GeoVax Labs, Inc. Q1 FY2025 Earnings Call

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. 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 significant advantage in the 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 and 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 about 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 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 catalysts 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 a 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 long-term value. 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 inhibitors 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 for 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.

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 start the question-and-answer session. 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?

Thank you, Jim. This is Dave, and I'm glad to address your question. There are significant differences between their program and ours. To start, Vaxart had already dosed 400 patients before their halt in February, with the notice coming on February 21. This meant they had a group of patients who were already dosed, which was also the case for another private company that had just begun its clinical trial. In February, two Stop Work Orders were issued. We know more about Vaxart since it is a public company. The challenge faced by them and the government involved managing individuals who had already been dosed, necessitating action. They took the time to evaluate the situation. You may remember that the Stop Work Order included a 90-day pause for the government to review the circumstances and provide feedback by around May 20. Ultimately, the decision was made to restart the program. I want to highlight that among the six vaccines in Project NextGen, two were already dosing patients when they received Stop Work Orders. At least one of those companies has had their order lifted and will continue. Notably, of the six vaccines awarded in Project NextGen, Vaxart and another private company, CastleVax, are still under Stop Work Orders, while Gritstone filed for bankruptcy and is no longer part of the program. The only company with limited available information is Codagenix, which is also private. So, I wouldn't want to speculate on what this means. We've posted our statement on our website, and I shared some thoughts today. We believe government efficiency may have led to the contract termination, as there were no negative reasons conveyed to us. We are aware of the $500 million allocation from BARDA for a universal influenza and coronavirus vaccine, though we are unsure if any funds originated from our award. In September 2023, our R&D team released a publication on a universal coronavirus vaccine which was well-received, and more recently, there was a peer-reviewed publication on a multi-antigen approach with additional constructs that might serve as candidates for a universal pan-coronavirus vaccine. I'm not in a position to guide you on what this means, but we made our announcement, and all we know is what has been communicated to us. We're focused on managing the company and not trying to interpret future events. I hope that answers your question, and feel free to ask any follow-ups.

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?

We currently have three Phase 2 trials in progress. One has been completed, involving healthy volunteers, where we assessed two doses of our vaccine among adults who previously received an mRNA vaccine. We expect to have results around mid-June as informed by our statistician. We anticipate making an announcement by the end of next month. The second trial involves CLL patients, for which we shared promising results in November. This trial compares our vaccine to the Pfizer vaccine, and during the interim review, the Pfizer group did not meet its endpoint, leading to its halt on the recommendation of the Data Safety Monitoring Board. Although it's an investigator-initiated study and we have less control, we are closely collaborating with the investigator and believe that approximately 24 more patients are needed to complete this trial by the end of the year. We are encouraged that our vaccine appears to be providing benefits for patients with compromised immune systems. The third trial involves hematologic cancer patients preparing for stem cell transplantation or CAR-T therapy, and it continues to enroll participants, with preliminary data showing positive results. This trial is also a randomized comparison between our vaccine and mRNA vaccines like Pfizer or Moderna. We have noted the recent comments from the Secretary of HHS, emphasizing a preference for multi-antigen vaccines over single-antigen ones for certain infectious diseases. We strongly believe in the enhanced value of multi-antigen vaccines. Furthermore, we have an active BARDA proposal regarding our advanced NDA-based manufacturing process, which has been recognized for potential funding. Although no awards have been made yet due to funding constraints, ours is in a two-year funding consideration as budget allows, and we're excited about that. Overall, we remain optimistic about our MVA vaccine CM04S1, our advanced MVA manufacturing process, and our collaboration with the government.

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

Thank you. Our next question comes from Robert LeBoyer with Noble Capital Markets. Your line is open.

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?

Our primary focus is on immunocompromised populations rather than otherwise healthy individuals. These individuals typically do not respond to antibody stimulation, which is the target for the vaccines currently authorized and in development. In the U.S. alone, there are over 40 million people who remain in a pandemic state because they do not respond to the existing mRNA vaccines or the protein adjuvant from Novavax. We see this as a significant point of differentiation for us, addressing an unmet medical need and making a real impact. Our goal has never been to pursue registration in a healthy volunteer population, as it would necessitate a much larger clinical trial, akin to what is being discussed with current vaccines. Novavax, for instance, is targeting that healthier demographic to capture market share from Pfizer and Moderna. However, we intend to create a new submarket that is currently unaddressed, providing us with a chance to lead in that area. We believe that conducting this trial will yield data reflecting how our vaccine functions in otherwise healthy populations. This was also our focus for Project NextGen. We were not interested in conducting a large study with 10,000 patients, as that would produce a strong database for comparison between immunocompromised patients and healthy individuals. Looking ahead, our focus will be twofold: first, we will assess the outcomes from the ongoing investigator-initiated trial for CLL patients. If results are promising, we will consider expanding the trial to include a company-sponsored study that could contribute to a registration dossier. This could also serve as a starting point for expedited discussions with regulatory authorities, as there are no vaccine options currently available for these patients. Our approach to developing CM04S1 is centered on immunocompromised individuals and addressing the gaps in vaccine availability for them. Notably, our vaccine has demonstrated more robust protection against variants, showing effectiveness from the initial Wuhan strain through the Omicron XBB.1.5 without needing reconfiguration. This represents a significant challenge that Novavax is facing, as they are required to conduct a full clinical trial to prove that their updated version meets FDA standards. The HHS is looking for solutions that are effective across various generations of variants, and so far, our GEO-CM04S1 is the only vaccine that has consistently demonstrated this capability. Thus, our focus remains on advancing a multi-antigen approach tailored for populations that are underserved by existing vaccines, which are largely single antigen or insufficient.

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 and early 1970s specifically for individuals with compromised immune systems, pregnant women, and children. Its inability to replicate in humans or mammals contributes to its recognized safety. You can always count on MVA being extremely safe. We have previously mentioned that we received an exemption from conducting animal toxicology studies due to MVA's recognized safety by regulatory authorities worldwide. Safety is one of the key attributes people acknowledge about MVA, as it was developed for patients who are contraindicated for the traditional Vaccinia. Without it, the world might not have been able to eradicate smallpox. We feel very strongly about this. However, the challenge with MVA has always been its complicated and cumbersome manufacturing process, which is slow and difficult. This is why products are typically stockpiled. Over four and a half years ago, we moved towards an advanced MVA manufacturing process, which is now in development. We have not observed any significant side effects from 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 to 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 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?

Currently, there are no MVA manufacturers or contract CDMO manufacturers based in the United States. Consequently, if you're producing MVA, the manufacturing must occur outside the U.S., specifically in France, which is why we are collaborating with Oxford Biomedica. As we advance our relationship with them and develop a new method, we expect future MVA manufacturing to take place in the United States. Over a year ago, we submitted a proposal for funding to Florida when the RFP was released, but no awards were given at that time. We have recently learned that our proposal was considered appropriate for funding and has passed the review process. It has been placed in a two-year funding timeline, which means it may become available as funding is released. Of course, it will compete with other options for government funding. We have engaged in discussions with legislators, Congress members, and senators about this initiative. We believe our goal is to transition towards U.S.-based manufacturing for our MVA-based vaccines. Some stakeholders have inquired about what it would take to accelerate this process, and the answer is straightforward: it relies on our financial position. These discussions are ongoing, and I plan to meet with decision-makers and their staff in Washington D.C. week after next. We are committed to establishing U.S.-based manufacturing, even if that involves partnering with a CDMO, which is our goal 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.

Thank you everyone for your interest. I want to acknowledge the ongoing support from our Board of Directors, advisers, staff, and all the consultants and contractors who help us achieve our success. We are committed to providing meaningful career development opportunities for competitive individuals who want to contribute to the advancement of cancer therapies and infectious disease vaccines. We are proud of our team and external partners who are dedicated to our mission. I want to express my gratitude to those participating today; your genuine interest and guidance are greatly appreciated. Our primary goal is to advance products toward registration to improve lives globally, particularly in these two areas. I look forward to updating you before our next call and at that call as well. Thank you, and have a wonderful day.

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