GeoVax Labs, Inc. (GOVX) Q4 2024 Earnings Report, Transcript and Summary

Good afternoon. And welcome everyone to the GeoVax Fourth Quarter Full Year 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’ll turn the call over to Max Gadicke of Precision AQ.

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.

Welcome to fourth quarter, full year 2024 GeoVax Corporate Update Call. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then we will address any questions you may have. 2024 includes several major events of the development of GeoVax , led by the BARDA Project Next-Gen Award, valued at almost $400 million, being announced during mid-June in support of GEO-CM04S1, our next-generation COVID-19 vaccine. This program is underway with confirmation of all study sites. Manufacturing and support of vaccine product is underway, and we continue our ongoing billing to BARDA. Relative to GEO-MVA, our vaccine candidate against Mpox and smallpox, during Q4 we completed cGMP product and quality release of the clinical batch of GEO-MVA. We anticipate having an available vaccine for clinical evaluation in the second half of this year. We are pleased to state that we have produced a sufficient amount of products to support the anticipated clinical evaluation, as well as additional products in support of potential additional clinical use in conjunction with various stakeholder discussions that we have underway. Relative to our plans for a Phase II Gedeptin trial, the clinical operations plans are underway as we complete the necessary regulatory aspects and product manufacturing in support of the trial. In addition, we are moving forward with our advanced MVA manufacturing process, utilizing our AGE-1 Master Cell Bank. This process is implemented, and we anticipate the ability to produce significantly more MVA-based vaccine material much faster, utilizing a flexible process to support local decentralized vaccine manufacturing, while reducing the manufacturing costs significantly. 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. Our priorities and anticipated milestones for 2025 remain focused on advancing GEO-CM04S1, especially relevant to Project NextGen. We remain in close contact with BARDA in support of plans to initiate the trial later this year or in early 2026. There is a clear need to fill the gap reflected in the first-generation COVID-19 vaccine, and we believe that GEO-CM04S1 has the potential, as well as expanded value, to fill this gap relative to the 40-plus million immunocompromised adults in the U.S. currently not served well by the authorized vaccine. Our vaccine uses 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, as well as among pregnant women. MVA is well-characterized, well-known, and accepted by regulatory authorities worldwide. There are essentially no outstanding questions pertaining to potential safety issues and uses within various critically important patient populations, which may not be the case for alternative vaccine technologies. Our vaccine platform, MVA, is also a standalone vaccine authorized for protection against Mpox and Smallpox. This is a unique feature with critically important clinical benefits, providing a significant differentiator for CM04S1, especially when considered as a potential COVID-19 vaccine in regions where Mpox is endemic. Finally, in addition to its benefits to immunocompromised individuals, we believe that CM04S1 has the potential for broader use as a heterologous booster to current mRNA vaccines, providing a durable and broad immune response against emerging variants. The intriguing possibility is that CM04S1 could, by virtue of this immune profile, reduce the need for the continuous vaccine reconfiguration that appears necessary with mRNA vaccines. In fact, the HHS press release announcing the Project NextGen award in support of CM04S1 specifically highlighted that our vaccine holds the potential for a COVID-19 vaccine that provides broader protection, meaning encompassing a wider array of variants and the potential for increased durability, in other words, longer lasting than that evidenced by the current authorized vaccines. Most important, we believe, is the value to immunocompromised patient populations who are currently not served well by the first-generation COVID-19 vaccine. Thus far, the clinical data from our Phase 2 studies is supportive of these potential next-generation benefits. Beyond the NextGen trial, 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 the prior receipt of an mRNA vaccine. 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. Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the tens of millions, if not hundreds of millions, on a global basis of immunocompromised patients, while also demonstrating the vaccine as a more robust, durable booster vaccine used in conjunction with first-generation vaccines. In 2025, we anticipate multiple presentations of clinical results for CM04S1 at various conferences, including the upcoming World Vaccine Congress, the European Hematology Association, the International Workshop on Chronic Leprosy and Leukemia, and the American Association of Immunologists, further underscoring the important potential medical value of this unique next-generation COVID-19 vaccine. These presentations can also serve as important catalysts for strategic partnership discussions. With the announcement of our Project NextGen Award and the progress in our Phase 2 clinical studies, our activities related to partnering and collaboration with CM04S1 have understandably increased. We believe that CM04S1 represents significant promise as a critically needed and important part of the COVID-19 vaccine armamentarium for public health worldwide. Turning now to GEO-MVA, our Mpox, Smallpox vaccine candidate. In August 2024, the WHO declared Mpox as a public health emergency of international concern, highlighting the critical global health threat posed by this highly virulent virus. As a result of the continued spread and contagious nature of the current Mpox variant, WHO has reiterated the global health emergency declaration in November of 2024 and even more recently on February the 27th of this year. Such a declaration of a global public health threat three times within six months underscores and emphasizes the significant global health threat posed by Mpox. GeoVax is well positioned and actively progressing GEO-MVA, intended to disrupt the current global monopoly in this important and critical area. Moreover, we believe that our efforts will establish GeoVax as the first U.S.-based supplier of such a vaccine, potentially resulting in our initial step to revenue generation. Increasingly, there appears to be significant government interest in U.S.-based supply chains versus the current overdependence on non-U.S. suppliers. The strong sentiment in favor of such onshoring initiatives remains a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders such as the White House, congressional offices, BARDA, WHO, the Africa CDC, and others regarding our progress towards having cGMP clinical vaccine produced and available for clinical evaluation and potential use. WHO has clearly underscored a critical need for expanded Mpox vaccine supply as a priority for WHO and other public health agencies worldwide. 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. Our strategic focus on oncology specifically related to Gedeptin remains a major priority for 2025 as well as the future of GeoVax. We have high expectations for the potential broad utilization of Gedeptin against various solid tumors, especially in combination with an immune checkpoint inhibitor. Last summer, we announced our plans to evaluate Gedeptin in combination with an 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. Our clinical operations plans for this trial are being finalized along with the regulatory aspects and necessary product manufacturing in support of the Phase 2 study. We also look forward to the upcoming Gedeptin presentation at the American Association of Cancer Research, or AACR. In addition, we're planning various animal validation studies further building a compelling basis of the potential value of Gedeptin addressing various solid tumors. We're confident we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. 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 status. Mark?

Thank you, David. The details of our full year 2024 financial results are summarized in today's press release. I'll start my review with the income statement. Revenues associated with our BARDA contract were approximately $4 million in 2024 versus zero in 2023 as the contract just began in June of this past year. This is a cost reimbursement contract, so our revenues directly correlate with billable personnel time and incremental expenses incurred. The total contract value to GeoVax is $26 million, but may increase to as much as $45 million. Note that a separate contract of $433 million was awarded to Allucent to conduct our trial. Those revenues won't be reported in our financial statements, but the funding will go directly to supporting our clinical trial. Research and development expenses were $23.7 million in 2024 versus $20.7 million in 2023, representing an increase of roughly $3 million, or 14%. The year-over-year increase is primarily associated with the cost of manufacturing clinical trial materials and other costs associated with the BARDA contract. Spending toward our Gedeptin and GEO-MVA programs also contributed to the increase. General and administrative expenses were $5.4 million in 2024 versus $6 million in 2023, representing a decrease of $600,000, or 11%, associated with lower stock-based compensation expense, patent costs, franchise tax expense, and a mix of other costs. Interest income was $173,000 in 2024 as compared to $776,000 in 2023, primarily reflecting lower interest income due to lower cash balances. We also reported $21,000 of interest expense in 2024, associated with a short-term bridge loan that was issued and retired during the year. So, overall, net loss for 2024 was approximately $25 million, or $4.82 per share, versus $26 million in 2023, or $14.29 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 December 31, 2024 were $5.5 million as compared to $6.5 million in the prior year, reflective of $24.7 million used in operating activities, offset by $23.8 million in financing transactions. Our outstanding common shares currently stand at $13.9 million, following recent financing activity. Supporting the BARDA contract, the NextGen award, continues to be our top priority in terms of operational focus and a significant use of our internal R&D staff, but it's important to keep in mind that this entire clinical program is fully funded by BARDA through the awards to GeoVax and to Allucent, our CRO partner. In terms of our funding needs, our current and planned clinical programs for CM04S1, Gedeptin, and GEO-MVA will be the most significant use of our cash for the foreseeable future. We continue to explore various strategies to fund these development programs through several valuation inflection points and extend our cash runway. These could include strategic partnerships, additional non-diluted funding, and additional offerings of our common stock. I'll be happy to answer any questions during the Q&A period, and I'll now turn the call back to David.

Thank you, Mark. My colleagues and I will now answer your questions. 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.

[Operator Instructions] Our first question comes from Jonathan Aschoff with ROTH Capital Partners.

Thank you. Good afternoon, guys. I got a few questions. I was wondering given the urgency of the Mpox threat, could you possibly be part of some sort of relatively near-term response by selling product without clinical testing? That testing that you said is now supposed to start around year-end ‘25.

Thank you, Jonathan. First of all, I jumped on the phone a little bit early there a minute ago, so I apologize to everyone. The answer is we don't know, and usually you cannot. But there is opportunity with the latitude of working with WHO through emergency use licensing and depending on the recognized need. Currently, there is a major need worldwide. In fact, Africa alone has stated repeatedly that they need 20 to 25 million doses right now, and it appears that the most they will be able to receive from the current supplier is no more than 5 million by yearend of this year. So that just underscores the critical importance of additional supply options. But keep in mind what we have done is we've produced more than enough product to support what we believe will be necessary for our clinical need, and then we have additional to use for additional clinical evaluation. Perhaps that could end up being to where we actually were able to deliver some and be able to book revenues, but time will tell on that, and we'll know more as we proceed through this year.

Okay. Sort of along that same line, how are you working with international partners, the EU regulatory agencies in low-income countries in Africa to maybe ensure in the not-too-distant future equitable vaccine access and manufacturing there?

Thank you. The whole issue of, I would say, equitable vaccine access on a global basis, especially in low-income countries, is a major factor on our focus and our discussions. We have been in discussions with representatives of Africa's CDC and health ministries in Africa with European colleagues, agents, regulatory agencies, et cetera, for over a year now, for a year and a half plus, and we continue to keep them updated. They're aware of where we are with our status, what we believe we may have, we haven't been specific with at this point in time, but we are keeping them very much updated. This includes the Africa Vaccine Manufacturing Initiative also, so just a note, UNICEF, UNICEF has an active RFP for funding and support, and we're in close contact with that organization, so we've been spending quite a bit of time over the last two years building these relationships, getting past the point of just getting to know one another, and then becoming much more substantive in our discussions with them.

Okay, and then lastly, David, what's actually needed to start the next Gedeptin trial? Is that still second quarter ‘25 to start enrollment, or really no guidance right now? Like, are you trying to maybe see if somebody else will fund it before starting it with your own funding?

No, basically what we're looking at is we're continuing to manufacture the product. We've had some issues with the cell line we had started with, and so we've been working on that. We have everything pretty much outlined, not fully outlined, but from the clinical trial operations. I believe we've selected our CRO at this stage, but it really is about advancing to have sufficient product supply. Investigators are identified, so we've got that, but we're looking now at probably more into, I would say, in the mid to latter part of next year that we would be initiating the clinical trial.

Okay. All right. So that's a substantial pushback. All right. Thank you very much, Dave.

Our next question comes from Robert LeBoyer with Noble Capital Markets.

Well, first, congratulations on all the progress you've made, and Dave, also congratulations on leading the company through what must have felt like the valley of death these past two or three years. My question has to do with the clinical trials and testing for MVA. The product is going to be tested in humans, but since this is a preventive vaccine protect, you can't test the protection by giving them the actual virus to see if it works. So could you just elaborate a little bit on how you're going to test efficacy and safety?

Yes. I'm going to call on Dr. John Sharkey, because he's also our executive lead for GEO-MVA, which is the Mpox or smallpox vaccine campaign. John?

So the standard, the typical rule has been previously that one dose non-human primates, and you showed efficacy in non-human primates. With animal testing, there's always a move to lower animals, but not as much as using possibly rabbits or ferrets or other things for different disease states. So we are having those discussions with the regulators. And again, they've not confirmed that we will need an efficacy trial in animals, but if we were, what animal would we use? The important thing here is that these are relatively short-term studies, so any animal studies we have to do, we could probably run in parallel with our clinical trials, because it's not a safety issue, it's an efficacy issue. So they would run in parallel, so even if they're required, they have no significant impact on the course of the clinical trial.

Okay, and when you run the clinical trial, any estimates at this point as to numbers of patients or endpoints?

Well, the endpoint is going to be an immunological endpoint. And as far as numbers, we are in an additional round of clarification with the regulators specifically on this question of what numbers we think we're going to need, and we're drafting the protocol as we speak. We're estimating it's going to probably be in the range of 400 patients or subjects, but that has to be, we have to reach agreement with the regulators on that. But based on our statistical, we're estimating in the range of 400 or so subjects would be required.

Okay, that's helpful. Thank you very much.

Let me ask also, Robert, as a follow-up to ask Dr. Kelly McKee just to comment on the regions in which we will plan to conduct the clinical program in support of GEO-MVA. Kelly?

Sorry, I forgot to unmute myself. Thanks, Robert. So our current thinking is we'll do this study probably primarily in Europe, Central and Eastern Europe, just because it's a low-cost area. But we're also going to have at least one trial site in Sub-Saharan Africa, sort of to address some of the potential questions that might arise around its immune response in African populations. As you know there's an approved MVA vaccine already, the Bavarian Nordics [Inaudible]. And our trial will be a non-inferiority study comparing immune response of our vaccine to that vaccine, which we anticipate should be non-inferior basically, so.

Our next question comes from James Molloy with Alliance Global Partners.

Hello, this is Laura Suriel on for Jim Malloy. Thank you for taking the questions. So, as mentioned, data readouts are expected later this year for the Phase 2 COVID-19 booster vaccine trial of CM04S1. So with this, when should we anticipate data readouts for the remaining two Phase 2 trials in immunocompromised patients, as well as any other timelines for these trials here?

Sure, I'll ask Kelly to provide the update on the plans in that area.

Okay, sure. So, the study that we have ongoing in our blood cancer patients that have received cell transplant therapies, we expect some readouts for that, to be disclosing some readouts from that, I should say, sometime during the early part, early to mid-part of 2026. We're in discussions about modifying the design of our studies in this population. And so that would sort of influence the timing of readouts on the currently enrollee trial. As for the CLL study, as you may recall, that's an investigator-initiated trial being conducted at the City of Hope Medical Center in California. They're in the process of opening up an additional City of Hope site beyond the main campus in Duarte. And just as soon as that site opens, we expect enrollment to proceed. And we're hopeful to have that study fully enrolled by the end of this year. There will be some presentations of the interim data. The study design was assignment two-stage design. And after the first stage, the DSMB met. And you may remember from our last call, the decision was made to proceed with enrolling only the CM04S1 arm and not the mRNA arm. And so there's going to be some presentations of that data at international conferences. And there's a publication being created for that data as well. So there's going to be information coming out about that trial, hopefully, before the end of the year.

Thank you. That's very helpful. And also, with all the uncertainty that's going on in Washington right now, particularly when it comes to pulling back on COVID-19 funding, how do you think these changes might affect the company moving forward, especially with the BARDA Project NextGen trial that's in place?

Sure. It's an excellent question. We've been receiving that question since probably even before the inauguration, as you might imagine. Pardon me. What we know is the following. We routinely are in touch with BARDA, including scheduled once-a-week call between our team and their team. It continues to be a very positive call, supportive call. We continue to provide what we're requested to provide in terms of our development side for the program and all. And so far, every indication we've had is business as usual. We're continuing to perform. There's been no direction to slow up. There's been no direction to change anything other than to move forward with a repeatedly underscored statement that we're to be able to start the clinical trial before yearend, so basically in Q4. So we're working, at this time, we're working off that assumption, and it would be our, certainly, desire to continue working on that assumption. And meanwhile, our CRO has confirmed all 80 sites that we need, so that part will be ready to go. And what we are charged with doing is all the regulatory filings, which we're doing on time. We filed some even, I think it was yet this week, if not the end of last week, to be prepared to be able to initiate the trial on schedule while we're working also with the manufacturing of the product. So can't be any more specific than that, but that literally is where we are. The discussions continue. We are aware that there have been a couple of pauses that have been incurred or been directed to occur, but so far, again, as recently as, I guess, today, our discussions are to continue with everything we're doing.

Got it. Thank you for taking the question.

Well, let me just add this one thing. I have no idea. No one knows because there's been no disclosure of why vaccines were asked to pause. And so, we're focused on what we're doing. What we do know is that our vaccine was selected to be in this program specifically, and this was, I mentioned this in my previous comments, but it was underscored by HHS or ISPRS’ press release that they issued at the time of the announcement, is the specific reasons we were selected is because thus far, our clinical data has demonstrated protective immunity across a much broader array of the emerging variants than what we've seen with the first-generation vaccine, meaning we don't have to continuously reconfigure them. We showed with our original construct from the Wuhan strain through the Omicron XBB1.5 without any revisions necessary, which wasn't true for mRNA. And then, secondly, our durability or how long does it last, our data has been indicating 8 to 12 months, which is about twice what we're seeing with the first-generation. And the desire stated for a next-generation COVID-19 vaccine was to identify vaccine candidates that have the potential to give more robust response against variants, so we feel at least so far, we've checked that off. And then, secondly, to improve upon basically the disappointing durability of three to six months that's been observed in the real world for the mRNA and I guess also the Novavax vaccine. And so, we continue to stay focused because of that and continue to have our discussions and continue to share information with BARDA. So, that's our working model. 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.

Thank you. And thank you, everyone, for participating in today's update, reviewing our 2024 achievements, our progress, and our outlook for 2025 as well as beyond. Your interest is greatly appreciated, and we look forward to our continued ongoing interactions. I always feel that we want to acknowledge and thank the GeoVax Board of Directors and Advisors, as well as our staff and the many other parties who 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're most proud and appreciative of our team, including those external partners who contribute and 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 part of this team. We appreciate their ongoing words of encouragement and support. Our overriding goal is to improve lives worldwide by our development and commercialization of novel, critically-needed cancer therapies and infectious disease vaccines. And with that, I want to wish everyone to have a safe and enjoyable day and evening. Thank you.

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