Earnings Call Transcript - GOVX Q2 2025

Operator, Operator

Good afternoon, and welcome, everyone, to the GeoVax Second Quarter 2025 Corporate Update Call. My name is Michelle, and I'll facilitate today's call. Joining 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. As a reminder, this conference is being recorded. Please note that certain statements in this presentation may be considered forward-looking statements under the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to change. Actual results may vary significantly due to various factors, including whether GeoVax can develop and manufacture its product candidates as intended and whether these products will be safe for human use. There is a possibility that GeoVax's vaccines will successfully prevent targeted infections in humans. Additionally, it's uncertain whether GeoVax's product candidates will obtain the necessary regulatory approvals to be licensed and marketed, or if GeoVax will secure the capital needed to advance its product development. The development of competitive products that may be more effective or user-friendly than GeoVax's offerings is also a consideration. Furthermore, GeoVax's ability to establish favorable manufacturing and distribution agreements may be influenced by factors outside of its control. GeoVax does not assume any obligation to update these forward-looking statements. Additional information about these factors can be found in GeoVax's filings with the Securities and Exchange Commission, including those outlined in the Risk Factors section of GeoVax's Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.

David Alan Dodd, CEO

Thank you. Welcome to the Second 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-MVA, GEO-CMO4S1, Gedeptin and the advanced MVA manufacturing process. Each of our product development candidates addresses 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. Today, I'll start with the recent exciting updates regarding GEO-MVA, our vaccine candidate against Mpox and smallpox. 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. This is encouraging news as 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. In addition, we continue to engage in dialogue with various stakeholders that may result in emergency use distribution of GEO-MVA prior to formal market authorization. Relative to GEO-MVA, 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 are pleased to note that in addition to product in support of our clinical evaluation, we plan to produce additional product in support of potential additional use in conjunction with various stakeholder discussions that are underway. We believe that GEO-MVA has 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. I'll note the significant governmental 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 initiative is a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders, such as the White House, Congressional Representatives, HHS, WHO, the Africa CDC and others regarding our progress relative to cGMP clinical inventory of GEO-MVA. Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. We remain committed to GEO-CMO4S1, our multi-antigen vaccine against COVID-19, especially 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 GEO-CMO4S1 provides potential for a more robust immune response against emerging variants, improved durability versus the first-generation single antigen COVID-19 vaccines 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 stem cell transplants and on completion of the investigator-initiated Phase II trial among chronic lymphocytic leukemia or CLL patients, one of the highest risk groups in need of reducing the risk of severe infection, hospitalization and the risk of death. Demonstrating the potential superior value of CMO4S1 among immunocompromised patients remains our focus for development of differentiation from the first generation and other single antigen-focused COVID-19 vaccines. The medical need for a COVID-19 vaccine, such as CMO4S1 remains substantial for those with medical conditions rendering their immune systems inadequately responsive to the first generation and other single antigen vaccines, placing them at a continued risk for severe disease, hospitalization and the risk of death. In fact, during the second quarter, at a second site located at the City of Hope facility in Orange County, California, the Lennar Foundation Cancer Center initiated CLL patient enrollment into this trial. We also believe that CMO4S1 provides the potential for a better booster to the first-generation single antigen vaccines. During the remainder of 2025, multiple presentations of clinical results for CMO4S1 will continue, including recent presentations at the World Vaccine Congress, The Keystone Symposia and The European Hematology Association. Upcoming presentations in the remainder of this year include the International Workshop on chronic lymphocytic leukemia, The World Vaccine Congress Europe, The European Society of Clinical Microbiology and Infectious Disease and additional conferences underscoring the important potential medical value of this unique next-generation COVID-19 vaccine. We also expect that these presentations will continue to provide important catalysts for strategic partnership discussions. Relative to our plans for a Phase II Gedeptin trial in head and neck cancer, the clinical operations plans, product manufacturing in support of the trial and the necessary regulatory aspects continue. During the second quarter, Dr. Marc Pipas presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the Phase II study. Following the recent 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 the KEYNOTE-689 trial as 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 of the head and neck who are being considered for surgical resection with curative intent. Our primary endpoint will be major pathological response. Relative to the initiation of this study, we anticipate that this protocol modification will still allow us to initiate the trial during the second half of 2026. 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. We are also 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 establishing business partnerships and collaborations in support of worldwide development, registration, commercialization and distribution. Our priorities and anticipated milestones for 2025 remain focused on advancing GEO-MVA to clinical evaluation readiness, advancing GEO-CMO4S1 for immune-compromised patients, advancing the progress of the advanced MVA manufacturing process and on our focus on oncology, specifically related to Gedeptin, this is a major priority for the future of GeoVax. We hold high expectations for the potential broad utilization of Gedeptin against various solid tumors, especially in combination with immune checkpoint inhibitors. 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 W. Reynolds, CFO

Thank you, David. The details of our second quarter 2025 financial results are summarized in today's press release. I'll start the review with our income statement. During the six months ended June 30, 2025, we reported revenues of $2.5 million versus $301,000 in 2024. This relates to the BARDA project NextGen contract that began during June 2024. As we previously discussed during our Q1 earnings call in April of this year, the contract was terminated as part of the government's efficiency program, or DOGE, so we won't report any further revenues from this contract beyond Q2. But as a reminder, this is a cost reimbursement contract, with the majority of the contract earmarked for incremental spending. So the net impact of termination on our overall cash flow projection is less than $750,000 annual. Research and development expenses were $10 million during the six-month period in 2025 versus $8.7 million in 2024, representing an increase of roughly $1.4 million or 16%. This increase during 2025 is primarily associated with costs for the BARDA contract as well as our Gedeptin and GEO-MVA programs. Costs were partially offset by lower costs related to the GEO-CMO4S1 clinical trials. General and administrative expenses were $3.2 million for 2025 versus $2.5 million in 2024, representing an increase of $686,000 or 27% associated primarily with higher investor relations consulting costs and stock-based compensation expense. Other income and expense was $96,000 in 2025 as compared to $31,000 in 2024, primarily reflecting lower interest income due to lower cash balances. So overall, net loss for the six-month period in 2025 was approximately $10.7 million or $0.79 per share versus $10.9 million in 2024 or $4.68 per share. Turning now to the balance sheet. Our cash balances at June 30, 2025, were $3.1 million as compared to $5.5 million at December 31, 2024, reflective of $10.3 million used in operating activities, offset by $7.9 million in financing transactions. I'll note also that subsequent to June 30, we concluded a follow-on public offering in July of almost $6 million in net proceeds that bolstered our cash balances. Our outstanding common shares currently stand at $25.2 million, reflecting the recent financing activity. Supporting these clinical programs will be the most significant use of our cash for the foreseeable future. We continue to explore various strategies to fund the development programs through several valuation inflection points and extend our cash runway. These could include 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 to David.

David Alan Dodd, CEO

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

Operator, Operator

Our first question comes from Jonathan Aschoff with ROTH Capital Partners.

Jonathan Matthew Aschoff, Analyst

I was wondering, regarding the new patch method to administer the MVA vaccine, is this what you now intend to use for the pivotal trial starting in the second half of '26? And the second part of that question is, is the making of enough vaccine product a limiting step that necessitates a 2H '26 start?

David Alan Dodd, CEO

Jonathan, thanks for your questions. We do not intend to use the patch for the clinical program. It's a valuation of the micro array patch that we believe could potentially be a very important manner of delivering the vaccine in certain parts of the world, specifically obviously in the African continent regions. But we plan to utilize the standard vaccine and delivery of it. And that's why the vialing should be completed or we are targeted to complete in the fourth quarter of this year.

Jonathan Matthew Aschoff, Analyst

Okay. And the 2H '26 start time, that's largely because you have to make the vaccine product itself, correct? That's the major step.

David Alan Dodd, CEO

The vaccine is mostly manufactured. I will ask John Sharkey and possibly Kelly if they would like to provide an update on the status of that, but we already have product produced. John?

John W. Sharkey, VP Business Development

Thank you for your question, Jonathan. In June, we announced to EMA a proposal based on MVA being highly similar to Bavarian Nordic. We suggested conducting an immunobridging study and received their agreement. Our statisticians are currently determining the necessary power for the study to demonstrate noninferiority. We will prepare the clinical trials and must then submit the dossier in Europe to obtain the necessary approvals for the CTAs to initiate the trials. It's not just about drug availability; all components must align to begin the trial in the second half of 2026. As you know, many factors need to come together before we can administer the first dose to a volunteer.

Jonathan Matthew Aschoff, Analyst

Certainly. Mark, did you say $10 million R&D for the quarter? Did I hear that correctly? Is Mark there or anybody that can take that?

Mark W. Reynolds, CFO

Yes, it was $10 million for the six-month period.

Jonathan Matthew Aschoff, Analyst

Six months. Okay. I definitely did not hear that correctly. Then I don't have a follow-up on that, that's in line. When will you file the Q, guys?

Mark W. Reynolds, CFO

The 10-Q was filed about 20 minutes ago.

Operator, Operator

Our next question comes from Robert LeBoyer with NOBLE Capital Markets.

Robert Michael LeBoyer, Analyst

Good afternoon, everybody. I had a question about the MVA trials. And in June when you announced that you would not need to do Phase I and Phase II and you would just do an immunobridging study. That was great news. And then you just recently made an announcement that mentioned a start in 2026, also great news. And my understanding, which was partially answered, was that this was going to be compared against a Bavarian Nordic on the immunotherapy. And this was not an immune response under the animal rule or anything like that. So it's going to be against the standard vaccine. Is that correct?

David Alan Dodd, CEO

Sharkey, would you like to answer that?

John W. Sharkey, VP Business Development

Sure, I'll take that. You're correct. We have proposed to the EMA and reached an agreement to conduct an immunobridging trial with healthy volunteers, assessing the immune response and ensuring the non-inferiority of GEO-MVA compared to MVA-BN. We will also provide supporting preclinical animal toxicology and other studies to justify the equivalence. What's important is that we are not required, as is typically mandated under animal rules, to demonstrate efficacy in an animal model. If we can show an equivalent immune response, the EMA has indicated that this would be sufficient for the consideration of the MAA.

Robert Michael LeBoyer, Analyst

Great. And since you're running the trial in the second half of '26, is there any U.S. action that could be taken as a result of the data from this? Or is this strictly for Europe?

John W. Sharkey, VP Business Development

David, do you want me to take that?

David Alan Dodd, CEO

Yes, please.

John W. Sharkey, VP Business Development

Sure. So the data we have filed with the EMA, we will be running the trial in Europe and some African sites also to support discussions with the WHO. That data would be sufficient to have discussions with the FDA about approval. The other thing to always keep in mind, and BARDA has said more than once in the presentation that when times are needed, they don't necessarily need a vaccine to be approved depending on what's going on in the world at any time. So would they consider using a vaccine that was approved in Europe and not the U.S.? You'd have to ask them, but they've indicated that if there was a pressing need, they would. But in regards to FDA that once we have agreement on all the final components of the clinical trial and everything else with EMA, our plans would be to engage with FDA and see where they would be willing to go with us, whether they would accept an immunobridging approach for approval in the U.S.

Robert Michael LeBoyer, Analyst

Okay. Great. And also had a follow-up question on Gedeptin. And the press release mentioned after the KEYNOTE-689, you've made some changes and David mentioned some of those in the prepared remarks. One of the endpoints is going to be major pathological response. Can you elaborate on what those responses are and if there's a primary endpoint selected yet?

David Alan Dodd, CEO

Let me ask Kelly to give you an update on that trial and the plans for it. Kelly?

Kelly T. McKee, Chief Medical Officer

Yes, I'm not an oncologist, so I might not express this perfectly. Major pathological response has been defined for the 689 study, and it relates to the level of response in the resected tumor tissue collected during the trial. For the standard of care and pembrolizumab alone, the major pathological response was quite low, typically ranging from 0 to 40%, around 20% to 30%. We believe that adding Gedeptin to pembrolizumab in the neoadjuvant space will significantly improve that outcome. Our primary endpoint will focus on pathological results, and we will also have a secondary endpoint measuring disease-free event-free survival after a year, which we can compare with data from the 689 study. That's the general outline of our plan.

Robert Michael LeBoyer, Analyst

Okay. And could you just repeat the changes that you made to the protocol? There was a mention of moving to first-line patients, and I didn't catch the rest of that sentence?

Kelly T. McKee, Chief Medical Officer

The study was initially designed to treat patients who had already not responded to first-line therapy and experienced recurrent disease after treatment. We are now focusing on patients who are at an earlier stage of the disease, specifically those receiving treatment for tumors that have primarily emerged due to the disease itself. These patients are being treated with first-line therapy and have not undergone any prior treatments aside from the standard care following surgery.

Operator, Operator

Our next question comes from James Molloy with Alliance Global Partners.

James Francis Molloy, Analyst

On the Gedeptin, is the start date for that second half '26 as well or is that...

David Alan Dodd, CEO

That's correct. Yes, second half of 2026 is what we're targeting.

James Francis Molloy, Analyst

What should we be looking for? I believe we are aiming for 36 patients for the endpoint. What is the current thinking about the trial's design in terms of size, duration, and similar factors?

David Alan Dodd, CEO

Kelly, do you want to take that?

Kelly T. McKee, Chief Medical Officer

Yes. We're still sort of refining those estimates, but we think it's going to be in the same range, 36 to 40 patients that will allow us to sort of demonstrate statistically improved performance over the pembro alone in the neoadjuvant space. And we think that because, again, it's a pathologic endpoint, once these tumors are resected and examined, we'll have readouts. So we should have readouts from this trial fairly quickly after it begins enrolling.

James Francis Molloy, Analyst

All right, great. And how come not overall survival on the endpoint?

Kelly T. McKee, Chief Medical Officer

Overall survival is a long-term follow-up. We will have 1-year event-free survival as a secondary endpoint.

James Francis Molloy, Analyst

What are the expectations for potential interim looks? I'm trying to understand how to approach the trials, specifically this one in MVA, which is set to begin in the second half of '26. What are the expectations for reaching either an interim or a final look on that trial as well?

Kelly T. McKee, Chief Medical Officer

To start with Gedeptin, it's a Simon 2-stage design. After the first stage, we'll conduct a statistical assessment to determine our status, which will serve as an interim evaluation. We anticipate that this trial will enroll fairly quickly, so while I can't provide a specific timeline, we expect it to take a few months. For the GEO-MVA, we won't have an interim analysis until all patients are enrolled in the non-inferiority study. Additionally, we will need to include more subjects to expand the safety database. Therefore, we will evaluate the non-inferiority results alongside the initiation of enrollment for the safety database portion of the trial. Depending on the speed of that enrollment, we may have an early look before the entire study is completed.

James Francis Molloy, Analyst

Is there an expectation for a potential start date in the second half of 2026? Are we talking about 2029 or 2030? I would like to get an idea of what to expect from an outsider's perspective.

Kelly T. McKee, Chief Medical Officer

For the GEO-MVA study?

James Francis Molloy, Analyst

Yes, please.

Kelly T. McKee, Chief Medical Officer

It all depends on how quickly we can enroll participants. Since we are working with healthy volunteer subjects, we believe the enrollment process won't take too long. However, there are many factors that could affect enrollment, making it difficult to provide a clear timeline. We are planning to include a couple of sites in Africa that we are confident will enroll quickly, which should benefit our situation. Still, I am cautious about giving a specific timeline for this.

Operator, Operator

Our next question comes from John Vandermosten with Zacks. Again, it all depends on the speed of enrollment. Since these are healthy volunteer subjects, we don't anticipate a long enrollment period. However, numerous factors can affect enrollment, making it difficult to provide a concrete timeline. We are incorporating a few African sites that we believe will enroll quickly, which should be beneficial. Nevertheless, I am reluctant to provide a projected timeline for that.

John D. Vandermosten, Analyst

You guys have the COVID vaccine program with BARDA, which was set aside. But recently, you mentioned that there was a manufacturing proposal that's under active review with BARDA, what does this mean for your work with them?

David Alan Dodd, CEO

I'll answer. So John, in 2024, BARDA announced a next-gen clinical manufacturing program through their RRPV program, and we responded to that in March 2024. At the beginning of this year, we were informed that between March and early 2025, there were no awards and minimal response from BARDA. In January, some companies were told they didn't qualify, while for us, we learned that our proposal was liked and qualified for funding, but it would rely on funding availability. Thus, it was placed in a holding basket for two years, contingent on funding. This was meant to support our AGE1 continuous cell line manufacturing process under development and our candidate product at that time was for our COVID-19 vaccine, CMO4S1. That remains in the basket, selected but dependent on funding availability. This situation applies to us and others who did not receive funding. From January until April, many products in the Phase IIb clinical trial, including ours, were eliminated. Currently, we have been selected for the manufacturing process to receive funding, which is positive news. The challenge is they do not have the necessary funding at this time. It's in this two-year basket, counting from January of this year. We will keep you updated, but that's the status for us and everyone else in that program.

John D. Vandermosten, Analyst

Okay. And then looking at the Gedeptin trial, you cited the recent study with KEYTRUDA and then successful in head and neck. And I wasn't quite sure if you had selected a checkpoint inhibitor to be in combination with. Is it going to be pembro? Or are you guys still considering which checkpoint inhibitor to combine with?

David Alan Dodd, CEO

We're planning to use pembro.

John D. Vandermosten, Analyst

Okay. And then shifting once again back to the COVID vaccine. With all the changes in guidance for who and how to use the vaccine, how has that changed your efforts with your clinical trials and perhaps endpoints and design and things like that and how you interact with the agencies going forward with your COVID program?

David Alan Dodd, CEO

Yes. Excellent question. We're asked that all the time. Our belief and our answer is that we actually think that what is coming out of HHS and what's being communicated relative to the targeted audiences for whom COVID-19 vaccines might be most appropriate fits with us because it's clearly those who have compromised immune systems for a variety of reasons. So we remain most focused on those populations. As you know, we have two Phase II trials. One is the investigator-initiated. And as I mentioned during the second quarter, the investigator-initiated trial the CLL trial opened another site there in the Orange County, Lennar Cancer Institute part of City of Hope. So we think that increasingly, what we are hearing coming out of HHS, FDA, etc., in terms of utilization of COVID-19 vaccines and where they're most needed fits ideally; we’re well aligned with what we're hearing. So we're continuing to focus on that, continuing to expand enrollment in our immunocompromised stem cell transplant patient population and adding more patients. Recall that we announced the interim results for the CLL trial where they halted the Pfizer arm and have just continued with only ours. So the remainder of that trial is only utilizing a CMO4S1. Our goal is to see that completed as soon as possible. And then we'll evaluate it and depending on the data, we may sit down with regulatory agencies to discuss an expedited path for specifically for CLL patients.

Kelly T. McKee, Chief Medical Officer

I might also add that our vaccine is a 2-antigen vaccine; it's a multi-antigen vaccine, which is different from those that are currently available on the market.

David Alan Dodd, CEO

Kelly makes an excellent point because we heard Secretary Kennedy in April acknowledge and discuss his preference or his belief that multi-antigen vaccines in particular areas of infectious disease needs are more appropriate than single antigen vaccines. And again, that aligns very well with us since we have a multi-antigen in this case, a dual-antigen approach. We believe that's what contributes to the performance of our vaccine, both in terms of breadth of protection, durability and also a utilization among immunocompromised populations.

Operator, Operator

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

David Alan Dodd, CEO

Thank you, everyone, for participating in today's update. Your interest is greatly appreciated, and we look forward to ongoing interactions. I want to acknowledge and thank the Board of Directors of GeoVax and our advisers, our GeoVax staff and the many other parties who continue to support us towards achieving success. We remain 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 are most proud and appreciative of our team, including those external contributors who continue to assist in the progress and success underway at GeoVax. For all of us, it is a great pleasure serving our shareholders and being a part of this team. Our overriding goal is to improve lives worldwide by our development and commercialization of novel critically needed cancer therapies and infectious disease vaccines. With that, I wish everyone to have a safe and enjoyable day. Thank you.

Operator, Operator

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