UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the Quarterly Period Ended Septemberquarterly period ended June 30, 20172022

OROr

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

 

For the Transition Periodtransition period from _____________ to _____________

Commission File Number: 001-37428Qualigen Therapeutics, Inc.

RITTER PHARMACEUTICALS, INC.

(Exact name of Registrantregistrant as specified in its Charter)charter)

Delaware001-3742826-3474527

(State or other jurisdiction of

incorporation or organization)of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification Number)No.)

1880 Century Park East, Suite 10002042 Corte Del Nogal, Carlsbad, California92011

Los Angeles, CA 90067

(Address and zip code of principal executive offices) (Zip Code)

(760)918-9165

(Registrant’s Telephone Number, Including Area Code:(310) 203-1000telephone number, including area code)

n/a

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

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

Title of each classTrading SymbolName of each exchange on which registered
Common Stock, par value $.001 per shareQLGNThe Nasdaq Capital Market of 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 [X] 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 [X] No [  ]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”filer,” “smaller reporting company,” and “smaller reporting“emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filerAccelerated Filerfiler[  ]Accelerated Filer[  ]
Non-accelerated filerSmaller reporting company
Non-Accelerated Filer[  ]Smaller Reporting CompanyEmerging growth company[X]
(Do not check if a smaller reporting company)
Emerging Growth Company[X]

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 [X]

As of October 27, 2017,August 15, 2022, there were 49,506,52138,795,541 shares of the registrant’s common stock, par value $0.001 per share, outstanding.

 

 
 

TABLE OF CONTENTS

Page
PART I.Financial Information1
Item 1.Condensed Consolidated Financial Statements (Unaudited)13
Condensed Consolidated Balance Sheets as of SeptemberJune 30, 2017 (unaudited)2022 and December 31, 2016202113
Condensed Consolidated Statements of Operations and Other Comprehensive Loss for the Three and NineSix Months Ended SeptemberJune 30, 20172022 and 2016 (unaudited)202124
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended June 30, 2022 and 20215
Condensed Consolidated Statements of Cash Flows for the NineSix Months Ended SeptemberJune 30, 20172022 and 2016 (unaudited)202136
Notes to Unaudited Condensed Consolidated Financial Statements47
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations1329
Item 3.Quantitative and Qualitative Disclosures About Market Risk2540
Item 4.Controls and Procedures2540
PART II.Other Information2642
Item 1.Legal Proceedings2642
Item 1A.Risk Factors2642
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds2643
Item 3.Defaults Upon Senior Securities43
Item 4.Mine Safety Disclosures43
Item 5.Other Information43
Item 6.Exhibits2744

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

QUALIGEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

  June 30,  December 31, 
  2022  2021 
ASSETS        
Current assets        
Cash 

$

9,746,257  $17,538,272 
Accounts receivable, net  719,883   822,351 
Inventory, net  1,310,213   1,055,878 
Prepaid expenses and other current assets  1,928,383   1,379,896 
Total current assets  13,704,736   20,796,397 
Restricted cash  5,719    
Right-of-use assets  1,535,764   1,645,568 
Property and equipment, net  329,630   204,216 
Intangible assets, net  5,858,446   171,190 
Goodwill  4,896,223    
Other assets  18,333   18,334 
Total Assets $26,348,851  $22,835,705 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities        
Accounts payable $918,327  $886,224 
Accrued expenses and other current liabilities  1,414,535   1,793,901 
R&D grant liability  1,098,733    
Deferred revenue, current portion  109,833   135,063 
Operating lease liability, current portion  177,439   134,091 
Short term debt-related party  939,919    
Warrant liabilities  987,300   1,686,200 
Total current liabilities  5,646,086   4,635,479 
Operating lease liability, net of current portion  1,425,808   1,542,564 
Deferred revenue, net of current portion  70,814   92,928 
Deferred tax liability  736,000    
Total liabilities  7,878,708   6,270,971 
Stockholders’ equity        
Qualigen Therapeutics, Inc. stockholders’ equity:        
Common stock, $0.001 par value; 225,000,000 shares authorized; 38,795,541 and 35,290,178 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively  38,795   35,290 
Additional paid-in capital  107,557,744   101,274,073 
Accumulated other comprehensive income  65,540    
Accumulated deficit  (93,187,820)  (84,744,629)
Total Qualigen Therapeutics, Inc. stockholders’ equity  14,474,259   16,564,734 
Noncontrolling interest  3,995,884    
Total Stockholders’ Equity  18,470,143   16,564,734 
Total Liabilities & Stockholders’ Equity $26,348,851  $22,835,705 

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

3 
 

 

QUALIGEN THERAPEUTICS, INC.

PART I — FINANCIAL INFORMATIONCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS

(Unaudited)

ITEM 1. FINANCIAL STATEMENTS

  2022  2021  2022  2021 
  For the Three Months Ended
June 30,
  For the Six Months Ended
June 30,
 
  2022  2021  2022  2021 
REVENUES                
Net product sales $1,430,534  $1,117,935  $2,152,563  $2,538,776 
License revenue           478,654 
Total revenues  1,430,534   1,117,935   2,152,563   3,017,430 
EXPENSES                
Cost of product sales  1,099,677   916,624   1,928,524   2,119,103 
General and administrative  2,660,857   2,952,100   5,559,608   5,826,038 
Research and development  1,506,227   4,508,466   3,370,972   8,007,840 
Sales and marketing  305,103   135,543   443,426   272,129 
Total expenses  5,571,864   8,512,733   11,302,530   16,225,110 
                 
LOSS FROM OPERATIONS  (4,141,330)  (7,394,798)  (9,149,967)  (13,207,680)
                 
OTHER INCOME (EXPENSE), NET                
Gain on change in fair value of warrant liabilities  14,800   1,982,256   698,042   2,535,064 
Interest income, net  4,824   12,718   11,132   30,061 
Other income (expense), net  (376)  2,352   (341)  2,894 
Total other income, net  19,248   1,997,326   708,833   2,568,019 
                 
LOSS BEFORE PROVISION FOR INCOME TAXES  (4,122,082)  (5,397,472)  (8,441,134)  (10,639,661)
                 
PROVISION FOR INCOME TAXES  5,438   605   6,173   1,135 
                 
NET LOSS  (4,127,520)  (5,398,077)  (8,447,307)  (10,640,796)
                 
Net loss attributable to noncontrolling interest  (4,116)     (4,116)   
                 
Net loss attributable to Qualigen Therapeutics, Inc. $(4,123,404) $(5,398,077) $(8,443,191) $(10,640,796)
                 
Net loss per common share, basic and diluted $(0.11) $(0.19) $(0.23) $(0.37)
Weighted—average number of shares outstanding, basic and diluted  36,680,156   28,850,451   35,990,933   28,510,014 
                 
Other comprehensive loss, net of tax                
Net loss $(4,127,520) $(5,398,077) $(8,447,307) $(10,640,796)
Foreign currency translation adjustment  65,540      65,540   

 
Other comprehensive loss  (4,061,980)  (5,398,077)  (8,381,767)  (10,640,796)
Comprehensive loss attributable to noncontrolling interest  (4,116)  

   (4,116)  

 
Comprehensive loss attributable to Qualigen Therapeutics, Inc. $(4,057,864) $(5,398,077) $(8,377,651) $(10,640,796)

RITTER PHARMACEUTICALS, INC.

CONDENSED BALANCE SHEETS

  September 30, 2017  December 31, 2016 
  (unaudited)    
ASSETS        
Current assets        
Cash and cash equivalents $3,558,874  $7,046,282 
Prepaid expenses  260,597   156,752 
Total current assets  3,819,471   7,203,034 
         
Other assets  10,326   10,326 
Deferred offering costs  310,786    
Property and equipment, net  19,606   23,542 
Total Assets $4,160,189  $7,236,902 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities        
Accounts payable $2,745,370  $1,896,368 
Accrued expenses  196,578   1,222,735 
Other liabilities  15,927   14,736 
Total current liabilities  2,957,875   3,133,839 
         
Stockholders’ equity        
Preferred stock, $0.001 par value; 15,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2017 and December 31, 2016      
Common stock, $0.001 par value; 225,000,000 shares authorized; 14,756,521 and 11,619,197 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively  14,757   11,619 
Additional paid-in capital  52,302,244   49,559,020 
Accumulated deficit  (51,114,687)  (45,467,576)
Total stockholders’ equity  1,202,314   4,103,063 
         
Total Liabilities and Stockholders’ Equity $4,160,189  $7,236,902 

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

14 
 

QUALIGEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited)

 

                         
                Total       
           Accumulated     Qualigen Therapeutics,      
   Common Stock Additional  Other    Inc.    Total 
   Shares  Amount
$
 Paid-In
Capital
  Comprehensive Income  

Accumulated

Deficit

  Stockholders’
Equity
  Noncontrolling Interest  

Stockholders’

Equity

 
Balance at December 31, 2021 - 35,290,178  $35,290 $101,274,073  $  $(84,744,629) $16,564,734  $  $16,564,734 
Stock issued upon exercise of warrants   5,363   5  4,711         4,716      4,716 
Stock-based compensation -      1,267,166         1,267,166      1,267,166 
Net loss              (4,319,787)  (4,319,787)     (4,319,787)
Balance at March 31, 2022 - 35,295,541  $35,295 $102,545,950  $  $(89,064,416) $13,516,829  $  $13,516,829 
Common stock issued for business acquisition   3,500,000   3,500  1,841,000         1,844,500     $1,844,500 
Prefunded warrants issued for business acquisition        1,746,816         1,746,816      1,746,816 
Foreign currency translation adjustment           65,540      65,540      65,540 
Fair value of noncontrolling interest related to business acquisition                    4,000,000   4,000,000 
Fair value of warrant modification for business acquisition        696         696      696 
Stock-based compensation -      1,423,282         1,423,282      1,423,282 
Net loss              (4,123,404)  (4,123,404)  (4,116)  (4,127,520)
Balance at June 30, 2022 - 38,795,541  $38,795 $107,557,744  $65,540  $(93,187,820) $14,474,259  $3,995,884  $18,470,143 

RITTER PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS

                               
                      Total       
  Series Alpha Convertible           Accumulated     Qualigen Therapeutics,      
  Preferred Stock  Common Stock  Additional  Other    Inc.    Total 
  Shares  Amount
$
  Shares  Amount
$
  Paid-In
Capital
  Comprehensive Income  Accumulated Deficit  Stockholders’
Equity
  Noncontrolling
Interest
  

Stockholders’

Equity

 
Balance at December 31, 2020 $180  $1   27,296,061  $27,296  $85,114,755  $  $(66,847,492) $18,294,560  $  $18,294,560 
Stock issued upon cash exercise of warrants        1,319,625   1,320   1,813,353   

 
      1,814,673   

   1,814,673 
Stock issued upon net-exercise of warrants        192,373   192   (192)  

         

    
Stock issued for professional services        25,000   25   101,725          101,750   

   101,750 
Stock-based compensation              1,262,123   

      1,262,123   

   1,262,123 
Net loss                     (5,242,719)  (5,242,719)     (5,242,719)
Balance at March 31, 2021  180  $1   28,833,059  $28,833  $88,291,764  $  $(72,090,211) $16,230,387  $  $16,230,387 
Stock issued upon cash exercise of warrants        69,129   69   142,513   

      142,582      142,582 
Stock-based compensation              1,286,926   

      1,286,926   

   1,286,926 
Net loss                     (5,398,077)  (5,398,077)  

   (5,398,077)
Balance at June 30, 2021  180  $1   28,902,188  $28,902  $89,721,203  $  $(77,488,288) $12,261,818  $  $12,261,818 

(Unaudited)

  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
  2017  2016  2017  2016 
Operating costs and expenses:                
Research and development $915,268  $2,348,755  $2,121,898  $7,112,177 
Patent costs  47,431   98,908   175,794   199,888 
General and administrative  1,052,236   1,091,647   3,367,781   3,533,608 
Total operating costs and expenses  2,014,935   3,539,310   5,665,473   10,845,673 
Operating loss  (2,014,935)  (3,539,310)  (5,665,473)  (10,845,673)
                 
Other income:                
Interest income  4,083   13,239   18,362   50,466 
Other income           1,214 
Total other income  4,083   13,239   18,362   51,680 
Net loss $(2,010,852) $(3,526,071) $(5,647,111) $(10,793,993)
                 
Net loss per common share ― basic and diluted $(0.14) $(0.41) $(0.42) $(1.26)
                 
Weighted-average common shares outstanding — basic and diluted  14,756,521   8,585,406   13,443,007   8,584,442 

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

25 
 

RITTER PHARMACEUTICALS,QUALIGEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

  For the Nine Months Ended
September 30,
 
  2017  2016 
Cash flows from operating activities        
Net loss $(5,647,111) $(10,793,993)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation  3,936   3,894 
Stock-based compensation  746,362   1,041,656 
Changes in operating assets and liabilities:        
Prepaid expenses  (103,845)  (57,092)
Accounts payable  849,002   2,131,022 
Accrued expenses  (1,026,157)  293,793 
Other liabilities  1,191   12,841 
Net cash used in operating activities  (5,176,622)  (7,367,879)
         
Cash flows from investing activities        
Purchases of property and equipment     (8,063)
Net cash used in investing activities     (8,063)
         
Cash flows from financing activities        
Proceeds from the issuance of shares from common stock purchase agreement  2,000,000    
Proceeds from exercise of options on common stock     8,504 
Deferred offering costs  (310,786)   
Net cash provided by financing activities  1,689,214   8,504 
         
Net decrease in cash and cash equivalents  (3,487,408)  (7,367,438)
         
Cash and cash equivalents at beginning of period  7,046,282   15,819,566 
Cash and cash equivalents at end of period $3,558,874  $8,452,128 
         
Supplemental disclosure of cash flow information        
Cash paid for taxes $800  $72,112 
         
Non-cash financing activities        
Shares issued as a commitment fee $93,380    
  2022  2021 
  For the Six Months Ended June 30, 
  2022  2021 
CASH FLOWS FROM OPERATING ACTIVITIES        
Net loss $(8,447,307) $(10,640,796)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  66,258   53,736 
Amortization of right-of-use assets  109,803   109,719 
Accounts receivable reserves and allowances  (75,295)  3,645 
Inventory reserves  (16,405)  40,644 
Stock-based compensation  2,690,447   2,549,049 
Change in fair value of warrant liabilities  (698,042)  (2,535,064)
         
Changes in operating assets and liabilities:        
Accounts receivable  250,201   (154,799)
Inventory and equipment held for lease  (237,930)  (89,617)
Prepaid expenses and other assets  (548,487)  746,787 
Accounts payable  27,941   283,706 
Accrued expenses and other current liabilities  (828,229)  1,176,970 
Operating lease liability  (73,408)  (122,780)
Deferred revenue  (47,345)  (206,257)
Net cash used in operating activities  (7,827,798)  (8,785,057)
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Purchases of property and equipment  (63,483)  (107,798)
Payments for patents and licenses     (6,893)
Net cash acquired in business combination  135,354    
Net cash provided by (used in) investing activities  71,871   (114,691)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Net proceeds from warrant exercises  3,859   294,319 
Principal payments on notes payable     (138,739)
Net cash provided by financing activities  3,859   155,580 
         
Net change in cash and restricted cash  (7,752,068)  (8,744,168)
Effect of exchange rate changes on cash and restricted cash  (34,228)   
Cash and restricted cash - beginning of period  17,538,272   23,976,570 
Cash and restricted cash - end of period $9,751,976  $15,232,402 
         
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION        
Cash paid during the year for:        
Interest $  $1,683 
Taxes $3,501  $2,200 
         
NONCASH FINANCING AND INVESTING ACTIVITIES:        
Issuance of common stock for professional services $  $101,750 
Net transfers to inventory from equipment held for lease $  $1,304 
Fair value of shares issued for cashless warrant exercises $  $722,970 
Fair value of warrant liabilities on date of exercise $858  $1,662,936 
         
ACQUISITION:        
Fair value of assets acquired $(5,896,278) $ 
Fair value of liabilities assumed, net of goodwill  2,439,620   

 
Fair value of Alpha Capital/Qualigen warrants repriced due to acquisition  696   

 
Fair value of Qualigen prefunded warrant issued in exchange for NanoSynex stock  1,746,816   

 
Fair value of Qualigen common stock issued in exchange for NanoSynex stock  1,844,500   

 
Net cash acquired in business acquisition (Note 3) $135,354 $

 
         
Cash and restricted cash included in the accompanying balance sheet was as follows:        
Cash $9,746,257  $15,232,402 
Restricted cash  5,719    
Total cash and restricted cash $9,751,976  $15,232,402 

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

36 
 

RITTER PHARMACEUTICALS,QUALIGEN THERAPEUTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

NOTE 1 — ORGANIZATION AND PRINCIPAL ACTIVITIESSUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES

Organization

Qualigen, Inc., now a subsidiary of Qualigen Therapeutics, Inc., was incorporated in Minnesota in 1996 to design, develop, manufacture and sell point-of-care quantitative immunoassay diagnostic products for use in physician offices and other point-of-care settings worldwide, and was reincorporated in Delaware in 1999. Qualigen Therapeutics, Inc. (the “Company”) operates in one business segment. In May 2020, Qualigen, Inc. completed a reverse recapitalization transaction with Ritter Pharmaceuticals, Inc. (“Ritter” or) and Ritter was renamed Qualigen Therapeutics, Inc. All shares of Qualigen, Inc.’s capital stock were exchanged for Qualigen Therapeutics, Inc.’s capital stock in the “Company”merger. Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol “RTTR,” commenced trading on the Nasdaq Capital Market, on a post-reverse-stock-split adjusted basis, under the trading symbol “QLGN” on May 26, 2020.

.

On May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd, (“NanoSynex”) from Alpha Capital Anstalt (“Alpha Capital”) in exchange for 3,500,000 shares of the Company’s common stock and a prefunded warrant to purchase 3,314,641 shares of the Company’s common stock at an exercise price of $0.001 per share. Concurrently with this transaction, the Company also purchased 381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $600,000. The transactions resulted in the Company acquiring a 52.8% interest in NanoSynex. The Company envisions future synergies from the integration of its own proprietary results-proven FastPack diagnostics platform with the innovative NanoSynex technology. NanoSynex is a Delaware corporation headquarteredmicro-biologics diagnostics company domiciled in Los Angeles, California. Israel.

Basis of Presentation

The Company was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural Sciences, LLC, and converted into a Delaware corporation on September 16, 2008.

Ritter develops therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases. The Company conducts human gut health research by exploring metabolic capacityunaudited condensed consolidated financial statements of the gut microbiota and translating the functionality of prebiotic-based therapeutics. The Company’s lead compound, RP-G28, is currently under development for the treatment of lactose intolerance. There currently is no drug approved by the Food and Drug Administration (“FDA”) for the treatment of lactose intolerance, a debilitating disease that affects over one billion people worldwide.

The Company currently operates in one business segment focusing on the development and commercialization of RP-G28. The Company is not organized by market and is managed and operated as one business. A single management team reports to the chief operating decision maker, the Chief Executive Officer. The Company does not currently operate any separate lines of business or separate business entities.

NOTE 2 — BASIS OF PRESENTATION

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicablethe rules and regulations of the SEC regardingSecurities and Exchange Commission (“SEC”) applicable to interim reports of companies filing as a smaller reporting company. These financial reporting. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. However,statements should be read in the opinion of management, all adjustments consisting of normal recurring adjustments considered necessary for a fair presentation of the financial position and results of operations have been included and management believes the disclosures that are made are adequate to make the information presented not misleading.

The condensed balance sheet at December 31, 2016 has been derived fromconjunction with the audited financial statements includedand notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 20162021 filed with the SECSecurities Exchange Commission on February 27, 2017March 31, 2022, as amended on April 29, 2022 (the “2016“2021 Annual Report”), but does not. In the opinion of management, the accompanying condensed consolidated interim financial statements include all ofadjustments necessary in order to make the information and footnotes required by GAAP for complete financial statements.

statements not misleading. The results of operations for the three and nine months ended September 30, 2017interim periods are not necessarily indicative of the results to be expected for the full fiscal year or any other future period. Certain notes to the financial statements that would substantially duplicate the disclosures contained in the audited financial statements for the most recent fiscal year as reported in the Company’s 2021 Annual Report have been omitted. The accompanying interim periodcondensed consolidated balance sheet at December 31, 2021 has been derived from the audited balance sheet at December 31, 2021 contained in the 2021 Annual Report.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and its majority owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment. In general, the functional currency of the Company and its subsidiaries is the U.S. dollar, however for NanoSynex, the functional currency is the local currency, New Israeli Shekels (NIS). As such, assets and liabilities for NanoSynex are translated into U.S. dollars and the effects of foreign currency translation adjustments are reflected as a component of accumulated other comprehensive income within the Company’s consolidated statements of changes in stockholders’ equity.

Accounting Estimates

Management uses estimates and assumptions in preparing its unaudited condensed financial statements and related financial information included in this Quarterly Report on Form 10-Q (“Quarterly Report”) should be read in conjunctionaccordance with the audited financial statements and notes thereto included in the Company’s 2016 Annual Report.

Going Concern and Liquidity

The accompanying condensed financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company has not generated any product revenue and has not achieved profitable operations. For the nine months ended September 30, 2017, the Company had a net loss of approximately $5.6 million and had net cash used in operating activities of approximately $5.2 million. At September 30, 2017, the Company had working capital of approximately $0.9 million, an accumulated deficit of approximately $51.1 million, and cash and cash equivalents of approximately $3.6 million. There is no assurance that profitable operations will ever be achieved, and, if achieved, could be sustained on a continuing basis. In addition, development activities, clinical and pre-clinical testing, and commercialization of the Company’s products will require significant financing. These matters, among others, raise substantial doubt about the Company’s ability to continue as a going concern.

RITTER PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

Since inception, the operations of the Company have been funded through the sale of common shares, preferred shares and convertible debt. Management cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company raises additional funds by issuing equity securities, the Company’s stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company’s ability to conduct business. If the Company is not able to raise additional capital when required or on acceptable terms, the Company may have to (i) significantly delay, scale back or discontinue the development and/or commercialization of RP-G28; (ii) seek collaborators at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; and/or (iii) relinquish or otherwise dispose of its rights to RP-G28.

The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

There have been no material changes in the Company’s significant accounting policies as of and for the nine months ended September 30, 2017, as compared with the significant accounting policies described in the Company’s 2016 Annual Report.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to makeU.S. GAAP. Those estimates and assumptions that affect the reported amounts of assets and liabilities, andthe disclosure of contingent assets and liabilities, as of the date of the financial statements and the reported amounts of revenues and expenses duringexpenses. The most significant estimates relate to the reporting period.estimated fair value of in-process research and development, goodwill, warrant liabilities, stock-based compensation, amortization and depreciation, inventory reserves, allowances for doubtful accounts and returns, and warranty costs. Actual results could differvary from those estimates.the estimates that were used.

Cash, cash equivalents and Cash Equivalentsrestricted cash

Cash consistsThe Company considers all highly liquid investments purchased with an initial maturity of amounts held90 days or less and money market funds to be cash equivalents. Restricted cash includes cash that is restricted due to Israeli banking regulations.

The Company maintains its cash in a financial institution and consists of immediately available fund balances. The funds are maintained at a stable financial institution, generally at amounts in excess ofbank deposits which exceed federally insured limits. Aslimits and could potentially be subject to significant concentrations of September 30, 2017 and December 31, 2016, approximately $3.6 million and approximately $6.8 million, respectively, in cash and cash equivalents were uninsured.credit risk on cash. The Company reviews the financial stability of its depository institutions on a regular basis, and has not experienced any loss on depositslosses in such accounts.

Inventory, Net

Inventory is recorded at the lower of cash and cash equivalents to date.

Clinical Trial and Pre-Clinical Study Accruals

cost or net realizable value. Cost is determined using the first-in, first-out method. The Company makesreviews the components of its inventory on a periodic basis for excess or obsolete inventory, and records reserves for inventory components identified as excess or obsolete.

Long-Lived Assets

The Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between the net book value of the assets and their estimated fair values. During the three and six months ended June 30, 2022 and 2021, 0 such impairment losses have been recorded.

Accounts Receivable, Net

The Company grants credit to domestic physicians, clinics, and distributors. The Company performs ongoing credit evaluations of its customers and generally requires no collateral. Customers can purchase certain products through a financing agreement that the Company has with an outside leasing company. Under the agreement, the leasing company evaluates the credit worthiness of the customer. Upon acceptance of the product by the customer, the leasing company remits payment to the Company at a discount. This financing arrangement is without recourse to the Company.

The Company records an allowance for doubtful accounts and returns equal to the estimated uncollectible amounts or expected returns. The Company’s estimates are based on historical collections and returns and a review of accruedthe current status of trade accounts receivable.

Accounts receivable, net is comprised of the following at:

SCHEDULE OF ACCOUNTS RECEIVABLE

  June 30,  December 31, 
  2022  2021 
Accounts Receivable $780,684  $958,448 
Less Allowances  (60,801)  (136,097)
Accounts receivable, net $719,883  $822,351 

Research and Development

Except for acquired in process research and development (IPR&D), the Company expenses research and development costs as incurred including therapeutics license costs.

Shipping and Handling Costs

The Company includes shipping and handling fees billed to customers in net sales. Shipping and handling costs associated with inbound and outbound freight are generally recorded in cost of sales which totaled approximately $72,000 and $28,000, respectively, for the three months ended June 30, 2022 and 2021, and approximately $111,000 and $58,000, respectively, for the six months ended June 30, 2022 and 2021. Other shipping and handling costs included in general and administrative, research and development, and sales and marketing expenses totaled approximately $4,000for both the three months ended June 30, 2022 and 2021, and approximately $8,000 and $5,000 for the six months ended June 30, 2022 and 2021, respectively.

Revenue from Contracts with Customers

We apply the following five-step model in accordance with ASC 606, Revenue from Contracts with Customers, in order to determine revenue: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.

Product Sales

The Company generates revenue from selling FastPack System analyzers, accessories and disposable products used with the FastPack System. Disposable products include reagent packs which are diagnostic tests for prostate-specific antigen (“PSA”), testosterone, thyroid disorders, pregnancy, and Vitamin D.

The Company provides disposable products and equipment in exchange for consideration, which occurs when a customer submits a purchase order and the Company provides disposable products and equipment at the agreed upon prices in the invoice. Generally, customers purchase disposable products using separate purchase orders after the equipment (“analyzer”) has been provided to the customer. The initial delivery of the equipment and reagent packs represents a single performance obligation and is completed upon receipt by the customer. The delivery of each balance sheet datesubsequent individual reagent pack represents a separate performance obligation because the reagent packs are standardized, are not interrelated in any way, and the customer can benefit from each reagent pack without any other product. There are no significant discounts, rebates, returns or other forms of variable consideration. Customers are generally required to pay within 30 days.

The performance obligation arising from the delivery of the equipment is satisfied upon the delivery of the equipment to the customer. The disposable products are shipped Free on Board (“FOB”) shipping point. For disposable products that are shipped FOB shipping point, the customer has the significant risks and rewards of ownership and legal title to the assets when the disposable products leave the Company’s shipping facilities, thus the customer obtains control and revenue is recognized at that point in time.

The Company has elected the practical expedient and accounting policy election to account for the shipping and handling as activities to fulfill the promise to transfer the disposable products and not as a separate performance obligation.

The Company’s contracts with customers generally have an expected duration of one year or less, and therefore the Company has elected the practical expedient in ASC 606 to not disclose information about its financial statementsremaining performance obligations. Any incremental costs to obtain contracts are recorded as selling, general and administrative expense as incurred due to the short duration of the Company’s contracts.

License Revenue

The Company enters into out-license agreements with counterparties to develop and/or commercialize its products in exchange for nonrefundable upfront license fees and/or sales-based royalties.

If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from nonrefundable upfront fees allocated to the license when the license is transferred to the customer and the customer can benefit from the license. For licenses that are bundled with other performance obligations, management uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition. During the three months ended June 30, 2022 and 2021, the Company recognized no license revenue, and during the six months ended June 30, 2022 and 2021, the Company recognized license revenue of $0 and approximately $479,000, respectively.

Contract Asset and Liability Balances

The timing of the Company’s revenue recognition may differ from the timing of payment by the Company’s customers. The Company records a receivable when revenue is recognized prior to payment and there is an unconditional right to payment. Alternatively, when payment precedes the performance of the related services, the Company records deferred revenue until the performance obligations are satisfied.

Multiple performance obligations included contracts that combined both the Company’s analyzer and a customer’s future reagent purchases under a single contract. In some sales contracts, the Company provided analyzers at no charge to customers. Title to the analyzer was maintained by the Company and the analyzer was returned by the customer to the Company at the end of the purchase agreement.

During the three months ended June 30, 2022 and 2021, product sales are stated net of an allowance for estimated returns of approximately $10,000 and $0, respectively. During the six months ended June 30, 2022 and 2021, product sales are stated net of an allowance for estimated returns of approximately $53,000 and $0, respectively.

Deferred Revenue

Payments received in advance from customers pursuant to certain collaborative research license agreements, deposits against future product sales, multiple element arrangements and extended warranties are recorded as a current or non-current deferred revenue liability based on the facts and circumstances knowntime from the condensed consolidated balance sheets date to it at that time. Accrued expenses for pre-clinical studies and clinical trials are based on estimatesthe future date of costs incurred and fees that may be associated with services provided by contract research organizations, clinical trial investigational sites, and other related vendors. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of milestones. In accruing service fees, management estimates the time period over which services will be performed and the level of effort to be expended in each period. If possible,revenue recognition.

Operating Leases

Effective April 1, 2020, the Company obtains information regarding unbilled services directly from these service providers. However, the Company may be required to estimate these services based on other information available to it. If the Company underestimates or overestimates the activity or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in the Company’s accruals.

RITTER PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

Recent Accounting Pronouncements

In February 2016, the Financial Accounting Standards Board (“FASB”) issuedadopted Accounting Standards Update 2016-02,(“ASU”) No. 2018-11, Leases (Topic 842) Targeted Improvements (“ASU 2016-02”Topic 842”). The provisions of ASU 2016-02 set outIn accordance with the principles forguidance in Topic 842, the recognition, measurement, presentationCompany recognizes lease liabilities and disclosure of leases for both parties to a contract (i.e., lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether the lease expense is recognized based on an effective interest method or on a straight line basis over the term of the lease. A lessee is also required to record a right-of-use asset and a lease liabilitycorresponding right-of-use-assets for all leases with a termterms of greater than 12 months regardless of their classification.months. Leases with a term of 12 months or less will be accounted for underin a manner similar to the existing guidance for operating leases today.prior to the adoption of Topic 842 supersedes(seeNote 12 – Commitments and Contingencies for more information).

Property and Equipment, Net

Property and equipment are stated at cost and are presented net of accumulated depreciation. Depreciation is provided for on a straight-line basis over the previousestimated useful lives of the related assets as follows:

SCHEDULE OF USEFUL LIVES OF PROPERTY AND EQUIPMENT

Machinery and equipment5 years
Computer equipment3 years
Molds and tooling5 years
Furniture and fixtures5 years

Leasehold improvements are amortized on a straight-line basis over the shorter of the lease standard,term or their estimated useful lives. The Company occasionally designs and builds its own machinery. The costs of these projects, which includes the cost of construction and other direct costs attributable to the construction, are capitalized as construction in progress. No provision for depreciation is made on construction in progress until the relevant assets are completed and placed in service.

The Company’s policy is to evaluate the remaining lives and recoverability of long-term assets on at least an annual basis or when conditions are present that indicate impairment.

Business Combinations

The Company accounts for business combinations using the acquisition method pursuant to FASB ASC Topic 840805. This method requires, among other things, that results of operations of acquired companies are included in Qualigen’s financial results beginning on the respective acquisition dates, and that assets acquired and liabilities assumed are recognized at fair value as of the acquisition date. Intangible assets acquired in a business combination are recorded at fair value using a discounted cash flow model. The discounted cash flow model requires assumptions about the timing and amount of future net cash flows, the cost of capital and terminal values from the perspective of a market participant. Each of these factors can significantly affect the value of the intangible asset. Any excess of the fair value of consideration transferred (the “Purchase Price”) over the fair values of the net assets acquired is recognized as goodwill. The fair value of assets acquired and liabilities assumed in certain cases may be subject to revision based on the final determination of fair value during a period of time not to exceed 12 months from the acquisition date. Legal costs, due diligence costs, business valuation costs and all other acquisition-related costs are expensed when incurred.

Leases

Goodwill

Goodwill represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets acquired, when accounted for using the purchase method of accounting. Goodwill has an indefinite useful life and is not amortized but is reviewed for impairment annually and whenever events or changes in circumstances indicate that the carrying value of the goodwill may not be recoverable.

In testing for impairment, the fair value of the reporting unit is compared to the carrying value. If the net assets assigned to the reporting unit exceed the fair value of the reporting unit, an impairment loss equal to the difference would be recorded.

10 

Intangible Assets

In Process R&D

Acquired in process R&D (IPR&D) represents the fair value assigned to the research and development assets that have not reached technological feasibility. The value assigned to IPR&D is determined by estimating the costs to develop the acquired technology into commercially viable products, estimating the resulting revenue from the projects, and discounting the net cash flow to present value. The revenue and cost projections used to value acquired IPR&D are, as applicable, reduced based on the probability of success of developing the new product. Additionally, projections consider relevant market sizes and growth factors, expected trends in technology and the nature and expected timing of new product introductions. The rates utilized to discount the net cash flow to its present value are commensurate with the stage of development of the project and uncertainties in the economic estimates used in the projections. Upon the acquisition of acquired IPR&D, an assessment is completed as to whether the acquisition constitutes an acquisition of the purchase of a single asset or a group of assets. Multiple factors are considered in this assessment, including the nature of the technology acquired, the presence or absence of separate cash flows, the development process and stage of completion, quantitative significance, and the Company’s rationale for entering into the transaction.

If a business is acquired, as defined under the applicable accounting standards, then the acquired IPR&D is capitalized as an intangible asset. If an asset or group of assets is acquired that do not meet the definition under the applicable accounting standards, then the acquired IPR&D is expensed on its acquisition date. Future costs to develop these assets are recorded to research and development expense in the Company’s condensed consolidated statements of operations and other comprehensive income (loss) as they are incurred.

IPR&D is evaluated for impairment annually using the same methodology as described above for calculating fair value. If the carrying value of the acquired IPR&D exceeds the fair value, then the intangible asset is written down to its fair value, with the resulting adjustment recorded as a charge to operations. Changes in estimates and assumptions used in determining the fair value of acquired IPR&D could result in an impairment.

Other Intangible Assets, Net

Other intangible assets consist of patent-related costs and costs for license agreements. Management reviews the carrying value of other intangible assets that are being amortized on an annual basis or sooner when there is evidence that events or changes in circumstances may indicate that impairment exists. The Company considers relevant cash flow and profitability information, including estimated future operating results, trends and other available information, in assessing whether the carrying value of intangible assets being amortized can be recovered.

If the Company determines that the carrying value of other intangible assets will not be recovered from the undiscounted future cash flows expected to result from the use and eventual disposition of the underlying assets, the Company considers the carrying value of such intangible assets as impaired and reduces them by a charge to operations in the amount of the impairment.

Costs related to acquiring patents and licenses are capitalized and amortized over their estimated useful lives, which is generally 5 to 17 years, using the straight-line method. Amortization of patents and licenses commences once final approval of the patent or license has been obtained. Patent and license costs are charged to operations if it is determined that the patent or license will not be obtained.

Derivative Financial Instruments and Warrant Liabilities

The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates all of its financial instruments, including issued stock purchase warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the condensed consolidated statements of operations and other comprehensive income (loss). Depending on the features of the derivative financial instrument, the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period (see Note 10 – Warrant Liabilities).

Fair Value Measurements

The Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established by accounting guidance and prioritizes the inputs used in measuring fair value. The Company discloses and recognizes the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows:

Level 1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date;
Level 2 - Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs in markets that are not considered to be active; and
Level 3 - Inputs that are unobservable.

Fair Value of Financial Instruments

Cash, accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.

Stock-Based Compensation

Stock-based compensation cost for equity awards granted to employees and non-employees is measured at the grant date based on the calculated fair value of the award using the Black-Scholes option-pricing model, and is recognized as an expense, under the straight-line method, over the requisite service period (generally the vesting period of the equity grant). If the Company determines that other methods are more reasonable, or other methods for calculating these assumptions are prescribed by regulators, the fair value calculated for the Company’s stock options could change significantly. Higher volatility, lower risk-free interest rates, and longer expected lives would result in an increase to stock-based compensation expense to employees and non-employees determined at the date of grant.

Income Taxes

Deferred income taxes are recognized for temporary differences in the basis of assets and liabilities for financial statement and income tax reporting that arise due to net operating loss carry forwards, research and development credit carry forwards and from using different methods and periods to calculate depreciation and amortization, allowance for doubtful accounts, accrued vacation, research and development expenses, and state taxes. A provision has been made for income taxes due on taxable income and for the deferred taxes on the temporary differences.

Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. Realization of the deferred income tax asset is dependent on generating sufficient taxable income in future years.

Sales and Excise Taxes

Sales and other taxes collected from customers and subsequently remitted to government authorities are recorded as accounts receivable with corresponding tax payable. These balances are removed from the condensed consolidated balance sheet as cash is collected from customers and remitted to the tax authority.

Warranty Costs

The Company’s warranty policy generally provides for one year of coverage against defects and nonperformance within published specifications for sold analyzers and for the term of the contract for equipment held for lease. The Company accrues for estimated warranty costs in the period in which the revenue is recognized based on historical data and the Company’s best estimates of analyzer failure rates and costs to repair.

Accrued warranty liabilities were approximately $101,000 and $60,000, respectively, as of June 30, 2022 and December 31, 2021 and are included in accrued expenses and other current liabilities on the accompanying condensed consolidated balance sheets. Warranty costs were approximately $22,000 and $20,000 for the three months ended June 30, 2022 and 2021, respectively, and approximately $41,000 and $41,000 for the six months ended June 30, 2022 and 2021, respectively, and are included in cost of product sales in the condensed consolidated statements of operations and other comprehensive loss.

Foreign Currency Translation

The functional currency for the Company is the U.S. dollar. The functional currency for NanoSynex, the Company’s newly acquired majority owned subsidiary, is the New Israeli Shekel (NIS). The financial statements of NanoSynex are translated into U.S. dollars using exchange rates in effect at each period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex is reflected as a separate component of other comprehensive income (loss).

12 

Other comprehensive loss related to the effects of foreign currency translation adjustments attributable to NanoSynex was $65,540 at June 30, 2022.

Recent Accounting Pronouncements

In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments, which supersedes current guidance by requiring recognition of credit losses when it is probable that a loss has been incurred. The new standard requires the establishment of an allowance for estimated credit losses on financial assets including trade and other receivables at each reporting date. The new standard will result in earlier recognition of allowances for losses on trade and other receivables and other contractual rights to receive cash. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842), which extends the effective date of Topic 326 for annual periods and interim periods within those annual periodscertain companies until fiscal years beginning after December 15, 2018, and is2022. The new standard will be effective for the Company forin the first quarter of fiscal year ending December 31, 2019.beginning January 1, 2023, and early adoption is permitted. The Company is currently evaluatinghas not completed its review of the impact of this standard on its condensed consolidated financial statements. However, based on the Company’s history of immaterial credit losses from trade receivables, management does not expect that the implementationadoption of this standard will have a material effect on the Company’s condensed consolidated financial statements.

On March 30, 2016,Impact of the FASB issued Accounting Standards Update No. 2016-09,Compensation - Stock Compensation (Topic 718): ImprovementsCOVID-19 Pandemic

Events surrounding the SARS-CoV-2 virus that emerged in late 2019 and the ensuing global pandemic have had a dramatic impact on businesses globally and our business as well. Our sales of diagnostic products fell significantly during 2020 and our net loss increased significantly, as deferral of patients’ non-emergency visits to Employee Share-Based Payment Accounting (“ASU 2016-09”). Among other things, ASU 2016-09 requires that entities recognize excess tax benefitsphysician offices, clinics and deficiencies relatedsmall hospitals sharply reduced demand for FastPack tests. Since then we have experienced some recovery in demand. The severity and duration of the pandemic and economic repercussions of the virus and government actions taken in response to employee share-based payment transactionsthe pandemic remain uncertain and will ultimately depend on many factors, including the speed of global dissemination and effectiveness of the vaccination and containment efforts throughout the world, the duration and spread of the virus, as income tax expensewell as seasonality, variants or benefit. ASU 2016-09 also eliminatesnew outbreaks.

In the requirementUnited States, federal, state, and local government directives and policies have been put in place throughout the course of the pandemic to reclassify excess tax benefitsmanage public health concerns and deficiencies from operatingaddress the economic impacts of the pandemic, including reduced business activity and overall uncertainty presented by this new healthcare challenge. Similar actions have been taken by governments around the world. Our facilities could be required to temporarily curtail production levels or temporarily cease operations based on government mandates or as a result of the pandemic. To mitigate risks, we continue to evaluate the extent to which COVID-19 may impact our business and operations and adjust risk mitigation planning and business continuity activities as needed.

Other accounting standard updates are either not applicable to financing activities in the statement of cash flows. The guidance is effective for the annual periods and interim periods within those annual periods beginning after December 15, 2016. The adoption of this standard didCompany or are not expected to have a material impact on the Company’s unaudited condensed financial statements.

On August 26, 2016,NOTE 2 — LIQUIDITY

The Company has incurred recurring losses from operations and has an accumulated deficit at June 30, 2022. The Company expects to continue to incur losses subsequent to the FASB issued Accounting Standards Update No. 2016-15,Statementcondensed consolidated balance sheet date of Cash Flows (Topic 230),a consensus of the FASB’s Emerging Issues Task Force (“ASU 2016-15”). The new guidance amends Accounting Standards Codification No. 230 (“ASC 230”) to add or clarify guidance on the classification of certain cash receipts and payments in the statement of cash flows. ASC 230 lacks consistent principles for evaluating the classification of cash payments and receipts in the statement of cash flows. This has led to diversity in practice and, in certain circumstances, financial statement restatements. Therefore, the FASB issued the ASU 2016-15 with the intent of reducing diversity in practice with respect to eight types of cash flows. ASU 2016-15 is effective for annual and interim periods in fiscal years beginning afterJune 30, 2022. In December 15, 2017, and is effective for2021, the Company for the year ending December 31, 2018. The Company is currently evaluating the impact that the implementation of this standard will haveraised $8.82 million through a Securities Purchase Agreement with several institutional investors.

Based on the Company’s financial statements.

In May 2017,current cash position, and assuming currently planned expenditures and level of operations, the FASB issued Accounting Standards Update No. 2017-09,Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting(“ASU 2017-09”). ASU 2017-09 provides guidance onCompany believes it has sufficient capital to fund operations for the types of changes12-month period subsequent to the terms or conditionsissuance of share-based payment awards to which an entity would be required to apply modification accounting. An entity would not apply modification accounting if the fair value, vesting conditions, and classification of the awards are the same immediately before and after the modification. The amendments are effective for the Company’s interim and annual reporting periods beginning January 1, 2018. The Company does not expect the adoption of ASU 2017-09 to have a material impact on its financial statements.

Other accounting standards updates effective after September 30, 2017 are not expected to have a material effect on the Company’s financial statements.

RITTER PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

NOTE 4 — PROPERTY AND EQUIPMENT

Property and equipment consists of the following:

  Estimated Life September 30, 2017  December 31, 2016 
Computer equipment 5 years $10,274  $10,274 
Furniture and fixtures 7 years  23,325   23,325 
Total property and equipment    33,599   33,599 
Accumulated depreciation    (13,993)  (10,057)
Property and equipment, net   $19,606  $23,542 

Depreciation expense of approximately $1,300 was recognized for each of the three months ended September 30, 2017 and 2016 and approximately $3,900 was recognized for the nine months ended September 30, 2017 and 2016, and classified in general and administrative expense in the accompanying unaudited condensed statementsfinancial statements. We will need substantial additional funding to continue our operations, particularly for QN-302 clinical trials, to continue preclinical development of QN-247 and RAS-F, and to continue funding the NanoSynex operations. (see Note 3 - Acquisition)

NOTE 5 — COMMITMENTS AND CONTINGENCIESAs a pre-clinical development-stage therapeutics biotechnology company, we expect to continue to have net losses and negative cash flow from operations, which over time will challenge our liquidity. There is no assurance that profitable operations will ever be achieved, or, if achieved, could be sustained on a continuing basis. In order to fully execute our business plan, we will require significant additional financing for planned research and development activities, capital expenditures, clinical and pre-clinical testing and commercialization activities. There can be no assurance that further financing can be obtained on favorable terms, or at all. If we are unable to obtain funding, we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect our business prospects.

13 

Master Services Agreement

On December 30, 2015,To the Company entered into a Master Service Agreement with Covance, Inc. (“Covance”), with an effective dateextent that we raise additional capital through the sale of December 29, 2015. Pursuant toequity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, commercialization, marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.

As a condition to the NanoSynex closing, the Company agreed to provide NanoSynex with up to $10.4 million of future funding based on NanoSynex’s achievement of certain future development milestones and subject to other terms and conditions described in the Master Service Agreement Covance (or one or morefor the Operational and Technological Funding of its affiliates) will provide Phase 1, 2, 3, and 4 clinical services forNanoSynex (the “Funding Agreement”) entered into with NanoSynex. These funding commitments are in the form of convertible promissory notes to be issued to the Company with a clinical study or studiesface value equal to the amount paid by the Company and,to NanoSynex upon satisfaction of the applicable performance milestone, bearing interest at the requestrate of 9% per annum on the principal balance from time to time outstanding under the particular promissory note, convertible at the option of the Company assist withinto additional shares of NanoSynex in order for the design of such studies,Company to maintain at least a 50.1% controlling ownership interest in accordance with the terms of separate individual project agreements to be entered into by the parties.NanoSynex, should NanoSynex issue additional shares. The termprincipal of the agreement is for threeconvertible notes are due and payable upon the sooner to occur of: i) five years and will renew automatically for successive one year periods unless Covance is no longer providing services underfrom the agreementdate of issuance of the particular promissory note; ii) the acquisition by any person or either party has terminatedentity of all or substantially all of the agreement upon written notice.share capital of NanoSynex, through share purchase, issuance or shares or merger of NanoSynex, or the purchase of all or substantially all of the assets of NanoSynex; or iii) the initial public offering of NanoSynex. The Company provided funding to NanoSynex of $1.5 million on July 5, 2022 pursuant to this agreement. The Company may terminate the Master ServiceFunding Agreement or any individual project agreement entered into under the Master Service Agreement prior to the applicable study’s completion at any time for any reasonafter October 29, 2022 upon 30 days written notice to Covance, except when the reason for termination is the safety of subjects, in which case it may be terminated immediately. Covance may not terminate any individual project agreement without cause, except when the reason for the termination is the safety of subjects, in which case it may be terminated immediately. In the event of a termination of the Master Service Agreement, Covance will be entitled to full payment for (i) work performed on the applicable project through the date work on such project is concluded and (ii) reimbursement for all non-cancellable and non-refundable expenses and financial obligations which Covance (or an affiliate) has incurred or undertaken on behalf of the Company.120 days’ notice.

Clinical Supply and Cooperation Agreement with Ricerche Sperimentali Montale (“Ricerche”) and Inalco SpA (“Inalco”)NOTE 3 — ACQUISITION

Effective July 24, 2015, the Company entered into an amended Clinical Supply and Cooperation Agreement (the “Amended Supply Agreement”) with Ricerche and Inalco (collectively, “RSM”). The Amended Supply Agreement amends certain terms of the Clinical Supply and Cooperation Agreement, dated December 16, 2009, amended on September 25, 2010.Business Combination


RITTER PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

Pursuant to the terms of the Amended Supply Agreement, the Company purchased the exclusive worldwide assignment of all right, title and interest to a purified GOS product (“Improved GOS”), the composition of matter of the Improved GOS and any information relating to the Improved GOS, including certain specified technical information and other intellectual property rights (the “Improved GOS IP”) on July 30, 2015 for $800,000. The Company also issued 100,000acquired a 52.8% voting equity interest in NanoSynex on May 26, 2022 (the “Acquisition Date”) through: (1) the purchase of 2,232,861 shares Preferred A-1 Stock of its common stock to RSM pursuant to a stock purchase agreement. The shares issued to RSM were subject to a lock-up agreement, pursuant to which RSM agreed that it would not sell these sharesNanoSynex for a period ending on the earlier of (i) the public release by the Company of the final results of its Phase 2b/3 clinical trial of RP-G28 and (ii) the filing of a Form 10-Q with the SEC for the fiscal quarter in which the Company receives the results of its Phase 2b/3 clinical trial of RP-G28, which condition was satisfied with the filing of the Company’s quarterly report on Form 10-Q on August 7, 2017.

Under the terms of the Amended Supply Agreement, if the Company fails to make any future option payment to RSM as required under the terms of the Amended Supply Agreement, the Company may be required to return the Improved GOS IP to RSM. The Amended Supply Agreement provides that the Company must pay RSM $400,000 within 10 days following FDA approval of a new drug application for the first product owned or controlled by the Company using Improved GOS as its active pharmaceutical ingredient and to pay RSM the sum of $250 per kilo for clinical supply of Improved GOS.

Lease Agreement

The Company leases office space for its headquarters in California. On July 9, 2015, the Company entered into a lease with Century Park, a California limited partnership, pursuant to which the Company is leasing approximately 2,780 square feet of office space in Los Angeles, California for its headquarters. The lease provides for a term of sixty-one (61) months, commencing on October 1, 2015. The Company paid no rent for the first month of the term, paid base rent of $9,174 per month for months 2 through 13 of the term, and will pay base rent of $9,449 per month for months 14 to 25 with increasing base rent for each twelve-month period thereafter under the term of the lease to a maximum of $10,325 per month for months 50 through 61. The base rent payments do not include the Company’s proportionate share of any operating expenses, including real estate taxes. The Company has the option to extend the term of the lease for one five-year term, provided that the rent would be subject to market adjustment at the beginning of the renewal term.

Rent expense, which is recognized on a straight-line basis over the lease term, was approximately $29,000 and $28,000 for the three months ended September 30, 2017 and 2016, respectively, and $86,000 for the nine months ended September 30, 2017 and 2016, and is recorded in general and administrative expenses in the accompanying unaudited condensed statements of operations.

Legal

The Company is not currently involved in any legal matters arising in the normal course of business. From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically, the Company reviews the status of significant matters, if any exist, and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict. Because of such uncertainties, accruals are based on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation.

RITTER PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

NOTE 6 — STOCKHOLDERS’ EQUITY

Authorized Shares

On September 15, 2017, the Company amended its Amended and Restated Certificate of Incorporation to authorize the issuance of up to 225,000,000 shares of common stock, $0.001 par value per share, and 15,000,000 shares of preferred stock, $0.001 par value per share.

As of September 30, 2017, the Company had 14,756,521 shares of common stock issued and outstanding. Each share of the Company’s common stock is entitled to one vote, and all shares rank equally as to voting and other matters. There are currently no shares of preferred stock issued and outstanding. Any preferred stock issued in the future will have the rights, preferences and privileges that the Company’s Board of Directors may determine from time to time.

Aspire Capital Financing Arrangement

On December 18, 2015, the Company entered into a common stock purchase agreement (the “2015 Aspire Purchase Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”), pursuant to which Aspire Capital was committed to purchase up to an aggregate of $10.0 million of the Company’s shares of common stock over the approximate 30-month term of the 2015 Aspire Purchase Agreement. As of September 30, 2017, the Company had issued an aggregate of 4,577,699 shares of its common stock to Aspire Capital under the 2015 Aspire Purchase Agreement for approximate proceeds of $5.0 million.

On May 4, 2017, the Company terminated the 2015 Aspire Purchase Agreement and entered into a new common stock purchase agreement with Aspire Capital (the “2017 Aspire Purchase Agreement”), which provides that upon the terms and conditions set forth therein, Aspire Capital is committed to purchase up to an aggregate of $6.5 million of3,500,000 shares of the Company’s common stock over the 30-month term of the 2017 Aspire Purchase Agreement. On any trading day on which the closing sale price of the Company’s common stock exceeds $0.25, the Company has the right, in its sole discretion, to present Aspire Capital withand a purchase notice, directing Aspire Capital (as principal)prefunded warrant to purchase up to 100,000 shares of the Company’s common stock per trading day, for up to $6.5 million of the Company’s common stock in the aggregate at a per share price, calculated by reference to the prevailing market price of the Company’s common stock (as provided in the 2017 Aspire Purchase Agreement).

As a condition to the 2017 Aspire Purchase Agreement, the Company issued 137,324 shares of its common stock to Aspire Capital as a commitment fee. As of the date of this Quarterly Report, no shares of common stock have been sold to Aspire Capital under the 2017 Aspire Purchase Agreement.

October 2016 Public Offering

On October 31, 2016, the Company closed a public offering, selling 2,127,6603,314,641 shares of the Company’s common stock at a purchase price to the public of $2.35$0.001 per share and, (2) the purchase of 381,786 shares of Series B preferred stock of NanoSynex from NanoSynex in exchange for aggregate gross proceeds to the Company of approximately $5.0 million. The Company paid to the underwriters underwriting discounts and commissions of approximately $0.4 million in connection with the offering, and approximately $0.2 million of other expenses in connection with the offering.$600,000.

914 
 

RITTER PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTSThe acquisition of the majority interest of NanoSynex was accounted for as a business combination using the acquisition method, in accordance with FASB ASC Topic 805. A summary of the consideration transferred and recorded fair value of assets acquired and liabilities assumed in the NanoSynex acquisition is as follows:

SCHEDULE OF CONSIDERATION TRANSFERRED

Consideration transferred, net of cash acquired    
Cash paid for NanoSynex preferred stock: $600,000 
     
Purchase of NanoSynex common Stock:    
Price per share of Qualigen Stock on May 26, 2022 $0.527 
     
FMV of 3,500,000 shares of Qualigen stock issued to Alpha Capital Anstalt $1,844,500 
FMV of 3,314,641 shares of Qualigen stock related to prefunded warrant issued to Alpha Capital Anstalt $1,746,816 
Total consideration paid for NanoSynex common stock $3,591,316 
     
FMV of consideration related to related to repricing of 70,478 shares of Alpha Capital/Qualigen warrants * $696 
     
NanoSynex cash acquired  (735,354)
Total consideration transferred, net of cash acquired $3,456,658 

 

This offering

*See disclosure under Noncompensatory Equity Classified Warrants regarding May 26, 2022 transaction in Note 14 – Stockholders Equity.

SCHEDULE OF ASSETS ACQUIRED AND LIABILITIES

  Purchase Price Allocation 
Accounts receivable $75,336 
Property and equipment  120,942 
In process R&D  5,700,000 
Accounts payable  (4,588)
Accrued expenses and other payables  (291,093)
R&D grant liability  (1,362,264)
Short term debt  (941,898)
Deferred tax liability  (736,000)
Noncontrolling interest assumed  (4,000,000)
Identifiable net assets acquired  (1,439,565)
Goodwill  4,896,223 
Total consideration transferred, net of cash acquired $3,456,658 

The purchase accounting adjustments are preliminary and subject to revision within the measurement period provided by ASC Topic 805. Qualigen transaction costs, which were immaterial, have been expensed as incurred and charged to the Company’s consolidated statements of operations and other comprehensive loss. There was made pursuantno provision for reimbursement of transaction costs from Qualigen to NanoSynex.

Goodwill represents the excess of the purchase price over the fair value of the net assets acquired as of the acquisition date. Goodwill represents the value of the future technology to be developed in excess of the identifiable assets as well as the operational synergies of the combined companies to be recognized. Goodwill has an indefinite useful life and is not amortized.

As a condition to the closing, the Company agreed to provide NanoSynex with up to $10.4 million of future funding based on NanoSynex’s achievement of certain future development milestones and subject to other terms and conditions described in the Funding Agreement entered into with NanoSynex (see Note 2 - Liquidity for further details regarding the terms and conditions of the Funding Agreement).

The Company’s condensed consolidated statement of operations and other comprehensive loss for the three and six months ended June 30, 2022 includes $8,722 of net loss associated with the results of operations of NanoSynex from the Acquisition Date to June 30, 2022.

The following pro forma information has been prepared as if the NanoSynex acquisition occurred on January 1, 2021. The following unaudited supplemental pro forma consolidated results do not purport to reflect what the combined Company’s results of operations would have been, nor do they project the future results of operations of the combined company. The unaudited supplemental pro forma consolidated results reflect the historical financial information of Qualigen and NanoSynex, adjusted to give effect to the NanoSynex acquisition as if it had occurred on January 1, 2021, as well as to record NanoSynex stock compensation expense and to record the net loss related to the noncontrolling interest, in accordance with generally accepted accounting principles.:

15 

SCHEDULE OF PRO FORMA INFORMATION

  Consolidated Pro Forma Financial Results for the Six Months Ending 
  

June 30,

2022

  

June 30,

2021

 

Net revenues $2,152,563  $3,017,430 
Net loss $(8,722,302) $(10,800,317)

NOTE 4 — INVENTORY, NET

Inventory, net consisted of the following at June 30, 2022 and December 31, 2021: 

SCHEDULE OF INVENTORY

  June 30,
2022
  December 31,
2021
 
Raw materials $808,815  $823,315 
Work in process  327,311   188,135 
Finished goods  174,087   44,428 
Total inventory $1,310,213  $1,055,878 

NOTE 5 — PREPAID EXPENSES AND OTHER CURRENT ASSETS

Prepaid expenses and other current assets consisted of the following at June 30, 2022 and December 31, 2021:

SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS

  June 30,  December 31, 
  2022  2021 
Prepaid insurance $1,810,413  $1,197,726 
Prepaid manufacturing expenses  54,741   67,410 
Other prepaid expenses  63,229   114,760 
Prepaid expenses and other current assets $1,928,383  $1,379,896 

NOTE 6 — PROPERTY AND EQUIPMENT, NET

Property and equipment, net consisted of the following at June 30, 2022 and December 31, 2021:

SCHEDULE OF PROPERTY AND EQUIPMENT

  June 30,  December 31, 
  2022  2021 
Machinery and equipment $2,505,367  $2,482,841 
Computer equipment  500,488   345,117 
Leasehold improvements  333,271   333,271 
Molds and tooling  260,002   260,002 
Furniture and fixtures  143,013   143,013 
Equipment held for lease, net  148   296 
Property and equipment, gross  3,742,289   3,564,540 
Accumulated depreciation  (3,412,659)  (3,360,324)
Property and equipment, net $329,630  $204,216 

Depreciation expense relating to property and equipment was approximately $24,000 and $17,000 for the three months ended June 30, 2022 and 2021, respectively, and $48,000 and $32,000 for the six months ended June 30, 2022 and 2021, respectively.

16 

NOTE 7 — GOODWILL, IPR&D AND OTHER INTANGIBLES

SCHEDULE OF GOODWILL AND OTHER INTANGIBLE

    June 30,  December 31, 
    2022  2021 
  Estimated Useful Lives Gross carrying
amounts
  Gross carrying
amounts
 
         
Goodwill (Note 3)   $4,896,223  $ 
           
Finite-lived intangible assets:          
Developed-product-technology rights 8 - 17 years $479,103  $479,103 
Licensing rights 10 years  418,836   418,836 
Less: Accumulated amortization    (739,493)  (726,749)
Total finite-lived intangible assets, net    158,446   171,190 
Indefinite-lived intangible assets:          
In-process research and development    5,700,000    
Total intangible assets, net   $5,858,446  $171,190 

The carrying value of the patents of approximately $150,000 and $159,000 at June 30, 2022 and December 31, 2021, respectively, are stated net of accumulated amortization of approximately $329,000 and $320,000, respectively. Amortization of patents charged to operations for the three months ended June 30, 2022 and 2021 was approximately $5,000 and $4,000 respectively, and for the six months ended June 30, 2022 and 2021 was approximately $9,000 and $7,000, respectively. Total future estimated amortization of patent costs for the five succeeding years is approximately $9,000 for the remaining six months in the year ending December 31, 2022, approximately $18,000 for year 2023, approximately $15,000 for year 2024, approximately $14,000 for years 2025, 2026 and 2027.

The carrying value of the in-licenses of approximately $9,000 and $12,000 at June 30, 2022 and December 31, 2021, respectively, are stated net of accumulated amortization of approximately $410,000 and $407,000, respectively, and amortization of licenses charged to operations for both the three months ended June 30, 2022 and 2021 was approximately $2,000. Amortization of licenses charged to operations for both the six months ended June 30, 2022 and 2021 was approximately $3,000. Total future estimated amortization of license costs is approximately $4,000 for the remaining six months in the year ending December 31, 2022, and approximately $5,000 for the year ending December 31, 2023.

NOTE 8 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accrued expenses and other current liabilities consisted of the following at June 30, 2022 and December 31, 2021:

SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

  June 30,  December 31, 
  2022  2021 
Board compensation $26,500  $17,500 
Franchise, sales and use taxes  20,467   14,090 
Income taxes  4,356   3,620 
Payroll  101,557   682,036 
Professional fees  139,551   225,308 
Research and development  299,288   232,712 
Royalties  13,900   10,152 
Vacation  457,022   282,910 
Warranty liability  101,103   60,281 
Other  250,791   265,292 
Accrued liabilities $1,414,535  $1,793,901 

NOTE 9 – SHORT TERM DEBT-RELATED PARTY

NanoSynex has four separate Notes Payable (‘the Notes”) outstanding to Alpha Capital, dated between March 26, 2020 and September 2, 2021, aggregating to a shelf registration statement on Form S-3, which was declared effectivetotal principal outstanding balance of $905,000, and aggregate accrued interest of $34,919 for a total outstanding balance of $939,919 as of June 30, 2022. The Notes all accrue interest at 2.62% per annum, accrued daily and provide that the full amount of principal and interest under each Note shall be due immediately prior to a Liquidation Event (the Maturity Date) unless due earlier in accordance with the terms of the Notes. “Liquidation Event” means either i) the merger or consolidation of NanoSynex into any other entity, other than one in control or under control of NanoSynex or NanoSynex’s majority shareholder; ii) a transaction or series of transactions resulting in the transfer of all or substantially all of NanoSynex’s assets or issued and outstanding share capital (other than to a company under the control of NanoSynex or NanoSynex’s majority shareholders; or iii) an underwritten public offering by NanoSynex of its ordinary shares. Notwithstanding the SEC on August 23, 2016. The shelf registration statement allowsabove, if NanoSynex receives subsequent debt, convertible debt, or equity funding with gross proceeds of USD $3,000,000 or more, then these Notes shall be due and payable upon the actual receipt of such funding.

17 

NOTE 10 – WARRANT LIABILITIES

In 2004, the Company issued warrants to issue, from time to time at pricesvarious investors and on terms to be determined at or prior tobrokers for the timepurchase of an offering, up to $150,000,000 of any combination of an indeterminate number of shares of common stock, an indeterminate number of shares ofSeries C preferred stock an indeterminate principal amountin connection with a private placement (the “Series C Warrants”). The Series C Warrants were subsequently extended and, upon closing of debt securities, an indeterminate number ofthe reverse recapitalization transaction with Ritter, exchanged for warrants rights and purchase contracts to purchase common stock or debt securities, and an indeterminate number of units. If any debt securities are issued at an original issue discount, then the offering price of such debt securities shall be in such greater principal amount as shall result in an aggregate offering price not to exceed $150,000,000, less the aggregate dollar amount of all securities previously issued hereunder. The securities registered also include such indeterminate number of shares of common stock and preferred stock that may be issued upon conversion or exchange of convertible or exchangeable securities being registered orCompany, pursuant to the anti-dilution provisionsSeries C Warrant terms as adjusted.

In exchange for the Series C Warrants, upon closing of any such securities.

October 2017 Public Offering

On October 3, 2017, the Company closed a public offering, sellingmerger with Ritter, the holders received warrants to purchase an aggregate of (i) 34,550,000 Class A Units consisting of 34,550,000 shares of the Company’s common stock and warrants to purchase 34,550,0004,713,490 shares of the Company’s common stock at approximately $0.72 per share, subject to adjustment. As of June 30, 2022, the warrants received in exchange for the Series C Warrants have remaining terms ranging from 1.4 to 1.9 years. The warrants were determined to be liability-classified pursuant to the guidance in ASC 480 and ASC 815-40, resulting from inclusion of a leveraged ratchet provision for subsequent dilutive issuances. On April 25, 2022 the warrants were repriced from $0.7195 to $0.60 with an additional 493,187 ratchet shares issued, and on May 26, 2022 the warrants were repriced from $0.60 to $0.5136 with an additional 499,520 ratchet shares issued. As a result of these repricings, 2,476,251 warrants were forfeited and 3,468,958 warrants were reissued at the current $0.5136 exercise price.

The following table summarizes the activity in the Common Stock Warrants (received in exchange for the Series C Warrants) for the six months ended June 30, 2022:

SCHEDULE OF WARRANTS ACTIVITY

  Common Stock Warrants (received in exchange for the
Series C Warrants)
 
  Shares  Weighted–
Average
Exercise
Price
  Range of Exercise
Price
  Weighted–
Average
Remaining Life (Years)
 
Total outstanding – December 31, 2021  2,481,614  $0.72       2.00 
Exercised  (5,363)  0.72         
Forfeited  (2,476,251)  0.72         
Expired              
Granted  3,468,958   0.51         
Total outstanding – June 30, 2022  3,468,958  $0.51         
Exercisable  3,468,958  $0.51  $0.51   1.51 

The following table summarizes the activity in the Common Stock Warrants (received in exchange for the Series C Warrants) activity for the six months ended June 30, 2021:

  Common Stock Warrants (received in exchange for the
Series C Warrants)
 
  Shares  Weighted– Average
Exercise
Price
  Range of Exercise
Price
  Weighted–
Average
Remaining
Life (Years)
 
Total outstanding –December 31, 2020  3,378,596  $0.72         
Exercised  (542,737)  0.72         
Forfeited  (36,097)  0.72         
Expired              
Granted              
Total outstanding – June 30, 2021  2,799,762  $0.72         
Exercisable  2,799,762  $0.72  $0.72   2.5 

18 

The following table presents the Company’s fair value hierarchy for its warrant liabilities and exercises (all of which arise under the warrants received in exchange for the Series C Warrants) measured at fair value on a recurring basis using Level 3 inputs as of June 30, 2022:

SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES

  Quoted          
  Market  Significant       
  Prices for  Other  Significant    
  Identical  Observable  Unobservable    
  Assets  Inputs  Inputs    
Common Stock Warrant liabilities (Level 1)  (Level 2)  (Level 3)  Total 
Balance as of December 31, 2021 $  $  $1,686,200  $1,686,200 
Exercises        (858)  (858)
Gain on change in fair value of warrant liabilities        (698,042)  (698,042)
Balance as of June 30, 2022 $  $  $987,300  $987,300 

There were no transfers of financial assets or liabilities between category levels for the three and six months ended June 30, 2022.

The value of the warrant liabilities was based on a valuation received from an independent valuation firm determined using a Monte-Carlo simulation. For volatility, the Company considers comparable public companies as a basis for its expected volatility to calculate the fair value of common stock warrants and transitions to its own volatility as the Company develops sufficient appropriate history as a public offering price of $0.40 per unit, and (ii) 9,180 Class B Units consisting of 9,180 shares of Series A Convertible Preferred Stock,company. The risk-free interest rate is based on U.S. Treasury notes with a statedterm approximating the expected term of the common stock warrant. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash dividends and does not expect to pay cash dividends in the foreseeable future. Any significant changes in the inputs may result in significantly higher or lower fair value measurements.

The following table shows the range of assumptions used in estimating the fair value of $1,000warrant liabilities as of June 30, 2022 and 2021:

SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES

  June 30, 2022  June 30, 2021 
  Range  Weighted
Average
  Range  Weighted
Average
 
Risk-free interest rate  2.80% — 2.87%  2.82%  0.34% — 0.46%  0.103%
Expected volatility (peer group)  74% — 96%  78.6%  82% — 83%  82.83%
Term of warrants (in years)  1.391.99   1.51   2.412.99   2.5 
Expected dividend yield  0.00%  0.00%  0.00%  0.00%

NOTE 11 — LOSS PER SHARE

Basic loss per unit,share (“EPS”) is computed by dividing net loss by the weighted-average number of common shares outstanding. Diluted EPS is computed based on the sum of the weighted-average number of common shares and convertiblepotentially dilutive common shares outstanding during the period. Potentially dilutive common shares consist of shares issuable from stock options and warrants.

19 

The following table reconciles net loss and the weighted-average shares used in computing basic and diluted EPS in the respective periods:

SCHEDULE OF EARNINGS PER SHARE BASIC AND DILUTED

                 
  For the Three Months Ended
June 30,
  For the Three Months Ended
June 30,
  For the Six Months Ended
June 30,
  For the Six Months Ended
June 30,
 
  2022  2021  2022  2021 
                 
Net loss used for basic earnings per share $(4,123,404) $(5,398,077) $(8,443,191) $(10,640,796)
                 
Basic weighted-average common shares outstanding  36,680,156   28,850,451   35,990,933   28,510,014 
Dilutive potential shares issuable from stock options and warrants    ��       
Diluted weighted-average common shares outstanding  36,680,156   28,850,451   35,990,933   28,510,014 


The following potentially dilutive securities have been excluded from diluted net loss per share as of June 30, 2022 and 2021 because their effect would be antidilutive:

SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE

  As of June 30,  As of June 30, 
  2022  2021 
Shares of common stock subject to outstanding options  4,767,834   4,133,856 
Shares of common stock subject to outstanding warrants  14,123,380   9,540,187 
Shares of common stock subject to conversion of Series Alpha Convertible Preferred Stock     243,418 
Total common stock equivalents  18,891,214   13,917,461 

NOTE 12 — COMMITMENTS AND CONTINGENCIES

Leases

The Company leases its facilities under a long-term operating lease agreement. On December 15, 2021, our wholly-owned subsidiary Qualigen, Inc. entered into a Second Amendment to Lease with Bond Ranch LP. This Amendment extended the Company’s triple-net leasehold on the Company’s existing 22,624-square-feet headquarters/manufacturing facility at 2042 Corte del Nogal, Carlsbad, California for the 61-month period of November 1, 2022 to November 30, 2027. Over the 61 months, the base rent payable by Qualigen, Inc. will total $1,950,710; however, the base rent for the first 12 months of the 61-month period will be only $335,966. Additionally, under the Second Amendment to Lease, Qualigen, Inc. is entitled to a $339,360 tenant improvement allowance.

The tables below show the operating lease right-of-use assets and operating lease liabilities as of June 30, 2022, including the changes during the periods:

SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES

  Operating lease right-of-use assets 
Net right-of-use assets at December 31, 2021 $1,645,568 
Less amortization of operating lease right-of-use assets  (109,804)
Operating lease right-of-use assets at June 30, 2022 $1,535,764 

  Operating lease liabilities 
Lease liabilities at December 31, 2021 $1,676,655 
Less principal payments on operating lease liabilities  (73,408)
Lease liabilities at June 30, 2022  1,603,247 
Less non-current portion  (1,425,808)
Current portion at June 30, 2022 $177,439 

As of June 30, 2022, the Company’s operating leases have a weighted-average remaining lease term of 5.4 years and a weighted-average discount rate of 8.9%.

20 

As of June 30, 2022, future minimum payments during the next five fiscal years and thereafter are as follows:

SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES

Year Ending December 31, Amount 
2022 (six months) $277,192 
2023  368,341 
2024  379,392 
2025  390,773 
2026  402,497 
2027  379,165 
Total  2,197,360 
Less present value discount  (594,113)
Operating lease liabilities $1,603,247 

Total lease expense was approximately $119,000 and $86,000 for the three months ended June 30, 2022 and 2021, respectively, and approximately $233,000 and $172,000, respectively, for the six months ended June 30, 2022 and 2021. Lease expense was recorded in cost of product sales, general and administrative expenses, research and development and sales and marketing expenses.

Termination of Sekisui Distribution Agreement

In March 2018, the Company extended a strategic partnership entered into in May 2016 with Sekisui Diagnostics, LLC (“Sekisui”). The Company appointed Sekisui as its diagnostics commercial partner and exclusive worldwide distributor with the exception of certain customer accounts retained by Qualigen; Sekisui’s distribution arrangement expired on March 31, 2022. Subsequent to the expiration of the agreement, the Company has a commitment to purchase leased FastPack rental systems back from Sekisui at Sekisui’s net book value, the amount of which has not yet been determined.

NanoSynex Funding Commitment

As a condition to the closing, the Company agreed to provide NanoSynex with up to $10.4 million of future funding based on NanoSynex’s achievement of certain future development milestones and subject to other terms and conditions described in the Funding Agreement entered into with NanoSynex (see Note 2 – Liquidity for further details regarding the terms and conditions of the Funding Agreement).

Litigation and Other Legal Proceedings

On November 9, 2021, the Company was named as a defendant in an action brought by Mediant Communications Inc. (“Mediant”) in the U.S. District Court for the Southern District of New York. The complaint alleged that Qualigen entered into an aggregateimplied contract with Mediant, whereby Qualigen retained Mediant to distribute proxy materials and subsequently conduct shareholder vote tabulations. The Company filed a Motion to Dismiss with the District Court and on March 14, 2022 a hearing was held during which the presiding judge ruled in favor of 22,950,000 sharesthe Motion to Dismiss. The Company and Mediant settled the litigation on April 5, 2022 in the amount of $96,558, at which time the amount was paid.

NOTE 13 — RESEARCH AND LICENSE AGREEMENTS

The University of Louisville Research Foundation

Between June 2018 and April 2022, the Company entered into license and sponsored research agreements with the University of Louisville Research Foundation (“ULRF”) for QN-247, a novel aptamer-based compound that has shown promise as an anticancer drug. Under the agreements, the Company will take over development, regulatory approval and commercialization of the compound from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return, ULRF received a $50,000 convertible promissory note in payment of an upfront license fee, which was subsequently converted into the Company’s common stock, and warrantsthe Company agreed to purchasereimburse ULRF for sponsored research expenses of up to approximately $805,000 and prior patent costs of up to $200,000. In addition, the Company agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization of anti-nucleolin agent-conjugated nanoparticles, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative $250,000,000), until expiration of the last to expire of the licensed patents, (ii) 30% to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred prior to June 2018, and (iv) payments ranging from $100,000 to $5,000,000 upon the achievement of certain regulatory and commercial milestones. Milestone payments for the first therapeutic indication would be $100,000 for first dosing in a Phase 1 clinical trial, $200,000 for first dosing in a Phase 2 clinical trial, $350,000 for first dosing in a Phase 3 clinical trial, $500,000 for regulatory marketing approval and $5,000,000 upon achieving a cumulative $500,000,000 of Licensed Product sales; the Company would also pay another $500,000 milestone payment for any additional regulatory marketing approval for each additional therapeutic (or diagnostic) indication. The Company also must pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for any year is less than the applicable annual minimum (ranging from $10,000 to $50,000) for such year.

21 

Sponsored research expenses related to these agreements for the three months ended June 30, 2022 and 2021 were approximately $77,000 and $89,000, respectively, and for the six months ended June 30, 2022 and 2021 were approximately $164,000 and $152,000, respectively, and these amounts are recorded in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss. License costs were approximately $14,000 and $17,000 related to these agreements for the three months ended June 30, 2022 and 2021, respectively, and approximately $69,000 and $53,000 related to these agreements for the six months ended June 30, 2022 and 2021, respectively, and are included in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss.

In March 2019, the Company entered into a sponsored research agreement and an aggregateoption for a license agreement with ULRF for development of 22,950,000 sharesseveral small-molecule RAS interaction inhibitor drug candidates. Under the terms of this agreement, the Company agreed to reimburse ULRF for sponsored research expenses of up to $693,000 for this program. In February 2021 and March 2022, the Company extended the term of this agreement until January 2023 and increased the amount that the Company will reimburse ULRF for sponsored research expenses to approximately $2.7 million. In July 2020, the Company entered into an exclusive license agreement with ULRF for RAS interaction inhibitor drug candidates. Under the agreement, the Company took over development, regulatory approval and commercialization of the candidates from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $112,000 for an upfront license fee and reimbursement of prior patent costs. In addition, the Company has agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative $250,000,000), until expiration of the licensed patent, and 2.5% (on net sales for any sales not covered by Licensed Patents), (ii) 30% to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred prior to July 2020, and (iv) payments ranging from $50,000 to $5,000,000 upon the achievement of certain regulatory and commercial milestones. Milestone payments for the first therapeutic indication would be $50,000 for first dosing in a Phase 1 clinical trial, $100,000 for first dosing in a Phase 2 clinical trial, $150,000 for first dosing in a Phase 3 clinical trial, $300,000 for regulatory marketing approval and $5,000,000 upon achieving a cumulative $500,000,000 of Licensed Product sales. The Company also must pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for any year is less than the applicable annual minimum (ranging from $20,000 to $100,000) for such year.

Sponsored research expenses related to these agreements for the three months ended June 30, 2022 and 2021 were approximately $220,000 and $99,000, respectively, and for the six months ended June 30, 2022 and 2021 were approximately $405,000 and $206,000, respectively, and are recorded in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss. License costs related to these agreements for the three months ended June 30, 2022 and 2021 were approximately $16,000 and $0, respectively, and for the six months ended June 30, 2022 and 2021 were approximately $18,000 and $40,000, respectively, and are included in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss.

In June 2020, the Company entered into an exclusive license agreement with ULRF for its intellectual property in the use of QN-165 as a treatment for COVID-19. Under the agreement, the Company took over development, regulatory approval and commercialization of the compound (for such use) from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $24,000 for an upfront license fee and reimbursement of prior patent costs. In addition, the Company was required to enter into a separate sponsored research agreement with ULRF (for QN-165 as a treatment for COVID-19) for at least $250,000. In November 2020, the Company executed a sponsored research agreement with ULRF (for QN-165 as a treatment for COVID-19) supporting up to approximately $430,000 in research which satisfied this requirement. This sponsored research agreement expired in November 2021.

In addition, the Company has agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization of QN-165 as a treatment for COVID-19, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative $250,000,000), until expiration of the licensed patents, and 2.5% (on net sales for any sales not covered by Licensed Patents), (ii) 30% to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred prior to June 2020, and (iv) payments ranging from $50,000 to $5,000,000 upon the achievement of certain regulatory and commercial milestones. Milestone payments would be $50,000 for first dosing in a Phase 1 clinical trial, $100,000 for first dosing in a Phase 2 clinical trial, $150,000 for first dosing in a Phase 3 clinical trial, $300,000 for regulatory marketing approval and $5,000,000 upon achieving a cumulative $500,000,000 of Licensed Product sales. The Company also must pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for any year is less than the applicable annual minimum (ranging from $5,000 to $50,000) for such year.

22 

Sponsored research expenses related to these agreements for the three months ended June 30, 2022 and 2021 were $0 and approximately $25,000, respectively, and for the six months ended June 30, 2022 and 2021 were $0 and $94,000, respectively, and are recorded in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss. License costs related to these agreements for the three months ended June 30, 2022 and 2021 were $0 and $16,000, respectively, and for the six months ended June 30, 2022 and 2021 were $0 and $16,000, respectively.

Advanced Cancer Therapeutics

In December 2018, the Company entered into a license agreement with Advanced Cancer Therapeutics, LLC (“ACT”), granting the Company exclusive rights to develop and commercialize QN-165, an aptamer-based drug candidate. In return, ACT received a $25,000 convertible promissory note in payment of an upfront license fee, which was subsequently converted into the Company’s common stock. In addition, the Company agreed to pay ACT (i) royalties, on net sales associated with the commercialization of QN-165, of 2% (only if patent-covered and only on net sales above a cumulative $3,000,000) or 1% (if not patent-covered, but only on net sales above a cumulative $3,000,000), until the 15th anniversary of the ACT license agreement and (ii) milestone payments of $100,000 for the Company raising a cumulative total of $2,000,000 in new equity financing after the date of the ACT license agreement, $100,000 upon any first QN-165-based licensed product receiving the CE Mark or similar FDA status, and $500,000 upon cumulative worldwide QN-165-based licensed product net sales reaching $3,000,000. For the three months ended June 30, 2022 and 2021, there were 0 license costs, and for the six months ended June 30, 2022 and 2021, there were $0 and approximately $2,000, respectively, related to this agreement which are included in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss.

Prediction Biosciences

In November 2015, the Company entered into a long-term development and supply agreement with Prediction Biosciences SAS to develop and manufacture diagnostic tests for use in the stroke point-of-care market. The Company recognizes development revenue and product sales over the performance period of the contract. For both the three and six months ended June 30, 2022 and 2021, there was 0 collaborative research revenue related to this agreement.

Sekisui Diagnostics

In March 2018, the Company extended a strategic partnership entered into in May 2016 with Sekisui. The Company appointed Sekisui as its diagnostics commercial partner and exclusive worldwide distributor with the exception of certain customer accounts retained by Qualigen. Sekisui’s distribution arrangement expired on March 31, 2022.

Under the terms of the arrangement, there were product sales to Sekisui of $0 and approximately $701,000, respectively, for the three months ended June 30, 2022 and 2021, and approximately $403,000 and $1.72 million, respectively, for the six months ended June 30, 2022 and 2021.

Yi Xin

In October 2020, the Company entered into a Technology Transfer Agreement with Yi Xin Zhen Duan Jishu (Suzhou) Ltd. (“Yi Xin”), of Suzhou, China, for Yi Xin to develop, manufacture and sell new generations of diagnostic test systems based on the Company’s core FastPack technology. In addition, the Technology Transfer Agreement authorized Yi Xin to manufacture and sell the Company’s current generations of FastPack System diagnostic products (1.0, IP and PRO) in China.

The Company will receive low- to mid-single-digit royalties on any future new-generations and current-generations product sales by Yi Xin. The Company recognized $0 and approximately $38,000 in product sales and $0 and approximately $479,000 in license revenue included in the statement of operations for the three months ended June 30, 2022 and 2021, respectively. The Company provided technology transfer and patent/know-how license rights to facilitate Yi Xin’s development and commercialization.

The Company gave Yi Xin the exclusive rights for China – which is a market the Company has not otherwise entered – both for Yi Xin’s new generations of FastPack-based products and for Yi Xin-manufactured versions of the Company’s common stock. The warrantsexisting FastPack product lines. Yi Xin will also have an exercise pricethe right to sell its new generations of $0.44, are exercisable upon issuance and expire five years fromFastPack-based diagnostic test systems throughout the date of issuance.

The Company granted the underwriters a 45-day optionworld (but not to purchase an additional 8,625,000 sharesor toward current customers of the Company’s existing generations of FastPack products). After March 31, 2022, Yi Xin has the right to sell Yi Xin-manufactured versions of existing FastPack 1.0, IP and PRO product lines worldwide (other than in the United States and other than to or toward current non-U.S. customers of those products), as well as the right to buy Company-manufactured FastPack 1.0, IP and PRO products from the Company at distributor prices for resale in and for the United States (but not to or toward current U.S. customers of those products); the Company did not license Yi Xin to sell in the United States market any Yi Xin-manufactured versions of those legacy FastPack 1.0, IP and PRO product lines. In the Technology Transfer Agreement, the Company also confirmed that it would not, after March 31, 2022, seek new FastPack customers outside the United States.

23 

STA Pharmaceutical

In November 2020, the Company entered into a contract with STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, for GMP production of QN-165, which was the Company’s lead drug candidate for the treatment of COVID-19 and other viral diseases, for potential clinical trials in 2021.

Research and development expenses related to this agreement for the three months ended June 30, 2022 and 2021 were $0 and $1.9 million, respectively, and for the six months ended June 30, 2022 and 2021 were approximately $9,000 and $3.1 million, respectively, and are recorded in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss.

UCL Business Limited

In January 2022, the Company entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London, including lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization company for University College London.) The program’s lead compound is now being developed at Qualigen under the name QN-302 as a candidate for treatment for pancreatic ductal adenocarcinoma (PDAC), which represents the vast majority of pancreatic cancers. The License Agreement required a $150,000 upfront payment, reimbursement of past patent prosecution expenses (approximately $160,000), and (if and when applicable) tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments and a percentage of any non-royalty sublicensing consideration paid to Qualigen.

For both the three months ended June 30, 2022 and 2021, there were license costs of $0, and for the six months ended June 30, 2022 and 2021 there were license costs of approximately $310,000 and $0, respectively, related to this agreement which are included in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss.

NOTE 14 — STOCKHOLDERS’ EQUITY

As of June 30, 2022 and December 31, 2021, the Company had two classes of authorized capital stock: common stock and/and Series Alpha convertible preferred stock.

Common Stock

Holders of common stock generally vote as a class with the holders of the preferred stock and are entitled to one vote for each share held. Subject to the rights of the holders of the preferred stock to receive preferential dividends, the holders of common stock are entitled to receive dividends when and if declared by the Board of Directors. Following payment of the liquidation preference of the preferred stock, as of June 30, 2022 any remaining assets would be distributed ratably among the holders of the common stock and, on an as-if-converted basis, the holders of Series Alpha convertible preferred stock upon liquidation, dissolution or warrants to purchase an additional 8,625,000winding up of the affairs of the Company. The holders of common stock have no preemptive, subscription or conversion rights and there are no redemption or sinking fund provisions.

At June 30, 2022, the Company has reserved 18,891,214 shares of the Company’sauthorized but unissued common stock. As of the closing of the offering, the underwriters have exercised their over-allotment optionstock for warrants to purchase 2,975,000possible future issuance.

At June 30, 2022, shares of the Company’s common stock.

Aggregate gross proceeds to the Company from the public offering were approximately $23.0 million. The Company paid to the underwriters underwriting discounts and commissions of approximately $1.6 millionreserved in connection with the offering,following:

SCHEDULE OF RESERVED SHARES

Exercise of issued and future grants of stock options4,767,834
Exercise of stock warrants14,123,380
Total18,891,214

Series Alpha Convertible Preferred Stock

As of June 30, 2022, and approximately $0.4 millionDecember 31, 2021, there were 0 shares of other expenses in connection withSeries Alpha convertible preferred stock outstanding.

24 

Stock Options and Warrants

The Company recognizes all compensatory share-based payments as compensation expense over the offering ofservice period, which approximately $0.3 million are recorded as deferred offering costs inis generally the Company’s financial statements as of, and for the nine months ended September 30, 2017.vesting period.

The securities described above were offered byIn April 2020, the Company pursuant to a registration statement filed withadopted the SEC that was declared effective on September 28, 2017. The final prospectus relating to the offering was filed with the SEC on October 2, 2017.

NOTE 7 — WARRANTS

The following represents a summary of the warrants outstanding at September 30, 2017 and changes during the period then ended:

  Warrants  Weighted Average Exercise Price 
Outstanding at December 31, 2016  578,323  $8.45 
Granted    $ 
Exercised/Expired/Forfeited   $ 
Outstanding at September 30, 2017  578,323  $8.45 
Exercisable at September 30, 2017  578,323  $8.45 

RITTER PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

NOTE 8 — STOCK-BASED COMPENSATION

Equity Incentive Plans

The Company has issued equity awards pursuant to its 2015 Equity2020 Stock Incentive Plan (the “2015“2020 Plan”), 2009 Stock Plan and 2008 Stock Plan (collectivelywhich provides for the “Plans”). The Plans permit the Company to grantgranting of incentive or non-statutory stock options, incentivecommon stock options and other equitytypes of awards to the Company’squalified employees, outsideofficers, directors, consultants and consultants; however, incentive stockother service providers. At June 30, 2022 and December 31, 2021 there were 4,767,834 and 4,748,000 outstanding options, may only be granted to the Company’s employees. Beginning June 29, 2015, no further awards may be grantedrespectively, under the 2009 Stock2020 Plan or 2008 Stock Plan. However, to the extent awardsand on such dates there were 2,789,323 and 2,809,157 shares reserved under the 20082020 Plan, or 2009 Plan are forfeited or lapse unexercised or are settled in cash, the common stock subject to such awards will berespectively, for future grant. The shares available for future issuance undergrant reflect a 2020 Plan amendment approved by the 2015 Equity Incentive Plan.

On June 2, 2017,Company’s stockholders on August 9, 2021 where the stockholders of the Company approved an amendment to the 2015 Plan at the 2017 annual meeting of stockholders, which among other things, increased the number of shares that may be issued pursuant to awards under the 2015 Plan by 838,000 shares of common stock.

On September 15, 2017, the stockholders of the Company approved an amendment to the 2015 Plan at a special meeting of stockholders, which among other things, increased the number of shares that may be issued pursuant to awards under the 2015 Plan by 25,858,711 shares of common stock. As of September 30, 2017, the aggregate number of shares of common stock authorizedavailable for issuance under the 20152020 Plan as amended, was 27,500,000.increased by 3,500,000.

The following represents a summary of the options granted (under the 2020 Plan and otherwise) to employees and non-employeesnon-employee service providers that are outstanding at SeptemberJune 30, 20172022, and changes during the six-month period then ended:

SCHEDULE OF STOCK OPTION ACTIVITY

  Shares  Weighted–
Average
Exercise
Price
  Range of
Exercise
Price
  Weighted–
Average
Remaining
Life (Years)
 
Total outstanding – December 31, 2021  4,841,856  $6.07  $1.24 — $1,465.75   8.52 
Granted  25,000   1.05   1.05   9.54 
Expired  (93,856)  93.59   5.75 - 1,465.75    
Forfeited  (5,166)  3.51   1.24 - 4.97    
Total outstanding – June 30, 2022  4,767,834  $4.33  $1.05 — $5.13   8.19 
Exercisable (vested)  2,643,665  $4.84  $1.24 — $5.13   8.00 
Non-Exercisable (non-vested)  2,124,169  $3.68  $1.05 — $5.13   8.48 

There was approximately $2.6 and $2.5 million of compensation cost related to outstanding options for the six months ended June 30, 2022 and 2021 respectively. As of June 30, 2022, there was approximately $5.6 million of total unrecognized compensation cost related to unvested stock-based compensation arrangements. This cost is expected to be recognized over a weighted average period of 1.1 years.

 

  Number of Shares  Weighted- Average Exercise Price  Aggregate Intrinsic Value  Weighted- Average Remaining Contractual Life (in years) 
Outstanding at December 31, 2016  2,476,924  $6.01  $497,351   8.3 
Options granted  88,000   2.89      8.8 
Options forfeited (5,000)  2.89       
Outstanding at September 30, 2017  2,559,924   5.91      7.6 
Exercisable at September 30, 2017  1,808,972  $5.88     7.2 

The following represents a summary of the options granted (under the 2020 Plan and otherwise) to employees and non-employee service providers that are outstanding at June 30, 2021, and changes during the six-month period then ended:

  Shares  Weighted–
Average
Exercise
Price
  Range of
Exercise
Price
  Weighted–
Average
Remaining
Life (Years)
 
Total outstanding – December 31, 2020  4,011,356  $7.05  $3.52 - $1,465.75   9.29 
Granted  127,000   2.12   1.803.29   9.83 
Expired            
Forfeited  (4,500)  3.68   3.524.97    
Total outstanding – June 30, 2021  4,133,856  $6.90  $1.80 - $1,465.75   8.82 
Exercisable (vested)  1,296,860  $11.50  $4.97— $1,465.75   8.36 
Non-Exercisable (non-vested)  2,836,996  $4.80  $1.80 — $5.13   9.04 

The exercise price for an option issued under the Plans2020 Plan is determined by the Board of Directors, but will be (i) in the case of an incentive stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the fair market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value per share on the date of grant; and (ii) in the case of a non-statutory stock option, no less than 100% of the fair market value per share on the date of grant.grant. The options awarded under the Plans2020 Plan will vest as determined by the Board of Directors but will not exceed a ten-year period. The weighted average grant date fair value per share of options granted during the six months ended June 30, 2022 was $0.84.

Fair Value of Equity Awards

The Company utilizes the Black-Scholes option pricing model to value awards under its Plans. Key valuation assumptions include:

RITTER PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

Expected dividend yield.The expected dividend is assumed to be zero, as the Company has never paid dividends and has no current plans to pay any dividends on the Company’s common stock.

25 
 

Expected stock-price volatility.As the The Company’s common stock only recently became publicly traded, the expected volatility is derived from the average historical volatilities of publicly traded companies within the Company’s industry that the Company considers to be comparable to the Company’s business over a period approximately equal to the expected term.
Risk-free interest rate.The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term.
Expected term.The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of a lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method provided by the SEC.Securities and Exchange Commission. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options.

The Company elected to adopt the amendments of ASU 2016-09 (described in Note 3) related to the presentation of excess tax benefits on the statement of cash flows using a prospective transition method but does not expect any impact on its financial statements.

The material factors incorporated in the Black-Scholes model in estimating the fair value of the options granted for the periods presented were as follows:

  Three Months Ended
September 30,
  

Nine Months Ended

September 30,

 
  2017  2016  2017  2016 
Expected dividend yield  0.00%  0.00%  0.00%  0.00%
Expected stock price volatility  53.08% - 53.68   53.60% - 54.73  53.08% – 53.90%  53.60% - 59.03
Risk-free interest rate  1.89% - 2.29  1.29% - 1.71  1.98% - 2.37  1.29% - 1.78
Term of options  10   10   10   10 
Stock price  $0.35 - $0.65   $1.27 - $1.68   $0.35 - $1.08   $1.13 - $1.68 

Stock-Based CompensationSCHEDULE OF ASSUMPTIONS USED IN BLACK-SCHOLES OPTION-PRICING METHOD

  

For the Six Months

Ended

June 30,

 
  2022  2021 
Expected dividend yield  0.00%  0.00%
Expected stock-price volatility  102%  102%
Risk-free interest rate  1.58% — 1.67%  0.84% — 1.81%
Expected average term of options (in years)  6.00   6.00 
Stock price $1.05  $2.12 

The Company recognized stock-basedrecorded share-based compensation expense and classified it in the condensed consolidated statements of operations and other comprehensive loss as follows:

SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE

  2022  2021 
  For the Six Months
Ended
June 30,
 
  2022  2021 
General and administrative $2,329,418  $2,201,499 
Research and development  361,029   347,550 
Total $2,690,447  $2,549,049 

Equity Classified Compensatory Warrants

In connection with the $4.0 million equity capital raise as part of the May 2020 reverse recapitalization transaction, the Company issued common stock warrants to an advisor and its designees for services withinthe purchase of 811,431 shares of the Company’s common stock at an exercise price of $1.11 per share. The issuance cost of these warrants was charged to additional paid-in capital, and did not result in expense in the Company’s condensed consolidated statements of operations and other comprehensive loss.

In addition, various service providers hold equity classified compensatory warrants issued in 2017 and earlier (originally exercisable to purchase Series C convertible preferred stock, and now instead exercisable to purchase common stock) for the purchase of 668,024 shares of Company common stock at a weighted average exercise price of $2.34 per share. These are to be differentiated from the Series C Warrants described in Note 10 – Warrant Liabilities.

During the year ended December 31, 2021, the Company issued equity classified compensatory warrants to a service provider for the purchase of 600,000 shares of Company common stock at an exercise price of $1.32 per share. The fair value issuance cost of approximately $0.3 million using the Black-Scholes options pricing model for these warrants was charged to general and administrative expenseexpenses in the accompanyingCompany’s condensed consolidated statements of operations and other comprehensive loss. On April 25, 2022, 600,000 warrants were repriced from $1.32 to $0.60 and extended from June 3, 2023 to September 14, 2023. The increase in fair value of approximately $203,000 and $333,000$67,370 using a Monte Carlo pricing model for the three months ended September 30, 2017modification of these warrants was charged to general and 2016, respectively,administrative expenses in the Company’s condensed consolidated statements of operations and $746,000other comprehensive loss. On April 25, 2022 and $1,042,000May 26, 2022 an additional 676,194 warrants were repriced from $1.11 to $0.5136. The increase in fair value of $31,010 using a Monte Carlo pricing model for the nine months ended September 30, 2017modification of these warrants was charged to additional paid-in capital and 2016, respectively. Asdid not result in expense on the Company’s condensed consolidated statements of September 30, 2017, there was approximately $263,000 of total unrecognized compensation cost related to unvested stock-based compensation arrangements. This cost is expected to be recognized over a weighted average period of 1.1 years.operations and other comprehensive loss.

No stock options were exercised during the three and nine months ended September 30, 2017. Approximately 8,000 options were exercised during the three months ended September 30, 2016, and approximately 11,000 options were exercised during the nine months ended September 30, 2016 with approximate proceeds to the Company of $9,000. The aggregate intrinsic value of stock options exercised during the nine months ended September 30, 2016 was approximately $18,000.

1226 
 

No compensatory warrants were issued during the six months ended June 30, 2022.

The following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30, 2022:

SCHEDULE OF WARRANT ACTIVITY

  Common Stock 
  Shares  Weighted– Average
Exercise
Price
  Range of
Exercise Price
  

Weighted–
Average
Remaining

Life (Years)

 
Total outstanding – December 31, 2021  1,790,648  $1.52  $1.11 — $2.54   2.64 
Granted to advisor and its designees              
Exercised              
Expired              
Forfeited              
Total outstanding – June 30, 2022  1,790,648  $1.06  $0.51362.54   2.23 
Exercisable  1,790,648  $1.06  $0.5136 — $2.54   2.23 
Non-Exercisable    $  $    

The following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30, 2021:

  Common Stock 
  Shares  Weighted– Average
Exercise
Price
  Range of
Exercise Price
  Weighted–
Average
Remaining
Life (Years)
 
Total outstanding – December 31, 2020  1,294,217  $1.66         
Granted              
Exercised  (38,390)  2.09         
Expired              
Forfeited  (65,179)  2.07         
Total outstanding – June 30, 2021  1,190,648  $1.62         
Exercisable  1,187,052  $1.62  $1.11 — $2.54   3.75 
Non-Exercisable  3,596  $2.54  $2.54   5.23 

There were $67,370 in compensation costs related to outstanding equity classified compensatory warrants for the six months ended June 30, 2022 and $0 for the six months ended June 30, 2021.

Noncompensatory Equity Classified Warrants

In May 2020, as a commitment fee, the Company issued noncompensatory equity classified warrants to an investor for the purchase of 270,478 shares of Company common stock at an exercise price of $1.11 per share (of which warrants for 200,000 shares were subsequently exercised in December 2020). In July 2020 the Company issued noncompensatory equity classified warrants to such investor for the purchase of 780,198 shares of Company common stock at an exercise price of $0.001 per share (which were subsequently exercised in July 2020), and 1,920,678 shares of Company common stock at an exercise price of $5.25 per share. In August 2020 the Company issued noncompensatory equity classified warrants to such investor for the purchase of 1,287,829 shares of Company common stock at an exercise price of $6.00 per share. In December 2020, the Company issued noncompensatory equity classified warrants to such investor for the purchase of 1,000,000 shares of Company common stock at an exercise price of $0.01 per share (which were exercised in February 2021) and 2,191,010 shares of Company common stock at an exercise price of $4.07 per share. In May 2022 the Company issued noncompensatory equity classified warrants to such investor for the purchase of 3,314,641 shares of Company common stock at an exercise price of $0.001 per share.

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During the year ended December 31, 2021, with the exception of the warrants to purchase 270,478 shares of the Company’s common stock at an exercise price of $1.11 per share, the exercise prices of all outstanding warrants to purchase a total of 5,399,517 shares of the Company’s common stock were modified to an exercise price of $2.00 per share on November 29, 2021 and each of their remaining terms extended by six months. The fair value of the modification cost of these warrant modifications of approximately $2.3 million was charged to additional paid-in capital and did not result in expense on the Company’s condensed consolidated statements of operations and other comprehensive loss. During the period ended June 30, 2022 pre-funded warrants to purchase 3,314,641 shares of the Company’s common stock at an exercise price of $0.001 per share with no expiration date were issued.

In conjunction with the NanoSynex acquisition, on April 25, 2022 the exercise price of 70,478 outstanding warrants at $1.11 was modified to an exercise price of $0.60. The increase in fair value of $2,533, using a Monte Carlo pricing model for the modification of these warrants, was charged to additional paid-in capital and did not result in expense on the Company’s condensed consolidated statements of operations and other comprehensive loss. On May 26, 2022 the exercise price of these warrants was modified again to $0.5136, and the increase in fair value of $696, using a Monte Carlo pricing model for the modification of these warrants, was included in consideration transferred in the NanoSynex acquisition (see Note 3 - Acquisitions).

Weighted average remaining life below was calculated excluding the 3,314,641 pre-funded warrants as they have no expiration date.

The following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2022:

SCHEDULE OF WARRANT ACTIVITY

  Common Stock 
  Shares  Weighted–
Average
Exercise
Price
  Range of
Exercise Price
  Weighted–
Average
Remaining
Life (Years)
 
Total outstanding – December 31, 2021  5,549,137  $2.01         
Granted  3,314,641   0.001   0.001     
Exercised              
Expired              
Forfeited              
Total outstanding – June 30, 2022  8,863,778   1.26         
Exercisable  8,863,778  $1.26  $0.001 — $3.77   0.82 
Non-Exercisable    $  $    

NOTE 15 - QUARTERLY FINANCIAL DATA (UNAUDITED)


As disclosed in
the 2021 Annual Report, the Company’s management identified an error in the previously issued March 31, 2021, June 30, 2021 and September 30, 2021 unaudited interim condensed consolidated financial statements in which the fair value of the Company’s exercised liability classified warrants had been inadvertently excluded from reclassification into shareholders’ equity. All financial information contained in the accompanying notes to these condensed consolidated financial statements has been revised to reflect the correction of this error as shown in the table below.

SCHEDULE OF ERROR CORRECTIONS AND PRIOR PERIOD ADJUSTMENTS

  As reported  Corrected  As reported  Corrected 
  For the Quarter
Ended
June 30, 2021
  For the Six Months
Ended
June 30, 2021
 
  As reported  Corrected  As reported  Corrected 
Gain on change in fair value of warrant liabilities $(2,075,100) $(1,982,256) $(4,198,000) $(2,535,064)
Net loss $(5,305,233) $(5,398,077) $(8,977,860) $(10,640,796)
Net loss per common share $(0.18) $(0.19) $(0.31) $(0.37)

NOTE 16 — SUBSEQUENT EVENTS

In conjunction with the Company’s Funding Agreement with NanoSynex, the Company provided $1.5 million in funding to NanoSynex on July 5, 2022. Repayment terms under the Funding Agreement are described in Note 2 - Liquidity.

Management has evaluated subsequent events pursuant to the requirements of ASC Topic 855, Subsequent Events, from the balance sheet date through August 15, 2022 and has determined that there are no material subsequent events that require disclosure in these financial statements, other than as disclosed above.

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

The following discussion and analysis should be read in conjunction with our interim unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q (“Quarterly(this “Quarterly Report”) and the audited financial statements and notes thereto as of and for the yeartwelve months ended December 31, 2016 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of2021, which are contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed with the Securities and Exchange Commission (“SEC”) on February 27, 2017 (the “2016March 31, 2022 (as amended, the “2021 Annual Report”Report.). As used in this report,Quarterly Report, unless the context suggests otherwise, “we,” “us,” “our,” or “Ritter”“Qualigen” refer to Ritter Pharmaceuticals,Qualigen Therapeutics, Inc. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.

SpecialCautionary Note Regarding Forward-LookingForward Looking Statements and Industry Data

This Quarterly Report contains forward-looking statements by Qualigen Therapeutics, Inc. that involve substantial risks and uncertainties. All statements other than statementsuncertainties and reflect our judgment as of historical facts contained inthe date of this Quarterly Report, includingReport. These statements regardinggenerally relate to future events or our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended toor operating performance. In some cases, you can identify forward-looking statements although not allbecause they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Such forward-looking statements contain these identifying words. These statements involve knownmay relate to, among other things, potential future development, testing and unknown risks, uncertaintieslaunch of products and other important factors thatproduct candidates. Actual events or results may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

Some of the factors that we believe could cause actual results to differ from those anticipated or predicted include:our expectations due to a number of factors.

These forward-looking statements include, but are not limited to, statements about:

our ability to obtain additional financing;successfully develop any drugs or therapeutic devices;
   
the accuracy of our estimates regarding expenses, future revenuesability to progress our drug candidates or therapeutic devices through preclinical and capital requirements;clinical development;
   
our ability to obtain the successrequisite regulatory approvals for our clinical trials and timing of our preclinical studiesto begin and clinical trials;complete such trials according to any projected timeline;
   
our ability to obtain and maintain regulatory approval of RP-G28 andcomplete enrollment in our clinical trials as contemplated by any other product candidates we may develop, and the labeling under any approval we may obtain;projected timeline;
   
regulatory developments in the United States andlikelihood that future clinical trial data will be favorable or that such trials will confirm any improvements over other countries;products or lack negative impacts;
   
the performance of third-party manufacturers;our ability to successfully commercialize any drugs or therapeutic devices;
   
our ability to developprocure or earn sufficient working capital to complete the development, testing and commercialize RP-G28 and any other product candidates that we may develop in the future;launch of our prospective therapeutic products;
   
the likelihood that patents will issue on our ability to obtainowned and maintain intellectual property protection for RP-G28 and any other product candidates we may develop in the future;in-licensed patent applications;
   
the successful development of our sales and marketing capabilities;ability to protect our intellectual property;
   
the potential markets for RP-G28 and any other product candidates we may develop in the future and our ability to serve those markets;compete;
   
the rateour ability to maintain or expand market demand and/or market share for our diagnostic products generally, particularly in light of COVID-19-related deferral of patients’ physician-office visits and degreein view of market acceptance of our products, if approved;FastPack reimbursement pricing challenges; and
   
our ability to maintain our diagnostic sales and marketing engine without interruption following the successexpiration of competing drugs that are or become available; and
the loss of key scientific or management personnel.our distribution agreement with Sekisui Diagnostics, LLC (“Sekisui”).

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. These risks and uncertainties include risks related to our financial position and our ability to raise additional capital as needed to fund our operations and product development; risks related to the initiation, cost, timing, progress and results of current and future research and development programs, preclinical studies and clinical trials and our ability to obtain and maintain regulatory approvals; risks related to our reliance on third party suppliers and manufacturers; risks related to market acceptance of our products and competition; risks related to our acquisition of NanoSynex, Ltd.; risks related to the ongoing COVID-19 pandemic and the war in Ukraine, including instability in the global credit markets and supply chain disruptions. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate, are consistent in some future periods with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments in other future periods.

Any forward-looking statement that we make in this Quarterly Report speaks only as of the date of this Quarterly Report, and we disclaim any intent or obligation to update these forward-looking statements beyond the date of this Quarterly Report, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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Future filings with the SEC, future press releases and future oral or written statements made by us or with our approval, which are not statements of historical fact, may also contain forward-looking statements. Because such statement,statements include risks and uncertainties, many of which are beyond our control, actual results may differ materially from those expressed or implied by such forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they are made.

Overview

We are a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug designation, while also commercializing diagnostics. Our cancer therapeutics pipeline includes QN-302, QN-247 and RAS-F. Our investigational QN-302 compound is a small molecule G4 selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells. Such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. QN-247 is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of this Quarterly Report. You should also read carefullycancer; the factors described innanoparticle conjugate technology is similar to the “Risk Factors” section of our 2016 Annual Report and this Quarterly Report to better understand the risks and uncertainties inherentcore nanoparticle coating technology used in our businessblood-testing diagnostic products. The foundational aptamer of QN-247 is QN-165 (formerly referred to as AS1411), which the Company has deprioritized as a drug candidate for treating COVID-19 and underlying any forward-looking statements.

Overview

Ritter Pharmaceuticals, Inc. develops novel therapeutic products that modulate the human gut microbiomeother viral-based infectious diseases. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes’ proteins from binding to treat gastrointestinal diseases.their effector proteins; preventing this binding could stop tumor growth, especially in RAS-driven tumors such as pancreatic, colorectal and lung cancers. We are advancing human gut health research by exploring the metabolic capacity of the gut microbiotaalso identifying strategic partnering opportunities for STARS, a DNA/RNA-based therapeutic device product concept for removing precisely targeted tumor-produced and translating the functionality of prebiotic-based therapeutics into applications intended to have a meaningful impact on a patient’s health. We completed a Phase 2a clinical trial of our leading product candidate, RP-G28, an orally administered, high purity oligosaccharide in November 2011.viral compounds from circulating blood.

We completed a Phase 2b/3 multi-center, randomized, double-blind, placebo-controlled, parallel group trial of RP-G28 in October 2016. The purpose of the trial was to evaluate the safety, efficacyOur FastPack System diagnostic instruments and tolerability of two dosing regimens of RP-G28 in patients with moderate to severe lactose intolerance symptoms. Enrollment was initiated in March 2016 and completed in August 2016, achieving our projected enrollment time period. The trial aimed to evaluate a patient’s ability to consume dairy foods post-treatment with improved tolerance and reduced digestive symptoms. A total of 377 subjects were enrolled in the trial with 18 clinical sites participating throughout the United States. Patients underwent a 30-day treatment, followed by a 30-day post-treatment evaluation of dairy tolerance. On October 17, 2016, the last patient completed dosing and all monitoring visits.

We held a Type C meeting with the FDA in March 2017, prior to the unblinding of our Phase 2b/3 data, to discuss our development plans and Phase 2b/3 clinical trial. The focus of the meeting was to obtain the FDA’s feedback on our Phase 2b/3 clinical trial, including our statistical analysis plan (“SAP”) prior to unblinding any data.

The meeting with the FDA was constructive and productively focused on best defining clinically meaningful benefits to patients suffering from lactose intolerance and how to reflect these benefits in endpoints. We modified aspects of our SAP to address certain FDA recommendations, including a change to our primary endpoint, which was changed to combine abdominal pain with relevant secondary endpoints to establish a composite score (abdominal pain, abdominal cramping, abdominal bloating and abdominal gas). The protocol design and the assessment utilized to collect lactose intolerance symptoms remained unchanged.

Topline results of the trial were announced in March 2017. Due to inconsistent data results from one study site, the data from this site was excluded from the primary analysis population (Efficacy Subset mITT). After excluding the data from the one anomalous study site, results showed a clinically meaningful benefit to subjects in the reduction of lactose intolerance symptoms across a variety of outcome measures. The majority of analyses showed positive outcome measures and the robustness of the data point to a clear drug effect. Treatment patients not only reported meaningful reduced symptoms, but also 30 days after taking the treatment, patients reported adequate relief from lactose intolerance symptoms and satisfaction with the results of the treatment, with RP-G28 preventing or treating their lactose intolerance symptoms. Greater milk and dairy product consumption was also reported by patients.

A subset of subjects from our Phase 2b/3 clinical trial has been rolled into a 12-month extension study to evaluate long-term durability of treatment. The study is also evaluating each participant’s microbiome, expanding our knowledge of the effects that RP-G28 may have on adapting the gut microbiota in a beneficial manner. The subjectstest kits are expected to complete the 12-month evaluation during the fourth quarter of 2017.

We held an End-of-Phase 2 meeting with the FDA’s Division of Gastroenterology and Inborn Errors Products in August 2017. The purpose of the meeting was to obtain the FDA’s feedback on our Phase 3 program. We reached general consensus with the FDA on certain elements of our current Phase 3 program and have received clear guidance and recommendations on many necessary components of our Phase 3 program; including the clinical, non-clinical, and chemistry, manufacturing and controls (CMC) requirements needed to support an NDA submission.

We have incorporated much of this guidance into our Phase 3 program. Our current Phase 3 clinical program will consist of two confirmatory clinical trials of similar trial design and size as our Phase 2b/3 clinical trial and will include additional components that may allow for claims for durability of effect. These additional trials may be run in parallel.

Financial Overview

We have incurred net losses in each year since our inception, including net losses of approximately $5.6 million for the nine months ended September 30, 2017. We had an accumulated deficit of approximately $51.1 million as of September 30, 2017. Substantially all of our net losses resulted from costs incurred in connection with our research and development programs, patent costs, stock-based compensation, and from general and administrative costs associated with our operations.

Revenue

We have not generated any revenue since our inception. Our ability to generate revenue in the future will depend almost entirely on our ability to successfully develop, obtain regulatory approval for and then successfully commercialize RP-G28sold commercially primarily in the United States. InStates, as well as certain European countries. The FastPack System menu includes a rapid, highly accurate immunoassay diagnostic testing system for cancer, men’s health, hormone function, and vitamin D status. We provide analyzers to our customers (physician offices, clinics and small hospitals) at low cost in order to increase sales volumes of higher-margin test kits. Prior to March 31, 2022, most of our FastPack product sales were through our partner Sekisui pursuant to a distribution agreement, but we maintained direct distribution for certain house accounts, including selling our total testosterone test kits to Low T Center, Inc. (“Low T”), the event we choose to pursue a partnering arrangement to commercialize RP-G28 or other products outsidelargest men’s health group in the United States, with 40 locations. The distribution agreement with Sekisui expired on March 31, 2022, at which time the services previously provided by Sekisui reverted to us and as of April 1, 2022 we would expectrecognize 100% of the revenue from the sales of our FastPack diagnostic instruments and test kits. We have licensed and technology-transferred our FastPack System technology to initiate additional researchYi Xin Zhen Duan Jishu (Suzhou) Ltd. for the China diagnostics market and developmentother markets outside of the United States in which the Company does not currently sell.

On May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd, (“NanoSynex”) from Alpha Capital Anstalt (“Alpha Capital”) in exchange for 3,500,000 shares of the Company’s common stock and clinical trial activitiesa prefunded warrant to purchase 3,314,641 shares of the Company’s common stock at an exercise price of $0.001 per share. Concurrently with this transaction, the Company also purchased 381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $600,000. The transactions resulted in the future.Company acquiring a 52.8% interest in NanoSynex. The Company envisions future synergies from the integration of its own proprietary results-proven FastPack diagnostics platform with the innovative NanoSynex technology. NanoSynex is a micro-biologics diagnostics company domiciled in Israel.

Our condensed consolidated financial statements do not separate out our diagnostics-related activities and our therapeutics-related activities. Although to date all our reported revenue is diagnostics-related, our reported expenses represent the total of our therapeutics-related and diagnostics-related expenses.

ResearchDistribution and Development ExpensesAgreement with Sekisui

SinceIn May 2016, through our inception,wholly-owned diagnostics subsidiary Qualigen, Inc., we entered into a Distribution and Development Agreement (the “Sekisui Distribution Agreement”) with Sekisui. Under the Sekisui Distribution Agreement, Sekisui served as the exclusive worldwide distributor for FastPack products (although we retained certain specific accounts for direct transactions). Sekisui’s exclusive distribution arrangements expired on March 31, 2022.

Under the Sekisui Distribution Agreement, we began development of a proposed “FastPack 2.0” product line for a new whole blood vitamin D assay, which if successfully introduced by us would have focused our resources on our researchbeen distributed by Sekisui. Between May 2016 and January 2018, Sekisui paid us a total of approximately $5.5 million upon the achievement of specified development activities, including conducting nonclinical studies and clinical trials, manufacturing development efforts and activitiesmilestones related to regulatory filings for RP-G28. Our research and development expenses consist primarily of:this product line.

fees paid to consultants and clinical research organizations (“CROs”), including in connection with our nonclinical and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis;
costs related to acquiring and manufacturing clinical trial materials;
depreciation of equipment, computers and furniture and fixtures;
costs related to compliance with regulatory requirements; and
overhead expenses for personnel in research and development functions.

From inception through September 30, 2017, we have incurred approximately $21.9 million in research and development expenses. We plan to increase our research and development expenses for the foreseeable future as we continue the development of RP-G28 for the reduction of symptoms associated with lactose intolerance in patients and other indications, subject to the availability of additional funding.

The successful development of RP-G28 is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of RP-G28 or the period, if any, in which material net cash inflows from RP-G28 may commence. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

the scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;
future clinical trial results; and
the timing and receipt of any regulatory approvals.

For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development of RP-G28 or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

Patent Costs

Patent costs consist primarily of professional fees for legal services to prosecute patents and maintain patent rights.

General and Administrative Expenses

General and administrative expenses include allocation of facilities costs, salaries, benefits, and stock-based compensation for employees, professional fees for directors, fees for independent contractors and accounting and legal services.

We expect that our general and administrative expenses will increase as we continue to operate as a public company and will increase further if RP-G28 is approved for commercialization. We believe that these increases will likely include increased costs for director and officer liability insurance, and increased fees for outside consultants, lawyers and accountants, among other expenses.

1630 
 

We conducted a clinical trial of FastPack 2.0 in March 2019, and determined in May 2019 that it was uncertain whether the results of the trial would enable the test to receive FDA approval. As a result, we discontinued our FastPack 2.0 project with Sekisui. Currently, no further FastPack 2.0 analyzer or test development is ongoing, and we have licensed and transferred our FastPack 2.0 technology to Yi Xin Zhen Duan Jishu (Suzhou) Ltd. for them to further develop and commercialize as described below.

Technology Transfer Agreement with Yi Xin

Interest Income

Interest income consistsThrough our wholly-owned diagnostics subsidiary Qualigen, Inc., we entered into a Technology Transfer Agreement dated as of interest earned on our cash.

Critical Accounting PoliciesOctober 7, 2020 with Yi Xin Zhen Duan Jishu (Suzhou) Ltd. (“Yi Xin”), of Suzhou, China, for Yi Xin to develop, manufacture and Estimates

This discussion and analysis issell new generations of diagnostic test systems based on our financial statements, which have been preparedcore FastPack technology. In addition, the Technology Transfer Agreement authorized Yi Xin to manufacture and sell our current generations of FastPack System diagnostic products (1.0, IP and PRO) in accordance with GAAP. The preparationChina.

Under the Technology Transfer Agreement, we received aggregate net cash payments of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to fair value of financial instruments, research and development costs, accrued expenses and stock-based compensation. We base our estimates on historical experience, known trends and events and various other factors we believe to be reasonable under the circumstances, the results$670,000, of which formwe recognized approximately $38,000 in product sales and $632,000 in license revenue during 2021. In addition, we will receive low- to mid-single-digit royalties on any future new-generations and current-generations product sales by Yi Xin. We recognized no product sales or license revenue for the basisthree months and six months ended June 30, 2022 .We recognized no product sales or license revenue in the three months ended June 30, 2021 and $38,000 in product sales and $479,000 in license revenue in the condensed consolidated statement of operations and other comprehensive loss for making judgments about the carrying valuessix months ended June 30, 2021

We provided technology transfer and patent/know-how license rights to facilitate Yi Xin’s development and commercialization.

In the Technology Transfer Agreement (as amended in August 2021), we gave Yi Xin the exclusive rights for China – which is a market we have not otherwise entered – both for Yi Xin’s new generations of assetsFastPack-based products and liabilities that arefor Yi Xin-manufactured versions of our existing FastPack product lines. Yi Xin also has the right to sell its new generations of FastPack-based diagnostic test systems throughout the world (but not readily apparentto or toward current customers of our existing generations of FastPack products). In addition, after March 31, 2022, Yi Xin has the right to sell Yi Xin-manufactured versions of existing FastPack 1.0, IP and PRO product lines worldwide (other than in the United States and other than to or toward current non-US customers of those products). Also, after March 31, 2022, Yi Xin has the right to buy Qualigen-manufactured FastPack 1.0, IP and PRO products from other sources. Actual results may differ from these estimates under different assumptions or conditions. There have been no material changesus at distributor prices for resale in our significant accounting policies as of and for the nine months ended September 30, 2017,United States (but not to or toward current US customers of those products); we did not license Yi Xin to sell in the United States market any Yi Xin-manufactured versions of those legacy FastPack product lines, even after March 31, 2022.

In the Technology Transfer Agreement, we also confirmed that we would not, after the March 31, 2022 expiration of the Sekisui Distribution Agreement, seek new FastPack customers outside the United States.

Yi Xin is a newly-formed company and its operations are subject to many risks. There can be no assurance that Yi Xin will successfully commercialize any products or that we will receive any royalties from Yi Xin.

Warrant Liabilities

In 2004, Qualigen, Inc. issued a series of Series C preferred stock warrants to investors and brokers in connection with a private placement. These warrants were subsequently extended and survived the May 2020 reverse recapitalization transaction and are now exercisable for Qualigen common stock. These warrants contained a provision that if Qualigen, Inc. issues shares (except in certain defined scenarios) at a price below the warrants’ exercise price, the exercise price will be re-set to such new price and the number of shares underlying the warrants will be increased in the same proportion as compared with the significantexercise price decrease. For accounting policies describedpurposes, this provision gives rise to “warrant liabilities” (even though there is not any “liability” in our 2016 Annual Report.

While our significant accounting policies are more fully described in Note 3the sense that we would be obligated to the financial statements included in this Quarterly Report, we believe that the following accounting policies are the most criticalpay any cash sum to aid you in fully understanding and evaluating our financial condition and results of operations.

Fair Value of Financial Instruments

Fair value measurement guidelines are prescribed by accountinganyone). Accounting principles generally accepted in the United States of America (“U.S. GAAP”) require us to value financial instruments. The guidance includes a definition of fair value, prescribes methods for measuring fair value, establishes a fair value hierarchy based on the inputs used to measure fair value and expands disclosures about the use of fair value measurements.

The valuation techniques utilized are based upon observable and unobservable inputs. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect internal market assumptions. Assets are classified in their entirety based on the lowest level of input that is significant torecognize the fair value measurement.

These two types of inputs create the following fair value hierarchy:

Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities.

Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observablewarrants as warrant liabilities on our condensed consolidated balance sheets and to reflect period-to-period changes in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.

Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable

The carrying amounts reported in the balance sheet for cash and cash equivalents, prepaid expenses, accounts payable and accrued expenses, approximate the fair values due to the short-term nature of the instruments.

Research and Development Costs

We expense the cost of research and development as incurred. Research and development expenses comprise costs incurred in performing research and development activities, including clinical study costs, contracted services, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received, rather than when payment is made, in accordance with ASC 730,Research and Development.

Accrued Expenses

As part of the process of preparing our financial statements, we are required to estimate our accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. The significant estimates in our accrued research and development expenses include fees due to service providers.

We base our expenses on our estimates of the services received and efforts expended pursuant to quotes and contracts with our service providers that conduct research and development on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the research and development expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period.

Stock-based Compensation

Stock-based compensation cost for equity awards granted to employees and nonemployees is measured at the grant date based on the calculated fair value of the award usingwarrant liabilities on our condensed consolidated statements of operations and other comprehensive loss.

Warrant liabilities were $1.0 million at June 30, 2022 and the Black-Scholes option-pricing model,change in fair value was $0.7 million for the six months ended June 30, 2022. Because fair value will be determined each quarter on a “mark-to-market” basis, this item will usually result in significant variability in our future quarterly and is recognized as an expense, under the straight-line method, over the requisite service period (generally the vesting periodannual statements of the equity grant). If we determine that other methods are more reasonable, or other methods for calculating these assumptions are prescribed by regulators,operations and condensed consolidated balance sheets based on changes in our public market common stock price. Pursuant to U.S. GAAP, a quarter-to-quarter increase in our stock price would result in a (possibly quite large) increase in the fair value calculated forof the warrant liabilities and a quarter-to-quarter decrease in our stock options could change significantly. Higher volatility and longer expected livesprice would result in an increase to stock-based compensation expense to non-employees determined at the date of grant.

In addition to the assumptions useda (possibly quite large) decrease in the Black-Scholes option-pricing model, we also estimate a forfeiture rate to calculatefair value of the stock-based compensation for our equity awards. We will continue to use judgment in evaluating the expected volatility, expected termswarrant liabilities. There were 3,468,958 and forfeiture rates utilized for our stock-based compensation calculations on a prospective basis.2,481,614 of these warrants outstanding at June 30, 2022 and December 31, 2021, respectively.

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Emerging Growth Company StatusCOVID-19 Update

On April 5, 2012, the JumpstartThe COVID-19 pandemic has had a dramatic impact on businesses globally and our business as well. Our Business Startups Actsales of 2012 (“JOBS Act”) was enacted. Section 107diagnostic products fell significantly during 2020 and our net loss increased significantly, as deferral of patients’ non-emergency visits to physician offices, clinics and small hospitals sharply reduced demand for FastPack tests. Since then we have experienced some recovery in demand. The ultimate severity and duration of the JOBS Act provides that an “emerging growth company” can take advantagepandemic and economic repercussions of the extended transition period providedvirus and government actions taken in Section 7(a)(2)(B)response to the pandemic remain uncertain at this time, and will ultimately depend on many factors, including the speed of global dissemination and effectiveness of the Securities Actvaccination and containment efforts throughout the world, as well as seasonality, and the emergence of 1933, as amended, for complying with new vaccine-resistant variants or revised accounting standards. new outbreaks.

In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise applyUnited States, federal, state, and local government directives and policies have been put in place from time to private companies. We have elected to usetime during the extended transition period for complying with new or revised accounting standards under Section 102(b)(1)course of the JOBS Act. This election allows uspandemic to delaymanage public health concerns and address the adoptioneconomic impacts of the pandemic, including reduced business activity and overall uncertainty presented by this new healthcare challenge. Similar actions have been taken by governments around the world. Our facilities could be required to temporarily curtail production levels or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Astemporarily cease operations based on government mandates or as a result of this election,the pandemic. To mitigate risks, we continue to evaluate the extent to which COVID-19 may impact our financial statements may not be comparable to companies that comply with public company effective dates.business and operations and adjust risk mitigation planning and business continuity activities as needed.

We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the date we completed our initial public offering, which was June 29, 2015, (b) in which we have total annual gross revenue of at least $1.07 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeded $700.0 million as of the prior June 30th, and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

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Results of Operations

Comparison of the Three Months Ended SeptemberJune 30, 20172022 and 20162021

The following table summarizes our results of operations for the three months ended SeptemberJune 30, 20172022 and 2016, together with2021:

  For the Three Months Ended
June 30,
 
  2022  2021 
REVENUES      
Net product sales $1,430,534  $1,117,935 
License revenue      
Total revenues  1,430,534   1,117,935 
         
EXPENSES        
Cost of product sales  1,099,677   916,624 
General and administrative  2,660,857   2,952,100 
Research and development  1,506,227   4,508,466 
Sales and marketing  305,103   135,543 
Total expenses  5,571,864   8,512,733 
         
LOSS FROM OPERATIONS  (4,141,330)  (7,394,798)
         
OTHER INCOME (EXPENSE), NET        
Gain on change in fair value of warrant liabilities  14,800   1,982,256 
Interest income, net  4,824   12,718 
Other income (expense), net  (376)  2,352 
Total other income, net  19,248   1,997,326 
         
LOSS BEFORE PROVISION FOR INCOME TAXES  (4,122,082)  (5,397,472)
         
PROVISION FOR INCOME TAXES  5,438   605 
         
NET LOSS  (4,127,520)  (5,398,077)
         
Net loss attributable to noncontrolling interest  (4,116)  

 
         
Net loss attributable to Qualigen Therapeutics, Inc. $(4,123,404) $(5,398,077)
         
Other comprehensive loss, net of tax        
Net loss $(4,127,520) $(5,398,077)
Foreign currency translation adjustment  65,540   

 
Other comprehensive loss  (4,061,980)  (5,398,077)
Comprehensive loss attributable to noncontrolling interest  (4,116)  

 
Comprehensive loss attributable to Qualigen Therapeutics, Inc. stockholders $(4,057,864) $(5,398,077)

Revenues

Net product sales

Net product sales are primarily generated from sales of diagnostic tests. Net product sales during the changes in those items in dollarsthree-month periods ended June 30, 2022 and as a percentage:

  For the Three Months Ended
September 30,
  Dollar  Percentage 
  2017  2016  Change  Change 
Statement of Operations Data:                
Operating costs and expenses                
Research and development $915,268  $2,348,755  $(1,433,487)  (61)%
Patent costs  47,431   98,908   (51,477)  (52)%
General and administrative  1,052,236   1,091,647   (39,411)  (4)%
Total operating costs and expenses  2,014,935   3,539,310   (1,524,375)  (43)%
Loss from operations  (2,014,935)  (3,539,310)  1,524,375   43%
Other income                
Interest income  4,083   13,239   (9,156)  (69)%
Total other income  4,083   13,239   (9,156)  (69)%
Net loss $(2,010,852) $(3,526,071) $1,515,219   43%

Research and Development Expenses

Research and development expenses decreased by2021 were approximately $1.4 million and $1.1 million, respectively, representing an increase of approximately $0.3 million, or 61%, during 28%. This increase was due to the three months ended September 30, 2017 as comparedexpiration of the Sekisui Distribution Agreement on March 31, 2022, at which time the services previously provided by Sekisui reverted to the three months ended September 30, 2016. The primary reason for this decrease is that our Phase 2b/3 clinical trial,Company, which was initiated in March 2016, was completed during the fourth quarter of 2016. Research and development expenses during the three months ended September 30, 2017 primarily reflect the Phase 2b/3 extension study fees and Phase 3 program planning expenses.

Patent Costs

Patent costs decreased by approximately $51,000, or 52%, during the three months ended September 30, 2017 as compared to the three months ended September 30, 2016. The decrease was attributable to the overall timing of certain costs related to our maintenance of patent rights and the prosecution of patents.

General and Administrative Expenses

General and administrative expenses decreased slightly by approximately $39,000, or 4%, during the three months ended September 30, 2017 as compared to the three months ended September 30, 2016, mainly due to lower stock-based compensation expenseresulted in the current fiscal quarter.Company recognizing 100% of the revenue from direct sales of our FastPack diagnostic instruments and test kits.

Other Income

Other income decreased by approximately $9,000, or 69%, during the three months ended September 30, 2017 as compared to the three months ended September 30, 2016, due to lower interest income for the current fiscal quarter.

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Expenses

Cost of Product Sales

Cost of product sales increased during the three months ended June 30, 2022, to $1.1 million, or 77% of net product sales, compared to approximately $0.9 million, or 82% of net product sales, during the three months ended June 30, 2021. This increase of $0.2 million, and decrease as a percentage of sales was due primarily to the increase in sales during the three-month period and higher average unit selling prices due to the termination of the Sekisui agreement on March 31, 2022.

General and Administrative Expenses

General and administrative expenses decreased 10% from $3.0 million, during the three months ended June 30, 2021, to $2.7 million during the three months ended June 30, 2022. This decrease was primarily due to a $0.4 million reduction in spending for professional fees related to investor relations, legal, accounting, and consulting fees, partially offset by a $0.1 million increase in employee/director stock-based compensation expense.

Research and Development Costs

Research and development costs include therapeutics and diagnostics research and product development costs. Research and development costs decreased from $4.5 million for the three months ended June 30, 2021 to $1.5 million for the three months ended June 30, 2022. Of the $1.5 million of research and development costs for the three months ended June 30, 2022, $1.1 million (73%) was attributable to therapeutics and $0.4 million (27%) was attributable to diagnostics. Of the $4.5 million of research and development costs for the three months ended June 30, 2021, $4.2 million (93%) was attributable to therapeutics and $0.3 million (7%) was attributable to diagnostics.

The decrease in therapeutics research and development costs during the three months ended June 30, 2022 compared to the three months ended June 30, 2021 was primarily due to a $3.4 million decrease in pre-clinical research costs related to the potential application of QN-165 for the treatment of COVID-19 (which has since been deprioritized to a non-core program), a $0.2 million decrease in legal and recruiting fees, offset by an increase of $0.1 million in pre-clinical research costs for QN-302, which we acquired in January 2022, an increase of $0.2 million in pre-clinical research costs for QN-247, and an increase of $0.2 million in pre-clinical research costs for our RAS program.

The increase in diagnostics research and development costs during the three months ended June 30, 2022 compared to the three months ended June 30, 2021 was due primarily to an increase in supplies expense of approximately $0.1 million.

For the future, we expect our therapeutic research and development costs to continue to outweigh our diagnostic research and development costs, and to be relatively lower in periods when we are focusing on pre-clinical activities and meaningfully higher in periods when we are provisioning for and conducting clinical trials, if any.

Sales and Marketing Expenses

Sales and marketing expenses were approximately $0.3 million for the three months ended June 30, 2022, an increase of $0.2 million or 125% from the three months ended June 30, 2021. This increase was primarily due to a $0.1 million increase in payroll expenses related to the assumption of Sekisui sales personnel in the current quarter, and also due to increased spending for advertising, conventions and tradeshows of $0.1 million.

Other Income (Expense), Net

Change in Fair Value of Warrant Liabilities

During the three months ended June 30, 2022 and 2021, we experienced a gain of approximately $15,000 and $2.0 million, respectively, on change in fair value of warrant liabilities, primarily due to declines in our stock price and reduction in the remaining terms of the warrants. Typically, a decline in our stock price would result in a decline in the fair value of our warrant liabilities, generating a gain, while an increase in our stock price would result in an increase in the fair value of our warrant liabilities, generating a loss.

Because the fair value of the warrant liabilities will be determined each quarter on a “mark-to-market” basis, this item is likely to continue to result in significant variability in our future quarterly and annual statements of operations based on unpredictable changes in our public market common stock price and the number of liability classified warrants outstanding at the end of each quarter.

Interest Income, Net

There was approximately $5,000 and $13,000 in interest income during the three months ended June 30, 2022 and 2021, respectively.

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Other Income, Net

Other income was immaterial during the three months ended June 30, 2022 and 2021.

Net loss attributable to noncontrolling interest

Net loss attributable to noncontrolling interest was immaterial during the three months ended June 30, 2022 and 2021.

Other comprehensive income-foreign currency translation adjustment

Other comprehensive income-foreign currency translation adjustment was $65,540 for the three months ended June 30, 2022 as compared to $0 for the three months ended June 30, 2021. The increase of $65,540 was due to the acquisition of NanoSynex in May 2022 and the translation of their June 30, 2022 financial statements into U.S. dollars from New Israeli Shekels.

Comparison of the NineSix Months Ended SeptemberJune 30, 20172022 and 20162021

The following table summarizes our results of operations for the ninesix months ended SeptemberJune 30, 20172022 and 2016, together with the changes in those items in dollars and as a percentage:2021:

  For the Nine Months Ended
September 30,
  Dollar  Percentage 
  2017  2016  Change  Change 
Statement of Operations Data:                
Operating costs and expenses                
Research and development $2,121,898  $7,112,177  $(4,990,279)  (70)%
Patent costs  175,794   199,888   (24,094)  (12)%
General and administrative  3,367,781   3,533,608   (165,827)  (5)%
Total operating costs and expenses  5,665,473   10,845,673   (5,180,200)  (48)%
Loss from operations  (5,665,473)  (10,845,673)  (5,180,200)  48%
Other income                
Interest income  18,362   50,466   (32,104)  (64)%
Other income     1,214   (1,214)  (100)%
Total other income  18,362   51,680   (33,318)  (64)%
Net loss $(5,647,111) $(10,793,993) $5,146,882   48%
  For the Six Months Ended
June 30,
 
  2022  2021 
REVENUES      
Net product sales $2,152,563  $2,538,776 
License revenue     478,654 
Total revenues  2,152,563   3,017,430 
         
EXPENSES        
Cost of product sales  1,928,524   2,119,103 
General and administrative  5,559,608   5,826,038 
Research and development  3,370,972   8,007,840 
Sales and marketing  443,426   272,129 
Total expenses  11,302,530   16,225,110 
         
LOSS FROM OPERATIONS  (9,149,967)  (13,207,680)
         
OTHER INCOME (EXPENSE), NET        
Gain on change in fair value of warrant liabilities  698,042   2,535,064 
Interest income, net  11,132   30,061 
Other income (expense), net  (341)  2,894 
Total other income, net  708,833   2,568,019 
         
LOSS BEFORE PROVISION FOR INCOME TAXES  (8,441,134)  (10,639,661)
         
PROVISION FOR INCOME TAXES  6,173   1,135 
         
NET LOSS  (8,447,307)  (10,640,796)
         
Net loss attributable to noncontrolling interest  (4,116)   
         
Net loss attributable to Qualigen Therapeutics, Inc. $(8,443,191) $(10,640,796)
         
Other comprehensive loss, net of tax        
Net loss $(8,447,307) $(10,640,796)
Foreign currency translation adjustment  65,540    
Other comprehensive loss  (8,381,767)  (10,640,796)
Comprehensive loss attributable to noncontrolling interest  (4,116)  

 
Comprehensive loss attributable to Qualigen Therapeutics, Inc. stockholders $(8,377,651) $(10,640,796)

Research and Development Expenses

Research and development expenses decreased by approximately $5.0 million, or 70%, during the nine months ended September 30, 2017 as compared to the same prior year period. The primary reason for the decrease is that our Phase 2b/3 clinical trial, which was initiated in March 2016, was completed during the fourth quarter of 2016. Research and development expenses during the nine months ended September 30, 2017 primarily reflect the Phase 2b/3 extension study fees and Phase 3 program planning expenses.

Patent Costs

The approximate $24,000, or 12%, decrease in patent costs during the nine months ended September30, 2017 as compared to the nine months ended September 30, 2016 was mainly attributable to the overall timing of certain costs related to our maintenance of patent rights and the prosecution of patents. As of September 30, 2017, we had 14 issued patents and 27 pending patent applications.

General and Administrative Expenses

General and administrative expenses decreased by approximately $166,000, or 5%, during the nine months ended September 30, 2017 as compared to the nine months ended September 30, 2016. The decrease was primarily due to lower stock compensation expense that was slightly offset by higher legal fees.

Other Income

Interest income was approximately $18,000 and $50,000 for the nine months ended September 30, 2017 and 2016, respectively. The decrease of approximately $32,000, or 64%, during the nine months ended September 30, 2017 reflects a decrease in interest on our average cash balances as a result of funding our Phase 2b/3 trial and extension study.

There was no other income during the nine months ended September 30, 2017 as compared to other income of approximately $1,000 for the nine months ended September 30, 2016.

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Revenues

Net product sales

Net product sales are primarily generated from sales of diagnostic tests. Net product sales during the six-month periods ended June 30, 2022 and 2021 were approximately $2.2 million and $2.5 million, respectively, representing a decrease of approximately $0.4 million, or 15%. This decrease was primarily due to the expiration of the Sekisui Distribution Agreement on March 31, 2022, which caused Sekisui to reduce its purchases from us during the first quarter of 2022, as it sold off its remaining inventory prior to the expiration of the agreement. However this reduction in Sekisui purchases during the first quarter was partially offset by higher direct sales of FastPack diagnostic instruments and test kits during the second quarter of 2022 and the Company recognizing 100% of the revenue from these sales, compared to the second quarter of 2021.

License Revenue

There was no license revenue for the six months ended June 30, 2022. During the six months ended June 30, 2021 there was approximately $0.5 million, due to the recognition of revenue from Yi Xin under the Technology Transfer Agreement.

Expenses

Cost of Product Sales

Cost of product sales decreased during the six months ended June 30, 2022, to $1.9 million, or 90% of net product sales, compared to approximately $2.1 million, or 83% of net product sales, during the six months ended June 30, 2021. This decrease of $0.2 million, and increase as a percentage of sales was due to a reduction in production volumes compared to the prior period due to the expiration of the Sekisui Distribution Agreement, as Sekisui sold off its remaining inventory during the first quarter.

General and Administrative Expenses

General and administrative expenses decreased from $5.8 million, during the six months ended June 30, 2021, to approximately $5.6 million during the six months ended June 30, 2022, a decrease of $0.3 million or 5%. This decrease was primarily due to a $0.6million decrease in investor relations, legal, accounting and consulting fees, partially offset by increases in stock-based compensation expense of $0.1 million, increases in wages/bonuses and related payroll taxes of $0.2 million

Research and Development Costs

Research and development costs include therapeutics and diagnostics research and product development costs. Research and development costs decreased from $8.0 million for the six months ended June 30, 2021 to $3.4 million for the six months ended June 30, 2022. Of the $3.4 million of research and development costs for the six months ended June 30, 2022, $2.7 million (80%) was attributable to therapeutics and $0.7 million (20%) was attributable to diagnostics. Of the $8.0 million of research and development costs for the six months ended June 30, 2021, $7.3 million (91%) was attributable to therapeutics and $0.7 million (9%) was attributable to diagnostics.

The decrease in therapeutics research and development costs during the six months ended June 30, 2022 compared to the six months ended June 30, 2021 was primarily due to a $6.0 million decrease in pre-clinical research costs related to the potential application of QN-165 for the treatment of COVID-19 (which has since been deprioritized to a non-core program), offset by an increase of $0.5 million in pre-clinical research costs for QN-302, which we acquired in January 2022, an increase of $0.6 million in pre-clinical research costs for QN-247, and an increase of $0.3 million in pre-clinical research costs for our RAS program.

There were no material changes in diagnostics research and development costs during the six months ended June 30, 2022 as compared to the six months ended June 30, 2021

For the future, we expect our therapeutic research and development costs to continue to outweigh our diagnostic research and development costs, and to be relatively lower in periods when we are focusing on pre-clinical activities and meaningfully higher in periods when we are provisioning for and conducting clinical trials, if any.

Sales and Marketing Expenses

Sales and marketing expenses were approximately $0.4 million for the six months ended June 30, 2022 , an increase of $0.2 million or 63% from the six months ended June 30, 2021. This increase was primarily due to a $0.1 million increase in payroll expenses related to the assumption of Sekisui sales personnel in the current period and also due to increased spending for advertising, conventions and tradeshows of $0.1 million.

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Other Income (Expense), Net

Change in Fair Value of Warrant Liabilities

During the six months ended June 30, 2022 and 2021, we experienced a gain of $0.7 million and $2.5 million, respectively, on change in fair value of warrant liabilities, primarily due to declines in our stock price, reductions in the remaining terms of the warrants during both periods, and warrant exercises during the prior period. Typically, a decline in our stock price would result in a decline in the fair value of our warrant liabilities, generating a gain, while an increase in our stock price would result in an increase in the fair value of our warrant liabilities, generating a loss.

Because the fair value of the warrant liabilities will be determined each quarter on a “mark-to-market” basis, this item is likely to continue to result in significant variability in our future quarterly and annual statements of operations based on unpredictable changes in our public market common stock price and the number of liability classified warrants outstanding at the end of each quarter.

Interest Income, Net

There was approximately $11,000 and $30,000 in interest income during the six months ended June 30, 2022 and 2021, respectively.

Other Income, Net

Other income was immaterial during the six months ended June 30, 2022 and 2021.

Net loss attributable to noncontrolling interest

Net loss attributable to noncontrolling interest was immaterial during the six months ended June 30, 2022 and $0 during the six months ended June 30, 2021.

Other comprehensive income-foreign currency translation adjustment

Other comprehensive income-foreign currency translation adjustment was $65,540 for the six months ended June 30, 2022 as compared to $0 for the six months ended June 30, 2021. The increase of $65,540 was due to the acquisition of NanoSynex in May 2022 and the translation of their June 30, 2022 financial statements into U.S. dollars from New Israeli Shekels.

Liquidity and Capital Resources

SinceAs of June 30, 2022, we had approximately $9.7 million in cash. The Company has incurred recurring losses from operations and has an accumulated deficit at June 30, 2022. The Company expects to continue to incur losses subsequent to the condensed consolidated balance sheet date of June 30, 2022. In December 2021, the Company raised $8.82 million through a Securities Purchase Agreement with several institutional investors.

Based on the Company’s current cash position, and assuming currently planned expenditures and level of operations, the Company believes it has sufficient capital to fund operations for the 12-month period subsequent to the issuance of the accompanying unaudited condensed financial statements. We will need substantial additional funding to continue our inception,operations, particularly for QN-302 clinical trials, to continue preclinical development of QN-247 and RAS-F, and to continue funding the NanoSynex operations.

As a pre-clinical development-stage therapeutics biotechnology company, we expect to continue to have incurred net losses and negative cash flowsflow from operations, which over time will challenge our liquidity. There is no assurance that profitable operations will ever be achieved, or, if achieved, could be sustained on a continuing basis. In order to fully execute our business plan, we will require significant additional financing for planned research and as of September 30, 2017,development activities, capital expenditures, clinical and pre-clinical testing and commercialization activities. There can be no assurance that further financing can be obtained on favorable terms, or at all. If we had an accumulated deficit of approximately $51.1 million. Substantially all of our net losses resulted from costs incurred in connection with ourare unable to obtain funding, we could be required to delay, reduce or eliminate research and development programs, stock-based compensation,product portfolio expansion or future commercialization efforts, which could adversely affect our business prospects.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and from generalthe terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, commercialization, marketing and administrative costs associateddistribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our operations.technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.

At SeptemberOur condensed consolidated balance sheet at June 30, 2017, we had working capital 2022 includes $1.0 million of approximately $0.9warrant liabilities. We do not consider the warrant liabilities to constrain our liquidity, as a practical matter. Our current liabilities at June 30, 2022 include $0.9 million of accounts payable and cash$1.4 million of approximately $3.6 million.accrued expenses and other current liabilities.

37 

Contractual Obligations and Commitments

On December 15, 2021, our wholly-owned subsidiary Qualigen, Inc. entered into a Second Amendment to Lease with Bond Ranch LP. This Amendment extended the Company’s triple-net leasehold on its existing 22,624-square-foot headquarters/manufacturing facility at 2042 Corte del Nogal, Carlsbad, California for the 61-month period of November 1, 2022 to November 30, 2027. Over the 61 months, the base rent payable will total $1,950,710; however, the base rent for the first 12 months of the 61-month period will be only $335,966. Additionally, Qualigen, Inc. is entitled to a $339,360 tenant improvement allowance. See Note 12 – Commitments and Contingencies of the consolidated financial statements for additional details.

We have no material contractual obligations that are not fully recorded on our condensed consolidated balance sheets or fully disclosed in the notes to the financial statements.

We have obligations under various license and sponsored research agreements to make future payments to third parties that become due and payable on the achievement of certain development, regulatory and commercial milestones (such as the start of a clinical trial, filing for product approval with the FDA or other regulatory agencies, product approval by the FDA or other regulatory agencies, product launch or product sales) or on the sublicense of our rights to another party. We have not generated any product revenuesincluded these commitments on our balance sheet because the achievement and havetiming of these events is not achieved profitable operations.fixed and determinable. Certain milestones are in advance of receipt of revenue from the sale of products and, therefore, we may require additional debt or equity capital to make such payments.

License and Sponsored Research Agreements with ULRF

 

We have multiple license and sponsored research agreements with UofL Research Foundation (“ULRF”). Under these agreements, we have taken over development, regulatory approval and commercialization of various drug compounds from ULRF and are responsible for maintenance of the related intellectual property portfolio. We agreed to reimburse ULRF for sponsored research expenses of up to $805,000 and prior patent costs of up to $200,000 for QN-247. As of June 30, 2022, there were no remaining unexpensed amounts under this sponsored research agreement for QN-247. We also agreed to reimburse ULRF for sponsored research expenses of up to $2.7 million and prior patent costs of up to $112,000 for RAS. As of June 30, 2022 we had up to $1.2 million remaining due under this sponsored research agreement for RAS. We agreed to reimburse ULRF for sponsored research expenses of up to $430,000 and prior patent costs of up to $24,000 for QN-165. As of June 30, 2022 we had no remaining unexpensed amounts under this sponsored research agreement for QN-165. Under the terms of these agreements, we are required to make patent maintenance payments and payments based upon development, regulatory and commercial milestones for any products covered by the in-licensed intellectual property. The maximum aggregate milestone payments we may be obligated to make per product are $5 million. We will also be required to pay a royalty on net sales of products covered by the in-licensed intellectual property in the low single digits. The royalty is subject to reduction for any third-party payments required to be made, with a minimum floor in the low single digits. We have the right to sublicense our rights under these agreements, and we will be required to pay a percentage of any sublicense income.

On January 13, 2022, we entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London, including lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization company for University College London.) The program’s lead compound will be further developed at Qualigen under the name QN-302 as a candidate for treatment of pancreatic ductal adenocarcinoma (PDAC), which represents the vast majority of pancreatic cancers. The Agreement requires (if and when applicable) tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments, and a percentage of any non-royalty sublicensing consideration paid to Qualigen.

Termination of Sekisui Distribution Agreement

Following the expiration of the Sekisui Distribution Agreement, in the second quarter of 2022 the Company has a commitment to purchase leased FastPack rental systems back from Sekisui at Sekisui’s net book value, the amount of which has not yet been determined.

Master Agreement for the Operational and Technological Funding of NanoSynex

As a condition to the closing of the NanoSynex transaction on May 26, 2022, the Company entered into a Master Agreement for the Operational and Technological Funding of NanoSynex (the “Funding Agreement”) pursuant to which we agreed to fund NanoSynex up to an aggregate of approximately $10.4 million over the next three years, subject to NanoSynex’s achievement of certain performance milestones specified in the Funding Agreement and the satisfaction of other terms and conditions described in the Funding Agreement. The Company may terminate the Funding Agreement after October 29, 2022 upon 120 days’ notice.

Other Service Agreements

We enter into contracts in the normal course of business, including with clinical sites, contract research organizations, and other professional service providers for the conduct of clinical trials, contract manufacturers for the production of our product candidates, contract research service providers for preclinical research studies, professional consultants for expert advice and vendors for the sourcing of clinical and laboratory supplies and materials. These contracts generally provide for termination on notice, and therefore are cancelable contracts.

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Cash Flows

The following table sets forth the significant sources and uses of cash for the periods set forth below:

 For the Six Months Ended 
 For the Nine Months Ended
September 30,
 June 30, 
 2017 2016 2022  2021 
Net cash (used in) provided by:                
Operating activities $(5,176,622) $(7,367,879) $(7,827,798) $(8,785,057)
Investing activities  —     (8,063)  71,871   (114,691)
Financing activities  1,689,214   8,504   3,859   155,580 
Net decrease in cash $(3,487,408) $(7,367,438) $(7,752,068) $(8,744,168)

Net Cash Used in Operating Activities

During the ninesix months ended SeptemberJune 30, 2017, net cash used in2022, operating activities used $7.8 million of approximately $5.2 millioncash, primarily reflects ourresulting from a net loss of $8.4 million. Cash flows from operating activities (as opposed to net loss) for the period of approximately $5.6six months ended June 30, 2022 benefitted from $2.7 million offset by non-cash charges of approximately $746,000 forin stock-based compensation expense, a $0.2 million decrease in net accounts receivable, and changesdepreciation and amortization of $0.2 million. Cash flows from operating activities (as opposed to net loss) for the six months ended June 30, 2022 were negatively impacted by a $0.8 million decrease in our working capital accounts, mainly consistingaccrued expenses and other current liabilities, a $0.6 million increase in prepaid expenses and other assets, $0.3 million increase in net inventory, a $0.7 million decrease in fair value of an approximate $849,000warrant liabilities and a $0.1 million decrease in operating lease liability.

During the six months ended June 30, 2021, operating activities used $8.8 million of cash, primarily resulting from a net loss of $10.6 million. Cash flows from operating activities for the six months ended June 30, 2021 benefitted from the $0.7 million decrease in prepaid expenses and other assets, a $2.5 million increase in stock-based compensation expense, a $1.2 million increase in accrued expenses and other current liabilities and a $0.3 million increase in accounts payable, due to higher costs related to therapeutics research and an approximate $1.0development. On the other hand, cash flows from operating activities for the six months ended June 30, 2021 were negatively impacted by a $2.5 million decrease in accrued expenses.

Net cash usedfair value of warrant liabilities, a $0.2 million increase in operating activities of approximately $7.4accounts receivable, and a $0.2 million during the nine months ended September 30, 2016 reflects our net loss of approximately $10.8 million, partially offset by stock-based compensation of approximately $1.0 million, an increase in deferred revenue. The decrease in prepaid expenses was primarily due to the expensing during the period of $1.1 million of previous prepayments to STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, our manufacturer of QN-165 for our anticipated clinical trials, but was offset in part by an approximately $57,000,$0.6 million increase of prepaid expenses for director and an increase in accounts payable, accrued expenses and other liabilities of approximately $2.1 million, $294,000 and $13,000, respectively.officer liability insurance.

Net Cash Provided by (Used in) Investing Activities

NoDuring the six months ended June 30, 2022, net cash was used inprovided by investing activities forwas approximately $0.1 million, primarily due to $0.7 million in cash acquired in the nineNanoSynex transaction, offset by the $0.6 million purchase of NanoSynex stock.

During the six months ended SeptemberJune 30, 2017. Net2021, net cash used in investing activities ofwas approximately $8,000 during the nine months ended September 30, 2016$0.1 million, primarily related to the purchase of office furnitureproperty and equipment.


Net Cash Provided by Financing Activities

Net cash provided by financing activities of approximately $1.7 million duringfor the ninesix months ended SeptemberJune 30, 2017 resulted2022 was approximately $4,000, due to net proceeds from proceeds received fromexercise of warrants.

Net cash provided by financing activities for the salesix months ended June 30, 2021 was approximately $0.2 million, due to approximately $0.3 million of common shares to Aspire Capital, LLC (“Aspire Capital”) pursuant to the Common Stock Purchase Agreement with Aspire Capital (the “2015 Aspire Purchase Agreement”). Deferred offering costs of approximately $311,000, related to our October 2017 public offering that was closed on October 3, 2017, slightly offset thenet proceeds from the saleexercise of common shares to Aspire Capital.warrants, offset by $0.1 million in principal payments on notes payable.

SourcesCritical Accounting Estimates

We believe the estimates, assumptions and judgments involved in the accounting policies described in “Management’s Discussion and Analysis of Liquidity

2015 Aspire Capital Financing Arrangement

On December 18, 2015, we entered into the 2015 Aspire Purchase Agreement with Aspire Capital, pursuant to which Aspire Capital was committed to purchase up to an aggregateFinancial Condition and Results of $10.0 millionOperations” in Item 7 of our shares of common stock over the approximate 30-month term of the 2015 Aspire Purchase Agreement.

On May 4, 2017, we terminated the 2015 Aspire Purchase Agreement and entered into a new common stock purchase agreement with Aspire Capital (the “2017 Aspire Purchase Agreement”), which provides that upon the terms and conditions set forth therein, Aspire Capital is committed to purchase up to an aggregate of $6.5 million of shares of our common stock over the 30-month term of the 2017 Aspire Purchase Agreement. On any trading day on which the closing sale price of our common stock exceeds $0.25, we have the right, in our sole discretion, to present Aspire Capital with a purchase notice, directing Aspire Capital to purchase up to 100,000 shares of our common stock per trading day, for up to $6.5 million of our common stock in the aggregate at a per share price, calculated by reference to the prevailing market price of our common stock (as provided in the 2017 Aspire Purchase Agreement).

As a condition to the 2017 Aspire Purchase Agreement, we issued 137,324 shares of our common stock to Aspire Capital as a commitment fee. As of the date of this QuarterlyAnnual Report no shares of common stock have been sold to Aspire Capital under the 2017 Aspire Purchase Agreement. We expect to use the Aspire facility to complement, rather than replace, other financing that may be required during the next twelve months to continue our operations and support our capital needs.

October 2016 Public Offering

On October 31, 2016, we closed a public offering of 2,127,660 shares of our common stock at a price to the public of $2.35 per share, for net proceeds of approximately $4.4 million, after deducting underwriting discounts and commissions and offering expenses payable by us in the offering. The offering was made pursuant to a shelf registration statement on Form S-3.

October 2017 Public Offering

On October 3, 2017, the Company closed a public offering, selling an aggregate of (i) 34,550,000 Class A Units consisting of 34,550,000 shares of the Company’s common stock and warrants to purchase 34,550,000 shares of the Company’s common stock at a public offering price of $0.40 per unit, and (ii) 9,180 Class B Units consisting of 9,180 shares of Series A Convertible Preferred Stock, with a stated value of $1,000, and convertible into an aggregate of 22,950,000 shares of the Company’s common stock, and warrants to purchase an aggregate of 22,950,000 shares of the Company’s common stock. The warrants have an exercise price of $0.44, are exercisable upon issuance and expire five years from the date of issuance.

The Company granted the underwriters a 45-day option to purchase an additional 8,625,000 shares of the Company’s common stock and/or warrants to purchase an additional 8,625,000 shares of the Company’s common stock. As of the closing of the offering, the underwriters have exercised their over-allotment option for warrants to purchase 2,975,000 shares of the Company’s common stock.

Aggregate gross proceeds to the Company from the public offering were approximately $23.0 million. The Company paid to the underwriters underwriting discounts and commissions of approximately $1.6 million in connection with the offering, and approximately $0.4 million of other expenses in connection with the offering., of which approximately $0.3 are recorded as deferred offering costs in the Company’s financial statements as of, and10-K for the nineyear ended December 31, 2021 (the “2021 Annual Report”) are most critical to understanding and evaluating our reported financial results. During the three and six months ended SeptemberJune 30, 2017.

The securities2022, other than the business combinations, IPR&D, and goodwill accounting policies described above were offered by the Company pursuant to a registration statement filed with the SEC that was declared effective on September 28, 2017. The final prospectus relating to the offering was filed with the SEC on October 2, 2017.

Future Funding Requirements

To date, we have not generated any revenue. We do not know when, or if, we will generate any revenue from product sales. We do not expect to generate significant revenue from product sales unless and until we obtain regulatory approval for and commercialize RP-G28. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for RP-G28. Additionally, we have incurred and will continue to incur additional costs associated with operating as a public company. In addition, subject to obtaining regulatory approval for RP-G28, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need substantial additional funding in connection with our continuing operations.

Based upon our current operating plan, we believe that our existing cash and cash equivalents (including the net proceeds from our October 2017 public offering), together with interest and any proceeds received from our sale of shares of common stock to Aspire Capital pursuant to the 2017 Aspire Purchase Agreement will enable us to fund our operating expenses and capital expenditure requirements through 2018. We will need to raise additional capital to fund operations and complete ongoing and planned clinical trials beyond 2018.

Our future capital requirements will depend on many factors, including:

the ability of RP-G28 and any other product candidates that we may develop in the future to progress through clinical development successfully;
the outcome, costs and timing of seeking and obtaining FDA approval;
the willingness of the EMA or other regulatory agencies outside the United States to accept our Phase 2b/3 and any Phase 3 trials of RP-G28, as well as our other completed and planned clinical and nonclinical studies and other work, as the basis for review and approval of RP-G28 in the European Union for the reduction of symptoms associated with lactose intolerance in patients;
our need to expand our research and development activities;
the costs associated with securing and establishing commercialization and manufacturing capabilities;
market acceptance of RP-G28 and any other product candidates that we may develop in the future;
the costs of acquiring, licensing or investing in businesses, products, product candidates and technologies;
our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

our need and ability to hire additional management and scientific and medical personnel;
the effect of competing technological and market developments;
our need to implement additional internal systems and infrastructure, including financial and reporting systems;
the economic and other terms, timing of and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future; and
the costs of operating as a public company.

Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our cash needs through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, commercialization, marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.

Contractual Obligations and Commitments

Therebelow, there have been no material changes to the critical accounting policies and estimates as described in Item 7 of our contractual obligations and commitments from those disclosed in our 20162021 Annual Report.

39 

 

Off-Balance Sheet ArrangementsThe Company accounts for business combinations using the acquisition method pursuant to FASB ASC Topic 805. This method requires, among other things, that results of operations of acquired companies are included in the Company’s financial results beginning on the respective acquisition dates, and that assets acquired and liabilities assumed are recognized at fair value as of the acquisition date. Intangible assets acquired in a business combination are recorded at fair value using a discounted cash flow model. The discounted cash flow model requires assumptions about the timing and amount of future net cash flows, the cost of capital and terminal values from the perspective of a market participant. Each of these factors can significantly affect the value of the intangible asset. Any excess of the fair value of consideration transferred (the “Purchase Price”) over the fair values of the net assets acquired is recognized as goodwill. The fair value of assets acquired and liabilities assumed in certain cases may be subject to revision based on the final determination of fair value during a period of time not to exceed 12 months from the acquisition date. Legal costs, due diligence costs, business valuation costs and all other acquisition-related costs are expensed when incurred.

Through September 30, 2017, weIPR&D represents the fair value assigned to the research and development assets that have not reached technological feasibility. The value assigned to IPR&D is determined by estimating the costs to develop the acquired technology into commercially viable products, estimating the resulting revenue from the projects, and discounting the net cash flow to present value. The revenue and cost projections used to value acquired IPR&D are, as applicable, reduced based on the probability of success of developing the new product. Additionally, projections consider relevant market sizes and growth factors, expected trends in technology and the nature and expected timing of new product introductions. The rates utilized to discount the net cash flow to its present value are commensurate with the stage of development of the project and uncertainties in the economic estimates used in the projections. Upon the acquisition of acquired IPR&D, an assessment is completed as to whether the acquisition constitutes an acquisition of the purchase of a single asset or a group of assets. Multiple factors are considered in this assessment, including the nature of the technology acquired, the presence or absence of separate cash flows, the development process and stage of completion, quantitative significance, and the Company’s rationale for entering into the transaction.

If a business is acquired, as defined under the applicable accounting standards, then the acquired IPR&D is capitalized as an intangible asset. If an asset or group of assets is acquired that do not have any off-balance sheet arrangements,meet the definition under the applicable accounting standards, then the acquired IPR&D is expensed on its acquisition date. Future costs to develop these assets are recorded to research and development expense in the Company’s consolidated statements of income as defined by applicable SEC regulations.they are incurred.

IPR&D is evaluated for impairment annually using the same methodology as described above for calculating fair value. If the carrying value of the acquired IPR&D exceeds the fair value, then the intangible asset is written down to its fair value, with the resulting adjustment recorded as a charge to operations. Changes in estimates and assumptions used in determining the fair value of acquired IPR&D could result in an impairment.

Goodwill represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets acquired, when accounted for using the purchase method of accounting. Goodwill has an indefinite useful life and is not amortized but is reviewed for impairment annually and whenever events or changes in circumstances indicate that the carrying value of the goodwill may not be recoverable.

In testing for impairment, the fair value of the reporting unit is compared to the carrying value. If the net assets assigned to the reporting unit exceed the fair value of the reporting unit, an impairment loss equal to the difference would be recorded.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide the information required by Item 3.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of SeptemberJune 30, 2017,2022, the end of the period covered by this Quarterly Report on Form 10-Q.Report.

Based on theirthis evaluation, we believeour principal executive officer and principal financial officer have concluded that our disclosure controls and procedures as of SeptemberJune 30, 20172022 were effective to provide reasonable assurance that the information required to be disclosed by us in reports filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act’), is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. We believe that a disclosure controls system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the disclosure controls system are met, and no evaluation of disclosure controls can provide absolute assurance that all disclosure control issues, if any, within a company have been detected.

40 

Changes in Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of condensed consolidated financial statements for external purposes in accordance with U.S. GAAP.

As of December 31, 2021, our management assessed the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (the “2013 Framework”). Based on this assessment, our management concluded that, as of December 31, 2021, our internal control over financial reporting was not effective because of a material weakness in our internal control over financial reporting related to the lack of accounting department resources and/or policies and procedures to ensure recording and disclosure of items in compliance with generally accepted accounting principles, as further described in our 2021 Annual Report. We have taken and are taking steps to remediate the material weakness, including implementing additional procedures and utilizing external consulting resources with experience and expertise in U.S. GAAP and public company accounting and reporting requirements to assist management with its accounting and reporting of complex and/or non-recurring transactions and related disclosures. Nevertheless, an internal control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the internal control system are met, and no evaluation of internal control can provide absolute assurance that all internal control issues and instances of fraud, if any, within a company have beenare detected.

Changes in Internal Control over Financial Reporting

ThereExcept as described above, there were no changes in ourto the Company’s internal control over financial reporting that occurredmade during our third fiscalthe quarter ended SeptemberJune 30, 20172022 that havewe believe materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We do expect to implement additional internal controls related to the acquisition of NanoSynex to include internal and external audits related to the international operations of this entity.

Notwithstanding the identified material weakness, our management believes that the condensed consolidated financial statements included in this Quarterly Report fairly represent in all material respects our financial condition, results of operations and cash flows at and for the periods presented in accordance with U.S. GAAP.

41 

PART II - OTHER INFORMATION

ItemITEM 1. Legal Proceedings.LEGAL PROCEEDINGS

The Company isWe are not currently involved in any legal matters arising in the normal course of business.matters. From time to time, the Companywe could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters.

ItemITEM 1A. Risk Factors.RISK FACTORS

The risksCompany’s business, reputation, results of operations and financial condition, as well as the price of its stock, can be affected by a number of factors, whether currently known or unknown, including those described in Part I, Item 1A. Risk Factors1A of our 2016the Company’s 2021 Annual Report under the heading “Risk Factors.” When any one or more of these risks materialize, the Company’s business, reputation, results of operations and quarterly reports on Form 10-Q filed withfinancial condition, as well as the SEC on May 9, 2017 and August 7, 2017 (the “2017 Quarterly Reports”) couldprice of its stock, can be materially and adversely affectaffected. Except for the following additional risk factors related to the acquisition of NanoSynex, Ltd., there have been no material changes to the Company’s risk factors described in the 2021 Annual Report.

Risks Related to the Acquisition of NanoSynex, Ltd. (“NanoSynex”)

The NanoSynex acquisition may not be successful in achieving its intended benefits and may disrupt our current operations.

In May 2022, we acquired a majority interest in NanoSynex, Ltd (“NanoSynex”). This acquisition poses a number of potential integration risks that may result in negative consequences to our business, financial condition, and results of operations. The risk factors discussedThese risks include, but are not limited to:

failure of the business to perform as planned following the acquisition, and to receive the necessary regulatory approvals for its Antimicrobial Susceptibility Testing (AST) platform;
the assimilation and retention of employees, including key employees;
higher than expected costs and/or a need to allocate resources to manage unexpected operating difficulties;
diversion of the attention and resources of management or other disruptions to current operations;
retaining required regulatory approvals, licenses, and permits;
the assumption of liabilities of the acquired business not identified during due diligence; and
other unanticipated issues, expenses, and liabilities.
establishing appropriate internal controls for the management of overseas financial and other resources.

In addition, while we are based in Carlsbad, California, NanoSynex’s operations are located in Ness Ziona, Israel, which could further stretch our 2016 Annual Reportresources and 2017 Quarterly Reports do not identify all risksmanagement’s time, and we will need to rely, to a large extent, on the existing executive team of NanoSynex. Failure to adequately integrate our operations and personnel could adversely affect our combined business and our ability to achieve our objectives and strategy. No assurance can be given that we face becausewill realize synergies in the areas we currently operate.

Our Master Agreement for the Operational and Technological Funding of NanoSynex obligates us to make milestone payments to NanoSynex.

As a condition to the closing with NanoSynex, we entered into a Master Agreement for the Operational and Technological Funding of NanoSynex (the “Funding Agreement”) with NanoSynex pursuant to which we have agreed to fund NanoSynex up to an aggregate of approximately $10.4 million over the next three years, subject to NanoSynex’s achievement of certain performance milestones specified in the Funding Agreement and the satisfaction of other terms and conditions described in the Funding Agreement.

The requirement to make any payments under the Funding Agreement will reduce our business operations could alsoliquidity. Furthermore, there can be affected by additional factorsno assurance that are not presently knownwe will have the funds necessary to make the required payments to NanoSynex, if required, or be able to raise such funds when needed on terms acceptable to us, or thatat all. As a result, we currently considermay be required to be immaterialdelay our product development or future commercialization efforts. In addition, our inability to make any required payments to NanoSynex could negatively impact NanoSynex’s ability to further its development efforts, which will ultimately have a negative impact on our business and results of operations due to our majority interest in NanoSynex. We may terminate this agreement after October 29, 2022, but only after providing 120 days’ notice.

Under the terms of the Funding Agreement, we will receive in exchange for any payment made to NanoSynex under the Funding Agreement one or more promissory notes (which may contain convertible features) with a face value equal to the amount paid by us to NanoSynex upon satisfaction of the applicable performance milestones. Any promissory notes issued to us by NanoSynex under the Funding Agreement will bear interest at a rate of 9.00% per annum on the principal balance from time to time outstanding under the promissory note. If NanoSynex is unable to make the required payments of principal or interest under any promissory notes that are issued, our liquidity will be negatively impacted, which may require us to delay our product development or future commercialization efforts.

42 

Because a significant portion of NanoSynex’s total assets are represented by goodwill, indefinite-lived intangible assets, and definite-lived intangible assets, we could be required to write off some or all of this goodwill and other intangibles, which may adversely affect our financial condition and results of operations. There have been no material changes

We used the acquisition method of accounting to account for the acquisition of a majority interest in NanoSynex consummated on May 26, 2022. A portion of the purchase price for this business is allocated to identifiable tangible and intangible assets and assumed liabilities based on estimated fair values at the date of acquisition. Goodwill is measured indirectly as the excess of the sum of (1) the consideration transferred (including contingent consideration, if any) and (2) the fair value of any noncontrolling interest in the risk factors discussedacquiree over the net assets acquired and liabilities assumed. The purchase price allocation resulted in our 2016 Annual Reporta goodwill value of $4.9 million and 2017 Quarterly Reports.a value of $5.7 million related to other intangible assets. The carrying value of these assets as of June 30, 2022, was $4.9 million and $5.7 million, respectively. When we perform impairment tests, it is possible that the carrying value of goodwill or other intangible assets could exceed their implied fair value and therefore would require adjustment. Such adjustment would result in a charge to operating income in that period. Once adjusted, there can be no assurance that there will not be further adjustments for impairment in future periods.

 

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

Unregistered Sales of Equity Securities and Use of Proceeds

Unregistered Sales of Equity SecuritiesNone

None

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

None

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None

ITEM 4. MINE SAFETY DISCLOSURES

Not Applicable

ITEM 5. OTHER INFORMATION

None

43 

ITEM 6. EXHIBITS

    Incorporated by Reference
Exhibit No. Description Form File No. Exhibit 

Filing Date

           
2.1 Agreement and Plan of Merger, among Ritter Pharmaceuticals, Inc., RPG28 Merger Sub, Inc. and Qualigen, Inc., dated January 15, 2020 8-K 001-37428 2.1 January 21, 2020
           
2.2 Amendment No. 1 to Agreement and Plan of Merger among Ritter Pharmaceuticals, Inc., RPG28 Merger Sub, Inc. and Qualigen, Inc., dated February 1, 2020 S-4 333-236235 Annex B April 6, 2020
           
2.3 Amendment No. 2 to Agreement and Plan of Merger among Ritter Pharmaceuticals, Inc., RPG28 Merger Sub, Inc. and Qualigen, Inc., dated March 26, 2020 S-4 333-236235 Annex C April 6, 2020
           
2.4 Contingent Value Rights Agreement, dated May 22, 2020, among the Company, John Beck in the capacity of CVR Holders’ Representative and Andrew J. Ritter in his capacity as a consultant to the Company. 8-K 001-37428 2.4 May 29, 2020
           
3.1 Amended and Restated Certificate of Incorporation 8-K 001-37428 3.1 July 1, 2015
           
3.2 Certificate of Amendment to the Amended and Restated Certificate of Incorporation 8-K 001-37428 3.1 September 15, 2017
           
3.3 Certificate of Amendment to the Amended and Restated Certificate of Incorporation 8-K 001-37428 3.1 March 22, 2018
           
3.4 Certificate of Designation of Preferences, Rights and Limitations of Series Alpha Preferred Stock of the Company, filed with the Delaware Secretary of State on May 20, 2020 8-K  001-37428 3.1 May 29, 2020
           
3.5 Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020 [reverse stock split] 8-K  001-37428 3.2 May 29, 2020
           
3.6 Certificate of Merger, filed with the Delaware Secretary of State on May 22, 2020 8-K  001-37428 3.3 May 29, 2020
           
3.7 Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020 [name change] 8-K  001-37428 3.4 May 29, 2020
           
3.8 Amended and Restated Bylaws of the Company, through August 10, 2021  10-Q  001-37428  3.8  August 16, 2021
           
4.1 Warrant Agency Agreement between Ritter Pharmaceuticals, Inc. and Corporate Stock Transfer, Inc. and Form of Warrant Certificate 8-K 001-37428 4.1 

October 4, 2017

 

 

None

4.2 First Amendment to Warrant Agency Agreement between Ritter Pharmaceuticals, Inc. and Corporate Stock Transfer, Inc. 8-K 001-37428 4.1 May 7, 2018
           
4.3 Second Amendment to Warrant Agency Agreement between the Company and Equiniti Group plc, dated November 9, 2020 10-K 001-37428 4.3 March 31, 2021
           
4.4 Warrant, issued by the Company in favor of Alpha Capital Anstalt, dated May 22, 2020 [post-Merger] 8-K 001-37428 10.13 May 29, 2020
           
4.5 Form of Warrant, issued by the Company in favor of GreenBlock Capital LLC and its designees, dated May 22, 2020 [post-Merger] 8-K 001-37428 10.10 May 29, 2020
           
4.6 Common Stock Purchase Warrant for 1,920,768 shares in favor of Alpha Capital Anstalt, dated July 10, 2020 8-K 001-37428 10.2 July 10, 2020
           
4.7 Pre-Funded Common Stock Purchase Warrant for 1,920,768 shares in favor of Alpha Capital Anstalt, dated July 10, 2020 8-K 001-37428 10.3 July 10, 2020
           
4.8 Common Stock Purchase Warrant for 1,287,829 shares in favor of Alpha Capital Anstalt, dated August 4, 2020 8-K 001-37428 10.3 August 4, 2020
           
4.9 “Two-Year” Common Stock Purchase Warrant for 1,348,314 shares in favor of Alpha Capital Anstalt, dated December 18, 2020 8-K 001-37428 10.3 December 18, 2020
           
4.10 “Deferred” Common Stock Purchase Warrant for 842,696 shares in favor of Alpha Capital Anstalt, dated December 18, 2020 8-K 001-37428 10.4 December 18, 2020
           
4.11 “Prefunded” Common Stock Purchase Warrant for 1,000,000 shares in favor of Alpha Capital Anstalt, dated December 18, 2020 8-K 001-37428 10.5 December 18, 2020
           
4.12 Form of liability classified Warrant to Purchase Common Stock (“exploding warrant”) 10-K 001-37428 4.13 March 31, 2021
           
4.13 Form of “service provider” (non-”exploding”) compensatory equity classified Warrant 10-K 001-37428 4.14 March 31, 2021
           
4.14 Description of Common Stock 10-K 001-37428 4.7 March 31, 2020

 

31.1*Certificate of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*Certificate of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*Certificate of principal executive officer and principal financial officer pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS#Inline XBRL Instance Document.
101.SCH#Inline XBRL Taxonomy Extension Schema Document.
101.CAL#Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF#Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB#Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE#Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104Cover page Interactive Data File (embedded within the Inline XBRL document)

Item 6. Exhibits.* Filed or furnished herewith.

    Incorporated by Reference 
Exhibit No. Description Form File No. Exhibit Filing
Date
           
1.1 Underwriting Agreement, dated September 29, 2017, between Ritter Pharmaceuticals, Inc. and Aegis Capital Corp., as representative of the several underwriters named therein 8-K 001-37428 1.1 10/4/2017
           
3.1 Certificate of Amendment to the Amended and Restated Certificate of Incorporation 8-K 001-37428 3.1 10/4/2017
           
3.2 Certificate of Designation of Series A Convertible Preferred Stock 8-K 001-37428 3.1 10/4/2017
           
4.1 Warrant Agency Agreement, dated September 29, 2017 by and between Ritter Pharmaceuticals, Inc. and Corporate Stock Transfer, Inc. (including the form of warrant certificate) 8-K 001-37428 4.1 10/4/2017
           
10.1 Ritter Pharmaceuticals, Inc. 2015 Equity Incentive Plan, as amended S-8 333-220907 99.1 10/11/2017
           
31.1 Certificate of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.        
           
31.2 Certificate of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.        
           
32.1 Certificate of principal executive officer and principal financial officer pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.        
           
101.INS# XBRL Instance Document.        
           
101.SCH# XBRL Taxonomy Extension Schema Document.        
           
101.CAL# XBRL Taxonomy Extension Calculation Linkbase Document.        
           
101.DEF# XBRL Taxonomy Extension Definition Linkbase Document.        
           
101.LAB# XBRL Taxonomy Extension Label Linkbase Document.        
           
101.PRE# XBRL Taxonomy Extension Presentation Linkbase Document.        

+ Indicates management contract or compensatory plan or arrangement.

# XBRL (Extensible Business Reporting Language) information is furnished and not filed herewith, is not a part of a registration statement or Prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections.

46 

 

SIGNATURES

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

October 31, 2017August 15, 2022RITTER PHARMACEUTICALS,QUALIGEN THERAPEUTICS, INC.
By:/s/ Michael D. StepS. Poirier
Name:Michael D. StepS. Poirier
Title:Chief Executive Officer

47