GeoVax Labs, Inc. (OTC:GOVX) held its special meeting of stockholders and shareholder vote on April 15, 2019. There was a 97.7% response rate for the issued and outstanding shares, representing 252.2 million equity units. The key matters under consideration for a vote was the grant of authority to the board of directors to effect a reverse stock split. The matter was approved with 52.2% of total shares outstanding voting for the authority. An 8-K filing was submitted to memorialize the outcome.
While many shareholders were concerned that the reverse stock split would lead to poor prospects for future share price performance, the authority was necessary. GeoVax was running out of authorized shares and would not be able to raise funds using equity as there would be insufficient shares to offer for sale. Additionally, the share price in the cents was seen as a deterrent to attracting long term shareholders and a higher price may allow trading on an exchange with greater visibility. Proceeds from additional financing will be applied towards advancing additional programs into the clinic. We believe the most likely candidates to be advanced are the Zika and/or the immuno-oncology programs.
GeoVax filed their annual 10-K and issued the accompanying press release on March 27, 2019 providing an operational and financial update on the company’s performance. There were several important highlights for the year including new collaborations, grants awarded from government entities and publications and presentations at scientific conferences.
Revenues for 2018 were $1.0 million, representing a 10% decline over 2017 levels. The vast majority of revenues consist of grant and collaboration funds from Zika, Lassa fever and HIV programs. During 2018, the two Lassa fever grants began to ramp up, offsetting the wind down of the HIV funding. Total expenditures for 2018 were $3.5 million, up 8% from 2017 levels. R&D expenditures of $1.9 million compared to $2.0 million in the prior year. G&A was $1.6 million, increasing from $1.2 million in 2017 with the increase almost entirely due to greater stock compensation expense.
As of December 31, cash on the balance sheet was $260,000 and debt outstanding was $40,000 in a note held by the Georgia Research Alliance. Cash burn for 2018 was ($1.5) million, which compares to ($1.7) million in 2017.
GeoVax has a full pipeline of programs with HIV holding the most advanced position with Phase II work being done. The remainder of the portfolio is centered on infectious disease and immuno-oncology preclinical work. Below, we summarize current status of the programs.
HIV Immunotherapy – In 2018, GeoVax received $256,000 for its HIV program from the NIH Small Business Innovative Research (SBIR) grant. Clinical trials for HIV are ongoing. The company plans another Phase I study in the near future with further evaluation of the protein boost. Looking forward, we anticipate a Phase IIb efficacy trial when additional grants or partnerships are secured.
Ebola – An ongoing outbreak in Congo has highlighted the need for a safe, effective and durable vaccine that can remain viable at room temperatures. GeoVax has had several publications of its preclinical Ebola trial results published in Atlas of Science and Nature. The study demonstrated 100% single-dose protection in a large primate model. We discuss the details of the articles here.
Lassa fever – A $300,000 Fast Track Phase I/II SBIR grant was received in support of further advancing the Lassa fever development program. Total project budget is $1.9 million for a Phase II award, which we anticipate will be secured. A U.S. Department of Defense (DoD) award for $2,442,307 was also granted in a cooperative agreement to develop Lassa vaccine. The Lassa vaccine has demonstrated 100% single dose protection in a mouse model.
Zika – A two year, $600,000 Small Business Innovative Research (SBIR) grant was awarded in June 2017 in support of the development program. Efforts will focus on preclinical testing of the Zika vaccine in nonhuman primates in preparation for human clinical trials. The Zika program is likely to be advanced into human clinical trials if sufficient funding is raised. Furthermore, there are ongoing discussions with Brazilian entities which may yield additional collaborations.
Malaria – An ongoing collaboration with the Australian Burnet Institute is underway to develop a vaccine using the MVA-VLP platform. A second collaboration is with Leidos, which was announced in February 2019. Leidos is developing candidates against Plasmodium falciparum malaria and will use the MVA-VLP platform in its development efforts.
Hepatitis B – Collaborations with Georgia State University Research Foundation (GSURF) and CaroGen Corporation are advancing work in this area.
Vaccine Delivery – A collaboration was announced with Enesi Pharma in January 2019 to develop needle free vaccine formulations. The formulations will be used in conjunction with Enesi’s ImplaVax device which may provide better consistency, stability in the vaccine administration and minimization of vaccination and needle phobia.
Cancer Immunotherapy – Collaborations with University of Pittsburgh and ViaMune are underway. The academic collaboration is focused on MUC1 with the goal of raising protective anti-tumor antibodies and T cell responses in cancer patients. Efforts with ViaMune are also centered on MUC1 and is seeking to combine a MUC1 vaccine for use with checkpoint inhibitors. Preclinical work in animal models have shown efficacy. Additional work with Vaxeal, Emory Vaccine Center, Virometrix and Leidos are also taking place in immuno-oncology. The immuno-oncology program is likely to be advanced into the clinic if sufficient capital is raised.
View Exhibit I – GeoVax Vaccine Pipeline
GeoVax has made numerous advances across its pipeline portfolio in 2018. Several programs were provided government grants, including the Lassa fever vaccine which received $2.4 million from the US Department of Defense, and the Zika vaccine which received $300,000 for the second year of the NIH SBIR grant. Many collaborations continue including the HIV program with American Gene Technologies (AGT) International, the oncology program with Vaxeal Holding and the Hepatitis B program with CaroGen Corporation. In addition to the details provided above, GeoVax is also working with Dr. Rafi Ahmed of Emory University Vaccine Center to develop an HPV vaccine.
Year to Date Highlights
‣ GeoVax & Vaxeal collaborate in immunotherapy – January 2018
‣ Ebola publication in Nature scientific journal – January 2018
‣ GeoVax & Carogen collaborate on hepatitis B vaccine – February 2018
‣ GeoVax awarded fast track for Lassa fever – April 2018
‣ GeoVax awarded NIH grant for Zika – May 2018
‣ GeoVax & Emory collaborate on HPV program for head & neck cancer – July 2018
‣ David Dodd appointed as Chairman and CEO – August 2018
‣ GeoVax & PharmaJet collaborate on Zika needle free vaccine – August 2018
‣ GeoVax awarded $2.4 million from DoD for Lassa fever Vaccine – September 2018
‣ Publication of HIV Vaccine Review – October 2018
‣ Presentation of Phase I trial for HVTN 114 (HIV) – October 2018
‣ Collaboration with Virometix on immunotherapy program for HPV – November 2018
‣ Collaboration with Leidos on immunotherapy program using PD-1 checkpoints – November 2018
‣ Collaboration with Enesi Pharma to develop vaccines using ImplaVax – January 2019
‣ Ebola vaccine study published in Atlas of Science – March 2019
‣ Expansion of Leidos collaboration in malaria – March 2019
GeoVax continues to develop programs with a variety of grants while they seek a partner and funding for later phase development of its HIV projects. The company has been focused on preclinical work in other pipeline programs while seeking funding or partnerships to pursue a registrational trial in HIV. The value of vaccines to global health should not be ignored and they can be a fundamental part of eliminating the HIV epidemic in the US. Additionally, the public health value of preventing the spread of Ebola, Lassa fever, Zika or any of the other infectious diseases targeted by the company’s MVA-VLP programs is immense. We adjust our price target to reflect current share balance and our estimate of dilutive securities generating a $0.15 per share target price.
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