GeoVax Labs (NASDAQ:GOVX) Q3 2020 Earnings Call

0:00 Good morning and welcome to the GeoVax Third Quarter 2020 Corporate Update Call. I am Cole with Course 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 conference specialists 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 Scott Gordon of Core IR, who will provide a forelooking statement regarding this call and information herein.

0:45 Please go ahead.

0:47 Thank you, Cole. And thank you, everyone, for joining the call. 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 G of X can develop and manufacture its vaccines, with the desired characteristics in a timely manner. GeoVax's vaccines will be safe for human use. GeoVax's vaccines will effectively prevent targeted infections in humans. GeoVax's vaccines will receive 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.

1:49 GeoVax will be 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 is not intended to do so. More information about these factors is contained in GeoVax's filing, Securities and Exchange Commission, including those set forth at risk factors in GeoVax's Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. David, please go ahead.

2:20 Thank you, Scott. Good morning, and thank you for participating in this inaugural GeoVax quarterly update call. During third quarter 2020, GeoVax capitalized the company and achieved a NASDAQ listing, securing the resources in support of accelerating our development programs towards clinical development, hopefully leading to eventual preventive vaccines and meaningful cancer immunotherapies. We are focused on delivering meaningful results and value milestones over the next six to 12 months. This would not have been possible without the support and commitment of our existing investors and more recent new shareholders, as well as our dedicated, highly capable staff and our excellent external support resource teams. Thank you to all of those individuals, and we hope that our efforts will provide improved health for people worldwide while delivering attractive financial returns to our investors and career development opportunities to GeoVax staff.

3:14 We look forward to your continued commitment and support as we advance our programs as well as value developments for shareholders, stakeholders, and public health worldwide. Throughout 2020, GeoVax has been highly focused on what many are calling the scourge of the century, now known as COVID-19. Our response to this pandemic has resulted in the development of four vaccine candidates that have either already begun or will soon begin animal testing and for which we are seeking federal funding support to more rapidly accelerate our program through animal testing, selection of a lead candidate, manufacturing scale-up, and into critical human testing. The recent NIH license illustrates our confidence in that it confirms GFacts' access to and use of critical NIH patents and materials in support of product development, clinical development, and continued progress through FDA registration, manufacturing, and commercialization.

4:10 Despite there being vaccines that have entered clinical testing constructed using different approaches and different vector platforms than ours, there is increasing evidence that alternative vaccine approaches, including vaccines for various cohort populations, will be necessary to successfully address COVID-19 and related coronaviruses. Most of all, the desired attributes of such vaccines, reflecting high efficacy of 75% or greater, single-dose administration, extensive safety validation, durability, and minimal refrigeration appear to remain elusive when considering the current first-tier candidates. This is where we believe that the GeoVax approach can make a meaningful difference, potentially delivering on most, if not all, of these targeted attributes.

4:58 With over 250 COVID-19 vaccines at various stages of development, critical challenges remain as to the timing of public use and distribution, attributes of the various vaccines, and long-term preparation readiness for potential future pandemic challenges. The initial COVID-19 vaccines and clinical trials being funded by BARDA under Operation Warp Speed are primarily focused on vaccine technologies where there existed established relationships between the federal government and specific vaccine developers. Because those vaccine technologies are largely unproven, major questions exist regarding their safety, efficacy, and durability, as well as the eventual public acceptance based on their performance profiles, not the least of which is that of feasible distribution to populations across the world's various environments.

5:51 RNA and DNA vaccines, such as those from Moderna, Pfizer, and Inovio, only allow for specific genetic fragments, meaning that they potentially result in a tight, narrow focus, such as the COVID-19 virus S protein, as the target for preventive success. Adenovirus-based vaccines, such as the AstraZeneca and J&J platforms, similarly do not target a broader base approach and typically require multiple dosing, and additional components or adjuvants to achieve meaningful efficacy. Finally, there remains the challenge of feasible distribution to the public of various environments and localities. This critical issue presents a major challenge, especially when extreme frozen refrigeration such as minus 70 or minus 80 degrees Celsius is required with most of these technologies.

6:46 The GeoVax approach enables insertion of multiple antigen fragments, potentially allowing broader spectrum virus prevention. As such, we have our four COVID-19 vaccine candidates in animal testing with the intent of selecting our lead candidate for proceeding to human testing. Using our approach, the inclusion of COVID-19 proteins support the virus-like particle or VLP formation, becoming targets for the cellular immune response. thereby increasing the overall immune response since the VLPs closely mimic what might be seen within a recovered patient. As a result, we anticipate a potentially stronger and broader immune response without presenting an increased infectious risk to the vaccinated patient.

7:35 The same GeoVax approach used in constructing our infectious disease vaccines has shown excellent progress in cancer in both therapeutic and preventive animal models. Our cancer immunotherapy concept is to combine a tumor-associated antigen vaccine with a potent anti-tumor agent such as an immune checkpoint inhibitor, resulting in regression of tumor growth and development. Starting with the Mach 1 tumor-associated antigen, or TAA, we have identified additional TAAs which we intend to incorporate into such an approach depending on the targeted tumor type. As an example, since the Mucin-1 TAA of Mach 1 is highly expressed in many different solid tumors, we constructed an MVA-VLP Mach 1 TAA vaccine, combining it with a checkpoint inhibitor, or CPI, testing it in a humanized mouse model against a human tumor.

8:33 The result of this combination was a 57% difference in tumor growth. within the cohort that received the vaccine CPI combination versus the cohort that didn't receive such therapy. Also, the GeoVax combo therapy was superior to that of either the vaccine or the CPI alone. In a preventive evaluation, again using humanized mice and a human tumor, the GeoVax MVA VLT Mach 1 vaccine plus a Mach One Peptide provided 100% prevention of tumor development versus 100% development of the tumor in the cohort that didn't receive the GeoVax vaccine peptide combination. These results have encouraged us to proceed as quickly as possible towards initiating a clinical development program. We believe that the GeoVax MVA-VLP combination approach provides an exciting and promising basis for novel efficacious cancer immunotherapies.

9:34 While our primary focus is on accelerating our COVID-19 vaccine and immuno-oncology programs, GeoVax has several programs advancing that are supported by non-diluted funding that address compelling areas of medical need and significant commercial opportunities. In addition, several of these programs target medical areas within the FDA priority review voucher program. These present significant non-diluted capital development opportunities as the product advances towards development completion and regulatory registration. To date, our developments in the areas of hemorrhagic fever virus vaccines, such as Lassa, Marburg, and Sudan, and our malaria vaccine continue to advance towards completion of animal testing via non-diluted funding, as we similarly have seen with our Ebola and Zika virus vaccine programs. Let me again note and underscore that all six of these vaccine programs target medical areas within the priority review program.

10:33 Currently, our Ebola vaccine has completed non-human primate testing, demonstrating 100% protection in a single dose with no adjuvants, ready to advance into human testing. The Lassa vaccine is being supported by the U.S. Army and is now in animal testing funded through non-human primates and preparation of the CGMP material for clinical development. We expect results of the animal testing of the Lassa vaccine either late this year or early next year. Both the Marburg and Sudan vaccines, having previously demonstrated 100% protection in rodent models, are being tested via the NIH preclinical services program through non-human primates at no cost to GeoVax. We expect results of the animal testing beginning first quarter of 2021.

11:23 Our malaria vaccine candidates have recently entered animal testing with the results expected yet this year. And our Zika virus vaccine, for which a major health need remains in the southern hemisphere, meaning South America and parts of Africa, is ready to proceed into clinical development, having demonstrated excellent preclinical results. Most notably, that our Zika virus vaccine avoids the risk of antibody-dependent enhancement. Our development programs are all focused on areas of major medical needs representing significant commercial opportunities. Ultimately, the commercial value of these opportunities will be dependent on numerous parameters, starting with the eventual success of our development. Beyond that obvious hurdle, we believe that the GFX technology and approach has the potential to deliver single-dose, safe, highly efficacious durable vaccines while also providing a new advance within cancer therapies.

12:21 The commercial opportunities are significant and we're focused on advancing into clinical development as soon as possible. Now I'd like to turn the presentation over to Mark Reynolds, GeoVax Chief Financial Officer for a review of our recent results in financial status. Mark.

12:38 Thanks, David. Obviously, the most important financial event during the third quarter was the closing of our public offering on September 29th and our uplisting to NASDAQ. So I'm going to start the financial review with our balance sheet since that really sets the stage for our progress moving forward. Cash balances at September 30 were $11.6 million as compared to just $283,000 at December 31st, 2019. Working capital at September 30 was $10.8 million as compared to a negative $1.6 million at the end of 2019. That increase is obviously primarily due to the September public offering where we received net proceeds of approximately $11.2 million. But there are a few other events that are also worth mentioning that happened during the year.

13:30 Over the past several years, this is a very important point I want to make. All of the GeoVax's officers and directors took significant salary and fee deferrals in order to help the company to conserve its cash resources and allow it to advance to where we are today. Concurrent with public offering, one and a half million of those deferrals were converted into equity under essentially the same terms as the units sold to the public. This removed a significant liability from our balance sheet further strengthened our financial condition moving forward and also demonstrates the commitment from our board and management team to the success of GeoVax. In June, we received net proceeds of approximately $900,000 from the issuance of convertible adventures or bridge loan that gave us the cash runway we needed to complete the public offering. Again, concurrent with the offering, those adventures were also converted into equity, thereby removing another significant liability from the balance sheet.

14:30 Back in April, we received $170,000 under a bank loan from the Paycheck Protection Program, or PPP, provision of the CARES Act. That loan is still on our balance sheet at September 30, but we recently applied for full forgiveness, which we expect to receive, so that liability will be eliminated as well. So in summary, with the proceeds of the offering and the elimination of a number of significant liabilities, our balance sheet is strong. and will support accelerating all of our development programs. Turning now to the attention to the income statement, I'll focus mostly on the comparative figures for the nine-month periods of 2020 versus 2019. Grant and collaboration revenues were $1.6 million during 2020 versus $907,000 in 2019.

15:17 2020 period also includes $1.2 million related to our grant from the U.S. Army supporting our loss of fever vaccine program compared to $445,000 in 2019. And at September 30, there's still a little over $400,000 remaining under that grant to be recognized in future periods. 2020 period also includes $385,000 related to our collaboration with Leidos for work on a malaria vaccine. Research and Development expenses were $1.7 million in 2020 versus $1.5 million in 2019, representing an increase of 14%. G&A expenses were $1.4 million versus $1.2 million, representing an increase of 12%. Interest expense was $143,000 in 2020 versus just $3,000 in 2019, with the increase primarily representing interest expense and debt discount amortization from the bridge loan I mentioned earlier and which has now been eliminated.

16:23 So that interest expense will disappear going forward. That loss for the nine-month period was $1.6 million versus $1.8 million in 2019. The variance in the per share amounts, it's not really comparable. It's $2.85 per share in 2019. versus a little over $14,000 per share in 2019. That difference results from retroactive restatement of our common shares outstanding from the reverse stock splits we affected in January and September of 2020. Our net cash flow from operating activities during the nine-month period of 2020 was approximately $1.2 million or $134,000 per month on an average basis.

17:10 We do expect that to increase as we've eliminated the salary and board fee deferrals, we plan additions to our scientific staff, we're investing in our laboratory infrastructure, and we will incur incremental external costs for advancing our development programs. But in general, we expect our cash resources to sustain our operating plans through early 2022. My final comments are related to GeoVax's capital structure. Over the past 12 to 18 months, we made a concerted effort to clean up the capital structure, culminating in the September offering. I won't go into those details here, but it's all discussed in the footnotes to our financial statements and the MD&A section of our 10-Q.

17:56 As of September 30, subsequent to the offering, we had common shares outstanding of $3.6 million, with another 3.9 million shares subject to warrants, with an average exercise price of $4.53 per share. Most importantly, none of those warrants contain any of the toxic conversion features associated with some of our prior securities, which are now fully converted and fully behind us. Our capital structure is clean, well positioned for supporting a further growth. I'll turn it back over to David now.

18:29 Thank you, Mark. My colleagues and I will now answer your questions. I am therefore turning the call over to Cole, the operator, for instructions on the question and answer period. Cole? Certainly, and we will now begin the question and answer session. To ask a question, you may press star then 1 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 2. And at this time, we'll pause momentarily just to assemble the roster. And our first question today will come from Jason McCarthy with Maxim Group. Please go ahead.

19:09 Good morning, all. Thanks for taking the questions. I just want to ask a couple questions on the ID side and one on the oncology side after. On the ID side, obviously, there's so much focus on COVID. David, can you give us a sense of the timeline to select one or more of your candidates to get through animal studies and get into the clinic? Just the announcement, we think just the announcement of the is significant. And also, as it relates to COVID vaccines, can you speak a little bit broadly about the safety aspects of an MVA vaccine in terms of that type of backbone being used in immunocompromised or high-risk patients and deemed as safe just from smallpox work that's been done? It's applicable, we think, to what you're doing.

20:08 Thank you, Jason. In terms of timing, based upon the current testing we've initiated and moving forward, what we are looking at is we don't know if we'll end up, obviously because we haven't completed the results, but we don't know if we'll end up with one lead candidate or if there might be two that we have a difficult decision to make, which would be a good situation to be in. We are targeting that in the second half of Thank you for joining us. and probably the latter part of first quarter, but first quarter and then clearly into early part of second quarter.

21:15 And we're in the queue right now to go faster with that. We have things on order. There's a challenge across the industry of access to and scheduling for non-human primates, as you might imagine. The one thing we've been able to do in this recent period following the financing is begin to step forward, take a little more risk in terms of getting in the queues and scheduling stuff. So our current plans are that in the second half of 2021, we would be initiating our clinical development. And so then I'll go to the question you had asked about MVA in general as the backbone. As some people or many people are aware of, MVA was developed specifically as a smallpox vaccine for individuals with compromised immune systems or comorbidities, etc. It's been tested in over 150,000 individuals.

22:17 It is exquisitely safe. I guess I think I would underscore it by saying that to the extent that for our COVID-19 program, the FDA has agreed to exempt us from having to do the full traditional toxicology testing because we are using MVA. So from that perspective, we believe that eventually there will be multiple vaccine approaches needed for different types of cohort populations. There is no better illustrated and validated and many more. issues crop up related to adenovirus-based vaccines.

23:21 We don't know about the safety of the RNA and DNA. That's to be determined. And so we do know that we're going in with a well-recognized, validated, safe backbone. And I'll just ask if Mark Newman has anything he'd like to add to answering this question. Mark? No, I think that covers it all. As you mentioned, the NBA is a vaccine on its own. and that is that we're building on that so that it's an approved vaccines in the European U.S. stockpiles so it's an ideal place to start.

23:59 Right and just building a little bit further because for the investment community I think you know sometimes they could look at vaccines for COVID as maybe a noisy crowded space right now especially if you're in the early stages but to our knowledge, you're the only other group that's working on MVA-based vaccines and help us understand the history behind MVA in terms of being a potential booster or an add-on to another COVID vaccine because that's what we saw with the MVA backbone for J&J's Ebola vaccine and that was a big deal in 2014 and 2015. Mark, can you talk a little bit about that? Yeah, sure.

24:44 So As David mentioned, and I think you're alluding to, the DNA and RNA products are totally experimental. There's nothing licensed. The adenoproducts, that's a viral vector based on adenovirus. So that's AstraZeneca and J&J. And those products are based on viruses that don't circulate at high levels in the population. But when you start immunizing several million people, you're now going to be inducing immune responses to both the vector and to the COVID antigens. So you're inducing anti-vector immunity. And we believe that boosters are going to be needed, just like a flu shot.

25:32 For a number of reasons, boosters will become part of this. It would be difficult in all likelihood to boost with an adenovirus-vectored vaccine because you're inducing an immune response to the vector, the backbone, as well as to the COVID. So you're going to start seeing a mix and a match. If you've got a J&J product to start with, there will be a booster opportunity next year with a different product so that you're not seeing vector-induced immunity inhibiting the vaccine efficacy. So it's not only a primary response, but then the booster. But additionally, as David mentioned and we showed in that cartoon, the virus-like particles, that's a much more complex antigen structure in the vaccine compared to what you're seeing with the warp speed products, which are all based just on the S proteins.

26:29 Those are designed to induce antibody responses, whereas the VLP will induce the same antibody responses plus helper and cytotoxic T lymphocyte responses. These are critical to amplifying the response to inducing immunological memory so that if you are re-exposed later, you can respond more rapidly. So it's very much builds on the next step of the vaccine design based on what we know in immunology.

27:00 Great, thank you. And then just last question on the oncology side, on that vaccine side. Can you guys talk just a little bit about combination therapies? It seems like, you know, investment calls we get all the time, like, well, it's another combination therapy for X, Y, or Z. But for cancer vaccines, you know, a lot has changed in the last, call it five or six years, where checkpoints have opened the door for cancer vaccines to finally have the success that they were looking for. Can you talk just a little bit about how that dynamic has changed and why the opportunity is now for cancer vaccines for like GeoVax?

27:42 David, do you want to take that or do you want me? Yeah, I think, Mark, I'll let you take that. You might be able to expand on that scientifically. So as I think you recognize and the people you're talking to recognize, cancer vaccines have been something that's been a target within the research and the medical community for quite some time. But they've never generated the types of immune responses that were needed to be really an added component to cancer therapy. and the reason for that is the auto regulatory components of the immune response and that's what the checkpoint inhibitors control. The checkpoint inhibitors, they inhibit the checkpoints and so that stops the immune response from being down regulated and allows it to increase over time with continued therapy.

28:36 The more potent the response, the more likelihood you're going to see anti-cancer effects. and so the checkpoint inhibitors literally have reopened the cancer vaccine field, in my opinion, and this gives you a new environment in which to induce the type of response that you want. Now, the nice thing about the cancer vaccines as far as the treatment is that it's somewhat of an independent part So if you look at normal cancer therapy, you would be looking at surgery and radiation and chemotherapy and these type of things as all individual components that can be mixed and matched, while the checkpoint inhibitor is a form of chemotherapy, essentially an immunotherapy, and then the cancer vaccines add to that. So it's a new component possibility within the therapy regimens. So it's not a total reinvention of the world. but it's taking it a step further.

29:37 So I personally, I believe that the cancer vaccine field has a lot of opportunity right now, primarily because of the checkpoint inhibitors working so well and then these new technologies, things like the MVA, VOP and potentially new adjuvants and things like that. Does that answer your question?

30:00 It does, very helpful, thank you guys.

30:04 Let me just add, if you think about it, the approach we're following in the cancer therapy of this combination approach is analogous to the trials that we are currently entering in HIV under the functional cure goals. So we're at University of California San Francisco, they're using our vaccine to create the stimulant and many others, and they're following it with a mix, a cocktail of antibodies and peptides to try and then knock down the viral level and hold it at a certain level for which there would be no need for the antiviral drugs. American Gene Technology, similarly, in one of their arms will use our vaccine for the same purpose of stimulating and priming and then coming with their gene therapy.

30:57 This is following the same general type of concept, but applied to it in cancer. So thank you.

31:05 Thank you, David. And our next question will come from Jeffrey Cross with Crystal Research Associates. Please go ahead.

31:15 Thank you very much. David, you've taken a number of different approaches to the vaccines, which I commend you for. A couple of questions. One, which of the collaborations that you're seeing, you've partnered in HPV, you went after the head and neck cancer with Emory University, you've also worked on technology and partnering other technology, as you mentioned, just with UCFF, and you've got other partnership technologies with Viromedics and other companies. Which of the vaccine programs, because you've got so many, the cancer, the COVID, the HIV, the malaria, which two are the ones that you would expect to move ahead first?

32:05 Because you have so many programs, it would be very difficult to focus on all of them. Which first two are the ones you expect to move ahead in your testing?

32:17 Okay, in the tech. Well, the first two programs, one will be the COVID-19, but if we look at the cancer immunotherapy area, the first one we think we'd be moving ahead would be in conjunction more than likely with Oya Thin at University of Pittsburgh into the clinic with the MVA-VLP Mach 1 approach. And that's what we're targeting from that standpoint. The other collaborations have all been established to really validate that and convince us that this technology and this approach is working and makes sense to move forward with. So in none of the others are there ones that would move collaborations necessarily forward. We're interested in continued discussions in depth with Viamune because that has gone very well.

33:08 That also targets in the Mach 1 area. We'd probably combine that association with what we're doing with OUFN. and then the other projects that we have in the infectious diseases. Those are all being led through government entities with the exception of malaria where we've been working with Leidos but with funding for that vaccine. So we could see, depending on the results, we could see that one moving forward because for malaria there's only one vaccine around a day. It requires four doses and it has an efficacy of less than 40%. and yet it's a major need worldwide. So if those results which are now in animal testing look promising, we could see that program accelerate but that would largely be led through non-diluted probably financing and going forward with that and we would be helping to manage and handle the IND and those parts and manage of it but it would not be distracting. I think within the cancer area and the COVID are two areas of focus. I will say that Zika virus vaccine is one that has sort of been on hold for over a year now.

34:29 We've had promising and interesting discussions for a full joint development going into the clinic based on what we've achieved thus far. That was all placed on hold due to the challenges of our capital structure. But with the more recent capitalization, we can move much more quickly. And that's an interesting one that personally would be very nice to see get started and move forward with some speed because we could move into the clinic very quickly. We know that there is a major, major medical need and significant commercial opportunity available for that. and we believe our vaccine differentiates from most of the others that are in development for sort of commercial development use because the others do not utilize the NS1 protein which avoids this antibody-dependent enhancement issue that is a big concern. So I hope that answer gives you some flavor, but clearly our primary focus right now is getting to the point, making a decision on the COVID-19 and moving into the clinic with our Mach 1.

35:37 Next question is, you've obviously had a lot of success and a lot of interest in the HIV-AIDS area. Clearly with over a million people walking around the United States with HIV, while people have been able to extend the survival, it still is very traumatic and being able to stop that and being able to stop the spread would be key. A number of people have partnered with you, obviously expressing and validating the interest in your technology. You were able to partner with American Gene Technologies. You also partnered with UCSF, and you were able to also go out, I believe, in another area to start a clinical trial. Your AGT trial has been cleared by the FDA, and you had expected the vaccine to be added to the trial in 2021. Is that still very much on track, and do you have any – and all the way through 2A, that that might be expedited as far as getting to the marketplace because of its strong and durable humoral and cellular immune responses.

36:47 Yeah, the AGT trial, you're correct, we expect everything we know from AGT, it's their IND, their program, We believe, and the latest we've been told is the arm that will include our vaccine will be in 2021. Now, I believe they plan to start patient enrollment in those activities starting in first quarter of 2021. I don't think they've started that yet. I do know that at UCSF, they started patient enrollment in early August. So, So that program is sort of underway operationally. The other one, the HVTN-132 is a phase one program using our vaccine against 70 patients looking at our vaccine with a novel booster.

37:36 Again, that is scheduled to start in 2021. It was originally scheduled to start last year of all things. It was placed on hold because one or the other participants in it had to redo some work then it was scheduled to start this year but COVID-19 has pushed it back off the planning because they're using all the clinical sites for for COVID-19 clinical programs so so that will go forward but the challenge with with HIV is as you point out it remains a major health need in the United States and worldwide and will never be ended until we have a preventive vaccine. And 40 years, essentially, or certainly 35 years after we were all introduced to HIV and AIDS, we remain without a vaccine.

38:29 It was just a year ago that there was a publication out of NBC News where it had interviewed Dr. Fauci and Dr. Bookbinder out of San Francisco. and they were discussing the possibility and that there was no better expectation than at that point that there would be a successful vaccine available for preventing HIV by 2021. They were discussing a program that was of a product that was underway in South Africa. Unfortunately, two months after that interview, they announced the halt of that trial, known as HBTN702. It was a Sanofi product with a booster from GSK.

39:17 And after several years and thousands of patients enrolled, they saw no difference between the vaccinated group and the placebo group. And so the challenge we have is to be able to move to a pivotal trial. You're right, the excellent data we've shown all the way through a Phase IIa but a pivotal trial, Phase IIb, is a very expensive trial, probably costing $50 million up and more based upon the protocol that NIH would want to follow. And it's a challenge because typically one is expected to contribute a significant financial portion of that cost when one is doing those trials. That's why we've only seen advances with the likes of Sanofi

40:03 are the J&Js, where they're very deep pockets.

40:06 We're ready to go forward. We're ready to move forward in the pivotal trial, have been for nine years now, frankly. We just need the financial support, but we will continue to advance, albeit far slower than we'd like, but we'll continue to advance our programs through these non-diluted funding and these collaborations But frankly, to move forward for building value and getting products to the market, we believe that focusing as we are now in these other areas of infectious disease and then also in cancer immunotherapies makes much better sense for ourselves as a company.

40:44 Great. One last question and a comment. Speaking with investors, investors have been very impressed that your entire team not only has Thank you for joining us. We have your worldwide patent estate at about 56 granted or pending patent applications over 16 patent families. Is that about right? Because obviously having the IP to protect all this is critical.

41:42 That is correct. I always get it wrong. It's either 5616 or 5815, but you're essentially right. I had it in front of me.

41:51 But you're correct.

41:52 The commonality is the backbone being the MVA. We reflected in that recent NIH license, which was a very important one because it covers us in terms of rights all the way through commercialization, so all aspects of it. So it's a very comprehensive license. But yes, that is what we have. And then we individually file patents on every product that we design and develop and construct. So yes, that is the PAM.

42:24 Great. Thank you.

42:25 Okay. Thank you. Thanks for your support. And this will conclude our question and answer session. I'd like to turn the conference back over to David Dodd for any closing remarks.

42:35 Thank you. And thank you to everyone for your continued support. and interest in the progress and transformation of GeoVax. We look forward to updating you on our advances when we discuss fourth quarter and full year 2020 results. The successful capitalization and NASDAQ listing of GeoVax has provided the foundation from which we hope to develop a highly valuable company, contributing to improved health options against various infectious threats and cancers. In the interim, we will provide timely updates regarding the various results and progress of our infectious disease vaccine and immuno-oncology programs. Thank you for your continued support and commitment to these goals. I also want to again acknowledge and thank our GeoVax staff and the many other parties that continue to support, assist, and advise us towards achieving success.

43:24 For all of us, it is a great pleasure serving our shareholders and being part of this team. Thank you. Have a safe and enjoyable day. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time