GeoVax Labs, Inc. (GOVX) Q1 2025 Earnings Report, Transcript and Summary

Good afternoon. And welcome everyone to the GeoVax First Quarter 2025 Corporate Update Call. My name is Michelle and I will facilitate today’s call. With me are David Dodd, Chairman and CEO; Mark Reynolds, 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. At this time, I’ll turn the call over to Max Gadicke of Precision AQ.

Thank you. 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. Actual results may differ materially from those included in these statements due to a variety of factors, including weather. GeoVax can develop and manufacture its product candidates with 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 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’ 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.

Thank you. Welcome to the first quarter 2025 GeoVax Corporate Update Call. 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-CM04S1, GEO-MVA, Gedeptin and the advanced MVA manufacturing process. Each of our product development candidates addresses 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 [indiscernible] advantage in production of MVA-based vaccines and therapies. We also wish to welcome Dr. Senthil Ranganathan to GeoVax as our Vice President Technical Development and CMC Operations, joining our team to guide our transition to the next phase towards registration and commercialization of our exciting portfolio. Before going any further, let me first address the recent Project NextGen Stop Work Order. Following the close of first quarter on April 11, we unexpectedly received a Stop Work Order notice relative to the BARDA Project NextGen program. The notice indicated that BARDA has decided to terminate the contract for convenience to the government pursuant to the terms of the project agreement. We can only assume this relates to the ongoing government efficiency efforts. We had no prior indication that the notice was forthcoming and we're surprised by the notice as both the GeoVax internal team our external contractors and consultants were making good progress and had a very good productive working relationship with the technical team at BARDA. The termination in no way implies any concerns as to the safety or potential efficacy of GEO-CM04S1 or the underlying MVA vaccine vector technology nor will the termination impact the ongoing Phase 2 clinical trials of CM04S1, primarily investigating our vaccine in immunocompromised patient populations. The funding from BARDA pursuant to the project agreement was mostly earmarked for incremental spending with a large portion going directly to the external clinical research organization to conduct a clinical trial. Given the structure of the award, the financial impact to GeoVax is estimated at less than $750,000 annually toward reimbursement of existing personnel overhead costs. As a result, we don't anticipate any significant changes to our ongoing operations. The decision by BARDA to terminate our contract is very disappointing to GeoVax and our stakeholders. However, we remain committed to CM04S1 as a critically needed next-generation multi-antigen COVID-19 vaccine, providing the potential for 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. During the Q&A session, we welcome the opportunity to address any further questions that you may have. Our current CM04S1 studies will continue, especially our focus on achieving the completion of the investigator-initiated Phase II trial among chronic lymphocytic leukemia patients, one of the highest risk groups in the need of reducing the risk of severe infection, hospitalization and risk of death coming from COVID-19. Demonstrating the potential superior value of CM04S1 among immunocompromised patients remains our focus for the development and differentiation from the first-generation and other single antigen-focused COVID-19 vaccines. The medical need for a COVID-19 vaccine such as CM04S1 is substantial, given that we estimate over 40 million adults in the United States have medical conditions rendering their immune systems inadequately responsive to the first-generation and other single antigen vaccine. Worldwide, we estimate over $400 million at such risk. In addition, we believe that CM04S1 provides the potential for a better booster for the first-generation single antigen vaccines. During 2025, we anticipate multiple presentations of clinical results for CM04S1, including the World Vaccine Congress presentation last week. In addition, presentations are scheduled for the European Hematology Association, the International Workshop on Chronic Lymphocytic Leukemia, the American Association of Immunologists, the Keystone Vaccinology and additional conferences underscoring the important potential medical value of this unique next-generation COVID-19 vaccine. These presentations will undoubtedly also serve as important catalyst for ongoing strategic partnership discussions. Relative to GEO-MVA, our vaccine candidate against mpox and smallpox, we recently completed cGMP production and quality release of the clinical batch of vaccine material. We anticipate having vaccine available for clinical evaluation later this year. We're pleased to state that we have produced sufficient amount of product to support the anticipated clinical evaluation as well as additional product in support of additional clinical use in conjunction with various stakeholder discussions that we have 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. Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. Relative to our plans for a Phase II Gedeptin trial in head and neck cancer, the clinical operations plans are underway as we complete the necessary regulatory aspects of product manufacturing in support of the trial. Just this week, Dr. Marc Pipas presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the Phase II study. In addition to the upcoming Phase II trial, we also plan additional studies of Gedeptin addressing other solid tumors beyond head and neck cancer. We believe that Gedeptin has the potential to address multiple solid tumors, especially via combination therapy, providing significant value long term. 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 establishing business partnerships and collaborations in support of the worldwide development, commercialization and distribution of our portfolio of products. Our priorities and anticipated milestones for 2025 remain focused on: one, first, advancing GEO-CM04S1 for immune compromised populations. Secondly, advancing GEO-MVA to clinical evaluation. I'll note the significant governmental interest exists relative to the U.S.-based supply chain versus the current overdependence on non-U.S. suppliers. The strong sentiment in favor of such onshoring initiatives remains a major national legislative focus of interest. We remain in active discussions and briefings with various stakeholders such as the White House, Congressional Representatives, HHS, BARDA, WHO, the Africa CDC, and others regarding our having produced a cGMP clinical batch of GEO-MVA vaccine planned for use in the upcoming clinical study as well as other potential uses. In fact WHO and other stakeholders have underscored the critical need for expanded Mpox vaccine supply as a priority for WHO and other public health agencies worldwide. Lastly, 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 continue to progress towards the implementation of our Phase II study to evaluate Gedeptin in combination with immune checkpoint inhibitor among patients with locally recurrent head and neck squamous cell carcinomas following primary therapy and for whom resection with curative intent is planned. Our clinical operations plans for this trial as I mentioned are coming together nicely along with the regulatory aspects and necessary product manufacturing in support of the Phase II study. As I previously noted this week Dr. Pipas has provided an overview of Gedeptin at the American Association of Cancer Research. In addition we're planning various animal validation studies further building a compelling basis of the potential value of Gedeptin addressing various solid tumors. Overall, 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's Chief Financial Officer for a review of our recent results and financial status. Mark?

Thank you, David. The details of our first quarter 2025 financial results are summarized in today's press release. I'll start my review with our income statement. Revenues associated with the BARDA contract were $1.6 million in 2025 versus zero in 2024 as the contract began during June of last year. As David mentioned, we received a Stop Work Order from BARDA in April with the expectation that the contract is to be terminated. So, there will be a final settlement amount billed to BARDA during Q2 of this year and then nothing more going forward. But as a reminder, this is a cost reimbursement contract with the vast majority of the contract earmarked for new incremental spending. So the, net financial impact to GeoVax is expected to be less than $750,000 annually for our billable personnel time and overhead. Research and development expenses were $5.4 million in 2025 versus $4.4 million in 2024, representing an increase of roughly $1 million or 21%. The increase during 2025 is primarily related to costs associated with the BARDA contract as well as our Gedeptin and GEO-MVA programs. These costs were partially offset by lower costs related to the CM04S1 clinical trial. General and administrative expenses were $1.7 million in 2025 versus $1.5 million in 2024, representing an increase of $200,000 or 16% associated with higher Investor Relations and consulting costs and stock-based compensation expense. Interest income was $47,000 in 2025 compared with $33,000 in 2024. So overall net loss for the first quarter of 2025 was approximately $5.4 million or $0.45 per share versus $5.9 million in 2024 or $2.47 per share. Turning now to the balance sheet; our cash balances at March 31st were $7.4 million as compared to $5.5 million at December 31st, reflective of $6 million used in operating activities, offset by $7.9 million in financing transactions. Our outstanding common shares currently stand at 15.2 million following recent financing activity. Including the ongoing GEO-CM04S1 clinical trials continues to be a top priority for us in terms of our operational focus. These trials were unaffected by the BARDA Stop Work Order. We also expect to accelerate our plans for clinical trials associated with the GEO-MVA and Gedeptin programs. Supporting these clinical programs will be the most significant use of our cash in the foreseeable future. We continue to explore various strategies to fund our development programs through several valuation inflection points and to extend our cash runway. These could come in the form of strategic partnerships, non-dilutive funding and additional offerings of our common stock. I'll be happy to answer any questions during the Q&A. And now I'll turn the call back over to David.

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.

Thank you. We will now begin the question-and-answer. [Operator Instructions] And our first question comes from James Molloy with Alliance Global Partners. Your line is open.

Hi, guys. Thank you very much for taking my question. I wanted to try to address I'm sure you saw that Vaxart recently got their hold lifted. I was wondering if you could talk a little bit about that any compare and contrast potentially between their program and your program. Is that a hopeful sign for potentially a change in the thinking of the administration with the Stop Work Order?

Hey Jim, thank you. This is Dave and I'll be happy to address that. There are some distinct differences between their program and ours program. First of all Vaxart had already dosed 400 patients [indiscernible] out of the 10,000. That was what was halted in February. They received notice I believe it was February 21. And so the situation they had was you had a group of patients out there already dosed. This was also true with another company which is a private company that had just started their clinical trial. There are actually two such holds issued -- Stop Work Orders in February. One we know much more about because it's a public company. That's Vaxart. So the challenge that they had and that the government had is you've got -- who have been dosed and you can't just leave them out there necessarily without doing something. And so they took the time they evaluated it. You may recall that Stop Work Order indicated there would be a 90-day pause in which the government would review the situation and get back by the end of the 90 days. That would have been around the 20th or thereabouts of May. As it was the termination was made to then reinstitute and start that program over. So I just want to underscore that in the case of two of the companies of the six vaccines that were in Project NextGen two of them were already dosing patients and both of them received a Stop Work Order. At least one of them that we know about because they made the public disclosure has -- it has been lifted and they'll then go forward. I'll also point out that of the six vaccines that had been given the Project NextGen awards of those -- you've had Vaxart the other, private company CastleVax is a private company. It remains on a Stop Work Order as we do. And also you had Gritstone which ended up filing bankruptcy so it's no longer in the program. The only one in which there's little information that we've been able and others have been able to find is Codagenix which is again, a private company. So it's hard to find out what I don't -- I would not try to guide anyone on what to read into this. We posted our statement on our website. I commented some today. We believe some element of government efficiency because there were no negative reasons that we could determine or that were conveyed to us of why the Stop Work Order occurred. Of course we have seen the announcement of $500 million going from BARDA now for a work towards a universal influenza vaccine and a universal coronavirus vaccine. We don't know if some of that money came from what was in our award or what. I would point out that in September of 2023 Vaccine Insight was a very well-received publication from our R&D team of a universal coronavirus vaccine and certainly, we have been positioning that. And more recently, there was a publication in vaccines, peer-reviewed journal of a multi-antigen a couple of additional constructs we have that are multi-antigens that could be candidates for universal pan-coronavirus vaccine. So I would just leave it at that, but I can't really guide you on what to read into this. We made our announcement. All we know is what has been communicated to us, and we're focused on running the company and not trying to read too much into events that may happen. I hope that helped answer your question. If you have any follow-up, just go ahead and ask that.

No, absolutely, of course. Let's see what happens. Maybe just one quick comment as well on the recent comments by the head of HHS about placebo-controlled vaccine trials. Does that impact your thoughts for your trials going forward? Any change to design or see if that even comes to pass?

Well, we have three Phase 2 trials underway. One has been completed, which is the healthy volunteers, where we're evaluating two different doses of our vaccine among healthy adults who had previously been vaccinated with mRNA vaccine. Those results, the readout, we believe will be around the middle or thereabouts of June. That's what the statistician is telling us because they told us other dates previously but they're crunching it out, and we're getting there. So we hope to be making an announcement within -- before the end of next month. So that would be there. We have the CLL trial, which we announced very promising, encouraging results in November. That was the randomized comparison of our vaccine to the Pfizer vaccine among CLL patients. You may recall that the -- at the interim review, the Pfizer arm did not meet its endpoint, and it was subsequently halted on the recommendation of the Data Safety Monitoring Board. The study continues. It's an investigator-initiated study. It continues towards completion. I think there remains about approximately 24 more patients to complete that trial. We're hoping they will be completed yet this year. Again, we don't -- it's not our sponsored study, so we have less control and influence over it, but we work as closely as we can with the investigator. That's one that we believe demonstrates very nicely and encouragingly that our vaccine is apparently doing something which we would like to see that is doing, providing value to patients with compromised immune systems where we're not seeing that being validated in various studies, but certainly in this study. And then we have the hematologic cancer patients, who are being prepped for stem cell transplantation or CAR-T therapy, and that study continues to enroll patients and the preliminary data that have been coming out, including what was presented last week at the World Vaccine Congress continue to be very encouraging on that. That's also a randomized comparison and that -- this case between our vaccine and the mRNA vaccine. So the patients in the other -- in the non- GeoVax arm are either receiving Pfizer or Moderna. So we're looking and monitoring the statements. And certainly, we saw the recent statement that the Secretary of HHS came out indicating his preference for multi-antigen vaccines versus single-antigen vaccines related to use within certain infectious disease categories. We obviously believe very strongly that there is an enhanced value by a multi-antigen vaccine. I'll also point out that we do have an active BARDA proposal for moving forward with our advanced NDA-based manufacturing process. That was deemed worthy. We received notice that was deemed worthy of funding by BARDA. But right now, they've made no awards because of funding or funding levels and considerations that are all that are going on. But they have indicated in some instances, proposals that were not acceptable. Ours has been placed into a two-year basket for funding as the money becomes available, and we're quite encouraged and excited about that also. So we remain with our MVA vaccine CM04S1 as well as our overall MVA advanced MVA manufacturing process and our dealings with the government. We remain optimistic and very positive in that regard.

Well, thank you, certainly a lot of moving parts. I appreciate your input.

Thank you. [Operator Instructions] Our next question comes from Robert LeBoyer with Noble Capital Markets. Your line is open. Q – Robert LeBoyer: Good afternoon. And based on the upcoming results in the healthy volunteers trial, what are you thinking in terms of the next steps for a trial in terms of size, funding and just length of trial? Any thoughts or guidance that you can share with us?

Sure. Our focus is not primarily on otherwise healthy individuals. It's always been focused on the immunocompromised populations, for the simple reason, that these are individuals who do not respond to antibody stimulation, which is the basis or the target for the single antigen vaccines those that are authorized as well as others in development. And we believe that this provides us in the case of United States, a 40-plus million population that currently remain in a pandemic state, because they don't respond to the current vaccines either the mRNAs or the protein adjuvant from Novavax. So, we continue to feel very strongly that this is an ideal point of differentiation for us fulfilling an unmet medical need, and making a real difference. And so our goal has never been to go further with towards registration in a healthy volunteer population. One it require a much larger type of clinical trial, as you're hearing in discussions with the current vaccines Novavax is a prime example of going after that population. So it's looking for taking market share away from Pfizer and Moderna. We've always looked at it, as we would be creating a new submarket, because it's currently not being addressed. So we would have the opportunity for a leadership position in there. We believe that by this trial, it would give us some good indication of data that would be reflective of how our vaccine operates within an otherwise healthy population. And that was also our focus for Project NextGen. We were not looking to go forward after doing 10,000 patients 5,000 each arm and doing a much larger study in otherwise healthy volunteers. It would have generated for us a very strong database, of how our vaccine works in otherwise healthy individuals which would then be the basis for comparison of how our vaccine works in otherwise healthy patients versus immunocompromised population be it CLL patients be it people with renal disease, whatever the target audience was. So, that's how we're looking for. Our focus going forward is going to be a couplefold. One is going to be to look at the results that come out of the current investigator initiated trial for CLL patients. If the results of that trial are -- continue to be encouraging, then we'll look at doing an expanded trial that will be a company-sponsored trial that would feed into a dossier that would be developed for registration. We would also utilize that as an initial entry point of discussion for expedited review with regulatory authorities because there is nothing else for these patients from a vaccine standpoint. So that's our general approach of developing CM04S1 is around immunocompromised, looking and fulfilling the opportunities where patients otherwise, do not have a vaccine that help prevent. And remember that our vaccine has shown much more robustness, in terms of protection against variants. If you recall, we've demonstrated protective immunity from the original Wuhan strain through the Omicron XBB.1.5 without having to reconfigure. Now, that in and of itself is a major deficiency and that's part of the problem that Novavax is dealing with is they're being asked to do a full clinical trial to show that an updated construct is worthy of signing off by the FDA. And what the FDA, and not the FDA what HHS is really looking for as they iterated in the announcement about the universal one, is something that works across multiple, I'll call it multiple generations of variants. And so far, the only vaccine we've seen that has consistently shown that has been GEO-CM04S1. So that's where our focus is and where we think we will have a major difference by taking the approach we have of a multi-antigen approach, targeting and applying it to populations for whom current existing vaccines, they all happen to be single antigen or simply inadequate. Q – Robert LeBoyer: Okay. Thank you very much.

Thank you. Appreciate your interest.

Thank you. Our next question comes from Jeffrey Kraws with Crystal Research Associates. Your line is open.

Thank you very much. David, several of my questions were answered, but two remaining questions. You haven't seen anything contrary to your balanced safety and efficacy with your Mpox vaccine that is you haven't seen any of the challenges in the complications that people are seeing with the myocarditis, encephalitis or other complications correct?

No, not at all. MVA was developed in the late 1960s early 1970s specifically to be utilized among people who have compromised immune systems, pregnant women and children. The fact that it does not replicate in humans or mammals, but humans means and it's been recognized for being exquisitely safe. And that's one thing you can count on with MVA. It's always been shown to be extremely safe. We've mentioned in the past that we received an exemption help [ph] from MVA -- to not have to do the animal toxicology studies because with MVA it's recognized for its safety by regulatory authorities worldwide. So one thing that most people recognize with MVA has always been its safety, because it was specifically developed for patients for whom the traditional Vaccinia was contraindicated. We would not have been able -- the world would not have been able to rid itself of smallpox otherwise. So we feel very strongly about that. The challenge with MVA and the hurdle has always been the complicated cumbersome manufacturing process because it's very slow, it's very cumbersome. And that's why typically products are stockpiled. But that's why we went forward 4.5-plus years ago towards this advanced MVA manufacturing process, which now we have in process development. But we have not seen those types of side effects in any of our MVA-based products.

Great. And that is helpful because the rumor mill out there of course runs wild with both those issues. So thank you for confirming what our beliefs were. The second question relates around the backbone of vaccine manufacturing. You indicated in the call here that, obviously, there's a move underway to move from having vaccines and all the constructs and vaccines manufactured outside this country as many of the bases are in China right now. Are you receiving support or indications of support in your conversations with the government for having a US-based manufacturing piece? I would think that would be something that they're involved in. I know you brought up BARDA and you said funding is all halted right now on that construct. But would you expect significant movement there given your proclivity for manufacturing here?

Well, everybody -- right now there's not a MVA manufacturer or contract CDMO manufacturer in the United States. So if you're doing MVA, you have to go -- and that's why we're working with Oxford Biomedica and the manufacturing for us right now is being done outside the US and France specifically. However, developing this new method and all in our relationship with Oxford Biomedica we would anticipate as we go forward with the advanced MVA manufacturing that that will be manufactured in the United States. And we do --- as I mentioned we submitted a proposal a little over a year ago when that RFP came out from Florida. They made no awards on it. But we recently were informed that our proposal was deemed appropriate for funding passed the mustard there. And it's been placed in a two-year, what they call it, basket, so that as funding may occur and come forward. And of course that will be competing with whatever alternative options people are looking at and this and that to utilize the funding from the government. We discussed this with legislators, with Congressmen, with the representatives, our senators. We've discussed it with other representatives on would have an interest in that. So we believe that what we will migrate towards will be U.S.-based manufacturing of our MVA-based vaccines. It can -- I have been asked by a couple of let's say, stakeholders, what would it take to go even faster? And the answer is very simple. Your balance sheet drives that. And I usually point out to them that I'm having to sit across, I happen to be sitting across from a person that could make a difference there. So those discussions so far no one has handed me a check, but so far -- handed us a check I should say. But so far those discussions continue. Week after next, I'll be briefing people in Washington D.C., legislators, their staffs, et cetera and decision-makers, influencers and all of that. So I'll be doing that both as part of a group as well as individually. So we continue to go forward with that, because our commitment is to establish U.S.-based manufacturing, even if it's using a CDMO and that's what we're working towards with our relationship with Oxford Biomedica.

Perfect. Thank you very much, David.

You're welcome. Thank you.

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.

All right. Thank you everyone. Really appreciate your interest. Let me just say that, as always, I'd like to acknowledge the ongoing support and thank our Board of Directors and our advisers and especially our staff, and the many others either consultants, contractors, but there are many other parties who continue to support us towards achieving the success we believe that we have underway here. We indeed remain committed to providing meaningful career development opportunities for what we consider highly competitive, quality-oriented individuals who want to be part of the disruption of the current paradigm of cancer therapies and infectious disease vaccines. And we're most proud and appreciative of our team, including those external partners, because they're dedicated to us, they're supportive of us. And they're part of our ongoing success. So for those of you who have taken the time to participate in this, we especially want to thank you, because you're not only are interested -- sometimes you may have been assigned to listen to this broadcast, but we know that you are sincere, you give us good counsel, good guidance. And we appreciate that. Just lastly, I would just underscore, that our overriding goal is to drive products through to the registration point to improve lives worldwide through these efforts and especially in these two areas. So with that, I look forward to keeping you updated, hopefully in between the next call, but also at the next call. So thank you, and have a wonderful day.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.