ATLANTA, March 28, 2012 /PRNewswire/ -- GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), an Atlanta-based biotechnology company developing innovative HIV/AIDS vaccines, today announced its financial results for the year ended December 31, 2011 and provided a business update.
“We are proud of our accomplishments during the past year in advancing our HIV/AIDS vaccine candidates,” said Robert T. McNally, Ph.D., GeoVax President and CEO. “Both our preventive and therapeutic vaccine clinical programs achieved significant milestones, and we are positioned to make exceptional progress during 2012.”
The following table reflects the current status of GeoVax’s vaccine candidates:
Vaccine Candidate | Stage of Indication | Clinical Development | Trial Sponsor | |
B DNA/MVA | HIV Prevention (Clade B) | Clinical Phase 2a | NIH/HVTN | |
B DNA-GM/MVA | HIV Prevention (Clade B) | Clinical Phase 1 | NIH/HVTN | |
B DNA/MVA | HIV Treatment (Clade B) | Clinical Phase 1/2 | GeoVax | |
B DNA-GM/MVA | HIV Treatment (Clade B) | Planning Phase 1/2 | NIH/IMPAACT | |
C DNA/MVA | HIV Prevention (Clade C) | Preclinical | n/a | |
C MVA | HIV Prevention (Clade C) | Preclinical | n/a | |
Clinical Development Highlights
- Preventive Vaccine Phase 2a Trial. The Phase 2a clinical trial was fully enrolled in December 2011 and patient inoculations were completed in January 2012. Study analysis and completion is expected during 2012.
- Preventive Vaccine GM-CSF Adjuvanted Version. The HIV Vaccine Trials Network (HVTN) agreed to sponsor and conduct Phase 1 clinical testing of the next generation of GeoVax’s preventive vaccine that demonstrated a 70% rate of infection prevention in preclinical studies. This trial is expected to commence in April 2012, and, assuming successful outcome, the Company expects this version of the vaccine to be carried forward into Phase 2b efficacy testing. GeoVax has commenced planning for the Phase 2b trial by scheduling vaccine production and beginning discussions with the HVTN regarding protocol development.
- Therapeutic Vaccine Treatment Interruption Study. GeoVax added a third clinical site to this Phase 1/2 trial during 2011, and inoculated the first patient in December 2011. The primary goal of this study is to document the safety and immunogenicity of the vaccine in HIV-positive patients with well-controlled infections. The Company anticipates full enrollment of the trial during 2012, with meaningful data in 2013.
- Therapeutic Vaccine Drug Combination. GeoVax is planning a Phase 1 clinical trial to investigate the use of its therapeutic vaccine in combination with standard-of-care drug therapy in young adults. This trial would likely be conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT), and the Company is currently seeking NIH financial support for the trial. Current theories include using the combination of an effective vaccine and oral medication together to potentially completely eradicate the HIV virus and thus cure the disease. The oral medication would suppress the virus to a low level and the subject’s immune system, which has been activated by the vaccine, could theoretically eradicate the remaining virus.
Dr. McNally continued, “Looking ahead into 2012, we expect to achieve several milestones, including the reporting of data from our Phase 2a preventive trial, enrollment completion for our Phase 1/2 therapeutic trial, and the potential initiation of two new government-supported Phase 1 trials. We are carrying out a well-focused strategy aimed at expeditiously and cost-effectively advancing our clinical programs.
“In addition to the clinical progress we expect to achieve, we are executing on our program to judiciously boost our financial resources, as demonstrated by our recent announcement of a $2.2 million private placement of convertible preferred stock and warrants. We will also be working toward uncovering and evaluating potential strategic corporate development opportunities and improving our visibility to potential investors.”
Full Year 2011 Financial Results
GeoVax reported a net loss for the year ended December 31, 2011 of $2.3 million, or $0.15 per share, based on 15.7 million weighted average shares outstanding. For the year ended December 31, 2010, the Company reported a loss of $2.7 million, or $0.18 per share, based on 15.7 million weighted average shares outstanding.
The Company reported revenues of $4.9 million for 2011, related to its Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant from the NIH. This compares to $5.2 million of grant revenue reported in 2010, which included $4.9 million related to the IPCAVD grant and a one-time award of $244,000 pursuant to the Qualifying Therapeutic Discovery Project (QTDP) program enacted as part of the Patient Protection and Affordable Care Act of 2010. As of December 31, 2011, there is approximately $3.9 million in unused IPCAVD grant funds available for use through August 31, 2012 (the end of the original project period).
Research and development (R&D) expenses were $4.3 million in 2011, compared with $4.8 million in 2010. R&D expenses include $3.0 and $3.4 million for 2011 and 2010, respectively, in direct costs funded by the IPCAVD grant; 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 the Phase 2a clinical trial of GeoVax’s preventative vaccine (being 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 $3.0 million and $3.2 million in 2011 and 2010, respectively. G&A expenses were lower during 2011 due to more efficient management of our operations, and lower costs associated with our financing activities.
GeoVax reported cash balances of $1.2 million at December 31, 2011, as compared to $1.1 million at December 31, 2010. 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, 2012.
About GeoVax
GeoVax Labs, Inc. is a biotechnology company developing human vaccines for diseases caused by HIV (Human Immunodeficiency Virus that leads to AIDS). GeoVax’s HIV/AIDS vaccine technology is exclusively licensed from Emory University in Atlanta, GA, and is the subject of more than 20 issued or filed patent applications. GeoVax vaccines are designed for use in uninfected people to prevent acquisition of HIV-1 and limit the progression to AIDS should a person become infected. GeoVax vaccines also may be effective as a therapeutic treatment (for people already infected with the HIV-1 virus).
GeoVax’s core vaccine technologies were developed by Dr. Harriet Robinson, Chief Scientific Officer, through a collaboration of colleagues at Emory University‘s Vaccine Center, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and GeoVax.
GeoVax’s vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded through a cooperative agreement with the NIH, is the largest worldwide clinical trials program dedicated to the development and testing of HIV/AIDS vaccines. Preclinical work enabling evaluation of the GeoVax DNA and MVA vaccines was funded and supported by the National Institute of Allergy and Infectious Disease (NIAID), which provided additional support to the GeoVax vaccine development program with a $20 million Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant awarded in late 2007.
