Stock Insights on GeoVax Labs Inc. (OTCMKTS:GOVX)

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GeoVax Labs, Inc.(OTCMKTS:GOVX) has been moving in a bearish trend since start of the year ,2014, but the stock did saw its highest in the month of January , 2014 when it touched its high of $0.575 at a trading volume of around $750k.

The share price saw it’s highest of $0.97 while its lowest was $0.19 in last one year. The stock maintains good liquidity with average volume of0.034 million shares per day.

GeoVax Labs, Inc.(OTCMKTS:GOVX) has been in news due to its strategy to exploit the hype created on Ebola infection and managed to get upward moment in ticker. GOVX did not able to maintain the ticker at its level because there is nothing material besides news, that it has initiated a new program for the development of a safe and effective vaccine to prevent Ebola infection.

GeoVax Labs, Inc.(OTCMKTS:GOVX) is a biotechnology company developing human vaccines using its novel DNA/MVA vaccine delivery platform. The Company’s lead development program is focused on vaccines to prevent, and treat, Human Immunodeficiency Virus (HIV) infections. Recently it has initiated a program to develop an Ebola virus vaccine. GeoVax’s unique, two component HIV vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara (MVA), is designed to stimulate both anti-HIV antibody and anti-HIV T cell immune responses. GeoVax’s DNA and MVA vaccines are used in a prime/boost protocol in which priming is done with the DNA and boosting with the MVA. Priming and boosting can also be done with the MVA. Both the DNA and MVA express the three major proteins of the HIV virus: Gag, Pol, and Env, and produce non-infectious virus-like particles. GeoVax’s vaccines are unique in expressing virus-like particles that display the native form of the trimeric membrane-bound HIV-1 envelope glycoprotein.

GeoVax Labs, Inc.(OTCMKTS:GOVX) a biotechnology company developing innovative human vaccines using its novel DNA/MVA platform technology, today announced financial results and recent developments for the three and nine months ended September 30, 2014.

Operations Update and Highlights

Ebola Vaccine Program: In October 2014, GeoVax announced its initiation of a new program for the development of a safe and effective vaccine to prevent Ebola infection. The Company is developing two Ebola vaccines, GOVX-E301 and GOVX-E302. Both utilize GeoVax’s MVA vaccine platform developed for its HIV vaccine program and are designed to produce non-infectious virus-like particles (VLPs). The VLPs display the Ebola virus surface protein (glycoprotein) and train the immune system to recognize and kill the real virus. GOVX-E301 is being developed as a single-dose vaccine for epidemic response against the Zaire strain of Ebola, the virus responsible for the current outbreak. GOVX-E302 is a two-dose vaccine being developed for routine immunization and is designed to protect against all three versions of Ebola known to be lethal in humans.

With a fast-moving epidemic threatening large populations in Africa, and no proven therapy available, an effective vaccine against Ebola is desperately needed. GeoVax’s recombinant MVA (modified vaccinia Ankara) platform is uniquely suited to deliver a potent and safe vaccine capable of protecting people against Ebola hemorrhagic fever. To facilitate its Ebola vaccine development efforts, GeoVax is in discussions with the U.S. Centers for Disease Control (CDC) in Atlanta to establish collaboration with CDC experts and access to Biosafety Level 4 (BSL-4) facilities for testing vaccine responses.

Since 1976, when Ebola was first discovered, 25 outbreaks have occurred. Ebola naturally infects animals including bats, creating a reservoir of Ebola that, like rabies, cannot be eradicated completely. An effective vaccine against Ebola would dramatically reduce the epidemic spread of infections as well as the transmission of Ebola from its natural animal hosts to humans. Should the current epidemic be successfully contained, there will still be a need for vaccines to prevent the spread of future outbreaks.

GeoVax is progressing in the product development stage for both GOVX-E301 and GOVX-E302, but will require additional funding to conduct preclinical animal studies and manufacturing, which it will seek from governmental and/or private sources. The Company’s immediate goal is to develop GOVX-E301 as quickly as possible, with production of the first vaccine lot available for clinical testing in humans anticipated in 2016.

Preventive HIV Vaccine Program: GeoVax’s most clinically advanced vaccine development program is a DNA/MVA vaccine regimen for the prevention of clade B HIV infection. The Company has completed multiple Phase 1 trials and a Phase 2a trial of various dosing regimens and formulations of its vaccines. These vaccines have been evaluated in nearly 500 humans. All of the clinical trials of GeoVax’s preventive vaccines have been conducted by the HIV Vaccine Trials Network, and fully funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The HIV Vaccine Trials Network (HVTN) is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. GeoVax is actively engaged in discussions with the HVTN and NIAID regarding the design of its next clinical study and various trial designs are being considered.

HIV Immunotherapy Program: Earlier in 2014, GeoVax completed a Phase 1 trial (GV-TH-01) investigating the therapeutic potential of its DNA/MVA vaccine regimen (GOVX-B11) in HIV-infected patients. The Company announced preliminary results of the trial in early 2014 and has continued to analyze the data generated from the study. During October 2014, the Company presented additional trial data at the HIV Research for Prevention 2014: AIDS Vaccine, Microbicide and ARV-based Prevention Science (HIVR4P) conference in Cape Town, South Africa. The presentation, entitled Elicitation of Immune Responses by a DNA/MVA Vaccine in ART Treated Patients in a Treatment Interruption Trial, was delivered by Harriet L. Robinson, Ph.D., GeoVax’s Chief Scientific Officer.

Based on data and observations from GV-TH-01, GeoVax is now planning an additional clinical trial to further develop its HIV immunotherapy program. Current antiretroviral therapies, though highly effective at suppressing HIV viral load, are unable to eliminate HIV infection entirely. A major challenge in the development of HIV therapeutics is the ability of HIV to persist in host cells in a latent proviral form, invisible to the immune system and inaccessible to antiretroviral drugs. In response to this problem, the NIH and other leaders in the HIV field have developed a new concept: the “shock and kill” strategy, in which patients remain on drugs while one drug (“shock agent”) is used to activate latent HIV and a second drug (“kill agent”) is used to recognize and eliminate cells that harbor the latent HIV reservoir. A shock and kill therapy could potentially contribute to a cure for HIV.

GeoVax believes that its DNA/MVA vaccines, or a component subset, may be effective as shock agents, and plans to evaluate the concept in a Phase 1b clinical trial. Because of their excellent safety record and established regulatory history, the GeoVax vaccines are well suited for immediate testing. Success in this trial will be a first step toward commercialization of the GeoVax vaccines for use as the shock agent in shock and kill protocols for curing HIV infections. The Company’s commercialization strategy will include use of its vaccines in combination with kill agents being developed by others as well as those undergoing development by GeoVax.

Robert T. McNally, GeoVax’s President & CEO, commented, “Our expectations have been that HVTN would advance our DNA/MVA preventive HIV vaccine (GOVX-B11) directly into a large Phase 2b efficacy study in 2015, but recent discussions have now included the concept of adding another component (protein boost) to our vaccine regimen, a concept that has been proposed before. If so, this will change the nature of the next clinical trial, which now may be a smaller study to evaluate the effect of a protein boost in individuals who participated in our previously completed Phase 2a trial. We are continuing discussions with the HVTN about future efficacy studies, and as our plans develop further we will provide additional updates.”

“We are fortunate in that our preventive HIV vaccine program being shepherded by the HVTN requires minimal resources on the part of GeoVax,” Dr. McNally continued. “While this program continues moving forward, we intend to focus our internal efforts on our HIV immunotherapy program and on the acceleration of our Ebola vaccine development. We are excited about this recent expansion of our product pipeline and we believe that our MVA platform is well-suited for Ebola, with good scientific rationale to expect success.”

Financial Review:

GeoVax reported a net loss of $514,515 ($0.02 per share) for the three months ended September 30, 2014, compared to $190,148 ($0.01 per share) for the same period in 2013. For the nine months ended September 30, 2014, the Company’s net loss was $1,809,970 ($0.07 per share) as compared to $1,413,229 ($0.07 per share) in 2013.

The Company reported revenues of $322,086 and $659,867 for the three-month and nine-month periods of 2014, respectively, related to grants from the NIH in support of its HIV/AIDS vaccine development efforts. This compares to $1,004,211 and $2,242,812 of grant revenue reported for the comparable periods of 2013. As of September 30, 2014, GeoVax reported approximately $452,000 in unused grant funds remaining and available for use.

Research and development (R&D) expenses were $425,498 and $1,344,560 for the three-month and nine- month periods of 2014, respectively, as compared to $879,104 and $2,314,291 for the comparable periods of 2013. R&D expenses include direct costs funded by NIH grants, as well as vaccine manufacturing and testing costs and expenses related to the Company’s HIV immunotherapy program. General and administrative (G&A) expenses were $411,814 and $1,128,478 for the three-month and nine-month periods of 2014, respectively, as compared to $316,452 and $1,345,179 for the comparable periods of 2013.

GeoVax reported cash balances of $862,191 at September 30, 2014, and also reported $873,400 subsequently received in October 2014 related to stock warrant exercises. Cash balances at December 31, 2013 were $2,513,861. 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.

GeoVax Labs, Inc.(OTCMKTS:GOVX) is a typical development stage company with $2.51million of cash and total assets of $2.84million. The company has total liabilities of $0.31 million resulting in positive equity. GOVX trading in red yet continues to trade in impressive volume, however does not seem to be moving anywhere close to its earlier position in the near future.

Considering the fundamentals its market capitalization of $6.78 million is clearly overstated.

 

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