Thank you. I hope everyone's having a good day, a good start of the week. So everybody having a good one? All right. Thank you, thank you. Okay, well, I appreciate the opportunity to tell you about GeoVax and the very exciting programs that we have underway. There are four words that drive what we do, and I'm not asking, you're not going to be tested on this, but I like them because I can remember them. One is to innovate, the other one is to differentiate, the other one is to accelerate, and finally, to collaborate. And that is the basis of the business strategy that we have as a corporation.
We want to focus on making sure that we have unique products and technologies that can deliver differentiated products that address the needs of those who are either underserved or not served well by what is existing therapy or either existing vaccine opportunities. We want to do this in a manner that will accelerate our path to commercialization, revenue development, and cash flow. We recognize that as a small company, even though we're developing all of our assets for global registration and global opportunity, we cannot distribute and administer those without strong business partnerships and collaborations. That is the basis of everything that we work on and that what drives what our planning and then our opportunities are. I'm not going to dwell on this, but we've got a lot of experience.
In other words, we've got a lot of old guys and we have some younger people also, but you're seeing some of us here in the room. I do want to emphasize that what I'm going to focus on today are areas that are either in the clinic or soon going into clinical development. But what I would want to underscore that in the U.S. alone, that these three assets represent over $25 billion in annual revenue opportunity. And so there's a lot available for where we are focused on, and I'm going to touch on each one of these programs and what they offer up to us and to patients in future opportunities. So let's start with oncology. So the medical need is for Gedeptin. You'll see in a minute what it is and what it does.
It's a brand name of a technology which is initially being developed for patients with advanced head and neck cancer. There are 15,000 such patients in the United States every year that unfortunately die. They've failed on everything. They're on palliative care. There are 67,000 new cases every year of head and neck cancer. We're focused on that population for whom there has really been nothing for them. We have orphan drug status in the current phase II program, which we announced last week. We had completed the enrollment of that program, is being funded by the FDA under the FDA Orphan Drugs Clinical Trials program. But our plans are to develop this asset to move quickly, to be able to...
This is the acceleration, to bring it to commercialization by targeting an unmet area of medical need, these particular patients, and then to work to earlier stage, both in monotherapy as well as in combination therapy, in conjunction with immune checkpoint inhibitors. And I'll touch on that. But it's basically been shown the technology to be tumor agnostic, so we're focused on solid tumors. Now, how does it work? I'm not going to get into a lot of discussion here. Just remember A, B, C, D, E. So A is you take a targeted tumor, and you inject a particular enzyme, the PNP enzyme, into that. B is it converts into the PNP cells. C is you then follow it with administration of Fludara or fludarabine phosphate.
Fludara or fludarabine phosphate is an approved hematologic chemotherapeutic agent, which in and of itself does nothing with solid tumors. But if it encounters a tumor that has been treated with the PNP enzyme, it converts into a highly cytotoxic compound called fluoroadenine that is destructive to the tumors. If there is no presence of the PNP enzyme in the tumor, it simply passes through, and it's very safe. So that is the basis of the technology that we are utilizing to go after solid tumors in a variety of different manners and at different stages, as well as in combination. So I mentioned some of the statistics and the prevalence on that, but worldwide, there are about 400,000 individuals who die annually of head and neck cancer. This is from the WHO.
So this is our initial indication, is going after this particular population, but with a focus on bringing it to earlier stage therapy and opportunities as we go forward. We presented at the annual meeting, international meeting in Montreal of the AACR, American Association for Cancer Research and American Head and Neck Society. We presented data on the current trial that showed that it is, in fact, extremely safe. That's always very important, but perhaps most importantly is that it does provide consistent reduction in the tumors, and that's what we're focused on doing in our current clinical program. Our goal and the guidance from the FDA for the current trial has not been survival. We're not trying to rescue these patients. These patients, unfortunately, are on palliative care. They're not going to survive.
But if we can provide them a reduction in the tumors so that they can swallow food better, they can perhaps speak better, now we're giving them a much better quality of life for their end stage of their life. The objective measures are the reduction on the tumor size through the treatment, but in reality, we recognize that this is not a rescue strategy at this stage. We're really focused on a very critically important group, which are individuals who otherwise have nothing, and it's a horrible disease if you've ever interacted with people who've had head and neck cancers. So following that, we will then focus on an expanded phase II. That's what our team is working on now to be able to go to the FDA and discuss the basis or the opportunity for an expedited process based upon an expanded phase II type trial.
And then we'll also develop additional monotherapy use. But at the same time, we've been supporting animal trials, and we expect to be going forward in the next year or a little bit more than a year with an IND for combination therapy in conjunction with immune checkpoint inhibitors. In that regard, we've seen some very encouraging data that demonstrates that if you utilize a checkpoint inhibitor in conjunction with Gadeptin, you end up seeing much greater, more consistent, successful performance of the checkpoint inhibitor. So we think there's a tremendous amount of opportunity with this technology and applying it. In infectious disease, we have a next-generation COVID-19 vaccine. Now everybody says, "I don't want to hear any more about COVID-19." We spent the last several years dealing with that.
But you may not be aware of it, that there are 15 million people in the United States, there are 240+ million people worldwide, who, because they have certain medical conditions, they may have blood cancers, they may have renal disease, they may be HIV positive, they may have sickle cell anemia, any number of, of conditions that have depleted their body's ability to respond to antibody stimulation. These are individuals who are not being adequately served by the current authorized vaccines for COVID-19 or the monoclonal antibodies. And that's a real challenge for these patients, and there's been nothing out there to, to deal with them. Some of them are at very high risk of, of severe disease, hospitalization, and, and death. And that's what we're targeting, and we're doing that for a couple of reasons.
1, obviously, being a small company, we cannot go toe-to-toe with very large players now. But if we can utilize our technology and go after a portion of the population for whom the current vaccines are inadequate and don't work, then we can own that space and have a very nice business. And that's our business plan and what we're focused on. Now, we do this because we take the SARS-CoV-2 virus, and instead of just utilizing the Spike Protein, which is what all the other vaccines are doing, to induce a strong antibody response, but remember, I mentioned these patients, their bodies do not respond to antibody stimulation.
But what we also do is we include another component of the virus called the nucleocapsid or N protein, and that is recognized for being conserved, meaning it isn't changed or affected by the virus, as you see with the spike protein, as new variants come along and evolve and all. And so it's conserved across all coronaviruses. So we have a dual antigen approach. The only product in clinical development that has a dual antigen approach is our product. And in that, it's important because this on the right side is out of a publication from 2022 in New England Journal of Medicine by Dan Barouch out of Harvard.
What he demonstrated in there, and I really like his figure here, so I utilize it all the time with proper reference, is that it demonstrates that antibodies are very important in the early stage of infection. But if you really want to reduce severe infection, hospitalization, and the risk of death, you have to induce and utilize T cells. And that's what we get and what we receive and what we induce by taking this dual antigen approach. We induce the antibodies, but with the nucleocapsid, we induce a very strong T cell response.
These data have been published, were published, in terms of the results in September of last year in Vaccines, demonstrating that our vaccine, without having to reconfigure it, as you have seen with all the other vaccines that are out there, the mRNA, et cetera, is that we've demonstrated protective immunity from the original ancestral Wuhan strain all the way through Delta and Omicron, the XBB.1.5. People keep asking me, "Have you done JN.1 yet?" The answer is not yet, but stay tuned because we continue to demonstrate that our construct does not have to be reconfigured. It's demonstrating thus far twice the durability that we're seeing with mRNA, with a very strong protective immunity response. What are our plans here? Is that, one, we think that by doing this, it's been basically shown to be variant agnostic.
We haven't had to reconfigure it, which means you can reduce the need for all the boosters that people are having to have, and it could also be a booster on top of, for instance, mRNA vaccines, which we think would give a more robust, more durable booster. Let me just go here. In fact, we have three phase II trials that are underway right now. One is immunocompromised patients, patients receiving stem cell transplantation. This is a very high-risk recognized group. That one is now currently in four sites in the United States at the Fred Hutchinson Cancer Center, University of Massachusetts, Wake Forest University, and ECU Health Medical Center. It's actively enrolling. We have immunocompromised patients who have chronic lymphocytic leukemia. Again, a very high-risk group from this blood disease.
That population is doing a direct randomized comparison of either our vaccine or the Pfizer vaccine as a booster for patients who have CLL or chronic lymphocytic leukemia. So that one is moving forward. We expect in 2024 to reach the point of an interim report on the data there, so we're looking forward to that. And then finally, as a booster among healthy individuals who received initially the mRNA vaccine, we have a fully enrolled... it was fully enrolled as of October of this past year. It's 63 patients, so what will occur during 2024 is we'll start seeing the data and reporting the data out of that. The patients are now coming in for different blood draws, as you can imagine. And what I'll also just underscore for those of you who may sometimes wonder, how do you afford all this?
The immunocompromised CLL trial is actually being funded by a private family foundation, so we're benefiting from their support and investment behind that. The data obviously is ours to use, but that's a nice way to have a program going. So we've got Gadeptin, which has been recently completed in the enrollment, which was funded by the FDA, and we have the CLL trial being funded by a private family foundation. So it's nice to have that. So what is our development plan? To basically validate the differentiation. Remember how important that is, that I pointed out. We expect to be able to demonstrate a more durable type of response, and to be the preferred vaccine for those individuals who fall into immunocompromised groups. And by doing that, we anticipate the opportunity for an expedited registration process.
So again, it goes back to those four terms I was mentioning, and we're very active in discussions already in about commercialization partnerships on a global basis, because, again, we have worldwide rights for this technology. So finally, I want to talk about everybody heard last year about monkeypox. We'd never heard about mpox before, it seemed like, and then suddenly, 2022, we were all inundated with it. There's one vaccine in the world that is authorized to prevent monkeypox as well as smallpox, and that's called Modified Vaccinia Ankara. But what's interesting is MVA is what is the basis or the platform for what we utilize as our vaccine platform for all of our infectious diseases. That includes the next generation COVID-19 vaccine. In fact, it's the only vaccine platform that in and of itself is a vaccine.
mRNA is not a—it's a platform, but it's not a vaccine. It does nothing until you put particular antigens in it. Adenovirus, which people at Johnson & Johnson and AstraZeneca might use, is not. It'll do nothing until you decide what antigens to put it in. But MVA, in and of itself, prevents monkeypox and smallpox. And we've demonstrated in a publication in August 2022, that our candidate, which is in clinical testing for COVID-19, which we refer to as GEO-CM04S1, also provides protective immunity against monkeypox. Some parts of the world, that becomes very important. But what we also recognize, there's only a single supplier worldwide of MVA as a standalone vaccine. It's a small Danish company, and they don't have the capacity or the capability to manufacture in a manner to meet the world demand.
So we looked at that and in late 2022, we acquired the rights from the NIH to be able to use MVA and develop it as a standalone vaccine for both monkeypox and smallpox. And to do that in a manner using a new advanced manufacturing system, but that will enable us to respond quickly with greater product being produced, with a higher yield, to be able to address epidemics and pandemics. And the purpose of this is, this could very likely be our first pathway to reaching revenue production and cash flow by moving forward with an MVA standalone vaccine, and it also is a priority for us. The objectives for this year is to report basically what we end up clarifying with regulatory authorities of the required pathway that we'll have with that.
So in here, there are a lot of patients that you can see of why it's used. We, we want to eliminate the need for stockpiling, but to be able to respond, because throughout the world in 2022, and even just today, we received a, a communication out of the Democratic Republic of the Congo about a big outbreak that they're having there. And, and they're in great need of product, but there's not enough product to go around. And so people are aware of what we're developing here and what our intentions are, and we expect to be the first U.S.-based supplier of MVA as a standalone vaccine against both monkeypox and smallpox. And keep in mind, smallpox is important because it's number one on the list of bioterrorism. That's how this whole strategic national stockpile got started, was because of the concerns about certain biological threats.
Following that is hemorrhagic fever viruses. They have very high fatality rates. You'll see, if you look into GeoVax, that we've also been demonstrating not only additional new patents being issued regarding of how we approach the hemorrhagic fever vaccine, but also recent publications of the data of our vaccine product candidates. Finally, I just want to underscore, I mentioned that the current manufacturer of MVA that is used and distributed in the world uses an antiquated and old manufacturing system. We put in place a few years ago, a process to try and transform to a new advanced manufacturing system that would be able to produce product in real time to respond to epidemics and pandemics. We ended up making several announcements last year.
One was to demonstrate the data that showed that we could produce using a continuous cell line of a SF-avian cell line, which means it comes from chickens or ducks, et cetera, that we could produce in that regard. We ended up disclosing what that cell line was when we completed the license of that, and we announced that in September. We also established a relationship with a contract manufacturer for producing MVA-based products that is well recognized and does a lot of work for the U.S. government with MVA manufacturing also. So we've got all the pieces in place, and a major objective this year. It doesn't get investors necessarily that excited because they like to think about product. But remember, everything we do that's infectious disease is based upon MVA.
Moving to an advanced manufacturing process means that we will then be able to leapfrog over anyone else that's utilizing MVA and be out there as not only being able to produce products that look good, let's say, in the lab, but when you demonstrate and validate them clinically, you can then produce in rapid time what is needed worldwide. So if we then simply look at what we're focused on this year, it's these four things that I've touched on. It's our next generation COVID-19 vaccine and the trials and the data that will be coming out. It's Gadeptin and reporting on what we see coming out of the trial that we've just completed the enrollment, as well as our plans for taking it forward, including in conjunction with immune checkpoint inhibitors.
It's MVA, or what we call GEO for GeoVax MVA, as our vaccine against monkeypox or smallpox, and it's our progress in the advanced manufacturing system. So that's what we're all about. So just remember, it all goes back to the concept of innovate, differentiate, accelerate, and collaborate. Because in the end, for us to generate the value for our shareholders and to have the fun we want to have by having these jobs, is we've got to be able to make sure that these products are not only distributed, but are able to be administered on a global basis. So with that, I'm finished with the presentation. I think we have five minutes. We can take a couple of questions if anyone has any. So if not?
Are there any questions from the audience?
Okay. All right, well, thank you so much. Oh, yes, ma'am.
Hold on.
Yes. I'm very interested in your drug. It's a vaccine? What's the, you know— Is it a vaccine or like a antibody? What kind of-
Vaccines.
Yes. So your drug is a vaccine, right?
Yes, vaccines as well as cancer therapy.
Okay. What kind of patients will meet the criteria for, to receive this medication?
So-
Like an early stage, a later stage, or prevent from the recurrence?
Well, for the next generation COVID-19 vaccine, it would could be used either as a primary vaccine or as someone needing a booster. And we made the business decision to focus specifically on immunocompromised patients for the simple reason that we don't think we have the the depth or the capabilities to compete with the Pfizers and Modernas of the world. Now, we do believe that ours would probably be a preferred booster on top of those other vaccines, but that's sort of the general population. From a business strategy, we're focusing on the development, on our clinical development among patient categories who have weak immune systems. Now, with Gadeptin, the initial indication is focused on end-stage patients because we believe that's the fastest route to market, and it represents a very high critical medical need per the FDA.
That's why they funded the study. So we think that's a way to go in. But as we develop the Gadeptin into other tumors, as well as in conjunction with immune checkpoint inhibitors, we believe we'll be able to, and we fully believe it will move to earlier stage types of cancer, people who've been diagnosed with earlier stage cancers, and will be able to address those tumors. So does that answer it? Okay, thank you. Okay. Bye. Yes, sir.
Quick questions, and if I miss it, I apologize. Do you have orphan status for some or all of these?
For Gadeptin, we have orphan drug status granted, and we were funded. The current trial that we announced the completion of enrollment last week was funded by the FDA, Orphan Drugs Clinical Trials Program.
And so with Gadeptin, that's the head and neck's?
Yes, that's advanced head and neck.
Any other,
Exactly.
Where else would you deploy it? Is that the scope?
Well, we expect to develop it for... well, the next stage would be earlier stage head and neck cancers.
Mm-hmm.
But the next development stage would actually be a larger phase II program, which we hope to be able to utilize as the basis for registration. And then we'll look at other solid tumors, and then as we go forward into the clinic with the combination therapy in conjunction with immune checkpoint inhibitors, we'll look at the opportunities there.
I see.
We just announced, I'll just mention, we just announced today a press release that we had, we announced the joining of our company, of our first medical director in oncology. So we have someone-
Great.
That shows you our confidence in this area of oncology.
So you've got orphan status, and then I guess my-
For that one indication, though. Keep in mind, orphan status is not for a product, it's for an indication.
Got you. And then, do you have... And if I miss it, apologize, how much human data do you have?
Well, on Gadeptin, we have phase I. We've presented recently-
Great
... the current phase, you know, stage of the Phase II. That was the chart that I referenced out of the Montreal meeting. With the COVID-19, we have the Phase I data. There have been numerous publications and presentations at international conferences on the Phase II programs that are underway, so those data are being presented. And we'll continue to and there was publication in Vaccines more recently. That was in September. It was very compelling data. And so there'll continue to be data rolling out on that.
Great.
Yes, sir. No, we're in phase II. Well, yes. There are a lot of questions there. And the answer is, it really all depends. Because if one goes into a business collaboration, more than likely, one would then be receiving an infusion of cash, which then reduces the amount of capital we would have to raise. I will say that publicly. No. Well, let me finish. Yeah, we've acknowledged that we are, you know, we're a pre-revenue company, which means we're always looking for capital. And the goal is to raise as much as you can. So $20+ million in 2024 would be a target that we're looking at. Exactly.
When you say to get to the end game, the end game will be defined as we learn with the data that comes out. That will guide us. So that's how we'll define the end game, is how well does the data that's being generated in the current clinical programs look at?
Okay. Actually... Sorry.
I have no idea.
Um.
Until we know what the end game is.
Okay.
Thank you.
Thank you for all of that.
Thank you.
So now it is a five-minute transition between company presentations. If you have any additional questions, David will be in public breakout room one, which is just in Yosemite B. You're right. So if you are staying for the next presentation, sit tight. If not, if you could please exit the room very quickly, we would appreciate that. Thank you. Thank you, David.