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GOVX: Third Quarter 2019 Results and Update

OTC:GOVX

GeoVax Labs, Inc. (OTC:GOVX) filed its third quarter 2019 10-Q and issued the accompanying press release on November 7, 2019 providing an operational and financial update on the company’s performance. During the third quarter and to date GeoVax gave several presentations related to the Lassa fever, HIV and Marburg programs, issued additional shares to satisfy convertible preferred liquidation, further oriented the company towards an oncology focus and announced a partner’s Investigational new Drug (IND) application for an HIV cure. Looking forward to the rest of 2019, we expect GeoVax will continue to seek additional capital to support its initiatives in immuno-oncology and apply for further grant funding to support the many vaccine programs in development.

Grant and collaboration revenues for 3Q:19 were $215,000, representing a 5% decrease compared to 3Q:18 levels. Revenues were recognized for Lassa fever related to the SBIR and US Army grants, while the Zika SBIR grant has been exhausted. Total expenditures for the first quarter were $759,000, down 25% from prior year levels. R&D expenditures of $0.5 million compared to $0.6 million in the prior year. G&A was $0.3 million, falling 36% from 3Q:18 levels with the decrease primarily attributable to lower levels of stock based compensation.

As of September 30, cash on the balance sheet was $569,000 and notes outstanding were carried at $42,000. Cash burn for the three month period was ($0.3) million, which compares to ($0.3) million in the comparable period. GeoVax received $700,000 in proceeds from sale of preferred stock. Following the end of the quarter, additional convertible preferred instruments were exercised increasing the shares outstanding to 426 million as of November 6, 2019.

Shift to Immuno-Oncology

GeoVax expects to continue to develop its HIV and infectious disease programs with grants and other available funding; but will shift its primary development focus towards immuno-oncology (IO). The company plans to leverage its validated Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform technology to deliver tumor-associated antigens (TAAs) to the immune system so that it may mark cancer cells for destruction. The primary target for the IO program is Mucin 1 (MUC1), which is an oncogenic transmembrane glycoprotein overexpressed in many hematologic malignancies and solid tumors. Some of the cancers that have been shown to overexpress MUC1 include breast cancer, lung cancer and multiple myeloma. GeoVax is seeking support to pursue a triple-combination approach with its MUC1 vaccine, checkpoint inhibitors and standard of care. Preclinical work with GeoVax’s candidate demonstrated a 57% reduction in tumor growth compared to controls when MVA-VLP-MUC1 was combined with anti-PD-1 antibodies. GeoVax will also pursue a second TAA, Cyclin B1, in collaboration with Vaxeal Holding SA. Other partners participating in the oncology collaboration include Emory University and Leidos, Inc., with the latter contributing a PD-1 checkpoint inhibitor to the effort.

Exhibit I – MVA-MUC1 Preclinical Model Data1

GeoVax is seeking collaborations with larger pharmaceutical or biotechnology companies or from government or non-profit organizations to support IO development. Due to the greater level of demand for new cancer therapies, GeoVax anticipates that after preclinical validation, funds could be raised to advance IO candidates through the clinic.

GeoVax has formed a separate subsidiary to house the oncology assets, which will allow targeted funding for these programs. All oncology work is expected to be performed in the new subsidiary, with joint development and licensing opportunities available. We expect further details on this structure in future quarters.

Partner IND Submission

Partner American Gene Technologies (AGT) submitted an IND application in mid-October for its lentiviral vector-based gene therapy candidate designated AGT103-T. If the FDA has no questions regarding the filing and does not place a clinical hold, AGT plans to enroll its first patients in January 2020. GeoVax will contribute its MVA-VLP HIV vaccine (MVA62B) to be used as a boost prior to removing T cells from the patient for reprogramming ex vivo. The trial will evaluate the use of AGT103-T alone and in combination with MVA62B. GeoVax’s Dr. Guirakhoo noted that in a Phase I trial the vaccine has stimulated CD8+ and CD4+ T cells in HIV-positive individuals, which suggests added efficacy from the boost.

Infectious Disease Programs

On July 16, GeoVax announced a presentation entitled “A Single Dose of MVA-Based Lassa Virus Vaccine Provides Complete Protection in a Mouse Lethal Challenge Model” at the Annual Meeting of the American Society of Virology in late July 2019. The topic of the presentation addresses the preclinical efficacy of a novel vaccine candidate for Lassa fever based on an MVA vector expressing two immunogens derived from the Lassa virus. After vaccination, the immunogens stimulate the formation of virus like particles (VLPs) that will develop immunity in the host against subsequent infections of Lassa. The study was funded by a Fast Track Phase I/II Small Business Innovative Research (SBIR) grant to GeoVax from the National Institute of Allergy and Infectious Diseases (NIAID).

In the fourth week of July, GeoVax’s Chief Scientific Officer, Dr. Harriet Robinson, delivered a presentation entitled “Protein-Supplemented DNA/MVA Vaccines: Preclinical Immunogenicity and Protection for Transmitted/Founder and CD4-induced gp120 Proteins” at the 10th International AIDS Society Conference in late July.

July was a busy month, and before it was over GeoVax reported 100% protection from preclinical challenge studies of its Marburg virus vaccine. GeoVax’s candidate, GEO-EM05, was administered to guinea pigs and compared against a control group. Eight weeks after inoculation, the animals were challenged with Marburg virus. In the active group, all animals survived with no negative health issues while all animals in the control group developed conditions that required them to be euthanized.

GeoVax has offered the infectious disease vaccines to public health agencies worldwide in return for development funding to advance the candidates towards approval. This approach could have benefits as it would further validate the MVA-VLP based vaccine platform and allow the company to potentially attract funds for development of other candidates in the portfolio as well as more quickly making life-saving vaccines available for populations that need them.

Year to Date Highlights

‣ 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

‣ Execution of 500:1 reverse stock split – May 2019

‣ Marburg Virus Vaccine Study Results – July 2019

Publication of Lassa Fever Study Results for GEO-LM01 – September 2019

‣ Presentation at World Immunotherapy Congress – October 2019

‣ Presentation at International Society of Virology – October 2019

‣ Presentation at World Vaccine Congress – October 2019

Exhibit II – GeoVax Vaccine Pipeline2

Summary

GeoVax continues to develop programs with a variety of grants while it seeks a partner and funding for later phase development of HIV projects. The company has reoriented its focus towards IO and has identified two targets that are appropriate for further research and combination therapies. GeoVax faces substantial dilution from conversions of its preferred stock and will be focused on identifying sources of investment that may potentially eliminate the additional $2.5 million in preferred stock outstanding. GeoVax’s portfolio has substantial value and company management is focused on identifying funding in order to advance the portfolio candidates. Participation in AGT’s HIV trial and an offer from non-profits to develop infectious disease candidates may bring additional attention and validation to the MVA-VLP platform and potentially attract investment funds.

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1. Source: GeoVax Press Release. Leveraging GeoVax's Vaccine Expertise To Take On Cancer, Atlanta, GA, September 9, 2019.

2. Source: GeoVax Website Accessed November 2019. https://www.geovax.com/technology-pipeline/pipeline-summary