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

Good afternoon. My name is [ Tony Russo ], and welcome to our last presentation for the day, GeoVax Labs from Smyrna, Georgia. GeoVax is focused on immuno-oncology vaccines. And presenting for the company is their Chairman and CEO, David Dodd.

Thank you, [ Tony ]. First, madam, 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 was. Anyway, thank you. So if you have your phones on to the game, silence them. If you're not aware, there's a game, University of Georgia is playing TCU, and we have some people here upset that we're here rather than in a bar watching their Bulldogs. But anyway, thank you for being here. It's a pleasure to tell you about GeoVax. And again, I'll probably get through with this. And so if you have questions outside, we can talk about them whatever, like to. So 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 disease as well as cancers on a global basis. We've got a very exciting profile of our portfolio. Our primary focus, as you can see, is on addressing -- you'll hear about these 2, 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 is a COVID-19 vaccine. And you say, oh, yawn, there is, how many can they 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. And 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. And 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 on -- we reported most recently $35 million in cash. We have no debt. So 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 relook 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 1 week in May in which we traded over 1 billion shares. At that time, we had 12 million to 15 million outstanding shares. So we had a quite exciting week. It was one of those with almost on an hourly basis you wonder what's going to happen next. And then in August, we brought in another $7 million by the exercise of warrants. So 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. And 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. So 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, so that will 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. And we'll be -- 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 because we have worldwide rights for our products, and we plan to see them develop for a worldwide distribution, and 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. And the current clinical program is being funded by the FDA under the FDA orphan drugs clinical trials program, and that's because there is such a need for patients in that situation. So we expect to go forward and complete that. In the second half our COVID-19 vaccine, which we refer to as CM04S1, we expect to see -- we have 2 trials you'll learn about. One is for healthy individuals who had 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. So rather than seeing multiple 4, 5, 6 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 including -- we'll be completing, excuse me, the booster trial this year. Also the expansion of -- for our immunocompromised trial, which you'll hear, you'll see a slide on this. This one, we are expanding to a multisite 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 have pretty much been destroyed from an antibody responsive standpoint. And we're evaluating in a direct randomized comparison as a primary vaccine against either the Pfizer or the Moderna vaccine. And the reason why is we believe that it will show a more durable and more robust level of protection for those patients. The #1 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, and 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 million to 20 million people fit into this category, about 250-plus million worldwide from what we can determine. That's what we are focused on, on developing our vaccine for and being able to move it forward with. We'll see some data readouts at different stages this year. And we'll also continue with our COVID-19. We'll be having regulatory discussions in that regard also. So 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. And so that's good. We in-licensed it, we thought it would fit for us very well, and it would jump-start 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 cancer. So we think -- benign tumor, excuse me. So we believe it has a tremendous value, quite frankly, to be out there. And we're supporting a 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, that's the only way I can do it is the way Gedeptin works is this enzyme PMP is injected into the tumor and then it's followed by the infusion of Fludara. Fludara is a hematologic agent that's already approved on the market. Those 2 then combine in a prodrug activity to form [ fluoralatadine ], which has highly potent destructive impact on tumors. So it destroys them. And it has no effect beyond that tumor. So it's shown to be extremely safe, that's how it works, and it's very exciting for us. The initial data, which was an animal data, shows that it's very potent, it works very quick. The data in the Phase I show that it does have a nice impact on there. Again, albeit a small patient population. It's extremely safe. And so, what we have looked at. And that one is expanding it to multiple sites, as I mentioned, and accelerating the pace of patient enrollment. COVID-19 for GEO-CMO4S1, we in-licensed this product and 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. So 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 nonfrozen state vaccine, if not a freeze-dried vaccine. Single dose is a possibility. In some cases, we've been able to demonstrate that. And so 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. So in a manner that does not require extreme frozen state nature and perhaps as simplistic that you can deliver in a single dose. So 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. But 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 response, 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. And so in doing that, the data shows that not only with a single dose, it works very well. We've seen from the Phase I data, very strong responses on that. You'll see a slide on this. And 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 CMO4, we have other candidates that are advancing. I would say CMO4 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 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 that we currently have in the clinic. So 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, and then of course the neutralizing antibody. So we're very pleased. These data were published last March in 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, with a heterologous-type booster makes a lot of sense. And 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 of their MVA. MVA is what is currently the vaccine that is stockpiled for protection against monkeypox and smallpox, as a single supplier worldwide, which is a small Danish company. And they produce in a manner that has to be stockpiled because 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. And 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 and nonhuman primates also prevented not only COVID-19, but also monkeypox. And the serum samples from the Phase I showed protective immunity against monkeypox also. So we look at the opportunity to having a line of vaccines built upon MVA. Could be an Ebola Zaire or an Ebola Sudan or Marburg, an endemic in those areas of the world. We also deal with monkeypox. So 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. So that one, as I mentioned, we acquired those rights. 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. So in a nutshell, 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 any questions you have, but GeoVax, GOVX, exciting company going forward to be the leader in the world with 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…

[indiscernible] yes.

Did you say yes?

Yes.

Okay. Thank you. Are there any questions?

I mean, based on -- so first, what would you say, first of all you are protecting the immunity deficiencies of people that, first of all, right? And that's where you first started. Is that your base on that? Can you use another company to come in with your immuno technology 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 situation, yes. But what we're focused on is recognizing that there are these populations 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 can keep pumping them with extra shots of mRNA. And it seems like it's going to be more frequent and it's going to be more. But 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 a concept behind what we have. And 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 want to be a direct competitor with those mammoth companies and all, but we would have the ownership, and that probably would also open up opportunities for further collaboration with those same parties, that's how I did.

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 yes, there is a lot of room for collaboration.

Yes, collaboration, yes.

Okay. Any other questions or? Yes, sir.

The current generation of COVID vaccines are adjusting because of the new variance and everything. Do you think what you've got is going to provide any benefit in that realm?

Well, we do believe that with this construct that we have, by combining multiple antigens, that we can sort of capture and have a broader protective nature. So the way we look at it is, the current vaccines are all chasing the variance. What we're trying to do is to get ahead and encompass the variance before they actually emerge. And 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. And what's nice about MVA is it's been demonstrated to, at times, be able to be -- to deliver a single dose. So having the possibility of a single-dose universal coronavirus vaccine would certainly be a huge game-changer for us. But again our, from a business standpoint, we would -- we focused on U.S., but we look for partnerships. That's a good bit of reason why we're here this week. Yes.

How do you, like do you have to find a new variant to be able to go that wide, predict the new variants that's coming out, you'd be more reactive to that of a new variant then just saying you're more encompassing new things that are coming before we kind of know about it?

Well, the current vaccines by their very nature, have to react. So they have to sort of rejig or 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.

And how many patents do you have within the immunity boost?

I don't know. I know that we have, as I mentioned, 115 patents. You saw the list of the different areas. They're across 24 families. So 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 5 years ago, that number instead of 115 might have been 30, something like that. So 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.