ATLANTA, Nov. 10 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX) ("GeoVax" or "the Company"), a biopharmaceutical firm developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced its third quarter 2008 financial results and provided an operational update.
Robert McNally, GeoVax's President and CEO, commented, "We are very pleased with the progress we've made during the third quarter of 2008 and for the year so far, as we've taken steps to address both short-term and long-term goals. We made a shipment of the vaccine to the HIV Vaccine Trials Network during October, which is a significant step in preparation for the largest clinical trial yet to be undertaken by GeoVax and we look forward to HVTN's initiation of the Phase 2a trial later this year. We are also nearing completion of a license with Vivalis S.A., a French biopharmaceutical company, for manufacturing platform technology for the MVA portion of our vaccine that we anticipate will significantly improve the long-term production capabilities for the vaccine."
Financial Results for the Three Months and Nine Months Ended September 30, 2008
The Company recorded a net loss of $722,108 for the three months ended September 30, 2008, compared to $1,165,519 for the same period in 2007. For the nine months ended September 30, 2008, the Company's net loss was $2,688,970 as compared to $3,085,926 in 2007. Net losses for 2008 were partially offset by grant revenues of $1,322,502 and $2,298,571 for the three month and nine month periods, respectively, related to the Company's grant from the National Institutes of Health (NIH) in support of its HIV/AIDS vaccine development activities. As of September 30, 2008, the Company reported cash balances totaling $2,784,706.
Summarized financial information is 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
Third Quarter Operational Highlights:
* On October 22, 2008, Dr. Robert McNally, GeoVax's President and CEO,
was the featured interview on the Wall St. Network's 3-Minute Press
Show, a daily program that features in-depth interviews with public
company executives. The interview may be viewed in its entirety at
* On October 31, 2008, an additional interview with Dr. McNally was
published by CEOCFO Interviews & News
(http://www.ceocfointerviews.com). Also, GeoVax was prominently
featured in a special Biotechnology supplement to the November issue
of Harvard Business Review, sponsored by the Michigan Economic
Development Corp (MEDC).
* On October 20, 2008, GeoVax announced shipment of both components
(DNA and MVA) of its AIDS vaccine to the HIV Vaccine Trials Network
(HVTN) pharmacy, for use in the upcoming Phase 2a human clinical
trial. GeoVax also announced the submission of a Biological Master
File Amendment to the U.S. Food and Drug Administration (FDA) for
review of the manufacturing data for the product shipped to HVTN.
The Phase 2a trial will be conducted by the HVTN and will involve
225 healthy volunteers from the United States and South America. The
trial will further evaluate the safety and immunogenicity of the
GeoVax preventative vaccine (vaccine administered prior to infection
with the HIV virus) and will broaden the base of safety and
immunogenicity data for the full dose of the GeoVax AIDS vaccine.
This trial will serve as a major milestone, as the Phase 2a trial is
the most advanced trial to-date for GeoVax. HVTN and the clinical
trial sites are moving forward with the administrative steps
necessary to prepare for commencement of the Phase 2a trial, which
GeoVax expects to begin before the end of the year.
* In October 2008, GeoVax announced that its company information is
now available via Standard and Poor's Market Access Program, an
information distribution service that enables subscribing
publicly-traded companies to have their company information
disseminated to users of Standard and Poor's Advisor Insight.
GeoVax's company information is also available via Standard & Poor's
Stock Guide database, which is distributed electronically to
virtually all major quote vendors. These services will help GeoVax
comply with numerous state "Blue Sky" laws to ensure that its stock
is made available to the broadest possible investor base.
* On October 15, 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 80 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 2nd MVA vaccination positively increased CD8 T cell and
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, UK, on September 28, 2008.
* 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.
* In July 2008, GeoVax and Vivalis S.A., a French biopharmaceutical
company that provides innovative cell-based solutions to the
pharmaceutical industry for the manufacture of vaccines and
proteins, jointly announced the signing of a letter of intent for
joint collaboration and commercial license on the use of Vivalis'
EBx(R) technology, to manufacture the MVA component of GeoVax's
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,
is expected to better provide for MVA vaccine product availability
in ample quantities to meet sizeable demand and at a lesser cost.
Vivalis' vaccine manufacturing technology is based on a duck
embryonic stem cell substrate platform. Specifically, the EB66(R)
cell line provides 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 large bioreactors for commercial-
scale production of the MVA viral vaccine. The details of the final
license agreement between the parties are being negotiated and
GeoVax expects the final agreement to be executed before the end of
"On the financing front," Dr. McNally noted, "we are pleased with the financing strategy provided by the $10 million common stock purchase agreement with Fusion Capital Fund II, LLC, from which we are drawing in a judicious manner, and we are also benefiting greatly from government support in two ways -- from both the 5 year $15 million grant (approximately $3 million awarded annually) initially awarded in October 2007 by the National Institutes of Health, and also from ongoing clinical trial support provided by the HVTN."
Dr. McNally concluded, "We believe we are well-positioned for success
in 2009 and beyond, with our preventative vaccine beginning Phase 2 human
testing and our therapeutic vaccine trial in the planning stage. Based on
highly promising results in preclinical non-human primate studies conducted
by Dr. Rama Amara at Emory University, we are eager to launch a therapeutic
Phase 1/2 human clinical trial in individuals already infected with HIV to
investigate the use of our vaccine as a therapeutic treatment to control
HIV-virus levels. We expect this trial may start in mid-2009 and we will
report on the development of this program as we conclude plans with our
GEOVAX LABS, INC.
Condensed Consolidated Statements of Operations Information
(amounts in thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 2008 2007
Grant Revenue $1,322 $- $2,298 $-
development 1,362 360 2,725 1,273
administrative 699 815 2,322 1,865
2,061 1,175 5,047 3,138
Interest income 17 9 60 52
17 9 60 52
Net loss $(722) $(1,166) $(2,689) $(3,086)
Loss per common share $(0.00) $(0.00) $(0.00) $(0.00)
GEOVAX LABS, INC.
Condensed Consolidated Balance Sheet Information
(amounts in thousands)
Sep. 30, Dec. 31,
Cash and cash equivalents $2,785 $1,990
Other current assets 578 1,041
Total current assets 3,363 3,031
Property, net 127 75
Other assets 368 140
Total assets $3,858 $3,246
Liabilities and stockholders' equity
Current liabilities $516 $598
Stockholders' equity 3,342 2,648
Total liabilities and stockholders' equity $3,858 $3,246
Shares Outstanding 743,415 731,628
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 HIV/AIDS vaccine technology is the subject of 20 issued or filed patent applications. GeoVax HIV/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 HIV/AIDS vaccines also may be effective as therapeutics (treatment of people already infected with AIDS virus). Studies evaluating these vaccines in HIV/AIDS infected individuals are in the planning stage.
GeoVax's core HIV/AIDS vaccine technologies were developed 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 the GeoVax team.
GeoVax HIV/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 HIV/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. 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 limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports
|SOURCE GeoVax Labs, Inc.|
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