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GeoVax Labs, Inc. Provides Third
Quarter 2009 Financial Results and Operational Update
ATLANTA, Nov. 6 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC
Bulletin Board: GOVX) ("GeoVax" or "the Company"), an
Atlanta-based, biopharmaceutical company developing human vaccines for
diseases caused by HIV-1 (Human Immunodeficiency Virus) and other
infectious agents, today announced its third quarter 2009 financial
results and provided an operational update.
Robert McNally, Ph.D., President and Chief Executive Officer commented,
"We are pleased with our progress during the third quarter of 2009 on
several fronts. Enrollment for our Phase 2a preventative trial being
conducted by the HVTN is proceeding according to plan. We are looking
forward to a pre-IND meeting with the FDA later this year to discuss our
plans for a Phase 1 therapeutic trial in early 2010. With a modest cash
burn rate, continuing support from the HVTN, our IPCAVD grant from the NIH
and with our common stock purchase agreement with Fusion Capital in place,
our finances are in order to take us into 2011. As we move forward, we
believe we will be in a strong position to seek additional government and
private support for advancing both our preventative and therapeutic
vaccines through Phase 2b and Phase 3 clinical trials."
"These are exciting times for GeoVax and everyone involved in
HIV/AIDS vaccine development," Dr. McNally continued. "The
recently announced success of a Thailand-based Phase 3 trial for an
HIV/AIDS vaccine candidate owned by Sanofi-Aventis and Global Solutions
for Infectious Diseases is encouraging to us all and has brought renewed
interest to the field. At GeoVax, we have always been confident in our
ability to develop an effective vaccine and this recent news has shown
that a vaccine is indeed possible."
Review of Financial Results
The Company recorded a net loss of $230,815 for the three months ended
September 30, 2009, compared to $722,108 for the same period in 2008. For
the nine months ended September 30, 2009, the Company's net loss was
$2,440,977 as compared to $2,688,970 in 2008. Net losses for all periods
were partially offset by revenues related to the Company's grant from the
National Institutes of Health (NIH) in support of its HIV/AIDS vaccine
development activities. Grant revenues were $1,808,551 and $3,271,506 for
the three and nine month periods ending September 30, 2009, respectively,
as compared to $1,322,502 and $2,298,571 for the same periods in 2008. As
of September 30, 2009, the Company reported cash balances totaling
$3,416,692.
Recent Highlights:
-- Effective November 3, 2009, the Company has relocated its corporate
headquarters and laboratory operations from the Emtech Bio incubator
facility located on the Emory University campus in Atlanta, Georgia to
1900 Lake Park Drive, Suite 380, Smyrna, Georgia, 30080 (metropolitan
Atlanta). The move provides additional space for GeoVax's current
activities, as well as space to accommodate planned expansion.
-- On October 19 - 22, 2009, Harriet Robinson, Ph.D., GeoVax's Chief
Scientific Officer, attended the AIDS Vaccine 2009 meeting in Paris.
This annual meeting is the largest scientific meeting each year
devoted to HIV/AIDS vaccines. Dr. Robinson presented a late breaking
poster "Comparison of the immunogenicity in humans and rhesus macaques
of vaccines consisting of DNA priming and MVA boosting and MVA priming
and boosting." Next year, the meeting will be hosted in Atlanta,
Georgia where Dr. Robinson will be one of the four local
co-organizers.
-- On October 15, 2009, GeoVax and Formatech, Inc. announced that GeoVax
will be the first recipient of an award under Formatech's
"Fillanthropy" program. Under this program, Formatech will donate the
services required to aseptically fill and finish one lot of the
vaccine for use in support of GeoVax's HIV/AIDS vaccine clinical
trials.
-- In September 2009, GeoVax announced that it had requested a
pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug
Administration (FDA) to discuss a proposed IND for GeoVax's
therapeutic vaccine as a treatment for individuals infected with the
HIV virus. A new IND with the FDA is required since this will be the
first time the GeoVax vaccine will be used for a therapeutic
application. The protocol for the Phase 1 clinical trial, conceived
with collaboration from ARCA (AIDS Research Consortium of Atlanta),
has specific objectives to optimize safety while evaluating the
ability for the vaccine to elicit protective immune responses in
vaccinated participants. The proposed trial is based on the
achievement of excellent post vaccine viral control in animal trials
conducted in recently infected non-human primates at the Yerkes
National Primate Research Center, affiliated with Emory University.
Assuming a positive outcome from the FDA, the Company expects that the
Phase 1 therapeutic trial could begin as early as during the first
quarter of 2010. In order to facilitate an understanding of the IND
process by GeoVax's shareholders, the Company has prepared a graphical
representation of the process, which is available on the Company's
website at www.geovax.com.
-- GeoVax's Phase 2a clinical trial for the preventative version of its
HIV/AIDS vaccine is ongoing and patient enrollment is proceeding to
the Company's satisfaction. This trial, designated as HVTN 205, is
being conducted by the HIV Vaccine Trials Network (HVTN). The HVTN,
funded and supported by the National Institutes of Allergy and
Infectious Disease (NIAID), is the largest worldwide clinical trials
network dedicated to the development and testing of HIV/AIDS vaccines.
When fully enrolled there will be a total of 225 volunteers (150
vaccine recipients and 75 placebo recipients). The trial is being
conducted at 13 HVTN trial sites: 11 in North America and two in South
America.
-- On September 24, 2009, highly encouraging results of the Phase 3 trial
in Thailand for an HIV/AIDS vaccine candidate owned by Sanofi-Aventis
and Global Solutions for Infectious Diseases were publicly announced.
This trial tested four priming injections of a recombinant canarypox
prime (ALVAC-HIV) followed by two booster injections of a protein
subunit boost (AIDSVAX B/E) and showed a strong trend for the
prevention of acquisition of HIV/AIDS. As such, it was the first
demonstration in humans that a vaccine can prevent HIV/AIDS
infections. The results of the Thai trial emphasizes the importance of
human clinical trials in testing HIV/AIDS vaccines and paves the way
for more advanced testing of the GeoVax vaccines. "There could not
have been a more important result for the advancement of the GeoVax
vaccine," said Dr. Robinson, "It is a very favorable and exciting
time for a vaccine with the characteristics of our vaccine to move
forward."
-- On September 10, 2009, Dr. McNally presented a company overview at the
Rodman & Renshaw 11th Annual Healthcare Conference in New York. An
archived replay of the presentation is available on the Company's site
through December 10, 2009. Dr. McNally presented an overview of
GeoVax's vaccine technology and reported the latest progress on the
Company's Phase 2a preventative human vaccine trial and plans for its
upcoming therapeutic human vaccine trials.
-- In August 2009, GeoVax received the award notice for the third year of
the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD)
grant initially awarded to the Company in 2007 by the NIH. The
project period for the grant, which is renewable annually, covers a
five year period which commenced October 2007, with an expected annual
award of generally between $3 - $4 million per year (approximately
$18.3 million in the aggregate). This award is for the period
September 1, 2009 through August 31, 2010 in the amount of $4.7
million. GeoVax is utilizing this funding to further its HIV/AIDS
vaccine development, optimization and production.
GEOVAX LABS, INC.
Condensed Consolidated Statements of Operations Information
(amounts in thousands, except per share data)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
------------- -------------
2009 2008 2009 2008
---- ---- ---- ----
Revenues:
Grant Revenue $1,808 $1,322 $3,272 $2,298
Operating expenses:
Research and development 1,470 1,362 3,530 2,725
General and administrative 574 699 2,204 2,322
--- --- ----- -----
2,044 2,061 5,734 5,047
----- ----- ----- -----
Other income:
Interest income 5 17 22 60
--- --- --- ---
5 17 22 60
--- --- --- ---
Net loss $(231) $(722) $(2,441) $(2,689)
===== ===== ======= =======
Loss per common share $(0.00) $(0.00) $(0.00) $(0.00)
====== ====== ====== ======
GEOVAX LABS, INC.
Condensed Consolidated Balance Sheet Information
(amounts in thousands)
(unaudited)
Sep. 30, Dec. 31,
-------- --------
2009 2008
---- ----
Assets:
Cash and cash equivalents $3,417 $2,191
Other current assets 597 611
--- ---
Total current assets 4,014 2,802
Property, net 164 139
Other assets 97 115
-- ---
Total assets $4,275 $3,056
Liabilities and stockholders' equity
Current liabilities $349 $346
Stockholders' equity 3,926 2,710
----- -----
Total liabilities and stockholders'
equity $4,275 $3,056
====== ======
Shares Outstanding 778,487 747,449
HIV/AIDS Background
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 become infected.
GeoVax AIDS vaccines also may be effective as a therapeutic treatment (for
people already infected with the HIV-1 virus).
GeoVax's core AIDS vaccine technologies were developed by Dr. Harriet
Robinson, Chief Scientific Officer, 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'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 an $18 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.
More information is available on the Company's website at
www.geovax.com.
Source: GeoVax Labs, Inc.
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