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 March 31, 2021
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to ________

For the quarterly period ended September 30, 2017

OR

Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from to

 

Commission file number 000-52091File Number: 001-39563

 

GEOVAX LABS,, INC.

(Exact name of Registrantregistrant as specified in its charter)

 

Delaware

87-0455038

87-0455038

(State or other jurisdiction

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

of incorporation or organization)

 
  

1900 Lake Park Drive,

Suite 380 

Suite 380

Smyrna, Georgia
30080

Smyrna, Georgia

30080

(Address of principal executive offices)

(Zip Code)

 

(678) 384-7220

(Registrant’sRegistrants telephone number, including area code)

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

Title of each Class

Trading Symbol

Name of each Exchange on which Registered

Common Stock $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 requirementsrequirements for the past 90 days.   Yes  ☒  No  ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted 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 and post 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

Non-accelerated filer

(Do not check if a smaller reporting company)

Smaller reporting company

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 9, 2017, 83,913,900of May 6, 2021, 6,316,702 shares of the Registrant’s common stock, $.001 par value, were issued and outstanding.

 

 

 

 

TABLE OF CONTENTS

 

 

Page

PART I FINANCIAL INFORMATION

Item 1Condensed Consolidated Financial Statements: 
 

Item 1

Condensed Consolidated Financial Statements:

Condensed Consolidated Balance Sheets as of September 30, 2017March 31, 2021 (unaudited) and December 31, 201620201
 Condensed Consolidated Statements of Operations for the three-month and nine-month periods ended September 30, 2017 March 31, 2021 and 20162020 (unaudited)2

Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficiency) for the three-month periods ended March 31, 2021 and 2020 (unaudited)3
Condensed Consolidated Statements of Cash Flows for the nine-monththree-month periods ended September 30, 2017 March 31, 2021 and 20162020 (unaudited)34

Notes to Condensed Consolidated Financial Statements (unaudited)45
   

Item 2

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

8

   

Item 3

Quantitative and Qualitative Disclosures about Market Risk

12

   

Item 4

Controls and Procedures

12

13
PART II OTHER INFORMATION
Item 1   Legal Proceedings13
   

PART II – OTHER INFORMATION

Item 1A
   Risk Factors13
   

Item 1

Legal Proceedings

13

2  

Item 1A

Risk Factors

13

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

13

   

Item 3

Defaults Upon Senior Securities

13

   

Item 4

Mine Safety Disclosures

13

14
   

Item 5

Other Information

13

14
   

Item 6

Exhibits

13

14
  

SIGNATURES

14

EXHIBIT INDEX

15

 


 

 

Part I -- FINANCIAL INFORMATION

 

Item 1Financial Statements

 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

  

September 30,

  

December 31,

 
  

2017

  

2016

 

ASSETS

 

(unaudited)

     

Current assets:

        

Cash and cash equivalents

 $343,826  $454,030 

Grant funds receivable

  89,895   28,074 

Prepaid expenses and other current assets

  12,420   62,275 
         

Total current assets

  446,141   544,379 
         

Property and equipment, net

  38,484   54,828 

Deposits

  11,010   11,010 
         

Total assets

 $495,635  $610,217 
         
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities:

        

Accounts payable

 $118,131  $75,607 

Accrued expenses (Note 6)

  613,411   294,240 
         

Total current liabilities

  731,542   369,847 
         

Commitments (Note 7)

        
         

Stockholders’ equity (deficiency):

        

Preferred stock, $.01 par value:

        

Authorized shares – 10,000,000

        

Series B convertible preferred stock, $1,000 stated value; 100 shares issued and outstanding at September 30, 2017 and December 31, 2016

  76,095   76,095 

Series C convertible preferred stock, $1,000 stated value; 2,690 and 2,868 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively

  882,348   940,705 

Series D convertible preferred stock, $1,000 stated value; 1,000 and -0- shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively

  980,000   - 

Common stock, $.001 par value:

        

Authorized shares – 600,000,000 and 300,000,000 at September 30, 2017 and December 31, 2016, respectively

        

Issued and outstanding shares – 70,913,900 and 55,235,233 at September 30, 2017 and December 31, 2016, respectively

  70,914   55,235 

Additional paid-in capital

  35,155,343   34,914,963 

Accumulated deficit

  (37,400,607)  (35,746,628)
         

Total stockholders’ equity (deficiency)

  (235,907)  240,370 
         

Total liabilities and stockholders’ equity

 $495,635  $610,217 

  

March 31

  

December 31,

 
  

2021

  

2020

 
  

(unaudited)

     

ASSETS

        

Current assets:

        

Cash and cash equivalents

 $20,842,782  $9,883,796 

Grant funds and other receivables

  -   182,663 

Prepaid expenses and other current assets

  118,430   168,689 

Total current assets

  20,961,212   10,235,148 

Property and equipment, net

  143,224   147,741 

Deposits

  11,010   11,010 
         

Total assets

 $21,115,446  $10,393,899 
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities:

        

Accounts payable

 $232,482  $267,702 

Accrued expenses

  36,623   359,281 

Current portion of notes payable

  182,844   183,326 

Total current liabilities

  451,949   810,309 

Note payable, net of current portion

  12,157   14,738 

Total liabilities

  464,106   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; 100 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively

  76,095   76,095 

Common stock, $.001 par value:

        

Authorized shares – 600,000,000

        

Issued and outstanding shares – 6,315,467 and 3,834,095 at March 31, 2021 and December 31, 2020, respectively

  6,315   3,834 

Additional paid-in capital

  67,937,289   55,294,504 

Accumulated deficit

  (47,368,359)  (45,805,581)

Total stockholders’ equity

  20,651,340   9,568,852 
         

Total liabilities and stockholders’ equity

 $21,115,446  $10,393,899 

 

See accompanying notes to condensed consolidated financial statements.

 


1

 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

  

Three Months Ended March 31,

 
  

2021

  

2020

 

Grant and collaboration revenues

 $110,417  $715,977 
         

Operating expenses:

        

Research and development

  602,783   808,936 

General and administrative

  1,071,710   502,345 

Total operating expenses

  1,674,493   1,311,281 
         

Loss from operations

  (1,564,076)  (595,304)
         

Other income (expense):

        

Interest income

  2,053   752 

Interest expense

  (755)  (1,142)

Total other income (expense)

  1,298   (390)
         

Net loss

 $(1,562,778) $(595,694)
         

Basic and diluted:

        

Net loss per common share

 $(0.29) $(2.54)

Weighted average shares outstanding

  5,332,058   234,395 

See accompanying notes to condensed consolidated financial statements.

2

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)

(Unaudited)

 

 

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2017

  

2016

  

2017

  

2016

 

Grant and collaboration revenue

 $247,994  $440,106  $895,866  $653,986 
                 

Operating expenses:

                

Research and development

  498,200   683,939   1,568,093   1,519,519 

General and administrative

  340,143   220,707   985,001   1,472,030 

Total operating expenses

  838,343   904,646   2,553,094   2,991,549 
                 

Loss from operations

  (590,349)  (464,540)  (1,657,228)  (2,337,563)
                 

Other income:

                

Interest income

  1,592   340   3,249   1,249 

Total other income

  1,592   340   3,249   1,249 
                 

Net loss

 $(588,757) $(464,200) $(1,653,979) $(2,336,314)
                 

Basic and diluted:

                

Loss per common share

 $(0.01) $(0.01) $(0.03) $(0.06)

Weighted averages shares outstanding

  67,000,857   44,305,161   60,757,109   38,796,896 
  

Three-Months Ended March 31, 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

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

Issuance of common stock upon warrant exercise

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

Issuance of common stock for services

  -   -   1,472   1   5,999   -   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 

 

 

  

Three-Months Ended March 31, 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)  674,068   674   1,855,664   -   - 

Issuance of common stock 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   689,581  $690  $41,202,172  $(43,443,207) $(1,864,250)

 

See accompanying notes to consolidated financial statements.

3

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

  

Three Months Ended March 31,

 
  

2021

  

2020

 

Cash flows from operating activities:

        

Net loss

 $(1,562,778) $(595,694)

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

        

Depreciation and amortization

  4,517   994 

Stock-based compensation expense

  76,790   6,000 

Changes in assets and liabilities:

        

Grant funds and other receivables

  182,663   (451,906)

Prepaid expenses and other current assets

  35,659   27,425 

Accounts payable and accrued expenses

  (357,878)  654,561 

Total adjustments

  (58,249)  237,074 

Net cash used in operating activities

  (1,621,027)  (358,620)
         

Cash flows from investing activities

  -   - 
         

Cash flows from financing activities:

        

Net proceeds from sale of common stock

  9,408,920   - 

Net proceeds from sale of preferred stock

  -   300,000 

Net proceeds from warrant exercises

  3,174,156   - 

Principal repayment of note payable

  (3,063)  (2,914)

Net cash provided by financing activities

  12,580,013   297,086 
         

Net increase (decrease) in cash and cash equivalents

  10,958,986   (61,534)

Cash and cash equivalents at beginning of period

  9,883,796   283,341 
         

Cash and cash equivalents at end of period

 $20,842,782  $221,807 

Supplemental disclosure of non-cash financing activities:

During the three months ended March 31, 2021, 145,866 shares of common stock were issued upon the cashless exercise of 188,668 stock purchase warrants. During the three months ended March 31, 2020, 1,686 shares of Series H Convertible Preferred Stock were converted into 469,697 shares of common stock and 700 shares of Series I Convertible Preferred Stock were converted into 204,371 shares of common stock.

 

See accompanying notes to condensed consolidated financial statements.

 


4

 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

  

Nine Months Ended September 30,

 
  

2017

  

2016

 

Cash flows from operating activities:

        

Net loss

 $(1,653,979) $(2,336,314)

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

        

Depreciation and amortization

  20,694   21,585 

Stock-based compensation expense

  43,535   525,887 

Changes in assets and liabilities:

        

Grant funds receivable

  (61,821)  111,213 

Prepaid expenses and other current assets

  49,855   (25,648)

Accounts payable and accrued expenses

  361,695   125,599 

Total adjustments

  413,958   758,636 

Net cash used in operating activities

  (1,240,021)  (1,577,678)
         

Cash flows from investing activities:

        

Purchase of property and equipment

  (4,350)  - 

Net cash used in investing activities

  (4,350)  - 
         

Cash flows from financing activities:

        

Net proceeds from sale of preferred stock

  980,000   - 

Net proceeds from sale of common stock

  154,167   1,028,426 

Net cash provided by financing activities

  1,134,167   1,028,426 
         

Net decrease in cash and cash equivalents

  (110,204)  (549,252)

Cash and cash equivalents at beginning of period

  454,030   1,060,348 
         

Cash and cash equivalents at end of period

 $343,826  $511,096 

Supplemental disclosure of cash flow information:

During the nine months ended September 30, 2017, 178 shares of Series C Convertible Preferred Stock were converted into 11,862,000 shares of common stock. During the nine months ended September 30, 2016, 132 shares of Series C Convertible Preferred Stock were converted into 1,400,000 shares of common stock (Note 8).

See accompanying notes to condensed consolidated financial statements.


GEOVAX LABS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2017March 31, 2021

(unaudited)

 

1.

Description of Business

 

GeoVax Labs, Inc. (“GeoVax” or the “Company”), is a clinical-stage biotechnology company developing humanimmunotherapies and vaccines against infectious diseases and cancers using oura novel vector vaccine platform. platform (Modified Vaccinia Ankara (MVA) Virus-Like Particle, or “GV-MVA-VLPTM”). In this platform, MVA, a large virus capable of carrying several vaccine antigens, expresses proteins that assemble into highly effective VLP immunogens in the person being vaccinated. 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 attenuated virus, while providing the safety characteristics of a replication-defective vector.

Our current development programs are focused on preventive vaccines against novel coronavirus (COVID-19), Human Immunodeficiency Virus (HIV), Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa), 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 for chronic Hepatitis B infections and cancers. We believe our technology and vaccine development expertise are well-suited for a variety of humanagainst infectious diseases and various cancers. With our design and development capabilities, we intendare progressing and validating an array of cancer and infectious disease immunotherapy and vaccine product candidates. Our goal is to pursue further expansion of our product pipeline.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.

 

Certain of ourour vaccine development activities have been, and continue to be, financially supported by the U.S. government.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 operate in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products require approval from, and are subject to, ongoing oversight 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 is to build a profitable company by generating income from products we develop and commercialize, either alone or with one or more potential strategic partners.

 

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

 

2.2.

Basis of Presentation

 

The accompanying condensed consolidated financial statements at September 30, 2017March 31, 2021 and for the three-month and nine-month periods ended September 30, 2017March 31, 2021 and 20162020 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-K for the year ended December 31, 2016.2020. 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.

We enacted reverse stock splits of our common stock on September 25, 2020 (1-for-20) and on January 21, 2020 (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 the twelve-month period following the issue date of thethese consolidated financial statements. We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates. We have funded our activities to date from government grants and clinical trial assistance, corporate and academic collaborations, and from sales of our equity securities. We will continue to require substantial funds to continue these activities.

We believe that our existing cash resources andtogether with current government funding commitments, will be sufficient to continue our planned operations into the first quarter of 2018. Due2023.

5

We expect to our history of operatingincur future net losses and our continuing need for capital to conductrequire substantial funds as we continue our research and development activities, there is substantial doubt concerningactivities. Our transition to profitability will be dependent upon, among other things, the successful development and commercialization of our abilityproduct candidates. We may never achieve profitability or positive cash flows, and unless and until we do, we will continue to operate as a going concern beyond that date.need to raise additional funding. We are currently exploring sourcesintend to fund future operations through additional private and/or public offerings of debt or equity securities. In addition, we may seek additional capital through additional government grants and contracts. We also intend to seek additional funds through sales of our equity securities, exercise of currently outstanding stock purchase warrants,arrangements with strategic partners or from other means. Management believessources. There can be no assurance that we will be successful in securing theable to raise additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt about the Company’s ability to operate as a going concern. Additional funding may not be available on favorable termsfunds or at all. If we fail to obtain additional capital when needed, we will be required to delay, scale back,achieve or eliminate somesustain profitability or all of our research and development programs as well as reduce our general and administrative expenses.positive cash flows from operations. 

 

3.3.

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-K for the year ended December 31, 20162020 those accounting policies that we consider significant in determining our results of operations and financial position. ThereDuring the three months ended March 31, 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.


In March 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-09, Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”), which amends Accounting Standards Codification Topic 718, Compensation – Stock Compensation. ASU 2016-09 is an attempt to simplify several aspects of the accounting for stock-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities,10-K, and classification on the statement of cash flows. We adopted ASU 2016-09 effective January 1, 2017; such adoption had no material impact on our financial statements.

In May 2017, the FASB issued Accounting Standards Update 2017-09, Scope of Modification Accounting (“ASU 2017-09”), which amends Accounting Standards Codification Topic 718, Compensation – Stock Compensation. ASU 2017-09 is an attempt to provide clarity and reduce both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718 Compensation – Stock Compensation, to a change to the terms or conditions of a share-based payment award. ASU 2017-09 is effective for the Company beginning January 1, 2018. We are currently evaluating the impact of the adoption of ASU 2017-09 on our financial statements.

In July 2017, the FASB issued Accounting Standards Update 2017-11, (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”), which amends Accounting Standards Codification Topic 260, Earnings Per Share, Topic 480, Distinguishing Liabilities from Equity, and Topic 815, Derivatives and Hedging. ASU 2017-11 changes the classification of certain equity-linked financial instruments (or embedded features) with down round features, and clarifies existing disclosure requirements for equity-classified instruments. ASU 2017-11 is effective for the Company beginning January 1, 2019. We are currently evaluating the impact of the adoption of ASU 2017-11 on our financial statements.

Therethere have been no other recent accounting pronouncements or changes in accounting pronouncements during the nine months ended September 30, 2017, as compared to the recent accounting pronouncements described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, which we expect to have a material impact on our financial statements.

 

4.4.

Basic and Diluted Loss Per Common Share

 

Basic netand diluted loss per common share isare computed usingbased on the weighted-averageweighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted-average number of common shares and potentially dilutive common share equivalents outstanding during the period. Potentially dilutive commonoutstanding. Common share equivalents consist of common shares issuable upon conversion of convertible preferred stock, and upon exercise of stock options and stock purchase warrants. CommonAll common share equivalents which potentially could dilute basic earningsare excluded from the computation of diluted loss per share insince the future, andeffect would be anti-dilutive. The weighted average number of common share equivalents which were excluded from the computation of diluted loss per share, as the effect would be anti-dilutive, totaled approximately 277.5 million3,055,097 and 73.1 million48,529 shares at September 30, 2017March 31, 2021 and 2016,2020, respectively.

 

5.5.

Property and Equipment

 

Property and equipment as shown on the accompanying Condensed Consolidated Balance Sheets is composed of thethe following as of September 30, 2017March 31, 2021 and December 31, 2016:2020:

 

  

September 30,

2017

  

December 31,

2016

 

Laboratory equipment

 $530,306  $525,956 

Leasehold improvements

  115,605   115,605 

Other furniture, fixtures & equipment

  28,685   28,685 

Total property and equipment

  674,596   670,246 

Accumulated depreciation and amortization

  (636,112)  (615,418)

Property and equipment, net

 $38,484  $54,828 
  

March 31,

2021

  

December 31,

2020

 

Laboratory equipment

 $532,100  $532,100 

Leasehold improvements

  115,605   115,605 

Other furniture, fixtures & equipment

  11,736   11,736 

Total property and equipment

  659,441   659,441 

Accumulated depreciation and amortization

  (516,217)  (511,700)

Property and equipment, net

 $143,224  $147,741 

 

6.6.

Accrued Expenses

 

Accrued expenses as shown on the accompanying Condensed Consolidated Balance Sheets isare composed of the following as of September 30, 2017March 31, 2021 and December 31, 2016:2020:

 

  

September 30,

2017

  

December 31,

2016

 

Accrued management salaries

 $441,942  $201,170 

Accrued directors’ fees

  156,469   78,070 

Other accrued expenses

  15,000   15,000 

Total accrued expenses

 $613,411  $294,240 
  

March 31,

2021

  

December 31,

2020

 

Accrued salaries and directors’ fees

 $-  $279,696 

Other accrued expenses

  36,623   79,585 

Total accrued expenses

 $36,623  $359,281 

 


7.7.

CommitmentsNotes Payable

 

GRA Note – On February 28, 2018, we entered into a Senior Note Purchase Agreement with Georgia Research Alliance, Inc. (GRA) pursuant to which we issued a five-year Senior Promissory Note (the “GRA Note”) to GRA in exchange for $50,000. The GRA Note bears an annual interest rate of 5%. Future principal repayments are expected to be $9,423 for the remainder of 2021, $13,126 in 2022, and $2,252 in 2023. Interest expense related to the GRA Note for the three-month periods ended March 31, 2021 and 2020 was $336 and $485, respectively.

6

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 pursuant to the Paycheck Protection Program (PPP) provisions of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The loan bears an annual interest rate of one percent and is due April 17, 2022. We have accrued interest payable associated with the PPP Loan of $1,623. In October 2020, we applied to the lender to have the loan forgiven, based upon our submission of qualifying information regarding eligible expenses; as of the date of this report our forgiveness application has not been processed. Interest expense related to the PPP Loan for the three-month periods ended March 31, 2021 and 2020 was $420 and $-0-, respectively.

8.

Commitments

Lease Agreement

 

We lease approximately 8,4008,400 square feet of office and laboratory space pursuant to an operating lease which expires on December 31, 2018, with an additional 12-month renewal option. As of September 30, 2017, our future2022. Rent expense for the three-month periods ended March 31, 2021 and 2020 was $42,803 and $41,539, respectively. Future minimum lease payments total $194,543, $37,998$128,410 for the remainder of which will2021 and $176,356 in 2022, although the lease may be payable during 2017 and $156,545 in 2018.terminated at any time by either party with ninety days written notice.

 

Other Commitments

 

In the normal course of business, we may enter into various firm purchase commitments related to production and testing of our vaccine, products, conduct of our clinical trials,research studies, and other research-related activities. As of September 30, 2017, we hadMarch 31, 2021, there are approximately $79,000$800,000 of unrecorded outstanding purchase commitments to our vendors and subcontractors, all of which we expect will be paid during 2017.due in 2021. We expect $211,326 of this entire amount to be reimbursable to us pursuant to currently outstandingexisting government grants (See Note 10).grants.

 

8.9.

Stockholders’Stockholders Equity

 

Series B Convertible Preferred Stock

AsPublic Offering On February 11, 2021, we closed an underwritten bought deal public offering of September 30, 2017, there are 100 shares of our Series B Convertible Preferred Stock (“Series B Preferred Stock”) outstanding. The Series B Preferred Stock may be converted at any time at the option of the holder into1,644,000 shares of our common stock, including 204,000 shares sold pursuant to the full exercise of the underwriter’s option to purchase additional shares, at a conversion price to the public of $0.35$6.25 per share, or 285,714 shares. Duringshare. Net proceeds after deducting underwriting discounts and commissions and other offering expenses were approximately $9.4 million. Additionally, we issued to the nine months ended September 30, 2017, there were no conversions or other transactions involving our Series B Preferred Stock.

Series C Convertible Preferred Stock

Asunderwriter, as a portion of September 30, 2017, there are 2,690the underwriting compensation, warrants to purchase up to a total of 72,000 shares of our Series C Convertible Preferred Stock (“Series C Preferred Stock”) outstanding.common stock. The Series C Preferred Stock may be convertedshares subject to the underwriter’s warrant agreement are exercisable at any time at$6.875 per share, are initially exercisable 180 days after the optioneffective date of the holder intooffering and have a term of three years from their initial exercise date.

Stock Options We have a stock-based incentive plan (the “2020 Plan”) pursuant to which our Board of Directors may grant stock options and other stock-based awards to our employees, directors and consultants. A total of 1,000,000 shares of our common stock atare reserved for issuance pursuant to the 2020 Plan. During the three-months ended March 31, 2021, there were no transactions related to the 2020 Plan. As of March 31, 2021, there were 602,000 stock options outstanding, with a conversionweighted-average exercise price of $0.015$2.79 per share or 179,349,733 shares. In May 2017,and a weighted-average remaining term of 9.7 years.

Stock Purchase Warrants During the three months ended March 31, 2021, 188,688 stock purchase warrants were exercised on a “cashless” basis, resulting in connection with the issuance of our Series D Convertible Preferred Stock discussed below, the conversion price of our Series C Preferred Stock was automatically reduced from $0.05 per share to $0.015 per share. During the nine months ended September 30, 2017, we issued an aggregate of 11,862,000145,866 shares of our common stock, related to conversionand 690,034 stock purchase warrants were exercised for cash, resulting in the issuance of 178 shares our Series C Preferred Stock.

Series D Convertible Preferred Stock

In May 2017, we issued 1,000 shares of our Series D Convertible Preferred Stock, $1,000 stated value (“Series D Preferred Stock”), for gross proceeds of $1.0 million. Net proceeds, after deduction of certain expenses, were $980,000.

Each share of Series D Preferred Stock is entitled to a liquidation preference equal to the initial purchase price, has no voting rights, and is not entitled to a dividend. The Series D Preferred Stock is convertible at any time at the option of the holders into690,034 shares of our common stock for net proceeds to us of $3,174,156. As of March 31, 2021, there are 2,793,635 stock purchase warrants outstanding, with an initial conversiona weighted-average exercise price of $0.015$5.07 per share. The Series D Preferred Shares contains price adjustment provisions, which may, under certain circumstances, reduce the conversion price on future dates according toshare and a formula based on the then-current market price for our common stock.weighted-average remaining term of 4.4 years.

 

We assessed the Series D Preferred Stock under ASC Topic 480, “Distinguishing Liabilities from Equity” (“ASC 480”), ASC Topic 815, “Derivatives and Hedging” (“ASC 815”), and ASC Topic 470, “Debt” (“ASC 470”). The preferred stock contains an embedded feature allowing an optional conversion by the holder into common stock which meets the definition of a derivative. However, we determined that the preferred stock is an “equity host” (as described by ASC 815) for purposes of assessing the embedded derivative for potential bifurcation and that the optional conversion feature is clearly and closely associated to the preferred stock host; therefore, the embedded derivative does not require bifurcation and separate recognition under ASC 815. We determined there to be a beneficial conversion feature (“BCF”) requiring recognition at its intrinsic value. Since the conversion option of the preferred stock was immediately exercisable, the amount allocated to the BCF was immediately accreted to preferred dividends, resulting in an increase in the carrying value of the preferred stock.

Increase in Authorized Shares of Common Stock

At a special meeting of our stockholders held on August 4, 2017, our stockholders approved an amendment to our certificate of incorporation to increase our authorized shares of common stock from 300,000,000 to 600,000,000 shares. The amendment to our certificate of incorporation was filed with the Delaware Secretary of State on August 4, 2017.


Other Common Stock Transactions

As discussed above, during – During the ninethree months ended September 30, 2017,March 31, 2021, we issued 11,862,0001,472 shares of our common stock pursuant to the conversiona consulting agreement for which we recognized $6,000 of 178 shares of our Series C Preferred Stock. During the nine months ended September 30, 2017, we also issued 3,816,667 shares of our common stock related to the exercise of stock purchase warrants, resulting in net proceeds to us of $154,167.stock-based compensation expense.

 

Stock Options

The following table presents a summary of our stock option transactions during the nine months ended September 30, 2017:

  

 

Number of Shares

  

Weighted Average

Exercise Price

 

Outstanding at December 31, 2016

  3,499,475  $1.21 

Granted

  --   -- 

Exercised

  --   -- 

Forfeited or expired

  (115,200)  17.75 

Outstanding at September 30, 2017

  3,384,275  $0.64 

Exercisable at September 30, 2017

  1,140,494  $1.76 

Stock Purchase Warrants

The following table presents a summary of stock purchase warrant transactions during the nine months ended September 30, 2017:

  

 

Number of Shares

  

Weighted Average

Exercise Price

 

Outstanding at December 31, 2016

  32,751,578  $0.07 

Granted

  --   -- 

Exercised

  (3,816,667)  0.04 

Forfeited or expired

  (1,112,001)  0.57 

Outstanding at September 30, 2017

  27,822,910  $0.02 

Exercisable at September 30, 2017

  27,822,910  $0.02 

Stock-Based Compensation Expense

10.

Stock-Based Compensation Expense

 

Stock-based compensation expense related to our stock option plansplan was $14,433$56,190 and $43,535 for the three-month and nine-month periods ended September 30, 2017, respectively, as compared to $13,686 and $41,058 for the three-month and nine-month periods ended September 30, 2016, respectively. Additionally,$-0- during the three-month and nine-month periods ended September 30, 2016, we recorded $15,030March 31, 2021 and $484,829, respectively, of stock-based2020, respectively. Stock-based compensation expense related to modifications to stock purchase warrants.

Stock-based compensation expense for stock options is 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, 2017,March 31, 2021, there was $88,449is $599,320 of unrecognized compensation expense relatedthat is expected to stock options, which we expect to recognizebe recognized over a weighted averageweighted-average period of 1.92.7 years.

 

7

Additionally, during the three-month periods ended March 31, 2021 and 2020 we recorded stock-based compensation expense of $20,600 and $6,000, respectively, associated with common stock issued for consulting and financial advisory services. As of March 31, 2021, there is $34,067 recorded as a prepaid expense for one of these arrangements, which will be recognized as expense during 2021 over the term of the related agreement.

9.11.

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 result in the expiration of net operating losses and credits before utilization.

 

10.12.

Grants and Collaboration Revenue

Government Grants and Contracts

 

We receive payments from government entities under our grants and contracts withfrom the National Institute of Allergy and Infectious Diseases (NIAID) and from the U.S. Department of Defense in support of certain of our vaccine research and development efforts. We record revenue associated with government grants and contracts as the reimbursable costs are incurred. During the three-month and nine-month periods ended September 30, 2017,March 31, 2021 and 2020, we recorded $247,994$110,417 and $800,866,$654,021, respectively, of revenues associated with these grants and contracts, as compared to $440,106 and $653,986, respectively, forgrants. During the comparable periodsthree-month period ended March 31, 2020, we also recorded $61,956 of 2016.revenue associated with a research collaboration agreement with Leidos, Inc. As of September 30, 2017,March 31, 2021, there is an aggregate of $744,769$355,010 in approved grant and contract funds available for use.use during 2021.

 


Collaboration Revenue

In March 2017, we entered into a clinical trial collaboration agreement with American Gene Technologies International, Inc. (“AGT”) whereby AGT intends to conduct a phase 1 human clinical trial investigating our combined technologies as a functional cure for HIV infection. In connection with the agreement, during the second quarter of 2017 AGT paid to us a non-refundable fee of $95,000, which we recorded as collaboration revenue during the nine-month period ended September 30, 2017.

11.

Subsequent Events

During October 2017, we issued 8,000,000 shares of our common stock pursuant to the conversion of 120 shares of our Series C Preferred Stock. During October and November 2017 we issued 5,000,000 shares of our common stock pursuant to the exercise of stock purchase warrants for net proceeds of $75,000.

 

 

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

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

 

FORWARD LOOKING STATEMENTS

 

In addition to historical information, the informationinformation included in this Form 10-Q contains forward-looking statements. Forward-looking statements involve numerous risks and uncertainties, including but not limited to the risk factors set forth under the heading “Risk Factors”Risk Factors in the Annual Report on Form 10-K for the year ended December 31, 2016,2020, and should not be relied upon as predictions of future events. Certain 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’‘‘anticipates or other variations thereof or comparable terminology, or by discussions of strategy, plans, or intentions. Such forward-looking statements are necessarily dependent 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;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’ss analysis only. We assume no obligation to update forward-looking statements.

 

Overview

 

GeoVax is a clinical-stage biotechnology company developing humanimmunotherapies and vaccines against cancers and infectious diseases and cancer using a novel patented Modifiedvector vaccine platform (Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) vectoror “GV-MVA-VLP™”). During 2020, we began a program to develop a vaccine platform. In this platform, MVA, a large virus capablefor prevention of carrying severalnovel coronavirus (COVID-19) infection. That effort has resulted in four COVID-19 vaccine antigens, expresses highly effective VLP immunogens in the personcandidates. These COVID-19 vaccine candidates have been designed and constructed and are being vaccinated. The platform elicits durable immune responses while providing the safety characteristics of a replication-defective vector.

Our currenttested using relevant experimental animal challenge models. Additional development programs are focused on preventive and therapeutic vaccines against HIV, ZikaHuman Immunodeficiency Virus hemorrhagic(HIV); preventive vaccines against hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa)and Lassa fever), Zika virus and malaria,malaria; as well as therapeuticimmunotherapies for solid tumor cancers.

8

For our infectious disease vaccines, our recombinant MVA vector expresses target proteins on highly immunogenic VLPs in the person being vaccinated, with the intended result of producing durable immune responses with the safety characteristics of the replication deficient MVA vector and cost-effective manufacturing.

In cancer immunotherapy, we believe that stimulating the immune system to treat or prevent cancers is a compelling concept and that the opportunity for chronic Hepatitis B infectionsimmune-activating technologies is promising, especially in light of advancements such as checkpoint inhibitors leading the way in oncology. Despite drug approvals in limited indications and cancers. Allpromising results in clinical trials, there remains a significant need and opportunity for further advancements. We believe our GV-MVA-VLP™ platform is well-suited for delivery of tumor-associated antigens and we plan to pursue development of our potential products areplatform in preclinical researchthis space.

Our most advanced vaccine program is focused on prevention of the clade B subtype of HIV prevalent in the regions of the Americas, Western Europe, Japan and development phases,Australia; our HIV vaccine candidate, GOVX-B11, will be included in an upcoming clinical trial (HVTN 132) managed by the HIV Vaccine Clinical Trials Network (HVTN) with support from the exceptionNational Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), which is targeted to begin in late 2021. Additionally, during August 2020 a consortium led by researchers at the University of California, San Francisco (UCSF) began a clinical trial using our vaccine as part of a combinational therapy to induce remission in HIV-positive individuals. Through the efforts of our preventivecollaborator, American Gene Technologies International, Inc. (AGT), we expect that our HIV vaccine which is currentlywill also enter clinical trials during 2021 in human clinical trials.combination with AGT’s gene therapy technology to seek a functional cure for HIV. Our other vaccine and immunotherapy programs are at various other stages of development.

 

Our corporate strategy is to advance, protect and protectexploit our vaccinedifferentiated vaccine/immunotherapy platform leading to the successful development of preventive and use its capabilities totherapeutic vaccines against infectious diseases and various cancers. With our design and developdevelopment capabilities, we are progressing and validating an array of products. We aimcancer 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 will also leverage third party resources through collaborations and partnerships for preclinical and clinical testing. Our current collaborators include National Institute of Allergytesting with multiple government, academic and Infectious Diseases (NIAID), HIV Vaccines Trial Network (HVTN), Centers for Disease Control and Prevention (CDC), United States Army Research Institute of Infectious Disease (USAMRIID), University of Pittsburgh, Georgia State University Research Foundation, University of Maryland, Peking University, Burnet Institute, American Gene Technologies International, Inc., and ViaMune, Inc.corporate entities.


 

We have not generated any revenues from the sale of any of ourthe 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.

 

Critical Accounting Policies and Estimates

 

This discussion and analysis of our financial condition and results of operations is based on the accompanying unaudited condensedour 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.

 

Our significantFor a description of critical accounting policies are summarizedthat 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 includedConsolidated Financial Statements contained in our Annual Report on Form 10-K for the year ended December 31, 2016. We believe the following2020. There have been no significant changes to our critical accounting policies affectfrom those disclosed in our more significant judgments and estimates used in the preparation of our financial statements:2020 Annual Report.

9

Recent Accounting Pronouncements

 

Revenue Recognition

We recognize revenueInformation regarding recent accounting pronouncements is contained in accordance with the Securities and Exchange Commission’s (SEC) Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, as amended by Staff Accounting Bulletin No. 104, Revenue Recognition, (“SAB 104”). SAB 104 provides guidance in applying U.S. generally accepted accounting principles (“GAAP”) to revenue recognition issues, and specifically addresses revenue recognition for upfront, nonrefundable fees received in connection with research collaboration agreements. Historically, our revenue has consisted primarily of grant and contract funding received from NIAID. Revenue from these arrangements is approximately equalNote 3 to the costs incurred and is recorded as income as the related costs are incurred.

In May 2014, the FASB issued Accounting Standards Update 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”), which creates a new Topic, Accounting Standards Codification Topic 606. The standard is principle-based and provides a five-step model to determine when and how revenue is recognized. The core principle is that an entity should recognize revenue when it transfers promised goods or services to customerscondensed consolidated financial statements, included in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 is effective for the Company beginning in 2018 and allows for either full retrospective adoption or modified retrospective adoption. We are currently evaluating the impact of the adoption of ASU 2014-09 on our financial statements.

Stock-Based Compensation

We account for stock-based transactions in which the Company receives services from employees, directors or others in exchange for equity instruments based on the fair value of the award at the grant date. Compensation cost for awards of common stock is estimated based on the price of the underlying common stock on the date of issuance. Compensation cost for stock options or warrants is estimated at the grant date based on each instrument’s fair value as calculated by the Black-Scholes option pricing model. We recognize stock-based compensation cost as expense ratably on a straight-line basis over the requisite service period for the award.this Quarterly Report.

 

Liquidity and Capital Resources

 

Historically, our primaryOur principal uses of cash have beenare to finance our researchresearch and development activities. Since inception, we have funded these activities primarily from government grants and clinical trial assistance, and from sales of our equity and debt securities. At September 30, 2017,March 31, 2021, we had cash and cash equivalents of $343,826$20,842,782 and total assets of $495,635,$21,115,446, as compared to $454,030$9,883,796 and $610,217,$10,393,899, respectively, at December 31, 2016.2020. At September 30, 2017,March 31, 2021, we had a working capital deficit of $285,401, compared to positive working capital of $174,532$20,509,263, compared to a $9,424,839 at December 31, 2016. Our current liabilities at September 30, 2017 include $598,411 of accrued management salaries and director fees, payment of which is continuing to be deferred.2020.


 

Net cash used in operating activities was $1,240,021$1,621,027 and $1,577,678$358,620 for the nine-monththree-month periods ended September 30, 2017March 31, 2021 and 2016,2020, respectively. Generally, the variances between periods are due to fluctuations in our net losses, offset by non-cash charges such as depreciation and stock-based compensation expense, and by net changes in our assets and liabilities. Our net losses generally fluctuate based on expenditures for our research activities, partially offset by government grant revenues. As of September 30, 2017, there is $744,769 in approved grant funds available for use during the remainder of 2017 and through June 30, 2018. See the table with further details under “Results of Operations – Grant and Collaboration Revenues” below.below for additional details concerning our government grants.

 

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 iswill also currently fundingfund the cost of an ongoingthe planned Phase 1 trial (HVTN 114), which is investigating the effect of adding a “protein boost” component132) to our vaccine. Concurrently, a preclinical study in non-human primates (funded by a NIAID grant) is evaluating two additional proteins specifically chosen as boosting agents for GOVX-B11, and planning is underway for a Phase 1 trial tofurther evaluate the safety and immunogenicity of these proteinsadding “protein boost” components to our vaccine, GOVX-B11. We expect HVTN 132 to commence patient enrollment during 2021. 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. AGT began the Phase 1 trial in humans. Based on the results from these studies,late 2020, and we expect NIAID may then be readythe addition of our vaccine into the trial during 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 supportinduce remission in HIV-positive individuals; this program entered clinical trials during August 2020. Each of these programs could experience delays as a large phase 2b efficacy trial. In July 2016, NIAID awarded us a contract of up to $7.8 million for the productionresult of the DNA vaccine component of GOVX-B11, which is intended for use in advanced clinical trials.

Net cash used in investing activities was $4,350 and $-0- for the nine-month periods ended September 30, 2017 and 2016, respectively. Our investing activities have consisted predominantly of capital expenditures.ongoing COVID-19 pandemic.

 

Net cash provided by financing activities was $1,134,167 $12,580,013 and $1,028,426$297,086 for the nine-monththree-month periods ended September 30, 2017March 31, 2021 and 2016,2020, respectively. DuringNet cash provided by financing activities during the nine-month2021 period ended September 30, 2017,relates to (i) net proceeds of $9,408,920 received in February 2021 from the public offering of our common stock (see discussion below), (ii) $3,174,156 of net proceeds from the exercise of warrants, and (iii) $3,063 in principal repayments toward a five-year Senior Promissory Note (the “GRA Note”) to purchasethe Georgia Research Alliance, Inc. Net cash provided by financing activities during the 2020 period relates to the sale by us of shares of our Series J convertible preferred stock for net proceeds of $300,000 and $2,914 in principal repayments toward the GRA Note.

Public Offering On February 11, 2021, we closed an underwritten bought deal public offering of 1,644,000 shares of our common stock, including 204,000 shares sold pursuant to the full exercise of the underwriter’s option to purchase additional shares, at a price to the public of $6.25 per share. Net proceeds after deducting underwriting discounts and commissions and other offering expenses were $9,408,920.

Warrant Exercises – During January and February 2021, holders of our warrants exercised 62,626 Series I Warrants, 126,042 Pre-Funded Warrants and 690,034 Unit Warrants, resulting in the issuance of 835,900 shares of our common stock for aggregate net proceeds to us of $154,167. During May 2017,$3,174,156.

PPP Loan. On April 17, 2020, we sold sharesreceived a $170,200 bank loan backed by the United States Small Business Administration 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. In October 2020, we applied to the lender to have the loan forgiven, based upon our Series D convertible preferred stock to certain institutional investors for net proceedssubmission of $980,000.qualifying information regarding eligible expenses; as of the date of this report our forgiveness application has not been processed.

 

As of September 30, 2017,March 31, 2021, we had an accumulated deficit of $37.4approximately $47.4 million. We expect for the foreseeable future we will continue to operate at a loss. The amount of the accumulated deficit will continue to increase, as it will be expensive to continue our research and development efforts. We will continue to require substantial funds to continue our activities and cannot predict the outcome of our efforts. We believe that our existing cash resources, combined with funding from existing NIHgovernment grants and clinical trial support, will be sufficient to fund our planned operations into the first quarter of 2018.2023. We willmay require additional funds to continue our planned operations beyond that date. We are currently seeking sources of capital through additional government grant programs and clinical trial support, and we may alsoplan to conduct additional offerings of our equity securities. However, additionalAdditional funding may not be available on favorable terms or at all and if we fail to obtain additional capital when needed, we may be required to delay, scale back, or eliminate some or all of our research and development programs as well as reduce our general and administrative expenses.

10

 

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.

 

Contractual Obligations

As of September 30, 2017, we had noncancelable lease obligations and other firm purchase obligations totaling approximately $274,000, as compared to approximately $457,000 at December 31, 2016. Approximately $79,000 of the purchase commitments at September 30, 2017 relate to subcontracts associated with our government grants, which we expect will be fully reimbursed to us pursuant to those grants. We have no committed lines of credit and no other committed funding or long-term debt. We have employment agreements with our senior management team, each of which may be terminated with 30 days advance notice. There have been no other material changes to the table presented in our Annual Report on Form 10-K for the year ended December 31, 2016.

Results of Operations

 

Net Loss

 

We recorded a net loss of $588,757$1,562,778 for the three monthsthree-month period ended September 30, 2017,March 31, 2021, as compared to $464,200$595,694 for the three monthsthree-month period ended September 30, 2016. For the nine months ended September 30, 2017, we recorded a net loss of $1,653,979, as compared to $2,336,314 for the nine months ended September 30, 2016.March 31, 2020. 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 RevenuesRevenues

 

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. During the three-month and nine-month periodsthree-month period ended September 30, 2017,March 31, 2021, we recorded grant and collaboration revenues of $247,994 and $895,866, respectively,$110,417, as compared to $440,106 and $653,986, respectively,$715,977 during the comparable periodsperiod of 2016.


Our grant revenues relate to grants and contracts from NIAID in support of our vaccine development activities. We record revenue associated with these grants as the related costs and expenses are incurred.2020. The differencevariance in our grant and collaboration revenues from period to period is dependent upon our expenditures for activities supported by the grants, and fluctuates based onprimarily relates to the timing and amount of the associated expenditures. Additional detail concerning our grant and collaboration revenues and the remaining funds available for use as of September 30, 2017March 31, 2021 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

 
  

2017

  

2016

  

2017

  

2016

  

Sep 30, 2017

 

HIV - SBIR Grant

 $-  $79,805  $158,972  $180,274  $-0- 

HIV - SBIR Grant

  185,909   344,528   493,132   457,939   449,609 

HIV - Vaccine Development Contract

  23,935   15,773   110,612   15,773   33,310 

Zika - SBIR Grant

  38,150   -   38,150   -   261,850 

Total Grants

 $247,994  $440,106  $800,866  $653,986  $744,769 

In March 2017, we entered into 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 goal of developing a functional cure for HIV infection. The cost of the clinical trial will be borne by AGT. The primary objectives of the trial will be to assess the safety and efficacy of the therapy, with secondary objectives to assess the immune responses as a measure of efficacy. In exchange for use of our vaccine product in the clinical trial, AGT paid us a fee of $95,000 which we received during the second quarter of 2017 and which is recorded as revenue in the nine-month period ended September 30, 2017. No commercial rights or licenses have yet been granted to AGT.

  

Revenues Recorded During

Three-Month Periods Ended March 31,

 

Approved Funds

Available at

Description

 

2021

  

2020

    March 31, 2021 

Lassa Fever – U.S. Army Grant

 $-  $654,021  $165,500 

Covid-19 – NIH SBIR Grant

  110,417   -   189,510 

Malaria – Leidos, Inc. Collaboration

  -   61,956   - 

Total

 $110,417  $715,977  $355,010 

 

Research and Development Expenses

 

During the three-month and nine-month periods ended September 30, 2017, we recordedOur research and development expense of $498,200expenses were $602,783 and $1,568,093, respectively, as compared to $683,939$808,936 for the three-month periods ended March 31, 2021 and $1,519,519, respectively, during the comparable periods of 2016.2020, respectively. Research and development expense for the three-month and nine-monththese periods of 2017 includes stock-based compensation expense of $6,513$21,468 and $19,775$-0-, respectively as compared to $5,894 and $17,681, respectively, for the comparable periods of 2016 (see discussion under “Stock-Based Compensation Expense” below).

 

Our research and development expenses can fluctuate considerably on a period-to-period basis, depending on our need for vaccine manufacturing by third parties, the timing of expenditures related to our government grants and other research projects, and other factors. Research and development expenses decreased by $206,153, or 25%, from NIAID,the 2020 period to 2021 primarily due to the timing of costs associated with clinical trials beingexternal expenditures related to our government grants. As of March 31, 2021, there is $355,010 in approved grant funds (as shown in the table above), which we expect to expend during the remainder of 2021. We plan to seek additional government grant funding directly by us, and other factors. The overall variance infor our development programs, which may increase our research and development expense fromexpenses in the 2016 periods to 2017 is primarily attributable to the timing and amount of costs associated with research subcontracts supported by our grants from NIAID. Our research and development costs do not include costs incurred by the HVTN in conducting clinical trials of our preventive HIV vaccines; those costs are funded directly to the HVTN by NIAID.future, although there can be no assurance any such funds will be obtained.

 

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 approximatesapproximate the costs incurred. We believe that additional project-by-project information would not form a reasonable basis for disclosure to our investors.

 

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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. 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 ExpenseExpensess

 

During the three-month and nine-month periods ended September 30, 2017, we recordedOur general and administrative expense of $340,143expenses were $1,071,710 and $985,001, respectively, as compared to $220,707$502,345 for the three-month periods ended March 31, 2021 and $1,472,030, respectively, during the comparable periods of 2016.2020 respectively. 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 2017 includeincludes stock-based compensation expense of $7,920$55,322 and $23,760, respectively; as compared to $22,822 and $508,206, respectively,$6,000 for the comparable2021 and 2020 periods, of 2016respectively (see discussion under “Stock-Based Compensation Expense” below). Excluding stock-based compensation expense, general and administrative expenses were $332,223$1,016,388 and $961,241 during$496,345 for the three-month and nine-month periods ended September 30, 2017,March 31, 2021 and 2020, respectively, as comparedrepresenting an increase of $520,043 (105%). This increase includes approximately $200,000 related to $197,885higher Delaware franchise taxes with the remainder primarily due to higher legal and $963,824, respectively duringpatent costs, consulting fees, and personnel costs. For the comparable periodsremainder of 2016. The overall variance in2021, we expect our general and administrative expense fromexpenses to remain reasonably consistent with that of the 2016 periods to 2017 is partially attributable in part to the timing of patent costs. Also, during the three months ended September 30, 2017, we incurred additional costs associated with the conduct of a special meeting of stockholders, which contributed to the increase as compared to the same period of 2016.first quarter. We expect that our general and administrative costs may increase in the futurebeyond 2021 in support of expanded research and development activities and other general corporate activities.

 

Stock-Based Compensation Expense

 

For the three-month and nine-month periods ended September 30, 2017 and 2016,The table below shows the components of stock-based compensation expense were as follows:

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2017

  

2016

  

2016

  

2016

 

Stock option expense

 $14,433  $13,686  $43,535  $41,058 

Warrant modification expense

  -   15,030   -   484,829 

Total stock-based compensation expense

 $14,433  $28,716  $43,535  $525,887 

for the three-month periods ended March 31, 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.For

  

Three Months Ended March 31,

 
  

2021

  

2020

 

Stock option expense

 $56,190  $- 

Stock issued for services

  20,600   6,000 

Total stock-based compensation expense

 $76,790  $6,000 

As a result of the three monthreverse stock splits enacted in April 2019 and nine month periods ended September 30, 2017in January 2020, we made adjustments and 2016,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 was allocated as follows:related to our stock option plan for the majority of 2020. We re-initiated employee stock option grants in December 2020.

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 

Expense Allocated to:

 

2017

  

2016

  

2017

  

2016

 

General and administrative expense

 $7,920  $22,822  $23,760  $508,206 

Research and development expense

  6,513   5,894   19,775   17,681 

Total stock-based compensation expense

 $14,433  $28,716  $43,535  $525,887 

 

Other IncomIncome (Expense)e

 

Interest income for the three-month and nine-monththree-month periods ended September 30, 2017March 31, 2021 and 2020 was $1,592$2,053 and $3,249, respectively, as compared to $340 and $1,249, respectively, for comparable periods of 2016.$752, respectively. The variances between periods are primarily attributable to cash available for investment and interest rate fluctuations.

 

Interest expense for the three-month periods ended March 31, 2021 and 2020 was $755 and $1,142, respectively, related to the GRA Note, PPP Loan, and financing costs associated with insurance premiums (for the 2020 period only).

Item 3

Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable.Item 3Quantitative and Qualitative Disclosures About Market Risk

 

Our exposure to market risk is limited primarily to interest income sensitivity, which is affected by changes in the general level of United States interest rates, particularly because a significant portion of our investments are in institutional money market funds. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income received without significantly increasing risk. Due to the nature of our short-term investments, we believe that we are not subject to any material market risk exposure. We do not have any derivative financial instruments or foreign currency instruments.

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Item 4Controls and Procedures

Controls 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.


 

Changes in internal control over financial reporting

 

There wasAlthough we have modified certain of our internal control procedures as a result of the COVID-19 pandemic, there were no changesignificant changes in our internal control over financial reporting that occurred during the three months ended September 30, 2017March 31, 2021 that hashave materially affected, or isare reasonably likely to materially affect, our internal control over financial reporting.

 

Limitations on Controls

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

 

None.Item 1Legal Proceedings

 

None.

Item 1A

Item 1ARisk Factors

 

For information regarding factors that could affect our results of operations, financial condition or liquidity, see the risk factors discussed under “Risk“Risk Factors” in Item 1A of our most recent Annual Report on Form 10-K. See also “Forward-Looking Statements,” included in Item 2 of this Quarterly Report on Form 10-Q. There have been no material changes from the risk factors previously disclosed in our most recent Annual Report on Form 10-K.

 

Item 2

Unregistered Sales

Item 2Unregistered Sales of Equity Securities and Use of Proceeds

 

None not previously disclosedEffective as of May 1, 2020, we entered into a Customer Agreement and Subscription Agreement with Content Carnivores, LLC, pursuant to which the Company received services related to the management of our social media accounts in exchange for the monthly issuance of shares of our common stock valued at $3,000. During the three-month period ended March 31, 2021, we issued 1,472 shares of our common stock to Content Carnivores, LLC at an aggregate value of $6,000. The Company relied on Form 8-K.an exemption from the registration requirements of the Securities Act afforded by Section 4(a) (2) thereof and Rule 506 of Regulation D.

 

Item 3

Defaults

Item 3Defaults Upon Senior Securities

 

None.None.

 

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Item 4

Item 4Mine Safety Disclosures

 

Not applicable

Item 5

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
NumberDescription
1.01Underwriting Agreement, dated February 8, 2021, between GeoVax Labs, Inc. and Maxim Group LLC (1)
10.1Form of Underwriter’s Warrant Agreement (1)
31.1*Certification pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934
31.2*Certification pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934
32.1*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**XBRL Instance Document
101.SCH**XBRL Taxonomy Extension Schema Document
101.CAL**XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF**XBRL Taxonomy Extension Definition Linkbase Document
101.LAB**XBRL Taxonomy Extension Label Linkbase Document
101.PRE**XBRL Taxonomy Extension Presentation Linkbase Document

_____________________

*             Filed herewith

**          XBRL (Extensible Business Reporting Language) information furnished hereto are 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 of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections.

 

The exhibits filed with this report are set forth on the exhibit index following the signature page and are incorporated(1)          Incorporated by reference in their entirety into this item.from the registrant’s Current Report on Form 8-K filed February 11, 2021.

 


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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)
 

 

 

 

 

 

 

 

 

Date:     November 9, 2017         May 6, 2021 

By:

/s/ Mark W. Reynolds

 

 

 

Mark W. Reynolds

 

Chief Financial Officer

  (duly authorized officer and principal
financial officer) 

 


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EXHIBIT INDEX

Exhibit Number

Description

3.1

Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed August 4, 2017 (2)

4.1

Form of Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock filed May 9, 2017 (1)

4.2

Form of Stock Certificate for the Series D Convertible Preferred Stock (1)

10.1

Form of Securities Purchase Agreement dated May 8, 2017 (1)

10.2

Form of Registration Rights Agreement dated May 8, 2017 (1)

31.1*

Certification pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934

31.2*

Certification pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934

32.1*

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*,***

The following financial information from GeoVax Labs, Inc. Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2017, formatted in Extensible Business Reporting Language (XBRL): (i) Condensed Consolidated Balance Sheets as of September 30, 2017 (unaudited) and December 31, 2016, (ii) Condensed Consolidated Statements of Operations (unaudited) for the three-month and nine-month periods ended September 30, 2017 and 2016, (iii) Condensed Consolidated Statements of Cash Flows (unaudited) for the nine-month periods ended September 30, 2017 and 2016, and (iv) Notes to Condensed Consolidated Financial Statements (unaudited).

_____________________

*

Filed herewith

**

Indicates a management contract or compensatory plan or arrangement

***

Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended and otherwise are not subject to liability under those sections

(1)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed May 9, 2017.

(2)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed August 4, 2017.

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