ATLANTA, GA -- (Marketwire) -- 11/14/12 -- GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing vaccines to prevent and treat HIV/AIDS, announced its financial results for the nine months ended September 30, 2012 and provided a business update.
GeoVax's President and CEO Robert McNally, Ph.D., commented, "The third quarter of 2012 was very active for GeoVax as it marked the completion of the Phase 2a trial (HVTN 205) of our preventive HIV/AIDS vaccine. Results of this trial were presented in September by the HIV Vaccine Trials Network (HVTN) at the AIDS Vaccine 2012 Conference in Boston. HVTN 205 confirmed our Phase 1 results, with our vaccines demonstrating an excellent safety profile and reproducible T cell and antibody immune responses. We expect publication of the full study results in the near future. The stage is now set for a Phase 2b efficacy trial, to commence after completion of the ongoing Phase 1 trial testing the safety of our second-generation product that co-expresses HIV proteins and granulocyte-macrophage colony-stimulating factor (GM-CSF) in the DNA prime."
Dr. McNally continued, "With regard to the use of our vaccines for therapeutic treatment of individuals already infected with HIV, patient recruitment for our Phase 1/2 'treatment interruption' clinical trial is on track for full enrollment by the end of 2012. We are also planning a Phase 1 trial to investigate the use of our vaccine in combination with standard-of-care drug therapy in HIV-positive young adults; we expect this trial to commence in early 2013 with sponsorship by the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT) and with financial support from the National Institutes of Health (NIH)."
"Additionally," Dr. McNally said, "We received a $1.9 million funding commitment from the NIH to begin the extension of our vaccine technology to cover clade C infections, the HIV subtype most prevalent in the developing world."
David Dodd, GeoVax's Chairman of the Board, remarked, "We are pleased that GeoVax continues to progress with the most promising vaccine candidates for preventing and treating HIV/AIDS. To date, our vaccines provide the strongest evidence of potential success in this global challenge to public health. As a result, GeoVax's success, progress and leadership in this field are increasingly recognized throughout the scientific and life sciences business communities."
GeoVax reported a net loss of $296,779 ($0.02 per share) for the three months ended September 30, 2012, compared to $375,852 ($0.02 per share) for the same period in 2011. For the nine months ended September 30, 2012, the Company's net loss was $1,525,055 ($0.09 per share) as compared to $1,193,478 ($0.08 per share) in 2011.
The Company reported revenues of $638,000 and $2,197,761 for the three-month and nine-month periods of 2012, respectively, related to its grants from the NIH. As of September 30, 2012, there is approximately $3.7 million in unused grant funds remaining and available for use.
Research and development (R&D) expenses were $601,690 and $2,386,460 for the three-month and nine- month periods of 2012, respectively. R&D expenses include direct costs funded by GeoVax's Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) grant, as well as vaccine manufacturing costs and expenses related to the Phase 1/2 clinical trial of the Company's therapeutic vaccine being sponsored by GeoVax. Costs associated with the Phase 2a clinical trial of GeoVax's preventative HIV vaccine and the Phase 1 trial of the adjuvanted vaccine, being conducted by the HVTN, are funded directly by the NIH and are not reflected in GeoVax's financial statements. General and administrative (G&A) expenses were $334,166 and $1,339,300 for the three-month and nine-month periods of 2012, respectively.
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