GeoVax Labs, Inc. (NASDAQ:GOVX) Q2 2022 Earnings Conference Call August 1, 2022 4:30 PM ET
Company Participants
David Dodd – Chairman and Chief Executive Officer
Mark Reynolds – Chief Financial Officer
Mark Newman – Chief Scientific Officer
John Sharkey – Head, Business Development
Conference Call Participants
Jason McCarthy – Maxim Group
Jeff Kraws – Crystal Research
Kumarguru Raja – Brookline Capital Markets
Operator
Good afternoon and welcome everyone to the GeoVax Second Quarter 2022 Corporate Update Call. I’m 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, M.D., M.P.H, Chief Medical Officer; and John Sharkey, PhD, Vice President, Business Development. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded.
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 require capital to complete vaccine development. There is development of competitive products that maybe more effective or easier to use han 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 Dodd
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 and that we advance clinical stage development status within the two priority areas and COVID-19 vaccine development and cancer therapy. In addition, we continue 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.
The in-licensing of GEO CMO4S1 Gedeptin have provided potential significant value expansion for the company. CMO4S1 is a leading next generation COVID-19 vaccine and Phase II clinical development, targeting both antibodies 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 and 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 and support of the current clinical trial coming from the FDA orphan drugs clinical trials program.
We believe that Gedeptin hold significant clinical promise, including a potential accelerated development pathway. Both CMO4S1 and Gedeptin are now under the sponsorship 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 and 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 CMO4S1 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 will evaluate, but we’re focused on execution towards our 2022 goals and building shareholder value. Mark Reynolds, GeoVax’s CFO will provide a more comprehensive overview of our financials.
Regarding Gedeptin, we previously confirmed two additional clinical sites on the assignment of [indiscernible] 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 the CDMO to ensure sufficient product with expanded clinical program, as well as to prepare for commercial manufacturer. We are confident that the Gedeptin Phase II program will be successfully managed by [indiscernible] and our clinical operations team with possible expansion of further additional clinical sites. We are highly excited about the outlook and promise of Gedeptin within advanced head and neck cancer. In addition, there are promising opportunities relative to 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 are looking forward to providing milestone updates throughout this year about the progress of our Gedeptin program.
We are highly focused on the clinical development of CMO4S1 against COVID-19, including the continued emerging variants of concern. CMO4S! utilizes synthetic Modified Vaccinia Ankara technology similar to our other vaccine programs under development at GeoVax. 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 nuclear capsid proteins different from the current authorized vaccines, which only includes spike protein. This is an important distinction. By inserting both of these protein to our vaccine design, the MVA delivery vehicles 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 neutralizing antibody response against the initial infection. While the end protein elicit 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 M protein.
The vaccine the 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 vaccine that gets ahead of the variance versus having to chase the variance. If successful, this vaccine will reduce reliance on the repeated administration of booster doses of existing vaccines. We believe that our 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 CMO4S1 demonstrated potent and equivalent T-cell cross reactivity against Delta and Omicron variance. These findings suggest that T-cell immunity stimulated by CMO4S1 may constitute a critical second line of defense to provide long-term protection against SARS-CoV-2 variant. Now repeat, these were based upon the analysis of data from the human clinical trial Phase I study of CMO4S1 which was indeed published in our 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 undergoing specific blood cancer therapies associated with transplantation or CAR T therapy that suppress or severely reduced pre-existing immunity to COVID-19 vaccine. 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.
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 were still at high risk of severe COVID-19 due to their immunocompromised status. The other Phase II trial underway is evaluating CMO4S1 as a booster for healthy patients who had 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 of 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 the continuously growing AVM cell line to increase production consistency and capacity will well match with the clinical development activities and full development schedule associated with the CMO4S1 and the CMO2 vaccines. We are not alone in recognizing the limitations of the current authorized COVID-19 vaccine. The continued need for a more durable immunity that are waning a 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 the significant incremental funding is needed in support of next-generation COVID vaccines, providing the promise, such as our CMO4S1 and our CMO2, as well as other vaccines, therapeutics and technologies.
This was underscored by the actions of the Senate Appropriation Committees recent FY ‘23 Health and Human Services Appropriations Bill, specifically targeting next generation COVID-19 vaccine development. We look forward to continued dialog and discussions in support of CMO4S1 and CMO2 as we continue to advance the development 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 risks from monkeypox to their populations. Currently there are two vaccines authorized in the US for prevention of monkeypox, the primary vaccine being Modified Vaccinia Ankara or MVA, which is also the vaccine to utilize in numerous GeoVax’s vaccines including our CMO4S1 and CMO2, which target COVID-19. In addition, MVA is the vaccine vector use in 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 address the successful prevention of monkeypox in non-human primate models following the administration of GeoVax MVA based HIV vaccine. Recognizing the global public health need and attention of monkeypox evaluation is underway related to CMO4S1 and the prevention of monkeypox. It is anticipated that the results will demonstrate successful protecting, validating the CMO4S1 is protective against both COVID-19 and monkeypox. We also anticipate validating our hemorrhagic fever virus vaccines is 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’s Chief Financial Officer for a review of our recent results and financial stats. Thank you. Mark?
Mark Reynolds
Thank you, David. Starting with our income statement. I’m going to go through some of this pretty quickly [indiscernible] wants to get to the Q&A. But starting with the income statement, I’ll focus on the comparative figures [indiscernible] Okay. Here we go. Income statement. Our grant revenues were $82,000 in six period of 2022 versus $190,000 in ’21. That’s reflecting a wind down in both our grant from the NIH supporting the COVID-19 vaccine and grant from US Army supporting our Lassa fever vaccine. As of June 30, 2022 all the currently available funds from branch have been utilized. We do intend to seek additional non-dilutive funding for our development programs in the future.
Our R&D expenses were $2.6 million in 2022 versus $1.4 million in ‘21 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. So overall net loss for the first six months of ’22 were $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 Gedeptin clinical trials.
Going back to the balance sheet. Our cash balance as at June 30 were approximately $31 million, this 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, offset by proceeds from our stock offerings in January and May. That combined net proceeds [indiscernible] nearly $28 million. 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.
Funding our three ongoing Phase III 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’ve just received $5 million [indiscernible] warrants and 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 the cash runway sufficient under operations and priority programs for the end of next year.
And I’ll be happy to answer any questions during the Q&A, but I’ll turn now the call back over to David.
David Dodd
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 call back to Andrew for instructions on the question-and-answer period.
Question-and-Answer Session
Operator
We will now begin the question-and-answer session. [Operator Instructions] First question comes from Jason McCarthy with Maxim Group. Please go ahead.
Jason McCarthy
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 work, it would be, I think the most advanced US based MVA player stage. So then we’re seeing some of the mRNA companies try to [indiscernible] today coming out and saying their stock is up sharply. Can you give us a little bit of color around those dynamics? What that stage could shape up to be or is it really just MVA and you guys could be significant players there.
David Dodd
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 and it’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 MRI may or may not be successful in producing a monkeypox vaccine. 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 peer-reviewed publications that I mentioned in my comments.
I don’t know if Kelly McKee would like to add anything else to that, but I’ll ask if he worth. Kelly?
Kelly McKee
Yeah. Hi. I mean, David, I think you sort of summarized the sort of overriding considerations. MVA is or at least vaccinia based or vaccinias in general are really the only proven preventive measure for monkeypox at this time. And the regulatory pathways for new entrants, I think, is yet to be decided. So how much Moderna or others will or will be able to play in this — I’m not sure anybody really knows at this time. 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.
Jason McCarthy
So do you take a multi-prong approach, meaning, you have — it 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 announced they’re going to do something in Kenya just this week.
David Dodd
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 a monkeypox that we see in Africa. Kelly, would you like to address that.
Kelly McKee
Sure. So Jason, I mean you — you’re thinking aligns very well with ours as well. The potential to offer sort of a twofer is certainly there for us and we have made some preliminary inquiries with — to individuals in some of the sub African countries to explore interest in some sort of a co-development program. I’m not at liberty to sort of disclose any — in the nature of those discussions, but suffice it to say, the potential is certainly there. The strains of monkeypox — there are two strains — predominant strains of monkeypox, share types of monkeypox that have been recognized. The one that’s causing sort of the global epidemic right now is the West Africa 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 is 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
And just last question, what about interest from pharma group like BARDA, where the stock piling could be because, I mean, the monkeypox virus that the MVA [indiscernible] as you know. I mean it’s for smallpox for immunecompromised people. Does that make your COVID vaccine for immunecompromised people that has cross-protection against monkeypox, particularly attractive to a government agency like that.
David Dodd
I would say we think it does potentially. We know that various federal government agencies are recognizing that the multi-antigen approach for COVID-19 is something to seriously be evaluating and reviewing. So we know that from discussions, etcetera, and we also believe –similar to what you’ve just raise and that the — having that, which is of increased interest as we see that at least continue limitations of the current authorized vaccine 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 other endemic areas.
Jason McCarthy
Sounds good. thank you for the questions or taking the questions rather.
Operator
[Operator Instructions] The next question comes from Jeff Kraws with Crystal Research. Please go ahead.
Jeff Kraws
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 military in Africa, as well as talking about our military. You’ve already had grants [indiscernible] grants. Is that something where, one, you would be able to actually supply that something you would pursue. And secondly, have you talked with — and this goes down the pharma line, obviously, even companies like Pfizer, 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 [indiscernible] that you will be able to supply? And the last question is, strength wise, obviously, if you have a combination vaccine, that’s great. As [Technical Difficulty] the government or the regulatory bodies want to put through a combination of vaccine. Are you thinking about doing it, offering it separate as well as combined.
David Dodd
To answer the second one, as has been commented on — there is 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 borrowers 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. So that’s sort of 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 will enable us to meet the demands at a much faster rate than in the traditional chicken eggs or chicken embryonic fibroblast. Mark?
Mark Newman
Yes, sure. So right now we manufacturer using a process based on chicken embryonic fibroblast which is the same thing that Bavarian Nordic users. So it’s a primary cell line and that has limitations that you start with eggs. We are — we got active program looking at getting into continuous cell manufacturing, cell-based manufacturing and this will be more comparable to what the adeno vectors. So if you think of the J&J or the AZ COVID vaccines, those are produced with these continuous cell lines. So that’s ongoing.
Now our focus has been on our vectored vaccines, particularly CMO4S1 and then some of the other products that at the research level. We actually haven’t looked at just producing MVA without one of these inserts in it. So let’s go to your other point, would you make something that was MVA specific, that would be the easiest path. I have no doubt, there is a lot of data out there that suggests there are multiple cell lines that can produce or support the production of MVA. We will be run into a little bit of our difficult situations when we have these combo vaccines. Because you’re incorporating an insert, you got to make sure that insert stays in there while you’re producing it. So that’s a — just to make a MVA vaccine with the cell line would probably be the easiest path. And we have –
Jeff Kraws
Yeah. That’s why I asked, because — That’s why I asked, because from a regulatory path [Technical Difficulty] the FDA has had some issues when try to do things combined. And I think your data is very clear and very convincing [Technical Difficulty] and I just think it might be easier for you to get [Technical Difficulty]. Even though, yes, doing it combined and all the benefits of working against this one or against that our and the whole platform. Great. I’m just thinking about what would be easiest [Technical Difficulty]out there and simple for someone to understand.
Mark Newman
I think you’re right. If it’s an HIV vaccine you’d have to get it approved for HIV and then you need to expand your claims, showing that it all work against monkeypox. I think that’s what we would face. So yeah, those are all things that are being discussed.
Jeff Kraws
Okay. Thank you very much for the answers.
David Dodd
Thank you, Jeff.
Operator
The next question comes from Kumarguru Raja from Brookline Capital Markets. Please go ahead.
Kumarguru Raja
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 considered in North Carolina, when can we get an update and what kind of information can we expect from that studies?
David Dodd
Kumar, thank you for your free interest, et cetera. Could you repeat your first question and then we’ll address the North Carolina one.
Kumarguru Raja
Yeah. The first question is just the details about how the enrollment is going. What do you are seeing there and what can we expect in terms updates.
David Dodd
Okay. So I’ll ask Kelly to discuss the Gedeptin and then I’ll ask Mark Newman to pick up on the development programs, including the UNC Charlotte. Kelly?
Kelly McKee
Yeah. Hi. We probably shouldn’t really talk about the enrollment dynamics at this time. We transitioned this trial and 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 to — 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 regulatory pathway for an accelerated approval.
David Dodd
Thank you. And I would just underscore that once we took over full sponsorship we then are in the driver 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.
Mark Newman
Yes, sure, I can do that. So we are working with the [indiscernible], which is a world expert in pancreatic cancer and things related to Mark-1. 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 are doing is a little bit different than what you have going on every day. So that’s been moving along in acceptable pace. All of 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. In-life portion of the study has got two pieces, 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.
Kumarguru Raja
So the expectation is that, data would be present that medical meetings. And also with regard to Gedeptin, where do you stand in terms of drug supply for the clinical trials. Thank you.
Mark Newman
The drug substance for the cancer trial.
Kumarguru Raja
That’s right. Yes.
Mark Newman
Okay. So what we are envisioning with the Mark 1 program — presented this before, it’ll be combination vaccine of the MVA vectored vaccine, which is ours and then we will 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 the 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 will be looking for, but we think we can fine-tune the immune response to more CD8 response are more antibody through these different immunization routines.
Now how would we move that into a clinic in terms of the drug substance. So first of all the peptide is available right now, we are using a GMP products produced at the BIO facility, 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 a supply agreement in place through a company — partnership with a company called [indiscernible]. The MVA would then have to be produced. And we have a number of potential players or partners that we could manufacture. And we would manufacture only in CES cell as to be a primary cell go faster, we would not do anything experimental with this. And then based on experience, like for example, with 04S1,
we’ll probably take between five and six months to manufacture a lot of material to support Phase I and Phase II testing.
Now just caveat being that is early-stage — early stage Phase I and II testing. So all of these products, at least the peptide and the MDA, then we would — assuming good looking results, then we would scale that and increase the quality control and everything, go with a real CDMO for production to really cement the product, but we don’t have to have that in place. And so we’re talking Phase III.
Kumarguru Raja
This is very helpful. Thanks so much.
David Dodd
And Kumar, will — the data results will be presented as they’ve been validated et cetera, at scientific meeting and will issue press releases notifications of all of that.
Kumarguru Raja
Thank you.
David Dodd
Are there any other question?
Operator
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.
David Dodd
Thank you, Andrew, and thank you everyone for participating in this corporate update call, sharing our achievements, progress and outlook. Your interest is greatly appreciate. Our focus is on execution and reporting updates and progress with Gedeptin, CMO4S1, CMO2 and our other development programs, such as the one we’re just talking about with the Mark 1, 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
The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.
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