GeoVax Labs, Inc. (GOVX) Earnings Call Transcript & Summary

All right. So the next presenting company is GeoVax Labs from Georgia, United States. And GeoVax Labs is focused on immuno-oncology infectious disease vaccines. And presenting for GeoVax Labs is their Chairman and CEO, David Dodd. David, over to you.

Thank you, and I appreciate everyone's potential interest in GeoVax, and welcome to our story. And I know that we're also webcasting this, so I welcome everyone who is participating otherwise. So thank you. So let's get started. There's a little something here, but anyway, we'll go ahead. So please take note of our forward-looking statements. We're a Phase II company. We'll talk about our programs that are going on. But I would just like also to mention that these 4 principles at the top sort of guide how we think about our company, how we make decisions about it, and that's innovate, differentiate, accelerate and collaborate. Obviously, to innovate, we want to make sure that we have patented proprietary products and all that we're able to differentiate and address unmet medical needs. We're targeting populations that are generally underserved or unserved by existing products or standard of care. You'll hear a number of points on that. And in doing that, we focus on pursuing expedited registration pathways. As a smaller company, we are reliant on potential partnering and collaboration. We have worldwide rights for all of our assets. We expect to have those broadly registered as they're developed and all for global commercialization. And we basically have what we can believe is a compelling story to tell, driven by a strategy that we believe has been validated by our years of experience in the industry. I'm going to focus on our advancing programs. I'm going to ask the person in the back. There is a little black box that is going through the slide as I'm looking at it, and it's disruptive. So I don't know if there's anything you can do about it. But I think you didn't hear anything I just said, so I'll continue and go. So what I'm going to talk about is, first, our next-generation COVID-19 vaccine, known as GEOCM-04S1. Obviously, GEO is the nomenclature we use to distinguish GeoVax. Now this is very critically important because we're differentiating, again, going back to that initial slide, on how we approach COVID-19. Most people sort of tired of it. They have COVID fatigue. However, there are significant populations, as I'll comment on, in which they are underserved and unserved populations. These are specifically those individuals who have medical conditions that result in their bodies being weakened or depleted in their ability to respond to antibody stimulation. So they're immunocompromised, and we'll talk about those. There's about 40-plus million adults in the United States in that collection of patients, over 400 million worldwide. So we're not talking about an insignificant number. We will talk about that. We also are focusing on our vaccine because we think it would be an ideal vaccine, certainly, in conjunction with what is currently out there, the first-generation of vaccines for health -- generally healthy adults. We think it will get more robust and longer lasting. We'll talk about that. GEO-MVA. You've heard a lot in the last 2 years about Mpox or monkeypox, which is also related and in the family of smallpox in the vaccine there. We'll talk about our rapidly progressing vaccine in that regard. And then finally, one of the most exciting things we have is a broad-based technology called Gedeptin, stands for gene-directed prodrug therapy, and that is progressing as a therapy for solid tumors. Our initial focus is on head and neck cancer, and we'll talk about that in our impending start of the Phase II trial. So I look forward to this and then answering your questions. So the first-generation vaccines, that -- what does that mean? That's the Pfizer-BioNTech, the Moderna and the Novavax vaccines. We've all gotten used to them, but we've also learned that they're not quite as perfect as we were told originally, 94%, 95% protected, going to last a year. What's the reality? Limited breadth of protection. Every time there seems to be a new variant of concern, you have to reformulate them. That takes time. By the time you get a reformulation out there, you're sort of midway to the next variant of concern. That's been a very major disappointment and limitation. Limited durability, not lasting a year, not lasting 8 months, but more like 4 to 6 months. Some people say 3 to 6 months. But basically, it requires continuous boosting. If anything, certainly, the mRNA appear to be more of antibody stimulants rather than actual vaccines. So we have a continuum there. And then most importantly is they provide an adequate protection for certain populations. And these are individuals, again, who have a medical condition, maybe a blood cancer, maybe kidney disease, maybe diabetes. They may have lupus. All of those and other conditions result in the human body being depleted in its ability to respond to antibody stimulation. If a vaccine is designed to stimulate antibodies production to neutralize those types of threats and yet the body has been depleted of that, then you are not helping those individuals. There are 40-plus million adults in the United States alone, as I mentioned, over 400 million worldwide. For them, the pandemic has never ended. They are still sequestered. They're still dealing with this. They're still at high risk of severe disease, hospitalization and even the risk of death. They're not like the rest of us -- many of us who you get COVID, it's like a bad cold. But for these populations, this is a severe and critically risky situation. So what's a next-generation vaccine? Well, it addresses each one of those points. And this is defined not by GeoVax, but by the White House in announcing Project NextGen in April of 2023. And they said, "We're looking for products either already in the clinic that have some data that can demonstrate the potential or can go quickly into the clinic that provide an increased breadth of protection, meaning in a broader array. So if there's a new variant arises, you do not necessarily have to reformulate it all the time." Also that gives you more likely 12 months of protection. So 10 to 12 months, something like that, as protection. And then most importantly, let's address that population that is so high risk, which are immunocompromised. Every time you read something about COVID today, it will still -- it will highlight very clearly that people with compromised immune systems are at high risk, and this is very important. Now why is that -- what is the point about it? Well, the first-generation vaccines are all built around inducing a strong antibody response. That's important. It's your first line of defense. However, the other side of the immune system, the cellular side, which is what we think of when we think about -- when we talk about T cells, that becomes critically important. This is out of the New England Journal of Medicine that was published in August of 2022 by Dan Barouch of Harvard. His whole point is that you need to utilize both sides of the immune system. You need to stimulate the antibodies for that first line of defense. But if you're going to address reducing the risk of severe infection, hospitalization, the risk of death, you have to engage the cellular immunity and T cells become critical. And so I encourage you to look it up, New England Journal of Medicine, August -- I believe it was August 31. It doesn't really matter. It's August, you can find it, of 2022. On the left-hand side here is really the design is our friend, the coronavirus, so the SARS-CoV-2 virus and all. All vaccines that are out there today, first-generation, focus on generating a strong response in attacking the spike protein. That creates neutralizing antibodies. The GeoVax approach is broader. Our technology enables us to encode or include additional antigens. That's not true with mRNA or other technologies as platforms. So ours, you can load in or encode multiple antigens. We utilize the nucleocapsid because that induces a very strong T cell response. And it's generally recognized to be conserved across all coronaviruses, which means it isn't depleted as the virus evolves. So that's the basis and differentiation of our product. What does that end up doing for us? It's so far, in our presentations and our publications, have shown a greater breadth of protection. There was a paper published. I think it was January or noted in January of 2024 that demonstrated protective immunity coming from our product from the original Wuhan strain, all the way through the Omicron XBB.1.5 without having to reconfigure the construct. So that becomes very important. Our durability in the clinic is currently estimated to be around 8 to 12 months. That's 2x what we're seeing from the first-generation. So this is very important. Also, we utilize as a platform modified vaccinia Ankara, which is recognized for its extreme safety. No surprises. It's been around since the late '60s. It was the vaccine that enabled the world to eradicate smallpox, that was announced in October of '77. And so it's well recognized. It's been tested in hundreds of thousands of people back in the late '60s, early '70s to show its safety. We've been given an exemption by the FDA to not have to do animal toxicology studies for our work with MVA and COVID-19. So it's got a lot of attributes. And I'll just also mention it can be freeze-dried. So mRNA requires minus 80 degrees Fahrenheit to be able to deliver. It's only good for 4 to 6 hours once you begin to utilize it. Ours, it can be delivered with minimal refrigeration or even freeze-dried or lyophilized. Fancy words there. Well, our biggest news was that in June of last year, we were awarded from BARDA approximately $400 million to support a Phase IIb trial, we'll touch on in a minute, of our vaccine compared in a randomized manner against the Moderna vaccine. Very important. The cost of this trial alone is almost -- it's like $340 million. So most of the money will go towards supporting the trial, and the rest is our manufacturing, regulatory, et cetera. The elements of this presentation are, as I mentioned, 10,000 patients. The 80 sites are now confirmed. The other work is going on so that in 2025, in the latter part, we can initiate the clinical trial. It always takes longer. The most frustrating thing for those of us in general management is always -- why it always takes longer, but that's reality. But that's where we are. But we're excited about that. Big news, it's cost reimbursement. We have other Phase II trials underway, and I'm going to touch on those. We have blood cancer trial of immunocompromised patients where we're evaluating our product, what we refer to as CM04S1 versus mRNA in a direct randomized comparison among -- as a primary vaccine. So we have that one underway. We're still adding sites. We've recently added Johns Hopkins and all and adding patients enrolled in there. Most excitingly is the immunocompromise among chronic lymphocytic leukemia patients. This is blood cancer. These patients are recognized. They have their inability to mount an antibody stimulation. They recognize that and their physicians recognize that they are unable -- they don't respond to the mRNA vaccines or to the Novavax vaccine. We'll touch on this in just a minute. This is a randomized comparison against the Pfizer vaccine. I'm going to touch on the next slide what the interim results that we recently reported indicated. And then we have a fully completed trial for which the final results will be coming out over the next month or thereabouts. It was completed. The last patient was enrolled in September 2023. So they're in there for a year. So that was September 2024. The statisticians are completing their work right now. And this is among healthy adults and is simply evaluating our vaccine. All the patients had received an mRNA, and we're evaluating 2 different doses of our vaccine to see if the lower dose is equivalent to the higher dose. So basically, lower dose is always better. So that's simply for support purposes for other plans. On November 19, we issued a press release. The DSMB, the Data and Safety Monitoring Board, reviewed the interim data of the comparison between the Pfizer and the GeoVax vaccine as a booster. So all the patients were CLL patients. They all had received, as an initial vaccine, the Pfizer vaccine, even though it was recognized it really doesn't do anything. But that's what -- what else you're going to do? It's what physicians do. So they did that. The report was the DSMB recognized that the Pfizer vaccine did not meet its primary endpoints. We met -- exceeded the primary endpoints. A recommendation was made and it's been implemented, halt the Pfizer arm and continue only with the GeoVax arm. That is underway now. We need only 26 more patients to complete that trial. So that should be done yet this year. That's the good news. The bad news is the trial is being done in Southern California, which has had a few problems. Our PI has been evacuated. Patients are hard to find now. So anyway, we still are focused on supporting them to complete this. Also, I want to point out this was -- this trial has been funded and is funded by -- largely from a private family foundation. So it's pretty much a non-dilutive for us, but it's exciting. So we plan to continue this. What is our marketing and business development strategy? That is to go after the immunocompromised patients and not go up against the big guys because we recognize we're small. Work with partners in other regions and all, but we believe that our vaccine has the opportunity to be the preferred vaccine for the 40-plus million adults in the U.S., the 400-plus million worldwide, to address their needs, which aren't being addressed today, and we'll live with that as a marketplace rather than the 9 billion or 10 billion people that are in the world. We'll let the big guys deal with that because we're seeing the uptake among general healthy people is diminishing and diminishing because they get tired of having to take more and more vaccine. We also hope to see that our vaccine provides a more robust, durable booster on top of mRNA, which would open up a tremendous series of opportunities for us, as you might imagine. So Mpox, August 14 to November 22 of this year, we learned about it 2 years ago when we heard something called monkeypox. Now it's called Mpox because we don't want to insult monkeys. That's important. But we had this year, in August 14, reiterated in -- on November 22 was the WHO declaration of Mpox as a public health emergency of international concern. That's the highest level of declaration WHO made. They do that. That gives money, some funding and support for that. So that occurred and was reiterated. So what's the big deal? This is not something that's going away. We now are on the second variant, known as Clade Ib. Clade IB, we had 2 years ago. That was largely among people transmitted through sexual contact. The current one is more virulent, higher mortality, easier transmitted. It can be picked up from bedsheets -- a [ channel ] from the bedsheet of some adult who's some relative, who's been visiting with them, they can pick it up. It's critically important to go after this with a vaccine. There are no therapeutics that address Mpox. You may recall that in August and then again, more recently, the therapeutic that is utilized against smallpox, both times failed in a clinical comparison trial to show that it also worked for Mpox. So vaccination is the tool that we have. But there's some real challenges there. First of all, this is a horrible disease. COVID, you don't really see and feel that much. It's a respiratory disease. This is one that gives you a lifelong scar. It's horrible to deal with. So what's the solution? Well, right now, there's a single supplier worldwide, and that's it. As a company, Bavarian Nordic, they make a vaccine. It's MVA. I've been talking about MVA because that's the basis of all of our infectious disease vaccines, and they provide that. MVA has a lot of great attributes. The downside is it's very cumbersome, very slow to manufacture. You can't transfer manufacturing because of a very complex process. They have a limited production capability. Africa alone needs -- has stated they need 20 million doses now, and it looks like they might be able to get 2 million to 5 million by the end of 2025. So this is a major issue. The same vaccine is also what -- the same vaccine that is -- that was used to eradicate -- as the tool to eradicate smallpox. It's stockpiled by the federal government and other nations worldwide against bioterrorism of smallpox. 2022, they had to redeploy the MVA Strategic National Stockpile, and we ended up going down to less than 10,000 doses. Then we spent 2 years rebuilding that, paying. Basically, the U.S. taxpayer is paying a Danish-based company to rebuild the stockpile, which 2 years later, they say, "Okay, we've gotten there. They're hitting record revenues with their contract." And then what happens in August of 2024, we've got another outbreak, and it's reiterated. So now we're depleting it again. And that's -- those are the tools that we have. So what is needed is an additional MVA. And a few years ago, we acquired the rights from the U.S. NIH of their MVA. Their MVA and the MVA from Bavarian Nordic both are derived from the same parental cell line. And so if there's anything as close as being what one might consider as a biosimilar in vaccines, just using that as a phrase, not as a regulatory statement, then it clearly would be our MVA and their MVA. So we have the rights -- worldwide rights of that to fully develop and commercialize. We now have completed the manufacturing of our clinical materials. We put acceleration on this year -- or last year, I should say, on that. And our final step is to go into the filing process, and then we'll have product available to start a human evaluation. Our regulatory strategy and guidance we've received does not require us to do a Phase I, Phase II, et cetera, trials. We're going to focus on doing a single Phase III trial. And then we'll also use the animal rule because this is not the type of disease that you're going to do some randomized comparisons. So one supplier worldwide isn't good. The U.S. government is very concerned that we're totally dependent on a foreign entity in this regard. There's not one manufacturer in the United States that does MVA. We utilize a CDMO that's out of France. So this manufacturer has significant experience. We're advancing ours. We're in dialogue. We've been meeting with WHO, with UNICEF, with BARDA, all the parties since last summer, dealing with them, and you can see we continue to go forward. And we do have underway, which I'm not really going to touch on, an advanced manufacturing that will enable MVA to be manufactured without going through the traditional complex challenging process and also be able to be flexible to move it around so that you can do it with suspension cells and not the traditional cells coming out of chicken embryonic fibroblast, which is the limiting factor. So I want to turn now lastly to Gedeptin, which I mentioned is a technology for which we hold worldwide rights against solid tumors. Our work thus far has been on head and neck cancer, specifically the Phase I and the Phase I/II. We're on advanced head and neck cancer. I'm not going to get into the mechanism of action. I encourage you to go to our website and look at that, but it's pretty straightforward and simple to utilize. And it's agnostic of the type of tumor, which is good long as it's needle accessible and you could treat it and utilize it, it works. So our initial focus has been, as I mentioned, on the advanced head and neck cancer. However, we recently announced and we've now selected the CRO. We haven't disclosed who it is. I got to keep some of these people sharp at this meeting and let them take us to dinner or something such as that, I guess. But basically, in July, we announced that our decision was based on a comprehensive review by our advisers in oncology of both the Phase I and the Phase I/II. We are proceeding with a Phase II trial that will be between 35 and 40 patients. It's going to be first recurrent head and neck cancer patients of Gedeptin in combination with an immune checkpoint inhibitor. And these are patients in preparation for first resection. So we're excited about that. This should start in the latter part around midyear to the latter half -- second half of 2025. So we're very excited about that. All of our milestones, which are outlined here, reflect what I've talked about, including the process development underway for the advanced MVA manufacturing, which we think will be a real game changer because it will open up capacity. It will open up flexibility. It will reduce cost. So it's got a lot of attributes that we think will push forward for GeoVax very significantly. So what does all this mean? This is not a sales forecast, I'll emphasize that. But people have asked, "Well, what's the value of going after all that?" Well, if we focus on COVID-19 on immunocompromised patients only and all -- as well as a mild penetration, I'll put it, of using our vaccine as a better booster, let's use the word better, more robust, more durable booster on top of mRNA, that's over $30 billion in value for us on a global basis. We have 2 minutes. That's fine. And so if we look at the smallpox, Mpox, you can see that, that is also a -- an additional. I'm waiting until that black box moves off there, $10 billion. Gedeptin, $15 billion, both early, basically head and neck cancer. And so when we look at that, that exceeds $50 billion. Now obviously, we're not going after that. But what I want to convey is that we, along with our eventual and hopefully, partners and collaborators on this, have a lot of opportunity. Again, going back to that concept of certainly collaboration, accelerating our process of going to the market, differentiating and then innovating, and we do think that the MVA product stand-alone, Mpox, smallpox, could well be our first revenue cash generator, and that could come up in the next few years. So thank you. Down the hall, there's a breakout room where I'm happy to answer questions. I have 1 minute exactly. So I appreciate your time, your attention and your potential interest. Thank you.

Thank you very much, David. So the Q&A would be in public breakout room #1. So you can follow him there.