GeoVax Labs - Q2 2022

Transcript

Operator (participant)

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

David A. Dodd (Chairman and CEO)

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 pre-clinical 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. The in-licensing of GEO-CM04S1 and Gedeptin have provided potential significant value expansion for the company.

CM04S1 is a leading next generation COVID-19 vaccine in phase 2 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. Gedeptin 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 Products Clinical Trials Program. We believe that Gedeptin holds significant clinical promise, including a potential accelerated development pathway. Both CM04S1 and Gedeptin 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 Gedeptin and GEO-CM04S1, and the transition to a more efficient, higher yield MVA manufacturing process. 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 Gedeptin, we previously confirmed two additional clinical sites in the assignment of Allucent as our CRO partner responsible for leading the expansion and acceleration of the Gedeptin clinical program. 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 are also engaged with a CDMO to ensure sufficient product for the expanded clinical program as well as to prepare for commercial manufacture. We're confident that the Gedeptin phase 2 program will be successfully managed by Allucent and our clinical operations team, with possible expansion of further additional clinical sites. We're highly excited about the outlook and promise of Gedeptin within advanced head and neck cancer. In addition, there are promising opportunities relative to the expanded use of Gedeptin in other indications, as well as the GDEP technology in conjunction with other therapies and potential synergy with our MVA-VLP tumor-associated antigen approach. We're looking forward to providing milestone updates throughout this year about the progress of our Gedeptin program. We're highly focused on the clinical development of CM04S1 against COVID-19, including the continued emerging variants of concern.

CM04S1 utilizes synthetic Modified Vaccinia Ankara technology, similar to our other vaccine programs under development at GeoVax. CM04S1 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.

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.

We believe that a multi-pronged 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-pronged approach. In fact, in July, analysis of data from the phase one study of CM04S1, 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. I'll repeat, these were based upon the analysis of data from the human clinical trial phase one study of CM04S1, which was indeed published in iScience. CM04S1 is currently being evaluated in two phase two clinical trials.

One trial is a comparative study of CM04S1 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 CAR T therapy that suppress or severely reduce pre-existing 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 CM04S1 will prove to be more potent because it is multi-antigenic, delivered using the MVA vector. We believe this will differentiate CM04S1 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 GEO-CM04S1 as a booster for healthy patients who have previously received either the Pfizer or Moderna mRNA vaccine. We believe that providing a heterologous booster rather than a continued multiple shots of the same vaccine or similar vaccine may provide more robust and durable immune response and protection. Heterologous prime boost immunizations are well-studied in other fields such as HIV, and are being evaluated in multiple countries using different COVID vaccines. Finally, the ongoing GeoVax effort to develop an advanced MVA manufacturing process based on a continuously growing avian cell line to increase production consistency and capacity will well mesh with the clinical development activities and full development schedule associated with the GEO-CM04S1 and the GEO-CM02 vaccines. We're not alone in recognizing the limitations of the current authorized COVID-19 vaccines.

The continued need for a 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. 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 CM004S1 and our CM002, as well as other vaccines, therapeutics, and technologies. This was underscored by the actions of the Senate Appropriations Committee's very recent FY 2023 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 CM004S1 and CM002 as we continue to advance the developments of these important COVID-19 or coronavirus vaccines. 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 Ankara, or MVA, which is also the vaccine vector utilized in numerous GeoVax vaccines, including our GEO-CM04S1 and GEO-CM02, which target COVID-19. In addition, MVA is the vaccine vector used in our hemorrhagic fever virus vaccines against Zaire ebolavirus, Sudan ebolavirus, and Marburg, as well as our development-stage Zika virus vaccine, and even our MUC1 cancer immunotherapy. In fact, previous peer-reviewed publications addressed the successful prevention of monkeypox in non-human primate models following the administration of GeoVax MVA-based HIV vaccines. Recognizing the global public health need and attention to monkeypox, evaluation is underway related to GEO-CM04S1 and the prevention of monkeypox.It is anticipated that the results will demonstrate successful protection, validating the CM004S1 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. 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, GeoVax Chief Financial Officer, for a review of our recent results and financial status. Thank you. Mark?

Mark Reynolds (CFO)

Thank you, David. Starting with our income statement, I'm gonna go through some of this pretty quickly, 'cause I know most everybody wants to get to the Q&A. 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 2021. That's reflecting a wind down of, on both our grant from the NIH supporting the COVID-19 vaccine and the grant from the U.S. Army supporting our Lassa 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.

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 2022 versus $1.8 million in 2021, with the increase also associated with higher personnel consulting and higher patent costs in there also. Overall net loss for the first six months of 2022 were $4.7 million or $0.47 per share, versus $2.9 million in 2021 or $0.49 per share.

Again, with the increase primarily associated with ramp up of organizational infrastructure and other costs associated with the GEO-CM04S1 and Gedeptin 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 2021. As David mentioned earlier, the change in the cash balances were reflective of eight point two million used in operating activities, offset by proceeds from our stock offerings in January and May, with combined net proceeds to us of nearly $28 million. These numbers, I'll point out, also do not reflect the additional $5 million that came in just this week from warrant exercises. Current cash stands at about $35 million.

Funding our three ongoing phase 2 clinical programs and preparing for the next stages of development are the most significant use of our cash and our top financial priority. 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 the current number. 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. I'll be happy to answer any other questions during the Q&A, but I'll turn now the call back over to David.

David A. Dodd (Chairman and CEO)

Thank you, Mark. My colleagues and I will now answer your questions. Again, joining us for the Q&A session are Doctors 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.

Operator (participant)

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

Jason McCarthy (Senior Managing Director and Head of Biotechnology Research)

Hey, guys. Thanks for taking the question. Can you guys talk a little bit about the dynamics around the need for a monkeypox vaccine? Because we know MVA works. You would be, I think, the most advanced U.S.-based MVA player space. We're seeing some of the mRNA companies try to nose 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 MVA, and you guys could be significant players there?

David A. Dodd (Chairman and CEO)

I'll start, then we'll see if any of my colleagues would like to. 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 mRNA may or may not be successful in producing a monkeypox vaccine.

You know, time will tell on that. We certainly recognize that MVA, which as we know is the basis for so many of our products, is approved for preventing monkeypox. That provides us an opportunity, and we validated that in previous, you know, 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?

Kelly McKee (CMO)

Yeah. Hi. I mean, David, I think you sort of summarized the sort of overriding considerations. You know, MVA is, or at least vaccinia-based or vaccinia in general are really the only proven preventive measure for monkeypox at this time. You know, the regulatory pathways for new entrants, I think is yet to be decided. You know, how much Moderna or others will be able to play in this, I'm not sure anybody really knows at this time. You know, as we look to how we would position ourselves for monkeypox, we've got to deal with some regulatory questions as well. It's kind of a wide open field right now.

Jason McCarthy (Senior Managing Director and Head of Biotechnology Research)

Do you take a multi-pronged approach, meaning you have what looks like a really good COVID vaccine that could also potentially cover monkeypox. You 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 announce they're going to do something in Kenya just this week.

David A. Dodd (Chairman and CEO)

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?

Kelly McKee (CMO)

Sure. Jason, I mean, your thinking aligns very well with ours as well. You know, the potential to offer sort of a twofer is certainly there for us, and we have made some preliminary inquiries 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 predominant strains of monkeypox, serotypes of monkeypox, 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. 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.

Jason McCarthy (Senior Managing Director and Head of Biotechnology Research)

Just last question. What about interest from a group like BARDA, where the stockpiling could be? Because, I mean, the monkeypox virus and the MVA one that they supply, you know, as you know, I mean, it's for smallpox for immune-compromised people. Like, does that make your COVID vaccine for immune-compromised people that has cross-protection against monkeypox particularly attractive to a government agency like that?

David A. Dodd (Chairman and CEO)

I would say we think it does potentially. You know, 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. We know that from discussions, etc. We also believe, based, you know, similar to what you've just raised, that the having that and which is of increased interest as we see, you know, these continued limitations of the current authorized vaccines related to COVID-19, but also then having the added benefit of being able to to address monkeypox could be very important to the stockpile program as well as to NGOs who are looking at, you know, other endemic areas.

Jason McCarthy (Senior Managing Director and Head of Biotechnology Research)

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

David A. Dodd (Chairman and CEO)

Thank you. Thanks.

Operator (participant)

Again, if you have a question, please press star then one. The next question comes from Jeffrey J. Kraws with Crystal Research Associates. Please go ahead.

Jeffrey J. Kraws (CEO)

Thank you. Jason asked several of my questions, but on that same wavelength, if you will, the combination, there were stories around this week talking about the military, talking about military in Africa, as well as talking about our military. You have already had grants, Army grants. Is that something where, one, you would be able to actually supply that and something you would pursue? Secondly, have you talked with? This goes down the pharma line. Obviously, 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, that you will be able to supply?

The last question is, strategy-wise, 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 doing it, offering it separate as well as combined?

David A. Dodd (Chairman and CEO)

To answer the second one, as has been commented on, you know, I would say this: we are reviewing. It's a very complex development regulatory pathway regarding MVA as an alternative to the existing MVA that's out there. So for us to go forward and bring that forward. What we recognized 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.

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 vaccine vector brings the benefit of also preventing monkeypox. 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 continue to make progress on moving towards a system that would enable us to meet the demands at a much faster rate than in the traditional chicken eggs or chicken embryo fibroblasts. Mark?

Mark Newman (Chief Scientific Officer)

Yeah, sure. Right now we manufacture using a process based on chicken embryonic fibroblasts. Which is the same thing that Bavarian Nordic uses. It's a primary cell line, and that has limitations in that you start with eggs. We have an active program looking at getting into continuous cell manufacturing, cell-based manufacturing. This is more comparable to what the adeno vectors. If you think of the J&J or the AZ COVID vaccines, those are produced with these continuous cell lines. That's ongoing. Our focus has been on our vectored vaccines, particularly GEO-CM04S1 and then some of the other products that are at the research level. We actually haven't looked at just producing MVA without one of these inserts in it.

To 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-

David A. Dodd (Chairman and CEO)

Mm-hmm

Mark Newman (Chief Scientific Officer)

of MVA. Where we run into a little bit of a more difficult situation is when we have these combo vaccines, 'cause you're incorporating an insert. You gotta make sure that insert.

David A. Dodd (Chairman and CEO)

Right

Mark Newman (Chief Scientific Officer)

... stays in there while you're producing it. Just to make an MVA vaccine with a cell line would probably be the easiest path. We have-

David A. Dodd (Chairman and CEO)

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

Mark Newman (Chief Scientific Officer)

Yeah, no, 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.

David A. Dodd (Chairman and CEO)

Right

Mark Newman (Chief Scientific Officer)

worked against monkeypox. Yeah, I think that's.

David A. Dodd (Chairman and CEO)

Perfect

Mark Newman (Chief Scientific Officer)

what we would face. Yeah.

David A. Dodd (Chairman and CEO)

Okay.

Mark Newman (Chief Scientific Officer)

Those are all things that are being discussed.

David A. Dodd (Chairman and CEO)

Great. Thank you very much for the answers. Thank you, Jeff. Thanks.

Operator (participant)

The next question comes from Kumar Raja from Brookline Capital Markets. Please go ahead.

Kumar Raja (Senior Biotechnology Analyst)

Thanks for taking my questions. 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 the studies?

David A. Dodd (Chairman and CEO)

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

Kumar Raja (Senior Biotechnology Analyst)

Yeah. The first question is, just the details about how the enrollment is going, what you are seeing there, and what can we expect in terms of updates?

David A. Dodd (Chairman and CEO)

Okay. I'll ask Kelly to discuss the, you know, the Gedeptin and all, and then I'll ask Mark Newman to pick up on the development programs, including the UNC Charlotte. Kelly?

Kelly McKee (CMO)

Yeah. Hi. Yeah, we probably shouldn't really talk about the enrollment dynamics at this time. You know, we transitioned this trial to take control. I mean, we in-licensed the Gedeptin 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.

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

David A. Dodd (Chairman and CEO)

Good. Thank you. 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 wanna pick up on the University of North Carolina at Charlotte work that's going on?

Mark Newman (Chief Scientific Officer)

Yeah, sure, I can do that. We're working with Pinku Mukherjee, which is a you know world expert in you know pancreatic cancer and things related to MUC1. 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. What we're doing is a little bit different than what she has going on every day. That's been moving along in acceptable pace. All these things take longer than you want. We are anticipating once the model is fully validated, we're comfortable with repeatability, the 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, you know, the second piece, depending on what we see with the first. That would be during Q1 and Q2 of next year. I think we'll be talking about progress later this year and then Q1 next year.

Kumar Raja (Senior Biotechnology Analyst)

The expectation is that data would be presented at medical meetings. Also with regard to where do you stand in terms of drug supply for the clinical trials? Thank you.

Mark Newman (Chief Scientific Officer)

The drug substance for the cancer trial?

Kumar Raja (Senior Biotechnology Analyst)

That's right, yes.

Mark Newman (Chief Scientific Officer)

Okay. All right. Well, what we're envisioning with the MVA 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 adjuvant. 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 a peptide? It would be beyond the scope of this call to explain to you the different logics of what we're looking for. We think we can fine-tune the immune response, you know, 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? 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 company 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. Now, we would manufacture only in CEF cells. This would be a primary cell, you know, go fast. We would not do anything experimental with this.

Based on experience, like for example with GEO-CM04S1, it would probably take between 5-6 months to manufacture a lot of material to support phase 1 and phase 2 testing. Now, just caveat being that is early stage phase 1 and phase 2 testing. All of these products, at least the peptide and the MVA, we would, assuming good-looking results, scale that and increase the quality control and everything. You know, go with a real CDMO for production of, you know, to really cement the product. We don't have to have that in place until we're talking phase 3.

Kumar Raja (Senior Biotechnology Analyst)

This is very helpful. Thanks so much.

Mark Newman (Chief Scientific Officer)

Kumar, the data results will be presented, you know, as they've been validated, et cetera, at scientific meetings. We'll issue press releases, notifications of all of that. Thank you. Are there any other questions? Go ahead, sir.

Operator (participant)

Oh, 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 A. Dodd for any closing remarks.

David A. Dodd (Chairman and CEO)

Thank you, Andrew. Thank you everyone for participating in this corporate update call, sharing in our achievements, progress, and outlook. Your interest is greatly appreciated. Our focus is on execution and reporting updates and progress with Gedeptin, GEO-CM04S1, GEO-CM02, and our other development programs, such as the one we're just talking about with the MUC1, as well as expansion of our capabilities and resources. Our goal is to build shareholder and stakeholder value. I want to acknowledge and thank the GeoVax Board of Directors, our GeoVax 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.

Operator (participant)

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