Geovax Labs Inc Aktie

My name is John Heerdink and welcome to our Tribe Public CEO Presentation titled Ebola, Marburg, Hantavirus, Mpox and Beyond: Building a Resilient Infectious Disease Portfolio Preparedness Strategy. The presentation will be co-hosted by David Dodd, Chairman and CEO of GeoVax Labs, trades on the NASDAQ under the symbol GOVX and is targeted to last about 30 minutes today.

GeoVax Labs is a clinical stage biotechnology company focused on developing vaccines and immunotherapies that address high-consequence infectious diseases and solid tumor cancers. GeoVax's priority program is GEO-MVA, a modified vaccinia Ankara MVA-based vaccine targeting Mpox and smallpox.

As many of you know, I am the managing member of Tribe Public. Our website is tribepublic.com, t-r-i-b-e-p-u-b-l-i-c dot com. Members from over 35 countries in all 50 states have joined Tribe Public freely to gain direct corporate access to leaders and experts they care about via our webinar events like today and via 41 venue sites located across the U.S. where we host in-person events over luncheons, dinners and speaking engagements with local tribe members.

Tribe members furthermore are invited to submit names of experts and leaders of industry via our free wish list process at our website, adding names of companies and subjects that span across all sectors so they can learn more. Please note that I am also the Managing Director of Vista Partners, LLC, a registered investment advisory firm in California, and its website is vistapglobal.com, that's v-i-s-t-a-p-g-l-o-b-a-l dot com.

Please review both sets of disclaimers at each site and know that I'm currently a shareholder of GeoVax and at times have been adviser to GeoVax.

I would also like to thank you all for participating and for all of your questions you have submitted and remind you all that you may send in more questions via the Zoom chat feature during this event, and we'll do our best to get to many of them. A video of this event will also be published on our Tribe Public YouTube channel and be sent out to all post this event via the Tribe this week, which is our weekly e-newsletter that goes at the end of each week. Thank you also to GeoVax Labs for joining us today.

Now let's get started. We have, again, David Dodd, Chairman and CEO. David, could you start with just giving us a little bit of your background and then begin your presentation?

Sure, John, and thank you for this opportunity. And I also want to not only welcome but thank all members of the Tribe Public as well as others who are participating in the day. Hopefully, you'll learn a little bit, become interested in GeoVax and want to do a little bit of follow-up and I look forward to that.

Just to get started, let me just mention that my own background is 40-plus years within the pharmaceutical vaccine industry. It's a wonderful industry in which to build a career, provides a tremendous amount of opportunity.

And what we're talking about today is one of the reasons why I've always advocated that younger people starting their career consider this industry. And that is it presents continuous challenges.

I mean just think back to when we were all much younger 40-plus years ago when we started hearing about something called AIDS. It wasn't even called that, some new disease. So there are always within our industry the opportunities for and the need for innovation for development on an individual basis, on an organizational basis.

And it's quite an exciting industry. There are winners and losers, of course, but it's a great industry in which to build one's career. And so I've had the good fortune of starting very young and continuing to stay in this industry and work with it across many different opportunities. I would encourage anyone else to consider that.

So we are facing today a global challenge. But this global challenge is not new. It does seem that it's happening more quickly and that is that emerging viral threats tend to test our limits of capability to be able to respond locally as well as globally.

And that continues to become perhaps an even greater challenge because as the world, in essence, gets smaller, we travel much more, we are seeing that emerging viral threats in fact, emerging pathogenic threats are happening, it seems like more frequently. They migrate much faster and we have to figure out ways to be able to respond to those.

But even more importantly, in response is really preparation and being prepared is what is most important for us. And so we've entered this persistent outbreak era. It was just a few weeks ago. Last month, we're talking about Hantavirus and Ebola was, frankly, not on our mind, certainly not in the United States, but then certainly starting within earlier this month, we started hearing about these outbreaks in Democratic Republic of the Congo, in Uganda, of some new type of strain we've never heard about and what was going on there.

But let's think about what we've been dealing with just within the recent past. We've been talking about what was originally monkeypox. We first started talking about that 4 years ago in 2022. Then it became known as Mpox, but more importantly, it went from an initial strain to a more virulent strain and now we have a new combination strain.

We're seeing the first initial cases in the U.S. from that. Then we have the Bundibugyo or the BDBV Ebola outbreak. That's the third version of the Ebola virus family that we've dealt with for, if you want to include Marburg. And we -- as I mentioned earlier, we were talking just recently about Hantavirus. Now these are all things that provide tremendous amount of not only concern, but threats.

What's happening starting probably next week? Well, what's happening next week is we're going to start seeing millions of people come to the United States for the World Cup. And when people are traveling as frequently as we do today globally throughout the world, what we're doing is we may not think about it, but we're carrying viruses with us.

Most of us have pretty good immune systems. So we don't have to deal with that. But that threat increases tremendous exposure and threats on a global basis. How we deal with those and how we can be prepared to deal with those becomes critically important.

And it's preparedness that is more important than simply respond. We respond when we're in the middle, the eye of the hurricane, the middle of a threat, but we need to be preparing for it in between crises and that we have much to continue to learn.

Now MVA, John mentioned, we use a technology called modified vaccinia Ankara. MVA is the name of what was originally developed as the smallpox vaccine. It enabled us to eliminate smallpox from the world because previously, we used to use vaccinia.

Unfortunately, vaccinia, which is still around today, is contraindicated in certain populations, pregnant women, children and people with compromised immune system. We never would have eradicated the world of smallpox had we not developed a new version of it, which was good and it was safe for all populations and yet maintains a very robust immune response against smallpox in this case or what we could call pox viruses. So that became critically important.

It worked. It goes back to the last case of smallpox was announced in October of 1977. It was declared eradicated in 1980 because there had not been any more cases since that 1977 last case. And then we repurposed MVA beyond being simply a vaccine in terms of being a platform because it does not replicate in humans.

It's exquisitely safe. It allows us the inclusion of multiple parts of a virus. So it's known as a multi-antigen vaccine, which means you can take various components of pathogens. Even you can speculate about doing a single vaccine that would integrate Ebola Zaire, Ebola Sudan, Ebola BDBV, Ebola even Marburg.

All of these are very, very threatening, highly fatal. They have fatality rates up to 95%, the latest one has one approximately 40%, but being to put all those into the single vaccine and being able to deal with that. You can't do that with mRNA. You can't do that with other types of technologies such that AstraZeneca utilizes an adenovirus vector, different versions of that, can't do it with the protein adjuvant types of technologies such as Novavax stuff. They can do combination, but they can't integrate it into one.

You have the opportunity. It's very challenging, but the opportunity to do it with MVA. So that type of platform enables you to take a single platform and address multiple outbreak opportunities and to do that in preparation, not simply in response.

So the core problem that drives everything is supply chain. People think it's about just developing something that within the lab seems to work. That's great. But if you can't manufacture it, keep it stable, ship it, be able to utilize it, not in a highly frozen state, but in a real time, administer wherever it needs to be, villages in Africa, villages in the Asia-Pacific region, in the Southern Hemisphere where many of these emerging pathogens, we see the outbreaks.

If you can't do it in those delivering millions and millions, hundreds of millions of doses if necessary, then all you have is a science project.

And far too often, we have something that's exciting in the lab. It may even show that in a well-developed nation with all the access to supply chain elements such as the United States or in parts of Europe, frozen state delivery that it works. That's great.

Now we go to the real world. What are these people doing today in Uganda, in the Democratic Republic of the Congo, the DRC. They are going from village to village, highly exposed, dealing with a highly contagious, in this case, the latest one being 40% plus in terms of fatal. But if you go to certain strains of the Ebola virus family, the filovirus family, you're dealing with 95%.

In those cases, if you cannot give people and administer successfully, it doesn't matter how well it might work in the United States, throughout the developed world, so to speak, it's not going to help them and we're going to have devastation. And that will not simply stay in that location, in that geography, it will travel because as people travel more and more coming to the World Cup, coming to other types of travel, they will be carrying that.

That's what we're seeing already with Mpox. And we've seen it previously with other parts of the Ebola family. We have to get away from that.

So I'm going to talk about a product that is close to initiating a Phase III trial. It's called GEO-MVA. That is the MVA vaccine that is the version from GeoVax. It's tied in with a global preparedness program.

The initial indication of the vaccine for which a Phase III, pivotal Phase III trial is scheduled to start in fourth quarter of this year is to target Mpox as well as smallpox. It's very important because today, there is a limited insufficient supply of MVA vaccine in the world.

The European Medicines Agency, or EMA, the EU equivalent of the FDA has provided GeoVax an expedited pathway for development. They have waived having to do the traditional Phase I and Phase II clinical trials in humans. They're only requiring a Phase III trial in healthy adults that will compare the immune response of our version of MVA with that of the only supplied product worldwide today, which is from a company out of Denmark known as Bavarian Nordic.

And they're doing that because our MVA and that of Bavarian Nordic were initially derived from the same parenteral cell line. They are about as close as one could get and being, for all intents and purposes, identical.

And we're targeted to start that trial in fourth quarter. And the reason why the EMA has done that is, first of all, because the extreme safety of MVA in general, but more importantly, the relationship between our MVA and that of Bavarian Nordic.

We have genetically sequenced our version of it and shown that it matches up 100% with all of what are known as the regions of interest or ROI that the regulatory authorities look at. So because of that, they've given us an expedited pathway.

We will initially be conducting a 500-patient trial. It will be healthy adults, 250 on our vaccine, 250 on the MVA-BN vaccine. We'll be looking at 2 endpoints. One will be neutralizing antibody and the other will be the sero conversion rate.

And that will be started as we have targeted right now, fourth quarter of 2026. We've already manufactured all the product. It's been packaged in the vials. It's ready to go. We've selected our CRO, our clinical research organization.

We've selected where the sites are going to be and we have it set up so that when the trial starts, it will be completed with all 500 patients within 12 weeks. That's essentially 3 months. We'll have the readout of that in the middle of next year and that will be based upon those 2 endpoints that I talked about, neutralizing antibody and seroconversion rate.

Why are we so confident that we will show noninferiority? The criteria we've been given that are the basis for registration or marketing authorization is to demonstrate noninferiority on those 2 measures of our GEO-MVA to MVA-BN. And the reason why is we share the same lineage, we have the 100% match with genetic sequencing.

We utilize for all intents and purposes, the same manufacturing process, the same dose and the route of administration we're following. We have the expedited pathway. We've been waived for Phase I, Phase II. And with that, we'll be going forward.

We feel that with this, we will be able to demonstrate that. If that all works out, we will -- and we're able to demonstrate that we have noninferiority on those endpoints, we will then pursue emergency use licensing with the WHO and we'll also pursue expedited approval with the EMA.

And then following that, we will then -- assuming we are granted either EUL or the expedited pathway, we will then be conducting a 3,000 patient safety study that will be 3,000 patients, adults, not those -- no efficacy measures required, just demonstrating that among the 3,000 patients that we will be doing, 2/3 of whom will be in Africa, 1/3 will be in the EU, that it's a safe product, just further validating what we already know about MVA, that it does not replicate in humans and there are no adverse events otherwise, maybe a sore at the site of injection.

But other than that, we hope to show rather -- which we've shown before in other studies rather benign any types of adverse events or tend to be localized related to the administration of the vaccine.

Now what does preparedness require? It requires manufacturing resilience because right now, if we look at it, there were approximately 7 million to 8 million doses of vaccine against Mpox delivered and utilized and administered in 2025.

However, there was an unmet need for further MVA vaccine in excess of 15 million doses, 10 million of which were specifically requested out of Africa, another 3 million thereabouts in the EU and then elsewhere, different contracting agencies, UNICEF and Gavi. We've got strategic stockpiles both across the world.

People are not aware of this, but in the U.S., Health Canada, U.K., Israel, Saudi Arabia, Middle East, throughout Asia-Pacific, most nations have stockpiles primarily developed related to the potential biodefense threat or bioterrorism threat of smallpox, but it's the same vaccine. So it becomes utilized when we have Mpox outbreak.

So we're looking for expanded capacity on a global basis, being able to do regional manufacturing and reliable access, not having to just build it when we absolutely need it, but build it on an ongoing basis. It's not just a vaccine story. It's an infrastructure story.

And this is what is most important. And the reason why is utilizing something such as the MVA-based platform, it allows us to move forward through cell line manufacturing, moving away from the historical somewhat very slow and cumbersome manufacturing process, same process we use, same process that Bavarian Nordic uses, but we're migrating to a new process that will be scalable, reduced costs, reduced time to develop a batch will provide a tenfold increase over the current manufacturing process, being able to do twice the number of batches within the same time frame, we can only do one batch today.

So we have a multiplier effect and also doing it at lower cost and frankly, being able to transfer this technology so there could be localized manufacturing, which is not the case today. So we're excited about it.

We hope to be able to transition to that new manufacturing technology within the next 3 to 5 years. But we will initially go to market with the same technology that is used to manufacture MVA today. Most important reason is it then provides a reference frame for being able to transition much faster to a new manufacturing process that would be cell line-driven and would have those attributes I just mentioned.

So why should anybody who's thinking about potentially investing in GeoVax be interested in it? And first of all, I want to encourage you and employ you to do your own due diligence because there are always things that can trip people up.

So our current plan is and what we're dealing with today is a very large and expanding market. I mentioned there were around 8 million doses last year. That translated last year into $700 million. That was the Bavarian Nordic product, the traditional vaccinia product with its limitations because of the contraindications. There's also a product out of Japan that also carries those same limitations of contraindications.

So the Bavarian Nordic product did approximately $500 million in sales last year in U.S. dollars equivalents. There were around another $100 million, almost $150 million from the traditional vaccinia product and then about another $50 million for the product out of Japan, which is from KM Biologics.

In total, that gives you about $700 million in the total market. However, the demand that was requested that could not be met is an additional $1.3 billion. Our focus will be to go after what is being unmet, not to directly compete with someone who's already supplying because what is out there is larger than the entire market that was satisfied last year.

So we will be going after that. We've already started discussions with potential contracting agency. We consider this a highly derisked program because we have the expedited pathway. We've been waived the Phase I, Phase II trials. We're focused on the immune-bridging 500-patient study with a midyear 2027 readout and we believe there's a high likelihood of success because of the attributes we've talked about.

And although we'll go to market with the current manufacturing, we are focused on moving forward in as timely a manner as possible to this new manufacturing process. And again, I want to emphasize, we're anticipating that will be 3 to 5 years. So we'll go to market with what we have for current -- for regulatory reasons, important reason being able to supply, but we will then transition as quickly as we're able to.

Now I want to turn -- I want to also comment because we're in the vaccine business. People over the last several years, certainly, we've seen more of reluctance from investors and others who might be funding for vaccine.

That seemed to end just the other day with Lilly's announcement of spending approximately $4 billion to acquire 3 infectious disease-related vaccine players. And that is opening up and we're starting to hear about it. We're starting to hear inquiries and receive inquiries about it, that it looks like that is turning the corner on the consideration of the vaccine industry, especially for companies who are in late-stage development towards registration, such we now find ourselves with our GEO-MVA that, that has been providing somewhat of some momentum and interest in there.

We anticipate that other large players, not just people already in the vaccine industry, but players that are looking to have sustainable growth opportunities will continue to look at this because vaccines are absolutely critical in addressing emerging threats, especially pathogenic threats, both from a viral infectious disease as well as a bacteria.

We're focused on the infectious disease viral standpoint. But again, we consider that a very positive for our industry, for players such as GeoVax potentially. It all takes, obviously, people to look at it, become familiar with the technology. It tends to due diligence have not conducted overnight, but we do believe that this is a real boost for those of us in the development stage, especially the late development stage of vaccines.

Now what is the opportunity ahead? Well, what we look at for us is a number of groups are looking at. The Africa CDC is very active, vocal and in need of instituting continental-based vaccine capabilities, being able to work with MVA.

We've been in discussions with the Africa CDC for the last 3 years in this. UNICEF and Gavi has an active process underway, building stockpile for GEO for products of MVA vaccine, specifically the MVA stand-alone vaccines such as GEO-MVA.

In Europe, HERA is driving the way WHO through the emergency use licensing pathway. In the U.S., under BARDA, HHS, we have a Strategic National Stockpile. Other such national stockpiles, as I mentioned, we have them in Saudi Arabia, throughout the Middle East.

We see it in Israel. We see it throughout in the U.K. We see at Health Canada. We see it in Australia. We see it in Japan. So it's all over the globe, we're seeing that there are stockpiles looking for MVA vaccine and MVA-based vaccine. That is what we are focused on as a company.

Pipeline optionality with the recent announcements about the latest outbreak in Ebola, I just want to remind everyone that we have previously successfully developed vaccines against Ebola Zaire. We showed 100% protection in a single dose and that one against Ebola Zaire.

Ebola Zaire has up to a 90% fatality rate. We've done Ebola Sudan. We've done Marburg. Marburg, the Angola strain of Marburg has a 95% estimated fatality rate. So we've worked on that. So we've done those 3 before, presented those at international conferences.

We've carried them all the way through nonhuman primate testing. So we continue to have interactions with government funding agencies and others such as CEPI or BARDA for the government side. And we'll continue to listen and look at those. We are not currently actively working on the new strain because we are so focused on our GEO-MVA to bring that to fruition and to initiate that Phase III trial in the fourth quarter.

So let me just close and say this is really all about not just 1 product or not just 2 products. It's all about what we need to be prepared because preparedness should be done in between crises.

Once we're in the middle of one, we're scrambling to try and get something developed. That's what's going on right now. You're seeing a lot of energy, a lot of activity of people trying to address this new strain. They're trying to play catch-up and that's what we intended to do worldwide, not just one nation, but everyone.

And the industry -- for the industry to move forward, especially companies, we will consistently be dependent upon the necessary funding that either comes from government agencies or NGOs that have a stake in all of this.

And with that and our capabilities, our expertise, our experience, we can move forward and better address such threats from a preparedness standpoint so that when the outbreaks do occur, we're all ready. We already have product manufactured. We already have product distributed. It's ready for administration as necessary. That is what we all need to be seeking.

And with that, I'll end my presentation, and I'm happy to take any questions that may arise. And I'll just hold this up in case any of the questions necessitate going back to a previous slide.

Well, thank you again, David. Very interesting, and thanks for giving this picture of both how GeoVax and how the world is dealing with these infectious diseases and how we might deal with them in the future.

Just a couple of minutes for questions now. One of them was with -- in regards to funding your company and maybe speak about what you've done recently to push forward the development.

Sure. Thank you, John, and thank you whoever had that question. It's a very good and most pertinent question because we are driven by our balance sheet. We're pre-revenue, which means we have no internal funding mechanism.

So we're either dependent on the sale of equity to raise capital or from a nondilutive funding. And we pursue both, as you might imagine. Last week, we had the opportunity. There was a very strong performance of our stock.

We traded in excess of 275 million shares, which was over 50x turnover of our outstanding shares during last week, all built upon this Ebola outbreak, the noise associated with that and the recognition that we sit right in the middle of it and our capabilities. It enabled us, we were able to take advantage of that.

We are a microcap company subject to baby shelf rule, et cetera. But we were able to, through the combination of a PIP as well as organic warrant exercises, we were able to bring into our balance sheet in excess of $4 million last week. We continue to have further discussions and there's also additional warrants out there that will likely be exercised in the near term also given the continued strength of our stock price.

So we'll continue to pursue those. And we're also obviously in touch with nondilutive funding sources, not just U.S.-based, but globally based for opportunities to be able to advance our programs forward, especially GEO-MVA because that becomes the basis for everything we do as our new platform going forward.

Okay. Thank you, David. Another one is in regards to your regulatory pathway. Says GeoVax recently highlighted an expedited regulatory pathway for GEO-MVA. Why do you believe that is important? Can you stress that? And are there any milestones ahead of us that you can highlight as well?

It's a critically important achievement. And the milestones are most important in few because we're so close to initiating that trial.

We started in 2022, 2023 discussions with the EMA on the concept of an expedited pathway. It would normally take 5 to 7 years to be able to get to -- at best to get to a Phase III trial. And we were -- after 2 rounds of scientific discussions or advice, as they call it, the EMA, we -- they accepted our proposal, which was to waive Phase I and Phase II, go directly to this immuno-bridging trial, just needing to demonstrate noninferiority of 2 immune response measures, not having to do safety and efficacy.

And based upon that, if we show noninferiority, we will then be -- it will be sufficient for authorization and we'll have the same labeling as the MVA-BN. That is critically important because it moves us to the transformation of a revenue-producing company much faster than we otherwise would be changing the whole course of GeoVax, which then will be supportive of our entire infectious disease portfolio because everything is built upon MVA, including our current candidate as a single-dose MVA as well as our new manufacturing process.

So this is critically important and from an investment standpoint, moves us forward. What are the milestones between now and when we -- let's say, when we get to the data readout in 2027? We're completing right now the necessary work in support of our clinical trial application, which is necessary to start the trial.

That will be completed and submitted by the beginning of September. So as I said, fourth quarter is we -- then we'll then go forward. We've already manufactured all of the product. It's all been packaged.

We need obviously 500 -- if you have 250 patients and they each -- they have 2 doses, that's 500 doses. We produced in excess so far of 6,000 doses. We have more than enough product already packaged, released, ready to go.

As I mentioned, we have the sites. So the milestones -- the biggest milestone right now is our balance sheet. We continue to be raising money and adding to the balance sheet to be able to go forward because once we initiate that trial, we expect to have the results from it mid-2027, a critically important milestone.

That is when we will either announce that we have met the criteria, which we believe we will. But again, we have to get there and demonstrate that, that we've met the criteria for the EMA. Based upon that, we'll then proceed with the formal discussion. We've been doing informal with both WHO and EMA about emergency use licensing as well as expedited EMA review.

And with that, the key will be to raise money to be able to produce additional product going forward, complete that safety database, but prepare for commercialization. We will begin to engage with contracting agencies while we have the immuno-bridging trial.

They've already asked us to start negotiating for contracts, but we've held off until we're into that trial. So those are the time lines. What will it take? We are focused on to be able to have a completion and an authorization, we're looking at less than $20 million that we're focused on raising part of that $4 million plus that we just raised last week contributes to that.

So we're on that pathway and we'll continue to focus on that. That's the milestones, the activities and the cost of getting to that point.

Thank you, David. This is in regards to Mpox. There was a little confusion apparently, a couple of folks in regards to the market -- approximate market size that you believe there is for Mpox. Is that $11 billion, $2 billion? What is the number that you were suggesting?

In dollars, it's a $2 billion market. That is broken down that $700 million was what the sales are estimated that were done last year. One was from Bavarian Nordic. They did $150 million in U.S. equivalent dollars if you convert their Danish kroner from their annual report.

So if you convert that, then if you look at what Emergent BioSolutions delivered, it was somewhere between $120 million to $150 million. So we're using $150 million. And if you look at the KM Biologics from Japan, they did around between $30 million and $50 million, we're using $50 million. That adds up to the $700 million. If you convert those back to doses, that's around 8 -- depending on pricing assumptions you have, that's around 8 million doses.

But what was actually requested out there was an additional 15 million doses that Africa CDC and others were seeking to buy, but there was not -- and that was all MVA vaccine. And so that's what we will be going after. If you turn that into a dollar equivalent, that's approximately $1.3 billion in opportunity that existed last year in request for product that could not be fulfilled and that's what we will be focusing on is that gap.

Okay. And then you've stressed regards to domestic manufacturing. Can you speak to that a bit?

Yes. Excellent question because currently today, there's not a single manufacturer, contract manufacturer or operating manufacturer in the United States capable of providing product in support of Phase III or commercial-grade product.

We currently are working with Oxford Biomedica or OXB. They are based in Oxford, the U.K., the manufacturing facility we utilize. They acquired another company a couple of years ago. We've been working with that company. But ABL, which is based -- they have operations for us for MVA vaccine in Strasberg, France and Lyon, France. They also have facilities OXB does in Boston as well as in North Carolina.

So we anticipate that we will be working -- we will be working with -- we don't anticipate we'll be working with OXB, but what we will do is transition as we move forward with the continuous cell line manufacturing I talked about over the next 3 to 5 years, we will be transitioning into a U.S.-domiciled manufacturing facility that will then provide the first domestic manufacturing, so U.S.-based manufacturing for either Phase III or commercial-grade products and it's important to talk about Phase III because for future products, we will be doing not just MVA alone, but other products also using MVA. So that will be based in the U.S.

Okay. Thank you, David. Another question says, what durability of immune responses are you looking for?

Durability of the immune responses. All we have to -- well, the durability -- the shelf life is typically 3 years and we'll be granted that if we meet the noninferiority. But we have gone back and tested and done tests in either animal models of monkeys where we went back 8 years after they have been vaccinated and they still maintain the immune response.

So it's long-term durability with MVA. That has been recognized. But from stability studies, the -- what will be granted will be what is currently given through the current manufacturing process and that will be 3 years.

Okay. And then -- what is the anticipated price per dose? And how would this compare with Bavarian Nordics product?

Great question, one that I would not disclose even if we had -- first of all, we don't have that yet because we're not at that point to have a pricing dose, which is another reason why we wouldn't engage in contract discussions. That will be worked out between ourselves and our CDMO, OXB.

We're working on that now and it's obviously tremendously assumption-driven. But what we will see as we move forward to the cell line manufacturing process is we see a fivefold cost reduction opportunity there. So we'll be more than competitive.

Okay. Well, David, I think we've exhausted the time we've had with you today and we appreciate you and GeoVax for joining us and all of the Tribe members from around the world, including Seoul, Luxembourg, England, Switzerland and beyond and all the U.S. folks across the 50 states.

So I want to thank you again for doing that. Remind everyone that we will be publishing a video on our Tribe Public YouTube channel later today that you can pass on to folks and/or review if you've missed something and want to share it with others.

And then we'll also include you as you signed in to the Tribe This Week that will come out Friday, typically after the close at 1:15 Pacific here in San Francisco.

Thanks again for being part of the tribe, everyone. And thanks again to David Dodd and GeoVax for sharing and getting us up to speed on this situation and also on GeoVax.

Thank you all, and I look forward to having you on our next event. And if you would like to meet with David personally at any of our 41 event venues across the U.S. and/or you want to establish a new one, please contact us at [email protected] and we'd love to hear your interest or go to the website at tribepublic.com and submit it into the wish list section where you would like us to host an event. Thanks again, David. Thanks again to all the Tribe.

Thank you.

And you guys have a great rest of the day, and we'll see you soon.

Thank you.

Good afternoon, and welcome, everyone, to the GeoVax Third Quarter 2025 Corporate Update Call. My name is Sherry, and I will 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 development of its products. There is a 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-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. Please go ahead.

Thank you. Welcome to the third quarter 2025 GeoVax corporate update. 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, Gedeptin and the game-changing MVA vaccine manufacturing process.

Each of our product development candidates address 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.

We're experiencing increased partnering and collaboration interest from established industry players as well as increased interest from nondilutive funding organizations, including stakeholders addressing various areas of worldwide vaccine needs.

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, our vaccine candidate against Mpox and Smallpox. This is most encouraging news in that 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 immuno-bridging trial.

As a result of this news, we're experiencing increased interest and dialogue with various industry colleagues and stakeholders regarding potential partnering, collaboration and funding.

Relative to GEO-MVA, we have initiated the fill/finish of clinical batch vaccine material. We anticipate having vaccine available for clinical evaluation early next 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 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.

Significant government 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 initiatives is a major national legislative focus and interest.

We remain in active discussions and briefings with various stakeholders, including the White House, Congressional Representatives, HHS, WHO, the International Vaccine Institute, the Africa CDC and others regarding our progress relative to cGMP clinical inventory of GEO-MVA.

In fact, this was the subject of numerous discussions during our recent series of meetings in Europe in conjunction with the World Vaccine Congress Europe, BIO-Europe and individual meetings held in Geneva and elsewhere.

Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. GEO-CM04S1, our multi-antigen vaccine against COVID-19 is increasingly recognized 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 CM04S1 provides potential for demonstrating a more robust immune response against emerging variants, improved durability versus the first-generation single antigen COVID-19 vaccine and especially in addressing the immune protection among those patients with compromised immune systems.

Our current CM04S1 studies are progressing, especially our focus on continued enrollment of severely immunocompromised patients with blood cancers who have received cell transplants and towards completion of the investigator-initiated Phase II trial among chronic lymphocytic leukemia patients.

Both the hematologic cell therapy patients and the CLL patients represent the highest risk groups in need of reducing the risk of severe infection, hospitalization and the risk of death resulting from COVID-19 infection.

For these individuals, the pandemic continues. Demonstrating the critically important value of CM04S1 among such immune-compromised patients remains our focus for differentiation from the first-generation COVID-19 vaccines.

The medical need for a vaccine such as CM04S1 remains substantial for those with medical conditions that render their immune systems inadequate in responding to the first-generation vaccine. It's noteworthy that just recently, the Infectious Disease Society of America, known as IDSA, issued updated guidelines regarding COVID-19 vaccine among immunocompromised patients. These critically important guidelines are well exceedingly well with our development of CM04S1.

During third quarter, multiple presentations of clinical results for CM04S1 were provided at the International Workshop on Chronic Lymphocytic Leukemia, the World Vaccine Congress Europe and the European Society of Clinical Microbiology and Infectious Disease.

Each of these presentations resulted in additional and expanded discussions regarding potential partnering and collaborative developments.

Let me point out, while such discussions tend to follow a somewhat tedious due diligence process, we are encouraged by the continued interest in CM04S1 as the leading multi-antigen COVID-19 vaccine in clinical development.

Relative to our plans for a Phase II Gedeptin trial in head and neck cancer, the primary determinant of the timing to initiate the Phase II trial is the completion of necessary product manufacturing. That is underway, along with the continued clinical operations plans and the necessary regulatory aspects.

Earlier this year, Dr. Marc Pipas presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the Phase II study.

Peer-reviewed publication of this work is forthcoming in JCO Oncology Advances, so be on the outlook for this.

Following the 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 KEYNOTE-689 trials 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 head and neck, who are being considered for surgical resection with curative intent.

Our primary endpoint will be major pathological response. 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.

In addition, we are 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 business partnerships and collaborations in support of worldwide development, commercialization and distribution.

Our priorities and anticipated milestones for 2025 through 2026 remain focused on advancing GEO-MVA to clinical evaluation, advancing GEO-CM04S1 for immune-compromised populations, advancing the progress of the advanced MVA manufacturing process and our focus on oncology, specifically related to Gedeptin is a major priority for the future of GeoVax.

We have high expectations for the potential broad utilization of Gedeptin against various solid tumors, especially in combination with immune checkpoint inhibitors.

We also are focused on progressing various partnering and collaboration discussions in support of these developments with the potential to accelerate the pace of these programs.

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 Chief Financial Officer, for a review of our recent results and financial status. Mark?

Thank you, David. And the details of our third quarter financial results are summarized in today's press release. I'll start the review with our income statement. During the 9 months ended September 30, 2025, we reported revenues of $2.5 million versus $3.1 million in 2024. This relates to the BARDA Project NextGen contract that began in June 2024.

And as we previously discussed in our Q1 earnings call this year, in April, the contract was terminated along with other Project NextGen funded contracts as part of the government's efficiency program, so there were no contract revenues reported during Q3.

Research and development expense for the quarter was $5 million versus $7.4 million in 2024. For the 9-month period, R&D expense was $15.1 million versus $16.1 million in 2024.

The decrease during 2025 is primarily related to discontinued costs associated with the termination of the BARDA contract as well as lower costs for the CM04S1 clinical trials and manufacturing costs associated with the CM04S1 and Gedeptin programs. These lower costs were partially offset by higher personnel and consulting costs and manufacturing costs associated with the GEO MVA development program in preparation for initiating clinical trials in 2026.

General and administrative expense was $1.3 million for the third quarter of '25 versus $1.2 million in '24. For the 9-month period, G&A expense was $4.6 million versus $3.8 million in '24.

The overall increase during 2025 is associated with higher personnel costs, investor relations consulting and other programmatic expenses and stock-based compensation expense.

Other income expense was $151,000 for the year-to-date period in '25 as compared to $70,000 in '24, primarily reflecting higher interest income. So overall net loss for the quarter was $6.3 million versus $5.8 million in '24 and $17 million for the year-to-date period versus $16.7 million in '24.

Turning now to the balance sheet. Our cash balances at September 30 were $5 million as compared to $5.5 million at December 31, '24, reflective of $16.5 million used in operating activities, offset by $16 million in financing transactions.

Our outstanding common shares currently stand at $27.7 million.

Supporting our clinical programs for the priority programs at CM04S1, GEO-MVA and Gedeptin will be the most significant use of our cash for the foreseeable future.

We continue to explore various strategies to fund these programs through several valuation inflection points and also to extend our cash runway. These could include strategic partnerships, nondilutive funding or additional offerings of our common stock. And I'll be happy to answer any questions during the Q&A, and I'll now 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.

[Operator Instructions] And our first question will come from the line of Jonathan Aschoff with ROTH Capital Partners.

I was kind of curious, can you envision any kind of scenario, an outbreak type of scenario that would get MVA into the hands of governments? Is there anything that you can think of that would make that go commercial at least temporarily way before you would do any sort of clinical trials with it?

This is David, Jonathan. I wouldn't anticipate that prior to any clinical evaluation that such a situation would occur. We do believe there may be an opportunity as well as a significant need for emergency use licensing, which would come through WHO based on certain situations occurring. And some of those types of discussions were part of our recent trip in Europe that we had with WHO and other parties.

Okay. I think that's really all that I had. The Q will come out soon, yes.

Yes.

The 10-Q.

Yes, the Q is [Technical Difficulty].

Yes, I think came out at 4.

One moment for our next question -- and that will come from the line of Robert LeBoyer with NOBLE Capital Markets.

Congratulations on all the progress you've been making. I know it's probably a little early to talk about the collaborations specifically. But on the broad strategic level, is there anything that you can tell us about what you're thinking in terms of the collaborations or partnerships or anything like that, that would be helpful in determining what the prospects are for kind of business combination or partnership?

Sure, Robert. This is David. We hold worldwide rights for all of our product assets. And our plan and our focus is to register broadly on a global basis. It doesn't mean every single country, as you know, but broadly to register on it. And our initial thinking is that we would be able to handle North America, which would be the U.S. and Canada, but I would also underscore that we'll always listen to any proposal that a potential partner has. We are quite active in attending various conferences as we just did, both World Vaccine Congress Europe as well as BIO-Europe. BIO-Europe is largely a partnering-oriented conference. We attend that every fall as well as in the spring as well as obviously U.S. based similar types of conferences.

So increasingly, our discussions related to potential partnering or collaboration, which would entail involvement of a partner as we develop it for a particular region, and you can sort of think through how certain rights would be distributed if someone was heavily focused in a certain region, the Pacific region, then they might be assisting us in the development process for their regulatory process, et cetera. So all of those types of concepts are actively discussed in meetings that we continue to have and have been having. And we're open to whatever makes sense from a win-win and from the basis of value for our shareholders as well as the stakeholders who are out there.

One moment for our next question. And that will come from the line of Jim Molloy with Alliance Global Partners.

This is Laura Suriel on for Jim Molloy. So for GEO-MVA, can you just talk a bit more about the collaboration you have in place with the University of Queensland and UniQuest for the needle-free administration method that you have for this vaccine? And also any research or manufacturing plans that you have in place here as well?

So we announced not too long ago that we were doing an evaluation in conjunction with the technology out of out of Vaxxas. And we believe it's very important and in fact, critically important for certain regions of the world to look at nontraditional delivery methods. And as you know, Vaxxas is a leader in the area of microarray patches. There's someone we've known for several years as well as other very good players in those delivery areas. And so we're evaluating it to see what the feasibility is relative to GEO-MVA.

And as information comes actively -- in evaluation now, as information comes forward, we will make appropriate announcements of that. And so that's what we're doing within that realm of it. You asked a question, I think, about manufacturing. What was that? I didn't quite get it, please.

Just the manufacturing that you might have for this particular program for GEO-MVA?

GEO-MVA, I'm going to ask our executive lead for our GEO-MVA program, John Sharkey to address that. John?

So in regards to our manufacturing, as we've explained before, our lead here is to manufacture on the CEF platform, Chicken Embryo Fibroblast. That is the fastest pathway to registration and EMA has understood this.

Our partner is, as we do with all our programs, we use CDMOs. And so we're partnered with Oxford Biomedica in the U.K. We are -- as David mentioned in the presentation, we're in the process of packaging our clinical supplies, and we are in active discussions with OXB to how we can expand the supply out of their facility as well in discussions with other potential manufacturers to add additional supply as we move -- when we move forward to commercialization.

[Operator Instructions] And our next question will come from the line of John Vandermosten with Zacks.

So you guys are working with CEPI, Africa CDC, WHO and others. What regions of the world are looking most supportive for your vaccine programs? And then what are their pathogens of greatest concern?

I think clearly -- and John, that from the perspective of GEO-MVA, it's obviously in the Southern Hemisphere, where you see endemic outbreaks. But then we're also seeing increasingly reports of Mpox and the new strain Mpox becoming evident not only in the U.S. but throughout Europe. But certainly, the concentration is in the Southern Hemisphere. And there's a significant interest from parties that relate to that. I mean we keep being encouraged and told by WHO leaders that this is not going away. It's going to continue to evolve. It's not going to get any better and that they really are in need of our supply contribution as well as the eventual shift to our AGE1, our suspension cell line, continuous manufacturing process for that. So I think from that standpoint, that's where that one is heavily concentrated, which sort of is intuitive. But it's on a broader basis. It's not just the stockpile needs, it will eventually also include the response in a more timely manner to endemic needs also. So we believe that.

When it comes to our CM04S1, clearly, the most significant need are among those populations who have inadequate -- they have medical conditions that have rendered their immune systems, basically inability to appropriately respond to antibody stimulation. And for these people, as I mentioned, the pandemic continues. I mean, these 40-plus million adults in the United States, the estimated 400 million worldwide who have various medical conditions, blood cancers, kidney disease, diabetes, multiple sclerosis, lupus, et cetera, it goes on and on. These are individuals that their risk is not so much, for instance, to die of the blood cancer that they have or to be hospitalized from, it's more from an infection. That's where they're risk.

And so that's where we see a broad interest for those parties that are caring for individuals who have such medical conditions. These medical practitioners, these medical health care groups, they are very interested in what our vaccine has the capability or potential to do and how can we move it faster. That's what we're always asked. And the answer is as a pre-revenue company, it's all about the balance sheet.

The stronger our balance sheet is, the faster we can move something forward. Obviously, we're all looking forward to the Phase II trial with Gedeptin. And as we go forward with the implementation of that, evaluating Gedeptin along with pembro in first-line therapy, you're following mimicking the KEYNOTE-689 trial. So there's a lot of interest in that related to any parties that are following solid tumor cancers.

So we get a question on all of these at various meetings. I would say right now, we have many more questions and interest because of the sense of urgency related to GEO-MVA. We spent a lot of time addressing that as well as opportunities with Gedeptin.

Okay. And my next question is on Gedeptin actually and the use of -- you mentioned that you're going to have it in combination with pembro. Do you think by the time this is approved, there'll be a biosimilar version of that available? And do you think that will help adoption?

I would say I really don't know because we may very well continue to develop Gedeptin across various immune checkpoint inhibitors. We have other players who have checkpoint inhibitors are interested in what we're doing. Obviously, we don't have the resources to do a blanket testing across all immune checkpoint inhibitors, but we do have potential interest, and that may evolve into some collaborative development opportunities.

We've had some discussions, but I would be -- it would be incorrect for me to suggest that we're actively in discussions that are going to, within a reasonable time period, expand it to other ICIs.

We have interest that's been expressed. We've had a few discussions, and we're certainly open to that and would encourage such discussions. But we'll just see how those discussions continue to evolve.

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

Well, thank you, everyone, for participating in today's update. We really appreciate your interest, and we look forward to ongoing interactions. As always, I wish to acknowledge and thank the GeoVax Board of Directors and advisers -- certainly, our GeoVax staff and the many other parties who contribute toward our success.

We're 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 welcome any and continued inquiries about opportunities at GeoVax. We're a small company, so we received many more inquiries than we have availability for, but we thank you for your interest.

We're most proud and appreciative of our team, including those external partners who continue to contribute to the progress and success underway at GeoVax.

For all of us, it's a great pleasure serving our shareholders and being a part of this team.

Our overriding goal is to improve lives worldwide through our development and commercialization of novel critically needed cancer therapies and infectious disease vaccines.

And with that, I want to wish everyone a safe and enjoyable day. And again, thank you for your time and attention.

This concludes today's program. Thank you for participating. You may now disconnect.

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 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 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 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 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 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 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 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 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?

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 6 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 6-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 6-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.

[Operator Instructions] Our first question comes from Jonathan Aschoff with ROTH Capital Partners.

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?

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 2H '26 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?

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 immunobridging study could -- and appropriate [ 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?

Yes, it was $10 million for the 6-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.

Our next question comes from Robert LeBoyer with 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 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 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. Yes, you're right. So what we have proposed to EMA, and we have agreement with is we will do an immunobridging 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 U.S. 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 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.

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?

Yes. 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 0 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?

Yes. 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.

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

On the Gedeptin, is the start date for that second half '266 as well or is that...

That's correct. Yes, 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?

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 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. So that's [indiscernible] we will have 1-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 2-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.

[Operator Instructions] Our next question comes from John Vandermosten with Zacks.

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 2 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 IIb 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 2-year process. So that would be 2 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?

Yes. 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 2 Phase II 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 2-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.

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