GeoVax Labs, Inc. (NASDAQ:GOVX) Q3 2025 Earnings Call Transcript

GeoVax Labs, Inc. (NASDAQ:GOVX) Q3 2025 Earnings Call Transcript November 13, 2025

GeoVax Labs, Inc. misses on earnings expectations. Reported EPS is $-0.31 EPS, expectations were $-0.24.

Operator: Good afternoon, and welcome, everyone, to the GeoVax Third Quarter 2025 Corporate Update Call. My name is Sherry, and I will facilitate today’s call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Vice President, Chief Financial Officer; Mark Newman, PhD, Chief Scientific Officer; Kelly McKee, MD, MPH, Chief Medical Officer; and John Sharkey, PhD, Vice President, Business Development. [Operator Instructions] As a reminder, this conference is being recorded. Please note the following: — certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances.

Actual results may differ materially from those included in these statements due to a variety of factors, including whether GeoVax can develop and manufacture its product candidates with the desired characteristics in a timely manner and such products will be safe for human use. GeoVax’s vaccines will effectively prevent targeted infections in humans. GeoVax’s product candidates will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises required capital to complete development of its products. There is a development of competitive products that may be more effective or easier to use than GeoVax’s products. GeoVax will be able to enter into favorable manufacturing and distribution agreements and other factors over which GeoVax has no control.

GeoVax assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in GeoVax’s filings with the Securities and Exchange Commission, including those set forth at Risk Factors in GeoVax’s Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. Please go ahead.

David Dodd: 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 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 nondilutive 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 immune-compromised 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 well exceedingly well with our development of CM04S1. During 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 outlook 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?

Mark Reynolds: 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, nondilutive 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: 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.

Q&A Session

Operator: [Operator Instructions] And our first question will come from the line of Jonathan Aschoff with ROTH Capital Partners.

Jonathan Aschoff: 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: 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: Okay. I think that’s really all that I had. The Q will come out soon, yes.

David Dodd: Yes.

Jonathan Aschoff: The 10-Q.

Mark Reynolds: Yes, the Q is [Technical Difficulty].

David Dodd: Yes, I think came out at 4.

Operator: One moment for our next question — and that will come from the line of Robert LeBoyer with NOBLE Capital Markets.

Robert LeBoyer: 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: 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, et cetera. 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: One moment for our next question. And that will come from the line of Jim Molloy with Alliance Global Partners.

Laura Suriel: 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: So we announced not too long ago that we were doing an evaluation in conjunction with the technology out of out of Vaxxas. And we believe it’s very important and in fact, critically important for certain regions of the world to look at nontraditional delivery methods. And as you know, Vaxxas is a leader in the area of microarray patches. There’s someone we’ve known for several years as well as other very good players in those delivery areas. And so we’re evaluating it to see what the feasibility is relative to GEO-MVA. And as information comes actively — in evaluation now, as information comes forward, we will make appropriate announcements of that. And so that’s what we’re doing within that realm of it. You asked a question, I think, about manufacturing. What was that? I didn’t quite get it, please.

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

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

John Sharkey: So in regards to our manufacturing, as we’ve explained before, our lead here is to manufacture on the CEF platform, Chicken Embryo Fibroblast. That is the fastest pathway to registration and EMA has understood this. Our partner is, as we do with all our programs, we use CDMOs. And so we’re partnered with Oxford Biomedica in the U.K. We are — as David mentioned in the presentation, we’re in the process of packaging our clinical supplies, and we are in active discussions with OXB to how we can expand the supply out of their facility as well in discussions with other potential manufacturers to add additional supply as we move — when we move forward to commercialization.

Operator: [Operator Instructions] And our next question will come from the line of John Vandermosten with Zacks.

John Vandermosten: 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: I think clearly — and John, that from the perspective of GEO-MVA, it’s obviously in the Southern Hemisphere, where you see endemic outbreaks. But then we’re also seeing increasingly reports of Mpox and the new strain Mpox becoming evident not only in the U.S. but throughout Europe. But certainly, the concentration is in the Southern Hemisphere. And there’s a significant interest from parties that relate to that. I mean we keep being encouraged and told by WHO leaders that this is not going away. It’s going to continue to evolve. It’s not going to get any better and that they really are in need of our supply contribution as well as the eventual shift to our AGE1, our suspension cell line, continuous manufacturing process for that.

So I think from that standpoint, that’s where that one is heavily concentrated, which sort of is intuitive. But it’s on a broader basis. It’s not just the stockpile needs, it will eventually also include the response in a more timely manner to endemic needs also. So we believe that. When it comes to our CM04S1, clearly, the most significant need are among those populations who have inadequate — they have medical conditions that have rendered their immune systems, basically inability to appropriately respond to antibody stimulation. And for these people, as I mentioned, the pandemic continues. I mean, these 40-plus million adults in the United States, the estimated 400 million worldwide who have various medical conditions, blood cancers, kidney disease, diabetes, multiple sclerosis, lupus, et cetera, it goes on and on.

These are individuals that their risk is not so much, for instance, to die of the blood cancer that they have or to be hospitalized from, it’s more from an infection. That’s where they’re risk. And so that’s where we see a broad interest for those parties that are caring for individuals who have such medical conditions. These medical practitioners, these medical health care groups, they are very interested in what our vaccine has the capability or potential to do and how can we move it faster. That’s what we’re always asked. And the answer is as a pre-revenue company, it’s all about the balance sheet. The stronger our balance sheet is, the faster we can move something forward. Obviously, we’re all looking forward to the Phase II trial with Gedeptin.

And as we go forward with the implementation of that, evaluating Gedeptin along with pembro in first-line therapy, you’re following mimicking the KEYNOTE-689 trial. So there’s a lot of interest in that related to any parties that are following solid tumor cancers. So we get a question on all of these at various meetings. I would say right now, we have many more questions and interest because of the sense of urgency related to GEO-MVA. We spent a lot of time addressing that as well as opportunities with Gedeptin.

John Vandermosten: Okay. And my next question is on Gedeptin actually and the use of — you mentioned that you’re going to have it in combination with pembro. Do you think by the time this is approved, there’ll be a biosimilar version of that available? And do you think that will help adoption?

David Dodd: I would say I really don’t know because we may very well continue to develop Gedeptin across various immune checkpoint inhibitors. We have other players who have checkpoint inhibitors are interested in what we’re doing. Obviously, we don’t have the resources to do a blanket testing across all immune checkpoint inhibitors, but we do have potential interest, and that may evolve into some collaborative development opportunities. We’ve had some discussions, but I would be — it would be incorrect for me to suggest that we’re actively in discussions that are going to, within a reasonable time period, expand it to other ICIs. We have interest that’s been expressed. We’ve had a few discussions, and we’re certainly open to that and would encourage such discussions. But we’ll just see how those discussions continue to evolve.

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: Well, thank you, everyone, for participating in today’s update. We really appreciate your interest, and we look forward to ongoing interactions. As always, I wish to acknowledge and thank the GeoVax Board of Directors and advisers — certainly, our GeoVax staff and the many other parties who contribute toward our success. We’re committed to providing meaningful career development opportunities for highly competitive, quality-oriented individuals seeking to disrupt the current paradigm of cancer therapies and infectious disease vaccines. We welcome any and continued inquiries about opportunities at GeoVax. We’re a small company, so we received many more inquiries than we have availability for, but we thank you for your interest.

We’re most proud and appreciative of our team, including those external partners who continue to contribute to the progress and success underway at GeoVax. For all of us, it’s a great pleasure serving our shareholders and being a part of this team. Our overriding goal is to improve lives worldwide through our development and commercialization of novel critically needed cancer therapies and infectious disease vaccines. And with that, I want to wish everyone a safe and enjoyable day. And again, thank you for your time and attention.

Operator: This concludes today’s program. Thank you for participating. You may now disconnect.