UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.Washington, DC 20549

 

FORM 10-Q

 

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

For the quarterly period ended September 30, 2021

For the quarterly period ended September 30, 2020

OR

Transition Report Pursuant to SectionTRANSITION REPORT PURSUANT TO SECTION 13 or 15(dOR 15(d) ofOF THE SECURITIES EXCHANGE ACT OF 1934

For the Securities Exchange Act of 1934transition period from to

For the transition period from to

 

Commission file number 001-39563File Number: 001-39563

 

GEOVAX LABS, INC.

(Exact name of Registrantregistrant as specified in its charter)

 

Delaware

87-0455038

(State or other jurisdiction

(I.R.S.IRS Employer Identification No.)

of incorporation or organization)

 
  

1900 Lake Park Drive, Suite 380

  

Smyrna, Georgia

30080

(Address of principal executive offices)

(Zip Code)Code

 

(678) 384-7220

(Registrant’sRegistrants telephone number, including area code)

 

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

Title of each Class

Trading Symbol

Name of each Exchange on which Registered

Common Stock $0.001 par value

GOVX

The Nasdaq Capital Market

Warrants to Purchase Common Stock

GOVXW

The Nasdaq Capital Market

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒   No   ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒      No ☐

 

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

Large accelerated filer             ☐                     Accelerated filer                           ☐   

Non-accelerated filer               ☒                     Emerging growth company          ☐

Smaller reporting company     ☒    

Accelerated filer

Non-accelerated filer

Emerging growth company

Smaller reporting company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.    ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):

Yes  ☐   No ☒

 

As of November 5, 2020, 3,810,83611, 2021, 6,381,541 shares of the Registrant’s common stock, $.001 par value, were issued and outstanding.

 


 

 

TABLE OF CONTENTS

 

  Page

PART I FINANCIAL INFORMATION

 

Item 1

Condensed Consolidated Financial Statements:

 

Condensed Consolidated Balance Sheets as of September 30, 20202021 (unaudited) and December 31, 20192020

1

Condensed Consolidated Statements of Operations for the three-month and nine-month periods ended  September 30, 20202021 and 20192020 (unaudited)

2

Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficiency)  for the three-month and nine-month periods ended September 30, 20202021 and 20192020 (unaudited)

3

Condensed Consolidated Statements of Cash Flows for the nine-month periods ended  September 30, 20202021 and 20192020 (unaudited)

5

 

Notes to Condensed Consolidated Financial Statements (unaudited)

6

   

Item 2

Management's Discussion and Analysis of Financial Condition and Results of Operations

1310

   

Item 3

Quantitative and Qualitative Disclosures about Market Risk

1816

   

Item 4

Controls and Procedures

1816

   

PART II  OTHER INFORMATION

 
   

Item 1

Legal Proceedings

1917

   

Item 1A

Risk Factors

1917

   

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

2717

   

Item 3

Defaults Upon Senior Securities

2817

   

Item 4

Mine Safety Disclosures

2817

   

Item 5

Other Information

2817

   

Item 6

Exhibits

2818

   

SIGNATURES

3019

 

 

 

Part I -- FINANCIAL INFORMATION

Item 1Financial Statements

Item 1

Financial StatementsGEOVAX LABS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

  

September 30,

  

December 31,

 
  

2021

  

2020

 
  

(unaudited)

     

ASSETS

        

Current assets:

        

Cash and cash equivalents

 $18,107,019  $9,883,796 

Grant funds and other receivables

  0   182,663 

Prepaid expenses and other current assets

  52,818   168,689 

Total current assets

  18,159,837   10,235,148 

Property and equipment, net

  168,653   147,741 

Deposits

  11,010   11,010 
         

Total assets

 $18,339,500  $10,393,899 
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities:

        

Accounts payable

 $289,438  $267,702 

Accrued expenses

  46,212   359,281 

Current portion of notes payable

  0   183,326 

Total current liabilities

  335,650   810,309 

Note payable, net of current portion

  0   14,738 

Total liabilities

  335,650   825,047 
         

Commitments (Note 8)

          
         

Stockholders’ equity:

        

Preferred Stock, $.01 par value:

        

Authorized shares – 10,000,000 Series B convertible preferred stock, $1,000 stated value; -0- and 100 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

  0   76,095 

Common stock, $.001 par value:

        

Authorized shares – 600,000,000 Issued and outstanding shares – 6,381,541 and 3,834,095 at September 30, 2021 and December 31, 2020, respectively

  6,382   3,834 

Additional paid-in capital

  68,630,363   55,294,504 

Accumulated deficit

  (50,632,895)  (45,805,581)

Total stockholders’ equity

  18,003,850   9,568,852 
         

Total liabilities and stockholders’ equity

 $18,339,500  $10,393,899 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

  

September 30,

  

December 31,

 
  

2020

  

2019

 
  

(unaudited)

     

ASSETS

        

Current assets:

        

Cash and cash equivalents

 $11,580,594  $283,341 

Grant funds and other receivables

  141,154   68,603 

Prepaid expenses and other current assets

  13,046   95,320 

Total current assets

  11,734,794   447,264 

Property and equipment, net (Note 5)

  10,093   10,606 

Deposits

  11,010   11,010 
         

Total assets

 $11,755,897  $468,880 
         

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)

        

Current liabilities:

        

Accounts payable

 $161,478  $152,653 

Accrued expenses (Note 6)

  579,585   1,851,040 

Current portion of notes payable

  182,584   12,500 

Total current liabilities

  923,647   2,016,193 

Note payable, net of current portion

  18,506   27,243 

Total liabilities

  942,153   2,043,436 
         

Commitments (Note 9)

        
         

Stockholders’ equity (deficiency):

        

Preferred Stock, $.01 par value (Note 10):

        

Authorized shares – 10,000,000

        

Issued and outstanding shares – 100 and 2,486 September 30, 2020 and December 31, 2019, respectively

  76,095   1,932,433 

Common stock, $.001 par value:

        

Authorized shares – 600,000,000

        

Issued and outstanding shares – 3,559,473 and 14,992 at September 30, 2020 and December 31, 2019, respectively

  3,559   15 

Additional paid-in capital

  55,203,149   39,340,509 

Accumulated deficit

  (44,469,059)  (42,847,513)

Total stockholders’ equity (deficiency)

  10,813,744   (1,574,556)
         

Total liabilities and stockholders’ equity (deficiency)

 $11,755,897  $468,880 

 

See accompanying notes to condensed consolidated financial statements.

 

1

 

 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

Three Months Ended September 30,

  

Nine Months Ended September 30,

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
 

2020

  

2019

  

2020

  

2019

  

2021

  

2020

  

2021

  

2020

 

Grant and collaboration revenue

 $415,458  $333,209  $1,572,037  $907,382  $30,414  $415,458  $220,539  $1,572,037 
                 

Operating expenses:

                 

Research and development

  416,756   467,674   1,687,113   1,474,619  1,224,362  416,756  2,659,980  1,687,113 

General and administrative

  435,013   291,475   1,364,650   1,214,189   757,432   435,013   2,562,641   1,364,650 

Total operating expenses

  851,769   759,149   3,051,763   2,688,808   1,981,794   851,769   5,222,621   3,051,763 
                 

Loss from operations

  (436,311)  (425,940)  (1,479,726)  (1,781,426) (1,951,380) (436,311) (5,002,082) (1,479,726)
                 

Other income (expense):

                 

Interest income

  90   2,560   902   4,665  877  90  3,998  902 

Interest expense

  (134,427)  (1,054)  (142,722)  (3,275) 0  (134,427) (1,286) (142,722)

Gain on debt extinguishment

  0   0   172,056   0 

Total other income (expense)

  (134,337)  1,506   (141,820)  1,390   877   (134,337)  174,768   (141,820)
   ��             

Net loss

 $(570,648) $(424,434) $(1,621,546) $(1,780,036) $(1,950,503) $(570,648) $(4,827,314) $(1,621,546)
                 

Basic and diluted:

                 

Net loss per common share

 $(0.73) $(1,282.28) $(2.85) $(14,016.03) $(0.31) $(0.73) $(0.80) $(2.85)

Weighted average shares outstanding

  782,978   331   569,955   127  6,349,297  782,978  6,005,032  569,955 

 

See accompanying notes to condensed consolidated financial statements.

 

2

 

 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’STOCKHOLDERS EQUITY (DEFICIENCY)

(Unaudited)

 

  

Three-Month and Nine-Month Periods Ended September 30, 2020

 
                          

Total

 
  

Preferred Stock (Note 10)

  

Common Stock

  

Additional

  

Accumulated

  

Stockholders’

 
  

Shares

  

Amount

  

Shares

  

Amount

  

Paid-in Capital

  

Deficit

  

Equity (Deficiency)

 

Balance at December 31, 2019

  2,486  $1,932,433   14,992  $15  $39,340,509  $(42,847,513) $(1,574,556)

Sale of convertible preferred stock for cash

  300   300,000   -   -   -   -   300,000 

Conversion of preferred stock to common stock

  (2,386)  (1,856,338)  674,067   674   1,855,664   -   - 

Common stock issued for services

  -   -   521   1   5,999   -   6,000 

Net loss for the three months ended March 31, 2020

  -   -   -   -   -   (595,694)  (595,694)

Balance at March 31, 2020

  400   376,095   689,580   690   41,202,172   (43,443,207)  (1,864,250)

Common stock issued for services

  -   -   2,124   2   11,998   -   12,000 

Warrants issued in bridge financing

  -   -   -   -   457,833   -   457,833 

Net loss for the three months ended June 30, 2020

  -   -   -   -   -   (455,204)  (455,204)

Balance at June 30, 2020

  400   376,095   691,704   692   41,672,003   (43,898,411)  (1,849,621)

Conversion of preferred stock to common stock

  (300)  (300,000)  42,723   43   299,957   -   - 

Warrants exercised for common stock

  -   -   36,902   37   (37)  -   - 

Common stock issued upon debenture conversion

  -   -   177,626   177   569,340   -   569,517 

Common stock issued upon cancellation of accrued compensation

  -   -   300,001   300   1,499,700   -   1,500,000 

Sale of common stock for cash

  -   -   2,310,000   2,310   11,156,186   -   11,158,496 

Common stock issued for services

  -   -   517   -   6,000   -   6,000 

Net loss for the three months ended September 30, 2020

  -   -   -   -   -   (570,648)  (570,648)

Balance at September 30, 2020

  100  $76,095   3,559,473  $3,559  $55,203,149  $(44,469,059) $10,813,744 
  

Three-Month and Nine-Month Periods Ended September 30, 2021

 
                          

Total

 
  

Preferred Stock

  

Common Stock

  

Additional

  

Accumulated

  

Stockholders’

 
  

Shares

  

Amount

  

Shares

  

Amount

  

Paid-in Capital

  

Deficit

  

Equity

 

Balance at December 31, 2020

  100  $76,095   3,834,095  $3,834  $55,294,504  $(45,805,581) $9,568,852 

Sale of common stock for cash

  0   0   1,644,000   1,644   9,407,276   0   9,408,920 

Issuance of common stock upon warrant exercise

  0   0   835,900   836   3,173,320   0   3,174,156 

Issuance of common stock for services

  0   0   1,472   1   5,999   0   6,000 

Stock option expense

  -   -   -   -   56,190   -   56,190 

Net loss for the three months ended March 31, 2021

  -   -   -   -   -   (1,562,778)  (1,562,778)

Balance at March 31, 2021

  100   76,095   6,315,467   6,315   67,937,289   (47,368,359)  20,651,340 

Repurchase of preferred stock

  (100)  (76,095)  0   0   75,095   0   (1,000)

Issuance of common stock for services

  0   0   12,235   13   65,828   0   65,841 

Stock option expense

  -   0   -   0   56,190   0   56,190 

Net loss for the three months ended June 30, 2021

  -   0   -   0   0   (1,314,033)  (1,314,033)

Balance at June 30, 2021

  0   0   6,327,702   6,328   68,134,402   (48,682,392)  19,458,338 

Issuance of common stock upon warrant exercise

  0   0   53,839   54   229,946   0   230,000 

Stock option expense

  -   0   -   0   56,190   0   56,190 

Issuance of warrant for technology license

  -   0   -   0   209,825   0   209,825 

Net loss for the three months ended September 30, 2021

  -   0   -   0   0   (1,950,503)  (1,950,503)

Balance at September 30, 2021

  0  $0   6,381,541  $6,382  $68,630,363  $(50,632,895) $18,003,850 

See accompanying notes to consolidated financial statements.

 

3


 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’STOCKHOLDERS EQUITY (DEFICIENCY)

(Unaudited)

 

  

Three-Month and Nine-Month Periods Ended September 30, 2019

 
                          

Total

 
  

Preferred Stock (Note 10)

  

Common Stock

  

Additional

  

Accumulated

  

Stockholders’

 
  

Shares

  

Amount

  

Shares

  

Amount

  

Paid-in Capital

  

Deficit

  

Equity (Deficiency)

 

Balance at December 31, 2018

  3,450  $1,971,333   11  $-  $37,483,204  $(40,476,884) $(1,022,347)

Sale of convertible preferred stock for cash and cancellation of note payable

  500   404,250   -   -   85,750   -   490,000 

Conversion of preferred stock to common stock

  (767)  (303,475)  3   -   303,475   -   - 

Stock option expense

  -   -   -   -   26,652   -   26,652 

Net loss for the three months ended March 31, 2019

  -   -   -   -   -   (701,454)  (701,454)

Balance at March 31, 2019

  3,183   2,072,108   14   -   37,899,081   (41,178,338)  (1,207,149)

Sale of convertible preferred stock for cash

  500   438,700   -   -   61,300   -   500,000 

Conversion of preferred stock to common stock

  (281)  (172,941)  6   -   172,941   -   - 

Issuance of common stock for services

  -   -   -   -   6,000   -   6,000 

Stock option expense

  -   -   -   -   26,664   -   26,664 

Net loss for the three months ended June 30, 2019

  -   -   -   -   -   (654,148)  (654,148)

Balance at June 30, 2019

  3,402   2,337,867   20   -   38,165,986   (41,832,486)  (1,328,633)

Sale of convertible preferred stock for cash

  700   700,000   -   -   -   -   700,000 

Conversion of preferred stock to common stock

  (1,048)  (716,044)  2,369   3   716,041   -   - 

Issuance of common stock for services

  -   -   1   -   6,000   -   6,000 

Stock option expense

  -   -   -   -   26,348   -   26,348 

Net loss for the three months ended September 30, 2019

  -   -   -   -   -   (424,434)  (424,434)

Balance at September 30, 2019

  3,054  $2,321,823   2,390  $3  $38,914,375  $(42,256,920) $(1,020,719)
  

Three-Month and Nine-Month Periods Ended September 30, 2020

 
                          

Total

 
  

Preferred Stock

  

Common Stock

  

Additional

  

Accumulated

  

Stockholders’

 
  

Shares

  

Amount

  

Shares

  

Amount

  

Paid-in Capital

  

Deficit

  

Equity (Deficiency)

 

Balance at December 31, 2019

  2,486  $1,932,433   14,992  $15  $39,340,509  $(42,847,513) $(1,574,556)

Sale of convertible preferred stock for cash

  300   300,000   -   -   -   -   300,000 

Conversion of preferred stock to common stock

  (2,386)  (1,856,338)  674,067   674   1,855,664   -   - 

Common stock issued for services

  0   0   521   1   5,999   0   6,000 

Net loss for the three months ended March 31, 2020

  -   -   -   -   -   (595,694)  (595,694)

Balance at March 31, 2020

  400   376,095   689,580   690   41,202,172   (43,443,207)  (1,864,250)

Common stock issued for services

  0   0   2,124   2   11,998   0   12,000 

Warrants issued in bridge financing

  -   0   -   0   457,833   0   457,833 

Net loss for the three months ended June 30, 2020

  -   0   -   0   0   (455,204)  (455,204)

Balance at June 30, 2020

  400   376,095   691,704   692   41,672,003   (43,898,411)  (1,849,621)

Conversion of preferred stock to common stock

  (300)  (300,000)  42,723   43   299,957   0   0 

Warrants exercised for common stock

  0   0   36,902   37   (37)  0   0 

Common stock issued upon debenture conversion

  0   0   177,626   177   569,340   0   569,517 

Common stock issued upon cancellation of accrued compensation

  0   0   300,001   300   1,499,700   0   1,500,000 

Sale of common stock for cash

  0   0   2,310,000   2,310   11,156,186   0   11,158,496 

Common stock issued for services

  0   0   517   0   6,000   0   6,000 

Net loss for the three months ended September 30, 2020

  -   0   -   0   0   (570,648)  (570,648)

Balance at September 30, 2020

  100  $76,095   3,559,473  $3,559  $55,203,149  $(44,469,059) $10,813,744 

 

See accompanying notes to consolidated financial statements.

 

4

 

 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

Nine Months Ended September 30,

  

Nine Months Ended September 30,

 
 

2020

  

2019

  

2021

  

2020

 

Cash flows from operating activities:

         

Net loss

 $(1,621,546) $(1,780,036) $(4,827,314) $(1,621,546)

Adjustments to reconcile net loss to net cash used in operating activities:

         

Depreciation and amortization

  2,983   5,693  26,806  2,983 

Stock-based compensation expense

  24,000   290,744 

Stock-based compensation for employees and directors

 168,570  0 

Stock-based compensation for consultants

 80,733  24,000 

Warrant issued for technology license fee

 209,825  0 

Gain on debt extinguishment

 (172,056) 0 

Changes in assets and liabilities:

         

Grant funds and other receivables

  (72,551)  18,329  182,663  (72,551)

Prepaid expenses and other current assets

  82,274   (83,637) 106,979  82,274 

Amortization of debt discount

  124,185   -  0  124,185 

Accounts payable and accrued expenses

  252,036   431,170   (289,477)  252,036 

Total adjustments

  412,927   662,299   314,043   412,927 

Net cash used in operating activities

  (1,208,619)  (1,117,737) (4,513,271) (1,208,619)
         

Cash flows from investing activities:

        

Cash flows from investing activities

 

Purchase of property and equipment

  (2,470)  (4,272)  (47,718)  (2,470)

Net cash used in investing activities

  (2,470)  (4,272) (47,718) (2,470)
         

Cash flows from financing activities:

         

Net proceeds from sale of common stock and warrants

 9,408,920  11,158,496 

Net proceeds from sale of preferred stock

  300,000   1,440,000  0  300,000 

Net proceeds from warrant exercises

 3,404,156  0 

Net proceeds from bridge financing

 0  888,500 

Net proceeds from issuance of note payable

  170,200   -  0  170,200 

Net proceeds from bridge financing

  888,500   - 

Net proceeds from sale of common stock and warrants

  11,158,496   - 

Repurchase of preferred stock

 (1,000) 0 

Principal repayment of note payable

  (8,854)  (8,333)  (27,864)  (8,854)

Net cash provided by financing activities

  12,508,342   1,431,667   12,784,212   12,508,342 
         

Net increase in cash and cash equivalents

  11,297,253   309,658  8,223,223  11,297,253 

Cash and cash equivalents at beginning of period

  283,341   259,701   9,883,796   283,341 
         

Cash and cash equivalents at end of period

 $11,580,594  $569,359  $18,107,019  $11,580,594 

 

Supplemental disclosure of non-cash financing activities:

During the nine months ended September 30, 2021:

149,705 shares of common stock were issued upon the cashless exercise of stock purchase warrants

$172,056 of principal and accrued interest related to a note payable was extinguished upon the loan’s forgiveness

During the nine months ended September 30, 2020:

 

716,790 shares of our common stock were issued upon conversion of convertible preferred stock were issued upon conversion of convertible preferred stock

 

36,902 shares of common stock were issued for aupon the cashless exercise of stock purchase warrants

 

300,001 shares of common stock and 300,001 Unit Warrantsstock purchase warrants were issued in exchange for cancellation of $1,500,000 owed to current and former employees and former employees and directors

 

177,626 shares of common stock, 126,042 Pre-Funded Warrantspre-funded stock purchase warrants and 303,668 Unit Warrants were issued upon conversion of $1,200,000 convertible debentures and $14,667 of related accrued interest

During the nine months ended September 30, 2019:

2,378 shares of our common stock purchase warrants were issued upon conversion of $1,200,000 convertible preferred stock

debentures and $14,667 of related accrued interest

250 shares of Series G Convertible Preferred Stock were issued in exchange for cancellation of $250,000 of term notes payable

 

See accompanying notes to condensed consolidated financial statements.

 

5

 

GEOVAX LABS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2020 30, 2021

(unaudited)

 

 

1.Description of Business

Description of Business

 

GeoVax Labs, Inc. (“GeoVax” or the “Company”), is a clinical-stage biotechnology company developing immunotherapies and vaccines against infectious diseases and cancers using a novel vector vaccine platforms. GeoVax’s Modified Vaccinia Ankara-Virus-Like Particle (MVA-VLP) based platform (Modified Vaccinia Ankara (MVA) Virus-Like Particle, or “GV-MVA-VLPTM”). In this platform,utilizes MVA, a large virus capable of carrying several vaccine antigens, expressesto express proteins that assemble into highly effective VLPvirus-like particle (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated.vaccinated can mimic virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP virus replicates to high titers in approved avian cells for manufacturing but cannot productively replicate in mammalian cells. Therefore, the MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live attenuatedlive-attenuated virus, while providing the safety characteristics of a replication-defective vector.

 

Our currentGeoVax’s MVA-VLP development programs are focused primarily on preventive vaccines against novel coronavirus (COVID-19), Human Immunodeficiency Virus (HIV),the SARS-CoV-2 virus (COVID-19) and immunotherapies for solid tumor cancers. Other development programs include preventive vaccines against Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa), Human Immunodeficiency Virus (HIV), and malaria, as well as immunotherapies for HIV and solid tumor cancers.

Our corporate strategy is to advance, protect and exploit our differentiated vaccine immunotherapy platform leading to the successful development of preventive and therapeutic vaccines against infectious diseases and various cancers. With our design and development capabilities, we are progressing and validating an array of cancer and infectious disease immunotherapy and vaccine product candidates. Our goal is to advance products through to human clinical testing, and to seek partnership or licensing arrangements for achieving regulatory approval and commercialization. We also leverage third party resources through collaborations and partnerships for preclinical and clinical testing with multiple government, academic and corporate entities.

malaria. Certain of our vaccine development activities have been, and continue to be, financially supported by the U.S. Government. This support has been both in the form of research grants and contracts awarded directly to us, as well as indirect support for the conduct of preclinical animal studies and human clinical trials.

 

We operateOn September 28, 2021, GeoVax entered into an Assignment and License Agreement with PNP Therapeutics, Inc., whereby GeoVax expanded its immuno-oncology pipeline and added a new technology platform through the acquisition of exclusive rights to Gedeptin®, a novel patented product for the treatment of solid tumors through a gene therapy strategy known as GDEPT (Gene-Directed Enzyme Prodrug Therapy). In GDEPT, a vector is used to selectively transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a nontoxic prodrug into a potent antitumor compound. A Phase 1/2 clinical trial is currently enrolling to evaluate the safety and efficacy of repeat cycles of Gedeptin therapy in a highly regulatedpatients with recurrent head and competitive environment.neck squamous cell carcinoma (HNSCC), with tumors accessible for injection and no curable treatment options. The manufacturingFDA has granted Gedeptin Orphan Drug status for the treatment of HNSCC and marketingthe initial stage of pharmaceutical products require approval from, and are subject to,the ongoing oversightclinical trial is being funded by the Food and Drug Administration (FDA) in the United States, by the European Medicines Agency (EMA) in the European Union, and by comparable agencies in other countries. Obtaining approval for a new pharmaceutical product is never certain, may take many years and often involves expenditure of substantial resources. Our goal isFDA pursuant to build a profitable company by generating income from products we develop and commercialize, either alone its Orphan Products Clinical Trials Grants Program. GeoVax’s license to Gedeptin includes rights to expand its use to all human diseases and/or with one or more potential strategic partners.conditions including, but not limited to, cancers.

 

GeoVax is incorporated under the laws of the State of Delaware and our principal offices are located in the metropolitan Atlanta, Georgia area.

 

 

2.Basis of Presentation

Basis of Presentation

 

The accompanying condensed consolidated financial statements at September 30, 2020 2021 and for the three-monththree-month and nine-monthnine-month periods ended September 30, 2020 2021 and 20192020 are unaudited, but include all adjustments, consisting of normal recurring entries, which we believe to be necessary for a fair presentation of the dates and periods presented. Interim results are not necessarily indicative of results for a full year. The financial statements should be read in conjunction with our audited consolidated financial statements included in our Annual Report on Form 10-K10-K for the year ended December 31, 2019. 2020. We expect our operating results to fluctuate for the foreseeable future; therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.

 

As described in Note 10, weWe enacted reverse stock splits of our common stock on April 30, 2019, September 25, 2020 (1-for-20) and on January 21, 2020 and September 30, 2020. Unless otherwise noted, the(1-for-2,000). The accompanying financial statements, and all share and per share information contained herein, have been retroactively restated to reflect the reverse stock splits.

 

Our financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business for at least the twelve-monthtwelve-month period following the issue date theof these consolidated financial statements are issued.statements. We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates.

6

For the last several years the audit reports We have funded our activities to our consolidated financial statements have included a “going concern” qualification, arising from our limited assets, our history of operating losses, and our continuing need for capital to conduct our research and development activities. These conditions continued through the second quarter of 2020. However, as a result of our financing activities consummated during the third quarter of 2020 (see Note 10), management has concluded that as of September 30, 2020 there is no longer a substantial doubt over the Company’s ability to operate as a going concern for at least the next twelve-month period. We believe that our existing cash resources together with current government funding commitments, will be sufficient to continue our planned operations into early 2022.

We expect to incur future net losses as we continue to fund the development of our product candidates. To date we have financed our operations primarily with proceeds from sales of our equity and debt securities, government grants and clinical trial assistance, and corporate and academic collaborations. We expect to incur future net losses and require substantial funds as we continue our research and development activities. Our transition to profitability will be dependent upon, among other things, the successful development and commercialization of our product candidates. We may never achieve profitability or positive cash flows, and unless and until we do, we will continue to need to raise additional funding. Management intendsWe intend to fund future operations through additional private and/or public offerings of debt or equity securities. In addition, we may seek additional capital through arrangements with strategic partners or from other sources. There can be no assurance that we will be able to raise additional funds or achieve or sustain profitability or positive cash flows from operations. 

6

 

 

3.Significant Accounting Policies and Recent Accounting Pronouncements

Significant Accounting Policies and Recent Accounting Pronouncements

 

We disclosed in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K10-K for the year ended December 31, 2019 2020 those accounting policies that we consider significant in determining our results of operations and financial position. ThereDuring the nine months ended September 30, 2021, there have been no material changes to, or in the application of, the accounting policies previously identified and described in the Form 10-K.

There10-K, and there have been no other recent accounting pronouncements or changes in accounting pronouncements during the nine months ended September 30, 2020, as compared to the recent accounting pronouncements described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which we expect to have a material impact on our financial statements.

 

 

4.Basic and Diluted Loss Per Common Share

Basic and Diluted Loss Per Common Share

 

Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. Common share equivalents consist of common shares issuable upon conversion of convertible preferred stock, and upon exercise of stock options and stock purchase warrants. All common share equivalents are excluded from the computation of diluted loss per share since the effect would be anti-dilutive. The weighted average number of common share equivalents which were excluded from the computation of diluted loss per share totaled 2,965,451 and 2,550,184 shares for the three-month and nine-month periods ended September 30, 2021, respectively, as compared to 204,553 and 78,754 shares for the three-monththree-month and nine-monthnine-month periods ended September 30, 2020, respectively, as compared to 273 and 272 shares for the three-month and nine-month periods ended September 30, 2019, respectively. See Note 10 for more information concerning our outstanding common share equivalents at September 30, 2020 that could potentially dilute earnings per share in the future.

 

 

5.Property and Equipment

Property and Equipment

 

Property and equipment as shown on the accompanying Condensed Consolidated Balance Sheets is composed of the following as of September 30, 2020 2021 and December 31, 2019:2020:

  

September 30,

2020

  

December 31,

2019

 

Laboratory equipment

 $537,047  $534,577 

Leasehold improvements

  115,605   115,605 

Other furniture, fixtures & equipment

  11,736   11,736 

Total property and equipment

  664,388   661,918 

Accumulated depreciation and amortization

  (654,295)  (651,312)

Property and equipment, net

 $10,093  $10,606 

7

  

September 30, 2021

  

December 31, 2020

 

Equipment and furnishings

 $591,554  $543,836 

Leasehold improvements

  115,605   115,605 

Total property and equipment

  707,159   659,441 

Accumulated depreciation and amortization

  (538,506)  (511,700)

Property and equipment, net

 $168,653  $147,741 

 

 

6.Accrued Expenses

Accrued Expenses

 

Accrued expenses as shown on the accompanying Condensed Consolidated Balance Sheets are composed of the following as of September 30, 2020 2021 and December 31, 2019:2020:

  

September 30, 2021

  

December 31, 2020

 

Accrued salaries

 $11,212  $279,696 

Other accrued expenses

  35,000   79,585 

Total accrued expenses

 $46,212  $359,281 

 

  

September 30,

2020

  

December 31,

2019

 

Accrued payroll and director fees

 $551,762  $1,732,702 

Other accrued expenses

  27,823   118,338 

Total accrued expenses

 $579,585  $1,851,040 

7.Notes Payable

7.

Notes Payable

 

GRA NoteOn February 28, 2018, we entered into a Senior Note Purchase Agreement with Georgia Research Alliance, Inc. (GRA) pursuant to which we issued a five-yearfive-year Senior Promissory Note (the “GRA Note”) to GRA in exchange for $50,000. The GRA Note bearsbore an annual interest rate of 5%, payable monthly. Future principal repayments are expected to be $3,026 for the remainder of 2020, $12,487 in 2021, $13,126 in 2022, and $2,252 in 2023.five percent. Interest expense related to the GRA Note for the three-monththree-month and nine-monthnine-month periods ended September 30, 2020 2021 was $411$-0- and $1,344,$633, respectively, as compared to $547$411 and $1,753,$1,344, respectively, for the same periods of 2019.2020. During May 2021, we repaid the remaining principal balance of $22,737 and retired the GRA Note.

 

CARES Act Paycheck Protection Program Loan On April 17, 2020, we received a $170,200 bank loan backed by the United States Small Business Administration (SBA) pursuant to the Paycheck Protection Program (PPP) provisions of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The loan bearsbore an annual interest rate of one percent and is due April 17, 2022. Commencing November 17, 2020, monthly payments of $9,578.16 will be due. Amounts due may be prepaid without penalty. percent. We recorded accrued interest expense associated withrelated to the PPP Loan of $-0- and $653 for the three-month and nine-month periods ended September 30, 2021, respectively, as compared to $429 and $774, respectively, for the three-month and nine-monthsame periods ended September 30, 2020, respectively. In October 2020, we applied toof 2020. During May 2021, upon receiving payment from the SBA, the lender to haveforgave the loan forgiven, based upon our submissionfull principal balance of qualifying information regarding eligible expenses; as of the date of this report our application has not been processed.

8.

Convertible Debentures

On June 26 2020, we entered into a Securities Purchase Agreement$170,200 together with two institutional investors, pursuant to which we received gross proceeds of $1,050,000 in exchange for the issuance of: (i) 5% Original Issue Discount Senior Secured Convertible Debentures (the “Convertible Debentures”) in the aggregate principal amount of $1,200,000; and (ii) five-year warrants (the “June 2020 Warrants”) to purchase an aggregate of 120,000 shares of our common stock at an exercise price of $10.00 per share. Net proceeds after deducting the original issue discount, finder’s fee and other debt issuance costs was $888,500. As a result of the public offering of our securities described in Note 10, on September 29, 2020 the exercise price of the June 2020 Warrants was reduced to $5.00. The Convertible Debentures had an original maturity of twelve months, bore interest at a rate of 5% per annum, and were secured by substantially all of the Company’s assets until such time as they were paid or converted in full.

The Convertible Debentures were mandatorily convertible upon our consummation of a public offering of common stock with gross proceeds of $6,000,000 or more, and which resulted in the listing of our common stock on a national securities exchange (a “Qualified Offering”). The conversion price upon the occurrence of a Qualified Offering was equal to the lower of (i) $10.00 per share or (ii) 80% of the offering price. The conversion provisions of the Convertible Debentures were subject to a “conversion blocker” such that each of the purchasers could not convert the Convertible Debentures to the extent that the conversion would result in the purchaser and its affiliates holding more than 4.99% of our outstanding common stock.

On September 29, 2020, upon our consummation of the public offering discussed in Note 10, the $1,200,000 maturity value of the Convertible Debentures and $14,667$1,856 of accrued interest were automatically converted at $4.00,and extinguished the Qualified Offering discounted price, resulting in the issuance of 303,667 conversion units. Of the 303,668 conversion units: (a) 177,626 consist of one share of common stock and a warrant to purchase one share of common stock (a “Conversion Warrant”), and (b) 126,042 consist of one pre-funded warrant to purchase one share of common stock (a “Pre-Funded Warrant”) and a Conversion Warrant. The Pre-Funded Warrants provide the holder the right to purchase one share of Common Stock at an exercise price of $0.01 per share, are immediately exercisable and will not expire until exercised in full. The Unit Warrants provide the holder the right to purchase one share of common stock, are immediately exercisable at an exercise price of $5.00 per share and expire five years after the issuance date.PPP Loan.

 

87

 

Upon the issuance of the Convertible Debentures, we recorded a debt discount of $769,334, including the $150,000 original issue discount, $457,834 of fair value allocated to the warrants (recorded as Additional Paid-in Capital), and $161,500 of direct transaction costs incurred. The debt discount was amortized to interest expense over the 12-month term of the Debentures using the effective interest rate method, up to the date of conversion. As a result of the mandatory conversion of the Convertible Debentures on September 29, 2020, the remaining unamortized debt discount ($645,150) was recorded as Additional Paid-in Capital in the accompanying Consolidated Balance Sheets. Interest expense associated with the Convertible Debentures was $133,148 and 138,851 for the three-month and nine-month periods ended September 30, 2020, respectively, including of $119,139 and $124,184, respectively, of debt discount amortization.

 

9.

8.Commitments

Commitments

 

Lease Agreement --

We lease approximately 8,400 square feet of office and laboratory space pursuant to an operating lease which expires on December 31, 2022. Rent expense for the three-monththree-month and nine-monthnine-month periods ended September 30, 2020 2021 was $41,539$42,803 and $124,617,$128,410, respectively, as compared to $40,316$41,539 and $120,949,$124,617, respectively, for the same periods of 2019.2020. Future minimum lease payments total $41,539 in 2020, $171,213 in $42,803 for the remainder of 2021 and $176,356 in 2022, although the lease may be terminated at any time by either party with ninety days’ written notice.

 

Other Commitments

In the normal course of business, we enter into various firm purchase commitments related to production and testing of our vaccine, conduct of research studies, and other activities. As of September 30, 2020, 2021, there wasare approximately $290,500$607,000 of unrecorded outstanding purchase commitments to our vendors and subcontractors, $228,000all of which we expect will be due in 2020 and $62,500 in 2021. We expect this entire amount to be reimbursable to us pursuant to existing government grants.

 

 

10.

9.Stockholders Equity

Stockholders’ Equity

 

Convertible Preferred Stock

We are authorized to issue up to 10,000,000On June 7, 2021, we repurchased the remaining 100 shares of our Preferred Stock, $.01 par value, which may be issued in one or more series. The table below presents our issued and outstanding series of preferred stock as of September 30, 2020 and December 31, 2019. Each series of our outstanding preferred stock has a stated value of $1,000 per share. Further information concerning each series of preferred stock, and the changes in each series during the nine months ended September 30, 2020 are discussed below the table.

  

September 30, 2020

  

December 31, 2019

 
      

Carrying

      

Carrying

 
  

Shares

  

Value

  

Shares

  

Value

 

Series B Convertible Preferred Stock

  100  $76,095   100  $76,095 

Series H Convertible Preferred Stock

  -   -   1,686   1,156,338 

Series I Convertible Preferred Stock

  -   -   700   700,000 

Total

  100  $76,095   2,486  $1,932,433 

As of September 30, 2020, there were 100 shares of Series B Convertible Preferred Stock outstanding, convertible intofor a negligible numbertotal price of shares$1,000. As of common stock. There were no transactions involving our Series B Preferred Stock during the nine months ended September 30, 2020.

During the first quarter of 2020, 1,6862021, there are 0 shares of our Series H Convertible Preferred Stock were converted into 469,696 shares of our common stock. As of September 30, 2020, there were no shares of Series H Preferred Stockpreferred stock outstanding.

 

During the first quarterPublic Offering On February 11, 2021, we closed an underwritten public offering of 2020, 700 shares of our Series I Convertible Preferred Stock were converted into 204,371 shares of our common stock. As of September 30, 2020, there were no shares of Series I Preferred Stock outstanding.

On January 24, 2020, we entered into a Securities Purchase Agreement with the purchasers identified therein providing for the issuance and sale to the purchasers of an aggregate of 300 shares of our Series J Convertible Preferred Stock (“Series J Preferred Stock”) for gross proceeds of $300,000. Our Series J Preferred Stock has rights and privileges as set forth in the pertinent Certificate of Designation of Preferences, Rights and Limitations, including a liquidation preference equal to the stated value per share. The Series J Preferred Stock has no voting rights and is not entitled to a dividend. During July 2020, 300 shares of Series J Preferred Stock were converted into 42,723 shares of our common stock. As of September 30, 2020, there were no shares of Series J Preferred Stock outstanding.

9

Common Stock

Reverse Stock Splits On April 30, 2019, we enacted a 1-for-500 reverse stock split of our common stock, on January 21, 2020, we effected a 1-for-2000 reverse split of our common stock and on September 25, 2020, we effected a 1-for-20 reverse split of our common stock.

Conversions of Preferred Stock – As discussed under “Preferred Stock” above, during the nine months ended September 30, 2020, we issued 716,7901,644,000 shares of our common stock, including 204,000 shares sold pursuant to conversions of our Series H, Series I, and Series J Preferred Stock.

Public Offering – On September 24, 2020, we entered into an Underwriting Agreement (the “Underwriting Agreement”) with Maxim Group LLC, as representativethe full exercise of the underwriters (the “Representative”), for an underwrittenunderwriter’s option to purchase additional shares, at a price to the public offering (the “Offering”) of an aggregate of 2,560,000 units of our equity securities (the “Units”). The Offering closed on September 29, 2020, with gross proceeds to us of approximately $12.8 million; net$6.25 per share. Net proceeds after deducting underwriting discounts and commissions and other offering expenses were approximately $11.2$9.4 million.

Of the 2,560,000 Units sold in the Offering: (a) 2,310,000 Units consist of one share of our common stock, and a Warrant to purchase one share of common stock (each, a “Unit Warrant”); and (b) 250,000 Units consisting of a Pre-Funded Warrant to purchase one share of common stock and a Unit Warrant. The Pre-Funded Warrants provide the holder the right to purchase one share of common stock at an exercise price of $0.01 per share, are immediately exercisable and will not expire until exercised in full. The Unit Warrants provide the holder the right to purchase one share of common stock, are immediately exercisable at an exercise price of $5.00 per share and expire five years after the issuance date. The public offering price was $5.00 per Unit ($4.99 for each Unit including a Pre-Funded Warrant). We granted the Representative a 45-day option to purchase up to 384,000 Units to cover over-allotments, if any.

Pursuant to the Underwriting Agreement, Additionally, we issued to the Representative,underwriter, as a portion of the underwriting compensation, warrants to purchase up to a total of 128,00072,000 shares of our common stock (the “Representative Warrants”). The Representative Warrants haveat an exercise price of $5.50$6.875 per share, are initially exercisable 180 days after the effective date of the Offering and have a term of three years from their initial exercise date.share.

 

ConversionStock Options We have a stock-based incentive plan (the “2020 Plan”) pursuant to which our Board of Deferred CompensationDirectors may grant stock options and other stock-based awards to Equity During 2016our employees, directors and 2017, to help conserve the Company’s cash resources, eachconsultants. A total of 1,500,000 shares of our executive officerscommon stock are reserved for issuance pursuant to the 2020 Plan. During the nine months ended September 30, 2021, there were no stock option transactions related to the 2020 Plan. As of September 30, 2021, there were 602,000 stock options outstanding, with a weighted-average exercise price of $2.79 per share and non-employee directors agreed to defer receipta weighted-average remaining term of all or9.2 years.

Stock Purchase Warrants During January and February 2021, 188,688 stock purchase warrants were exercised on a portion (at varying levels) of their respective cash compensation. On September 29, 2020, upon our consummation of the Offering, $1,500,000 of the accumulated deferrals were converted at the $5.00 offering price,cashless basis, resulting in the issuance of 300,001 units substantially similar to the units sold in the public offering, with each unit consisting of one share145,866 shares of our common stock, and one warrant substantially similar to a Unit Warrant (a “Management Warrant”).

Conversion690,034 stock purchase warrants were exercised for cash, resulting in the issuance of Convertible Debentures to Equity – As discussed in Note 8, upon our consummation of the Offering, we issued an aggregate of 177,625690,034 shares of our common stock 126,042 Pre-Funded Warrantsfor net proceeds to us of $3,174,156.

During August 2021, 27,004 stock purchase warrants were exercised on a cashless basis, resulting in the issuance of 3,839 shares of our common stock, and 303,667 Conversion Warrants upon50,000 stock purchase warrants were exercised for cash, resulting in the mandatory conversionissuance of $1,214,66750,000 shares of Convertible Debenturesour common stock for net proceeds to us of $230,000.

On September 28, 2021, in connection with our entering into an Assignment and accrued interest.License Agreement with PNP Therapeutics, Inc. (PNP) we issued a five-year stock purchase warrant to PNP for 100,000 shares of our common stock at an exercise price of $13.00 per share.

As of September 30, 2021, there are 2,816,631 stock purchase warrants outstanding, with a weighted-average exercise price of $5.35 per share and a weighted-average remaining term of 3.9 years.

 

Other Common Stock Transactions During the nine months ended September 30, 2020, 2021, we issued an aggregate of 3,16213,707 shares of our common stock pursuant to a consulting agreement. See “Stock-Based Compensation Expense” below.

Stock Options

As a result of the reverse stock splits of our common stock all of our outstanding stock options were automatically adjusted such that all of such stock options as of the beginning of 2020 were eliminated. On June 19, 2020, our Board of Directors approved the GeoVax Labs, Inc. 2020 Stock Incentive Plan (the “2020 Plan”) to replace our prior stock option plan and reserved up to 250,000 shares of our common stock for issuance pursuant to the 2020 Plan. No equity awards were made from the 2020 Plan during the nine months ended September 30, 2020.

Stock Purchase Warrants

Series G Warrants – In August 2020, the holders of the Series G Warrants agreed to their cancellation and there were no Series G Warrants outstanding as of September 30, 2020.agreements.

 

10


 

Series H Warrants – During July 2020, all outstanding Series H Warrants were exercised using the “cashless” exercise feature of the warrants, resulting in the issuance of 7,147 shares of our common stock. There were no Series H Warrants outstanding as of September 30, 2020.10.Stock-Based Expense

 

Series I Warrants – During July 2020, Series I Warrants were exercised usingStock-based compensation expense related to employee and director stock options was $56,190 and $168,570 during the “cashless” exercise feature of the warrants, resulting in the issuance of 29,755 shares of our common stock. As of three-month and nine-month periods ended September 30, 2020,2021, respectively; there were 62,626 Series I Warrants outstanding, with an exercise price of $5.00 per share, reflective of anti-dilution adjustments resulting from the Offering.

June 2020 Warrants – As discussed in Note 8, on June 26, 2020, in connection with the issuance of the Convertible Debentures, we issued warrants to purchase 120,000 shares of common stock, with a five-year term and an exercise price of $10.00. As a result of the Offering, on September 29, 2020 the exercise price was reduced to $5.00.

Warrants Issued Upon Conversion of Convertible Debentures – As discussed in Note 8, on September 29, 2020, upon the conversion of the Convertible Debentures into our equity securities, we issued 126,042 Pre-Funded Warrants and 303,668 Conversion Warrants to purchase our common stock.

Warrants Issued Upon Conversion of Deferred Compensation – As discussed above under “Common StockConversion of Deferred Compensation to Equity”, on September 29, 2020, upon the conversion of amounts owed to current and former executive officers and directors, we issued Management Warrants to purchase 300,001 shares of common stock.

Warrants Issued in Connection with Public Offering – As discussed above under “Common Stock – Public Offering”, on September 29, 2020, in connection with the Offering, we issued Unit Warrants to purchase 2,560,000 shares of common stock; Pre-Funded Warrants to purchase 250,000 shares of common stock; and Representative Warrants to purchase 128,000 shares of common stock.

Summary of Warrants Outstanding– The following table presents summary information about our warrants outstanding as of September 30, 2020:

 

Warrant Description

 

Number

of Shares

  

Exercise

Price

 

 

Expiration

Series I Warrants

  62,626  $5.00 

Oct-Dec 2024

June 2020 Warrants

  120,000   5.00 

Jun 2025

Pre-Funded Warrants

  376,042   0.01 

Perpetual

Unit, Conversion and Management Warrants

  3,163,669   5.00 

Sep 2025

Representative Warrants

  128,000   5.50 

Mar 2024

Total Warrants Outstanding at September 30, 2020

  3,850,337      
          

Weighted-Average Exercise Price

 $4.53      

Weighted-Average Remaining Life (excluding Pre-Funded Warrants)(in years)

  4.9      

Stock-Based Compensation Expense

There was no0 stock-based compensation expense related to ouremployee stock option plan recognized inoptions during the consolidated statementcomparable periods of operations for the three-month or nine-month periods ended September 30, 2020 and there was no unrecognized2020. Stock-based compensation expense related to stock options asis recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the related employee classification. As of September 30,2021, there is $486,940 of unrecognized compensation expense that we expect to recognize over a weighted-average period of 2.2 years.

During the three-month and nine-month periods ended September 30, 2020. During the three-month and nine-month periods ended September 30, 2020 2021, we recorded stock-based compensation expense of $6,000$29,560 and $24,000,$80,733, respectively, associated with common stock issued for consulting services, as compared to $6,000 and $24,000, respectively, during the comparable periods of 2020. As of September 30, 2021, there is $39,773 recorded as a consulting agreement.prepaid expense for these arrangements, which will be recognized as expense over the remaining terms of the related agreements.

During September 2021, we recorded $209,825 of expense associated with the issuance of a stock purchase warrant to PNP in connection with our entering into a technology licensing agreement; such amount was recorded as research and development expense.

 

 

11.Income Taxes

Income Taxes

 

Because of our historically significant net operating losses, we have not paid income taxes since inception. We maintain deferred tax assets that reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. These deferred tax assets are comprised primarily of net operating loss carryforwards and also include amounts relating to nonqualified stock options and research and development credits. The net deferred tax asset has been fully offset by a valuation allowance because of the uncertainty of our future profitability and our ability to utilize the deferred tax assets. Utilization of operating losses and credits will be subject to substantial annual limitations due to ownership change provisions of Section 382 of the Internal Revenue Code. The annual limitation will may result in the expiration of net operating losses and credits before utilization.

 

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12.Grants and Collaboration Revenue

12.

Grant and Collaboration Revenue

 

We receive payments from government entities under our grants from the National Institute of Allergy and Infectious Diseases (NIAID) and from the U.S. Department of Defense in support of our vaccine research and development efforts. We record revenue associated with government grants as the reimbursable costs are incurred. During the three-monththree-month and nine-monthnine-month periods ended September 30, 2020, 2021, we recorded $231,330$30,414 and $1,186,844,$220,539, respectively, of revenues associated with these grants, and contracts, as compared to $214,765$231,330 and $754,022,$1,186,844, respectively, for the comparable periods of 2019. As of 2020. During the three-month and nine-month periods ended September 30, 2020, there was an aggregate of $417,121 in approved grant funds available for use through September 2021.

During the three-month and nine-month periods ended September 30, 2020, we also recorded $184,127$184,128 and $385,193, respectively, of revenues associated with research collaboration agreements with third parties, as compared parties. As of September 30, 2021, there is an aggregate of $244,888 in approved grant funds available for use through mid-2022.

13.Subsequent Event

On November 9, 2021, we entered into an Exclusive License Agreement the (“License Agreement”) with City of Hope (“COH”) under which we obtained exclusive worldwide rights to $118,444key patents, know-how, regulatory filings and $153,360,clinical materials related to COH’s COVID-19 vaccine program, currently undergoing human clinical trials. We will pay an upfront fee to COH of $5,000,000 within 30 days of the effective date of the License Agreement and are obligated to pay additional fees of $3,000,000 and $2,000,000 on the first and second anniversaries, respectively, forof the comparable periodseffective date of 2019.the License Agreement. We will also pay COH milestone fees based on achievement of success-based development and regulatory milestones, and annual royalties on net sales of products covered by the License Agreement.


 

 

13.

Item 2Managements Discussion and Analysis of Financial Condition and Results of Operations

Subsequent Events

 

During October 2020, holdersThe following Managements Discussion and Analysis of Financial Condition and Results of Operations (MD&A) is intended to help the reader understand our Pre-Funded Warrants exercised 250,000results of such warrants, resultingoperations and financial condition. This MD&A is provided as a supplement to, and should be read in conjunction with, our condensed consolidated financial statements and the issuance of 250,000 shares of our common stock for an aggregate exercise price of $2,500.

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Item 2

Management’s Discussion and Analysis of Financial Condition and Results of Operations

FORWARD-LOOKING STATEMENTS

In addition to historical information, the informationaccompanying notes thereto and other disclosures included in this Quarterly Report on Form 10-Q (this Report), and our audited financial statements and the accompanying notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission on March 23, 2021.

Forward-Looking Statements

Information included in this Report contains forward-looking statements.statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. All statements in this Report, other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, intentions, expectations and objectives could be forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve numerous risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties includingand factors include, but are not limited to, the riskthose factors set forth underin our Annual Report on Form 10-K for the heading “Risk Factors”fiscal year ended December 31, 2020. We operate in Item 1A,a highly competitive, highly regulated and shouldrapidly changing environment and our business is constantly evolving. Therefore, it is likely that new risks will emerge, and that the nature and elements of existing risks will change, over time. It is not be relied upon as predictionspossible for management to predict all such risk factors or changes therein, or to assess either the impact of future events. Certainall such forward-looking statements can be identified by the use of forward-looking terminology such as ‘‘believes,’’ ‘‘expects,’’ ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘seeks,’’ ‘‘approximately,” ‘‘intends,’’ ‘‘plans,’’ ‘‘pro forma,’’ ‘‘estimates,’’ or ‘‘anticipates’’ or other variations thereof or comparable terminology, or by discussions of strategy, plans, or intentions. Such forward-looking statements are necessarily dependentrisk factors on assumptions, data, or methods that may be incorrect or imprecise and may be incapable of being realized. The following factors, among others, could cause actual results and future events to differ materially from those set forth or contemplated in the forward-looking statements:

whether we can raise additional capital as and when we need it;

whether we are successful in developing our products;

whether we are able to obtain regulatory approvals in the United States and other countries for sale of our products;

whether we can compete successfully with others in our market; and

whether we are adversely affected in our efforts to raise cash by the volatility and disruption of local and national economic, credit and capital markets and the economy in general.

Readers are cautioned not to place undue reliance on forward-looking statements, which reflect our management’s analysis only.business. We assume no obligation to publicly update or revise any forward-looking statements.statements, whether as a result of new information, future events or otherwise. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this Report.

 

Overview

 

GeoVax is a clinical-stage biotechnology company developing immunotherapies and vaccines against infectious diseases and cancers using a novel vector vaccine platforms. GeoVax’s Modified Vaccinia Ankara-Virus-Like Particle (MVA-VLP) based platform (Modified Vaccinia Ankara (MVA) Virus-Like Particle, or “GV-MVA-VLPTM”). In this platform,utilizes MVA, a large virus capable of carrying several vaccine antigens, expressesto express proteins that assemble into highly effective VLPvirus-like particle (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated.vaccinated can mimic virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP virus replicates to high titers in approved avian cells for manufacturing but cannot productively replicate in mammalian cells. Therefore, the MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live attenuatedlive-attenuated virus, while providing the safety characteristics of a replication-defective vector.

 

Our currentGeoVax’s MVA-VLP development programs are focused primarily on preventive vaccines against novel coronavirusthe SARS-CoV-2 virus (COVID-19), Human Immunodeficiency Virus (HIV), and immunotherapies for solid tumor cancers. Other development programs include preventive vaccines against Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa), Human Immunodeficiency Virus (HIV), and malaria,malaria. Certain of our vaccine development activities have been, and continue to be, financially supported by the U.S. Government. This support has been both in the form of research grants and contracts awarded directly to us, as well as immunotherapiesindirect support for HIVthe conduct of preclinical animal studies and human clinical trials.

On September 28, 2021, we entered into an Assignment and License Agreement with PNP Therapeutics, Inc., whereby we expanded our immuno-oncology pipeline and added a new technology platform through the acquisition of exclusive worldwide rights to Gedeptin®, a novel patented product for the treatment of solid tumors through a gene therapy strategy known as GDEPT (Gene-Directed Enzyme Prodrug Therapy). In GDEPT, a vector is used to selectively transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a nontoxic prodrug into a potent antitumor compound. GeoVax’s license to Gedeptin includes rights to expand its use to all human diseases and/or conditions including, but not limited to, cancers.

On November 9, 2021, we entered into an Exclusive License Agreement with City of Hope, whereby we obtained exclusive worldwide rights to develop and commercialize COH04S1, a multi-antigenic COVID-19 vaccine currently undergoing Phase 2 human clinical trials. This program is supplemental to, and synergistic with, our existing pan coronavirus vaccine (GEO-CM02), currently in preclinical testing.

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Our programs are in various stages of development:

COH04S1 is currently undergoing a Phase 2 clinical trial, evaluating its safety and efficacy as a preventive COVID-19 vaccine in blood cancer patients who have receive a bone marrow transplant or chimeric antigen receptor therapy (CAR T). The trial is also the first to compare an investigational COVID-19 vaccine to the current FDA-approved vaccine from Pfizer in people who are immunocompromised and receiving immunosuppressive therapy.

Gedeptin® is currently undergoing a Phase 1/2 clinical trial for treatment of patients with advanced head and neck cancer, which is being conducted with funding support from the U.S. Food & Drug Administration (FDA) pursuant to its Orphan Products Grants Program.

Our preventive HIV vaccine is focused on prevention of the subtype of HIV prevalent in the regions of the Americas, Western Europe, Japan and Australia, and which we expect will be included in an upcoming clinical trial (HVTN 132) managed by the HIV Vaccine Clinical Trials Network (HVTN) with support from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

A consortium led by researchers at the University of California, San Francisco (UCSF) is conducting a clinical trial using our HIV vaccine as part of a combinational therapy to induce remission in HIV-positive individuals.

Our pan coronavirus vaccine (GEO-CM02) is progressing in preclinical studies with support from a Small Business Innovative Research (SBIR) grant from NIAID.

Our Lassa Fever vaccine program is undergoing preclinical studies with grant support from the U.S. Department of Defense.

Development of our Sudan ebolavirus and Marburg virus vaccine candidates is being supported, in part, through a collaboration with researchers at the University of Texas Medical Branch (UTMB) and Battelle Memorial Institute utilizing the suite of preclinical services from NIAID.

 

Our corporate strategy is to advance, protect and exploit our differentiated vaccine vaccine/immunotherapy platform leading to the successful development of preventive and therapeutic vaccines against infectious diseases and various cancers. With our design and development capabilities, we are progressing and validating an array of cancer and infectious disease immunotherapy and vaccine product candidates. Our goal is to advance products successfully through to human clinical testing and to seekregistration, while considering partnership or licensing arrangements for achieving regulatory approval and commercialization. We also leverage third partythird-party resources through collaborations and partnerships for preclinical and clinical testing, and manufacturing with multiple government, academic and corporate entities.

 

We have not generated any revenues from the sale of any suchthe products we are developing, and we do not expect to generate any such revenues for at least the next several years. Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use and will require significant costs for commercialization. We may not be successful in our research and development efforts, and we may never generate sufficient product revenue to be profitable.

 


Results of Operations

The following tables summarize our results of operations for the three-month and nine-month periods ended September 30, 2021 and 2020:

  

Three Months Ended September 30,

     
  

2021

  

2020

  

Change

 

Grant and collaboration revenue

 $30,414  $415,458  $(385,044)

Operating expenses:

            

Research and development

  1,224,362   416,756   807,606 

General and administrative

  757,432   435,013   322,419 

Total operating expenses

  1,981,794   851,769   1,130,025 

Loss from operations

  (1,951,380)  (436,311)  (1,515,069)

Total other income (expense)

  877   (134,337)  135,214 

Net loss

 $(1,950,503) $(570,648) $(1,379,855)

  

Nine Months Ended September 30,

     
  

2021

  

2020

  

Change

 

Grant and collaboration revenue

 $220,539  $1,572,037  $(1,351,498)

Operating expenses:

            

Research and development

  2,659,980   1,687,113   972,867 

General and administrative

  2,562,641   1,364,650   1,197,991 

Total operating expenses

  5,222,621   3,051,763   2,170,858 

Loss from operations

  (5,002,082)  (1,479,726)  (3,522,356)

Total other income (expense)

  174,768   (141,820)  316,588 

Net loss

 $(4,827,314) $(1,621,546) $(3,205,768)

Grant and Collaboration Revenues

Our grant and collaboration revenues relate to grants and contracts from agencies of the U.S. government and collaborative arrangements with other third parties in support of our vaccine development activities. Detail concerning our grant and collaboration revenues and the remaining funds available for use as of September 30, 2021 is presented in the table below.

  

Revenues Recorded During the Periods:

  

Unused Funds

 
  

Three Months Ended September 30,

  

Nine Months Ended September 30,

  

Available at

September 30,

 
  

2021

  

2020

  

2021

  

2020

  

2021

 

Lassa Fever – U.S. Army Grant

 $-  $231,330  $-  $1,186,844  $165,500 

Covid-19 – NIH SBIR Grant

  30,414   -   220,539   -   79,388 

Malaria – Collaboration Revenue

  -   184,128   -   385,193   - 

Total

 $30,414  $415,458  $220,539  $1,572,037  $244,888 

Grant and collaboration revenues decreased by $385,044 (93%) for the three-month period ended September 30, 2021 compared to the three-month period ended September 30, 2020, and by $1,351,498 (86%) for the nine-month period ended September 30, 2021 compared to the nine-month period ended September 30, 2020, attributable to the differing mix of active grants and collaborations as shown in the table above, as well as the timing of expenditures related to such grants and collaborations.

Research and Development Expenses

Our research and development expenses can fluctuate considerably on a period-to-period basis, depending on the timing of expenditures related to our government grants and other research projects, and other factors. We do not disclose our research and development expenses by project, since our employees’ time is spread across multiple programs and our laboratory facility is used for multiple vaccine candidates. We track the direct cost of research and development expenses related to government grant revenue by the percentage of assigned employees’ time spent on each grant and other direct costs associated with each grant. Indirect costs associated with grants are not tracked separately but are applied based on a contracted overhead rate negotiated with the NIH. Therefore, the recorded revenues associated with government grants approximate the costs incurred.

For the three-month and nine-month periods ended September 30, 2021, research and development expenses increased by $807,606 (194%) and $972,867 (58%), respectively, versus the 2020 periods. Of these increases, $459,825 during each period relates to upfront license fees (inclusive of $209,825 of stock-based expense) associated with our in-license of Gedeptin in September 2021. Research and development expense for the three-month and nine-month periods ended September 30, 2021 includes stock-based compensation expense of $21,468 and $64,404, respectively associated with employee stock options; no stock-based compensation expense was allocated to research and development expense for the comparable periods of 2020 (see discussion under “Stock-Based Compensation Expense” below). The remaining increases of $326,313 and $448,638 for the three-month and nine-month periods ended September 30, 2021, respectively, relate primarily due to expenditures related to our COVID-19 vaccine program, manufacturing process development, and a generally higher level of activity, offset in part by lower external expenditures related to our government grants.

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General and Administrative Expenses

For the three-month and nine-month periods ended September 30, 2021, general and administrative expenses increased by $322,419 (74%) and $1,197,991 (88%), respectively. General and administrative expense for the three-month and nine-month periods ended September 30, 2021 included stock-based compensation expense of $64,282 and $184,899, respectively; as compared to $6,000 and $24,000, respectively, for the comparable periods of 2020 (see discussion under “Stock-Based Compensation Expense” below). A significant portion of the increase during each period is attributable to higher Delaware franchise taxes, with the remainder primarily due to higher legal, accounting and patent costs; insurance costs; consulting fees; Nasdaq listing fees; investor relations costs; and personnel costs.

Stock-Based Compensation Expense

The table below shows the components of stock-based compensation expense for the three-month and nine-month periods ended September 30, 2021 and 2020. In general, stock-based compensation expense is allocated to research and development expense or general and administrative expense according to the classification of cash compensation paid to the employee, consultant or director to whom the stock compensation was granted.

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2021

  

2020

  

2021

  

2020

 

Stock option expense

 $56,190  $-  $168,570  $- 

Stock issued for consulting services

  29,560   6,000   80,733   24,000 

Total stock-based compensation expense

 $85,750  $6,000  $249,303  $24,000 

As a result of the reverse stock splits enacted in April 2019 and in January 2020, we made adjustments and retroactive restatements to all of our outstanding stock options such that the balances in January 2020 were negligible. We therefore recorded no stock-based compensation expense related to our stock option plan for the majority of 2020. We re-initiated employee stock option grants in December 2020.

Other Income (Expense)

Interest income for the three-month and nine-month periods ended September 30, 2021 was $877 and $3,998, respectively, as compared to $90 and $902, respectively, for comparable periods of 2020. The variances between periods are primarily attributable to cash available for investment and interest rate fluctuations.

Interest expense for the three-month and nine-month periods ended September 30, 2021 was $-0- and $1,286, respectively, as compared to $134,427 and $142,772, respectively, for comparable periods of 2020. Interest expense for the 2021 periods relates to the GRA Note and PPP Loan, and for the 2020 periods relates to the GRA Note, PPP loan, financing costs associated with insurance premiums, and convertible debentures which were retired during 2020.

During the nine-month period ended September 30, 2021, we recorded a $172,056 gain on debt extinguishment associated with the forgiveness of the PPP loan principal and accrued interest.

 

Critical Accounting Policies and Estimates

 

This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates and adjusts the estimates as necessary. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

 

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For a description of critical accounting policies that affect our significant judgments and estimates used in the preparation of our financial statements, refer to Item 7 in Management’s Discussion and Analysis of Financial Condition and Results of Operations and Note 2 to our Consolidated Financial Statements contained in our Annual Report on Form 10-K for the year ended December 31, 2019.2020. There have been no significant changes to our critical accounting policies from those disclosed in our 20192020 Annual Report.

 

Recent Accounting Pronouncements

Information regarding recent accounting pronouncements is contained in Note 3 to the condensed consolidated financial statements, included in this Quarterly Report.

 

Liquidity and Capital Resources

 

Our principal uses of cash are to finance our research and development activities. SinceFrom inception through September 30, 2021, we have accumulated net losses of approximately $50.6 million and we expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. We have funded these activitiesour operations to date primarily from sales of our equity securities and from government grants and clinical trial assistance,assistance.

The following tables summarize our liquidity and from salescapital resources as of our equity securities. At September 30, 2020, we had cash2021 and cash equivalents of $11,580,594 and total assets of $11,755,897, as compared to $283,341 and $468,880, respectively, at December 31, 2019. At September 30, 2020, we had positive working capital of $10,811,147, compared to a working capital deficit of $1,568,929 at December 31, 2019.

Netand our cash used in operating activities was $1,208,619 and $1,117,737flows for the nine-month periods ended September 30, 20202021 and 2019, respectively. Generally,2020:

Liquidity and Capital Resources

 

September 30, 2021

  

December 31, 2020

 

Cash and cash equivalents

 $18,107,019  $9,883,796 

Working capital

  17,824,187   9,424,839 

  

Nine Months Ended September 30,

 

Cash Flow Data

 

2021

  

2020

 

Net cash provided by (used in):

        

Operating activities

 $(4,513,271) $(1,208,619)

Investing activities

  (47,718)  (2,470)

Financing activities

  12,784,212   12,508,342 

Net increase in cash and cash equivalents

 $8,223,223  $11,297,253 

Operating Activities – Net cash used in operating activities of $4,513,271 for the variances between periods arenine months ended September 30, 2021, was primarily due to fluctuationsour net loss of $4,827,314, offset by non-cash items such as depreciation expense, stock-based compensation expense and the gain recognized on extinguishment of our PPP loan, and by changes in our working capital accounts. Net cash used in operating activities of $1,208,619 for the nine months ended September 30, 2020, was primarily due to our net losses,loss of $1,621,546, offset by non-cash charges such as depreciation and stock-based compensation expense, and by net changes in our assetsworking capital accounts.

Investing Activities – Net cash used in investing activities was $47,718 and liabilities. $2,470 for the nine-month periods ended September 30, 2021 and 2020, respectively, and relates to purchases of property and equipment.

Financing Activities – Net cash provided by financing activities was $12,784,212 for the nine-month period ended September 30, 2021, consisting primarily of (i) net proceeds of $9,408,920 from a public offering of our common stock, (ii) $3,404,156 of net proceeds from the exercise of warrants, (iii) $1,000 expended for the repurchase of outstanding convertible preferred stock, and (iv) $27,864 in principal repayments toward a note payable to the Georgia Research Alliance, Inc. (the “GRA Note”); the GRA Note has now been fully repaid. Additionally, during May 2021, our PPP loan of $170,200, together with $1,856 of accrued interest, was forgiven by the lender and extinguished.

Net cash provided by financing activities was $12,508,342 for the nine-month period ended September 30, 2020, consisting of (i) net proceeds of $11,158,496 from a public offering of our common stock and warrants, (ii) net proceeds of $300,000 from the sale of our convertible preferred stock, (iii) $170,200 of PPP loan proceeds, (iv) $888,500 of net proceeds from issuance of a note payable, and (v) $8,854 in principal repayments toward the GRA Note.

Funding Requirements and Sources of Capital

Our net losses generally fluctuateprimary uses of capital are for salaries and related expenses for personnel, manufacturing costs for preclinical and clinical materials, third-party research services, laboratory and related supplies, legal and other regulatory expenses, and general overhead costs. We expect these costs will continue to be the primary operating capital requirements for the near future.

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We believe our existing cash and cash equivalents will be sufficient to meet our anticipated cash requirements through mid-2022. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties and is based on assumptions that may prove to be wrong; actual results could vary materially. We may need to obtain additional funds sooner than planned or in greater amounts than we currently anticipate. The actual amount of funds we will need to operate is subject to many factors, some of which are beyond our control. These factors include the progress of our research activities; the number and scope of our research programs; the progress and success of our pre-clinical and clinical development activities; the progress of the development efforts of parties with whom we have entered into research and development agreements; the costs of manufacturing our product candidates, and the progress of efforts with parties with whom we may enter into commercial manufacturing agreements; our ability to maintain current research and development programs and to establish new research and development and licensing arrangements; the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; the impact of any natural disasters or public health crises, such as the COVID-19 pandemic; the costs associated with any products or technologies that we may in-license or acquire; and the costs and timing of regulatory approvals.

We will need to continue to raise additional capital to support our future operating activities, including progression of our development programs, preparation for commercialization, and other operating costs. Financing strategies we may pursue include, but are not limited to, the public or private sale of equity, debt financings or funds from other capital sources, such as government funding, collaborations, strategic alliances or licensing arrangements with third parties. There can be no assurances additional capital will be available to secure additional financing, or if available, that it will be sufficient to meet our needs on favorable terms. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development of one or more of our product candidates.

We expect our research and development costs to increase as we continue development of our various programs and as we move toward later stages of development, especially with regard to clinical trials. Our expenditures during 2022 and beyond will increase significantly as a result of the license fees and development costs we assumed related to the Gedeptin and COH04S1 clinical programs. We do not provide forward-looking estimates of costs and time to complete our research programs due to the many uncertainties associated with biotechnology research and development. Due to these uncertainties, our future expenditures are likely to be highly volatile in future periods depending on the outcomes of the trials and studies. As we obtain data from pre-clinical studies and clinical trials, we may elect to discontinue or delay certain development programs to focus our resources on more promising product candidates. Completion of preclinical studies and human clinical trials may take several years or more, but the length of time can vary substantially depending upon several factors. The duration and the cost of future clinical trials may vary significantly over the life of the project because of differences arising during development of the human clinical trial protocols, including the length of time required to enroll suitable patient subjects, the number of patients that ultimately participate in the clinical trial, the duration of patient follow-up, and the number of clinical sites included in the clinical trials.

We expect, for the remainder of 2021, our general and administrative expenses to remain reasonably consistent with that of the third quarter of 2021. We expect that our general and administrative costs will increase during 2022 in support of expanded research and development activities and other general corporate activities.

Grant Funding – We have ongoing government support for our research activities, partially offset by governmentCOVID-19 vaccine program through a Small Business Innovative Research (SBIR) grant revenues.from NIAID and for our Lassa Fever vaccine program via a grant from the U.S. Department of Defense. As of September 30, 2020,2021, there was $417,121is $244,888 in approved grant funds remaining and available for use through September 2021. Of these amounts, we expect that approximately $290,500mid-2022. Additionally, our Sudan ebolavirus and Marburg virus vaccine candidates are being developed in collaboration with researchers at the University of Texas Medical Branch (UTMB) and Battelle Memorial Institute utilizing the suite of preclinical services from NIAID. We are currently seeking sources of capital through additional government and quasi-government grant programs and clinical trial support, although there can be no assurance any such funds will be used by us to reimburse third parties who will provide services covered by our grants. See “Results of Operations – Grant and Collaboration Revenues” below for additional details concerning our government grants.obtained.

 

Clinical Trial Support – NIAID has funded the costs of conducting all of our human clinical trials (Phase 1 and Phase 2a) to date for our preventive HIV vaccines, with GeoVax incurring certain costs associated with manufacturing the clinical vaccine supplies and other study support. We expect that NIAID will also fund the cost of the planned Phase 1 trial (HVTN 132) to further evaluate the safety and immunogenicity of adding “protein boost” components to our vaccine, GOVX-B11. We expectThe start of HVTN 132 has been delayed due to commence patient enrollment in early 2021.COVID-19, and we await further information from NIAID and HVTN on when the trial may commence. Additionally, we are party to a collaboration with American Gene Technologies International, Inc. (AGT) whereby AGT intends to conduct a Phase 1 human clinical trial with our combined technologies, with the ultimate goal of developing a functional cure for HIV infection. We expect that AGT will begin the Phase 1 trial during 2020, with the addition of our vaccine into the trial in early 2021. A similar effort is underway with a consortium led by researchers at the University of California, San Francisco (UCSF), using our vaccine as part of a combinational therapy to induce remission in HIV-positive individuals; this program enteredis currently undergoing clinical trials during August 2020. Eachtrials. Similar to HVTN 132, this trial has been affected by the pandemic, so we await further information regarding the status of these programs could experience delays aspatient enrollment and trial results. Our prior collaboration with American Gene Technologies International, Inc. (AGT) was recently discontinued due to AGT’s remodeling of their clinical trial plans. Gedeptin is in a resultPhase 1/2 trial, being conducted at Stanford University in collaboration with Emory University; the initial stage of the ongoing COVID-19 pandemic.

Net cash used in investing activities was $2,470 and $4,272 for the nine-month periods ended September 30, 2020 and 2019, respectively. Our investing activities have consisted predominantly of capital expenditures.

Net cash provided by financing activities was $12,508,342 and $1,431,667 for the nine-month periods ended September 30, 2020 and 2019, respectively. Net cash provided by financing activities during the 2020 period relates to (i) the sale in January 2020 of shares of our Series J convertible preferred stock for net proceeds of $300,000, (ii) $170,200 of PPP loan proceeds received in April 2020 (see discussion below), (iii) $888,500 of net proceeds received in June 2020 from our issuance of Convertible Debentures (see discussion below), (iv) net proceeds of approximately $11.2 million received in September 2020 from the public offering of our equity securities (see discussion below), and (v) $8,854 in principal repayments toward the GRA Note. Net cash provided by financing activities during the 2019 period relates to the sale of shares of our Series G and Series I convertible preferred stock for aggregate net proceeds of $1,440,000 and $8,333 in principal repayments toward the GRA Note.

14

PPP Loan – On April 17, 2020, we received a $170,200 bank loan backedstudy (10 patients) is being funded by the United States Small Business AdministrationFDA pursuant to the Paycheck Protection Program (PPP) provisions of the CARES Act. The loan bears an annual interest rate of one percent and is due April 17, 2022. Commencing November 17, 2020, monthly payments of $9,578.16 will be due. Amounts due may be prepaid without penalty. In October 2020, we applied to the lender to have the full principal amount forgiven based upon our providing qualifying information regarding eligible expenses; as of the date of this report our application has not been processed.

Conversion of Deferred Compensation to Equity During 2016 and 2017, to help conserve the Company’s cash resources, each of our executive officers and non-employee directors agreed to defer receipt of all or a portion (at varying levels) of their respective cash compensation; the deferrals continued during 2018, 2019 and 2020. As of August 31, 2020, the aggregate accumulated deferrals were approximately $2,025,198. On September 29, 2020, upon our consummation of the public offering discussed below, $1,500,000 of the accumulated deferrals were converted at the $5.00 offering price, resulting in the issuance of 300,001 units substantially similar to the units sold in the public offering. The remaining $525,198 of deferred compensation owed as of August 31, 2020 will be paid in cash. Subsequent to the public offering all deferred compensation arrangements have been discontinued.

Issuance of Convertible Debentures and Subsequent Conversion to Equity – On June 26 2020, we entered into a Securities Purchase Agreement with two institutional investors, pursuant to which we received gross proceeds of $1,050,000 in exchange for the issuance of:(i) 5% Original Issue Discount Senior Secured Convertible Debentures in the aggregate principal amount of $1,200,000; and (ii) warrants to purchase an aggregate of 120,000 shares of our common stock The Convertible Debentures had an original maturity of twelve months, bore interest at a rate of 5% per annum, and were secured by substantially all of the Company’s assets until such time as they were paid or converted in full.

On September 29, 2020, upon our consummation of the public offering discussed below, pursuant to the terms of the Convertible Debentures, the $1,200,000 maturity value and $14,667 of accrued interest were automatically converted at $4.00, resulting in the issuance of 303,667 conversion units. Of the 303,667 conversion units: (a) 177,625 consist of one share of common stock and a warrant to purchase one share of common stock (a “Conversion Warrant”), and (b) 126,042 consist of one pre-funded warrant to purchase one share of common stock (a “Pre-Funded Warrant”) and a Conversion Warrant. The Pre-Funded Warrants provide the holder the right to purchase one share of Common Stock at an exercise price of $0.01 per share, are immediately exercisable and will not expire until exercised in full. The Conversion Warrants provide the holder the right to purchase one share of common stock, are immediately exercisable at an exercise price of $5.00 per share and expire five years after the issuance date.

Public Offering – On September 24, 2020, we entered into an Underwriting Agreement (the “Underwriting Agreement”) with Maxim Group LLC, as representative of the underwriters (the “Representative”), for an underwritten public offering (the “Offering”) of an aggregate of 2,560,000 units of our equity securities (the “Units”). The Offering closed on September 29, 2020, with gross proceeds to us of approximately $12.8 million; net proceeds after deducting underwriting discounts and commissions and other offering expenses were approximately $11.2 million.

Of the 2,560,000 Units sold in the Offering: (a) 2,310,000 Units consist of one share of our common stock, and a warrant to purchase one share of common stock (each, a “Unit Warrant”); and (b) 250,000 Units consist of a Pre-Funded Warrant to purchase one share of common stock and a Unit Warrant. The Pre-Funded Warrants provide the holder the right to purchase one share of common stock at an exercise price of $0.01 per share, are immediately exercisable and will not expire until exercised in full. The Unit Warrants provide the holder the right to purchase one share of common stock, are immediately exercisable at an exercise price of $5.00 per share and expire five years after the issuance date. The public offering price was $5.00 per Unit ($4.99 for each Unit including a Pre-Funded Warrant). We granted the Representative a 45-day option to purchase up to 384,000 Units to cover over-allotments, if any. Pursuant to the Underwriting Agreement, we issued to the Representative, as a portion of the underwriting compensation, warrants to purchase up to a total of 128,000 shares of common stock (the “Representative Warrants”). The Representative Warrants have an exercise price of $5.50 per share, are initially exercisable 180 days after the effective date of the Offering and have a term of three years from their initial exercise date.

We intend to use the net proceeds from the Offering to advance our product candidates, including research and technical development, manufacturing, clinical studies, capital expenditures, and working capital. Our primary use of proceeds with respect to advancing our product candidates will be to focus on our COVID-19 and immuno-oncology programs. Certain of our vaccine programs are currently advancing under funding and/or collaboration agreements with government agencies and others; these include our HIV, Lassa Fever, and malaria vaccine programs. We may also use the net proceeds from the Offering to acquire and invest in complementary products, technologies or businesses; however, we currently have no agreements or commitments to complete any such transaction. These plans may change to the extent that other funding is secured for these programs from government agencies and others.its Orphan Products Clinical Trials Grants Program.

 

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Equity Funding – During February 2021, we closed an underwritten public offering of our common stock for net proceeds of $9,408,920. During January, February and August 2021, certain of our outstanding stock purchase warrants were exercised, resulting in net proceeds to us of $3,404,156. As of September 30, 2020,2021, there are 2,816,631 stock purchase warrants outstanding, including 1,819,966 publicly-traded warrants (Nasdaq: GOVXW) exercisable for cash at $5.00 per share and expiring on September 29, 2025. Should these warrants be exercised in full, we had an accumulated deficit of $44.5 million. We expect to incur future net losses as we continue to fund the development of our product candidates. To date, we have financed our operations primarily with proceeds from multiple sales of equity and debt securities, government grants and clinical trial assistance, and corporate collaborations. We believe that our existing cash resources together with current government funding commitments, will be sufficient to continue our planned operations into early 2022. We will require additional funds to continue our planned operations beyond that date. Our transition to profitability will be dependent upon, among other things, the successful development and commercialization of our product candidates. We may never achieve profitability or positive cash flows, and unless and until we do, we will continue to need to raise additional funding. We intend to fund future operations through additional private and/or public offerings of debt or equity securities. In addition, we may seek additional capital through arrangements with strategic partners or from other sources. There can be no assurance that we will be able to raise additional funds or achieve or sustain profitability or positive cash flows from operations. would receive approximately $9.1 million in gross proceeds.

 

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements that are likely or reasonably likely to have a material effect on our financial condition or results of operations.

Results of Operations

Net Loss

We recorded a net loss of $570,648 for the three-month period ended September 30, 2020, as compared to $424,434 for the three-month period ended September 30, 2019. For the nine-month period ended September 30, 2020, we recorded a net loss of $1,621,546, as compared to $1,780,036 for the nine-month period ended September 30, 2019. Our net losses will typically fluctuate due to the timing of activities and related costs associated with our vaccine research and development activities and our general and administrative costs, as described in more detail below.

Grant and Collaboration Revenues

During the three-month and nine-month periods ended September 30, 2020, we recorded grant and collaboration revenues of $415,458 and $1,572,037, respectively, as compared to $333,209 and $907,382, respectively, during the comparable periods of 2019.

Grant Revenues – Our grant revenues relate to grants and contracts from agencies of the U.S. Government in support of our vaccine development activities. We record revenues associated with these grants as the related costs and expenses are incurred. The difference in our grant revenues from period to period is dependent upon our expenditures for activities supported by the grants and fluctuates based on the timing of the expenditures. Additional detail concerning our grant revenues and the remaining funds available for use as of September 30, 2020 is presented in the table below.

  

Grant Revenues Recorded During the Periods:

  

Unused Funds

 
  

Three Months Ended Sep 30,

  

Nine Months Ended Sep 30,

  

Available at

 
  

2020

  

2019

  

2020

  

2019

  

Sep 30, 2020

 

Lassa Fever – U.S. Army Grant

 $231,330  $150,015  $1,186,844  $444,519  $417,121 

Lassa Fever – NIH SBIR Grant

  -   64,750   -   147,042   - 

Zika – NIH SBIR Grant

  -   -   -   162,461   - 

Total

 $231,330  $214,765  $1,186,844  $754,022  $417,121 

Collaboration Revenues – In addition to the grant revenues above, during the three-month and nine-month periods ended September 30, 2020 we recorded revenues associated with research collaborations with third parties of $184,128 and $385,193, respectively, as compared to $118,445 and $153,360, respectively, during the comparable periods of 2019. These amounts primarily represent amounts paid to us by the other parties for materials and other costs associated with joint studies.

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We continue to seek additional support for our product development programs via grants and collaborative arrangements with governmental funding agencies and other third parties, but there is no assurance that we will be successful in these efforts and we therefore do not predict what impact such funding, if received, may have on our operations.

Research and Development Expenses

Our research and development expenses were $416,756 and $1,687,113 for the three-month and nine-month periods ended September 30, 2020 as compared to $467,674 and $1,474,619 for the comparable periods of 2019. Research and development expense for the three-month and nine-month periods of 2020 included no stock-based compensation expense, as compared to $11,006 and $33,647, respectively, for the comparable periods of 2019 (see discussion under “Stock-Based Compensation Expense” below).

Our research and development expenses can fluctuate considerably on a period-to-period basis, depending on the timing of expenditures related to our government grants and other research projects, and other factors. Research and development expenses increased by $212,494, or 14%, from the nine-month period of 2019 to 2020 primarily due to the timing and amount of expenditures related to our government grants. Our research and development costs do not include costs incurred by the HIV Vaccine Trials Network (HVTN) or other collaborators in conducting clinical trials of our HIV vaccines; those costs are funded by the collaborators, or through their respective funding sources (such as NIAID’s funding of HVTN). We expect that our research and developments expenses will increase in the future as we expand our scientific staff and incur additional costs in support of our product development activities, particularly related to our COVID-19 vaccine and cancer immunotherapy programs, following completion of the Offering.

We do not disclose our research and development expenses by project, since our employees’ time is spread across multiple programs and our laboratory facility is used for multiple vaccine candidates. We track the direct cost of research and development expenses related to government grant revenue by the percentage of assigned employees’ time spent on each grant and other direct costs associated with each grant. Indirect costs associated with grants are not tracked separately but are applied based on a contracted overhead rate negotiated with the NIH. Therefore, the recorded revenues associated with government grants approximate the costs incurred.

We do not provide forward-looking estimates of costs and time to complete our research programs due to the many uncertainties associated with vaccine development. Due to these uncertainties, our future expenditures are likely to be highly volatile in future periods depending on the outcomes of the trials and studies. As we obtain data from pre-clinical studies and clinical trials, we may elect to discontinue or delay vaccine development programs to focus our resources on more promising vaccine candidates. Completion of preclinical studies and human clinical trials may take several years or more, but the length of time can vary substantially depending upon several factors. The duration and the cost of future clinical trials may vary significantly over the life of the project because of differences arising during development of the human clinical trial protocols, including the number of patients that ultimately participate in the clinical trial; the duration of patient follow-up that seems appropriate in view of the results; the number of clinical sites included in the clinical trials; and the length of time required to enroll suitable patient subjects.

General and Administrative Expenses

Our general and administrative expenses were $435,013 and $1,364,650 for the three-month and nine-month periods ended September 30, 2020, as compared to $291,475 and $1,214,189 during the comparable periods of 2019. General and administrative costs include officers’ salaries, legal and accounting costs, patent costs, and other general corporate expenses. General and administrative expense for the three-month and nine-month periods of 2020 included stock-based compensation expense of $6,000 and $24,000, respectively; as compared to $21,342 and $257,097, respectively, for the comparable periods of 2019 (see discussion under “Stock-Based Compensation Expense” below). Excluding stock-based compensation expense, general and administrative expenses were $429,013 and $1,340,650 during the three-month and nine-month periods ended September 30, 2020, respectively, as compared to $270,133and $957,092, respectively during the comparable periods of 2019, representing an increase of $383,558, or 40%, from the nine-month period of 2019 to the comparable period of 2020. The overall increase in general and administrative expense from 2019 to 2020 is primarily attributable to higher legal and other costs associated with our capital restructuring, stockholders meetings and other corporate activities, as well as higher legal costs associated with our patent prosecution and negotiation of license agreements with the NIH. We expect that our general and administrative costs will increase in the future in support of expanded research and development activities and other general corporate activities.

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Stock-Based Compensation Expense

The table below shows the components of stock-based compensation expense for the three-month and nine-month periods ended September 30, 2020 and 2019. In general, stock-based compensation expense is allocated to research and development expense or general and administrative expense according to the classification of cash compensation paid to the employee, consultant or director to whom the stock compensation was granted.

  

Three Months Ended Sep 30,

  

Nine Months Ended Sep 30,

 
  

2020

  

2019

  

2020

  

2019

 

Stock option expense

 $-  $26,348  $-  $79,664 

Stock issued for services

  6,000   6,000   24,000   211,080 

Total stock-based compensation expense

 $6,000  $32,348  $24,000  $290,744 

The reverse stock splits enacted in April 2019 and in January 2020 automatically adjusted our outstanding stock options such that the number of such options as of January 1, 2020 was negligible. No new stock options were granted during the nine-month period ended September 30, 2020. We therefore recorded no stock-based compensation expense related to our stock option plan for the three-month or nine-month periods ended September 30, 2020. We expect to make additional grants under our 2020 Stock Incentive Plan and will therefore incur related compensation expenses.

During the three-month and nine-month periods ended September 30, 2020 we recorded stock-based compensation expense of $6,000 and $24,000, respectively, associated with common stock issued for a consulting agreement, as compared to $6,000 and $211,080, respectively, during the same periods of 2019, associated with common stock issued for consulting and financial advisory services.

Other Income (Expense)

Interest income for the three-month and nine-month periods ended September 30, 2020 was $90 and $902, respectively, as compared to $2,560 and $4,665, respectively, for comparable periods of 2019. The variances between periods are primarily attributable to cash available for investment and interest rate fluctuations.

Interest expense for the three-month and nine-month periods ended September 30, 2020 was $134,427 and $142,722, respectively, as compared to $1,054 and $3,275, respectively, for comparable periods of 2019. Interest expense for the 2020 periods relates to the Convertible Debentures, GRA Note, PPP Loan, and financing costs associated with insurance premiums. For the nine-month period ended September 30, 2020, interest expense included $14,667 of accrued interest payable and $124,184 of amortized debt discount related to the Convertible Debentures. Subsequent to the full conversion of the Convertible Debentures into our equity securities on September 29, 2020, there will be no more interest expenses associated with the Convertible Debentures, and we expect other interest expense will be minimal.

Item 3

Quantitative and Qualitative Disclosures About Market Risk

Item 3Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable.applicable to smaller reporting companies.

Item 4

Controls and Procedures

Item 4Controls and Procedures

Evaluation of disclosure controls and procedures

 

Disclosure controls and procedures are controls and other procedures that are designed to ensure that the information required to be disclosed in reports filed or submitted under the Securities Exchange Act of 1934, as amended (Exchange Act), is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to management, including the Chief Executive Officer and Principal Financial and Accounting Officer, as appropriate to allow timely decisions regarding required disclosure.

 

Our management has carried out an evaluation, under the supervision and with the participation of our Principal Executive Officer and our Principal Financial and Accounting Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Exchange Act Rules 13a-15 and 15d-15 as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.

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Changes in internal control over financial reporting

 

Although we have modified certain of our internal control procedures as a result of the COVID-19 pandemic, there were no significant changes in our internal control over financial reporting that occurred during the three months ended September 30, 20202021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Limitations on Controlscontrols

 

Management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and fraud. Any control system, no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected.

 


 

PART II -- OTHER INFORMATION

Item 1

Legal Proceedings

Item 1Legal Proceedings

 

None.

Item 1A

Risk Factors

Risks Related to Our Business

 

We have a history of operating losses, and we expect losses to continue for the foreseeable future.Item 1ARisk Factors

 

As a research and development-focused company, we have had no product revenue to date and revenues fromFor information regarding factors that could affect our government grants and other collaborations have not generated sufficient cash flows to cover operating expenses. Since our inception, we have incurred operating losses each year due to costs incurredresults of operations, financial condition or liquidity, see the risk factors discussed under “Risk Factors” in connection with research and development activities and general and administrative expenses associated with our operations. We expect to incur additional operating losses and expect cumulative losses to increase as our research and development, preclinical, clinical, and manufacturing efforts expand. Our ability to generate revenue and achieve profitability depends on our ability to successfully complete the developmentItem 1A of our product candidates, conduct preclinical tests and clinical trials, obtain the necessary regulatory approvals, and manufacture and market or otherwise commercialize our products. Unless we are able to successfully meet these challenges, we will not be profitable and may not remainmost recent Annual Report on Form 10-K. See also “Forward-Looking Statements,” included in business.

Our business will require continued funding. If we do not receive adequate funding, we will not be able to continue our operations.

To date, we have financed our operations principally through the saleItem 2 of our equity securities and through government grants and clinical trial support. We will require substantial additional financing at various intervals for our operations, including clinical trials, operating expenses, intellectual property protection and enforcement, for pursuit of regulatory approvals, and for establishing or contracting out manufacturing, marketing and sales functions. There is no assurance that such additional funding will be availablethis Quarterly Report on terms acceptable to us or at all. If we are not able to secure the significant funding that is required to maintain and continue our operations at current levels, or at levels that may be required in the future, we may be required to delay clinical studies or clinical trials, curtail operations, or obtain funds through collaborative arrangements that may require us to relinquish rights to some of our products or potential markets.

The costs of conducting all of our human clinical trials to date for our preventive HIV vaccine have been borne by the HVTN, with funding by NIAID, and we expect NIAID support for additional clinical trials. GeoVax incurs costs associated with manufacturing the clinical vaccine supplies and other study support. We cannot predict the level of support we will receive from the HVTN or NIAID for any additional clinical trials of our HIV vaccines.

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Our current operations are also partially supported by a U.S. government grant awarded to us to support our Lassa Fever vaccine program. As of September 30, 2020, there was approximately $417,000 of unused grant funds remaining and available for use through September 2021. Of this amount, we anticipate that approximately $290,500 will be paid by us to unaffiliated third parties who are providing services called for by the grant. We are pursuing additional support from the federal government for our vaccine programs; however, as we progress to the later stages of our vaccine development activities, government financial support may be more difficult to obtain, or may not be available at all. Furthermore, there is some risk that actual funding for grants could be delayed, cut back, or eliminated due to government budget constraints. Therefore, it will be necessary for us to look to other sources of funding to finance our development activities.

We expect that our current working capital, combined with proceeds from current government grants will be sufficient to support our planned level of operations into early 2022. We will need to raise additional funds to significantly advance our vaccine development programs and to continue our operations. In order to meet our operating cash flow needs we plan to seek sources of non-dilutive capital through government grant programs and clinical trial support. We may also plan additional offerings of our equity securities, debt, or convertible debt instruments. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could have a material adverse effect on our business, operating results, financial condition and prospects.

Significant disruptions of information technology systems or breaches of information security systems could adversely affect our business.

We rely upon a combination of information technology systems and traditional recordkeeping to operate our business. In the ordinary course of business, we collect, store, and transmit confidential information (including, but not limited to, personal information and intellectual property). We have also outsourced elements of our operations to third parties, including elements of our information technology systems and, as a result, we manage a number of independent vendor relationships with third parties who may or could have access to our confidential information. Our information technology and information security systems and records are potentially vulnerable to security breaches, service interruptions, or data loss from inadvertent or intentional actions by our employees or vendors. Our information technology and information security systems and records are also potentially vulnerable to malicious attacks by third parties. Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of expertise and motives (including, but not limited to, financial crime, industrial espionage, and market manipulation).

While we have invested, and continue to invest, a portion of our limited funds in our information technology and information security systems, there can be no assurance that our efforts will prevent security breaches, service interruptions, or data losses. Any security breaches, service interruptions, or data losses could adversely affect our business operations and/or result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal, business, and reputational harm to us or allow third parties to gain material, inside information that they may use to trade in our securities.

Our business could be adversely affected by widespread public health epidemics, such as COVID-19, or other catastrophic events beyond our control.

In addition to our reliance on our own employees and facilities, we depend on our collaborators, laboratories and other facilities for the continued operation of our business. Despite any precautions we take, public health epidemics, such as COVID-19, or other catastrophic events, such as natural disasters, terrorist attack, hurricanes, fire, floods and ice and snowstorms, may result in interruptions in our business.

In response to the COVID-19 pandemic, we have suspended all non-essential travel for our employees, are canceling or postponing in-person attendance at industry events and limiting in-person work-related meetings. Currently, as a result of the work and travel restrictions related to the ongoing pandemic, several of our business activities are being conducted remotely which might be less effective than in-person meetings or in-office work. Despite these precautions, the necessary work within our laboratory and of our collaborators has continued without significant interruption. Although we continue to monitor the situation and may adjust our current policies as more information and guidance become available, temporarily suspending travel and limitations on doing business in-person has and could continue to negatively impact our business development efforts and create operational or other challenges, any of which could harm our business, financial condition and results of operations.

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In addition, the COVID-19 pandemic could disrupt our operations due to absenteeism by infected or ill members of management or other employees because of our limited staffing. COVID-19 related illness could also impact members of our Board of Directors resulting in absenteeism from meetings of the directors or committees of directors, and making it more difficult to convene the quorums of the full Board of Directors or its committees needed to conduct meetings for the management of our affairs.

Risks Related to Development and Commercialization of Product Candidates and Dependence on Third Parties

Our products are still being developed and are unproven. These products may not be successful.

To become profitable, we must generate revenue through sales of our products. However, our products are in varying stages of development and testing. Our products have not been proven in human clinical trials and have not been approved by any government agency for sale. If we cannot successfully develop and prove our products and processes, or if we do not develop other sources of revenue, we will not become profitable and at some point, we would discontinue operations.

We depend upon key personnel who may terminate their employment with us at any time. If we were to lose the services of any of these individuals, our business and operations may be adversely affected.

The success of our business strategy will depend to a significant degree upon the continued services of key management, technical and scientific personnel and our ability to attract and retain additional qualified personnel and managers. Competition for qualified personnel is intense among companies, academic institutions and other organizations. The ability to attract and retain personnel is adversely affected by our financial challenges. If we are unable to attract and retain key personnel and advisors, it may negatively affect our ability to successfully develop, test, commercialize and market our products and product candidates.

Regulatory and legal uncertainties could result in significant costs or otherwise harm our business.

To manufacture and sell our products, we must comply with extensive domestic and international regulation. In order to sell our products in the United States, approval from the U.S. Food and Drug Administration (the “FDA”) is required. Satisfaction of regulatory requirements, including FDA requirements, typically takes many years, and if approval is obtained at all, it is dependent upon the type, complexity and novelty of the product, and requires the expenditure of substantial resources. We cannot predict whether our products will be approved by the FDA. Even if they are approved, we cannot predict the time frame for approval. Foreign regulatory requirements differ from jurisdiction to jurisdiction and may, in some cases, be more stringent or difficult to meet than FDA requirements. As with the FDA, we cannot predict if or when we may obtain these regulatory approvals. If we cannot demonstrate that our products can be used safely and successfully in a broad segment of the patient population on a long-term basis, our products would likely be denied approval by the FDA and the regulatory agencies of foreign governments.

We face intense competition and rapid technological change that could result in products that are superior to the products we will be commercializing or developing.

The market for vaccines that protect against or treat human infectious diseases is intensely competitive and is subject to rapid and significant technological change. We have numerous competitors in the United States and abroad, including, among others, large companies with substantially greater resources than us. If any of our competitors develop products with efficacy or safety profiles significantly better than our products, we may not be able to commercialize our products, and sales of any of our commercialized products could be harmed. Some of our competitors and potential competitors have substantially greater product development capabilities and financial, scientific, marketing and human resources than we do. Competitors may develop products earlier, obtain FDA approvals for products more rapidly, or develop products that are more effective than those under development by us. We will seek to expand our technological capabilities to remain competitive; however, research and development by others may render our technologies or products obsolete or noncompetitive, or result in treatments or cures superior to ours.

Our product candidates are based on new medical technology and, consequently, are inherently risky. Concerns about the safety and efficacy of our products could limit our future success.

We are subject to the risks of failure inherent in the development of product candidates based on new medical technologies. These risks include the possibility that the products we create will not be effective, that our product candidates will be unsafe or otherwise fail to receive the necessary regulatory approvals, and that our product candidates will be hard to manufacture on a large scale or will be uneconomical to market.

21

Many pharmaceutical products cause multiple potential complications and side effects, not all of which can be predicted with accuracy and many of which may vary from patient to patient. Long term follow-up data may reveal previously unidentified complications associated with our products. The responses of potential physicians and others to information about complications could materially adversely affect the market acceptance of our products, which in turn would materially harm our business.

We may experience delays in our clinical trials that could adversely affect our financial results and our commercial prospects.

We do not know whether planned pre-clinical and clinical trials will begin on time or whether we will complete any of our trials on schedule, if at all. Product development costs will increase if we have delays in testing or approvals or if we need to perform more or larger clinical trials than planned. Significant delays may adversely affect our financial results and the commercial prospects for our products and delay our ability to become profitable.

We rely heavily on the HVTN, independent clinical investigators, vaccine manufacturers, and other third-party service providers for successful execution of our clinical trials, but do not control many aspects of their activities. We are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with standards, commonly referred to as Good Clinical Practices, for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. Third parties may not complete activities on schedule or may not conduct our clinical trials in accordance with regulatory requirements or our stated protocols. The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of our product candidates. There is also a risk of changes in clinical trial strategy and timelines due to the HVTN and NIAID altering their trial strategy.

Failure to obtain timely regulatory approvals required to exploit the commercial potential of our products could increase our future development costs or impair our future sales.

None of our vaccines are approved by the FDA for sale in the United States or by other regulatory authorities for sale in foreign countries. To exploit the commercial potential of our technologies, we are conducting and planning to conduct additional pre-clinical studies and clinical trials. This process is expensive and can require a significant amount of time. Failure can occur at any stage of testing, even if the results are favorable. Failure to adequately demonstrate safety and efficacy in clinical trials could delay or preclude regulatory approval and restrict our ability to commercialize our technology or products. Any such failure may severely harm our business. In addition, any approvals we obtain may not cover all of the clinical indications for which approval is sought or may contain significant limitations in the form of narrow indications, warnings, precautions or contraindications with respect to conditions of use, or in the form of onerous risk management plans, restrictions on distribution, or post-approval study requirements.

State pharmaceutical marketing compliance and reporting requirements may expose us to regulatory and legal action by state governments or other government authorities.

Several states have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs and file periodic reports on sales, marketing, pricing and other activities. Similar legislation is being considered in other states. Many of these requirements are new and uncertain, and available guidance is limited. Unless we are in full compliance with these laws, we could face enforcement action, fines, and other penalties and could receive adverse publicity, all of which could harm our business.

Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict, and may have a significant adverse effect on our business and results of operations.

In the United States and foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval. Among policy makers and payors in the United States and elsewhere, including in the European Union, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.

22

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “Affordable Care Act”), substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The Affordable Care Act includes a number of provisions that are intended to lower healthcare costs, including provisions relating to prescription drug prices and government spending on medical products.

Since its enactment, there have also been judicial and Congressional challenges to certain aspects of the Affordable Care Act, as well as efforts by the Trump administration to repeal or replace certain aspects of the statute. We continue to evaluate the effect that the Affordable Care Act and subsequent changes to the statute has on our business. It is uncertain the extent to which any such changes may impact our business or financial condition.

There has also been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products.Form 10-Q. There have been several Congressional inquiries and proposed bills, as well as state efforts, designed to, among other things, bring more transparency to product pricing, reviewno material changes from the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. In June 2017, the FDA issued a Drug Competition Action plan intended to lower prescription drug prices by encouraging competition from generic versions of existing products. In July 2018, the FDA issued a Biosimilar Action Plan, intended to similarly promote competition to prescription biologics from biosimilars.

Individual states in the United States have also become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures. For example, in September 2017, the California State Assembly approved SB17, which requires pharmaceutical companies to notify health insurers and government health plans at least 60 days before any scheduled increases in the prices of their products if they exceed 16% over a two-year period, and further requiring pharmaceutical companies to explain the reasons for such increase. Effective in 2016, Vermont passed a law requiring certain manufacturers identified by the state to justify their price increases.

We expect that these, and other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and lower reimbursement, and in downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our drugs, once marketing approval is obtained.

We may not be successful in establishing collaborations for product candidates we seek to commercialize, which could adversely affect our ability to discover, develop, and commercialize products.

We expect to seek collaborations for the development and commercialization of product candidates in the future. The timing and terms of any collaboration will depend on the evaluation by prospective collaborators of the clinical trial results and other aspects of a product’s safety and efficacy profile. If we are unable to reach agreements with suitable collaborators for any product candidate, we will be forced to fund the entire development and commercialization of such product candidates, ourselves, and we may not have the resources to do so. If resource constraints require us to enter into a collaboration agreement early in the development of a product candidate, we may be forced to accept a more limited share of any revenues the product may eventually generate. We face significant competition in seeking appropriate collaborators. Moreover, these collaboration arrangements are complex and time-consuming to negotiate and document. We may not be successfulrisk factors previously disclosed in our efforts to establish collaborations or other alternative arrangements for any product candidate. Even if we are successful in establishing collaborations, we may not be able to ensure fulfillment by collaborators of their obligations or our expectations.

We do not have manufacturing, sales, or marketing experience.

We do not have experience in manufacturing, selling, or marketing. To obtain the expertise necessary to successfully manufacture, market, and sell our products, we must develop our own commercial infrastructure and/or collaborative commercial arrangements and partnerships. Our ability to execute our current operating plan is dependentmost recent Annual Report on numerous factors, including, the performance of third-party collaborators with whom we may contract.Form 10-K.

23

Our products under development may not gain market acceptance.

Our products may not gain market acceptance among physicians, patients, healthcare payers and the medical community. Significant factors in determining whether we will be able to compete successfully include:

the efficacy and safety of our products;

the time and scope of regulatory approval;

reimbursement coverage from insurance companies and others;

the price and cost-effectiveness of our products, especially as compared to any competitive products; and

the ability to maintain patent protection.

We may be required to defend lawsuits or pay damages for product liability claims.

Product liability is a major risk in testing and marketing biotechnology and pharmaceutical products. We may face substantial product liability exposure in human clinical trials and for products that we sell after regulatory approval. We carry product liability insurance and we expect to continue such policies. However, product liability claims, regardless of their merits, could exceed policy limits, divert management’s attention, and adversely affect our reputation and demand for our products.

Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our products, it is less likely that they will be widely used.

Market acceptance of products we develop, if approved, will depend on reimbursement policies and may be affected by, among other things, future healthcare reform measures. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish payment levels. We cannot be certain that reimbursement will be available for any products that we may develop. Also, we cannot be certain that reimbursement policies will not reduce the demand for, or the price paid for our products. If reimbursement is not available or is available on a limited basis, we may not be able to successfully commercialize products that we develop.

Risks Related to Our Intellectual Property

We could lose our license rights to our important intellectual property if we do not fulfill our contractual obligations to our licensors.

Our rights to significant parts of the technology we use in our products are licensed from third parties and are subject to termination if we do not fulfill our contractual obligations to our licensors. Termination of intellectual property rights under any of our license agreements could adversely impact our ability to produce or protect our products. Our obligations under our license agreements include requirements that we make milestone payments to our licensors upon the achievement of clinical development and regulatory approval milestones, royalties as we sell commercial products, and reimbursement of patent filing and maintenance expenses. Should we become bankrupt or otherwise unable to fulfill our contractual obligations, our licensors could terminate our rights to critical technology that we rely upon.

If we are unable to finalize our license agreements with the NIH, we may not be able to continue our work.

We have secured a non-exclusive commercial license to the NIH MVA backbone for our SARS CoV-2 vaccine with the NIAID of the NIH on behalf of the United States, which includes the use of certain patents and patent applications arising from the Moss laboratory and the provided materials. We have also agreed on material terms for a non-exclusive research and development license to use the MVA backbone for our other vaccine candidates, which has been approved by the appropriate committees within the NIH and is awaiting final signature. If we later decide to commercialize vaccine candidates that are under the research and development license, we will need to negotiate appropriate commercialization licenses. If we are unable to finalize these agreements on the agreed-upon terms, we may have to accept less favorable terms, and it is possible that we will be unable to agree. In that case, we may not be able to continue our work.

24

Other parties may claim that we infringe their intellectual property or proprietary rights, which could cause us to incur significant expenses or prevent us from selling products.

Our success will depend in part on our ability to operate without infringing the patents and proprietary rights of third parties. The manufacture, use and sale of new products have been subject to substantial patent rights litigation in the pharmaceutical industry. These lawsuits generally relate to the validity and infringement of patents or proprietary rights of third parties. Infringement litigation is prevalent with respect to generic versions of products for which the patent covering the brand name product is expiring, particularly since many companies that market generic products focus their development efforts on products with expiring patents. Pharmaceutical companies, biotechnology companies, universities, research institutions or other third parties may have filed patent applications or may have been granted patents that cover aspects of our products or our licensors’ products, product candidates or other technologies.

Future or existing patents issued to third parties may contain patent claims that conflict with those of our products. We expect to be subject to infringement claims from time to time in the ordinary course of business, and third parties could assert infringement claims against us in the future with respect to our current products or with respect to products that we may develop or license. Litigation or interference proceedings could force us to:

stop or delay selling, manufacturing or using products that incorporate, or are made using the challenged intellectual property;

pay damages; or

enter into licensing or royalty agreements that may not be available on acceptable terms, if at all.

Any litigation or interference proceedings, regardless of their outcome, would likely delay the regulatory approval process, be costly and require significant time and attention of our key management and technical personnel.

Any inability to protect intellectual property rights in the United States and foreign countries could limit our ability to manufacture or sell products.

We will rely on trade secrets, unpatented proprietary know-how, continuing technological innovation and, in some cases, patent protection to preserve our competitive position. Our patents and licensed patent rights may be challenged, invalidated, infringed or circumvented, and the rights granted in those patents may not provide proprietary protection or competitive advantages to us. We and our licensors may not be able to develop patentable products with acceptable patent protection. Even if patent claims are allowed, the claims may not issue, or in the event of issuance, may not be sufficient to protect the technology owned by or licensed to us. If patents containing competitive or conflicting claims are issued to third parties, we may be prevented from commercializing the products covered by such patents or may be required to obtain or develop alternate technology. In addition, other parties may duplicate, design around or independently develop similar or alternative technologies.

We may not be able to prevent third parties from infringing or using our intellectual property, and the parties from whom we may license intellectual property may not be able to prevent third parties from infringing or using the licensed intellectual property. We generally attempt to control and limit access to, and the distribution of, our product documentation and other proprietary information. Despite efforts to protect this proprietary information, unauthorized parties may obtain and use information that we may regard as proprietary. Other parties may independently develop similar know-how or may even obtain access to these technologies.

The laws of some foreign countries do not protect proprietary information to the same extent as the laws of the United States, and many companies have encountered significant problems and costs in protecting their proprietary information in these foreign countries.

Neither the U.S. Patent and Trademark Office nor the courts have established a consistent policy regarding the breadth of claims allowed in pharmaceutical patents. The allowance of broader claims may increase the incidence and cost of patent interference proceedings and the risk of infringement litigation. On the other hand, the allowance of narrower claims may limit the value of our proprietary rights.

25

Risks Related to Our Common Stock

Upon exercise of our outstanding warrants we will be obligated to issue a substantial number of additional shares of common stock which will dilute our present shareholders.

We are obligated to issue additional shares of our common stock in connection with our outstanding warrants. Currently outstanding warrants are exercisable for 3,600,337 shares. The exercise of these warrants will cause us to issue additional shares of our common stock and will dilute the percentage ownership of our shareholders.

The market price of our common stock is highly volatile.

The market price of our common stock has been, and is expected to continue to be, highly volatile. Certain factors, including announcements of new developments by us or other companies, regulatory matters, new or existing medicines or procedures, concerns about our financial position, operating results, litigation, government regulation, developments or disputes relating to agreements, patents or proprietary rights, may have a significant impact on the market price of our stock. In addition, potential dilutive effects of future sales of shares of common stock by us, and subsequent sales of common stock by the holders of our Convertible Debentures and other options and warrants, including the June 2020 Warrants, could have an adverse effect on the market price of our shares.

In addition, the securities markets from time to time experience significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our common stock.

Our common stock does not have a vigorous trading market and investors may not be able to sell their securities when desired.

We have a limited active public market for our common stock. A more active public market, allowing investors to buy and sell large quantities of our common stock, may never develop even though our shares are now listed on Nasdaq. Consequently, investors may not be able to liquidate their investments in the event of an emergency or for any other reason.

We will need additional capital, and the sale of additional shares or other equity securities could result in additional dilution to our stockholders.

In order to meet our operating cash flow needs, we may plan additional offerings of our equity securities, debt, or convertible debt instruments. The sale of additional equity securities could result in significant additional dilution to our stockholders. Certain securities, such as our outstanding warrants, and subsequent issuances, contain or may contain anti-dilution provisions which could result in the issuance of additional shares at lower prices if we sell other shares below specified prices. The incurrence of indebtedness could result in debt service obligations and operating and financing covenants that would restrict our operations. We cannot assure investors that financing will be available in amounts or on terms acceptable to us, if at all.

We have never paid dividends and have no plans to do so.

Holders of shares of our common stock are entitled to receive such dividends as may be declared by our Board of Directors. To date, we have paid no cash dividends on our shares of common stock and we do not expect to pay cash dividends on our common stock in the foreseeable future. We intend to retain future earnings, if any, to provide funds for operations of our business. Therefore, any potential return investors may have in our common stock will be in the form of appreciation, if any, in the market value of their shares of common stock.

If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud.

We are subject to reporting obligations under the United States securities laws. The SEC, as required by the Sarbanes-Oxley Act of 2002, adopted rules requiring every public company to include a management report on such company’s internal controls over financial reporting in its annual report. Effective internal controls are necessary for us to produce reliable financial reports and are important to help prevent fraud. As a result, our failure to achieve and maintain effective internal controls over financial reporting could result in the loss of investor confidence in the reliability of our financial statements, which in turn could negatively impact the trading price of our stock.

Public company compliance may make it more difficult for us to attract and retain officers and directors.

The Sarbanes-Oxley Act, the Dodd-Frank Act, the JOBS Act, the FAST Act, and rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies. As a public company, we expect these rules and regulations, and amendments to them, to contribute to our compliance costs and to make certain activities more time consuming and costly. As a public company, we also expect that these rules and regulations may make it difficult and expensive for us to obtain director and officer liability insurance and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be difficult for us to attract and retain qualified persons to serve on our board of directors or as executive officers.

26

Our Certificate of Incorporation and Bylaws may be amended by the affirmative vote of a majority of our stockholders.

Under the Delaware General Corporation Law, a corporation’s certificate of incorporation may be amended by the affirmative vote of the holders of a majority of the outstanding shares entitled to vote, and a majority of the outstanding shares of each class entitled to vote as a class, unless the articles require the vote of a larger percentage of shares. Our Certificate of Incorporation, as amended, does not require the vote of a larger percentage of shares. As permitted under the Delaware General Corporation Law, our Bylaws give our board of directors the power to adopt, amend, or repeal our Bylaws. Our stockholders entitled to vote have concurrent power to adopt, amend, or repeal our Bylaws.

Broker-dealers may be discouraged from effecting transactions in shares of our common stock if we are considered to be a penny stock and thus subject to the penny stock rules.

The SEC has adopted a number of rules to regulate “penny stocks” that restrict transactions involving stock which is deemed to be penny stock. Such rules include Rules 3a51-1, 15g-1, 15g-2, 15g-3, 15g-4, 15g-5, 15g-6, 15g-7, and 15g-9 under the Exchange Act. These rules may have the effect of reducing the liquidity of penny stocks. “Penny stocks” generally are equity securities with a price of less than $5.00 per share (other than securities registered on certain national securities exchanges or quoted on Nasdaq if current price and volume information with respect to transactions in such securities is provided by the exchange or system). Our securities have in the past constituted, and may again in the future, if we are delisted from Nasdaq, constitute, “penny stock” within the meaning of the rules. The additional sales practice and disclosure requirements imposed upon U.S. broker-dealers may discourage broker-dealers from effecting transactions in shares of our common stock, which could severely limit the market liquidity of such shares and impede their sale in the secondary market.

A U.S. broker-dealer selling penny stock to anyone other than an established customer or “accredited investor” (generally, an individual with net worth in excess of $1,000,000 (exclusive of personal residence) or an annual income exceeding $200,000, or $300,000 together with his or her spouse) must make a special suitability determination for the purchaser and must receive the purchaser’s written consent to the transaction prior to sale, unless the broker-dealer or the transaction is otherwise exempt. In addition, the “penny stock” regulations require the U.S. broker-dealer to deliver, prior to any transaction involving a “penny stock”, a disclosure schedule prepared in accordance with SEC standards relating to the “penny stock” market, unless the broker-dealer or the transaction is otherwise exempt. A U.S. broker-dealer is also required to disclose commissions payable to the U.S. broker-dealer and the registered representative and current quotations for the securities. Finally, a U.S. broker-dealer is required to submit monthly statements disclosing recent price information with respect to the “penny stock” held in a customer’s account and information with respect to the limited market in “penny stocks”.

Stockholders should be aware that, according to the SEC, the market for “penny stocks” has suffered in recent years from patterns of fraud and abuse. Such patterns include (i) control of the market for the security by one or a few broker-dealers that are often related to the promoter or issuer; (ii) manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases; (iii) “boiler room” practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales persons; (iv) excessive and undisclosed bid-ask differentials and markups by selling broker-dealers; and (v) the wholesale dumping of the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, resulting in investor losses. Our management is aware of the abuses that have occurred historically in the penny stock market. Although we do not expect to be in a position to dictate the behavior of the market or of broker-dealers who participate in the market, management will strive within the confines of practical limitations to prevent the described patterns from being established with respect to our securities.

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

 

None.Item 2Unregistered Sales of Equity Securities and Use of Proceeds

 

27

There were no sales of unregistered securities during the period covered by this report that have not previously been reported on Form 8-K.

Item 3

Defaults Upon Senior Securities

Item 3Defaults Upon Senior Securities

 

None.

Item 4

Mine Safety Disclosures

Item 4Mine Safety Disclosures

 

Not applicable.applicable

Item 5

Other Information

Item 5Other Information

 

During the period covered by this report, there was no information required to be disclosed by us in a Current Report on Form 8-K that was not so reported, nor were there any material changes to the procedures by which our security holders may recommend nominees to our board of directors.

 


Item 6Exhibits

Exhibit

Item 6Number

Exhibits

Exhibit

NumberDescription

Description

1.1

Underwriting Agreement dated September 24, 2020 between the Company and Maxim Group LLC, as representative of the underwriters (7)

3.1

Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed January 21, 2020 (1)

3.2

Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed September 24, 2020 (7)

4.1

Form of Stock Certificate representing the Company’s Common Stock, par value $0.001 per share (1)

4.1.2

Form of Stock Certificate representing the Company’s Common Stock par value $0.001 per share after the reverse stock split effected September 25, 2020 (9)

4.2

Form of Stock Certificate for the Series J Convertible Preferred Stock (2)

4.3

Form of Common Stock Purchase Warrant (11)

4.3.1

Form of Pre-Funded Warrant (7)

4.3.2

Form of Pre-Funded Warrant issued to holders of Convertible Debentures (8)

4.3.3

Form of Warrant issued to holders of Convertible Debentures (8)

4.3.4

Form of Representative’s Warrant Agreement (10)

4.3.5

Form of Warrant issued to Management Creditors (10)

4.4

Warrant Agent AgreementPNP Therapeutics, Inc., dated September 29, 2020 between the Company and American Stock Transfer & Trust Company, LLC (8)28, 2021 (2)

4.5

Form of Subscription Agreement executed by Management Creditors (10)

10.1

OfficeAssignment and Laboratory LeaseLicense Agreement, dated September 28, 2021, by and between UCB,GeoVax, Inc. and GeoVax,PNP Therapeutics, Inc. (3) (2)

10.2

Form of Securities PurchaseExclusive License Agreement, dated January 24, 2020 (2)November 9, 2021, by and between GeoVax, Inc. and City of Hope (3)

10.310.3*,**

Form of Note dated April 17, 2020 (4)

10.4

GeoVax Labs, Inc. 2020 Stock Incentive Plan, (5)as amended and restated August 11, 2021

10.531.1*

Certification pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Purchase Agreement dated June 26, 2020 (6)Exchange Act of 1934

10.631.2*

FormCertification pursuant to Rule 13a-14(a) or 15d-14(a) of 5% Original Issue Discount Senior Secured Convertible Debenture dated June 26, 2020 (6)the Securities Exchange Act of 1934

10.7

Form of Common Stock Purchase Warrant dated June 26, 2020 (6)

10.8

Form of Security Agreement dated June 26, 2020 (6)

10.9

Form of Subsidiary Guarantee dated June 26, 2020 (6)

10.10

Agreement Regarding Outstanding Convertible Preferred Stock and Warrants dated June 26, 2020 (6)

10.11

Patent and Biological Materials License Agreement with the National Institute of Allergy and Infectious Diseases, dated October 22, 2020 (12)

31.1*32.1*

Certification pursuant to Rule 13a-14(a) or 15d-14(a)18 U.S.C. Section 1350, as adopted by Section 906 of the Securities ExchangeSarbanes-Oxley Act of 19342002

31.2*32.2*

Certification pursuant to Rule 13a-14(a) or 15d-14(a)18 U.S.C. Section 1350, as adopted by Section 906 of the Securities ExchangeSarbanes-Oxley Act of 19342002

32.1*101.INS

Certification pursuant to 18 U.S.C. Section 1350, as adopted by Section 906 of the Sarbanes-Oxley Act of 2002

32.2*

Certification pursuant to 18 U.S.C. Section 1350, as adopted by Section 906 of the Sarbanes-Oxley Act of 2002

101.INS**

Inline XBRL Instance Document (the Instance Document does not appear in the Interactive Data Files because its XBRL tags are embedded with the Inline XBRL Document) (1)

101.SCH**101.SCH

Inline XBRL Taxonomy Extension Schema Document (1)

101.CAL**101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document (1)

101.DEF**101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document (1)

101.LAB**101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document (1)

101.PRE**101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document (1)

104

Inline XBRL for the cover page of this Quarterly Report on Form 10-Q and included in the Exhibit 101 Inline XBRL Document Set (1)

 

28

_____________________

*

*Filed herewith

Filed herewith

**

XBRL (Extensible Business Reporting Language) information furnished hereto areIndicates a management contract or compensatory plan or arrangement

(1)

These interactive data files shall not be deemed not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes ofor Section 18 of the Securities Exchange Act of 1934, as amended, andor otherwise is not subject to liability under these sections.

(1)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed January 21, 2020.

(2)

Incorporated by reference from the registrant’sRegistrant’s Current Report on Form 8-K filed January 24, 2020.September 29, 2021.

(3)

Incorporated by reference from the registrant’s Annual Report on Form 10-K filed March 24, 2020.

(4)

Incorporated by reference from the registrant’sRegistrant’s Current Report on Form 8-K filed April 20, 2020.

(5)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed June 25, 2020.

(6)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed June 26, 2020.

(7)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed September 25, 2020.

(8)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed September 29, 2020.

(9)

Incorporated by reference from the Amendment No. 2 to registrant’s Registration Statement on Form S-1 (File No. 333-239958) filed August 26, 2020

(10)

Incorporated by reference from the Amendment No. 3 to registrant’s Registration Statement on Form S-1 (File No. 333-239958) filed September 8, 2020

(11)

Incorporated by reference from the Amendment No. 4 to registrant’s Registration Statement on Form S-1 (File No. 333-239958) filed September 23, 2020

(12)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed October 26, 2020. Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as the Company has determined (i) the omitted information is not material and (ii) the omitted information would likely cause competitive harm to the Company if publicly disclosed.November 10, 2021.

 

29


 

SIGNATURES

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this quarterly report on Form 10-Q to be signed on its behalf by the undersigned thereunto duly authorized.

GEOVAX LABS, INC.

(Registrant)

(Registrant)

Date:         November 5, 202012, 2021

By:

/s/ Mark W. Reynolds

Mark W. Reynolds

Chief Financial Officer

(duly authorized officer and principal


financial officer)

 

3019