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8-K - FORM 8-K - GeoVax Labs, Inc. | c13227e8vk.htm |
GeoVax Labs Reports Fourth Quarter and
Year-End 2010 Financial Results
Year-End 2010 Financial Results
ATLANTA, GA, February 25, 2011 GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), an Atlanta-based
biotechnology company that creates, develops, and tests innovative HIV/AIDS vaccines, today
announced its financial results for the fourth quarter and year ended December 31, 2010.
GeoVax reported a net loss of $478,784 for the fourth quarter ended December 31, 2010, as compared
to a net loss of $843,275 for the comparable period in 2009. For the full year of 2010, the Company
reported a net loss of $2,747,328 as compared to a net loss of $3,284,252 in 2009. Grant revenues
were $5,185,257 and $3,668,195 for the years ended December 31, 2010 and 2009, respectively. As of
December 31, 2010, the Company reported cash balances totaling $1,079,087. Summarized financial
information is attached. Further information concerning the Companys financial position and
results of operations are included in its Annual Report on Form 10-K, expected to be filed with the
Securities and Exchange Commission before March 31, 2011.
Highlights of the Companys scientific and clinical progress during 2010 are as follows:
| Early results from the Phase 2a trial for the preventative version of GeoVaxs vaccine
indicated an excellent safety profile and highly reproducible immunogenicity. This trial
was expanded to include testing of an additional, simpler vaccine regimen, and we expect
patient enrollment and vaccinations to be completed during 2011. |
| During 2010, GeoVax began recruiting and screening patients for a Phase 1/2 trial for
the therapeutic version of our vaccine. In order to accelerate enrollment in this
important study, a second site at the University of Alabama, Birmingham was recently added
to complement the enrollment already underway in Atlanta. |
| We reported preclinical results using GM-CSF (granulocyte/macrophage colony-stimulating
factor) as an adjuvant, or immune system booster, with the DNA priming component of our
preventative vaccine. Results using GM-CSF showed protection from infection by a
genetically distinct simian immunodeficiency virus (SIV monkey version of the HIV virus)
in 70% of the animals tested. We believe this is the highest level for prevention of an
immunodeficiency virus infection ever reported in a nonhuman primate model. Based on the
results from this study, we now hope that our DNA/MVA vaccine supplemented with GM-CSF
could actually prevent, not just control, HIV infections in humans. |
Robert T. McNally, Ph.D., president and chief executive officer, commented, During 2010 we made
solid, steady progress in developing our HIV/AIDS vaccines. For 2011, our goals include advancing
our Phase 1/2 therapeutic clinical program to the point of seeing crucial data from vaccinated
patients, completion of patient enrollment and vaccinations in the Phase 2a trial of our
preventative vaccine, and commencement of planning for the Phase 2b trial in the preventative
program. In addition we expect the HIV Vaccine Trials Network (HVTN) to initiate a Phase 1 trial
for the GM-CSF adjuvanted version of our preventative vaccine in the latter part of 2011.
Dr. McNally continued, We continue to benefit from tremendous financial, operational, and
technical support provided to us by the National Institutes of Health (NIH) and by the HVTN. The
HVTN, funded by the NIH, is the largest worldwide clinical trials network dedicated to development
and testing of promising HIV/AIDS vaccines. While we are deeply appreciative of the governmental
support we receive, it does not cover all of our activities, so fund-raising is also one of our
primary goals for 2011. We began the effort during 2010 and have laid the groundwork for success in 2011 through corporate capital restructuring, establishment of
investment banking relationships, and making numerous contacts among potential institutional
investors.
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About GeoVax
GeoVax Labs, Inc. is a biotechnology company developing human vaccines for diseases caused by HIV
(Human Immunodeficiency Virus that leads to AIDS). GeoVaxs AIDS vaccine technology is
exclusively licensed from Emory University in Atlanta, GA, and is the subject of more than 20
issued or filed patent applications. GeoVax AIDS vaccines are designed for use in uninfected
people to prevent acquisition of HIV-1 and limit the progression to AIDS should a person become
infected. GeoVax HIV/AIDS vaccines also may be effective as a therapeutic treatment (for people
already infected with the HIV-1 virus).
GeoVaxs core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Chief Scientific
Officer, through a collaboration of colleagues at Emory Universitys Vaccine Center, the National
Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and GeoVax.
GeoVaxs 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 NIH, is the largest worldwide clinical trials program dedicated to the
development and testing of AIDS vaccines. Preclinical work enabling evaluation of the GeoVax DNA
and MVA vaccines was funded and supported by the National Institute of Allergy and Infectious
Disease (NIAID), which provided additional support to the GeoVax vaccine development program with
an $19 million Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant awarded in
late 2007.
For more information, please visit www.geovax.com.
About GeoVaxs Technology
GeoVaxs unique two component vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara
(MVA), is designed to stimulate both anti-HIV T cell and anti-HIV antibody immune responses.
Stimulation of both T cells and antibodies differentiates the GeoVax vaccine from many other
vaccine candidates. GeoVaxs DNA and MVA vaccines are used in a prime/boost protocol in which
priming is done with the DNA and boosting with the MVA. Both the DNA and MVA express the three
major proteins of the AIDS virus: Gag, Pol, and Env, and produce non-infectious
virus-like-particles. These particles contain proteins that mimic more than half of the components
of the HIV virus, but cannot cause AIDS. This multi-protein approach is designed to elicit a broad
multi-target protective T cell response. The Env protein is designed to elicit a protective
antibody response against the natural form of the virus envelope glycoprotein as well as protective
T cells. GeoVaxs vaccines are unique in expressing virus like particles that display the trimeric
membrane bound form of the HIV-1 envelope glycoprotein. All preventative Phase 1 human clinical
trials conducted to date tested various combinations and doses of our DNA and MVA vaccines, their
ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic T cell) immune responses, as
well as the vaccines safety.
About HIV/AIDS
AIDS is an epidemic that can affect anyone, regardless of race, gender, age or sexual orientation.
33 million people are currently infected globally and it is estimated that there will be 2.5
million new infections this year. Since the beginning of the epidemic, over a million people in the
U.S. have contracted the virus. Every 91/2 minutes, someone in the U.S. is infected with AIDS.
Globally, HIV is the top killer among women of reproductive age. HIV is a worldwide disease with
different subtypes (or clades) of the virus predominating in different regions of the world. Clade
B is the predominant subtype in North America. Globally, most infections involve subtypes AG, B,
and C. GeoVax vaccines are currently designed t function against clade B. In 2008, antiretroviral
treatment in low and middle income countries was restricted to about 3 million people. In the
United States, about 50% of those who are infected are estimated to be on drug treatment.
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Forward-Looking Statements
Certain statements in this document are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on managements current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: HVTN will commence, complete enrollment, and generate data regarding GeoVax vaccine clinical trials as and when expected, GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVaxs vaccines will be safe for human use, GeoVaxs 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, less costly, or easier to use than GeoVaxs products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, 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. More information about these factors is contained in GeoVaxs filings with the Securities and Exchange Commission including those set forth at Risk Factors in GeoVaxs Form 10-K.
Certain statements in this document are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on managements current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: HVTN will commence, complete enrollment, and generate data regarding GeoVax vaccine clinical trials as and when expected, GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVaxs vaccines will be safe for human use, GeoVaxs 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, less costly, or easier to use than GeoVaxs products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, 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. More information about these factors is contained in GeoVaxs filings with the Securities and Exchange Commission including those set forth at Risk Factors in GeoVaxs Form 10-K.
FINANCIAL TABLES FOLLOW
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Statements of Operations Data
(amounts in thousands, except per share data)
Statements of Operations Data
(amounts in thousands, except per share data)
Three Months Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Grant Revenue |
$ | 946 | $ | 397 | $ | 5,185 | $ | 3,668 | ||||||||
Operating expenses: |
||||||||||||||||
Research and development |
774 | 538 | 4,794 | 4,068 | ||||||||||||
General and administrative |
654 | 711 | 3,162 | 2,915 | ||||||||||||
1,428 | 1,249 | 7,956 | 6,983 | |||||||||||||
Loss from operations |
(482 | ) | (852 | ) | (2,771 | ) | (3,315 | ) | ||||||||
Interest income |
3 | 9 | 24 | 31 | ||||||||||||
Net loss |
$ | (479 | ) | $ | (843 | ) | $ | (2,747 | ) | $ | (3,284 | ) | ||||
Net loss per common share |
$ | (0.03 | ) | $ | (0.05 | ) | $ | (0.18 | ) | $ | (0.22 | ) | ||||
Weighted averages shares outstanding |
15,655 | 15,608 | 15,651 | 15,191 |
Balance Sheet Data
(amounts in thousands)
(amounts in thousands)
December 31, | ||||||||
2010 | 2009 | |||||||
Cash and cash equivalents |
$ | 1,079 | $ | 3,516 | ||||
Working capital |
1,081 | 3,309 | ||||||
Total assets |
2,358 | 4,316 | ||||||
Deficit accumulated during the development stage |
(20,285 | ) | (17,538 | ) | ||||
Total stockholders equity |
1,836 | 3,744 |
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