ATLANTA, Nov. 15 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based biotechnology company (the "Company"), today announced its financial results and provided an operational update for the quarter ended September 30, 2007.
Financial Results for the Quarter Ended September 30, 2007
The Company recorded a net loss of $1,165,509 for the three months ended September 30, 2007, compared to $283,434 for the same period in 2006. For the nine months ended September 30, 2007, the Company's net loss was $3,085,926 as compared to $426,890 in 2006. The increase in the net loss during 2007 is attributable to (a) no grant revenues recorded during the first nine months 2007, (b) higher research and development expenses as the Company continued to support its four ongoing Phase I human AIDS vaccine clinical trials and prepares for initiation of Phase II trials, (c) overall higher general and administrative expenses primarily 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., and (d) $928,302 of share-based compensation expense recorded in 2007, compared with $- 0 - for 2006. As of September 30, 2007, the Company reported cash balances totaling $731,976.
See the summarized financial information attached. Further information concerning the Company's financial position and results of operations are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.
Recent Operational 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 1sthttp://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 limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.p>
of these four trials evaluated a low dose (1/10th of the vaccine dose)
vaccination program. Preliminary results from this blinded trial
demonstrated excellent vaccine safety and positive anti-HIV-1 immune
responses to the vaccine in 9 of 11 participants where 9 people
received GeoVax HIV/AIDS vaccines and 2 received placebos. All trial
participants were normal, healthy individuals. Final results will be
compiled for later public release. 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 early
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 cannot 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 $15,000,000
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 including Phase 2 human clinical trials
planned for 2008.
-- 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
systemic 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.
-- On September 21, 2007, Merck & Co., Inc. announced their 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 forward.
* 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
* 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
-- In November, GeoVax filed a Form 8-K with the SEC disclosing that it
was unlikely to receive the full amount of its previously announced
$7.5 million equity placement with Pure Capital LLC ("Pure"). The
Company received $300,000 from Pure during September, but Pure appeared
to be unable to fulfill its commitment for the remaining $7.2 million.
GeoVax has already initiated contacts with alternative sources of
equity capital and preliminary discussions with prospective investors
are promising. However, the Company can provide no assurance that such
other sources of equity capital will be available on favorable terms,
if at all.
Donald Hildebrand, Chief Executive Officer of GeoVax, commented, "We continue to be excited about the promise of our AIDS vaccine technology. We are particularly encouraged by the recent $15 million grant award from the NIH, which we view as a strong validation of the prospects for our vaccine. We also are very pleased with the additional positive results we've seen for both our full and 1/10th dose groups in our Phase I human trials. These results are extremely encouraging and provide a strong foundation for proceeding with phase 2 human testing.
Hildebrand continued, "As with all biotechnology companies, fund-raising is a challenge and it's no different with GeoVax. Although the $15 million grant from the NIH will fund a portion of our existing operations, part of the grant is earmarked for new projects requiring incremental spending. And, while we are disappointed with the inability of Pure Capital to fulfill its recent financing commitment to us, we believe in our ability to secure other sources of capital and continue our ongoing activities."
GEOVAX LABS, INC.
Condensed Consolidated Statements of Operations
(amounts in thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2007 2006 2007 2006
Grant Revenue $ - $ - $ - $ 479
Research and development 360 173 1,273 510
General and administrative 815 136 1,865 438
1,175 309 3,138 948
Other income (expense)
Interest income 9 26 52 42
9 26 52 42
Net loss $(1,166) $(283) $(3,086) $(427)
Income (loss) per common share $(0.00) $0.00 $(0.00) $(0.00)
GEOVAX LABS, INC.
Condensed Balance Sheet Highlights
(amounts in thousands)
Sep. 30, Dec. 31
Cash and cash equivalents $732 $2,088
Other current assets 24 38
Total current assets 756 2,126
Property and other assets 228 270
Total assets $984 $2,396
Liabilities and stockholders'
Current liabilities $683 $193
Stockholders' equity (deficit) 301 2,203
Total liabilities and stockholders' equity $984 $2,396
Shares Outstanding 712,835 711,168
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.
GeoVax's DNA and Recombinant MVA HIV/AIDS vaccines:
-- Protected 22 of 23 (96%) non-human primates for over 3 1/2 years post-
infection with an AIDS causing virus - 5 of 6 non-vaccinates controls
died of AIDS
-- Are manufactured and tested under GMP/GLP - EMEA (EU) and FDA
-- Satisfactorily completed early Phase 1 human clinical trial for DNA
-- Are currently in 2 ongoing human trials started in 2006 with positive
immune responses reported in the majority of vaccine recipients as well
as good vaccine safety
-- Began 2 additional human trials in June 2007 with a large Phase 2 trial
in planning for 2008
|SOURCE GeoVax Labs, Inc.|
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