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Note 1 - Description of Company and Basis of Presentation
9 Months Ended
Sep. 30, 2011
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
1.           Description of Company and Basis of Presentation

GeoVax Labs, Inc. (“GeoVax” or the “Company”), is a biotechnology company dedicated to developing vaccines to prevent and fight Human Immunodeficiency Virus (“HIV”) infections that result in Acquired Immunodeficiency Syndrome (“AIDS”).  We have exclusively licensed from Emory University (“Emory”) vaccine technology which was developed in collaboration with the National Institutes of Health (“NIH”) and the Centers for Disease Control and Prevention (“CDC”).  GeoVax is incorporated under the laws of the State of Delaware and our principal offices are located in Smyrna, Georgia (metropolitan Atlanta area).

Our HIV/AIDS vaccines are being evaluated in humans who are not HIV infected for their potential to be used to prevent infection should the person be exposed to HIV.  We are also evaluating our vaccines in HIV-infected individuals for their potential to serve as a therapy for those who are already infected.  Our preventative vaccines seek to prevent or control infection by HIV, reduce the rate of disease progression to AIDS and reduce the risk of HIV transmission. Our therapeutic vaccines target impeding viral replication to reduce viral load in HIV infected individuals with a view to reducing or eliminating the need for anti-HIV medications, and thereby reduce the cost of treatment and the detrimental side effects associated with current drug treatments.

The therapeutic use of our vaccines is being tested in a Phase 1/2 human clinical trial sponsored by GeoVax.  This trial was initiated based on promising preclinical data from therapeutic trials in infected non-human primates. We expect the Phase 1/2 human trial to begin generating vaccine safety and performance data during early 2012.  If the data are encouraging, we expect to amend and expand this study into a larger Phase 2 clinical trial.

The preventative use of our vaccine is being tested in humans by the NIH-funded HIV Vaccine Trials Network (“HVTN”).  The first generation of our preventative vaccine is one of only five vaccine candidates out of more than 80 tested by the HVTN to have progressed to Phase 2 testing.  Patient enrollment of this 299 participant Phase 2a clinical trial is complete and we expect to complete inoculations during early 2012.  The HVTN is also planning human clinical testing of a second generation of our vaccine (co-expressing granulocyte-macrophage colony-stimulating factor (GM-CSF)) that was successfully tested in non-human primates, with a target start date of Phase 1 clinical testing in early 2012.  In preclinical non-human primate testing, the new vaccine induced immune responses that resulted in a 70% rate of prevention of infection.

Our current vaccines being tested address the subtype, known as clade B, of the HIV virus that is most prevalent in the developed world.  Our goals include applying our technology and expertise to develop additional HIV vaccines for global markets that have different clades of the virus, manufacturing and testing these vaccines, conducting human trials for vaccine safety and effectiveness, and obtaining regulatory approvals to advance the development and commercialization of our vaccines.

GeoVax is devoting all of its present efforts to research and development and is a development stage enterprise as defined by Financial Accounting Standards Board (“FASB”) Accounting Standard Codification (“ASC”) Topic 915, Development Stage Entities.  The accompanying financial statements at September 30, 2011 and for the three month and nine month periods ended September 30, 2011 and 2010 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, 2010.  We expect our operating results to fluctuate for the foreseeable future; therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.

The accompanying financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate the continuation of the Company as a going concern. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.  We have had no product revenue to date and there can be no assurance that we will ever generate any product revenue. Our ability to generate revenue and achieve profitability depends on our ability to successfully complete the development of our product candidates, obtain the necessary regulatory approvals, and manufacture and market the resulting products. To date, we have financed our operations principally through the sale of equity securities and through NIH grants, but we will require substantial additional financing at various intervals to conduct our operations.  There is no assurance that adequate funding will continue to be available to us, and, if available, on terms acceptable to the Company.  If we are not able to secure the significant funding that is required to maintain and continue our operations, we may be required to delay clinical studies or clinical trials, curtail operations, or obtain funds through collaborative arrangements that may require us to relinquish rights to some of our products or potential markets.  The Company’s ability to continue as a going concern is also dependent on many events outside of its direct control, including, among other things improvement in the economic climate. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

We disclosed in Note 2 to our financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2010 those accounting policies that we consider significant in determining our results of operations and financial position.  There have been no material changes to, or in the application of, the accounting policies previously identified and described in the Form 10-K.