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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 14, 2023
Virpax Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
|
001-40064 |
|
82-1510982 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
1055 Westlakes Drive, Suite 300
Berwyn, PA 19312
(Address of principal executive offices, including
zip code)
(610) 727-4597
(Registrant’s telephone number, including
area code)
N/A
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to
Section 12(b) of the Act:
Title of Each Class: |
|
Trading Symbol |
|
Name of Each Exchange on which Registered |
Common Stock, par value $0.00001 per share |
|
VRPX |
|
The Nasdaq Capital Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR§230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR §240.12b-2).
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 pursuant to Section 13(a) of the Exchange Act.
Item 2.02. Results of Operation
and Financial Condition.
On August 14, 2023, Virpax Pharmaceuticals, Inc., a Delaware corporation
(the “Registrant”), issued a press release that included financial information for its quarter ended June 30, 2023. A copy
of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02 and in the press
release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2)
of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1
to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission
made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished with this Current Report on
Form 8-K:
Signature
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
VIRPAX PHARMACEUTICALS, INC. |
|
|
|
Dated: August 14, 2023 |
By: |
/s/ Anthony Mack |
|
|
Anthony Mack |
|
|
Chief Executive Officer |
Exhibit 99.1
VIRPAX
PHARMACEUTICALS REPORTS 2023 SECOND QUARTER RESULTS AND RECENT DEVELOPMENTS
BERWYN,
PA, August 14, 2023 — Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ:
VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous
system (CNS) disorders and viral barrier indications, today announced its financial results for the three months ended June 30, 2023,
and other recent developments.
“In the second quarter, we continued to make progress with our
Rx product candidates,” commented Anthony P. Mack, Chairman and Chief Executive Officer of Virpax. “As well, we strengthened
the organization with the appointment of a new Chief Financial Officer (CFO), who aside from his experience with public biotech companies
has a broad financial background encompassing licensing, M&A and fund raising. Additionally, we added a leading expert in liposomal
drug delivery and nanotechnology to support the advancement of our leading product candidate, ProbudurTM. I am proud of the
high caliber talent that we have attracted to Virpax, joining us as we develop our pipeline of innovative drug candidates.”
“We
successfully won another competitive cooperative research and development agreement (CRADA). This one is for our NobrXiolTM
product candidate which is being designed to identify novel agents to meet unmet medical needs in epilepsy. We now have CRADA’s
for all three of our Rx product candidates, two with the National Institutes of Health (NIH) and one with the Department of Defense (DOD).
These successes reinforce our non-dilutive grant funding strategy and demonstrate how Virpax has been able to develop a team to support
this effort.
“In May, our grants
core team participated in the virtual CB Tech Watch Seminar showcasing our Molecular Envelope Technology (MET) and our over-the-counter
(OTC) AnQlarTM product candidate for viral inhibition. Participating in this event were representatives of a number of Federal
agencies including Defense Advanced Research Products Agency (DARPA), Defense Threat Reduction Agency (DTRA), and the U.S. Army and Navy
among others. This was an excellent opportunity for us to introduce Virpax to these groups, and we expect it to be beneficial as we continue
to apply for grant funding from the DOD.
“Finally,
as we enter the second half of 2023, we anticipate reporting results from additional pre-IND studies in advance of entering the clinic
in 2024, initiating studies for our Probudur and NobrXiol CRADAs by year end, submitting additional grant applications and potentially
monetizing our OTC product candidates,” concluded Mr. Mack.
RECENT
DEVELOPMENTS
| ● | On August 10, 2023, Virpax announced that it filed a new provisional patent application with the
United States Patent and Trademark Office (USPTO) entitled “NSAID Formulation and Method” related to its
EpoladermTM product candidate. Epoladerm is an over-the-counter diclofenac topical spray film that the Company is
developing for pain associated with Osteoarthritis. |
| ● | On
July 24, 2023, Virpax rang the Nasdaq closing bell. |
| ● | On July 13, 2023, Virpax announced that it had filed a new provisional
patent application with the USPTO entitled “Intranasal Delivery” related to its Envelta™ product candidate. Envelta
utilizes MET for the delivery of Enkephalin intranasally for severe cancer pain and non-cancer pain. The enkephalin/MET formulation is
delivered using a delivery device which propels the formulation into nose such that the enkephalin is delivered to the brain. |
| ● | On June 21, 2023, Virpax
announced that it has entered into a CRADA with the National Institute of Neurological Disorders and Stroke (NINDS), part
of the U.S. NIH Division of Translational Research which conducts and funds research on brain and nervous system disorders. Virpax will
be partnering with the Epilepsy Therapy Screening Program (ETSP) whose mission is to identify novel agents to address unmet medical
needs in epilepsy, including the identification of next generation products focused on addressing drug resistant epilepsy, disease prevention
and modification. Under the CRADA, NINDS ETSP will evaluate Virpax’s NobrXiol™
product candidate that is being developed for the management of rare pediatric epilepsy. |
| ● | On June 20, 2023, Virpax announced
the appointment of Vinay Shah as Chief Financial Officer. Mr. Shah joins Virpax from Aravive, Inc., a clinical stage biotech company,
where he served for five years as the CFO. Prior to Aravive, he was with Pacira Pharmaceuticals, Inc. for nine years in financial positions
of increasing responsibilities. Mr. Shah has over 30 years of financial experience, successfully establishing financial functions, participating
in licensing and M&A transactions, and engaging in fund raising activities. |
| ● | On May 10, 2023, Virpax announced that it had been invited to present
its MET, as well as its AnQlarTM product candidate for viral inhibition that utilizes MET, at the June 8, 2023, virtual CB
Tech Watch Seminar. CB Tech Watch Seminar is a forum for companies to highlight their science and technology to agencies within the DOD
as well as other Federal agencies and military branches. |
| ● | On
April 27, 2023, Virpax announced that it has engaged Dr. Pardeep Gupta, a leading expert
in liposomal drug delivery and nanotechnology, to support the development of Probudur, Virpax’s
proprietary patented long-acting injectable liposomal bupivacaine for postoperative pain
management. Dr. Gupta’s involvement is expected to include advising on chemistry, manufacturing
and controls (CMC), technology transfer and buildout required for the commercialization of
Probudur. |
| ● | On April 5, 2023, Virpax announced the successful completion of dose
ranging studies for rats and dogs in its EnveltaTM development program. Envelta is the
Company’s non-opioid pain product candidate for acute and chronic pain that is being funded under an in-kind grant from the National
Center for Advancing Translational Sciences (NCATS), part of the NIH. |
SECOND
QUARTER 2023 FINANCIAL RESULTS
General
and administrative expenses were $1.9 million for the three months ended June 30, 2023, compared to $2.6 million for the same period
in 2022. The decrease was primarily due to lower legal defense costs related to litigation and was partially offset by an increase in
salaries and wages, severance, and fees related to market assessment efforts.
Research
and development expenses were $1.3 million for the three months ended June 30, 2023, compared to $3.3 million for the same period in
2022. The decrease was primarily attributable to decreases in preclinical activities for AnQlar, NobrXiol, and Epoladerm. This was slightly
offset by an increase in preclinical activity related to Probudur.
The
operating loss for the three months ended June 30, 2023 was $3.2 million, compared to an operating loss of $5.9 million for the same
period in 2022.
As
of June 30, 2023, cash and cash equivalents were $14.8 million, compared to $19.0 million as of December 31, 2022.
About
Virpax Pharmaceuticals
Virpax
is developing branded, non-addictive pain management product candidates using its proprietary technologies to optimize and target drug
delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery
platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and
Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including
pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop two other product candidates.
PES200 is a product candidate being developed to manage post-traumatic stress disorder (PTSD) and NobrXiol™ is a product candidate
being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax
recently acquired global rights to NobrXiol. Virpax is also seeking approval of two nonprescription product candidates: AnQlarTM,
which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac
spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit virpaxpharma.com
and follow us on Twitter, LinkedIn and YouTube.
Forward-Looking
Statement
This
press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the
Company’s planned clinical trials, product development, clinical and regulatory timelines, market opportunity, competitive position,
possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive
in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry
and markets in which we operate and management’s current beliefs and assumptions.
These
statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,”
“intend,” “plan,” “believe,” “estimate,” “potential,” “predict,”
“project,” “should,” “would” and similar expressions and the negatives of those terms and include
statements such as the Company continuing to make progress with its Rx product candidates, the virtual CB Tech Watch Seminar being beneficial
as the Company continues to apply for grant funding from the DOD, reporting results from additional pre-IND studies in advance of entering
the clinic in 2024, initiating studies for Probudur and NobrXiol CRADAs, submitting additional grant applications and potentially monetizing
the Company’s OTC product candidates and the benefits anticipated from the appointment of Dr. Gupta and Mr. Shah . These statements
relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors,
including the Company’s ability to successfully complete research and further development, including reporting results from additional
pre-IND studies in advance of entering the clinic in 2024, and commercialization of Company drug candidates in current or future indications;
the Company’s ability to obtain additional grant funding, the uncertainties inherent in clinical testing; the Company’s ability
to manage and successfully complete clinical trials and the research and development efforts for multiple product candidates at varying
stages of development; t; the timing, cost and uncertainty of obtaining regulatory approvals for the Company’s product candidates;
the Company’s ability to protect its intellectual property; the loss of any executive officers or key personnel or consultants
and the ability of such executives to make valuable contributions to the Company; competition; changes in the regulatory landscape or
the imposition of regulations that affect the Company’s product candidates; the Company’s ability to continue to obtain capital
to meet its long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete
clinical trials that the Company plans to initiate; and other factors listed under “Risk Factors” in our annual report on
Form 10-K and quarterly reports on Form 10-Q that the Company files with the U.S. Securities and Exchange Commission. Prospective investors
are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release.
The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future
events or otherwise.
CONDENSED
BALANCE SHEETS
| |
June 30,
2023 | | |
December 31,
2022* | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | |
| |
Current assets | |
| | |
| |
Cash | |
$ | 14,804,000 | | |
$ | 18,995,284 | |
Prepaid expenses and other current assets | |
| 1,147,368 | | |
| 678,365 | |
Total current assets | |
| 15,951,368 | | |
| 19,673,649 | |
Total assets | |
$ | 15,951,368 | | |
$ | 19,673,649 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 1,646,770 | | |
$ | 1,094,590 | |
Estimated litigation liability | |
| 2,000,000 | | |
| 2,000,000 | |
Total current liabilities | |
| 3,646,770 | | |
| 3,094,590 | |
Total liabilities | |
| 3,646,770 | | |
| 3,094,590 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ equity | |
| | | |
| | |
Preferred stock, par value $0.00001, 10,000,000 shares authorized; no shares issued and outstanding as of both June 30, 2023 and December 31, 2022 | |
| — | | |
| — | |
Common stock, $0.00001 par value; 100,000,000 shares authorized, 11,714,284 shares issued and outstanding as of June 30, 2023 and December 31, 2022 | |
| 117 | | |
| 117 | |
Additional paid-in capital | |
| 61,292,409 | | |
| 60,933,569 | |
Accumulated deficit | |
| (48,987,928 | ) | |
| (44,354,627 | ) |
Total stockholders’ equity | |
| 12,304,598 | | |
| 16,579,059 | |
Total liabilities and stockholders’ equity | |
$ | 15,951,368 | | |
$ | 19,673,649 | |
* |
Derived
from audited financial statements |
CONDENSED
STATEMENTS OF OPERATIONS
(UNAUDITED)
| |
For the Three Months Ended
June 30, | | |
For the Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
OPERATING EXPENSES | |
| | |
| | |
| | |
| |
General and administrative (net of insurance reimbursement of $0 and $1,250,000 during the three and six months ended June 30, 2023 - See Note 5) | |
$ | 1,948,700 | | |
$ | 2,645,618 | | |
$ | 2,364,151 | | |
$ | 4,428,031 | |
Research and development | |
| 1,290,787 | | |
| 3,258,471 | | |
| 2,526,401 | | |
| 6,599,877 | |
Total operating expenses | |
| 3,239,487 | | |
| 5,904,089 | | |
| 4,890,552 | | |
| 11,027,908 | |
Loss from operations | |
| (3,239,487 | ) | |
| (5,904,089 | ) | |
| (4,890,552 | ) | |
| (11,027,908 | ) |
| |
| | | |
| | | |
| | | |
| | |
OTHER INCOME | |
| | | |
| | | |
| | | |
| | |
Other income | |
| 126,720 | | |
| 19,374 | | |
| 257,251 | | |
| 6,191 | |
Loss before tax provision | |
| (3,112,767 | ) | |
| (5,884,715 | ) | |
| (4,633,301 | ) | |
| (11,021,717 | ) |
Income taxes | |
| — | | |
| — | | |
| — | | |
| — | |
Net loss | |
$ | (3,112,767 | ) | |
$ | (5,884,715 | ) | |
$ | (4,633,301 | ) | |
$ | (11,021,717 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per share | |
$ | (0.27 | ) | |
$ | (0.50 | ) | |
$ | (0.40 | ) | |
$ | (0.94 | ) |
Basic and diluted weighted average common stock outstanding | |
| 11,714,284 | | |
| 11,712,753 | | |
| 11,714,284 | | |
| 11,710,733 | |
CONDENSED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
| |
For the Six Months Ended
June 30, | |
| |
2023 | | |
2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| |
Net loss | |
$ | (4,633,301 | ) | |
$ | (11,021,717 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Stock-based compensation | |
| 358,840 | | |
| 456,041 | |
Change in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| (469,003 | ) | |
| (610,863 | ) |
Accounts payable and accrued expenses | |
| 552,180 | | |
| 395,682 | |
Net cash used in operating activities | |
| (4,191,284 | ) | |
| (10,780,857 | ) |
| |
| | | |
| | |
Net change in cash | |
| (4,191,284 | ) | |
| (10,780,857 | ) |
Cash, beginning of year | |
| 18,995,284 | | |
| 36,841,992 | |
Cash, end of year | |
$ | 14,804,000 | | |
$ | 26,061,135 | |
| |
| | | |
| | |
Supplemental disclosure of cash and non-cash transactions | |
| | | |
| | |
Cash paid for interest | |
$ | — | | |
$ | — | |
Cash paid for taxes | |
$ | — | | |
$ | — | |
Contact:
Vinay
Shah
Chief
Financial Officer
vshah@virpaxpharma.com
610-727-4597
Or
Betsy
Brod
Affinity
Growth Advisors
betsy.brod@affinitygrowth.com
212-661-2231
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Virpax Pharmaceuticals (NASDAQ:VRPX)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Virpax Pharmaceuticals (NASDAQ:VRPX)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024