Robert T. McNally, Ph.D., GeoVax's President and CEO, commented, "Our relationship with the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH continues to be strong, and we look forward to their continued support of our vaccine development programs. Most recently, the NIH awarded us a grant of $1.9 million to begin the extension of our vaccine technology to the clade C subtype of the HIV virus prevalent in South Africa and India."
Dr. McNally continued, "Looking ahead into 2013 and beyond, we are excited about the milestones we expect to achieve, including completion of the Phase 1 trial of our second-generation preventive vaccine, completion of the pilot Phase 1/2 trial of our therapeutic vaccine (treatment interruption trial), and initiation of a new, NIH-supported, Phase 1 trial of our therapeutic vaccine in combination with standard-of-care drug therapy. Each of these trials takes us further down the path toward the goal of an effective solution to the HIV/AIDS pandemic. We are very proud of the outstanding progress that our team continues to achieve in this critical development area for people worldwide."
Full Year 2012 Financial Results
GeoVax reported a net loss for the year ended December 31, 2012 of $2.1 million, or $0.12 per share, based on 18.3 million weighted average shares outstanding. For the year ended December 31, 2011, the Company reported a loss of $2.3 million, or $0.15 per share, based on 15.7 million weighted average shares outstanding.
The Company reported revenues of $2.7 million for 2012, related to grants from the NIH. This compares to $4.9 million of grant revenue reported in 2011. As of December 31, 2012, there is approximately $3.0 million in unused grant funds available for use through August 31, 2013 (the end of the grant project periods).
Research and development (R&D) expenses were $3.0 million in 2012, compared with $4.3 million in 2011. R&D expenses include $1.8 million and $3.0 million for 2012 and 2011, respectively, in direct costs funded by NIH grants; and also include vaccine manufacturing costs and costs related to the Phase 1/2 clinical trial of the Company's therapeutic vaccine, being sponsored by GeoVax. Costs associated with the conduct of a Phase 2a clinical trial of GeoVax's preventative vaccine (completed during 2012) and a Phase 1 clinical trial of GeoVax's second-generation vaccine (both trials conducted by the HVTN) are being funded directly by the NIH and are therefore not reflected in GeoVax's financial statements.
General and administrative (G&A) expenses were $1.8 million and $3.0 million in 2012 and 2011, respectively. G&A expenses were lower during 2012 primarily due to lower legal costs, patent costs and stock-based compensation expense related to investment advisory fees and investor warrant extensions.
GeoVax reported cash balances of $1.0 million at December 31, 2012, as compared to $1.2 million at December 31, 2011. Summarized financial information is attached. Further information concerning the Company's 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, 2013.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV. GeoVax's 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. Successful results from a Phase 1 study supported a Phase 2a trial that was completed in the 3rd quarter of 2012. GeoVax's second-generation preventive vaccine is currently in phase 1 testing and is planned to progress to phase 2 efficacy testing, given safety and immunogenicity are as expected. Overall, the GeoVax vaccine, in various doses and combinations, has been tested in close to 500 humans. GeoVax is also enrolling patients in a Phase 1 therapeutic trial for individuals already infected with HIV. For more information, please visit www.geovax.com.
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