GeoVax Labs, Inc. - Quarter Report: 2007 September (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2007
OR
o | 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)
Illinois (State or other jurisdiction of incorporation or organization) |
87-0455038 (I.R.S. Employer Identification No.) |
|
1256 Briarcliff Road, N.E. | ||
Emtech Bio Suite 500 | ||
Atlanta, Georgia | 30306 | |
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (404) 727-0971
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 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 o | Non-Accelerated filer þ |
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
Yes o No þ
As of November 14, 2007, 712,834,703 shares of the Registrants common stock, $.001 par value, were
issued and outstanding.
GEOVAX LABS, INC.
AND SUBSIDIARY
AND SUBSIDIARY
Index
Table of Contents
Part I FINANCIAL INFORMATION
Item 1 Financial Statements
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, | December 31, | |||||||
2007 | 2006 | |||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 731,976 | $ | 2,088,149 | ||||
Prepaid expenses and other |
23,753 | 38,130 | ||||||
Total current assets |
755,729 | 2,126,279 | ||||||
Property and equipment, net of accumulated depreciation of $70,157 and
$47,092 at September 30, 2007 and December 31, 2006, respectively |
81,654 | 104,719 | ||||||
Other assets: |
||||||||
Licenses, net of accumulated amortization of $103,168 and $84,504
at September 30, 2007 and December 31, 2006, respectively |
145,688 | 164,352 | ||||||
Deposits |
980 | 980 | ||||||
Total other assets |
146,668 | 165,332 | ||||||
Total assets |
$ | 984,051 | $ | 2,396,330 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable and accrued expenses |
$ | 370,551 | $ | 83,983 | ||||
Advance for purchase of common stock |
300,000 | | ||||||
Accrued salaries |
12,908 | 109,131 | ||||||
Total current liabilities |
683,459 | 193,114 | ||||||
Commitments (Note 5) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $.01 par value, 10,000,000 shares authorized; no shares
issued at September 30, 2007 and December 31, 2006, respectively |
| | ||||||
Common stock, $.001 par value, 900,000,000 shares authorized
712,834,703 and 711,167,943 shares outstanding at
September 30, 2007 and December 31, 2006, respectively |
712,835 | 711,168 | ||||||
Additional paid-in capital |
8,957,296 | 7,775,661 | ||||||
Deficit accumulated during the development stage |
(9,369,539 | ) | (6,283,613 | ) | ||||
Total stockholders equity |
300,592 | 2,203,216 | ||||||
Total liabilities and stockholders equity |
$ | 984,051 | $ | 2,396,330 | ||||
See accompanying notes to financial statements.
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Table of Contents
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
(A DEVELOPMENT-STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended | Nine Months Ended | From Inception | ||||||||||||||||||
September 30, | September 30, | (June 27, 2001) to | ||||||||||||||||||
2007 | 2006 | 2007 | 2006 | September 30, 2007 | ||||||||||||||||
Revenues |
||||||||||||||||||||
Grant revenue |
$ | | $ | | $ | | $ | 478,853 | $ | 3,411,181 | ||||||||||
| | | 478,853 | 3,411,181 | ||||||||||||||||
Operating expenses: |
||||||||||||||||||||
Research and development |
360,227 | 173,047 | 1,273,245 | 509,371 | 8,266,294 | |||||||||||||||
General and administrative |
814,803 | 136,290 | 1,864,978 | 438,314 | 4,708,853 | |||||||||||||||
1,175,030 | 309,337 | 3,138,223 | 947,685 | 12,975,147 | ||||||||||||||||
Loss from operations |
(1,175,030 | ) | (309,337 | ) | (3,138,223 | ) | (468,832 | ) | (9,563,966 | ) | ||||||||||
Other income (expense) |
||||||||||||||||||||
Interest income |
9,511 | 25,903 | 52,297 | 41,942 | 200,096 | |||||||||||||||
Interest expense |
| | | | (5,669 | ) | ||||||||||||||
9,511 | 25,903 | 52,297 | 41,942 | 194,427 | ||||||||||||||||
Net loss and comprehensive loss |
$ | (1,165,519 | ) | $ | (283,434 | ) | $ | (3,085,926 | ) | $ | (426,890 | ) | $ | (9,369,539 | ) | |||||
Basic and diluted: |
||||||||||||||||||||
Income (loss) per common share |
$ | (0.00 | ) | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.03 | ) | |||||
Weighted average shares |
712,834,703 | 317,112,375 | 712,814,124 | 315,687,273 | 351,572,527 |
See accompanying notes to financial statements.
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GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
(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) | |||||||||||||||||||
Capital contribution at inception (June 27, 2001) |
| $ | | $ | 10 | $ | | $ | | $ | 10 | |||||||||||||
Net loss for
the year ended December 31, 2001 |
| | | | (170,592 | ) | (170,592 | ) | ||||||||||||||||
Balance at December 31, 2001 |
| | 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 GeoVax, Inc. preferred
stock to
common stock in connection with merger |
177,542,538 | 177,543 | 897,573 | | | 1,075,116 | ||||||||||||||||||
Common shares issued to Dauphin
Technology, Inc.
in the merger on September 28, 2006 |
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 (unaudited) |
1,666,760 | 1,667 | 253,333 | | | 255,000 | ||||||||||||||||||
Stock compensation expense (unaudited) |
| | 928,302 | | | 928,302 | ||||||||||||||||||
Net loss for the nine months ended
September 30, 2007 (unaudited) |
| | | | (3,085,926 | ) | (3,085,926 | ) | ||||||||||||||||
Balance at September 30, 2007 (unaudited) |
712,834,703 | $ | 712,835 | $ | 8,957,296 | $ | | $ | (9,369,539 | ) | $ | 300,592 | ||||||||||||
See accompanying notes to financial statements.
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Table of Contents
GEOVAX LABS, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
From Inception | ||||||||||||
Nine Months Ended September 30, | (June 27, 2001) to | |||||||||||
2007 | 2006 | September 30, 2007 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (3,085,926 | ) | $ | (426,890 | ) | $ | (9,369,539 | ) | |||
Adjustments to reconcile net loss to net cash
used in operating activities: |
||||||||||||
Depreciation and amortization |
41,729 | 33,050 | 173,325 | |||||||||
Accretion of preferred stock redemption value |
| 58,561 | 346,673 | |||||||||
Share-based compensation expense |
928,302 | | 928,302 | |||||||||
Changes in assets and liabilities: |
||||||||||||
Prepaid expenses |
14,377 | 141,151 | (23,753 | ) | ||||||||
Deposits |
| | (980 | ) | ||||||||
Accounts payable and accrued expenses |
490,345 | (221,675 | ) | 683,459 | ||||||||
Unearned grant revenue |
| (478,853 | ) | | ||||||||
Total adjustments |
1,474,753 | (467,766 | ) | 2,107,026 | ||||||||
Net cash used in operating activities |
(1,611,173 | ) | (894,656 | ) | (7,262,513 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchase of property and equipment |
| (1,843 | ) | (151,811 | ) | |||||||
Net cash used in investing activities |
| (1,843 | ) | (151,811 | ) | |||||||
Cash flows from financing activities: |
||||||||||||
Net proceeds from sale of common stock |
255,000 | 2,212,849 | 7,417,857 | |||||||||
Net proceeds from sale of preferred stock |
| | 728,443 | |||||||||
Proceeds from issuance of note payable |
| | 250,000 | |||||||||
Repayment of note payable |
| | (250,000 | ) | ||||||||
Net cash provided by financing activities |
255,000 | 2,212,849 | 8,146,300 | |||||||||
Net increase (decrease) in cash and cash equivalents |
(1,356,173 | ) | 1,316,350 | 731,976 | ||||||||
Cash and cash equivalents at beginning of period |
2,088,149 | 1,272,707 | | |||||||||
Cash and cash equivalents at end of period |
$ | 731,976 | $ | 2,589,057 | $ | 731,976 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Interest paid |
$ | | $ | | $ | 5,669 |
See accompanying notes to financial statements.
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GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2007
1. Description of Company and Basis of Presentation
GeoVax Labs, Inc. (GeoVax or the Company), is a development stage biotechnology company
engaged in research and development activities with a mission to develop, license and commercialize
the manufacture and sale of human vaccines for diseases caused by Human Immunodeficiency Virus
(HIV) and other infectious agents. The Company has exclusively licensed from Emory University
certain Acquired Immune Deficiency Syndrome (AIDS) vaccine technology which was developed in
collaboration with the National Institutes of Health and the Centers for Disease Control and
Prevention.
GeoVax was originally incorporated under the laws of Illinois as Dauphin Technology, Inc.
(Dauphin). Until December 2003, Dauphin marketed mobile hand-held, pen-based computers and
broadband set-top boxes and provided private, interactive cable systems to the extended stay
hospitality industry. The Company was unsuccessful and its operations were terminated in December
2003. On September 28, 2006, Dauphin completed a merger (the Merger) with GeoVax, Inc. which was
incorporated on June 27, 2001 (date of inception). As a result of the Merger, the shareholders
of GeoVax, Inc. exchanged their shares of common stock for Dauphin common stock and GeoVax, Inc.
became a wholly-owned subsidiary of Dauphin. In connection with the Merger, Dauphin changed its
name to GeoVax Labs, Inc., replaced its officers and directors with those of GeoVax, Inc. and moved
its offices to Atlanta, Georgia. The Company currently does not plan to conduct any business other
than GeoVax, Inc.s business of developing new products for the protection from, and treatment of,
human diseases.
The Merger was accounted for under the purchase method of accounting as a reverse acquisition
in accordance with U.S. generally accepted accounting principles. Under this method of accounting,
Dauphin was treated as the acquired company and, for accounting purposes, the Merger was treated
as the equivalent of GeoVax, Inc. issuing stock for the net monetary assets of Dauphin, accompanied
by a recapitalization of GeoVax, Inc. Accordingly, all prior year comparative financial
information presented in the accompanying condensed consolidated financial statements, or in the
notes herein, as well as any references to prior operations, are those of GeoVax, Inc.
The Company is a development stage enterprise as defined by Statement of Financial Accounting
Standards (SFAS) No. 7, Accounting and Reporting by Development Stage Enterprises, and we are
devoting substantially all of our present efforts to research and development. We have funded our
activities to date almost exclusively from equity financings and government grants. We will
continue to require substantial funds to continue our research and development activities,
including preclinical studies and clinical trials of our product candidates, and to commence sales
and marketing efforts, if the United States Food and Drug Administration (FDA) or other
regulatory approvals are obtained. In September 2007, the National Institutes of Health awarded
the Company a grant of approximately $15 million to be funded over a 5 year period (See Note 8).
Although a portion of the proceeds of this grant will be used to fund our existing operations, the
majority of the proceeds are earmarked for new projects requiring incremental spending. In order
to meet our current and future operating cash flow requirements we are considering additional
offerings of our common stock, debt or convertible debt instruments. While we believe that we will
be successful in obtaining the necessary financing to fund our operations, there can be no
assurances that such additional funding will be achieved and that we will succeed in our future
operations. The accompanying financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and the satisfaction of liabilities and commitments in
the normal course of business. The financial statements do not include any adjustments relating to
the recoverability and classification of recorded asset amounts or amounts of liabilities that
might be necessary should the Company be unable to continue in existence.
The accompanying consolidated financial statements at September 30, 2007 and for the three
month and nine month periods ended September 30, 2007 and 2006 are unaudited, but include all
adjustments, consisting of normal recurring entries, which the Companys management believes 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 the Companys audited financial statements included in its Annual Report on Form
10-K filed with the SEC on March 28, 2007. 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.
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The Company disclosed in Note 2 to its financial statements included in the Form 10-K for the
year ended December 31, 2006 those accounting policies that it considers significant in determining
its results of operations and financial position. There have been no material changes to, or
application of, the accounting policies previously identified and described in the Form 10-K.
2. New Accounting Pronouncements
In July 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation No.
48, Accounting for Uncertainty in Income Taxesan
interpretation of FASB Statement No. 109 (FIN
48), which seeks to reduce the diversity in practice associated with the accounting and reporting
for uncertainty in income tax positions. FIN 48 prescribes a comprehensive model for the financial
statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or
expected to be taken in an income tax return. FIN 48 presents a two-step process for evaluating a
tax position. The first step is to determine whether it is more-likely-than-not that a tax position
will be sustained upon examination, based on the technical merits of the position. The second step
is to measure the benefit to be recorded from tax positions that meet the more-likely-than-not
recognition threshold, by determining the largest amount of tax benefit that is greater than 50
percent likely of being realized upon ultimate settlement, and recognizing that amount in the
financial statements. The accounting provisions of FIN 48 became effective for us beginning January
1, 2007. See Note 7.
In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities (SFAS 159). SFAS 159 permits
entities to choose to measure many financial instruments and certain other items at fair value that
are not currently required to be measured at fair value. SFAS 159 will be effective for the us on
January 1, 2008. We do not expect the adoption of this statement to have a material impact on our
financial condition or results of operations.
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. 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 63.6 million and 56.4 million shares at September 30, 2007 and 2006,
respectively.
4. Stock-Based Compensation
We currently have one equity-based compensation plan from which stock-based compensation
awards can be granted to employees and directors. We have also issued stock options and stock
purchase warrants to external consultants for services rendered. We recorded stock-based
compensation expense of $653,318 and $928,302 for the three month and nine month periods ended
September 30, 2007. Included in these amounts are (a) $227,288 of expense associated with a 5 year
extension of a previously issued stock option grant to our President and Chief Executive Officer,
which was due to expire in December 2007, and (b) $53,775 associated with the issuance of a stock
purchase warrant for consulting services. For the three month period ending September 30, 2007,
total stock-based compensation expense of $653,318 was allocated $173,014 to research and
development expense and $480,304 to general and administrative expense. For the nine month period
ending September 30, 2007, total stock-based compensation expense of $928,302 was allocated
$186,899 to research and development expense and $741,403 to general and administrative expense.
No stock-based compensation expense was recorded for the same periods in 2006.
The following table sets forth fair value per share information, including related weighted
average assumptions, used to determine stock-based compensation cost for our stock options
consistent with the requirements of Statement of Financial Accounting Standards No.123 (revised
2004), Share-Based Payments (SFAS 123R):
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Nine Months Ended September 30, | ||||||||
2007 | 2006 | |||||||
Weighted average fair value per share of options granted |
$ | 0.30 | $ | n/a | ||||
Assumptions: |
||||||||
Expected volatility |
107.91 | % | n/a | |||||
Expected annual dividend yield |
0.00 | % | n/a | |||||
Risk-free rate of return |
4.47 | % | n/a | |||||
Expected option term (years) |
6.9 | n/a |
The following table summarizes stock option activity for the nine months ended September 30, 2007:
Weighted Average | ||||||||
Number of Shares | Exercise Price | |||||||
Outstanding at December 31, 2006 |
34,431,032 | $ | 0.04 | |||||
Granted |
9,810,000 | 0.35 | ||||||
Exercised |
(123,550 | ) | 0.04 | |||||
Forfeited or Expired |
(5,989,725 | ) | 0.04 | |||||
Outstanding at September 30, 2007 |
38,127,757 | 0.12 | ||||||
Exercisable at September 30, 2007 |
31,407,249 | $ | 0.07 |
In addition to outstanding stock options, as of September 30, 2007 we have a total of
25,471,605 outstanding stock purchase warrants issued to investors and consultants with exercise
prices ranging from $0.07 to $0.75.
As of September 30, 2007, there was $2,915,717 of unrecognized compensation expense related to
stock-based compensation arrangements. The unrecognized compensation expense is expected to be
recognized over a weighted average period of 2.1 years.
5. Commitments Manufacturing Contracts
In June 2007, we entered into two manufacturing contracts with third party suppliers for the
production of vaccine to be used in our Phase II human clinical trials planned for 2008. The terms
of the contracts call for a total of approximately $1,488,000 to be paid during the contract
periods (anticipated to run through early 2008). Through September 30, 2007, we recorded
approximately $412,000 of expense associated with these contracts (including our estimate of
contract expenses incurred but unbilled), leaving approximately $1,076,000 in unrecorded
contractual commitments as of that date.
6. Private Placements of Common Stock and Warrants
In January 2007, we sold 1,543,210 shares of our common stock to two individual accredited
investors for an aggregate purchase price of $250,000. We also issued to the investors warrants to
purchase an aggregate of 771,605 shares of common stock at a price of $0.75 per share, expiring on
December 31, 2009.
In July 2007, we entered into a Subscription Agreement with an institutional investor (the
Investor), pursuant to which we agreed, subject to certain customary closing conditions, to sell
to the Investor 48,387,097 shares of our common stock for a price of $0.155 per share, or an
aggregate of $7,500,000. Pursuant to the Subscription Agreement, we also agreed to issue to the
Investor a 3 year stock purchase warrant to purchase 18,333,333 shares of our common stock at an
exercise price of $0.33 per share upon the first closing, and, upon the second closing, a warrant
to purchase 16,666,667 shares of our common stock at an exercise price equal to the closing market
price of our common stock as of the date immediately preceding the final closing. The Subscription
Agreement originally contemplated the consummation of the transaction in two closings, during
August and November. To date, the Investor has been unable to close this transaction due to
administrative factors associated with the formation of the investment fund managed by the
Investor. In September 2007, the Investor advanced $300,000 to us as payment towards its
obligation associated with the first closing, but it is unlikely the remainder of the funds will be
received.
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7. Income Taxes
As discussed in Note 2, we adopted the provisions of FIN 48 effective January 1, 2007. There
was no impact on our financial statements upon adoption. Because of our historically significant
net operating losses, we have not been subject to income tax 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 include net operating loss carryforwards and research and
development credits. The net deferred tax asset has been fully offset by a valuation allowance
because of the uncertainty of our future profitability and our ability to utilize the deferred tax
assets. Utilization of operating losses and credits may be subject to substantial annual
limitations due to ownership change provisions of Section 382 of the Internal Revenue Code. The
annual limitation may result in the expiration of net operating losses and credits before
utilization.
8. Receipt of NIH Grant
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 covers a five year period commencing October 2007, with
an award of approximately $3 million per year, or $15 million in the aggregate. We will utilize
this funding to further our HIV/AIDS vaccine development, optimization, production and human
clinical trial testing including Phase 2 human clinical trials planned for 2008. We will record
revenue associated with the grant as the related costs and expenses are incurred.
Item 2 Managements Discussion and Analysis of Financial Condition And Results of
Operations
SAFE HARBOR STATEMENT
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 product;
whether we are able to obtain regulatory approvals in the United States and other countries for
sale of our product; and
whether we can compete successfully with others in our market.
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 results of operations and financial condition are
based upon our financial statements. These statements have been prepared in accordance with
accounting principles generally accepted in the United States of America. These principles require
management to make certain estimates, judgments and assumptions that affect the reported amounts of
assets, liabilities, revenues and expenses, and related disclosure of contingent assets and
liabilities. On an ongoing basis we evaluate these estimates based on historical experience and
various other assumptions that we believe 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 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 AIDS vaccine technology which was developed in collaboration
with the National Institutes of Health and the Centers for Disease Control and Prevention.
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Our AIDS vaccine candidates have successfully completed preclinical efficacy testing in
non-human primates and Phase I clinical testing trial in humans. The human trial was conducted by
the HIV Vaccine Trials Network (HVTN), a division of the National Institute of Allergy and
Infectious Disease (NIAID) of the National Institutes of Health (NIH) and was satisfactorily
concluded in June 2004.
A series of four additional human trials (conducted by the HVTN) evaluating our AIDS vaccines
at several locations in the United States began in April 2006. One trial began in April 2006, a
second trial began in September 2006, and the third and fourth trials began in July 2007. We
anticipate beginning a Phase II human clinical trial in 2008. The cost of conducting the human
clinical trials to date have been borne by HVTN, with GeoVax incurring costs associated with
manufacturing the clinical vaccine supplies and other study support. Our vaccine manufacturing
costs, as well as the costs of our preclinical testing have been partially funded by grants from
the National Institutes of Health issued to Dr. Harriet Robinson at Emory University and
subcontracted to us pursuant to collaborative arrangements with Emory. Dr. Robinson is a founder
of GeoVax and also serves as our Chief Scientific Officer. We do not anticipate any further
subcontracting revenue through the arrangement with Emory, but we expect that HVTN will bear the
cost of conducting our planned Phase II human clinical study. 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. We also expect that losses will fluctuate from quarter to quarter and that
such fluctuations may be substantial. Conducting clinical trials for our drug candidates in
development is a lengthy, time-consuming and expensive process. We do not expect to generate
product sales from our drug discovery and 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 would be adversely impacted.
Critical Accounting Policies and Estimates
We have identified the following accounting principles that we believe are key to an
understanding of our financial statements. These important accounting policies require
managements most difficult, subjective judgments.
Other Assets Other assets consist principally of license agreements for the use of
technology obtained through the issuance of our common stock. These license agreements are
amortized on a straight line basis over ten years.
Impairment of Long-Lived Assets We review long-lived assets 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.
Stock-Based Compensation Effective January 1, 2006, we adopted SFAS 123R, which 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. SFAS 123R replaces SFAS 123,
Accounting for Stock-Based Compensation (SFAS 123), and supersedes Accounting Principles Board
Opinion No. 25, Accounting for Stock Issued to Employees. We adopted SFAS 123R using the
prospective application method which requires us to apply the provisions of SFAS 123R 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 of SFAS
123R and recognized on a straight line basis over the service periods of each award. Our adoption
of SFAS 123R had no impact on our prior period financial statements. Prior to adoption of SFAS
123R, we accounted for stock-based compensation expense using the intrinsic-value method, in which
compensation expense was based on the difference, if any, on the measurement date (generally the
grant date) between the fair value of the Companys stock and the exercise price. During the three
month and nine month periods ending September 30, 2007, our adoption of SFAS 123R required us to
recognize $653,318 and $928,302, respectively, of stock-based compensation expense; no stock-based
compensation expense was recorded for the comparable periods of 2006. As of September 30, 2007,
there was $2,915,717 of unrecognized compensation expense related to stock-based compensation
arrangements. The unrecognized compensation expense is expected to be recognized over a weighted
average period of 2.1 years.
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Results of Operations
We recorded a net loss of $1,165,519 for the three months ended September 30, 2007 as compared
to $283,434 for the three months ended September 30, 2006. For the nine months ended September 30,
2007, we recorded a net loss of $3,085,926, as compared to $429,890 for the nine months ended
September 30, 2006. Our operating results will typically fluctuate due to the timing of activities
and related costs associated with our vaccine research and development activities. However, the
increase in our net loss from 2006 to 2007 is primarily attributable to (a) the lack of grant
revenues during 2007, (b) increased research and development expenditures and (c) overall higher
general and administrative costs, all of which are described in more detail below.
During the three months and nine months ended September 30, 2007 we recorded no grant revenue,
as compared to $-0- and $478,853 recorded during the three months and nine months ended September
30, 2006, respectively. Grant revenue reported during the 2006 periods relates to projects covered
by grants from the National Institutes of Health issued to Emory University and subcontracted to us
pursuant to collaborative arrangements with Emory University. The activities associated with these
grants were completed during 2006 and we received no additional grant funding during the nine month
period ended September 30, 2007. During September, however, we were notified by the National
Institutes of Health (NIH) that it had awarded us an Integrated Preclinical/Clinical AIDS Vaccine
Development (IPCAVD) grant to support our HIV/AIDS vaccine program. The project period for this
grant covers a five year period commencing October 2007, with an award of approximately $3 million
per year, or $15 million in the aggregate. We will utilize this funding to further our HIV/AIDS
vaccine development, optimization, production and human clinical trial testing including Phase 2
human clinical trials planned for 2008. We will record revenue associated with the grant as the
related costs and expenses are incurred.
During the three months and nine months ended September 30, 2007, we incurred $360,227 and
$1,273,245, respectively, of research and development expense as compared to $173,047 and $509,371,
respectively, during the three months and nine months ended September 30, 2006. Research and
development expense for the three month and nine month periods of 2007 include stock compensation
expense of $173,014 and $186,899, respectively (see discussion below). Research and development
expenses vary considerably on a quarter-to-quarter basis, depending on our need for vaccine
manufacturing and testing of manufactured vaccine by third parties. Currently we expect that our
planned human clinical trials will be conducted and funded by the HVTN, but that we will be
responsible for the manufacture of vaccine product to be used in the trials. During the nine
months ended September 30, 2007, we incurred approximately $412,000 associated with two
manufacturing contracts to produce vaccine for use in our Phase II human clinical trials planned to
begin in 2008. We expect to incur approximately an additional $1,076,000 during the remainder of
2007 and early 2008 associated with these contracts. We expect that our research and development
costs will continue to increase as we progress through the human clinical trial process leading up
to possible product approval by the FDA. Research and development costs will also increase as a
direct result of our receipt of the NIH grant discussed above, since a significant portion of the
grant funds are earmarked to be spent on new projects requiring external resources and new
personnel.
During the three months and nine months ended September 30, 2007, we incurred general and
administrative costs of $814,803 and $1,864,978, respectively, as compared to $136,290 and
$438,314, respectively, during the three months and nine months ended September 30, 2006. General
and administrative costs include officers salaries, legal and accounting costs, patent costs, and
amortization expense associated with intangible assets. General and administrative costs for the
three month and nine month periods of 2007 include stock compensation expense of $480,304 and
$741,403, respectively (see discussion below). Our general and administrative costs have increased
substantially over the prior year, primarily due to the additional costs associated with being a
public company subsequent to the Merger in September 2006. These costs include the hiring of a
Chief Financial Officer and of a Senior Vice President, higher legal and accounting fees, fees and
expenses associated with an expanded Board of Directors, and the cost of implementing an investor
relations program.
During the three months and nine months ended September 30, 2007, we recorded total stock
compensation expense of $653,318 and $928,302, 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. No stock compensation expense was recorded during 2006. Stock compensation expense is
calculated and recorded in accordance with the provisions of SFAS 123R. We adopted SFAS 123R using
the prospective application method which requires us to apply its 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 of SFAS 123R and
recognized on a straight line basis over the service periods of each award. We did not grant or
modify any share-based compensation during the three months or nine
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months
ended September 30,
2006, thus no expense was recorded during those periods. As of September 30, 2007, there was
$2,915,717 of unrecognized compensation expense related to stock-based compensation arrangements.
The unrecognized compensation expense is expected to be recognized over a weighted average period
of 2.1 years.
Interest income for the three months and nine months ended September 30, 2007 was $9,511 and
$52,297, respectively, as compared to $25,903 and $41,942, respectively, for the three months and
nine months ended September 30, 2006. The variances between periods are primarily attributable to
the incremental cash balances available for investment during 2007.
Liquidity and Capital Resources
At September 30, 2007 our cash and cash equivalents totaled $731,976, as compared to
$2,088,149 at December 31, 2006, a decrease of $1,356,173. Working capital totaled $72,270 at
September 30, 2007, compared to $1,933,165 at December 31, 2006. We believe that our current
working capital, combined with the proceeds from the newly awarded grant from the NIH (see Note 8)
will be sufficient to support our planned level of operations through the end of 2007. In order to
meet our current and future operating cash flow requirements we are considering additional
offerings of our common stock, debt or convertible debt instruments, and we are currently in
discussions with several sources of potential capital. While we believe that we will be successful
in obtaining the necessary financing to fund our operations, there can be no assurances that such
additional funding will be achieved and that we will succeed in our future operations.
Sources of Cash. 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 source
of cash during the three months and nine months ended September 30, 2007 was from sales of our
equity securities.
Cash Flows from Operating Activities. Net cash used in operating activities was $1,611,173
for the nine months ended September 30, 2007, as compared to $894,656 for the nine months ended
September 30, 2006. The difference between the periods is primarily due to fluctuations in our net
losses, offset by non-cash items such as depreciation, amortization and share-based compensation
expense, and net changes in our assets and liabilities.
Cash Flows from Investing Activities. Our investing activities have consisted predominantly
of capital expenditures. We have had no capital expenditures thus far during 2007. Capital
expenditures for the nine months ended September 30, 2006 were $1,843.
Cash Flows from Financing Activities. Net cash provided by financing activities was $255,000
and $2,212,849 for the nine months ended September 30, 2007 and 2006, respectively. During the
nine months ended September 30, 2007, we received $250,000 in proceeds from the sale of our common
stock (see Note 6) and $5,000 from the exercise of employee stock options.
In July 2007, we entered into a Subscription Agreement with an institutional investor (the
Investor) for the private placement of our common stock for an aggregate total of $7.5 million.
This agreement originally contemplated the consummation of the transaction in two closings, during
August and November. To date, the Investor has been unable to close this transaction due to
administrative factors associated with the formation of the investment fund managed by the
Investor. In September 2007, the Investor advanced $300,000 to us as payment towards its
obligation associated with the first closing, but it is unlikely that the remainder of the funds
will be received. We are continuing discussions with the Investor, but have also initiated
discussions with alternative sources of equity capital.
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 do not expect to generate revenues from our products for at least
several years and we will be dependent on obtaining financing from third parties in order to
maintain our operations, including our clinical program. In order to meet our future operating
cash flow requirements we will consider additional offerings of our common stock, debt or
convertible debt instruments. We cannot assure that adequate additional funding will be available
to us on favorable terms, 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.
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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, 2007 that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
PART II OTHER INFORMATION
Item 1 Legal Proceedings
None
Item 1A Risk Factors
We face a number of substantial risks. Our business, financial condition, results of
operations and stock price could be materially adversely affected by any of these risks. The
following factors should be considered in connection with the other information contained in this
Quarterly Report on Form 10-Q.
We are a development stage company and, other than research and development, have no other
operations.
We are a development stage company and, other than our research and development activities,
have no other operations. Our products are not ready for sale. These factors raise substantial
doubt about our ability to continue in business. During the nine months ended September 30, 2007,
we had a net loss of $3,085,926 and a net loss since inception of $9,369,539.
Our products are still being developed and are unproven. These products may not be successful.
In order to become profitable we must generate revenue through sales of our products, however
our products are in varying stages of development and testing. Our products have not been proven in
human research trials and have not been approved by any government agency for sale. If we cannot
successfully develop and prove our products, and if we do not develop other sources of revenue, we
will not become profitable and at some point we would discontinue operations.
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We have sold no products or generated any product or licensing revenues and we do not anticipate
any significant revenues to be generated for several years.
We have conducted pre-clinical trials and are conducting clinical trials and will continue to
do so for several more years before we are able to commercialize our technology. There can be no
assurance that we will ever generate significant revenues from the sale or licensing of our
products or technology.
Our business will require continued funding. If we do not receive adequate funding, we may not be
able to continue our operations.
To date, we have financed our operations principally through the private placement of common
and preferred stock, and from government grants. We will require substantial additional financing
at various intervals for our operations, including for clinical trials, for operating expenses
including intellectual property protection and enforcement, for pursuit of regulatory approvals and
for establishing or contracting out manufacturing, marketing and sales functions. There is no
assurance that such additional funding will be available on terms acceptable to us or at all. If we
are not able to secure the significant funding that is required to maintain and continue our
operations at current levels or at levels that may be required in the future, we may be required to
severely curtail, or even to cease, our operations.
In July 2007, we entered into a Subscription Agreement with an institutional investor (the
Investor), for the sale of $7,500,000 of our common stock (See Note 6). The Subscription
Agreement originally contemplated the consummation of the transaction in two closings, during
August and November. To date, the Investor has been unable to close this transaction due to
administrative factors associated with the formation of the investment fund managed by the
Investor. In September 2007, the Investor advanced $300,000 to us as payment towards its
obligation associated with the first closing, but it is unlikely that the remainder of the funds
will be received. We are continuing discussions with the Investor, but have also initiated
discussions with alternative sources of equity capital. While we believe that we will be
successful in obtaining the necessary financing to fund our operations, there can be no assurances
that such additional funding will be achieved and that we will succeed in our future operations.
We are subject to the risks and uncertainties inherent in new businesses. Our failure to plan or
forecast accurately could have a material adverse impact on our development.
We are subject to the risks and uncertainties inherent in new businesses, including the
following:
| we may not have enough money to develop our products and bring them to market; | ||
| we may experience unanticipated development or marketing expenses, which may make it more difficult to develop our products and bring them to market; | ||
| even if we are able to develop products and bring them to market, we may not earn enough revenue from the sales of our products to cover the costs of operating our business. |
If, because of our failure to plan or project accurately, we are unsuccessful in our efforts
to develop products or if the products we develop do not produce revenues as anticipated, it is not
likely we will ever become profitable and we may be required to curtail some or all of our
operations.
Our success will be dependent, in part, upon our President and Chief Executive Officer, Donald
Hildebrand and Harriet Robinson, Chairman of our Scientific Advisory Board. The loss of the
services of either of these individuals would have an adverse effect our operations.
Our success depends, to a significant degree, on our continued receipt of services from our
President and Chief Executive Officer, Mr. Donald G. Hildebrand, and on the research expertise of
Dr. Harriet Robinson. The loss of services of either of these individuals would have a material
adverse effect on our business and operations.
Regulatory and legal uncertainties could result in significant costs or otherwise harm our
business.
In order to manufacture and sell our products, we must comply with extensive international and
domestic regulation. In order to sell our products in the United States, approval from the FDA is
required. The FDA approval process is expensive and time-consuming. We cannot predict whether our
products will be approved by the FDA. Even if they are approved, we cannot predict the time frame
for approval. Foreign regulatory requirements differ from jurisdiction to jurisdiction and may, in
some cases, be more stringent or difficult to obtain than FDA approval. As with the FDA, we cannot
predict if or when we may obtain these regulatory approvals. If we cannot demonstrate that our
products can be
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used safely and successfully in a broad segment of the patient population on a
long-term basis, our products would likely be denied approval by the FDA and the regulatory
agencies of foreign governments.
We will face intense competition and rapid technological change that could result in products that
are superior to the products we will be commercializing or developing.
The market for vaccines that protect against and treat HIV/AIDS is intensely competitive and
is subject to rapid and significant technological change. We will have numerous competitors in the
United States and abroad, including, among others, large companies such as
Merck & Co. and Chiron Inc. These competitors may develop technologies and products that are more
effective or less costly than any of our future products or that could render our products obsolete
or noncompetitive. We expect most of these competitors to have substantially more resources than
us. In addition, the pharmaceutical industry continues to experience consolidation, resulting in an
increasing number of larger, more diversified companies than us. Among other things, these
companies can spread their research and development costs over much broader revenue bases than we
can and can influence customer and distributor buying decisions.
Our products may not gain market acceptance among physicians, patients, healthcare payors and
the medical community. Significant factors in determining whether we will be able to compete
successfully include:
| the efficacy and safety of our vaccines; | ||
| the time and scope of regulatory approval; | ||
| reimbursement coverage from insurance companies and others; | ||
| the price and cost-effectiveness of our products; and | ||
| patent protection. |
Our product candidates are based on new technology and, consequently, are inherently risky.
Concerns about the safety and efficacy of our products could limit our future success.
We are subject to the risks of failure inherent in the development of product candidates based
on new technologies. These risks include the possibility that the products we create will not be
effective, that our product candidates will be unsafe or otherwise fail to receive the necessary
regulatory approvals or that our product candidates will be hard to manufacture on a large scale or
will be uneconomical to market.
Many pharmaceutical products cause multiple potential complications and side effects, not all
of which can be predicted with accuracy and many of which may vary from patient to patient. Long
term follow-up data may reveal additional complications associated with our products. The
responses of potential physicians and others to information about complications could materially
affect the market acceptance of our products, which in turn would materially harm our business.
Unsuccessful or delayed regulatory approvals required to exploit the commercial potential of our
products could increase our future development costs or impair our future sales.
None of our products or technologies have been approved by the FDA for sales in the United
States or in foreign countries. To exploit the commercial potential of our technologies, we are
conducting and planning to conduct additional pre-clinical studies and clinical trials. This
process is expensive and can require a significant amount of time. Failure can occur at any stage
of testing, even if the results are favorable. Failure to adequately demonstrate safety and
efficacy in clinical trials would prevent regulatory approval and restrict our ability to
commercialize our technologies. Any such failure may severely harm our business. In addition, any
approvals we obtain may not cover all of the clinical indications for which approval is sought, or
may contain significant limitations in the form of narrow indications, warnings, precautions or
contraindications with respect to conditions of use, or in the form of onerous risk management
plans, restrictions on distribution, or post-approval study requirements.
State pharmaceutical marketing compliance and reporting requirements may expose us to regulatory
and legal action by state governments or other government authorities.
In recent years, several states, including California, Vermont, Maine, Minnesota, New Mexico
and West Virginia, have enacted legislation requiring pharmaceutical companies to establish
marketing compliance programs and file periodic reports on sales, marketing, pricing and other
activities. Similar legislation is being considered in other states. Many of these requirements are
new and uncertain, and available guidance is limited. Unless we are in full compliance with these
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laws, we could face enforcement action and fines and other penalties and could receive adverse
publicity, all of which could harm our business.
We may be subject to new federal and state legislation to submit information on our open and
completed clinical trials to public registries and databases.
In 1997, a public registry of open clinical trials involving drugs intended to treat serious
or life-threatening diseases or conditions was established under the Food and Drug Administration
Modernization Act, or the FDMA, in order to promote public awareness of and access to these
clinical trials. Under the FDMA, pharmaceutical manufacturers and other trial sponsors are required
to post the general purpose of these trials, as well as the eligibility criteria, location and
contact information of the trials. Since the establishment of this registry, there has been
significant public debate focused on broadening the types of trials included in this or other
registries, as well as providing for public access to clinical trial results. A voluntary coalition
of medical journal editors has adopted a resolution to publish results only from those trials that
have been registered with a no-cost, publicly accessible database, such as www.clinicaltrials.gov.
Federal legislation was introduced in the fall of 2004 to expand www.clinicaltrials.gov and to require the inclusion of study results in this
registry. The Pharmaceutical Research and Manufacturers of America has also issued voluntary
principles for its members to make results from certain clinical studies publicly available and has
established a website for this purpose. Other groups have adopted or are considering similar
proposals for clinical trial registration and the posting of clinical trial results. Failure to
comply with any clinical trial posting requirements could expose us to negative publicity, fines
and other penalties, all of which could materially harm our business.
We will face uncertainty related to pricing and reimbursement and health care reform.
In both domestic and foreign markets, sales of our products will depend in part on the
availability of reimbursement from third-party payors such as government health administration
authorities, private health insurers, health maintenance organizations and other health
care-related organizations. Reimbursement by such payors is presently undergoing reform and there
is significant uncertainty at this time how this will affect sales of certain pharmaceutical
products.
Medicare, Medicaid and other governmental healthcare programs govern drug coverage and
reimbursement levels in the United States. Federal law requires all pharmaceutical manufacturers to
rebate a percentage of their revenue arising from Medicaid-reimbursed drug sales to individual
states. Generic drug manufacturers agreements with federal and state governments provide that the
manufacturer will remit to each state Medicaid agency, on a quarterly basis, 11% of the average
manufacturer price for generic products marketed and sold under abbreviated new drug applications
covered by the states Medicaid program. For proprietary products, which are marketed and sold
under new drug applications, manufacturers are required to rebate the greater of (a) 15.1% of the
average manufacturer price or (b) the difference between the average manufacturer price and the
lowest manufacturer price for products sold during a specified period.
Both the federal and state governments in the United States and foreign governments continue
to propose and pass new legislation, rules and regulations designed to contain or reduce the cost
of health care. Existing regulations that affect the price of pharmaceutical and other medical
products may also change before any products are approved for marketing. Cost control initiatives
could decrease the price that we receive for any product developed in the future. In addition,
third-party payors are increasingly challenging the price and cost-effectiveness of medical
products and services and litigation has been filed against a number of pharmaceutical companies in
relation to these issues. Additionally, some uncertainty may exist as to the reimbursement status
of newly approved injectable pharmaceutical products. Our products may not be considered cost
effective or adequate third-party reimbursement may not be available to enable us to maintain price
levels sufficient to realize an adequate return on our investment.
Other companies may claim that we infringe their intellectual property or proprietary rights, which
could cause us to incur significant expenses or prevent us from selling products.
Our success will depend in part on our ability to operate without infringing the patents and
proprietary rights of third parties. The manufacture, use and sale of new products have been
subject to substantial patent rights litigation in the pharmaceutical industry. These lawsuits
generally relate to the validity and infringement of patents or proprietary rights of third
parties. Infringement litigation is prevalent with respect to generic versions of products for
which the patent covering the brand name product is expiring, particularly since many companies
which market generic products focus their development efforts on products with expiring patents.
Other pharmaceutical companies, biotechnology companies, universities and research institutions may
have filed patent applications or may have been granted patents that cover aspects of our products
or our licensors products, product candidates or other technologies.
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Future or existing patents issued to third parties may contain patent claims that conflict
with our products. We expect to be subject to infringement claims from time to time in the ordinary
course of business, and third parties could assert infringement claims against us in the future
with respect to our current products or with respect to products that we may develop or license.
Litigation or interference proceedings could force us to:
| stop or delay selling, manufacturing or using products that incorporate or are made using the challenged intellectual property; | ||
| pay damages; or | ||
| enter into licensing or royalty agreements that may not be available on acceptable terms, if at all. |
Any litigation or interference proceedings, regardless of their outcome, would likely delay
the regulatory approval process, be costly and require significant time and attention of our key
management and technical personnel.
Any inability to protect intellectual property rights in the United States and foreign countries
could limit our ability to manufacture or sell products.
We will rely on trade secrets, unpatented proprietary know-how, continuing technological
innovation and, in some cases, patent protection to preserve a competitive position. Our patents
and licensed patent rights may be challenged, invalidated, infringed or circumvented, and the
rights granted in those patents may not provide proprietary protection or competitive advantages to
us. We and our licensors may not be able to develop patentable products. Even if patent claims are allowed, the claims may not
issue, or in the event of issuance, may not be sufficient to protect the technology owned by or
licensed to us. Third party patents could reduce the coverage of the patents license, or that may
be licensed to or owned by us. If patents containing competitive or conflicting claims are issued
to third parties, we may be prevented from commercializing the products covered by such patents, or
may be required to obtain or develop alternate technology. In addition, other parties may
duplicate, design around or independently develop similar or alternative technologies.
We may not be able to prevent third parties from infringing or using our intellectual
property, and the parties from whom we may license intellectual property may not be able to prevent
third parties from infringing or using the licensed intellectual property. We generally will
attempt to control and limit access to, and the distribution of, our product documentation and
other proprietary information. Despite efforts to protect this proprietary information, however,
unauthorized parties may obtain and use information that we may regard as proprietary. Other
parties may independently develop similar know-how or may even obtain access to these technologies.
The laws of some foreign countries do not protect proprietary information to the same extent
as the laws of the United States, and many companies have encountered significant problems and
costs in protecting their proprietary information in these foreign countries.
The U.S. Patent and Trademark Office and the courts have not established a consistent policy
regarding the breadth of claims allowed in pharmaceutical patents. The allowance of broader claims
may increase the incidence and cost of patent interference proceedings and the risk of infringement
litigation. On the other hand, the allowance of narrower claims may limit the value of our
proprietary rights.
We may be required to defend lawsuits or pay damages for product liability claims.
Product liability is a major risk in testing and marketing biotechnology and pharmaceutical
products. We may face substantial product liability exposure in human clinical trials and for
products that we sell after regulatory approval. We carry product liability insurance and we
expect to continue such policies. Product liability claims, regardless of their merits, could
exceed policy limits, divert managements attention, and adversely affect our reputation and the
demand for our products.
Compliance with requirements of Section 404 of the Sarbanes-Oxley Act of 2002 will increase our
costs and require additional management resources, and we may not successfully comply.
As directed by Section 404 of the Sarbanes-Oxley Act of 2002, the SEC adopted rules requiring
public companies to include a report of management on the Companys internal controls over
financial reporting in their annual reports on Form 10-K. In addition, the independent registered
public accounting firm auditing the Companys financial statements must attest to and report on
managements assessment of the effectiveness of the Companys internal controls over financial
reporting. Although the SEC has postponed the effectiveness of these requirements several times, if
the SEC does
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not postpone or otherwise alter these requirements again, then we expect that the
requirement to include a report of management on the Companys internal controls, including the
requirement to include the attestation report of the Companys independent registered public
accounting firm, will first apply to our annual report on Form 10-K for our fiscal year ending
December 31, 2007. We will incur significant accounting and other expenses related to our
compliance efforts; and compliance will occupy a substantial amount of time of our board of
directors and management. If we are unable to complete the required assessment as to the adequacy
of our internal control reporting or if we conclude that our internal controls over financial
reporting are not effective or if our independent registered public accounting firm is unable to
provide us with an unqualified report as to the effectiveness of our internal controls over
financial reporting as of December 31, 2007 and future year-ends, investors could lose confidence
in the reliability of our financial reporting. In addition, while we may expand our staff to assist
in complying with the additional requirements when and if they become applicable, we may encounter
substantial difficulty attracting qualified staff with requisite experience due to the high level
of competition for experienced financial professionals.
We may issue preferred stock in the future, and the terms of the preferred stock may reduce the
value of our common stock
We are authorized to issue up to 10,000,000 shares of preferred stock in one or more series.
Our board of directors may determine the terms of future preferred stock offerings without further
action by our stockholders. If we issue preferred stock, it could affect the rights or our common
stockholders or reduce the value of our outstanding common stock. In particular, specific rights
granted to future holders of preferred stock may include voting rights, preferences as to dividends
and liquidation, conversion and redemption rights, sinking fund provisions, and restrictions on our
ability to merge with or sell our assets to a third party.
We may experience volatility in our stock price, which may adversely affect the trading price of
our common stock.
The market price for our common stock has been, and may continue to be, volatile and subject
to price and volume fluctuations in response to market and other factors, including the following,
some of which are beyond our control:
| the increased concentration of the ownership of our shares by a limited number of affiliated stockholders following the Merger may limit interest in our securities; | ||
| variations in quarterly operating results from the expectations of securities analysts or investors; | ||
| announcements of technological innovations or new products or services by us or our competitors; | ||
| general technological, market or economic trends; | ||
| investor perception of the industry or our prospects; | ||
| investors entering into short sale contracts; | ||
| regulatory developments affecting the biopharmaceutical industry; and | ||
| additions or departures of key personnel. |
Future sales of substantial amounts of our common stock may adversely affect our market price.
In connection with the Merger, we issued a significant number of additional shares of our
common stock to a small number of stockholders. Although the shares issued in the Merger were not
immediately freely tradable, such shares became tradable in market transactions on or about
September 28, 2007 (one year after the closing of the Merger), subject to the requirements of Rule
144 promulgated under the Securities Exchange Act of 1934, as amended. Future sales of substantial
amounts of our common stock into the public market, or perceptions in the market that such sales
could occur, may adversely affect the prevailing market price of our common stock.
Item 2 Unregistered Sales of Equity Securities and Use of Proceeds
In January 2007 we issued 1,543,210 shares of our common stock to two individual investors for
an aggregate purchase price of $250,000. We relied on section 506 of the Securities Act of 1933 to
issue the common stock, inasmuch as the common stock was sold without any form of general
solicitation or general advertising and sales were made only to accredited investors.
In January 2007 we issued 123,550 shares of our common stock to a former employee for an
aggregate purchase price of $5,000 pursuant to the exercise of stock options. We relied on section
4(2) of the Securities Act of 1933 to issue the common stock, inasmuch as the common stock was sold
without any form of general solicitation or general advertising
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and the offeree occupied a status relative to us that afforded him effective access to the information registration would otherwise
provide.
Item 3 Default Upon Senior Securities
None.
Item 4 Submission of Matters to a Vote of Security Holders
We held a Special Meeting of Stockholders on September 28, 2007 for the purpose of approving
an amendment to our Articles of Incorporation in order to increase the number of authorized shares
of our common stock from 850,000,000 to 900,000,000. With respect to the proposal: (i) 533,404,741
votes were cast for, (ii) 11,298,357 votes were cast against, and (iii) 162,282 shares abstained.
Accordingly, the proposal was approved by our stockholders.
Item 5 Other Information
None.
Item 6 Exhibits
The Exhibits listed on the accompanying Index to Exhibits are filed as part hereof, or
incorporated by reference into, the report.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this quarterly report on Form 10-Q to be signed on its behalf by the undersigned thereunto duly
authorized.
GEOVAX LABS, INC. (Registrant) |
Date: November 14, 2007 | By: | /s/ Mark W. Reynolds | ||
Mark W. Reynolds | ||||
Chief Financial Officer
(duly authorized officer and principal financial officer) |
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INDEX TO 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
|
Articles of Incorporation | |
3.2
|
Bylaws, as amended December 7, 2006 (4) | |
10.1
|
Subscription Agreement (5) | |
10.2
|
Extension Agreement (6) | |
31.1
|
Certification of President Pursuant to Section 302 of the Sarbanes-Oxley Act | |
31.2
|
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act | |
32.1
|
Certification of President Pursuant to Section 906 of the Sarbanes-Oxley Act | |
32.2
|
Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act |
(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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 28, 2007. | |
(5) | Incorporated by reference from the registrants Current Report on Form 8-K filed with the Securities and Exchange Commission on July 31, 2007. | |
(6) | Incorporated by reference from the registrants Current Report on Form 8-K filed with the Securities and Exchange Commission on October 30, 2007. |