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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: March 31, 2023

 

☐ 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.)

 

6500 Trans-Canada Highway

4th Floor

Pointe-Claire, Quebec, Canada H9R 0A5

(Address of principal executive offices)

 

(514) 426-6161

(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

Common Stock Purchase Warrants

SBFM

SBFMW

The NASDAQ Stock Market LLC

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 May 10, 2023, was 22,139,921 shares.

 

   

 

 

TABLE OF CONTENTS

 

    Page
     
  PART I. FINANCIAL INFORMATION  
     
Item 1. Financial Statements 3
  Consolidated Unaudited Balance Sheet as of March 31, 2023 and December 31, 2022 3
  Consolidated Unaudited Statements of Operations for the Three Months Ended March 31, 2023 and 2022 4
  Consolidated Unaudited Statements of Cash Flows for the Three Months Ended March 31, 2023 and 2022 5
  Consolidated Unaudited Statement of Shareholders' Equity for the Three Months Ended March 31, 2023 and 2022 6
  Notes to Unaudited Consolidated Financial Statements 7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 12
Item 3. Quantitative and Qualitative Disclosures About Market Risk 18
Item 4. Controls and Procedures 18

 

  PART II. OTHER INFORMATION  
   
Item 1. Legal Proceedings 19
Item 1A. Risk Factors 19
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 19
Item 3. Defaults Upon Senior Securities 19
Item 4. Mine Safety Disclosures 19
Item 5. Other Information 19
Item 6. Exhibits 19
  Signatures 20

 

 

 

 2 

 

  

PART I.  FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

Sunshine Biopharma, Inc.

Consolidated Balance Sheets

 

         
   March 31,   December 31, 
   2023   2022 
   (Unaudited)      
ASSETS          
           
Current Assets:          
Cash and cash equivalents  $19,294,218   $21,826,437 
Accounts receivable   1,790,480    1,912,153 
Inventory   3,709,987    3,289,945 
Prepaid expenses   152,262    283,799 
Total Current Assets   24,946,947    27,312,334 
           
Property and equipment   368,032    394,249 
Intangible assets   948,240    776,856 
Right-of-use-asset   728,129    760,409 
           
TOTAL ASSETS  $26,991,348   $29,243,848 
           
LIABILITIES          
           
Current Liabilities:          
Accounts payable and accrued expenses  $2,736,154   $2,802,797 
Earnout payable   3,632,000    3,632,000 
Income tax payable   416,245    373,191 
Right-of-use-liability   121,303    123,026 
Total Current Liabilities   6,905,702    6,931,014 
           
Long-Term Liabilities:          
Deferred tax liability   43,032    43,032 
Right-of-use-liability   613,136    642,232 
Total Long-Term Liabilities   656,168    685,264 
           
TOTAL LIABILITIES   7,561,870    7,616,278 
           
SHAREHOLDERS' EQUITY          
           

Preferred Stock, Series B $0.10 par value per share; 1,000,000 shares authorized;

10,000 shares issued and outstanding

   1,000    1,000 

Common Stock, $0.001 par value per share; 3,000,000,000 shares authorized;

22,139,921 and 22,585,632 issued and outstanding as of March 31, 2023 and December 31, 2022, respectively

   22,139    22,585 
Capital paid in excess of par value   80,335,376    80,841,752 
Accumulated comprehensive income   173,007    161,847 
Accumulated (Deficit)   (61,102,044)   (59,399,614)
           
TOTAL SHAREHOLDERS' EQUITY   19,429,478    21,627,570 
           
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY  $26,991,348   $29,243,848 

 

The accompanying notes are an integral part of these unaudited financial statements

 

 

 3 

 

 

Sunshine Biopharma, Inc.

Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

 

         
   March 31,   March 31, 
   2023   2022 
         
Sales  $4,894,053   $122,645 
Cost of sales   3,065,931    59,845 
Gross profit   1,828,122    62,800 
           
General and Administrative Expenses:          
Accounting   169,750    73,800 
Consulting   131,615    5,498 
Director fees   100,000    50,000 
Legal   107,449    136,225 
Marketing   127,913    95,040 
Office   482,458    282,505 
Patent fees   6,308    8,334 
R&D   432,925    361,652 
Salaries   2,000,257    270,000 
Taxes   63,718    – 
Depreciation and amortization   34,710    3,110 
Total General and Administrative Expenses   3,657,103    1,286,164 
           
(Loss) from operations   (1,828,981)   (1,223,364)
           
Other Income (Expenses):          
Foreign exchange   15    (9)
Interest income   213,881    3 
Interest expense   (41,075)   (12,864)
Total Other Income (Expenses)   172,821    (12,870)
           
Net (loss) before income taxes   (1,656,160)   (1,236,234)
Provision for income taxes   46,270    – 
Net (Loss)   (1,702,430)   (1,236,234)
           
Gain from foreign exchange translation   11,160    1,007 
Comprehensive (Loss)   (1,691,270)   (1,235,227)
           
Basic (loss) per common share  $(0.08)  $(0.23)
           
Weighted average common shares outstanding (Basic & Diluted)   22,036,272    5,272,856 

 

The accompanying notes are an integral part of these unaudited financial statements

 

 

 4 

 

 

Sunshine Biopharma, Inc.

Consolidated Statements of Cash Flows (Unaudited)

 

         
   March 31,   March 31, 
   2023   2022 
Cash Flows From Operating Activities:          
Net (Loss)  $(1,702,430)  $(1,236,234)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   34,710    3,110 
Foreign exchange   –    9 
Accounts receivable   135,891    7,774 
Inventory   (417,318)   (73,865)
Prepaid expenses   129,849    (9,007)
Accounts payable & accrued expenses   (73,661)   52,292 
Income tax payable   42,853    – 
Interest payable   –    (48,287)
Net Cash Flows (Used) in Operations   (1,850,106)   (1,304,208)
           
Cash Flows From Investing Activities:          
Reduction in Right-of-use asset   32,934    – 
Cash from Nora Pharma Inc. acquisition   (1,135)   – 
Purchase of intangible assets   (178,395)   – 
Purchase of equipment   293    – 
Net Cash Flows (Used) in Investing Activities   (146,303)   – 
           
Cash Flows From Financing Activities:          
Common stock issued for public offerings   –    14,436,673 
Purchase of treasury stock   (506,822)   (99,000)
Lease liability   (31,477)   – 
Payments of notes payable   –    (1,900,000)
Net Cash Flows (Used In) Provided by Financing Activities   (538,299)   12,437,673 
           
Cash and cash equivalents at beginning of period   21,826,437    2,045,167 
Net Increase (Decrease) in cash and cash equivalents   (2,534,708)   11,133,465 
Effect of exchange rate changes on cash   2,489   (1,007) 
Cash and cash equivalents at end of period  $19,294,218   $13,177,625 
           
Supplementary Disclosure of Cash Flow Information:        
Cash paid for interest  $–   $15,271 
Cash paid for income taxes  $–   $– 

 

The accompanying notes are an integral part of these unaudited financial statements

 

 

 5 

 

 

Sunshine Biopharma, Inc.

Consolidated Statement of Shareholders' Equity (Unaudited)

 

                                  
   Number of Common Shares Issued   Common Stock   Capital Paid in Excess of Par Value    Number of Preferred Shares Issued  

Preferred

Stock

  

Compre-

hensive Income

   Accumulated Deficit   Total 
Three Months Period Ended March 31, 2022                                         
Balance December 31, 2021   2,595,620   $2,596   $32,787,379     1,000,000   $100,000   $(23,139)  $(32,655,174)  $211,662 
Common stock and pre-funded warrants issued in public offerings   4,183,706    4,184    13,610,086     –    –    –    –    13,614,270 
Exercise of warrants   370,452    370    822,033     –    –    –    –    822,403 
Preferred stock purchased from related party   –    –    –     (990,000)   (99,000)   –    –    (99,000)
Net (loss)   –    –    –     –    –    1,007    (1,236,234)   (1,235,227)
Balance at March 31, 2022   7,149,778   $7,150   $47,219,498     10,000   $1,000   $(23,139)  $(32,655,174)   14,549,335 
                                          
Balance December 31, 2022   22,585,632   $22,585   $80,841,752     10,000   $1,000   $161,847   $(59,399,614)  $21,627,570 
Repurchased stock   (445,711)    (446)    (506,376)     –    –    –    –    (506,822)
Net (loss)   –    –    –     –    –    11,160    (1,702,430)   (1,691,270)
Balance at March 31, 2023   22,139,921   $22,139   $80,335,376     10,000    1,000   $173,007   $(61,102,044)   19,429,478 

 

The accompanying notes are an integral part of these unaudited financial statements

 

 

 6 

 

 

Sunshine Biopharma, Inc.

Notes to Consolidated Financial Statements (Unaudited)

For the three months ended March 31, 2023 and 2022

 

Note 1 – Description of Business

 

The Company was originally 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. 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 transaction, the Company changed its name to Sunshine Biopharma, Inc. and began operating as a pharmaceutical company focusing on the development of the licensed Adva-27a anticancer drug. In December 2015, the Company acquired all rights to Adva-27a by purchasing PCT/FR2007/000697 and PCT/CA2014/000029 and terminated the License Agreement.

 

On May 22, 2020, the Company filed a provisional patent application in the United States for a new treatment for Coronavirus infections. The Company’s 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, the Company 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. The Company’s lead Anti-Coronavirus compound arising from these patents bears the laboratory name SBFM-PL4.

 

On February 18, 2022, the Company entered into a research agreement (the “SRA”) 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 SRA, the University of Arizona granted the Company 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, the Company and the University of Arizona entered into an option agreement (the “Option Agreement”) whereby the Company was granted a first option to negotiate a royalty-bearing commercial license for the underlying technology of the Research Project. On September 13, 2022, the Company exercised its option under the Option Agreement and on February 24, 2023 entered into an exclusive worldwide license agreement with the University of Arizona for all of the technology related to the Research Project.

 

On April 20, 2022, the Company 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 such mRNA molecules. The lead anticancer mRNA molecule arising from this technology is targeted for liver cancer and bears the laboratory name K1.1.

 

On October 20, 2022, the Company acquired Nora Pharma Inc. (“Nora Pharma”), a Canadian generic pharmaceuticals company based in the greater Montreal area. Nora Pharma has 37 employees and operates in a 15,000 square foot facility certified by Health Canada. Nora Pharma currently offers 50 generic prescription drugs and 11 OTC products. The consolidated financial statements contained in this Report include the results of operations of Nora Pharma from January 1, 2023 through March 31, 2023.

 

Note 2 – Basis of Presentation

 

The unaudited financial statements of the Company for the three months periods ended March 31, 2023 and 2022 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, 2022 was derived from the audited financial statements included in the Company's financial statements as of and for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on April 4, 2023. These financial statements should be read in conjunction with that report.

 

 

 

 7 

 

 

Note 3 – Acquisition of Nora Pharma Inc.

 

On October 20, 2022 the Company acquired all of the issued and outstanding shares of Nora Pharma Inc. The purchase price for the shares was $18,860,637 which was paid in cash ($14,346,637) and by the issuance of 3,700,000 shares of the Company’s common stock valued at $4,514,000 or $1.22 per share. Nora Pharma is a certified company offering generic pharmaceutical products in Canada. Nora Pharma’s operations are authorized by a Drug Establishment License issued by Health Canada. Nora Pharma is also registered with the FDA.

 

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:

 

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 3,700,000 common shares issued as part of the consideration paid for Nora Pharma was determined based on the closing market price of the Company’s common shares on the acquisition date, October 20, 2022 ($1.22 per share).

 

The Company impaired 100% of the goodwill amount in 2022 and is intending to depreciate the intangible assets over 5 years using the straight-line method.

 

As part of the consideration paid for Nora Pharma, the Company agreed to a $5,000,000 CAD ($3,632,000 USD) earnout amount payable to Mr. Malek Chamoun, the Seller of Nora Pharma. 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 earnout amount of $3,632,000 has been recorded as a salary payable.

 

 

 

 

 8 

 

 

The unaudited financial information in the table below summarizes the combined results of operations of the Company (Sunshine Biopharma and Nora Pharma) for the years ended December 31, 2022 and 2021, on a pro forma basis, as though the companies had been combined as of January 1, 2021. The unaudited pro forma financial information does not purport to be indicative of the Company's combined results of operations which would have been obtained had the acquisition taken place on January 1, 2021, nor should it be taken as indicative of future consolidated results of operations:

 

Pro Forma results from acquisition  December 31,
2022		   December 31,
2021		 
Total revenues  $14,758,115   $7,927,165 
Net (loss) from operations  $(26,192,503)  $(2,224,253)
Net (loss)  $(26,164,764)  $(12,289,655)
           
Basic and fully diluted (loss) per share  $(1.74)  $(4.70)
Weighted average number of shares outstanding   15,056,097    2,612,061 

 

Note 4 – Reverse Stock Splits

 

Effective February 9, 2022, the Company completed a 1 for 200 reverse split of its common stock. The Company had previously completed two 20 to 1 reverse stock splits, one in 2019 and the other in 2020. The Company’s financial statements reflect all three reverse stock splits on a retroactive basis for all periods presented and for all references to common stock, unless specifically stated otherwise.

 

Note 5 – Capital Stock

 

The Company’s authorized capital is comprised of 3,000,000,000 shares of $0.001 par value common stock and 30,000,000 shares of $0.10 par value preferred stock, to have such rights and preferences as the Directors of the Company have or may assign from time to time. Out of the authorized Preferred Stock, the Company had previously designated 850,000 shares as Series “A” Preferred Stock (“Series A”). At December 31, 2019, the Company had no issued and outstanding shares of Series A. On June 17, 2020, the Company filed an amendment to its Articles of Incorporation (the “Amendment”) eliminating the Series A shares and the designation thereof, which shares were returned to the status of undesignated shares of Preferred Stock. In addition, the Amendment increased the number of authorized Series B Preferred Shares from five hundred thousand (500,000) to one million (1,000,000) shares. The Series B Preferred Stock is non-convertible, non-redeemable and non-retractable. It has superior liquidation rights to the common stock at $0.10 per share and gives the holder the right to 1,000 votes per share. As of December 31, 2021, there were 1,000,000 shares of the Series B Preferred Stock held by the CEO of the Company.

 

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 1,882,353 shares of common stock and 4,102,200 warrants to purchase shares of common stock (the “Tradeable Warrants”).

 

On February 22, 2022, the Company redeemed 990,000 shares of Series B Preferred Stock from the CEO of the Company at a redemption price equal to the stated value of $0.10 per share.

 

 

 

 9 

 

 

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) 2,301,353 shares of its common stock together with investor warrants (“Investor Warrants”) to purchase up to 2,301,353 shares of common stock, and (ii) 1,302,251 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 1,302,251 shares of common stock. Each share of common stock and accompanying Investor Warrant was sold together at a combined offering price of $2.22 and each Pre-Funded Warrant and accompanying Investor Warrant were sold together at a combined offering price of $2.219. The Pre-Funded Warrants were immediately exercisable, at a nominal exercise price of $0.001, and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. The Investor Warrants have an exercise price of $2.22 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) 2,472,820 shares of its common stock together with warrants (“April Warrants”) to purchase up to 4,945,640 shares of common stock, and (ii) 2,390,025 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 4,780,050 shares of common stock. Each share of common stock and accompanying two April Warrants were sold together at a combined offering price of $4.01 and each Pre-Funded Warrant and accompanying two April Warrants were sold together at a combined offering price of $4.009. The Pre-Funded Warrants were immediately exercisable, at a nominal exercise price of $0.001, 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 $3.76 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 3,700,000 shares of common stock as part of the acquisition of Nora Pharma. These shares were valued at $4,514,000, or $1.22 per share.

 

During the fiscal year ended December 31, 2021, the Company issued an aggregate of 559,144 shares of its common stock valued at $12,705,214 in connection with the conversion of $2,867,243 in debt and interest of $127,986 resulting in a loss of $9,726,485 on conversion. In addition, the Company issued 300,000 shares of its common stock valued at $918,000 as compensation to its directors. In total, 859,114 shares of common stock were issued during the fiscal year ended December 31, 2021.

 

On January 19, 2023, the Company announced a stock repurchase program of up to $2 million under SEC Rule 10B-18. During the three months ended March 31, 2023, the Company repurchased a total of 445,711 shares of common stock at an average price of $1.1371 per share for a total cost of $506,822. The 445,711 repurchased common shares were cancelled and returned to treasury reducing the number of issued and outstanding shares from 22,585,632 to 22,139,921.

 

Through March 31, 2023 and December 31, 2022, the Company has a total of 22,139,921 and 22,585,632 shares of common stock issued and outstanding, respectively.

 

The Company has declared no dividends since inception.

 

Note 6 – 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.

 

 

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In 2022, the Company completed three financing events, and in connection therewith, it issued warrants as follows:

             
Type   Number   Exercise Price   Expiry Date
Pre-Funded Warrants   3,692,276   $0.001   Unlimited
Tradeable Warrants   4,102,200   $2.22*   February 2027
Investor Warrants   3,603,604   $2.22   March 2027
April Warrants   9,725,690   $3.76   April 2027

 

* The Tradeable Warrants had an initial exercise price of $4.25, subject to adjustment. Upon the closing of the Company's private placement on March 14, 2022, the exercise price of the Tradeable Warrants was reduced to $2.22, in accordance with the terms thereof.

 

As of March 31, 2023, all of the Pre-Funded Warrants and a total of 3,138,507 Tradeable Warrants were exercised resulting in aggregate proceeds of $6,971,178 received by the Company. During the three month period ended March 31, 2023, no Investor Warrants or April Warrants were exercised.

 

The Company’s outstanding warrants at March 31, 2023 consisted of the following: 

             
Type   Number   Exercise Price   Expiry Date
Pre-Funded Warrants   None   $0.001   Unlimited
Tradeable Warrants   963,693   $2.22   February 2027
Investor Warrants   800,901   $2.22   March 2027
April Warrants   9,725,690   $3.76   April 2027

 

Note 7 – Net Loss Per Common Share

 

Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents.

 

Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, taking into consideration common stock equivalents.

 

In February 2022, the Company issued 4,102,200 Tradeable Warrants pursuant to the Company’s Public Offering. In March and April 2022, the Company issued 3,603,604 Investor Warrants and 9,725,690 April Warrants pursuant to two private placements. As of March 31, 2023, 3,138,507 Tradeable Warrants and 2,802,703 Investor Warrants were exercised, leaving 963,693 Tradeable Warrants, 800,901 Investor Warrants and 9,725,690 April Warrants outstanding. These warrants are dilutive and were included in the diluted earnings per share.

 

In March and April 2022, the Company issued and sold Pre-Funded Warrants to purchase an aggregate of 3,692,276 shares of common stock at a nominal exercise price of $0.001 per share (see Note 3). During the three months ended March 31, 2023, all of these warrants were exercised and therefore had no remaining dilutive effect.

 

Note 8 – Lease

 

The Company has obligations as a lessee for office 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 contract include fixed payments plus a variable Payment. The Company’s office space 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.

 

 

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Amounts reported on the balance sheet as of March 31, 2023 were as follows:

 
Operating lease ROU asset $728,129
Operating Lease liability - Short-term $121,303
Operating lease liability - Long-term $613,136
Remaining lease term 6 years 9 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 March 31, 2023 are as follows: 

 
   
2023 $91,654
2024 $115,978
2025 $116,166
2026 $110,028
2027 $103,636
Thereafter $196,976

  

Note 9 – Management and Director Compensation

 

The Company paid its officers cash compensation totaling $820,000 and $270,000 for the three month periods ended March 31, 2023 and 2022, respectively.

 

The Company paid its directors cash compensation totaling $100,000 and $50,000 for the three month period ended March 31, 2023 and 2022, respectively.

 

Note 10 – Subsequent Events

 

In accordance with ASC 855 – Subsequent Events, the Company has analyzed its operations after March 31, 2023 to the date these unaudited financial statements were available. No subsequent transactions were identified.

 

 

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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 regarding Sunshine Biopharma, Inc. 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, 2021. 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 to the SEC.

 

About Sunshine Biopharma

 

Sunshine Biopharma Inc. is a pharmaceutical company offering and researching life-saving medicines in a wide variety of therapeutic areas, including oncology and antivirals. In addition to our own drug development operations, we operate three wholly owned subsidiaries, including (i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation with a portfolio consisting of 50 prescription drugs on the market in Canada and 28 additional drugs scheduled to be launched in 2023 and 2024, (ii) Sunshine Biopharma Canada Inc. (“Sunshine Canada”), a Canadian corporation which develops and sells OTC supplements, and (iii) NOX Pharmaceuticals, Inc., a Colorado corporation which is inactive and is scheduled to be dissolved later this year.

 

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. was holding an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a (the “License Agreement”). Upon completion of the reverse acquisition transaction, we changed our name to Sunshine Biopharma, Inc. and began operating as a pharmaceutical company focusing on the development of the licensed Adva-27a anticancer drug. In December 2015, we acquired all worldwide 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.

 

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 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 Inc. (“Nora Pharma”), a Canadian generic pharmaceuticals company based in the greater Montreal area. Nora Pharma has 37 employees and operates in a 15,000 square foot facility certified by Health Canada. Nora Pharma currently offers 50 generic prescription drugs and 11 nonprescription OTC products. Nora Pharma sales were $10.7 million USD during its fiscal year ended June 30, 2022. The consolidated financial statements contained in this report include the results of operations of Nora Pharma from October 20, 2022 through December 31, 2022.

 

 

 

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Products on the Market

 

As a result of the acquisition of Nora Pharma we now have the following generic prescription drugs on the market in Canada:

 

Drug   Action/Indication   Reference Brand
Alendronate   Osteoporosis   Fosamax®
Amlodipine   Cardiovascular   Norvasc®
Apixaban   Cardiovascular   Eliquis®
Atorvastatin   Cardiovascular   Lipitor®
Azithromycin   Antibacterial   Zithromax®
Candesartan   Hypertension   Atacand®
Candesartan HCTZ   Hypertension   Atacand®
Celecoxib   Anti-inflammatory   Celebrex®
Cetirizine   Allergy   Reactine®
Ciprofloxacin   Antibiotic   Cipro®
Citalopram   Central nervous system   Celexa®
Clindamycin   Antibiotic   Dalacin®
Clopidogrel   Cardiovascular   Plavix®
Donepezil   Central nervous system   Aricept®
Duloxetine   Central nervous system   Cymbalta®
Dutasteride   Urology   Avodart®
Escitalopram   Central nervous system   Cipralex®
Ezetimibe   Cardiovascular   Ezetrol®
Finasteride   Urology   Proscar®
Flecainide   Cardiovascular   Tambocor®
Fluconazole   Antifungal   Diflucan®
Fluoxetine   Central nervous system   Prozac®
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®
Olanzapine ODT   Central nervous system   Zyprexa®
Olmesartan   Cardiovascular   Olmetec®
Olmesartan HCTZ   Cardiovascular   Olmetec Plus®
Pantoprazole   Acid Reflux   Pantoloc®
Paroxetine   Central nervous system   Paxil®
Perindopril   Cardiovascular   Coversyl®
Pravastatin   Cardiovascular   Pravachol®
Pregabalin   Central nervous system   Lyrica®
Quetiapine   Central nervous system   Seroquel®
Quetiapine XR   Central nervous system   Seroquel XR®
Ramipril   Cardiovascular   Altace®
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®
Tramadol Acetaminophen   Central nervous system   Tramacet®
Zolmitriptan   Central nervous system   Zomig®
Zopiclone   Central nervous system   Imovane®

 

 

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In addition, we have the following nonprescription OTC products on the market in Canada and partially in the U.S.:

 

Product   Description
Essential 9™   Essential Amino Acids capsules (761 mg)
L-Arginine   L-Arginine capsules (500 mg)
L-Carnitine   L-Carnitine capsules (667 mg)
Extreme-Mass™   Weight Gain powder
Iso-Whey™   Whey Protein powder
BCAA 2:1:1™   Branched-Chain Amino Acids capsules (600 mg)
L-Creatine   L-Creatine Monohydrate powder
Nora B12-1000   Vitamin B-12 tablets (Cyanocobalamine, 1,000 mcg)
Nora Calcium   Calcium Carbonate tablets (500 mg)
Nora Cal-D 400   Calcium Carbonate (500 mg) + Vitamin D (400 IU) tablets
Nora Cal-D 1000   Calcium Carbonate (500 mg) + Vitamin D (1,000 IU) tablets
Nora D-400   Vitamin D tablets (Calciferol 400 IU)
Nora D-1000   Vitamin D tablets (Calciferol 1,000 IU)
Nora Senna   Senna Alexandrina tablets (8.6 mg)
Nora Sennosides   Senna Alexandrina tablets (8.6 mg)
NRA-ASA   Acetylsalicylic Acid tablets (80 mg)
NRA-Docusate Sodium   Docusate Sodium capsules (100 mg)
NRA K-20   Potassium Chloride tablets (1,500 mg)

 

Products in Development

 

The following table summarizes our generic and proprietary drugs in development:

 

Generic Drugs   Therapeutic Area(s)   Development Stage   Launch Date
Group A (4 Products)   Central Nervous System, Urology, Cardiovascular   Under Regulatory Review   2023Q2
Group B (3 Products)   Central Nervous System, Gastrointestinal   Under Regulatory Review   2023Q3
Group C (1 Product)   Oncology   Under Regulatory Review   2023Q4
Group D (8 Products)   Central Nervous System, Cardiovascular, Metabolism   Under Regulatory Review   2024Q1
Group E (5 Products)   Cardiovascular, Urology, Endocrinology   Under Regulatory Review   2024Q2
Group F (6 Products)   Urology, Cardiovascular, Oncology, Anti-infectives   Under Regulatory Review   2024Q3

 

Proprietary Drugs   Therapeutic Area   Development Stage   Launch Date
Adva-27a (Small Molecule)   Oncology (Pancreatic Cancer)   IND-Enabling Studies   TBD
K1.1 (mRNA LNP)   Oncology (Liver Cancer)   Animal Testing   TBD
SBFM-PL4 (Small Molecule)   Antiviral (COVID-19)   Animal Testing   TBD

 

Proprietary Drugs in Development

 

Adva-27a Anticancer Drug

 

In the area of oncology, our proprietary drug development activities have been focused on the development of a small molecule called Adva-27a 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.

 

 

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Adva-27a is a GEM-difluorinated C-glycoside derivative of Podophyllotoxin. Another derivative of Podophyllotoxin called Etoposide is currently on the market and is used to treat various types of cancer including leukemia, lymphoma, testicular cancer, lung cancer, brain cancer, prostate cancer, bladder cancer, colon cancer, ovarian cancer, liver cancer and several other forms of cancer. Etoposide is one of the most widely used anticancer drugs. Adva-27a and Etoposide are similar in that they both attack the same target in cancer cells, namely the DNA unwinding enzyme, Topoisomerase II. Unlike Etoposide however, Adva-27a is able to penetrate and destroy Multidrug Resistant Cancer cells. In addition, Adva-27a has been shown to have distinct and more desirable biological and pharmacological properties compared to Etoposide. In side-by-side studies using Multidrug Resistant Breast Cancer cells and Etoposide as a reference, Adva-27a showed markedly greater cell killing activity (see Figure 1).

 

 

Figure 1

 

In February 2023, we signed a research agreement with the Jewish General Hospital (“JGH”), to complete the IND-enabling studies. The JGH has also agreed to negotiate with us the terms for Phase I Clinical Trials. Adva-27a’s initial indication will be pancreatic cancer for which there are currently little or no treatment options available. All aspects of the clinical trials in Canada will employ FDA standards at all levels.

 

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. We recently concluded an agreement with a specialized partner for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles, ready for use to conduct studies in xenograft mice. We anticipate commencing such studies later this year.

 

SBFM-PL4 COVID-19 Treatment

 

The initial genome expression products of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), 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 (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 viral proteins, it is also responsible for suppression of the human immune system making the virus more life-threatening.

 

 

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Our COVID-19 research effort has been focused on developing an inhibitor of PLpro, the viral enzyme that mediates suppression of the human immune system. On May 22, 2020, we filed a 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 Coronavirus main protease (Mpro) and papain-like protease (PLpro).

 

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 the Company a first option to negotiate a commercial, royalty-bearing license for all intellectual property developed by University of Arizona personnel under the Research Project. In addition, the Company and the University of Arizona entered into an option agreement (the “Option Agreement”) whereby the Company was 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 option under the Option Agreement 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.

 

Intellectual Property

 

We are the sole owner of all worldwide 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 (US Patent Number 8,236,935 and 10,272,065), Europe, and Canada.

 

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.

 

Our recently acquired 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 two NPN’s issued by Health Canada: NPN 80089663 authorizes us to manufacture and sell our in-house developed OTC product, Essential 9™, and NPN 80093432 authorizes us to manufacture and sell the OTC product, Calcium-Vitamin D under the brand name Essential Calcium-Vitamin D™.

  

Results of Operations

 

Comparison of results of operations for the three months ended March 31, 2023 and 2022

 

During the three months ended March 31, 2023, we generated $4,894,053 in sales, compared to $122,645 for the three months ended March 31, 2022, an increase of $4,771,408. The increase is attributable to sales generated by our recently acquired wholly owned subsidiary, Nora Pharma. The direct cost for generating these sales was $3,065,931 (62.6%) for the three months ended March 31, 2023, compared to $59,845 for the three months ended March 31, 2022 (48.8%). The increase in the cost of goods sold in 2023 is due to the cost of manufacturing of the generic prescription drugs sold by Nora Pharma. Our gross profit grew to $1,828,122 for the three months ended March 31, 2023, compared to $62,800 for the three months ended March 31, 2022.

 

 

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General and administrative expenses during the three month period ended March 31, 2023 were $3,657,103, compared to $1,286,164 during the three month period ended March 31, 2022, an increase of $2,370,939. This increase was the result of increased overhead associated with being a Nasdaq listed company and expenses related to Nora Pharma operations. Specifically, we incurred increased costs in accounting ($95,951), consulting ($126,117), office costs ($199,953), research and development ($71,273), salaries ($1,739,257) and taxes ($63,718). Overall, we incurred a loss of $1,828,981 from our operations for the three months ended March 31, 2023, compared to a loss of $1,223,364 from our operations in the three month period ended March 31, 2022.

 

In addition, we had net interest income of approximately $172,821 during the three months ended March 31, 2023, compared to a net interest expense of approximately $12,870 during the three months ended March 31, 2022, as a result of interest earned on the cash on hand.

 

As a result, we incurred a net loss of $1,702,430 for the three months ended March 31, 2023, compared to a net loss of $1,236,234 for the three month period ended March 31, 2022.

 

Liquidity and Capital Resources

 

As of March 31, 2023, we had cash or cash equivalents of $19,294,218.

  

Net cash used in operating activities was $1,850,106 during the three months ended March 31, 2023, compared to $1,304,208 during the three month period ended March 31, 2022. The increase was a result of the addition of Nora Pharma’s operations.

 

Cash flows used in investing activities were $146,303 for the three months ended March 31, 2023, compared to $0 for the three months ended March 31, 2022. The increase was the result of cash invested in Nora Pharma.

 

Cash flows used in financing activities were $(538,299) for the three months ended March 31, 2023, compared to $12,437,673 provided by financing activities for the three months ended March 31, 2022. The decrease was primarily as a result of no offerings made during the three months ended March 31, 2023 compared to two offerings completed in February and March 2022, and due to our purchase of $506,822 in common stock under Rule 10B-14 in the first quarter of 2023 period compared to $0 during the same period in 2022.

 

We are not generating adequate revenues from our operations to fully implement our business plan as set forth herein. On February 17, 2022, we received net proceeds of approximately $6.8 million from the sale of common stock and warrants in an underwritten public offering. On March 14, 2022, we received net proceeds of approximately $6.8 million from the sale of common stock and warrants in a private placement. On April 28, 2022, we received net proceeds of approximately $16.8 million from the sale of common stock and warrants in a private placement. We believe our existing cash will be sufficient to fund our operations, including general and administrative expenses, expanded research and development activities, and OTC supplements business, for the next 24 months. There is no assurance our estimates will be accurate.

 

Management estimates that we will need additional capital in the amount of approximately $30 million to fully implement our business plan, including funding for further research and development activities and possibly clinical trials, as well as expansion of our generic pharmaceuticals operations arising from the Nora Pharma acquisition. Additional capital may not be available on terms acceptable to us, or at all. Currently, we do not have any firm committed arrangements for financing and can provide no assurance that we will be able to obtain financing when required. No assurance can be given that we will obtain access to capital markets in the future or that financing, adequate to satisfy the cash requirements of implementing our business will be available on acceptable terms. Our inability to obtain acceptable financing could have an adverse effect upon the results of our operations and financial condition.

 

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 are believed 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, 2022, including our financial statements and notes thereto included therein as filed with the SEC on April 4, 2023.

 

 

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Recently Adopted Accounting Standards

 

In February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update No. 2016-02, Leases (Topic 842) which amends the effective date of the original pronouncement for smaller reporting companies. ASU 2016-13 and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after December 15, 2022. The Company believes the adoption will modify the way the Company analyzes financial instruments, but it does not anticipate a material impact on results of operations. The Company is in the process of determining the effects adoption will have on its consolidated financial statements.

 

In August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40), (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is evaluating the impact of this guidance on its unaudited consolidated financial statements.

 

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 March 31, 2023, 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 March 31, 2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

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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.

 

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

 

None.

 

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.
  ** Furnished herewith.   

 

 

 

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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 May 10, 2023.

 

  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)

  

 

 

 

 

 

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