ATLANTA, March 14 /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, 2007.
GeoVax recorded a net loss of $1,155,870 for the fourth quarter ended
December 31, 2007, as compared to $157,276 for the comparable period in
2006. For the full year of 2007, the Company recorded a net loss of
$4,241,796 as compared to $584,166 in 2006. GeoVax's operating results
fluctuate due to the timing of activities and related costs associated with
its vaccine research and development activities. The overall increase in
the Company's net loss from 2006 to 2007 is primarily attributable to:
-- Substantial costs for manufacture and testing of AIDS vaccines for
Phase 2 human trials planned for summer 2008.
-- Increased research and development expenditures as the Company
continued to support its three ongoing Phase 1 human AIDS vaccine
clinical trials and prepares for initiation of Phase 2 trials in 2008.
-- Lower grant revenues during 2007. During the first nine months of
2007, GeoVax had no grant revenues. During the fourth quarter of 2007,
the Company recorded $234,004 in grant revenues associated with an
estimated $15 million, 5 year grant from the NIH (see discussion
-- Overall higher general and administrative costs due to the additional
costs associated with being a public company subsequent to the merger
between Dauphin Technology, Inc. and GeoVax, Inc. in September 2006.
These higher costs included expansion of the Company's management team,
initiation of an investor relations program, increased legal and
accounting costs, and costs associated with achieving compliance with
the Sarbanes-Oxley Act of 2002.
-- Stocs, risks detailed in the
Companies Securities and Exchange Commission filings and reports.
GEOVAX LABS, INC.
Statements of Operations Data
(amounts in thousands, except per share data)
Three Months Ended Twelve Months Ended
December 31, December 31,
2007 2006 2007 2006
Grant Revenue $237 $374 $237 $853
development 484 156 1,757 666
administrative 919 405 2,784 843
1,403 561 4,541 1,509
Loss from operations (1,166) (187) (4,304) (656)
Interest income 10 30 62 72
Net loss $(1,156) $(157) $(4,242) $(584)
Net loss per common
share $(0.00) $0.00 $(0.00) $(0.00)
shares outstanding 717,925 709,354 714,102 414,919
Balance Sheet Data
(amounts in thousands)
Cash and cash equivalents $1,990 $2,088
Working capital 1,392 1,933
Total assets 2,349 2,396
Deficit accumulated during the
development stage (10,525) (6,284)
Total stockholders' equity 1,750 2,203k-based compensation expense of $1,518,496 during 2007. In
accordance with accounting rules, no stock-based compensation expense
was recorded during 2006. This was an accounting adjustment and did not
result in actual cash expenditures.
Summarized financial information is shown below. GeoVax's full set of
audited financial statements are included in its Form 10-K filing with the
Securities and Exchange Commission.
2007 and Early 2008 Highlights:
-- In July, GeoVax announced an early start of two new HIV/AIDS vaccine
clinical (human) trials. These FDA compliant trials were previously
scheduled to start later in 2007 and are the 3rd and 4th in a four
clinical trial series intended to evaluate both human safety and immune
responses to GeoVax's HIV/AIDS vaccines. Starting April 2006, the 1st
of these four trials evaluated a low dose (1/10th of the vaccine dose)
vaccination program. Results from this blinded trial demonstrated
excellent vaccine safety and positive anti-HIV-1 immune responses. All
trial participants were normal, healthy individuals. The 2nd of four
trials, initiated September 2006, is designed to evaluate results from
full dose administration of GeoVax HIV/AIDS vaccines. Recent data
indicates excellent safety in this full dose trial with immune response
data from the majority of vaccine recipients.
-- In June and July, GeoVax announced it engaged Althea Technologies,
Inc., and BioReliance Corporation, as contract manufacturers for its
HIV-1 DNA and HIV-1 MVA (AIDS) vaccines. These vaccines will be
utilized in GeoVax's advanced Phase 2 clinical trials planned for 2008.
GeoVax HIV/AIDS vaccines are designed to prevent development of
Acquired Immunodeficiency Disease (AIDS) caused by the virus known as
HIV-1 by vaccinating individuals prior to AIDS virus infection. The
vaccine regimen employs a two-vaccine "prime-boost strategy." Trial
participants will be administered GeoVax HIV-1 DNA vaccine which
"primes" the immune system followed by GeoVax's HIV-1 MVA (Modified
Vaccinia Virus) boost. Both vaccines deliver over 50% of the AIDS virus
components but can not cause AIDS. Safety and immunological results
from earlier as well as ongoing human trials are very encouraging thus
supporting planned acceleration of large scale Phase 2 clinical
-- 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 Institutes of Health-National Institute of Allergy &
Infectious Disease [NIH-NIAID], an agency of the U.S. Government. The
grant funding period is over a five year period commencing 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 will utilize this funding to
further its HIV/AIDS vaccine development, optimization, production and
human clinical trial testing.
GeoVax announced in January 2008 that it had been 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.
-- In September, GeoVax announced the presentation of successful human
trial results for its HIV/AIDS vaccines at the AIDS Vaccine 2007
Conference held August 20-23, 2007 in Seattle, Washington. GeoVax
HIV/AIDS human trial results were presented by Dr. Paul Goepfert, MD in
a talk "HIV-1 DNA Prime followed by Recombinant MVA Boost is Well
Tolerated and Immunogenic When Administered to Healthy Seronegative
Adults." Dr. Goepfert, from the University of Alabama-Birmingham, is
Protocol Chair of HVTN 065, a series of human clinical trials currently
evaluating GeoVax's HIV/AIDS vaccine. GeoVax HIV/AIDS vaccine trial
data was presented to over 900 AIDS researchers at the week long
conference. Conference Chair, Dr. Lawrence Corey stated, "It has become
clear that a preventative vaccine is essential to controlling the
global AIDS epidemic." The AIDS Vaccine 2007 Conference was organized
under the guidance of the Global HIV Vaccine Enterprise, an alliance of
independent global organizations dedicated to accelerating preventative
AIDS vaccine development. The conference reported the AIDS epidemic
continuing as a global threat with the disease increasing in every
region of the world, especially East and Central Asia and Eastern
Europe where AIDS incidence was 21% higher in 2006 than in 2004.
Key GeoVax HIV/AIDS Vaccine Human Trial conclusions presented at the
AIDS Vaccine 2007 Conference included:
-- GeoVax DNA and MVA vaccines are safe and immunogenic (stimulate
anti-HIV/AIDS immune responses) at both low (1/10th) dose and full
-- GeoVax vaccines were well tolerated with no or mild local and
reactions in the majority of trial participants.
-- 80% of both the low and full dose trial participants responded to the
vaccine which stimulated highly desirable anti-HIV T-cell (white
blood cell) and antibody responses.
-- 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.
-- 2nd MVA vaccination positively increased the number of CD8 T cell
responders and antibody responders.
-- Excellent results led to authorization to start two new trials with
GeoVax HIV/AIDS vaccines which began in June 2007.
-- In September, GeoVax responded to the announcement by Merck & Co., Inc.
that Merck's candidate AIDS vaccine failed to provide protection in a
human study designed to test for efficacy. In this Merck trial
involving high risk volunteers, an equal number of people received
either placebo or AIDS vaccine. The independent Data Safety Monitoring
Board recommended that the trial be stopped because it was not reaching
its efficacy endpoints. GeoVax responded to the discontinuance of
Merck's trial by pointing out significant differences between the
GeoVax vaccine technology and the technology used in the Merck trial.
GeoVax AIDS vaccines advancing in human trials represent a
significantly different vaccine approach, vaccine composition and
results to date than the Merck vaccine.
-- Prototypes for the GeoVax vaccines were selected from a series of
trials in non-human primates for their ability to protect against the
development of AIDS when vaccinated individuals were administered an
AIDS causing virus. At each major step along the development pathway,
GeoVax vaccines providing the best protection against AIDS were moved
-- GeoVax AIDS vaccines demonstrated excellent protective results in
non-human primate models, much better protective results than
reported for Merck's vaccine in similar models. GeoVax AIDS vaccines
protected 22/23 non-human primates for over 3 1/2 years and 5/6
non-vaccinated controls died of AIDS post-AIDS virus infection.
-- GeoVax AIDS vaccines are designed to elicit protective antibodies
(Ab) as well as protective T cells (white blood cells) against the
AIDS virus. The Merck vaccine stimulates only T cells for providing
protection and does not include the Env protein of HIV which is the
target for protective antibody (Ab).
-- Protective Ab has been difficult to elicit with HIV/AIDS vaccines.
GeoVax has approached this challenge by vaccinating with the natural
form of Env (HIV envelope antigens) under conditions that elicit
tightly binding Ab. GeoVax studies in non-human primates clearly show
this Ab correlates with protection.
-- GeoVax vaccines use an attenuated smallpox vaccine to provide pulses
of HIV proteins (antigen) to stimulate protective anti-AIDS vaccine
responses. Pulses of antigen from the GeoVax vaccines elicit T cell
responses that rapidly mobilize and then contract into a state called
"central memory" from which they rapidly expand to fight the
appearance of HIV.
-- In November, GeoVax announced excellent safety and immunogenicity data
from its full-dose HIV/AIDS vaccine human trial which began in
September 2006. This full-dose trial is the second in a series of four
Phase 1 human trials designed to test the safety and immunogenicity of
the GeoVax HIV/AIDS vaccines. Involving 36 participants of which 30
received vaccine and 6 received placebo, this trial protocol included
vaccination with two full-doses of GeoVax's DNA vaccine to prime the
immune response followed by two full-doses of GeoVax's MVA vaccine to
boost the immune response. GeoVax's DNA and MVA vaccines express over
50% of the AIDS virus (HIV-1) protein components in order to stimulate
a broad anti-HIV immune response. The vaccines cannot cause AIDS
because they do not include complete virus. A Phase 1 human trial,
started in April 2006, evaluated the delivery of only 1/10th of the
full dosage and utilized the same vaccine regimen evaluated in the full
From data collected from the 26 participants who completed the trial,
the following positive conclusions were observed:
-- GeoVax HIV/AIDS vaccines, both DNA and MVA, continue to demonstrate
that they are quite safe and immunogenic following the delivery of
the four full-doses (two of each vaccine) used in the trial's
-- The full-dose regimen of GeoVax vaccines continues to be well
tolerated without any type of reaction, mild or systemic, in the
majority of participants.
-- CD4 T-cell responses are high in both the low and full-dose regimens,
84% and 78% of participants.
-- CD8 T-cell responses are present in 42% of the full-dose recipients
and 33% of the 1/10th dose recipients.
-- Antibody responses to the envelope glycoprotein (Env) increased
following the fourth vaccination, and were present in 88% of the
-- Delivery of the fourth vaccination increased the frequency and
magnitude of the CD8 T-cell and Antibody responses.
-- During November 2007 through January 2008, GeoVax raised approximately
$3 million in equity capital through a series of privately negotiated
transactions with individual accredited investors and one institutional
investor. These funds, along with the funds received pursuant to the
NIH grant discussed above will be used to offset the Company's ongoing
research and development costs and operating losses. GeoVax will
continue to seek additional financing through offerings of its equity
-- In February 2008, GeoVax announced the addition of company co-founder
Dr. Harriet Robinson to its staff as Vice President of Research &
Development. Dr. Robinson is known worldwide for her outstanding work
on retrovirus biology and development of DNA vaccines with special
emphasis on HIV/AIDS. Significant advances by GeoVax's HIV/AIDS vaccine
development program warrant Dr. Robinson's full time participation.
She has been instrumental in GeoVax's success through her HIV/AIDS
vaccine development activities while at Emory University and as Chief
Scientific Advisor to GeoVax. Dr. Robinson joined GeoVax part time in
November 2007 and became a full time employee in February 2008. By
focusing her efforts exclusively at GeoVax, Dr. Robinson intends to
speed up the vaccine development and human trial evaluation program
required to meet FDA regulatory requirements and future vaccine
-- During February 2008, GeoVax announced that its Vaccine is only the 5th
AIDS Vaccine moving forward into Phase 2a human trials by the HIV
Vaccine Trials Network (HVTN), a network supported by the National
Institutes of Health (NIH). Most recently, GeoVax Senior Vice President
of Research & Development, Dr. Harriet Robinson, and President, Don
Hildebrand, attended a meeting with key HTVN officials in Seattle,
Washington to plan and prepare necessary documents for the next phase
of testing of GeoVax's promising HIV/AIDS vaccine, namely Phase 2a
human trials designated as Protocol # HVTN 205. The other four Vaccines
which had/or are participating in the HVTN human trials are designated
as Protocol # HVTN 201-204. GeoVax AIDS vaccine technology and
composition are significantly different than the Merck & Co. Inc. AIDS
vaccines that recently had their human trials halted due to safety and
About GeoVax Labs, Inc.
GeoVax Inc. is an Atlanta, Georgia USA 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 vaccine technology is protected by 20 issued and filed patent applications.
For more information, contact the Company at (404) 727-0971 or visit http://www.geovax.com.
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 as of 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
determined to be safe for use in humans, GeoVax's vaccines will be
effective in preventing AIDS in humans, the vaccines will receive the
regulatory approvals necessary to be licensed and marketed, GeoVax can
raise the required capital to complete development of its vaccines, 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
|SOURCE GeoVax Labs, Inc.|
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