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

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: September 30, 2021March 31, 2022

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

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)

Nevada26-0204284
(State or other jurisdiction(I.R.S. Employer
of 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 classTrading Symbol(s)Name of each exchange on which registered
N/AN/AN/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 filerAccelerated filer
Non-accelerated filerSmaller 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, $0.001$0.01 par value, outstanding as of November 15, 2021: 12,454,790May 2, 2022: 13,290,540

 

 

 

 

TABLE OF CONTENTS

Page 
PART I
Item 1.Financial StatementsF-1
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations31
Item 3.Quantitative and Qualitative Disclosures About Market Risk85
Item 4.Controls and Procedures85
PART II
Item 1.Legal Proceedings96
Item 1A.Risk Factors96
Item 6.Exhibits96

i

 

RAPHAEL PHARMACEUTICAL INC. AND ITS SUBSIDIARY

CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

AS OF MARCH 31, 2022

AS OF SEPTEMBER 30, 2021UNAUDITED

 

UNAUDITED

U.S. DOLLARS IN THOUSANDS

INDEX

Page 
Condensed Consolidated Interim Balance SheetsF-2
Condensed Consolidated Interim Statements of Comprehensive LossF-3
Condensed Consolidated Interim Statements of Changes in Stockholders’ EquityF-4
Condensed Consolidated Interim Statements of Cash FlowsF-5
Notes to Condensed Consolidated Interim Financial StatementsF-6 – F-8

- - - - - - - - - - -

-F-1-

 

RAPHAEL PHARMACEUTICAL INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

  As of
September 30,
  As of
December 31,
 
  2021  2020 
  (Unaudited)  (Audited) 
Assets      
Current assets:      
Cash and cash equivalents   $37  $95 
Other current assets    25   228 
         
Total current assets    62   323 
         
Total assets   $62  $323 
         
Liabilities and stockholders’ equity (deficit)          
         
Current liabilities:          
Accounts payable    12   -- 
Other accounts payable    175   9 
Loan    -   357 
         
Total current liabilities    187   366 
         
Stockholders’ equity:          
Preferred stock, $0.001 par value:    -   - 
Authorized: 500,000 shares at September 30, 2021 and December 31, 2020; None issued and outstanding        
Common stock, $0.001 par value:    12   9 
Authorized: 21,020,560 shares at September 30, 2021 and December 31, 2020;        
Issued and outstanding: 12,142,790 and 9,459,253 at September 30, 2021 and December 31, 2020, respectively;        
Additional paid-in capital    1,964   991 
Accumulated deficit    (2,101)  (1,043)
         
Total stockholders’ equity (deficit)    (125)  (43)
         
Total liabilities and stockholders’ equity    $62  $323 

  As of
March 31,
  As of
December 31,
 
  2022  2021 
   (Unaudited)  (Audited) 
Assets      
Current assets:      
Cash and cash equivalents $81  $153 
Other current assets  99   269 
         
Total current assets  180   422 
         
Total assets $180  $422 
         
Liabilities and stockholders’ equity        
         
Current liabilities:        
Other account payables and accrued expenses  76   272 
Payable to related party  1   22 
         
Total current liabilities  77   294 
         
Stockholders’ equity:        
Common stock, $0.01 par value:        
         
Authorized: 21,020,560 shares at March 31, 2022 and December 31, 2021;        
         
Issued and outstanding: 13,290,540 and 12,970,540 at March 31, 2022 and December 31, 2021, respectively;  133   130 
Additional paid-in capital  2,823   2,665 
Accumulated deficit  (2,853)  (2,667)
         
Total stockholders’ equity  103   128 
         
Total liabilities and stockholders’ equity $180  $422 

The accompanying notes are an integral part of the interim condensed consolidated interim financial statements.

-F-2-

 

RAPHAEL PHARMACEUTICAL INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

U.S dollars in thousands (except for share and per share data)

  

Three months ended

March 31,

 
  2022  2021 
  Unaudited 
       
Research and development expenses $86  $169 
         
General and administrative expenses  89   83 
         
Operating loss  175   252 
         
Total financial expense  10   3 
         
Net loss $185  $255 
         
Basic and diluted net loss per share $0.01  $0.02 
         
Weighted average number of shares of common stock used in computing basic and diluted net loss per share (*)  13,035,371   9,459,253 

   Nine months ended
 September 30,  
  Three months ended
 September 30,
 
   2021     2020    2021  2020 
   Unaudited    Unaudited 
             
Research and development expenses $552  $241  $161  $69 
                 
General and administrative expenses  503   238   257   166 
                 
Operating loss  1,055   479   418   235 
                 
Total financial expense (income), net  3   9   (2)  8 
                 
Net loss  1,058   488   416   243 
                 
Basic and diluted net loss per share  0.09   0.05   0.03   0.02 
                 
Weighted average number of ordinary shares used in computing basic and diluted net loss per share (**)  10,811,014   9,459,253   12,131,663   9,459,253 

(**)(*) Number of shares has been retroactively adjusted based on the equivalent number of shares received by the accounting acquirer in the reverse recapitalization transaction and to reflect adjustment to the share par value (refer to Note 1a).

The accompanying notes are an integral part of the interim condensed consolidated interim financial statements.

-F-3-

 

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 shares  Additional
paid-in
  Accumulated  Total 
  Number  Amount  capital  deficit  equity 
                
Balance as of January 1, 2020 (**)  9,459,253  $9  $524  $(325) $208 
                     
Net loss  -   -   -   (245)  (245)
                     
Balance as of June 30, 2020  9,459,253  $9  $524  $(570) $(37)
                     
Net loss  -   -   -   (243)  (243)
                     
Balance as of September 30, 2020  9,459,253   9  $524  $(813) $(280)
  Common stock  Additional
paid-in
  Accumulated   
  Number  Amount  capital  deficit  Total equity 
                
Balance as of January 1, 2022  12,970,540  $130  $2,666  $(2,668) $128 
                     
Issuance of common stock and warrants  320,000   3   157   -   160 
                     
Net loss  -   -   -   (185)  (185)
                     
Balance as of March 31, 2022  13,290,540  $133  $2,823  $(2,853) $103 

  Common stock  Additional
paid-in
  Accumulated  Total 
  Number  Amount  capital  deficit  equity 
                
Balance as of January 1, 2021 (**)  9,459,253  $9  $991  $(1,043) $(43)
                     
Issuance of share capital  1,542,497   2   368   -   370 
                     
Effect of reverse recapitalization transaction (Notes 1a and 6b)  1,051,028   1   505   -   506 
                     
Net loss  -   -   -   (642)  (642)
                     
Balance as of June 30, 2021  12,052,778  $12  $1,864  $(1,685) $191 
                     
Issuance of share capital  90,012   (*)   100   -   100 
                     
Net loss  -   -   -   (416)  (416)
                     
Balance as of September 30, 2021  12,142,790  $12  $1,964  $(2,101) $(125)
                     
  Common stock  Additional
paid-in
  Accumulated   
  Number  Amount  capital  deficit  Total equity 
                
Balance as of January 1, 2021 (*)  9,459,253  $95  $905  $(1,043) $(43)
                     
Net loss  -   -   -   (255)  (255)
                     
Balance as of March 31, 2021 (*)  9,459,253  $95  $905  $(1,298) $(298)

(*)Represents amount less than $1
(**)Number of shares has been retroactively adjusted based on the equivalent number of shares received by the accounting acquirer in the reverse recapitalization transaction (refer to Note 1a).

(*) Number of shares has been retroactively adjusted based on the equivalent number of shares received by the accounting acquirer in the reverse recapitalization transaction and to reflect adjustment to the share par value (refer to Note 1a).

The accompanying notes are an integral part of the condensed consolidated interim consolidated financial statements.

-F-4-

 

 

RAPHAEL PHARMACEUTICAL INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

U.S dollars in thousands (except for share and per share data)

 Nine months Ended
September 30,
  Three months ended
March 31,
 
 2021  2020  2022  2021 
Cash flows from operating activities          
          
Net loss $(1,058) $(488) $(185) $(255)
Adjustments to reconcile net loss to net cash used in operating activities:                
                
Changes in:                
Other current assets  203   135   170   99 
Account payables  140   42   (67)  27 
                
Net cash used in operating activities  (715)  (311)  (82)  (129)
                
Cash flows from investing activities                
                
  -   -   -   - 
                
Net cash provided by investing activities  -   -   -   - 
                
Cash flows from financing activities                
                
Issuance of common stock and warrants  10   - 
Receipt of a loan  174   -   -   44 
Proceeds from issuance of common stock  470   297 
Cash acquired in the reverse recapitalization  13   - 
Net cash provided by financing activities  657   297   10   44 
                
Change in cash and cash equivalents  (58)  (14)  (72)  (85)
Cash and cash equivalents at the beginning of the period  95   50   153   95 
                
Cash and cash equivalents at the end of the period $37  $36  $81  $10 
                
Supplement disclosure of non-cash activities:        
Current assets (excluding cash and cash equivalents)  (531)  - 
Current liabilities  38   - 
Reverse recapitalization effect on equity  506   - 
Cash acquired in connection with reverse recapitalization transaction  13   - 
Non cash supplement        
Issuance of common stock and warrants $150   - 

The accompanying notes are an integral part of the condensed consolidated interim consolidated financial statements.

-F-5-

 

 

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 pharmaceuticalPharmaceutical 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 Karmiel,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 shareholdersstockholders entered into a certain share exchange agreementShare 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,Share Exchange, the shareholders of Raphael will hold 90% of the issued and outstanding share capitalcommon stock of the Company, and the existing shareholders of the Company will hold the remaining 10% of the issued and outstanding share capital.common stock.

 

On May 14, 2021, Thethe Company’s board of directors and stockholders approved a 1-for-100 reverse split of the Company’s Common Stock,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 Stockstock 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. The reverse stock split did not affect the Preferred Stock of the Company.

 

On May 14, 2021, Raphael and the Company, completed a share exchange agreement (the “Share Exchange”)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 share capitalcommon stock of the Company immediately after the Share Exchange while the Company’s shareholders hold, following the Share exchange,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 Merger,Share Exchange, Raphael’s activities are the sole activities of the Company.

 

The MergerShare 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. Under reverse capitalization accounting,As the shareholders of Raphael willreceived the largest ownership interest in the Company, Raphael was determined to be considered the acquirer for accounting and financial reporting purposes.“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.

 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’sCompany's future operating losses and the timing of becoming profitable are uncertain. As of September 30, 2021,March 31, 2022, the Company’sCompany's accumulated deficit was $2,101.$2,853. 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.

 

-F-6-

 

 

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. In the event the CompanyIf such sufficient financing is unable to have its loan converted as planned or its repayment date deferred,not received timely, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. If such sufficient financing or payment deferral is not received timely, the Companycontemplated 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, 2020.2021. The significant accounting policies applied in the annual financial statements of the Company as of December 31, 2020,2021, are applied consistently in these interim financial statements.

 

NOTE 3:-UNAUDITED INTERIM FINANCIAL STATEMENTS

 

The accompanying balance sheet as of September 30, 2021, the statements of comprehensive loss and the statements of cash flows for the nine and three months ended September 30, 2021 and 2020, as well as the statement of changes in stockholders’ equity for the nine and three months ended September 30, 2021, are unaudited.

These unaudited condensed consolidated interim financial statements have been prepared in accordance with U.S. generally accepted accounting principles in(“GAAP”) for interim financial information and with the United States (“U.S. GAAP”)instructions to Form 10-Q and applicable rules and regulationsArticle 10 of theU.S. Securities and Exchange Commission regarding interimRegulation S-X. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles for complete financial reporting.statements. In management’sthe 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 unaudited interimconsolidated financial statements include all adjustments of a normal recurring nature necessaryand footnotes thereto included in the Company’s Annual Report on Form 10-K for the fair presentation of the Company’s financial position as of September 30, 2021, as well as itsyear ended December 31, 2021. Operating results of operations and cash flows for the nine and three months ended September 30, 2021 and 2020. The results of operations for the nine months ended September 30, 2021March 31, 2022 are not necessarily indicative of the results tothat may be expected for the year ending December 31, 2021.2022.

 

NOTE 4:-LOAN

In August 31, 2020, the Company and Raphael signed an investment agreement according to which the Company will raise up to $950 from investors. The funds, which the Company will raise will be transferred to Raphael for its current activity. Until such time that the share exchange between the Company and Raphael is complete, the funds transferred to Raphael by the Company are to be considered as a loan which will become an equity investment once the share exchange is complete. The loan bears no interest and has no repayment date.

-F-7-

 

 

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 4:-LOAN (Cont.)

As of part of the merger (see Note 1a), the loan was converted into equity.

NOTE 5:-SHAREHOLDERS’ EQUITY

 

a.During nine months period ended September 30, 2021,On March 2, 2022, the Company raised $478 (net of issuance expenses of $52)$10 and issued 1,542,49750,000 shares of Commoncommon stock and 30,000 warrants to purchase common stock at an exercise price of $1.25 per share to certain investors of the Company. An amount of $160 was received before the merger (see Note 1a)The warrants were classified as equity and an amount of $370 was received after the merger.are exercisable until February 28, 2023.

 

b.On May 14, 2021, the Company, completed a share exchange agreement (the “Share Exchange”) pursuant to whichMarch 15, 2022, the Company issued 9,459,253270,000 shares of common stock and 180,000 warrants to the shareholders of Raphael, and the shareholders of Raphael became the holders of 90% of the issued and outstanding share capital of the Company while the Company’s shareholders hold, immediately following the share exchange, 1,051,028purchase common stock which represents 10%at an exercise price of $1.13 per share to Company’s service provider in consideration of past services at the Company (see also Note 1a).amount of $150. The warrants were classified as equity and are exercisable until December 31, 2023.

NOTE 5:-SUBSEQUENT EVENTS

 

c.a.In July 2021,On April 28, 2022, the Company raised $100signed an agreement to raise $50 and issued 90,012to issue 300,000 shares of Commoncommon stock and 100,000 warrants to purchase common stock at an exercise price of $0.7 per share to certain investor of the Company. The warrants are exercisable until April 30, 2024.The funds were received in May 2022.

b.On April 28, 2022 the Company and a certain investor signed a finder fee agreement according to which the Company will issue to the investor 70,000 shares of common stock and 100,000 warrants to purchase common stock at an exercise price of $0.5 per share. The warrants will be exercisable until April 30, 2024. The agreement will become effective once the investor will provide the Company with an equity investment of $550.
c.

On May 2, 2022, the Company signed several agreements to raise $250 and to issue 250,000 shares of common stock and 100,000 warrants to purchase common stock at an exercise price of $1.13 per share to certain investors of the Company. The warrants are exercisable until April 30, 2024. The funds were received in May 2022.

In addition, it was agreed that the Company will issue 250,000 shares of common stock and 100,000 warrants to purchase common stock at an exercise price of $1.13 per share to a certain investor in consideration of additional $250 if the Company’s stock will be publicly traded on the OTC market prior to August 15, 2022. The additional warrants once issued will be exercisable for 2 years.

 

-F-8-

 

 

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 prospectus, 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,” 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;
   
 completion and receiving favorable results of clinical trials for our product candidates;
   
 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;
   
 our expectations regarding the impact of the COVID-19 pandemic, including on our planned clinical trials, operations and financial position;

 


 

 

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. For a discussion of these and other risks that relate to our business and investing in our common stock, you should carefully review the risks and uncertainties described in this Quarterly Report on Form 10-Q, and those described from time to time in our future reports filed with the Securities and Exchange Commission. The forward-looking statements contained in this Quarterly Report on Form 10-Q are expressly qualified in their entirety by this cautionary statement. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.

 

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, oil. Unless indicated otherwise, we plan on using oil derived from cannabidiol, or 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 rheumatoid arthritis, or 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 inflammation related to COVID-19, or our COVID-19 product candidate, which may be based on data or studies related to our RA product candidate. Our goal is to become a leader in development of CBD oil-based pharmaceutical drug products for the treatment of indications in which we believe there is a high unmet medical need in a range of disorders, including those related to inflammation in the body, including RA and COVID-19.

 

The Company was incorporated in the State of Nevada in May 2007 and was formerly known as Easy Energy, Inc. On May 14, 2021, Easy Energy and Raphael Israel completed the Share Exchange, as a result of which, Raphael Israel’s shareholders own 90% of our Company and Easy Energy’s shareholders hold the remaining 10%. Raphael Israel was incorporated in 2019 in the State of Israel and has focused to date on developing its lead product candidate for the treatment of RA. Easy Energy did not have any ongoing business or operations before the Share Exchange and following the Share Exchange we adopted Raphael Israel’s business plan.

 

On July 17, 2019,Initially, we entered into a sponsored research agreement, or the Research Agreement, with Rambam Med-Tech Ltd., or Rambam MT, pursuantintend to which the Company agreed to fund a research project, to be performed by Rambam MT, with a research plan aimed at identifying the effects of different cannabis strains on the function of immune cells.

In October 2020, we entered into an agreement with Way of Life Cannabis Ltd., or Wolc, pursuant to which Raphael Israel is scheduled to be provided with up to 15 liters of CBD oil, from a strain of cannabis of our selection, during a term of 18 months, to be provided in two to three deliveries of between one to seven milliliters of CBD oil. We believe that our current agreement with Wolc will provide us with sufficient amounts of CBD oil in order to complete our clinical development and for initial sales of our pharmaceutical drug products.

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. In January 2021, we commenced at the laboratories of Rambam Hospital a pre-clinical trial in miceobtain approvals for our RA product candidatecandidates from the FDA and Medical Cannabis Unit of the Ministry of Health of Israel. Upon obtaining FDA approvals, or in the event that we expect will take fourare not successful in obtaining such approvals, we intend to five months.


On February 15, 2021,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 strains for the Companypurpose of growing, cultivating, manufacturing, 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. This agreement is for an initial term of 48 months.

COVID-19 Developments

As of the date of this quarterly report, to date, we have not experienced any material impact on our financial condition and results of operations due to COVID-19, and we do not expect to experience any material impact on our overall liquidity positions and outlook as a result of the outbreak. Nevertheless, given that COVID-19 is still an ongoing eventdistributing Raphael Pharmaceutical medical indications in different parts of the world, it is still not possible at this time to estimate the full impact that the COVID-19 pandemic, the continued spread of COVID-19, and any additional measures taken by governments, health officials or by us in response to such spread, could have on our business results of operations and financial condition.their designated territories. 

 

Critical Accounting Policies

 

Our financial statements are prepared in accordance with US GAAP. There are no critical accounting estimates for the years ended December 31, 20202021 and 2019.2020. 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 September 30, 2021March 31, 2022 compared to the three months ended September 30, 2020March 31, 2021

 

Revenues. We had no revenues during the three months ended September 30, 2021March 31, 2022 and September 30, 2020.March 31, 2021.


 

Research and Development Expenses. Our research and development expenses totaled $161,000$86,000 for the three months ended September 30, 2021,March 31, 2022, representing an increasea decrease of $92,000,$83,000, or 133%49%, compared to $69,000$169,000 for the three months ended September 30, 2020.March 31, 2021. The increasedecrease was primarily attributable to the increasedecrease in research and development agreement with Rambam hospital.pre-clinical trial expenses.

  

General and Administrative Expenses. Our general and administrative expenses totaled $257,000$89,000 for the three months ended September 30, 2021,March 31, 2022, representing ana increase of $91,000,$6,000, or 55%7%, compared to $166,000$83,000 for the three months Ended September 30, 2020.ended March 31, 2021. The increase was primarily attributabledue to the increaselower professional services expenses in professional services.2021.

 

Operating Loss. Our operating loss totaled $418,000$175,000 for the three months ended September 30, 2021,March 31, 2022, representing an increasea decrease of $183,000,$77,000, or 78%30%, compared to $235,000$252,000 for the three months ended September 30, 2020.March 31, 2021.

 

Financing Expenses, Net.Financial Expense. We recognized financing income, netfinancial expense of $2,000$10,000 for the three months ended September 30, 2021,March 31, 2022, representing a decreasean increase of $10,000,$7,000, or 125%233%, compared to finance expenses, net of $8,000$3,000 for the three months ended September 30, 2020.March 31, 2021. The decreaseincrease was primarily attributabledue to an increase in exchange rate differences.

  

Net and Comprehensive Loss. As a result of the foregoing, our loss totaled $416,000$185,000 for the three months ended September 30, 2021,March 31, 2022, representing an increasea decrease of $173,000,$70,000, or 71%27%, compared to $243,000$255,000 for the three months ended September 30, 2020.

Nine months ended September 30, 2021 compared to the nine months ended September 30, 2020

Revenues. We had no revenues during the nine months ended September 30, 2021 and September 30, 2020.

Research and Development Expenses. Our research and development expenses totaled $552,000 for the nine months ended September 30, 2021, representing an increase of $311,000, or 129%, compared to $241,000 for the nine months ended September 30, 2020. The increase was primarily attributable to the increase in research and development agreement with Rambam hospital.


General and Administrative Expenses. Our general and administrative expenses totaled $503,000 for the nine months ended September 30, 2021, representing an increase of $265,000, or 111%, compared to $238,000 for the nine months Ended September 30, 2020. The increase was primarily attributable to the increase in professional services.

Operating Loss. Our operating loss totaled $1,055,000 for the nine months ended September 30, 2021, representing an increase of $576,000, or 120%, compared to $479,000 for the nine months ended September 30, 2020.

Financing Expenses, Net. We recognized financing expense, net of $3,000 for the nine months ended September 30, 2021, representing a decrease of $6,000, or 67%, compared to $9,000 for the nine months ended September 30, 2020. The decrease considers to be immaterial.

Net and Comprehensive Loss. As a result of the foregoing, our loss totaled $1,058,000 for the nine months ended September 30, 2021, representing an increase of $570,000, or 117%, compared to $488,000 for the nine months ended September 30, 2020.March 31, 2021.

 

Liquidity and Capital Resources

 

Since inception, we have funded our operations primarily through our founder’s capital and capital received from Easy Energy. As of September 30, 2021,March 31, 2022, we had $37,000$81,000 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 $715,000$82,000 for the ninethree months period ended September 30, 2021,March 31, 2022, compared with net cash used in operating activities of $311,000$129,000 for the same period in 2020.2021. The $404,000 increase$47,000 decrease in the net cash used in operating activities during 2021,2022, compared to 2020,2021, was primarily the result of $570,000 increase$70,000 decrease in net loss.

 

Net cash used in investing activities for the ninethree months period ended September 30, 2021March 31, 2022 and for the same period in 20202021 was zero.

 

Net cash provided by financing activities for the ninethree months period ended September 30, 2021March 31, 2022 was $657,000$10,000 compared to $297,000$44,000 for the same period in 2020.2021. The increasedecrease in net cash provided by financing activities during 20212022 compared to 20202021 was mainly due to increase in proceeds from issuance of Common Stock at the amount of $173,000 and$10,000 which was offset by a receipt of a loan in 2021 at the amount of $174,000.$44,000. 

 

Off Balance Sheet Arrangements

 

Rambam Research Agreement

 

Pursuant to the Research Agreement with Rambam MT, the Company agreed to fund a research project, to be performed by Rambam MT, 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 Research Agreement is for an initial term of 48 months.

 

Pursuant to the Research Agreement, we agreed to pay Rambam $1.4 million in four equal payments, due on the first day of August on each successive year from 2019 through 2022. Furthermore, in accordance with the terms of the Research Agreement, we and Rambam MT will have joint ownership of any 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.

 

As of September 30, 2021,March 31, 2022, the Company has made twothree of the four equal payments due pursuant to the Research Agreement, for a total amount of $700,000.$1,050,000.

 

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.

 

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 capital received from Easy Energy. We have incurred losses and generated negative cash flows from operations since inception in 2019. 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 prospectus.

 

As of September 30, 2021,March 31, 2022, our cash and cash equivalents were $37,000.$81,000. We believe that our existing cash and cash equivalents will not be sufficient to fund our projected cash requirements through December 2021.September 2022. Therefore, we will require significant additional financing in the near future to fund our operations. We currently anticipate that we will require approximately $2$0.6 million for research and development activities over the course of the next 12 months. We also anticipate that we will require between $2approximately $1.4 million for capital expenditures over such 12-month period, which consists primarily of expenditures for pre-clinical trials, mice modelclinical trials and clinical trials, in addition to the dailygeneral 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: 

 

 our research and development efforts, including our ability to finish research and development projects or product development within the allotted or expected timeline;


 the cost, timing and outcomes of seeking to commercialize our products in a timely manner;
   
 our ability to generate cash flows;
   
 economic weakness, including inflation, or political instability in particular foreign economies and markets;
   
 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
   
 the costs of, and timing for, strengthening our manufacturing agreements for production of our wave energy systems.


  

In addition to the foregoing, based on our current assessment, we do not expect any material impact on our long-term liquidity due to the COVID-19 pandemic. However, we will continue to assess the effect of the pandemic to our operations. The extent to which the COVID-19 pandemic will impact our business and operations will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the duration of the COVID-19 pandemic, any restrictions on the ability of hospitals and trial sites to conduct trials that are not designed to address the COVID-19 pandemic and the perceived effectiveness of actions taken in Israel, the United States and Europe and other countries to contain and treat the disease. While the potential economic impact brought by COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global financial markets, reducing our ability to access capital in the future. In addition, a recession or long-term market correction resulting from the spread of COVID-19 could materially affect our business and the value of our Common Stock.

 

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 September 30, 2021,March 31, 2022, 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 September 30, 2021.March 31, 2022.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting during the fiscal quarter ended September 30, 2021,March 31, 2022, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 


 

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings

 

There have been no material changes to our legal proceedings as described in “Item 8.3. Legal Proceedings” in our Registration StatementAnnual Report on Form 10filed10-K filed with the SEC on September 2, 2021.March 30, 2022.

 

Item 1A. Risk Factors

 

There have been no material changes to our risk factors from those disclosed in “Item 1A. Risk Factors” in our Registration StatementAnnual Report on Form 10filed10-K filed with the SEC on SeptemberMarch 30, 2022.  

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Set forth below are the sales of all securities by the Company in the three months ended March 31, 2022, which were not registered under the Securities Act of 1933, as amended, or the Securities Act. The Company believes that each of such issuances was exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act and/or Regulation S under the Securities Act.

On March 2, 2021.  2022, the Company raised $10,000 and issued 50,000 shares of Common Stock and 30,000 warrants to purchase shares of Common Stock at an exercise price of $1.25 per share to certain investors of the Company. The warrants are exercisable until February 28, 2023.

On March 15, 2022, the Company issued 270,000 shares of Common Stock and 180,000 warrants to purchase Common Stock at an exercise price of $1.13 per share to the Company’s service provider in consideration of past services at the amount of $150,000. The warrants are exercisable until December 31, 2023.


 

Item 6. Exhibits

 

EXHIBIT INDEX

 

Exhibit No. Description
   
3.1Restated Certificate of Incorporation (incorporated by reference from Amendment No. 2 to our registration statement on Form 10 filed September 23, 2021)
3.2Bylaws (incorporated by reference from Amendment No. 2 to our registration statement on Form 10 filed September 23, 2021)
10.1Share Exchange Agreement by and between Easy Energy, Inc. and Raphael Pharmaceutical Ltd. (incorporated by reference from Amendment No. 2 to our registration statement on Form 10 filed September 23, 2021)
10.2Contractual Agreement between Raphael Pharmaceutical Ltd. and Way of Life Cannabis Ltd. (incorporated by reference from Amendment No. 2 to our registration statement on Form 10 filed September 23, 2021)
10.3Sponsored Research Agreement with Rambam Med-Tech Ltd. (incorporated by reference from Amendment No. 2 to our registration statement on Form 10 filed September 23, 2021)
31.1* Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a)..
   
31.2* Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a)..
   
32.1* Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 13501350..
   
32.2* Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 13501350..
   
101.INS Inline XBRL Instance Document
   
101.SCH Inline XBRL Taxonomy Extension Schema Document
   
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document
   
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document
   
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document
   
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document
   
104* Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)

 

**Filed herewith.

 


 

 

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: NovemberMay 16, 20212022By:/s/ Shlomo Pilo
 Name:Shlomo Pilo
 Title:Chief Executive Officer
(Principal Executive Officer)
   
Date: NovemberMay 16, 20212022By:/s/ Guy Ofir
 Name:Guy Ofir
 Title:

Chief Financial Officer

(Principal Financial Officer)

 

 

108

 

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