GeoVax Labs Q2 2025 Earnings Report

GeoVax Labs EPS Results

• Actual EPS: -$0.35
• Consensus EPS: -$0.41
• Beat/Miss: Beat by +$0.06
• One Year Ago EPS: N/A

GeoVax Labs Revenue Results

• Actual Revenue: $0.85 million
• Expected Revenue: $0.37 million
• Beat/Miss: Beat by +$483.00 thousand
• YoY Revenue Growth: N/A

GeoVax Labs Announcement Details

• Quarter: Q2 2025
• Date: 7/28/2025
• Time: After Market Closes
• Conference Call Date: Monday, July 28, 2025
• Conference Call Time: 4:30PM ET

GeoVax Labs (NASDAQ:GOVX), Inc., a clinical-stage biotechnology company, develops human vaccines and immunotherapies against infectious diseases and solid tumor cancers using modified vaccinia ankara virus-like particle vaccine platform. It is developing various preventive vaccines against (COVID-19), human immunodeficiency virus (HIV); Zika virus; malaria; and hemorrhagic fever viruses, such as Ebola, Sudan, Marburg, and Lassa, as well as therapeutic vaccines for HIV, chronic Hepatitis B infections, and solid tumor cancers. The company is developing GEO-CM04S1, a vaccine candidate that is in Phase 2 clinical trial for the treatment of preventive COVID-19; Gedeptin, a novel patented product/technology for the treatment of solid tumors, and Phase 1/2 clinical trial for the treatment of advanced head and neck squamous cell carcinoma; and GEO-CM02, a pan-coronavirus vaccine. In addition, it is developing GEO-ZM02, a vaccine candidate, which is in preclinical trial for the treatment of GEO-ZM02, a vaccine candidate, which is in preclinical trial for the treatment of Zika; GEO-MM02 treatment for malaria; other infectious disease vaccines for the treatment of fever viruses, such as Ebola, Sudan, and Marburg; GEO-LM01 for the treatment of Lassa fever. It has collaboration and partnership agreements with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health; U.S. Department of Defense; Emory University; and the Burnet Institute. GeoVax Labs, Inc. was incorporated in 1988 and is headquartered in Smyrna, Georgia.

GeoVax Labs Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Geovax received EMA guidance for an expedited path for its GEO-MVA smallpox/monkeypox vaccine, allowing it to skip Phases 1 & 2 and move directly into a Phase 3 immuno-bridging trial projected to start in H2 2026, with GMP clinical material already produced.
• Positive Sentiment: The GEO-CM04S1 multi-antigen COVID-19 vaccine program is advancing in Phase 2 studies focused on severely immunocompromised patients (including stem cell transplant and CLL cohorts), aiming to demonstrate a more robust and durable immune response versus first-generation vaccines.
• Positive Sentiment: Gideptin’s Phase 2 head and neck cancer trial protocol has been modified to a neoadjuvant, first-line setting in combination with pembrolizumab, using major pathological response as the primary endpoint and targeting initiation in H2 2026.
• Neutral Sentiment: In H1 2025, revenues rose to $2.5 million (driven by the BARDA cost-reimbursement contract) versus $0.3 million a year ago; net loss was $10.7 million and cash stood at $3.1 million as of 6/30/25, later bolstered by ~$6 million in a July follow-on offering.
• Neutral Sentiment: Geovax is actively exploring strategic partnerships, non-dilutive funding and additional equity offerings to extend its cash runway and support ongoing clinical and manufacturing programs.

Presentation

[Operator]

Good afternoon, and welcome, everyone, to the Geovac Second Quarter twenty twenty five 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 and Chief Financial Officer Mark Newman, Ph. D. Chief Scientific Officer Kelly McKee, MD Miles per hour Chief Medical Officer, and John Sharkey, PhD Vice President Business Development.

[Operator]

At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. Please note the following. Certain statements in this presentation may constitute forward looking statements within the meanings of the Private Securities Litigation Reform Act.

[Operator]

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 development of its products.

[Operator]

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's filings with the Securities and Exchange Commission, including those set forth at Risk Factors in Geovax's Form 10 ks. It is now my pleasure to introduce the Chairman and CEO of Geovax, David Dodd.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Thank you. Welcome to the second quarter twenty twenty five 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 CM04S1, Gideptin, 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.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

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 MPOXX 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 GLMVA. 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 one and Phase two clinical trials and proceed directly to a Phase three immuno bridging trial. In addition, we continue to engage in dialogue with various stakeholders that may result in emergency use distribution of GeoMVA prior to formal market authorization.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Relative to GeoMVA, 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 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 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 U.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

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.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. We remain committed to GOCM04S1, our multi antigen vaccine against COVID-nineteen, especially as a critically needed vaccine for use among the over forty million immunocompromised adults in The US, as well as the over four hundred million worldwide. Based on the clinical data results thus far, we believe that GLCMO4S1 provides potential for a more robust immune response against emerging variants, improved durability versus the first generation single antigen COVID-nineteen vaccines, and especially in addressing the immune protection among those patients with compromised immune systems. Our current CMOS4S1 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 two 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 CMOS4S1 among immunocompromised patients remains our focus for development of differentiation from the first generation and other single antigen focused COVID-nineteen vaccines.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

The medical need for a COVID-nineteen vaccine such as CMOS4S1 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 CML4S1 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 CML4S1 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-nineteen vaccine.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

We also expect that these presentations will continue to provide important catalysts for strategic partnership discussions. Relative to our plans for a Phase two Gadeptin trial in head and neck cancer, the clinical operations plans, product manufacturing support of the trial and the necessary regulatory aspects continue. During second quarter, Doctor. Mark Pipes 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-six eighty nine study presented at ASCO, we have modified the Gideptin Phase II study protocol, changing the target population to first line therapy mimicking KEYNOTE-six eighty nine trial as historical control.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

As such, our focus will be on evaluating neoadjuvant gadeptin 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 twenty twenty six. We believe that gadeptin has the potential to address multiple solid tumors, especially via combination therapy providing significant value long term. We also plan additional studies of Gideptin addressing other solid tumors beyond head and neck cancer.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

We're also engaging in various discussions related to potential collaborations in the long term development and commercialization of Gideptin. 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 CMOS4S1 for immune compromised patients, advancing the progress of the advanced MVA manufacturing process, and on our focus on oncology specifically related to the cadeptin. This is a major priority for the future of GIVACS.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

We hold high expectations for the potential broad utilization of Gideptin 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, GFX chief financial officer for a review of our recent results and financial status. Mark?

[Mark Reynolds, CFO at GeoVax Labs]

Thank you, David. The details of our second quarter twenty twenty five financial results are summarized in today's press release. I'll start the review with our income statement. During the six months ended 06/30/2025, we reported revenues of two and a half million versus 301,000 in 2024. This relates to the BARDA Project NextGen contract that began during June 2024.

[Mark Reynolds, CFO at GeoVax Labs]

As we previously discussed during our q one earnings call, in April, the contract was terminated as part of the government sufficiency 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 annually. Research and development expense was $10,000,000 during the six month period in 2025 versus $8,700,000 in 2024, representing an increase of roughly $1,400,000 or 16 percent. This increase during 2025 is primarily associated with costs for the BARDA contract as well as our gideptin and GEO MVA programs.

[Mark Reynolds, CFO at GeoVax Labs]

Costs were partially offset by lower costs related to the GEO CM04S1 clinical trials. General and administrative expense was $3,200,000 for 2025 versus $2,500,000 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 $10,700,000 or $0.79 per share versus $10,900,000 in 2024 or $4.68 per share. Turning now to the balance sheet.

[Mark Reynolds, CFO at GeoVax Labs]

Our cash balances at 06/30/2025, were $3,100,000 as compared to $5,500,000 at 12/31/2024, reflective of $10,300,000 used in operating activities, offset by $7,900,000 in financing transactions. I'll note also that subsequent to June 30, we concluded a follow on public offering in July of almost $6,000,000 in net proceeds that bolstered our cash balances. Our outstanding common stock common shares currently stand at $25,200,000 reflecting the recent financing activity. Including our ongoing CMOS-one 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 Gideptin programs.

[Mark Reynolds, CFO at GeoVax Labs]

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 and A. And now I'll turn the call back to David.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Thank you, Mark.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

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

[Operator]

Thank you. And our first question comes from Jonathan Aschoff with ROTH Capital Partners. Your line is open.

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

Thank you very much. Good afternoon, guys. I was wondering regarding the new patch method to administer the MDA vaccine, is this what you now intend to use for the pivotal trial starting in the second half of twenty six? And the second part of that question is, is the making of enough vaccine product a limiting step that necessitates a two h twenty six start?

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Jonathan, thanks for your questions. We do not intend to use the patch for the clinical program. It's an evaluation of the microarray 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 and regions and all. But we plan to utilize the standard vaccine and delivery of it, and that's why the the filing should be completed or we're targeted to complete it in the fourth quarter of this year.

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

Okay. And and and the 02/08/1926 start time that's no largely because you have to make the vaccine product itself. Correct? That's the major step.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

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

[John W. Sharkey, VP - Business Development at GeoVax Labs]

Yeah. Hey, Jonathan. Thanks for the question. Yeah. So I mean, what we announced in June is the EMA, we presented them a proposal that if we based on MVA being highly similar to the variant Nordic, if we were to do an immuno bridging study and appropriate atom work, could we bypass?

[John W. Sharkey, VP - Business Development at GeoVax Labs]

And they agreed. So we are now, the statisticians are powering the study to what we would need to show non inferiority. We will prepare the clinical trials. We then need to submit the dossier to Europe to get approval of 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 twenty twenty six.

[John W. Sharkey, VP - Business Development at GeoVax Labs]

As you well know, there's a lot of moving parts that need to come together before you can inject your first volunteer.

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

Certainly. Mark, did you say 10,000,000 r and d for the quarter? Did I hear that correctly? Is Mark there or anybody can take that?

[Mark Reynolds, CFO at GeoVax Labs]

Yeah. Let me just Yeah. Can can you hear me now?

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

Yeah. I can.

[Mark Reynolds, CFO at GeoVax Labs]

I'm sorry. I hit the wrong mute button. Yeah. It was, 10,000,000 for the six month period.

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

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

[Mark Reynolds, CFO at GeoVax Labs]

Was filed about, twenty minutes ago.

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

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

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Thank you John.

[Operator]

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

[Robert Leboyer, Senior Biotechnology Analyst at 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 one and phase two, 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.

[Robert Leboyer, Senior Biotechnology Analyst at Noble Capital Markets]

And my understanding, which was partially answered was that this was gonna be compared against Bavarian Nordic on the immunotherapy. And this was not immunother this was not an immune response under the animal rule or anything like that. So it's gonna be against the standard vaccine. Is that correct?

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Sharkey, would you like to answer that or

[John W. Sharkey, VP - Business Development at GeoVax Labs]

Sure,

[John W. Sharkey, VP - Business Development at GeoVax Labs]

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 the GMBA to the MVABN. And we'll have supporting preclinical animal toxicology and other studies to support the equivalence. What we're not required to do is normally under the animal rules, one demonstrates efficacy in an animal model, and we're not gonna be required to do that.

[John W. Sharkey, VP - Business Development at GeoVax Labs]

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

[Robert Leboyer, Senior Biotechnology Analyst at Noble Capital Markets]

Great. And since you're running the trial in the second half of the twenty six, is there any US 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 at GeoVax Labs]

David, do want me to take that?

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Yes, please.

[John W. Sharkey, VP - Business Development at GeoVax Labs]

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.

[John W. Sharkey, VP - Business Development at GeoVax Labs]

The other thing to always keep in mind, and BARDA has said more than once in a 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.

[Robert Leboyer, Senior Biotechnology Analyst at Noble Capital Markets]

Okay, great. And also a follow-up question on Gideptin. And the press release mentioned after the keynote six eighty nine, 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 Dodd, Chairman, President & CEO at GeoVax Labs]

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

[Kelly McKee, Chief Medical Officer at GeoVax Labs]

Yeah, so with the caveat that I'm not an oncologist so I'm gonna sort of stumble my way through this a little bit. So the major pathologic response defined, has been defined for the June 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 for pembro alone, the major pathologic response was not very impressive. It was in the zero to forty to thirty percent range.

[Kelly McKee, Chief Medical Officer at GeoVax Labs]

So we think we've got a pretty good shot at bettering that with Gideptin as an add on to pembro in the neoadjuvant space. But our primary endpoint is gonna be pathological. We a secondary endpoint that's gonna be disease free, or event free survival after a year, which will also be able to compare with the data from the June study. But that's kind of our overall plan.

[Robert Leboyer, Senior Biotechnology Analyst at Noble Capital Markets]

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 McKee, Chief Medical Officer at GeoVax Labs]

Yeah, so the way 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 tumor. So it's first line therapy that they've not received other treatments except for the standard of care which is post resection.

[Robert Leboyer, Senior Biotechnology Analyst at Noble Capital Markets]

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

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Thank you, Roma.

[Operator]

Thank you. Our next question comes from James Molloy with Alliance Global Partners. Your line is open.

[James Molloy, MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners]

Hey, guys. Thank you for taking my questions. On the Gidepti, what is the start date for that second half twenty six as well? Is that

[David Dodd, Chairman, President & CEO at GeoVax Labs]

That's correct, Jeff. Yes, second half to twenty twenty six is what we're targeting.

[James Molloy, MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners]

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

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Kelly, do you want to take that?

[Kelly McKee, Chief Medical Officer at GeoVax Labs]

We're still sort of refining those estimates, but we think it's going to be in the same range, thirty six to forty patients. It'll allow us to sort of demonstrate statistically improved performance over the pembro alone in the neoadjuvant space. And we think it's gonna 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. And so we should have readouts from this trial fairly quickly after it begins enrolling.

[James Molloy, MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners]

Okay, and how come not overall survival on the endpoint?

[Kelly McKee, Chief Medical Officer at GeoVax Labs]

Well, I mean, survival is a long term follow-up. So that's one aspect. We will have one year event free survival as a secondary endpoint.

[James Molloy, MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners]

Then what's the expectations for potential interim looks? Trying to get an idea how to thinking about these trials, this one in NBA. NBA starting second half twenty six as well, what's the expectation for sort of getting to either an interim or a final look on that trial too?

[Kelly McKee, Chief Medical Officer at GeoVax Labs]

Well, so start off with the Gideptin. Gideptin, 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. Again, we're expecting this trial to enroll fairly quickly.

[Kelly McKee, Chief Medical Officer at GeoVax Labs]

So I can't give you a time estimate, but it should be a matter of a few months we think. For the GeoMVA, 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.

[James Molloy, MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners]

Is there an expectation on the twenty sixth, second half twenty sixth start date potential, are we talking 2020, '29, 02/1930, what's going to get an idea for what we should be looking at on the outside of looking in

[Kelly McKee, Chief Medical Officer at GeoVax Labs]

For the geo MVA study?

[James Molloy, MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners]

Yeah, please.

[Kelly McKee, Chief Medical Officer at GeoVax Labs]

Again, it all depends on the rapidity of enrollment. Because these are healthy volunteer subject, we don't think it's gonna take a long time to enroll. But there's so many variables out there that impact enrollment is really gonna be hard to say. We are including a couple of African sites that we have confidence are gonna enroll very quickly.

[Kelly McKee, Chief Medical Officer at GeoVax Labs]

So that's going to help our case. But I'm hesitant to give you a projected timeline for that.

[James Molloy, MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners]

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

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Thanks, Jeff.

[Operator]

Thank you. Our next question comes from John Vandermosten with Zacks. Your line is open.

[John Vandermosten, Senior Analyst at Zacks Small Cap Research]

Great, thank you and good afternoon everyone. You guys have the COVID vaccine program with BARDA But recently, you mentioned that there was a manufacturing proposal that's under active review with with BARDA. What does this mean for your work with them?

[David Dodd, Chairman, President & CEO at GeoVax Labs]

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

[David Dodd, Chairman, President & CEO at GeoVax Labs]

But in January, they informed some companies, thanks, but no thanks. You know, it 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 in what they refer to as a a basket, I would call it a holding basket, for for two years of of depending on, you know, of funding availability.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

And that was intended to fund our AGE one continuous cell line manufacturing process that we have underdeveloped. And it and and our candidate product at that time was for the CMO four s one, our COVID nineteen vaccine. So that continues to be in the basket. And so it has been selected, but it's dependent on on funding availability. And that's not just true for us, but none of them have been funding.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

And as you know, the early part from January until through April, we saw the activities that eliminated most of the products that were in 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'd be two years from from January.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

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

[John Vandermosten, Senior Analyst at Zacks Small Cap Research]

Okay. And and then looking at the Gideptin trials, 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 Dodd, Chairman, President & CEO at GeoVax Labs]

We're planning to use pembro.

[John Vandermosten, Senior Analyst at Zacks Small Cap Research]

Okay. And then shifting once again to back to the the the COVID vaccine. With all the changes from you know, in guidance for who and 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 Dodd, Chairman, President & CEO at GeoVax Labs]

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 the targeted audiences for whom COVID nineteen vaccines might be most appropriate, etcetera, it 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 two trials.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

One is the investigator initiated. As I mentioned, during second quarter, the investigator initiated trial, the CLL trial, opened another site there in the Orange County Lennar Cancer Institute, of City Of Hope. So we think that increasingly what we are hearing coming out of HHS, FDA, etcetera, in terms of utilization of COVID nineteen vaccines and where they are 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.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Recall that we had last fall we announced the interim results for the CLL trial where they halted the Pfizer arm and have just continued with only hours. The remainder of that trial is only utilizing a CMO4S1, and our goal is to see that completed. And it's 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 specifically for CLL patients.

[Kelly McKee, Chief Medical Officer at GeoVax Labs]

Might also add that our vaccine is a two antigen vaccine, a multi antigen vaccine, which you know, is different from those that are currently available on the market.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Excellent point because we heard secretary Kennedy in April acknowledge and discuss his preference or his belief that multi antigen vaccines in in particular areas of infectious disease need or more appropriate than single antigen vaccines. And, again, that 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 to the performance of our vaccine, both in terms of breadth of protection, durability, and also utilization among immunocompromised populations.

[John Vandermosten, Senior Analyst at Zacks Small Cap Research]

Okay. Great. Thank you, David.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Thank you. Thank you, John.

[Operator]

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.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

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 GFX and our advisors, our GFX 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 disease vaccines.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

We are most proud and appreciative of our team, including those external contributors who continue to assist in progress and success underway at GEAVAX. 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]

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

Participants

Executives

• David Dodd, Chairman, President & CEO
• Mark Reynolds, CFO
• John W. Sharkey, VP - Business Development
• Kelly McKee, Chief Medical Officer

Analysts

• Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC
• Robert Leboyer, Senior Biotechnology Analyst at Noble Capital Markets
• James Molloy, MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners
• John Vandermosten, Senior Analyst at Zacks Small Cap Research