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GeoVax Labs, Inc. Reports Fourth Quarter and Year-End 2008 Financial Results

ATLANTA, March 12 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based biotechnology company focused on development of an HIV/AIDS vaccine, today announced its financial results for the fourth quarter and year ended December 31, 2008, and provided a summary of recent operational highlights for calendar year 2009 to date.

GeoVax reported a net loss of $1,039,217 for the fourth quarter ended December 31, 2008, as compared to a net loss of $1,155,870 for the comparable period in 2007. For the full year of 2008, the Company reported a net loss of $3,728,187 as compared to a net loss of $4,241,796 in 2007. GeoVax's operating results fluctuate due to the timing of activities and related costs associated with its vaccine research and development activities. Summarized financial information is presented below. GeoVax's full set of audited financial statements are included in its Annual Report on Form 10-K filed with the Securities and Exchange Commission.

Robert T. McNally, Ph.D., GeoVax's president and chief executive officer, stated, "For a company of GeoVax's size and stage of clinical development, our financial position is on target. Our operational expenses are reduced by the National Institutes of Health's (NIH) support of our ongoing Phase 2a preventative clinical trial being conducted by the HIV Vaccine Trials Network (HVTN), and are further offset by the direct grant from the NIH to GeoVax, covering research and development for future vaccine improvements. Our financial security is enhanced by the common stock purchase agreement with Fusion Capital Fund II, LLC. These funds are providing the Company with resources to conduct its own clinical trial in HIV infected, drug controlled subjects. Planning for this therapeutic trial is underway with a projected start for later this year."

            Recent Operational Highlights for Year 2009 - to date

    *    In February 2009, GeoVax announced the first injections in its Phase
         2a Human Clinical Vaccine Trial for its candidate HIV/AIDS vaccine.
         The trial, designated HVTN 205, is being conducted by the HVTN
         (already provided definition above).  The HVTN, funded and supported
         by the National Institutes of Allergy and Infectious Diseases
         (NIAID), is the largest worldwide clinical trials network dedicated
         to the development and testing of HIV/AIDS vaccines.  The HVTN has
         sponsored over 80 Phase 1 trials for the initial evaluation of
         safety and immunogenicity of candidate HIV/AIDS vaccines.  Of these,
         only five have progressed to Phase 2 trials since 1992.  Progressing
         to Phase 2 was a significant achievement for GeoVax.

         First injections for the Phase 2a trial were conducted at the HVTN
         network sites at the University of Alabama, Birmingham, and
         Vanderbilt University, Nashville. The trial will include a total of
         225 volunteers (150 vaccine recipients and 75 placebo recipients)
         and take place at 13 HVTN sites: 11 in North America and 2 in South
         America.  Sites in the United States include Emory University,
         Atlanta; Harvard Medical School, Brigham & Women's Hospital and
         Harvard-Fenway Hospital in Boston; Vanderbilt University, Nashville;
         University of Rochester; Fred Hutchinson Cancer Research Center,
         Seattle; the San Francisco Department of Public Health; University
         of Alabama, Birmingham, and sites at Columbia University, Union
         Square, and the Bronx in New York City.  In South America,
         participants are to be enrolled in Peru at sites in Iquitos and
         Miraflores (Lima).

    *    In February 2009, GeoVax presented a corporate update at the
         Eleventh Annual BIO CEO & Investor Conference 2009, held in New York
         City. Dr. McNally presented a corporate overview of GeoVax and its
         DNA/MVA vaccine technology, showcasing the scientific rationale and
         encouraging data from the Company's completed studies and trials.
         GeoVax's presentation was offered via a live webcast. A replay of
         the webcast is available on the Company's website until April 10.

                     Operational Highlights for Calendar Year 2008

    Clinical Progress
    *    In October 2008, GeoVax presented data on its Phase 1 AIDS vaccine
         trial (HVTN 065) at the AIDS Vaccine 2008 conference, in Cape Town,
         South Africa. The presentation, entitled "Two HIV DNA Primes
         Maximize T Cell Responses Induced by the GeoVax DNA/MVA Vaccine
         Regimen Administered to Healthy Seronegative Adults (HVTN 065)," was
         given by Dr. Paul A. Goepfert, M.D., Associate Professor, Division
         of Infectious Diseases, Department of Medicine, University of
         Alabama. Dr. Goepfert is the HVTN 065 Protocol Team chair. The trial
         results reveal the GeoVax DNA and MVA vaccines are safe and
         immunogenic (stimulate anti-HIV/AIDS immune responses) at both low
         (1/10th) dose and full doses. Other highlights of the presentation
         O    GeoVax vaccines were well tolerated with no or mild local and
              systemic reactions in the majority of trial participants.
         O    Eighty percent of both the low and full dose trial
              participants responded to the vaccine which stimulated anti-
              HIV T-cell (white blood cell) and antibody responses.
         O    More volunteers had antibody responses to the full dose than
              to the 1/10th dose vaccine, whereas response rates for T cells
              were similar for the 1/10th and full dose.
         O    Two DNA primes were more effective than one DNA prime or no
              DNA primes at eliciting T cell responses.
         O    The second MVA vaccination positively increased CD8 T cell and
              antibody responses.

         Dr. Harriet Robinson, the developer of the vaccine and GeoVax's Vice
         President of Research and Development, also presented these same
         results at the Viral Vector Vaccines 2008 meeting, at the Wellcome
         Trust Conference Center near Cambridge, U.K., on September 28, 2008.

    *    Phase 2a Preventive Human Trial - As mentioned above, GeoVax's Phase
          2a trial began patient enrollment in February 2009.  The Phase 2a
         human trial will broaden the base of safety and immunogenicity data
         for the full dose of the GeoVax AIDS vaccine with a view to
         protecting recipients from developing AIDS should they be exposed to
         the virus.  In October 2008, GeoVax shipped both components (DNA and
         MVA) of its AIDS vaccine to the HVTN pharmacy, and sites were
         initiated in December.  A tremendous amount of work conducted by
         both GeoVax and HVTN during 2008 led to the initiation of this

    *    Planning for Therapeutic Human Trials - GeoVax reported summary data
         from a pilot study on therapeutic vaccination in simian
         immunodeficiency virus (SIV) infected non-human primates with the
         SIV prototype of GeoVax's AIDS vaccine. In this small pilot study,
         conducted by Dr. Rama Amara at Emory University, two non-human
         primates were infected with SIV. Data from the study revealed
         outstanding results with the vaccine controlling the infection with
         from 100 to 1000 times reduction in viral levels. The excellent
         control of the virus infection in the absence of drug treatment was
         associated with the vaccine raising the types of CD4 and CD8 T cells
         that are found in the rare individuals who spontaneously control
         their HIV infections. Based on these excellent results, planning for
         a therapeutic trial in infected and drug-treated humans has been
         initiated. The intent of therapeutic vaccination will be to
         "control" HIV virus levels in infected individuals to very low
         levels thus blocking the development of AIDS.  The Company expects
         to initiate human clinical studies for a therapeutic vaccine during
         the second half of 2009.

    Manufacturing Progress
    *    In July 2008, GeoVax and Vivalis S.A., a French biopharmaceutical
         company, signed a letter of intent for joint collaboration and
         commercial license on the use of Vivalis' EBx(R) technology, to
         manufacture the MVA component of the GeoVax HIV-1 vaccine.  The
         breakthrough manufacturing technology developed by Vivalis, through
         further development collaboration with GeoVax, will create a new
         standard for manufacture of the MVA component of GeoVax's HIV/AIDS
         vaccine. Vivalis' EBx(R) manufacturing platform, with its increased
         effectiveness, superior quality and reliability, will speed time to
         market MVA vaccine product availability in ample quantities to meet
         sizeable demand and expectedly at a lesser cost. Vivalis' vaccine
         manufacturing technology is based on a duck embryonic stem cell
         substrate platform, providing continuous growth from a fully
         characterized frozen cell bank without necessitating fertilized
         embryo extraction and processing, as with present chicken cell based
         technologies. Furthermore, the EB66(R) cell line can be grown in
         suspension (without the cells attached to the surface of the growth
         vessel) and can be scaled up for growth in giant bioreactors (a
         cutting edge industrial method) for large scale production of the
         MVA viral vaccine.

    *    In December 2008, GeoVax engaged the services of VGX International,
         Inc. (VGXI), whereby VGXI will manufacture plasmid (DNA) for use in
         GeoVax's future preventative and therapeutic clinical human trials.

    Strengthened Management Team
    *    In February 2008, GeoVax announced the addition of company co-
         founder Dr. Harriet Robinson to its staff as Vice President of
         Research & Development, and in June 2008 Dr. Robinson joined the
         Company's Board of Directors. Dr. Robinson is known worldwide for
         her outstanding work on retrovirus biology and a pioneer of DNA
         vaccines with special emphasis on HIV/AIDS. Dr. Robinson has
         published extensively on HIV/AIDS vaccine research, with more than
         150 referred scientific journal publications, 50 monograph reviews
         and six book chapters authored. She has consulted for the U.S.
         National Institutes of Health, the U.S. Food and Drug
         Administration, the Bill and Melinda Gates Foundation and the World
         Health Organization.  She served as Chief of Microbiology and
         Immunology at Emory University's Yerkes National Primate Research
         Center and was an Asa Griggs Candler Professor of Microbiology and
         Immunology at the Emory University School of Medicine. Dr. Robinson
         is the inventor of GeoVax's HIV-1 AIDS vaccine technology and co-
         founder of the Company.

    *    In April 2008, GeoVax named Dr. Robert McNally as its President and
         CEO.  Former President/CEO and Company co-founder Don Hildebrand
         remained as Chairman of the Board of Directors and continues to be
         involved in company development, growth and expansion plans in the
         AIDS vaccine arena. Dr. McNally has been a member of the GeoVax
         Board of Directors since 2006 and was previously a co-founder and
         CEO of Cell Dynamics, LLC, and Cell Design, LLC, companies
         specializing in GMP processing of human cells for pharmaceutical and
         therapeutic applications. Dr. McNally was also co-founder and Sr.
         Vice President of Clinical Research for CryoLife, Inc., a pioneering
         company in transplantable human tissues. He has had previous
         experience as European Regional Manager for Intermedics
         International, Inc., and European Marketing Manager for Pacesetter
         Systems-Europe, Ltd., in the U.K. Dr. McNally serves as a member of
         the advisory boards of the Parker H. Petit Institute for
         Bioengineering and Bioscience and DuPree College of Management at
         the Georgia Institute of Technology. He is an elected fellow of the
         American Institute for Medical and Biological Engineering, and is a
         past Chairman for the Georgia Biomedical Partnership, a trade
         association, and is recipient of the 2004 Biomedical Industry Growth
         Award for the State of Georgia. Dr. McNally has a Ph.D. and MSE in
         Bioengineering from University of Pennsylvania and an electrical
         engineering degree (B.E.E.) from Villanova University.

    *    In August 2008, GeoVax announced the appointment of Mr. Peter
         Tsolinas to its Board of Directors.  Mr. Tsolinas also was
         subsequently appointed to membership on GeoVax's Audit Committee and
         Compensation Committee. Mr. Tsolinas currently serves as Chairman
         and CEO of TMA Group Development Corp., a Chicago-based real estate,
         architectural and development firm.

    Financing Events
    *    In January 2008, GeoVax was recognized by Georgia Bio, the state
         trade organization, as a 2007 "Deal of the Year" award winner for
         receipt of the $15 million IPCAVD grant from the National Institutes
         of Health (NIH). The award was presented at Georgia Bio's annual
         awards dinner on January 24, 2008. This grant is believed to be one
         of the largest grants of its kind to be awarded in the last fiscal
         year. In September, GeoVax announced receipt of an estimated $15
         million Integrated Preclinical/Clinical AIDS Vaccine Development
         (IPCAVD) Grant to support its HIV/AIDS vaccine program. This large
         grant was awarded by the National Institute of Allergy & Infectious
         Disease (NIAID), a division of the NIH.  The grant funding period is
         over a five year period which commenced in October 2007.  Only
         meritorious HIV/AIDS prevention vaccine candidates are considered to
         receive an IPCAVD award. Candidate companies are highly scrutinized
         and must supply substantial positive AIDS vaccine data to support
         their application.  IPCAVD grants are awarded on a competitive basis
         and are designed to support later stage vaccine research,
         development and human trials.  GeoVax is utilizing this funding to
         further its HIV/AIDS vaccine development, optimization and

    *    During April and May 2008, the Company raised $1,365,000 in capital
         through a private placement of its common stock and warrants sold to
         individual accredited investors.

    *    In May 2008, the Company entered into a $10 million common stock
         purchase agreement with Fusion Capital Fund II, LLC, a Chicago-based
         institutional investor. Under the agreement, the Company may sell,
         from time to time, up to $10 million of its common stock to Fusion
         over a 25-month period, following approval of the Company's
         registration statement by the Securities and Exchange Commission
         (declared effective on July 1, 2008). The Company has the right to
         sell shares of its common stock to Fusion, from time to time, in
         amounts ranging from $80,000 to $1 million, depending on certain
         conditions, up to $10 million in the aggregate. The purchase price
         of the shares is based on the prevailing market prices of the
         Company's shares at the time of sales without any fixed discount,
         and the Company will control the timing and amount of any sales of
         shares to Fusion.  During 2008, the Company raised $500,000 through
         the Fusion facility, with $9.5 million remaining available at
         December 31, 2008.

About GeoVax Labs, Inc.

GeoVax Labs, Inc. is a biotechnology company focused on developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax's AIDS vaccine technology is the subject of 20 issued or filed patent applications. GeoVax AIDS vaccines are designed for use in uninfected people to prevent Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, should the person ever become infected. GeoVax AIDS vaccines also may be effective as therapeutics, treatment of people already infected with AIDS virus.

GeoVax's core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Senior V.P. of Research and Development, through a collaboration of colleagues at Emory University's Vaccine Center, the National Institutes of Health (NIH), The Centers for Disease Control and Prevention (CDC) and GeoVax.

GeoVax AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded through a cooperative agreement with the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of AIDS vaccines. Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided additional support to GeoVax AIDS vaccine development program with a $15 million IPCAVD grant awarded in late 2007.

Safe Harbor Statement

All statements in this news release, not statements of historical fact, are forward-looking statements. These statements are based on expectations and assumptions on the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. Risks and uncertainties include, but are not limited to, whether: GeoVax can develop and manufacture these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent AIDS in humans, vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward-looking statements involving certain risks and uncertainties including, without limitation, risks detailed in the Company's Securities and Exchange Commission filings and reports.

                             FINANCIAL TABLES FOLLOW

                              GEOVAX LABS, INC.
                        Statements of Operations Data
                  (amounts in thousands, except per share data)

                                 Three Months Ended      Year Ended
                                    December 31,         December 31,
                                  2008       2007      2008      2007
    Grant Revenue                 $612       $237     $2,910     $237

    Operating expenses:
      Research and development   1,016        484      3,741    1,757
      General and administrative   648        919      2,970    2,784
                                 1,664      1,403      6,711    4,541
    Loss from operations        (1,052)    (1,166)    (3,801)  (4,304)
    Interest income                 13         10         73       62

    Net loss                   $(1,039)   $(1,156)   $(3,728) $(4,242)

    Net loss per common share   $(0.00)    $(0.00)    $(0.01)  $(0.01)

    Weighted averages shares
     outstanding               746,067    717,925    740,143  714,102

                                Balance Sheet Data
                              (amounts in thousands)

                                                       December 31,
                                                    2008         2007
    Cash and cash equivalents                     $2,191       $1,990
    Working capital                                2,455        2,432
    Total assets                                   3,056        3,246
    Deficit accumulated during the development
     stage                                       (14,254)     (10,525)
    Total stockholders' equity                     2,710        2,648

SOURCE GeoVax Labs, Inc.
Copyright©2009 PR Newswire.
All rights reserved

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