Meet GeoVax Labs: Fly exclusive interview with CEO David Dodd

In an exclusive interview, GeoVax Labs’ (GOVX) CEO David Dodd met with The Fly to discuss the company, its pipeline, ongoing trials, upcoming milestones, and much more.

CLINICAL STAGE, PRE-REVENUE: GeoVax Labs is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The company’s development pipeline includes ongoing human clinical trials for a next-generation COVID-19 vaccine — GEO-CM04S1 — and therapy for advanced head and neck cancer — Gedeptin. Additional research and development programs include preventive vaccines against Mpox, or monkeypox, and smallpox, hemorrhagic fever viruses, malaria and Zika virus, as well as therapies for various solid tumors.

“GeoVax is a clinical stage company, pre-revenue. We’re focused on advancing next generation vaccines for infectious diseases and immunotherapy to treat solid tumors. Our lead programs, which are three of them, target high priority health challenges, such as MPOX, COVID-19 — particularly among immunocompromised individuals — as well as head-neck cancer, where we are advancing towards a phase 2 trial that will be starting withing the next year. That’s really who we are. Our vaccines developments are all built upon a platform called Modified Vaccinia Ankara or MVA. It has over 50 years of established safety, so not something new and unknown, and it was specifically developed for highly vulnerable populations. It’s been validated in in the clinic and approvals. In oncology, we use a gene therapy that we refer to as Gedeptin, and that is advancing to scheduled phase 2 trial, which will start about a year from now. It will start at the beginning of the third quarter of next year. We’re going to be working with Merk’s Keytruda,” CEO David Dodd told The Fly.

CLEAR REGULATORY PATHWAY: GeoVax Labs has recently received positive Scientific Advice from the European Medicines Agency for GEO-MVA, its MVA-based vaccine for the prevention of Mpox and smallpox. Alliance Global Partners said that the positive Scientific Advice from the European Medicines Agency provides a clear regulatory pathway ahead, and if successful, could lead to a potential accelerated regulatory approval timeline.

“What the EMA’s decision allows us to do is bypass or eliminate Phase 1 and 2 studies and be allowed to procced directly to Phase 3 immunobridging trial. That’s a significant regulatory milestone and somewhat rare. The streamlined path will accelerate our timeline. We have already manufactured all the product, pending trial. We anticipated this to be the outcome. Now, we’re laying down the protocol for this trial,” the executive added.

“We will be the first and only U.S.-based supplier of a MVA vaccine for MPOX, smallpox. What we keep hearing is that the variants continue to evolve related to MPOX. There is an extreme need for another source; there’s a monopoly today with a single source supplier out of Denmark. And the supply right now is limited.”

POLYVALENT VACCINES: U.S. HHS Secretary Robert F. Kennedy Jr. said that monovalent vaccines do not work against respiratory viruses given the high viral mutation rates, and that the FDA is now prioritizing polyvalent vaccines against respiratory viruses. Roth Capital analyst Jonathan Aschoff saw this as a positive for GeoVax. “We do think that the current political climate is highly favorable for GeoVax, especially related to the ongoing need of vaccines – not only for COVID-19 but also other areas – that are polyvalent,” Dodd shared with The Fly.

“Looking at COVID-19, all the authorized vaccines were built around a single agent or are monovalent. Ours is a multiantigen vaccine, polyvalent and the most advanced in the clinic in the world. It has been generating and demonstrating very good data. The importance of multiple antigens is that you don’t only address the antibody side of the immune system but also the T-cells side. The latter becomes critically important with individuals who have conditions like blood cancers, lupus, renal disease, and diabetes. Their bodies have lost the ability to respond to antibody stimulation. The result of that is the current authorized or the first generation of COVID-19 don’t work for them. For them, the pandemic continues. That’s why it is so important to have multiantigen,” the executive added.

UPCOMING EVENTS: Discussing near- and medium-term milestones, CEO David Dodd told The Fly that, “the most important near-term event that we have and that has the potential of transforming the company into a revenue generation organization is the completion of the full finish process for our GEO-MVA in the fourth quarter, which will allow us to move forward into Phase 3 immunobridging trial in 2026. Second, the continue release of data for our COVID-19 vaccine, specifically among immunocompromise individuals. Additionally, the biggest transformative event or activity we have underway that will be within the next year is the initiation of Phase 2 trial in the first recurrent head and neck cancer in combination with Keytruda. We think that technology is applicable to any solid tumor, and we have an entire development program.”

CAPITAL RAISE: “When you’re a clinical stage company, pre-revenue, it means that you’re continuously living off your balance sheet and you have to build it on an ongoing basis,” GeoVax CEO said. “When you are a pre-revenue micro-cap company, you have to continuously add capital in a dilutive or a non-diluted matter. It always seems to be this misconception on ‘why can’t we just fund the company without having to dilute holdings?’ To be able to proceed and go after these opportunities in an accelerated matter it does take capital. And we seek all ways to do so.”

Meet the Company” is The Fly’s recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.