GeoVax Labs (NASDAQ:GOVX) Q2 2021 Earnings Call

0:00 Good day and welcome to the Geofacts Second Quarter 2021 Corporate Update Call. I am Grant 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, PhD, Chief Scientific Officer. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your telephone keypad. To withdraw your question, please press star, then 2. Please note this event is being recorded. I would now like to turn the conference over to Joel Abraham of Core IR, who will provide a forward-looking statement regarding this call and information herein.

0:57 Thank you, Grant. Good afternoon, everyone. We'd like to have you please note the following. Certain statements in this presentation may constitute statements within the meaning of the Private Secured Litigation Reform Act. These statements are based on management's current expectations in terms of 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 vaccine 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.

2:00 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 intend 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's now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. David.

2:33 Thank you, Jules.

2:34 Good afternoon, everyone, and thank you for participating in the 2021 Second Quarter Update Call. We are pleased to have this opportunity to review and discuss our continued progress in accelerating are priority development programs towards clinical development and continuing to secure significant resources in 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 and value milestones over the next 12 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.

3:23 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 CEPI have issued requests for proposals for canned coronavirus vaccine development projects, specifically seeking to fund preventative Thank you for joining us. In other words, the continued challenge will be to provide vaccines that will be adaptable against variants that might emerge.

4:18 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 save and David Latham. In January, we announced receipt of NIH funding in support of our universal coronavirus vaccine development program. We remain in contact with NIH, BARDA and other entities with whom we'll review our results. already based upon encouraging results that we received thus far in our animal testing, we've submitted another larger proposal to NIH in support of our universal coronavirus vaccine development.

5:21 Similarly, we will be submitting significant funding requests to other entities based upon the encouraging results we've seen so far.

5:28 Dr. Mark Newman, our chief scientific officer, will provide an update on our universal coronavirus program and approach a little later in the call.

5:38 Following the announcement of the initial NIH grant in support of our universal coronavirus program, we had the opportunity to further increase our cash position, successfully raising over $10 million. We also added over $3 million resulting from warrant exercises. Today, we have a cash position of approximately $20 million. We expect to further strengthen our balance sheet as similar opportunities present to increase our capital base on favorable terms. In summary, we are well capitalized advanced priority programs in clinical development over the next 12 to 18 months. Our priority remains focused on the universal coronavirus program and immuno-oncology. We're also strengthening our resources in support of accelerating our product development and path to clinical development.

6:27 As noted in our previous corporate update, we continue to strengthen our IP portfolio. now having over 70 granted or pending patent applications spread over 20 patent families with additional applications occurring during first quarter. In February, we filed international and U.S. patent applications in our key focus areas of SARS-CoV-2 or COVID-19 and cancer immunotherapy. More recently, in July, the company announced the issuance of a U.S. patent covering our hepatitis B vaccine. We are confident that we have a strong IP position, providing an increasingly more competitive position in the marketplace. In addition to our universal coronavirus vaccine program, we continue to progress other initiatives. This includes advancing plans relative to immuno-oncology, where our animal testing results have been encouraging in support of progressing into clinical development. Also, our Sudan, Ebola, Lassa, and Marburg vaccine programs are currently completing animal testing through non-human primate evaluation, supported through federal government non-diluted funding.

7:32 In summary, we have a compelling pipeline focused on major medical needs, providing significant commercial opportunities with near-term value milestones. Included in our development portfolio are six indications that qualify for the FDA priority voucher program. Our priority focus remains on advancing our universal coronavirus vaccine program and our immuno-oncology developments while these other programs will advance requiring minimal resources from GeoVax. In advancing our developments, we'll also consider opportunities to accelerate our progress through various strategic considerations that we might identify. Now I'd like to turn the call over to Mark Newman, our Chief Scientific Officer. Thank you, David.

8:18 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.

8:37 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 localized 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. Now, in 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.

9:33 For a vaccine to really be optimally effective, it 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 are referred to as memory cells. Memory cells are important because these are the cells that are capable of responding rapidly at subsequent infections. The COVID virus represents a very challenging situation for vaccines. This is because mutations can accumulate within the virus that change the structures of the proteins.

10:24 These will lead to variants that are not recognized by existing immune responses. And then if you get a variant that is not recognized by a preexisting antibody-induced response, then these will be referred to as an escape mutant. I'm sure you've all heard of this type of thing in just the general press. Just on this graphic on the right here, I want to show you this is the variation that has been tracked within a population of COVID variants with just over a year. So it's a highly variable virus within the population and this started from a single type of virus. The next slide shows you the The next slide shows you the concern that the World Health Organization puts on this.

11:12 There are multiple mutations in the S protein, and these can lead to varying forms of virus that escape the immune responses that are induced by the first generation vaccines. Remember, first generation vaccines are based on the S protein. S protein mutations not only impact the ability of the antibodies induced by the vaccine to neutralize the virus, but these mutations in the S protein can actually impact the effectiveness of the virus to infect cells and increases transmissibility. Today we're witnessing the Delta strain or the Delta variant. This variant is as of today the most highly transmissible of the COVID strains yet studied.

11:58 It's also somewhat resistant to the first generation antibodies that are induced The antibodies that are induced with the first-generation vaccines. So it's posing a real significant problem. Now, it's a major concern, and if you look at this table, it becomes quite obvious. The Delta variant is the fourth variant down. There's already four more variants that are labeled as COVID variants of concern by the World Health Organization. We don't yet know the risk of these. We also don't yet know the effectiveness of the current generation of vaccines to protect against them. But it's clear that we need to be doing something else. Now, the GeoVax program is the design vaccine that will also induce the T-cell responses.

12:47 Why target T-cell responses? Well, a study of T-cell responses has been completed by a number of labs using blood samples obtained from individuals that got COVID naturally but recovered from the infections. So this type of analysis can be used to document the importance of T cells. What it shows is that T cell responses specific to many proteins can be measured. This includes the S protein but also other structural and non-structural proteins. CD4 T lymphocytes tend to predominate the response. This is a type of cell, a T cell, that can directly reduce virus replication. but it's also a type of T cell that supports the development and maintenance of other immune system functions. This includes memory and active antibody production and CD8 T cells. These are the cells that are commonly referred to as killer T cells, which mediate the clearance of virus from an infected individual.

13:52 Importantly, the study of severely infected patients has demonstrated that those that have a significantly better T cell response are likely to do better, spend less time in a hospital, and recover more quickly. So this is important in a vaccine setting and can be tied back to the original SARS infections which occurred back in 2003. Individuals that recovered from the SARS virus back in 2003, still have memory T cell responses to the virus. So the T cells can be long-lived, providing a long duration of response. This is critical because the induction of durable immunological memory is the goal of a successful vaccination.

14:40 We believe this can be optimally achieved through the induction of the correct T cell responses. Now, next slide shows you how to target the T cell responses appropriately. The rise of variance in alterations is typically characterized based on variation in the S protein. If you look at this figure here in this graph, what this shows you is that when we evaluate the genomes of multiple COVID variants and related viruses, we see that There are proteins that are not variable. These are shown in this graphic as the ORF1A and ORF1B. These are proteins that are critical to basic coronavirus functions. When we get into the S protein, the surface protein, or the spike protein, you can see that the variation increases dramatically, and this is shown as a decrease in the relatedness of the different viruses.

15:44 What this tells you is that the virus is capable of changing the S protein, leading to variations without destroying the virus's ability to replicate. Now, the proteins that are encoded by genes that are much more highly conserved are required for virus replication. And these become obvious targets for vaccine design because the virus cannot allow for escape cannot allow for variation in the generation of variants.

16:17 The next slide shows you where we are in the GeoVax system. This is a slide that's been shown before, so you might recognize it. Design of vaccines that induce immune responses specific for multiple COVID viral proteins has been the focus of the GeoVax effort. We can do this because our ability to work with the MVA viral vector. This is central to the GeoVax approach. The MVA vector allows us to produce vaccines that encode multiple viral gene proteins at the same time in a single vaccine construct, not in the mixture. On this graphic, this would be shown as the blue antigen, the orange antigen, and the green antigen.

17:03 Now, our initial efforts are focused on MVA-vectored vaccines that encode multiple forms of the S protein in combination with the membrane and the envelope proteins. So this is S, M, and E. The expression of S, M, and E proteins together drives the formation of virus-like particles within the cells of the body of the vaccinated animal. This is shown as the little satellite figures in this picture. The VLP structure is important because it presents the immune system with the vaccine proteins in a form that mimics a virus, but it's non-infectious. It looks authentic. It concentrates the vaccine proteins into a particle, but it's non-infectious.

17:51 So we believe these properties of the VLP will augment the potency and induce immune responses that are most relevant to inducing a protective response. The next slide just shows the lead candidate at this stage of the game. This is referred to as CMO2. What I'm showing you here is we have a construct. It is stable, which is important because this means that we can produce it. This is shown in the left side. The virus-like particle structure is shown in the lower left. These are actual virus-like particles produced by the, your directed, whose production is directed in the body by the MVA. They look like the SARS virus, but they are not.

18:38 The right side was showing that we can, or in fact can detect the expression of the S protein, which of course will be the antibody target. We're using a pre-fusion stabilized confirmation of the protein, which is the same S protein that is used in the first generation vaccines and is known to induce the best neutralizing antibodies. The VLP also contains the M and the E proteins, which is shown in the lower right side with the different colored figures. This shows the expression in the cells that are infected with the MVA. These will be targets that are highly conserved and will generate T cell responses, which is separate from the S proteins.

19:25 On the final slide, I just want to point out that the results of the initial studies with small animals led to the selection of this CMO2 product, as well as the data that I've shown you here in the lab characterization. The animal studies will be the basis of the, this vaccine will be the basis of the COVID, of the GeoVax universal COVID vaccine efforts. wherein we can add additional gene products to expand T cell responses. These results will be presented in more detail at the European Society of Medicine Conference, which is to be held in approximately one week, August 19th in Berlin. This MVA vector vaccine represents the first step towards a universal vaccine goal because it is designed to induce immune responses beyond the S protein.

20:18 were including the highly conserved membrane protein as a T cell target. Importantly, the CMO2 can be a scaffold which is used to design and to produce experimental vaccines that will target additional proteins of the COVID virus, selecting those which are most highly conserved to induce a broad T cell response to work in concert with the antibody responses. The design and production of these next-generation vaccine efforts is already the subject of efforts that David mentioned. We have a larger grant proposal in with the FDA, and we'll be submitting a proposal for support with CEPI. Now I'd like to turn the presentation over to Mark Reynolds.

21:11 Thank you, Mark. After the scientific review, I'm going to just go over some numbers here. I know that most everybody's 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 2020. and the increase in our cash balances would do 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. Those warrants were issued in connection with the offering that brought us onto NASDAQ last September.

22:04 As a quick recap, those warrants are publicly traded under 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, could bring in another $9.3 million to the company. Turning to the income statement, I'm going to focus mostly on the comparative figures for the six-month periods of 2021 versus 2020. Grant collaboration revenues were $190,021 versus $1.2 million in 2020. And the 21-period revenues relate entirely to our grant from the NIH supporting the COVID-19 vaccine, while the 2020 numbers include revenues from the grant for a loss of vaccine from the U.S.

23:04 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 the COVID vaccine program, manufacturing process development, and an overall generally higher level of activity. G&A expenses were $1.8 million in 21 versus $930,000 in 2020. That is a big increase, but a large portion of the increase here relates to our annual Delaware franchise tax, which is based on our capitalization. It was minimal in 2020. It was very significant in 21, so with payment of the 2020 tax and also estimated taxes for 21.

23:58 Other increases were in Patent costs, legal fees, consulting fees, and personnel costs, all generally associated with a higher level of activity following capital raise. During the second quarter of 21, we reported $172,000 gain on extinguishing of debt that was associated with the forgiveness of the PPP loan we received in early 2020. And overall, our net loss for 21 was 2.9 million, for 49 cents per share versus 1.1 million in 2020, or $2.27 per share. I'll note that the variance in the per share amounts is in large part due to the dilutive effect of September 2020 and February 21 stock offers.

24:46 So our net cash flow from operating activities during 21 was essentially the same as the net loss for the quarter at 2.9 million. And in general, we expect our current cash resources to sustain operating plans at least through mid-2023. Our cash burn rate for core operations, that's personnel, facilities, lab operations, et cetera, is less than $5 million annually, but our incremental program spending will increase as we progress to clinical trials in a couple of areas. So finally, a summary of our capital structure. We currently have $6.3 million Common Shares Outstanding, and as I mentioned earlier, 1.9 million of the publicly traded warrants.

25:34 There are an additional one and a half million of other stock options and warrants with an average exercise price of about four and a quarter. And that's it. I'll be happy to answer any questions during the Q&A. I'll turn it back to David. Thank you, Mark.

25:51 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. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question will come from Jason McCarthy with Maxim Group. Please go ahead.

26:31 Hey, guys. Thanks for taking the questions. I have a question for Dr. Newman. Specifically around the talk of the mRNA, the current double vaccines don't cover the Delta variant or other variants seemingly or The lack of immunological memory, we've noticed, and you and I have talked about this extensively, that that's true. 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 mention that to people, they look at me like I'm crazy. But I also know infectious diseases, and they don't. But how does that impact your thinking when you're developing your vaccine?

27:18 Is this a problem? that needs to come out more? Yeah, thanks for the question. You know, if you look at most vaccines, you know, your pediatric vaccines and things, you have a cycle of these that you get at a certain time, and then you would get a booster once every five or ten years. So if you get a tetanus shot, it's good for, you know, ten years typically, hepatitis once you're immunized. You'd only get a booster shot in at-risk situations. And I think that in this case, there's two points. Number one, the pandemic response required that the industry move quickly with what they could do. And they attacked this with the target that made a lot of sense.

28:08 It was the S protein, induce antibody responses, protect as many individuals as you can. These mRNA vaccines do induce some cellular 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 the literature on coronaviruses that cause colds, you know, the immunity is just short-lived. This might be in nature of the coronavirus. But there's also bias because you measure antibody 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.

29:19 But the protective 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 generally talked about in the press. Antibody responses are easier to measure. If you've got a vaccine, you can 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 cellular response. You can't measure immunological memory 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.

30:12 I don't have an answer to the question other than, yeah, we should target it, yeah. 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 the current vaccines. And what they've done is incredible with what they had and how fast they did it, but How much of the need now impacts how NIAID is willing to support groups like GeoVax with more funding to get next-gen vaccines 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 move it into a clinical study?

31:08 Well, so the first part of that question is NIAID is definitely aware of this. They have a program out there specifically targeting the development of universal COVID vaccines. And 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 they're looking for new technology. believing it may be needed or be new formulations or something with old technologies. But they're clearly aware of that. And then, I'm sorry, what was the second question?

31:51 The timing for GeoVax to select a candidate to move it into the clinic. Still 2022? Is that still in fact? So this sort of thing is somewhat flexible. Remember, we've got the immuno-oncology program and I think we presented at 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 theoretically 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 we could actually make a bigger bang for the buck Thank you for taking the question.

33:09 Our next question will come from Kumar Raja with Brookline. Please go ahead. Hi, I'm Shubendu 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 preclinical data? 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.

33:55 There's multiple animal models for this. Some of them measure pathogenesis, recovery 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 one 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 move right into people, then 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.

34:51 Great, 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? Well, so you've heard David Dodd talk before. We recognize that the MVA is – there's particular niches where this vector technology may be 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 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, will come down to recruiting patients that are either recovered from a natural infection or they will be patients that have already been vaccinated.

36:06 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 also with the M and the 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 MDA serves as a booster, can I increase a higher titer of S antibodies and can I expand the response or increase the preexisting response to the M and the 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 it 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.

37:03 Thank you. Thanks for the call. I'll get back to you. Again, to ask a question is star then one. Our next question will come from Jeffrey Cross with Crystal Research. Please go ahead.

37:21 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 3rd 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 in 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 masks, et cetera, and the The CDC doctor, Dr. Rochelle, wants to say that higher viral loads suggest an increased risk of transmission and raise concern that unlike other variants of vaccinated peoples, the Delta variant can transmit the virus. Are you receiving enough attention from the NIEB, the CDC, or the World Health Organization?

38:30 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, S, M, and E proteins and the fact that you do provide this boost and 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 have 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 are getting it. I know many people who got COVID who then got vaccinated with either Moderna, Pfizer, J&J, whatever, and then got COVID again.

39:22 And this study is, you know, supporting just that.

39:30 Mark, would you like me to comment and then if you want to pick up on them? Yeah, you can handle the geopolitical stuff, okay? Yeah, that's right. I'll deal with the science.

39:40 I'll get us in trouble. I'll get us in trouble. 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, et cetera. And I'd say in general, we never receive the level of attention that we believe we ought to receive. Now, that doesn't mean that that's an accurate statement. 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.

40:40 And that's reflected in the fact that both NIH NIAID as well as CEPI are aggressively in pursuit under their pan-coronavirus funding programs. But again, if we were suddenly to start sending signals throughout that what we have today may not be enough because of all these variants.

40:59 That could be very alarming and disturbing.

41:01 So I think the approach from that standpoint makes a lot of sense. But behind the scenes, there is quite a bit of attention to, and that's why we put together, I think, an outstanding proposal in response to NIAID's request. They're well aware of our approach and what we're doing, and we submitted that in July. and we're now moving forward to submit to CEPI. So I think 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 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.

42:01 So I think these points are well-recognized, but not acknowledged a lot, and probably appropriately so, but we are- Because they just want-

42:12 Sure. 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 always talk about falling behind.

42:26 That is true. I think, you know, the greatest event, one of the greatest events certainly in life science and certainly in vaccine was the speed with which people brought forward vaccines to provide an initial level of protection. So that's 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 emergent of variants and you saw the slide we showed that WHO is far ahead of just simply the Delta looking at at what is occurring here so there's 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're a trade-off.

43:19 So I think working together, we ought to be able to arm the world with the right types of vaccines.

43:26 Great, because I think that booster is obviously needed, and it is alarming to see 75% of people vaccinated, you know, getting the variant, which sort of supports the fact that the vaccines aren't working too well.

43:40 Mark, do you want to add anything in there or not? Well, 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 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. 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.

44:26 And so keeping people out of the hospital and looking at a super spreader event versus a general population,

44:36 I think the story is the vaccines are working. Can they be made better? Yes, I think absolutely. And I think that NIAID, Rural Health, everybody believes that. That's why these programs are out there. And with David, I think that we would love more attention, and we think we are putting ourselves in that position.

44:59 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% in the Angola strain of Marburg, for instance, as 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 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.

45:58 So let me just say that I want to thank everybody for your interest, your continued support, and we'll 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 to 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. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.