Vaccine Production Technology Reaches Milestone With Manufacturing Facility Validation

FY2023 Reported With A Review Of Clinical Progress and Upcoming Milestones

Initial Phase 2 Data Shows Immune Responses In COVID-19 Booster Trial

3Q23 Quarterly Report Includes 2024 Milestones

Robert LeBoyer

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Healthcare

Biotechnology

Geovax Labs

Summary. GeoVax reported a FY2023 loss of $26.0 million or $(14.29) per share, after adjusting for a 1-for-15 reverse split in January 2024. The loss for 4Q23 was $7.6 million or $(4.29) per share, compared with our estimated loss of $9.0 million. Cash on December 31 was $6.5 million.
New Gedeptin Trials Planned.&nbsp;In July 2023, GeoVax reported initial data from the Phase 1/2 trial testing Gedeptin in patients with head and neck cancer. Gedeptin delivers the PNP gene from E. coli to metabolize a prodrug, fludarabine, into an active cytotoxic drug, fluoroadenine, inside the tumor cells.
The trial enrolled patients with refractory head and neck squamous cell carcinoma (HNSCC) to receive up to 5 cycles of the Gedeptin combination, consisting of 3 intratumoral injections of Gedeptin over two days followed by daily infusions of fludarabine for three days. The data showed that Gedeptin can successfully deliver the PNP gene and activate fludarabine, showing safety, tumor reduction, and clinically stable disease.
The trial completed full enrollment in 2Q23, with additional results expected in HQ24. Expansion of Phase 2 of the combination trial is planned. Additional trials using Gedeptin as a neoadjuvant at earlier stages of disease or in combination with immune checkpoint inhibitors are under consideration. An advisory panel is expected to make recommendations on further trials during 2Q24. Updates on future indications and&nbsp; FDA guidance on regulatory requirements are expected as they become available.
The COVID Pandemic Isnâ€™t Over For Everybody. While most healthy people under age 65 no longer consider COVID-19 a threat, immunocompromised patients cannot produce a full immune response and remain vulnerable. GM04S1 is an MVA-based vaccine designed to stimulate immunity against two SARS-CoV-2 viral proteins, the spike (S) and nucleocapsid (N). It is the first vaccine to use GeoVaxâ€™s MVA vaccine technology, designed to carry multiple vaccine antigens to the immune system in a single dose.
CM04S1 has shown both antibody and T-cell responses against conserved regions of the virus that are less likely to mutate. It has shown protection against the original Wuhan strain and many variants including Omicron XBB.1.5, with additional testing against current strains in progress. Since CM04S1 stimulates immunity against the Spike (S) protein on the viral surface and the highly-conserved Nucleocapsid (N) protein, it is expected to be effective against any future mutations without the need for new formulations.
There are two Phase 2 clinical trials testing CM04S1 in immunocompromised patients. Initial data from these trials has shown stimulation of both the antibody and cellular arms of the immune systems that could provide long-term immunity and improved durability of response.
The first trial is a Phase 2 trial testing CM04S1 as a primary vaccine in immunocompromised hematological cancer patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy. &nbsp;The response in these patients will be compared with the approved mRNA vaccines. The second trial is testing CM04S1 as a booster in immunocompromised patients with chronic lymphocytic leukemia (CLL) after vaccination with an mRNA vaccine.&nbsp;
Booster in Healthy Volunteers. The third trial is a Phase 2 testing GM04S1 as a booster vaccine in patients who had previously been vaccinated with an mRNA vaccine from Pfizer or Moderna. Initial results announced in early February showed safety, tolerability and neutralizing antibody responses, with increased levels of both antibodies against SARS-CoV2 spike protein and specific T-cell responses. The subjects will be followed for one year, and the trial remains blinded as to the dose each subject received.
Improved Vaccines Are Still Needed. On February 28-29, the CDCâ€™s Advisory Committee on Immunization Practices (ACIP) recommended all persons over age 65 receive an additional dose of the current COVID-19 vaccines. Although the approved vaccines are expected to provide protection for about 6 months, clinical testing has shown effective antibody protection lasts from 2 to 8 months. Additional boosters for high-risk populations were recommended.
Project NextGen Could Add Dilution Free Capital. GeoVax could receive funding through the Federal Governmentâ€™s Project NextGen, the $5 billion successor to Project WARP Speed. The money will be used to develop new vaccines for infectious diseases, including improved vaccines for COVID-19. GeoVax may receive a grant through the program, but such grants remain uncertain until official notification of an award. No guidance on amounts or timing can be given. We have not included any grant funding in our models and would consider see the sponsorship as upside for the shareholders.
Proprietary MVA Manufacturing Process Continues. GeoVax has developed a proprietary manufacturing process for vaccine manufacturing the uses its modified vaccinia technologies. We anticipate an announcement on the regulatory path for the cGMP plant and the first MVA products later this year.
Conclusion.&nbsp;GeoVax has made significant progress in advancing Gedeptin and CM04S1 through its early clinical testing to show safety and initial efficacy. We look forward to the regulatory updates and additional data to drive the stock during 2024. We are reiterating our Outperform rating and $6 price target.

Geovax Labs (GOVX)

FY2023 Reported With A Review Of Clinical Progress and Upcoming Milestones

Fundamental Analysis:

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Vaccine Production Technology Reaches Milestone With Manufacturing Facility Validation (GOVX)

FY2023 Reported With A Review Of Clinical Progress and Upcoming Milestones (GOVX)

Initial Phase 2 Data Shows Immune Responses In COVID-19 Booster Trial (GOVX)

3Q23 Quarterly Report Includes 2024 Milestones (GOVX)

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