Our next presenting company is GeoVax Labs from Smyrna, Georgia. GeoVax is focused on infectious disease, oncology, and vaccines. Presenting for GeoVax Labs is old friend David Dodd. David, thank you.
Thank you. Excuse me. Thank you. Thank you for your interest and your attention. Oh, it's a pleasure to be here. Welcome to San Francisco. We're a NASDAQ company listed on the NASDAQ. GeoVax is our symbol, and I'm going to go through this, and if we have time, I'll take questions. If we don't have time, if you have questions, I can address those probably outside, so this is.
I'm not going to go through every slide. If you're interested in these slides and I create any type of interest and motivation in you, let me know and I'll send you the presentation. So we'll do it that way. We'll probably have it posted on the website, but this is our investment thesis. Basically, we have multiple clinical stage programs that are hitting on certain catalysts and milestones, some sooner rather than later and all.
And because of the stage and where we are in development, we're on a path that may very likely lead to revenue generation within the next three to four years. So we're quite excited at this stage, and I'm happy to be able to tell you about it. This just sort of takes you through some history of what we've done. Basically, built around the 2020 listing on NASDAQ we did and the reset, we went from being a preclinical company straight into phase II through transactions. That was our goal. We wanted to catapult and get things moving. And we did that, and we picked up the products. And then more recently, we added another product, and we'll talk about it. But we've been given an expedited development path, eliminating the need for a phase I, phase II, and going directly to a phase III.
We'll talk about that because that is probably the most de-risked phase III program in the entire industry that's out there right now. I've never heard of it, but it took us a couple of years of negotiation with regulatory authorities, but we did achieve that. These are the upcoming catalysts. This is what I really want to talk about. Again, if I stimulate any interest or if you have questions, these would be the thing, those things have it. GEO-MVA, so our nomenclature generally is GEO, stands for GeoVax, obviously. MVA is Modified Vaccinia Ankara. Now, MVA, just so you know, is years ago when I was redheaded, we were dealing with smallpox throughout the world. In 1977, in October of 1977, we had the last reported case of smallpox. It was declared eradicated from the world in 1980.
You always have to leave some time to sort of see that it happened. The way that happened was prior to that, when some of us were young, we used to get a little scratch on our shoulder and we got a scar, and that was the smallpox vaccine. That was using something called Vaccinia. The challenge with Vaccinia is that it's contraindicated, cannot be administered to us, too harsh, etc., to pregnant women, children, and people with a compromised immune system. So we never would have eradicated that, but during the 1950s and into the 1960s, a researcher was working and started trying to modify Vaccinia. So I got the M and the V out of Modified Vaccinia Ankara there, and he modified it by taking it through passages through chicken cells, so avian cell line.
Eventually, MVA, doing the work in Ankara, MVA, that's what it stands for, ended up being that it is a non-replicating viral vector, virus rather, or vaccine in this case, meaning that it does not carry any risk for mammals or for humans. It's exquisitely safe, but it retained that protective nature to it. That is how we were able to rid the world of smallpox, was through MVA. Later on, it was repurposed because it has a very large loading capacity, meaning you can put multiple antigens into it as a platform for vaccines. You can't do that with mRNA, for instance. You can put one antigen at a time. You can't do that with adenovirus, another platform. You can do one at a time. With MVA, you can do up to five different ones. You can have a multi-antigen.
That means you can deal with generating antibodies as well as T cells, perhaps have a broader, more robust type of vaccine, etc., etc. So that was why we've always worked with MVA. So there is one MVA product approved in the world. It's from Bavarian Nordic. It's what's used in the stockpile against smallpox, but that's also what is utilized when we have these Mpox outbreaks. So we have MVA, one supplier, monopoly, based in Denmark, funded in excess of $2 billion by the U.S. taxpayer over the years, including their manufacturing facility. Frankly, that doesn't appeal to us from that standpoint. So we acquired the rights a few years ago when that first outbreak in 2022 came. We acquired the rights to MVA from the U.S. NIH because of a couple of reasons.
One, the U.S. MVA came from the same parental cell line as the product that is used by Bavarian Nordic, so they're very similar from that standpoint. And that started a discussion between ourselves, and we went to the European Medicines Agency, the European equivalent of FDA, to negotiate to be able to have an expedited path for development because of "the similarity." And so with that, we learned in May of this year, after a lot of discussion, that we were given an expedited path where we would not have to do a phase I nor a phase II clinical trial. We could go straight to an immunobridging trial of our GEO-MVA to the MVA-BN, known as JYNNEOS, and Imvanex, whatever it's called. And elsewhere in the world, we call it JYNNEOS in the U.S., so we would go with that.
That will be starting in the second half of this year. We've already manufactured the product. It's been packaged. It's currently in release testing. We're quite excited about that. That trial, we'll start it this year. We have a pretty quick readout to tell us it's a non-inferiority, so not a real high bar. If that's the case, then we're going to be engaging in further. We'll build a safety database, but that will trigger some discussions that we will have with WHO, etc., on emergency use licensing and those things because right now, believe it or not, the demand in the world far exceeds the supply. Africa alone needs 25 million doses a year, but Bavarian Nordic can supply them two to five million, maybe. They can find two million, maybe a little bit more. There's a tremendous amount of opportunity there.
And we expect we'll be the first U.S. source supplier of that. We'll be the second supplier on a global basis. And we've been spending the last couple of years also a lot of time with WHO, with the International Vaccine Institute, Africa CDC, all the players there to drive that forward. I take time on that because that is our priority, and that is what we're trying to accelerate to go to.
So then also we have GEO-CM04S1. I know that COVID is not a great interest anymore, certainly from the investors that most times they say, "Why are you even talking about that?" I made the comment earlier. It ranks just barely above talking about an HIV vaccine, which we spent years talking about in terms of generating interest or lack of interest when you do that. However, we have a multi-antigen vaccine against COVID-19. It has been in three phase II clinical trials. One was healthy volunteers that were first vaccinated with mRNA to see if adding this on top would give it a greater response rate, broader, etc. That one has been completed.
The manuscript's being written, so perhaps, again, I can't control who's writing the manuscript and getting it published, but it'll be out sooner rather than later. The second one is a phase II trial among hematologics, so blood cancer patients who are receiving stem cell transplantation. That trial is a multi-center trial that does a direct comparison against mRNA. So half the patients receive our vaccine. The other half receive either an mRNA or, excuse me, either a Pfizer or a Moderna vaccine. That trial ended enrollment in December, this past December. And so we should begin to see the results because it's 56 days after the patient has been vaccinated. So in the first half of this year, we'll see what we have between that direct randomized comparison of our product versus the mRNA.
The third one is a trial among chronic lymphocytic leukemia patients, another blood cancer group that is at high risk because their bodies do not respond to antibody stimulation, which means that these individuals are not receiving the desired benefit from mRNA vaccines. They don't have any other vaccine out there. It's an investigator-initiated trial about a year, a little over a year ago. The interim results were reviewed. It's a direct comparison between our vaccine and the Pfizer vaccine.
The Data Safety Monitoring Board ended up halting the Pfizer arm because it did not meet the trigger, the predetermined endpoint. Ours exceeded it. The remainder of the trial has continued only with our vaccine. We're quite excited about that. And we only need 12 more patients to finish that trial. So that will occur this year also. So we have that excitement behind that. So we see a lot of opportunity. I'll just put it this way.
There are 40 million people in the United States, about 10 x that worldwide, who have medical conditions that result in the depletion of their body's ability to mount the adequate response to antibody stimulation. That means that for those people, they're your friends, your neighbors, your cousins. Some of you may, I actually was doing this talk at one place in New York City, and one of the people in the audience was a CLL patient, for instance. And so these are individuals who are still in the pandemic. Many of them are still quarantined and sequestered.
What we hope to demonstrate is that for these immunocompromised populations, a multi-antigen vaccine that addresses not only antibody stimulation similar to what mRNA and other vaccines do, Novavax, but also a very strong, robust T cell response gives them the immune levels that they need for protection. That's been the whole thesis and basis of us, is by having this multi-antigen approach, which you can't do with the other technologies, we're able to potentially achieve that. For us, it's still critically important for public health, and we'll continue with that.
Lastly, we have Gedeptin. Gedeptin is a gene therapy delivered in through a vaccine vector, not the same vaccine vector we use for infectious diseases. It's for solid tumor cancers, so you need to inject that. I'll show you the mechanism of action in a minute, but the summary, I think, what is most important. We've completed a phase I and a phase I/II trials among patients with advanced head and neck cancers. We saw sufficient response and encouragement from those studies that our plans are. We've announced this publicly as we are going forward with a phase II trial that'll be for first-line head and neck cancer.
If you're familiar with oncology, you're familiar with Keytruda, and you're familiar with the fact that they recently received, around last June or spring, whatever, they received an indication for first-line treatment in head and neck cancer under their KEYNOTE-689 trial. Our data that we've been generating shows that when we do a combination of Gedeptin with Keytruda, it significantly improves the performance of Keytruda among those patient populations and the consistency of performance of that. We are currently manufacturing the product to be able to initiate that trial. We tell people, hopefully by year-end, it may very well more likely be at the beginning of 2027, but if there's any way we can get it ready and go forward, we pick the CRO, but the rate-limiting step is manufacturing the product.
We're manufacturing sufficient products so that when we look at the interim review, if we see certain responses compared to what is known with just Keytruda alone, we'll go to the regulatory authorities, and our recommendation and request will be able to convert into a phase III and have a more accelerated path, so we want to have enough material to do that and also to be prepared for commercialization, so that suggests or indicates how confident we are in that. That's what we are all about.
Our capital needs annually are essentially $30 million-$35 million. Now, some people say, "Well, you just raised $3 million." $3 million is about 10% of what we need. We need to raise a lot more because that's what will drive these programs forward. But make no mistake, our priority and focus is on the GEO-MVA for the reasons that I've outlined and the opportunity because achieving that will enable us to then go forward in the manner we'd like to with the other assets. So it's not that we're not doing anything there. It's just where we have our focus on and what we're looking forward to. So these are. I've just told you about these inflection points that we have and the milestones we're achieving. That's exactly what those have to do there.
If we were to look at this platform, people ask, "Why did you pick that platform?" I've tried to explain it. MVA is known as a very. It's a very large virus. You can do multiple antigens into it. It's exquisitely safe. So it has all those benefits. The downside to it historically is that it is a bear, to say the least, to manufacture. Very cumbersome. It's based upon chicken embryonic fibroblasts. We started several years ago on a new method to try and move it to a continuous cell line, getting rid of having to inoculate the specially bred and source chicken eggs and then work with that. Very slow process. Over the last couple of years, we have announced and rolled out that we have successfully been able to develop the upstream process. We've succeeded with that.
This year, in the first half, we hope to complete the downstream process and come forward. We have the cell line license for all of our MVA projects. We have a relationship to move forward and then to eventually transition into the new manufacturing process so that we can supply a lot of product very quickly at lower cost than what would normally be the case, and that's what we're working on.
This chart is our pipeline. I've talked about it, but it gives you a sense of the potential. Those are not sales forecasts, but there's a lot of need, and I like being able to put not applicable under phase I and phase II for GEO-MVA because you will not see that on any other company that's presenting here that's in clinical stage. They're going to have to do a phase I. They're going to have to do a phase II, but we were successful in negotiating.
And then more recently, we received confirmation on our clinical protocol outline from the EMA, so right now, we're in the process of final selection of CROs. We have the product. The initial product is all produced. It's all been packaged, just going through release testing, and again, the sooner we can get going with the site selection and getting that going, the better, and you can see where the others are. We have over 130 patents either issued or pending across 22 families. I've got to look this up. It used to say 23 families. I don't know which family we lost, but we lost a family somewhere in there, but we'll find out.
We hold worldwide rights for all of our assets, and we're in continuous discussions, including this week, in terms of collaborations and partnerships. Our plan is to register the product broadly, but obviously, as a small company, we don't have the resources to carry it forward. But we think that there are players out there, and we know from the discussions we've been having not only this week, but at the recent World Vaccine Congress in Europe, at BIO-Europe meeting. That was in October and November of this year. And even this week, the meetings we have, we know that there is significant interest in having partners in there. As always, it's like people that walk in a car a lot.
They first just go in to kick tires and blow horns, but eventually, they see something, and they want to know a little bit more about and a little bit more about. So we're confident that we'll have partnerships in there because the significant opportunity there. We're getting a lot of interest now in this GEO-MVA for the obvious reasons that we're starting to see a light that says you can start booking sales now, that type of thing. All this does is take you through, and again, I'm happy to send this out to everyone, but this just takes more in a more articulate manner than what I'm probably showing of where these things fit. The Mpox has not gone away. Just last Friday, there was a new article in Nature about the continued evolving of this virus.
If you go to WHO, they tell you it's not going away. You guys need to go as fast as you can. We need additional product. And so we're very excited about that. It's not going to be constrained or controlled without vaccination. And the manufacturing has historically been the bottleneck for MVA. We plan to change that over time and transition to it. It's an ugly disease, so I try not to show this slide at luncheons or dinners because it ruins dessert and stuff.
But it is bad. It has mortality. The more recent strains or versions, they call them clades, but the more recent ones are more contagious, more easily transmitted, and also higher mortality, rates of mortality. So that's what you're dealing with there. The competitive landscape, we plan to end the global monopoly that Bavarian Nordic has had. And that's what we plan to do.
If I'm not mistaken, they booked over $400 million in sales in 2024, their last reported full year on doing that. We're not trying to be piggish about this, but we think it's much better. And it's much better for all parties to have more players out there. Right now, their whole initiative, including the manufacturing, as I mentioned, was funded by the U.S. taxpayer. We think it's time that, first of all, we should not be dependent on this foreign supplier.
There's plenty of need out there. As I said, they can supply maybe 10% at most of the market demand right now. If it's growing, we need more. And you can see there are the comparisons that we've put together. Again, this is our COVID-19. The key to this is really showing you that you can't really address SARS-CoV-2 or COVID-19 without addressing both the antibody side of the immune system as well as the cellular side.
And this was an article that was published in August of 2022 out of Dan Barouch of Harvard. We have no affiliation with him. In fact, we compete with him at times and all. But I thought it was an excellent article because it underscores, if you want to reduce severe infection, hospitalization, and the risk of death, you have to engage both sides of the immune system and bring them into play. And that's what it's all about. And you can only achieve that through a multi-antigen approach. And our GEO-CM04S1 is referred to as the most advanced multi-antigen vaccine against COVID-19 in the world at this stage in clinical development.
We'll continue with that regardless of people getting bored of hearing about COVID. These are the two trials I talked about. With oncology, this is what we're doing with Gedeptin. Again, we held worldwide rights for all indications for this technology. We plan to continue to work on this. We're looking at beyond head and neck. Should we look at melanoma, triple-negative breast cancer? There's a number of areas that we'll be continuing to evaluate in animal models to see where to go next. We get a lot of guidance. I have two slides here for a mechanism of action. This one is more creative but harder to follow. This one is easier to follow. Maybe not as flashy, but it does basically take you through that.
Our next steps is really this phase II where we're talking different sources for non-dilutive funding, but also partnering, which we're seeing a lot in oncology. Corporate, this is our handsome, attractive team that we have. So we like to always show that. People told me we've never had a corporate slide before, so we put those in. And I would just say here is, for us, this is how we focus. We focus on having a very strong patent portfolio. That's innovate, targeting populations that are underserved. That's differentiation. Expedited registration pathways will accelerate us. And then we know that to be able to get the job done, we're going to have to collaborate. And that's what we mean by those. And we focus very heavily, where can we de-risk these things.
We're going to be looking at expedited pathways, not only with GEO-MVA, but also among immunocompromised patients for COVID-19. We think we have that. And we may be able to do something with Gedeptin at some point in time. We currently have already been granted orphan drug status for advanced head and neck cancer patients. Our phase I/II trial was funded by the FDA under their Orphan Drugs Clinical Program. So we do try to focus on areas that will move us in an accelerated manner, de-risked manner to try and get to the true inflection point, which is when one starts booking sales. And then everybody focuses on, "Why can't you do better on your sales?" I mean, we know that nobody ever gets satisfied, but that's what we're working on doing.
Our capital strategy is not just simply selling stock, but it's also the non-dilutive funding with various groups such as this, strategic partnerships. And then, obviously, that will result in us being able to reduce our dependency on equity-sourced capital needs, and that especially post the phase III success of GEO-MVA. And so this just reminds you of what I had up there. And again, thank you. I know I went fast, but that's all the time we have. We have a minute and 45 seconds left. I'm happy to take any questions that you might have. And again, if you're interested in the presentation, just give me your card or either send me an email, and we'll get it to you. Okay? Thank you.
David will be available in presentation room one for follow-up discussion. Thank you, David. We'll be back in just a couple of minutes.