GeoVax Labs (NASDAQ:GOVX) Q2 2022 Earnings Call

0:00 Good afternoon and welcome everyone to the GeoVax Second Quarter 2022 Corporate Update Call. I am Andrew with Chorus Call and will facilitate today's call. With me are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, Mark Newman, PhD, Chief Scientific Officer, Kelly McKee, MD, MPH, Chief Medical Officer, and John Sharkey, PhD, Vice President, Business Development. 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 one on your telephone keypad. To withdraw your question, please press star then two.

0:55 Please note this event is being recorded. 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 will be safe for human use. Geovax's vaccines will effectively prevent targeted infections in humans.

1:44 Geovax's vaccines will receive regulatory approvals necessary to be licensed and marketed. Geovax raises required capital to complete vaccine developments. There is development of competitive products that may be more effective or easier to use than Geovax's products. 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 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 at Risk Factors in GeoVax's Form 10-K.

2:34 It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.

2:40 Thank you. Good afternoon, everyone. Thank you for participating in the 2022 second quarter update call. Second quarter represented an exciting and critical period for GeoVax in that we advanced clinical stage development status within the two priority areas of COVID-19 vaccine development and cancer therapy. In addition, we continued to advance our preclinical development stage programs. We also successfully strengthened our balance sheet during a very difficult investment environment, especially for the biotech sector. Our mission is to improve lives worldwide, preventing or treating some of the world's most challenging infectious diseases and cancers. Our pursuit is to deliver safe, affordable products, delivering increased value to shareholders and stakeholders while providing motivating career development opportunities to members of our team.

3:36 The in-licensing of GEO CMO4 S1 and Godeptin have provided potential significant value expansion for the company. CMO4S1 is a leading next generation COVID-19 vaccine and phase two clinical development targeting both antibody and cellular immunity with the goal of providing more robust and durable protection than the current authorized vaccines. This vaccine holds promise from several critical areas of differentiation and value over the current authorized vaccines. Goodeptin is a cancer therapy currently in an expanding multi-site evaluation among patients suffering from advanced head and neck cancers. The product has received orphan drug designation from the FDA, as well as the initial funding in support of the current clinical trial coming from the FDA Orphan Drugs Clinical Trials Program. We believe that Goodeptin holds significant clinical promise, including a potential accelerated development pathway.

4:40 Both CMO4S1 and Godeptin are now under the sponsorship of GeoVax, and our focus is on accelerating the clinical development of each of these products, including the potential for expedited regulatory review. At the same time, we continue to advance other internal development programs on the path to IND filing. Earlier this year, we issued a 2021 milestone report addressing the goals we established and communicated early last year. That report outlined our successful performance in executing upon our 2021 goals. In addition, we provided our goals for 2022. Our focus and activities remain on this year's goals, primarily reflecting and focusing on the acceleration of clinical development for Godeptin and CMO4S1 and the transition to a more efficient higher yield MVA manufacturing process.

5:35 In January, we strengthened our balance sheet with a $10 million direct investment. In May, we closed a $20 million direct investment. In fact, just this week, an additional $5 million was added as a result of the exercise of warrants. We continue to receive strong interest related to investment capital, which we'll evaluate. But we're focused on execution towards our 2022 goals and building shareholder value. Mark Reynolds, GeoVax CFO, will provide a more comprehensive overview of our financials. Regarding Gdeptin, we previously confirmed two additional clinical sites in the assignment of Ellucian as our CRO partner responsible for leading the expansion and acceleration of the Gdeptin clinical program.

6:23 Our focus on accelerated and expanded patient enrollment is actively underway. with the goal to complete patient enrollment in early 2023, followed by completion of patient evaluations by the end of 2023 or 2024. Should the results be supportive, a BLA filing may follow shortly thereafter, but that will determine based upon further discussions with the FDA. In parallel with the ongoing clinical program, we're also engaged with the CDMO to ensure sufficient product for the expanded clinical program, as well as to prepare for commercial manufacturing. We're confident that the Gdeptin Phase II program will be successfully managed by Ellucian and our clinical operations team with possible expansion of further additional clinical sites.

7:12 We're highly excited about the outlook and promise of Gdeptin within advanced head and neck cancer. In addition, there are promising opportunities relative to the expanded use of Gdeptin and other indications as well as the GDEP technology in conjunction with other therapies and potential synergy with our MVA-BLP tumor-associated antigen approach. We're looking forward to providing milestone updates throughout this year about the progress of our GDEPTED program. We're highly focused on the clinical development of CMO4S1 against COVID-19, including the continued emerging variants of concern. CMO4S1 utilizes synthetic modified vaccinia-ancra technology, similar to our other vaccine programs under development at Geovax.

8:01 CMO4S1 induces immunity to SARS-CoV-2 by stimulating the immune system to produce antibodies against SARS-CoV-2 that can block the virus from entering healthy cells, while the immune system can also grow new disease-fighting T cells that can recognize and Destroy Infected Cells. The vaccine includes both SARS-CoV-2 spike and nucleocapsid proteins differing from the current authorized vaccines, which only include the spike protein. This is an important distinction. By inserting both of these proteins into our vaccine design, the MVA delivery vehicle is able to drive the expression of both proteins within the body of the vaccine recipient, inducing immune responses.

8:48 The role of the S protein is to elicit a neutralizing antibody response against the initial infection, while the N protein elicits a T cell response to directly attack virus-infected cells, reduce viral replication, and reduce severity, and provide viral clearance. Thus, the vaccine is designed to induce both neutralizing antibodies and T cell responses specific for the S protein and the N protein. The vaccine design was implemented specifically to induce an expanded immune response to better combat and clear infections regardless of the circulating SARS-CoV-2 variants. This vaccine is the first step in the worldwide goal to provide a vaccine that gets ahead of the variants versus having to chase the variants. If successful, this vaccine will reduce reliance on the repeated administration of booster doses of existing vaccines.

9:46 We believe that a multi-punch approach such as this has the potential for providing a more robust and durable immune response and protection than the current authorized vaccines. We also believe that various high-risk populations, such as immune-compromised individuals, will benefit from such a multi-prong approach. In fact, in July, analysis of data from the Phase I study of CMO4S1 published in the peer-reviewed journal iScience showed that CM04S1 demonstrated potent and equivalent T-cell cross-reactivity against Delta and Omicron variants. These findings suggest that T-cell immunity stimulated by CM04S1 may constitute a critical second line of defense to provide long-term protection against SARS-CoV-2 variants. And I'll repeat, these were based upon the analysis of data from the Human Clinical Trial Phase 1 study of CM04S1.

10:47 O4S1, which was indeed published in iScience. CMO4S1 is currently being evaluated in two Phase II clinical trials. One trial is a comparative study of CMO4S1 as the primary vaccine versus the current FDA-approved Pfizer vaccine in people that have received or are undergoing specific blood cancer therapies associated with transplantation or Part T therapy that suppress or severely reduce preexisting immunity to COVID-19 vaccines. Multiple clinical evidence has demonstrated that such patients fail to respond optimally to the current generation vaccines, and we believe that the CMO4S1 will prove to be more potent because it is multi-antigenic, delivered using the MVA vector.

11:37 We believe this will differentiate CMO4S1 from the other vaccines by providing both a strong antibody response and a sustained T cell response in these patients who are still at high risk of severe COVID-19 due to their immunocompromised status. The other phase two trial underway is evaluating CMO4S1 as a booster for healthy patients who have previously received either the Pfizer or Moderna mRNA vaccine. We believe that providing a heterologicus booster rather than a continued multiple shots of the same vaccine or similar vaccine may provide more robust and durable immune response and protection. Heterologicus prime boost immunizations are well studied in other fields such as HIV and are being evaluated in multiple countries using different COVID vaccines.

12:33 Finally, the ongoing GeoVax effort to develop an advanced MVA manufacturing process based on a continuously growing cell line to increase production consistency and capacity will well mesh with the clinical development activities and full development schedule associated with the CM04S1 and the CM02 vaccine. We're not alone in recognizing the limitations of the current authorized COVID-19 vaccines. The continued need for more durable immunity, the waning of protective response, insufficient protection among various high-risk immunocompromised populations, and other evident issues are well documented and of increasing concern.

13:20 We applaud the federal government for realizing that significant incremental funding is needed in support of next-generation COVID vaccines, providing the promise such as our CMO4 S1 and our CMO2, as well as other vaccines, therapeutics, and technologies. This was underscored by the actions of the Senate Appropriations Committee's recent FY23 Health and Human Services Appropriations Bill, specifically targeting next generation COVID-19 vaccine developments. We look forward to continued dialogue and discussions in support of CMO4 S1 and CMO2 as we continue to advance the developments of these important COVID-19 or coronavirus vaccines.

14:07 Recently, the WHO declared monkeypox a public health emergency of international concern. Nations worldwide are enacting procedures and policies in support of minimizing the health risk from monkeypox to their populations. Currently, there are two vaccines authorized in the U.S. for prevention of monkeypox, the primary vaccine being modified vaccinia agra or MVA, which is also the vaccine vector utilized in numerous GeoVax vaccines, including our CM04S1 and CM02, which target COVID-19. In addition, MVA is the vaccine vector used in our hemorrhagic fever virus vaccines against Zaire Ebola virus, Sudan Ebola virus, and Marburg, as well as our development stage Zika virus vaccine and even our Mach 1 cancer immunotherapy.

15:01 In fact, previous peer-reviewed publications addressed the successful prevention of monkeypox and non-human primate models following the administration of GeoVax's MVA-based HIV vaccines. Recognizing the global public health need and attention to monkeypox, Evaluation is underway related to CMO4S1 and the prevention of monkeypox. It is anticipated that the results will demonstrate successful protection, validating the CMO4S1 as protective against both COVID-19 and monkeypox. We also anticipate validating our hemorrhagic fever virus vaccines as protective against monkeypox, potentially providing unique vaccines preventing both hemorrhagic fever viruses and Monkeypox in a single vaccine.

15:51 This would be very important in certain endemic areas of the world. We look forward to reporting more on this topic soon. Now I'd like to turn the presentation over to Mark Reynolds, GFX Chief Financial Officer for a review of our recent results and financial status. Thank you, Mark.

16:10 Thank you, David. Starting with our income statement, I'm going to go through some of this pretty quickly. I know most everybody wants to get to the Q&A. But starting with the income statement, I'll focus on the comparative figures. Actually, that's our balance sheet showing up first. Okay, here we go. Income statement. Grant revenues were 82,000 in the six-month period of 2022 versus 190 in 21. That's reflecting a wind down in both our grant from the NIH supporting the COVID-19 vaccine and the grant from the U.S. Army supporting our loss of fever vaccine program. As of June 30, 2022, all the currently available funds from those grants have been utilized. We do intend to seek additional non-dilutive funding for our development programs in the future, though.

17:01 R&D expenses were $2.6 million in 2022 versus $1.4 million in 2021, with the increase, as expected, primarily associated with new clinical trial activity for COVID-19 and the cancer programs. and that includes manufacturing costs for clinical trial materials. The increase is also reflective of higher personnel and consulting costs as we staffed up for an overall higher level of activity. G&A expenses were $2.1 million in 22 versus $1.8 million in 21 with the increase also associated with higher personnel, consulting and higher patent costs in there also.

17:46 So overall net loss for the first six months of 22, or $4.7 million, or $0.47 per share, versus $2.9 million in 21, or $0.49 per share. Again, with the increase primarily associated with ramp-up of organizational infrastructure and other costs associated with the CMO4S1 and Cadeptin clinical trials. Going back to the balance sheet, Our cash balances at June 30 were approximately $31 million, as compared to $11.4 million at the end of 21. And as David mentioned earlier, the change in the cash balances were reflective of 8.2 million used in operating activities, all set by proceeds from our stock offerings in January and May, with combined net proceeds of nearly $28 million.

18:40 and these numbers I'll point out also do not reflect the additional $5 million that came in just this week from warrant exercises. So current cash stands at about $35 million. Funding our three ongoing Phase II clinical programs and preparing for the next stages of development are the most significant use of our cash and our top financial priority. And as I noted, we just received the $5 million through the exercise of the warrants Based on that, our outstanding shares now stand at $24.7 million. That's a current number. So in summary, we are well positioned to accelerate and advance our clinical programs with a cash runway sufficient to fund our operations and priority programs toward the end of next year.

19:29 And I'll be happy to answer any other questions during the Q&A, but I'll turn now the call back over to David.

19:37 Thank you, Mark. My colleagues and I will now answer your questions. Again, joining us for the Q&A session are Drs. Mark Newman, Kelly McKee, and John Sharkey, our Chief Scientific Officer, Chief Medical Officer, and Vice President of Business Development, respectively. I'm therefore turning the call back to Andrew 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 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. At this time, we will pause momentarily to assemble our roster.

20:27 The first question comes from Jason McCarthy with Maxim Group. Please go ahead.

20:34 Hey, guys. Thanks for taking the question. Can you guys talk a little bit about the dynamics around the need for a monkey POC stack team? Because we know NBA works. You would be, I think, the most advanced U.S.-based NBA player in the state. So then we're seeing some of the MRNA companies try to knows in Moderna today coming out and saying their stock is up sharply. Can you give us a little bit of color around those dynamics? What that space could shape up to be or is it really just NBA and you guys could be significant players there?

21:13 I'll start and then we'll see if any of my colleagues would like to. So first of all, Jason, thank you for your question. Appreciate your interest in the company. We do recognize that we more than likely are the leading MVA company, certainly in the United States. We all know that there is a single source supplier for monkeypox currently. That's out of Denmark. We think it's very important for there to be a supplier out of the United States that addresses this for numerous reasons, not only to reduce the total dependence on a single supplier. I have no idea to the degree to which Moderna with their MRA may or may not be successful in producing a monkeypox vaccine.

22:07 Time will tell on that, but we certainly recognize that MVA, which as we know is the basis for so many of our products, is approved for preventing monkeypox. So that provides us an opportunity and we validated that in previous in previous peer-reviewed publications that I mentioned in my comments. Now, I don't know if Kelly McKee would like to add anything else to that, but I'll ask if he would. Kelly?

22:36 Yeah, hi. I mean, David, I think you sort of summarized the sort of overriding considerations. You know, MVAs, or at least vaccinia-based, or vaccinia, vaccinias in general, are really the only proven preventive measure for monkeypox at this time. And, you know, the regulatory pathways for new entrants, I think, is yet to be decided. So, you know, how much Moderna or others will... will be able to play in this. I'm not sure anybody really knows at this time.

23:26 As we look to how we would position ourselves for monkeypox, we've got to deal with some regulatory questions as well. So it's kind of a wide open field right now.

23:40 So do you take a multi-pronged approach, meaning you have It looks like a really good COVID vaccine that could also potentially cover monkeypox. We also have Sudan and Marburg and Ebola and monkeypox might be more of an issue in other countries. Would you consider doing something here in the States and maybe something in like West Africa? We saw another group announced they're going to do something in Kenya just this week.

24:09 The answer is yes, and I'll ask Kelly to elaborate a little bit about our outreach to Africa and the concepts there, and also the difference in monkeypox and the strain of monkeypox that we see in Africa. Kelly, would you like to address that?

24:24 Thank you. Thank you. to individuals in some of the sub-Saharan African countries to explore interest in some sort of a co-development program. I'm not at liberty to sort of disclose the nature of those discussions, but suffice it to say the potential is certainly there. You know, the strains of monkeypox, there are two strains, predominant strains of monkeypox, stereotypes of monkeypox.

25:18 that have been recognized. The one that's causing sort of the global epidemic right now is a West African strain, while the Central African strain of monkeypox, which is predominant in Central African Republic and sort of neighboring countries, is a much more virulent, it seems to be much more virulent than the West African strains. and so I think there's a lot more concern in these potentially endemic countries for having access to an effective vaccine and the opportunity to offer protection against both monkeypox and another endemic virus, be it COVID or one of the hemorrhagic fever viruses is certainly an appealing prospect.

26:13 And this last question, what about interest from a group like BARDA where the stockpiling could be? Because, I mean, the monkeypox virus, the NVA one that they supply, as you know, I mean, it's for smallpox for immune compromised people. Does that make your COVID vaccine for immune compromised people that has cross protection against monkeypox particularly attractive to a government agency like that?

26:41 I would say We think it does potentially. We know that various federal government agencies are recognizing that the multi-antigenic approach for COVID-19 is something to seriously be evaluating and reviewing. So we know that from discussions, et cetera. And we also believe, similar to what you've just raised, and that having that, which is of increased interest as we see these continued limitations of the current authorized vaccines related to COVID-19, but also then having the added benefit of being able to address monkeypox could be very important to the stockpile program as well as to NGOs who are looking at and other endemic areas.

27:45 Sounds good. Thank you for the questions, or taking the questions, rather, David.

27:49 Thanks. Again, if you have a question, please press star then 1. The next question comes from Jeff Cross with Crystal Research. Please go ahead.

28:03 Thank you. I've been asked several of my questions, but on that same and a number of other people. And I think it's really important for us to be able to do that. And I think it's really important for us to be able to do that. And I think it's really important for us to be able to do that. even companies like Pfizer and Moderna with the COVID vaccine were not able to supply enough. Have you been able to move far enough down that line to be comfortable that with these going through or even the monkeypox one going through that you will be able to supply? And the last question is strategy-wise.

28:58 Obviously, if you have a combination vaccine, that's great. As long as the government or the regulatory bodies want to put through a combination vaccine, are you thinking about offering it separate as well as combined?

29:15 To answer the second one, as has been commented, there's a complex, I would say this, we are reviewing, it's a very complex development regulatory pathway regarding to MVA as an alternative to the existing MVA that's out there. So for us to go forward, and bring that forward. What we recognize is that our MVA-based vaccines have that added benefit of preventing monkeypox. So if we have an MVA-VLP or MVA-based Zika virus vaccine and we were to further that in development, let's say in a collaboration relative to the Southern Hemisphere, South America, we know that, for instance, in Brazil, that monkeypox is fairly common and is also a threat. So there we would be able to meet the needs not so much from a, I'll call it dual indication, but from the recognition that the MVA-based vector brings the benefit of also preventing monkeypox.

30:28 So that's sort of the approach that we're looking from that. From the standpoint of Manufacturing, I'll ask if Dr. Mark Newman would comment on that, because as I mentioned in my comments, we can continue to make progress on moving towards a system that will enable us to meet the demands at a much faster rate than in the traditional chicken eggs or chicken embryo fibroblasts. Mark?

30:57 Yeah, sure. So right now, we manufacture using a process based on chicken embryonic fibroblasts, which is the same thing that Bavarian Nordic uses. So it's a primary cell line, and that has limitations. Limitations in that you start with eggs. We have an active program looking at getting into continuous cell manufacturing, cell-based manufacturing. And this would be more... more comparable to what the adenovectors. So if you think of the JNJ or the AZ COVID vaccines, those are produced with these continuous cell lines. And so that's ongoing. Now our focus has been on our vectored vaccines, particularly CMO4S1 and then some of the other products that are at the research level.

31:49 We actually haven't looked at just producing MVA without one of these inserts in it. Go to your other point, would you make something that was MVA specific? That would be the easiest path, I have no doubt. There's a lot of data out there that suggests there are multiple cell lines that can produce or support the production of MVA. Where we run into a little bit of a more difficult situation is when we have these combo vaccines. Because you're incorporating an insert, you've got to make sure that insert stays in there while you're producing it. So that's a, just to make an MVA vaccine with a cell line would probably be the easiest path.

32:31 And we have- Yeah, that's why I asked, because, right, that's why I asked, because from a regulatory path, historically, the FDA has had some issues when trying to do things combined, and I think your data is very clear and very convincing and separate, and I just think it might be easier for you to get the, even though, yes, doing it combined and all the benefits of working against this one and working against that one and the whole platform, great. I'm just thinking about what would be easiest for out there and simplest for someone to understand.

33:04 I think you're right. If it's an HIV vaccine, you'd have to get it approved for HIV and then you'd expand your claims showing that it also worked against monkeypox. I think that's what we would face. Those are all things that have been discussed.

33:21 Thank you very much for the answers. Thank you, Jeff. The next question comes from Kumara Guru Raja from Brookline Capital Markets. Please go ahead.

33:35 Thanks for taking my questions and shifting gears to oncology. What are you seeing in terms of enrollment and also in terms of the Animal Studies that are being conducted in North Carolina. When can we get an update and what kind of information can we expect from that study?

33:59 Kumar, thank you for your interest, et cetera. Could you repeat your first question and then we'll address the North Carolina one?

34:07 Yeah, the first question is just the details about how the enrollment is going, what you are seeing, what can we expect in terms of updates. Okay.

34:16 So I'll ask Kelly to discuss the GDAPTA and then I'll ask Mark Newman to pick up on the development programs, including the UNC Charlotte. Kelly?

34:30 Yeah, hi. We probably shouldn't really talk about the enrollment dynamics at this time. We transitioned this trial. to take control. I mean, we in-licensed the Gidepton product a number of months back, and we've been in the process of transitioning the IND and expanding the trial from a single-site to a multi-site study. And that has resulted in sort of a pause in the initial enrollment, and we anticipate accelerating it In short order, as David indicated in his introductory remarks, we hope to have the current trial completed sometime next year.

35:27 Beyond that, we need to be talking to the regulators to see what they want us to present to them. for further studies or, you know, a regulatory pathway for an accelerated approval.

35:48 Good. Thank you. And I would just underscore that, you know, once we took over full sponsorship, we then are in the driver's seat to initiate for those types of discussions and to focus on the acceleration across the multi-sites. And that's where we are right now, so as Kelly said. Mark, do you want to pick up on the University of North Carolina Charlotte work that's going on?

36:14 Yeah, sure, I can do that. So we're working with Pinko Mukherjee, which is a world expert in pancreatic cancer and things related to MUC1. And she has a fairly unique animal model or an animal model resource. Where we are right now is we're validating the animal model for our use in her lab. And what we're doing is a little bit different than what she has going on every day. So that's been moving along at an acceptable pace. All these things take longer than you want. But we are anticipating once the study, once the model is fully validated, we're comfortable with repeatability. this in-life portion of the study it's got two pieces the first data will be coming out by the end of the year and then we have follow-ups the second piece depending on what we see with the first so that would be during q1 and q2 of next year but I think we'll have we'll be talking about progress later this year than q1 next year so the expectation is that data would be

37:25 presented at medical meetings. And also with regard to cadeptin, where do you stand in terms of drug supply for the clinical trials? Thank you.

37:40 The drug substance for the cancer trial?

37:45 That's right, yes.

37:47 Okay, all right. Well, so what we're envisioning with the Mach 1 program, and we've presented this before, It'll be a combination vaccine of the MVA vectored vaccine, which is ours, and then we'll be boosting it with a peptide and adjuvant. So the questions you're asking right now with the mouse model is, do we start out with a peptide and then boost with the MVA? Do we start out with the MVA and boost with the peptide? And it would be beyond the scope of this call to explain to you the different logics we're looking for, but we think we can fine tune the immune response to more CD8 response or more antibody through these different immunization routines. Now, how would we move that into a clinic in terms of drug substance?

38:34 So first of all, the peptide is available right now. We're using a GMP product produced at the biofacility University of Pittsburgh, and that would be our partner moving in through the National Cancer Institute. That material is available. We have a liposome encapsulated toll receptor agonist as the adjuvant. That's already produced GMP, and we've got the supply agreement in place through a partnership with a company called Oncovir. The MVA would then have to be produced, and we have a number of potential players or partners that we could manufacture. We would manufacture only in CES cells. This would be a primary cell. Go fast. We would not do anything experimental with this.

39:22 and then based on experience like for example with O4S1 would probably take between five and six months to manufacture a lot of material to support phase one and phase two testing. Now just caveat being that is early stage phase test a early stage phase one and two testing so all of these products at least the peptide and the mba then we would assuming good looking results then we would scale that and increase the quality control and everything. You know, go with a real CDMO for production, you know, to really cement the product. But we don't have to have that in place until we're talking phase three.

40:05 This is very helpful. Thanks so much.

40:08 And Kumar, the data results will be presented, you know, as they've been validated, etc., and scientific meetings. And we'll issue press releases, notifications of all of that. Thank you.

40:24 Are there any other questions? Not at all. Seeing no further questions, this concludes our question and answer session. I would like to turn the conference back over to David Dodd for any closing remarks.

40:40 Thank you, Andrew, and thank you, everyone, for participating in this corporate update call, sharing in our achievements, progress, and outlook.

40:48 Your interest is greatly appreciated.

40:51 Our focus is on execution and reporting updates and progress for Gdeptan, CMO4, S1, CMO2, and our other development programs, such as the one we're just talking about, the Mach 1, as well as the expansion of our capabilities and resources. Our goal is to build shareholder and stakeholder value. I want to acknowledge and thank the GFX Board of Directors, our GFX staff, and the many other parties that continue to support, assist, and advise us towards achieving success. For all of us, it is a great pleasure serving our shareholders and stakeholders and being a part of this team. We wish you a safe and enjoyable day, and thank you. We look forward to speaking with you at the next conference call. The conference has now concluded. Thank you for attending today's presentation.

41:39 You may now disconnect