Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2010
OR
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o |
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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)
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Delaware
(State or other jurisdiction
of incorporation or organization)
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87-0455038
(I.R.S. Employer Identification No.) |
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1900 Lake Park Drive
Suite 380
Smyrna, Georgia
(Address of principal executive offices)
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30080
(Zip Code) |
(678) 384-7220
(Registrants 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 þ No o
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 45 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 o No o
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 o |
Accelerated filer þ | Non-accelerated filer o (Do not check if a smaller reporting company) | Smaller reporting company o
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act): Yes o No þ
As of August 6, 2010, 15,654,846 shares of the Registrants common stock, $.001 par value, were
issued and outstanding.
Part I FINANCIAL INFORMATION
Item 1 Financial Statements
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30, |
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December 31, |
|
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2010 |
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2009 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
|
$ |
1,807,647 |
|
|
$ |
3,515,784 |
|
Grant funds receivable |
|
|
1,102,923 |
|
|
|
320,321 |
|
Prepaid expenses and other |
|
|
37,791 |
|
|
|
44,615 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total current assets |
|
|
2,948,361 |
|
|
|
3,880,720 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Property and equipment, net of accumulated depreciation and amortization
of $236,741 and $177,686 at June 30, 2010 and December 31, 2009,
respectively |
|
|
285,147 |
|
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344,202 |
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|
|
|
|
|
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Other assets: |
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Licenses, net of accumulated amortization of $171,604 and $159,161
at June 30, 2010 and December 31, 2009, respectively |
|
|
77,252 |
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|
89,695 |
|
Deferred offering costs |
|
|
524,886 |
|
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|
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|
Deposits and other |
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11,990 |
|
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|
980 |
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|
|
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|
|
|
|
|
|
|
|
|
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Total other assets |
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614,128 |
|
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|
90,675 |
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|
|
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|
|
|
|
|
|
|
|
|
|
|
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Total assets |
|
$ |
3,847,636 |
|
|
$ |
4,315,597 |
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|
|
|
|
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable and accrued expenses |
|
$ |
602,047 |
|
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$ |
408,344 |
|
Amounts payable to Emory University (a related party) |
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622,460 |
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163,021 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total current liabilities |
|
|
1,224,507 |
|
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|
571,365 |
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|
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Commitments |
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Stockholders equity: |
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Common stock, $.001 par value, 18,000,000 shares authorized;
15,654,846 and 15,632,564 shares outstanding at
June 30, 2010 and December 31, 2009, respectively |
|
|
15,655 |
|
|
|
15,633 |
|
Additional paid-in capital |
|
|
21,769,200 |
|
|
|
21,266,447 |
|
Deficit accumulated during the development stage |
|
|
(19,161,726 |
) |
|
|
(17,537,848 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
2,623,129 |
|
|
|
3,744,232 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
3,847,636 |
|
|
$ |
4,315,597 |
|
|
|
|
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
1
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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From Inception |
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June 30, |
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|
June 30, |
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(June 27, 2001) to |
|
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2010 |
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|
2009 |
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|
2010 |
|
|
2009 |
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|
June 30, 2010 |
|
Grant revenue |
|
$ |
1,737,169 |
|
|
$ |
752,800 |
|
|
$ |
3,075,729 |
|
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$ |
1,462,955 |
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|
$ |
13,302,279 |
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Operating expenses: |
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|
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|
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Research and development |
|
|
1,741,966 |
|
|
|
1,202,894 |
|
|
|
3,111,151 |
|
|
|
2,060,130 |
|
|
|
19,671,496 |
|
General and administrative |
|
|
935,868 |
|
|
|
906,055 |
|
|
|
1,604,689 |
|
|
|
1,629,870 |
|
|
|
13,117,659 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
2,677,834 |
|
|
|
2,108,949 |
|
|
|
4,715,840 |
|
|
|
3,690,000 |
|
|
|
32,789,155 |
|
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|
|
|
|
|
|
|
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|
|
|
|
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|
|
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|
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|
|
|
|
|
|
|
|
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|
|
|
|
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|
Loss from operations |
|
|
(940,665 |
) |
|
|
(1,356,149 |
) |
|
|
(1,640,111 |
) |
|
|
(2,227,045 |
) |
|
|
(19,486,876 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Interest income |
|
|
7,576 |
|
|
|
7,495 |
|
|
|
16,233 |
|
|
|
16,882 |
|
|
|
330,819 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,669 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
(expense) |
|
|
7,576 |
|
|
|
7,495 |
|
|
|
16,233 |
|
|
|
16,882 |
|
|
|
325,150 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(933,089 |
) |
|
$ |
(1,348,654 |
) |
|
$ |
(1,623,878 |
) |
|
$ |
(2,210,163 |
) |
|
$ |
(19,161,726 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Basic and diluted: |
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share |
|
$ |
(0.06 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.15 |
) |
|
$ |
(1.96 |
) |
Weighted average shares
outstanding |
|
|
15,653,380 |
|
|
|
15,038,659 |
|
|
|
15,647,712 |
|
|
|
15,008,250 |
|
|
|
9,770,758 |
|
See accompanying notes to condensed consolidated financial statements.
2
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIENCY)
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Accumulated |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
during the |
|
|
Stockholders |
|
|
|
Common Stock |
|
|
Additional |
|
|
Subscription |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Paid-In Capital |
|
|
Receivable |
|
|
Stage |
|
|
(Deficiency) |
|
Capital contribution at inception (June 27, 2001) |
|
|
|
|
|
$ |
|
|
|
$ |
10 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
10 |
|
Net loss for the period ended December 31, 2001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(170,592 |
) |
|
|
(170,592 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2001 |
|
|
|
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
(170,592 |
) |
|
|
(170,582 |
) |
Sale of common stock for cash |
|
|
2,789,954 |
|
|
|
2,790 |
|
|
|
(2,320 |
) |
|
|
|
|
|
|
|
|
|
|
470 |
|
Issuance of common stock for technology license |
|
|
704,534 |
|
|
|
705 |
|
|
|
148,151 |
|
|
|
|
|
|
|
|
|
|
|
148,856 |
|
Net loss for the year ended December 31, 2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(618,137 |
) |
|
|
(618,137 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002 |
|
|
3,494,488 |
|
|
|
3,495 |
|
|
|
145,841 |
|
|
|
|
|
|
|
(788,729 |
) |
|
|
(639,393 |
) |
Sale of common stock for cash |
|
|
1,229,278 |
|
|
|
1,229 |
|
|
|
2,458,380 |
|
|
|
|
|
|
|
|
|
|
|
2,459,609 |
|
Net loss for the year ended December 31, 2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(947,804 |
) |
|
|
(947,804 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003 |
|
|
4,723,766 |
|
|
|
4,724 |
|
|
|
2,604,221 |
|
|
|
|
|
|
|
(1,736,533 |
) |
|
|
872,412 |
|
Sale of common stock for cash and stock
subscription
receivable |
|
|
1,482,605 |
|
|
|
1,483 |
|
|
|
2,988,436 |
|
|
|
(2,750,000 |
) |
|
|
|
|
|
|
239,919 |
|
Cash payments received on stock subscription
receivable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
750,000 |
|
|
|
|
|
|
|
750,000 |
|
Issuance of common stock for technology license |
|
|
49,420 |
|
|
|
49 |
|
|
|
99,951 |
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Net loss for the year ended December 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,351,828 |
) |
|
|
(2,351,828 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004 |
|
|
6,255,791 |
|
|
|
6,256 |
|
|
|
5,692,608 |
|
|
|
(2,000,000 |
) |
|
|
(4,088,361 |
) |
|
|
(389,497 |
) |
Cash payments received on stock subscription
receivable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,500,000 |
|
|
|
|
|
|
|
1,500,000 |
|
Net loss for the year ended December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,611,086 |
) |
|
|
(1,611,086 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005 |
|
|
6,255,791 |
|
|
|
6,256 |
|
|
|
5,692,608 |
|
|
|
(500,000 |
) |
|
|
(5,699,447 |
) |
|
|
(500,583 |
) |
Cash payments received on stock subscription
receivable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500,000 |
|
|
|
|
|
|
|
500,000 |
|
Conversion of preferred stock to common stock |
|
|
3,550,851 |
|
|
|
3,551 |
|
|
|
1,071,565 |
|
|
|
|
|
|
|
|
|
|
|
1,075,116 |
|
Common stock issued in connection with merger |
|
|
4,359,891 |
|
|
|
4,360 |
|
|
|
1,708,489 |
|
|
|
|
|
|
|
|
|
|
|
1,712,849 |
|
Issuance of common stock for cashless warrant
exercise |
|
|
56,825 |
|
|
|
57 |
|
|
|
(57 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the year ended December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(584,166 |
) |
|
|
(584,166 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
14,223,358 |
|
|
|
14,224 |
|
|
|
8,472,605 |
|
|
|
|
|
|
|
(6,283,613 |
) |
|
|
2,203,216 |
|
Sale of common stock for cash |
|
|
406,729 |
|
|
|
407 |
|
|
|
3,162,543 |
|
|
|
|
|
|
|
|
|
|
|
3,162,950 |
|
Issuance of common stock upon stock option exercise |
|
|
2,471 |
|
|
|
2 |
|
|
|
4,998 |
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
1,518,496 |
|
|
|
|
|
|
|
|
|
|
|
1,518,496 |
|
Net loss for the year ended December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,241,796 |
) |
|
|
(4,241,796 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
14,632,558 |
|
|
$ |
14,633 |
|
|
$ |
13,158,642 |
|
|
$ |
|
|
|
$ |
(10,525,409 |
) |
|
$ |
2,647,866 |
|
Continued on following page
3
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
during the |
|
|
Stockholders |
|
|
|
Common Stock |
|
|
Additional |
|
|
Subscription |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Paid-In Capital |
|
|
Receivable |
|
|
Stage |
|
|
(Deficiency) |
|
Balance at December 31, 2007 |
|
|
14,632,558 |
|
|
$ |
14,633 |
|
|
$ |
13,158,642 |
|
|
$ |
|
|
|
$ |
(10,525,409 |
) |
|
$ |
2,647,866 |
|
Sale of common stock for cash in private
placement transactions |
|
|
176,129 |
|
|
|
176 |
|
|
|
1,364,824 |
|
|
|
|
|
|
|
|
|
|
|
1,365,000 |
|
Transactions related to common stock purchase
agreement with Fusion Capital |
|
|
130,290 |
|
|
|
130 |
|
|
|
405,961 |
|
|
|
|
|
|
|
|
|
|
|
406,091 |
|
Stock-based compensation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
|
|
|
|
1,798,169 |
|
|
|
|
|
|
|
|
|
|
|
1,798,169 |
|
Consultant warrants |
|
|
|
|
|
|
|
|
|
|
146,880 |
|
|
|
|
|
|
|
|
|
|
|
146,880 |
|
Issuance of common stock for consulting services |
|
|
10,000 |
|
|
|
10 |
|
|
|
73,990 |
|
|
|
|
|
|
|
|
|
|
|
74,000 |
|
Net loss for the year ended December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,728,187 |
) |
|
|
(3,728,187 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
14,948,977 |
|
|
|
14,949 |
|
|
|
16,948,466 |
|
|
|
|
|
|
|
(14,253,596 |
) |
|
|
2,709,819 |
|
Transactions related to common stock purchase
agreement with Fusion Capital |
|
|
216,261 |
|
|
|
216 |
|
|
|
1,519,784 |
|
|
|
|
|
|
|
|
|
|
|
1,520,000 |
|
Sale of common stock for cash upon exercise of
stock purchase warrant |
|
|
462,826 |
|
|
|
463 |
|
|
|
1,499,537 |
|
|
|
|
|
|
|
|
|
|
|
1,500,000 |
|
Stock-based compensation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
|
|
|
|
1,221,764 |
|
|
|
|
|
|
|
|
|
|
|
1,221,764 |
|
Consultant warrants |
|
|
|
|
|
|
|
|
|
|
45,401 |
|
|
|
|
|
|
|
|
|
|
|
45,401 |
|
Issuance of common stock for consulting services |
|
|
4,500 |
|
|
|
5 |
|
|
|
31,495 |
|
|
|
|
|
|
|
|
|
|
|
31,500 |
|
Net loss for the year ended December 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,284,252 |
) |
|
|
(3,284,252 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
15,632,564 |
|
|
|
15,633 |
|
|
|
21,266,447 |
|
|
|
|
|
|
|
(17,537,848 |
) |
|
|
3,744,232 |
|
Issuance of common stock in lieu of
cash payment (unaudited) |
|
|
12,000 |
|
|
|
12 |
|
|
|
89,988 |
|
|
|
|
|
|
|
|
|
|
|
90,000 |
|
Stock-based compensation (unaudited): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
|
|
|
|
299,638 |
|
|
|
|
|
|
|
|
|
|
|
299,638 |
|
Consultant warrants |
|
|
|
|
|
|
|
|
|
|
60,534 |
|
|
|
|
|
|
|
|
|
|
|
60,534 |
|
Issuance of common stock for consulting services |
|
|
10,500 |
|
|
|
10 |
|
|
|
53,803 |
|
|
|
|
|
|
|
|
|
|
|
53,813 |
|
Fractional share payout upon reverse split (unaudited) |
|
|
(218 |
) |
|
|
|
|
|
|
(1,210 |
) |
|
|
|
|
|
|
|
|
|
|
(1,210 |
) |
Net loss for the six months ended
June 30, 2010 (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,623,878 |
) |
|
|
(1,623,878 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2010 (unaudited) |
|
|
15,654,846 |
|
|
$ |
15,655 |
|
|
$ |
21,769,200 |
|
|
$ |
|
|
|
$ |
(19,161,726 |
) |
|
$ |
2,623,129 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
4
GEOVAX LABS, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
From Inception |
|
|
|
June 30, |
|
|
(June 27, 2001) to |
|
|
|
2010 |
|
|
2009 |
|
|
June 30, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,623,878 |
) |
|
$ |
(2,210,163 |
) |
|
$ |
(19,161,726 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
71,498 |
|
|
|
34,500 |
|
|
|
408,345 |
|
Accretion of preferred stock redemption value |
|
|
|
|
|
|
|
|
|
|
346,673 |
|
Stock-based compensation expense |
|
|
413,985 |
|
|
|
769,830 |
|
|
|
5,250,195 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Grant funds receivable |
|
|
(782,602 |
) |
|
|
(36,765 |
) |
|
|
(1,102,923 |
) |
Prepaid expenses and other current assets |
|
|
(117,386 |
) |
|
|
260,963 |
|
|
|
(222,001 |
) |
Deposits & other assets |
|
|
(11,010 |
) |
|
|
(2,500 |
) |
|
|
(11,990 |
) |
Accounts payable and accrued expenses |
|
|
741,932 |
|
|
|
(13,800 |
) |
|
|
1,313,297 |
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
|
256,417 |
|
|
|
1,012,228 |
|
|
|
5,981,596 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(1,367,461 |
) |
|
|
(1,197,935 |
) |
|
|
(13,180,130 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
|
|
|
|
|
|
|
|
(521,888 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
|
|
|
|
|
|
|
|
(521,888 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from sale of common stock |
|
|
|
|
|
|
830,000 |
|
|
|
15,121,898 |
|
Net proceeds from sale of preferred stock |
|
|
|
|
|
|
|
|
|
|
728,443 |
|
Costs associated with planned stock offering |
|
|
(340,676 |
) |
|
|
|
|
|
|
(340,676 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided (used) by financing activities |
|
|
(340,676 |
) |
|
|
830,000 |
|
|
|
15,509,665 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
(1,708,137 |
) |
|
|
(367,935 |
) |
|
|
1,807,647 |
|
Cash and cash equivalents at beginning of period |
|
|
3,515,784 |
|
|
|
2,191,180 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
1,807,647 |
|
|
$ |
1,823,245 |
|
|
$ |
1,807,647 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
|
|
|
$ |
|
|
|
$ |
5,669 |
|
See accompanying notes to condensed consolidated financial statements.
5
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2010
(unaudited)
1. Description of Company and Basis of Presentation
GeoVax Labs, Inc. (GeoVax or the Company), is a biotechnology company dedicated to developing
vaccines that prevent and fight Human Immunodeficiency Virus (HIV) infections, that result in
Acquired Immunodeficiency Syndrome (AIDS). We have exclusively licensed from Emory University
(Emory) vaccine technology which was developed in collaboration with the National Institutes of
Health (NIH) and the Centers for Disease Control and Prevention (CDC). GeoVax is incorporated
under the laws of the State of Delaware and our principal offices are located in Smyrna, Georgia
(metropolitan Atlanta area).
We have preventative vaccines being evaluated in a Phase 2a human clinical trial in individuals who
are not HIV infected and have recently begun a Phase 1 human therapeutic clinical trial in
individuals who are HIV infected. Our preventative vaccines seek to prevent or control infection
by HIV, reduce the rate of disease progression to AIDS and reduce the risk of HIV transmission. Our
therapeutic vaccines target impeding viral replication to reduce viral load in HIV infected
individuals with a view to reducing or eliminating the need for anti-HIV medications, and thereby
reduce the cost of treatment and the detrimental side effects associated with current drug
treatments.
Our current vaccines under development address the subtype, known as clade B, of the HIV virus that
is most prevalent in the developed world. Our vaccines have been shown to induce strong T-cell (a
type of white blood cell) and antibody immune responses in non-human primates against the simian
immunodeficiency virus, the primate version of the HIV virus. Our goals include applying our
technology and expertise to develop additional HIV vaccines for global markets that have different
clades of the virus, manufacturing and testing these vaccines, conducting human trials for vaccine
safety and effectiveness, and obtaining regulatory approvals to advance the development and
commercialization of our vaccines.
GeoVax is devoting all of its present efforts to research and development and is a development
stage enterprise as defined by Financial Accounting Standards Board (FASB) Accounting Standard
Codification (ASC) Topic 915, Development Stage Entities. The accompanying financial statements
at June 30, 2010 and for the three and six month periods ended June 30, 2010 and 2009 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, 2009. Our operating results are expected 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 disclosed in Note 2 to our financial statements included in our Annual Report on Form 10-K for
the year ended December 31, 2009 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.
As described in Note 5, on April 27, 2010, GeoVax effected a one-for-fifty reverse stock split of
its common stock. The accompanying financial statements and all share and per share information
contained herein, have been retroactively restated to reflect the reverse stock split.
2. New Accounting Standards
There have been no recent accounting pronouncements or changes in accounting pronouncements during
the six months ended June 30, 2010, as compared to the recent accounting pronouncements described
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2009, which we expect to
have a material impact on our financial statements.
3. 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 shares outstanding during the period. Potentially
dilutive common shares primarily consist of employee stock options and warrants issued to
investors. 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 1.9 million and 2.3 million shares at June 30,
2010 and 2009, respectively.
6
4. Commitments
Lease Agreement
We lease approximately 8,400 square feet of office and laboratory space located in Smyrna, Georgia
(metropolitan Atlanta). Future minimum lease payments pursuant to the operating lease total
$57,570 for the remainder of 2010, $118,010 in 2011, $121,560 in 2012, $125,180 in 2013 and
$128,920 in 2014.
Other Commitments
In the normal course of business, we may enter into various firm purchase commitments related to
production and testing of our vaccine material, and other research-related activities. As of June
30, 2010, we had approximately $505,000 of unrecorded outstanding purchase commitments to our
vendors and subcontractors, all of which will be due in less than one year.
5. Stockholders Equity
Reverse Stock Split
The accompanying financial statements reflect a one-for-fifty reverse split of the Companys common
stock approved by the board of directors and stockholders of the Company and made effective by an
amendment to the Companys certificate of incorporation on April 27, 2010. All share and per share
information herein that relates to the Companys common stock has been retroactively restated to
reflect the reverse stock split.
Increase in Authorized Shares of Common Stock
On April 13, 2010, the stockholders of the Company approved an increase to the Companys authorized
shares of common stock, from 18,000,000 to 40,000,000, made effective by filing an amendment to the
Companys certificate of incorporation on April 13, 2010.
Common Stock Transactions
In February 2010, we issued 12,000 shares of our common stock in settlement of an obligation
accrued at December 31, 2009 in the amount of $90,000. During March 2010 we issued an aggregate of
8,250 shares for consulting services and recorded general and administrative expense of $46,500
related to the issuances. During June 2010 we issued 2,250 shares for consulting services and
recorded general and administrative expense of $7,313 related to the issuance.
Stock Options
In 2006 we adopted the GeoVax Labs, Inc. 2006 Equity Incentive Plan (the 2006 Plan) for the
granting of qualified incentive stock options (ISOs), nonqualified stock options, restricted
stock awards or restricted stock bonuses to employees, officers, directors, consultants and
advisors of the Company. The exercise price for any option granted may not be less than fair value
(110% of fair value for ISOs granted to certain employees). Options granted under the 2006 Plan
have a maximum ten-year term and generally vest over three years. The Company has reserved
1,040,000 shares of its common stock for issuance under the 2006 Plan.
The following table summarizes stock option activity for the six months ended June 30, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
Number of Shares |
|
|
Exercise Price |
|
Outstanding at December 31, 2009 |
|
|
958,956 |
|
|
$ |
5.87 |
|
Granted |
|
|
76,800 |
|
|
|
5.94 |
|
Exercised |
|
|
|
|
|
|
|
|
Forfeited or Expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2010 |
|
|
1,035,756 |
|
|
$ |
5.87 |
|
|
|
|
|
|
|
|
|
|
Exercisable at June 30, 2010 |
|
|
804,849 |
|
|
$ |
5.64 |
|
Stock-based compensation expense related to the 2006 Plan was $157,794 and $299,638 for the three
month and six month periods ended June 30, 2010, as compared to $381,009 and $769,829 for the three
month and six month periods ended June 30, 2009, respectively. The table below shows the
allocation of stock-based compensation expense related to our stock option plan between general and
administrative expense and research and development expense. As of June 30, 2010, there
was $1,041,337 of unrecognized compensation expense related to stock-based compensation
arrangements subject to the 2006 Plan, which is expected to be recognized over a weighted average
period of 2.0 years.
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
Expense Allocated to: |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
General and Administrative Expense |
|
$ |
106,348 |
|
|
$ |
295,570 |
|
|
$ |
196,747 |
|
|
$ |
598,952 |
|
Research and Development Expense |
|
|
51,446 |
|
|
|
85,439 |
|
|
|
102,891 |
|
|
|
170,878 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
157,794 |
|
|
$ |
381,009 |
|
|
$ |
299,638 |
|
|
$ |
769,830 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensatory Warrants
We may, from time to time, issue stock purchase warrants to consultants or other service providers
in exchange for services. As of June 30, 2010, there were a total of 59,400 shares of our common
stock covered by outstanding stock warrants (58,050 of which are currently exercisable) with a
weighted average exercise price of $7.00 per share and a weighted average remaining contractual
life of 2.2 years. We recorded general and administrative expense of $30,267 and $60,534 for the
three and six month periods ended June 30, 2010 respectively, related to the issuance of stock
purchase warrants in exchange for services, all of which was allocated to general and
administrative expense. There was no expense associated with compensatory warrants during the three
month or six month periods ended June 30, 2009. As of June 30, 2010, there was $60,523 of
unrecognized compensation expense related to compensatory warrant arrangements, which is expected
to be recognized over a weighted average period of 0.5 years.
Investment Warrants
In addition to outstanding stock options and compensatory warrants, as of June 30, 2010 we had
stock purchase warrants covering a total of 848,194 shares of our common stock which were issued to
investors in previous transactions, all of which are currently exercisable. Such warrants have a
weighted-average exercise price of $16.50 per share and a weighted-average remaining contractual
life of 2.1 years.
6. 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.
7. NIH Grant Funding
In September 2007, the National Institutes of Health (NIH) awarded us an Integrated
Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant to support our HIV/AIDS vaccine
program. The project period for the grant, which is renewable annually, covers a five year period
which commenced October 2007, with an expected annual award of generally between $3 and $4 million
per year (approximately $18.3 million in the aggregate). The most recent award is for the period
September 1, 2009 through August 31, 2010 in the amount of $4.7 million. We are utilizing this
funding to further our HIV/AIDS vaccine development, optimization and production. We record
revenue associated with the grant as the related costs and expenses are incurred and such revenue
is reported as a separate line item in our statements of operations.
8. 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. The expense associated
with these ongoing patent cost reimbursements to Emory amounted to $21,333 during the six month
period ending June 30, 2010.
We have entered into two research agreements with Emory for the purpose of conducting research and
development activities associated with our IPCAVD grant from the NIH (see Note 7). During the six
month period ending June 30, 2010, we recorded $1,029,879 of expense associated with these
contracts. All amounts paid to Emory under these agreements are reimbursable to us pursuant to the
IPCAVD grant from the NIH.
8
In March 2008, we entered into a consulting agreement with Donald Hildebrand, the Chairman of our
Board of Directors and our former President and Chief Executive Officer, pursuant to which Mr.
Hildebrand provides business and technical advisory services to the Company. The term of the
consulting agreement began on April 1, 2008 and will end on December 31, 2010. During the six
month period ended June 30, 2010 we recorded $28,800 of expense associated with the consulting
agreement.
Item 2 Managements 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
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:
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whether we can raise additional capital as and when we need it; |
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whether we are successful in developing our products; |
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whether we are able to obtain regulatory approvals in the United States and other countries
for sale of our products; |
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whether we can compete successfully with others in our market; and |
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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
managements analysis only. We assume no obligation to update forward-looking statements.
Overview
GeoVax, a biotechnology company, focuses on developing vaccines to protect against or to treat
diseases caused by HIV. We have exclusively licensed vaccine technology from Emory University that
was developed at Emory University in collaboration with the NIH and the CDC.
Our major ongoing research and development programs are focused on the clinical development of
vaccines designed for use in a prime-boost system for the prevention and/or treatment of HIV/AIDS.
We are developing two clinical pathways for our vaccine candidates (i) as a preventative vaccine
to prevent or control infection of individuals who are exposed to the HIV virus, and (ii) as a
therapeutic vaccine to prevent development of AIDS in those individuals who have already been
infected with the HIV virus. Our vaccine candidates incorporate two delivery components: a
recombinant DNA (deoxyribonucleic acid); and a recombinant poxvirus, designated modified vaccinia
Ankara (MVA), which both deliver genes that encode inactivated HIV derived proteins to the immune
system. Both components are designed to support production of non-infectious virus-like particles
in vaccinated individuals that prime and boost immune responses. When administered in series, our
vaccine candidates induce strong T cell and antibody responses against multiple HIV proteins.
Our HIV vaccine candidates have successfully completed pre-clinical efficacy testing in non-human
primates and our preventative HIV vaccine candidate has completed Phase 1 clinical testing trials
in humans.
Our preventative vaccine candidate is currently in a Phase 2a human clinical trial, being conducted
by the HIV Vaccine Trials Network (the HVTN) with funding from the NIH. We expect to complete
patient enrollment for this trial by the end of 2010, with trial completion during 2011.
With regard to our therapeutic vaccine candidate, we recently initiated a Phase 1 human clinical
trial and are recruiting patients. We expect the Phase 1 clinical trial to begin generating vaccine
safety and performance data during the first half of 2011 with trial completion in the 2012-2013
timeframe.
In addition to our clinical development program for our vaccine candidates, we are conducting
preclinical research on the impact of adding an adjuvant (immune system stimulant) to the DNA
priming component of our vaccine to investigate whether they can improve the effectiveness of our
vaccine candidates. This work is being funded by the NIH through an Integrated Preclinical/Clinical
AIDS Vaccine Development Grant (an IPCAVD grant) to GeoVax. We are currently
formulating plans to begin Phase 1 human clinical testing of this product during 2011, which may
result in a second generation of our preventative HIV vaccine.
9
Critical Accounting Policies and Estimates
This discussion and analysis of our financial condition and results of operations is based on our
consolidated financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States. The preparation of these financial statements
requires management to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. On
an ongoing basis, management evaluates its estimates and adjusts the estimates as necessary. We
base our estimates on historical experience and on various other assumptions that are believed to
be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other
sources. Actual results may differ materially from these estimates under different assumptions or
conditions.
Our significant accounting policies are summarized in Note 2 to our consolidated financial
statements included in our Form 10-K for the year ended December 31, 2009. We believe the following
critical accounting policies affect our more significant judgments and estimates used in the
preparation of our consolidated financial statements:
Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held
and used is measured by a comparison of the carrying amount of the assets to the future net cash
flows expected to be generated by such assets. If such assets are considered to be impaired, the
impairment to be recognized is measured by the amount by which the carrying amount of the assets
exceeds the discounted expected future net cash flows from the assets.
Revenue Recognition
We recognize revenue in accordance with the SECs 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 to revenue recognition issues, and specifically addresses revenue recognition for
upfront, nonrefundable fees received in connection with research collaboration agreements. Our
revenue consists solely of grant funding received from the NIH. Revenue from this arrangement is
approximately equal to the costs incurred and is recorded as income as the related costs are
incurred.
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 instruments 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.
Liquidity and Capital Resources
At June 30, 2010, we had cash and cash equivalents of $1,807,647 and total assets of $3,847,636, as
compared to $3,515,784 and $4,315,597, respectively, at December 31, 2009. Working capital totaled
$1,723,854 at June 30, 2010, compared to $3,309,355 at December 31, 2009.
Sources and Uses of Cash
We are a development-stage company (as defined by ASC Topic 915, Development Stage Entities) and do
not have any products approved for sale. Due to our significant research and development
expenditures, we have not been profitable and have generated operating losses since our inception
in 2001. Our primary sources of cash are from sales of our equity securities and from government
grant funding.
Cash Flows from Operating Activities
Net cash used in operating activities was $1,367,461 for the six month period ended June 30, 2010,
as compared to $1,197,935 for the comparable period in 2009. Generally, the differences between
years are due to fluctuations in our net losses which, in turn, result primarily from fluctuations
in expenditures from our research activities, offset or increased by net changes in our assets and
liabilities.
10
The costs of conducting all of our human clinical trials to date, except for the therapeutic trial,
have been borne by the HVTN, funded by the NIH, with GeoVax incurring costs associated with
manufacturing the clinical vaccine supplies and other study support. The HVTN and NIH are bearing
the cost of conducting our ongoing Phase 2a human clinical study, but we cannot predict the level
of support we will receive from the HVTN and NIH for any additional clinical studies.
We are currently not receiving any governmental support for our Phase 1 therapeutic vaccine trial,
but we have applied for certification of up to $7.7 million of our qualified expenditures during
2009 and 2010 (including expenditures for the Phase 1 trial) under the Qualifying Therapeutic
Discovery Project (QTDP) Program enacted as part of the Patient Protection and Affordable Care Act
of 2010. If our application is approved, it may result in a cash grant to GeoVax of up to $3.8
million (50% of qualified expenditures) during 2011. We cannot, however, predict whether our
application will be approved, or whether we will receive the full amount of our request.
Our operations are also partially funded by the IPCAVD grant awarded to us in September 2007 by the
NIH to support our HIV/AIDS vaccine program. The project period for the grant, which is renewable
annually, covers a five-year period which commenced in October 2007, with an expected annual award
of generally between $3 and $4 million per year (approximately $18.3 million in the aggregate). The
most recent annual award under the grant is for the period that commenced on September 1, 2009
through August 31, 2010 in the amount of $4.7 million. We are utilizing this funding to further
our HIV/AIDS vaccine development, optimization and production for human clinical trial testing,
primarily with regard to our research into vaccine adjuvants. The funding we receive pursuant to
this grant is recorded as revenue at the time the related expenditures are incurred, and thus
partially offsets our net losses. As of June 30, 2010, there is approximately $950,000 remaining
from the current grant years award and (assuming that the remaining budgeted amounts under the
grant are awarded annually to the Company) there is an additional $7.5 million available through
the grant for the remainder of the original five year project period ending August 31, 2012. If
the annual grant does not occur, we will experience a shortfall in anticipated cash flow and will
be required to promptly seek other funds to address the shortfall.
We intend to pursue additional grants from the federal government. However, as we progress to the
later stages of our vaccine development activities, government financial support may be more
difficult to obtain, or may not be available at all. Therefore, it will be necessary for us to
look to other sources of funding in order to finance our development activities.
Cash Flows from Investing Activities
Our investing activities have consisted predominantly of capital expenditures. There were no
capital expenditures during the six month period ended June 30, 2010 or for the comparable period
in 2009.
Cash Flows from Financing Activities
Net cash used by financing activities was $340,676 for the six month period ended June 30, 2010, as
compared to net cash provided by financing activities of $830,000 for the comparable period in 2009. The cash used by financing activities during the 2010 period relates to costs associated with our planned stock offering (see discussion below). The cash generated from financing
activities during the 2009 period relates to the sale of our common stock to an investor pursuant
to a stock purchase agreement that provided us the right to sell shares to the investor through
July 31, 2010. We chose not to sell any of our stock pursuant to this agreement during the 2010
period and this agreement has now expired.
Our capital requirements, particularly as they relate to product research and development, have
been and will continue to be significant. We anticipate incurring additional losses for several
years as we expand our drug development and 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 or
license of our products for at least several years, if at all. For the foreseeable future, we will
be dependent on obtaining financing from the government and other third parties in order to
maintain our operations, including our clinical program. Due to the existing uncertainty in the
capital and credit markets, and adverse regional and national economic conditions which may persist
or worsen, capital may not be available on terms acceptable to us, or at all. If we fail to obtain
additional funding when needed, we will be forced to scale back or terminate our operations, or to
seek to merge with or to be acquired by another company. And if we are unable to successfully
develop our products, our business, financial condition and results of operations will be adversely
impacted.
On March 31, 2010, we filed a registration statement on Form S-1 with the U.S. Securities and
Exchange Commission for a public offering of our common stock and warrants, with the intention of
raising gross proceeds of up to $30 million for the Company. The primary purpose of the offering
was to generate funds to support expanded clinical trials and a more aggressive approach to our
clinical pathways. In June, we decided to defer and modify the offering based on market conditions
both in the broad market and with our own stock. We have not yet determined the details of a
revised offering or made a final decision to conduct one. Currently we believe it will be
deferred until after Labor Day, will likely be for a much smaller amount than originally
anticipated (possibly in the $5-10 million range), and will be marketed to both retail and
institutional investors. We do not expect to include any selling stockholders. The specific
number of units to be offered, the price range for the offering, and the closing date of the
offering, if any, have yet to be determined. If we decide to conduct the deferred offering, we
will amend the registration statement on file with the SEC to reflect changes in
the terms of the offering and to update other information. There can be no assurance that we will
be able to successfully complete the offering, or that we will be able to sell all of the
securities offered.
11
Our current working capital, combined with the proceeds from the IPCAVD grant awarded from the NIH,
should be sufficient to support our planned level of operations into the first quarter of 2011,
with no changes to our current business plan. As discussed above, we anticipate raising additional
capital during the remainder of 2010, although there can be no assurance that we will be able to do
so. We project that a successful offering with gross proceeds of $5.0 million or more will be
sufficient to fund our planned operations into 2012. While we believe that we will be successful in
obtaining the necessary financing to fund our operations through government grants, the offering
discussed above, and/or other sources, there can be no assurances that such additional funding will
be available 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.
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 June 30, 2010, we had firm purchase obligations of approximately $505,000 as compared to less
than $10,000 at December 31, 2009; the increase relates primarily to initiation of a vaccine
manufacturing contract. 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, 2009.
Results of Operations
Net Loss
We recorded a net loss of $933,089 for the three months ended June 30, 2010 as compared to a net
loss of $1,348,654 for the three months ended June 30, 2009. For the six months ended June 30,
2010, we recorded a net loss of $1,623,878, as compared to a net loss of $2,210,163 for the six
months ended June 30, 2009. Our net losses 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 six month periods ended June 30, 2010 we recorded grant revenue of $1,737,169
and $3,075,729, respectively, as compared to $752,800 and $1,462,955, respectively, during the
comparable periods of 2009. During 2007, we were awarded the IPCAVD grant by the NIH to support
our HIV/AIDS vaccine program. The grant is subject to annual renewal, with the latest grant award
covering the period from September 2009 through August 2010 in the amount of $4.7 million. As of
June 30, 2010, there is approximately $950,000 remaining from the current grant years award and
(assuming that the remaining budgeted amounts under the grant are awarded annually to the Company)
there is an additional $7.5 million available through the grant for the remainder of the original
five year project period ending August 31, 2012.
Research and Development
During the three month and six month periods ended June 30, 2010, we incurred $1,741,966 and
$3,111,151, respectively, of research and development expense as compared to $1,202,894 and
$2,060,130, respectively, during the three month and six month periods ended June 30, 2009.
Research and development expenses can vary considerably on a period-to-period basis, depending on
our need for vaccine manufacturing by third parties, and due to fluctuations in the timing of
expenditures related to our IPCAVD grant from the NIH. Research and development expense for the
three month and six month periods of 2010 includes stock-based compensation expense of $51,446 and
$102,891, respectively, while the comparable periods of 2009 include stock-based compensation
expense of $85,439 and $170,878, respectively (see discussion under Stock-Based Compensation
Expense below). Our research and development costs do not include costs incurred by HVTN in
conducting trials of GeoVax vaccines.
The increase in research and development expense during the three and six month periods ended June
30, 2010, as compared to the same periods in 2009, is due primarily to increased costs associated
with activities funded by our IPCAVD grant, vaccine manufacturing costs, and costs associated with
initiating a Phase 1 clinical trial for our therapeutic vaccine candidate. We expect that our
research and development costs will continue to increase during the remainder of 2010 and beyond as
we progress through the human clinical trial process leading up to possible product approval by the
FDA.
12
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 cost of the ongoing Phase 2a clinical trial for our preventative vaccine is being
funded by the HVTN, but we cannot be certain whether the HVTN or any other external source will
provide funding for further development. We intend to seek government or third party support for
future clinical human 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:
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the number of patients that ultimately participate in the clinical trial; |
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the duration of patient follow-up that seems appropriate in view of the results; |
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the number of clinical sites included in the clinical trials; and |
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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 six month periods ended June 30, 2010, we incurred general and
administrative costs of $935,868 and $1,604,689, respectively, as compared to $906,055 and
$1,629,870, respectively, during the comparable periods in 2009. 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 six month periods of 2010 include stock-based
compensation expense of $106,348 and $196,747, respectively; while the comparable periods of 2009
include stock-based compensation expense of $295,570 and $598,952, respectively (see discussion
under Stock-Based Compensation Expense below). We expect that our general and administrative
costs will increase in the future in support of expanded research and development activities and
other general corporate activities
Stock-Based Compensation Expense
We recorded stock-based compensation expense of $195,374 and $413,985 during the three month and
six month periods ended June 30, 2010, respectively, as compared to $381,009 and $769,829,
respectively, during the comparable periods of 2009. In addition to amounts related to the issuance
of stock options to employees, the figures include amounts related to common stock and stock
purchase warrants issued to consultants. We allocate stock-based compensation expense to research
and development expense or general and administrative expense according to the classification of
cash compensation paid to the employee, consultant or director to whom the stock compensation was
granted. For the three month and six month periods ended June 30, 2010 and 2009, stock-based
compensation expense was allocated as follows:
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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Expense Allocated to: |
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2010 |
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2009 |
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2010 |
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2009 |
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General and Administrative Expense |
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$ |
143,928 |
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$ |
295,570 |
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$ |
311,094 |
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$ |
598,952 |
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Research and Development Expense |
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51,446 |
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85,439 |
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102,891 |
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170,878 |
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Total Stock-Based Compensation Expense |
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$ |
195,374 |
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$ |
381,009 |
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$ |
413,985 |
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$ |
769,830 |
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Other Income
Interest income for the three month and six month periods ended June 30, 2010 was $7,576 and
$16,233, respectively, as compared to $7,495 and $16,882, respectively, for the three months and
six months ended June 30, 2009. The variances
between periods are attributable to generally lower interest rates, and lower incremental cash
balances available for investment during each respective period.
13
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 short-term bank certificates of deposits and 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.
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 SECs rules and forms and (2) accumulated and
communicated to management, including the chief executive officer and principal financial 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 as of the end
of the period covered by this report. Based on that evaluation, our President and Chief Financial
Officer have concluded that 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
Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commissions 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 June 30, 2010 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
14
Part 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 June 1, 2010, we issued 2,250 shares of our common stock to Equinox One Consulting, 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 did not involve a general
solicitation.
Item 3 Defaults Upon Senior Securities
None.
Item 4 (Removed and Reserved)
None.
Item 5 Other Information
None.
15
Item 6 Exhibits
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Exhibit |
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Number |
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Description |
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2.1
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Agreement and Plan of Merger by and among GeoVax, Inc., GeoVax Acquisition Corp. and Dauphin
Technology, Inc. dated January 20, 2006 (1) |
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2.2
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First Amendment to Agreement and Plan of Merger by and among GeoVax, Inc., GeoVax Acquisition
Corp. and Dauphin Technology, Inc. dated June 29, 2006 (2) |
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2.3
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Second Amendment to Agreement and Plan of Merger by and among GeoVax, Inc., GeoVax
Acquisition Corp. and Dauphin Technology, Inc. dated September 27, 2006 (3) |
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3.1
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Certificate of Incorporation (4) |
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3.1.1
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Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed April 13, 2010 (5) |
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3.1.2
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Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed April 27, 2010 (6) |
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3.2
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Bylaws (4) |
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31.1*
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Certification pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934 |
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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 |
|
|
|
* |
|
Filed herewith |
|
(1) |
|
Incorporated by reference from the registrants Current Report on Form 8-K filed with the
Securities and Exchange Commission on January 24, 2006. |
|
(2) |
|
Incorporated by reference from the registrants Current Report on Form 8-K filed with the
Securities and Exchange Commission on July 13, 2006. |
|
(3) |
|
Incorporated by reference from the registrants Current Report on Form 8-K filed with the
Securities and Exchange Commission on October 4, 2006. |
|
(4) |
|
Incorporated by reference from the registrants Current Report on Form 8-K filed with the
Securities and Exchange Commission on June 23, 2008. |
|
(5) |
|
Incorporated by reference to Exhibit 3.1 to the registrants Current Report on Form 8-K filed
April 14, 2010. |
|
(6) |
|
Incorporated by reference to Exhibit 3.1 to the registrants Current Report on Form 8-K filed
April 28, 2010. |
16
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: August 6, 2010 |
By: |
/s/ Mark W. Reynolds
|
|
|
|
Mark W. Reynolds |
|
|
|
Chief Financial Officer
(duly authorized officer and principal
financial officer) |
|
17
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
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. |
18