Earnings Call Transcript - GOVX Q3 2025

Operator, Operator

Good afternoon, and welcome to the GeoVax Third Quarter 2025 Corporate Update Call. My name is Sherry, and I will be facilitating today's call. Joining me are David Dodd, Chairman and CEO; Mark Reynolds, Vice President and Chief Financial Officer; Mark Newman, PhD, Chief Scientific Officer; Kelly McKee, MD, MPH, Chief Medical Officer; and John Sharkey, PhD, Vice President of Business Development. This conference is being recorded. Please note that some statements in this presentation may be forward-looking as defined by the Private Securities Litigation Reform Act. These statements rely on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ significantly from those expressed in these statements due to various factors, such as GeoVax's ability to develop and manufacture its product candidates as intended and on time, the safety of these products for human use, the effectiveness of GeoVax's vaccines in preventing target infections, obtaining necessary regulatory approvals for licensing and marketing, raising the required capital to complete product development, competition from other potentially more effective products, and entering favorable manufacturing and distribution agreements, among other uncontrollable factors. GeoVax does not assume any obligation to update these forward-looking statements. For more information on these factors, please refer to GeoVax's filings with the Securities and Exchange Commission, including those listed under Risk Factors in GeoVax's Form 10-K. It is now my pleasure to introduce David Dodd, the Chairman and CEO of GeoVax. Please go ahead.

David Dodd, CEO

Thank you. Welcome to the third quarter 2025 GeoVax corporate update. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then we will address any questions that you may have. We remain confident in the continued progress and compelling outlook for our portfolio of GEO-MVA, GEO-CM04S1, Gedeptin and the game-changing MVA vaccine manufacturing process. Each of our product development candidates address critically important unmet health care needs, providing opportunities for expedited registration paths and strong opportunities to commercialize differentiated solutions supporting patient needs worldwide. We also anticipate that the advanced MVA manufacturing process will provide a game-changing advantage in the production of MVA-based vaccines and therapies. We're experiencing increased partnering and collaboration interest from established industry players as well as increased interest from non-dilutive funding organizations, including stakeholders addressing various areas of worldwide vaccine needs. In June, we announced the receipt of guidance from the European Medicines Agency, referred to as the EMA, providing an expedited development path for GEO-MVA, our vaccine candidate against Mpox and Smallpox. This is most encouraging news in that it provides the potential for GeoVax to achieve marketing authorization and revenue generation sooner, allowing us to bypass Phase I and Phase II clinical trials and proceed directly to a Phase III immuno-bridging trial. As a result of this news, we're experiencing increased interest and dialogue with various industry colleagues and stakeholders regarding potential partnering, collaboration and funding. Relative to GEO-MVA, we have initiated the fill/finish of clinical batch vaccine material. We anticipate having vaccine available for clinical evaluation early next year. We're pleased to note that in addition to product in support of our clinical evaluation, we plan to produce additional product in support of potential use in conjunction with various stakeholder discussions that are underway. We believe that GEO-MVA provides the potential to end the current monopoly of MVA vaccine supply, expanding the global supply of this critically needed vaccine, addressing both the needs resulting from epidemic outbreaks as well as the various stockpile opportunities worldwide. Significant government interest exists relative to U.S.-based supply chains versus the current overdependence on non-U.S. suppliers. The strong sentiment in favor of such onshoring initiatives is a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders, including the White House, Congressional Representatives, HHS, WHO, the International Vaccine Institute, the Africa CDC and others regarding our progress relative to cGMP clinical inventory of GEO-MVA. In fact, this was the subject of numerous discussions during our recent series of meetings in Europe in conjunction with the World Vaccine Congress Europe, BIO-Europe and individual meetings held in Geneva and elsewhere. Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. GEO-CM04S1, our multi-antigen vaccine against COVID-19 is increasingly recognized as a critically needed vaccine for use among the over 40 million immunocompromised adults in the U.S. as well as the over 400 million worldwide. Based on the clinical data results thus far, we believe that CM04S1 provides potential for demonstrating a more robust immune response against emerging variants, improved durability versus the first-generation single antigen COVID-19 vaccine and especially in addressing the immune protection among those patients with compromised immune systems. Our current CM04S1 studies are progressing, especially our focus on continued enrollment of severely immunocompromised patients with blood cancers who have received cell transplants and towards completion of the investigator-initiated Phase II trial among chronic lymphocytic leukemia patients. Both the hematologic cell therapy patients and the CLL patients represent the highest risk groups in need of reducing the risk of severe infection, hospitalization and the risk of death resulting from COVID-19 infection. For these individuals, the pandemic continues. Demonstrating the critically important value of CM04S1 among such immunocompromised patients remains our focus for differentiation from the first-generation COVID-19 vaccines. The medical need for a vaccine such as CM04S1 remains substantial for those with medical conditions that render their immune systems inadequate in responding to the first-generation vaccine. It's noteworthy that just recently, the Infectious Disease Society of America, known as IDSA, issued updated guidelines regarding COVID-19 vaccine among immunocompromised patients. These critically important guidelines are exceedingly well with our development of CM04S1. During the third quarter, multiple presentations of clinical results for CM04S1 were provided at the International Workshop on Chronic Lymphocytic Leukemia, the World Vaccine Congress Europe and the European Society of Clinical Microbiology and Infectious Disease. Each of these presentations resulted in additional and expanded discussions regarding potential partnering and collaborative developments. Let me point out, while such discussions tend to follow a somewhat tedious due diligence process, we are encouraged by the continued interest in CM04S1 as the leading multi-antigen COVID-19 vaccine in clinical development. Relative to our plans for a Phase II Gedeptin trial in head and neck cancer, the primary determinant of the timing to initiate the Phase II trial is the completion of necessary product manufacturing. That is underway, along with the continued clinical operations plans and the necessary regulatory aspects. Earlier this year, Dr. Marc Pipas presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the Phase II study. Peer-reviewed publication of this work is forthcoming in JCO Oncology Advances, so be on the lookout for this. Following the impressive results of the KEYNOTE-689 study presented at ASCO, we have modified the Gedeptin Phase II study protocol, changing the target population to first-line therapy, mimicking KEYNOTE-689 trials historical control. As such, our focus will be on evaluating neoadjuvant Gedeptin and pembro, offering meaningful efficacy and tolerability in patients with primary squamous cell carcinoma head and neck, who are being considered for surgical resection with curative intent. Our primary endpoint will be major pathological response. We believe that Gedeptin has the potential to address multiple solid tumors, especially via combination therapy, providing significant value long term. We also plan additional studies of Gedeptin addressing other solid tumors beyond head and neck cancer. In addition, we are engaging in various discussions related to potential collaborations in the long-term development and commercialization of Gedeptin. Overall, our goal is to successfully develop innovative cancer therapies and infectious disease vaccines, addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate business partnerships and collaborations in support of worldwide development, commercialization and distribution. Our priorities and anticipated milestones for 2025 through 2026 remain focused on advancing GEO-MVA to clinical evaluation, advancing GEO-CM04S1 for immune-compromised populations, advancing the progress of the advanced MVA manufacturing process and our focus on oncology, specifically related to Gedeptin is a major priority for the future of GeoVax. We have high expectations for the potential broad utilization of Gedeptin against various solid tumors, especially in combination with immune checkpoint inhibitors. We also are focused on progressing various partnering and collaboration discussions in support of these developments with the potential to accelerate the pace of these programs. We're confident that we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. Now I'd like to turn the presentation over to Mark Reynolds, GeoVax Chief Financial Officer, for a review of our recent results and financial status.

Mark Reynolds, CFO

Thank you, David. And the details of our third quarter financial results are summarized in today's press release. I'll start the review with our income statement. During the 9 months ended September 30, 2025, we reported revenues of $2.5 million versus $3.1 million in 2024. This relates to the BARDA Project NextGen contract that began in June 2024. And as we previously discussed in our Q1 earnings call this year, in April, the contract was terminated along with other Project NextGen funded contracts as part of the government's efficiency program, so there were no contract revenues reported during Q3. Research and development expense for the quarter was $5 million versus $7.4 million in 2024. For the 9-month period, R&D expense was $15.1 million versus $16.1 million in 2024. The decrease during 2025 is primarily related to discontinued costs associated with the termination of the BARDA contract as well as lower costs for the CM04S1 clinical trials and manufacturing costs associated with the CM04S1 and Gedeptin programs. These lower costs were partially offset by higher personnel and consulting costs and manufacturing costs associated with the GEO MVA development program in preparation for initiating clinical trials in 2026. General and administrative expense was $1.3 million for the third quarter of '25 versus $1.2 million in '24. For the 9-month period, G&A expense was $4.6 million versus $3.8 million in '24. The overall increase during 2025 is associated with higher personnel costs, investor relations consulting and other programmatic expenses and stock-based compensation expense. Other income expense was $151,000 for the year-to-date period in '25 as compared to $70,000 in '24, primarily reflecting higher interest income. So overall net loss for the quarter was $6.3 million versus $5.8 million in '24 and $17 million for the year-to-date period versus $16.7 million in '24. Turning now to the balance sheet. Our cash balances at September 30 were $5 million as compared to $5.5 million at December 31, '24, reflective of $16.5 million used in operating activities, offset by $16 million in financing transactions. Our outstanding common shares currently stand at $27.7 million. Supporting our clinical programs for the priority programs at CM04S1, GEO-MVA and Gedeptin will be the most significant use of our cash for the foreseeable future. We continue to explore various strategies to fund these programs through several valuation inflection points and also to extend our cash runway. These could include strategic partnerships, non-dilutive funding or additional offerings of our common stock. And I'll be happy to answer any questions during the Q&A, and I'll now turn the call back to David.

David Dodd, CEO

Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Dr. Mark Newman, Kelly McKee and John Sharkey, our Chief Scientific Officer, Chief Medical Officer and Vice President of Business Development, respectively. I'll now turn the call over to the operator for instructions on the question-and-answer period.

Operator, Operator

Our first question will come from Jonathan Aschoff with ROTH Capital Partners.

Jonathan Aschoff, Analyst

I was kind of curious, can you envision any kind of scenario, an outbreak type of scenario that would get MVA into the hands of governments? Is there anything that you can think of that would make that go commercial at least temporarily, way before you would do any sort of clinical trials with it?

David Dodd, CEO

This is David, Jonathan. I wouldn't anticipate that prior to any clinical evaluation that such a situation would occur. We do believe there may be an opportunity as well as a significant need for emergency use licensing, which would come through WHO based on certain situations occurring. And some of those types of discussions were part of our recent trip in Europe that we had with WHO and other parties.

Jonathan Aschoff, Analyst

Okay. I think that's really all that I had. The 10-Q will come out soon, yes.

David Dodd, CEO

Yes.

Mark Reynolds, CFO

Yes, the question is about a technical difficulty.

Operator, Operator

One moment for our next question, which will come from the line of Robert LeBoyer with NOBLE Capital Markets.

Robert LeBoyer, Analyst

Congratulations on all the progress you've been making. I know it's probably a little early to talk about the collaborations specifically. But on the broad strategic level, is there anything that you can tell us about what you're thinking in terms of the collaborations or partnerships or anything like that, that would be helpful in determining what the prospects are for kind of business combination or partnership?

David Dodd, CEO

Sure, Robert. This is David. We hold worldwide rights for all of our product assets. And our plan and our focus is to register broadly on a global basis. It doesn't mean every single country, as you know, but broadly to register on it. And our initial thinking is that we would be able to handle North America, which would be the U.S. and Canada, but I would also underscore that we'll always listen to any proposal that a potential partner has. We are quite active in attending various conferences as we just did, both World Vaccine Congress Europe as well as BIO-Europe. BIO-Europe is largely a partnering-oriented conference. We attend that every fall as well as in the spring as well as obviously U.S.-based similar types of conferences. So increasingly, our discussions related to potential partnering or collaboration, which would entail involvement of a partner as we develop it for a particular region, and you can sort of think through how certain rights would be distributed if someone was heavily focused in a certain region, the Pacific region, then they might be assisting us in the development process for their regulatory process, etc. So all of those types of concepts are actively discussed in meetings that we continue to have and have been having. And we're open to whatever makes sense from a win-win and from the basis of value for our shareholders as well as the stakeholders who are out there.

Operator, Operator

One moment for our next question. And that will come from the line of Jim Molloy with Alliance Global Partners.

Laura Suriel, Analyst

This is Laura Suriel on for Jim Molloy. So for GEO-MVA, can you just talk a bit more about the collaboration you have in place with the University of Queensland and UniQuest for the needle-free administration method that you have for this vaccine? And also any research or manufacturing plans that you have in place here as well?

David Dodd, CEO

We recently announced our evaluation in partnership with Vaxxas, as we think it’s crucial, especially in certain parts of the world, to explore nontraditional delivery methods. Vaxxas is a leader in microarray patches, and we've been familiar with them and other strong players in this field for several years. We are currently assessing the feasibility of using this technology for GEO-MVA. As we continue our evaluation and gather more information, we will share relevant updates. Now, regarding your question about manufacturing, could you please repeat that?

Laura Suriel, Analyst

Just the manufacturing that you might have for this particular program for GEO-MVA?

David Dodd, CEO

GEO-MVA, I'm going to ask our executive lead for our GEO-MVA program, John Sharkey to address that. John?

John Sharkey, Vice President, Business Development

In terms of our manufacturing, as previously mentioned, our focus is to produce on the CEF platform, Chicken Embryo Fibroblast. This is the quickest route to registration, which EMA has recognized. We collaborate with CDMOs for all our programs, and currently, we are partnered with Oxford Biomedica in the U.K. As David noted during the presentation, we are in the process of packaging our clinical supplies and are actively discussing with OXB how we can increase supply from their facility, as well as exploring other potential manufacturers to enhance our supply as we advance toward commercialization.

Operator, Operator

And our next question will come from John Vandermosten with Zacks.

John Vandermosten, Analyst

So you guys are working with CEPI, Africa CDC, WHO and others. What regions of the world are looking most supportive for your vaccine programs? And then what are their pathogens of greatest concern?

David Dodd, CEO

I believe it’s clear that from the GEO-MVA perspective, the focus is primarily on the Southern Hemisphere, where we are observing endemic outbreaks. Additionally, we are increasingly receiving reports of Mpox and its new strain appearing not only in the U.S. but also across Europe, although the primary concentration remains in the Southern Hemisphere. There is substantial interest from relevant parties in this situation. WHO leaders continue to emphasize that this issue is persistent and evolving, indicating a constant need for our supply contributions along with the eventual transition to our AGE1 suspension cell line and continuous manufacturing process. Therefore, while the main concentration is evident, the broader context is that it’s not limited to stockpile needs; it will also encompass a more timely response to endemic requirements. Regarding our CM04S1, the most pressing need exists among populations with compromised immune systems who are unable to respond effectively to antibody stimulation. The pandemic is ongoing for these individuals, including over 40 million adults in the U.S. and an estimated 400 million worldwide with various medical conditions such as blood cancers, kidney disease, diabetes, multiple sclerosis, and lupus. Their primary risk stems not from their underlying conditions but from infections. This has generated significant interest from healthcare professionals caring for such patients. They are eager to learn how our vaccine could help and how we can expedite its availability. As a pre-revenue company, our ability to advance is closely tied to our balance sheet; a stronger balance sheet allows us to progress more quickly. We are also looking forward to the Phase II trial with Gedeptin. As we implement this trial, we will evaluate Gedeptin alongside pembro in first-line therapy, paralleling the KEYNOTE-689 trial. There is considerable interest surrounding this, especially from parties involved with solid tumor cancers. Currently, we are receiving many inquiries and interest, largely driven by the urgent situation surrounding GEO-MVA. We have devoted significant time to addressing these issues and exploring opportunities with Gedeptin.

John Vandermosten, Analyst

Okay. My next question is about Gedeptin and its use in combination with pembro. Do you think that by the time it is approved, a biosimilar version will be available? And do you think that will aid in its adoption?

David Dodd, CEO

I really don't know because we may continue to develop Gedeptin alongside various immune checkpoint inhibitors. There are other companies with checkpoint inhibitors that are interested in our work. Although we lack the resources for extensive testing across all immune checkpoint inhibitors, there is potential interest that could lead to collaborative development opportunities. We've had some conversations, but it would be inaccurate for me to imply that we are currently in active discussions that will soon extend to other ICIs. We have received expressed interest and have had a few discussions, and we are certainly open to more dialogue and would encourage such conversations. We'll just see how those discussions progress.

Operator, Operator

This concludes our question-and-answer session. I would like to turn the conference back over to David Dodd for any closing remarks.

David Dodd, CEO

Thank you all for joining today's update. We genuinely appreciate your interest and look forward to continuing our interactions. I want to express my gratitude to the GeoVax Board of Directors, our staff, and everyone else who contributes to our success. We are dedicated to offering valuable career development opportunities for highly skilled individuals who aim to change the current landscape of cancer therapies and infectious disease vaccines. We welcome ongoing inquiries about opportunities at GeoVax. Since we are a small company, we receive more inquiries than we can accommodate, but we appreciate your interest. We take great pride in our team and the external partners who help drive our progress and success at GeoVax. It is a pleasure for all of us to serve our shareholders and to be part of this team. Our main objective is to enhance lives globally by developing and commercializing urgently needed cancer therapies and infectious disease vaccines. With that, I wish everyone a safe and enjoyable day. Thank you for your time and attention.

Operator, Operator

This concludes today's program. Thank you for participating. You may now disconnect.