Q3 2024 GeoVax Labs Inc Earnings Call
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The
Speaker Change: Good afternoon and welcome everyone to the GEOVAX third quarter 2024 corporate update call. My name is Michelle and I'll 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
Speaker Change: and John Sharkey, Ph.D., Vice President, Business Development. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation.
As a reminder, this conference is being recorded.
Speaker Change: At this time, I'm turning the call over to Max Gadicke of PrecisionAQ.
Thank you. Please note the following.
Speaker Change: Certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act.
Speaker Change: These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances.
Speaker Change: Actual results may differ materially from those included in these statements due to a variety of factors, including weather.
Speaker Change: Geovacs can develop and manufacture its product candidates with desired characteristics in a timely manner and such products will be safe for human use.
Geobax's vaccines will effectively prevent targeted infections in humans.
Speaker Change: GeoVax's product candidates will receive regulatory approvals necessary to be licensed and marketed.
GeoVax raises required capital to complete development of its products.
Speaker Change: There is development of competitive products that may be more effective or easier to use than Geovax's products.
Speaker Change: GeoVacs will be able to enter into favorable manufacturing and distribution agreements.
and other factors over which GeoVax has no control.
Speaker Change: GeoVacs assumes no obligation to update these forward-looking statements and does not intend to do so.
Speaker Change: More information about these factors is contained in GEOVAX's filings with the Securities and Exchange Commission, including those set forth as risk factors in GEOVAX's Form 10-K.
Speaker Change: It is a pleasure to welcome everyone to the third quarter 2024 GFX Corporate Update Call. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials and then your questions will be addressed.
Speaker Change: The third quarter included several major events in the development of GEOVAX, led by the BARDA Project Next-Gen Award, valued at almost $400 million, being announced during mid-June.
Speaker Change: This program is already underway with confirmation that all study sites have been selected, as well as our ongoing billings to Barnard.
Speaker Change: Mark will further discuss this during the financial review. We're delighted to have been paired by BARDA with Ellucent as our CRO for the project next-gen trial as Ellucent is our existing CRO supporting our ongoing CMO for S1 and recently completed GADEPT in clinical trials.
In addition, during quarter three,
Speaker Change: We announce plans to conduct a Phase 2 trial of Gadeptin in combination with an immune checkpoint inhibitor.
Speaker Change: among patients with locally recurrent head and neck squamous cell carcinomas following primary therapy and for whom resection with curative intent is planned.
Speaker Change: Thus far, clinical evaluation of gadeptin therapy has demonstrated an acceptable safety profile and sufficient tumor stabilization or reduction activity to support plans to advance clinical development of gadeptin in such an expanded Phase II clinical trial.
relative to GOMBA, our vaccine candidate against mpox and smallpox.
Speaker Change: We've 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.
Speaker Change: In addition, we are moving forward with our advanced MVA manufacturing process with preparation of our AGE-1 Master Cell Bank being initiated.
Speaker Change: These activities represent significant progress and milestones for GFX. 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.
Speaker Change: We anticipate establishing business partnerships and collaborations in support of worldwide development, commercialization, and distribution.
Speaker Change: In late July, we announced plans to initiate a Phase II trial with GADEPTIV in combination with an immune checkpoint inhibitor for treatment of previously treated patients with recurrent head and neck cancer.
Speaker Change: The primary goal of this trial will be to demonstrate a pathological response with neoadjuvant adeptin therapy combined with an immune checkpoint inhibitor and previously treated patients with recurrent squamous cell head and neck cancer in whom surgery with curative intent is planned.
Speaker Change: The company has initiated the necessary planning activities, including protocol development, manufacturing, and CRO selection, with the trial activation anticipated during 2025.
Speaker Change: We believe that the GADEPTA mechanism of action will enable us to address a variety of solituners, both cancerous and benign.
Speaker Change: We hold worldwide rights for all indications of this technology, and we are participating in various oncology and partnering conferences.
Speaker Change: 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.
Speaker Change: Our big news recently was the announcement of the BARDA Project Next Gen Award of almost $400 million, supporting GEO CMO4S1 in a 10,000 patient comparative trial against an FDA authorized mRNA vaccine.
Speaker Change: This represents a highly significant event in the evolution of our company, which we believe represents a validation of our MVA technology and expertise.
Speaker Change: The vetting process was lengthy and rigorous, but we remained confident throughout and we're delighted to be part of the Project Next Gen vaccine program. Let me note that our vaccine selection represents one of only six vaccines awarded under Project Next Gen.
Speaker Change: Already, all participating sites have been identified and selected by Ellucent, and manufacturing activities or proceedings in support of the study start during 2025.
Speaker Change: Our aim with CMO4S1 is to provide a more practical, public health-friendly COVID-19 vaccine than that offered from the first-generation approved vaccine.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: clinical benefits, providing a significant differentiator for CMO4S1, especially when considered as a potential COVID-19 vaccine in regions endemic to MPOS.
Speaker Change: A current example is within the Democratic Republic of the Congo, or the DRC, where there is a threatening outbreak underway.
Speaker Change: Also, the CDC recently issued a warning of continued impact threats and risk within the U.S.
Speaker Change: In addition to its benefits in immunocompromised individuals and protecting from severe COVID-19, we believe that CMO4S1 has the potential for more general use as a heterologous booster to current mRNA vaccines, providing a durable and broadly functional immune response against emerging variants.
Speaker Change: The intriguing possibility is that GOCM04S1 could, by virtue of this immune profile, reduce the need for continuous vaccine reconfiguration that appears necessary with the mRNA vaccines.
Speaker Change: In fact, the HHS press release announcing our Project NextGen award specifically highlighted our award as 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.
Speaker Change: The current data thus far from our existing Phase II studies is supportive of that potential.
Speaker Change: Relative to CMO4S1, we anticipate partnering, collaborations, and additional clinical and research efforts, and in support of worldwide commercialization and distribution. Active initiatives are underway in these areas.
Speaker Change: Three Phase II clinical trials are underway with CMO4S1, two of which address populations of immunocompromised patients at high risk for developing severe COVID-19. The other Phase II trial evaluates our vaccine as a heterogeneous booster among healthy adults, following prior receipt of an mRNA vaccine.
Speaker Change: 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 is a more robust, durable booster vaccine used in conjunction with mRNA vaccines.
Speaker Change: 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.
Speaker Change: With the announcement of our Project Next Gen award and the progress in our other Phase II clinical studies, our activities related to partnering and collaboration with GEO and CMO for S1 have increased.
Speaker Change: We believe that GEO CMO4S1 represents significant promise as a critically needed and important part of the COVID-19 Vaccine Armamentarium for public health worldwide.
Speaker Change: In August, the WHO declared MPOGS as a public health emergency of international concern, highlighting the critical medical threat posed by this highly virulent virus.
Speaker Change: GFX is well positioned and actively progressing, GEO, MVA, our vaccine against MPOCS and smallpox, intended to disrupt the current global monopoly in that important area.
Speaker Change: Moreover, we believe that our efforts will establish SteelVax as the first U.S.-based supplier of such a vaccine.
Speaker Change: This may also provide GFX our initial step into revenue generation due to significant governmental interest in U.S.-based supply chains versus over-dependence on non-U.S. suppliers.
Speaker Change: The strong sentiment in favor of such on-sourcing initiatives remains a major national legislative focus and interest.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Finally, we anticipate providing continued updates related to our advanced MVA manufacturing process, targeted to enable GFX to efficiently produce and distribute MVA-based vaccines in response to real-time market needs.
Speaker Change: We're 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.
Speaker Change: 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 healthcare, both clinically and commercially.
Speaker Change: Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence we have relative to the outlook for GFX, our shareholders, and our stakeholders.
Speaker Change: Now I'd like to turn the presentation over to Mark Reynolds, GEOVAG's Chief Financial Officer, for a review of our recent results and financial stats. Mark?
Mark Reynolds: Thank you, David. I'll start reviewing with the income statement to begin with.
during the third quarter into September 30.
Mark Reynolds: We reported $2.8 million of revenues and $3.1 million for the nine-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.
Mark Reynolds: The total contract value in direct-to-GVACs is currently $26 million, but may actually increase up to $45 million.
Mark Reynolds: And keep in mind that a separate contract of $443 million was awarded directly to Ellucent, the CRO that is conducting our trial. Those revenues won't show up in our financial statements.
Mark Reynolds: Research and development expenses were $16.1 million during the first nine months of 2024 versus $14.5 million in 2023, representing an increase of roughly $1.6 million, or 11%.
Mark Reynolds: This year-over-year increase is primarily associated with the cost of manufacturing clinical trial materials and other costs associated with the BARDA contract.
Mark Reynolds: General 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%.
Mark Reynolds: Primarily associated with lower stock-based compensation expense and a mix of other costs.
Mark Reynolds: 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.
or $4.52 per share.
Mark Reynolds: 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.
Mark Reynolds: 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.
Mark Reynolds: reflective of 16.9 million used in operating activities offset by 19.1 million in financing transactions along with changes to our non-cash asset and liability balances.
Mark Reynolds: Our outstanding common shares currently stand at $9.4 million following the recent financings.
Mark Reynolds: Going forward, supporting the BARDA Project Mixed Gen Award is our top priority in terms of operational focus and the significant use of our research and development personnel.
Mark Reynolds: But it's important to keep in mind that the entire clinical program is fully funded by BARDA through the awards to GUX and to Ellucent, our CRO partner.
Mark Reynolds: In terms of our actual funding needs, the GADEPTN and CMO4S1 clinical programs, as well as the development activities for the GEO MBA IMPOPS program, will be the most significant use of our cash for the foreseeable future.
Mark Reynolds: We are currently developing our capital formation plans to fund those programs through several valuation inflection points.
Speaker Change: 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.
David Dodd: Joining us for the Q&A session are Drs. Mark Newman, Kelly McKee, and John Sharkey, our Chief Scientific Officer, Chief Medical Officer, and Vice President of Business Development, respectively. I'll now turn the call over to the operator for instructions on the question and answer period.
Speaker Change: We will now begin the question and answer session. To ask a question, you may press star then 11 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys.
Speaker Change: To withdraw your question, please press star 11 again. At this time, we will pause momentarily to assemble our roster.
Speaker Change: Our first question comes from Jonathan Askoff with Roth Capital Partners. Your line is open.
Speaker Change: Thank you. Good afternoon, guys. I was curious, regarding that AGE1 cell line, you know, for MVA manufacturing, what must you do to submit test batches to the FDA, you know, to get to that point, and can you help us on that timing?
Speaker Change: This is David. Thanks for your question. I'm going to ask...
Speaker Change: Mark Newman, and also perhaps John Sharkey to weigh in on that film.
I mean, that's well-defined to the regulatory agencies.
Speaker Change: The key element will be purifying the virus to, again, standards that are acceptable by the FDA.
Speaker Change: We're just starting on the process development on that and generating, we have plans to find to generate cell banks. So giving you timing on it would be a bit difficult.
Speaker Change: I could estimate that once we start throwing people at it, this was, um...
Speaker Change: qualifying the cell line, getting it to where we want, and then starting to run test batches, which would not be GMP, but would be products where it would be a test quality of the virus, quality of our process, purity. That's probably an 18-month process minimum.
Thank you.
Speaker Change: But it could potentially be, this is one of those areas where you can put more effort on it and more people and expedite it if there's a reason to do so.
Speaker Change: Okay, thanks for that. David, when might, you know, for both the CLL and the Healthy Volunteer trials, you know, when would we be able to see interim and final results respectively for those two trials?
I think clearly this quarter
and probably...
Speaker Change: 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
Speaker Change: 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
Speaker Change: Cleaned up the database, analysis is being done, and we're obviously urging the statistician to move faster rather than slower. So our goal is to be able to report both by year-end.
Speaker Change: I think with certainty, we feel regarding the interim results of the CLL study and relative to the Healthy Volunteer booster trial, that may hold over into early next year, but we're hoping that it does.
Speaker Change: Okay, the last couple are just, you know, have you made much progress? Can you tell us the progress that you've made?
Speaker Change: in your request for expedited regulatory pathway for MPOCS. And then I just saw nothing about when you'll start enrolling trial patients in your 10,000 patient phase two COVID trial. I was just hoping that was
Speaker Change: something that was at least going to start by the middle of 2025, but you gave no timing on that so I was wondering, you know, when you could start enrolling those patients and the progress you made in expedite a regulatory pathway for mPUCs.
Let me ask...
Speaker Change: John Sharkey, who also serves as our executive lead on the GOMBA, so to discuss that one and then I'll ask for Dr. McKee and Kelly to then address the Project NextGen study.
Sure. Hey, Jonathan.
Speaker Change: We have not disclosed our regulatory strategy per se, but what I can share is that we are in active engagement with the regulators. The guidance we're getting is because it is MBA, generally recognized as safe, that we're manufacturing on the chicken embryo fiberglass platform for the initial registration.
Speaker Change: that there is indeed an expedited pathway for us that will involve abbreviated trial structure.
probably at most some bridging talks in animal models.
Speaker Change: We are continuing those discussions with the agency to finalize agreement on the clinical protocol design.
Speaker Change: as well as what, if any, additional animal work they would want to see to support the registration. But they've been clear.
that
Speaker Change: They do not see a need for us to do the traditional
Speaker Change: pull tops, phase one, phase two, phase three for the SASSEC, given that
Speaker Change: It is MVA, that ancestrally it's very close to what is already approved and we are, for the initial product introduction, will be using the chicken embryo fibroblast platform.
Speaker Change: Okay, so you wouldn't even have to do efficacy in animals?
Speaker Change: Well, remember how MVA is approved for smallpox and monkeypox. It is approved with an immunological evaluation in humans as well as safety.
Speaker Change: 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.
Speaker Change: 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 demilogical trial.
Thank you. And just finally the next-gen trial start timing.
Speaker Change: Hi, this is Kelly. Right now, we are projecting enrollment to begin around the 1st of October.
Speaker Change: The early part of October of 2025, that's being driven by the manufacturing timelines and that's kind of where we are.
Okay, thank you very much guys.
Speaker Change: Thank you. Our next question comes from James Malloy with Alliance Global Partners. Your line is open.
I guess. Thank you very much.
The
Speaker Change: Looking out past the fourth quarter here, what are some of the next steps we should anticipate here in early 2025?
Speaker Change: for the, you know, the primary vaccine trial, the CLL trial.
the booster vaccine.
trial.
Speaker Change: all of which we'll be putting out data end of this year, early next.
Speaker Change: Well, what kind of next steps we should anticipate and where...
Speaker Change: What's the sort of end game on each of those trials where you can go to the FDA and start talking about next steps or potentially filing?
Speaker Change: 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 the interim results of the CLL trial. Now remember that's an investigator initiated trial.
Speaker Change: We've always felt that such a high-need immunocompromised population that there is an opportunity, we believe, for an expedited development process.
Speaker Change: 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, etc., what the outcome might be. From the
of study participants, and also it's a comparative trial.
Speaker Change: 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 add any other comments on our trials for CMO fourth one? No, we've You pretty much
Kelly McKee: hit the high points just to keep in mind the Healthy Volunteer Study.
Kelly McKee: We're comparing two doses of the vaccine. There's no active control and there's no placebo control in that study. And so, you know, we're not anticipating any surprises to come out of that.
Kelly McKee: but as David indicated we should we should have results of that you know by sort of sometime in the first quarter of 2025 I think.
Kelly McKee: For the cell transplant study, we're continuing to enroll our current trial. We anticipate continuing that enrollment through the end of next year.
Kelly McKee: We've added a couple of additional sites, which should be coming online very shortly. I mean literally within weeks
Kelly McKee: 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 30, 31 patients up to this point in time.
Kelly McKee: So that study is continuing to acquire, accumulate data, which will be very important to us, you know, going forward. It's not a registrational trial. We sort of recognized that from the outset.
Kelly McKee: But the data that's coming out of that study is gonna be very, very supportive to any registrational trial that we do. We have another.
Kelly McKee: sort of more robust trial designed. The study protocol drafted already and we're ready to launch that at the conclusion of this study.
Kelly McKee: of the current study, which I think, you know, again, with the data from the current study added to it, should give us a pretty, should position us pretty well to go talk to the agency about the registrational pathway.
Thank you for watching!
All right. Thank you.
on MPOCS.
Speaker Change: and Smallpox. A few folks, you know, looking to get some vaccines together for these. Who do you see as sort of the clear leader, besides yourselves of course, in this space and what do you think gets you to the finish line?
Speaker Change: Who didn't get to the finish line first there? What do you think? It's something where you'll need multiple, multiple vaccines, different populations, what have you.
John, do you want to pick up on that?
John Sharkey: Sure, so the benefit of, I mean, there's three vaccines out there. There's ACAM2000, Vaxinia.
John Sharkey: LC-16 is a minimally, referred to as a minimally replicating virus. Then there's MDA, which doesn't replicate.
John Sharkey: So, the nice part about NBA when you look at the WHO recommendation, it's recommended for healthy individuals, immune compromised, pregnant women, lactating women, children as preferred vaccine.
John Sharkey: So, given all things being equal as far as availability, I think the general trend is if you have the option, you vaccinate with MVA so you don't have to worry about the patient's current health state.
John Sharkey: So, we believe that the MVA will remain the preferred product in this space?
Speaker Change: If you want to make more MBA, you've got to build new facilities. The process doesn't transfer easily to other facilities, which is the whole basis of our ATE-1 platform, why we're going to that.
Speaker Change: The benefits of the AG1, besides being more productive, it's also a suspensive cell line which will now allow us to implement manufacturing in currently built manufacturing, vacuum manufacturing facilities that typically handle suspensive cell lines.
Speaker Change: So that's how you change the paradigm in supply for these MBAs.
Thank you.
Okay, the last question then.
Speaker Change: Thank you for taking them. Could you characterize how the collaboration partnership environment looks currently and then maybe it's a mechanistic question on the top line. About three million and a quarter that we should anticipate until you get to the 26 or whatever the ultimate number comes to be for the BARDA contract. Thank you very much.
Speaker Change: Mark Reynolds, do you want to touch on the financial first and then I'll address the department? Okay. Okay.
Mark Reynolds: Yes, so the financials, the reimbursement is on the cost reimbursement basis. So we're recording, 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 bills, the respective bills come in.
Mark Reynolds: from manufacturing activities. The clinical trial piece of that is not going to be reflected in our financials. That's through Ellucian, the CRO, who had a direct award from BARDA.
I'm not sure if that answered the question, Jim.
Speaker Change: Oh, 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.
Speaker Change: It's a little uncertain on our end, but I think that's how I model it for our internal cash flow projections.
Great, thank you.
Speaker Change: And regarding the question about the partnering environment, etc., I'm going to ask John to weigh in on that because he and I have just returned from several weeks in Europe interacting with people about potential partners, etc. So, John?
Yeah, the...
The partnering area is still...
Somewhat.
Speaker Change: 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 Gadipton. You know, the
Speaker Change: The O4S1 is a little harder for some people to get their hands around because of all the political noise around it.
Speaker Change: and that, you know, it's not a big issue if the pandemic's passed. But once we can engage them and explain that, yeah, it's passed for the healthy individual, but not for the immunocompromised individual. These are still the people at risk.
Speaker Change: They then begin to engage and understand that there is potentially a commercial opportunity present here for them.
Speaker Change: So I would say that, you know, people are engaging, they are interested in GADEPT, and clearly O4S1, 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 about finding that match.
Thank you.
Also, yeah, I think, okay, go ahead.
I was just going to add, Jim, that the...
Speaker Change: It was surprising from some quarters to hear of the interest because of the need and the lack of...
Speaker Change: access to Impox vaccine, so to the existing MVA, and so we had people pointing out that in their particular region of the world, their location is all they'd be very interested in and have asked us to keep them updated as we progress with the GeoMBA.
Speaker Change: Yeah, I was thinking, too, the, you know, Pfizer putting $2.3 billion in the quarter of VaxLavid, much as interest may have waned on Wall Street on COVID. COVID hasn't gotten tired of us.
No. No. No.
Speaker Change: You know, you know, there's another thing that might be worth mentioning and that is that you know There was a recent publication out of the Fred Hutch Highlighted the fact that that the clinical trials for the COVID vaccines have traditionally avoided enrolling immunocompromised patients
Speaker Change: And, you know, given that the need is so great in that population.
Speaker Change: 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.
Speaker Change: and we're hoping that 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.
Thank you for taking the questions.
Speaker Change: Thank you. Our next question comes from Jason Colbert with the Boyle Capital. Your line is open.
Speaker Change: Thanks guys. A couple of questions. I'm just wondering if you've 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?
Speaker Change: So I'll ask Kelly if he'd like to weigh in on that.
Kelly McKee: Yeah, we're certainly aware of that, you know, that it was launched and, you know, it's clearly offering benefit to these patients.
Kelly McKee: and the fact that the half-life of these antibodies is pretty much restricted by the nature of what they are.
Kelly McKee: And so, you know, one of the advantages that we think we're bringing to the table
Speaker Change: Yeah, I can't answer the exact strategy adjacent other than to say that we've got multiple tools in our tool Britain towboat now we've got we've recently installed <unk>.
Speaker Change: M facility.
Speaker Change: We've got ongoing conversations with multiple bankers.
Speaker Change: And we've recently.
Speaker Change: Been able to extract ourselves out of the.
Speaker Change: The baby shelf restriction.
Speaker Change: For selling shares under our under our shelf registration so we've got.
Speaker Change: A lot of opportunities here to efficiently raise capital with better terms that we've seen in the past and I'll kind of leave it at that.
Speaker Change: Okay fair enough. Thanks, so much for the update.
Speaker Change: Okay.
Speaker Change: Thank you. Our next question comes from Vernon Bernardino with H C. Wainwright Your line is open.
Speaker Change: Hi.
Speaker Change: And everyone else.
Speaker Change: Thanks for taking my question and I apologize for the granting us of this.
Speaker Change: Connection.
Speaker Change: I just wanted to ask.
Speaker Change: About.
Speaker Change: Are there any expenses.
Speaker Change: Costs do you think you may continue to incur regarding manufacturing materials for their clinical trials with <unk>, one and the BARDA contract.
Speaker Change: With.
Oxford biomedical manufacturing.
Speaker Change: Supply for you or is that something where you.
Speaker Change: The manufacturer supplier and you pay them, what kind of accounting treatment is as use there.
Speaker Change: Level of expenses.
Speaker Change: You incur there.
Speaker Change: Thank you Mark do you want to address those.
Mark: I'm trying to trying to answer the question as best I can.
Mark: Our relationship with Oxford, Biomedical, we have multiple task orders with them for various different.
Mark: Manufacturing campaigns for different different products.
Mark: And it is a I won't call it necessarily a bill as you go but.
Mark: There are.
Mark: Like the standard contract might be 40% upfront, 40% on a.
Mark: Certain milestone and then 20%.
Mark: Sure.
Mark: What you received reflected in our financials.
Mark: We've had some some heavy expenses during during 2024 for manufacturing campaign and most of much of that is there's going to be behind us now.
Mark: So we're in a good position.
Mark: Relative to the material for the BARDA.
Mark: Contract, that's going to be fully paid for by BARDA.
Mark: We pay for it but we can get reimbursement BARDA. So it's really a wash for us.
Mark: Much of that cost is still in front of us.
Mark: But it really doesn't affect us on a cash flow basis, except for a minor bit of working capital needs just mobile great on getting getting reimbursed from BARDA, which is quick.
Mark: Pay us within 30 days of.
Mark: When we submit the expenses.
Mark: So.
Mark: I don't know just does that sufficiently answered the question.
Speaker Change: Yes, just to clarify those.
Speaker Change: So if you were to be pay if you were to incur those expenses.
Speaker Change: Months could you repeat paid in December and not in January.
Speaker Change: If we.
Speaker Change: You, we would probably paid in January because we.
Speaker Change: <unk> Billboard on a monthly basis at the end of the month, so our cost incurred in November exempt for example.
Speaker Change: We if we pay for that right away or even if we don't pay for it with the expense comes in in November we submit our invoice to BARDA first week of December we get paid the first week of January.
Speaker Change: Great that's very helpful. I appreciate.
Speaker Change: Answering my questions and congrats on the process.
Speaker Change: Our progress looking forward to the Readouts in the coming weeks.
Speaker Change: Thank you Brian I appreciate it.
Speaker Change: Thank you. Our next question comes from Robert Leboyer with Noble capital markets. Your line is open.
Speaker Change: Good afternoon, and congratulations on a really great quarter.
Speaker Change: Just wanted to congratulate the whole team on all of the achievements that have been.
Speaker Change: Ported in the last quarter.
Speaker Change: Just applaud the progress that you've made in the face of.
Speaker Change: Some really difficult times in the past my question has to do with your debt.
Speaker Change: And the mentioned in the press release that the phase two we will have a single cycle will be a single cycle trial.
Speaker Change: And pathological response rate will be the primary endpoint.
Speaker Change: I was curious if you could expand a little bit about.
Speaker Change: The treatment.
Speaker Change: And whether a single cycle trial means single cycle of <unk>.
Speaker Change: <unk>.
Speaker Change: Standard dosing of the checkpoint inhibitor for one single cycle of Beach and if there were any specific pathological response endpoints that you could share at this point.
Kelly McKee: Thank you Kelly.
Speaker Change: Yes, I'll do my best.
Speaker Change: We have a.
Speaker Change: Clinical oncologists on staff, that's been sort of driving this.
Speaker Change: The design and.
Speaker Change: Prosecution to this program.
Speaker Change: So.
Speaker Change: Where we are is the single cycle refers to the single cycle the depth and the study will actually involve.
Speaker Change: Michael Godette, 10, plus plus which is ADP NP plus fludarabine.
Speaker Change: Along with a single cycle of <unk>.
Speaker Change: Followed by another psych.
Speaker Change: Cycle of embolism, and then followed by <unk>.
Speaker Change:
Surgery surgical resection of the tumor and observation for research.
So.
Speaker Change: It's.
Speaker Change: Again to answer your question directly it's a single cycle of.
The depth and plus Pembroke, but.
Speaker Change: We are going to be two rounds of enbrel given prior to surgical resection.
Speaker Change: Now the endpoints we are looking for.
Speaker Change:
Speaker Change: Complete response, but we're also going to be.
Speaker Change: Monitoring for.
Speaker Change: All sort of levels of pathological response.
The.
Speaker Change: Our comparator is a recently completed trial with that looked at <unk> alone.
Speaker Change: As neo adjuvant treatment for these.
Speaker Change: This class of patients in which they were there is simply no complete responses seen.
Speaker Change: We think we've got a pretty good shot at.
Speaker Change: Demonstrating something thats better than what the current standard.
Speaker Change: Offers in that regard.
Speaker Change: Okay, Great. That's very helpful. Thank you.
Speaker Change: Thank you.
Last question comes from Karen Goldfarb with Crystal Research Your line is open.
Thank you, it's actually Jeffrey Cros.
Speaker Change: I wanted to ask for my questions have already been answered, but I wanted to ask.
Speaker Change: The durability, because obviously immuno compromised patients address this before there's so many immunocompromised patients in immunocompromised children out there when you go to run your test for not only your.
Speaker Change: Your clinical trials.
Speaker Change: The push to include immuno compromised patients how big of an effort is that on your behalf and the second part is obviously.
Speaker Change: All the vaccine platform sure working on durability, and having the differentiation of having T cells activated and having the T cells educated and learn to go after the virus as it replicates.
Speaker Change: Along do you plan on conducting those studies and links to try and show that your product is more durable.
Speaker Change: Kevin.
Speaker Change: So.
Speaker Change: Sorry, I had to get myself off of <unk> I'm.
Speaker Change: I'm sorry.
Speaker Change: So the.
Speaker Change: Dan to answer your first question our immuno compromised.
Speaker Change: Patient population is really our primary patient population target for CMO for <unk>.
Speaker Change: And that's where we put the majority of our effort.
Speaker Change: Besides the BARDA trial, obviously.
Speaker Change: In our development programs.
Speaker Change: The the durability question.
In an ideal world wed like to see us being able to reliably measure durability over at least the one year period and we're following all of our patients in our trials for one year after.
Speaker Change: Following their first dose of vaccine.
Speaker Change: What complicates that is the virus continues to sort of be very prevalent.
Globally.
Speaker Change: And there is there continue to be.
Speaker Change: Ongoing in Texas in these patients and so when.
Speaker Change: When we're trying to differentiate natural infection from a vaccine induced immune response.
Speaker Change: Immune response to a national infection from net.
Speaker Change: Just by vaccines and patients that are getting infected.
Speaker Change: Of course, a follow up it becomes very difficult.
Speaker Change: And so.
Speaker Change: We were very interested in the in the we know we're seeing breakthrough infections, we're not seeing any severe breakthrough infections to date.
Speaker Change: And we're very interested in following the intensity of infections that will be occurring in these patients.
Speaker Change: But trying to trying to sort of sort that out or immunologically.
Speaker Change: It's kind of a challenge for us, but we're working on we're trying.
Speaker Change: Trying to be trying to come up with some workarounds.
Speaker Change: Great I appreciate that and last question I have is.
Speaker Change: Referring earlier to the 10000 patient study when we were talking about we werent sure. When the first patient is going to be enrolled.
Speaker Change: When you look at the timetable after the first patient was rolled what is the timetable that you have right now that you're planning to see to get those 10000 patients all enrolled.
Speaker Change: The current the current thinking is it will get all of those.
Assuming we start this trial when we think we're going to start this trial, which is again beginning of October 2025.
Speaker Change: We should be able to enroll this fully enrolled this study within six months.
Speaker Change: That's the discussion that we have with our CRO solution as well as with BARDA and Thats kind of where we're thinking.
Speaker Change: Great. Thank you very much and thank you for the transparency it's appreciated.
Speaker Change: Okay.
Speaker Change: Thank you. 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 our members of our team who have been so helpful. In answering these questions but.
David Dodd: But we've had the opportunity to review our achievements of our progress as well as our outlook.
David Dodd: We strongly believe that Q3 represented continued and significant progress in the <unk> development as a result of the project next Gen Award our decision to proceed with an expanded codec in phase II clinical trial, and our progress with Geo MBA as well as the advance on VA manufacturing process.
David Dodd: These are our priorities these represent our focus.
David Dodd: <unk> is greatly appreciated and we look forward to ongoing interactions as always I'd like to acknowledge and thank the <unk> board of directors and advisors, 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 <unk>.
David Dodd: Positive quality oriented individuals seeking disrupt the current paradigm of cancer therapies in infectious disease vaccines, we like doing that we're most proud and appreciative of our team, including those external partners who contribute tenure.
David Dodd: Turning to contribute to the progress and success underway at <unk> for.
David Dodd: 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 for infectious disease vaccines.
For today have a safe enjoyable day and thank you again for your support and interest.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.