ATLANTA, GA -- (Marketwired) -- 08/12/13 -- GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing vaccines to prevent and treat HIV/AIDS, announced its financial results for the six months ended June 30, 2013 and provided a clinical development update.
GeoVax reported a net loss of $526,284 ($0.02 per share) for the three months ended June 30, 2013, compared to $497,763 ($0.03 per share) for the same period in 2012. For the six months ended June 30, 2013, the Company's net loss was $1,223,081 ($0.06 per share) as compared to $1,228,276 ($0.07 per share) in 2012.
The Company reported revenues of $441,561 and $1,238,601 for the three-month and six-month periods of 2013, respectively, related to grants from the National Institutes of Health (NIH) in support of its HIV/AIDS vaccine development efforts. This compares to $705,698 and $1,559,761 of grant revenue reported for the comparable periods of 2012. As of June 30, 2013, there is approximately $1.8 million in unused grant funds remaining and available for use.
Research and development (R&D) expenses were $553,199 and $1,435,187 for the three-month and six- month periods of 2013, respectively, as compared to $712,416 and $1,784,770 for the comparable periods of 2012. R&D expenses include direct costs funded by NIH grants, as well as vaccine manufacturing costs and expenses related to the Phase 1 clinical trial of the Company's therapeutic HIV vaccine. Costs associated with the ongoing Phase 1 clinical trial of GeoVax's preventive HIV 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 $415,784 and $1,028,727 for the three-month and six-month periods of 2013, respectively, as compared to $492,316 and $1,005,134 for the comparable periods of 2012.
GeoVax reported cash balances of $1,881,393 at June 30, 2013, as compared to $1,035,925 at December 31, 2012. 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 Exchange Commission.
Clinical Development Update
Therapeutic Vaccine Program
•Phase 1 "Treatment Interruption" Trial - In 1H2013, GeoVax reported that patient enrollment for GV-TH-01, a Phase 1 "treatment interruption" clinical trial, was completed. The Company expects preliminary data in in the second half 2013, and should report final results and evaluation of trends in the first half 2014. The primary endpoint of this 9-patient study is to document the safety and immunogenicity of GeoVax's vaccine in HIV-positive patients with well-controlled infections who are being treated with oral HIV medications. Following the vaccination series, the trial includes a short period of drug treatment interruption to evaluate the vaccine's ability to control the infection in the absence of continuing drug therapy. The combined vaccination period, treatment interruption period and treatment reinstitution period for each patient is approximately 11 months.
•Phase 1 "Combination" Trial - As previously disclosed, GeoVax has been in discussions with the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT) regarding a potential Phase 1 clinical trial investigating the treatment of HIV-positive young adults with GeoVax's vaccine in combination with standard-of-care antiretroviral drug therapy. However, IMPAACT has recently conducted a review of its core resources in light of current budget constraints and has now informed GeoVax that it will be unable to support this trial with its available resources. This decision by IMPAACT has no effect on NIH's support for GeoVax's preventive vaccine program. GeoVax intends to explore other options for advancing and financing its vaccine + antiretrovirals therapeutic vaccine program.
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