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    SEC Form 10-Q filed by Sunshine Biopharma Inc.

    11/5/24 4:05:21 PM ET
    $SBFM
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $SBFM alert in real time by email
    SUNSHINE BIOPHARMA INC. Form 10-Q
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    Table of Contents

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    WASHINGTON, D.C. 20549

     

    FORM 10-Q

     

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

     

    For the quarterly period ended: September 30, 2024

     

    ☐ 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: 001-41282

     

     

    SUNSHINE BIOPHARMA INC.

    (Exact name of registrant as specified in its charter)

     

    Colorado   20-5566275
    (State of other jurisdiction of incorporation)   (IRS Employer ID No.)

     

    333 Las Olas Way

    CU4 Suite 433

    Fort Lauderdale, FL 33301

    (Address of principal executive offices)

     

    954-330-0684

    (Issuer’s Telephone Number)

     

    Securities registered pursuant to Section 12(b) of the Act:

     

    Title of Each Class   Trading Symbol   Name of Each Exchange on Which Registered
    Common Stock   SBFM   The NASDAQ Stock Market LLC
    Common Stock Purchase Warrants   SBFMW   The NASDAQ Stock Market LLC

     

    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 (§232.405 of this chapter) 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. (Check one)

     

      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, par value $0.001, issued and outstanding as of November 5, 2024, was 1,999,660 shares.

     

     

     

     

     

       

     

      

    TABLE OF CONTENTS

     

        Page
         
      PART I. FINANCIAL INFORMATION  
         
    Item 1. Financial Statements 3
      Consolidated Balance Sheets as of September 30, 2024 (Unaudited) and December 31, 2023 3
      Consolidated Statements of Operations for the Nine Months Ended September 30, 2024 and 2023 (Unaudited) 4
      Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023 (Unaudited) 5
      Consolidated Statement of Shareholders' Equity for the Nine Months Ended September 30, 2024 and 2023 (Unaudited) 6
      Notes to Unaudited Consolidated Financial Statements 7
    Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 16
    Item 3. Quantitative and Qualitative Disclosures About Market Risk 22
    Item 4. Controls and Procedures 22

     

      PART II. OTHER INFORMATION  
       
    Item 1. Legal Proceedings 23
    Item 1A. Risk Factors 23
    Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 23
    Item 3. Defaults Upon Senior Securities 23
    Item 4. Mine Safety Disclosures 23
    Item 5. Other Information 23
    Item 6. Exhibits 23
      Signatures 24

     

     

     

     

     

     

     2 

     

     

    PART I. FINANCIAL INFORMATION

     

    ITEM 1. FINANCIAL STATEMENTS

     

    Sunshine Biopharma Inc.

    Consolidated Balance Sheets

     

               
       September 30,   December 31, 
       2024   2023 
       (Unaudited)     
    ASSETS        
    Current Assets:          
    Cash and cash equivalents  $12,206,655   $16,292,347 
    Accounts receivable   3,218,682    2,552,362 
    Inventory   9,820,730    5,734,755 
    Prepaid expenses   735,796    310,591 
    Total Current Assets   25,981,863    24,890,055 
    Long-Term Assets:          
    Property & equipment   590,801    365,868 
    Intangible assets   2,942,684    1,444,259 
    Right-of-use-asset   541,468    646,779 
    Total Long-Term Assets   4,074,953    2,456,906 
    TOTAL ASSETS  $30,056,816   $27,346,961 
               
    LIABILITIES          
    Current Liabilities:          
    Accounts payable & accrued expenses  $4,157,253   $2,585,466 
    Earnout payable   –    2,547,831 
    Income tax payable   254,971    299,869 
    Current portion - right-of-use-liability   116,253    118,670 
    Total Current Liabilities   4,528,477    5,551,836 
    Long-Term Liabilities:          
    Deferred tax liability   48,729    48,729 
    Right-of-use-liability   440,298    539,035 
    Total Long-Term Liabilities   489,027    587,764 
    TOTAL LIABILITIES   5,017,504    6,139,600 
               
    SHAREHOLDERS' EQUITY          
    Preferred Stock, Series B $0.10 par value per share; 1,000,000 shares authorized; 130,000 and 10,000 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively  
     
     
     
     
    13,000
     
     
     
     
     
     
     
    1,000
     
     
    Common Stock, $0.001 par value per share; 3,000,000,000 shares authorized; 1,999,660 and 14,012 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively  
     
     
     
     
     
     
     
    2,000
     
     
     
     
     
     
     
     
     
     
     
    14
     
     
     
    Capital paid in excess of par value   91,737,284    84,415,900 
    Accumulated comprehensive income   168,590    696,105 
    Accumulated (Deficit)   (66,881,562)   (63,905,658)
    TOTAL SHAREHOLDERS' EQUITY   25,039,312    21,207,361 
               
    TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY  $30,056,816   $27,346,961 

     

    See Accompanying Notes To These Financial Statements

     

     

     

     

     3 

     

     

     

    Sunshine Biopharma Inc.

    Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

     

                         
      

    3 Months Ended

    September 30,

      

    9 Months Ended

    September 30,

     
       2024   2023   2024   2023 
                     
    Sales  $8,435,178   $5,957,668   $25,279,291   $16,412,586 
    Cost of sales   5,569,027    3,967,412    17,702,546    10,641,461 
    Gross profit   2,866,151    1,990,256    7,576,745    5,771,125 
                         
    General & Administrative Expenses:                    
    Accounting   124,772    56,350    565,172    301,381 
    Consulting   475,032    221,781    576,481    745,850 
    Director fees   100,000    100,000    300,000    300,000 
    Legal   118,311    133,302    563,745    392,874 
    Marketing   282,745    241,897    737,116    502,987 
    Office   530,334    544,215    2,203,970    1,422,058 
    R&D   126,362    238,012    784,630    1,039,502 
    Salaries   2,093,850    1,144,377    5,183,738    4,344,801 
    Taxes   56,471    52,586    278,177    212,953 
    Depreciation   64,627    37,210    158,115    106,797 
    Total General & Administrative Expenses:   3,972,504    2,769,730    11,351,144    9,369,203 
                         
    (Loss) from operations   (1,106,353)   (779,474)   (3,774,399)   (3,598,078)
                         
    Other Income (Expense):                    
    Foreign exchange (loss)   15,153    40    295,921    (206)
    Interest income   108,614    207,431    396,698    624,361 
    Interest expense   –    (38,527)   (245)   (107,198)
    Total Other Income (Expense)   123,767    168,944    692,374    516,957 
                         
    Net (loss) before income taxes   (982,586)   (610,530)   (3,082,025)   (3,081,121)
    Provision for income taxes   (215,217)   (40,952)   106,121    (174,899)
    Net (Loss)  $(1,197,803)  $(651,482)  $(2,975,904)  $(3,256,020)
                         
    Comprehensive Income (Loss):                    
    Gain (Loss) from foreign exchange translation   851,640    (460,507)   (527,515)   42,702 
    Comprehensive Income (Loss)  $(346,163)  $(1,111,989)  $(3,503,419)  $(3,213,318)
                         
    Basic and fully diluted (Loss) per common share  $(0.94)  $(50.72)  $(13.61)  $(265.71)
    Weighted Average Common Shares Outstanding (Basic)   1,267,565    12,845    218,634    12,254 

     

    See Accompanying Notes To These Financial Statements

     

     

     

     

     4 

     

     

     

    Sunshine Biopharma Inc.

    Consolidated Statements of Cash Flows (Unaudited)

     

               
       September 30,   September 30, 
       2024   2023 
             
    Cash Flows From Operating Activities:          
    Net (Loss)  $(2,975,904)  $(3,256,020)
    Adjustments to reconcile net loss to net cash used in operating activities:          
    Depreciation and amortization   158,128    106,794 
    Foreign Exchange   –    (374)
    Stock issued for services   12,000    – 
    Accounts receivable   (1,321,173)   (118,482)
    Inventory   (4,201,955)   (1,221,112)
    Prepaid expenses   251,391    247,977 
    Accounts Payable & accrued expenses   2,229,074    (587,973)
    Earn-out payable   (2,547,831)   (172,076)
    Income tax payable   (727,628)   (1,084,169)
    Net Cash Flows (Used In) Operating Activities   (9,123,898)   (6,085,435)
               
    Cash Flows From Investing Activities:          
    Reduction in right-of-use asset   92,231    97,498 
    Purchase of intangible assets   (327,088)   (19,804)
    Purchase of equipment   (1,554,455)   (464,614)
    Net Cash Flows (Used In) Investing Activities   (1,789,312)   (386,920)
               
    Cash Flows From Financing Activities:          
    Proceeds from public offering net (common stock)   8,522,411    4,089,218 
    Exercise of warrants   1,940,610    1,156 
    Purchase of treasury stock   (3,139,651)   (541,143)
    Lease liability   (87,852)   (93,125)
    Net Cash Flows Provided by Financing Activities   7,235,518    3,456,106 
               
    Cash and Cash Equivalents at Beginning of Period   16,292,347    21,826,437 
    Net increase (decrease) in cash and cash equivalents   (3,677,692)   (3,016,249)
    Foreign currency translation adjustment   (408,000)   35,952 
    Cash and Cash Equivalents at End of Period  $12,206,655   $18,846,140 
               
    Supplementary Disclosure of Cash Flow Information:          
    Cash paid for income taxes  $956,012   $– 
    Stock issued for services  $12,000   $– 

     

    See Accompanying Notes To These Financial Statements

     

     

     

     

     

     5 

     

     

     

    Sunshine Biopharma Inc.

    Consolidated Statements of Shareholders' Equity (Unaudited)

     

                                         
    Three Months  Number Of Common Shares   Common   Capital Paid in Excess of Par   Treasury   Number Of Preferred Shares   Preferred   Comprehensive   Accumulated     
    Periods  Issued   Stock   Value   Stock   Issued   Stock   Income   Deficit   Total 
    Balance June 30, 2024   1,170,510    1,171   $89,842,503   $–    130,000   $13,000   $(683,050)  $(65,683,759)  $23,489,865 
    Exercise of warrants   829,150    829    1,894,781    –     –    –     –     –    1,895,610 
    Net (loss)   –    –    –    –    –    –    851,640    (1,197,803)   (346,163)
    Balance at September 30, 2024   1,999,660   $2,000   $91,737,284   $–    130,000    13,000   $168,590   $(66,881,562)   25,039,312 
                                                  
                                                  
    Balance June 30, 2023   12,873   $13   $84,447,876   $–    10,000   $1,000   $665,056   $(62,004,152)  $23,109,793 
    Repurchase stock   (34)   –    (34,321)   –     –     –     –    –    (34,321)
    Net (loss)   –    –     –    –     –    –    (460,507)   (651,482)   (1,111,989)
    Balance at September 30, 2023   12,839   $13   $84,413,555   $–    10,000   $1,000   $204,549   $(62,655,634)  $21,963,483 
                                                  
                                                  
    Nine Months                                             
    Periods                                             
    Balance December 31, 2023   14,012    14   $84,415,900   $–    10,000   $1,000   $696,105   $(63,905,658)  $21,207,361 
    Preferred Stock issued to related party   –    –     –     –    120,000    12,000    –    –    12,000 
    Common stock and pre-funded warrants issued in an underwritten offering   13,214    13    8,522,398    –    –    –    –    –    8,522,411 
    Exercise of warrants   1,972,434    1,973    1,938,637    –    –    –    –    –    1,940,610 
    Repurchase of warrants   –    –    (3,139,651)   –    –    –    –    –    (3,139,651)
    Net (loss)   –    –    –    –    –    –    (527,515)   (2,975,904)   (3,503,419)
    Balance at September 30, 2024   1,999,660   $2,000   $91,737,284   $–    130,000    13,000   $168,590   $(66,881,562)   25,039,312 
                                                  
                                                  
    Balance December 31, 2022   11,293   $11   $80,864,326   $–    10,000   $1,000   $161,847   $(59,399,614)  $21,627,570 
    Repurchase stock   (257)   –    (541,143)    –     –    –    –    –    (541,143)
    Common stock and prefunded warrants issued in a private offering   1,225    1    4,089,217    –    –    –    –    –    4,089,218 
    Exercise of warrants   578    1    1,155    –    –    –    –    –    1,156 
    Net (loss)   –    –    –    –    –    –    42,702    (3,256,020)   (3,213,318)
    Balance at September 30, 2023   12,839   $13   $84,413,555   $–    10,000   $1,000   $204,549   $(62,655,634)  $21,963,483 

     

    See Accompanying Notes To These Financial Statements

     

     

     

     

     6 

     

     

    Sunshine Biopharma Inc.

    Notes to Unaudited Consolidated Financial Statements

    For the Nine Months Ended September 30, 2024 and 2023

     

    Note 1 – Description of Business

     

    The Company was incorporated under the name Mountain West Business Solutions, Inc. on August 31, 2006, in the State of Colorado. Effective October 15, 2009, the Company acquired Sunshine Biopharma Inc. in a transaction classified as a reverse acquisition. Upon completion of the reverse acquisition, the Company changed its name to Sunshine Biopharma Inc. and began operating as a pharmaceutical company.

     

    Sunshine Biopharma operates two wholly owned subsidiaries: (i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation with a portfolio of pharmaceutical products consisting of 63 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc. (“Sunshine Canada”), a Canadian corporation which develops and sells nonprescription over-the-counter (“OTC”) products.

     

    The Company has determined that it has two reportable segments:

     

      · Prescription Generic Pharmaceuticals (“Generic Pharmaceuticals”)
      · Nonprescription Over-The-Counter Products (“OTC Products)

     

    Through September 30, 2024, sales from the Generic Pharmaceuticals segment represented approximately 97% of total revenues of the Company while the remaining approximately 3% was generated from the sale of OTC Products. Based on these results, the Company deems segmentation reporting to be immaterial at September 30, 2024.

     

    The Company is not subject to material customer concentration risks as it sells its products directly to pharmacies in several Canadian provinces. However, in Canada provincial governments reimburse patients for their prescription drugs expenditures to various degrees under drug reimbursement programs, making generic drugs prices highly dependent on governmental policies which may change over time. The most recent negotiations between the pan-Canadian Pharmaceutical Alliance and the Canadian Generic Pharmaceutical Association resulted in updated generic pricing for certain products which took effect on October 1, 2023. The updated prices are valid for three years and the agreement may be extended for an additional two years.

     

    In addition, the Company is engaged in the development of the following proprietary drugs:

     

      · Adva-27a, a small chemotherapy molecule for treatment of pancreatic cancer (IND-enabling studies were paused on November 2, 2023)
      · K1.1 mRNA, a lipid nano-particle (LNP) targeted for liver cancer
      · SBFM-PL4, a protease inhibitor for treatment of SARS Coronavirus infections

     

     

     

     

     7 

     

     

    Note 2 – Basis of Presentation

     

    The unaudited consolidated financial statements of the Company for the three and nine month periods ended September 30, 2024 and 2023, have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the financial position and the results of operations. Results shown for interim periods are not necessarily indicative of the results to be obtained for a full fiscal year. The balance sheet information as of December 31, 2023, was derived from the audited financial statements included in the Company's financial statements as of and for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2024. These financial statements should be read in conjunction with that report.

     

    On April 17, 2024 and August 8, 2024, the Company completed 1-for-100 and 1-for-20 reverse splits of its common stock, respectively (the “Reverse Splits”). The share amounts, warrants, and related parameters specified in this report have been adjusted to reflect both Reverse Splits on a retroactive basis.

     

    Note 3 – Underwritten Public Offering

     

    On February 15, 2024, the Company completed an underwritten public offering for gross proceeds of approximately $10 million, before deducting fees to the underwriter and other offering expenses payable by the Company. The net proceeds received by the Company were $8,522,411.

     

    The offering consisted of 35,714 Units, consisting of (i) 13,214 Common Units, with each Common Unit consisting of one share of common stock, one-tenth of a Series A warrant to purchase one share of common stock (“Series A Warrant”) and two-tenths of a Series B warrant to purchase one share of common stock (“Series B Warrant”), and (ii) 22,500 Pre-Funded Units, with each Pre-Funded Unit consisting of one pre-funded warrant to purchase one share of common stock (“Pre-Funded Warrants”), one-tenth of a Series A Warrant and two-tenths of a Series B Warrant. The public offering price was $280 per Common Unit and $278 per Pre-Funded Unit. The Pre-Funded Warrants have an exercise price of $2.00 per share. The Pre-Funded Warrants are immediately exercisable and may be exercised at any time until exercised in full. The initial exercise price of each Series A Warrant was $4,200 per share of common stock or pursuant to an alternative cashless exercise option. Under the alternative cashless exercise provision, which became effective following stockholder approval in March 2024, each Series A Warrant was exercisable on a cashless basis for two shares of common stock. The Series A Warrants were exercisable immediately and expire 30 months after the initial issuance date. The initial exercise price of each Series B Warrant was $4,760 per share of common stock. The Series B Warrants are exercisable immediately and expire 60 months after the initial issuance date.

     

    In addition (effective following stockholder approval), the Series A Warrants and Series B Warrants included a provision under which, following a reverse split of the common stock, the exercise price will be adjusted to the lowest volume weighted average price (“VWAP”) for the five trading days immediately preceding and immediately following the date of reverse stock split, and the number of shares issuable upon exercise of the Series A Warrants or Series B Warrants will be adjusted such that the aggregate exercise price of the Series A Warrants or Series B Warrants will remain unchanged. The Series B Warrants do not include an alternate cashless exercise provision and can only be exercised for cash so long as the Company’s registration statement for the underlying shares remains effective.

     

     

     

     8 

     

     

    In addition, the Company granted the underwriter, Aegis Capital Corp. ("Aegis"), a 45-day option to purchase up to an additional 15% of the total number of shares of common stock and/or Pre-Funded Warrants and/or Series A Warrants and/or Series B Warrants sold in the offering, solely to cover overallotments, if any. On February 15, 2024, Aegis partially exercised its over-allotment option for a total of 415 Series A Warrants and 830 Series B Warrants.

     

    On February 13, 2024, the Company obtained stockholder approval for (i) adjustment of the number of underlying shares and exercise price for both the Series A Warrants and the Series B warrants, and (ii) the alternate cashless exercise provision for the Series A warrants.

     

    As of September 30, 2024, all of the Pre-Funded Warrants, all of the Series A warrants, and 678,865 Series B Warrants have been exercised resulting in the Company issuing 22,500, 1,120,784, and 678,865 shares of common stock, respectively. In connection with such exercises, the Company received net proceeds of $45,000, $0, and $1,892,608, respectively.

     

    As of September 30, 2024, the only warrants remaining outstanding in connection with this offering are 12,934,062 Series B Warrants exercisable at $2.7879 per share. The exercise price and number of underlying shares under the Series B Warrants are subject to further adjustments.

     

    Note 4 – Acquisition of Nora Pharma Inc.

     

    On October 20, 2022, the Company acquired all of the issued and outstanding shares of Nora Pharma Inc. (“Nora Pharma”), a Canadian privately held pharmaceutical company. The purchase price for the shares was $18,860,637, $14,346,637 of which was paid in cash and the remainder was paid through the issuance of 1,850 shares of the Company’s common stock valued at $4,514,000 or $2,440 per share. Nora Pharma sells generic pharmaceutical products in Canada. Nora Pharma’s operations are authorized by a Drug Establishment License issued by Health Canada.

     

    The following table summarizes the allocation of the purchase price as of October 20, 2022, the acquisition date using Nora Pharma’s balance sheet assets and liabilities:

    Schedule of allocation of purchase price    
    Accounts receivable  $1,358,121 
    Inventory   3,181,916 
    Intangible assets   659,571 
    Equipment & furniture   210,503 
    Other assets   1,105,093 
    Total assets   6,515,204 
    Liabilities assumed   (5,981,286)
    Net assets   533,918 
    Goodwill   18,326,719 
    Total Consideration  $18,860,637 

     

    The value of the 1,850 shares issued as part of the consideration paid for Nora Pharma was determined based on the reverse splits adjusted closing market price of the Company’s common stock on the acquisition date, October 20, 2022 ($2,440 per share). See Note 6 – Reverse Stock Splits

     

    The Company impaired 100% of the goodwill amount in 2022 and plans to depreciate the intangible assets as detailed in Note 5 below.

     

    As part of the consideration paid for Nora Pharma, the Company agreed to a $5,000,000 CAD ($3,632,000 USD) earn-out payable to Mr. Malek Chamoun, the Seller of Nora Pharma and its current President. The earnout is payable in the form of twenty (20) payments of $250,000 CAD for every $1,000,000 CAD increase in gross sales (as defined in the Purchase Agreement) above Nora Pharma’s June 30, 2022 gross sales, provided that his employment with the Company is not terminated pursuant to the Company’s employment agreement with him. The total earn-out amount of $3,632,000 has been recorded as a salary payable. During the fiscal year ended December 31, 2023, the Company paid an earn-out of $1,084,169 for the fiscal year ended December 31, 2022. On April 22, 2024, the Company paid an earn-out of $3,093,878 CAD (approximately $2,291,761 USD) for the earn-out realized in fiscal year 2023. The current remaining earn-out balance is $479,207 CAD (approximately $354,968 USD).

     

     

     

     9 

     

     

    Note 5 – Intangible Assets

     

    Intangible assets, net consisted of the following:

     Schedule of intangible assets        
       September 30,
    2024
       December 31,
    2023
     
    Balance at beginning of the year  $1,444,259    776,856 
    Purchase of additional intangible assets (licenses)   1,594,373    710,372 
    Total   3,038,632    1,487,228 
    Less accumulated amortization   (95,948)   (42,969)
    Finite-lived intangible assets, net  $2,942,684   $1,444,259 

     

    As of September 30, 2024, the estimated amortization amounts of the Company’s intangible assets for each of the next five years are as follows: 

     Schedule of estimated amortization expense     
     2025   $105,462 
     2026    105,462 
     2027    105,462 
     2028    71,032 
     2029    19,621 

     

    Note 6 – Reverse Stock Splits

     

    Effective April 17, 2024 and August 8, 2024, the Company completed 1-for-100 and 1-for-20 reverse splits of its common stock, respectively. The Company had previously completed three (3) reverse stock splits including a 1-for-200 reverse split on February 9, 2022, and two 1-for-20 reverse splits, one in 2019 and the other in 2020. The Company’s financial statements included in this report reflect all five (5) reverse stock splits on a retroactive basis for all periods presented and for all references to common stock, unless specifically stated otherwise.

     

    Note 7 – Capital Stock

     

    The Company’s authorized capital is comprised of 3,000,000,000 shares of common stock, par value $0.001, and 30,000,000 shares of preferred stock, $0.10 par value. As of September 30, 2024, the Company had authorized 1,000,000 shares of Series B Preferred Stock. The Series B Preferred Stock is non-convertible and non-redeemable. It has a liquidation preference equal to the stated value of $0.10 per share, relative to the common stock and gives the holder the right to 1,000 votes per share. As of September 30, 2024, 130,000 shares of Series B Preferred Stock were outstanding and held by the Company’s Chief Executive Officer.

     

    On February 17, 2022, the Company completed a public offering and received net proceeds of $6,833,071 from the offering. Pursuant to the public offering, the Company issued and sold an aggregate of 941 shares of common stock and 20,051 warrants to purchase shares of common stock (the “Tradeable Warrants”).

     

    On October 12, 2023, the Company held a special meeting of the holders of the outstanding Tradeable Warrants in which the holders of the majority of the outstanding Tradeable Warrants approved an amendment to the Warrant Agent Agreement to eliminate the provision that prohibited the Company’s CEO from exercising his voting rights under the Series B Preferred Stock, as well as to lower the exercise price of the Tradeable Warrants from $4,440 to $220. The Company entered into the amendment to the Warrant Agent Agreement on October 18, 2023.

     

     

     

     10 

     

     

    On March 14, 2022, the Company completed a private placement and received net proceeds of $6,781,199. In connection with this private placement, the Company issued (i) 1,150 shares of its common stock together with investor warrants (“Investor Warrants”) to purchase up to 1,150 shares of common stock, and (ii) 651 pre-funded warrants (“Pre-Funded Warrants”) with each Pre-Funded Warrant exercisable for one share of common stock, together with Investor Warrants to purchase up to 6,511 shares of common stock. Each share of common stock and accompanying Investor Warrant was sold together at a combined offering price of $4,440 and each Pre-Funded Warrant and accompanying Investor Warrant were sold together at a combined offering price of $4,438. The Pre-Funded Warrants were immediately exercisable, at an exercise price of $2.00, and could be exercised at any time until all of the Pre-Funded Warrants were exercised in full. The Investor Warrants have an exercise price of $4,440 per share (subject to adjustment as set forth in the warrant), are exercisable upon issuance and will expire five years from the date of issuance.

     

    On April 28, 2022, the Company completed another private placement and received net proceeds of $16,752,915. In connection with this private placement, the Company issued (i) 1,236 shares of its common stock together with warrants (“April Warrants”) to purchase up to 2,472 shares of common stock, and (ii) 1,195 pre-funded warrants (“Pre-Funded Warrants”) with each Pre-Funded Warrant exercisable for one share of common stock, together with April Warrants to purchase up to 2,390 shares of common stock. Each share of common stock and accompanying two April Warrants were sold together at a combined offering price of $8,020 and each Pre-Funded Warrant and accompanying two April Warrants were sold together at a combined offering price of $8,018. The Pre-Funded Warrants were immediately exercisable, at an exercise price of $2.00, and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. The April Warrants have an exercise price of $7,520 per share (subject to adjustment as set forth in the warrant), are exercisable upon issuance and will expire five years from the date of issuance.

     

    On October 20, 2022, the Company issued 1,850 shares of common stock as part of the acquisition of Nora Pharma. These shares were valued at $4,514,000, or $2,440 per share.

     

    On January 19, 2023, the Company announced a stock repurchase program of up to $2 million (“Stock Repurchase Program”). During the six months ended June 30, 2023, the Company repurchased a total of 2,228 shares of common stock at an average price of $2,274.20 per share for a total cost of $506,822. The 2,228 repurchased shares were cancelled and returned to treasury reducing the number of issued and outstanding shares from 11,292 to 9,064.

     

    On May 16, 2023, the Company completed a private placement pursuant to a securities purchase agreement with an institutional investor for gross proceeds of approximately $5 million, before deducting fees to the placement agent and other offering expenses payable by the Company. The net proceeds received by the Company were $4,089,218. In connection with the private placement, the Company issued (i) 1,225 shares of common stock, (ii) 1,751 pre-funded warrants (the “May Pre-Funded Warrants”), and (iii) investor warrants (the “May Warrants”) to purchase up to 5,952 shares of common stock. Each share of common stock and accompanying two May Warrants were sold together at a combined offering price of $1,680 and each May Pre-Funded Warrant and accompanying two May Warrants were sold together at a combined offering price of $1,678. The May Pre-Funded Warrants are immediately exercisable, at an exercise price of $2.00, and may be exercised at any time until all of the May Pre-Funded Warrants are exercised in full. The May Warrants have an exercise price of $1,180 per share (subject to adjustment as set forth therein), are exercisable upon issuance and will expire five and a half years from the date of issuance.

     

    In 2022 and 2023, the Company issued a total of 5,396 shares of common stock in connection with warrant exercises for aggregate net proceeds of $13,196,681.

     

    In July 2023, the Company repurchased a total of 34 shares of common stock under the Stock Repurchase Program announced on January 19, 2023, at an average price of $1,009.20 per share for a total cost of $34,321. In October 2023, the 34 repurchased shares were cancelled and returned to treasury reducing the number of issued and outstanding shares from 12,873 to 12,839.

     

     

     

     11 

     

     

    On November 16, 2023, the Company issued 1,173 shares of common stock and received net proceeds of $2,346 in connection with the exercise of all 1,173 remaining May Pre-Funded Warrants at an exercise price of $2.00 per share.

     

    On February 8, 2024, the Company issued 20,000 shares of Series B Preferred Stock to the Company’s CEO for a purchase price of $0.10 per share.

     

    On February 15, 2024, the Company completed an underwritten public offering and in connection therewith it issued an aggregate of 35,714 shares of common stock, of which 22,500 shares were issued in connection with pre-funded warrant exercises.

     

    On March 4, 2024, the Company issued 100,000 shares of Series B Preferred Stock to the Company’s CEO for a purchase price of $0.10 per share.

     

    On April 17, 2024, the Company completed a 1-for-100 reverse split of its common stock.

     

    In April and May 2024, the Company issued 1,120,784 shares of common stock in connection with the cashless exercise of all of the Series A Warrants and received $0 in net proceeds.

     

    On August 16, 2024, the Company issued 150,285 shares of common stock in connection with the rounding up of fractional shares following the reverse stock splits of April 17, 2024 and August 8, 2024.

     

    In August and September 2024, the Company issued 678,865 shares of common stock in connection with the exercise of 678,865 Series B Warrants and received aggregate net proceed of $1,892,608.

     

    As of September 30, 2024 and December 31, 2023, the Company had a total of 1,999,660 and 14,012 shares of common stock issued and outstanding, respectively.

     

    The Company has declared no dividends since inception.

     

    Note 8 – Warrants

     

    The Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10 or ASC 815-40. Under ASC 480-10, warrants are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.

     

     

     

     12 

     

     

    In 2022, 2023, and during the nine months ended September 30, 2024, the Company completed five (5) financing events, and in connection therewith, it issued warrants as follows:

    Schedule of warrants issued with financing             
    Type   Number   Exercise Price   Expiry Date
    2022 Pre-Funded Warrants   1,846   $2.00   Unlimited
    Tradeable Warrants   2,051   $4,440.00   February 2027
    Investor Warrants   1,801   $4,440.00   March 2027
    April Warrants   4,862   $7,520.00   April 2027
    May Pre-Funded Warrants   1,751   $2.00   Unlimited
    May Investor Warrants   5,952   $1,180.00   November 2028
    2024 Pre-Funded Warrants   22,500   $2.00   Unlimited
    Series A Warrants   3,986*   $4,200.00*   August 2026
    Series B Warrants   7,973*   $4,760.00*   February 2029

     

    * Subject to adjustments per the Series A and Series B Warrant Agreements.

     

    As of September 30, 2024, all of the 2022 Pre-Funded Warrants, all of the May Pre-Funded Warrants, all of the 2024 Pre-Funded Warrants, a total of 1,569 Tradeable Warrants, 1,401 Investor Warrants, all of the Series A Warrants, and 678,865 Series B Warrants were exercised resulting in aggregate net proceeds of $15,134,289 received by the Company.

     

    On February 11, 2024, the Company redeemed all of the April Warrants and all of the May Investor Warrants for an aggregate purchase price of $3,139,651.

     

    The Company’s outstanding warrants as of September 30, 2024 consisted of the following:

     Schedule of warrants outstanding            
    Type   Number   Exercise Price   Expiry Date
    Tradeable Warrants   481   $220.00   February 2027
    Investor Warrants   400   $4,440.00   March 2027
    Series B Warrants   12,934,062*   $2.7879*   February 2029
     
    * As adjusted and subject to further adjustments per the Series B Warrant Agreements.

      

    Note 9 – Earnings Per Share

     

    The following table sets forth the computation of basic and diluted net income per share for the quarters ended September 30:

    Schedule of computation of basic and diluted net income per share        
       2024   2023 
    Net gain (loss) attributable to common stock  $(1,197,803)  $(651,482)
    Basic weighted average outstanding shares of common stock   1,267,565    12,845 
    Dilutive common share equivalents   –    – 
    Dilutive weighted average outstanding shares of common stock   1,267,565    12,845 
    Net gain (loss) per share attributable to common stock  $(0.94)  $(50.72)

     

     

     

     13 

     

     

    Note 10 – Lease

     

    The Company has obligations as a lessee for office and warehouse space with initial non-cancellable terms in excess of one year. The Company classified the lease as an operating lease. The lease contains a renewal option for a period of five years. Because the Company is certain to exercise the renewal option, the optional period is included in determining the lease term, and associated payments under the renewal option are included in the lease payments. The Company’s lease does not include termination options for either party to the lease or restrictive financial or other covenants. Payments due under the lease include fixed payments plus a variable payment. The Company’s lease requires it to make variable payments for the Company’s proportionate share of building’s property taxes, insurance, and common area maintenance. These variable lease payments are not included in lease payments used to determine lease liability and are recognized as variable costs when incurred.

     

    Amounts reported on the balance sheet as of September 30, 2024, were as follows:

    Schedule of lease information       
    Operating lease ROU asset     $541,468
    Operating lease liability - Short-term     $116,253
    Operating lease liability - Long-term     $440,298
    Remaining lease term     5 years 3 months
    Discount rate     6%

     

    Amounts disclosed for ROU assets obtained in exchange for lease obligations and reductions of ROU assets resulting from reductions of lease obligations include amounts reduced from the carrying amount of ROU assets resulting from deferred rent.

     

    Maturities of lease liabilities under non-cancellable operating leases at September 30, 2024 are as follows:

    Schedule of maturities of lease liabilities          
    2024     $ 28,418  
    2025     $ 116,458  
    2026     $ 110,305  
    2027     $ 103,897  
    2028     $ 97,861  
    Thereafter     $ 99,611  

     

    Note 11 – Management and Director Compensation

     

    The Company paid its officers cash compensation totaling $240,176 and $245,000, and $1,595,711 and $1,290,000 for the three- and nine-month periods ended September 30, 2024 and 2023, respectively. Of the $1,595,711 amount, $400,000 was paid to Advanomics Corporation, a company controlled by the CEO of the Company.

     

    The Company paid its directors aggregate cash compensation totaling $100,000 for each of the three months periods ended September 30, 2024 and 2023, and $300,000 for each of the nine-month periods ended September 30, 2024 and 2023.

     

     

     

     14 

     

     

    Note 12 – Income Taxes

     

    Our Income tax (expense) / benefit of $(130,551) and $190,787 for the three and nine months ended September 30, 2024, respectively, is primarily due to operations outside of the United States and changes in valuation allowance related to certain deferred tax assets generated or utilized in the applicable period.

     

    Our income tax (expense) of $(40,952) and $(174,899) for the three and nine months ended September 30, 2023, respectively, is primarily due to operations outside of the United States and changes in valuation allowance related to certain deferred tax assets generated or utilized in the applicable period.

     

    Deferred tax assets are regularly reviewed for recoverability by jurisdiction and valuation allowances are established based on historical and projected future taxable losses and the expected timing of the reversal of existing temporary differences. The Company has recorded valuation allowances against the majority of its deferred tax assets of September 30, 2024, and the Company expects to maintain these valuation allowances until there is sufficient evidence that future earnings can be achieved, which is uncertain at this time.

     

    The Company's consolidated financial statements contain various tax related entries the same being due to the operations of the two Canadian subsidiaries and are in compliance with Canadian tax laws.

     

     

     

     

     

     

     15 

     

     

    ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

     

    The following discussion should be read in conjunction with our consolidated financial statements and notes thereto included herein. This discussion includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. The statements contained in this Report that are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,” “likely,” “expects,” “anticipates,” “estimates,” “believes” or “plans,” or comparable terminology, are forward-looking statements based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to us that could cause such material differences are identified in this report and in our annual report on Form 10-K for the year ended December 31, 2023. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law. You are advised, however, to consult any future disclosures we make on related subjects in future reports we file with the SEC.

     

    About Sunshine Biopharma

     

    We are a pharmaceutical company offering and researching life-saving medicines in a wide variety of therapeutic areas, including oncology and antivirals. We operate two wholly owned subsidiaries: (i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation with a portfolio consisting of 63 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc. (“Sunshine Canada”), a Canadian corporation which develops and sells nonprescription over-the-counter (“OTC”) products.

     

    In addition, we are conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA targeted for liver cancer, (ii) SBFM-PL4, a PLpro protease inhibitor for SARS Coronavirus infections, and (iii) Adva-27a for pancreatic cancer. Development of the latter has been paused pending further analysis of unfavorable in vitro results obtained in the second half of 2023. See “Drugs in Development” below.

     

    History

     

    We were incorporated in the State of Colorado on August 31, 2006, and on October 15, 2009, we acquired Sunshine Biopharma Inc. in a transaction classified as a reverse acquisition. Sunshine Biopharma Inc. held an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a (the “License Agreement”). Upon completion of the reverse acquisition, we changed our name to Sunshine Biopharma Inc. and began operating as a pharmaceutical company.

     

    In December 2015, we acquired all issued (US Patent Number 8,236,935, and 10,272,065) and pending patents under PCT/FR2007/000697 and PCT/CA2014/000029 for the Adva-27a anticancer compound and terminated the License Agreement. Development of Adva-27a has recently been paused pending further analysis of unexpected in vitro results obtained in the latter part of 2023. See “Drugs in Development” below.

     

    In early 2020, we initiated a new R&D project focused on the development of a treatment for COVID-19 and on May 22, 2020, we filed a provisional patent application in the United States for the new coronavirus treatment. The patent application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro. On April 30, 2021, we filed a PCT application containing new research results and extending coverage to include inhibitors for the Coronavirus Papain-Like protease, PLpro.

     

    In June 2021, we initiated another R&D project in which we set out to determine if certain mRNA molecules can be used as anticancer agents. The data obtained for mRNA molecules bearing the laboratory name K1.1 became the subject of a new patent application filed in April 2022.

     

    On October 20, 2022, we acquired Nora Pharma, a Canadian generic pharmaceuticals company based in the greater Montreal area. Nora Pharma has 46 employees and operates in a 23,500 square foot facility certified by Health Canada. Nora Pharma currently has 63 generic prescription drugs on the market in Canada and is planning to launch 32 additional generic prescription drugs in the remainder of 2024 and 2025.

     

     

     

     

     16 

     

     

    Products on the Market

     

    Through Nora Pharma we currently have the following generic prescription drugs on the market in Canada:

     

    Drug   Action/Indication   Reference Brand
    Abiraterone*   Oncology   Zytiga®
    Alendronate   Osteoporosis   Fosamax®
    Amlodipine   Cardiovascular   Norvasc®
    Apixaban   Cardiovascular   Eliquis®
    Aripiprazole   Antipsychotic   Abilify®

    Atorvastatin

     

    Cardiovascular

     

    Lipitor®

    Betahistine   Vertigo   Serc®
    Azithromycin   Antibacterial   Zithromax®
    Candesartan   Hypertension   Atacand®
    Candesartan HCTZ Hypertension   Atacand Plus®
    Celecoxib   Anti-inflammatory   Celebrex®
    Cetirizine   Allergy   Reactine®
    Clobetasol*   Anti-inflammatory   Clobex®
    Ciprofloxacin   Antibiotic   Cipro®
    Citalopram   Central nervous system   Celexa®
    Clindamycin   Antibiotic   Dalacin®
    Clopidogrel   Cardiovascular   Plavix®
    Dapagliflozin   Diabetes   Forxiga®
    Daptomycin*   Antibacterial   Cubicin®
    Dasatinib*   Oncology   Sprycel®
    Donepezil   Central nervous system   Aricept®
    Duloxetine   Central nervous system   Cymbalta®
    Dutasteride   Urology   Avodart®
    Ertapenem*   Antibacterial   Invanz®
    Escitalopram   Central nervous system   Cipralex®
    Ezetimibe   Cardiovascular   Ezetrol®
    Finasteride   Urology   Proscar®
    Flecainide   Cardiovascular   Tambocor®
    Fluconazole   Antifungal   Diflucan®
    Fluoxetine   Central nervous system   Prozac®
    Hanzema®*   Dermatology   Toctino®
    Hydroxychloroquine Antimalarial   Plaquenil®
    Lacosamide   Central nervous system   Vimpat®
    Letrozole   Oncology   Femara®
    Levetiracetam   Central nervous system   Keppra®
    Mirtazapine   Central nervous system   Remeron®
    Metformin   Diabetes   Glucophage®
    Montelukast   Allergy   Singulair®
    Olmesartan   Cardiovascular   Olmetec®
    Olmesartan HCTZ Cardiovascular   Olmetec Plus®
    Pantoprazole   Gastroenterology   Pantoloc®
    Paroxetine   Central nervous system   Paxil®
    Perindopril   Cardiovascular   Coversyl®
    Pravastatin   Cardiovascular   Pravachol®
    Pregabalin   Central nervous system   Lyrica®
    Progesterone*   Women's Health   Prometrium®
    Quetiapine   Central nervous system   Seroquel®
    Quetiapine XR   Central nervous system   Seroquel XR®
    Ramipril   Cardiovascular   Altace®
    Rivaroxaban*   Cardiovascular   Xarelto®
    Rizatriptan ODT Central nervous system   Maxalt® ODT
    Rosuvastatin Cardiovascular   Crestor®
    Sertraline Central nervous system   Zoloft®
    Sildenafil Urology   Viagra®
    Tadalafil Urology   Cialis®
    Telmisartan Cardiovascular   Micardis®
    Telmisartan HCTZ Cardiovascular   Micardis Plus®
    Topiramate Anticonvulsant    Topamax®

    Tramadol Acetaminophen

    Central nervous system

     

    Tramacet®

    Varenicline Smoking cessation   Champix®
    Zoledronic Acid* Osteoporosis   Aclasta®
    Zolmitriptan Central nervous system   Zomig®
    Zopiclone Central nervous system   Imovane®

     

    *Sold through distribution agreements

     

     

     

     17 

     

     

    In addition to the 63 drugs currently on the market, we have 32 additional drugs scheduled to be launched in Q4 2024 and in 2025. These new drugs will address various human health areas including cardiovascular, oncology, gastroenterology, central nervous system, diabetes, urology, endocrinology, anti-infective, and anti-inflammatory. Among the new drugs to be launched in 2024 is NIOPEG®, a biosimilar of NEULASTA®. Like NEULASTA®, NIOPEG® is a long-acting form of recombinant human granulocyte colony-stimulating factor (filgrastim). It is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving anti-neoplastic therapy. Nora Pharma received Health Canada marketing approval for NIOPEG® on April 17, 2024. NIOPEG® is anticipated to be on the market in Canada in Q4 2024.

     

    We believe the addition of these new products to our existing portfolio will strengthen our presence in the Canadian $9.7 billion a year generic drugs market and provide us with greater access to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.

     

    Drugs in Development

     

    The following table summarizes our proprietary drugs in development:

     

    Drug Candidate   Therapeutic Area   Development Stage
    Adva-27a (Small Molecule)   Oncology (Pancreatic Cancer)   Paused*
    K1.1 (mRNA LNP)   Oncology (Liver Cancer)   Animal Testing
    SBFM-PL4 (Small Molecule)   Antiviral (SARS Coronavirus)   Animal Testing

     

    * See “Adva-27a Anticancer Compound” below

     

    Adva-27a Anticancer Compound

     

    Adva-27a is a small molecule designed for the treatment of aggressive forms of cancer. A Topoisomerase II inhibitor, Adva-27a has been shown to be effective at destroying Multidrug Resistant Cancer cells including Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). We are the direct owner of all patents pertaining to Adva-27a including U.S. Patents Number 8,236,935 and 10,272,065.

     

    In December 2022, we entered into a research agreement with the Jewish General Hospital (“JGH”), to conduct the IND-enabling studies of Adva-27a (the “Research Agreement”). In August 2023, we were informed by the JGH that the laboratory test results of the Adva-27a molecule were not favorable. After conclusion of an internal review of the laboratory results on November 2, 2023, we provided notice to JGH of termination of the Research Agreement. We have paused the IND-enabling studies of Adva-27a pending a review of the results and the possibility of chemical modification of the compound to address the suboptimal performance of the molecule in certain studies.

     

     

     

     18 

     

     

    K1.1 Anticancer mRNA

     

    In June 2021, we initiated a new research project in which we set out to determine if certain mRNA molecules can be used as anti-cancer agents. The data collected to date have shown that a selected group of mRNA molecules are capable of destroying cancer cells in vitro including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2). Studies using non-transformed (normal) human cells (HMEC cells) showed that these mRNA molecules had little cytotoxic effects. These new mRNA molecules, bearing the laboratory name K1.1, are readily adaptable for delivery into patients using the mRNA vaccine technology. In April 2022, we filed a provisional patent application in the United States covering the subject mRNA molecules.

     

    In November 2022, we concluded an agreement with a specialized commercial partner for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles (“LNP”) for use to conduct xenograft mice studies. The initial results of our xenograft mice studies indicate that our K1.1 mRNA-LNP is effective at reducing the size of liver cancer xenograft tumors in mice. We are currently seeking to confirm these results by conducting additional xenograft experiments on a broader scale and in more detailed dose-response studies.

     

    SBFM-PL4 SARS Coronavirus Treatment

     

    The initial genome expression products following infection by Betacoronavirus, the causative agent of COVID-19, are two large polyproteins, referred to as pp1a and pp1ab. These two polyproteins are cleaved at 15 specific sites by two virus encoded proteases, called Mpro and PLpro, to generate 16 different non-structural proteins essential for viral replication. Mpro and PLpro represent attractive anti-viral drug development targets as they play a central role in the early stages of viral replication. PLpro is of particular interest as a therapeutic target in that, in addition to processing essential viral proteins, it is also responsible for suppression of the human immune system making the virus more life-threatening. PLpro is present only in Betacoronaviruses, the subgroup of Coronaviruses represented by the highly pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.

     

    Our Anti-Coronavirus research effort has been focused on developing an inhibitor of PLpro and, on May 22, 2020, we filed a patent application in the United States covering composition subject matter pertaining to small molecules for inhibition of the Coronavirus PLpro as well as Mpro.

     

    In February 2022, we expanded our PLpro inhibitors research effort by entering into a research agreement with the University of Arizona for the purposes of conducting research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research Project”). Under the agreement, the University of Arizona granted us a first option to negotiate a commercial, royalty-bearing license for all intellectual property developed by University of Arizona under the Research Project. In addition, we and the University of Arizona have entered into an option agreement (the “Option Agreement”) whereby we were granted a first option to negotiate a royalty-bearing commercial license for the underlying technology of the Research Project. On September 13, 2022, we exercised our options, and on February 24, 2023, we entered into an exclusive worldwide license agreement with the University of Arizona for all of the technology related to the Research Project.

     

    We have recently broadened our objective to include the development of an injectable drug candidate of first-in-class PLpro inhibitor to treat SARS-CoV2 and potentially SARS-CoV and MERS-CoV infection in patients who could not use Paxlovid, Molnupiravir, or Remdesivir, due to concerns about drug interactions and possible ‘rebound’ infections and other side effects.

     

     

     

     19 

     

     

    Intellectual Property

     

    We are the sole owner of all rights pertaining to Adva-27a. These patent rights are covered by PCT/FR2007/000697 and PCT/CA2014/000029. The patent applications filed under these two PCT's have been issued in the United States under US Patent Number 8,236,935 and 10,272,065.

     

    On May 22, 2020, we filed a provisional patent application in the United States for a new treatment for Coronavirus infections. Our patent application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro, an enzyme that is essential for viral replication. The patent application has a priority date of May 22, 2020. On April 30, 2021, we filed a PCT application containing new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro. The priority date of May 22, 2020 has been maintained in the newly filed PCT application.

     

    On April 20, 2022, we filed a provisional patent application in the United States covering mRNA molecules capable of destroying cancer cells in vitro. The patent application contains composition and utility subject matter pertaining to the structure and sequence of the relevant mRNA molecules.

     

    Effective February 24, 2023, we became the exclusive, worldwide licensee of the University of Arizona for three (3) patents related to small molecules which inhibit the Coronavirus protease, PLpro.

     

    Our wholly owned subsidiary, Nora Pharma, owns 152 DIN’s issued by Health Canada for prescription drugs currently on the market in Canada. These DIN’s were secured through in-licenses or cross-licenses from international manufacturers of generic pharmaceutical products.

     

    In addition, we are the owner of four (4) NPN’s issued by Health Canada including (i) NPN 80089663 which authorizes us to manufacture and sell our in-house developed OTC product, Essential•9, (ii) NPN 80093432 which authorizes us to manufacture and sell the OTC product, Calcium-Vitamin D under the brand name Essential Calcium-Vitamin D, (iii) NPN 80125047 which authorizes us to manufacture and sell the OTC product, L-Citrulline, and (iv) NPN 80127436 which authorizes us to manufacture and sell the OTC product, Taurine.

     

    Results of Operations

     

    Comparison of results of operations for the three months ended September 30, 2024 and 2023

     

    During the three months ended September 30, 2024, we generated $8,435,178 in sales, compared to $5,957,668 for the three months ended September 30, 2023, an increase of $2,477,510, or 42%. The increase is attributable to expanded marketing and sales efforts by our wholly owned subsidiary, Nora Pharma. The direct cost for generating these sales was $5,569,027 (66%) for the three months ended September 30, 2024, compared to $3,967,412 (67%) for the three months ended September 30, 2023. Our gross profit grew to $2,866,151 for the three months ended September 30, 2024, compared to $1,990,256 for the three months ended September 30, 2023.

     

    General and administrative expenses during the three-month period ended September 30, 2024, were $3,972,504, compared to $2,769,730 during the three-month period ended September 30, 2023, an increase of $1,202,774. The increase was due to increases in accounting fees ($68,422), consulting ($253,251), marketing ($40,848), and salaries ($949,473). The increase in salaries was due to the hiring of two (2) new employees and a bonus paid to the CEO of the Company. The only expense category that saw a decrease was R&D, which was reduced by $111,650. Overall, we incurred a loss of $1,106,353 from our operations for the three months ended September 30, 2024, compared to a loss of $779,474 from our operations in the three-month period ended September 30, 2023.

     

     

     

     20 

     

     

    In addition, we had interest income of $108,614 during the three months ended September 30, 2024, compared to net interest income of $168,904 during the three months ended September 30, 2023, as a result of less interest earned on cash on hand.

     

    As a result, we incurred a net loss of $1,197,803 ($0.94 per share) for the three months ended September 30, 2024, compared to a net loss of $651,482 ($50.72 per share) for the three-month period ended September 30, 2023.

     

    Comparison of results of operations for the nine months ended September 30, 2024 and 2023

     

    During the nine months ended September 30, 2024, we generated revenues of $25,279,291, compared to revenue of $16,412,586 for the nine months ended September 30, 2023, an increase of $8,866,705, or 54%. The increase is attributable to expanded marketing and sales efforts by our wholly owned subsidiary, Nora Pharma. The direct cost for generating these revenues was $17,702,546 for the nine months ended September 30, 2024 (70%), compared to $10,641,461 (65%) for the nine months ended September 30, 2023. The increase in the cost of sales in the nine-month period of 2024 is related to greater retailer allowances offered to gain access to new regional markets. Our gross profit increased to $7,576,745 for the nine months ended September 30, 2024, compared to a gross profit of $5,771,125 for the same period in 2023.

     

    General and administrative expenses during the nine-month period ended September 30, 2024, were $11,351,144, compared to $9,369,203 during the nine-month period ended September 30, 2023, an increase of $1,981,941. The increase was a result of increases in accounting ($263,791), legal ($170,871), marketing ($234,129), office costs ($781,912), and salaries ($838,937). The two expense categories that saw a decrease were consulting ($169,369), and R&D ($254,872). Overall, we incurred a loss of $3,774,399 from our operations in the nine-month period ended September 30, 2024, compared to a loss from operations of $3,598,078 in the similar period of 2023.

     

    In addition, we had interest income of $396,453 during the nine months ended September 30, 2024, compared to interest income of $517,163 during the nine months ended September 30, 2023. The decrease was due to the Company having less cash on hand.

     

    As a result, we incurred a net loss of $2,975,904 ($13.61 per share) for the nine-month period ended September 30, 2024, compared to a net loss of $3,256,020 ($265.71 per share) for the nine-month period ended September 30, 2023.

     

    Liquidity and Capital Resources

     

    As of September 30, 2024, we had cash and cash equivalents of $12,206,655.

     

    Net cash used in operating activities was $9,123,898 during the nine months ended September 30, 2024, compared to $6,085,435 during the nine-month period ended September 30, 2023. The increase was a result of increased business activities by Nora Pharma.

     

    Cash flows used in investing activities were $1,789,312 for the nine months ended September 30, 2024, compared to $386,920 for the nine months ended September 30, 2023. The increase was the result of cash invested in Nora Pharma to finance increase in inventory and expansion of operations and product line.

     

    Cash flows provided by financing activities were $7,235,518 during the nine months ended September 30, 2024, compared to $3,456,106 during the nine months ended September 30, 2023. The increase was primarily a result of the approximately $10 million financing event completed in February 2024, compared to an approximately $5 million financing event completed in May 2023.

     

    We are not generating adequate revenues from our operations to fully implement our business plan as set forth herein. We believe our existing cash on hand will be sufficient to fund our pharmaceuticals sales operations and research and development activities for the next 24 months. There is no assurance our estimates will be accurate. We currently have no committed sources of capital and we anticipate that we will need to raise additional capital in the future, including for further research and development activities and possibly clinical trials, as well as expansion of our generic pharmaceuticals operations. Additional capital may not be available on terms acceptable to us, or at all.

     

     

     

     21 

     

     

    Critical Accounting Estimates

     

    The discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates based on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

     

    For a detailed list of significant accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31, 2023, including our financial statements and notes thereto included therein as filed with the SEC on March 28, 2024.

     

    Recently Adopted Accounting Standards

     

    We have adopted all new accounting standards impacting operations.

     

    Off Balance-Sheet Arrangements

     

    None.

     

    ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

     

    We are a smaller reporting company and are not required to provide the information under this item.

     

    ITEM 4. CONTROLS AND PROCEDURES

     

    Evaluation of Disclosure Controls and Procedures

     

    Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report.

     

    These controls are designed to ensure that information required to be disclosed in the reports we file or submit pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission, and that such information is accumulated and communicated to our management, including our CEO and CFO, to allow timely decisions regarding required disclosure.

     

    Based on this evaluation, our management, including our CEO and CFO concluded that our disclosure controls and procedures were effective as of September 30, 2024, at reasonable assurance levels.

     

    Changes in Internal Control Over Financial Reporting

     

    There were no changes in our internal control over financial reporting during the quarter ended September 30, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

     

     

     

     

     

     

     

     22 

     

     

    PART II. OTHER INFORMATION

     

    ITEM 1. LEGAL PROCEEDINGS

     

    We are not party to, and our property is not the subject of, any material legal proceedings, and we are unaware of any threatened actions.

     

    ITEM 1A. RISK FACTORS

     

    We are a smaller reporting company and are not required to provide the information under this item.

     

    ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

     

    None.

     

    ITEM 3. DEFAULTS UPON SENIOR SECURITIES

     

    None.

     

    ITEM 4. MINE SAFETY DISCLOSURES

     

    Not Applicable.

     

    ITEM 5. OTHER INFORMATION

     

    During the quarter ended September 30, 2024, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

     

    ITEM 6. EXHIBITS

     

    Exhibit No.   Description
         
    31.1   Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
    31.2   Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2022*
    32.1   Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
    101   Inline XBRL Document Set for the financial statements and accompanying notes in Part I, Item 1, of this Quarterly Report on Form 10-Q.*
    104   Inline XBRL for the cover page of this Quarterly Report on Form 10-Q, included in the Exhibit 101 Inline XBRL Document Set.*

    __________________

      * Filed herewith.

     

     

     

     

     

     

     

     23 

     

    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, on November 5, 2024.

     

      SUNSHINE BIOPHARMA INC.
         
      By: /s/ Dr. Steve N. Slilaty                       
        Dr. Steve N. Slilaty
        Chief Executive Officer (principal executive officer)
         
         
      By: /s/ Camille Sebaaly                           
        Camille Sebaaly
        Chief Financial Officer (principal financial and accounting officer)

     

     

     

     

     

     

     24 

     

     

     

     

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