GeoVax Labs Inc (GOVX) 2025 Q2 法說會逐字稿

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. With me are David Dodd, Chairman and CEO; Mark Reynolds, Vice President, Chief Financial Officer; Mark Newman, PhD, Chief Scientific Officer; Kelly McKee, MD, MPH Chief Medical Officer; and John Sharkey, PhD Vice President, Business Development. (Operator Instructions)

As a reminder, this conference is being recorded. Please note the following: certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances.

Actual results may differ materially from those included in these statements due to a variety of factors, including whether GeoVax can develop and manufacture its product candidates with the desired characteristics in a timely manner and such products will be safe for human use.

GeoVax's vaccines will effectively prevent targeted infections in humans. GeoVax's product candidates will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises required capital to complete the development of its products.

There is development of competitive products that may be more effective or easier to use then 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 and 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 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 most encouraging news and that it provides the potential for GeoVax to achieve marketing authorization and revenue generation sooner, allowing us to bypass Phase 1 and Phase 2 clinical trials and proceed directly to a Phase 3 immuno-bridging 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 a potential additional use in conjunction with various stakeholder discussions that are underway.

We believe that GEO-MVA provides the potential to end the current monopoly of MVA vaccine supply, expanding the global supply of this critically needed vaccine, addressing both the needs resulting from epidemic outbreaks as well as the various stockpile opportunities worldwide.

I'll note the significant governmental interest exists relative to US-based supply chains versus the current overdependence on non-US 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 US 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 2 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 the severe disease, hospitalization and the risk of death.

In fact, during second quarter, 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 the 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 2 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 second quarter, Dr. Marc Pipas presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the Phase 2 study. Following the recent impressive results of the KEYNOTE-689 study presented at ASCO, we have modified the Gedeptin Phase 2 study protocol, changing the target population to first line therapy, mimicking 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 second half 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 immunocompromised 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?

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 expense was $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 expense was $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 stock common shares currently stand at $25.2 million, reflecting the recent financing activity.

Including our ongoing CMO4S1 clinical trials continues to be a top priority in terms of our operational focus. We've also accelerated 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 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.

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.

(Operator Instructions)

Jonathan Aschoff, Roth Capital Partners.

Thank you very much. Good afternoon, guys. 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 2H26 start?

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 were targeted to complete in the fourth quarter of this year.

Okay. And the 2H26 start time, that's largely because you have to make the vaccine product itself, correct? That's the major step.

The vaccine is largely manufactured, I'll -- let me ask John Sharkey and perhaps, Kelly, if he'd like to add on, just to update you on the status of that, but we have product already produced. John?

Yeah, hey, Jonathan, thanks for the question. Yes. So I mean, what we announced in June is EMA, we presented to them a proposal that if we based on MVA being highly similar to the Bavarian Nordic, if we were to do an immuno-bridging study could -- and appropriate [Adam] work could we bypass and they agreed. So we are now -- the statisticians are powering the study to what we would need to show noninferiority. We will prepare the clinical trials.

We then need to submit the dossier to Europe to get approval to the CTAs to get them running. So I wouldn't say it's just drug availability, it's all the parts together to get that trial started in the second half of 2026. As you all know, there's a lot of moving parts that need to come together before you can inject your first volunteer.

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?

Yeah, let me just --

Yeah, can you hear me now? Yeah, I'm sorry I hit the wrong mute button. Yeah, it was $10 million for the six-month period.

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?

The 10-Q was filed about 20 minutes ago.

Okay. Great. Then I must have a slow connection way up here in the middle of nowhere. Thank you very much, guys

Thank you, John.

Robert LeBoyer, Noble Capital Markets.

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 1 and Phase 2 and you would just do an immuno-bridging 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 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?

Sharkey, would you like to answer that?

Sure, I'll take it. Yeah, you're right. So what we have proposed to EMA, and we have agreement with is we will do an immuno-bridging trial in otherwise healthy volunteers, comparing the immune response, non-inferiority of the immune response to GEO-MVA to the MVA-BN.

The -- and we'll have supporting preclinical animal toxicology and other studies to support the equivalents. What we're not required to do is normally under the animal rules, one, demonstrate efficacy in an animal model, and we're not going to be required to do that.

If we show equivalent immune response, the EMA has indicated that, that would be sufficient for consideration of the MAA.

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

David, do you want me to take that?

Yes, please.

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 US?

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 immuno-bridging approach for approval in the US.

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 end points is going to be major pathological response. Can you elaborate on what those responses are and if there's a primary endpoint selected yet?

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

Yeah, so with the caveat that I'm not an oncologist, so I'm going to sort of stumble my way through this a little bit. But major pathologic response is defined -- has been defined for the 689 study and it has to do with the -- obviously, the extent of response in the resected tumor tissue that's obtained during the trial.

And for the standard of care and for the pembro alone, the major pathologic response was not very impressive. It was in the zero to 40% to 20%, 30% range. So we think we've got a pretty good shot at bettering that with Gedeptin as an add-on to pembro in the neoadjuvant space.

But our primary endpoint is going to be pathological, okay? We have a secondary endpoint that's going to be disease-free event-free survival after a year which we'll also be able to compare with the data from the 689 study. But that's kind of our overall plan.

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?

Yeah, so the way that the study was originally designed was to treat sort of patients that had already sort of failed a first-line therapy and had recurrent disease after treatment. So this -- we're sort of moving up in the evolution of the disease in an individual patient, such that these are patients that essentially are getting treated for lesions that appear primarily as a result of the tumor. So it's first-line therapy that they've not received other treatments, except for the standard of care, which is post resection.

Okay, great. And that just about does it for my questions. So thank you very much.

Thank you.

James Molloy, Alliance Global Partners.

Hey guys, thank you for taking my questions. On the Gedeptin, is the start date for that second half '26 as well or is that --

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

And what should we look for? I think the 36 is the -- looking like 36 patients before for the endpoint? And what's the sort of -- what's the thinking on the design of the trial at this point for size and duration and this sort of thing?

Kelly, do you want to take that?

Yeah. 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 it's going to enroll fairly quickly, especially for first-line therapy. 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.

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

Well, I mean overall survival is a long-term follow-up (technical difficulty) one aspect but we do have, so that's we will have one-year event-free survival as a secondary endpoint.

And then what's the expectations for potential interim looks? Trying to get an idea of how to thinking about these trial -- this one in MVA, MVA starting in second half of '26 as well, what's the expectation for sort of getting to either an interim or a final look on that trial, too?

Well, so start off with Gedeptin, it's a Simon two-stage design. So after the first stage, we'll have a statistical look to see where we are with that. So that's an interim look. And again, we are expecting this trial to enroll fairly quickly. So I can't give you a time estimate, but it should be a matter of a few months, we think.

For the GEO-MVA, we won't look at that until we won't have an interim look at that until all of the patients are enrolled in the non-inferiority study. However, we also are going to be required to provide a number of subjects to expand the safety database.

And so we'll be looking at the non-inferiority results in conjunction with enrolling -- starting the enrollment in the safety database portion of the trial. So again, depending on how quickly that enrolls, we'll have sort of an early look, if you will, before the entire study is completed.

Is there an expectation on '26 -- second half '26 start date potential, are we talking in 2029, 2030? I was just going to get an idea for what should be looking at as the outsider looking in here?

For the GEO-MVA study?

Yes, please.

Again, it all depends on the rapidity of enrollment. We -- because these are healthy volunteer subjects, we don't think it's going to take a long time to enroll. But there's so many variables out there that impact enrollment is really going to be hard to say.

We are including a couple of African sites that we have confidence are going to enroll very quickly, so that's going to help our case. But I'm hesitant to give you a projected time line for that.

All right. Thank you very much for taking the questions.

Thanks, Jim.

(Operator Instructions)

John Vandermosten, Zacks.

Great. Thank you, and good afternoon, everyone. 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?

I'll answer. So John, in 2024, BARDA announced through their RRPV program, a project next-gen clinical manufacturing program. We responded to that. That was in March of 2024. In the beginning of this year, we were notified that they hit -- between March and the beginning of 2025, there were no awards and basically no real response from BARDA.

But in January, they informed some companies, thanks, but no thanks, didn't qualify. And then for others, such as ourselves, we were informed that they liked our proposal, it qualified for funding, but it would be dependent on funding becoming available.

So that it would be placed and what they refer to as a basket, I'll call it a holding basket for two years, depending on funding availability. And that was intended to fund our AGE1 continuous cell line manufacturing process that we have underdeveloped. And our candidate product at that time was for the CM04S1, our COVID-19 vaccine. So that continues to be in the basket. And so it has been selected, but it's dependent on funding availability.

And that's not just true for us, but none of them have been funding. And as you know, the early part from January of this year until -- through April, we saw the activities that have eliminated most of the products that were in for the Phase 2b clinical trial, ours being included, which we announced in April and all.

So right now, the status of it is that we were awarded and selected for the manufacturing process to be funded. That's great news. The challenge is that they don't have the necessary funding at this stage. It's in this basket for a two-year process. So that would be two years from January of this year.

So we'll keep you appraised of it, but that's where it stands for us and everyone else that was in that program.

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?

We're planning to use pembro.

Okay. And then shifting once again back to the COVID vaccine. With all the changes from -- 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?

Yeah. Excellent question. We're asked that all the time. And 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, et cetera. It fits with us because it's clearly those who have compromised immune systems, from a variety of reasons.

So we remain most focused on those populations. As you know, we have two Phase 2 trials. One is the investigator initiated. And as I mentioned during 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, et cetera, 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 -- last fall, 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 CM04S1. And our goal is to see that completed and it's around -- I don't have the latest update, but it's around 20 to 22, something like that, around 20 patients remaining to complete that trial.

Our interest is seeing 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.

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

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. And 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.

Okay, great. Thank you, David.

Thank you. Thank you, John.

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. Good questions 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.

The conference is now concluded. Thank you for attending today's presentation. You may not disconnect.