GeoVax Labs at H.C. Wainwright: Strategic Focus on Vaccine Innovation

On Monday, 08 September 2025, GeoVax Labs (NASDAQ:GOVX) presented at the H.C. Wainwright 27th Annual Global Investment Conference. The company, led by CEO David A. Dodd, showcased its strategic focus on developing vaccines and immunotherapies for infectious diseases and cancers. While emphasizing innovation and market potential, the presentation also highlighted challenges in expedited development pathways and global distribution.

Key Takeaways

• GeoVax is advancing three priority programs: GEO-MVA for mpox and smallpox, GEO-CM04S1 for COVID-19, and Gedeptin for solid tumors.
• The company highlighted significant market opportunities, including an $11 billion market for mpox vaccines and a $30 billion market for COVID-19 vaccines targeting immunocompromised individuals.
• Clinical data showed GEO-CM04S1 outperformed Pfizer’s vaccine in immunocompromised patients with chronic lymphocytic leukemia.
• GeoVax received EMA approval for an expedited development pathway for GEO-MVA, potentially generating revenue within three years.
• The company is enhancing its manufacturing process with an advanced continuous cell line platform for faster, cost-effective vaccine production.

Financial Results

• Mpox Vaccine (GEO-MVA): Over $11 billion annual global market opportunity.
• COVID-19 Vaccine for Immunocompromised: Exceeds $30 billion annually.
• Head and Neck Cancer Therapy (Gedeptin): Represents a $15 billion global market opportunity.
• GEO-MVA is expected to generate revenue within the next three years.

Operational Updates

• Mpox Vaccine (GEO-MVA):

- Received EMA expedited development pathway, exempting Phase 1 and Phase 2 trials.

- Requires an immuno-bridging study to MVA-BN by Bavarian Nordic.

- Product manufacturing and quality release expected in October/November.

• COVID-19 Vaccine (GEO-CM04S1):

- Multi-antigen vaccine with increased protection breadth.

- Durability of 8-12 months observed.

- Three Phase 2 trials in progress, with data readout expected soon.

• Solid Tumor Therapy (Gedeptin):

- Phase 2 program to start in the third quarter of next year for head and neck cancer, in combination with Keytruda.

Future Outlook

• Continued updates on clinical programs for GEO-MVA, GEO-CM04S1, and Gedeptin.
• Focus on the COVID-19 vaccine for immunocompromised patients, aiming to be the preferred product.
• Expansion of the advanced continuous cell line manufacturing process to revolutionize vaccine production.

For more details, refer to the full transcript below.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Maya, Research Associate, HC Wainwright: Everyone, and thank you for tuning in to the HC Wainwright 27th Annual Global Investment Conference. My name is Maya, and I’m a Research Associate here at HC Wainwright. We’re excited to introduce you to about 600 companies presenting at our conferences here across our key sectors of life sciences, cryptocurrency, fintech, clean tech, metals and mining, and TMT. Now, I’d like to welcome David A. Dodd, President and CEO of GeoVax Labs. GeoVax Labs is a clinical stage biotech company developing vaccines and immunotherapies for infectious diseases and cancers. With that, I yield the floor to David to introduce himself and the company.

David A. Dodd, President and CEO, GeoVax Labs: Thank you, Maya, and thank you to HC Wainwright for the opportunity to again participate in your wonderful annual conference. Thank you for those who are watching this presentation who have a potential interest in GeoVax Labs. We look forward to having discussions with you during the conference and also any follow-up discussions. As Maya mentioned, we’re a phase two clinical stage company focused on infectious disease vaccines and therapy for solid tumors. We focus very heavily on patented products. That’s very critical to us to differentiate what we’re doing. We are very innovative, as well as populations that are either unserved or underserved. That’s how we you.

Maya, Research Associate, HC Wainwright: Hello, everyone, and thank you for tuning in to the HC Wainwright 27th Annual Global Investment Conference. My name is Maya, and I’m a Research Associate here at HC Wainwright. We’re excited to introduce you to about 600 companies presenting at our conferences here across our key sectors of life sciences, cryptocurrency, fintech, clean tech, metals and mining, and TMT. Now, I’d like to welcome David A. Dodd, President and CEO of GeoVax Labs. GeoVax Labs is a clinical stage biotech company developing vaccines and immunotherapies for infectious diseases and cancers. With that, I yield the floor to David to introduce himself and the company.

David A. Dodd, President and CEO, GeoVax Labs: Thank you, Maya, and thank you to HC Wainwright for the opportunity to again participate in your wonderful annual conference. Thank you for those who are watching this presentation who have a potential interest in GeoVax. We look forward to having discussions with you during the conference and also any follow-up discussions. As Maya mentioned, we’re a phase two clinical stage company focused on infectious disease vaccines and therapy for solid tumors. We focus very heavily on patented products. That’s very critical to us to differentiate what we’re doing. We are very innovative, as well as populations that are either unserved or underserved. That’s how we differentiate, especially when they can provide expedited registration pathways. We hold rights on a global basis for all of our assets.

We plan to widely develop and register those products and work with other companies and collaborations and partnerships to ensure broad-based global distribution and commercialization. We take an approach that we believe, from an investment standpoint, de-risk it by focusing on expedited pathways, being able to move faster to the market, and being able to differentiate and hold leadership roles in certain areas of competition. We also are focused on being as well aligned as possible with the new administration that has come into play, but it’s actually with bipartisan priorities. This is very important for all companies working, certainly within healthcare in general and biotechnology specifically. We focus very heavily. You’ve heard probably throughout the year so far comments out of the administration about looking for multivalent, multi-antigen vaccines. That’s the approach that we take. It provides us a very strong differentiated platform.

We have a well-validated, long-term validated for safety platform we utilize for infectious disease vaccines. We focus on a number of areas to ensure the widest eventual distribution of our product to ensure equity as well as utilization where products need to be delivered. In some cases, in some of the most distant sort of foreign lands or where we find people that also have the least access to the product. We focused on technologies that will enable us to meet those needs. We have three priority programs advancing the registration milestones. I’ll be touching on each one of these. One is GEO-MVA, which is our candidate for mpox and smallpox vaccine. We recently announced from the EMA, the European Medicines Agency, the equivalent of the FDA for Europe, that we were receiving and we have received an expedited development pathway where we can be exempt from doing phase one.

Phase two will only be required to do a phase three immuno-bridging trial to an existing product that’s out there in the marketplace. We’ll talk about that more. That represents an annual global market opportunity of over $11 billion. It’s a huge opportunity, a huge need, medical need. GEO-CM04S1 is our multi-antigen next generation COVID-19 vaccine. I know many people seem to be fatigued and just bored with hearing about COVID-19. However, in the U.S. alone, there are over 40 million individuals who suffer from various medical conditions that deplete their body’s ability to respond appropriately and adequately to the current authorized vaccines. That means the mRNA vaccines or the protein adjuvant vaccine. There’s over 400 million such individuals worldwide. That’s a critical need that represents an annual global market opportunity in excess of $30 billion.

We have multiple clinical trials doing direct randomized comparison against mRNA vaccines going on right now. So far, our products are looking better than what we’re seeing with the authorized vaccines. We also have, through a different technology, we deliver Gedeptin, which is an acronym for gene-directed prodrug enzyme therapy. It’s a technology that we hold worldwide rights, and it allows us to target solid tumors and provide therapy in there. This opportunity in just head and neck cancer alone represents over $15 billion of need, or at least from a commercial standpoint of opportunity on a global basis. We’ll talk about the phase two trial we anticipate initiating about this time next year. We’re currently manufacturing product for that in head and neck cancer, and we’ll talk about that also as we go through the presentation.

WHO last August announced that mpox, formerly known as monkeypox, represented again, as it had in 2022, what is known as a public health emergency of international concern. That is the largest declaration of a health emergency that WHO has. It releases billions of dollars for the care of individuals. They not only announced it last August, they’ve reiterated it several times in November of 2024, in February of this year, and more recently in June. This is a major issue that continues to spread. The current strain of mpox is not just in Africa. It’s also now cases in the U.S. and North America, throughout the EU, as well as Africa. It’s much more virulent, holding a mortality rate of 3 to 7 times what we saw in 2022. It’s a very deadly one, and there is not enough vaccine of the current vaccine. There’s a single source supplier.

There’s not enough vaccine to go around. In fact, it’s horrible symptoms you can see. It can blind. It can kill children. A very bad situation. Currently, there’s a single supplier worldwide. Their product generically is known as MVA-BN for Bavarian Nordic. Ours, we go by GEO for GeoVax MVA. They are unable to meet the demand not only globally, but even within Africa. Africa CDC has stated that they need 25 million doses in the year 2025 alone, and they were told they could get at most 2 to 5 million. You can see how great the need is. We have a rapidly advancing product, GEO-MVA. We’ve manufactured the product. It’s been released by quality in October and November of this year. We’ll be completing the vialing, so the fill-finish operation.

We also announced in June that the EMA had granted us an expedited development pathway where we are exempted from having to conduct a phase one or a phase two study, and the requirement is only to conduct an immuno-bridging study between our GEO-MVA and the MVA-BN to show that they’re essentially the same, which we believe is the case. That could form, therefore, the basis for a marketing authorization. What does this mean? This means that this global opportunity of $11+ billion, we expect the opportunity to be able to begin to book revenues within the next three years. That’ll be a major transition and transformation for GeoVax into the realm of a commercialization status. This is simply the copy of the press release we announced on June the 16th.

COVID-19, as we mentioned, the current vaccines that are approved known as single antigen vaccines, those are the mRNA vaccines from either Pfizer BioNTech or Moderna or the protein subunit from Novavax. They all have been recognized for having a limited breadth of protection. They require continuous configuration as the virus continues to evolve. You may recall we started with Wuhan. We then went to Delta. We went to bivalent types of approaches. We went on Omicron, et cetera. They ended up with limited durability, lasting maybe 4 to 6 months. Yet the goal has always been 12 months. Most importantly, for the 40+ million adults in the U.S. who suffer from various medical conditions that put them as immunocompromised patients, and remember there are 400+ million such patients worldwide. These are people with blood cancers, renal disease, diabetes, lupus, HIV, multiple sclerosis.

It goes on and on and different blood cancers especially. They simply are inadequate for those individuals. Our multi-antigen vaccine has shown increased breadth of protection. We published clinical data that shows we provide protective immunity from the original Wuhan strain through Omicron without having to reconfigure. Thus far, our clinical data is showing durability as a result of that durability of eight to 12 months, just what we’re targeting. We have published papers. There was a recent presentation at the European Hematology Association where we demonstrated that in a comparative trial against the Pfizer vaccine among patients with chronic lymphocytic leukemia, our product worked. The Pfizer product did not work, and the Data Safety Monitoring Board subsequently halted the Pfizer arm, and the completion of the study is only utilizing the GeoVax GEO-CM04S1 vaccine.

This is where we clearly differentiate, and we believe we will also be able to qualify for expedited pathways. This goes back to that initial slide where we talked about how we focused on items. How are we able to achieve this? It’s very simple. Ours is a multi-antigen, just as we see with the single antigen where we focus on inducing a strong antibody response. We, however, also include another protein from the virus, and in doing that, we also induce a very strong T cell or cellular immune effect.

The combination of going after not only the antibody side, but also the cellular side of immunity is that we not only provide the upfront sort of protection just as everyone else does, we also, though, give a much broader, more robust response, which is what is critically important to be able to reduce the risk of severe infection, hospitalization, or the risk of death. Through our multi-antigen approach, we’ve been able to validate that clinically as well as through immuno analyses also. As we mentioned, we have three phase two trials currently underway. One of them is among healthy individuals who initially, these are adults who initially received mRNA vaccine. This trial has been completed. We expect the data readout to be in the third quarter of this year, so this quarter that we’re in right now.

In that one, we’re evaluating how our vaccine works on top of an mRNA vaccine. We believe it’ll show a more robust, broader, longer acting type of response, enhancing that booster need that many patients have. However, the other two trials are both among various blood cancer patients, and those trials are immunocompromised blood cancer patients. A trial among cell transplant patients is continuing to grow, and patients will be expanding to additional sites in the UK during the first half of 2026. In our chronic lymphocytic leukemia patients, that one, as I mentioned, we announced results last fall that showed that our vaccine worked, the Pfizer vaccine did not work among these patients. Recently, the data were presented at the European Hematology Association. There’ll be another upcoming presentation of the data at the International Workshop on Chronic Lymphocytic Leukemia Patients.

That will be in Kraków, Poland, and that will be in September of this year, next month, in a few weeks, in fact. We continue to demonstrate the value of our approach as a multi-antigen versus what is out there currently, and we can differentiate and demonstrate that we bring value that otherwise is not occurring for patients. Our plan is, as we mentioned, it’s a $30+ billion opportunity. We plan to develop very heavily focused on immunocompromised patients, be able to be the lead product that’s preferred in that population, and also be able to demonstrate that we provide a better booster approach, sort of a prime boost approach on top of mRNA as opposed to mRNA with another updated mRNA. I’d like to now take a moment on our technology, Gedeptin. This deals with solid tumor cancers.

Our work to date, which includes completion of a phase one trial as well as a phase one/two trial, the latter of which was funded by the FDA’s Office of Orphan Drug Status. We’ve received orphan drug status for advanced head and neck cancer. FDA funded the recently completed phase one/two trial. That was based upon the encouraging results that we had seen. We’re planning on implementing in around the third quarter of next year a phase two program that will be looking at initial diagnosed patients of head and neck cancers, and they’ll receive Gedeptin in combination with an immune checkpoint inhibitor.

Our plans are to utilize Keytruda in that regard, and we believe that what we will be able to demonstrate is that the combination approach will give a much more consistent and better response in combination of Gedeptin and the immune checkpoint inhibitor than simply the ICI alone. We have recently announced plans in that regard also. Our upcoming milestones are basically to keep everybody updated on what we’re doing with each of these clinical programs, as well as the continued progress we’re making with our advanced continuous cell line manufacturing process for our infectious disease basis platform, which is Modified Vaccinia Ankara. That continues to progress. We think that’ll revolutionize the use and the application of Modified Vaccinia Ankara MVA as a platform for infectious disease vaccines, being able to manufacture a much greater product much faster at lower cost. We’ve been able to validate that in numerous studies.

We’ve presented it at various conferences, and we’ll continue to roll that out and keep everybody informed. With that, I again thank HC Wainwright for this opportunity. I thank the viewers and the participants of the conference and look forward for all of us to have a wonderful conference in New York City. Thank you.

Maya, Research Associate, HC Wainwright: All right, just to close out, thank you, David, for sharing the GeoVax Labs story with us, and thank you, audience, for tuning in. We appreciate the time and effort that went into your presentation, David, and of course, we appreciate your presence at our conference this year and hope to see you again next year.

David A. Dodd, President and CEO, GeoVax Labs: Thank you. Look forward to it.

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