HIV Vaccine Infects 172 Patients During Clinical Trials
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Full Year 2012 Financial Results
GeoVax 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 was 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 I/II clinical trial of the Company's therapeutic vaccine, being sponsored by GeoVax. Costs associated with the conduct of a Phase IIa clinical trial of GeoVax's preventative vaccine (completed during 2012) and a Phase I 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.
The Company 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.
Cash balances as of December 31, 2012 was $1.0 million, as compared to $1.2 million at December 31, 2011.
We think the earnings report is a non-event for GeoVax. Investors should be focused on the Company's progress in its clinical programs. In this regard, we think GeoVax has made great progress for its HIV/AIDS programs and is on track to further advance these clinical programs in 2013.
Progress on Clinical Development
Preventive Vaccine - Phase IIa Trial. The Phase IIa trial (HVTN 205) of GeoVax's preventive HIV/AIDS vaccine has been completed. Results of this trial were presented in September 2012 by the HIV Vaccine Trials Network (HVTN) at the AIDS Vaccine 2012 Conference in Boston. HVTN 205 confirmed the Phase I results, with the GeoVax vaccine demonstrating an excellent safety profile and reproducible T cell and antibody immune responses. The Company expects formal publication of the full study results by the end of 2013.
Preventive Vaccine (2nd-generation) - Phase I Trial. Patient enrollment was completed in December 2012 for the Phase I trial testing the safety of GeoVax's second-generation vaccine (GM-CSF adjuvanted). GeoVax expects the Phase I trial to be completed in the second half of 2013.
Preventive Vaccine (2nd-generation) - Phase II Efficacy Trial Planning. Pending successful outcome of Phase I testing of the second-generation vaccine, GeoVax expects to advance this version of its preventive vaccine into Phase II efficacy testing in high-risk individuals, expected to begin in 2014. The Company is currently in discussions with the HVTN regarding protocol development and anticipates knowing more about the trial design and the government funding consortium in late 2013.
Therapeutic Vaccine - Treatment Interruption Study. The Company's ongoing Phase I/II "treatment interruption" clinical trial, investigating the use of its vaccine for treatment of individuals already infected with HIV, completed enrollment at the end of 2012. GeoVax expects to see data readouts from this study during 2013, which might indicate the potential use of its vaccines to treat HIV infection, either as a standalone therapy or in conjunction with an oral drug regimen.
New Clinical Trial Planned for Combination Therapy
GeoVax is collaborating with the NIH and planning is underway for a second therapeutic clinical trial to begin in mid-2013. This Phase I trial will investigate the use of GeoVax's therapeutic vaccine in combination with standard-of-care drug therapy in HIV-positive young adults. The Company expects this trial to be conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT), a program supported by the NIH. Because of the mechanisms by which current oral drugs work, if the virus is in latent phase (non-replicating), the drugs are not effective, thus it is impossible to totally eradicate the virus. There is hope for a combination approach using the patient's own immune system stimulated by the vaccine, together with oral drugs to eradicate the virus -- thereby potentially offering a cure.
We think GeoVax has made great progress in its HIV/AIDS vaccine clinical programs. We are especially pleased to see that the Company is planning a new clinical trial combining its HIV/AIDS therapeutic vaccine with AIDS drugs in mid-2013. This will provide a new big market for the Company's vaccine.
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