Next, we have GeoVax Labs Inc. It trades on the NASDAQ under the symbol GOVX and is a clinical stage biotech company developing novel vaccines for many of the world's most threatening infectious diseases and therapies for solid tumor cancers. Happy to welcome Chairman, President, and CEO David Dodd. Welcome back, David.
Thank you, Anna. It's good to be here. This is our third year working together now. I just looked it up. Thank you.
Oh, that's great. Yeah, we're so happy. And what a success it's been so far. So for some of our viewers, why don't you remind us of GeoVax, your business, and your goals?
Sure. I'm happy to do that. So, all right, thank you everyone for your attention. I'm just going to highlight that there are four principles that drive GeoVax. We're a Phase 2 clinical stage biotech company. Anna explained what we're focused on, but the four guiding principles that drive everything that we do and which we invest, et cetera, are innovate, differentiate, accelerate, and collaborate. And what we mean by that is we have a very strong patent portfolio because we focus on innovation. We have over 120 granted or pending patents across 24 different families. We differentiate in that we focus on patient populations for whom they either are being underserved or unserved by current therapies or standard of care. And in doing that, we look to accelerate our development pathway to the point of licensing and registration. That's very critical to us.
As a smaller company, yet we hold worldwide rights for all of our assets, and our plans are to essentially register all of our products on a broad global basis. We're very active even as we speak and have been in discussions about partnerships and collaboration so that we can ensure the greatest access, distribution, and administration of our life-enhancing products. There's three programs that are our priorities. I talk about these all the time because this is where our balance sheet goes. One, and we're going to speak about each of them today. One is our next generation COVID-19 vaccine. We're going to talk about that. We're going to talk about our mpox or monkeypox, smallpox vaccine, where it stands, why it's important, et cetera.
Then also Gedeptin, which is our solid tumor therapy for which we have made some announcements yet this week about the progress there and our plans on that.
David, last summer you announced a major federal government award in support of your next generation COVID-19 that you mentioned. Remind us of the basis of and maybe some particulars of that award.
Sure. So the background is that the first generation vaccines, which were very important, as we all know, they sort of halted the pandemic that was just exploding worldwide. But when I refer to the first generation COVID-19 vaccines, I mean the Pfizer vaccine, the Moderna vaccine, and the Novavax vaccine. And yet, as we've had those out there since late 2020, when we first heard about the first successful development, what we have learned on a global basis from a public health perspective is they have an unacceptable limited breadth of protection. What that means is we keep hearing about new variants. A new variant arises, and then the vaccine has to be configured, and it's taking like six months to do that so that by the time they get a new one, we're on halfway to the next variant.
So we started with, you know, everybody knew the Wuhan strain. We now are dealing with Omicron, JN.1, and those types of things. But that just isn't acceptable long term. The second limitation is the lasting power or the durability. In reality, what we found is these vaccines last about three to six months. And that's versus the stated goal and continued goal of approximately 12 months. And then I'll just add that the third limitation is that there are populations who have medical conditions that result in depleting people's immune system from providing sufficient protection when they are vaccinated. These are people with blood cancers, kidney disease, diabetes. They may be organ transplant patients on immunosuppressive drugs which suppress their immune system. So we have to have something that works for them.
Let me just add there are over 40 million adults in the United States who have various medical conditions for whom the current vaccines are inadequate. So that's a lot of people. It's actually over 400 million worldwide. So in 2023, the federal government defined and announced an initiative going after what they refer to as next generation COVID-19 vaccines, and specifically, those were to be vaccines that were either already in clinical evaluation or could quickly go to clinical evaluation that had been showing the potential or showed the possible potential of overcoming each of those limitations.
That has resulted in last June. GeoVax was awarded an award from BARDA, a federal government entity out of the Department of Defense, valued at approximately $400 million to conduct a major trial that evaluates our vaccine versus the Moderna vaccine, randomized in 10,000 patients, 5,000 on our vaccine, 5,000 on the Moderna vaccine. These are healthy adults. It would be evaluating our vaccine to see if we can overcome those limitations. Our product was selected because it has demonstrated in the clinic. It's demonstrated a durability of eight to 12 months versus the three to six we see with the current authorized. We had been demonstrating that we showed protective immunity from the original Wuhan strain all the way through the Omicron strain without having to reconfigure. We were showing long-lasting power.
And perhaps most importantly, we were showing that we induced very strong T cells as well as antibodies. What's all that mean? It means that for those people who have blood cancers, chronic lymphocytic leukemia, diabetes, kidney disease, et cetera, for those populations, that we're providing them a greater breadth of protection. So that became very important. So the current status of this program is that the 10,000 patients haven't started being enrolled, but the 80 sites are now confirmed. We're signing contracts with them right now. And we expect to see this study activated in the second half of 2025, probably around October. In between now and then is the work that goes into confirming the sites contractually, but also producing the vaccine so that we have all the, at the time we start, we're going to have all of the vaccine already produced and ready to go forward.
So that's where we are. That's a very exciting program. And that's really the current status in terms of the BARDA Project NextGen program.
And David, when will the results of that be available? And tell us a little bit else what is going on with this vaccine?
Yeah, as I mentioned, the program, the vaccine is probably going to start. We expect it'll start in October. That's the current schedule. There's a contract, a clinical research organization, CRO, that's being funded directly by the government on our behalf. We work obviously very closely with them. If we start in October, the current plan and anticipation is it'll take six months to enroll all 10,000 patients. The study will then last for a year, and then they'll be monitored for another year. So that means we would then get into 2026, then 2027, and 2028 is what we'd be looking at. But there will be interim, you know, reports of the progress. Let me also mention that there were only six vaccines that have been selected. Each vaccine is following the same type of protocol.
So some are, for instance, an intranasal, some are an oral vaccine, but in each case, it's a 10,000 comparative trial against one of the first generation vaccines and that evaluation vaccine. And in each one, it's the same type of protocol. So it's, once we start vaccination, it's anticipated to take six months, all patients. Then we'll monitor them. That'll take a, it'll go for a year, so it'll last for a year. And then we'll monitor them for another year and also have that data analysis. So that'll give you some insight in terms of what we're looking at from a timing standpoint.
Fantastic. And you have some more news about what else is going on with this vaccine. I see here some more clinical trials.
Sure. We really do. And I'm going to focus on one in particular. So I'm talking about immunocompromised individuals. chronic lymphocytic leukemia is a recognized. It's a blood cancer, but it's well recognized in medicine that patients with CLL, their bodies have lost the ability to respond to antibody stimulation. It's well known in the CLL community that a CLL patient does not respond to the current vaccines because those are focused on inducing a strong antibody response, yet they don't have it. These patients are still being sequestered in some cases. And they're, again, in total, there are over 40 million adults who have some type of medical condition that put people in this state. We selected the CLL patient population initially because A, they have a great need. B, they qualify for, because there's so few of them, that they qualify for orphan drug status.
Then C, most importantly, we believe that by addressing also the T cell side of immunity, so the cellular side, we would be able to see a difference there. What has been conducted has been a trial. The interim results were recently announced. Basically, it's a direct comparison against the Pfizer vaccine of our vaccine versus the Pfizer vaccine. In November, as this slide demonstrates, the Data Safety Monitoring Board reviewed the interim data according to the protocol, and they ended up announcing that the Pfizer vaccine had not met its endpoints, and they recommended halting that because it was viewed as being insufficient and not doing anything for the CLL patients. But the recommendation included to continue the trial with all patients being placed on our vaccine because our vaccine exceeded the endpoint that was being looked at. We are very excited about this.
It's the first time that there's been clinical evidence in a direct comparison between an mRNA vaccine and an evaluative or a testing vaccine among immunocompromised patients that our vaccine has worked, theirs failed. So we're very excited about it. We need only 26 more patients to complete this trial, which we anticipate will be done in 2025. Should the final results be representative, reflective of what we've already seen, then we're going to focus on meeting with the regulators to talk about a next stage expanded trial under orphan drug status that will enable us to go forward with an expedited pathway towards licensing and registration. So we're quite excited about that. And then finally, I'll just mention that what we're doing is also to evaluate the same vaccine as a better booster on top of mRNA. But let me just emphasize, we have global rights.
We're in discussions right now for various partnerships because there are 400 plus million such adults around the world. We need a vaccine or we need vaccines that give you a broader, longer term protection, including addressing the needs of immunocompromised patients.
Now, thank you, David, for all of that. I know that over the past couple of years, we've heard a lot about monkeypox or mpox. And so I want you to tell us a little bit about this disease and how much of a threat it represents. Should we be concerned?
Sure, Anna, this is critically important. And I say that not because we're working in it, but on August the 14th of 2024, reiterated on November the 22nd, the WHO declared mpox or monkeypox as a public health emergency of international concern. That state is a formal statement of WHO, the highest level declaration they make about an epidemic or infectious disease outbreak. It's critically important. We dealt with it two years ago in 2022. That was a different strain. And now we're dealing with a much virulent, a higher mortality one now. And so why is this though so important that they announced this? Well, first of all, it's easier transmitted this time around, but the greatest challenge is that there is not enough product or source of vaccine to be available not only in Africa, but elsewhere in the world.
So it's a very big concern with WHO, with whom we've been meeting on a continuous basis. The symptoms are horrible. So I'm not going to dwell on this because it can blind people, getting these marked in their eyes. It's long lasting. It's in their mouth. It's just a terrible situation. So let me just go to probably the next point, which would be, what are we doing and what's the solution, if you don't mind? Because I get very passionate about this. I've recently been in person briefing the WHO, the Africa CDC, UNICEF, other parties that are very focused on this. The number one need is additional vaccine. The vaccine that is utilized to prevent mpox is the same vaccine that is also authorized against smallpox.
It's one and the same because both of them have that pox name in them because they're of the same pox family, as they call it. Now, what is critically important to know is that right now there's only one company worldwide that supplies this vaccine, and they do not have enough supply, nor do they have enough capacity to be able to produce the supply. GeoVax acquired the rights to be able to develop this vaccine from the U.S. NIH a few years ago. We've been working on it, knowing that there was insufficient supply. We've got a monopoly. Monopolies mean that the price is too high. Even if Africa can get limited quantities, it's very expensive. What we're seeing is Africa currently needs. The Africa CDC has stated repeatedly, they need 20 million doses. They may get two to five million by the end of this year.
We need some in the U.S. Also, we've had outbreaks there. It's in Europe now, so GeoVax put forward a process over the last year and a half to manufacture, produce our vaccine, which is essentially the same as the one that currently is available through the single supplier. We've recently announced that we have now completed, under good manufacturing practices, the clinical material, which means product that can go into humans to be evaluated and hopefully be able to contribute to slowing down this outbreak and all, and our next and final step is to place it, basically package it, meaning putting it in vials. We literally are negotiating that final step for closure this week.
What we're focused on is getting it done as fast as possible at its lowest cost because we want to deliver this product at a lower cost than what the monopolistic supplier is currently doing because they're supplying it. It's like $300 at least in the United States. Africa, even if they can get access to it, can't afford it. This is a critical and a critically important issue that we're dealing with right now.
Absolutely. David, let's switch to cancer therapy and tell us a little bit about your Gedeptin technology and why investors should be interested in GeoVax in this area.
Sure, Anna, this is very important because solid tumors typically are addressed and they're a little bit different addressing depending on which solid tumor it is. GeoVax has a basic technology. We've been working on head and neck cancers the last several years, but it's applicable to any solid tumor that is needle accessible, which is essentially every solid tumor nowadays with today's technology. So it's very important. I'm going to not spend any time on the mechanism of action other than saying that it has been validated in Phase 1 clinical testing. We recently completed Phase 1/ 2 testing type thing. So we know that it does what we want it to do and it's also frankly very safe.
What have you learned so far about the potential for Gedeptin and what can investors expect to occur during 2025?
What we've learned, which is very important, is first of all, it's very safe, and secondly, perhaps equally important, is that it indeed does reduce, if not eliminate, treated tumors, so this becomes very important. Other data we found was that if you use Gedeptin in combination with a product such as Keytruda, these are known as immune checkpoint inhibitors, which have inconsistent performance. There's high hope for immune checkpoint inhibitors such as Keytruda, Opdivo, but they don't work consistently and all, and so the question was, is there a way to improve their performance? If you combine an immune checkpoint inhibitor with Gedeptin, what we have seen is much greater performance consistently.
What we have recently announced, and we actually have issued a press release, I believe it was yesterday on this, was that we are going forward with a Phase 2 clinical trial that will be initiated in third quarter of this year that will be looking specifically at first recurrent head and neck cancer in combination with an immune checkpoint inhibitor. So this is very exciting. This trial will go fairly fast from everything we can anticipate. So we anticipate reporting data on it in 2026 during the first half. So we're excited about this, but this may open the way because we're also looking at triple-negative breast cancer and other areas here. So this is a very exciting area for us to look at. And we think it's going to bring a lot, a very important therapy to use in numerous solid tumors.
Thank you for these updates, David. Can you provide any insight to what these various opportunities might mean to investors, as well as the 2025 milestones you're expecting?
If you look at the value, sort of the potential, the opportunity, you can see that looking at the COVID-19 vaccine, the mpox, smallpox vaccine, and then Gedeptin , just in head and neck cancers together, they represent a market potential, not a forecast, but market potential worldwide of approximately $55 billion. There's a lot that really translates to how much medical need there is. Secondly, this year we will be reporting milestones throughout the year on each of these three programs. The other areas, we do have an advanced manufacturing system that is going to be able to produce COVID-19 vaccine, as well as our mpox, smallpox vaccine, much faster, at greater quantity, at a much lower cost. That'll be a very good breakthrough. It's not as exciting as talking about products, but that'll cut across numerous products.
So we're excited about that. So we look forward to working with you and your colleagues and talking to the investment community throughout the year and reporting on our updates.
Wonderful. And we do have some questions from our viewers, if you would like to take a few of them, David.
Sure. Go ahead.
Great. Let's jump in. Oh, sorry. So some of this you probably already addressed, but let's talk about the timeline for the commercialization of the mpox, if you can hit that one more time.
Exactly. That's an excellent question because I really didn't hit on it, but it's an important one. What we are working right now, we've been in discussions and been given guidance from regulators, so this is a highly focused to go as fast as possible because the need is so great, so what we believe is that within the first half of this year, we will have, we have all the product produced, we will have it vialed, so that'll be done, and we will then be working with WHO and others to begin some different forms of clinical evaluation. We anticipate initiating our own clinical trial. We have been given guidance that we only need a single immuno-bridging trial for registration because our product is essentially already on the market through a competitor, so they're essentially the same.
They come from the same parental cell line as it's known, so we can go quickly with that. We can potentially go even faster by working with WHO under their emergency use licensing, so we may very well, well, we fully expect that our product will be in people yet this year, and then we will be monitoring those data because the trial will be a very fast trial. It's not long term. Again, it's an immuno-bridging type trial, so we get data very quickly within six months, and we will be talking not only to regulators, but also to WHO, so we think that we may see if we look at it on a traditional registration, we're probably looking at around the beginning or end of 2028, something like that.
But we do believe that that may very well be able to be sped up by 18 months or more by focusing on it in the manner we have. And I'll just emphasize, we've been in touch and discussions with regulators on this and as well as WHO. Met with WHO in person just a couple of months ago and others. So we've been in those discussions for over the last two years. So we see a very quick timeline. The mpox, smallpox vaccine could very well and likely be our first revenue cash generator.
Would the company receive public or international or governmental funds for the mpox vaccine development?
We are pursuing that as we speak. That's why we spent three weeks in Europe talking to WHO, Africa CDC, UNICEF, other funding entities that do, let's say, non-dilutive funding. So it's not just coming out of equity sales and all. So we recognize the importance of that. And they have a great need to see additional supply. So we're in those discussions and negotiations as we speak. And again, we hope to be, well, we will update on those. We hope to update with very positive outcome of those discussions.
Kyle wants to know, will you need to raise money in the future? Are there any upcoming contracts coming up?
We absolutely need to raise money because we are a pre-revenue company and we live off our balance sheet as any company does, so we are focused on that. You know, we've been raising money a long time. The BARDA Project NextGen, that is fully funded, so that's approximately $400 million, but it's a cost reimbursement, so it's as we do the work that the money is paid. It's not a bolus of money that is given to you and go have a good time, but we could not pursue that trial if we did not have that funding. We have other discussions with non-dilutive entities that would bring funding in, but we do anticipate raising money, and I would say our operating cash needs over the next two years are between $25 and $30 million each year. That's what will support and drive our programs.
We don't have to have all that at once, but the sooner that we have a significant amount, the faster we can go because for some of these programs, there are opportunities to accelerate the pathway to critical milestones that could lead to accelerated registration. But we need to have that money on our balance sheet. So we're in discussions. Again, this week we're at the JP Morgan meeting out at San Francisco. And you can imagine we've been here all week and this is all about either partnering or building the balance sheet.
Question, can GeoVax be the next Moderna?
We would rather. I was at NASDAQ recently and they showed me in their museum that they had the first vial of the Moderna vaccine that came off the line. And I said, "Well, hopefully in the next few years, you'll be replacing that with the GeoVax vial." So what we believe is that we can be the preferred vaccine worldwide for individuals who have compromised immune systems as their COVID-19 vaccine. And we think that is realistic because we know that the Pfizer vaccine, the Moderna vaccine, and the Novavax vaccine is inadequate for that population. And right now, we are the lead vaccine developer going after immunocompromised individuals. And as you saw, that's an opportunity that's valued up to $30 billion. So we're not using that as a sales forecast. We do believe we could be a significant contributor by focusing on that critically high at-risk group.
That's what we're working towards.
You can end with this question, David: talk about some catalysts for your products that are under development for the remainder of this year and early next year.
It's really the same things because Project NextGen will start late this year. It'll continue into the next year. I would say another big catalyst will be the resolution as we get the results of the chronic lymphocytic leukemia CLL trial with the COVID-19. What we then announced through our discussions with regulators of how we're going to go after a registration for that in an expedited manner during the next two years, we'll be much more discreetly updating with hard facts and data about the mpox vaccine. Frankly, over the next two years, we'll have the results more than likely of the Gedeptin phase 2, or at least we'll have the interim results. I think we'll have very good clarity on how Gedeptin is doing in combination with the ICI.
So it's a good question because the next two years, what I showed as milestones, we should pretty much have the answers to those, including the advanced manufacturing process.
All right, David. Well, thank you so much for this very thorough presentation. We look forward to seeing you again, hopefully in the near future.
Thank you. Have a great day. Thank you, everyone, for listening.