e10vq
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 September 30, 2009
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
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(State or other jurisdiction
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87-0455038 |
of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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1900 Lake Park Drive |
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Suite 380 |
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Smyrna, Georgia
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30080 |
(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: (678) 384-7220
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):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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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 November 6, 2009, 779,888,307 shares of the Registrants common stock, $.001 par value, were
issued and outstanding.
GEOVAX LABS, INC.
AND SUBSIDIARY
Index
Part I FINANCIAL INFORMATION
Item 1 Financial Statements
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED BALANCE SHEETS
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September 30, |
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December 31, |
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2009 |
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2008 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
|
$ |
3,416,692 |
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$ |
2,191,180 |
|
Grant funds receivable |
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|
544,238 |
|
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|
311,368 |
|
Prepaid expenses and other |
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53,292 |
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|
299,286 |
|
|
|
|
|
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|
|
|
|
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Total current assets |
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4,014,222 |
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|
2,801,834 |
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Property and equipment, net of accumulated depreciation of $150,587 and
$112,795 at September 30, 2009 and December 31, 2008, respectively |
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163,788 |
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|
138,847 |
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Other assets: |
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Licenses, net of accumulated amortization of $152,940 and $134,276
at September 30, 2009 and December 31, 2008, respectively |
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95,916 |
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114,580 |
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Deposits and other |
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|
980 |
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|
980 |
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|
|
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|
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|
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|
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Total other assets |
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96,896 |
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|
115,560 |
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Total assets |
|
$ |
4,274,906 |
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$ |
3,056,241 |
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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 |
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$ |
98,354 |
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$ |
176,260 |
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Amounts payable to Emory University (a related party) |
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250,420 |
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170,162 |
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Total current liabilities |
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348,774 |
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346,422 |
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Commitments |
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Stockholders equity: |
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Common stock, $.001 par value, 900,000,000 shares authorized
778,487,547 and 747,448,876 shares outstanding at
September 30, 2009 and December 31, 2008, respectively |
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|
778,488 |
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|
747,449 |
|
Additional paid-in capital |
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19,842,217 |
|
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|
16,215,966 |
|
Deficit accumulated during the development stage |
|
|
(16,694,573 |
) |
|
|
(14,253,596 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total stockholders equity |
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3,926,132 |
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|
2,709,819 |
|
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|
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|
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|
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Total liabilities and stockholders equity |
|
$ |
4,274,906 |
|
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$ |
3,056,241 |
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|
See accompanying notes to 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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Nine Months Ended |
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From Inception |
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September 30, |
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September 30, |
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(June 27,2001) to |
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2009 |
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2008 |
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2009 |
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2008 |
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September 30, 2009 |
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Revenues |
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Grant revenue |
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$ |
1,808,551 |
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$ |
1,322,502 |
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$ |
3,271,506 |
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$ |
2,298,571 |
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$ |
9,829,861 |
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1,808,551 |
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1,322,502 |
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3,271,506 |
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2,298,571 |
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9,829,861 |
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Operating expenses: |
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Research and development |
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1,470,200 |
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1,362,490 |
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3,530,329 |
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2,725,176 |
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16,021,992 |
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General and administrative |
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573,906 |
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698,948 |
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2,203,776 |
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2,322,292 |
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10,801,901 |
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Total operating expenses |
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2,044,106 |
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2,061,438 |
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5,734,105 |
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5,047,468 |
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26,823,893 |
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Loss from operations |
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(235,555 |
) |
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|
(738,936 |
) |
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(2,462,599 |
) |
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(2,748,897 |
) |
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(16,994,032 |
) |
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Other income (expense) |
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Interest income |
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4,740 |
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|
16,828 |
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|
21,622 |
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|
59,927 |
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|
305,128 |
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Interest expense |
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|
|
|
|
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|
|
|
|
|
|
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(5,669 |
) |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,740 |
|
|
|
16,828 |
|
|
|
21,622 |
|
|
|
59,927 |
|
|
|
299,459 |
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|
|
|
|
|
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Net loss and comprehensive loss |
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$ |
(230,815 |
) |
|
$ |
(722,108 |
) |
|
$ |
(2,440,977 |
) |
|
$ |
(2,688,970 |
) |
|
$ |
(16,694,573 |
) |
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|
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Basic and diluted: |
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Loss per common share |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.04 |
) |
Weighted average shares |
|
|
756,722,052 |
|
|
|
744,082,804 |
|
|
|
752,538,759 |
|
|
|
738,098,197 |
|
|
|
458,538,469 |
|
See accompanying notes to financial statements.
2
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIENCY)
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|
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|
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|
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|
|
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|
|
|
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|
|
Deficit |
|
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|
|
|
|
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|
|
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|
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Accumulated |
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Total |
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|
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Stock |
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|
during the |
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Stockholders |
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Common Stock |
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Additional |
|
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Subscription |
|
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Development |
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Equity |
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|
Shares |
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Amount |
|
|
Paid In Capital |
|
|
Receivable |
|
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Stage |
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|
(Deficiency) |
|
Capital contribution at inception (June 27, 2001) |
|
|
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|
|
$ |
|
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|
$ |
10 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
10 |
|
Net loss for the year ended December 31, 2001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(170,592 |
) |
|
|
(170,592 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Balance at December 31, 2001 |
|
|
|
|
|
|
|
|
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|
10 |
|
|
|
|
|
|
|
(170,592 |
) |
|
|
(170,582 |
) |
Sale of common stock for cash |
|
|
139,497,711 |
|
|
|
139,498 |
|
|
|
(139,028 |
) |
|
|
|
|
|
|
|
|
|
|
470 |
|
Issuance of common stock for technology license |
|
|
35,226,695 |
|
|
|
35,227 |
|
|
|
113,629 |
|
|
|
|
|
|
|
|
|
|
|
148,856 |
|
Net loss for the year ended December 31, 2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(618,137 |
) |
|
|
(618,137 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002 |
|
|
174,724,406 |
|
|
|
174,725 |
|
|
|
(25,389 |
) |
|
|
|
|
|
|
(788,729 |
) |
|
|
(639,393 |
) |
Sale of common stock for cash |
|
|
61,463,911 |
|
|
|
61,464 |
|
|
|
2,398,145 |
|
|
|
|
|
|
|
|
|
|
|
2,459,609 |
|
Net loss for the year ended December 31, 2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(947,804 |
) |
|
|
(947,804 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003 |
|
|
236,188,317 |
|
|
|
236,189 |
|
|
|
2,372,756 |
|
|
|
|
|
|
|
(1,736,533 |
) |
|
|
872,412 |
|
Sale of common stock for cash and stock
subscription receivable |
|
|
74,130,250 |
|
|
|
74,130 |
|
|
|
2,915,789 |
|
|
|
(2,750,000 |
) |
|
|
|
|
|
|
239,919 |
|
Cash payments received on stock subscription
receivable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
750,000 |
|
|
|
|
|
|
|
750,000 |
|
Issuance of common stock for technology license |
|
|
2,470,998 |
|
|
|
2,471 |
|
|
|
97,529 |
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Net loss for the year ended December 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,351,828 |
) |
|
|
(2,351,828 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004 |
|
|
312,789,565 |
|
|
|
312,790 |
|
|
|
5,386,074 |
|
|
|
(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 |
|
|
312,789,565 |
|
|
|
312,790 |
|
|
|
5,386,074 |
|
|
|
(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 |
|
|
177,542,538 |
|
|
|
177,543 |
|
|
|
897,573 |
|
|
|
|
|
|
|
|
|
|
|
1,075,116 |
|
Common stock issued in connection with merger |
|
|
217,994,566 |
|
|
|
217,994 |
|
|
|
1,494,855 |
|
|
|
|
|
|
|
|
|
|
|
1,712,849 |
|
Issuance of common stock for cashless warrant
exercise |
|
|
2,841,274 |
|
|
|
2,841 |
|
|
|
(2,841 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the year ended December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(584,166 |
) |
|
|
(584,166 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
711,167,943 |
|
|
|
711,168 |
|
|
|
7,775,661 |
|
|
|
|
|
|
|
(6,283,613 |
) |
|
|
2,203,216 |
|
Sale of common stock for cash |
|
|
20,336,433 |
|
|
|
20,336 |
|
|
|
3,142,614 |
|
|
|
|
|
|
|
|
|
|
|
3,162,950 |
|
Issuance of common stock upon stock option exercise |
|
|
123,550 |
|
|
|
124 |
|
|
|
4,876 |
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
731,627,926 |
|
|
|
731,628 |
|
|
|
12,441,647 |
|
|
|
|
|
|
|
(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 |
|
|
731,627,926 |
|
|
|
731,628 |
|
|
|
12,441,647 |
|
|
|
|
|
|
|
(10,525,409 |
) |
|
|
2,647,866 |
|
Sale of common stock for cash in private
placement transactions |
|
|
8,806,449 |
|
|
|
8,806 |
|
|
|
1,356,194 |
|
|
|
|
|
|
|
|
|
|
|
1,365,000 |
|
Transactions related to common stock purchase
agreement with Fusion Capital |
|
|
6,514,501 |
|
|
|
6,515 |
|
|
|
399,576 |
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
500,000 |
|
|
|
500 |
|
|
|
73,500 |
|
|
|
|
|
|
|
|
|
|
|
74,000 |
|
Net loss for the year ended December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,728,187 |
) |
|
|
(3,728,187 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
747,448,876 |
|
|
|
747,449 |
|
|
|
16,215,966 |
|
|
|
|
|
|
|
(14,253,596 |
) |
|
|
2,709,819 |
|
Transactions related to common stock purchase
agreement with Fusion Capital (unaudited) |
|
|
7,784,882 |
|
|
|
7,785 |
|
|
|
1,032,215 |
|
|
|
|
|
|
|
|
|
|
|
1,040,000 |
|
Sale of common stock for cash upon exercise of
stock purchase warrant (unaudited) |
|
|
23,141,289 |
|
|
|
23,141 |
|
|
|
1,476,859 |
|
|
|
|
|
|
|
|
|
|
|
1,500,000 |
|
Stock-based compensation (unaudited): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
|
|
|
|
1,087,530 |
|
|
|
|
|
|
|
|
|
|
|
1,087,530 |
|
Consultant warrants |
|
|
|
|
|
|
|
|
|
|
15,134 |
|
|
|
|
|
|
|
|
|
|
|
15,134 |
|
Issuance of common stock for consulting services |
|
|
112,500 |
|
|
|
113 |
|
|
|
14,513 |
|
|
|
|
|
|
|
|
|
|
|
14,626 |
|
Net loss for the nine months ended
September 30, 2009 (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,440,977 |
) |
|
|
(2,440,977 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009 (unaudited) |
|
|
778,487,547 |
|
|
$ |
778,488 |
|
|
$ |
19,842,217 |
|
|
$ |
|
|
|
$ |
(16,694,573 |
) |
|
$ |
3,926,132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
4
GEOVAX LABS, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From Inception |
|
|
|
Nine Months Ended September 30, |
|
|
(June 27, 2001) to |
|
|
|
2009 |
|
|
2008 |
|
|
September 30, 2009 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,440,977 |
) |
|
$ |
(2,688,970 |
) |
|
$ |
(16,694,573 |
) |
Adjustments
to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
56,456 |
|
|
|
38,064 |
|
|
|
303,527 |
|
Accretion of preferred stock redemption value |
|
|
|
|
|
|
|
|
|
|
346,673 |
|
Stock-based compensation expense |
|
|
1,117,290 |
|
|
|
1,620,295 |
|
|
|
4,654,835 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Grant funds receivable |
|
|
(232,870 |
) |
|
|
(182,587 |
) |
|
|
(544,238 |
) |
Prepaid expenses and other current assets |
|
|
245,994 |
|
|
|
(246,625 |
) |
|
|
(53,292 |
) |
Deposits and other assets |
|
|
|
|
|
|
|
|
|
|
(980 |
) |
Accounts payable and accrued expenses |
|
|
2,352 |
|
|
|
(82,722 |
) |
|
|
348,774 |
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
|
1,189,222 |
|
|
|
1,146,425 |
|
|
|
5,055,299 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(1,251,755 |
) |
|
|
(1,542,545 |
) |
|
|
(11,639,274 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(62,733 |
) |
|
|
(71,646 |
) |
|
|
(314,375 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(62,733 |
) |
|
|
(71,646 |
) |
|
|
(314,375 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from sale of common stock |
|
|
2,540,000 |
|
|
|
2,408,541 |
|
|
|
14,641,898 |
|
Net proceeds from sale of preferred stock |
|
|
|
|
|
|
|
|
|
|
728,443 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
2,540,000 |
|
|
|
2,408,541 |
|
|
|
15,370,341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
1,225,512 |
|
|
|
794,350 |
|
|
|
3,416,692 |
|
Cash and cash equivalents at beginning of period |
|
|
2,191,180 |
|
|
|
1,990,356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
3,416,692 |
|
|
$ |
2,784,706 |
|
|
$ |
3,416,692 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
|
|
|
$ |
|
|
|
$ |
5,669 |
|
See accompanying notes to financial statements.
5
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
September 30, 2009
1. Description of Company and Basis of Presentation
GeoVax Labs, Inc. (GeoVax or the Company), is a biotechnology company focused on developing
human vaccines for diseases caused by Human Immunodeficiency Virus (HIV) and other infectious
agents. The Company has 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). The Company is incorporated under the laws of the
State of Delaware and its principal offices are located in Smyrna, Georgia (metropolitan Atlanta
area).
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 September 30, 2009 and for the three month and nine month periods ended September 30,
2009 and 2008 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, 2008. 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.
The Company disclosed in Note 2 to its financial statements included in the Form 10-K for the year
ended December 31, 2008 those accounting policies that it considers significant in determining its
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. New Accounting Pronouncements
Recently Adopted Accounting Pronouncements
In June 2009, the FASB issued guidance now codified as ASC Topic 105, Generally Accepted
Accounting Principles, as the single source of authoritative nongovernmental U.S. generally
accepted accounting principles (GAAP). ASC Topic 105 does not change current U.S. GAAP, but is
intended to simplify user access to all authoritative GAAP by providing all authoritative
literature related to a particular topic in one place (the Codification). The Codification
became the source of authoritative GAAP recognized by the FASB to be applied by nongovernmental
entities. Rules and interpretive releases of the Securities and Exchange Commission (SEC) under
authority of federal securities laws are also sources of authoritative GAAP for SEC registrants.
On the effective date of ASC Topic 105, the Codification superseded all then-existing non-SEC
accounting and reporting standards. All other non-grandfathered non-SEC accounting literature not
included in the Codification became non-authoritative. The provisions of ASC Topic 105 are
effective for interim and annual periods ending after September 15, 2009 and, accordingly, are
effective for the Company for the current fiscal reporting period. The adoption of ASC Topic 105
did not have an impact on our results of operations, financial position, or cash flows, but will
impact our financial reporting process by eliminating all references to pre-codification standards.
All references to accounting literature included in the notes to our financial statements have
been changed to reference the appropriate sections of the Codification.
Following ASC Topic 105, the FASB will not issue new standards in the form of Statements, FASB
Staff Positions, or Emerging Issues Task Force Abstracts. Instead, it will issue Accounting
Standards Updates. The FASB does not consider Accounting Standards Updates as authoritative in
their own right. Accounting Standards Updates serve only to update the Codification, provide
background information about the guidance, and provide the bases for conclusions on changes in the
Codification.
In September 2006, the FASB issued guidance now codified as ASC Topic 820, Fair Value Measurements
and Disclosures, which provides enhanced guidance for using fair value to measure assets and
liabilities, provides a common definition of fair value, and establishes a framework to make the
measurement of fair value under GAAP more consistent and comparable. The pronouncement also
requires expanded disclosures to provide information about the extent to which
6
fair value is used to measure assets and liabilities, the methods and assumptions used to measure
fair value, and the effect of fair value measures on earnings. In February 2008, the FASB released
additional guidance also now codified under ASC Topic 820, which delayed the January 1, 2008
effective date for application of certain guidance related to non-financial assets and
non-financial liabilities, except for items that are recognized or disclosed at fair value in the
financial statements on a recurring basis, until January 1, 2009. The implementation of this
pronouncement did not have a material effect on our results of operations, financial position, or
cash flows.
In March 2008, the FASB issued guidance now codified as ASC Topic 815, Derivatives and Hedging,
which amends and expands the disclosure requirements previously required for derivative instruments
and hedging activities. We adopted this pronouncement effective January 1, 2009 and it did not
have a material effect on our results of operations, financial position, or cash flows.
In April 2008, the FASB issued guidance now codified as ASC Topic 350, Intangibles Goodwill and
Other, which amends the factors that should be considered in developing renewal or extension
assumptions used to determine the useful life of a recognized intangible asset. We adopted the
provisions of this pronouncement effective January 1, 2009, and it did not have a material effect
on our results of operations, financial position, or cash flows.
In June 2008, the FASB issued guidance now codified as ASC Topic 260, Earnings Per Share. This
pronouncement addresses whether instruments granted in share-based payment transactions are
participating securities prior to vesting, and therefore, need to be included in the earnings
allocation in calculating earnings per share under the two-class method of computing earnings per
share. This pronouncement requires companies to treat unvested share-based payment awards that
have non-forfeitable rights to dividend or dividend equivalents as a separate class of securities
in calculating earnings per share. We adopted this pronouncement effective January 1, 2009 and it
did not have a material effect on our results of operations, financial position, or cash flows.
In April 2009, the FASB issued guidance now codified as ASC Topic 825, Financial Instruments,
which amends previous Topic 825 guidance to require disclosures about fair value of financial
instruments in interim as well as annual financial statements. We adopted this pronouncement
effective April 1, 2009 and it did not have a material effect on our results of operations,
financial position, or cash flows.
In May 2009, the FASB issued guidance now codified as ASC Topic 855, Subsequent Events, which
establishes general standards of accounting for, and disclosures of, events that occur after the
balance sheet date but before financial statements are issued or are available to be issued. We
adopted this pronouncement effective June 30, 2009 and it did not have a material effect on our
results of operations, financial position, or cash flows. We have performed an evaluation of
subsequent events through November 6, 2009, which is the date these financial statements were
issued.
Recent Accounting Pronouncements Not Yet Adopted
We do not believe that any other recently issued, but not yet effective, accounting standards if
currently adopted would have a material effect 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 91.9 million and 111.5 million shares at September 30, 2009
and 2008, respectively.
4. Commitments
Lease Agreements
Since 2001, we have leased the office and laboratory space used for our operations in Atlanta,
Georgia under a lease agreement with Emtech Biotechnology Development, Inc., a related party
associated with Emory University. In September 2009, we executed a lease agreement, effective
November 1, 2009, for approximately 8400 square feet of office and laboratory space located in
Smyrna, Georgia (the Smyrna Facility) and we will vacate the Emtech facility during
7
November 2009. Future minimum lease payments pursuant to the 62 month lease for the Smyrna
Facility total $114,570 in 2010, $118,010 in 2011, $121,560 in 2012, $125,180 in 2013 and $128,920
in 2014.
Other Contractual Obligations
As of September 30, 2009, we had approximately $20,000 of unrecorded outstanding purchase
commitments to our vendors and subcontractors. We expect to receive and pay for these materials and
services within the next three to four months.
5. Stockholders Equity
Common Stock Transactions
We may, from time to time, issue shares of our common stock to consultants or other service
providers in exchange for services. During August 2009, we entered into an agreement whereby we
issued 112,500 shares of our common stock for consulting services and agreed to issue an additional
337,500 shares over the following twelve months. We recorded general and administrative expense of
$14,626 for the three and nine month periods ended September 30, 2009 related to issuance of our
common stock in exchange for services, as compared to $18,084 and $55,917 for the three and nine
month periods ended September 30, 2008, respectively.
Common Stock Purchase Agreement
In May 2008, we signed a common stock purchase agreement (the Purchase Agreement) with Fusion
Capital Fund II, LLC (Fusion Capital). The Purchase Agreement allows us to require Fusion
Capital to purchase up to $10 million of our common stock in amounts ranging from $80,000 to $1.0
million per purchase transaction, depending on certain conditions, from time to time over a
25-month period beginning July 1, 2008, the date on which the SEC declared effective the
registration statement related to the transaction.
The purchase price of the shares relating to the Purchase Agreement is based on the prevailing
market prices of our shares at the times of the sales without any fixed discount, and we control
the timing and amounts of any sales of shares to Fusion Capital. Fusion Capital does not have the
right or the obligation to purchase any shares of our common stock on any business day that the
purchase price of our common stock is below $0.05 per share. As primary consideration for entering
into the Purchase Agreement, and upon the execution of the Purchase Agreement we issued to Fusion
Capital 2,480,510 shares of our common stock as a commitment fee, and we agreed to issue to Fusion
Capital up to an additional 2,480,510 commitment fee shares, on a pro rata basis, as we receive the
$10 million of future funding. The Purchase Agreement may be terminated by us at any time at our
discretion without any additional cost to us. There are no negative covenants, restrictions on
future financings, penalties or liquidated damages in the agreement.
During the nine month period ended September 30, 2009, we sold 7,526,910 shares to Fusion Capital
under the terms of the Purchase Agreement for an aggregate purchase price of $1,040,000, and we
also issued an additional 257,972 shares to Fusion Capital pursuant to the pro rata deferred
commitment fee arrangement mentioned above. As of September 30, 2009, Fusion Capital has purchased
a cumulative total of 12,153,316 shares for $1,700,000 pursuant to the Purchase Agreement, and we
have issued a total of 2,902,197 shares as a commitment fee.
During October and November 2009 (through November 6), we sold an additional 1,341,228 shares to
Fusion Capital for an aggregate purchase price of $240,000, and issued 59,532 shares pursuant to
the deferred commitment fee arrangement.
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 four years. The Company has reserved
51,000,000 shares of its common stock for issuance under the 2006 Plan.
We did not grant any stock options pursuant to the 2006 Plan during the nine months ended September
30, 2009. As of September 30, 2009, there were nonqualified stock options covering a total of
45,764,424 shares of our common stock outstanding with a weighted average exercise price of $0.12
and a weighted average remaining contractual term of 5.5
8
years; including options as to 39,001,092 shares currently exercisable, with a weighted average
exercise price of $0.12 and a weighted average remaining contractual term of 4.9 years.
Stock-based compensation expense related to the 2006 Plan was $317,701 and $1,087,530 for the three
month and nine month periods ended September 30, 2009, as compared to $347,606 and $1,146,298 for
the three month and nine month periods ended September 30, 2008, 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 September 30, 2009,
there was $656,254 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 1.7 years.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
Expense Allocated to: |
|
2009 |
|
2008 |
|
2009 |
|
2008 |
|
General and Administrative Expense |
|
$ |
232,262 |
|
|
$ |
293,894 |
|
|
$ |
831,215 |
|
|
$ |
1,007,361 |
|
Research and Development Expense |
|
|
85,439 |
|
|
|
53,712 |
|
|
|
256,316 |
|
|
|
438,937 |
|
|
|
|
Total Stock-Based Compensation Expense |
|
$ |
317,701 |
|
|
$ |
347,606 |
|
|
$ |
1,087,530 |
|
|
$ |
1,446,298 |
|
|
|
|
Compensatory Warrants
We may, from time to time, issue stock purchase warrants to consultants or other service providers
in exchange for services. As of September 30, 2009, there were a total of 2,970,000 shares of our
common stock covered by outstanding stock warrants all of which are currently exercisable at a
weighted average exercise price of $0.14 per share and a weighted-average remaining contractual
life of 2.9 years. We recorded general and administrative expense of $15,134 for the three and
nine month periods ended September 30, 2009 related to issuance of stock purchase warrants in
exchange for services, as compared to $41,040 and $118,080 for the three and nine month periods
ended September 30, 2008, respectively. As of September 30, 2009, there was $151,325 of
unrecognized compensation expense related to compensatory warrant arrangements, which is expected
to be recognized over a weighted average period of 1.3 years.
Investment Warrants
In addition to outstanding stock options and compensatory warrants, as of September 30, 2009 we had
stock purchase warrants covering a total of 43,181,345 shares of our common stock which were issued
to investors in previous transactions. Such warrants have a weighted-average exercise price of
$0.34 per share and a weighted-average remaining contractual life of 2.8 years. During September
2009, we issued 23,141,289 shares of our common stock and received $1,500,000 upon the exercise of
an outstanding stock purchase warrant.
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.
9
8. Related Party Transactions
In June 2008, we entered into two subcontracts with Emory for the purpose of conducting research
and development activities associated with our IPCAVD grant from the NIH (see Note 7). During the
three and nine month periods ended September 30, 2009, we recorded $389,158 and $853,608 of expense
associated with these subcontracts as compared to $393,697 and $572,699 for the comparable periods
of 2008. All amounts paid to Emory under these subcontracts are reimbursable to us pursuant to the
NIH grant.
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, 2009. During the three
month and nine month periods ended September 30, 2009, we recorded $14,400 and $43,200,
respectively, of expense associated with the consulting agreement as compared to $24,000 and
$40,000 for the comparable periods of 2008.
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:
|
|
whether we can raise additional capital as and when we need it; |
|
|
|
whether we are successful in developing our products; |
|
|
|
whether we are able to obtain regulatory approvals in the United States and other countries
for sale of our products; |
|
|
|
whether we can compete successfully with others in our market; and |
|
|
|
whether we are adversely affected in our efforts to raise cash by the volatility and
disruption of local and national economic, credit and capital markets and the economy in
general. |
Readers are cautioned not to place undue reliance on forward-looking statements, which reflect our
managements analysis only. We assume no obligation to update forward-looking statements.
Managements 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.
Overview
GeoVax is a clinical-stage biotechnology company focused on developing human vaccines for diseases
caused by Human Immunodeficiency Virus and other infectious agents. We have exclusively licensed
from Emory University certain HIV vaccine technology which was developed in collaboration with the
National Institutes of Health (NIH) and the Centers for Disease Control and Prevention.
10
Our HIV vaccine candidates have successfully completed preclinical efficacy testing in non-human
primates and our preventative HIV vaccine candidate has completed Phase 1 clinical testing trials
in humans. A Phase 2a human clinical trial for our preventative HIV vaccine candidate was
initiated during the fourth quarter of 2008, and patient enrollment commenced in February 2009.
The costs of conducting all of our human clinical trials to date have been borne by the HIV Vaccine
Trials Network (HVTN), funded by the NIH, with GeoVax incurring costs associated with manufacturing
the clinical vaccine supplies and other study support. HVTN is bearing the cost of conducting our
ongoing Phase 2a human clinical study, but we cannot predict the level of support we will receive
from HVTN for any additional clinical studies. Our operations are also partially supported by an
Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Grant from the NIH. The project
period for the grant covers a five year period which commenced October 2007, with an expected
annual award of generally between $3-4 million per year (approximately $18.3 million in the
aggregate). 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. 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. It will, therefore, be necessary for us to look to other sources of
funding in order to finance our development activities.
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 do
not expect to generate product sales from our development efforts for several years. If we are
unable to successfully develop and market pharmaceutical products over the next several years, our
business, financial condition and results of operations will be adversely impacted.
Critical Accounting Policies and Estimates
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, 2008. 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 guidance issued by the SEC and now
codified under FASB ASC Topic 605, Revenue Recognition. ASC Topic 605 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 primarily of government grant
revenue, which is recorded as income as the related costs are incurred.
Stock-Based Compensation. Effective January 1, 2006, we adopted a pronouncements by the FASB now
codified under ASC Topic 718, Compensation Stock Compensation and under ASC Topic 505,
"Equity. This pronouncement requires the measurement and recognition of compensation expense for
all share-based payments made to employees and directors based on estimated fair values on the
grant date. We adopted the pronouncement using the prospective application method which requires
us to apply the provisions prospectively to new awards and to awards modified, repurchased or
cancelled after December 31, 2005. Awards granted after December 31, 2005 are valued at fair value
in accordance with the provisions ASC Topic 718 and are recognized on a straight line basis over
the service periods of each award.
Liquidity and Capital Resources
At September 30, 2009, we had cash and cash equivalents of $3,416,692 and total assets of
$4,274,906, as compared to $2,191,180 and $3,056,241, respectively, at December 31, 2008. Working
capital totaled $3,665,448 at September 30, 2009, compared to $2,455,412 at December 31, 2008.
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.
11
Cash Flows from Operating Activities. Net cash used in operating activities was $1,251,755 for the
nine month period ended September 30, 2009 as compared to $1,542,545 for the comparable period in
2008. 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 by
net changes in our assets and liabilities.
In September 2007, the 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 for human clinical trial testing. 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.
Cash Flows from Investing Activities. Our investing activities have consisted predominantly of
capital expenditures. Capital expenditures for the nine months ended September 30, 2009 and 2008
were $62,733 and $71,646, respectively. In September 2009, we executed a lease agreement
(effective November 1, 2009) for the relocation of our operations a short distance within the
metropolitan Atlanta area. In connection with this move, we expect to incur approximately $115,000
in relocation-related costs (inclusive of facility improvements) and we also expect to incur
between $50,000 and $75,000 of costs associated with the acquisition of equipment to replace that
which was previously made available to us at our previous location.
Cash Flows from Financing Activities. Net cash provided by financing activities was $2,540,000 and
$2,408,541 for the nine month periods ended September 30, 2009 and 2008, respectively. During the
2009 period we received $1,040,000 from the sale of our common stock to Fusion Capital (see
discussion below) and $1,500,000 from the exercise of a previously outstanding stock purchase
warrant which was to expire in September 2009. During the 2008 period, we received $2,262,450
from the sale of our common stock and warrants to individual accredited investors and $146,091 from
the sale of our common stock to Fusion Capital, offset by costs associated with the financing
arrangement.
In May 2008, we signed a Purchase Agreement with Fusion Capital Fund II, LLC, an Illinois limited
liability company (Fusion Capital) which provides for the sale of up to $10 million of shares of
our common stock. In connection with this agreement, we filed a registration statement related to
the transaction with the SEC covering the shares that have been issued or may be issued to Fusion
Capital under the Purchase Agreement. The SEC declared effective the registration statement on
July 1, 2008, and we now have the right until July 31, 2010 to sell our shares of common stock to
Fusion Capital from time to time in amounts ranging from $80,000 to $1 million per purchase
transaction, depending on certain conditions as set forth in the Purchase Agreement. During the
nine months ended September 30, 2009, we received $1,040,000 from the sale of our common stock to
Fusion Capital pursuant to this arrangement. Through September 30, 2009, we have received a
cumulative total of $1,700,000 from Fusion Capital, leaving $8,300,000 available pursuant to the
Purchase Agreement as of that date. Depending on general stock market conditions, and the
prevailing price of our common stock leading up to the date upon which the Purchase Agreement ends
(July 31, 2010), we may not be able to, or may be choose not to, access the full amount remaining
pursuant to the Purchase Agreement. The extent to which we rely on the Purchase Agreement as a
source of funding will depend on a number of factors including the prevailing market price of our
common stock and the extent to which we can secure working capital from other sources if we choose
to seek such other sources.
We believe that our current working capital, combined with the proceeds from the IPCAVD grant
awarded annually from the NIH, will be sufficient to support our planned level of operations
through 2010. We intend to draw on the Fusion Capital facility to increase our cash reserves to
provide funding for our operations beyond 2010. Even if we are able to access the remainder of the
full $10 million under the Purchase Agreement with Fusion Capital, we may still need additional
capital in the future to fully implement our business, operating and development plans. Should the
financing we require to sustain our working capital needs be unavailable or prohibitively expensive
when we require it, the consequences could be a material adverse effect on our business, operating
results, financial condition and prospects. While we believe that we will be successful in
obtaining the necessary financing to fund our operations through grants, the Purchase Agreement
and/or other sources, there can be no assurances that such additional funding will be available to
us on reasonable terms or at all.
Our capital requirements, particularly as they relate to product research and development, have
been and will continue to be significant. We intend to seek FDA approval of our products, which
may take several years. We will not generate revenues from the sale of our products for at least
several years, if at all. We will be dependent on obtaining financing from third parties in order
to maintain our operations, including our clinical program. Due to the existing uncertainty in the
capital
12
and credit markets, and adverse regional and national economic conditions which may persist or
worsen, capital may not be available on terms acceptable to the Company or at all. If 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 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
Since 2001, we have leased the office and laboratory space used for our operations in Atlanta,
Georgia under a lease agreement with Emtech Biotechnology Development, Inc., a related party
associated with Emory University. In September 2009, we executed a lease agreement, effective
November 1, 2009, for approximately 8400 square feet of office and laboratory space located in
Smyrna, Georgia (the Smyrna Facility) and we will vacate the Emtech facility during November
2009. Future minimum lease payments pursuant to the 62 month lease for the Smyrna Facility total
approximately $608,000. As of September 30, 2009, we had approximately $20,000 of unrecorded
outstanding purchase commitments to our vendors and subcontractors; we expect to receive and pay
for these materials and services within the next three to four months
As of September 30, 2009, we had no other material firm purchase obligations or commitments, 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. We have no other contractual obligations, with the exception of commitments which are
contingent upon the occurrence of future events.
Results of Operations
Net
Loss
We recorded a net loss of $230,815 for the three months ended September 30, 2009 as compared to
$722,108 for the three months ended September 30, 2008. For the nine months ended September 30,
2009, we recorded a net loss of $2,440,977, as compared to a net loss of $2,688,970 for the nine
months ended September 30, 2008. 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 nine month periods ended September 30, 2009 we recorded grant revenue of
$1,808,551 and $3,271,506, respectively, as compared to $1,322,502 and $2,298,571, respectively,
during the comparable periods of 2008. During 2007, we were awarded an Integrated
Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant 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 October 2007, with an expected annual award of generally between $3 to $4
million per year (approximately $18.3 million in the aggregate). We are utilizing this funding to
further our HIV/AIDS vaccine development, optimization and production. 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 September 30, 2009, there is approximately $4.6 million
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 nine month periods ended September 30, 2009, we incurred $1,470,200 and
$3,530,329, respectively, of research and development expense as compared to $1,362,490 and
$2,725,176, respectively, during the three month and nine month periods ended September 30, 2008.
Research and development expense for the three month and nine month periods of 2009 includes
stock-based compensation expense of $85,439 and $256,316, respectively, while the comparable
periods of 2008 include stock-based compensation expense of $53,712 and $438,937, respectively (see
discussion under Stock-Based Compensation Expense below).
Research and development expenses can vary considerably on a period-to-period basis, depending on
our need for vaccine manufacturing and testing of manufactured vaccine by third parties, and due to
fluctuations in the timing of other external expenditures related to our IPCAVD grant from the NIH.
The increase in research and development expense from the 2008 periods to the 2009 periods is due
primarily to costs associated with our vaccine manufacturing activities in preparation for the
commencement of Phase 2 clinical testing, costs associated with our activities funded by our NIH
grant, and higher personnel costs associated with the addition of new scientific personnel. Our
recently initiated Phase 2a clinical trial is being conducted and funded by the HVTN, but we are
responsible for the manufacture of vaccine product to be used in the
13
trial. We cannot predict the level of support we may receive from HVTN or other federal agencies
(or divisions thereof) for our future clinical trials. We expect that our research and development
costs will continue to increase in 2010 and beyond as we progress through the human clinical trial
process leading up to possible product approval by the FDA.
General
and Administrative Expense
During the three month and nine month periods ended September 30, 2009, we incurred general and
administrative costs of $573,906 and $2,203,776, respectively, as compared to $698,948 and
$2,322,292, respectively, during the three month and nine month periods ended September 30, 2008.
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 2009
include stock-based compensation expense of $262,021 and $890,974, respectively; while the
comparable periods of 2008 include stock-based compensation expense of $352,118 and $1,181,358,
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
During the three month and nine month periods ended September 30, 2009, we recorded total
stock-based compensation expense of $347,460 and $1,117,290, respectively, which is included in
research and development expense, or general and administrative expense according to the
classification of cash compensation paid to the employee, consultant or director to which the stock
compensation was granted. Stock-based compensation expense for the three month and nine month
periods ended September 30, 2008 was $405,830 and $1,620,295, respectively. 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. As of September 30, 2009, there
was $807,579 of unrecognized compensation expense related to stock-based compensation arrangements.
Other
Income
Interest income for the three month and nine month periods ended September 30, 2009 was $4,740 and
$21,622, respectively, as compared to $16,828 and $52,927, respectively, for the three months and
nine months ended September 30, 2008. The variances between periods are attributable to generally
lower interest rates.
Item 3 Quantitative and Qualitative Disclosures About Market Risk
We do not currently have any market risk sensitive instruments held for trading purposes or
otherwise, therefore, we do not have exposure to interest rate risk, foreign currency exchange rate
risk, commodity price risk, and other relevant market risks.
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 President and our Principal Financial 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 September 30, 2009 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
None not previously disclosed on Form 8-K.
Item 3 Defaults Upon Senior Securities
None.
Item 4 Submission of Matters to a Vote of Security Holders
None.
Item 5 Other Information
None.
15
Item 6 Exhibits
|
|
|
Exhibit |
|
|
Number |
|
Description |
2.1
|
|
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) |
|
|
|
3.2
|
|
Bylaws (4) |
|
|
|
10.1*
|
|
Office and Laboratory Lease between UCB, Inc. and GeoVax, Inc. |
|
|
|
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 |
|
|
|
* |
|
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 19, 2008. |
The representations, warranties and covenants contained in the agreements identified above as
exhibits, together with those incorporated by reference, were made only for the purposes of those
agreements, are between and among the parties to them, as of specific dates, and are solely for the
benefit of those parties. The agreements may be subject to contractual limitations agreed to by the
parties as well as standards of materiality that differ from those generally applicable to
investors, and may reflect an allocation of risk. Various provisions may be interpreted differently
by the parties, and may be waived or modified. While the agreements constitute public disclosure
under the federal securities laws, when reading representations, warranties and covenants in those
agreements, investors should consider the foregoing, as well as information provided by us in this
filing and in our other filings, and should not rely solely upon such agreements as
characterizations of an actual state of facts.
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)
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|
Date: November 6, 2009 |
By: |
/s/ Mark W. Reynolds
|
|
|
|
Mark W. Reynolds |
|
|
|
Chief Financial Officer
(duly authorized officer and principal
financial officer) |
|
17
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.1 |
|
Office and Laboratory Lease between UCB, Inc. and GeoVax, Inc. |
|
|
|
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