GeoVax Labs, Inc.

Good afternoon and welcome everyone to the GeoVax third quarter 2025 corporate update call. My name is Cherie 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, Ph.D., Vice President, Business Development. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. 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 products 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.

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 GeoMVA, GeoCMO4S1, Godeptin, and the game-changing MVA vaccine manufacturing process. Each of our product development candidates address critically important unmet healthcare 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 non-diluted 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 GeoMVA, our vaccine candidate against MPOCs 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 immunobridging 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 GOMVA, 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 GLMVA 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 interests exist relative to U.S.-based supply chains versus the current over-dependence on non-U.S. suppliers. The strong sentiment in favor of such on-shoring 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 GLMVA. 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. GEOCMO4S1, 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 CMO4S1 provides the 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 CMO4S1 studies are progressing, especially our focus on continued enrollment of severely immunocompromised patients with blood cancers who have received cell transplants and for its 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 CMO4S1 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 CMO4S1 remains substantial for those with medical conditions that render their immune systems inadequate in responding to the first generation vaccines. 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 CMO4S1. During third quarter, multiple presentations of clinical results for CMO4S1 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 CMO4S1 as the leading multi-antigen COVID-19 vaccine in clinical development. Relative to our plans for a Phase II gadepin 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. Mark Pipus presented at the AACR meeting in Chicago, reviewing the clinical results thus far in 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've modified the gadeptin phase two 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 gadeptin in PIMBRO 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 gadeptin has the potential to address multiple solid tumors, especially via combination therapy providing significant value long term. We also plan additional studies of gadeptin 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 gadeptin. Overall, our goal is 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-CMO4S1 for immune compromised populations, Advancing the progress of the advanced MVA manufacturing process and our focus on oncology, specifically related to gadeptin, is a major priority for the future of Geovax. We have high expectations for the potential broad utilization of gadeptin 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, GFX Chief Financial Officer, for a review of our recent results and financial status. Mark?

Thank you, David. 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 nine months ended September 30, 2025, we reported revenues of $2.5 million versus $3.1 million in 2024. This relates to the BARDA project and exchange 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 sufficiency 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 nine-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 CMO4S1 clinical trials and manufacturing costs associated with the CMO4S1 and GADEPTIN programs. These lower costs are partially offset by higher personnel and consulting costs and manufacturing costs associated with the GEO MVA development program and preparation for initiating clinical trials in 2026. General administrative expense was $1.3 million for the third quarter of 2025 versus $1.2 million in 2024. For the nine-month period, G&A expense was $4.6 million versus $3.8 million in 2024. The overall increase during 2025 is associated with higher personnel costs, investor relations consulting and other programmatic expenses, and stock-based compensation expense. The 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 31st of 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 CMO4S1, GEO, MVA, and Gidepton 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-diluted 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.

Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Drs. 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.

Thank you. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, press star 1-1 again. Due to time restraints, we ask that you please limit yourself to one question and one follow-up question. You may then return to the queue. Please stand by while we compile the Q&A roster. And our first question will come from the line of Jonathan Ashkoff with Roth Capital Partners. Your line is open.

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

This is David. Jonathan, thank you for your question. 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.

Okay. I think that's really all that I had. Yeah, Q will come out soon, yes? Yeah, the 10Q. Okay, thank you very much.

Yeah, the Q is live right now. Yeah, thank you. It came out at 4.

Thank you. One moment for our next question. And that will come from the line of Robert LaBoyer with Noble Capital Markets. Your line is open.

Good afternoon, and 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?

Sure, Robert. This is David. Thank you for your question and participation. 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 BioEurope. BioEurope is largely a partnering-oriented conference. 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 of value for our shareholders as well as the stakeholders who are out there.

Okay, great. That's helpful. Thank you very much. You're welcome.

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

Hello, this is Laura Suriel on for Jim Molloy. Thank you for taking our questions. So for GLMBA, 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?

So we announced not too long ago that we were doing an evaluation in conjunction with the technology out of out of access. And we believe it's very important. And in fact, critically important for certain regions of the world to look at non traditional delivery methods. And as you know, Vaxos 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 and in those delivery areas. And so we're evaluating it to see what the feasibility is relative to GOMVA. And as information cuts 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.

Just the manufacturing that you might have for this particular program, for GLMBA.

For GLMBA? I'm going to ask our executive lead for our GLMBA program, John Sharkey, to address that. John?

So in regards to our manufacturing, as we've explained before, our lead here is the manufacturer on the SET platform, Chicken Embryo Fiber Blast. 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. 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 when we move forward to commercialization.

All right. Sounds good. Thank you for taking the question. You're welcome.

Thank you. As a reminder, if you would like to ask a question, please press star 1-1. And our next question will come from the line of John Vandermosten with Zacks. Your line is open.

Thank you, and good afternoon. 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?

I think clearly, and thank you, John, that from the perspective of GeoMVA, it's obviously in the southern hemisphere where you see endemic outbreaks, but then we're also seeing increasingly reports of impacts in the new strain impacts 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 supply. AG1, 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, you know, CMO4S1, 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. It's more from an infection. That's where they're risking. 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 vaccines trial with gadeptin. And as we go forward with the implementation of that, evaluating gadeptin along with PEMBRO in first-line therapy, 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 to question on all of these at various meetings. I would say right now we have many more questions and interest because the sense of urgency related to GEO-MBA. We spent a lot of time addressing that as well as opportunities with GADAPTIN.

Okay. And my next question is on GADAPTIN actually and the use of, you know, you mentioned that you're going to have it in combination with PEMBRO. Do you think by the time this is approved there will be a biosimilar version of that available and do you think that will help adoption?

I would say I really don't know because we may very well continue to develop gadeptin 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 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 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.

Okay. Thanks, David.

You're welcome. Thank you.

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

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 GEOVAC's Board of Directors and Advisors, certainly our GEOVAC 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 continued inquiries about opportunities at GEOVACT. We're a small company, so we receive 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 GFX. 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.

this concludes today's program thank you for participating you may now disconnect