GeoVax Labs Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
November 12, 2024

Key Takeaways

  • GeoVax secured a BARDA Project NextGen award valued at almost $400 million to compare its MVA-based COVID-19 vaccine CM04S1 against an FDA-authorized mRNA vaccine in a 10,000-patient Phase 2 trial starting in 2025.
  • Announced plans to initiate a Phase 2 trial of gedepetintin plus a checkpoint inhibitor (pembrolizumab) in recurrent head and neck squamous cell carcinoma, with neoadjuvant dosing ahead of surgery and pathological response as the primary endpoint.
  • Advanced GEO MVA mpox/smallpox vaccine program with cGMP production of master seed virus complete, working seed virus established, and first clinical cGMP batch in production for release by year-end; initiated AGE1 master cell bank for scaled MVA manufacturing.
  • CM04S1 is in three parallel Phase 2 studies targeting high-risk immunocompromised populations and as a heterologous booster, aiming to demonstrate broader, durable immunity and support positioning as a heterologous booster to mRNA vaccines.
  • Q3 2024 net loss was $16.7 million (vs. $18.4 million in 2023) on revenues of $2.8 million, with a cash balance of $8.6 million at September 30, requiring additional financing to support ongoing clinical and manufacturing programs.
AI Generated. May Contain Errors.
Earnings Conference Call
GeoVax Labs Q3 2024
00:00 / 00:00

There are 13 speakers on the call.

Operator

Good afternoon, and welcome everyone to the GeoVax Third Quarter 20 24 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, Ph. D, Chief Scientific Officer Kelly McKie, MD, Miles per hour, Chief Medical Officer and John Sharkey, Ph. D, Vice President, Business Development.

Operator

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. At this time, I'm turning the call over to Max Gatica of Precision AQ.

Speaker 1

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.

Speaker 1

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.

Speaker 1

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

Speaker 2

It is a pleasure to welcome everyone to the Q3 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 Q3 included several major events in the development of GeoVax, led by the BARDA Project Next Gen award valued at almost $400,000,000 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.

Speaker 2

We're delighted to have been paired by BARDA with Elucent as our CRO for the Project NEXTGEN trial as Elucent is our existing CRO supporting our ongoing CMO for S1 and recently completed gedepitant clinical trials. In addition, during quarter 3, we announced plans to conduct a Phase 2 trial of gedepitant 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 Godeptin therapy has demonstrated an acceptable safety profile and sufficient tumor stabilization or reduction activity to support plans to advance clinical development of Godeptin in such an expanded Phase 2 clinical trial. Relative to GOMVA, our vaccine candidate against mpox and smallpox, we've continued to advance the program this past quarter from having the cGMP production of 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 AGE1 master cell bank being initiated.

Speaker 2

These activities represent significant progress and milestones for Gevacs. 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 Godeptin 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 adaptin 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.

Speaker 2

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 Godaptan 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're 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 $400,000,000 supporting GOCMO4S1 in a 10,000 patient comparative trial against an FDA authorized mRNA vaccine.

Speaker 2

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 Next Gen vaccine program. Let me note that our vaccine selection represents 1 of only 6 vaccines awarded under Project Next Gen. Already, all participating sites have been identified, selected by Lucent and manufacturing activities are proceeding in support of the study start during 2025. Our aim with CM04S1 is to provide a more practical public health friendly COVID-nineteen vaccine than that offered from the 1st generation approved vaccine.

Speaker 2

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 1st 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.

Speaker 2

That our vaccine platform, MVA, is also a standalone vaccine authorized for protection against mpox and smallpox is a unique feature with critically important clinical benefits providing a significant differentiator for CM04S1, especially when considered as a potential COVID-nineteen vaccine in regions endemic to NMOS. 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-nineteen, 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 2

The intriguing possibility is that GOCM 04S1 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-nineteen 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 CMO4S1, we anticipate partnering collaborations and additional clinical research efforts and in support of worldwide commercialization distribution. Active initiatives are underway in these areas.

Speaker 2

3 Phase 2 clinical trials are underway with CMO4S1, 2 of which address populations of immunocompromised patients at high risk for developing severe COVID-nineteen. 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-nineteen 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 and 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 GOCMO4S1 have increased.

Speaker 2

We believe that GOCMO4S1 represents significant promise as a critically needed and important part of the COVID-nineteen 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. GFX is well positioned and actively progressing GEO MVA, 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 1st U. S.-based supplier of such a vaccine.

Speaker 2

This may also provide GeoVax our initial step into revenue generation to the significant governmental interest in U. S.-based supply chains versus overdependence on non U. S. Suppliers. The strong sentiment in favor of such own sourcing initiatives remains a major national legislative focus and interest.

Speaker 2

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'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 2

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 reflection of the significance of the need to address these critically important areas of healthcare, 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 GeoVx, our shareholders and their stakeholders.

Speaker 2

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. Mark?

Speaker 3

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 Q2. During the Q3 ended September 30, we reported 2,800,000 dollars of revenues and $3,100,000 for the 9 month period. There were no comparable revenues reported during the 2023 periods.

Speaker 3

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 Gevacs is currently $26,000,000 but may actually increase up to 45,000,000 dollars And keep in mind that a separate contract of $443,000,000 was awarded directly to Elucent, the CRO that is conducting our trial. Those revenues won't show up in our financial statements. Research and development expenses were $16,100,000 during the 1st 9 months of 2024 versus $14,500,000 in 2023, representing an increase of roughly $1,600,000 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.

Speaker 3

General and administrative expenses were $3,800,000 for the 9 month period in 2024 versus $4,600,000 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 1st 9 months of 2024 was approximately $16,700,000 or $4.52 per share versus $18,400,000 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 $8,600,000 compared to $6,500,000 at December 31, 2023, reflective of $16,900,000 used in operating activities, offset by $19,100,000 in financing transactions along with changes to our non cash asset and liability balances.

Speaker 3

Our outstanding common shares currently stand at $9,400,000 following the recent financings. Going forward, supporting the BARDA Net Project Next Gen 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 GeoVx and to Elucin, our CRO partner. In terms of our actual funding needs, the gadeptan and CMO4S1 clinical programs as well as the development activities for the GEO MBA 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.

Speaker 3

I'll be happy to answer any further questions during the Q and A. And I'll now turn the call back to David.

Speaker 2

Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q and 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'll now turn the call over to the operator for instructions on the question and answer period.

Operator

We will now begin the question and answer session. Our first question comes from Jonathan Aschoff with ROTH Capital Partners. Your line is open.

Speaker 4

Thank you. Good afternoon, guys. I was curious regarding that AGE-one cell line for MVA 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?

Speaker 2

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.

Speaker 5

Phil? Okay. So there's a pretty standard process evaluation that we would go through. So in 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.

Speaker 5

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. But I could estimate that once we start throwing people at it, this was 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 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 expedite it if there's a reason to do so.

Speaker 4

Okay. Thanks for that. David, when might 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?

Speaker 2

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, analysis is being done and we're obviously urging the statistician to move faster rather than slower.

Speaker 2

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 hold over into early next year, but we're hoping that it will.

Speaker 4

Okay. The last couple are just, 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 trials, 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 MPONX?

Speaker 2

So let me ask John Sharkey, who also serves as our executive lead on the GOMDA, so to discuss that one and then I'll ask for Doctor. Key to Kelly to then address the Project NextGen study.

Speaker 6

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 MBA, then we recognize the SAIC 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.

Speaker 6

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 the they do not see a need for us to do the traditional pull tops Phase 1, Phase 2, Phase 3 for this asset given that it is MVA that ancestrally is very close to what is already approved and we are for the initial product introduction will be using the chicken embryo fibroblast platform.

Speaker 4

Okay. And so you wouldn't even have to do efficacy in animals?

Speaker 6

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.

Speaker 6

So it would not be at all rate limiting for us. The rate limiting will be running the immunological trial.

Speaker 4

Thank you. And just finally the next gen trial start timing?

Speaker 2

Yes, Kelly?

Speaker 7

Yes. Hi, Jonathan. This is Kelly. The right now we are projecting enrollment to begin around the 1st October, the early part of October, of 2025. That's being driven by the sort of manufacturing timeline.

Speaker 7

And that's kind of where we are.

Speaker 4

Okay. Thank you very much guys. Thank

Operator

you. Our next question comes from James Molloy with Alliance Global Partners. Your line is open.

Speaker 8

Hey guys, thank you very much. Looking up past the quarter, what are the sort of the next steps we should anticipate here in early 'twenty five for the primary vaccine trial, the CLL trial, the booster vaccine trial, all of which are putting out data end of this year early next. What 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 next steps or potentially in filing?

Speaker 2

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. Now remember that's an investigator initiated trial.

Speaker 2

We've always felt that it's such a high need immunocompromised population that there is an opportunity we believe for an expedited development process. We'll look at the results, we'll decide to do we want to go forward with the company sponsored trial and pursue that. That would involve also discussions in advance with the agency about our plans, etcetera, what the outcome might be. From the healthy volunteer trial is really we're seeking to see the final results from there when one thinks about it. Project NextGen is actually the expansion of that.

Speaker 2

It's a much larger trial. It's generally healthy, but it's a very diverse population type of study participants and also it's a comparative trial. Our stem cell transplant trial continues to add sites and the broma. And I guess I'd say with that, Kelly, would you like to pick up, add any other comments on sort of trials for CMO course 1?

Speaker 7

No. You've pretty much hit the high points. Just to keep in mind the healthy volunteer study, there's we're comparing 2 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.

Speaker 7

But as David indicated, we should have results of that by sort of sometime in the Q1 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, 2 additional sites to add to the 3 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.

Speaker 7

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 sort of recognize 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.

Speaker 7

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 give us a pretty should position us pretty well to go talk to the agency about the registrational pathway.

Speaker 2

Okay. Thank you.

Speaker 7

Okay. Thank you. And

Speaker 8

then on mpox and smallpox, a few folks 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? Who do you get to the finish line first there? What do you think it's somebody where you'll need multiple vaccines, different populations, what have

Speaker 2

you? John, do you want to pick up on that?

Speaker 6

Sure. So the benefit of I mean, there's 3 vaccines out there. There's ACAM2000 vaccinia, which is indicated as usable in healthy individuals. There's LC16, which was registered in Japan and that was tested in children. The vaccinia is a replicating virus.

Speaker 6

The LC16 is a minimally referred with the minimally replicating virus. Then there's MVA, which doesn't replicate. So the nice part about MVA, when you look at the WHO recommendation, it's recommended for healthy individuals, immunocompromised, pregnant women, lactating women, children as 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 MVA, so you don't have to worry about the patient's current health state. So we believe that the MVA will remain the preferred product in this space.

Speaker 6

The other ones were there and depending on need can be used, but our general sense of talking with people is that MBA 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 AGE-one platform, while we're going to that because the benefits of the AGE-one besides being more productive, it's also a suspended cell line, which will now allow us to implement manufacturing in currently built manufacturing, back to manufacturing facilities that typically handle suspended cell line. So that's how you change the paradigm in supply for these MBAs.

Speaker 8

Okay. The last question and the thank you for taking them. Could you talk could you characterize how the collaboration partnership environment looks currently? And then maybe just a mechanistic question, the top line, about $3,000,000 a quarter, is that we should anticipate until you get to the $26,000,000 or whatever the ultimate number comes to be for the BARDA contract? Thank you very much.

Speaker 2

Mark, Reynolds, do you want to touch on the financial first and then I'll address the partner?

Speaker 3

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 overage layered on top and the rest will come as the bills 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 the LUCENT, the CRO who had a direct award from Vartafone.

Speaker 3

I'm not sure if that answered the question, Jim.

Speaker 8

Just as we remodel that on this end, we sort of plug in about $3,000,000 a quarter roughly going forward to run through the $26,000,000 Yes. I think that

Speaker 3

for your model, I think that's a fair approach. It's a little uncertain on our end, but I think that that's how I model it for our internal cash flow projections.

Speaker 8

Great. Thank you.

Speaker 2

And Jim, regarding the question about the partnering environment, etcetera, 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 partnering, etcetera. So John? Yes.

Speaker 6

The partnering area is still somewhat difficult in the sense that M and 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 Godaptan. 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 with the pandemic's past.

Speaker 6

But once we can engage them and explain that, yes, it's past for the healthy individual, but not for the immunocompromised individual, these are still the people at risk. They then begin to engage and understand that there is potentially a commercial opportunity present here for them. So I would say that people are engaging. They are interested in adapting clearly O4S1. If we get the chance to tell them the story of where we see it fits, they will engage.

Speaker 6

And like anything else, it's safe to get in finding that match.

Speaker 2

Also Yes,

Speaker 9

actually, I would

Speaker 3

think go ahead.

Speaker 2

I was just going to add, Jim, that the it was surprising from some quarters to hear of the interest because of the need and the lack of access to MPOX vaccine, so to the existing MVA. And so we had people pointing out that in their particular region of the world, their locations, all they'd be very interested and have asked us to keep them updated as we progress with the GLMDA.

Speaker 8

Yes. I was thinking to the Pfizer putting in $2,300,000,000 in the quarter of baxlovid and much as interest may have waned on Wall Street on COVID. COVID hasn't gotten tired of us.

Speaker 6

No problem.

Speaker 7

There's 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're 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.

Speaker 8

Thank you for taking the questions.

Operator

Thank you. Our next question comes from Jason Kolbert with Deboer Capital. Your line is open.

Speaker 10

Thanks guys. A couple of questions. I'm just wondering if you've been watching the launch of Pembarta 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 2

So I'll ask Kelly if he'd like to weigh in on that.

Speaker 7

Yes. We're certainly aware of 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.

Speaker 7

And so one of the advantages that we think we're bringing to the with our vaccine is by stimulating a strong T cell response, we're enhancing sort of the memory response that these patients will develop to vaccination and will offer them a more prolonged protection against developing severe disease or worse. So I think Pimgara is certainly can be viewed as a competitor product in one sense, but it has advantages and disadvantages just like vaccines do.

Speaker 10

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.

Speaker 10

Can you talk a little bit about what the strategy is to kind of get across the next 12 to 24 months where it seems like you have multiple inflection points coming? Thanks.

Speaker 2

Thank you. So Mark, would you like to pick that up? I'll toss that to you.

Speaker 3

Yes. I can't answer the exact strategy, Jason, other than to say that we've got multiple tools in our tool belt now. We've got we've recently installed an ATM facility. We've got ongoing conversations with multiple bankers and we've recently been able to extract ourselves out of the baby shelf restriction for selling shows under our shelf registration. So we've got 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 2

Okay, fair enough. Thanks so much for the update. You're welcome. Thanks.

Operator

Thank you. Our next question comes from Vernon Bernardino with H. C. Wainwright. Your line is open.

Speaker 11

Hi, David and everyone. Thanks for taking my question and apologize for the graininess of this connection. I just wanted to ask a question about RDA expenses. What costs do you think you may continue to incur regarding manufacturing materials for the clinical trials with O4S1 and the border contract? And with Oxford Biomedica Manufacturing supply for you, is that something where you they manufacture supply and then you pay them?

Speaker 11

What kind of accounting treatment is used there and what level of expenses do you incur there?

Speaker 2

Mark, you want to address those?

Speaker 3

Yes. I'll 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've had some heavy expenses during 2024 for our manufacturing campaign and most of much of that is going to be behind us now.

Speaker 3

So we're 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 what we're waiting on getting reimbursed from BARDA, which is quick.

Speaker 3

They pay us within 30 days of when we submit the expenses. So

Speaker 2

I

Speaker 3

don't know, does that sufficiently answer the question?

Speaker 11

Yes. Just to clarify those. So if you were to incur those expenses this month, you would be paid in December and not in January? If we

Speaker 3

we would probably pay it in January because we bill BARDA on

Speaker 2

a monthly basis at the end

Speaker 3

of the month. So our cost incurred in November, for example, we not 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 1st week of December, we get paid the 1st week of January.

Speaker 11

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. Good.

Speaker 2

Thank you, Bhaj. Appreciate that.

Operator

Thank you. Our next question comes from Robert LeBoyer with NOBLE Capital Markets. Your line is open.

Speaker 9

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've 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 have a single cycle 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 dedeptin and standard dosing of the checkpoint inhibitor or one single cycle of each? And if there were any specific pathological response endpoints that you could share at this point?

Speaker 2

Thank you. Kelly?

Speaker 7

Yes, I'll do my best. We have a clinical oncologist on staff that's been sort of driving the design and prosecution to this program. But so where we are is the single cycle refers to the single cycle of gedepptin. The study will actually involve a cycle of gadeptan plus which is ADP and P plus fludarabine, along with a single cycle of pembrolizumab that will be followed by another cycle of Pembrolizumab then followed by surgery, surgical resection of the tumor and observation for effect. So, it's again, it's to answer your question directly, it's a single cycle of gedepatin plus pembro, but they're actually going to be 2 rounds of pembro given prior to surgical resection.

Speaker 7

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 recently completed trial with that looked at pembro alone as new adjuvant treatment for this class of patients in which there is essentially no complete response is 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.

Speaker 2

Okay,

Speaker 9

great. That's very helpful. Thank you.

Operator

Thank you. And our last question comes from Karen Goldfarb with Crystal Research. Your line is open.

Speaker 3

Thank you.

Speaker 12

It's actually Jeffrey Cross. I wanted to ask 4 of my questions have already been answered, but I wanted to ask, with the durability, because obviously immunocompromised patients, we've addressed this before, there's 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?

Speaker 2

Calum, you want to address that?

Speaker 7

Sorry, I had to get myself off on mute.

Speaker 2

Got you.

Speaker 7

So the Dan, to answer your first question, our immunocompromised patient population is really our primary patient population target for CMO4S1. And that's where we put majority of our effort beside the BARDA trial, obviously, in our development programs. The durability question, in an ideal world, what we'd 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.

Speaker 7

And so when we're trying to differentiate a natural infection from a vaccine induced immune response from a natural 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 or immunologically is kind of a challenge for us.

Speaker 7

But we're working on that. We're trying to come up with some workarounds.

Speaker 12

Great. Appreciate that. And the last question I have is referring earlier to the 10,000 patient study, we were talking about we weren't sure when the first patient is 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?

Speaker 7

The current thinking is it will 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, Elucent, as well as with BARDA and that's kind of where we're thinking.

Speaker 3

Great.

Speaker 12

Thank you very much and thank you for the transparency. It's appreciated.

Operator

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.

Speaker 2

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 GeoMVAX development as a result of the Project NextGen award, our decision to proceed with an expanded gadeptan 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.

Speaker 2

Your interest is greatly appreciated and we look forward to ongoing interactions. As always, I'd like to acknowledge and thank the GeoVac's Board of Directors and Advisors, our entire GeoVac 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 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 contribute can continue to contribute to the progress and success underway at GeoVax.

Speaker 2

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.

Powered by Quartr