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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-Q

 

 

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

For the quarterly period ended March 31, 2015

For the quarterly period ended September 30, 2014

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 000-52091

 

GEOVAX LABS, INC.

(Exact name of Registrant as specified in its charter)

 

Delaware

87-0455038

(State (State or other jurisdiction

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

of incorporation or organization)

 

1900 Lake Park Drive

Suite 380

Smyrna, Georgia

30080

(Address

 (Address of principal executive offices)

(Zip

 (Zip Code)

 

(678) 384-7220

(Registrant’s telephone number, including area code)

 

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T 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, or a non-accelerated filer. See the definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer ☐

Accelerated filer ☐

  

Non-accelerated filer 
(Do not check if a smaller reporting company)

Smaller reporting company ☒

 

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

Yes ☐    No ☒Yes☐    No☒

 

As of November 11, 2014,May 13, 2015, 31,950,813 shares of the Registrant’s common stock, $.001 par value, were issued and outstanding.

 

 
 

 

 

GEOVAX LABS, INC.TABLE OF CONTENTS

 

Index

 

 Page
  

PartPART I – FINANCIAL INFORMATION

 
   

Item 1

Condensed Consolidated Financial Statements:

1

 

Condensed Consolidated Balance Sheets as of September 30, 2014March 31, 2015 (unaudited) and December 31, 20132014

1

 

Condensed Consolidated Statements of Operations for the three month and nine month periods ended September 30,March 31, 2015 and 2014 and 2013 (unaudited)

2

Condensed Consolidated Statements of Cash Flows for the ninethree month periods ended September 30,March 31, 2015 and 2014 and 2013 (unaudited)

3

Notes to Condensed Consolidated Financial Statements (unaudited)

4

   

Item 2

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

8

   

Item 3

Quantitative and Qualitative Disclosures about Market Risk

1312

   

Item 4

Controls and Procedures

1312

   

PartPART II. – OTHER INFORMATION

 
   

Item 1

Legal Proceedings

1413

   

Item 1A

Risk Factors

1413

   

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

1413

   

Item 3

Defaults Upon Senior Securities

1413

   

Item 4

Mine Safety Disclosures

1413

   

Item 5

Other Information

1413

   

Item 6

Exhibits

13

SIGNATURES

14

   

SIGNATURES

15

EXHIBIT INDEX

1615

 

 
 

 

 

Part 1I -- FINANCIAL INFORMATION

 

Item 1     Financial Statements

 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

  

September 30,

  

December 31,

 
  

2014

  

2013

 
  (unaudited)     

ASSETS

 

 

     

Current assets:

        

Cash and cash equivalents

 $862,191  $2,513,861 

Grant funds receivable

  -   140,909 

Prepaid expenses and other current assets

  64,200   43,569 
         

Total current assets

  926,391   2,698,339 
         

Property and equipment, net

  113,227   120,227 
         

Other assets

  13,510   21,010 
         

Total assets

 $1,053,128  $2,839,576 
         
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities:

        

Accounts payable

 $82,197  $155,943 

Accrued expenses

  8,279   96,406 

Amounts payable to Emory University (a related party)

  79,757   60,000 
         

Total current liabilities

  170,233   312,349 
         

Commitments (Note 5)

        
         

Stockholders’ equity:

        

Preferred stock, $.01 par value:

        
Authorized shares – 10,000,000        

Series A convertible preferred stock, $1,000 stated value; -0- and 71 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively

  -   60,586 

Series B convertible preferred stock, $1,000 stated value; 1,125 and 1,650 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively

  856,070   1,255,569 

Common stock, $.001 par value:

        

Authorized shares – 75,000,000

        

Issued and outstanding shares – 25,718,037 and 23,765,180 at September 30, 2014 and December 31, 2013, respectively

  25,718   23,765 

Additional paid-in capital

  28,863,162   28,239,392 

Deficit accumulated during the development stage

  (28,862,055)  (27,052,085)
         

Total stockholders’ equity

  882,895   2,527,227 
         

Total liabilities and stockholders’ equity

 $1,053,128  $2,839,576 
    

March 31,

  

December 31,

 
    

2015

  

2014

 

ASSETS

 

(unaudited)

     

Current assets:

        
 

Cash and cash equivalents

 $3,146,728  $1,101,651 
 

Grant funds receivable

  47,955   79,341 
 

Prepaid expenses and other current assets

  48,160   44,503 
           
  

Total current assets

  3,242,843   1,225,495 
           

Property and equipment, net

  105,309   96,693 
           

Deposits

  11,010   11,010 
           
  

Total assets

 $3,359,162  $1,333,198 
           
           

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities:

        
 

Accounts payable

 $45,912  $55,616 
 

Accrued expenses

  68,180   52,490 
 

Amounts payable to Emory University (a related party)(Note 11)

  102,638   78,917 
           
  

Total current liabilities

  216,730   187,023 
           

Commitments (Note 6)

        
           

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, 2015and December 31, 2014

  76,095   76,095 
  

Series C convertible preferred stock, $1,000 stated value;3,000 and -0- shares issued and outstanding at March 31, 2015and December 31, 2014, respectively

  983,941   - 
 

Common stock, $.001 par value:

        
  

Authorized shares – 75,000,000

        
  

Issued and outstanding shares – 31,950,813 at March 31, 2015and December 31, 2014

  31,951   31,951 
 

Additional paid-in capital

  32,536,539   30,823,769 
 

Accumulated deficit

  (30,486,094)  (29,785,640)
           
  

Total stockholders’ equity

  3,142,432   1,146,175 
           
  

Total liabilities and stockholders’ equity

 $3,359,162  $1,333,198 

 

See accompanying notes to condensed consolidated financial statements.

 

 

 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

Three Months Ended September 30,

  

Nine Months Ended September 30,

  

Three Months Ended March 31,

 
 

2014

  

2013

  

2014

  

2013

  

2015

  

2014

 

Grant revenue

 $322,086  $1,004,211  $659,867  $2,242,812  $103,424  $157,340 
                        

Operating expenses:

                        

Research and development

  425,498   879,104   1,344,560   2,314,291   403,629   402,860 

General and administrative

  411,814   316,452   1,128,478   1,345,179   401,441   371,802 

Total operating expenses

  837,312   1,195,556   2,473,038   3,659,470   805,070   774,662 
                        

Loss from operations

  (515,226)  (191,345)  (1,813,171)  (1,416,658)  (701,646)  (617,322)
                        

Other income:

                        

Interest income

  711   1,197   3,201   3,429   1,192   1,404 

Total other income

  711   1,197   3,201   3,429 
                        

Net loss

 $(514,515) $(190,148) $(1,809,970) $(1,413,229) $(700,454) $(615,918)
                        

Basic and diluted:

                        

Loss per common share

 $(0.02) $(0.01) $(0.07) $(0.07) $(0.02) $(0.02)

Weighted averages shares outstanding

  25,325,141   21,666,610   25,109,811   20,979,675 

Weighted average shares outstanding

  31,950,813   24,765,307 

 

See accompanying notes to condensed consolidated financial statements.

 

 

 

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

Nine Months Ended September 30,

  

Three Months Ended March 31,

 
 

2014

  

2013

  

2015

  

2014

 

Cash flows from operating activities:

                

Net loss

 $(1,809,970) $(1,413,229) $(700,454) $(615,918)

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

        

Adjustments to reconcile net loss to net cashused in operating activities:

        

Depreciation and amortization

  50,003   52,652   7,234   16,372 

Stock-based compensation expense, including warrant modification expense and common stock issued for services

  165,638   354,769 

Stock-based compensation expense

  16,902   26,307 

Changes in assets and liabilities:

                

Grant funds receivable

  140,909   241,234   31,386   140,909 

Prepaid expenses and other current assets

  (20,631)  (5,961)  (3,657)  5,801 

Accounts payable and accrued expenses

  (142,116)  (101,505)  29,707   (77,006)

Total adjustments

  193,803   541,189   81,572   112,383 

Net cash used in operating activities

  (1,616,167)  (872,040)  (618,882)  (503,535)
                

Cash flows from investing activities:

                

Purchase of property and equipment

  (35,503)  (86,602)  (15,850)  - 

Net cash used in investing activities

  (35,503)  (86,602)  (15,850)  - 
                

Cash flows from financing activities:

                

Net proceeds from sale of common stock

  -   1,643,333 

Net proceeds from sale of preferred stock

  2,679,809   - 

Net cash provided by financing activities

  -   1,643,333   2,679,809   - 
                

Net increase (decrease) in cash and cash equivalents

  (1,651,670)  684,691   2,045,077   (503,535)

Cash and cash equivalents at beginning of period

  2,513,861   1,035,925   1,101,651   2,513,861 
                

Cash and cash equivalents at end of period

 $862,191  $1,720,616  $3,146,728  $2,010,326 

 

Supplemental disclosure of non-cash investing and financing activities:cash flow information:

During the nine months ended September 30, 2014, an aggregate of 71 shares of Series A Convertible Preferred Stock were converted into 202,857 shares of common stock, and an aggregate of 525 shares of Series B Convertible Preferred Stock were converted into 1,500,000 shares of common stock (see Note 6).None.

 

See accompanying notes to condensed consolidated financial statements.

 

 

 

GEOVAX LABS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30March 31, 201415

(unaudited)

 

 

1.        Description of Company and Basis of Presentation

 

GeoVax Labs, Inc. (“GeoVax” or the “Company”), is a clinical-stage biotechnology company developing innovative human vaccines using our novel DNA/MVA platform technology. Our primary focus is to developcurrent development programs are focused on vaccines that preventagainst Ebola and fightMarburg viruses, and Human Immunodeficiency Virus (“HIV”) infections,(HIV). Our vaccine delivery technology generates virus-like particles (VLPs) that are effective at eliciting safe and weeffective immune responses. All of the clinical trials for our preventive HIV vaccine have recently expanded our research and development efforts to include vaccines to preventbeen conducted by the HIV Vaccine Trials Network (HVTN) with funding from the National Institutes of Health (NIH). Our proprietary Ebola virus infection. We have exclusively licensed from Emory University (“Emory”) certain vaccine technology whichhas been developed internally, while our HIV vaccine technology was developed in collaboration with Emory University, the National Institutes of Health (“NIH”)NIH, and the Centers for Disease Control and Prevention (“CDC”). (CDC) and is exclusively licensed to us.

Our Ebola vaccine development efforts were initiated in 2014 and we expect to conduct preclinical animal studies during 2015, with the goal of beginning human clinical testing in late 2016 or early 2017. Our HIV vaccine development efforts are focused on a preventive vaccine to address the clade B subtype of the HIV virus that is most prevalent in the developed world – primarily North America and Western Europe. Our preventive clade B HIV vaccine has successfully completed Phase 2a clinical trials and we are currently exploring our options to secure funding to advance our vaccine directly into pivotal Phase 2b efficacy trials. In the meantime, through collaboration with the NIH and HVTN, in late 2015 we expect to initiate a Phase 1 clinical trial investigating the effect of a “protein boost” to increase the antibody responses elicited by our vaccine. We are also planning clinical trials to evaluate our clade B HIV vaccine as an immunotherapy agent for individuals already infected with HIV, and we have begun early-stage preclinical studies to develop HIV vaccine candidates for the clade C subtype of HIV prevalent in the developing world.

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

 

Our most advanced vaccines under development address the clade B subtype

2.        Basis of the HIV virus that is most prevalent in the United States and western Europe. Our preventive clade B HIV vaccine has successfully completed Phase 2a clinical trials and we are currently planning the next stage of human clinical testing. We are also planning clinical trials to evaluate our clade B HIV vaccine as an immunotherapy agent for individuals already infected with HIV. We have begun preclinical studies to develop HIV vaccine candidates for the clade C subtype of HIV prevalent in the developing world. Our Ebola vaccine development efforts have recently been initiated and we expect to begin preclinical animal studies during 2015, with the goal of beginning human clinical testing in 2016.

Our activities are subject to significant risks and uncertainties. We have neither received regulatory approval for any of our vaccine candidates, nor do we have any commercialization capabilities; therefore, it is possible that we may never successfully derive significant product revenues from any of our existing or future development programs or product candidates.

We have funded our activities to date from government grants and clinical trial assistance, and from sales of our equity securities. We believe that our existing cash resources, combined with the proceeds from the NIH grants discussed in Note 8 and the warrant exercises discussed in Note 10, will be sufficient to fund our operations into the second quarter of 2015. We will require additional funds to continue our planned operations beyond that date. We are currently seeking sources of non-dilutive capital through government grant programs and clinical trial support, and we also intend to conduct additional offerings of our equity securities. However, additional funding may not be available on favorable terms or at all and if we fail to obtain 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.Presentation

 

The accompanying condensed consolidated financial statements at September 30, 2014March 31, 2015 and for the three month and nine month periods ended September 30,March 31, 2015 and 2014 and 2013 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 financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2013.2014. 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.

 

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 date of the financial statements. We are devoting substantially all of our present efforts to research and development of our vaccine candidates. We have funded our activities to date from government grants and clinical trial assistance, 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 and grant commitments will be sufficient to fund our planned operations through the first quarter of 2016.

We expect we will need to raise additional funds to significantly advance our vaccine development programs and we are currently exploring sources of capital through government grant programs and clinical trial support. We may also secure additional funds through the exercise of currently outstanding stock purchase warrants, and we may seek funds through additional sales of our equity securities. However, additional funding may not be available on favorable terms or at all. 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.

3.        Significant Accounting Policies and Recent Accounting Pronouncements

We disclosed in Note 2 to our financial statements included in our Annual Report on Form 10-K for the year ended December 31, 20132014 those accounting policies that we consider significant in determining our results of operations and financial position. There have been no material changes to, or in the application of, the accounting policies previously identified and described in the Form 10-K.

 

2.                Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“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 customers 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 2017 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.

 

 

In June 2014, the FASB issued Accounting Standards Update 2014-10, Development Stage Entities (Topic 915) ("ASU 2014-10"). The amendments in ASU 2014-10 remove the definition of a development stage entity from Topic 915, thereby removing the distinction between development stage entities and other reporting entities from U.S. GAAP. In addition, the amendments eliminate the requirements for development stage entities to (1) present inception-to-date information on the statements of income, cash flows, and shareholder’s equity, (2) label the financial statements as those of a development stage entity, (3) disclose a description of the development stage activities in which the entity is engaged, and (4) disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development stage. For public business entities, those amendments are effective for annual reporting periods beginning after December 15, 2014, and interim periods therein. Early adoption is permitted. We have evaluated this accounting standard and determined it to have a material impact on our financial statements. We adopted ASU-2014-10 effective June 30, 2014 and the effects of the adoption are reflected in our financial statements and footnotes contained herein.

In August 2014, the FASB issued Accounting Standards Update 2014-15, Presentation of Financial Statements – Going Concern (“ASU 2014-15”), which requires management of all entities to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued, and to make certain disclosures if it concludes that substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern. ASU 2014-15 is effective for the Company for annual reporting periods beginning in 2016 and for interim reporting periods starting in the first quarter of 2017. We are currently evaluating the impact of the adoption of ASU 2014-15 on our financial statements.

There have been no other recent accounting pronouncements or changes in accounting pronouncements during the ninethree months ended September 30,March 31, 2015, as compared to the recent accounting pronouncements described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, which we expect to have a material impact on our financial statements.

 

3.4.        Basic and Diluted Loss Per Common Share

 

Basic net loss per share is computed using the weighted-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 common share equivalents consist of convertible preferred stock, stock options and stock purchase warrants. Common share equivalents which potentially could dilute basic earnings per share in the future, and which were excluded from the computation of diluted loss per share, as the effect would be anti-dilutive, totaled approximately 12.574.6 million and 10.313.0 million shares at September 30,March 31, 2015 and 2014, and 2013, respectively.

 

4.                Balance Sheet Components5.        Property and Equipment

 

The tables below provide a breakdown of certain line itemsProperty and equipment as shown on the accompanying condensed consolidated balance sheets.Condensed Consolidated Balance Sheets is composed of the following as of March 31, 2015 and December 31, 2014:

 

 

September 30,

2014

  

December 31,

2013

  

March 31,

2015

  

December 31,

2014

 

Property and equipment:

        

Laboratory equipment

 $510,106  $474,603  $525,956  $510,106 

Leasehold improvements

  115,605   115,605   115,605   115,605 

Other furniture, fixtures & equipment

  28,685   28,685   28,685   28,685 

Total property and equipment

  654,396   618,893   670,246   654,396 

Accumulated depreciation and amortization

  (541,169)  (498,666)  (564,937)  (557,703)

Property and equipment, net

 $113,227  $120,227  $105,309  $96,693 
        

Other assets:

        

Technology licenses

 $248,855  $248,855 

Deposits

  11,010   11,010 

Accumulated amortization – technology licenses

  (246,355)  (238,855)

Total other assets

 $13,510  $21,010 

 

5.6.        Commitments

 

Lease Agreement

 

We lease approximately 8,400 square feet of office and laboratory space located in Smyrna, Georgia (metropolitan Atlanta)., pursuant to an operating lease which expires on December 31, 2015, with two successive 12-month renewal options. As of September 30, 2014,March 31, 2015, our future minimum lease payments pursuant tofor the 62 month operatingcurrent lease term (not including the renewal periods) total $32,710$109,569 for the remainder of 2014.2015.


 

OtherCommitments

 

In the normal course of business, we may enter into various firm purchase commitments related to production and testing of our vaccines,vaccine material, conduct of our clinical trials, and other research-related activities. As of September 30, 2014,March 31, 2015, we had approximately $211,000$85,200 of unrecorded outstanding purchase commitments to our vendors and subcontractors, all of which we expect will be due in 2014.2015.

 

6.                Stockholders’ Equity7.        Preferred Stock

 

Preferred Stock Transactions

During the nine months ended September 30, 2014, we issued an aggregate of 202,857 and 1,500,000 shares of our common stock related to conversions of our Series A and Series B Convertible Preferred Stock respectively.

As of September 30, 2014,March 31, 2015, there are no shares of our Series A Convertible Preferred Stock outstanding, and 1,125100 shares of our Series B Convertible Preferred Stock outstanding, convertible into 3,214,286285,714 shares of our common stock. During the three months ended March 31, 2015, there were no conversions or other transactions involving our Series B Convertible Preferred Stock.

Series C Convertible Preferred Stock

Our Certificate of Incorporation authorizes us to issue up to 10,000,000 shares of preferred stock, $.01 par value. In February 2015, we established from the authorized preferred stock a series of preferred stock, consisting of 3,000 shares of Series C Convertible Preferred Stock, $1,000 stated value (“Series C Preferred Shares”) and entered into a Securities Purchase Agreement (“SPA”) whereby we issued to two institutional investors (“Purchasers”) the Series C Preferred Shares for gross proceeds of $3.0 million. Net proceeds to the Company from this transaction, after deduction of placement agent fees and other expenses, were approximately $2.7 million.

The Series C Preferred Shares may be converted at any time at the option of the Purchasers into shares of our common stock at an initial conversion price of $0.18 per share (“Conversion Price”), for an aggregate total of 16,666,666 shares of our common stock (“Conversion Shares”). The Series C Preferred Shares have a liquidation preference equal to the initial purchase price, have no voting rights, and are not entitled to a dividend.The Series C Preferred Shares contains price adjustment provisions, which may, under certain circumstances, reduce the conversion price on several future dates, including the effective date of the registration statement covering resale of the common stock subject to the Series C Preferred Shares, according to a formula based on the then-current market price for our common stock.


Pursuant to the terms of the SPA, we issued to each Purchaser Series D, E and F Warrants (collectively, the “Investor Warrants”), each to purchase up to a number of shares of our common stock equal to 100% of the Conversion Shares underlying the Series C Preferred Shares (up to 16,666,666 shares in the aggregate for each of the three series of warrants, or 49,999,998 shares in total). The Series D Warrants have an initial exercise price of $0.22 per share, are exercisable immediately, and have a term of exercise equal to five years from the date of issuance. The Series E Warrants have an initial exercise price of $0.18 per share, are exercisable immediately, and have a term of exercise equal to one year from the date of issuance. The Series F Warrants have an initial exercise price of $0.22 per share and have a term of exercise equal to five years from the date of issuance, but only vest and become exercisable upon, and in proportion to, the exercise of the one-year Series E Warrants.We also issued to our placement agent warrants (“Placement Agent Warrants”) to acquire 1,333,333 shares of our Common Stock with terms substantially the same as the Series D Warrants.The Investor Warrants and Placement Agent Warrants contain anti-dilution and price adjustment provisions, which may, under certain circumstances, (i) reduce the exercise price on several future dates, including the effective date of the registration statement covering resale of the shares subject to the warrants, according to a formula based on the then-current market price for our common stock and (ii) reduce the exercise price to match if we sell or grant options to purchase, including rights to reprice, our common stock or common stock equivalents at a price lower than the exercise price of the warrants, or if we announce plans to do so. The number of shares subject to warrants will not increase due to such reductions in exercise price.

In connection with the sale of the Series C Preferred Shares, we entered into a Registration Rights Agreement (“RRA”) with the Purchasers, pursuant to which we filed a registration statement with the Securities and Exchange Commission (“SEC”) on March 20, 2015. It was declared effective by the SEC on April 8, 2015, which triggered the price adjustment provisions of the Series C Preferred Shares and the related warrants. As of that date, the conversion price of the Series C Preferred Shares was reduced to $0.142, the exercise price of the Series D and Series F Warrants was reduced to $0.1704, and the exercise price of the Series E Warrants and Placement Agent Warrants was reduced to $0.142.

Accounting Treatment and Allocation of Proceeds. We first assessed the Series C Preferred Shares under ASC Topic 480, “Distinguishing Liabilities from Equity” (“ASC 480”) and determined such preferred stock not to be a liability under ASC 480. We next assessed the preferred stock under ASC Topic 815. “Derivatives and Hedging” (“ASC 815”). 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 believe that the preferred stock is an “equity host” (as described by ASC 815) for purposes of assessing the embedded derivative for potential bifurcation and determined that the optional conversion feature is clearly and closely associated to the preferred stock host; we therefore determined that the embedded derivative does not require bifurcation and separate recognition under ASC 815. We then assessed the preferred stock under ASC Topic 470, “Debt” (“ASC 470”), and determined there to be no beneficial conversion feature (“BCF”) requiring recognition at the issuance date. We also assessed the warrants issued in connection with the financing under ASC 815 and determined that they do not initially meet the definition of a derivative, but will require evaluation on an on-going basis.

The following is a summary of the allocation of the net proceeds from the preferred stock financing:

Net proceeds after transaction costs

 $2,679,809 

Less: Fair value of warrants (recorded to Additional Paid-in Capital)

  (1,695,868)

Recorded value of Series C Preferred Shares at March 31, 2015

 $983,941 

8.        Common Stock

Increase in Authorized Shares of Common Stock

At our annual meeting of stockholders held on May 12, 2015, our stockholders approved an amendment to our certificate of incorporation to increase our authorized shares of common stock from 75,000,000 shares to 150,000,000 shares. The amendment to our certificate of incorporation was filed with the Delaware Secretary of State on May 13, 2015.

 

Common Stock Transactions

 

In addition to common stock issued pursuant toDuring the conversion ofthree months ended March 31, 2015, there were no transactions involving our Series A and Series B Convertible Preferred Stock described above, in July 2014, we issued 250,000 shares of our common stock for certain consulting services from a third party and recorded stock-based compensation expense of $50,000 related to the issuance.Common Stock.


 

Stock Options

 

We maintain a stock option plan that provides the Board of Directors broad discretion in creating equity incentives for employees, officers, directors and consultants. Theconsultants.The following table presents a summary of stock option transactions during the ninethree months ended September 30, 2014:March 31, 2015:

 

 

Number of Shares

  

Weighted Average

Exercise Price

  

Number of Shares

  

Weighted Average

Exercise Price

 

Outstanding at December 31, 2013

  1,197,044  $3.79 

Outstanding at December 31, 2014

  1,183,100  $3.50 

Granted

  7,500   0.29   26,400   0.15 

Exercised

  --   --   --   -- 

Forfeited or expired

  (231,444)  1.89   (32,000)  0.94 

Outstanding at September 30, 2014

  973,100  $4.22 

Exercisable at September 30, 2014

  616,594  $6.30 

Outstanding at March 31, 2015

  1,177,500  $3.49 

Exercisable at March 31, 2015

  753,594  $5.27 

 

Stock Purchase Warrants

 

We have previously issuedThe following table presents a summary of stock purchase warrants in connection with financingwarrant transactions and also in exchange for services from consultants and others. As of September 30, 2014, there are 8,284,826 stock purchase warrants outstanding, with a weighted average exercise price of $0.54. During October 2014, 3,176,000 of these warrants were exercised for cash (see Note 10).

Effective September 30, 2014, we reduced the exercise price of certain warrants to purchase an aggregate of 818,376 shares of our common stock from $16.50 to $1.00 per share, and extended the expiration date of the warrants from December 31, 2014 to December 31, 2016. We recorded general and administrative expense of $39,711 associated with these modifications, all of which was recognized during the three month periodmonths ended September 30, 2014.March 31, 2015:

  

Number of Shares

  

Weighted Average

Exercise Price

 

Outstanding at December 31, 2014

  5,108,826  $0.66 

Issued – Series D Warrants (1)

  16,666,666   0.22 

Issued – Series E Warrants (1)

  16,666,666   0.18 

Issued – Series F Warrants (1)

  16,666,666   0.22 
Issued – Placement Agent Warrants (1)  1,333,333   0.22 

Outstanding at March 31, 2015

  56,442,157  $0.24 

Exercisable at March 31, 2015

  39,775,491  $0.25 

(1)

See discussion under “Series C Convertible Preferred Stock” in Note 7.

 

Stock-Based Compensation Expense

 

During the three month and nine month periods ended September 30,March 31, 2015 and 2014, we recorded share-based compensation expense related to stock options of $24,573$16,902 and $75,927, respectively, as compared to $33,348 and $116,600 for the three month and nine month periods ended September 30, 2013,$26,307, respectively. Share-based compensation expense 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, 2014,March 31, 2015, there was $106,939$96,327 of unrecognized compensation expense related to stock options, which is expected to be recognized over a weighted average period of 1.71.8 years.

As discussed under “Stock Purchase Warrants” above, during the three month and nine month periods ended September 30, 2014, we recorded general and administrative expense associated with modifications to certain stock purchase warrants of $39,711. During the comparable periods of 2013, we recorded general and administrative expense associated with modifications to then-outstanding stock purchase warrants of $-0- and $238,169, respectively.

As discussed under “Common Stock Transactions” above, during the three month and nine month periods ended September 30, 2014, we recorded general and administrative expense associated with the issuance of 250,000 shares of our common stock for consulting services of $50,000.


 

Common Stock Reserved

 

A summary of our common stock reserved for future issuance is as follows as of September 30, 2014:March 31, 2015:

 

Series B Convertible Preferred Stock (see Note 10)

  3,214,286285,714

Series C Convertible Preferred Stock

16,666,666 

Common Stock Purchase Warrants (see Note 10)

  8,284,82656,442,157 

Equity Incentive Plans

  1,197,529 

Total

  12,696,64174,592,066 

 

7.9.        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 may be subject to substantial annual limitations due to ownership change provisions of Section 382 of the Internal Revenue Code. The annual limitation may result in the expiration of net operating losses and credits before utilization.

 


8.10.        Government Grants

In September 2007, the NIH awarded us an Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant to support our HIV/AIDS vaccine program. We have utilized this funding to further our HIV/AIDS vaccine development, optimization and production. The aggregate award (including subsequent amendments) totaled approximately $20.4 million and, as of September 30, 2014, there is approximately $215,000 of unused grant funds remaining and available for use.

In July 2013, the NIH awarded us a Small Business Innovative Research (SBIR) grant entitled “Enhancing Protective Antibody Responses for a GM-CSF Adjuvanted HIV Vaccine.” The initial grant award of approximately $277,000 was for the first year of a two year project period beginning August 1, 2013 and has been fully utilized. In July 2014, the NIH awarded us a grant of approximately $290,000 for the second year of the project period, and as of September 30, 2014, there is approximately $237,000 of unused grant funds remaining and available for use.

 

We record revenue associated with thesegovernment grants as the related costs and expenses are incurred and such revenue is reported as a separate line item in our statements of operations. Grant revenues recorded during the three months ended March 31, 2015 and 2014 relate to grants from the NIH in support of our HIV vaccine development activities. There is an aggregate of approximately $125,541 in approved grant funds remaining and available for use as of March 31, 2015, which we anticipate recognizing as revenue during the remainder of 2015.

 

9.11.        Related Party Transactions

 

We are obligated to reimburse Emory University (a significant stockholder of the Company) for certain prior and ongoing costs in connection with the filing, prosecution and maintenance of patent applications subject to our technology license agreement from Emory. During the nine month periodthree months ended September 30,March 31, 2015 and 2014, we recorded $135,150$41,315 and $43,919, respectively, of general and administrative expense associated with these patent cost reimbursements to Emory.

  

10.              Subsequent Events

During October 2014, we issued 2,928,571 shares of our common stock related to conversions of our Series B Convertible Preferred Stock. Subsequent to these conversions, 100 shares of our Series B Convertible Preferred Stock remain outstanding, convertible into 285,715 shares of our common stock.

During October 2014, we entered into an agreement with certain holders of our Series A and Series C Common Stock Purchase Warrants (“Warrants”) with respect to the payment to them of a warrant exercise fee of $0.075 per share for each share purchased upon exercise of Warrants held by them. In exchange for the fee, they immediately exercised Warrants for an aggregate of 3,176,000 shares of our common stock, resulting in proceeds to us of $873,400 (net of the exercise fee). We reserved the right to revoke this warrant exercise fee arrangement as to any unexercised Warrants upon five business days’ notice.

In November 2014, we issued 128,205 shares of our common stock for certain consulting services from a third party and recorded stock-based compensation expense of $50,000 related to the issuance.


 

Item 2        Management’s Discussion and Analysis of Financial Condition And Results of Operations

 

FORWARD LOOKING STATEMENTS

 

In addition to historical information, the information 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” in the Annual Report on Form 10-K for the year ended December 31, 2013,2014, 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’’ 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; and

whether we are adversely affected in our efforts to raise capitalcash 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. We assume no obligation to update forward-looking statements.

 

Overview

 

GeoVax is a clinical-stage biotechnology company developing innovative human vaccines using our novel DNA/MVA platform technology. Our primary focus is to develop vaccines that preventlead development programs are focused on Ebola, Marburg, and fightHIV. Our HIV infections, and we have recently expanded our research and development efforts to include vaccines to prevent Ebola virus infection. We have exclusively licensed from Emory University (“Emory”) certain vaccine technology which was developed in collaboration with researchers at Emory University, the National Institutes of Health (“NIH”)NIH, and the Centers for Disease ControlCDC, and Prevention (“CDC”). GeoVax is incorporated underexclusively licensed to us from Emory University. We also have nonexclusive licenses to certain patents owned by the laws ofNIH. Our Ebola/Marburg vaccines are being developed with technology licensed to us from the State of Delaware and our principal offices are located in Smyrna, Georgia (metropolitan Atlanta area). 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.NIH.

 

Our most advanced vaccines underEbola vaccine development efforts were initiated in 2014 and we expect to conduct preclinical animal studies during 2015, with the goal of beginning human clinical testing in 2016. Our HIV vaccine development efforts are focused on a preventive vaccine to address the clade B subtype of the HIV virus that is most prevalent in the United Statesdeveloped world – primarily North America and Western Europe. Our preventive clade B HIV vaccine has successfully completed Phase 2a clinical trials and we are currently planningexploring our options to secure funding to advance our vaccine directly into pivotal Phase 2b efficacy trials. In the next stagemeantime, through collaboration with the NIH and HVTN, in late 2015 we expect to initiate a Phase 1 clinical trial investigating the effect of human clinical testing.a “protein boost” to increase the antibody responses elicited by our vaccine. We are also planning clinical trials to evaluate our clade B HIV vaccine as an immunotherapy agent for individuals already infected with HIV. WeHIV, and we have begun earlierearly-stage preclinical studies to develop HIV vaccine candidates for the clade C subtype of HIV prevalent in the developing world. Our Ebola vaccine development efforts have recently been initiated and we expect to begin preclinical animal studies during 2015, with the goal of beginning human clinical testing in 2016.

 

Our activities are subject to significant risks and uncertainties, including our ability to secure the funding necessary to complete our research and development efforts. We have neither received regulatory approval for any of our vaccine candidates, nor do we have any commercialization capabilities; therefore, it is possible that we may never successfully derive significant product revenues from any of our existing or future development programs or product candidates.

 


We expect for the foreseeable future our operations will result in a net loss on a quarterly and annual basis. As of September 30, 2014, we had an accumulated deficit of approximately $28.9 million.

 

 

Critical Accounting Policies and Estimates

 

This discussion and analysis of our financial condition and results of operations is based on the accompanying unaudited condensed 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 significant accounting policies are summarized in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2013.2014. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements:

 

Revenue Recognition

 

We recognize revenue in accordance with the SEC’s Staff Accounting Bulletin No. 101,Revenue Recognition in Financial Statements,as amended by Staff Accounting Bulletin No. 104,Revenue Recognition, (SAB 104)(“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, non-refundablenonrefundable fees received in connection with research collaboration agreements. OurDuring 2015 and 2014, our revenue consists solelyconsisted of grant funding received from the NIH. Revenue from this arrangementthese arrangements is approximately equal to the costs incurred and is recorded as income as the related costs are incurred.

In May 2014, the Financial Accounting Standards Board (“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 customers 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 2017 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-valuefair 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.

 

Liquidity and Capital Resources

 

At September 30, 2014, we hadHistorically, our primary uses of cash have been to finance our research and cash equivalents of $862,191 and total assets of $1,053,128, as compared to $2,513,861 and $2,839,576, respectively, at December 31, 2013. Working capital totaled $756,158 at September 30, 2014, compared to $2,385,990 at December 31, 2013.

Sources and Uses of Cash

development activities. We have funded our activities to date primarily from government grants and clinical trial assistance, and from sales of our equity securities. We will continueDue to require substantial funds to continue these activities. our significant research and development expenditures, we have not been profitable and have generated operating losses since our inception in 2001.

We believe that our existing cash resources combined with the proceeds from the NIH grants discussed below will be sufficient to fund our planned operations intothrough the first quarter of 2015.2016. We will require additional funds to continue our planned operations beyond that date. We are currently seeking sources of non-dilutive capital through government grant programs and clinical trial support, and we may also intend to conduct additional offerings of our equity securities. However, additional 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.

 

Cash Flows from Operating ActivitiesAt March 31, 2015, we had cash and cash equivalents of $3,146,728 and working capital of $3,026,113, as compared to $1,101,651 and $1,038,472, respectively, at December 31, 2014. As of March 31, 2015, we had an accumulated deficit of $30.5 million and we expect for the foreseeable future our operations will result in a net loss on a quarterly and annual basis.

 

Net cash used in operating activities was $1,616,167$618,882 and $503,535 for the ninethree month periodperiods ended September 30,March 31, 2015 and 2014, as compared to $872,040respectively.


Net cash used in investing activities was $15,850 and $-0- for the comparable period in 2013. Generally,three month periods ended March 31, 2015 and 2014, respectively.

Net cash provided by financing activities was $2,679,809 and $-0- for the differences betweenthree month periods are dueended March 31, 2015 and 2014, respectively. The increase is related 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, offset by government grant revenues.February 2015 financing discussed below.

 

The NIH 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 are actively engaged in discussions withalso expect the HIV Vaccine Trials Network (HVTN) and NIH regardingto fully fund the next stagecost of another Phase 1 trial (HVTN 114) of our preventive clinical trials. While we believe that HVTN and NIH will continue their support of our HIV vaccine developmentto begin in late 2015, which will investigate the effect of adding a “protein boost” component to our vaccine. While efforts are underway to evaluate the specific path forward is currently uncertain andprotein boost concept, we cannot be fully assured of the level of support, if any, we will receive from the HVTN or the NIH for additional clinical trials. Our expectations have been that HVTN would advancealso intend to seek funding to expedite our DNA/MVAun-boosted vaccine (GOVX-B11) directly into apivotal Phase 2b efficacy study, but recent discussions have included the concept of adding another component (protein boost) to the vaccine regimen. If so, this will change the nature of the next clinical trial. The HVTN and NIH are continuing to consider future efficacy studies, and members are working to develop collaborative clinical development plans, as well as initiating regulatory planning. The plans for large-scale clinical trials may change as researchers continue to gather information from our earlier studies and are influenced by results from other vaccine trials. Trial start dates are dependent on many factors and are likely to change.

 


Earlier inDuring 2014, we completed a Phase 1 clinical trial (GV-TH-01) investigating the therapeutic use of our GOVX-B11 vaccine in HIV-infected patients. We received no federal assistance in conducting this study. Data and observations from this trial have led usFuture therapeutic studies of our vaccine may investigate the vaccine’s ability to plan an additional clinical trial to investigate our DNA/MVA vaccinesact as “shock” agents for potential usea “shock agent” in a “shockshock and kill” clinical strategykill therapy in combination with standard of care antiretroviral drug therapy to seek a cure for HIV infection. Our planningWe are currently not contemplating the use of any of our existing cash resources for this trial is fluid, but currently we anticipate a Phase 1bprogram. The timetable and specific plans for additional clinical trial testing this concept to begin during 2015. Initiation of this trial, which we expect will cost under $1 million,studies will be dependent upon our ability to secure external funding for the required funding. We planprogram, and on the nature of any potential collaborations we may establish.

Our Ebola/Marburg vaccine program began in late 2014, and our primary activities during 2015 are focused on constructing the vaccines and conducting preclinical animal studies. During April 2015, we entered into a Research Collaboration Agreement with the National Institute of Allergy and Infectious Disease (NIAID), part of NIH, pursuant to seek funding from U.S. government sources to conduct this trial, but wewhich NIAID will also consider obtaining funds from issuance of our equity securities or other sources. Successcontribute certain materials and will carry out animal protection studies in this trial will be a first step toward commercialization of our vaccines for use as the shock agentsmall animals and, potentially, in shock and kill protocols for curing HIV infections. Our commercialization strategy will include use of our vaccines in combination with kill agents being developed by others as well as those undergoing development by GeoVax.non-human primates.

 

In addition to clinical trial support from the NIH for our preventive HIV vaccines and collaborative research support from NIAID for our Ebola vaccine program, our operations have been partially funded by NIH research grants. We record the funding we receive pursuant to these grants as revenue at the time the related expenditures are incurred.for our HIV program. As of September 30, 2014,March 31, 2015, there iswas an aggregate of approximately $452,000$125,500 of unused grant funds available for use during the remainder of 2014 and through July 2015. We intend to pursue additional grants from the federal government for our HIV and Ebola programs but cannot be assured of success. 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. Therefore, it will be necessary for us to look to other sources of funding in order to finance our clinical trials and other vaccine development activities.

 

Cash Flows from Investing Activities

Our investing activities consist predominantlyIn February 2015, we sold shares of capital expenditures. During the nine months ended September 30, 2014, we incurred $35,503Series C convertible preferred stock for an aggregate purchase price of capital expenditures, as compared to $86,602 during the comparable period in 2013.

Cash Flows from Financing Activities

No cash was provided by financing activities for the nine month period ended September 30, 2014, as compared to $1,643,333 for the comparable period in 2013. The cash generated by our financing activities during the nine month period ended September 30, 2013 relates to the exercise of certain stock purchase warrants.

Our capital requirements, particularly as they relate to our research and development activities, have been and will continue to be significant. We anticipate incurring additional losses for several years as we expand our clinical programs and proceed into higher cost human clinical trials. Conducting clinical trials for our vaccine candidates in development is a lengthy, time-consuming and expensive process. We will not generate revenues from the sale of our technology or products for at least several years, if at all. For the foreseeable future, we will be dependent on obtaining financing from third parties in order to maintain our operations, including our clinical program. Such capital may not be available on terms acceptable$3.0 million.Net proceeds to the Company or at all. Ifwere approximately $2.7 million. As part of this transaction, we fail to obtain additional funding when needed, we would be forced to scale back or terminate our operations, or to seek to merge with or to be acquired by another company.

We expect that our current working capital combined with the remaining available funds from the NIH grants will be sufficient to support our planned levelalso issued several series of operations into the second quarter of 2015. We anticipate raising additional capital during 2014 or early 2015, although there can be no assurance that we will be able to do so. While we believe that we will be successful in obtaining the necessary financing to fund our operations through government grantsfive-year and clinical trial support, exercise ofone-year stock purchase warrants. The one-year warrants or other sources, there can be no assurances that such additional funding will be availablehave a current exercise price of $0.142 and an expiration date of February 27, 2016. If exercised in full, these warrants would result in net cash proceeds to us on reasonable terms or at all. 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.of approximately $2.4 million.

 

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, 2014,March 31, 2015, we had noncancellable lease obligations and other firm purchase obligations totaling approximately $243,000,$195,000, as compared to approximately $206,000$297,000 at December 31, 2013.2014. 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, 2013.2014.


 

Results of Operations

 

Net Loss

 

We recorded a net loss of $514,515$700,454 for the three months ended September 30, 2014,March 31, 2015, as compared to a net loss of $190,148$615,918 for the three months ended September 30, 2013. For the nine months ended September 30, 2014, we recorded a net loss of $1,809,970, as compared to a net loss of $1,413,229 for the nine months ended September 30, 2013.March 31, 2014. 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 Revenue

 

During the three and nine month periodsmonths ended September 30, 2014March 31, 2015, we recorded aggregate grant revenuerevenues of $322,086 and $659,867, respectively,$103,424, as compared to $1,004,211 and $2,242,812, respectively,$157,340 during the comparable periodsperiod of 2013.2014. Grant revenues for these periods relate to grants from the NIH in support of our HIV vaccine development activities (see discussion under “Liquidity and Capital Resources” above).activities. We record revenue associated with these grants as the related costs and expenses are incurred. The difference in our grant revenues from period to period is directly related to our expenditures for activities supported by the grants, and can fluctuate significantly based on the timing of the related expenditures.


In September 2007, the NIH awarded us a grant entitled “GM-CSF-Adjuvanted Clade C DNA/MVA and MVA/MVA Vaccines”. The aggregate award (including subsequent amendments) totaled approximately $20.4 million. We recorded grant revenues of $60,628 and $103,352 for the three months ended March 31, 2015 and 2014, respectively, related to this grant. There is an aggregate$14,836 of approximately $452,000 in approvedunrecognized grant funds remaining and available for use pursuant to this grant as of September 30, 2014,March 31, 2015, which we anticipate recognizing as revenue during the remainder of 2015.

In July 2013, the NIH awarded us a Small Business Innovative Research (SBIR) grant entitled “Enhancing Protective Antibody Responses for a GM-CSF Adjuvanted HIV Vaccine.” The initial grant award was $276,690 for the first year of a two year project period beginning August 1, 2013. In July 2014, the NIH awarded us $289,641 for the second year of the project period. We recorded grant revenues of $42,796 and through July$53,988 for the three months ended March 31, 2015 and 2014, respectively, related to this grant. There is $110,705 of unrecognized grant funds remaining and available for use pursuant to this grant as of March 31, 2015, which we anticipate recognizing as revenue during the remainder of 2015.

 

Research and Development

 

During the three month and nine month periodsmonths ended September 30, 2014,March 31, 2015, we incurred $425,498 and $1,344,560, respectively,recorded $403,629 of research and development expense, as compared to $879,104 and $2,341,291, respectively,$402,860 during the three month and nine month periodsmonths ended September 30, 2013.March 31, 2014. Research and development expense for the three month and nine monththese periods of 2014 includes stock-based compensation expense of $7,404$5,316 and $24,420, respectively, while$9,138 for the comparable2015 and 2014 periods, of 2013 include stock-based compensation expense of $9,048 and $32,789, respectively (see discussion under “Stock-Based Compensation Expense” below).

Our research and development expenses can fluctuate considerably on a period-to-period basis. The overall decrease in research and development expense duringbasis, depending on our need for vaccine manufacturing by third parties, the three and nine month periods ended September 30, 2014, as compared to the comparable 2013 periods, can mostly be attributed to lowertiming of expenditures related to the activities supported by our grants from the NIH, and lower expendituresthe timing of costs associated with a Phase 1 trial of our therapeutic HIV vaccine, which was completed during the first quarter of 2014. We have not received any government support for clinical trials of our therapeutic vaccine. Our researchbeing funding directly by us, 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 the NIH.other factors.

 

We cannot predict the level of support we may receive from the HVTN, NIH, or other federal agencies (or divisions thereof) for our future clinical trials. We expect that our research and development costs will increase in the future as we progress into the later stage human clinical trials for our HIV vaccines and as we expand our Ebola and Marburg vaccine development program.

 

Our vaccine candidates still require significant, time-consuming and costly research and development, testing and regulatory clearances. Completion of clinical development will take several years or more, but the length of time generally varies substantially according to the type, complexity, novelty and intended use of a product candidate. The NIH has funded the costs of conducting all of our completed and ongoing human clinical trials to date for our preventive HIV vaccine, with GeoVax incurring costs associated with manufacturing the clinical vaccine supplies and other study support. We are having discussions with the HVTN and NIH with regard to the conduct of an additional trial of our preventive vaccine, and we expect the NIH will provide support for this trial as well. We intend to seek government and/or third party support for future clinical human trials and for production of our vaccine product for use in clinical trials, but there can be no assurance that we will be successful.

 

The duration and the cost of future clinical trials may vary significantly over the life of the project as a result of differences arising during development of the human clinical trial protocols, including, among others:

 

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.

 

Due to the uncertainty regarding the timing and regulatory approval of clinical trials and pre-clinical studies, our future expenditures are likely to be highly volatile in future periods depending on the outcomes of the trials and studies. From time to time, we will make determinations as to how much funding to direct to these programs in response to their scientific, clinical and regulatory success, anticipated market opportunity and the availability of capital to fund our programs.


 

In developing our product candidates, we are subject to a number of risks that are inherent in the development of products based on innovative technologies. For example, it is possible that our vaccines may be ineffective or toxic, or will otherwise fail to receive the necessary regulatory clearances, causing us to delay, extend or terminate our product development efforts. Any failure by us to obtain, or any delay in obtaining, regulatory approvals could cause our research and development expenditures to increase which, in turn, could have a material adverse effect on our results of operations and cash flows. Because of the uncertainties of clinical trials, estimating the completion dates or cost to complete our research and development programs is highly speculative and subjective. As a result of these factors, we are unable to accurately estimate the nature, timing and future costs necessary to complete the development of our product candidates. In addition, we are unable to reasonably estimate the period when material net cash inflows could commence from the sale, licensing or commercialization of such product candidates, if ever.

 


General and Administrative Expense

 

During the three month and nine month periods ended September 30, 2014, we incurredOur general and administrative costs of $411,814 and $1,128,478, respectively,expenses were $401,441 during the three months ended March 31, 2015, as compared to $316,452 and $1,345,179, respectively,$371,802 during the comparable periods in 2013.three months ended March 31, 2014. General and administrative costs include officers’ salaries, legal and accounting costs, patent costs, amortization expense associated with intangible assets, and other general corporate expenses. General and administrative expense for the three month and nine month periods of 2014 includeincludes stock-based compensation expense of $106,880$11,586 and $141,218, respectively; while$17,169 for the comparable periods of 2013 include stock-based compensation expense of $24,300three months ended March 31, 2015 and $321,980,2014, respectively (see discussion under “Stock-Based Compensation Expense” below). Excluding stock-based compensation expense, general and administrative expenses during the three and nine month periods ended September 30, 2014 were $304,934 and $987,260, respectively, as compared to $292,152 and $1,023,199, respectively, during the comparable periods in 2013. We expect that our general and administrative costs may increase in the future in support of expanded research and development activities and other general corporate activities.

 

Stock-Based Compensation Expense

 

We recorded stock-based compensation expense of $114,284$16,902 and $165,638$26,307 during the three monthmonths ended March 31, 2015 and nine month periods ended September 30, 2014, respectively, as compared to $33,348 and $354,769, respectively, during the comparable periods of 2013. We allocate stock-based compensation expensewhich was 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. In addition to amounts related to the issuance of stock options to employees and directors, the figures amounts related to common stock issued to consultants. Also, during both 2014 and 2013, we modified the terms of certain warrants issued to investors in previous financing rounds to reduce the exercise prices and extend the expiration dates of such warrants; the amounts recorded as stock-based compensation expense related to these modifications were $39,711 for both the three month and nine month periods ended September 30, 2014, and $-0- and $238,169 for the three month and nine month periods ended September 30, 2013, respectively.

For the three monthmonths ended March 31, 2015 and nine month periods ended September 30, 2014, and 2013, stock-based compensation expense was allocated as follows:

 

 

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

  

Three Months Ended March 31,

 

Expense Allocated to:

 

2014

  

2013

  

2014

  

2013

 
 

2015

  

2014

 

General and Administrative Expense

 $106,880  $24,300  $141,218  $321,980  $11,586  $17,169 

Research and Development Expense

  7,404   9,048   24,420   32,789   5,316   9,138 

Total Stock-Based Compensation Expense

 $114,284  $33,348  $165,638  $354,769  $16,902  $26,307 

 

Other Income

 

Interest income for the three monthmonths ended March 31, 2015 and nine month periods ended September 30, 2014 was $711$1,192 and $3,201, respectively, as compared to $1,197 and $3,429, respectively, for comparable periods of 2013.$1,404, respectively. The variances between periods are primarily attributable to cash available for investment and interest rate fluctuations.


 

Item 3        Quantitative 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.

 

Item 4        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 was no change in our internal control over financial reporting that occurred during the three months ended September 30, 2014March 31, 2015 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

 

 

PartPART II -- OTHER INFORMATION

 

Item 1        Legal Proceedings

 

None.

 

Item 1A     Risk Factors

 

For information regarding factors that could affect the our results of operations, financial condition or liquidity, see the risk factors discussed under “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 of Equity Securities and Use of Proceeds

 

On July 16, 2014, we issued 250,000 shares of our common stock to Acorn Management Partners, LLC for services rendered pursuant to a consulting agreement with the Company. For this transaction the Company relied upon Section 4(2) of the Securities Act and Rule 506 promulgated thereunder to issue the common stock. The shares were offered to a single accredited investor who acquired the shares for investment in a transaction that didNone not involve a general solicitation.previously disclosed on Form 8-K.

 

Item 3        Defaults Upon Senior Securities

 

None.

 

Item 4        Mine Safety Disclosures

 

Not applicable

 

Item 5        Other 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 6        Exhibits

 

The exhibits filed with this report are set forth on the exhibit index following the signature page and are incorporated by reference in their entirety into this item.

 

 

 

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:     May 14, 2015

Date:     November 11, 2014By:/s/

By: /s/ Mark W. Reynolds

Mark W. Reynolds

Chief Financial Officer

(duly authorized officer and principal

financial officer)

 

 

 

EXHIBIT INDEX

Exhibit

Exhibit
NumberDescription

2.1

NumberDescription

Agreement and Plan of Merger dated January 20, 2006 by and among GeoVax, Inc., GeoVax Acquisition Corp. and Dauphin Technology, Inc. (1)

2.2

First Amendment to Agreement and Plan of Merger (2)

2.3

Second Amendment to Agreement and Plan of Merger (3)

 

3.1

Certificate of Incorporation (4)(1)

3.1.1

Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed April 13, 2010 (5)(2)

3.1.2

Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed April 27, 2010 (6)(3)

3.1.3

Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed August 2, 2013 (8)(4)

3.1.4

Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed May 13, 2015 (7)

3.2

Bylaws (4)(1)

4.1.1

Amendment to Certificate of Designation of Series A Convertible Preferred Stock filed December 13, 2013 (9)

4.1.24.2.1

Form of Stock Certificate for the Series B Convertible Preferred Stock (9)

4.2

Form of Stock Certificate for the Series A Convertible Preferred Stock (7)

4.3

Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock filed December 13, 2013 (9)(5)

4.44.2.2

Form of Stock Certificate for the Series B Convertible Preferred Stock (5)

4.3.1

Form of Certificate of Designation of Preferences, Rights and Limitations of Series AC Convertible Preferred Stock filed March 20, 2012 (7)February 27, 2015 (6)

4.3.2

Form of Stock Certificate for the Series C Convertible Preferred Stock (6)

10.1

Form of LetterSecurities Purchase Agreement dated October 14, 2014 providing for payment of warrant exercise fee (10)February 25, 2015 (6)

10.2

Form of Registration Rights Agreement dated February 25, 2015 (6)

10.3

Form of Series D Warrant dated February 27, 2015 (6)

10.4

Form of Series E Warrant dated February 27, 2015 (6)

10.5

Form of Series F Warrant dated February 27, 2015 (6)

10.6

Form of Maxim warrant dated February 27, 2015 (6)

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 quarter ended September 30, 2014,March 31, 2015, formatted in Extensible Business Reporting Language (XBRL): (i) Condensed Consolidated Balance Sheets as of September 30, 2014March 31, 2015 (unaudited) and December 31, 2013,2014, (ii) Condensed Consolidated Statements of Operations (unaudited) for the three month and nine month periods ended September 30,March 31, 2015 and 2014, and 2013, (iii) Condensed Consolidated Statements of Cash Flows (unaudited) for the ninethree month periods ended September 30,March 31, 2015 and 2014, and 2013, and (iv) Notes to Condensed Consolidated Financial Statements (unaudited).

 

_____________________

*

*     Filed herewith

**

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 on January 24, 2006.

(2)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed on July 13, 2006.

(3)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed on October 4, 2006.

(4)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed on June 23, 2008.

(5)(2)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed April 14, 2010.

(6)(3)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed April 28, 2010.

(7)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed March 22, 2012.

(8)(4)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed August 2, 2013.

(9)(5)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed December 17, 2013.

(10)(6)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed October 15, 2014March 2, 2015.

(7)

Incorporated by reference from the registrant’s Current Report on Form 8-K filed May 14, 2015.

15

16