Full Press Release Details
404.727.0971 or rmcnally@geovax.com
At Financial Relations Board:
312.640.6672 or lloyet@mww.com
312.640.6732 or nsnodgrass@mww.com
FRIDAY, AUGUST 7, 2009
LABS, INC. ANNOUNCES SIX MONTH 2009 FINANCIAL
RESULTS AND PROVIDES OPERATIONAL UPDATE
ATLANTA, Ga., August 7, 2009 GeoVax Labs, Inc. (OTC BB: GOVX), an Atlanta-based,
biopharmaceutical firm (the Company ), developing human vaccines for diseases caused by HIV-1
(Human Immunodeficiency Virus) and other infectious agents, today announced its financial results
and provided an operational update for the six months ended June 30, 2009.
GeoVax has had a productive year so far in 2009, commented Robert McNally, PhD, president and
chief executive officer. In February, we began patient injections in our Phase 2a clinical trial
for our candidate vaccine for the prevention of AIDS. And, as we previously announced, we have
enrolled approximately 30% of the necessary volunteers. As is typical in the enrollment process,
as the number of clinical sites are approved, the speed of enrollment increases. This trial is
being conducted by the HIV Vaccine Trials Network (HVTN), funded and supported by the National
Institutes of Allergy and Infectious Diseases (NIAID). The HVTN is the largest worldwide clinical
trials network dedicated to the development and testing of HIV/AIDS vaccines and 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. Achieving the Phase 2
milestone is a significant step for GeoVax and its efforts to develop an effective vaccine for
Dr. McNally continued, We recognize the lengthy process to shepherd a preventative vaccine through
clinical trials and FDA approval. We therefore have initiated a secondary clinical pathway to
develop our HIV/AIDS vaccine candidate as a therapeutic vaccine. The approval path for this project
has a much shorter duration than our current program for the development of a preventative vaccine.
We have already commenced protocol development for our first Phase 1 human clinical trials
investigating the therapeutic vaccine approach. Our reassessment of the time required to gain
approval from the FDA is such that we expect this trial to begin during the first quarter of 2010.
Our plan is to produce data from our therapeutic vaccine trials in support of future
capital-raising and corporate partnering efforts.
Dr. McNally concluded, Continued funding of our clinical programs and research and development
is critical. At the same time we are diligently managing our cash outlays. Our financial
condition is stable,
with the ongoing support provided by HVTN (through their conduct of our Phase 2a trial), the
five-year $17 million grant to GeoVax from the National Institutes of Health (NIH), awarded in late
2007, and the equity financing facility with Fusion Capital Fund II, LLC. We are pursuing a number
of funding options to accelerate our therapeutic vaccine clinical trials program. The latest of
which was a proposed cooperative arrangement with Cook County (metro Chicago), the Cook County
Health and Hospitals System, and the Ruth M. Rothstein s CORE Foundation. Although it now appears
that our original proposal will not progress, it is an example of the type of initiative we will
continue to pursue. We remain in discussions with various Cook County-based parties and continue to
explore related funding opportunities.
Review of Financial Results
The Company recorded a net loss of $1,348,654 for the three months ended June 30, 2009, compared to
$1,284,352 for the same period in 2008. For the six months ended June 30, 2009, the Company s net
loss was $2,210,163 as compared to $1,966,862 in 2008. Net losses were partially offset by grant
revenues related to the Company s grant from the NIH in support of its HIV/AIDS vaccine development
activities; such revenues were $752,800 and $1,462,955 for the three month and six month periods of
2009, respectively, as compared to $376,078 and $976,069 for the three month and six month periods
of 2008, respectively. As of June 30, 2009, the Company reported cash balances totaling
Summarized financial information is presented below. Further information concerning the Company s
financial position and results of operations are included in its Quarterly Report on Form 10-Q to
be filed with the Securities and Exchange Commission.
HIV affects the entire globe and comes in a variety of subtypes. Clade B is the predominant
subtype in North America where there are roughly 60,000 new infections each year. Globally, there
are about 2.5 million AIDS infections per year, most primarily involving subtypes AG, B, and C. In
2007, UNAIDS reported 1.3 million people living with AIDS in North America and 33.2 million people
living with AIDS worldwide. Presently, there is little to prevent HIV transmission other than
education, circumcision, and condoms. It is obvious from the spread of the disease that these
methods are not adequate. Existing treatments for individuals infected with HIV include
anti-retroviral therapies that are effective but have serious medical side effects and are very
expensive (upwards of $1,500/month). This cost is borne primarily by the individual and sometimes
by third party insurance, local healthcare, federal or world health organizations. Development and
distribution of an effective HIV/AIDS vaccine holds great promise. The GeoVax Vaccine would cost a
fraction of the cost of current treatments and, to date, has not elicited serious adverse side
effects in several human trials. A population vaccinated with an effective HIV-1 vaccine would be
expected to significantly decrease the prevalence of AIDS over time.
About GeoVax Labs, Inc.
GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and
commercialize 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
GeoVax s 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 $17 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