UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: June 30, 2024
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 000-53002
Raphael Pharmaceutical Inc.
(Exact name of registrant as specified in its charter)
Nevada | | 26-0204284 |
(State or other jurisdiction of | | (I.R.S. Employer |
incorporation or organization) | | Identification No.) |
4 Lui Paster Street
Tel Aviv-Jaffa, Israel 6803605
(Address of principal executive offices)
(Zip Code)
(+972) 52-775-5072
(Registrant’s telephone number, including
area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
N/A | | N/A | | N/A |
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒
No ☐
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 pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
No ☒
The number of shares of the registrant’s common stock, $0.01
par value, outstanding as of August 12, 2024: 18,701,418.
TABLE OF CONTENTS
Item 1. Financial Statements
RAPHAEL PHARMACEUTICAL INC. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
AS OF JUNE 30, 2024
UNAUDITED
U.S. DOLLARS IN THOUSANDS
INDEX
- - - - - - - - - - -
RAPHAEL PHARMACEUTICAL INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED INTERIM BALANCE SHEETS
U.S dollars in thousands (except for share
and per share data)
| |
As of June 30, | | |
As of December 31, | |
| |
2024 | | |
2023 | |
| |
(Unaudited) | | |
(Audited) | |
Assets | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 120 | | |
$ | 230 | |
Other current assets | |
| 6 | | |
| 107 | |
| |
| | | |
| | |
Total current assets | |
| 126 | | |
| 337 | |
| |
| | | |
| | |
Fixed assets, net | |
| 2 | | |
| 2 | |
| |
| | | |
| | |
Total assets | |
$ | 128 | | |
$ | 339 | |
| |
| | | |
| | |
Liabilities and stockholders’ equity | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Other account payables and accrued expenses | |
| 392 | | |
| 34 | |
Payable to related party | |
| 26 | | |
| 38 | |
| |
| | | |
| | |
Total current liabilities | |
| 418 | | |
| 72 | |
| |
| | | |
| | |
Stockholders’ equity (deficit): | |
| | | |
| | |
Common stock, $0.01 par value: | |
| | | |
| | |
| |
| | | |
| | |
Authorized: 50,000,000 shares at June 30, 2024, and 21,020,560 shares at December 31, 2023; | |
| | | |
| | |
| |
| | | |
| | |
Issued and outstanding: 18,701,418 and 18,502,918 at June 30, 2024 and December 31, 2023, respectively; | |
| 187 | | |
| 185 | |
Additional paid-in capital | |
| 7,631 | | |
| 7,392 | |
Accumulated deficit | |
| (8,108 | ) | |
| (7,310 | ) |
| |
| | | |
| | |
Total stockholders’ equity (deficit) | |
| (290 | ) | |
| 267 | |
| |
| | | |
| | |
Total liabilities and stockholders’ equity (deficit) | |
$ | 128 | | |
$ | 339 | |
The accompanying notes are an integral part of
the condensed consolidated interim financial statements.
RAPHAEL PHARMACEUTICAL INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share
and per share data)
| |
Six months ended June 30, | | |
Three months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Unaudited | | |
Unaudited | |
| |
| | |
| | |
| | |
| |
Research and development expenses | |
$ | 403 | | |
$ | 407 | | |
$ | 24 | | |
$ | 293 | |
| |
| | | |
| | | |
| | | |
| | |
General and administrative expenses | |
| 393 | | |
| 270 | | |
| 225 | | |
| 126 | |
| |
| | | |
| | | |
| | | |
| | |
Operating loss | |
| 796 | | |
| 677 | | |
| 249 | | |
| 419 | |
| |
| | | |
| | | |
| | | |
| | |
Total financial expense | |
| 2 | | |
| 4 | | |
| (1 | ) | |
| (2 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| 798 | | |
| 681 | | |
| 248 | | |
| 417 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per share | |
| 0.04 | | |
| 0.04 | | |
| 0.01 | | |
| 0.03 | |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of shares of common stock used in computing basic and diluted net loss per share | |
| 18,646,401 | | |
| 16,037,214 | | |
| 18,676,084 | | |
| 16,109,514 | |
The accompanying notes are an integral part of
the condensed consolidated interim financial statements.
RAPHAEL PHARMACEUTICAL INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (UNAUDITED)
U.S dollars in thousands (except for share
and per share data)
| |
Common stock | | |
Additional paid-in | | |
Accumulated | | |
Total | |
| |
Number | | |
Amount | | |
capital | | |
deficit | | |
equity | |
| |
| | |
| | |
| | |
| | |
| |
Balance as of January 1, 2024 | |
| 18,502,918 | | |
$ | 185 | | |
$ | 7,392 | | |
$ | (7,310 | ) | |
$ | 267 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock and warrants | |
| 158,500 | | |
| 2 | | |
| 178 | | |
| - | | |
| 180 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (550 | ) | |
| (550 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as of March 31, 2024 | |
| 18,661,418 | | |
$ | 187 | | |
$ | 7,570 | | |
$ | (7,860 | ) | |
$ | (103 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock in exchange for services | |
| 40,000 | | |
| (* | ) | |
| 61 | | |
| - | | |
| 61 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (248 | ) | |
| (248 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as of June 30, 2024 | |
| 18,701,418 | | |
| 187 | | |
$ | 7,631 | | |
$ | (8,108 | ) | |
$ | (290 | ) |
| |
Common stock | | |
Additional paid-in | | |
Accumulated | | |
Total | |
| |
Number | | |
Amount | | |
capital | | |
deficit | | |
equity | |
Balance as of January 1, 2023 | |
| 15,624,040 | | |
$ | 157 | | |
$ | 5,975 | | |
$ | (6,026 | ) | |
$ | 106 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock and warrants | |
| 378,750 | | |
| 3 | | |
| 146 | | |
| - | | |
| 149 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (264 | ) | |
| (264 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as of March 31, 2023 | |
| 16,002,790 | | |
$ | 160 | | |
$ | 6,121 | | |
$ | (6,290 | ) | |
$ | (9 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock and warrants | |
| 164,378 | | |
| 2 | | |
| 163 | | |
| - | | |
| 165 | |
Issuance of common stock in exchange for services | |
| 201,000 | | |
| 2 | | |
| 198 | | |
| - | | |
| 200 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (417 | ) | |
| (417 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as of June 30, 2023 | |
| 16,368,168 | | |
| 164 | | |
$ | 6,482 | | |
$ | (6,707 | ) | |
$ | (61 | ) |
The accompanying notes are an integral part of
the condensed consolidated interim financial statements.
RAPHAEL PHARMACEUTICAL INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
U.S dollars in thousands (except for share
and per share data)
| |
Six months ended June 30 | |
| |
2024 | | |
2023 | |
Cash flows from operating activities | |
| | |
| |
| |
| | |
| |
Net loss | |
$ | (798 | ) | |
$ | (681 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
| |
| | | |
| | |
Share-based payment in exchange for services | |
| 61 | | |
| 200 | |
Depreciation | |
| (* | ) | |
| 1 | |
| |
| | | |
| | |
Changes in: | |
| | | |
| | |
Other current assets | |
| 1 | | |
| 36 | |
Account payables and related party | |
| 346 | | |
| (170 | ) |
| |
| | | |
| | |
Net cash used in operating activities | |
| (390 | ) | |
| (614 | ) |
| |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | |
| |
| | | |
| | |
Issuance of common stock and warrants | |
| 280 | | |
| 314 | |
Advance payment on account of shares | |
| - | | |
| 123 | |
Net cash provided by financing activities | |
| 280 | | |
| 437 | |
| |
| | | |
| | |
Change in cash and cash equivalents | |
| (110 | ) | |
| (177 | ) |
Cash and cash equivalents at the beginning of the period | |
| 230 | | |
| 288 | |
| |
| | | |
| | |
Cash and cash equivalents at the end of the period | |
$ | 120 | | |
$ | 111 | |
(*) | Less than 1 thousand. |
The accompanying notes are an integral part of
the condensed consolidated interim financial statements.
RAPHAEL PHARMACEUTICAL INC. AND SUBSIDIARY
NOTES TO
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED)
U.S dollars in thousands (except for share
and per share data)
NOTE
1:- GENERAL
| a. | Raphael Pharmaceutical Inc. (formerly Easy Energy, Inc.) (the “Company”) was incorporated under the laws of the State of Nevada on May 17, 2007. The Company is headquartered in Tel Aviv-Jaffa, Israel. From April 1, 2011 until December 31, 2019, the Company was not active. On October 8, 2020, the Company and its stockholders entered into a Share Exchange Agreement (the “Share Exchange”) with an Israeli pharmaceutical company (“Raphael”), according to which, among other matters, all shareholders of Raphael will sell and convey the entire holdings in Raphael to the Company such that following the Share Exchange, the shareholders of Raphael will hold 90% of the issued and outstanding common stock of the Company, and the existing shareholders of the Company will hold the remaining 10% of the issued and outstanding common stock. On May 14, 2021, the Company’s board of directors and stockholders approved a 1-for-100 reverse split of the Company’s common stock, which was implemented and became effective as of May 14, 2021. The reverse split combined each one hundred (100) shares of the Company’s issued and outstanding common stock into one share of common stock. No fractional shares were issued in connection with the reverse split, and any fractional shares resulting from the reverse split were rounded up to the nearest whole share. On May 14, 2021, Raphael and the Company completed the Share Exchange pursuant to which 9,459,253 common stock were issued to the shareholders of Raphael so that they became the holders of 90% of the issued and outstanding common stock of the Company immediately after the Share Exchange while the Company’s shareholders held, following the Share Exchange, 1,051,028 common stock which represents 10% of the Company. On May 19, 2021, as agreed by the parties to the Share Exchange, the Company changed its name to Raphael Pharmaceutical Inc. Following such Share Exchange, Raphael’s activities are the sole activities of the Company. The Share Exchange was accounted for as a reverse recapitalization which is outside the scope ASC 805, “Business Combinations” (“ASC 805”), as the Company, the legal acquirer, is considered a non-operating public shell, and is therefore not a business as defined in ASC 805. As the shareholders of Raphael received the largest ownership interest in the Company, Raphael was determined to be the “accounting acquirer” in the Share Exchange. As a result, the historical financial statements of the Company were replaced with the financial statement of Raphael for all periods presented. Company’s common stock began public trading on the over-the-counter market in the U.S. in January 2023 under the symbol “RAPH”. |
| | |
| b. | Going concern and management plans |
The accompanying financial statements
have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal
course of business. Since its inception, the Company has devoted substantially all of its efforts to research and development, clinical
trials, and raising capital. The Company is still in its development and clinical stage and has not yet generated revenues. The extent
of the Company’s future operating losses and the timing of becoming profitable are uncertain. As of June 30, 2024, the Company’s
accumulated deficit was $8,108. The Company has funded its operations to date primarily through equity financing and the issuance of a
loan. Additional funding will be required to complete the Company’s research and development and clinical trials, to attain regulatory
approvals, to begin the commercialization efforts of the Company’s product and to achieve a level of sales adequate to support the
Company’s cost structure.
RAPHAEL PHARMACEUTICAL INC. AND SUBSIDIARY
NOTES TO
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED)
U.S dollars in thousands (except for share
and per share data)
NOTE
1:- GENERAL (Cont.)
Management’s plans include, but
are not limited to, raising capital in the United States. There can be no assurance that it will be able to successfully raise additional
financing, including in a public offering, or obtain additional financing on a timely basis or on terms acceptable to the Company, or
at all.
Management expects that the Company
will continue to generate losses from the development, clinical development and regulatory activities of its product, which will result
in negative cash flow from operating activity. This has led management to conclude that substantial doubt about the Company’s ability
to continue as a going concern exists in the event that additional funding does not occur. If such sufficient financing is not received
timely, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated and
would then need to pursue a plan to license its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy
protection. The Company’s financial statements do not reflect any adjustments that might result from the outcome of this uncertainty.
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES
These unaudited interim financial statements
should be read in conjunction with the audited financial statements and accompanying notes for the year ended December 31, 2023. The significant
accounting policies applied in the annual financial statements of the Company as of December 31, 2023, are applied consistently in these
interim financial statements.
NOTE
3:- UNAUDITED INTERIM FINANCIAL STATEMENTS
The accompanying unaudited condensed
consolidated interim financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”)
for interim financial information and with the instructions to Form 10-Q and Article 10 of U.S. Securities and Exchange Commission Regulation
S-X. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles for complete
financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation have been included (consisting
only of normal recurring adjustments except as otherwise discussed). For further information, reference is made to the consolidated financial
statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Operating
results for the six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending
December 31, 2024.
NOTE
4:- SHAREHOLDERS’ EQUITY
| a. | In January 2024, the Company and certain investors signed an investment agreement according to which the investors transferred $80 and the Company issued 58,500 shares. |
| | |
| b. | In January 2024, the Company signed an agreement to raise $100 and to issue 100,000 shares of common stock and 100,000 warrants to purchase common stock at an exercise price of $1 per share to certain investor of the Company. The warrants are exercisable until December 31, 2024. |
| | |
| c. | In January 2024, the Company received $50 from certain shareholder as part of shareholders’ warrants exercise which occurred in December 2023. |
| | |
| d. | In May 2024, the Company issued 40,000 shares in connection with service agreement with certain service provider. |
| | |
| e. | On June 26, 2024, the Company increased the number of authorized shares of common stock, $0.01 par value per share, from 21,020,560 shares to 50,000,000 shares. |
NOTE
5:- SUBSEQUENT EVENTS
In April 2024, the Company announced
a significant development in its clinical trial program. Leveraging the insights gleaned from pre-clinical experiments conducted at Rambam
Health Care Campus, the Company has commenced a proof of concept clinical study in the USA.
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations
The following discussion
and analysis of our financial condition and results of operations should be read in conjunction with the accompanying condensed consolidated
financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q.
On May 14, 2021, Raphael
Pharmaceutical Ltd., an Israeli company, and Easy Energy, Inc., a Nevada corporation, completed a share exchange agreement, or the Share
Exchange, pursuant to which the shareholders of Raphael Pharmaceutical Ltd. became the holders of 90% of the issued and outstanding share
capital of Easy Energy, Inc., while Easy Energy, Inc.’s shareholders hold, following the share exchange, 10% of Easy Energy, Inc.
On May 19, 2021, as agreed by the parties to the Share Exchange, Easy Energy, Inc. changed its name to Raphael Pharmaceutical Inc. Unless
otherwise mentioned or unless the context requires otherwise, when used in this Quarterly Report, the terms “Raphael,” “Company,”
“we,” “us,” and “our” refer to Raphael Pharmaceutical Inc. and its subsidiary, Raphael Pharmaceutical
Ltd., or Raphael Israel. References to Easy Energy are to Easy Energy, Inc. Unless otherwise mentioned or unless the context requires
otherwise, the information provided in this Quarterly Report on Form 10-Q relates to Raphael Israel.
Forward-Looking Statements
This Quarterly Report on Form
10-Q contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and
other federal securities laws, which include information relating to future events, future financial performance, strategies, expectations,
competitive environment and regulation. Words such as “may,” “will,” “should,” “could,”
“would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,”
“future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions,
as well as statements in future tense, identify forward-looking statements. Forward-looking statements should not be read as a guarantee
of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking
statements are based on information we have when those statements are made or our management’s good faith belief as of that time
with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially
from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but
are not limited to:
|
● |
the regulatory pathways that we may elect to utilize in seeking U.S. Food and Drug Administration, or FDA, European Medicines Agency, or EMA, and other regulatory approvals, if any; |
|
|
|
|
● |
obtaining (and the cost thereof) FDA and EMA approval of, or other regulatory action in Europe or the United States and elsewhere with respect to our product candidates; |
|
|
|
|
● |
the commercial launch and future sales of our product candidates and our advancement of product candidates for other indications in our pipeline; |
|
|
|
|
● |
the potential cost of our rheumatoid arthritis product candidate, or RA and RA product candidate, respectively, for patients; |
|
|
|
|
● |
our expectations regarding the timing of commencing clinical trials; |
|
● |
our expectations regarding the supply of the active pharmaceutical ingredient for our product candidates; |
|
|
|
|
● |
third-party payor reimbursement for our product candidates; |
|
|
|
|
● |
our estimates regarding anticipated expenses, capital requirements and our needs for additional financing; |
|
|
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|
● |
completion and receiving favorable results of clinical trials for our product candidates; and |
|
|
|
|
● |
the filing by us, and the subsequent issuance of patents to us, by the U.S. Patent and Trademark Office and other governmental patent agencies. |
The foregoing does not represent
an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced
with that may cause our actual results to differ from those anticipated in our forward-looking statements. Please see “Item 1A.
Risk Factors” for additional risks that could adversely impact our business and financial performance.
Moreover, new risks regularly
emerge and it is not possible for our management to predict or articulate all the risks we face, nor can we assess the impact of all risks
on our business or the extent to which any risk, or combination of risks, may cause actual results to differ from those contained in any
forward-looking statements. All forward-looking statements included in this Quarterly Report are based on information available to us
on the date of this Quarterly Report. Except to the extent required by applicable laws or rules, we undertake no obligation to publicly
update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All subsequent written
and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the
cautionary statements contained above and throughout this Quarterly Report.
In this Quarterly Report,
unless otherwise specified, all dollar amounts are expressed in United States dollars. Except as otherwise indicated by the context, references
in this Quarterly Report to “Raphael,” “Company”, “we,” “us” and “our” are
references to Raphael Pharmaceutical Inc., a Nevada corporation, together with its consolidated subsidiaries.
Overview
We are a pharmaceutical drug
research and development company focused on the discovery and clinical development of life-improving drug therapies based on cannabinoids,
including cannabidiol, or CBD. Unless indicated otherwise, we plan on using oil derived from CBD strains with low levels of Tetrahydrocannabinol,
or THC. All references to the use of CBD in our product candidates refer to CBD strains with less than 0.3% of THC.
We are currently in the pre-clinical
development stage for our lead product candidate, our RA product candidate for the treatment of RA. In addition, we are aiming to develop
a pharmaceutical drug product for the treatment of hyperinflammatory syndrome and lung inflammation related to COVID-19. At Rambam Health
Care Campus, or Rambam Hospital, we have successfully completed preclinical studies on human-derived immune cells and mouse models for
both the COVID-19 and RA products.
In November 2022, we submitted
a proposal to the Ministry of Health of Israel, or MOH for a clinical trial of a cannabis-based drug intended to alleviate the deterioration
of COVID-19 patients.
On February 9, 2022, we filed
an application for a clinical trial with the Medical Cannabis Unit of the Ministry of Health of Israel, or MOH. On February 16, 2022 we
submitted an application with the Helsinki Committee at Rambam Hospital for a clinical trial in COVID-19 patients.
In April 2024 we began a proof-of-concept
clinical trial in the United States, leveraging insights from the pre-clinical experiments it has conducted at the Rambam Hospital. This
proof-of-concept clinical trial aims to evaluate the efficacy of Cannabigerol in patients with active RA. The estimated timeline to finalize
such proof-of-concept clinical trial is six months from the recruitment of the first participant.
On March 27, 2023, the Israel
Ministry of Health, or MOH, accepted our proposal for a clinical trial aimed at preventing the deterioration of hospitalized COVID-19
patients.
We have engaged with MindMate,
Inc./ dba Citruslabs (“Citruslabs”) to oversee such proof-of-concept clinical trial. Our collaboration with Citruslab underscores
our dedication to conducting such proof-of-concept clinical trial in accordance with applicable industry standards and regulations, including
the International Conference on Harmonisation Good Clinical Practice guidelines, and dedication to bringing treatments to fruition and
improving the lives of individuals affected by RA. This milestone represents a significant stride forward in our mission to pioneer innovative
solutions for managing RA and underscores its commitment to driving advancements in medical research, addressing the unmet needs of patients.
As we move forward, our focus will be on further
investigating and refining the formula through continued pre-clinical research. Our goal is to ensure that the formula meets all the necessary
standards and regulations set forth by the FDA, allowing us to progress towards clinical treatments.
Our vision is to emerge as
a pioneering company at the forefront of formulating pharmaceutical drugs that harness the potential of purified cannabinoids and full-spectrum
CBD oil. Our primary mission is to cater to the unmet medical requirements of patients grappling with various disorders, with a particular
focus on conditions linked to inflammation, such as chronic lung inflammation, RA and COVID-19.
By leveraging our expertise
in this field, we are committed to providing innovative solutions to improve the lives of those afflicted with these challenging medical
conditions. Through our dedication to research, development, and compassionate care, we aim to contribute significantly to the well-being
of patients worldwide, offering them much-needed relief and hope for a better future.
In order to achieve our goal,
we have and will continue to build an experienced team of senior executives and scientists, with experience in all facets of pharmaceutical
research and development, drug formulation, clinical trial execution and regulatory submissions. We intend to leverage the knowledge of
our team in order to complete the clinical trials needed to receive approvals of our product candidates from applicable regulatory authorities.
Initially, we intend to obtain
approvals for our product candidates from the FDA and the Medical Cannabis Unit of the Israeli Ministry of Health, or MOH. Upon obtaining
FDA approvals, or in the event that we are not successful in obtaining such approvals, we intend to apply for EMA and other countries’
governmental regulatory agencies approvals for our product candidates. If we are successful in obtaining FDA approvals for our product
candidates, we intend to enter into royalty agreements with good manufacturing practice, or GMP, approved medical manufactures and distributors,
having them using our medical formulas for the purpose of growing, cultivating, manufacturing, and distributing Raphael Pharmaceutical
medical indications in their designated territories.
For this purpose, in October
2022, we entered into an agreement with the Medical Cannabis Research Center at Rambam Health Care Campus, and Rambam MedTech for the
development of a new, patentable formulation that combines purified cannabinoids to treat rheumatoid diseases.
The overall objective of this
study is to identify a novel cannabinoid based patentable formulation to treat Rheumatoid diseases. Specifically, to investigate combination
of purified cannabinoids to downregulate inflammation related to Rheumatoid diseases. We propose to base our study on data derived from
Dr. Igal Louria-Hayon’s studies (Helsinki # 0442-20-RMB) on the evaluation of the immune regulation properties of cannabinoids on
the immune system and the data derived from the cannabinoids receptors study (Helsinki # 0331-20-RMB). We will analyze the activation
of cannabinoid receptors on mouse models and will study the role of purified cannabinoid as a potential to develop a novel patentable
formulation to treat RA.
Our discovery platform currently
focuses the use of CBD oil, one of the cannabinoids in cannabis plants, as the active pharmaceutical ingredient, or API, for our RA product
candidate and COVID-19 product candidate. Research results published in 2018 (“Translational Investigation of the Therapeutic Potential
of Cannabidiol (CBD): Toward a New Age”) has shown that there may be benefits to treading medical conditions, or their effects,
with cannabinoids, and more specifically, with CBD, which may help reduce chronic pain by impacting endocannabinoid receptor activity,
reducing inflammation and interacting with neurotransmitters. This research has also shown that CBD may have neuroprotective properties,
and could have the ability to (i) reduce anxiety and depression, (ii) alleviate cancer-related symptoms, (iii) reduce acne and (iv) benefit
heart health.
Critical Accounting Estimates
Our financial statements are
prepared in accordance with U.S. GAAP. There are no critical accounting estimates for the years ended December 31, 2023, and 2022. Also,
please see Note 2 of Part I, Item 1 of this Quarterly Report on Form 10-Q for the summary of significant accounting policies.
Results of Operations
Three months ended June 30, 2024,
compared to the three months ended June 30, 2023
Revenues. We had no
revenues during the three months ended June 30, 2024, and June 30, 2023.
Research and Development
Expenses. Our research and development expenses totaled $24,000 for the three months ended June 30, 2024, representing a decrease
of $269,000, or 91.8%, compared to $293,000 for the three months ended June 30, 2023. The decrease was primarily attributable to value
of shares issued to Wolc in June 2023 which did not recur in 2024.
General and Administrative
Expenses. Our general and administrative expenses totaled $225,000 for the three months ended June 30, 2024, representing an increase
of $99,000, or 78.5%, compared to $126,000 for the three months ended June 30, 2023. The increase was primarily due to increase in professional
services in the second quarter of 2024.
Operating Loss. Our
operating loss totaled $249,000 for the three months ended June 30, 2024, representing a decrease of $170,000, or 40.5%, compared to $419,000
for the three months ended June 30, 2023. The decrease was primarily due to the decrease in our research and development expenses offset
by an increase in our general and administrative expenses.
Financial income, net.
We recognized financial income, net, of $1,000 for the three months ended June 30, 2024, representing a decrease of $1,000, or 50%,
compared to financial income, net of $2,000 for the three months ended June 30, 2023. The decrease was immaterial.
Net Loss. As a result
of the foregoing, our net loss totaled $248,000 for the three months ended June 30, 2024, representing a decrease of $169,000, or 40.5%,
compared to $417,000 for the three months ended June 30, 2023. The decrease was primarily due to decrease in our research and development
expenses offset by an increase in our general and administrative expenses.
Six months ended June 30, 2024 compared to
the six months ended June 30, 2023
Revenues. We had no
revenues during the six months ended June 30, 2024 and June 30, 2023.
Research and Development
Expenses. Our research and development expenses totaled $403,000 for the six months ended June 30, 2024, representing a decrease of
$4,000, or 1%, compared to $407,000 for the six months ended June 30, 2023. The decrease was immaterial.
General and Administrative
Expenses. Our general and administrative expenses totaled $393,000 for the six months ended June 30, 2024, representing an increase
of $123,000, or 45.5%, compared to $270,000 for the six months ended June 30, 2023. The increase was primarily due to increase in professional
services in the second quarter of 2024.
Operating Loss. Our
operating loss totaled $796,000 for the six months ended June 30, 2024, representing an increase of $119,000, or 17.5%, compared to $677,000
for the six months ended June 30, 2023. The increase was primarily due to the increase in our general and administrative expenses.
Financial Expense, net.
We recognized financial expense, net of $2,000 for the six months ended June 30, 2024, representing a decrease of $2,000, or 50%,
compared to $4,000 for the six months ended June 30, 2023. The decrease was immaterial.
Net Loss. As a result
of the foregoing, our net loss totaled $798,000 for the six months ended June 30, 2024, representing an increase of $117,000, or 17.2%,
compared to $681,000 for the six months ended June 30, 2023. The increase was primarily due to the increase in our general and administrative
expenses.
Liquidity and Capital Resources
Since inception, we have funded
our operations primarily through our founder’s capital and capital received from Easy Energy, Inc. As of June 30, 2024, we had $120,000
in cash and cash equivalents, and have invested most of our available cash funds in ongoing cash accounts.
Net cash used in operating
activities was $390,000 for the six months period ended June 30, 2024, compared with net cash used in operating activities of $614,000
for the corresponding period in 2023. The $224,000 decrease in the net cash used in operating activities during the six months period
ended June 30, 2024, compared to the same period in 2023, was primarily due to an increase in Company’s net loss for the period
in the amount of $117,000 which was offset by a change in account payables and related party and other current assets of $341,000.
There was no net cash used
in investing activities for the six months period ended June 30, 2024 and for the same period in 2023.
Net cash provided by financing
activities for the six months period ended June 30, 2024 was $280,000 compared to $437,000 for the same period in 2023. The decrease in
net cash provided by financing activities during the six months period ended June 30, 2024 compared to the corresponding period in 2023
was mainly due to a decrease in funds received from issuance of shares and warrants and proceeds received from exercise of warrants.
Off Balance Sheet Arrangements
Rambam Research Agreement
On July 17, 2019, we entered
into a sponsored research agreement, or the Research Agreement, with Rambam MT, pursuant to which the Company agreed to fund a research
project, to be performed by Rambam MD, with a research plan aimed at identifying the effects of different cannabis strains on the function
of immune cells. On October 28, 2020, the Company and Rambam MT agreed to expand the research plan to study the anti-inflammatory activities
of cannabis extracts in an RA mouse model. On February 15, 2021, the Company and Rambam MT agreed to further expand the research plan
to study the effect of cannabis extracts on the immunopathology of the COVID-19 disease. The Sponsored Researched Agreement is for an
initial term of 48 months. On October 23, 2022, the Company and Rambam MT entered into a supplement to the Research Agreement, or the
Supplement Agreement, pursuant to which the Company exercised an option to extend the Research Agreement by additional two years until
December 31, 2024.
Pursuant to the Research Agreement,
we agreed to pay Rambam MT $1.4 million in four equal payments, due on the first day of August on each successive year from 2019 through
2022. Pursuant to the Supplement Agreement, we agreed to pay Rambam MT $960,000 plus VAT in four biannual payments from May 2023 through
December 2024. Furthermore, in accordance with the terms of the Research Agreement, we and Rambam MT will have joint ownership of any
intellectual property (IP) created as a result of research programs covered by such agreement. In connection with the Research Agreement,
Rambam MT agreed not to work, study or develop any technologies with other entities that compete with our work with Rambam MT for our
COVID-19 product candidate or RA product candidate for a term of three and seven years, respectively, from the end of the parties’
collaboration with respect to the COVID-19 product candidate and seven years from the end of the term of the Research Agreement with respect
to the RA product candidate.
Subject to commercial sales
of any product candidate using the IP created as a part of the research covered by such agreement, Raphael Israel is required to pay Rambam
MT a royalty in an amount equal to 6% of all net sales, subject to certain deductions, such as taxes paid by any purchaser, transportation
and shipping costs, and other customary deductions.
On December 25, 2023, the
Company received an extension to pay the remaining $350,000 pursuant to the Research Agreement until the end of June 2024. As of May 15,
2024, the Company has made all four of the four equal payments due pursuant to the Research Agreement, for a total amount of $1.4 million
and $120,000 for the Supplement Agreement.
Way of Life Cannabis Agreement
In October 2020, Raphael Israel
entered into an engagement agreement with Wolc, pursuant to which, subject to its completing the Share Exchange with Easy Energy, Raphael
Israel will be provided with up to 15 liters of CBD oil, from a strain of cannabis during a term of 18 months, to be provided in two to
three deliveries of between one to seven milliliters of CBD oil. In accordance with Raphael Israel’s agreement with Wolc, Raphael
Israel has agreed to issue to certain persons affiliated with Wolc 3% of Raphael’s issued and outstanding share capital as of the
date of the Share Exchange, to be provided in three equal issuances; provided, however, that such persons may elect to receive a cash
payment of $100,000 instead of any one issuance of Raphael’s shares. In addition to the issuance of shares, Raphael Israel has also
agreed to pay Wolc a royalty fee equal to 15% of the net royalties generated from sales of Raphael Israel’s pharmaceutical drug
products that are developed at Rambam hospital in Israel.
On July 27, 2022, we issued
100,500 shares of common stock to Wolc in connection with the engagement agreement. The value of such issued shares was based on the value
of the service provided, which amounted to $100,000. In June 2023, we issued the remaining 201,000 shares of common stock to Wolc in connection
with the services agreement dated October 2020.The value of the shares issued was based on the value of the service provided, which amounted
to $200,000.
Except for the above, we have
not engaged in any off-balance sheet arrangements, such as the use of unconsolidated subsidiaries, structured finance, special purpose
entities or variable interest entities.
We do not believe that our
off-balance sheet arrangements and commitments have or are reasonably likely to have a current or future effect on our financial condition,
changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that
is material to investors.
Current Outlook
We have financed our operations
to date primarily through proceeds from our founder’s capital and issuance of shares and warrants. We have incurred losses and generated
negative cash flows from operations since inception. To date we have not generated revenue, and we do not expect to generate significant
revenues from the sale of our products in the near future.
We do not believe that our
current cash on hand will be sufficient to fund our projected operating requirements. This raises substantial doubt about our ability
to continue as a going concern. At this time, there is no guarantee that we will be able to obtain an adequate level of financial resources
required for the short and long-term support of our operations or that we will be able to obtain additional financing as needed, or meet
the conditions of such financing, or that the costs of such financing may not be prohibitive. These conditions raise substantial doubt
about our ability to continue as a going concern for a period within one year from the date of the financial statements included elsewhere
in this Quarterly Report.
As of June 30, 2024, our cash
and cash equivalents were $120,000. We believe that our existing cash and cash equivalents will not be sufficient to fund our projected
cash requirements through the end of the year. Therefore, we will require significant additional financing
in the near future to fund our operations. We currently anticipate that we will require approximately $700,000 for research and development
activities over the course of the next 12 months. We also anticipate that we will require approximately $500,000 for capital expenditures
over such 12-month period, which consists primarily of expenditures for clinical trials and general Company operating costs.
In addition, our operating
plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than
planned. Our future capital requirements will depend on many factors, including:
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our research and development efforts, including our ability to finish research and development projects or product development within the allotted or expected timeline; |
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the cost, timing and outcomes of seeking to commercialize our products in a timely manner; |
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our ability to generate cash flows; |
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● |
economic weakness, including inflation, or political instability in particular foreign economies and markets; |
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government regulation in our industry, and more specifically, the costs and timing of obtaining regulatory approval or permits to launch our technology in various geographical markets; and |
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● |
the costs of, and timing for, strengthening our manufacturing agreements for production of our wave energy systems. |
Until we can generate significant
revenues, if ever, we expect to satisfy our future cash needs through our existing cash, cash equivalents and short-term deposits, loans,
or debt or equity financings. We cannot be certain that additional funding will be available to us on acceptable terms, if at all. If
funds are not available, we may be required to delay, reduce the scope of, or eliminate research or development plans for, or commercialization
efforts with respect to, one or more applications of our products. This may raise substantial doubts about our ability to continue as
a going concern.
Item 3. Quantitative and Qualitative Disclosures
About Market Risk.
Not applicable.
Item 4. Controls and Procedures
Management’s Conclusions Regarding Effectiveness
of Disclosure Controls and Procedures
As of June 30, 2024, we conducted
an evaluation, under the supervision and participation of management including our Chief Executive Officer and Chief Financial Officer,
of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Securities Exchange
Act of 1934, as amended). There are inherent limitations to the effectiveness of any system of disclosure controls and procedures. Accordingly,
even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives.
Based upon this evaluation,
our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective at the reasonable
assurance level as of June 30, 2024.
Internal Control over Financial Reporting
There were no changes in our
internal control over financial reporting during the fiscal quarter ended June 30, 2024, that materially affected, or are reasonably likely
to materially affect, our internal control over financial reporting.
Management is responsible
for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under
the Exchange Act. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally
accepted in the United States of America.
Because of inherent limitations,
internal control over financial reporting may not prevent or detect misstatements. Therefore, even internal controls determined to be
effective can provide only reasonable assurance with respect to financial statement preparation and presentation. The effectiveness of
our internal control over financial reporting is subject to various inherent limitations, including cost limitations, judgments used in
decision making, assumptions about the likelihood of future events, the possibility of human error, and the risk of fraud. The projection
of any evaluation of effectiveness to future periods is subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with policies may deteriorate. Because of these limitations, there can be no assurance that
any system of internal control over financial reporting will be successful in preventing all errors or fraud or in making all material
information known in a timely manner to the appropriate levels of management.
This Quarterly Report does
not include an attestation report of the company’s registered public accounting firm regarding internal control over financial reporting.
Management’s report was not subject to attestation by the company’s registered public accounting firm pursuant to rules of
the Commission that exempt from this requirement issuers that are neither accelerated filers nor large accelerated filers.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
There have been no material
changes to our legal proceedings as described in “Item 3. Legal Proceedings” in our Annual Report on Form 10-K, as filed with
the SEC on March 28, 2024.
Item 1A. Risk Factors
There have been no material
changes to our risk factors from those disclosed in “Item 1A. Risk Factors” in our Annual Report on Form 10-K, as filed with
the SEC on March 28, 2024.
Item 6. Exhibits
EXHIBIT INDEX
SIGNATURES
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 thereunto duly authorized.
|
RAPHAEL PHARMACEUTICAL INC. |
|
|
Date: August 12, 2024 |
By: |
/s/ Shlomo Pilo |
|
Name: |
Shlomo Pilo |
|
Title: |
Chief Executive Officer (Principal Executive Officer) |
|
|
|
Date: August 12, 2024 |
By: |
/s/ Guy Ofir |
|
Name: |
Guy Ofir |
|
Title: |
Chief Financial Officer
(Principal Financial Officer) |
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In connection with the quarterly
report of Raphael Pharmaceutical Inc., or the Company, on Form 10-Q for the period ended June 30, 2024, as filed with the Securities and
Exchange Commission on the date hereof, or the Report, I, Shlomo Pilo, Chief Executive Officer of the Company, certify, pursuant to 18
U.S.C. Section 1350, that to my knowledge:
In connection with the quarterly
report of Raphael Pharmaceutical Inc., or the Company, on Form 10-Q for the period ended June 30, 2024, as filed with the Securities and
Exchange Commission on the date hereof, or the Report, I, Guy Ofir, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C.
Section 1350, that to my knowledge: