 approved
by Lawrence Gerrans, the Company’s then Chief Executive Officer, President and sole director, in 2018 the Company issued 27,000,000
shares of its common stock to Sanovas Ophthalmology LLC, and issued 3,000,000 shares of its Series F preferred stock to Halo Management
LLC (“Halo”), an entity owned by Mr. Gerrans, for certain enumerated consideration that was purported to have been provided.
Thereafter, and in part based upon the evidence and testimony presented, and verdict and conviction rendered, in the Criminal Action
(discussed below), including, but not limited to, the fact that Mr. Gerrans misled and coerced the board of Sanovas regarding the terms
and need for approval of the Amended and Restated Employment Agreement, the Company’s board of directors, acting in concert with
the board of directors of Sanovas, carried out an investigation with respect to actions taken by Mr. Gerrans and have determined that
Halo did not provide the Company with valid consideration for the Series F preferred stock, and the Company disputes whether any of the
shares of the Company issued to Halo were validly issued.
In
January 2020, a jury in the United States District Court for the Northern District of California found Mr. Gerrans guilty, in a criminal
proceeding (the “Criminal Action”), on 12 felony counts of wire fraud, money laundering, perjury, contempt of court, witness
tampering, and obstruction of justice in connection with his activities as an officer and director of Sanovas. Thereafter, in November
2020, Sanovas commenced an action in the Court of Chancery of the State of Delaware (the “Delaware Action”) against Halo
and Mr. Gerrans seeking an order declaring that any rights that Halo and/or Mr. Gerrans may have with respect to any equity securities
in Sanovas and each of its affiliated subsidiaries (including, but not limited to, the Company) are void or voidable and may be cancelled.
The Delaware Action is currently still pending.
On
November 21,2021, the Company’s Board of Directors resolved to rescind the 3,000,000 shares of Series F preferred stock purported
to be issued to Halo Management Group LLC for lack of contract consideration. The Company is aware that the management/ownership of Halo
Management Group LLC may dispute this decision however, the Company is prepared to defend its decision in this case. In addition, the
Company reserves the right to void the shares and adjust its filings accordingly if necessary.
Common
Stock
During
2019, the Company commenced a private offering of its shares of common stock at a purchase price of $1.00 per share. For the years ended
December 31, 2022 and 2021, the Company sold an aggregate of 60,500 and 398,057 shares of its common stock, respectively.
The
common stockholders, voting as a separate class, are entitled to elect one member of the Board of Directors.
Preferred
Stock
As
of December 31, 2022 and 2021, there were 3,000,000 shares of preferred stock designated as Series F preferred stock, none of which were
outstanding.
The
rights and privileges of the Series F preferred stock are summarized as follows:
Voting
Privileges and Protective Features:
Each
holder of outstanding shares of Series F preferred stock is entitled to cast the number of votes equal to the number of whole shares
of common stock into which the Series F preferred stock held by such holder are convertible as of the record date for determining stockholders
entitled to vote on such matter. The holders of record of a majority of outstanding Series F preferred stock shall be entitled to elect
two of the members of the Board of Directors of the Company. The right to elect two directors shall terminate on the date upon which
there are less than 25,000 shares of Series F preferred stock issued and outstanding.
For
so long as at least 25,000 shares of Series F preferred stock remain outstanding, the vote or written consent of the holders of the majority
of the outstanding shares of Series F preferred stock is necessary for the Company to conduct certain corporate actions, including, but
not limited to, merger, consolidation or dissolution of the Company; certain amendments to the Certificate of Incorporation or bylaws
of the Company; authorization or issuance of shares of any additional class or series of capital stock unless the same ranks on parity
or junior to the Series F preferred stock with respect to voting rights.
Redemption:
The
Series F preferred stock does not have redemption features.
Dividends:
There
are no stated dividends on the Series F preferred stock.
Conversion:
Each
share of Series F preferred stock is convertible, at the option of the holder, at any time and from time to time into shares of common
stock at a conversion rate as is determined by dividing the Series F Original Issue Price by the Series F Conversion Price. “Series
F Original Issue Price” initially means $0.01 and “Series F Conversion Price” initially means $0.01, as adjusted for
any dilutive transaction such as stock splits, certain dividends, mergers or acquisitions.
All
of the outstanding shares of Series F preferred stock will automatically convert into shares of the Company’s common stock upon
the consummation of an underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933,
as amended, resulting in gross proceeds of at least $15,000,000 to the Company or upon written consent of at least 67% of the Series
F preferred shareholders.
NOTE
E - STOCK PLAN
The
Company has reserved 10,000,000 shares of common stock for issuance to employees or consultants from the RetinalGenix Technologies Inc.
2017 Equity Incentive Plan (the “Plan”). The Company may grant stock options, restricted stock or other types of equity incentive
instruments under the Plan.
In
November 2019, the Company issued stock options to purchase up to 1,800,000 shares of common stock at an exercise price of $1.00 per
share to members of the Company’s medical advisory board and consultants pursuant to the Plan. The options vest over a five-year
period and were unexercised at December 31, 2022 and December 31, 2021. The estimated aggregate fair value of the stock options at the
date of grant was determined to be $1,101,028 using a Black Scholes model.
In
the year ended December 31, 2021, the Company issued stock options to purchase up to 82,500 shares of common stock at an exercise price
of $1.00 per share to members of the Company’s medical advisory board and consultants pursuant to the Plan. The options vested
immediately. The estimated aggregate fair value of the stock options at the date of grant was determined to be approximately $63,900
using a Black Scholes model.
In
August 2022, the Company issued stock options to purchase up to 500,000 shares of common stock at an exercise price of $1.00 per share
to members of the Company’s medical advisory board and consultants pursuant to the Plan. The options vest over a three-year period.
The estimated aggregate fair value of the stock options at the date of grant was determined to be $287,487 using a Black Scholes model.
The
Company recognized approximately $259,000 and $232,000 of stock-based compensation expense during the year ended December 31, 2022 and
2021, respectively, related to stock options which is included in the accompanying statements of operations. As of December 31, 2022,
there was approximately $655,000 of total unrecognized compensation expense related to non-vested share-based compensation arrangements
granted under the Plan. That cost is expected to be recognized over a weighted-average period of approximately 2.0 years.
At
December 31, 2022, there were 5,115,000 shares available to be issued under the Plan. The following table summarizes stock option activity
of the Plan through December 31, 2022:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Options Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
Options outstanding – December 31, 2020 | |
| 1,800,000 | | |
$ | 1.00 | |
Granted | |
| 82,500 | | |
| 1.00 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
| |
| | | |
| | |
Options outstanding – December 31, 2021 | |
| 1,882,500 | | |
$ | 1.00 | |
Granted | |
| 502,500 | | |
| 1.00 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Options outstanding – December 31, 2022 | |
| 2,360,000 | | |
$ | 1.00 | |
Additional
information regarding the exercisable options and average remaining contractual life of the options outstanding as of December 31, 2022
is as follows:
SCHEDULE OF STOCK OPTIONS OUTSTANDING AND EXERCISABLE
Exercise
Price |
|
|
Number
Outstanding |
|
|
Weighted
Average
Remaining
Contractual Life |
|
|
Number
Exercisable at
December
31, 2022 |
|
|
Number
Exercisable at
December
31, 2021 |
|
$ |
1.00 |
|
|
|
2,360,000 |
|
|
|
7.2
Years |
|
|
|
1,204,444 |
|
|
|
525,000 |
|
The
fair value of each option grant was estimated on the date of grant to be $0.53 per share using the Black-Scholes option-pricing model
with the following assumption weighted-averages in 2021:
SCHEDULE
OF STOCK OPTIONS FAIR VALUE ASSUMPTIONS
Risk-free
interest rates |
|
|
1.2%
- 2.42 |
% |
Expected
life in years |
|
|
5.0 |
|
Expected
volatility |
|
|
73.1 |
% |
Expected
dividend yield |
|
|
0 |
% |
Fair
value common stock |
|
$ |
1.00 |
|
The
fair value of each option grant was estimated on the date of grant to be $0.56 per share using the Black-Scholes option-pricing model
with the following assumption weighted-averages in 2022:
Risk-free
interest rates |
|
|
2.19 |
% |
Expected
life in years |
|
|
3.5 |
|
Expected
volatility |
|
|
80 |
% |
Expected
dividend yield |
|
|
0 |
% |
Fair
value common stock |
|
$ |
1.00 |
|
The
risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero-coupon issues with a remaining
term commensurate with the expected term of the award. Management has estimated expected volatility based on similar comparable industry
sector averages. Expected life of the option represents the period of time options are expected to be outstanding. The estimate for dividend
yield is 0% because the Company has not historically paid, and does not intend to pay a dividend on its common stock in the foreseeable
future.
NOTE
F - WARRANTS
In
2021, the Company finalized the issuance of warrants to purchase 150,000 shares of common stock at $1.10 per share which are fully vested
as of December 31, 2021, and exercisable over 7 years, to a consulting firm. The fair value of such warrants was estimated on the date
of grant to be $0.61 per share using the Black-Scholes option-pricing model with the following assumption weighted-averages in 2021:
SCHEDULE
OF WARRANTS FAIR VALUE ASSUMPTIONS
Risk-free
interest rates |
|
|
2.42 |
% |
Expected
life in years |
|
|
3.5 |
|
Expected
volatility |
|
|
73.1 |
% |
Expected
dividend yield |
|
|
0 |
% |
Fair
value common stock |
|
$ |
1.00 |
|
The
risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero-coupon issues with a remaining
term commensurate with the expected term of the award. Management has estimated expected volatility based on similar comparable industry
sector averages. Expected life of the option represents the period of time options are expected to be outstanding. The estimate for dividend
yield is 0% because the Company has not historically paid, and does not intend to pay a dividend on its common stock in the foreseeable
future. The Company recognized stock-based compensation expense of approximately $75,000 and $0 in the year ended December 31, 2021 and
2022, respectively. At December 31, 2022, there is no remaining compensation expense to be recognized.
The
following table summarizes warrant activity through December 31, 2022:
SCHEDULE
OF WARRANTS ACTIVITY
| |
Warrants Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
Warrants outstanding – December 31, 2020 | |
| 62,500 | | |
$ | 1.00 | |
Granted | |
| 150,000 | | |
| 1.10 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| (13,500 | ) | |
| 1.00 | |
| |
| | | |
| | |
Warrants outstanding – December 31, 2021 | |
| 199,000 | | |
$ | 1.07 | |
| |
| | | |
| | |
Granted | |
| - | | |
| - | |
Canceled | |
| (12,500 | ) | |
| 1.00 | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Warrants outstanding – December 31, 2022 | |
| 161,500 | | |
$ | 1.09 | |
Additional
information regarding the warrants outstanding as of December 31, 2022 is as follows:
SCHEDULE
OF WARRANTS OUTSTANDING
Exercise
Price |
|
|
Number
Outstanding |
|
|
Weighted
Average
Remaining
Contractual Life |
|
|
Number
Exercisable |
|
$ |
1.00 |
|
|
|
11,500 |
|
|
|
.7
Years |
|
|
|
11,500 |
|
$ |
1.10 |
|
|
|
150,000 |
|
|
|
5.7
Years |
|
|
|
150,000 |
|
|
|
|
|
|
161,500 |
|
|
|
|
|
|
|
161,500 |
|
Pre-funded
Warrant
On
December 27, 2021, the Company entered into an exchange agreement with Sanovas Ophthalmology (the “Exchange Agreement”) pursuant
to which it exchanged 28,014,540 shares of common stock (the “Exchange Securities”) held by Sanovas Ophthalmology for a pre-funded
warrant (the “Pre-funded Warrant”) to purchase up to an aggregate of 28,014,540 shares of the Company’s common stock.
The Pre-funded Warrant is immediately exercisable at an exercise price of $0.0001 per share and terminates when exercised in full. As
part of the Exchange Agreement, Sanovas Ophthalmology relinquished any and all rights related to the Exchange Securities.
NOTE
G – SHAREHOLDERS’ NOTES PAYABLE
During
2021, the Company borrowed an aggregate of $73,000 from several stockholders pursuant to note agreements bearing interest at 8% per annum
and maturing December 31, 2022. The Company has informally extended the maturity date to December 31, 2023 under the same terms. During
the year ended December 31, 2022, one of the noteholders exercised outstanding warrants with an aggregate exercise price of $25,000 through
the offset of the note payable due to them from the Company, such that $48,000 remain outstanding at December 31, 2022. Interest expense
amounted to $5,140 and $2,619 for the years ended December 31, 2022 and 2021, respectively. The accrued interest payable at December
31, 2022 and 2021 was $7,759 and $2,619, respectively.
NOTE
H – INCOME TAXES
The
Company had no current income tax expense for the years ended December 31, 2022 and 2021 due to operating losses. The effective income
tax rate for the years ended December 31, 2022 and 2021 is zero, as the deferred tax benefits are fully offset by the valuation allowance
against such deferred income tax assets.
At
December 31, 2022, the Company had net operating loss carryforwards (“NOL”) of approximately $4,499,000 for federal income
tax purposes of which $3,724,000 has no expiration date, $775,000 which begins to expire in 2034, and approximately $4,499,000 for state
income tax purposes which begins to expire in 2030.
The
resulting net deferred tax assets of approximately $1,714,000 ($1,350,000 applicable to net operating loss carryforwards, $236,000 applicable
to stock-based compensation and $128,000 applicable to accruals) and $1,193,000 ($992,000 applicable to net operating loss carryforwards,
$158,000 applicable to stock based compensation and $43,000 applicable to accruals) at December 31, 2022 and December 31, 2021, respectively,
has been fully reserved due to the uncertainty of future realization. The valuation allowance increased by approximately $521,000 and
$389,000 at December 31, 2022 and 2021, respectively. In assessing the realizability of deferred tax assets, management considered whether
it is more likely than not that some portion or all of the deferred taxes will not be realized. The ultimate realization of deferred
tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible.
Due
to the change in ownership provisions of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”), the
availability of the Company’s NOL carryforwards may be subject to annual limitations against taxable income in future periods,
which could substantially limit the eventual utilization of such carryforwards. The Company has not analyzed the historical or potential
impact of its equity financings on beneficial ownership and therefore no determination has been made whether the NOL carryforward is
subject to any Internal Revenue Code Section 382 limitation. To the extent there is a limitation, there would be a reduction in the deferred
tax asset with an offsetting reduction in the valuation allowance.
The
Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. The open years for tax examination
are 2017 and thereafter.
NOTE
I - CONTINGENCY
The Company received a claim against it relating to a former indirect
vendor. The Company believes the claim is without merit and intends to vigorously defend itself. The Company does not believe the claim
would have a material impact on the financial condition of the Company.
NOTE
J - SUBSEQUENT EVENTS
The Company has evaluated the effect of events and transactions subsequent
to December 31, 2022 through the date of issuance of the consolidated financial statements, and determined that no subsequent events have
occurred that require recognition in the consolidated financial statements.
RETINALGENIX
TECHNOLOGIES INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
| |
June
30, 2023
(Unaudited)
| | |
December
31, 2022
(Audited)
| |
ASSETS | |
| | | |
| | |
Current Assets | |
| | | |
| | |
Cash | |
$ | 1,913 | | |
$ | 38 | |
Total Current Assets | |
| 1,913 | | |
| 38 | |
Equipment, net of accumulated depreciation of $101 | |
| 206 | | |
| 256 | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 2,119 | | |
$ | 294 | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
Liabilities | |
| | | |
| | |
Current Liabilities | |
| | | |
| | |
Accounts payable and accrued liabilities | |
$ | 697,073 | | |
$ | 475,480 | |
Due to Sanovas | |
| 811,176 | | |
| 427,933 | |
Due to related parties | |
| 210,022 | | |
| 109,185 | |
Shareholders’ notes payable | |
| 49,000 | | |
| 49,000 | |
Accrued interest payable | |
| 9,679 | | |
| 7,759 | |
Total Liabilities | |
| 1,776,950 | | |
| 1,069,357 | |
Stockholders’ Deficit: | |
| | | |
| | |
Preferred stock, $0.0001
par value; 40,000,000 shares
authorized; Series F preferred stock – 3,000,000
shares designated, 0
issued and outstanding at June 30, 2023 and December 31, 2022 | |
| - | | |
| - | |
Common stock, $0.0001 par value; 80,000,000 shares authorized; 17,272,116 shares issued and outstanding at June 30, 2023 and December 31, 2022 | |
| 1,783 | | |
| 1,783 | |
Additional paid in capital | |
| 8,104,478 | | |
| 7,947,460 | |
Accumulated deficit | |
| (9,881,092 | ) | |
| (9,018,306 | ) |
Total Stockholders’ Deficit | |
| (1,774,831 | ) | |
| (1,069,063 | ) |
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
$ | 2,119 | | |
$ | 294 | |
The
accompanying notes are an integral part of these consolidated financial statements.
RETINALGENIX
TECHNOLOGIES INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
| |
2023 | | |
2022 | |
| |
For The Three Months Ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Revenues | |
$ | - | | |
$ | - | |
Operating expenses: | |
| | | |
| | |
General and administrative expenses | |
| 120,097 | | |
| 167,385 | |
Research and development | |
| 152,577 | | |
| 135,439 | |
Stock-based compensation | |
| 78,509 | | |
| 55,051 | |
| |
| | | |
| | |
Total operating expenses | |
| 351,183 | | |
| 357,875 | |
| |
| | | |
| | |
Interest expense | |
| 960 | | |
| 1,460 | |
| |
| | | |
| | |
Net loss | |
$ | (352,143 | ) | |
$ | (359,335 | ) |
| |
| | | |
| | |
Net loss per share – basic and diluted | |
$ | (0.02 | ) | |
$ | (0.02 | ) |
| |
| | | |
| | |
Weighted average number of common shares outstanding during the period- basic and diluted | |
| 17,272,116 | | |
| 14,523,114 | |
The
accompanying notes are an integral part of these consolidated financial statements.
RETINALGENIX
TECHNOLOGIES INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
| |
2023 | | |
2022 | |
| |
For The Six Months Ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Revenues | |
$ | - | | |
$ | - | |
Operating expenses: | |
| | | |
| | |
General and administrative expenses | |
| 323,339 | | |
| 328,580 | |
Research and development | |
| 380,509 | | |
| 292,932 | |
Stock-based compensation | |
| 157,018 | | |
| 110,102 | |
| |
| | | |
| | |
Total operating expenses | |
| 860,866 | | |
| 731,614 | |
| |
| | | |
| | |
Interest expense | |
| 1,920 | | |
| 2,920 | |
| |
| | | |
| | |
Net loss | |
$ | (862,786 | ) | |
$ | (734,534 | ) |
| |
| | | |
| | |
Net loss per share – basic and diluted | |
$ | (0.05 | ) | |
$ | (0.05 | ) |
| |
| | | |
| | |
Weighted average number of common shares outstanding during the period- basic and diluted | |
| 17,272,116 | | |
| 14,400,037 | |
The
accompanying notes are an integral part of these consolidated financial statements.
RETINALGENIX
TECHNOLOGIES INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT (UNAUDITED)
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND JUNE 30, 2022
| |
Shares | | |
Par Value | | |
Paid-in Capital | | |
Accumulated Deficit | | |
Total | |
| |
Common Stock | | |
Additional | | |
| | |
| |
| |
Shares | | |
Par Value | | |
Paid-in Capital | | |
Accumulated Deficit | | |
Total | |
2022 Period | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as at December 31, 2021 | |
| 14,221,814 | | |
$ | 1,423 | | |
| 4,638,218 | | |
$ | (5,104,316 | ) | |
$ | (464,675 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| 55,051 | | |
| - | | |
| 55,051 | |
Stock purchased by investors | |
| 60,500 | | |
| 61 | | |
| 60,439 | | |
| - | | |
| 60,500 | |
Net loss | |
| - | | |
| | | |
| - | | |
| (375,199 | ) | |
| (375,199 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as at March 31, 2022 | |
| 14,282,314 | | |
$ | 1,484 | | |
$ | 4,753,708 | | |
$ | (5,479,515 | ) | |
$ | (724,323 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| 55,051 | | |
| - | | |
| 55,051 | |
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology
LLC | |
| 353,432 | | |
| 35 | | |
| 353,397 | | |
| - | | |
| 353,432 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (359,335 | ) | |
| (359,335 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as at June 30, 2022 | |
| 14,635,746 | | |
$ | 1,519 | | |
$ | 5,162,156 | | |
$ | (5,838,850 | ) | |
$ | (675,175 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
2023 Period | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as at December 31, 2022 | |
| 17,272,116 | | |
$ | 1,783 | | |
$ | 7,947,460 | | |
$ | (9,018,306 | ) | |
$ | (1,069,063 | ) |
Stock-based compensation | |
| | | |
| | | |
| 78,509 | | |
| | | |
| 78,509 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (510,643 | ) | |
| (510,643 | ) |
Balance as at March 31, 2023 | |
| 17,272,116 | | |
$ | 1,783 | | |
$ | 8,025,969 | | |
$ | (9,528,949 | ) | |
$ | (1,774,831 | ) |
Beginning balance | |
| 17,272,116 | | |
$ | 1,783 | | |
$ | 8,025,969 | | |
$ | (9,528,949 | ) | |
$ | (1,774,831 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| | | |
| 78,509 | | |
| - | | |
| 78,509 | |
Net loss | |
| - | | |
| - | | |
| | | |
| (352,143 | ) | |
| (352,143 | ) |
Balance as at June 30, 2023 | |
| 17,272,116 | | |
$ | 1,783 | | |
$ | 8,104,478 | | |
$ | (9,881,092 | ) | |
$ | (1,774,831 | ) |
Ending balance | |
| 17,272,116 | | |
$ | 1,783 | | |
$ | 8,104,478 | | |
$ | (9,881,092 | ) | |
$ | (1,774,831 | ) |
The
accompanying notes are an integral part of these consolidated financial statements.
RETINALGENIX
TECHNOLOGIES INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
| |
2023 | | |
2022 | |
| |
For The Six Months Ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Cash Flows From (Used In) Operating Activities | |
| | | |
| | |
Net loss | |
$ | (862,786 | ) | |
$ | (734,534 | ) |
Adjustments to reconcile net loss to net cash (used in) operating activities | |
| | | |
| | |
Non-cash items: | |
| | | |
| | |
Stock-based compensation expense | |
| 157,018 | | |
| 110,102 | |
Depreciation expense | |
| 50 | | |
| - | |
Expenses paid by Sanovas on behalf of Company, net | |
| 280,820 | | |
| 426,109 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Increase in accounts payable and accrued liabilities | |
| 221,593 | | |
| 88,297 | |
Increase in accrued interest | |
| 1,920 | | |
| 2,920 | |
Total adjustments | |
| 661,401 | | |
| 627,428 | |
Net cash (used in) operating activities | |
| (201,385 | ) | |
| (107,106 | ) |
| |
| | | |
| | |
Cash Flows From Financing Activities | |
| | | |
| | |
Proceeds from common stock sold, net of costs | |
| - | | |
| 60,500 | |
Advances from related parties | |
| 203,260 | | |
| 41,686 | |
Net cash provided by financing activities | |
| 203,260 | | |
| 102,186 | |
Net increase (decrease) in cash | |
| 1,875 | | |
| (4,920 | ) |
Cash at beginning of period | |
| 38 | | |
| 4,947 | |
Cash at end of period | |
$ | 1,913 | | |
$ | 27 | |
| |
| | | |
| | |
Supplemental information: | |
| | | |
| | |
Interest paid | |
$ | - | | |
$ | - | |
Income taxes paid | |
| - | | |
| - | |
The
accompanying notes are an integral part of these consolidated financial statements.
RETINALGENIX
TECHNOLOGIES INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
A – HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN
RetinalGenix
Technologies Inc. (the “Company”), a Delaware corporation, was formed in November 2017 by Sanovas Ophthalmology, LLC (“Sanovas
Ophthalmology”), a majority owned subsidiary of Sanovas Inc. (“Sanovas”), a privately held research and development
incubator. During the periods ended June 30, 2023 and 2022, a portion of the operations of the Company were conducted by Sanovas, who
invoices the Company for costs and expenses paid for on behalf of the Company and costs and expenses allocated to the Company for services
performed on behalf of the Company.
The
Company was formed to develop technologies to diagnose and treat ophthalmic disorders. The Company sublicensed certain technology initially
developed by Sanovas from Sanovas Ophthalmology – See Note C. Since 2018, the Company has been developing its screening device
and home monitoring and physician alert system.
On
October 8, 2019, the Company entered into an option exchange agreement (the “Option Exchange Agreement”) with Diopsys, Inc.
(“Diopsys”) pursuant to which the Company agreed to issue Diopsys an option to purchase up to 10% of its issued and outstanding
shares of common stock and Diopsys granted the Company an option to purchase up to 10% of the issued and outstanding shares of common
stock of Diopsys on the Closing Date (the “Option Exchange”). “Closing Date” means a date that is within 30 days
of the date that all of the contingencies set forth in the Option Exchange Agreement are satisfied including, but not limited to, approval
of a product by the U.S. Food and Drug Administration. In addition, pursuant to the Option Exchange Agreement, upon the closing of the
Option Exchange, the Company agreed to enter into an exclusive distribution agreement with Diopsys pursuant to which Diopsys shall act
as the Company’s exclusive distributor of such product. On February 14, 2022, the Company entered into a Termination of Option
Exchange Agreement (the “Termination Agreement”) with Diopsys pursuant to which the prior Option Exchange Agreement between
the Company and Diopsys was terminated effective immediately and of no further force and effect, and neither party has any past, current
or future obligations or liabilities to the other (or any other person or entity) with respect to any rights, obligations or any of the
transactions contemplated in the Option Exchange Agreement. At the time of such termination, none of the conditions in the Option Exchange
Agreement were satisfied and no options thereunder had been issued to either the Company or Diopsys. In addition, the Exclusive Distribution
Agreement to be entered into between the Company and Diopsys and referred to in the Option Exchange Agreement has not been negotiated
and as of the second quarter of 2022, there are no plans to move forward with Diopsys.
On
December 27, 2021, the Company entered into an exchange agreement (the “Exchange Agreement”) with Sanovas Ophthalmology pursuant
to which the Company exchanged 28,014,540 shares of common stock held by Sanovas Ophthalmology for a pre-funded warrant (the “Pre-funded
Warrant”) to purchase up to an aggregate of 28,014,540 shares of the Company’s common stock. The Pre-funded Warrant is immediately
exercisable at an exercise price of $0.0001 per share and terminates when exercised in full.
On
July 5, 2022, the Company entered into an exchange agreement with Dr. Lawrence Perich pursuant to which it acquired all the outstanding
shares of DNA/GPS Inc., a pharmacogenetics company based in Tampa, Florida (“DNA/GPS”), in exchange for the issuance of 2,000,000
shares of the Company’s common stock. The acquisition of DNA/GPS combines DNA/GPS’ genetic mapping capabilities with the
Company’s retinal imaging capabilities. The combined technology is expected to have the ability to screen, monitor and provide
data to profile trends and create diagnostic markers for systemic and retinal disorders in the cardiovascular, Alzheimer’s, Parkinson
disease. The markers and data analysis are rapid and cost effective, thereby eliminating expensive diagnostic equipment such as MRI or
CT scanning. The results are confidential to the patient and anonymous for any third party without permission of the patient. The Company
accounted for this transaction as an asset acquisition in the quarter ending September 30, 2022. The estimated fair value of the transaction
was $2,000,000 plus legal fees associated with the transaction of $32,889 is recorded as acquired in-process research and development
costs in the associated consolidated statement of operations in the quarter ended September 30, 2022.
Liquidity
and Going Concern
The
Company has had net losses since inception and has an accumulated deficit of approximately $9,881,000
at June 30, 2023. In addition, as of June 30,
2023 and December 31 2022, we had liabilities of approximately $1,777,000
and $1,069,000,
respectively, the majority of which is with related parties. The Company has minimal cash at June 30, 2023 and remains dependent on related
parties for much of its financing. The Company expects that operating losses and negative cash flows from operations will occur for at
least the next several years, and the Company will need to access additional funds to achieve its strategic goals with respect to the
sublicensed technology. The Company completed a private offering of shares of its common stock raising net proceeds of $60,500
in the six months ended June 30, 2022 –
See Note D.
Sanovas
has paid a significant portion of the Company’s operating expenses through June 2023, and was owed approximately $811,000 as of
June 30, 2023 by the Company. The Company also issued shares of its common stock to offset amounts due to Sanovas for payment of expenses
on behalf of the Company of $353,432 in May 2022 and $586,370 in November 2022 (see Note C).
As
of the date of this report, the Company does not have adequate resources to fund its operations through August 2024 without considering
any potential future milestone payments that it may receive under any new collaborations that it may enter into in the future or any
future capital raising transactions. The Company will need to raise additional funding to complete the development of its products and
commence the market launch, assuming regulatory approval is obtained. The Company does not know whether additional financing will be
available when needed, whether it will be available on favorable terms, or if it will be available at all. These factors raise substantial
doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
NOTE
B – SIGNIFICANT ACCOUNTING POLICIES
A
summary of significant accounting policies consistently applied in the preparation of the accompanying consolidated financial statements
is as follows:
1.
Basis of Presentation
The
Company’s consolidated financial statements were prepared in accordance with accounting principles generally accepted in the United
States of America (“US GAAP”). As of June 30, 2023, there have been no material changes in the Company’s significant
accounting policies from those that were disclosed in the Annual Report for the year ended December 31, 2022 (the “2022 Annual
Report”).
2.
Cash Equivalents
For
purpose of the consolidated statements of cash flows, the Company considers all short-term investments purchased with a maturity of three
months or less to be cash equivalents.
3.
Use of Estimates
In
preparing the Company’s consolidated financial statements in conformity with US GAAP, management is required to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the
date of the consolidated financial statements, as well as the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates.
4.
Income Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future
tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted
tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
date.
The
Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
Topic 740-10 Income Taxes. ASC Topic 740-10 clarifies the accounting for income taxes by prescribing a minimum recognition threshold
a tax position is required to meet before being recognized in the financial statements. It also provides guidance on the recognition,
measurement, and classification of amounts relating to uncertain tax positions, accounting for and disclosure of interest and penalties,
accounting in interim periods and disclosures. The application of that guidance did not result in the recognition of any unrecognized
tax benefits at June 30, 2023 or December 31, 2022. The Company’s policy is to expense any penalties and interest associated with
this topic. At June 30, 2023 and December 31, 2022, there were no amounts accrued for penalties and interest.
5.
Income (Loss) Per Common Share
The
Company computes net income (loss) per share in accordance with ASC 260, Earnings Per Share (“EPS”). Under the provisions
of ASC 260, basic net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number
of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for
the period by the weighted-average number of common and common equivalent shares outstanding during the period. However, common shares
that are considered anti-dilutive are excluded from the computation of diluted EPS. Since the Company had a loss during the three and
six months ended June 30, 2023 and 2022, the basic and diluted net loss per share is the same.
Potentially
dilutive securities not included in the computation of loss per share for the three and six months ended June 30, 2023, include stock
options to purchase 2,360,000 shares of common stock, pre-funded warrants to purchase 28,014,540 shares of common stock, and warrants
to purchase 161,500 shares of common stock. Potentially dilutive securities not included in the computation of loss per share for the
three and six months ended June 30, 2022 stock options to purchase 1,882,500 shares of common stock, pre-funded warrant to purchase 28,014,540
shares of common stock and warrants to purchase 199,000 shares of common stock. The shares of common stock potentially issuable to Diopsys
upon the resolution of specified contingencies and exercise of stock options are also excluded from the loss per share calculation for
the three months ended June 30, 2022.
6.
Stock-based compensation:
The
Company recognizes expense for stock-based compensation in accordance with ASC Topic 718, Stock-Based Compensation. For stock-based
awards, the Company calculates the fair value of the award on the date of grant using the Black Scholes option-pricing model. The expense
is recognized over the service period for awards expected to vest. The estimate of stock-based awards that will ultimately vest requires
judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative
adjustment in the period the estimates are revised. Stock options granted to non-employee consultants are revalued at the end of each
reporting period until vested and the changes in their fair value are recorded as adjustments to expense over the related vesting period.
7.
Research and Development costs:
Research
and development costs are expensed as incurred. Costs incurred in obtaining technology licenses outside of business combinations are
charged to research and development expense as acquired in-process research and development if the technology licensed has not reached
technological feasibility and has no alternative future use.
licensed
has not reached technological feasibility and has no alternative future use.
8.
Property and Equipment:
Property
and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives (3
years), once the asset is placed in service. Expenditures for maintenance and repairs, which do not extend the economic useful life of
the related assets, are charged to operations as incurred, and expenditures which extend the economic life are capitalized. When assets
are retired or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and
any gain or loss on disposal is recognized in the consolidated statement of operations for the respective period.
The
Company’s long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying
amount of the asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result
from the use of the asset and its eventual disposition are less than its carrying amount.
9.
Recent Accounting Pronouncements:
The
following pronouncement may have an impact on the accounting policies of the Company:
In
February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“ASU 2016-02”). ASU 2016-02 requires an
entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require
new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing,
and uncertainty of cash flows arising from leases. The FASB issued ASU No. 2018-10 “Codification Improvements to Topic 842, Leases”
(“ASU 2018-10”), ASU No. 2018-11 “Leases (Topic 842) Targeted Improvements” (“ASU 2018-11”) in July
2018, and ASU No. 2018-20 “Leases (Topic 842) – Narrow Scope Improvements for Lessors” (“ASU 2018-20”)
in December 2018. ASU 2018-10 and ASU 2018-20 provide certain amendments that affect narrow aspects of the guidance issued in ASU 2016-02.
ASU 2018-11 allows all entities adopting ASU 2016-02 to choose an additional (and optional) transition method of adoption, under which
an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening
balance of retained earnings in the period of adoption. Pursuant to ASU 2019-10 the effective date for ASC 842 was deferred an additional
year. The Company expects to recognize operating lease right-of-use assets and lease liabilities on the balance sheet upon adoption of
this ASU when it obtains a lease. The Company does not current have a lease.
A
variety of proposed or otherwise potential accounting standards are currently under study by standard-setting organizations. Due to the
tentative and preliminary nature of those proposed standards, management has not determined whether the implementation of such proposed
standards would be material to the consolidated financial statements of the Company.
NOTE
C – RELATED PARTY TRANSACTIONS
Sanovas
The
Company is related to Sanovas through common ownership and management. Sanovas Ophthalmology is a majority owned subsidiary of Sanovas
and Jerry Katzman, the Company’s Chief Executive Officer, is also a director of Sanovas Ophthalmology and in such capacity has
the right to vote and dispose of the securities held by such entity.
Commencing
in 2019, Sanovas began paying expenses on behalf of the Company, and began allocating a portion of expenses and infrastructure costs
to the Company and other entities where Sanovas was performing shared services. Included in such allocated costs is approximately $281,000
and $106,000 in costs related to an officer of the Company in the six months ending June 30, 2023 and 2022,
respectively.
The
following summarizes the transactions between the Company and Sanovas for the six months ended June 30, 2023 and 2022:
SCHEDULE
OF RELATED PARTY TRANSACTIONS
| |
|
|
|
|
|
| |
| |
Six months Ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Balance due to ( Sanovas – beginning of year | |
$ | 427,933 | | |
$ | 142,721 | |
| |
| | | |
| | |
Costs paid by Sanovas on the Company’s behalf | |
| - | | |
| 36,289 | |
Costs of Sanovas allocated to the Company | |
| 280,820 | | |
| 168,702 | |
Proceeds from costs charged by Sanovas to the Company, net | |
| 102,423 | | |
| 221,119 | |
Retirement of due to Sanovas through the issuance of shares to Sanovas Ophthalmology | |
| - | | |
| (353,432 | ) |
| |
| | | |
| | |
Balance due to Sanovas – end of period | |
$ | 811,176 | | |
$ | 215,398 | |
The
Company issued 353,432 and 586,370 shares of its common stock to offset amounts due to Sanovas for payment of expenses on behalf of the
Company of $353,432 in May 2022 and $586,370 in November 2022, respectively.
Sublicense
On
June 24, 2021, the Company entered into a sublicense agreement (“Sublicense Agreement”) with Sanovas Ophthalmology pursuant
to which Sanovas Ophthalmology granted the Company an exclusive worldwide (“Territory”) license to certain intellectual property
licensed to Sanovas Ophthalmology by Sanovas Intellectual Property LLC relating to certain technologies for eye and ocular visualization
and monitoring (“Licensed IP”) for uses related to the screening, examination, diagnosis, prevention and/or treatment of
any eye disease, medical condition or disorder, or any disease, medical condition or disorder affecting the eye. Pursuant to the Sublicense
Agreement, commencing on the date of the first commercial sale of a Licensed Product (as defined in the Sublicense Agreement), in each
country in the Territory and continuing on a country by country basis until the expiration or termination of the last Valid Claim (as
defined in the Sublicense Agreement) of a licensed patent in such country (the “Royalty End Date”), the Company is obligated
to pay Sanovas Ophthalmology a royalty equal to a mid-single digit percentage of any Net Sales (as defined in the Sublicense Agreement)
of any Licensed Product. The Sublicense Agreement continues until the Royalty End Date, unless earlier terminated pursuant to its terms.
The Sublicense Agreement may be terminated by either party if the other party materially breaches the Sublicense Agreement in a manner
that cannot be cured, or materially breaches the Sublicense Agreement in a manner that can be cured and such breach remains uncured for
more than 30 days after the receipt by the breaching party of notice specifying the breach. Furthermore, the Company may terminate the
Sublicense Agreement at any time upon 90 days written notice to Sanovas Ophthalmology. No royalties have been paid through June 30, 2023
under this Sublicense Agreement.
Due
to affiliates
From
time to time, an officer of the Company, a shareholder of the Company and affiliates of Sanovas advanced funds or paid expenses on behalf
of the Company. There is no formal notes or repayment plan for such advances. At June 30, 2023 and December 31, 2022, the Company had
received an aggregate of $210,022 and $109,185 pursuant to such advances, respectively.
Shareholders’
notes payable – See Note G
NOTE
D – COMMON AND PREFERRED STOCK
Pursuant
to the Company’s Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”),
filed with the Delaware Secretary of State on January 8, 2018, the Company is authorized to issue 40,000,000 shares of preferred stock
and 80,000,000 shares of common stock each with a par value of $0.0001 per share. The Company has designated 3,000,000 shares of preferred
stock as Series F preferred stock.
Pursuant
to the terms of an employment agreement dated January 1, 2012 (the “Effective Date”) by and between Sanovas and Lawrence
Gerrans, the then President and Chief Executive Officer of Sanovas (the “Original Employment Agreement”), in consideration
for Mr. Gerrans’ services, Mr. Gerrans was to receive, among other consideration, the following equity securities: (i) 441,177
shares of restricted common stock of each of the wholly-owned subsidiaries of Sanovas, as of the Effective Date (the “Affiliate
Subsidiaries”), representing 7.5% of the total equity capital of each such subsidiary issued and outstanding as of the date of
grant; and (ii) 5,000 shares of Series F preferred stock of Sanovas and each of the Affiliate Subsidiaries. The Company was incorporated
in Delaware on November 17, 2017, subsequent to the Effective Date, and as such these shares were never issued by the Company because
the Company was not an Affiliate Subsidiary of Sanovas. Thereafter, in May 2015, Mr. Gerrans’ Original Employment Agreement was
amended and restated with an effective date of January 1, 2012 (the “Amended and Restated Employment Agreement”), the same
as the Effective Date of the Original Employment Agreement. Pursuant to the Amended and Restated Employment Agreement, in consideration
for Mr. Gerrans’ services, Mr. Gerrans was to receive, among other consideration, the following equity securities: (i) 7.5% of
the total equity capital of each of Sanovas’ Affiliate Subsidiaries as of the Effective Date or thereafter formed (collectively,
the “New Subsidiaries”); and (ii) 5,000 shares of Series F preferred stock of Sanovas, each of the Affiliate Subsidiaries
and each of the New Subsidiaries, including the Company. Subsequently, pursuant to a board resolution dated December 1, 2017 approved
by Lawrence Gerrans, the Company’s then Chief Executive Officer, President and sole director, in 2018 the Company issued 27,000,000
shares of its common stock to Sanovas Ophthalmology LLC, and issued 3,000,000 shares of its Series F preferred stock to Halo Management
LLC (“Halo”), an entity owned by Mr. Gerrans, for certain enumerated consideration that was purported to have been provided.
Thereafter, and in part based upon the evidence and testimony presented, and verdict and conviction rendered, in the Criminal Action
(discussed below), including, but not limited to, the fact that Mr. Gerrans misled and coerced the board of Sanovas regarding the terms
and need for approval of the Amended and Restated Employment Agreement, the Company’s board of directors, acting in concert with
the board of directors of Sanovas, carried out an investigation with respect to actions taken by Mr. Gerrans and have determined that
Halo did not provide the Company with valid consideration for the Series F preferred stock, and the Company disputes whether any of the
shares of the Company issued to Halo were validly issued.
In
January 2020, a jury in the United States District Court for the Northern District of California found Mr. Gerrans guilty, in a criminal
proceeding (the “Criminal Action”), on 12 felony counts of wire fraud, money laundering, perjury, contempt of court, witness
tampering, and obstruction of justice in connection with his activities as an officer and director of Sanovas. Thereafter, in November
2020, Sanovas commenced an action in the Court of Chancery of the State of Delaware (the “Delaware Action”) against Halo
and Mr. Gerrans seeking an order declaring that any rights that Halo and/or Mr. Gerrans may have with respect to any equity securities
in Sanovas and each of its affiliated subsidiaries (including, but not limited to, the Company) are void or voidable and may be cancelled.
The Delaware Action is currently still pending.
On
November 21,2021, the Company’s Board of Directors resolved to rescind the 3,000,000 shares of Series F preferred stock purported
to be issued to Halo Management Group LLC for lack of contract consideration. The Company is aware that the management/ownership of Halo
Management Group LLC may dispute this decision however, the Company is prepared to defend its decision in this case. In addition, the
Company reserves the right to void the shares and adjust its filings accordingly if necessary.
Common
Stock
During
2019, the Company commenced a private offering of its shares of common stock at a purchase price of $1.00 per share. For the six months
ended June 30, 2022, the Company sold an aggregate of 60,500 shares of its common stock, and the offering was concluded. No shares were
sold in 2023.
The
common stockholders, voting as a separate class, are entitled to elect one member of the Board of Directors.
Preferred
Stock
As
of June 30, 2023 and December 31, 2022, there were 3,000,000 shares of preferred stock designated as Series F preferred stock, none of
which were outstanding.
The
rights and privileges of the Series F preferred stock are summarized as follows:
Voting
Privileges and Protective Features:
Each
holder of outstanding shares of Series F preferred stock is entitled to cast the number of votes equal to the number of whole shares
of common stock into which the Series F preferred stock held by such holder are convertible as of the record date for determining stockholders
entitled to vote on such matter. The holders of record of a majority of outstanding Series F preferred stock shall be entitled to elect
two of the members of the Board of Directors of the Company. The right to elect two directors shall terminate on the date upon which
there are less than 25,000 shares of Series F preferred stock issued and outstanding.
For
so long as at least 25,000 shares of Series F preferred stock remain outstanding, the vote or written consent of the holders of the majority
of the outstanding shares of Series F preferred stock is necessary for the Company to conduct certain corporate actions, including, but
not limited to, merger, consolidation or dissolution of the Company; certain amendments to the Certificate of Incorporation or bylaws
of the Company; authorization or issuance of shares of any additional class or series of capital stock unless the same ranks on parity
or junior to the Series F preferred stock with respect to voting rights.
Redemption:
The
Series F preferred stock does not have redemption features.
Dividends:
There
are no stated dividends on the Series F preferred stock.
Conversion:
Each
share of Series F preferred stock is convertible, at the option of the holder, at any time and from time to time into shares of common
stock at a conversion rate as is determined by dividing the Series F Original Issue Price by the Series F Conversion Price. “Series
F Original Issue Price” initially means $0.01 and “Series F Conversion Price” initially means $0.01, as adjusted for
any dilutive transaction such as stock splits, certain dividends, mergers or acquisitions.
All
of the outstanding shares of Series F preferred stock will automatically convert into shares of the Company’s common stock upon
the consummation of an underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933,
as amended, resulting in gross proceeds of at least $15,000,000 to the Company or upon written consent of at least 67% of the Series
F preferred shareholders.
NOTE
E – STOCK PLAN
The
Company has reserved 10,000,000 shares of common stock for issuance to employees or consultants from the RetinalGenix Technologies Inc.
2017 Equity Incentive Plan (the “Plan”). The Company may grant stock options, restricted stock or other types of equity incentive
instruments under the Plan.
In
August 2022, the Company issued stock options to purchase up to 500,000 shares of common stock at an exercise price of $1.00 per share
to members of the Company’s medical advisory board and consultants pursuant to the Plan. The options vest over a three-year period.
The estimated aggregate fair value of the stock options at the date of grant was determined to be $287,487 using a Black Scholes model.
The
Company recognized $157,018 and $110,012 of stock-based compensation expense during the six month periods ended June 30, 2023 and 2022,
respectively, related to stock options which is included in the accompanying consolidated statements of operations. As of June 30, 2023,
there was approximately $498,000 of total unrecognized compensation expense related to non-vested share-based compensation arrangements
granted under the Plan. That cost is expected to be recognized over a weighted-average period of approximately 1.4 years.
At
June 30, 2023, there were 5,115,000 shares available to be issued under the Plan. The following table summarizes stock option activity
of the Plan through June 30, 2023:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Options Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
Options outstanding – December 31, 2021 | |
| 1,882,500 | | |
$ | 1.00 | |
Granted | |
| 502,500 | | |
| 1.00 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Options outstanding – December 31, 2022 | |
| 2,360,000 | | |
| 1.00 | |
Granted | |
| - | | |
| | |
Canceled | |
| - | | |
| | |
Exercised | |
| - | | |
| | |
Options outstanding – June 30, 2023 | |
| 2,360,000 | | |
$ | 1.00 | |
Additional
information regarding the exercisable options and average remaining contractual life of the options outstanding as of June 30, 2023 is
as follows:
SCHEDULE OF STOCK OPTIONS OUTSTANDING AND EXERCISABLE
Exercise Price | | |
Number Outstanding | | |
Weighted Average Remaining Contractual Life | |
Number Exercisable at December 31, 2022 | | |
Number Exercisable at June 30, 2023 | |
$ | 1.00 | | |
| 2,360,000 | | |
6.9 Years | |
| 1,204,444 | | |
| 1,532,778 | |
The
fair value of each option grant was estimated on the date of grant to be $0.56 per share using the Black-Scholes option-pricing model
with the following assumption weighted-averages in 2022:
SCHEDULE OF STOCK OPTIONS FAIR VALUE ASSUMPTIONS
Risk-free interest rates | |
| 2.19 | % |
Expected life in years | |
| 3.5 | |
Expected volatility | |
| 80 | % |
Expected dividend yield | |
| 0 | % |
Fair value common stock | |
$ | 1.00 | |
The
risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero-coupon issues with a remaining
term commensurate with the expected term of the award. Management has estimated expected volatility based on similar comparable industry
sector averages. Expected life of the option represents the period of time options are expected to be outstanding. The estimate for dividend
yield is 0% because the Company has not historically paid, and does not intend to pay a dividend on its common stock in the foreseeable
future.
NOTE
F – WARRANTS
The
following table summarizes warrant activity through June 30, 2023:
SCHEDULE
OF WARRANTS ACTIVITY
| |
Warrants Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
| |
| | |
| |
Warrants outstanding – December 31, 2021 | |
| 199,000 | | |
$ | 1.07 | |
| |
| | | |
| | |
Granted | |
| - | | |
| - | |
Canceled | |
| (12,500 | ) | |
| 1.00 | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Warrants outstanding – December 31, 2022 | |
| 161,500 | | |
| 1.09 | |
Granted | |
| - | | |
| | |
Canceled | |
| - | | |
| | |
Exercised | |
| - | | |
| | |
Warrants outstanding – June 30, 2023 | |
| 161,500 | | |
$ | 1.09 | |
Additional
information regarding the warrants outstanding as of June 30, 2023 is as follows:
SCHEDULE
OF WARRANTS OUTSTANDING
Exercise Price | | |
Number Outstanding | | |
Weighted Average Remaining Contractual Life | |
Number Exercisable | |
$ | 1.00 | | |
| 11,500 | | |
.4 Years | |
| 11,500 | |
$ | 1.10 | | |
| 150,000 | | |
5.4 Years | |
| 150,000 | |
| | | |
| 161,500 | | |
| |
| 161,500 | |
Pre-funded
Warrant
On
December 27, 2021, the Company entered into an exchange agreement with Sanovas Ophthalmology (the “Exchange Agreement”) pursuant
to which it exchanged 28,014,540 shares of common stock (the “Exchange Securities”) held by Sanovas Ophthalmology for a pre-funded
warrant (the “Pre-funded Warrant”) to purchase up to an aggregate of 28,014,540 shares of the Company’s common stock.
The Pre-funded Warrant is immediately exercisable at an exercise price of $0.0001 per share and terminates when exercised in full. As
part of the Exchange Agreement, Sanovas Ophthalmology relinquished any and all rights related to the Exchange Securities.
NOTE
G – SHAREHOLDERS’ NOTES PAYABLE
During
2021, the Company borrowed an aggregate of $74,000 from several stockholders pursuant to note agreements bearing interest at 8% per annum
and maturing December 31, 2022. The Company has informally extended the maturity date to December 31, 2023 under the same terms. During
the year ended December 31, 2022, one of the noteholders exercised outstanding warrants with an aggregate exercise price of $25,000 through
the offset of the note payable due to them from the Company, such that $49,000 remain outstanding at June 30, 2023 and December 31, 2022.
Interest expense amounted to $1,920 and $2,920 for the six months ended June 30, 2023 and 2022, respectively. The accrued interest payable
at June 30, 2023 and December 31, 2022 was $9,679 and $7,759, respectively.
NOTE
H – SUBSEQUENT EVENTS
Subsequent
events were reviewed through August 11, 2023, the date these consolidated financial statements were available for issuance.
PART
II- INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM
13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The
following table sets forth the costs and expenses payable by the Company in connection with the issuance and distribution of the securities
being registered hereunder. All amounts are estimates except the SEC registration fee.
SEC registration fees | |
$ | 117 | |
Printing expenses | |
$ | 1,000 | |
Accounting fees and expenses | |
$ | 1,500 | |
Legal fees and expenses | |
$ | 25,000 | |
Blue sky fees | |
$ | 5,000 | |
Miscellaneous | |
$ | 2,383 | |
Total | |
$ | 35,000 | * |
*previously
paid
ITEM
14. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Section
102 of the DGCL permits a corporation to eliminate the personal liability of directors of a corporation to the corporation or its stockholders
for monetary damages for a breach of fiduciary duty as a director, except where the director breached his duty of loyalty, failed to
act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a
stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. Our Certificate of Incorporation provides
that our directors shall not be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duty as
a director, notwithstanding any provision of law imposing such liability, except to the extent that the DGCL prohibits the elimination
or limitation of liability of directors for breaches of fiduciary duty.
Section
145 of the DGCL provides that a corporation has the power to indemnify a director, officer, employee, or agent of the corporation, or
a person serving at the request of the corporation for another corporation, partnership, joint venture, trust or other enterprise in
related capacities against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably
incurred by the person in connection with an action, suit or proceeding to which he was or is a party or is threatened to be made a party
to any threatened, ending or completed action, suit or proceeding by reason of such position, if such person acted in good faith and
in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and, in any criminal action or proceeding,
had no reasonable cause to believe his conduct was unlawful, except that, in the case of actions brought by or in the right of the corporation,
no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable
to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the
adjudication of liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnity
for such expenses which the Court of Chancery or such other court shall deem proper.
Our
Certificate of Incorporation and Bylaws provide indemnification for our directors and officers to the fullest extent permitted by the
DGCL. We will indemnify each person who was or is a party or threatened to be made a party to any threatened, pending or completed action,
suit or proceeding (other than an action by or in the right of us) by reason of the fact that he or she is or was, or has agreed to become,
a director or officer, or is or was serving, or has agreed to serve, at our request as a director, officer, partner, employee or trustee
of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (all such persons being
referred to as an “Indemnitee”), or by reason of any action alleged to have been taken or omitted in such capacity, against
all expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection
with such action, suit or proceeding and any appeal therefrom, if such Indemnitee acted in good faith and in a manner he or she reasonably
believed to be in, or not opposed to, our best interests, and, with respect to any criminal action or proceeding, he or she had no reasonable
cause to believe his or her conduct was unlawful. Our Certificate of Incorporation and Bylaws provides that we will indemnify any Indemnitee
who was or is a party to an action or suit by or in the right of us to procure a judgment in our favor by reason of the fact that the
Indemnitee is or was, or has agreed to become, a director or officer, or is or was serving, or has agreed to serve, at our request as
a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture,
trust or other enterprise, or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including
attorneys’ fees) and, to the extent permitted by law, amounts paid in settlement actually and reasonably incurred in connection
with such action, suit or proceeding, and any appeal therefrom, if the Indemnitee acted in good faith and in a manner he or she reasonably
believed to be in, or not opposed to, our best interests, except that no indemnification shall be made with respect to any claim, issue
or matter as to which such person shall have been adjudged to be liable to us, unless a court determines that, despite such adjudication
but in view of all of the circumstances, he or she is entitled to indemnification of such expenses. Notwithstanding the foregoing, to
the extent that any Indemnitee has been successful, on the merits or otherwise, he or she will be indemnified by us against all expenses
(including attorneys’ fees) actually and reasonably incurred in connection therewith. Expenses must be advanced to an Indemnitee
under certain circumstances.
In
addition, we, through Sanovas have a general liability insurance policy that covers certain liabilities of directors and officers of
our corporation arising out of claims based on acts or omissions in their capacities as directors or officers.
ITEM
15. RECENT SALES OF UNREGISTERED SECURITIES.
2023
In
September 2023, the Company issued stock options to purchase aggregate of 300,000 shares of common stock at an exercise price of $3.00
per share to consultants for services.
Also
in September 2023, the Company issued 316,695 shares of common stock Opthalmology, LLC to discharge $950,086 of debt due to Sanovas.
2022
In
November 2022, the Company issued 586,370 shares of common stock to Sanovas Ophthalmology, LLC to discharge amounts due at September
30, 2022 of $586,370.
During
the quarter ended September 30, 2022, an option and a warrant to purchase an aggregate of 50,000 shares of common stock was exercised
upon the payment of $50,000. The shares were issued in reliance upon an exemption provided by Section 4(a)(2) of the Securities Act promulgated
thereunder for the offer and sale of securities not involving a public offering.
In
August 2022, the Company issued stock options to purchase up to 500,000 shares of common stock at an exercise price of $1.00 per share
to members of the Company’s medical advisory board and consultants pursuant to the Plan. The options vest over a three-year period.
On
July 5, 2022, the Company issued 2,000,000 shares of common stock as consideration for its acquisition of DNA/GPS Inc. valued at $2,000,000.
In
May 2022, the Company issued 353,432 shares of common stock to Sanovas Ophthalmology, LLC to discharge amounts due at March 31, 2022
of $353,432.
From
January 1, 2022 to May 31, 2022, the Company issued an aggregate of 60,000 shares of its common stock for a purchase price of $1.00 per
share.
2021
From
January 2021 to May 2021, the Company issued an aggregate of 617,473 shares of its common stock at a purchase price of $1.00 per share.
In
March 2021 and June 2021, the Company issued options to purchase up to an aggregate of 20,000 shares of the Company’s common stock
at an exercise price of $1.00 per share to consultants for services.
In
May 2021, the Company issued 12,500 shares of its common stock upon the exercise of warrants to purchase shares of the Company’s
common stock at an exercise price of $1.00 per share.
From
June to September 2021, the Company issued an aggregate of 215,000 shares of its common stock at a purchase price of $1.00 per share.
In
June 2021, the Company issued 390,358 shares of its common stock to a related party to retire $390,358 of debt due from the Company.
In
October and November 2021, the Company issued an aggregate of 247,000 shares of its common stock at a purchase price of $1.00 per share.
On
December 27, 2021, the Company exchanged 28,014,540 shares of its outstanding common stock for a pre-funded warrant to purchase up to
an aggregate of 28,014,540 shares of the Company’s common stock at an exercise price of $0.0001 per share.
The
offers, sales and issuances of the securities described above were deemed to be exempt from registration under the Securities Act in
reliance upon (i) Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder as transactions by an issuer not involving
a public offering or (ii) Section 3(a)(9) of the Securities Act.
ITEM
16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
(a)
Exhibits
The
exhibit index attached hereto is incorporated herein by reference.
(b)
Financial Statement Schedule
All
schedules have been omitted because the information required to be set forth in the schedules is either not applicable or is shown in
the financial statements or notes thereto.
EXHIBIT
INDEX |
Exhibit
No. |
|
Description |
3.1** |
|
First Amended and Restated Certificate of Incorporation of RetinalGenix Technologies Inc. (Incorporated by reference to Exhibit 3.1 the Company’s Registration Statement on Form S-1 filed with the SEC on August 5, 2021) |
3.2** |
|
Bylaws of RetinalGenix Technologies Inc. (Incorporated by reference to Exhibit 3.2 the Company’s Registration Statement on Form S-1 filed with the SEC on August 5, 2021) |
4.1 |
|
Description of Registrant’s Securities (Incorporated by reference to Exhibit 4.1 the Company’s Annual Report on Form 10-K filed with the SEC on March 31, 2023) |
5.1* |
|
Opinion of Blank Rome LLP |
10.1** |
|
Option Exchange Agreement by and between the Company and Diopsys, Inc. dated October 8, 2019 (Incorporated by reference to Exhibit 10.1 the Company’s Registration Statement on Form S-1 filed with the SEC on August 5, 2021) |
10.2**+ |
|
RetinalGenix Technologies Inc. 2017 Equity Incentive Plan (Incorporated by reference to Exhibit 10.2 the Company’s Registration Statement on Form S-1 filed with the SEC on August 5, 2021) |
10.3** |
|
Amended and Restated Master Services Agreement by and between the Company and ADM Tronics Unlimited, Inc. dated June 24, 2021 (Incorporated by reference to Exhibit 10.3 the Company’s Registration Statement on Form S-1 filed with the SEC on August 5, 2021) |
10.4**+# |
|
Sublicense Agreement by and between the Company and Sanovas Ophthalmology LLC dated June 24, 2021 (Incorporated by reference to Exhibit 10.4 the Company’s Registration Statement on Form S-1 filed with the SEC on August 5, 2021) |
10.5** |
|
Termination of Option Exchange Agreement by and between the Company and Diopsys, Inc., dated February 17, 2022 (Incorporated by reference to Exhibit 10.1 the Company’s Form 8-K filed with the SEC on February 17, 2022) |
10.6*+ |
|
Exchange Agreement by and between the Company and Sanovas Ophthalmology LLC, dated May 9, 2022 (Incorporated by reference to Exhibit 10.1 the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 13, 2022) |
10.7** |
|
Exchange Agreement by and between the Company and Lawrence Perich, dated July 5, 2022 (Incorporated by reference to Exhibit 10.1 the Company’s Current Report on Form 8-K filed with the SEC on July 7, 2022) |
23.1* |
|
Consent of Liebman Goldberg & Hymowitz LLP, independent registered public accounting firm |
23.2* |
|
Consent of Blank Rome LLP (included in Exhibit 5.1) |
24.1** |
|
Power of Attorney |
107** |
|
Filing Fee Table |
*
Filed herewith.
**
Previously filed.
+
Indicates a management contract or any compensatory plan, contract or arrangement.
#
Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions
with an asterisk because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly
disclosed.
Financial
Statement Schedules
Schedules
have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements
or notes thereto.
ITEM
17. UNDERTAKINGS.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons
of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities
and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the
event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid
by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted
by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the
opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question
whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of
such issue.
The
undersigned registrant hereby undertakes that:
(1)
For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed
as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant
to Rule 424(b) (1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time
it was declared effective.
(2)
For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of
prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this Post-Effective Amendment No. 3 to
the Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Petaluma,
State of California, on November 6, 2023.
|
RETINALGENIX
TECHNOLOGIES INC. |
|
|
|
By: |
/s/
Jerry Katzman |
|
|
Jerry
Katzman |
|
|
Chief
Executive Officer, President
and Chairman of the Board |
KNOW
ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Jerry Katzman, his true and lawful
attorney-in-fact and agent with full power of substitution and re-substitution, for him and in his name, place and stead, in any and
all capacities to sign any or all amendments (including, without limitation, post-effective amendments) to this Registration Statement,
any related Registration Statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and any or all pre- or
post-effective amendments thereto, and to file the same, with all exhibits thereto, and all other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent, full power and authority to do and perform
each and every act and thing requisite and necessary to be done in and about the premises, as fully for all intents and purposes as he
or she might or could do in person, hereby ratifying and confirming that said attorney-in-fact and agent, or any substitute or substitutes
for him, may lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Act of 1933, as amended,
the following persons in the capacities and on the dates indicated have signed this Registration Statement below.
Pursuant
to the requirements of the Securities Act of 1933, as amended, this Registration Statement on Form S-1 has been signed by the following
persons in the capacities and on the dates indicated below.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/
Jerry Katzman |
|
Chief
Executive Officer, President and Chairman of the Board |
|
November
6, 2023 |
Jerry
Katzman |
|
(Principal
Executive Officer and Principal Financial and Accounting Officer) |
|
|
|
|
|
|
|
/s/ Herbert Gould
|
|
Director |
|
November
6, 2023 |
Herbert
Gould |
|
|
|
|
|
|
|
|
|
/s/
Vinay Mehindru |
|
Director |
|
November
6, 2023 |
Vinay
Mehindru |
|
|
|
|
Exhibit
5.1
1271
Avenue of the Americas |New York, NY 10020
blankrome.com
November
6, 2023
RetinalGenix
Technologies Inc.
1450
North McDowell Boulevard, Suite 150
Petaluma,
CA 94954
Re: |
RetinalGenix
Technologies Inc. Inc.
Post-Effective
Amendment 3 to Registration Statement on Form S-1 |
Dear
Ladies and Gentlemen:
We
have acted as U.S. securities counsel to RetinalGenix Technologies Inc. Inc., a Delaware corporation (the “Company”),
in connection with the preparation and filing with the Securities and Exchange Commission (the “Commission”) pursuant
to the Securities Act of 1933, as amended (the “Securities Act”), of a Post-Effective Amendment No. 3 to Registration
Statement on Form S-1, File No. 333-258528 (the “Registration Statement”) filed on the date hereof relating to the
registration by the Company of an aggregate of 1,559,820 shares (the “Shares”) of the Company’s common stock,
par value $0.0001 per share (the “Common Stock”), by the selling stockholders named in the Registration Statement
(the “Selling Stockholders”). This opinion is being furnished in accordance with the requirements of Item 601(b)(5)
of Regulation S-K under the Securities Act.
In
rendering the opinion set forth herein, we have examined originals or copies, certified or otherwise identified to our satisfaction,
of (i) the Registration Statement; (ii) the agreements pursuant to which the Shares were issued to the Selling Stockholders; (iii) resolutions
adopted by the Board of Directors of the Company (the “Board”); (iv) the first amended and restated certificate of
incorporation of the Company (the “Certificate of Incorporation”); (v) the bylaws of the Company (the “Bylaws”);
and (vi) such other corporate records, agreements, certificates, including, but not limited to, certificates or comparable documents
of public officials and of officers and representatives of the Company, statutes and other instruments and documents as we considered
relevant and necessary as a basis for the opinions hereinafter expressed.
In
rendering this opinion, we have assumed, without inquiry, (i) the authenticity of all documents submitted to us as originals; (ii) the
conformity to the original documents of all documents submitted to us as facsimile, electronic, certified or photostatic copies, and
the authenticity of the originals of such copies; (iii) the legal capacity of all natural persons and the genuineness of all signatures
on the Registration Statement and all documents submitted to us; and (iv) that the books and records of the Company are maintained in
accordance with proper corporate procedures.
Blank
Rome LLP | blankrome.com
RetinalGenix
Technologies Inc. Inc.
November
6, 2023
Page
2
As
to any facts material to the opinions expressed herein that we have not independently established or verified, we have relied upon, and
assumed the accuracy of, statements and representations of officers and other representatives of the Company and others.
Based
on the foregoing, we are of the opinion that the Shares are duly and validly issued, fully paid and non-assessable. We are opining solely
on all applicable statutory provisions of Delaware corporate law, including the rules and regulations underlying those provisions, all
applicable provisions of the Delaware Constitution and all applicable judicial and regulatory determinations. This opinion is limited
to the laws of the State of Delaware as in effect on the date hereof and we express no opinion with respect to the laws of any other
jurisdiction.
We
hereby consent to the filing of this opinion as an Exhibit to the Registration Statement. We also hereby consent to the use of our name
as your counsel under “Legal Matters” in the Prospectus constituting part of the Registration Statement. In giving this consent,
we do not thereby concede that we come within the categories of persons whose consent is required by the Securities Act or the General
Rules and Regulations promulgated thereunder.
|
Very
truly yours, |
|
|
|
/s/
BLANK ROME LLP |
|
BLANK
ROME LLP |
Blank
Rome LLP | blankrome.com
Exhibit 23.1
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S
CONSENT
We consent to the inclusion in this Registration
Statement of RetinalGenix Technologies Inc. on Post-Effective Amendment No. 3 on Form S-1 of our report dated March 31, 2023, which includes
an explanatory paragraph as to the Company’s ability to continue as a going concern, with respect to our audit of the financial
statements of RetinalGenix Technologies Inc. as of December 31, 2022 and 2021, which report appears in the Prospectus, which is part of
this Registration Statement. We also consent to the reference to our Firm under the heading “Experts” in such Prospectus.
/s/ Liebman Goldberg & Hymowitz LLP
Liebman Goldberg & Hymowitz LLP
Garden City, NY
November 6, 2023
v3.23.3
Cover
|
6 Months Ended |
Jun. 30, 2023 |
Entity Addresses [Line Items] |
|
Document Type |
POS AM
|
Amendment Flag |
true
|
Amendment Description |
This
Post-Effective Amendment No. 3 (this “Post-Effective Amendment”) relates to the registration statement on Form S-1 (File
No. 333-258528), initially filed by RetinalGenix Technologies Inc., a Delaware corporation (the “Registrant”), with the Securities
and Exchange Commission (the “SEC”) on August 5, 2021 and declared effective by the SEC on October 7, 2021 (the “Registration
Statement”).
|
Entity Registrant Name |
RETINALGENIX
TECHNOLOGIES INC.
|
Entity Central Index Key |
0001836295
|
Entity Tax Identification Number |
82-3936890
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
1450
North McDowell Boulevard
|
Entity Address, Address Line Two |
Suite 150
|
Entity Address, City or Town |
Petaluma
|
Entity Address, State or Province |
CA
|
Entity Address, Postal Zip Code |
94954
|
City Area Code |
(415)
|
Local Phone Number |
578-9583
|
Entity Filer Category |
Non-accelerated Filer
|
Entity Small Business |
true
|
Entity Emerging Growth Company |
true
|
Elected Not To Use the Extended Transition Period |
true
|
Business Contact [Member] |
|
Entity Addresses [Line Items] |
|
Entity Address, Address Line One |
1450
North McDowell Boulevard
|
Entity Address, Address Line Two |
Suite 150
|
Entity Address, City or Town |
Petaluma
|
Entity Address, State or Province |
CA
|
Entity Address, Postal Zip Code |
94954
|
City Area Code |
(415)
|
Local Phone Number |
578-9583
|
Contact Personnel Name |
Jerry
Katzman
|
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v3.23.3
Condensed Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Current Assets |
|
|
|
Cash |
$ 1,913
|
$ 38
|
$ 4,947
|
Total Current Assets |
1,913
|
38
|
4,947
|
Equipment, net of accumulated depreciation of $101 |
206
|
256
|
|
TOTAL ASSETS |
2,119
|
294
|
4,947
|
Current Liabilities |
|
|
|
Accounts payable and accrued liabilities |
697,073
|
475,480
|
251,282
|
Shareholders’ notes payable |
49,000
|
49,000
|
73,000
|
Accrued interest payable |
9,679
|
7,759
|
2,619
|
Total Liabilities |
1,776,950
|
1,069,357
|
469,622
|
Stockholders’ Deficit: |
|
|
|
Preferred stock, $0.0001 par value; 40,000,000 shares authorized; Series F preferred stock – 3,000,000 shares designated, 0 issued and outstanding at June 30, 2023 and December 31, 2022 |
|
|
|
Common stock, $0.0001 par value; 80,000,000 shares authorized; 17,272,116 shares issued and outstanding at June 30, 2023 and December 31, 2022 |
1,783
|
1,783
|
1,423
|
Additional paid in capital |
8,104,478
|
7,947,460
|
4,638,218
|
Accumulated deficit |
(9,881,092)
|
(9,018,306)
|
(5,104,316)
|
Total Stockholders’ Deficit |
(1,774,831)
|
(1,069,063)
|
(464,675)
|
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT |
2,119
|
294
|
4,947
|
Affiliated Entity [Member] |
|
|
|
Current Liabilities |
|
|
|
Due to related parties |
811,176
|
427,933
|
142,721
|
Related Party [Member] |
|
|
|
Current Liabilities |
|
|
|
Due to related parties |
$ 210,022
|
$ 109,185
|
|
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v3.23.3
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Accumulated depreciation |
$ 101
|
$ 52
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
40,000,000
|
40,000,000
|
40,000,000
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
80,000,000
|
80,000,000
|
80,000,000
|
Common stock, shares issued |
17,272,116
|
17,272,116
|
14,221,814
|
Common stock, shares outstanding |
17,272,116
|
17,272,116
|
14,221,814
|
Series F Preferred Stock [Member] |
|
|
|
Preferred stock, shares authorized |
3,000,000
|
3,000,000
|
3,000,000
|
Preferred stock, shares issued |
0
|
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
0
|
X |
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v3.23.3
Condensed Consolidated Statements of Operations - USD ($)
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Income Statement [Abstract] |
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
General and administrative expenses |
120,097
|
167,385
|
323,339
|
328,580
|
807,406
|
1,120,949
|
Research and development |
152,577
|
135,439
|
380,509
|
292,932
|
809,255
|
747,808
|
Acquired in-process research and development |
|
|
|
|
2,032,889
|
|
Stock-based compensation |
78,509
|
55,051
|
157,018
|
110,102
|
259,300
|
307,918
|
Total operating expenses |
351,183
|
357,875
|
860,866
|
731,614
|
3,908,850
|
2,176,675
|
Interest expense |
960
|
1,460
|
1,920
|
2,920
|
5,140
|
2,619
|
Net loss |
$ (352,143)
|
$ (359,335)
|
$ (862,786)
|
$ (734,534)
|
$ (3,913,990)
|
$ (2,179,294)
|
Net loss per share - basic |
$ (0.02)
|
$ (0.02)
|
$ (0.05)
|
$ (0.05)
|
$ (0.25)
|
$ (0.05)
|
Net loss per share - diluted |
$ (0.02)
|
$ (0.02)
|
$ (0.05)
|
$ (0.05)
|
$ (0.25)
|
$ (0.05)
|
Weighted average number of common shares outstanding during the period- basic |
17,272,116
|
14,523,114
|
17,272,116
|
14,400,037
|
15,584,346
|
41,246,915
|
Weighted average number of common shares outstanding during the period- diluted |
17,272,116
|
14,523,114
|
17,272,116
|
14,400,037
|
15,584,346
|
41,246,915
|
X |
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v3.23.3
Condensed Consolidated Statements of Stockholders' Deficit - USD ($)
|
Common Stock [Member] |
Preferred Stock [Member]
Series F Preferred Stock [Member]
|
Subscription Receivable Preferred Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance at Dec. 31, 2020 |
$ 4,067
|
$ 300
|
$ (300)
|
$ 2,840,599
|
$ (2,925,022)
|
$ (80,356)
|
Beginning balance, shares at Dec. 31, 2020 |
40,678,323
|
3,000,000
|
|
|
|
|
Stock purchased by investors |
$ 117
|
|
|
1,083,082
|
|
1,083,199
|
Stock purchased by investors, shares |
1,154,173
|
|
|
|
|
|
Stock-based compensation |
|
|
|
307,918
|
|
307,918
|
Exercise of warrants |
$ 1
|
|
|
13,499
|
|
13,500
|
Exercise of warrants, shares |
13,500
|
|
|
|
|
|
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC |
$ 39
|
|
|
390,319
|
|
$ 390,358
|
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC, shares |
390,358
|
|
|
|
|
390,358
|
Exchange of shares owned by Sanovas Ophthalmology LLC for pre-funded warrants |
$ (2,801)
|
|
|
2,801
|
|
|
Exchange of shares owned by Sanovas Ophthalmology LLC for pre-funded warrants, shares |
(28,014,540)
|
|
|
|
|
|
Recission of preferred stock |
|
$ (300)
|
300
|
|
|
|
Recission of preferred stock, shares |
|
(3,000,000)
|
|
|
|
|
Net loss |
|
|
|
|
(2,179,294)
|
(2,179,294)
|
Ending balance at Dec. 31, 2021 |
$ 1,423
|
|
|
4,638,218
|
(5,104,316)
|
(464,675)
|
Ending balance, shares at Dec. 31, 2021 |
14,221,814
|
|
|
|
|
|
Stock purchased by investors |
$ 61
|
|
|
60,439
|
|
60,500
|
Stock purchased by investors, shares |
60,500
|
|
|
|
|
|
Stock-based compensation |
|
|
|
55,051
|
|
55,051
|
Net loss |
|
|
|
|
(375,199)
|
(375,199)
|
Ending balance at Mar. 31, 2022 |
$ 1,484
|
|
|
4,753,708
|
(5,479,515)
|
(724,323)
|
Ending balance, shares at Mar. 31, 2022 |
14,282,314
|
|
|
|
|
|
Beginning balance at Dec. 31, 2021 |
$ 1,423
|
|
|
4,638,218
|
(5,104,316)
|
$ (464,675)
|
Beginning balance, shares at Dec. 31, 2021 |
14,221,814
|
|
|
|
|
|
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC, shares |
|
|
|
|
|
353,432
|
Net loss |
|
|
|
|
|
$ (734,534)
|
Ending balance at Jun. 30, 2022 |
$ 1,519
|
|
|
5,162,156
|
(5,838,850)
|
(675,175)
|
Ending balance, shares at Jun. 30, 2022 |
14,635,746
|
|
|
|
|
|
Beginning balance at Dec. 31, 2021 |
$ 1,423
|
|
|
4,638,218
|
(5,104,316)
|
(464,675)
|
Beginning balance, shares at Dec. 31, 2021 |
14,221,814
|
|
|
|
|
|
Stock purchased by investors |
$ 61
|
|
|
60,439
|
|
60,500
|
Stock purchased by investors, shares |
60,500
|
|
|
|
|
|
Stock-based compensation |
|
|
|
259,300
|
|
259,300
|
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC |
$ 94
|
|
|
939,708
|
|
$ 939,802
|
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC, shares |
939,802
|
|
|
|
|
939,802
|
Net loss |
|
|
|
|
(3,913,990)
|
$ (3,913,990)
|
Exercise of warrants and options |
$ 5
|
|
|
49,995
|
|
50,000
|
Exercise of warrants and options, shares |
50,000
|
|
|
|
|
|
Issuance of shares upon acquisition of in process research and development |
$ 200
|
|
|
1,999,800
|
|
$ 2,000,000
|
Issuance of shares upon acquisition of in process research and development, shares |
|
|
|
|
|
2,000,000
|
Ending balance at Dec. 31, 2022 |
$ 1,783
|
|
|
7,947,460
|
(9,018,306)
|
$ (1,069,063)
|
Ending balance, shares at Dec. 31, 2022 |
17,272,116
|
|
|
|
|
|
Beginning balance at Mar. 31, 2022 |
$ 1,484
|
|
|
4,753,708
|
(5,479,515)
|
(724,323)
|
Beginning balance, shares at Mar. 31, 2022 |
14,282,314
|
|
|
|
|
|
Stock-based compensation |
|
|
|
55,051
|
|
55,051
|
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC |
$ 35
|
|
|
353,397
|
|
353,432
|
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC, shares |
353,432
|
|
|
|
|
|
Net loss |
|
|
|
|
(359,335)
|
(359,335)
|
Ending balance at Jun. 30, 2022 |
$ 1,519
|
|
|
5,162,156
|
(5,838,850)
|
(675,175)
|
Ending balance, shares at Jun. 30, 2022 |
14,635,746
|
|
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 1,783
|
|
|
7,947,460
|
(9,018,306)
|
(1,069,063)
|
Beginning balance, shares at Dec. 31, 2022 |
17,272,116
|
|
|
|
|
|
Stock-based compensation |
|
|
|
78,509
|
|
78,509
|
Net loss |
|
|
|
|
(510,643)
|
(510,643)
|
Ending balance at Mar. 31, 2023 |
$ 1,783
|
|
|
8,025,969
|
(9,528,949)
|
(1,774,831)
|
Ending balance, shares at Mar. 31, 2023 |
17,272,116
|
|
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 1,783
|
|
|
7,947,460
|
(9,018,306)
|
$ (1,069,063)
|
Beginning balance, shares at Dec. 31, 2022 |
17,272,116
|
|
|
|
|
|
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC, shares |
|
|
|
|
|
|
Net loss |
|
|
|
|
|
$ (862,786)
|
Ending balance at Jun. 30, 2023 |
$ 1,783
|
|
|
8,104,478
|
(9,881,092)
|
(1,774,831)
|
Ending balance, shares at Jun. 30, 2023 |
17,272,116
|
|
|
|
|
|
Beginning balance at Mar. 31, 2023 |
$ 1,783
|
|
|
8,025,969
|
(9,528,949)
|
(1,774,831)
|
Beginning balance, shares at Mar. 31, 2023 |
17,272,116
|
|
|
|
|
|
Stock-based compensation |
|
|
|
78,509
|
|
78,509
|
Net loss |
|
|
|
|
(352,143)
|
(352,143)
|
Ending balance at Jun. 30, 2023 |
$ 1,783
|
|
|
$ 8,104,478
|
$ (9,881,092)
|
$ (1,774,831)
|
Ending balance, shares at Jun. 30, 2023 |
17,272,116
|
|
|
|
|
|
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v3.23.3
Condensed Consolidated Statements of Cash Flows - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Cash Flows From (Used In) Operating Activities |
|
|
|
|
Net loss |
$ (862,786)
|
$ (734,534)
|
$ (3,913,990)
|
$ (2,179,294)
|
Non-cash items: |
|
|
|
|
Stock-based compensation expense |
157,018
|
110,102
|
259,300
|
307,918
|
Acquired In-process research and development through issuance of common stock |
|
|
2,000,000
|
|
Depreciation expense |
50
|
|
51
|
|
Expenses paid by Sanovas on behalf of Company, net |
280,820
|
426,109
|
1,225,014
|
548,148
|
Changes in operating assets and liabilities: |
|
|
|
|
Increase in accounts payable and accrued liabilities |
221,593
|
88,297
|
225,198
|
109,851
|
(Increase) decrease in deferred offering costs |
|
|
|
43,787
|
Increase in accrued interest |
1,920
|
2,920
|
5,140
|
2,619
|
Total adjustments |
661,401
|
627,428
|
3,714,703
|
1,012,323
|
Net cash (used in) operating activities |
(201,385)
|
(107,106)
|
(199,287)
|
(1,166,971)
|
Cash Flows (Used In) Investing Activities |
|
|
|
|
Equipment purchase |
|
|
(307)
|
|
Cash Flows From Financing Activities |
|
|
|
|
Proceeds from common stock sold, net of costs |
|
60,500
|
60,500
|
1,083,199
|
Proceeds from exercise of warrants and options |
|
|
25,000
|
13,500
|
Proceeds from shareholders’ notes payable |
|
|
|
73,000
|
Advances from related parties |
203,260
|
41,686
|
109,185
|
|
Net cash provided by financing activities |
203,260
|
102,186
|
194,685
|
1,169,699
|
Net increase (decrease) in cash |
1,875
|
(4,920)
|
(4,909)
|
2,728
|
Cash at beginning of period |
38
|
4,947
|
4,947
|
2,219
|
Cash at end of period |
1,913
|
27
|
38
|
4,947
|
Supplemental information: |
|
|
|
|
Retirement of due to Sanovas through the issuance of common stock to Sanovas Ophthalmology LLC (Note C) |
|
|
939,802
|
390,358
|
Exchange of common stock by Sanovas Ophthalmology LLC for pre-funded warrants |
|
|
|
2,801
|
Repayment of shareholders’ note payable through the exercise of warrants |
|
|
$ 25,000
|
|
Interest paid |
|
|
|
|
Income taxes paid |
|
|
|
|
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v3.23.3
HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Accounting Policies [Abstract] |
|
|
HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN |
NOTE
A – HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN
RetinalGenix
Technologies Inc. (the “Company”), a Delaware corporation, was formed in November 2017 by Sanovas Ophthalmology, LLC (“Sanovas
Ophthalmology”), a majority owned subsidiary of Sanovas Inc. (“Sanovas”), a privately held research and development
incubator. During the periods ended June 30, 2023 and 2022, a portion of the operations of the Company were conducted by Sanovas, who
invoices the Company for costs and expenses paid for on behalf of the Company and costs and expenses allocated to the Company for services
performed on behalf of the Company.
The
Company was formed to develop technologies to diagnose and treat ophthalmic disorders. The Company sublicensed certain technology initially
developed by Sanovas from Sanovas Ophthalmology – See Note C. Since 2018, the Company has been developing its screening device
and home monitoring and physician alert system.
On
October 8, 2019, the Company entered into an option exchange agreement (the “Option Exchange Agreement”) with Diopsys, Inc.
(“Diopsys”) pursuant to which the Company agreed to issue Diopsys an option to purchase up to 10% of its issued and outstanding
shares of common stock and Diopsys granted the Company an option to purchase up to 10% of the issued and outstanding shares of common
stock of Diopsys on the Closing Date (the “Option Exchange”). “Closing Date” means a date that is within 30 days
of the date that all of the contingencies set forth in the Option Exchange Agreement are satisfied including, but not limited to, approval
of a product by the U.S. Food and Drug Administration. In addition, pursuant to the Option Exchange Agreement, upon the closing of the
Option Exchange, the Company agreed to enter into an exclusive distribution agreement with Diopsys pursuant to which Diopsys shall act
as the Company’s exclusive distributor of such product. On February 14, 2022, the Company entered into a Termination of Option
Exchange Agreement (the “Termination Agreement”) with Diopsys pursuant to which the prior Option Exchange Agreement between
the Company and Diopsys was terminated effective immediately and of no further force and effect, and neither party has any past, current
or future obligations or liabilities to the other (or any other person or entity) with respect to any rights, obligations or any of the
transactions contemplated in the Option Exchange Agreement. At the time of such termination, none of the conditions in the Option Exchange
Agreement were satisfied and no options thereunder had been issued to either the Company or Diopsys. In addition, the Exclusive Distribution
Agreement to be entered into between the Company and Diopsys and referred to in the Option Exchange Agreement has not been negotiated
and as of the second quarter of 2022, there are no plans to move forward with Diopsys.
On
December 27, 2021, the Company entered into an exchange agreement (the “Exchange Agreement”) with Sanovas Ophthalmology pursuant
to which the Company exchanged 28,014,540 shares of common stock held by Sanovas Ophthalmology for a pre-funded warrant (the “Pre-funded
Warrant”) to purchase up to an aggregate of 28,014,540 shares of the Company’s common stock. The Pre-funded Warrant is immediately
exercisable at an exercise price of $0.0001 per share and terminates when exercised in full.
On
July 5, 2022, the Company entered into an exchange agreement with Dr. Lawrence Perich pursuant to which it acquired all the outstanding
shares of DNA/GPS Inc., a pharmacogenetics company based in Tampa, Florida (“DNA/GPS”), in exchange for the issuance of 2,000,000
shares of the Company’s common stock. The acquisition of DNA/GPS combines DNA/GPS’ genetic mapping capabilities with the
Company’s retinal imaging capabilities. The combined technology is expected to have the ability to screen, monitor and provide
data to profile trends and create diagnostic markers for systemic and retinal disorders in the cardiovascular, Alzheimer’s, Parkinson
disease. The markers and data analysis are rapid and cost effective, thereby eliminating expensive diagnostic equipment such as MRI or
CT scanning. The results are confidential to the patient and anonymous for any third party without permission of the patient. The Company
accounted for this transaction as an asset acquisition in the quarter ending September 30, 2022. The estimated fair value of the transaction
was $2,000,000 plus legal fees associated with the transaction of $32,889 is recorded as acquired in-process research and development
costs in the associated consolidated statement of operations in the quarter ended September 30, 2022.
Liquidity
and Going Concern
The
Company has had net losses since inception and has an accumulated deficit of approximately $9,881,000
at June 30, 2023. In addition, as of June 30,
2023 and December 31 2022, we had liabilities of approximately $1,777,000
and $1,069,000,
respectively, the majority of which is with related parties. The Company has minimal cash at June 30, 2023 and remains dependent on related
parties for much of its financing. The Company expects that operating losses and negative cash flows from operations will occur for at
least the next several years, and the Company will need to access additional funds to achieve its strategic goals with respect to the
sublicensed technology. The Company completed a private offering of shares of its common stock raising net proceeds of $60,500
in the six months ended June 30, 2022 –
See Note D.
Sanovas
has paid a significant portion of the Company’s operating expenses through June 2023, and was owed approximately $811,000 as of
June 30, 2023 by the Company. The Company also issued shares of its common stock to offset amounts due to Sanovas for payment of expenses
on behalf of the Company of $353,432 in May 2022 and $586,370 in November 2022 (see Note C).
As
of the date of this report, the Company does not have adequate resources to fund its operations through August 2024 without considering
any potential future milestone payments that it may receive under any new collaborations that it may enter into in the future or any
future capital raising transactions. The Company will need to raise additional funding to complete the development of its products and
commence the market launch, assuming regulatory approval is obtained. The Company does not know whether additional financing will be
available when needed, whether it will be available on favorable terms, or if it will be available at all. These factors raise substantial
doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
|
NOTE
A – HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN
RetinalGenix
Technologies Inc. (the “Company”), a Delaware corporation, was formed in November 2017 by Sanovas Ophthalmology, LLC (“Sanovas
Ophthalmology”), a majority owned subsidiary of Sanovas Inc. (“Sanovas”), a privately held research and development
incubator. During the years ended December 31, 2022 and December 31, 2021, a substantial portion of the operations of the Company were
conducted by Sanovas, who invoices the Company for costs and expenses paid for on behalf of the Company and costs and expenses allocated
to the Company for services performed on behalf of the Company.
The
Company was formed to develop technologies to diagnose and treat ophthalmic disorders. The Company sublicensed certain technology initially
developed by Sanovas from Sanovas Ophthalmology – See Note C. Since 2018, the Company has been developing its screening device
and home monitoring and physician alert system.
In
October 2021, the Company filed a registration statement on Form S-1 (the “Registration Statement”) with the Securities and
Exchange Commission pursuant to which it registered for resale shares of common stock, including shares of common stock issuable upon
exercise of outstanding options and warrants. The Company did not raise any cash from the resale of the securities offered by the Registration
Statement, and accordingly, the previously deferred offering costs were applied against the proceeds of the shares of common stock sold
in 2021 pursuant to the Company’s previous private offering of securities.
On
October 8, 2019, the Company entered into an option exchange agreement (the “Option Exchange Agreement”) with Diopsys, Inc.
(“Diopsys”) pursuant to which the Company shall issue Diopsys an option to purchase up to 10% of its issued and outstanding
shares of common stock and Diopsys shall grant the Company an option to purchase up to 10% of the issued and outstanding shares of common
stock of Diopsys on the Closing Date (the “Option Exchange”). “Closing Date” means a date that is within 30 days
of the date that all of the contingencies set forth in the Option Exchange Agreement are satisfied including, but not limited to, approval
of a product by the U.S. Food and Drug Administration. In addition, pursuant to the Option Exchange Agreement, upon the closing of the
Option Exchange, the Company shall enter into an exclusive distribution agreement with Diopsys pursuant to which Diopsys shall act as
the Company’s exclusive distributor of such product. On February 14, 2022, the Company entered into a Termination of Option Exchange
Agreement (the “Termination Agreement”) with Diopsys pursuant to which the prior Option Exchange Agreement between the Company
and Diopsys dated October 8, 2019 (the “Option Exchange Agreement”) was terminated effective immediately and of no further
force and effect, and neither party has any past, current or future obligations or liabilities to the other (or any other person or entity)
with respect to any rights, obligations or any of the transactions contemplated in the Option Exchange Agreement. At the time of such
termination, none of the conditions in the Option Exchange Agreement were satisfied and no options thereunder had been issued to either
the Company or Diopsys. In addition, the Exclusive Distribution Agreement to be entered into between the Company and Diopsys and referred
to in the Option Exchange Agreement has not been negotiated and as of the second quarter of 2022, there are no plans to move forward
with Diopsys.
On
December 27, 2021, RetinalGenix Technologies Inc. entered into an exchange agreement (the “Exchange Agreement”) with Sanovas
Ophthalmology pursuant to which the Company exchanged 28,014,540 shares of common stock held by Sanovas Ophthalmology for a pre-funded
warrant (the “Pre-funded Warrant”) to purchase up to an aggregate of 28,014,540 shares of the Company’s common stock.
The Pre-funded Warrant is immediately exercisable at an exercise price of $0.0001 per share and terminates when exercised in full.
On
July 5, 2022, RetinalGenix Technologies Inc. entered into an Exchange Agreement (the “Exchange Agreement”) with Dr. Lawrence
Perich pursuant to which it acquired all the outstanding shares of DNA/GPS Inc., a pharmacogenetics company based in Tampa, Florida (“DNA/GPS”),
in exchange for the issuance of 2,000,000 shares of the Company’s common stock. The acquisition of DNA/GPS combines DNA/GPS’
genetic mapping capabilities with the Company’s retinal imaging capabilities. The combined technology is expected to have the ability
to screen, monitor and provide data to profile trends and create diagnostic markers for systemic and retinal disorders in the cardiovascular,
Alzheimer’s, Parkinson and other diseases. The markers and data analysis are rapid and cost effective, thereby eliminating expensive
diagnostic equipment such as MRI or CT scanning. The results are to confidential to the patient and anonymous for any third party without
permission of the patient. The Company accounted for this transaction as an asset acquisition in 2022. The estimated fair value of the
transaction was $2,000,000 plus legal fees associated with the transaction of $32,889 is recorded as acquired in-process research and
development costs in the associated consolidated statement of operations.
Liquidity
and Going Concern
The
Company has had net losses since inception and has an accumulated deficit of approximately $9,018,000 at December 31, 2022. In addition,
as of December 31, 2022 and December 31 2021, the Company had liabilities of approximately $1,069,000 and $470,000, respectively, the
majority of which is with related parties. The Company has minimal cash at December 31, 2022 and remains dependent on Sanovas for much
of its operations. The Company expects that operating losses and negative cash flows from operations will occur for at least the next
several years, and the Company will need to access additional funds to achieve its strategic goals with respect to the sublicensed technology.
The Company commenced private offerings of shares of its common stock raising net proceeds of approximately $1,083,000 in the year ended
December 31, 2021, and $60,500 in the year ended December 31, 2022 - See Note D. In February 2021, the Company entered into an agreement
with an investment banker to raise funds for the Company which led to the private offering of shares mentioned above. The Company is
in discussions with investment bankers and individual investors with respect to raising additional capital for the Company and potentially
up-listing to the NASDAQ exchange.
Sanovas
has paid a significant portion of the Company’s operating expenses through December 2022, and was owed approximately $428,000 as
of December 31, 2022 by the Company. The Company also issued shares of its common stock to offset amounts due to Sanovas for payment
of expenses on behalf of the Company of $390,358 in June 2021 and $353,432 in May 2022 and $586,370 in November 2022 (see Note C).
As
of the date of this report, the Company does not have adequate resources to fund its operations through April 2024 without considering
any potential future milestone payments that it may receive under any new collaborations that it may enter into in the future or any
future capital raising transactions. The Company will need to raise additional funding to complete the development of its products and
commence the market launch, assuming regulatory approval is obtained. The Company does not know whether additional financing will be
available when needed, whether it will be available on favorable terms, or if it will be available at all. These factors raise substantial
doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
|
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Accounting Policies [Abstract] |
|
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE
B – SIGNIFICANT ACCOUNTING POLICIES
A
summary of significant accounting policies consistently applied in the preparation of the accompanying consolidated financial statements
is as follows:
1.
Basis of Presentation
The
Company’s consolidated financial statements were prepared in accordance with accounting principles generally accepted in the United
States of America (“US GAAP”). As of June 30, 2023, there have been no material changes in the Company’s significant
accounting policies from those that were disclosed in the Annual Report for the year ended December 31, 2022 (the “2022 Annual
Report”).
2.
Cash Equivalents
For
purpose of the consolidated statements of cash flows, the Company considers all short-term investments purchased with a maturity of three
months or less to be cash equivalents.
3.
Use of Estimates
In
preparing the Company’s consolidated financial statements in conformity with US GAAP, management is required to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the
date of the consolidated financial statements, as well as the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates.
4.
Income Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future
tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted
tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
date.
The
Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
Topic 740-10 Income Taxes. ASC Topic 740-10 clarifies the accounting for income taxes by prescribing a minimum recognition threshold
a tax position is required to meet before being recognized in the financial statements. It also provides guidance on the recognition,
measurement, and classification of amounts relating to uncertain tax positions, accounting for and disclosure of interest and penalties,
accounting in interim periods and disclosures. The application of that guidance did not result in the recognition of any unrecognized
tax benefits at June 30, 2023 or December 31, 2022. The Company’s policy is to expense any penalties and interest associated with
this topic. At June 30, 2023 and December 31, 2022, there were no amounts accrued for penalties and interest.
5.
Income (Loss) Per Common Share
The
Company computes net income (loss) per share in accordance with ASC 260, Earnings Per Share (“EPS”). Under the provisions
of ASC 260, basic net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number
of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for
the period by the weighted-average number of common and common equivalent shares outstanding during the period. However, common shares
that are considered anti-dilutive are excluded from the computation of diluted EPS. Since the Company had a loss during the three and
six months ended June 30, 2023 and 2022, the basic and diluted net loss per share is the same.
Potentially
dilutive securities not included in the computation of loss per share for the three and six months ended June 30, 2023, include stock
options to purchase 2,360,000 shares of common stock, pre-funded warrants to purchase 28,014,540 shares of common stock, and warrants
to purchase 161,500 shares of common stock. Potentially dilutive securities not included in the computation of loss per share for the
three and six months ended June 30, 2022 stock options to purchase 1,882,500 shares of common stock, pre-funded warrant to purchase 28,014,540
shares of common stock and warrants to purchase 199,000 shares of common stock. The shares of common stock potentially issuable to Diopsys
upon the resolution of specified contingencies and exercise of stock options are also excluded from the loss per share calculation for
the three months ended June 30, 2022.
6.
Stock-based compensation:
The
Company recognizes expense for stock-based compensation in accordance with ASC Topic 718, Stock-Based Compensation. For stock-based
awards, the Company calculates the fair value of the award on the date of grant using the Black Scholes option-pricing model. The expense
is recognized over the service period for awards expected to vest. The estimate of stock-based awards that will ultimately vest requires
judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative
adjustment in the period the estimates are revised. Stock options granted to non-employee consultants are revalued at the end of each
reporting period until vested and the changes in their fair value are recorded as adjustments to expense over the related vesting period.
7.
Research and Development costs:
Research
and development costs are expensed as incurred. Costs incurred in obtaining technology licenses outside of business combinations are
charged to research and development expense as acquired in-process research and development if the technology licensed has not reached
technological feasibility and has no alternative future use.
licensed
has not reached technological feasibility and has no alternative future use.
8.
Property and Equipment:
Property
and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives (3
years), once the asset is placed in service. Expenditures for maintenance and repairs, which do not extend the economic useful life of
the related assets, are charged to operations as incurred, and expenditures which extend the economic life are capitalized. When assets
are retired or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and
any gain or loss on disposal is recognized in the consolidated statement of operations for the respective period.
The
Company’s long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying
amount of the asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result
from the use of the asset and its eventual disposition are less than its carrying amount.
9.
Recent Accounting Pronouncements:
The
following pronouncement may have an impact on the accounting policies of the Company:
In
February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“ASU 2016-02”). ASU 2016-02 requires an
entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require
new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing,
and uncertainty of cash flows arising from leases. The FASB issued ASU No. 2018-10 “Codification Improvements to Topic 842, Leases”
(“ASU 2018-10”), ASU No. 2018-11 “Leases (Topic 842) Targeted Improvements” (“ASU 2018-11”) in July
2018, and ASU No. 2018-20 “Leases (Topic 842) – Narrow Scope Improvements for Lessors” (“ASU 2018-20”)
in December 2018. ASU 2018-10 and ASU 2018-20 provide certain amendments that affect narrow aspects of the guidance issued in ASU 2016-02.
ASU 2018-11 allows all entities adopting ASU 2016-02 to choose an additional (and optional) transition method of adoption, under which
an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening
balance of retained earnings in the period of adoption. Pursuant to ASU 2019-10 the effective date for ASC 842 was deferred an additional
year. The Company expects to recognize operating lease right-of-use assets and lease liabilities on the balance sheet upon adoption of
this ASU when it obtains a lease. The Company does not current have a lease.
A
variety of proposed or otherwise potential accounting standards are currently under study by standard-setting organizations. Due to the
tentative and preliminary nature of those proposed standards, management has not determined whether the implementation of such proposed
standards would be material to the consolidated financial statements of the Company.
|
NOTE
B - SIGNIFICANT ACCOUNTING POLICIES
A
summary of significant accounting policies consistently applied in the preparation of the accompanying financial statements is as follows:
1.
Basis of Presentation
The
Company’s financial statements were prepared in accordance with accounting principles generally accepted in the United States of
America (“US GAAP”). As of December 31, 2022, there have been no material changes in the Company’s significant accounting
policies from those that were disclosed in the 2021 Annual Report. The consolidated financial statements include the accounts of the
Company and its wholly owned subsidiary, DNA/GPS, Inc. All intercompany accounts and transactions have been eliminated in consolidation.
2.
Cash Equivalents
For
purpose of the statements of cash flows, the Company considers all short-term investments purchased with a maturity of three months or
less to be cash equivalents.
3.
Offering Costs
Deferred
offering costs are expenses directly related to an expected financing. These costs consisted of legal fees that the Company capitalized.
These costs are offset against the resultant capital raised.
4.
Use of Estimates
In
preparing the Company’s financial statements in conformity with US GAAP, management is required to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial
statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those
estimates.
5.
Income Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future
tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted
tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
date.
The
Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
Topic 740-10 Income Taxes. ASC Topic 740-10 clarifies the accounting for income taxes by prescribing a minimum recognition threshold
a tax position is required to meet before being recognized in the financial statements. It also provides guidance on the recognition,
measurement, and classification of amounts relating to uncertain tax positions, accounting for and disclosure of interest and penalties,
accounting in interim periods and disclosures. The application of that guidance did not result in the recognition of any unrecognized
tax benefits At December 31, 2022 or December 31, 2021. The Company’s policy is to expense any penalties and interest associated
with this topic. At December 31, 2022 and December 31, 2021, there were no amounts accrued for penalties and interest.
6.
Income (Loss) Per Common Share
The
Company computes net income (loss) per share in accordance with ASC 260, Earnings Per Share (“EPS”). Under the provisions
of ASC 260, basic net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number
of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for
the period by the weighted-average number of common and common equivalent shares outstanding during the period. However, common shares
that are considered anti-dilutive are excluded from the computation of diluted EPS. Since the Company had a loss during the year ended
December 31, 2022 and 2021, the basic and diluted net loss per share is the same.
Potentially
dilutive securities not included in the computation of loss per share for the year ended December 31, 2022, include stock options to
purchase 2,360,000 shares of common stock, pre-funded warrant to purchase 28,014,540 shares of common stock, and warrants to purchase
161,500 shares of common stock. Potentially dilutive securities not included in the computation of loss per share for the year ended
December 31, 2021 included 3,000,000 shares of Series F preferred stock, stock options to purchase 1,882,500 shares of common stock,
and warrants to purchase 212,500 shares of common stock. The shares of common stock potentially issuable to Diopsys upon the resolution
of specified contingencies and exercise of stock options are also excluded from the loss per share calculation for the year ended December
31, 2021.
7.
Stock-based compensation:
The
Company recognizes expense for stock-based compensation in accordance with ASC Topic 718, Stock-Based Compensation. For stock-based
awards, the Company calculates the fair value of the award on the date of grant using the Black Scholes option-pricing model. The expense
is recognized over the service period for awards expected to vest. The estimate of stock-based awards that will ultimately vest requires
judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative
adjustment in the period the estimates are revised. Stock options granted to non-employee consultants are revalued at the end of each
reporting period until vested and the changes in their fair value are recorded as adjustments to expense over the related vesting period.
8.
Research and Development costs:
Research
and development costs are expensed as incurred. Costs incurred in obtaining technology licenses outside of business combinations are
charged to research and development expense as acquired in-process research and development if the technology licensed has not reached
technological feasibility and has no alternative future use.
licensed
has not reached technological feasibility and has no alternative future use.
9.
Property and Equipment:
Property
and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives (3
years), once the asset is placed in service. Expenditures for maintenance and repairs, which do not extend the economic useful life of
the related assets, are charged to operations as incurred, and expenditures which extend the economic life are capitalized. When assets
are retired or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and
any gain or loss on disposal is recognized in the statement of operations for the respective period.
The
Company’s long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying
amount of the asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result
from the use of the asset and its eventual disposition are less than its carrying amount.
10.
Recent Accounting Pronouncements:
The
following pronouncement may have an impact on the accounting policies of the Company:
In
February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“ASU 2016-02”). ASU 2016-02 requires
an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require
new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing,
and uncertainty of cash flows arising from leases. The FASB issued ASU No. 2018-10 “Codification Improvements to Topic 842,
Leases” (“ASU 2018-10”), ASU No. 2018-11 “Leases (Topic 842) Targeted Improvements” (“ASU
2018-11”) in July 2018, and ASU No. 2018-20 “Leases (Topic 842) - Narrow Scope Improvements for Lessors” (“ASU
2018-20”) in December 2018. ASU 2018-10 and ASU 2018-20 provide certain amendments that affect narrow aspects of the guidance issued
in ASU 2016-02. ASU 2018-11 allows all entities adopting ASU 2016-02 to choose an additional (and optional) transition method of adoption,
under which an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to
the opening balance of retained earnings in the period of adoption. Pursuant to ASU 2019-10 the effective date for ASC 842 was deferred
an additional year. The Company expects to recognize operating lease right-of-use assets and lease liabilities on the balance sheet upon
adoption of this ASU when it obtains a lease. The Company is currently evaluating these ASUs and their impact on its financial statements,
but does not expect it will have a material effect on the consolidated financial statements.
A
variety of proposed or otherwise potential accounting standards are currently under study by standard-setting organizations. Due to the
tentative and preliminary nature of those proposed standards, management has not determined whether the implementation of such proposed
standards would be material to the financial statements of the Company.
11.
Reclassification:
The
Company reclassified approximately $68,000 of costs incurred during the year ended December 31, 2021 from general and administrative
expense to research and development costs to conform to the current presentation.
|
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.23.3
RELATED PARTY TRANSACTIONS
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Related Party Transactions [Abstract] |
|
|
RELATED PARTY TRANSACTIONS |
NOTE
C – RELATED PARTY TRANSACTIONS
Sanovas
The
Company is related to Sanovas through common ownership and management. Sanovas Ophthalmology is a majority owned subsidiary of Sanovas
and Jerry Katzman, the Company’s Chief Executive Officer, is also a director of Sanovas Ophthalmology and in such capacity has
the right to vote and dispose of the securities held by such entity.
Commencing
in 2019, Sanovas began paying expenses on behalf of the Company, and began allocating a portion of expenses and infrastructure costs
to the Company and other entities where Sanovas was performing shared services. Included in such allocated costs is approximately $281,000
and $106,000 in costs related to an officer of the Company in the six months ending June 30, 2023 and 2022,
respectively.
The
following summarizes the transactions between the Company and Sanovas for the six months ended June 30, 2023 and 2022:
SCHEDULE
OF RELATED PARTY TRANSACTIONS
| |
|
|
|
|
|
| |
| |
Six months Ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Balance due to ( Sanovas – beginning of year | |
$ | 427,933 | | |
$ | 142,721 | |
| |
| | | |
| | |
Costs paid by Sanovas on the Company’s behalf | |
| - | | |
| 36,289 | |
Costs of Sanovas allocated to the Company | |
| 280,820 | | |
| 168,702 | |
Proceeds from costs charged by Sanovas to the Company, net | |
| 102,423 | | |
| 221,119 | |
Retirement of due to Sanovas through the issuance of shares to Sanovas Ophthalmology | |
| - | | |
| (353,432 | ) |
| |
| | | |
| | |
Balance due to Sanovas – end of period | |
$ | 811,176 | | |
$ | 215,398 | |
The
Company issued 353,432 and 586,370 shares of its common stock to offset amounts due to Sanovas for payment of expenses on behalf of the
Company of $353,432 in May 2022 and $586,370 in November 2022, respectively.
Sublicense
On
June 24, 2021, the Company entered into a sublicense agreement (“Sublicense Agreement”) with Sanovas Ophthalmology pursuant
to which Sanovas Ophthalmology granted the Company an exclusive worldwide (“Territory”) license to certain intellectual property
licensed to Sanovas Ophthalmology by Sanovas Intellectual Property LLC relating to certain technologies for eye and ocular visualization
and monitoring (“Licensed IP”) for uses related to the screening, examination, diagnosis, prevention and/or treatment of
any eye disease, medical condition or disorder, or any disease, medical condition or disorder affecting the eye. Pursuant to the Sublicense
Agreement, commencing on the date of the first commercial sale of a Licensed Product (as defined in the Sublicense Agreement), in each
country in the Territory and continuing on a country by country basis until the expiration or termination of the last Valid Claim (as
defined in the Sublicense Agreement) of a licensed patent in such country (the “Royalty End Date”), the Company is obligated
to pay Sanovas Ophthalmology a royalty equal to a mid-single digit percentage of any Net Sales (as defined in the Sublicense Agreement)
of any Licensed Product. The Sublicense Agreement continues until the Royalty End Date, unless earlier terminated pursuant to its terms.
The Sublicense Agreement may be terminated by either party if the other party materially breaches the Sublicense Agreement in a manner
that cannot be cured, or materially breaches the Sublicense Agreement in a manner that can be cured and such breach remains uncured for
more than 30 days after the receipt by the breaching party of notice specifying the breach. Furthermore, the Company may terminate the
Sublicense Agreement at any time upon 90 days written notice to Sanovas Ophthalmology. No royalties have been paid through June 30, 2023
under this Sublicense Agreement.
Due
to affiliates
From
time to time, an officer of the Company, a shareholder of the Company and affiliates of Sanovas advanced funds or paid expenses on behalf
of the Company. There is no formal notes or repayment plan for such advances. At June 30, 2023 and December 31, 2022, the Company had
received an aggregate of $210,022 and $109,185 pursuant to such advances, respectively.
Shareholders’
notes payable – See Note G
|
NOTE
C - RELATED PARTY TRANSACTIONS
Sanovas
The
Company is related to Sanovas through common ownership and management. Sanovas Ophthalmology is a majority owned subsidiary of Sanovas
and Jerry Katzman, the Company’s Chief Executive Officer, is also a director of Sanovas Ophthalmology and in such capacity has
the right to vote and dispose of the securities held by such entity.
Commencing
in 2019, Sanovas began paying expenses on behalf of the Company, and began allocating a portion of expenses and infrastructure costs
to the Company and other entities where Sanovas was performing shared services. Included in such allocated costs is approximately $344,000
and $391,000 in costs related to an officer of the Company in the year ending December 31, 2022 and 2021, respectively.
The
following summarizes the transactions between the Company and Sanovas for the year ended December 31, 2022 and December 31, 2021:
SCHEDULE
OF RELATED PARTY TRANSACTIONS
| |
| | |
| |
| |
Years Ended | |
| |
December 31, | | |
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Balance due to (from) Sanovas – beginning of year | |
$ | 142,721 | | |
$ | (15,069 | ) |
| |
| | | |
| | |
Costs paid by Sanovas on the Company’s behalf | |
| 79,290 | | |
| 68,073 | |
Costs of Sanovas allocated to the Company | |
| 453,047 | | |
| 803,997 | |
Proceeds from (repayment of) costs charged by Sanovas to the Company, net | |
| 692,677 | | |
| (323,922 | ) |
Retirement of due to Sanovas through the issuance of common stock to Sanovas Ophthalmology | |
| (939,802 | ) | |
| (390,358 | ) |
| |
| | | |
| | |
Balance due to Sanovas - end of year | |
$ | 427,933 | | |
$ | 142,721 | |
The
Company issued 390,358, 353,432 and 586,370 shares of its common stock to offset amounts due to Sanovas for payment of expenses on behalf
of the Company of $390,358 in June 2021 and $353,432 in May 2022 and $586,370 in November 2022, respectively.
Sublicense
On
June 24, 2021, the Company entered into a sublicense agreement (“Sublicense Agreement”) with Sanovas Ophthalmology pursuant
to which Sanovas Ophthalmology granted the Company an exclusive worldwide (“Territory”) license to certain intellectual property
licensed to Sanovas Ophthalmology by Sanovas Intellectual Property LLC relating to certain technologies for eye and ocular visualization
and monitoring (“Licensed IP”) for uses related to the screening, examination, diagnosis, prevention and/or treatment of
any eye disease, medical condition or disorder, or any disease, medical condition or disorder affecting the eye. Pursuant to the Sublicense
Agreement, commencing on the date of the first commercial sale of a Licensed Product (as defined in the Sublicense Agreement), in each
country in the Territory and continuing on a country by country basis until the expiration or termination of the last Valid Claim (as
defined in the Sublicense Agreement) of a licensed patent in such country (the “Royalty End Date”), the Company shall pay
Sanovas Ophthalmology a royalty equal to a mid-single digit percentage of any Net Sales (as defined in the Sublicense Agreement) of any
Licensed Product. The Sublicense Agreement shall continue until the Royalty End Date, unless earlier terminated pursuant to its terms.
The Sublicense Agreement may be terminated by either party if the other party materially breaches the Sublicense Agreement in a manner
that cannot be cured, or materially breaches the Sublicense Agreement in a manner that can be cured and such breach remains uncured for
more than 30 days after the receipt by the breaching party of notice specifying the breach. Furthermore, the Company may terminate the
Sublicense Agreement at any time upon 90 days written notice to Sanovas Ophthalmology. No royalties have been paid through December 31,
2022 under this Sublicense Agreement.
Due
to affiliates
From
time to time, an officer of the Company, a shareholder of the Company and affiliates of Sanovas advances funds or paid expenses on behalf
of the Company. There is no formal notes or repayment plan for such advances. At December 31, 2022, the Company had received $109,185
pursuant to such advances.
Shareholders’
notes payable – See Note G
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.3
COMMON AND PREFERRED STOCK
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Equity [Abstract] |
|
|
COMMON AND PREFERRED STOCK |
NOTE
D – COMMON AND PREFERRED STOCK
Pursuant
to the Company’s Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”),
filed with the Delaware Secretary of State on January 8, 2018, the Company is authorized to issue 40,000,000 shares of preferred stock
and 80,000,000 shares of common stock each with a par value of $0.0001 per share. The Company has designated 3,000,000 shares of preferred
stock as Series F preferred stock.
Pursuant
to the terms of an employment agreement dated January 1, 2012 (the “Effective Date”) by and between Sanovas and Lawrence
Gerrans, the then President and Chief Executive Officer of Sanovas (the “Original Employment Agreement”), in consideration
for Mr. Gerrans’ services, Mr. Gerrans was to receive, among other consideration, the following equity securities: (i) 441,177
shares of restricted common stock of each of the wholly-owned subsidiaries of Sanovas, as of the Effective Date (the “Affiliate
Subsidiaries”), representing 7.5% of the total equity capital of each such subsidiary issued and outstanding as of the date of
grant; and (ii) 5,000 shares of Series F preferred stock of Sanovas and each of the Affiliate Subsidiaries. The Company was incorporated
in Delaware on November 17, 2017, subsequent to the Effective Date, and as such these shares were never issued by the Company because
the Company was not an Affiliate Subsidiary of Sanovas. Thereafter, in May 2015, Mr. Gerrans’ Original Employment Agreement was
amended and restated with an effective date of January 1, 2012 (the “Amended and Restated Employment Agreement”), the same
as the Effective Date of the Original Employment Agreement. Pursuant to the Amended and Restated Employment Agreement, in consideration
for Mr. Gerrans’ services, Mr. Gerrans was to receive, among other consideration, the following equity securities: (i) 7.5% of
the total equity capital of each of Sanovas’ Affiliate Subsidiaries as of the Effective Date or thereafter formed (collectively,
the “New Subsidiaries”); and (ii) 5,000 shares of Series F preferred stock of Sanovas, each of the Affiliate Subsidiaries
and each of the New Subsidiaries, including the Company. Subsequently, pursuant to a board resolution dated December 1, 2017 approved
by Lawrence Gerrans, the Company’s then Chief Executive Officer, President and sole director, in 2018 the Company issued 27,000,000
shares of its common stock to Sanovas Ophthalmology LLC, and issued 3,000,000 shares of its Series F preferred stock to Halo Management
LLC (“Halo”), an entity owned by Mr. Gerrans, for certain enumerated consideration that was purported to have been provided.
Thereafter, and in part based upon the evidence and testimony presented, and verdict and conviction rendered, in the Criminal Action
(discussed below), including, but not limited to, the fact that Mr. Gerrans misled and coerced the board of Sanovas regarding the terms
and need for approval of the Amended and Restated Employment Agreement, the Company’s board of directors, acting in concert with
the board of directors of Sanovas, carried out an investigation with respect to actions taken by Mr. Gerrans and have determined that
Halo did not provide the Company with valid consideration for the Series F preferred stock, and the Company disputes whether any of the
shares of the Company issued to Halo were validly issued.
In
January 2020, a jury in the United States District Court for the Northern District of California found Mr. Gerrans guilty, in a criminal
proceeding (the “Criminal Action”), on 12 felony counts of wire fraud, money laundering, perjury, contempt of court, witness
tampering, and obstruction of justice in connection with his activities as an officer and director of Sanovas. Thereafter, in November
2020, Sanovas commenced an action in the Court of Chancery of the State of Delaware (the “Delaware Action”) against Halo
and Mr. Gerrans seeking an order declaring that any rights that Halo and/or Mr. Gerrans may have with respect to any equity securities
in Sanovas and each of its affiliated subsidiaries (including, but not limited to, the Company) are void or voidable and may be cancelled.
The Delaware Action is currently still pending.
On
November 21,2021, the Company’s Board of Directors resolved to rescind the 3,000,000 shares of Series F preferred stock purported
to be issued to Halo Management Group LLC for lack of contract consideration. The Company is aware that the management/ownership of Halo
Management Group LLC may dispute this decision however, the Company is prepared to defend its decision in this case. In addition, the
Company reserves the right to void the shares and adjust its filings accordingly if necessary.
Common
Stock
During
2019, the Company commenced a private offering of its shares of common stock at a purchase price of $1.00 per share. For the six months
ended June 30, 2022, the Company sold an aggregate of 60,500 shares of its common stock, and the offering was concluded. No shares were
sold in 2023.
The
common stockholders, voting as a separate class, are entitled to elect one member of the Board of Directors.
Preferred
Stock
As
of June 30, 2023 and December 31, 2022, there were 3,000,000 shares of preferred stock designated as Series F preferred stock, none of
which were outstanding.
The
rights and privileges of the Series F preferred stock are summarized as follows:
Voting
Privileges and Protective Features:
Each
holder of outstanding shares of Series F preferred stock is entitled to cast the number of votes equal to the number of whole shares
of common stock into which the Series F preferred stock held by such holder are convertible as of the record date for determining stockholders
entitled to vote on such matter. The holders of record of a majority of outstanding Series F preferred stock shall be entitled to elect
two of the members of the Board of Directors of the Company. The right to elect two directors shall terminate on the date upon which
there are less than 25,000 shares of Series F preferred stock issued and outstanding.
For
so long as at least 25,000 shares of Series F preferred stock remain outstanding, the vote or written consent of the holders of the majority
of the outstanding shares of Series F preferred stock is necessary for the Company to conduct certain corporate actions, including, but
not limited to, merger, consolidation or dissolution of the Company; certain amendments to the Certificate of Incorporation or bylaws
of the Company; authorization or issuance of shares of any additional class or series of capital stock unless the same ranks on parity
or junior to the Series F preferred stock with respect to voting rights.
Redemption:
The
Series F preferred stock does not have redemption features.
Dividends:
There
are no stated dividends on the Series F preferred stock.
Conversion:
Each
share of Series F preferred stock is convertible, at the option of the holder, at any time and from time to time into shares of common
stock at a conversion rate as is determined by dividing the Series F Original Issue Price by the Series F Conversion Price. “Series
F Original Issue Price” initially means $0.01 and “Series F Conversion Price” initially means $0.01, as adjusted for
any dilutive transaction such as stock splits, certain dividends, mergers or acquisitions.
All
of the outstanding shares of Series F preferred stock will automatically convert into shares of the Company’s common stock upon
the consummation of an underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933,
as amended, resulting in gross proceeds of at least $15,000,000 to the Company or upon written consent of at least 67% of the Series
F preferred shareholders.
|
NOTE
D - COMMON AND PREFERRED STOCK
Pursuant
to the Company’s Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”),
filed with the Delaware Secretary of State on January 8, 2018, the Company is authorized to issue 40,000,000 shares of preferred stock
and 80,000,000 shares of common stock each with a par value of $0.0001 per share. The Company has designated 3,000,000 shares of preferred
stock as Series F preferred stock.
Pursuant
to the terms of an employment agreement dated January 1, 2012 (the “Effective Date”) by and between Sanovas and Lawrence
Gerrans, the then President and Chief Executive Officer of Sanovas (the “Original Employment Agreement”), in consideration
for Mr. Gerrans’ services, Mr. Gerrans was to receive, among other consideration, the following equity securities: (i) 441,177
shares of restricted common stock of each of the wholly-owned subsidiaries of Sanovas, as of the Effective Date (the “Affiliate
Subsidiaries”), representing 7.5% of the total equity capital of each such subsidiary issued and outstanding as of the date of
grant; and (ii) 5,000 shares of Series F preferred stock of Sanovas and each of the Affiliate Subsidiaries. The Company was incorporated
in Delaware on November 17, 2017, subsequent to the Effective Date, and as such these shares were never issued by the Company because
the Company was not an Affiliate Subsidiary of Sanovas. Thereafter, in May 2015, Mr. Gerrans’ Original Employment Agreement was
amended and restated with an effective date of January 1, 2012 (the “Amended and Restated Employment Agreement”), the same
as the Effective Date of the Original Employment Agreement. Pursuant to the Amended and Restated Employment Agreement, in consideration
for Mr. Gerrans’ services, Mr. Gerrans was to receive, among other consideration, the following equity securities: (i) 7.5% of
the total equity capital of each of Sanovas’ Affiliate Subsidiaries as of the Effective Date or thereafter formed (collectively,
the “New Subsidiaries”); and (ii) 5,000 shares of Series F preferred stock of Sanovas, each of the Affiliate Subsidiaries
and each of the New Subsidiaries, including the Company. Subsequently, pursuant to a board resolution dated December 1, 2017 approved
by Lawrence Gerrans, the Company’s then Chief Executive Officer, President and sole director, in 2018 the Company issued 27,000,000
shares of its common stock to Sanovas Ophthalmology LLC, and issued 3,000,000 shares of its Series F preferred stock to Halo Management
LLC (“Halo”), an entity owned by Mr. Gerrans, for certain enumerated consideration that was purported to have been provided.
Thereafter, and in part based upon the evidence and testimony presented, and verdict and conviction rendered, in the Criminal Action
(discussed below), including, but not limited to, the fact that Mr. Gerrans misled and coerced the board of Sanovas regarding the terms
and need for approval of the Amended and Restated Employment Agreement, the Company’s board of directors, acting in concert with
the board of directors of Sanovas, carried out an investigation with respect to actions taken by Mr. Gerrans and have determined that
Halo did not provide the Company with valid consideration for the Series F preferred stock, and the Company disputes whether any of the
shares of the Company issued to Halo were validly issued.
In
January 2020, a jury in the United States District Court for the Northern District of California found Mr. Gerrans guilty, in a criminal
proceeding (the “Criminal Action”), on 12 felony counts of wire fraud, money laundering, perjury, contempt of court, witness
tampering, and obstruction of justice in connection with his activities as an officer and director of Sanovas. Thereafter, in November
2020, Sanovas commenced an action in the Court of Chancery of the State of Delaware (the “Delaware Action”) against Halo
and Mr. Gerrans seeking an order declaring that any rights that Halo and/or Mr. Gerrans may have with respect to any equity securities
in Sanovas and each of its affiliated subsidiaries (including, but not limited to, the Company) are void or voidable and may be cancelled.
The Delaware Action is currently still pending.
On
November 21,2021, the Company’s Board of Directors resolved to rescind the 3,000,000 shares of Series F preferred stock purported
to be issued to Halo Management Group LLC for lack of contract consideration. The Company is aware that the management/ownership of Halo
Management Group LLC may dispute this decision however, the Company is prepared to defend its decision in this case. In addition, the
Company reserves the right to void the shares and adjust its filings accordingly if necessary.
Common
Stock
During
2019, the Company commenced a private offering of its shares of common stock at a purchase price of $1.00 per share. For the years ended
December 31, 2022 and 2021, the Company sold an aggregate of 60,500 and 398,057 shares of its common stock, respectively.
The
common stockholders, voting as a separate class, are entitled to elect one member of the Board of Directors.
Preferred
Stock
As
of December 31, 2022 and 2021, there were 3,000,000 shares of preferred stock designated as Series F preferred stock, none of which were
outstanding.
The
rights and privileges of the Series F preferred stock are summarized as follows:
Voting
Privileges and Protective Features:
Each
holder of outstanding shares of Series F preferred stock is entitled to cast the number of votes equal to the number of whole shares
of common stock into which the Series F preferred stock held by such holder are convertible as of the record date for determining stockholders
entitled to vote on such matter. The holders of record of a majority of outstanding Series F preferred stock shall be entitled to elect
two of the members of the Board of Directors of the Company. The right to elect two directors shall terminate on the date upon which
there are less than 25,000 shares of Series F preferred stock issued and outstanding.
For
so long as at least 25,000 shares of Series F preferred stock remain outstanding, the vote or written consent of the holders of the majority
of the outstanding shares of Series F preferred stock is necessary for the Company to conduct certain corporate actions, including, but
not limited to, merger, consolidation or dissolution of the Company; certain amendments to the Certificate of Incorporation or bylaws
of the Company; authorization or issuance of shares of any additional class or series of capital stock unless the same ranks on parity
or junior to the Series F preferred stock with respect to voting rights.
Redemption:
The
Series F preferred stock does not have redemption features.
Dividends:
There
are no stated dividends on the Series F preferred stock.
Conversion:
Each
share of Series F preferred stock is convertible, at the option of the holder, at any time and from time to time into shares of common
stock at a conversion rate as is determined by dividing the Series F Original Issue Price by the Series F Conversion Price. “Series
F Original Issue Price” initially means $0.01 and “Series F Conversion Price” initially means $0.01, as adjusted for
any dilutive transaction such as stock splits, certain dividends, mergers or acquisitions.
All
of the outstanding shares of Series F preferred stock will automatically convert into shares of the Company’s common stock upon
the consummation of an underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933,
as amended, resulting in gross proceeds of at least $15,000,000 to the Company or upon written consent of at least 67% of the Series
F preferred shareholders.
|
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- DefinitionThe entire disclosure for equity.
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v3.23.3
STOCK PLAN
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Equity [Abstract] |
|
|
STOCK PLAN |
NOTE
E – STOCK PLAN
The
Company has reserved 10,000,000 shares of common stock for issuance to employees or consultants from the RetinalGenix Technologies Inc.
2017 Equity Incentive Plan (the “Plan”). The Company may grant stock options, restricted stock or other types of equity incentive
instruments under the Plan.
In
August 2022, the Company issued stock options to purchase up to 500,000 shares of common stock at an exercise price of $1.00 per share
to members of the Company’s medical advisory board and consultants pursuant to the Plan. The options vest over a three-year period.
The estimated aggregate fair value of the stock options at the date of grant was determined to be $287,487 using a Black Scholes model.
The
Company recognized $157,018 and $110,012 of stock-based compensation expense during the six month periods ended June 30, 2023 and 2022,
respectively, related to stock options which is included in the accompanying consolidated statements of operations. As of June 30, 2023,
there was approximately $498,000 of total unrecognized compensation expense related to non-vested share-based compensation arrangements
granted under the Plan. That cost is expected to be recognized over a weighted-average period of approximately 1.4 years.
At
June 30, 2023, there were 5,115,000 shares available to be issued under the Plan. The following table summarizes stock option activity
of the Plan through June 30, 2023:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Options Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
Options outstanding – December 31, 2021 | |
| 1,882,500 | | |
$ | 1.00 | |
Granted | |
| 502,500 | | |
| 1.00 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Options outstanding – December 31, 2022 | |
| 2,360,000 | | |
| 1.00 | |
Granted | |
| - | | |
| | |
Canceled | |
| - | | |
| | |
Exercised | |
| - | | |
| | |
Options outstanding – June 30, 2023 | |
| 2,360,000 | | |
$ | 1.00 | |
Additional
information regarding the exercisable options and average remaining contractual life of the options outstanding as of June 30, 2023 is
as follows:
SCHEDULE OF STOCK OPTIONS OUTSTANDING AND EXERCISABLE
Exercise Price | | |
Number Outstanding | | |
Weighted Average Remaining Contractual Life | |
Number Exercisable at December 31, 2022 | | |
Number Exercisable at June 30, 2023 | |
$ | 1.00 | | |
| 2,360,000 | | |
6.9 Years | |
| 1,204,444 | | |
| 1,532,778 | |
The
fair value of each option grant was estimated on the date of grant to be $0.56 per share using the Black-Scholes option-pricing model
with the following assumption weighted-averages in 2022:
SCHEDULE OF STOCK OPTIONS FAIR VALUE ASSUMPTIONS
Risk-free interest rates | |
| 2.19 | % |
Expected life in years | |
| 3.5 | |
Expected volatility | |
| 80 | % |
Expected dividend yield | |
| 0 | % |
Fair value common stock | |
$ | 1.00 | |
The
risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero-coupon issues with a remaining
term commensurate with the expected term of the award. Management has estimated expected volatility based on similar comparable industry
sector averages. Expected life of the option represents the period of time options are expected to be outstanding. The estimate for dividend
yield is 0% because the Company has not historically paid, and does not intend to pay a dividend on its common stock in the foreseeable
future.
|
NOTE
E - STOCK PLAN
The
Company has reserved 10,000,000 shares of common stock for issuance to employees or consultants from the RetinalGenix Technologies Inc.
2017 Equity Incentive Plan (the “Plan”). The Company may grant stock options, restricted stock or other types of equity incentive
instruments under the Plan.
In
November 2019, the Company issued stock options to purchase up to 1,800,000 shares of common stock at an exercise price of $1.00 per
share to members of the Company’s medical advisory board and consultants pursuant to the Plan. The options vest over a five-year
period and were unexercised at December 31, 2022 and December 31, 2021. The estimated aggregate fair value of the stock options at the
date of grant was determined to be $1,101,028 using a Black Scholes model.
In
the year ended December 31, 2021, the Company issued stock options to purchase up to 82,500 shares of common stock at an exercise price
of $1.00 per share to members of the Company’s medical advisory board and consultants pursuant to the Plan. The options vested
immediately. The estimated aggregate fair value of the stock options at the date of grant was determined to be approximately $63,900
using a Black Scholes model.
In
August 2022, the Company issued stock options to purchase up to 500,000 shares of common stock at an exercise price of $1.00 per share
to members of the Company’s medical advisory board and consultants pursuant to the Plan. The options vest over a three-year period.
The estimated aggregate fair value of the stock options at the date of grant was determined to be $287,487 using a Black Scholes model.
The
Company recognized approximately $259,000 and $232,000 of stock-based compensation expense during the year ended December 31, 2022 and
2021, respectively, related to stock options which is included in the accompanying statements of operations. As of December 31, 2022,
there was approximately $655,000 of total unrecognized compensation expense related to non-vested share-based compensation arrangements
granted under the Plan. That cost is expected to be recognized over a weighted-average period of approximately 2.0 years.
At
December 31, 2022, there were 5,115,000 shares available to be issued under the Plan. The following table summarizes stock option activity
of the Plan through December 31, 2022:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Options Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
Options outstanding – December 31, 2020 | |
| 1,800,000 | | |
$ | 1.00 | |
Granted | |
| 82,500 | | |
| 1.00 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
| |
| | | |
| | |
Options outstanding – December 31, 2021 | |
| 1,882,500 | | |
$ | 1.00 | |
Granted | |
| 502,500 | | |
| 1.00 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Options outstanding – December 31, 2022 | |
| 2,360,000 | | |
$ | 1.00 | |
Additional
information regarding the exercisable options and average remaining contractual life of the options outstanding as of December 31, 2022
is as follows:
SCHEDULE OF STOCK OPTIONS OUTSTANDING AND EXERCISABLE
Exercise
Price |
|
|
Number
Outstanding |
|
|
Weighted
Average
Remaining
Contractual Life |
|
|
Number
Exercisable at
December
31, 2022 |
|
|
Number
Exercisable at
December
31, 2021 |
|
$ |
1.00 |
|
|
|
2,360,000 |
|
|
|
7.2
Years |
|
|
|
1,204,444 |
|
|
|
525,000 |
|
The
fair value of each option grant was estimated on the date of grant to be $0.53 per share using the Black-Scholes option-pricing model
with the following assumption weighted-averages in 2021:
SCHEDULE
OF STOCK OPTIONS FAIR VALUE ASSUMPTIONS
Risk-free
interest rates |
|
|
1.2%
- 2.42 |
% |
Expected
life in years |
|
|
5.0 |
|
Expected
volatility |
|
|
73.1 |
% |
Expected
dividend yield |
|
|
0 |
% |
Fair
value common stock |
|
$ |
1.00 |
|
The
fair value of each option grant was estimated on the date of grant to be $0.56 per share using the Black-Scholes option-pricing model
with the following assumption weighted-averages in 2022:
Risk-free
interest rates |
|
|
2.19 |
% |
Expected
life in years |
|
|
3.5 |
|
Expected
volatility |
|
|
80 |
% |
Expected
dividend yield |
|
|
0 |
% |
Fair
value common stock |
|
$ |
1.00 |
|
The
risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero-coupon issues with a remaining
term commensurate with the expected term of the award. Management has estimated expected volatility based on similar comparable industry
sector averages. Expected life of the option represents the period of time options are expected to be outstanding. The estimate for dividend
yield is 0% because the Company has not historically paid, and does not intend to pay a dividend on its common stock in the foreseeable
future.
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- DefinitionThe entire disclosure for shareholders' equity and share-based payment arrangement. Includes, but is not limited to, disclosure of policy and terms of share-based payment arrangement, deferred compensation arrangement, and employee stock purchase plan (ESPP).
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v3.23.3
WARRANTS
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Warrants |
|
|
WARRANTS |
NOTE
F – WARRANTS
The
following table summarizes warrant activity through June 30, 2023:
SCHEDULE
OF WARRANTS ACTIVITY
| |
Warrants Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
| |
| | |
| |
Warrants outstanding – December 31, 2021 | |
| 199,000 | | |
$ | 1.07 | |
| |
| | | |
| | |
Granted | |
| - | | |
| - | |
Canceled | |
| (12,500 | ) | |
| 1.00 | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Warrants outstanding – December 31, 2022 | |
| 161,500 | | |
| 1.09 | |
Granted | |
| - | | |
| | |
Canceled | |
| - | | |
| | |
Exercised | |
| - | | |
| | |
Warrants outstanding – June 30, 2023 | |
| 161,500 | | |
$ | 1.09 | |
Additional
information regarding the warrants outstanding as of June 30, 2023 is as follows:
SCHEDULE
OF WARRANTS OUTSTANDING
Exercise Price | | |
Number Outstanding | | |
Weighted Average Remaining Contractual Life | |
Number Exercisable | |
$ | 1.00 | | |
| 11,500 | | |
.4 Years | |
| 11,500 | |
$ | 1.10 | | |
| 150,000 | | |
5.4 Years | |
| 150,000 | |
| | | |
| 161,500 | | |
| |
| 161,500 | |
Pre-funded
Warrant
On
December 27, 2021, the Company entered into an exchange agreement with Sanovas Ophthalmology (the “Exchange Agreement”) pursuant
to which it exchanged 28,014,540 shares of common stock (the “Exchange Securities”) held by Sanovas Ophthalmology for a pre-funded
warrant (the “Pre-funded Warrant”) to purchase up to an aggregate of 28,014,540 shares of the Company’s common stock.
The Pre-funded Warrant is immediately exercisable at an exercise price of $0.0001 per share and terminates when exercised in full. As
part of the Exchange Agreement, Sanovas Ophthalmology relinquished any and all rights related to the Exchange Securities.
|
NOTE
F - WARRANTS
In
2021, the Company finalized the issuance of warrants to purchase 150,000 shares of common stock at $1.10 per share which are fully vested
as of December 31, 2021, and exercisable over 7 years, to a consulting firm. The fair value of such warrants was estimated on the date
of grant to be $0.61 per share using the Black-Scholes option-pricing model with the following assumption weighted-averages in 2021:
SCHEDULE
OF WARRANTS FAIR VALUE ASSUMPTIONS
Risk-free
interest rates |
|
|
2.42 |
% |
Expected
life in years |
|
|
3.5 |
|
Expected
volatility |
|
|
73.1 |
% |
Expected
dividend yield |
|
|
0 |
% |
Fair
value common stock |
|
$ |
1.00 |
|
The
risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero-coupon issues with a remaining
term commensurate with the expected term of the award. Management has estimated expected volatility based on similar comparable industry
sector averages. Expected life of the option represents the period of time options are expected to be outstanding. The estimate for dividend
yield is 0% because the Company has not historically paid, and does not intend to pay a dividend on its common stock in the foreseeable
future. The Company recognized stock-based compensation expense of approximately $75,000 and $0 in the year ended December 31, 2021 and
2022, respectively. At December 31, 2022, there is no remaining compensation expense to be recognized.
The
following table summarizes warrant activity through December 31, 2022:
SCHEDULE
OF WARRANTS ACTIVITY
| |
Warrants Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
Warrants outstanding – December 31, 2020 | |
| 62,500 | | |
$ | 1.00 | |
Granted | |
| 150,000 | | |
| 1.10 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| (13,500 | ) | |
| 1.00 | |
| |
| | | |
| | |
Warrants outstanding – December 31, 2021 | |
| 199,000 | | |
$ | 1.07 | |
| |
| | | |
| | |
Granted | |
| - | | |
| - | |
Canceled | |
| (12,500 | ) | |
| 1.00 | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Warrants outstanding – December 31, 2022 | |
| 161,500 | | |
$ | 1.09 | |
Additional
information regarding the warrants outstanding as of December 31, 2022 is as follows:
SCHEDULE
OF WARRANTS OUTSTANDING
Exercise
Price |
|
|
Number
Outstanding |
|
|
Weighted
Average
Remaining
Contractual Life |
|
|
Number
Exercisable |
|
$ |
1.00 |
|
|
|
11,500 |
|
|
|
.7
Years |
|
|
|
11,500 |
|
$ |
1.10 |
|
|
|
150,000 |
|
|
|
5.7
Years |
|
|
|
150,000 |
|
|
|
|
|
|
161,500 |
|
|
|
|
|
|
|
161,500 |
|
Pre-funded
Warrant
On
December 27, 2021, the Company entered into an exchange agreement with Sanovas Ophthalmology (the “Exchange Agreement”) pursuant
to which it exchanged 28,014,540 shares of common stock (the “Exchange Securities”) held by Sanovas Ophthalmology for a pre-funded
warrant (the “Pre-funded Warrant”) to purchase up to an aggregate of 28,014,540 shares of the Company’s common stock.
The Pre-funded Warrant is immediately exercisable at an exercise price of $0.0001 per share and terminates when exercised in full. As
part of the Exchange Agreement, Sanovas Ophthalmology relinquished any and all rights related to the Exchange Securities.
|
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v3.23.3
SHAREHOLDERS’ NOTES PAYABLE
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Debt Disclosure [Abstract] |
|
|
SHAREHOLDERS’ NOTES PAYABLE |
NOTE
G – SHAREHOLDERS’ NOTES PAYABLE
During
2021, the Company borrowed an aggregate of $74,000 from several stockholders pursuant to note agreements bearing interest at 8% per annum
and maturing December 31, 2022. The Company has informally extended the maturity date to December 31, 2023 under the same terms. During
the year ended December 31, 2022, one of the noteholders exercised outstanding warrants with an aggregate exercise price of $25,000 through
the offset of the note payable due to them from the Company, such that $49,000 remain outstanding at June 30, 2023 and December 31, 2022.
Interest expense amounted to $1,920 and $2,920 for the six months ended June 30, 2023 and 2022, respectively. The accrued interest payable
at June 30, 2023 and December 31, 2022 was $9,679 and $7,759, respectively.
|
NOTE
G – SHAREHOLDERS’ NOTES PAYABLE
During
2021, the Company borrowed an aggregate of $73,000 from several stockholders pursuant to note agreements bearing interest at 8% per annum
and maturing December 31, 2022. The Company has informally extended the maturity date to December 31, 2023 under the same terms. During
the year ended December 31, 2022, one of the noteholders exercised outstanding warrants with an aggregate exercise price of $25,000 through
the offset of the note payable due to them from the Company, such that $48,000 remain outstanding at December 31, 2022. Interest expense
amounted to $5,140 and $2,619 for the years ended December 31, 2022 and 2021, respectively. The accrued interest payable at December
31, 2022 and 2021 was $7,759 and $2,619, respectively.
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.23.3
INCOME TAXES
|
12 Months Ended |
Dec. 31, 2022 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
NOTE
H – INCOME TAXES
The
Company had no current income tax expense for the years ended December 31, 2022 and 2021 due to operating losses. The effective income
tax rate for the years ended December 31, 2022 and 2021 is zero, as the deferred tax benefits are fully offset by the valuation allowance
against such deferred income tax assets.
At
December 31, 2022, the Company had net operating loss carryforwards (“NOL”) of approximately $4,499,000 for federal income
tax purposes of which $3,724,000 has no expiration date, $775,000 which begins to expire in 2034, and approximately $4,499,000 for state
income tax purposes which begins to expire in 2030.
The
resulting net deferred tax assets of approximately $1,714,000 ($1,350,000 applicable to net operating loss carryforwards, $236,000 applicable
to stock-based compensation and $128,000 applicable to accruals) and $1,193,000 ($992,000 applicable to net operating loss carryforwards,
$158,000 applicable to stock based compensation and $43,000 applicable to accruals) at December 31, 2022 and December 31, 2021, respectively,
has been fully reserved due to the uncertainty of future realization. The valuation allowance increased by approximately $521,000 and
$389,000 at December 31, 2022 and 2021, respectively. In assessing the realizability of deferred tax assets, management considered whether
it is more likely than not that some portion or all of the deferred taxes will not be realized. The ultimate realization of deferred
tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible.
Due
to the change in ownership provisions of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”), the
availability of the Company’s NOL carryforwards may be subject to annual limitations against taxable income in future periods,
which could substantially limit the eventual utilization of such carryforwards. The Company has not analyzed the historical or potential
impact of its equity financings on beneficial ownership and therefore no determination has been made whether the NOL carryforward is
subject to any Internal Revenue Code Section 382 limitation. To the extent there is a limitation, there would be a reduction in the deferred
tax asset with an offsetting reduction in the valuation allowance.
The
Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. The open years for tax examination
are 2017 and thereafter.
|
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- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.3
CONTINGENCY
|
12 Months Ended |
Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] |
|
CONTINGENCY |
NOTE
I - CONTINGENCY
The Company received a claim against it relating to a former indirect
vendor. The Company believes the claim is without merit and intends to vigorously defend itself. The Company does not believe the claim
would have a material impact on the financial condition of the Company.
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v3.23.3
SUBSEQUENT EVENTS
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Subsequent Events [Abstract] |
|
|
SUBSEQUENT EVENTS |
NOTE
H – SUBSEQUENT EVENTS
Subsequent
events were reviewed through August 11, 2023, the date these consolidated financial statements were available for issuance.
|
NOTE
J - SUBSEQUENT EVENTS
The Company has evaluated the effect of events and transactions subsequent
to December 31, 2022 through the date of issuance of the consolidated financial statements, and determined that no subsequent events have
occurred that require recognition in the consolidated financial statements.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Accounting Policies [Abstract] |
|
|
Basis of Presentation |
1.
Basis of Presentation
The
Company’s consolidated financial statements were prepared in accordance with accounting principles generally accepted in the United
States of America (“US GAAP”). As of June 30, 2023, there have been no material changes in the Company’s significant
accounting policies from those that were disclosed in the Annual Report for the year ended December 31, 2022 (the “2022 Annual
Report”).
|
1.
Basis of Presentation
The
Company’s financial statements were prepared in accordance with accounting principles generally accepted in the United States of
America (“US GAAP”). As of December 31, 2022, there have been no material changes in the Company’s significant accounting
policies from those that were disclosed in the 2021 Annual Report. The consolidated financial statements include the accounts of the
Company and its wholly owned subsidiary, DNA/GPS, Inc. All intercompany accounts and transactions have been eliminated in consolidation.
|
Cash Equivalents |
2.
Cash Equivalents
For
purpose of the consolidated statements of cash flows, the Company considers all short-term investments purchased with a maturity of three
months or less to be cash equivalents.
|
2.
Cash Equivalents
For
purpose of the statements of cash flows, the Company considers all short-term investments purchased with a maturity of three months or
less to be cash equivalents.
|
Offering Costs |
|
3.
Offering Costs
Deferred
offering costs are expenses directly related to an expected financing. These costs consisted of legal fees that the Company capitalized.
These costs are offset against the resultant capital raised.
|
Use of Estimates |
3.
Use of Estimates
In
preparing the Company’s consolidated financial statements in conformity with US GAAP, management is required to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the
date of the consolidated financial statements, as well as the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates.
|
4.
Use of Estimates
In
preparing the Company’s financial statements in conformity with US GAAP, management is required to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial
statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those
estimates.
|
Income Taxes |
4.
Income Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future
tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted
tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
date.
The
Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
Topic 740-10 Income Taxes. ASC Topic 740-10 clarifies the accounting for income taxes by prescribing a minimum recognition threshold
a tax position is required to meet before being recognized in the financial statements. It also provides guidance on the recognition,
measurement, and classification of amounts relating to uncertain tax positions, accounting for and disclosure of interest and penalties,
accounting in interim periods and disclosures. The application of that guidance did not result in the recognition of any unrecognized
tax benefits at June 30, 2023 or December 31, 2022. The Company’s policy is to expense any penalties and interest associated with
this topic. At June 30, 2023 and December 31, 2022, there were no amounts accrued for penalties and interest.
|
5.
Income Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future
tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted
tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
date.
The
Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
Topic 740-10 Income Taxes. ASC Topic 740-10 clarifies the accounting for income taxes by prescribing a minimum recognition threshold
a tax position is required to meet before being recognized in the financial statements. It also provides guidance on the recognition,
measurement, and classification of amounts relating to uncertain tax positions, accounting for and disclosure of interest and penalties,
accounting in interim periods and disclosures. The application of that guidance did not result in the recognition of any unrecognized
tax benefits At December 31, 2022 or December 31, 2021. The Company’s policy is to expense any penalties and interest associated
with this topic. At December 31, 2022 and December 31, 2021, there were no amounts accrued for penalties and interest.
|
Income (Loss) Per Common Share |
5.
Income (Loss) Per Common Share
The
Company computes net income (loss) per share in accordance with ASC 260, Earnings Per Share (“EPS”). Under the provisions
of ASC 260, basic net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number
of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for
the period by the weighted-average number of common and common equivalent shares outstanding during the period. However, common shares
that are considered anti-dilutive are excluded from the computation of diluted EPS. Since the Company had a loss during the three and
six months ended June 30, 2023 and 2022, the basic and diluted net loss per share is the same.
Potentially
dilutive securities not included in the computation of loss per share for the three and six months ended June 30, 2023, include stock
options to purchase 2,360,000 shares of common stock, pre-funded warrants to purchase 28,014,540 shares of common stock, and warrants
to purchase 161,500 shares of common stock. Potentially dilutive securities not included in the computation of loss per share for the
three and six months ended June 30, 2022 stock options to purchase 1,882,500 shares of common stock, pre-funded warrant to purchase 28,014,540
shares of common stock and warrants to purchase 199,000 shares of common stock. The shares of common stock potentially issuable to Diopsys
upon the resolution of specified contingencies and exercise of stock options are also excluded from the loss per share calculation for
the three months ended June 30, 2022.
|
6.
Income (Loss) Per Common Share
The
Company computes net income (loss) per share in accordance with ASC 260, Earnings Per Share (“EPS”). Under the provisions
of ASC 260, basic net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number
of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for
the period by the weighted-average number of common and common equivalent shares outstanding during the period. However, common shares
that are considered anti-dilutive are excluded from the computation of diluted EPS. Since the Company had a loss during the year ended
December 31, 2022 and 2021, the basic and diluted net loss per share is the same.
Potentially
dilutive securities not included in the computation of loss per share for the year ended December 31, 2022, include stock options to
purchase 2,360,000 shares of common stock, pre-funded warrant to purchase 28,014,540 shares of common stock, and warrants to purchase
161,500 shares of common stock. Potentially dilutive securities not included in the computation of loss per share for the year ended
December 31, 2021 included 3,000,000 shares of Series F preferred stock, stock options to purchase 1,882,500 shares of common stock,
and warrants to purchase 212,500 shares of common stock. The shares of common stock potentially issuable to Diopsys upon the resolution
of specified contingencies and exercise of stock options are also excluded from the loss per share calculation for the year ended December
31, 2021.
|
Stock-based compensation |
6.
Stock-based compensation:
The
Company recognizes expense for stock-based compensation in accordance with ASC Topic 718, Stock-Based Compensation. For stock-based
awards, the Company calculates the fair value of the award on the date of grant using the Black Scholes option-pricing model. The expense
is recognized over the service period for awards expected to vest. The estimate of stock-based awards that will ultimately vest requires
judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative
adjustment in the period the estimates are revised. Stock options granted to non-employee consultants are revalued at the end of each
reporting period until vested and the changes in their fair value are recorded as adjustments to expense over the related vesting period.
|
7.
Stock-based compensation:
The
Company recognizes expense for stock-based compensation in accordance with ASC Topic 718, Stock-Based Compensation. For stock-based
awards, the Company calculates the fair value of the award on the date of grant using the Black Scholes option-pricing model. The expense
is recognized over the service period for awards expected to vest. The estimate of stock-based awards that will ultimately vest requires
judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative
adjustment in the period the estimates are revised. Stock options granted to non-employee consultants are revalued at the end of each
reporting period until vested and the changes in their fair value are recorded as adjustments to expense over the related vesting period.
|
Research and Development costs |
7.
Research and Development costs:
Research
and development costs are expensed as incurred. Costs incurred in obtaining technology licenses outside of business combinations are
charged to research and development expense as acquired in-process research and development if the technology licensed has not reached
technological feasibility and has no alternative future use.
licensed
has not reached technological feasibility and has no alternative future use.
|
8.
Research and Development costs:
Research
and development costs are expensed as incurred. Costs incurred in obtaining technology licenses outside of business combinations are
charged to research and development expense as acquired in-process research and development if the technology licensed has not reached
technological feasibility and has no alternative future use.
licensed
has not reached technological feasibility and has no alternative future use.
|
Property and Equipment |
8.
Property and Equipment:
Property
and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives (3
years), once the asset is placed in service. Expenditures for maintenance and repairs, which do not extend the economic useful life of
the related assets, are charged to operations as incurred, and expenditures which extend the economic life are capitalized. When assets
are retired or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and
any gain or loss on disposal is recognized in the consolidated statement of operations for the respective period.
The
Company’s long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying
amount of the asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result
from the use of the asset and its eventual disposition are less than its carrying amount.
|
9.
Property and Equipment:
Property
and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives (3
years), once the asset is placed in service. Expenditures for maintenance and repairs, which do not extend the economic useful life of
the related assets, are charged to operations as incurred, and expenditures which extend the economic life are capitalized. When assets
are retired or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and
any gain or loss on disposal is recognized in the statement of operations for the respective period.
The
Company’s long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying
amount of the asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result
from the use of the asset and its eventual disposition are less than its carrying amount.
|
Recent Accounting Pronouncements |
9.
Recent Accounting Pronouncements:
The
following pronouncement may have an impact on the accounting policies of the Company:
In
February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“ASU 2016-02”). ASU 2016-02 requires an
entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require
new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing,
and uncertainty of cash flows arising from leases. The FASB issued ASU No. 2018-10 “Codification Improvements to Topic 842, Leases”
(“ASU 2018-10”), ASU No. 2018-11 “Leases (Topic 842) Targeted Improvements” (“ASU 2018-11”) in July
2018, and ASU No. 2018-20 “Leases (Topic 842) – Narrow Scope Improvements for Lessors” (“ASU 2018-20”)
in December 2018. ASU 2018-10 and ASU 2018-20 provide certain amendments that affect narrow aspects of the guidance issued in ASU 2016-02.
ASU 2018-11 allows all entities adopting ASU 2016-02 to choose an additional (and optional) transition method of adoption, under which
an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening
balance of retained earnings in the period of adoption. Pursuant to ASU 2019-10 the effective date for ASC 842 was deferred an additional
year. The Company expects to recognize operating lease right-of-use assets and lease liabilities on the balance sheet upon adoption of
this ASU when it obtains a lease. The Company does not current have a lease.
A
variety of proposed or otherwise potential accounting standards are currently under study by standard-setting organizations. Due to the
tentative and preliminary nature of those proposed standards, management has not determined whether the implementation of such proposed
standards would be material to the consolidated financial statements of the Company.
|
10.
Recent Accounting Pronouncements:
The
following pronouncement may have an impact on the accounting policies of the Company:
In
February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“ASU 2016-02”). ASU 2016-02 requires
an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require
new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing,
and uncertainty of cash flows arising from leases. The FASB issued ASU No. 2018-10 “Codification Improvements to Topic 842,
Leases” (“ASU 2018-10”), ASU No. 2018-11 “Leases (Topic 842) Targeted Improvements” (“ASU
2018-11”) in July 2018, and ASU No. 2018-20 “Leases (Topic 842) - Narrow Scope Improvements for Lessors” (“ASU
2018-20”) in December 2018. ASU 2018-10 and ASU 2018-20 provide certain amendments that affect narrow aspects of the guidance issued
in ASU 2016-02. ASU 2018-11 allows all entities adopting ASU 2016-02 to choose an additional (and optional) transition method of adoption,
under which an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to
the opening balance of retained earnings in the period of adoption. Pursuant to ASU 2019-10 the effective date for ASC 842 was deferred
an additional year. The Company expects to recognize operating lease right-of-use assets and lease liabilities on the balance sheet upon
adoption of this ASU when it obtains a lease. The Company is currently evaluating these ASUs and their impact on its financial statements,
but does not expect it will have a material effect on the consolidated financial statements.
A
variety of proposed or otherwise potential accounting standards are currently under study by standard-setting organizations. Due to the
tentative and preliminary nature of those proposed standards, management has not determined whether the implementation of such proposed
standards would be material to the financial statements of the Company.
|
Reclassification |
|
11.
Reclassification:
The
Company reclassified approximately $68,000 of costs incurred during the year ended December 31, 2021 from general and administrative
expense to research and development costs to conform to the current presentation.
|
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v3.23.3
RELATED PARTY TRANSACTIONS (Tables)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Related Party Transactions [Abstract] |
|
|
SCHEDULE OF RELATED PARTY TRANSACTIONS |
The
following summarizes the transactions between the Company and Sanovas for the six months ended June 30, 2023 and 2022:
SCHEDULE
OF RELATED PARTY TRANSACTIONS
| |
|
|
|
|
|
| |
| |
Six months Ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Balance due to ( Sanovas – beginning of year | |
$ | 427,933 | | |
$ | 142,721 | |
| |
| | | |
| | |
Costs paid by Sanovas on the Company’s behalf | |
| - | | |
| 36,289 | |
Costs of Sanovas allocated to the Company | |
| 280,820 | | |
| 168,702 | |
Proceeds from costs charged by Sanovas to the Company, net | |
| 102,423 | | |
| 221,119 | |
Retirement of due to Sanovas through the issuance of shares to Sanovas Ophthalmology | |
| - | | |
| (353,432 | ) |
| |
| | | |
| | |
Balance due to Sanovas – end of period | |
$ | 811,176 | | |
$ | 215,398 | |
|
The
following summarizes the transactions between the Company and Sanovas for the year ended December 31, 2022 and December 31, 2021:
SCHEDULE
OF RELATED PARTY TRANSACTIONS
| |
| | |
| |
| |
Years Ended | |
| |
December 31, | | |
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Balance due to (from) Sanovas – beginning of year | |
$ | 142,721 | | |
$ | (15,069 | ) |
| |
| | | |
| | |
Costs paid by Sanovas on the Company’s behalf | |
| 79,290 | | |
| 68,073 | |
Costs of Sanovas allocated to the Company | |
| 453,047 | | |
| 803,997 | |
Proceeds from (repayment of) costs charged by Sanovas to the Company, net | |
| 692,677 | | |
| (323,922 | ) |
Retirement of due to Sanovas through the issuance of common stock to Sanovas Ophthalmology | |
| (939,802 | ) | |
| (390,358 | ) |
| |
| | | |
| | |
Balance due to Sanovas - end of year | |
$ | 427,933 | | |
$ | 142,721 | |
|
X |
- DefinitionTabular disclosure of related party transactions. Examples of related party transactions include, but are not limited to, transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners and (d) affiliates.
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v3.23.3
STOCK PLAN (Tables)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Equity [Abstract] |
|
|
SCHEDULE OF STOCK OPTION ACTIVITY |
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Options Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
Options outstanding – December 31, 2021 | |
| 1,882,500 | | |
$ | 1.00 | |
Granted | |
| 502,500 | | |
| 1.00 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Options outstanding – December 31, 2022 | |
| 2,360,000 | | |
| 1.00 | |
Granted | |
| - | | |
| | |
Canceled | |
| - | | |
| | |
Exercised | |
| - | | |
| | |
Options outstanding – June 30, 2023 | |
| 2,360,000 | | |
$ | 1.00 | |
|
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Options Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
Options outstanding – December 31, 2020 | |
| 1,800,000 | | |
$ | 1.00 | |
Granted | |
| 82,500 | | |
| 1.00 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
| |
| | | |
| | |
Options outstanding – December 31, 2021 | |
| 1,882,500 | | |
$ | 1.00 | |
Granted | |
| 502,500 | | |
| 1.00 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Options outstanding – December 31, 2022 | |
| 2,360,000 | | |
$ | 1.00 | |
|
SCHEDULE OF STOCK OPTIONS OUTSTANDING AND EXERCISABLE |
Additional
information regarding the exercisable options and average remaining contractual life of the options outstanding as of June 30, 2023 is
as follows:
SCHEDULE OF STOCK OPTIONS OUTSTANDING AND EXERCISABLE
Exercise Price | | |
Number Outstanding | | |
Weighted Average Remaining Contractual Life | |
Number Exercisable at December 31, 2022 | | |
Number Exercisable at June 30, 2023 | |
$ | 1.00 | | |
| 2,360,000 | | |
6.9 Years | |
| 1,204,444 | | |
| 1,532,778 | |
|
Additional
information regarding the exercisable options and average remaining contractual life of the options outstanding as of December 31, 2022
is as follows:
SCHEDULE OF STOCK OPTIONS OUTSTANDING AND EXERCISABLE
Exercise
Price |
|
|
Number
Outstanding |
|
|
Weighted
Average
Remaining
Contractual Life |
|
|
Number
Exercisable at
December
31, 2022 |
|
|
Number
Exercisable at
December
31, 2021 |
|
$ |
1.00 |
|
|
|
2,360,000 |
|
|
|
7.2
Years |
|
|
|
1,204,444 |
|
|
|
525,000 |
|
|
SCHEDULE OF STOCK OPTIONS FAIR VALUE ASSUMPTIONS |
The
fair value of each option grant was estimated on the date of grant to be $0.56 per share using the Black-Scholes option-pricing model
with the following assumption weighted-averages in 2022:
SCHEDULE OF STOCK OPTIONS FAIR VALUE ASSUMPTIONS
Risk-free interest rates | |
| 2.19 | % |
Expected life in years | |
| 3.5 | |
Expected volatility | |
| 80 | % |
Expected dividend yield | |
| 0 | % |
Fair value common stock | |
$ | 1.00 | |
|
The
fair value of each option grant was estimated on the date of grant to be $0.53 per share using the Black-Scholes option-pricing model
with the following assumption weighted-averages in 2021:
SCHEDULE
OF STOCK OPTIONS FAIR VALUE ASSUMPTIONS
Risk-free
interest rates |
|
|
1.2%
- 2.42 |
% |
Expected
life in years |
|
|
5.0 |
|
Expected
volatility |
|
|
73.1 |
% |
Expected
dividend yield |
|
|
0 |
% |
Fair
value common stock |
|
$ |
1.00 |
|
The
fair value of each option grant was estimated on the date of grant to be $0.56 per share using the Black-Scholes option-pricing model
with the following assumption weighted-averages in 2022:
Risk-free
interest rates |
|
|
2.19 |
% |
Expected
life in years |
|
|
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|
|
80 |
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v3.23.3
WARRANTS (Tables)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Warrants |
|
|
SCHEDULE OF WARRANTS FAIR VALUE ASSUMPTIONS |
|
SCHEDULE
OF WARRANTS FAIR VALUE ASSUMPTIONS
Risk-free
interest rates |
|
|
2.42 |
% |
Expected
life in years |
|
|
3.5 |
|
Expected
volatility |
|
|
73.1 |
% |
Expected
dividend yield |
|
|
0 |
% |
Fair
value common stock |
|
$ |
1.00 |
|
|
SCHEDULE OF WARRANTS ACTIVITY |
The
following table summarizes warrant activity through June 30, 2023:
SCHEDULE
OF WARRANTS ACTIVITY
| |
Warrants Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
| |
| | |
| |
Warrants outstanding – December 31, 2021 | |
| 199,000 | | |
$ | 1.07 | |
| |
| | | |
| | |
Granted | |
| - | | |
| - | |
Canceled | |
| (12,500 | ) | |
| 1.00 | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Warrants outstanding – December 31, 2022 | |
| 161,500 | | |
| 1.09 | |
Granted | |
| - | | |
| | |
Canceled | |
| - | | |
| | |
Exercised | |
| - | | |
| | |
Warrants outstanding – June 30, 2023 | |
| 161,500 | | |
$ | 1.09 | |
|
The
following table summarizes warrant activity through December 31, 2022:
SCHEDULE
OF WARRANTS ACTIVITY
| |
Warrants Issued | | |
Weighted-Average Exercise Price | |
| |
| | |
| |
Warrants outstanding – December 31, 2020 | |
| 62,500 | | |
$ | 1.00 | |
Granted | |
| 150,000 | | |
| 1.10 | |
Canceled | |
| - | | |
| - | |
Exercised | |
| (13,500 | ) | |
| 1.00 | |
| |
| | | |
| | |
Warrants outstanding – December 31, 2021 | |
| 199,000 | | |
$ | 1.07 | |
| |
| | | |
| | |
Granted | |
| - | | |
| - | |
Canceled | |
| (12,500 | ) | |
| 1.00 | |
Exercised | |
| (25,000 | ) | |
| 1.00 | |
| |
| | | |
| | |
Warrants outstanding – December 31, 2022 | |
| 161,500 | | |
$ | 1.09 | |
|
SCHEDULE OF WARRANTS OUTSTANDING |
Additional
information regarding the warrants outstanding as of June 30, 2023 is as follows:
SCHEDULE
OF WARRANTS OUTSTANDING
Exercise Price | | |
Number Outstanding | | |
Weighted Average Remaining Contractual Life | |
Number Exercisable | |
$ | 1.00 | | |
| 11,500 | | |
.4 Years | |
| 11,500 | |
$ | 1.10 | | |
| 150,000 | | |
5.4 Years | |
| 150,000 | |
| | | |
| 161,500 | | |
| |
| 161,500 | |
|
Additional
information regarding the warrants outstanding as of December 31, 2022 is as follows:
SCHEDULE
OF WARRANTS OUTSTANDING
Exercise
Price |
|
|
Number
Outstanding |
|
|
Weighted
Average
Remaining
Contractual Life |
|
|
Number
Exercisable |
|
$ |
1.00 |
|
|
|
11,500 |
|
|
|
.7
Years |
|
|
|
11,500 |
|
$ |
1.10 |
|
|
|
150,000 |
|
|
|
5.7
Years |
|
|
|
150,000 |
|
|
|
|
|
|
161,500 |
|
|
|
|
|
|
|
161,500 |
|
|
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v3.23.3
HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
6 Months Ended |
12 Months Ended |
|
Jul. 05, 2022 |
Jul. 05, 2022 |
Oct. 08, 2019 |
Oct. 08, 2019 |
Nov. 30, 2022 |
May 31, 2022 |
Jun. 30, 2021 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 27, 2021 |
Shares issued for acquisitions |
|
|
|
|
|
|
|
|
2,000,000
|
|
|
Estimated fair value of transaction |
|
|
|
|
|
|
|
|
$ 2,000,000
|
|
|
Accumulated deficit |
|
|
|
|
|
|
|
$ 9,881,092
|
9,018,306
|
5,104,316
|
|
Liabilities |
|
|
|
|
|
|
|
1,776,950
|
1,069,357
|
469,622
|
|
Sanovas Ophthalmology LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Payment of expenses |
|
|
|
|
$ 586,370
|
$ 353,432
|
$ 390,358
|
|
|
|
|
Affiliated Entity [Member] |
|
|
|
|
|
|
|
|
|
|
|
Due to Sanovas |
|
|
|
|
|
|
|
811,176
|
427,933
|
142,721
|
|
Affiliated Entity [Member] | Sanovas Ophthalmology LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Due to Sanovas |
|
|
|
|
|
|
|
|
428,000
|
|
|
Private Placement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of private offerings |
|
|
|
|
|
|
|
$ 60,500
|
$ 60,500
|
$ 1,083,000
|
|
Option Exchange Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Options to purchase shares, percentage |
|
|
10.00%
|
10.00%
|
|
|
|
|
|
|
|
Exchange Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Shares issued for acquisitions |
2,000,000
|
2,000,000
|
|
|
|
|
|
|
|
|
|
Exchange Agreement [Member] | Research and Development Expense [Member] |
|
|
|
|
|
|
|
|
|
|
|
Estimated fair value of transaction |
$ 2,000,000
|
$ 2,000,000
|
|
|
|
|
|
|
|
|
|
Legal fees |
$ 32,889
|
$ 32,889
|
|
|
|
|
|
|
|
|
|
Exchange Agreement [Member] | Pre-funded Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares exchange |
|
|
|
|
|
|
|
|
|
|
28,014,540
|
Warrant, shares exchanged |
|
|
|
|
|
|
|
|
|
|
28,014,540
|
Warrant exercise price |
|
|
|
|
|
|
|
|
|
|
$ 0.0001
|
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Property and equipment useful life |
3 years
|
|
3 years
|
|
Research and Development Expense [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Research and development costs |
|
|
|
$ 68,000
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Antidilutive securities excluded from computation of earnings per share |
2,360,000
|
1,882,500
|
2,360,000
|
1,882,500
|
Pre-funded Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Antidilutive securities excluded from computation of earnings per share |
28,014,540
|
28,014,540
|
28,014,540
|
|
Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Antidilutive securities excluded from computation of earnings per share |
161,500
|
199,000
|
161,500
|
212,500
|
Series F Preferred Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Antidilutive securities excluded from computation of earnings per share |
|
|
|
3,000,000
|
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v3.23.3
SCHEDULE OF RELATED PARTY TRANSACTIONS (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Related Party Transaction [Line Items] |
|
|
|
|
Costs paid by Sanovas on the Company’s behalf |
|
$ 36,289
|
$ 79,290
|
$ 68,073
|
Costs of Sanovas allocated to the Company |
|
|
344,000
|
391,000
|
Proceeds from costs charged by Sanovas to the Company, net |
$ 102,423
|
$ 221,119
|
$ 692,677
|
$ (323,922)
|
Retirement of due to Sanovas through the issuance of shares to Sanovas Ophthalmology |
|
(353,432)
|
(939,802)
|
(390,358)
|
Related Party [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
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$ 427,933
|
$ 142,721
|
$ 142,721
|
$ (15,069)
|
Costs of Sanovas allocated to the Company |
280,820
|
168,702
|
453,047
|
803,997
|
Balance due to Sanovas - end of year |
|
|
$ 427,933
|
$ 142,721
|
Balance due to Sanovas – end of period |
$ 811,176
|
$ 215,398
|
|
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v3.23.3
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
|
1 Months Ended |
6 Months Ended |
12 Months Ended |
Nov. 30, 2022 |
May 31, 2022 |
May 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Related party cost |
|
|
|
|
|
|
$ 344,000
|
$ 391,000
|
Sanovas Ophthalmology LLC [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Related party cost |
|
|
|
|
$ 281,000
|
$ 106,000
|
|
|
Value of shares issuance to offset due amounts |
$ 586,370
|
$ 353,432
|
|
$ 390,358
|
|
|
|
|
Officer [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Due to affiliate |
|
|
|
|
|
|
109,185
|
|
Related Party [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Related party cost |
|
|
|
|
280,820
|
168,702
|
453,047
|
$ 803,997
|
Due to affiliate |
|
|
|
|
811,176
|
$ 215,398
|
|
|
Related Party [Member] | Officer [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Due to affiliate |
|
|
|
|
$ 210,022
|
|
$ 109,185
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
issuance of shares of common stock |
586,370
|
353,432
|
353,432
|
390,358
|
|
|
|
|
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v3.23.3
COMMON AND PREFERRED STOCK (Details Narrative) - USD ($)
|
|
1 Months Ended |
6 Months Ended |
12 Months Ended |
|
|
|
|
Jan. 01, 2012 |
May 31, 2015 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2018 |
Mar. 31, 2023 |
Nov. 21, 2021 |
Dec. 31, 2019 |
Jan. 08, 2018 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
40,000,000
|
|
40,000,000
|
40,000,000
|
|
|
|
|
40,000,000
|
Common stock, shares authorized |
|
|
80,000,000
|
|
80,000,000
|
80,000,000
|
|
|
|
|
80,000,000
|
Common stock, par value |
|
|
$ 0.0001
|
|
$ 0.0001
|
$ 0.0001
|
|
|
|
|
$ 0.0001
|
Preferred stock, voting right |
|
|
The right to elect two directors shall terminate on the date upon which
there are less than 25,000 shares of Series F preferred stock issued and outstanding.
|
|
The right to elect two directors shall terminate on the date upon which
there are less than 25,000 shares of Series F preferred stock issued and outstanding.
|
|
|
|
|
|
|
Private Placement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Shares issued price per share |
|
|
|
|
|
|
|
|
|
$ 1.00
|
|
Sale of stock, shares issued |
|
|
|
60,500
|
60,500
|
398,057
|
|
|
|
|
|
Sanovas Ophthalmology LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued during period |
|
|
|
|
|
|
27,000,000
|
|
|
|
|
Original Employment Agreement [Member] | Mr. Gerrans [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of restricted shares issued |
441,177
|
|
|
|
|
|
|
|
|
|
|
Percentage of shares issued |
7.50%
|
|
|
|
|
|
|
|
|
|
|
Amended and Restated Employment Agreement [Member] | Mr. Gerrans [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Percentage of shares issued |
|
7.50%
|
|
|
|
|
|
|
|
|
|
Series F Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
3,000,000
|
|
3,000,000
|
3,000,000
|
|
|
3,000,000
|
|
3,000,000
|
Shares issued price per share |
|
|
$ 0.01
|
|
$ 0.01
|
|
|
|
|
|
|
Preferred stock, shares outstanding |
|
|
0
|
|
0
|
0
|
|
|
|
|
|
Preferred stock, dividend |
|
|
$ 0
|
|
$ 0
|
|
|
|
|
|
|
Preferred stock, conversion price |
|
|
$ 0.01
|
|
$ 0.01
|
|
|
|
|
|
|
Proceeds from issuance of preferred stock |
|
|
$ 15,000,000
|
|
$ 15,000,000
|
|
|
|
|
|
|
Series F Preferred Stock [Member] | Holders [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares outstanding |
|
|
|
|
25,000
|
|
|
25,000
|
|
|
|
Series F Preferred Stock [Member] | Halo Management LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued during period |
|
|
|
|
|
|
3,000,000
|
|
|
|
|
Series F Preferred Stock [Member] | Original Employment Agreement [Member] | Mr. Gerrans [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of restricted shares issued |
5,000
|
|
|
|
|
|
|
|
|
|
|
Series F Preferred Stock [Member] | Amended and Restated Employment Agreement [Member] | Mr. Gerrans [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of restricted shares issued |
|
5,000
|
|
|
|
|
|
|
|
|
|
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v3.23.3
SCHEDULE OF STOCK OPTION ACTIVITY (Details) - $ / shares
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Equity [Abstract] |
|
|
|
Stock Options, Outstanding, Beginning Balance |
2,360,000
|
1,882,500
|
1,800,000
|
Weighted average exercise price, beginning balance |
$ 1.00
|
$ 1.00
|
$ 1.00
|
Stock Options, Granted |
|
502,500
|
82,500
|
Weighted average exercise price, granted |
|
$ 1.00
|
$ 1.00
|
Stock Options, Canceled |
|
|
|
Weighted average exercise price, canceled |
|
|
|
Stock Options, Exercised |
|
(25,000)
|
|
Weighted average exercise price, exercised |
|
$ 1.00
|
|
Stock Options, Outstanding, Ending Balance |
2,360,000
|
2,360,000
|
1,882,500
|
Weighted average exercise price, ending balance |
$ 1.00
|
$ 1.00
|
$ 1.00
|
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v3.23.3
SCHEDULE OF STOCK OPTIONS OUTSTANDING AND EXERCISABLE (Details) - $ / shares
|
6 Months Ended |
12 Months Ended |
|
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
Equity [Abstract] |
|
|
|
|
Exercise price |
$ 1.00
|
$ 1.00
|
$ 1.00
|
$ 1.00
|
Number of options, outstanding |
2,360,000
|
2,360,000
|
1,882,500
|
1,800,000
|
Weighted average remaining contractual life |
6 years 10 months 24 days
|
7 years 2 months 12 days
|
|
|
Number of options, exercisable |
1,532,778
|
1,204,444
|
525,000
|
|
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- DefinitionThe estimated dividend rate (a percentage of the share price) to be paid (expected dividends) to holders of the underlying shares over the option's term.
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v3.23.3
STOCK PLAN (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Aug. 31, 2022 |
Nov. 30, 2019 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Common stock shares reserved for future issuance |
|
|
5,115,000
|
|
5,115,000
|
|
5,115,000
|
|
Stock-based compensation expense |
|
|
$ 78,509
|
$ 55,051
|
$ 157,018
|
$ 110,102
|
$ 259,300
|
$ 307,918
|
Unrecognized compensation expense |
|
|
$ 498,000
|
|
$ 498,000
|
|
$ 655,000
|
|
Weighted-average period for recognition |
|
|
|
|
1 year 4 months 24 days
|
|
2 years
|
|
Fair value of option grant price per share |
|
|
|
|
|
|
$ 0.56
|
$ 0.53
|
Expected dividend yield |
|
|
|
|
0.00%
|
|
0.00%
|
0.00%
|
Equity Option [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
|
|
$ 157,018
|
$ 110,012
|
$ 259,000
|
$ 232,000
|
2017 Equity Incentive Plan [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Common stock shares reserved for future issuance |
|
|
10,000,000
|
|
10,000,000
|
|
10,000,000
|
|
Exercise price |
$ 1.00
|
$ 1.00
|
|
|
|
|
|
$ 1.00
|
Options, vesting period |
3 years
|
5 years
|
|
|
|
|
|
|
Aggregate fair value of stock options |
$ 287,487
|
$ 1,101,028
|
|
|
|
|
|
$ 63,900
|
2017 Equity Incentive Plan [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Number of stock options to purchase common stock |
500,000
|
1,800,000
|
|
|
|
|
|
82,500
|
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v3.23.3
SCHEDULE OF WARRANTS ACTIVITY (Details) - $ / shares
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Warrants |
|
|
|
Stock warrants issued, beginning balance |
161,500
|
199,000
|
62,500
|
Weighted average exercise price, beginning balance |
$ 1.09
|
$ 1.07
|
$ 1.00
|
Warrants issued, granted |
|
|
150,000
|
Weighted average exercise price, granted |
|
|
$ 1.10
|
Warrants issued, canceled |
|
(12,500)
|
|
Weighted average exercise price, canceled |
|
$ 1.00
|
|
Warrants issued, exercised |
|
(25,000)
|
(13,500)
|
Weighted average exercise price, exercised |
|
$ 1.00
|
$ 1.00
|
Stock warrants issued, ending balance |
161,500
|
161,500
|
199,000
|
Weighted average exercise price, ending balance |
$ 1.09
|
$ 1.09
|
$ 1.07
|
Warrants issued, canceled |
|
(12,500)
|
|
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v3.23.3
SCHEDULE OF WARRANTS OUTSTANDING (Details) - $ / shares
|
6 Months Ended |
12 Months Ended |
|
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
|
|
Number outstanding |
161,500
|
161,500
|
199,000
|
62,500
|
Number exercisable |
161,500
|
161,500
|
|
|
Exercise Price 1 [Member] |
|
|
|
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
|
|
Exercise price |
$ 1.00
|
$ 1.00
|
|
|
Number outstanding |
11,500
|
11,500
|
|
|
Weighted average remaining contractual life |
4 months 24 days
|
8 months 12 days
|
|
|
Number exercisable |
11,500
|
11,500
|
|
|
Exercise Price 2 [Member] |
|
|
|
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
|
|
Exercise price |
$ 1.10
|
$ 1.10
|
|
|
Number outstanding |
150,000
|
150,000
|
|
|
Weighted average remaining contractual life |
5 years 4 months 24 days
|
5 years 8 months 12 days
|
|
|
Number exercisable |
150,000
|
150,000
|
|
|
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v3.23.3
WARRANTS (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 27, 2021 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
|
Warrants estimated fair value |
|
|
|
|
$ 1.00
|
$ 1.00
|
|
Expected dividend yield |
|
|
0.00%
|
|
0.00%
|
0.00%
|
|
Stock-based compensation expense |
$ 78,509
|
$ 55,051
|
$ 157,018
|
$ 110,102
|
$ 259,300
|
$ 307,918
|
|
Unrecognized compensation expense |
$ 498,000
|
|
$ 498,000
|
|
$ 655,000
|
|
|
Exchange Agreement [Member] | Pre-funded Warrant [Member] |
|
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
|
Warrant, shares exchanged |
|
|
|
|
|
|
28,014,540
|
Exercise price per shares |
|
|
|
|
|
|
$ 0.0001
|
Common stock, shares exchange |
|
|
|
|
|
|
28,014,540
|
Exercisable, exercise price per shares |
|
|
|
|
|
|
$ 0.0001
|
Warrant [Member] |
|
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
|
Expected dividend yield |
|
|
|
|
0.00%
|
|
|
Stock-based compensation expense |
|
|
|
|
$ 0
|
$ 75,000
|
|
Unrecognized compensation expense |
|
|
|
|
$ 0
|
|
|
Consulting Firm [Member] |
|
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
|
Warrant, shares exchanged |
|
|
|
|
|
150,000
|
|
Exercise price per shares |
|
|
|
|
|
$ 1.10
|
|
Warrants, term |
|
|
|
|
|
7 years
|
|
Warrants estimated fair value |
|
|
|
|
|
$ 0.61
|
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v3.23.3
SHAREHOLDERS’ NOTES PAYABLE (Details Narrative) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Debt Disclosure [Abstract] |
|
|
|
|
Debt instrument, face amount |
|
|
|
$ 74,000
|
Interest rate |
|
|
|
8.00%
|
Maturity date |
|
|
|
Dec. 31, 2022
|
Proceeds from exercise of warrants |
|
|
$ 25,000
|
$ 13,500
|
Notes payable remaining |
$ 49,000
|
|
49,000
|
|
Interest expense |
1,920
|
$ 2,920
|
5,140
|
2,619
|
Accrued interest |
9,679
|
|
$ 7,759
|
$ 2,619
|
Proceeds from exercise of warrants |
$ 25,000
|
|
|
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v3.23.3
INCOME TAXES (Details Narrative) - USD ($)
|
12 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Operating Loss Carryforwards [Line Items] |
|
|
Operating Loss Carryforwards, Limitations on Use |
the Company had net operating loss carryforwards (“NOL”) of approximately $4,499,000 for federal income
tax purposes of which $3,724,000 has no expiration date, $775,000 which begins to expire in 2034, and approximately $4,499,000 for state
income tax purposes which begins to expire in 2030
|
|
Operating loss carryforwards |
$ 4,499,000
|
|
Deferred Tax Assets, Net of Valuation Allowance |
1,714,000
|
$ 1,193,000
|
Deferred Tax Assets, Operating Loss Carryforwards |
1,350,000
|
992,000
|
Deferred tax assets applicable to accruals |
236,000
|
158,000
|
Deferred Tax Asset, Tax Deferred Expense, Reserve and Accrual, Accounts Receivable, Allowance for Credit Loss |
128,000
|
43,000
|
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount |
521,000
|
$ 389,000
|
No Expiration Date [Member] |
|
|
Operating Loss Carryforwards [Line Items] |
|
|
Operating loss carryforwards |
3,724,000
|
|
Expire in 2034 [Member] |
|
|
Operating Loss Carryforwards [Line Items] |
|
|
Operating loss carryforwards |
$ 775,000
|
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Retinalgenix Technologies (QB) (USOTC:RTGN)
과거 데이터 주식 차트
부터 10월(10) 2024 으로 11월(11) 2024
Retinalgenix Technologies (QB) (USOTC:RTGN)
과거 데이터 주식 차트
부터 11월(11) 2023 으로 11월(11) 2024