Earnings Labs

GeoVax Labs, Inc. (GOVX)

Q2 2021 Earnings Call· Wed, Aug 11, 2021

$1.10

-0.90%

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Transcript

Operator

Operator

Good day and welcome to the GeoVax Second Quarter 2021 Corporate Update Call. I am [Gran], with Chorus Call and will facilitate today's call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Chief Financial Officer; and Mark Newman, Ph.D., Chief Scientific Officer. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Jules Abraham of CORE IR, who will provide a forward-looking statement regarding this call and information herein.

Jules Abraham

Analyst

Thank you, [Gran]. Good afternoon, everyone. We would like to have you please note the following: certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines being safe for human use, GeoVax's vaccines effectively preventing targeted infections in humans, GeoVax's vaccines receiving regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax being able to enter into favorable manufacturing and distribution agreements and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements and does not intended to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission, including those set forth as risk factors in GeoVax's Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. David?

David Dodd

Analyst

Thank you, Jules. Good afternoon and thank you for participating in the 2021 second quarter update call. We're pleased to have this opportunity to review and discuss our continued progress and accelerating our priority development programs towards clinical development and continuing to secure significant resources and support of GeoVax growth and development. Over the past year, we strengthened our cash position by advancing towards important data milestones related to several of our programs. We remain focused on delivering meaningful results of value milestones over the next 12 months to 18 months focused on our priority programs related to COVID-19 and immuno-oncology, developing increased value for shareholders, stakeholders, and public health worldwide. All of us are aware that increasingly variants of the COVID-19 continue to emerge presenting further pandemic threats to health worldwide. As a result, the NIH and [SEPI] have issued requests for proposals for Pan-Coronavirus vaccine development projects, specifically seeking to fund preventative vaccines able to provide broad and durable protection against coronaviruses, especially COVID-19 and others with pandemic potential. Indeed, it is now apparent that COVID-19 virus will continue to evolve, require an expanded virus variant coverage, otherwise requiring annual reconfigured vaccines similar to what is necessary relative to influenza vaccination. In other words, the continued challenge will be to provide vaccines that will be adaptable against variants that might emerge. Recent research related to long-term immunity to the disease appears to underscore the importance of a broad-based vaccine design beyond simply targeting the spike protein also focusing on stimulating cellular immunity. This is exactly our approach. Our goal and efforts continue to focus on providing a single dose safe, durable, universal coronavirus vaccines, providing immunity against a number of potential variants before they emerge. And our technology allows for minimal to no refrigeration providing a potential major…

Mark Newman

Analyst

Thank you, David. Let me start with a general slide here to point out that immune responses against viral infections are characterized by both antibodies and cell-based effector mechanisms. The antibodies are specific for virus surface proteins, and their function is to block the virus from infecting the cell. This is referred to as virus neutralization. You've probably heard the term in the news. These can also limit not only the initial infection, but the spread from one cell to another within the body and localize the infection. Now, the first generation COVID vaccines were designed primarily to induce antibodies. They're specific to the S Protein, the Surface Protein of COVID, and their effectiveness is typically measured and reported as a function of virus neutralization, and a natural virus infection, cellular immune responses are also important. These responses are characterized as the activity of T lymphocytes, also referred to as T-cells. These cells directly limit virus replication in the body. They also contribute to the clearance of viral infection in the body by actually killing virus infected cells. For a vaccine to really be optimally effective, needs to induce both antibodies and T-cells. And that needs to function in a coordinated manner. We need to induce a subpopulation of cells, both antibodies and T-cells that will remain in the body for a long period of time and refer to as memory cells. Memory cells are important because these are the cells that are capable of responding rapidly at subsequent infections. So, the COVID virus, next slide presents a very challenging situation for vaccines. This is because mutations can accumulate within the virus, they change the structures of the proteins. These will lead to variants that are not recognized by existing immune responses. And then if you get a variant that…

Mark Reynolds

Analyst

Thank you, Mark. After the scientific review, I’m going to just go over some numbers here. I know that most everybody is more interested in the corporate updates, so I'll be relatively brief here. Starting with our balance sheet review, the cash balances at June 30 were 19.5 million, compared to 9.9 million at the end of last year. Our working capital was 19.3 million, as compared to 9.4 million at the end of 20. The increase in our cash balances were due primarily to the February offering that David had mentioned earlier, with net proceeds of 9.4 million. During the first quarter of the year, we also received a little over 3 million from the exercise of warrants, as warrants were issued in connection with the offering the broadest onto NASDAQ last September. As a quick recap, those warrants are publicly traded on the symbol GOVXW. They have a $5 exercise price, and they expire in approximately four years, September 2025. After those recent exercises, there are still 1.9 million of those warrants outstanding, which if exercised in full can bring in another 9.3 million. Turning to the income statement, I'm going to focus mostly or compare to figures for six month periods of 2021 versus 2020. Grant and collaboration revenues were 190,000 in 2021 versus 1.2 million in 2020. And the 2021 period revenues relate entirely to our grant from the NIH supporting the COVID-19 vaccine, [although] 2020 numbers include revenues from the grant for a loss of vaccine in the U.S. Army, and also related to a collaboration with Leidos to work on a malaria vaccine. R&D expenses were 1.4 million in 2021 versus 1.3 million in 2020, with the increase associated with COVID vaccine program, manufacturing process development, and an overall generally higher level of activity.…

David Dodd

Analyst

Thank you, Mark. Now my colleagues and I will answer your questions. So, I'm therefore turning the call over to the operator for instructions on the question-and-answer period.

Operator

Operator

[Operator Instructions] Our first question will come from Jason McCarthy with Maxim Group. Please go.

Jason McCarthy

Analyst

Hey, guys, thanks for taking the questions. The question for Dr. Newman, specifically around the talk of the mRNA – the currently available vaccines don't cover the Delta variant or other variants seemingly or the lack of immunological memory we've known as and we do not talk about this extensively. That's true. You know, this is done. It's like a dirty secret, but nobody talks about it. And do you think that there's a lack of attention to those two factors in the general public. Because when I mentioned that to people they look at me like I'm crazy. But I also know infectious diseases and they don't, but, you know, how does that impact your thinking, when you're developing your vaccines? Is there a problem that needs to come out more?

Mark Newman

Analyst

Yeah, thanks for the question. You know, if you look at most vaccines, you know, your pediatric vaccines, the things, you have a cycle of these that you get at a certain time, and then you would get a booster once every 5 years or 10 years. So, if you get a tetanus shot, it's good for, you know, 10 years typically, hepatitis, once you're immunize. You'd only get a booster shot and at-risk situations. And I think that in this case, there's two points. The number one, the pandemic response required that the industry move quickly with what they could do, and they, you know, attack this with the target that would made a lot of sense. It was the S Protein, induced antibody responses, protect as many individuals as you can. These mRNA vaccines do induce some [selling] their responses as well, but of course, it's limited to the S Protein and will be subject to variation just like the antibodies. How much memory they induce will have to be determined over time. The coronavirus is somewhat – if you read literature on, you know coronaviruses that cause colds, you know, the immunity is just short lived. This might be a nature of the coronavirus, but there's also bias, because you measure antibiotic responses, because it's much easier to do. The groups that measure T-cell responses are fewer, and the assays are more laborious. So, it might just be that there's less work done in coronaviruses, and targeting these kinds of responses. But yeah, we clearly believe that we need to induce both, and I think what – you're not going to see and you're not going to see in the general population, as people understand, I'm going to induce a protective immune response by vaccination. But the protected immune response involves multiple cell types. It's your B-cells producing antibodies, it's your T-cells directly impacting the virus and supporting the induction of memory. So, in the field, these are aspects that people are looking at, but I would agree it's not something that is, you know, generally talked about, you know, in the press. Antibody responses are easier to measure. You've got a vaccine, you can, you know, have your doctor request a diagnostic that will tell you, yes or no you have a high level of the S antibody, and you can't do that with a [CELU] response. You can't measure immunological memory, even with a kit from a drugstore. So, I think we're measuring what we can easily. And then as we move up into the more technical questions then they become more lab based and more science based. I don't have an answer to the question. Yeah, we should target. Yeah.

Jason McCarthy

Analyst

Yeah. It’s just more of just hearing your thoughts on it. So, you know, with that said, given everything that's happening with Delta, obviously, groups like the NIAID are clearly aware that there's an issue even with their current vaccines, and what they've done is incredible with what they had and how fast they did it. But you know, how much of the need now impacts how NIAIS is willing to support groups like GeoVax with more funding to get next gen vaccines, you know, from the bench and into the clinic? And on top of that, what's the timeline do you think to select a candidate from you guys and moving into a clinical study?

Mark Newman

Analyst

Well, so the first part of that question is NIAID is definitely, you know, aware of this. They have a program out there specifically targeting the development of universal COVID vaccines. And yeah, I think it's a research based program. They're looking for new technologies. And as I said, we have put a proposal into that program. My personal view is, is they're looking for new technology, believing it may be needed, or be new formulations or something with old technologies. But you know, they're clearly aware of that. And then, I'm sorry, what’s the second question?

Jason McCarthy

Analyst

The timing for GeoVax to select the candidate and move it into the clinic [indiscernible]?

Mark Newman

Analyst

You know, this sort of thing is somewhat flexible. Remember, we've got the immuno-oncology program, and I think we presented in a previous time that this is the lead candidate, where we are forming our business relationships and working out all the processes for manufacturing. So yes, the timeline, you know, theoretically could would be that and if we decide to focus on the current generation, which is the first step towards a universal. If something were to come up and tell me that, you know, we could actually make a bigger bang for the box with waiting for the next step to the universal we start incorporating these other targets in the CMO2 then it could be, you know, the plans could be delayed. But the manufacturing efforts are now all focused on the cancer program with this program to be then be next in line as we work out all the bugs and move forward.

Jason McCarthy

Analyst

Okay. Thank you for taking the question.

Operator

Operator

Our next question will come from Kumar Raja with Brookline. Please go ahead.

Unidentified Analyst

Analyst

Hi, I'm [Subhendu] calling in for Kumar from Brookline. Thanks for the update. For the preclinical studies of the COVID vaccine, I was wondering if you are planning studies with non-human primates as well. And by when do you expect to share the pre-clinical data?

Mark Newman

Analyst

So as I mentioned in the [talk], the initial preclinical studies will be presented in about a week in the first scientific conference. We're trying to present the experimental data through the normal venues. We have a second set of studies ongoing with a different small animal model. We would expect to be able to talk about that data at the end of the year. There's multiple animal models for this. Some of measure pathogenesis recovered from disease. Some of them are live dead experiments where you have an animal that is not protected would be lethal. The primate study is an open question. We are keeping our options open on that. The issue is the primates are very difficult to get a hold of now. There's just a shortage of primates for these studies. The FDA does not require primate studies for us to move into a Phase 1 trial. So the value has to be questioned at each step. If we can do toxicology studies, which should be very limited because of the MVA history in an animal model like a rabbit and move right into people. The non-human primate studies don't potentially add a lot of value, but it will change as we see what the availability of these animals is.

Unidentified Analyst

Analyst

Right. Thank you. And with regards to the clinical trials, could you talk a little bit about how you're thinking about subject recruitment, including age group now that a large adult population is already vaccinated. And are you thinking of having sites in the U.S. or internationally as well?

Mark Newman

Analyst

Well, so you've heard David Dodd talk before, you know, we recognize that the MVA is that there are particular niches where this vector technology may be, you know, really well suited. And so there are specific programs out there to look at immune compromise. Individuals who are not responding for one reason or another, to the existing current vaccines, people that that are, you know, just can't tolerate a particular product. So, we're well aware of the fact that anything we do, will have to be considered as a booster, because as you said, if the current campaigns are successful, recruiting patients will come down to recruiting patients that are either recovered from a national infection, or there will be patients that have already been vaccinated. Now, that's not a difficult thing for us to control because remember, we're not immunizing with just the S Protein, we'll be immunizing with the – also with the M&E protein. So the way you would design a study with that is to ask the question, if I come back with a booster or the MBA serves as a booster, can I increase a higher titer of S Protein – S antibodies? And can I expand the response or increase the pre-existing response to the M&E proteins? So the study is a little more complex, maybe on the lab side, it's not necessarily more complex to design and recruit. It's just that we will do it with the recognition that either or will be a specific niche market, immune compromise or something like that where we need a more potent product, or it will be reviewed as a booster.

Unidentified Analyst

Analyst

Thank you. Thanks for the color. I’ll get back in queue.

Operator

Operator

[Operator Instructions] Our next question will come from Jeffrey Kraws with Crystal Research. Please go ahead.

Jeffrey Kraws

Analyst

Thank you, David or Dr. Newman. There was recent data out from the CDC that you may have seen that came out from their study that started July 3 in Provincetown that reviewed the 469 cases and it showed that three quarters of the cases occurred in fully vaccinated people. So, about 69% among eligible adults in the study at the time. It also found that there was no significant difference in the viral load present in breakthrough infections occurring fully vaccinated people and other cases suggesting that the viral load of vaccinated and unvaccinated persons infected with the coronavirus is similar. Given that they're pushing, you know, wearing the right mask, etcetera and the CD, CDC doctor, Dr. [indiscernible] wants to set a higher viral load suggest an increased risk of transmission and raise concern that unlike other variants, vaccinated peoples, the Delta variant can transmit the virus. Are you receiving enough attention from the NA, be the CDC or the World Health Organization? I mean, I know these big pharmaceutical companies, you know, have the attention because they were first to get the vaccines out there. But given what was just discussed about the, you know, SM&E proteins, and the fact that you do provide this boost in the [titer], are you getting enough, I guess, penetration with those groups to get them to take a serious look at it? I know you're going to run the test, but are they giving you enough attention or are they just looking at the current vaccines that are out there because they've got so many people who've been vaccinated with the three vaccines out there that they're, sort of looking at this longer-term? Because this could be a significant, you know, obviously change, especially since the data continues to come out, saying people who are vaccinated or getting it. I know many people who've got COVID, who then got vaccinated with either Moderna, Pfizer, J&J whatever, and then got COVID again, and this study is, you know, supporting just that.

David Dodd

Analyst

Mark, would you like me to comment, and then if you want to pick up on it?

Mark Newman

Analyst

Yeah. You can handle the geopolitical stuff, okay, and I'll deal with the [indiscernible].

David Dodd

Analyst

Yeah. I’ll get us in trouble. Well, first of all, I'd say, thank you, Jeff, for your question. We're very aware of the Massachusetts study and the subsequent comments by the CDC etcetera. And I’d say in general we never received the level of attention that we believe we ought to receive. Now, that doesn't mean that that's an accurate conclusion. It's just our, you know, our prejudicial statement. We'd always like to receive more attention from those bodies [and all]. But in all seriousness, I think that the NIH and [SEPI] and others are highly well aware and attuned to the need for different approaches, as Mark mentioned earlier. I think it would not make a lot of sense to alarm the public and highlight how important it is to be looking at something broader than targeting the S Protein. And that's reflected in the fact that both NIH, NIAID, as well as [SEPI] are aggressively in pursuit under their Pan-Coronavirus funding programs. But again, if we were suddenly to start sending signals, throughout that this is what we have today may not be enough, because of all these variants, that could be very alarming and disturbing. So, I think the approach from that standpoint makes a lot of sense, but behind the scenes, there is quite a bit of attention too. And that's why we put together, I think that an outstanding proposal in response to NIAID’s requests. They're well aware of our approach and what we're doing, and we submitted that in July. And we're now working full – moving forward to submit the [SEPI]. So, I think that the – that those who ought to know are well aware of the critical importance of something that is a broader approach to be able to deliver it, and we don't talk a lot about the need if possible for delivering in a single dose and as simply as possible for distribution and supply. That's why there are parts of the world where it required – where if you can't deliver something in a simple manner, if it's requiring extreme frozen state and only good for six hours after [thawing], it becomes a real challenge. So, I think these points are well recognized, but not acknowledged a lot and probably appropriately. So, but we don't …

Jeffrey Kraws

Analyst

Because they just want – because you said, they don't want people to panic, but it is a fair statement to say that the vaccines out there, you know, there are a lot of people getting COVID, despite being vaccinated. I mean, that's, you know, people are talking about falling the science, so…

David Dodd

Analyst

That is true. I think, you know, the greatest event, one of the greatest events certainly and life science and may and certainly in vaccine was the speed with which people brought forward vaccines to provide an initial level of protection. So, that's like, you know, unprecedented. We all know that. And so, I don't want to diminish anything about that. But I do want to underscore that as some of the slides that Mark showed, there is such a continued emergence of variance and you saw the slide we showed that WHO is far ahead of just simply the Delta and looking at what is occurring here. So, there's strong recognition that other technologies are necessary. mRNA and the Adenoviruses cannot multiple encode these protein components as we're able to. We can't manufacture as fast and as simple as they can. So, they are a trade off. So, I think working together, we ought to be able to arm the world with the right types of vaccines.

Jeffrey Kraws

Analyst

Great. Because I think that booster is obviously needed and it's it is alarming to see 75% of people vaccinated, you know, getting the variant, which is sort of support the fact that the vaccines aren't working too well.

David Dodd

Analyst

Mark, do you want to add anything in there or not?

Mark Newman

Analyst

Well, yeah, I'm going to take the glass half full approach and point out that while the vaccines are not necessarily stopping infection, they're keeping people out of the hospital. And so while we are seeing breakthrough responses, and the, you know, the cape - in the Massachusetts Cape area, is kind of a special area in terms of how people were behaving and the exposure with concerts and things like that. So, it's a very harsh test of a vaccine. Where – but the secondary infection of fully vaccinated individuals, there's two more population studies that I just saw the announcement on, is much, much lower. And so keeping people out of the hospital, and you know, looking at a super spreader event versus a general population. I think the story is the vaccines are working, can they be made better? Yes, I think absolutely. And I think the NIAID, rural health, everybody believes that, that's why these programs are out there. And I'm with David, I think that, you know, we would love more attention and we think we are putting ourselves in that position.

David Dodd

Analyst

And I’d just also like to add that people may have seen the announcement this week of the first outbreak of the Marburg virus in West Africa, and if you're familiar with that, you know that the fatality rate exceeds 50%. And the Angola strain of Marburg, for instance, has a 90% fatality rate. These are things we don't discuss unless it suddenly occurs in the U.S. But this is again, one of the hemorrhagic fever viruses. And as we've mentioned, we're in development work through non-human primates with – in conjunction with NIH preclinical services. So, these are other areas that we're focused on utilizing, again, our MVA VLP approach to try and deliver single dose very effective vaccines that will save lives and protect lives. So let me just say that I want to thank everybody for your interest, your continued support, and we will continue to update you on the progress and the transformation of GeoVax. We do look forward to staying in touch, making announcements. So, thank you for supporting our goals. And as always, I want to finally thank and acknowledge our staff and the many other parties that continue support, assist, and advise us towards achieving success. And so, have a great rest of the day. And we look forward to updating you in the near future on some more progress. Thank you.

Operator

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.