ATLANTA, Aug. 14 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. , an Atlanta-based biotechnology company (the "Company"), today announced its financial results and provided an operational update for the quarter ended June 30, 2007.
Operating Results for the Quarter Ended June 30, 2007
The Company recorded a net loss of $1,333,126 for the three months ended June 30, 2007, compared to net income of $197,750 for the same period in 2006. For the six months ended June 30, 2007, the Company's net loss was $1,920,407 as compared to a loss of $143,456 in 2006. The increase in the net loss during 2007 is attributable to (a) no grant revenues recorded during 2007 as the Company progressed beyond basic research and into product development activities, (b) higher research and development expenses as the Company continued to support its four ongoing Phase I human clinical trials and prepares for initiation of Phase II studies, and (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. As of June 30, 2007, the Company reported cash balances totaling $1,009,302.
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 1st 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 a administration of GeoVax HIV/AIDS vaccines. Recent data indicates excellent safety in this full dose trial with immune response data soon to be available. * 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 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 studies. * In April, GeoVax announced an extension of a research license signed 4/2005 with Vivalis (Nantes, France) to evaluate Vivalis' EBx(R) cell lines (avian embryonic derived stem cell lines) for the production of GeoVax's MVA (Modified Vaccinia Ankara) based HIV/AIDS vaccines. Results obtained from Vivalis and GeoVax demonstrated that EBx(R) cell technology is possibly a more economical alternative to chicken embryonic fibroblasts (CEFs) for the replication of GeoVax specific recombinant MVA based AIDS vaccines. Simultaneously, GeoVax's promising results in preclinical trials as well as encouraging and positive immune response data from two ongoing human trials provided the impetus for accelerating clinical evaluations of GeoVax's vaccines and for considering the EBx(R) cell platform in industrial vaccine production. Vivalis and GeoVax collaborations focus on scaling-up MVA based HIV/AIDS vaccine production processes in EBx(R) cells. In addition, Vivalis plans preparation of an EBx(R) platform Biological Master File for filing with the FDA. In parallel, GeoVax is evaluating plans for an immunogenicity comparability study of GeoVax's MVA based HIV/AIDS vaccines produced in CEFs and those produced in EBx(R) cells. This information may be presented in a pre-IND meeting with the FDA concerning potential use of this cell line.
Management Commentary
Donald Hildebrand, Chief Executive Officer of GeoVax, commented, "Recent developments at GeoVax encourage and excite us as we continue working toward our ultimate goal of making available a safe and effective vaccine for the prevention of AIDS. We are particularly encouraged by the recent accelerated start date of our two new human clinical trials, resulting primarily from the excellent safety and anti-HIV immune response results obtained to date from our ongoing 1/10th and full dose vaccine trials. We are also pleased with the positive response to our progress at GeoVax as reflected by our recent financing announcement. This substantial $7.5 million investment will enhance our HIV/AIDS vaccine development and human clinical trials program, thus allowing us to push forward into large scale Phase 2 AIDS vaccine trials involving many more human participants."
GEOVAX LABS, INC. Condensed Consolidated Statements of Operations (amounts in thousands, except per share data) Three Months Ended Six Months Ended June 30, June 30, 2007 2006 2007 2006 Revenues Grant Revenue $ - $479 $ - $479 Operating expenses: Research and development 701 108 913 336 General and administrative 650 179 1,050 302 1,351 287 1,963 638 Other income (expense) Interest income 18 6 43 16 18 6 43 16 Net loss $(1,333) $198 $(1,920) $(143) Income (loss) per common share $(0.00) $0.00 $(0.00) $(0.00) GEOVAX LABS, INC. Balance Sheet Highlights (amounts in thousands) June 30, Dec. 31, 2007 2006 Assets: Cash and cash equivalents $1,009 $2,088 Other current assets 77 38 Total current assets 1,086 2,126 Property and other assets 242 270 Total assets $1,328 $2,396 Liabilities and stockholders' equity Current liabilities $515 $193 Stockholders' equity (deficit) 813 2,203 Total liabilities and stockholders' equity $1,328 $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 31/2 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 guidelines * Satisfactorily completed early Phase 1 human clinical trial for DNA HIV/AIDS vaccine * 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
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.
GeoVax Labs, Inc.CONTACT: Donald Hildebrand or Jennifer Nelms of GeoVax Labs, Inc.,+1-404-727-0971
Web site: http://www.geovax.com//
