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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, 2021

 

Or

 

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

 

For the transition period ended:

 

QSAM Biosciences, Inc.

(Exact name of Registrant as specified in its Charter)

 

Delaware   000-55148   20-1602779

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

9442 Capital of Texas Hwy N, Plaza 1, Suite 500

Austin, TX 78759

(Address of Principal Executive Offices)

 

(512) 343-4558

(Registrant’s Telephone Number, including area code)

 

 

(Former name or former address, if changed since last report.)

 

Securities registered pursuant to Section 12(b) of the Act: None

 

Securities registered pursuant to Section 12(g) of the Act: Common Stock, par value $0.0001

 

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

 

Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐ No ☒

 

Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes ☒ No ☐

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act 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.

(1) Yes ☒ No ☐; (2) 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:

 

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 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

 

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date:

 

As of November 12, 2021, the registrant had 36,829,736 common shares outstanding.

 

Documents incorporated by reference: None.

 

 

 

 
 

 

QSAM BIOSCIENCES, INC.

 

FORM 10-Q

TABLE OF CONTENTS

 

    Page
     
PART I – FINANCIAL STATEMENTS   6
     
ITEM 1. FINANCIAL STATEMENTS   6
     
Condensed Consolidated Balance Sheets as of September 30, 2021 (unaudited) and December 31, 2020   6
     
Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2021 and 2020 (unaudited)   7
     
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and nine months ended September 30, 2021 and 2020 (unaudited)   8
     
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2021 and 2020 (unaudited)   10
     
Notes to Condensed Consolidated Financial Statements (unaudited)   11
     
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND PLAN OF OPERATIONS   25
     
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK   32
     
ITEM 4. CONTROLS AND PROCEDURES   32
     
PART II – OTHER INFORMATION   33
     
ITEM 1. LEGAL PROCEEDINGS   33
     
ITEM 1A. RISK FACTORS   33
     
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS   34
     
ITEM 3. DEFAULTS UPON SENIOR SECURITIES   34
     
ITEM 4. MINE SAFETY DISCLOSURES   34
     
ITEM 5. OTHER INFORMATION   34
     
ITEM 6. EXHIBITS   34
     
SIGNATURES   35

  

2
 

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q (“Report”), including this “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, regarding future events and the future results of the Company that are based on current expectations, estimates, forecasts, and projections about the industry in which the Company operates and the beliefs and assumptions of the management of the Company. Words such as “expects,” “anticipates,” “targets,” “goals,” “projects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “may”, “could” and variations of such words, and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict. In particular, as discussed in greater detail below, our financial condition and results could be materially adversely affected by the continued impacts and disruptions caused by the novel coronavirus (COVID-19) global pandemic and governmental responses thereto. Forward-looking statements are based on certain assumptions, discuss future expectations, describe future plans and strategies, contain financial and operating projections or state other forward-looking information. Our ability to predict results or the actual effect of future events, actions, plans or strategies is inherently uncertain. Although we believe that the expectations reflected in our forward-looking statements are based on reasonable assumptions, our actual results and performance could differ materially from those set forth or anticipated in our forward-looking statements. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, those discussed elsewhere in this Report, including under “Risk Factors”, and in other reports the Company files with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the SEC on April 15, 2021 (under the heading “Risk Factors” and in other parts of that report).

 

Summary Risk Factors

 

We face risks and uncertainties related to our business, many of which are beyond our control. In particular, risks associated with our business include:

 

  COVID-19 and the related governmental restrictions have had, and are expected to continue to have, a material and adverse effect on our business, financial condition and results of operations.
     
  Drug development is a long and inherently uncertain process with a high risk of failure at every stage of development.
     
  The future of our business and operations depends on the success of our development and commercialization programs.
     
  If we do not obtain regulatory approval for our product candidates or if the terms of any approval impose significant restrictions or limitations on use, our business, results of operations and financial condition will be adversely affected.
     
  Setbacks in clinical development programs could have a material adverse effect on our business.
     
  Our business is highly dependent on our lead product candidate, CycloSam®, and a failure to obtain regulatory approval or successfully commercialize our product could adversely affect our financial condition and results of operations.
     
  Our FDA approvals are dependent upon successful clinical trials for our product candidates. Clinical trial results may be unfavorable or inconclusive, and often take longer and cost more than expected.
     
  We are subject to extensive and ongoing regulation, which can be costly and time consuming, may interfere with marketing approval for our product candidates, and can subject us to unanticipated limitations, restrictions, delays and fines.

 

3
 

 

  We are increasingly dependent on information technology, and potential cyberattacks, security problems, or other disruption and expanding social media vehicles present new risks.
     
  We have been and expect to continue to be dependent on collaborators for the development, manufacturing and sales of certain products and product candidates, which expose us to the risk of reliance on these collaborators.
     
  Manufacturing resources could limit or adversely affect our ability to commercialize products.
     
  Failure of any manufacturer of our various product candidates to comply with applicable regulatory requirements could subject us to penalties and have a material adverse effect on supplies of our product candidates.
     
  The validity, enforceability and commercial value of our patents and other intellectual property rights are highly uncertain.
     
  We have a limited operating history and are operating at a loss, and there is no guaranty that we will remain as a going concern or become profitable.
     
  Because our history is limited and we are subject to intense competition, any investment in us would be inherently risky.
     
  We have a high concentration of stock ownership and control within our executive officers and certain existing stockholders.
     
  The Company has Preferred Stock with additional priority rights.
     
  We are a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to smaller reporting companies will make our common shares less attractive to investors.
     
  We have identified certain material weaknesses in our internal control over financial reporting and if our remediation of such material weaknesses is not effective, or if we fail to develop and maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired.

 

4
 

 

Exchange Act Reporting Requirements

 

Section 14(a) of the Exchange Act requires all companies with securities registered pursuant to Section 12(g) of the Exchange Act like we are to comply with the rules and regulations of the SEC regarding proxy solicitations, as outlined in Regulation 14A. Matters submitted to shareholders at a special or annual meeting thereof or pursuant to a written consent will require us to provide our shareholders with the information outlined in Schedules 14A (where proxies are solicited) or 14C (where consents in writing to the action have already been received or anticipated to be received) of Regulation 14, as applicable; and preliminary copies of this information must be submitted to the SEC at least 10 days prior to the date that definitive copies of this information are forwarded to our shareholders. We are also required to file annual reports on Form 10-K and quarterly reports on Form 10-Q with the SEC on a regular basis, and will be required to timely disclose certain material events (e.g., changes in corporate control; acquisitions or dispositions of a significant amount of assets other than in the ordinary course of business; and bankruptcy) in a Current Report on Form 8-K. All public filing made with the SEC are available via the SEC’s website on EDGAR at www.sec.gov.

 

5
 

 

PART I – FINANCIAL INFORMATION

 

Item 1: Financial StatementS

 

QSAM BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

   September 30,   December 31, 
  

2021

   2020 
   (Unaudited)     
         
ASSETS          
           
CURRENT ASSETS          
Cash  $1,067,287   $8,304 
Prepaid expenses and other current assets   19,197    12,896 
Deferred offering costs   

35,000

    - 
TOTAL CURRENT ASSETS   1,121,484    21,200 
           
TOTAL ASSETS  $1,121,484   $21,200 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)          
           
CURRENT LIABILITIES          
Accounts payable and accrued expenses  $241,266   $308,157 
Accrued payroll and related expenses   48,006    48,006 
Accrued interest - related parties   1,478    - 
Notes payable - related parties   7,500    63,992 
Paycheck Protection Program Loan - current portion   -    34,163 
Debentures   35,000    137,500 
Convertible bridge notes, at fair value   -    3,598,000 
TOTAL CURRENT LIABILITIES   333,250    4,189,818 
           
Paycheck Protection Program Loan - net of current portion   -    108,779 
           
TOTAL LIABILITIES   333,250    4,298,597 
           
Redeemable convertible preferred stock - Series A; $0.0001 par value, 1,500 designated Series A, and 480 and 600 shares issued and outstanding (liquidation preference of $686,380 and $784,044) as of September 30, 2021 and December 31, 2020, respectively    686,380    784,044 
           
STOCKHOLDERS’ EQUITY (DEFICIT)          
Preferred stock, Series B, $0.001 par value; 2,500 shares authorized, 1,509 and 281 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively   2    - 
Preferred stock, Series E-1, $0.0001 par value; 8,500 shares authorized, 8,500 and 0 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively   1    - 
Common stock, $0.0001 par value, 300,000,000 shares authorized, 34,958,306 and 19,472,241 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively   3,496    1,947 
Unearned deferred compensation   (1,307,593)   (148,333)
Subscription receivable   -    (25,000)
Additional paid-in capital   27,243,381    11,021,840 
Accumulated deficit   (25,837,433)   (15,911,895)
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)   101,854    (5,061,441)
           
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)  $1,121,484   $21,200 

 

See notes to the unaudited condensed consolidated financial statements.

 

6
 

 

QSAM BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

 

                 
   For the three months ended   For the nine months ended 
   September 30,   September 30, 
   2021   2020   2021   2020 
                 
REVENUES  $-   $-   $-   $- 
                     
OPERATING EXPENSES FROM CONTINUING OPERATIONS                    
Compensation and related expenses   540,450    192,912    5,555,471    608,029 
Professional fees   473,017    173,279    1,427,703    327,961 
General and administrative   18,839    16,884    64,887    121,692 
Research and development expenses   164,378    96,943    385,785    206,943 
Total Operating Expenses   1,196,684    480,018    7,433,845    1,264,625 
                     
LOSS FROM CONTINUING OPERATIONS   (1,196,684)   (480,018)   (7,433,845)   (1,264,625)
                     
OTHER INCOME (EXPENSE) FROM CONTINUING OPERATIONS                    
Financing costs including interest   (450)   (153,628)   (38,978)   (431,790)
Change in fair value of convertible bridge notes   -    (1,348,237)   -    (1,666,422)
Other miscellaneous income   -    -    -    5,000 
Gain on sale of equity method investment   -    -    100,000     
Loss on debentures and accrued expenses converted to common stock   -    -    (390,068)   - 
Gain on forgiveness of debt from Paycheck Protection Program   142,942    -    142,942    - 
Gain (loss) on conversion of bridge notes including accrued interest and debt forgiveness   -    (503,762)   (744,505)   (503,762)
Total Other Income (Expense)   142,492    (2,000,627)   (930,609)   (2,596,974)
                     
Loss from continuing operations before income taxes   (1,054,192)   (2,480,645)   (8,364,454)   (3,861,599)
                     
INCOME TAXES   -    -    -    - 
Loss from continuing operations   (1,054,192)   (2,480,645)   (8,364,454)   (3,861,599)
                     
DISCONTINUED OPERATIONS:                    
Income from discontinued operations before income taxes   -    56,056   -    126,964
                     
INCOME TAXES   -    -    -    - 
                     
Income from discontinued operations   -    56,056   -    126,964
                     
NET LOSS   (1,054,192)   (2,424,589)   (8,364,454)   (3,734,635)
                     
PREFERRED STOCK                    
Series A and Series B preferred contractual dividends and deemed dividends   (870,204)   (9,074)   (1,583,421)   (26,366)
                     
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS  $(1,924,396)  $(2,433,633)  $(9,947,875)  $(3,761,001)
                     
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS: BASIC AND DILUTED:                    
CONTINUING OPERATIONS  $(0.06)  $(1.05)  $(0.36)  $(1.69)
DISCONTINUED OPERATIONS   -    0.02   -    0.06
Earnings Per Share, Basic and Diluted  $(0.06)  $(1.03)  $(0.37)  $(1.64)
                     
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:    31,452,858    

2,365,613 

    27,318,388    2,296,748 

 

See notes to the unaudited condensed consolidated financial statements.

 

7
 

 

QSAM BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020

(UNAUDITED)

 

   Shares      Shares       Shares        Shares                    
    Series B Preferred Stock     Series E-1 Preferred Stock           Common Stock     Deferred     Additional                 Total Stockholders’  
    Shares    

Par

Value

    Shares    

Par

Value

         

 

    Shares    

Par

Value

   

Stock-based

Compensation

   

Paid-In

Capital

   

Stock

Subscription

   

Accumulated

Deficit

   

Equity

(Deficit)

 
                                                                                 
Balance, January 1, 2021     281       -        -                  -       19,472,241     $ 1,947     $ (148,333 )   $ 11,021,840     $ (25,000 )   $ (15,911,895 )   $ (5,061,441 )
                                                                                                     
Stock-based compensation for services     -       -       -       -                   250,000       25       115,000       537,367       -       -       652,392  
                                                                                                     
Conversion of debentures and accrued expenses     -       -       -       -                   632,995       62       -       515,006       -       -       515,068  
                                                                                                     
Conversion of bridge notes and accrued interest to common stock     -       -       -       -                   6,627,692       664       -       4,377,824       -       -       4,378,488  
                                                                                                     
Conversion of Series A preferred stock to common stock     -       -       -       -                   750,000       75       -       662,425       -       (542,500 )     120,000  
                                                                                                     
Series A, preferred stock contractual dividends     -       -       -       -                   -       -       -       (7,899 )     -       -       (7,899 )
                                                                                                     
Issuance of Series B, preferred stock for cash     2,196       2       -       -                   -       -       -       2,195,998       25,000       -       2,221,000  
                                                                                                     
Issuance of Series B, conversion of notes payable to preferred stock     23       -       -       -                   -       -       -       23,000       -       -       23,000  
                                                                                                     
Stock-based compensation to employees and directors     -       -       8,500       1                   -       -       (4,141,777 )     6,527,999       -       -       2,386,223  
                                                                                                     
Net loss for the three months ended March 31, 2021     -               -       -            -       -       -       -       -       -       (4,406,059 )     (4,406,059 )
                                                                                                     
Balance, March 31, 2021     2,500       2       8,500       1            -       27,732,928       2,774       (4,175,110 )     25,853,559       -       (20,860,454 )     820,772  
                                                                                                     
Stock-based compensation for services and warrant modification     -       -       -       -                   -       -       33,333       7,841       -       -       41,174  
                                                                                                     
Deemed dividend from warrant modification     -       -       -       -                   -       -       -       155,639       -       (155,639 )     -  
                                                                                                     
Series A, preferred stock contractual dividends     -       -       -       -            -       -       -       -       (7,180 )     -       -       (7,180 )
                                                                                                     
Stock-based compensation to employees and directors     -       -       -       -                   -       -       2,439,249       -       -       -       2,439,249  
                                                                                                     
Net loss period for the three months ended June 30, 2021     -       -       -       -                   -       -       -       -       -       (2,904,203 )     (2,904,203 )
                                                                                                     
Balance, June 30, 2021     2,500       2       8,500       1            -       27,732,928       2,774       (1,702,528 )     26,009,859       -       (23,920,296 )     389,812  
                                                                                                     
Conversion of Series B preferred stock to common stock     (991 )     -       -       -                   6,525,378       652       -       (652       -     -       -  
                                                                                                     
Issuance of stock for services     -       -       -       -                   700,000       70       -       244,930         -     -       245,000  
                                                                                                     
Incremental value from warrant modifications     -       -       -       -                   -       -       -       694,575         -     (694,575 )     -  
                                                                                                     
Cumulative contractual dividends of Series B preferred stock     -       -       -       -                   -       -       -       115,309         -     (115,309 )     -  
                                                                                                     
Series A, preferred stock contractual dividends     -       -       -       -                   -       -       -       (7,259 )     -       -       (7,259 )
                                                                                                     
Cumulative contractual dividends of Series B preferred stock converted to common stock     -       -       -       -                   -       -       -       53,061         -     (53,061 )     -  
                                                                                                     
Compensation expense due to warrant modification     -       -       -       -                   -       -       -       101,366       -       -       101,366  
                                                                                                     
Stock-based compensation to employees and directors     -       -       -       -                   -       -       394,935       32,192       -       -       427,127 
                                                                                                     
Net loss for the three months ended September 30, 2021     -       -       -       -                   -       -       -       -       -       (1,054,192 )     (1,054,192 )
                                                                       
Balance, September 30, 2021     1,509     $ 2       8,500     $ 1            -       34,958,306     $ 3,496     $ (1,307,593 )   $ 27,243,381     $ -     $ (25,837,433 )   $ 101,854  

 

See notes to the unaudited condensed consolidated financial statements.

 

8
 

 

    Shares       Value     Shares     Value     Shares     Value           Capital     Receivable     Deficit     Deficit  
    Series B Preferred Stock     Series E-1 Preferred Stock     Common Stock     Deferred Stock-based   Additional
Paid In
   

Stock

    Accumulated     Total
Stockholders’
 
    Shares     Value     Shares     Value     Shares     Value     Compensation   Capital     Receivable     Deficit     Deficit  
                                                                               
Balance, December 31, 2019     -     $ -       -     $ -       2,079,898     $ 5,199     $ -     $ 6,470,676     -     $ (11,049,210 )   $ (4,573,335 )
                                                                                         
Stock-based compensation for services     -        -         -        -       200,000       500       (29,167 )     49,980       -        -       20,833  
                                                                                         
Stock-based compensation expense and stock option modification     -        -         -        -       -       -       -       24,327       -        -       24,327  
                                                                                         
Series A, preferred stock contractual dividends     -        -         -        -       -       -       -       (8,317 )     -        -       (8,317 )
                                                                                         
Net loss for the three months ended March 31, 2020     -       -       -       -       -       -       -       -        -       (437,402 )     (437,402 )
                                                                                         
Balance, March 31, 2020     -     $ -       -     $ -       2,279,898     $ 5,699     $ (29,167 )   $ 6,536,186      $  -     $ (11,486,612 )   $ (4,973,894 )
                                                                                         
Stock-based compensation for services     -       -         -        -       -       -       25,000       -       -        -       25,000  
                                                                                         
Series A, preferred stock contractual dividends     -        -         -        -       -       -       -       (8,975 )     -        -       (8,975 )
                                                                                         
Net loss period for the three months ended June 30, 2020     -       -       -       -       -       -       -       -             (872,645 )     (872,645 )
                                                                                         
Balance, June 30, 2020     -     $ -       -     $ -       2,279,898     $ 5,699     $ (4,167 )   $ 6,527,211      $  -     $ (12,359,257 )   $ (5,830,513 )
                                                                                         
Stock-based compensation for services     -       -         -        -       600,000       60       4,167       126,940       -        -       131,167  
                                                                                         
Conversion of bridge notes and accrued interest to common stock     -        -         -        -       11,418,069       1,142       -       2,396,653       -        -       2,397,795  
                                                                                         
Series A, preferred stock contractual dividends     -        -         -        -       -       -       -       (9,074 )     -        -       (9,074 )
                                                                                         
Net loss for the three months ended September 30, 2020     -       -       -       -       -       -       -       -        -       (2,424,588 )     (2,424,588 )
                                                                                         
Balance, September 30, 2020     -     $ -       -     $ -       14,297,967     $ 6,421     $ -     $ 9,041,210      $  -     $ (14,783,844 )   $ (5,735,213 )

 

See notes to the unaudited condensed consolidated financial statements.

 

9
 

 

QSAM BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

(UNAUDITED)

 

  

For the nine

months ended

  

For the nine

months ended

 
   September 30,   September 30, 
   2021   2020 
         
CASH FLOWS FROM OPERATING ACTIVITIES          
Net Loss  $(8,364,454   $(3,734,635)
Adjustments to reconcile net loss to net cash used in operations:          
Stock-based compensation for services and warrant modification   1,039,932    177,000 
Stock-based compensation to employees and directors   5,252,599      
Stock-based compensation and stock option modification   -     24,327 
Loss on conversion bridge notes and accrued interest   744,505    -  
Loss on conversion of debentures and accrued expense to common stock   390,068    -  
Change in fair value of convertible bridge notes   -     1,666,422 
Amortization of debt issuance costs   -     1,250 
Paid-in-kind interest - convertible bridge notes   35,983     427,360 
Loss on extinguishment of debt   -     503,762 
Gain on forgiveness of debt   (142,942)    -

 
Changes in operating assets and liabilities          
Increase in prepaid expenses and other current assets   (6,301)   (1,335)
Deferred offering costs   (35,000)   - 
(Decrease) increase in accounts payable and accrued expenses   (44,393   75,278
Increase accrued payroll and related expenses   -    194,881 
Increase in accrued interest– related parties   1,478     45,572 
Net cash used in operating activities   (1,128,525)   (620,118)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
Proceeds from convertible notes payable and notes payable - related parties   -     335,873 
Repayment on promissory notes – related party   (33,492)     
Proceeds from convertible notes payable   -     142,500 
Proceeds for the issuance of preferred stock – Series B   2,221,000      
Proceeds from Paycheck Protection Program   -     142,942 
Net cash provided by financing activities   2,187,508     621,315 
           
NET INCREASE IN CASH   1,058,983     1,197 
           
CASH - Beginning of period   8,304     478 
           
CASH - End of period  $1,067,287   $1,675
           
SUPPLEMENTAL CASH FLOW DISCLOSURES:          
Payment of interest in cash  $-   $-
Payment of income taxes  $-   $- 
           
NON-CASH INVESTING AND FINANCING ACTIVITIES:          
Accrual of contractual dividends on Series A convertible preferred stock  $22 ,338    $26,366  
Accrual of contractual dividends on Series B convertible preferred stock  $168,370   $-  
Deemed dividend on conversion of Series A preferred stock to common stock  $542,500   $- 
Deemed Dividend on warrant modifications   $850,214   $- 
Conversion of convertible bridge notes and accrued interest to 6,627,692 and 11,418,069 shares of common stock, respectively  $3,633,983   $2,511,975 
Conversion of debentures and accrued expenses to common stock  $125,000   $- 
Conversion of Series A preferred stock to common stock  $120,000   $- 
Conversion of notes payable with related parties to Series B preferred stock and warrants  $23,000   $- 

 

See notes to the unaudited condensed consolidated financial statements.

 

10
 

 

QSAM BIOSCIENCES INC.

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS

 

QSAM Biosciences Inc. (hereinafter the “Company”, “we”, “our”, “us”), incorporated in Delaware on August 26, 2004, is currently engaged in the business of developing a novel radiopharmaceutical drug candidate for the treatment of bone cancer. This business line commenced in earnest in the fourth fiscal quarter of 2020 as a result of the separation and transfer pursuant to an Omnibus Separation Agreement dated November 6, 2020 (the “Separation Agreement”) of the Company’s prior business of managing compost and soil manufacturing facilities (the “Legacy Business”) through an unconsolidated investee entity called Earth Property Holdings LLC, a Delaware limited liability company (“EPH”). Pursuant to the Separation Agreement, the Company transferred to EPH all assets and related liabilities in connection with the Legacy Business in return for a forgiveness of debt. The financial statements presented herein have been adjusted to account for the Legacy Business as discontinued operations (see Note 4 – Separation Agreement and Note 9 – Discontinued Operations). The Company sold its entire equity interest in EPH to a third party in the first quarter of 2021 for $100,000, and currently holds no ownership in EPH.

 

In April 2020, the Company established QSAM Therapeutics Inc. (“QSAM”) as a wholly-owned subsidiary incorporated in the state of Texas, and through QSAM, executed a Patent and Technology License Agreement and Trademark Assignment (the “License Agreement”) with IGL Pharma, Inc. (“IGL”). The License Agreement provides QSAM with exclusive, worldwide and sub-licensable rights to all of IGL’s patents, product data and knowhow with respect to Samaium-153 DOTMP aka CycloSam® (the “Technology”), a clinical stage novel radiopharmaceutical meant to treat different types of bone cancer and related diseases.

 

In connection with the transition to the biosciences sector, the Company changed its name to QSAM Biosciences Inc. on September 4, 2020, and subsequently changed its stock symbol to QSAM, to better reflect its business moving forward.

 

On September 4, 2020, the Company completed a 25:1 reverse stock split of its common shares. All shares and share prices set forth in this report have been adjusted to account for this reverse stock split as if it had occurred on the date presented.

 

Prior to 2017, the Company owned and licensed technology that converts waste fuels and heat to power, which it sold to a licensee in August of that year. Much of these operations were conducted through a wholly-owned subsidiary of the Company called Q2Power Corp. (“Q2P”), which still exists but has no current operations. Q2P and QSAM are sometimes referred to herein as the “Subsidiary”. Formerly, the Company’s name was Q2Power Technologies, Inc., and before that, Anpath Group, Inc.

 

The recent outbreak of the novel coronavirus (COVID-19) is impacting worldwide economic activity. COVID-19 poses the risk that we or our employees and our other partners may be prevented from conducting business activities for an indefinite period of time, including due to the spread of the disease or shutdowns that may be requested or mandated by governmental authorities. While it is not possible at this time to estimate the full impact that COVID-19 could have on our business, the continued spread of COVID-19 could disrupt our research and development of CycloSam and other related activities, which could have a material adverse effect on our business, financial condition and results of operations. In addition, a severe or prolonged economic downturn could result in a variety of risks to the business. While we have not yet experienced any material disruptions in our business or other negative consequences relating to COVID-19, the extent to which the COVID-19 pandemic impacts our results will depend on future developments that are highly uncertain and cannot be predicted.

 

NOTE 2 – BASIS OF PRESENTATION AND GOING CONCERN

 

The accompanying unaudited condensed financial statements are prepared in accordance with Rule 8-01 of Regulation S-X of the Securities Exchange Commission (“SEC”). Accordingly, certain information and note disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures included in these unaudited condensed financial statements are adequate to make the information presented not misleading. The unaudited condensed financial statements included in this document have been prepared on the same basis as the annual financial statements, and in our opinion reflect all adjustments, which include normal recurring adjustments necessary for a fair presentation in accordance with US GAAP and SEC regulations for interim financial statements. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of the results that the Company will have for any subsequent period or for the calendar year ended December 31, 2021. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes to those statements for the year ended December 31, 2020 which was filed with the SEC on April 15, 2021.

 

11
 

 

The Company raised a total of $2,851,908 in convertible bridge notes (the “Bridge Notes”) starting in March 2017 and ending in 2019. In 2020, $2,928,679 of the Bridge Notes inclusive of principal and accrued and capitalized interest were converted by the holders into 13,312,175 shares of common stock. As of March 31, 2021, all remaining Bridge Notes of $1,447,315 inclusive of principal and accrued and capitalized interest were converted into 6,578,701 shares of common stock. There are no Bridge Notes currently outstanding as of September 30, 2021.

 

The Company’s convertible debentures of $35,000 and $480,000 of redeemable convertible preferred stock was in default as of September 30, 2021. Management is in discussions with the holders of these debt and equity securities to reach an agreement to convert the outstanding balances into common stock or otherwise amend the respective maturity and redemption dates.

 

For the nine months ended September 30, 2021, the Company used net cash in operating activities for its continuing operations of $1,128,525 and incurred a loss from its continuing operations of $8,364,454. The Company’s accumulated deficit is $25,837,433 and has cash of $1,067,287.

 

The Company has supported operations through the issuance of common stock, preferred stock and debt over the last 12 months. This includes the Series B preferred stock offering in the first quarter of 2021, the recent exercise of warrants issued in connection with the Series B offering, and also a recent convertible debt offering conducted after the end of the third quarter of 2021. Management expects expenses to increase in 2022 as our drug technology enters into clinical trials, and as a result, we will need to raise additional capital to support these operations. Management believes that it can do so through equity raises in 2022; however, there is no guarantee that such plan will be successful. If we are not successful in raising additional capital, we may need to delay clinical trials, reduce overhead, or in the most extreme scenario, shut down operations.

 

These conditions raise substantial doubt about the Company’s ability to continue as a going concern. There is no guarantee whether the Company will be able to generate revenue and/or raise capital sufficient to support its continuing operations. The ability of the Company to continue as a going concern is dependent on management’s plans which include implementation of its business model to develop and commercialize its drug candidate, seek strategic partnerships to advance clinical trials and other research endeavors which could provide additional capital to the Company, and continue to raise funds for the Company through equity or debt offerings. There is no assurance, however, that the Company will be successful in raising the needed capital and, if funding is available, that it will be available on terms acceptable to the Company. The unaudited condensed financial statements do not include any adjustments that might result from the outcome of these uncertainties.

 

In January 2021, the Company closed a $2.5 million Series B Preferred Stock private placement to advance its new business model, which is expected to support continuing operations through the end of 2021. In 2020 and the first quarter of 2021, management also was able to reduce debt significantly, in part from the forgiveness of notes payable owed to EPH (see Note 4 – Separation Agreement) and also by converting a significant portion of additional liabilities into common stock (see Note 7 – Debentures, Convertible Bridge Notes and Notes Payable).

 

Subsequent to September 30, 2021, eight non-affiliated investors in the Company’s Series B Preferred stock exercised their warrants at $0.25 per share and the proceeds received were $467,858 plus a subscription receivable of $35,714. The Company issued 1,871,432 shares of common stock, not including 142,857 unissued shares of common stock subject to the subscription receivable. See Note 13- Subsequent Events.

 

Also, subsequent to September 30, 2021, the Company issued six convertible promissory notes in a private placement offering among six non-affiliated accredited investors in the total amount of $555,000. The notes are convertible into common stock prior to the maturity date of December 31, 2023, or automatically upon the Company completing a qualified offering in the amount of $5 million or uplisting its common shares to NASDAQ. The note bears interest at the rate of 6% per annum, with all interest and principal due at maturity, unless earlier converted. The investors also received a total of 925,001 common stock warrants, exercisable at $0.60 per share at any time prior to October 31, 2022. See Note 13- Subsequent Events.

 

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Principles of Consolidation

 

The unaudited condensed financial statements include the accounts of the Company and its Subsidiaries. All significant inter-company transactions and balances have been eliminated in consolidation. References herein to the Company include the Company and its Subsidiary unless the context otherwise requires.

 

12
 

 

Cash and Cash Equivalents

 

The Company considers cash, short-term deposits, and other investments with original maturities of no more than ninety days when acquired to be cash and cash equivalents for the purposes of the statement of cash flows. The Company maintains cash balances at one financial institution and has experienced no losses with respect to amounts on deposit. The Company held no cash equivalents as of September 30, 2021 and 2020.

 

Revenue Recognition

 

The Company recognizes revenue in accordance with ASC Topic 606, “Revenue from Contracts with Customers (“ASC 606”) and all the related amendments.

 

The core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. ASC 606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process than previously required under U.S. GAAP, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation.

 

The Company had no revenue in 2021 and 2020 from continuing operations.

 

Stock Based Compensation

 

The Company applies the fair value method of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 718, “Share Based Payment”, in accounting for its stock-based compensation with employees and non-employees. This standard states that compensation cost is measured at the grant date based on the fair value of the award and is recognized over the service period, which is usually the vesting period. The Company values stock-based compensation at the market price for the Company’s common stock and other pertinent factors at the grant date.

 

The Black-Scholes option pricing valuation method is used to determine fair value of stock options consistent with ASC 718, “Share Based Payment”. Use of this method requires that the Company make assumptions regarding stock volatility, dividend yields, expected term of the awards and risk-free interest rates.

 

Research and Development

 

Research and development costs are expensed as incurred. Research and development costs were $164,378 and $385,785 for the three and nine months ended September 30, 2021, respectively, and are a result of the Company’s activities to commence clinical trials of its drug Technology, as secured by the Company under a License Agreement executed in the second quarter of 2020. Research and development costs were $96,943 and $206,943 for the three and nine months ended September 30, 2020, respectively, and are also a result of the License Agreement as well as expenses incurred on the Technology prior to the signing of the License Agreement (see Note 10 – Commitments and Contingencies).

 

Fair Value Measurement

 

The Company measures fair value in accordance with a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The Company’s convertible Bridge Notes are valued by using Monte Carlo Simulation methods and discounted future cash flow models. Where possible, the Company verifies the values produced by its pricing models to market prices. Valuation models require a variety of inputs, including contractual terms, market prices, yield curves, credit spreads, measures of volatility and correlations of such inputs. These convertible Bridge Notes do not trade in liquid markets, and as such, model inputs cannot generally be verified and do involve significant management judgment. Such instruments are typically classified within Level 3 of the fair value hierarchy.

 

13
 

 

Equity Method Investment

 

Investments in partnerships, joint ventures and less-than majority-owned subsidiaries in which we have significant influence are accounted for under the equity method. The Company’s consolidated net income includes the Company’s proportionate share of the net income or loss of our equity method investee. When we record our proportionate share of net income, it increases income (loss) — net in our consolidated statements of operations and our carrying value in that investment. Conversely, when we record our proportionate share of a net loss, it decreases income (loss) — net in our consolidated statements of income and our carrying value in that investment. The Company’s proportionate share of the net income or loss of our equity method investees includes significant operating and nonoperating items recorded by our equity method investee. These items can have a significant impact on the amount of income (loss) — net in our consolidated statements of operations and our carrying value in those investments. The Company divested its investment in its equity method investee in March 2021.

 

Discontinued Operations

 

In accordance with ASC 205-20 Presentation of Financial Statements: Discontinued Operations, a disposal of a component of an entity or a group of components of an entity is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results when the components of an entity meets the criteria in paragraph 205-20-45-10. In the period in which the component meets held-for-sale or discontinued operations criteria the major current assets, other assets, current liabilities, and noncurrent liabilities shall be reported as components of total assets and liabilities separate from those balances of the continuing operations. At the same time, the results of all discontinued operations, less applicable income taxes (benefit), shall be reported as components of net income (loss) separate from the net income (loss) of continuing operations.

 

The Company disposed of a component of its business pursuant to a Separation Agreement in November 2020, which met the definition of a discontinued operation. Accordingly, the operating results of the business disposed are reported as income (loss) from discontinued operations in the accompanying unaudited condensed statements of operations for the three months ended September 30, 2021 and 2020. For additional information, see Note 4 – Separation Agreement and Note 9 - Discontinued Operations.

 

Income Taxes

 

Income taxes are accounted for under the asset and liability method as stipulated by FASB ASC 740, “Income Taxes” (“ASC 740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740, the effect on deferred tax assets and liabilities or a change in tax rate is recognized in income in the period that includes the enactment date. Deferred tax assets are reduced to estimated amounts to be realized by the use of a valuation allowance. A valuation allowance is applied when in management’s view it is more likely than not (50%) that such deferred tax will not be utilized.

 

In the event that an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there is a probability that the uncertain tax position taken would be sustained upon examination by the taxing authorities. Reserves for uncertain tax positions would be recorded if the Company determined it is probable that a position would not be sustained upon examination or if payment would have to be made to a taxing authority and the amount is reasonably estimated. As of September 30, 2021 and December 31, 2020, the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to the taxing authorities; however, federal returns have not been filed since the Company’s inception in 2014. Such delinquencies are being resolved by management and a retained tax expert. Interest and penalties related to any unrecognized tax benefits is recognized in the unaudited condensed consolidated financial statements as a component of income taxes. The Company will need to be in compliance with the tax authorities by filing past federal and state income tax returns.

 

14
 

 

Basic and Diluted Loss Per Share

 

Net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period plus any potentially dilutive shares related to the issuance of stock options, shares from the issuance of stock warrants, shares issued from the conversion of redeemable convertible preferred stock and shares issued for the conversion of convertible debt.

 

As of September 30, 2021, there were the following potentially dilutive securities that were excluded from diluted net loss per share because their effect would be anti-dilutive:

 

SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE 

Shares from the conversion of Series B Preferred Stock not inclusive of dividends   9,431,250
Shares from the conversion of Series E-1 Preferred Stock (subject to vesting in 2021 through 2023 and potential forfeiture)   8,500,000 
Shares from common stock options   1,112,619 
Shares from common stock warrants    7,559,289 
Shares from the conversion of debentures   218,750 
Shares from the conversion of redeemable convertible preferred stock (based upon an assumed conversion price at September 30, 2021 of $0.16 per share; inclusive of cumulative dividends which may be converted to shares of common stock under certain conditions)   4,286,875 

 

As of September 30, 2020, there were the following potentially dilutive securities that were excluded from diluted net loss per share because their effect would be anti-dilutive:

 

Shares from common stock options   468,619 
Shares from common stock warrants   46,154 
Shares from the conversion of debentures   66,000 
Shares that may be converted from Bridge Notes (based upon an assumed conversion price at September 30, 2020 of $1.98 per share)   8,079,617 
Shares from the conversion of redeemable convertible preferred stock (inclusive of cumulative dividends which may be converted to shares of common stock under certain conditions).   3,522,591 

 

Significant Estimates

 

U.S. Generally Accepted Accounting Principles (“GAAP”) requires the Company to make judgments, estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited financial statements, the reported amounts of revenues and expenses, cash flows and the related footnote disclosures during the period. On an on-going basis, the Company reviews and evaluates its estimates and assumptions, including, but not limited to, those that relate to the fair value of stock-based compensation fair value of convertible bridge notes, and a valuation allowance on deferred tax assets and contingencies. Actual results could differ from these estimates.

 

Recent Accounting Pronouncements

 

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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”) to simplify accounting for certain financial instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective January 1, 2022 and should be applied on a full or modified retrospective basis, with early adoption permitted beginning on January 1, 2021. The Company adopted ASU 2020-06 effective January 1, 2021. The adoption of ASU 2020-06 did not have an impact on the Company’s financial statements.

 

Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material effect on its unaudited financial statements.

 

Reclassifications

 

Certain reclassifications of prior year amounts have been made to conform to the 2021 presentation. These reclassifications had no effect on net loss or loss per share as previously reported.

 

15
 

 

Concentration of Risk

 

The Company expects cash to be the asset most likely to subject the Company to concentrations of credit risk. The Company’s bank deposits may at times exceed federally insured limits. The Company’s policy is to maintain its cash with high credit quality financial institutions to limit its risk of loss exposure. The Company’s cash balance as of September 30, 2021, is in excess of FDIC limits in the amount of approximately $808,800.

 

The Company is subject to a number of risks similar to those of other companies at a clinical-stage for radiopharmaceutical drug candidates, including dependence on key individuals; the need to develop commercially viable therapeutics; competition from other companies, many of which are larger and better capitalized; and the need to obtain adequate additional financing to fund the development of its products. The Company currently depends on third-party, suppliers for key materials and services used in its research and development manufacturing process, and is subject to certain risks related to the loss of these third-party suppliers or their inability to supply the Company with adequate materials and services.

 

The Company had no revenue from its continuing operations for the three and nine months ended September 30, 2021 and 2020. Revenue included in discontinued operations was generated from one related customer for the three and nine months ended September 30, 2020.

 

Fair Value of Financial Instruments

 

In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash is carried fair value.

 

Other financial instruments, including accounts payable, accrued liabilities and short-term debt, are carried at cost, which approximates fair value given their short-term nature.

 

Deferred Offering Cost

 

Costs incurred prior to an equity offering are capitalized until the offering occurs. Upon the equity offering, all accumulated costs are charged against proceeds. If the Company determines that the equity offering will not occur, the accumulated costs are charged to operations.

 

Segment Reporting

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company views its operations and manages its business as one segment.

 

NOTE 4 – SEPARATION AGREEMENT

 

On November 6, 2020, the Company entered into the Separation Agreement with its unconsolidated investee, EPH. The Company’s board of directors approved the Separation Agreement in support of the Company’s previously disclosed plan to secure new technologies and business opportunities in the broader biosciences sector, and to significantly reduce debt and liabilities of the Company and eliminate under-performing assets and agreements. The Separation Agreement resulted in the discontinuance of the Company’s management of businesses and assets focused on compost and soil manufacturing to focus solely on the development of its exclusively licensed pharmaceutical Technology, as well as other drug candidates that it may license or otherwise secure in the future. Pursuant to the Separation Agreement:

 

  The Management Agreement, dated January 18, 2019, as amended, between EPH and the Company was terminated by mutual agreement of the parties. Fees from this agreement constituted most of the Company’s revenue over the prior two years.

 

  In lieu of any severance or other termination payments due under the Management Agreement, EPH released the Company from a total of $993,985 in liabilities, inclusive of advanced management fees and multiple promissory notes, including accrued and unpaid interest. An additional $114,700 in promissory notes owed to an affiliate of EPH were converted into Company common stock at a price of $0.22 per share.
     
  The Company agreed to transfer to EPH its license agreement with Agrarian Technologies LLC and Mulch Masters Inc. for the ABS soil enhancement product and all associated knowhow, trade secrets and trademark/service marks. Accrued license fees in connection with this license agreement were also assumed by EPH in the amount of $37,500.
     
  The prior officers and employees of the Company engaged in the Legacy Business were released from any non-competition, non-solicitation or other restricted covenant pursuant to their respective employment agreements. Effective October 1, 2020, several of these employees had already separated from the Company.
     
  EPH received the right in its sole discretion to use the name “Q2Earth” in all jurisdictions of the United States and worldwide.

 

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Pursuant to ASC 205-20 Presentation of Financial Statements: Discontinued Operations and amended by ASU No. 2014-08, management has determined that the Separation Agreement results in the disposal of a component that represents a strategic shift in the Company’s business operations that will have a major effect on the Company’s operations and financial results. Therefore, the net income (loss) generated from this disposed component have been presented as discontinued operations for the period ended September 30, 2020 on the statement of operations.

 

NOTE 5 – EQUITY METHOD INVESTMENT

 

During November 2018, the Company invested $50,000 for a 19.9% Class B limited liability membership interest in EPH and recorded this transaction as an equity method investment due to the Company’s ability to exercise significant influence over EPH. The carrying value of the investment in EPH was reduced to zero after recording the proportionate share of the investee’s net loss for the 2018 fiscal year. In January 2019, the Company committed an additional $21,588 through a subscription payable to maintain its 19.9% Class B limited liability interests in EPH, after additional Class A units were sold to investors, which was fully paid in April 2020. The carrying value of the investment at December 31, 2020 was zero due to continued losses incurred by EPH. In the first quarter of 2021, the Company sold this equity interest to an unrelated third party for $100,000. There were no distributions received from the equity method investment in 2021 or 2020. See Note 4 for discussion of the Separation Agreement with our equity method investment in November 2020.

 

Our prior Chairman and CEO of the Company, also serves as President of EPH; and Christopher Nelson, General Counsel and Director of the Company, also serves as General Counsel and Secretary of EPH. See Note 6 – Related Party Transactions for transactions with our equity method investment during the three and nine months ended September 30, 2021 and 2020.

 

NOTE 6 – RELATED PARTY TRANSACTIONS

 

The Company currently has a License Agreement with IGL Pharma, Inc., an entity in which the Company’s Executive Chairman serves as President, holds options to purchase less than a 1% non-controlling equity interest and receives a $500 per month fee (see Note 12).

 

The Company currently maintains an executive office in Florida, which is leased by an investment firm in which the Company’s General Counsel serves as an officer but does not hold any equity or voting rights. The Company has no formal agreement for this space and pays no rent.

 

During the three and months ended September 30, 2020, the Company received $174,999 and $524,997 from its equity method investee, EPH, as management fee revenue, respectively. The Company did not receive any revenue from EPH for any period in 2021. Due to the Separation Agreement disclosed in Note 4, management fee revenues received during the period ended September 30, 2020 have been presented on the statement of operations as discontinued operations (see Note 9 – Discontinued Operations). Management fee revenues were the Company’s primary source of revenue during that period.

 

In the nine-month period ended September 30, 2021, the Company paid to EPH $34,136 arising from notes payable and accrued interest which was included in notes payable-related parties in prior periods in the consolidated balance sheet.

 

During the year ended December 31, 2020, the Company received $45,500 of proceeds from short-term notes payable with officers and directors of the Company bearing interest at 10%. As of September 30, 2021, $7,500 of principal remains outstanding on certain of these short-term notes payable. During the nine months ended September 30, 2021, $23,000 of these short-term notes payable was converted into 23 shares of the Company’s Series B preferred stock at a conversion ratio of $1,000 per share and warrants to purchase 65,714 shares of common stock at an exercise price of $0.35 per share, which resulted in no gain or loss on conversion (see Note 9).

 

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During the three and nine months ended September 30, 2021, the Company incurred $8,163 and $58,043 in legal fees with a law firm in which the Company’s audit committee chair is an employee. During the three and nine months ended September 30, 2020, the Company incurred $10,993 and $52,752 of legal services with this related party. As of September 30, 2021 and December 31, 2020, accounts payable and accrued expenses include $25,942 and $32,716 for legal fees due to the law firm for services, respectively.

 

NOTE 7 – DEBENTURES, CONVERTIBLE BRIDGE NOTES, AND NOTES PAYABLE

 

Debentures

 

The Company has Original Issue Discount Senior Secured Convertible Debentures (the “Debentures”) in the aggregate amount of $35,000 and $165,000 outstanding as of September 30, 2021 and 2020, respectively. All assets of the Company are secured under the Debentures. The Debentures contain certain anti-dilutive protection provisions in the instance that the Company issues stock at a price below the conversion price of the Debentures, as adjusted from time to time, as well as other standard protections for the holder. There is no interest on these notes. In the first quarter of 2021, the two institutional holders of the debentures converted an aggregate of $102,500 into 517,086 shares of common stock, and the Company recognized a loss on the two debenture conversions of $356,454. As of September 30, 2021, the outstanding amount of $35,000 was in default.

 

Convertible Bridge Notes

 

In 2017 and 2018, the Company issued a total of $2,771,908 in a convertible promissory note (the “Bridge Notes”) offering, which included three of the Company’s directors converting $156,368 and one shareholder converting $11,784 of prior notes and cash advances, including interest thereon, into the offering. In 2019, an additional $30,000 Bridge Note was issued to one investor. In June 2018, one of the original Bridge Notes for $50,000 plus $7,664 accrued interest was converted by its holder into 24,538 shares of common stock. Maturity for the Bridge Notes was 36 months from issuance (24 months for the Bridge Notes issued in 2018 and 2019) with 15% annual interest which is capitalized each year into the principal of the Bridge Notes and paid in kind.

 

As of March 31, 2021, all Bridge Notes remaining at the end of 2020, inclusive of principal and accrued and capitalized interest, were settled with the holders of these notes converting their debt into a total of 6,627,692 shares of common stock of the Company with a fair value of $4,378,488 based on the stock price of the Company on the date of conversion. The Company recorded a loss on extinguishment of these Bridge Notes of $744,205 for the nine months ended September 30, 2021, which is included in loss on conversion of bridge notes and accrued interest, as other income expenses in the unaudited condensed statements of operations.

 

Pursuant to ASC 825-10-25-1, Fair Value Option, the Company made an irrevocable election at the time of issuance to report the Bridge Notes at fair value, with changes in fair value recorded through the Company’s condensed consolidated statements of operations as other income (expense) in each reporting period. The estimated fair value of the remaining outstanding Bridge Notes as of September 30, 2021 and December 31, 2020 was $0 and $0 (see Note 8 – Fair Value Measurement), respectively. During the three and nine month ended September 30, 2020, the change in fair value resulted in a loss of $1,348,237 and $1,666,422, respectively, which is presented as change in fair value of convertible bridge notes on the unaudited condensed statements of operations (see Note 8 - Fair Value Measurement).

 

Paycheck Protection Program

 

On April 14, 2020, the Company received $142,942 under the Paycheck Protection Program (PPP) overseen by the U.S. Small Business Administration. The loan has an annual interest rate of 1% with loan payments being deferred six months from the date of the loan with a maturity date of April 2022. On July 14, 2021, the Company’s PPP loan was forgiven, resulting in $142,492 gain on forgiveness of debt which is included as other income (expense) in the unaudited condensed statements of operations.

 

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NOTE 8 – FAIR VALUE MEASUREMENT

 

The Company measures fair value in accordance with a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below:

 

  Level 1 Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
     
  Level 2 Quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability; and
     
  Level 3 Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (supported by little or no market activity).

 

As disclosed in Note 7, the Bridge Notes are reported at fair value, with changes in fair value recorded through the Company’s condensed consolidated statements of operations as a component of other income (expense) in each reporting period.

 

The following tables set forth the Company’s unaudited financial assets and liabilities measured at fair value by level within the fair value hierarchy as of September 30, 2021 and December 31, 2020. Assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.

 

  SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE

   Total   Level 1   Level 2   Level 3 
Convertible Bridge Notes  $-   $-   $-   $- 
Fair value as of September 30, 2021  $-   $-   $-   $- 

 

   Total   Level 1   Level 2   Level 3 
Convertible Bridge Notes  $3,598,000   $-   $          -   $3,598,000 
Fair value as of December 31, 2020  $3,598,000   $-   $-   $3,598,000 

 

The following tables present a reconciliation of the beginning and ending balances of items measured at fair value on a recurring basis that use significant unobservable inputs (Level 3) that has been recorded in the condensed consolidated balance sheets which is as follows:

 

  SCHEDULE OF RECONCILIATION OF LEVEL 3 CONVERSION OPTION LIABILITY

Fair value, December 31, 2020  $3,598,000 
Accrued interest   35,983 
Conversion to shares of common stock   (3,633,983)
Fair value, September 30, 2021  $- 

 

NOTE 9 – DISCONTINUED OPERATIONS

 

On November 6, 2020, the Company executed a Separation Agreement (see Note 4 – Separation Agreement), whereby the Company transferred its Legacy Business and the related assets and liabilities to EPH, a related party and equity method investee.

 

ASC 205-20 “Discontinued Operations” establishes that the disposal or abandonment of a component of an entity or a group of components of an entity should be reported in discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s unaudited operations and financial results. As a result, the component’s results of operations have been reclassified as discontinued operations on a retrospective basis for the period ended September 30, 2020. There were no results of operations from the component in the current period. As of September 30, 2021, there were no assets or liabilities held associated with this business. The results of operations of this component, for all periods, are separately reported as “discontinued operations” on the unaudited condensed statements of operations.

 

As disclosed in Note 4 – Separation Agreement, the Company sold its equity interest in EPH as of March 31, 2021. There have been no transactions between the Company and EPH since the Separation Agreement.

 

A reconciliation of the major classes of line items constituting the income (loss) from discontinued operations, net of income taxes as is presented in the consolidated statements of operations for the three and nine month ended September 30, 2021 and 2020, are summarized below:

 

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Reconciliation of revenue and expense items in discontinued operations in the unaudited condensed statements of operations:

SCHEDULE OF DISCONTINUED OPERATION 

          
  For the Three Months Ended   For the Nine Months Ended 
  September 30,   September 30, 
    2020   2020 
          
REVENUES   $191,199   $541,197 
            
OPERATING EXPENSES          
Payroll and related expenses    106,310    320,463 
General and administrative    13,562    51,375 
Total operating expenses    119,872    371,838 
Operating Income    71,327    169,359 
Financing costs including interest    (15,271)   (42,395)
OTHER EXPENSE    (15,271)   (42,395)
INCOME FROM DISCONTINUED OPERATIONS   $56,056   $126,964

 

Reconciliation of cash flows from operating activities and financing activities on the unaudited condensed statements of cash flows:

 

Nine Months ended 
  September 30, 
    2020 
CASH FLOWS FROM OPERATING ACTIVITIES    

 
Net income from discontinued operations   $126,964
Adjustments to reconcile net income to net cash provided by discontinued operations:      
Changes in operating assets and liabilities      
Increase in accounts payable and accrued expenses    

22,500

 
Increase in accrued interest - related party    

42,395

 
Net cash provided by operating activities   276,649
       
CASH FLOWS FROM FINANCING ACTIVITIES      
Proceeds from promissory notes - related parties    

290,373

 
Net cash provided by financing activities    

290,373

 
       
Net cash provided by discontinued operations   $482,232