Welcome to our last presentation for the day, GeoVax Labs from Smyrna, Georgia. GeoVax is focused on immuno-oncology vaccines. Presenting for the company is their Chairman and CEO, David Dodd.
Thank you, Tony. First met him, I was thinking Tony La Russa, and I said, "You've got a famous name there," but it's Tony Russo. Anyway. He said, "I wish I were." Anyway, thank you. If you have your phones on to the game, silence them. If you're not aware, there's a game, University of Georgia's playing TCU, and we have some people here upset that we're here rather than in a bar watching their Bulldogs. Thank you for being here. It's a pleasure to tell you about GeoVax.
Again, I'll probably get through with this, so, if you have, you know, questions outside, we can talk about them, whatever you'd like to. Indeed, we are a clinical stage program. We're in phase II clinical. We're developing both immunotherapies in oncology, as well as vaccines against a wide variety of very challenging infectious diseases, as well as cancers on a global basis. We've got a very exciting our profile of our portfolio. Our primary focus, as you can see, is on addressing, you'll hear about these two, our current clinical stage programs, one of which is targeting as a therapy, advanced head and neck cancer, so that's solid tumors. The other one, excuse me, is a COVID-19 vaccine.
You say, "Oh, y'all, and there's, how many can there be out there?" You'll hear and you'll learn that we have one that is clearly differentiated from what is out there today, and we think will enable us to own a portion of the real estate of that marketplace, a very important portion also. We won't be in direct comparison with the others because what we do, we don't believe that their technology is able to do. That's a nice position to be in. We have other items we're working on, all of which through different stages of development and preclinical testing and all. We have 26.3 million shares outstanding. We reported most recently $35 million in cash. We have no debt.
You can see the profile there. Last year was a successful year for us from the capital development when most of the industry was struggling and being challenged with the ability to raise capital and some having to re-look at their programs, place some on hold, et cetera. We were able to add to our balance sheet $37 million during the year. We added $10 million in January. In May, we added an additional $20 million. I have to comment that there was one week in May in which we traded over 1 billion shares, and at that time, we had 12 million-15 million outstanding shares. We had a quite exciting week. It was one of those where almost on an hourly basis, you wonder what's gonna happen next.
Then in August, we brought in another $7 million by the exercise of warrants. We strengthened our balance sheet. We anticipate based on our spending pattern and our plans for an accelerated pace of patient enrollment that we're capitalized to pretty much get us through 2023, at least in the mid fourth quarter. We'd hope to actually shorten that and raise money prior to that, which would mean we're going even faster in patient enrollment for our clinical programs, which would be all of our goals, I'm sure. We have very strong IP, as you can see. Not only do we have 115 granted or pending patent applications, it's also spread over 24 patent families. We're very solid in the area of intellectual property. We continue to develop that.
We were just informed that one of the pending patents, we just informed a week or so ago, has also now been given a notice of allowance. That'll still be 115. We'll just have more that are granted. Our critical milestones for this year that we've laid out are that, first of all, we have in the first half of the year, we anticipate having regulatory discussions about, in certain instances, we believe there is an opportunity. Not necessarily at this stage would we say a probability, but there's an opportunity for potential expedited pathways for registration. We're engaged right now with certain consultants and experts.
We'll be talking to regulatory authorities, not only the FDA, but also other jurisdictions on that, 'cause we have worldwide rights for our products, we plan to see them develop for worldwide distribution. We anticipate working with, obviously with collaborators and with partnerships in that regard. The completion of various patient enrollment behind Gedeptin. Gedeptin is our gene therapy, which is being developed for treating advanced head and neck cancers. It's received Orphan Drug status, the current clinical program is being funded by the FDA under the FDA's Office of Orphan Products Development Clinical Trials Grants Program, and that's because there's such a need for patients in that situation now. We expect to go forward and complete that.
In the second half, our COVID-19 vaccine, which we refer to as GEO-CM04S1, we expect to see we have two trials you'll learn about. One is for healthy individuals who previously been vaccinated with an mRNA vaccine. We're testing ours as a booster for that because we believe that a heterologous booster has a greater opportunity to give a more robust, more durable protection. Rather than seeing, you know, multiple four, five, six or whatever continued boosters, we would hope to be able to reduce that by having our vaccine as a booster. We're expanding. That one will be completing, excuse me, the booster trial this year. The expansion for our immunocompromised trial, which you'll see a slide on this.
This one, we are expanding to a multi-site program from what had been a single site. This is a program that's looking at patients or evaluating patients who suffer from various blood cancers or hematologic malignancies. These are people whose immune system has pretty much been destroyed from an antibody responsive standpoint. We're evaluating it in a direct randomized comparison as a primary vaccine against either the Pfizer or the Moderna vaccine. The reason why is we believe that it'll show a more durable and more robust level of protection for those patients. The number one at-risk group that's been published time and time again, in terms of COVID-19 are individuals with certain hematologic malignancies. This is a major issue.
People with other conditions such as dialysis, sickle cell anemia, HIV, any group that has a compromised immune system becomes a candidate for, we believe, our vaccine. That's where we're focused on differentiating. Not on those who are generally healthy or younger, but for that population. In the United States, around 15-20 million people fit into this category, about 250+ million worldwide from what we can determine. That's what we are focused on developing our vaccine for and being able to move it forward with. We'll see some data readouts in different, at different stages this year, and we'll also continue with our COVID-19. We'll be having regulatory discussions in that regard also. Gedeptin, as I mentioned, the phase I results, we in-licensed this product in September of 2021.
It was from a little small private company, and it was being developed for advanced head and neck cancers. It had a successful, albeit small, phase I program, but it was such that the FDA indicated that it would fund the beginning of a phase II program, which it is doing. That's good. We in-licensed it. We thought it would fit for us very well, and it would jumpstart us into the clinical stage. We've expanded it from a single site, which was at Stanford, to now it includes Stanford, Thomas Jefferson University in Philadelphia, and also Emory University in Atlanta. We anticipate additional sites coming into that. We have worldwide rights for all indications, which means for cancerous tumors as well as benign cancers, benign tumors, excuse me.
We believe it has a tremendous value, quite frankly, to be out there. We're supporting preclinical data, animal testing data right now that is highly encouraging that is showing the results when you use Gedeptin in conjunction with immune checkpoint inhibitors. It appears to enhance the performance of the checkpoint inhibitors. We anticipate publications of those data on animal data coming out yet this year also. Just very simply, it's the only way I can do it, is the way Gedeptin works is this enzyme PNP is injected into the tumor and then is followed by the infusion of Fludara. Fludara is a hematologic agent that's already approved on the market. Those two then combine in a prodrug activity to form fluoroadenine, which has highly potent destructive impact on tumors. It destroys them.
If it has no effect beyond that tumor. It's been shown to be extremely safe. That's how it works, and it's very exciting for us. The initial data, which were animal data, shows that it's very, very potent. It works very quick. The data in the phase I showed that it does have a nice impact on there. Again, albeit a small patient population. It's extremely safe. What we have looked at on that one is expanding it to multiple sites, as I mentioned, and accelerating the pace of patient enrollment. COVID-19 for GEO-CM04S1, we in-licensed this product in also in late 2021 from the City of Hope National Medical Center. It was already in the clinic.
We were working with a similar type of vaccine, same type of platform, one that we believe very strongly on. It again enabled us to move forward very quickly into being in phase II. We believe that as a booster, it can demonstrate to be potentially a more robust, more durable booster. We think that for the immunocompromised populations, that this can become the predominant vaccine to be used for those populations. The MVA platform, which stands for Modified Vaccinia Ankara, has been around since the 1960s. It's well-characterized, well-accepted by regulatory authorities, and it also gives you the potential because it can be lyophilized for delivering a non-frozen state vaccine, if not a freeze-dried vaccine. Single dose is a possibility. In some cases, we've been able to demonstrate that.
It actually gets you to the point that we'd like to see, which is not only being able to develop a vaccine that works in certain settings, but one that is practical and can be administered worldwide. In a manner that does not require extreme frozen state nature and perhaps as simplistic that you can deliver it in a single dose. As a next-generation vaccine, where we differ is the current vaccines all focus on inducing a very strong antibody response by targeting the spike protein, and that probably makes sense.
There's another part of the immune system and that's the T cells or the cellular immune system, and that's very important because if you're an individual with a compromised immune system and your body is not going to mount much of an antibody, a response to an antibody stimulation, then what you need to rely on is your T cells and your cellular immunity. That's the concept by including not only the spike protein but the nucleocapsid protein also. In doing that, the data shows that it not only with a single dose, it's it works very well. We've seen from the phase I data very strong responses on that. You'll see a slide on this.
The other vaccines, the other platforms, be it mRNA or adenovirus, they're unable to encode multiple antigens into a single vaccine as we are able to with MVA, and that's another reason why we like it so much. This is just a structure that in addition to CM004, we have other candidates that are advancing. I would say CM004 is probably the furthest along and first example of a next-generation vaccine. We're hearing as recent as today other companies that have vaccines in development have gone back and decided that, "You know, in addition to the spike protein, maybe we ought to be including the nucleocapsid also to give us the breadth of coverage." That's what we've been working on and that we currently have in the clinic. We feel very good about that.
The phase I data, as you can see there, we had very strong responses in inducing T cells, both in the spike, from the spike, as well as the nucleocapsid, then of course the neutralizing antibodies. We're very pleased. These data were published last March in The Lancet Microbe. Our current trials, as I mentioned, the phase II, the immunocompromised trial is the primary vaccine in the direct comparison. It's proceeding along. We're expanding it to sites. The booster again we think will provide a much better, more acceptable booster. It's been well documented in certain areas such as HIV that a prime-boost regimen makes an awful lot with a heterologous-type booster makes a lot of sense, that's the approach that we're taking in this regard also.
Essentially finally, I'll mention that in November we announced that we had acquired the rights from NIH to their MVA. MVA is what is currently the vaccine that is stockpiled for protection against monkeypox and smallpox. There's a single supplier worldwide, which is a small Danish company. They produce in a manner that has to be stockpiled 'cause they can't produce a lot in a short time period. We acquired the rights to this. We're proceeding. Our goal and our intention is to be the first U.S.-based supplier of MVA as a vaccine for smallpox and monkeypox.
The added benefit is by using MVA, which is already well documented and recognized to prevent smallpox and monkeypox. We've been able to demonstrate in certain studies, for instance, that the COVID-19 vaccine we currently have in phase II in non-human primates also prevented not only COVID-19, but also monkeypox, and the serum samples from the phase I showed protective immunity against monkeypox also. We look at the opportunity to having a line of vaccines built upon MVA. Could be an Ebola Zaire or an Ebola Sudan or a Marburg. In endemic in those areas of the world, we also deal with monkeypox.
In one vaccine, we would be providing not only the primary against the primary target, in this case, for instance, the Ebola Sudan, but also conveying the benefit of protection against monkeypox, and that would be true across our various MVA. We'll be putting in place, discussions with regulatory authorities and proceeding in that regard, with a priority similar to what we have behind our Gedeptin and our COVID-19 vaccine as we go through 2023. In a nutshell, you know, we're in clinical stage. We've got a very exciting future. We've put some stuff really into place in the last couple of years. It's very exciting. I'm happy to answer, you know, any questions you have.
GOVX, G-O-V-X, exciting company going forward to be the leader in the world with a COVID-19 vaccine for immunocompromised patients, to bring Gedeptin forward with multiple indications, and also to fully develop and register and have our, excuse me, monkeypox or Mpox vaccine out there. Thank you. Tony, do we take questions here or how?
We'll take it stage, right? Yeah.
Did you say yes?
Yes.
Okay, thank you. Are there any questions?
I mean, based on. First, what would you say, first of all, you are? 'Cause you're protecting the immunity deficiencies of people that first of all, right? That's where you first started. Is that your base on that? Can you use another company to come in with your immunotechnology to keep the immune system up and use their. Do you use other companies' vaccines also to partner with?
Well, you could do prime-boost type of regimens depending on the, on the situation, yes. What we're focused on is recognizing that there are these populations, you know, throughout the world who have compromised immune systems for which their bodies mount minimal, if any, of an antibody response to antibody stimulation. Which means how many. You know, you can keep pumping them with extra shots of mRNA, and it seems like it's gonna be more frequent and it's gonna be more. If you're able to also address, this is our concept, the T cells or the cellular side of the immune system, then you'll be able to give them a more robust and more durable protection. That's the concept behind what we have.
If we're able to demonstrate that sufficiently in the clinic, then that will enable us to not be a direct competitor from a business standpoint, because we don't wanna be a direct competitor with those mammoth companies and all. We would have the ownership, and that probably would also open up opportunities for further collaboration with those same parties.
Love it.
That's the idea.
That's the central point of the company, because you could help any company out there be better at what they're doing.
Well, I don't know if it's any company, but yeah, there's a lot of room for collaboration.
Yes, a lot of room.
Okay. Any other questions or... Yes, sir?
You know, the current generation of COVID vaccines are adjusting now because of the new variants and everything. Do you think what you've got is going to provide any benefit in that realm?
Well, we do believe that with the construct that we have by combining multiple antigens, that we can sort of capture and have a broader protective nature so that the way we look at it is the current vaccines are all chasing the variants. What we're trying to do is to get ahead and encompass the variants before they actually emerge. If we're able to do that by broadening the sort of protective ability of the vaccine and the clearance ability through the additional components we would add in, the nucleocapsid or maybe the membrane, the envelope, then we finally have an opportunity for having a true universal coronavirus vaccine. What's nice about MVA is that it's been demonstrated to, at times, to deliver a single dose.
Having the possibility of a single-dose universal coronavirus vaccine would certainly be a huge game changer for us. Again, from a business standpoint, we're focused on U.S., but we look for partnerships. That's a good bit of reason why we're here this week. Yes?
Like, you have to find the new variant to be able to go that wide to predict the new variants that's coming out. You'd be more reactive to that, of a new variant, than just, you know, saying you're more encompassing new things that are coming before we even know about it.
Well, the current vaccines, by their very nature, have to react. They have to sort of rejigger, you know, reevaluate, understand what the variant is, what its nature is, and then figure out how to go after it. If by incorporating more than just simply one protein of the virus but additional components of it, we can then give such a broad coverage of that, then we have a greater likelihood of being able to encompass whatever might be arising, without even knowing what that might be. That's the concept.
How many patents do you have within the immunity boost?
I don't know. You know, I know that we have, as I mentioned, 115 patents. You saw the list of the different areas. They're across 24 families. I would say that what we do is pretty well-protected, and we spend a lot of time doing that. I would chance it to say that maybe five years ago, that numbers of 115 might've been 30, something like that. We've really expanded it. It's very important to us. Any other questions? If not, thank you, everyone. Get to the game. Thank you.
Okay. Thanks.