GeoVax Labs, Inc. (GOVX) on Q3 2024 Results - Earnings Call Transcript
Operator: Good afternoon and welcome everyone to the GeoVax Third Quarter 2024 Corporate Update Call. My name is Michelle and I 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. [Operator Instructions] As a reminder, this conference is being recorded. At this time, I’m turning the call over to Max Gadicke of Precision AQ.
Max Gadicke: Thank you. 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 weather. GeoVax can develop and manufacture its product candidates with desired characteristics in a timely manner and such products will be safe for human use. GeoVax’s vaccines will effectively prevent targeted infections in humans. GeoVax’s product candidates will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises required capital to complete development of its products. 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’ 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: It is a pleasure to welcome everyone to the third quarter 2024 GeoVax corporate update call. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials and then your questions will be addressed. The third quarter included several major events in the development of GeoVax, led by the BARDA Project NextGen award valued at almost $400 million being announced during mid-June. This program is already underway with confirmation that all study sites have been selected as well as our ongoing billings to BARDA. Mark will further discuss this during the financial review. We are delighted to have been paired by BARDA with Allucent as our CRO for the Project NextGen trial as Allucent is our existing CRO supporting our ongoing CM04S1 and recently completed Gedeptin clinical trials. In addition, during quarter three, we announced plans to conduct a Phase 2 trial of Gedeptin in combination with immune checkpoint inhibitor among patients with locally recurrent head and neck squamous cell carcinomas following primary therapy and for whom resection with curative intent is planned. Thus far, clinical evaluation of Gedeptin therapy has demonstrated an acceptable safety profile and sufficient tumor stabilization or reduction activity to support plans to advance clinical development of Gedeptin in such an expanded Phase 2 clinical trial. Relative to GEO-MVA, our vaccine candidate against Mpox and smallpox, we have continued to advance the program this past quarter from having the cGMP production of a master seed virus to establishing the working seed virus and currently having production of the first cGMP clinical substance batch underway with release anticipated by year-end. In addition, we are moving forward with our advanced MVA manufacturing process with preparation of our AGE.1 master cell bank being initiated. These activities represent significant progress and milestones for GeoVax. Our goal is to successfully develop innovative cancer therapies and infectious disease vaccines, addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate establishing business partnerships and collaborations in support of worldwide development, commercialization and distribution. In late July, we announced plans to initiate a Phase 2 trial with Gedeptin in combination with an immune checkpoint inhibitor for treatment of previously treated patients with recurrent head and neck cancer. The primary goal of this trial will be to demonstrate a pathological response with neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in previously treated patients with recurrent squamous cell head and neck cancer in whom surgery with curative intent is planned. The company has initiated the necessary planning activities including protocol development, manufacturing and CRO selection with the trial activation anticipated during 2025. We believe that the Gedeptin mechanism of action will enable us to address a variety of solid tumors, both cancers and benign. We hold worldwide rights for all indications of this technology, and we are participating in various oncology and partnering conferences. We are encouraged by the clinical results we’ve seen thus far, and we’re even more excited about trial activation as soon as possible. Our big news recently was the announcement of the BARDA Project NextGen award of almost $400 million, supporting GEO-CM04S1 in a 10,000-patient comparative trial against an FDA-authorized mRNA vaccine. This represents a highly significant event in the evolution of our company, which we believe represents a validation of our MVA technology and expertise. The vetting process was lengthy and rigorous, but we remain confident throughout, and we’re delighted to be part of the Project NextGen vaccine program. Let me note that our vaccine selection represents 1 of only 6 vaccines awarded under Project NextGen. Already, all participating sites have been identified, selected by Allucent and manufacturing activities are proceeding in support of the study start during 2025. Our aim with GEO-CM04S1 is to provide a more practical public health-friendly COVID-19 vaccine than that offered from the first-generation approved vaccine. We believe that this is achieved by stimulating a robust and durable immune response across multiple virus variants as a result of the induction of both the antibody and cellular arms of the immune system against multiple virus antigens. This distinction is critically important in addressing the high-risk populations of immune compromised individuals for whom the current vaccines are often inadequate. This represents the key differentiation between our vaccine and the first-generation authorized vaccines. Our vaccine utilizes a proven safe and efficient delivery platform, Modified Vaccinia Ankara or MVA, which does not replicate in mammalian cells. The safety of MVA has been well established and accepted by regulatory authorities worldwide, especially among patients with weakened immune systems such as among pregnant women. That our vaccine platform, MVA is also a stand-alone vaccine authorized for protection against Mpox and smallpox is a unique feature, which critically important clinical benefits, providing a significant differentiator for CM04S1, especially when considered as a potential COVID-19 vaccine in regions endemic to Mpox. A current example is within the Democratic Republic of the Congo or the DRC, where there is a threatening outbreak underway. Also, the CDC recently issued a warning of continued Mpox threats and risk within the U.S. In addition to its benefits in immunocompromised individuals and protecting from severe COVID-19, we believe that CM04S1 has potential for more general use as a heterologous booster to current mRNA vaccines, providing a durable and broadly functional immune response against emerging variants. The intriguing possibility is that GEO-CM04S1 could, by virtue of this immune profile, reduce the need for continuous vaccine reconfiguration that appears necessary with the mRNA vaccines. In fact, the HHS press release announcing our Project NextGen award specifically highlighted our award is providing the potential for a COVID-19 vaccine that provides broader protection, meaning encompassing a wider variety of variants and the potential for increased durability than that evidenced by the current authorized vaccines. The current data thus far from our existing Phase 2 studies is supportive of that potential. Relative to CM04S1, we anticipate partnering collaborations and additional clinical research efforts and in support of worldwide commercialization and distribution. Active initiatives are underway in these areas. Three Phase 2 clinical trials are underway with CM04S1, two of which address populations of immunocompromised patients at high risk for developing severe COVID-19. The other Phase 2 trial evaluates our vaccine as a heterologous booster among healthy adults following prior receipt of an mRNA vaccine. Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the tens of millions of immunocompromised patients while also demonstrating the vaccine as a more robust durable booster vaccine used in conjunction with mRNA vaccines. I won’t delve further into these specific trials at this time, but we welcome any questions you may have during our Q&A session. With the announcement of our Project NextGen award and the progress in our other Phase 2 clinical studies, our activities related to partnering and collaborations with GO CM04S1 have increased. We believe that GOCM04S1 represents significant promise as a critically needed and important part of the COVID-19 vaccine armamentarium for public health worldwide. In August, the WHO declared Mpox as a public health emergency of international concern, highlighting the critical medical threat posed by this highly virulent virus. GeoVax is well positioned and actively progressing GEOMVA, our vaccine against Mpox and smallpox, intended to disrupt the current global monopoly in that important area. Moreover, we believe that our efforts will establish GeoVax as the first U.S.-based supplier of such a vaccine. This may also provide GeoVax our initial step into revenue generation due to significant governmental interest in U.S.-based supply chains versus overdependence on non-U.S. suppliers. The strong sentiment in favor of such on-sourcing initiatives remains a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders, such as the White House, BARDA, WHO, the African CDC and others regarding our progress towards having a cGMP clinical batch produced and manufacturing capabilities advancing. WHO has clearly stated the expectation of continued expanded migration of the Mpox virus reflected in recent reports of multiple cases in the UK. The need for expanded Mpox vaccine supply is a priority for WHO and other public health agencies globally. Finally, we anticipate providing continued updates related to our advanced MVA manufacturing process targeted to enable GeoVax to efficiently produce and distribute MVA-based vaccines in response to real-time market needs. We are confident that we’re on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. From a commercial perspective, these medical need opportunities represent a tremendous estimated annual U.S. revenue potential. I’ll underscore that this isn’t a sales forecast, but rather a reflection of the significance of the need to address these critically important areas of health care, both clinically and commercially. Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence we have relative to the outlook for GeoVax, our shareholders and our stakeholders. 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. Mark?
Mark Reynolds: Thank you, David. I’ll start reviewing with the income statement to begin with. Our contract with BARDA began on June 12. So there were minimal revenues reported during the second quarter. But during the third quarter ended September 30, we reported $2.8 million of revenues and $3.1 million for the 9-month period. There were no comparable revenues reported during the 2023 periods. This is a cost reimbursement contract, so future revenues will directly correlate with our billable personnel time and incremental expenses incurred. The total contract value direct to GeoVax is currently $26 million, but may actually increase up to $45 million. And keep in mind that a separate contract of $443 million was awarded directly to Ilucent, the CRO that is conducting our trial. Those revenues won’t show up in our financial statements. Research and development expenses were $16.1 million during the first 9 months of 2024 versus $14.5 million in 2023, representing an increase of roughly $1.6 million or 11%. This year-over-year increase is primarily associated with the cost of manufacturing clinical trial materials and other costs associated with the BARDA contract. General and administrative expenses were $3.8 million for the 9-month period in 2024 versus $4.6 million in 2023, representing a decrease of around $800,000 or 17%, primarily associated with lower stock-based compensation expense and a mix of other costs. Other income and expense was $70,000 in 2024 as compared to $675,000 in 2023, primarily reflecting lower interest income due to lower cash balances invested through our money market accounts. So overall, net loss for the first 9 months of 2024 was approximately $16.7 million or $4.52 per share versus $18.4 million in 2023 or $10.42 per share, again, with the increase primarily being driven by manufacturing activities and costs associated with the BARDA contract. Turning now to the balance sheet. Our cash balances at September 30 were $8.6 million compared to $6.5 million at December 31, 2023, reflective of $16.9 million used in operating activities, offset by $19.1 million in financing transactions, along with changes to our noncash asset and liability balances. Our outstanding common shares currently stand at $9.4 million following the recent financings. Going forward, supporting the BARDA Project NextGen award is our top priority in terms of operational focus and the significant use of our research and development personnel. But it’s important to keep in mind that the entire clinical program is fully funded by BARDA through the awards to GeoVax and through Ilucent, our CRO partner. In terms of our actual funding needs, the Gedeptin and CM04S1 clinical programs as well as the development activities for the EOMDA Mpox program will be the most significant use of our cash for the foreseeable future. We are currently developing our capital formation plans to fund those programs through several valuation inflection points. I’ll be happy to answer any further questions during the Q&A. And I’ll now turn the call back to David.
David Dodd: Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Dr. Mark Newman, Kelly McKee and John Sharkey, our Chief Scientific Officer, Chief Medical Officer and Vice President of Business Development, respectively. I’ll now turn the call over to the operator for instructions on the question-and-answer period.
Operator: [Operator Instructions] Our first question comes from Jonathan Aschoff with ROTH Capital Partners. Your line is open.
Jonathan Aschoff: Thank you. Good afternoon, guys. I was curious regarding that AGE1 cell line for MDA manufacturing, what must you do to submit test batches to the FDA to get to that point? And can you help us on that timing?
David Dodd: Sure, Jonathan. This is David. Thanks for your question. I’m going to ask Mark Newman and also perhaps John Sharkey to weigh in on that don’t.
Mark Newman: Okay. So there’s a pretty standard process evaluation that we would go through. So process development and I mean that’s well defined to the regulatory agencies. The key element will be purifying the virus to, again, standards that are acceptable by the FDA. We’re just starting on the process development on that and generating – we have plans defined to generate cell banks. So giving you timing on it would be a bit difficult. But I could estimate that once we start throwing people at it, this was qualifying the cell line, getting to where we want and then starting to run test batches, which would not be GMP, but would be products where we test quality of the virus quality of our process purity. That’s probably an 18-month process minimum. But it could potentially be, this is one of those areas where you can put more effort on it and more people and expedited if there’s a reason to do so.
Jonathan Aschoff: Okay. Thanks for that. David, when might you know for both the CLL and the healthy volunteer trials, when would we be able to see interim and final results, respectively, for those two trials?
David Dodd: I think clearly this quarter and probably sooner rather than later. But before year-end, we anticipate to be announcing and reporting the interim results for the CLL study as well as the final result. Now the final results for the healthy volunteer just from the basis of knowing a little bit about where the statisticians are, that could move into early next year. But as you’re aware, that’s a completed study. It’s being cleaned up the database. The analysis is being done, and we’re obviously urging the statisticians to move faster rather than slower. So our goal is to be able to report both by year-end. I think with certainty, we feel regarding the interim results of the CLL study and relative to the healthy volunteer booster trial, that may fold over into early next year, but we’re hoping that it won’t.
Jonathan Aschoff: Okay. And the last couple are just you know have you made much progress? Can you tell us the progress that you’ve made in your request for expedited regulatory pathway for Mpox? And then I just saw nothing about when you’ll start enrolling trial patients in your 10,000-patient Phase 2 COVID trial. I was just hoping that was something that was at least going to start by the middle of 2025, but you gave no timing on that. So I was wondering when you could start enrolling those patients and the progress you made in expedited regulatory pathway for Mpox.
David Dodd: So let me ask John Sharkey, who also serves as our executive lead on the GONDA so to discuss that one, and then I’ll ask for Dr. Key Kelly to then address the Project NextGen study.
John Sharkey: Sure. Hey, Jonathan, we have not disclosed our regulatory strategy per se. But what I can share is we are in active engagement with the regulators. The guidance we’re getting is because it is MDA generally recognized the say that we’re manufacturing on the chicken embryo fiberglass platform for the initial registration that there is indeed an expedited pathway for us that will involve abbreviated trial structure and probably at most some bridging tox in animal models. We are continuing those discussions with the agency to finalize agreement on the clinical protocol design as well as what, if any, additional animal work they would want to see to support the registration. But they’ve been clear that they do not see a need for us to do the traditional full top, Phase 1, Phase 2, Phase 3 for this asset, given that it is MVA that essentially, it’s very close to what is already approved. And we are – for the initial product introduction, we will be using the chicken embryo fibroblast platform.
Jonathan Aschoff: Okay. And so you wouldn’t even have to do efficacy in animals?
John Sharkey: Well, remember how MVA is approved for smallpox and monkeypox. It is approved with an immunological evaluation in humans as well as safety. Efficacy is demonstrated in animal models. We are having discussions with them what, if any, efficacy parameter would they want to see in an animal model to basically match the immunological response we’re going to measure. If they end up requiring an animal efficacy leg, we could run that in parallel with the clinical trial. So it would not be at all rate limiting for us. The rate limiting will be running the immunological trial.
Jonathan Aschoff: Thank you. And just finally, the NextGen trial start timing.
Kelly McKee: Yeah. Hi, Jonathan, this is Kelly. Right now, we are projecting enrollment to begin around the 1st of October, the early part of October of 2025. That’s being driven by the sort of manufacturing time lines. And that’s kind of where we are.
Jonathan Aschoff: Okay. Thank you very much, guys.
John Sharkey: Okay.
Operator: Our next question comes from James Molloy with Alliance Global Partners. Your line is open.
James Molloy: Hey, guys. Thank you very much. Looking out past the fourth quarter here, what are the sort of the next steps we should anticipate here for in early ‘25 for the primary vaccine trial, the CLL trial, the booster vaccine trial, all of which will be putting out data end of this year, early next. What are kind of next steps we should anticipate? And where – what’s the sort of end game on each of those trials where you can go to the FDA and start talking about the next steps or potentially filing?
David Dodd: Jim, thank you. This is David. I’ll touch on those. And then Kelly, if you want to add to it, but the way we’re looking at it is we want to see the results of the interim results of the CLL trial. And remember, that’s an investigator-initiated trial. We’ve always felt that it’s such a high need immuocompromised population that there is an opportunity, we believe, for an expedited development process. We’ll look at the results. We’ll decide do we want to go forward with a company-sponsored trial and pursue that. That would involve also discussions in advance with the agency about our plans, et cetera, what the outcome might be. From the healthy volunteer trial is really we’re seeking to see the final results from there. And when one thinks about it, Project NextGen is actually the expansion of that. It’s a much larger trial. It’s generally healthy, but it’s a very diverse population type of both of study participants and also it’s a comparative trial. Our stem cell transplant trial continues to add sites and enrollment. And I guess I’d say with that, Kelly, would you like to pick up and add any other comments on this on our trials for CM041?
Kelly McKee: No, you pretty much hit the high points. Just to keep in mind, the healthy volunteer study, we’re comparing two doses of the vaccine. There’s no active control and there’s no placebo control in that study. And so we’re not anticipating any surprises to come out of that. But as David indicated, we should have results of that by sort of sometime in the first quarter of 2025, I think. For the cell transplant study, we’re continuing to enroll our current trial. We anticipate continuing that enrollment through the end of next year. We’ve added a couple of additional sites, which should be coming online very shortly, I mean, literally within weeks, two additional sites to add to the three that are currently enrolling patients. We’ve got patients in active screening. So we’re adding to the number that we’ve already enrolled, which is around 31 patients up to this point in time. So that study is continuing to acquire, accumulate data, which will be very important to us going forward. It’s not a registrational trial. We’ve sort of recognized that from the outset. But the data that’s coming out of that study is going to be very, very supportive to any registrational trial that we do. We have another sort of more robust trial designed. The study protocol drafted already, and we’re ready to launch that at the conclusion of this study. Of the current study, which I think, again, with the data from the current study added to it should position us pretty well to go talk to the agency about a registrational pathway.
James Molloy: Thank you. And then on Mpox and smallpox, a few folks looking to get some vaccines together for disease, who do you see as sort of the clear leader yourselves, of course, in this space? And what do you think gets you to the finish line? Who didn’t get to the finish line first there or do you think it’s something where you’ll need multiple vaccines, different populations, what have you?
David Dodd: John, do you want to pick up on that?
John Sharkey: Sure. So the benefit of – I mean, there is three vaccines out there. There’s ACAN2000 vaccinia, which is indicated as usable in healthy individuals. There’s LC-16, which was registered in Japan, and that was tested in children. The Vaccinia is a replicating virus. The LC-16 is referred to as a minimally replicating virus. Then there’s MBA, which doesn’t replicate. So the nice part about MBA, when you look at the WHO recommendation, it’s recommended for healthy individuals, immune compromised, pregnant women, lactating women, children as a preferred vaccine. So given all things being equal as far as availability, I think the general trend is if you have the option, you vaccinate with MBA because you don’t have to worry about the patient’s current health state. So we believe that the MBA will remain the preferred product in this space. The other ones are there and depending on need can be used, but our general sense of talking with people is that MA is the preferred product. It is currently right now, as you well know, a single source manufacturer, very complicated manufacturing process. If you want to make more MVA, you got to build new facilities. The process doesn’t transfer easily to other facilities, which is the whole basis of our AGE1 platform while we’re going to that because the benefits of the AGE1 besides being more productive, it’s also a suspension cell line, which will now allow us to implement manufacturing in currently built manufacturing back manufacturing facilities that typically handle suspension cell lines. So that’s how you change the paradigm in supply for these MVAs.
James Molloy: Okay. The last question then can you characterize how the collaboration partnership environment looks currently? And then maybe just on a mechanistic question on the top line, about $3 million a quarter is that we should anticipate until you get to the ‘26 or whatever the ultimate number comes to be for the BARDA contract?
David Dodd: Mark Reynolds, do you want to touch on the financial first, and then I’ll address the partner.
Mark Reynolds: Yes. So the financials, the reimbursement is on the cost reimbursement basis. So the revenue we record is based on just standard personnel time each month with overheads layered on top, and the rest will come as the respective bills come in. from manufacturing activities. The clinical trial piece of that is not going to be reflected in our financials. That’s through Lucent, the CRO, who had a direct award from BARDA. I’m not sure if that answered the question, Jim.
James Molloy: Just as we’re modeling on this, we sort of plug in about $3 million a quarter roughly going forward to run through the $26 million.
Mark Reynolds: Yes. I think for your model, I think that’s a fair approach. It’s a little uncertain on our end, but I think that’s how I model it for our internal cash flow projections.
David Dodd: And in regard Jim, regarding the question about the partnering environment, et cetera, I’m going to ask John to weigh in on that because he and I have just returned for several weeks in Europe, interacting with people about potential partnering, et cetera. So John?
John Sharkey: Yes. The partnering area is still somewhat difficult in the sense that M&A and licensing has been a little bit depressed with everything going on. It’s definitely picking up. People are actively engaging with us. They’re reaching out to us to talk at the meetings, seeing some significant interest in Gedeptin. The 04S1 is a little harder for some people to get their hands around because of all the political noise around it and that it’s not a big issue if the pandemic is passed. But once we can engage them and explain that, yes, it’s passed for the healthy individual, but not for the immune-compromised individual. These are still the people at risk. They then begin to engage and understand that there’s potentially a commercial opportunity present here for them. So I would say that people are engaging. They are interested in adapting clearly, 04S1, if we get the chance to tell them the story of where we see it fits, they will engage. And like anything else, it’s finding that match.
David Dodd: I was just going to add, Jim, that it was surprising from some quarters to hear the interest because of the need and the lack of access to Mpox vaccine. So, to the existing MDA, and so we had people pointing out that in their particular region of the world, their locations are, they would be very interested and have asked us to keep them updated as we progress with the Geo MDA [ph].
James Molloy: I was thinking to the Pfizer putting $2.3 billion in the quarter of Paxlovid, much as interest may have waned on Wall Street on COVID. COVID hasn’t gotten tired of us.
David Dodd: No doubt.
Kelly McKee: There is another thing that might be worth mentioning, and that is that there was a recent publication out of the Fred Hutch highlighted the fact that the clinical trials for the COVID vaccines have traditionally avoided enrolling immunocompromised patients. And given that the need is so great in that population, there is sort of an increasing momentum to recognize the fact that these patients need to be in clinical trials. They need to be offered the opportunity to participate in vaccine trials. And we are hoping that, that’s going to – the attention that, that’s starting to get with the institutions that manage these patients is going to encourage some greater participation on the part of both investigators and patients.
James Molloy: Thanks for taking my questions.
Operator: Thank you. Our next question comes from Jason Kolbert with EF Hutton. Your line is open.
Jason Kolbert: Thanks guys. A couple of questions, I am just wondering if you have been watching the launch of Pemgarda and what you think of that because it is, while it’s not a traditional vaccine, it’s a monoclonal antibody, it is targeting immunocompromised patients for COVID, and are there any lessons to be learned from that?
David Dodd: So, I will ask Kelly, if he would like to weigh in on that.
Kelly McKee: Yes. We are certainly aware that it was launched, and it’s clearly offering benefit to these patients. I think it’s worth recognizing that monoclonal antibodies are not totally innocuous on the one hand. There are a number of patients that have had bad reactions to those, not necessarily that one, but other monoclonal antibodies. And the fact that the half-life of these antibodies is pretty much restricted by the nature of what they are. And so one of the advantages that we think we are bringing with our vaccine is by stimulating a strong T-cell response, we are enhancing sort of the memory response that these patients will develop to vaccination and we will offer them a more prolonged protection against developing severe disease or worse. So, I think Pemgarda is certainly can be viewed as a competitive product in one sense, but it has advantages and disadvantages just like vaccines do.
Jason Kolbert: Yes. Fair enough. I think it’s interesting. I think they could actually be complementary in a lot of ways. You did a very good financing in August, particularly when you look at where the stock was then and where it is now. One of the biggest challenges in the microcap world is financing. Can you talk a little bit about what the strategy is to kind of get across the next 12 months to 24 months where it seems like you have multiple inflection points coming? Thanks.
David Dodd: Thank you. So, Mark, would you like to pick that up, I will toss that to you.
Mark Reynolds: Yes. I can’t answer the exact strategy, Jason, other than to say that we have got multiple tools in our tool belt now. We have got – we recently installed an ATM facility. We have got ongoing conversations with multiple bankers, and we have recently been able to extract ourselves out of the baby shelf restriction for selling shares under our shelf registration. So, we have got a lot of opportunities here to efficiently raise capital with better terms that we have seen in the past. And I will kind of leave it at that.
Jason Kolbert: Okay. Fair enough. Thanks so much for the update.
Mark Reynolds: You’re welcome.
Operator: Thank you. Our next question comes from Vernon Bernardino with H.C. Wainwright. Your line is open.
Vernon Bernardino: Hi. Another one. Thanks for taking my question and I apologize for the graininess of this connection. I just wanted to ask a question about R&D expenses. What costs do you think you may continue to incur regarding manufacturing materials for the clinical trials with 04S1 and the BARDA contract? And with Oxford Biomedica manufacturing supply for you, is that something where they manufacture supply, and then you pay them? What kind of accounting treatment is used there? And what level of expenses do you incur there? Thank you.
David Dodd: Mark, do you want to address those?
Mark Reynolds: Yes. I will try to answer the question as best I can. Our relationship with Oxford Biomedica is we have multiple task orders with them for various different manufacturing campaigns for different products. And it is a – I won’t call it necessarily a bill as you go, but there are like the standard contract might be 40% upfront, 40% on a certain milestone and then 20%. What you will see reflected in our financials, we have had some heavy expenses during 2024 for our manufacturing campaign and much of that is going to be behind us now. So, we are in a good position. Relative to the material for the BARDA contract, that’s going to be fully paid for by BARDA. I mean we pay for it, but it gets reimbursed by BARDA, so it’s really a wash for us. Much of that cost is still in front of us, but it really doesn’t affect us on a cash flow basis, except for a minor bit of working capital needs just while we wait on getting reimbursed from BARDA, which is quick. They pay us within 30 days of when we submit the expenses. So, I don’t know, does that sufficiently answer the question?
Vernon Bernardino: Yes. Just to clarify those. So, if you were to be paid – if you were to incur those expenses this month, you would be paid in December and not in January?
Mark Reynolds: If we would probably pay it in January, because we bill BARDA on a monthly basis at the end of the month, so a cost incurred in November, for example, we – if we pay for that right away or even if we don’t pay for it, if the expense comes in, in November, we submit our invoice to BARDA first week of December. We get paid the first week of January.
Vernon Bernardino: Great. That’s very helpful. I appreciate answering my questions and congrats on the process – on progress, looking forward to the readouts in the coming weeks.
Mark Reynolds: Thank you, Vernon. Appreciate it.
Operator: Thank you. Our next question comes from Robert LeBoyer with Noble Capital Markets. Your line is open.
Robert LeBoyer: Good afternoon and congratulations on a really great quarter. Just wanted to congratulate the whole team on all of the achievements that have been reported in the last quarter and just applaud the progress that you have made in the face of some really difficult times in the past. My question has to do with Gedeptin and the mention in the press release that the Phase 2 will be a single cycle trial and pathological response rate will be the primary endpoint. I was curious if you could expand a little bit about the treatment and whether a single cycle trial means single cycle of Gedeptin and standard dosing of the checkpoint inhibitor or one single cycle of each? And if there are any specific pathological response endpoints that you could share at this point?
David Dodd: Kelly?
Kelly McKee: Yes, I’ll do my best. We have a clinical oncologist on staff that’s been sort of driving the design and prosecution of this program. But so where we are is the single cycle refers to the single cycle of Gedeptin. The study will actually involve a cycle of Gedeptin plus which is ADPNP plus fludarabine, along with a single cycle of pembrolizumab that will be followed by another cycle of pembrolizumab, then followed by surgical resection of the tumor and observation for effect. So, it’s again, to answer your question directly, it’s a single cycle of Gedeptin plus pembro, but they’re actually going to be two rounds of pembro given prior to surgical resection. Now the endpoints, we’re looking for complete response, but we’re also going to be monitoring for all sort of levels of pathological response. Our comparator is a recently completed trial that looked at pembro alone as neoadjuvant treatment for this class of patients in which there is essentially no complete responses seen. So we think we’ve got a pretty good shot at demonstrating something that’s better than what the current standard offers in that regard.
Operator: Thank you. And our last question comes from Karen Goldfarb with Crystal Research. Your line is open.
Jeffrey Kraws: Thank you. It’s actually Jeffrey Kraws. I wanted to ask four of my questions have already been answered, but I wanted to ask with the durability, because obviously, the immunocompromised patients, we’ve addressed this before. There is so many immunocompromised patients and immunocompromised children out there. When you go to run your test for not only your clinical trials, the push to include immunocompromised patients, how big of an effort is that on your behalf? And the second part is, obviously, across all the vaccine platforms you’re working on, durability and having the differentiation of having T cells activated and having the T cells educated and learned to go after the virus as it replicates. How long do you plan on conducting those studies in length to try and show that your product is more durable?
David Dodd: Kelly, do you want to address that?
Kelly McKee: Sorry, I had to get myself off on mute. So to answer your first question, our immunocompromised patient population is really our primary patient population target for CM04S1. And that’s where we put the majority of our effort besides the BARDA trial, obviously, in our development programs. The durability question, in an ideal world, what we would like to see is being able to reliably measure durability over at least a 1-year period. And we’re following all of our patients in our trials for 1-year after following their first dose of vaccine. What complicates that is the virus continues to sort of be very prevalent globally, and there continue to be ongoing infections in these patients. And so when we’re trying to differentiate a natural infection from a vaccine-induced immune – an immune response from a national infection from that induced by vaccines and patients that are getting infected throughout the course of follow-up, it becomes very difficult. And so we’re very interested in the – we know we’re seeing breakthrough infections. We’re not seeing any severe breakthrough infections to-date. And we’re very interested in following the intensity of infections that will be occurring in these patients. But trying to sort of sort that out immunologically is kind of a challenge for us. But we’re working on trying to come up with some workarounds.
Jeffrey Kraws: Great. Appreciate that. And the last question I have is where referring earlier to the 10,000-patient study when we were talking about we weren’t sure when the first patient was going to be enrolled. When you look at the timetable after the first patient is enrolled, what is the timetable that you have right now that you’re planning to see to get those 10,000 patients all enrolled?
Kelly McKee: The current thinking is that we’ll get all those, assuming we start this trial when we think we’re going to start this trial, which is, again, beginning of October 2025, we should be able to enroll this, fully enroll this study within 6 months. That’s the discussion that we have with our CRO, Allucent, as well as with BARDA and that’s kind of where we’re thinking.
Jeffrey Kraws: Great. Thank you very much and thank you for the transparency. It’s appreciated.
Operator: 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: I want to thank everybody for participating in today’s update and also especially members of our team who have been so helpful in answering these questions. But we’ve had the opportunity to review our achievements, our progress as well as our outlook. We strongly believe that Q3 represented continued and significant progress in the GeoVax development as a result of the Project NextGen award, our decision to proceed with an expanded Gedeptin Phase 2 clinical trial and our progress with GEO MVA as well as the advanced MVA manufacturing process. These are our priorities. These represent our focus. Your interest is greatly appreciated, and we look forward to ongoing interactions. As always, I’d like to acknowledge and thank the GeoVax Board of Directors and advisers, our entire GeoVax staff and the many other parties that continue to support us towards achieving success. We remain committed to providing meaningful career development opportunities for highly competitive, quality-oriented individuals seeking to disrupt the current paradigm of cancer therapies and infectious disease vaccines. We like doing that. We’re most proud and appreciative of our team, including those external partners who continue to contribute to the progress and success underway at GeoVax. For all of us, it is a great pleasure serving our shareholders and being a part of this team. Our overriding goal is to improve lives worldwide through our development and commercialization of novel, critically needed cancer therapies and infectious disease vaccines. For today, have a safe, enjoyable day and thank you again for your support and interest.
Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.
