GOVX

Good afternoon, and welcome, everyone, to the GeoVax Third Quarter 2025 Corporate Update Call. My name is Sherry, and I will facilitate today's call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Vice President, 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. Please note the following: -- certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether GeoVax can develop and manufacture its product candidates with the 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 a 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's filings with the Securities and Exchange Commission, including those set forth at Risk Factors in GeoVax's Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. Please go ahead.

Thank you. Welcome to the third quarter 2025 GeoVax corporate update. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then we will address any questions that you may have. We remain confident in the continued progress and compelling outlook for our portfolio of GEO-MVA, GEO-CM04S1, Gedeptin and the game-changing MVA vaccine manufacturing process. Each of our product development candidates address critically important unmet health care needs, providing opportunities for expedited registration paths and strong opportunities to commercialize differentiated solutions supporting patient needs worldwide. We also anticipate that the advanced MVA manufacturing process will provide a game-changing advantage in production of MVA-based vaccines and therapies. We're experiencing increased partnering and collaboration interest from established industry players as well as increased interest from nondilutive funding organizations, including stakeholders addressing various areas of worldwide vaccine needs. In June, we announced the receipt of guidance from the European Medicines Agency, referred to as the EMA, providing an expedited development path for GEO-MVA, our vaccine candidate against Mpox and Smallpox. This is most encouraging news in that it provides the potential for GeoVax to achieve marketing authorization and revenue generation sooner, allowing us to bypass Phase I and Phase II clinical trials and proceed directly to a Phase III immuno-bridging trial. As a result of this news, we're experiencing increased interest and dialogue with various industry colleagues and stakeholders regarding potential partnering, collaboration and funding. Relative to GEO-MVA, we have initiated the fill/finish of clinical batch vaccine material. We anticipate having vaccine available for clinical evaluation early next year. We're pleased to note that in addition to product in support of our clinical evaluation, we plan to produce additional product in support of potential use in conjunction with various stakeholder discussions that are underway. We believe that GEO-MVA provides the potential to end the current monopoly of MVA vaccine supply, expanding the global supply of this critically needed vaccine, addressing both the needs resulting from epidemic outbreaks as well as the various stockpile opportunities worldwide. Significant government interest exists relative to U.S.-based supply chains versus the current overdependence on non-U.S. suppliers. The strong sentiment in favor of such onshoring initiatives is a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders, including the White House, Congressional Representatives, HHS, WHO, the International Vaccine Institute, the Africa CDC and others regarding our progress relative to cGMP clinical inventory of GEO-MVA. In fact, this was the subject of numerous discussions during our recent series of meetings in Europe in conjunction with the World Vaccine Congress Europe, BIO-Europe and individual meetings held in Geneva and elsewhere. Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. GEO-CM04S1, our multi-antigen vaccine against COVID-19 is increasingly recognized as a critically needed vaccine for use among the over 40 million immunocompromised adults in the U.S. as well as the over 400 million worldwide. Based on the clinical data results thus far, we believe that CM04S1 provides potential for demonstrating a more robust immune response against emerging variants, improved durability versus the first-generation single antigen COVID-19 vaccine and especially in addressing the immune protection among those patients with compromised immune systems. Our current CM04S1 studies are progressing, especially our focus on continued enrollment of severely immunocompromised patients with blood cancers who have received cell transplants and towards completion of the investigator-initiated Phase II trial among chronic lymphocytic leukemia patients. Both the hematologic cell therapy patients and the CLL patients represent the highest risk groups in need of reducing the risk of severe infection, hospitalization and the risk of death resulting from COVID-19 infection. For these individuals, the pandemic continues. Demonstrating the critically important value of CM04S1 among such immune-compromised patients remains our focus for differentiation from the first-generation COVID-19 vaccines. The medical need for a vaccine such as CM04S1 remains substantial for those with medical conditions that render their immune systems inadequate in responding to the first-generation vaccine. It's noteworthy that just recently, the Infectious Disease Society of America, known as IDSA, issued updated guidelines regarding COVID-19 vaccine among immunocompromised patients. These critically important guidelines are well exceedingly well with our development of CM04S1. During third quarter, multiple presentations of clinical results for CM04S1 were provided at the International Workshop on Chronic Lymphocytic Leukemia, the World Vaccine Congress Europe and the European Society of Clinical Microbiology and Infectious Disease. Each of these presentations resulted in additional and expanded discussions regarding potential partnering and collaborative developments. Let me point out, while such discussions tend to follow a somewhat tedious due diligence process, we are encouraged by the continued interest in CM04S1 as the leading multi-antigen COVID-19 vaccine in clinical development. Relative to our plans for a Phase II Gedeptin trial in head and neck cancer, the primary determinant of the timing to initiate the Phase II trial is the completion of necessary product manufacturing. That is underway, along with the continued clinical operations plans and the necessary regulatory aspects. Earlier this year, Dr. Marc Pipas presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the Phase II study. Peer-reviewed publication of this work is forthcoming in JCO Oncology Advances, so be on the outlook for this. Following the impressive results of the KEYNOTE-689 study presented at ASCO, we have modified the Gedeptin Phase II study protocol, changing the target population to first-line therapy, mimicking KEYNOTE-689 trials historical control. As such, our focus will be on evaluating neoadjuvant Gedeptin and pembro, offering meaningful efficacy and tolerability in patients with primary squamous cell carcinoma head and neck, who are being considered for surgical resection with curative intent. Our primary endpoint will be major pathological response. We believe that Gedeptin has the potential to address multiple solid tumors, especially via combination therapy, providing significant value long term. We also plan additional studies of Gedeptin addressing other solid tumors beyond head and neck cancer. In addition, we are engaging in various discussions related to potential collaborations in the long-term development and commercialization of Gedeptin. Overall, 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 business partnerships and collaborations in support of worldwide development, commercialization and distribution. Our priorities and anticipated milestones for 2025 through 2026 remain focused on advancing GEO-MVA to clinical evaluation, advancing GEO-CM04S1 for immune-compromised populations, advancing the progress of the advanced MVA manufacturing process and our focus on oncology, specifically related to Gedeptin is a major priority for the future of GeoVax. We have high expectations for the potential broad utilization of Gedeptin against various solid tumors, especially in combination with immune checkpoint inhibitors. We also are focused on progressing various partnering and collaboration discussions in support of these developments with the potential to accelerate the pace of these programs. 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. Now I'd like to turn the presentation over to Mark Reynolds, GeoVax Chief Financial Officer, for a review of our recent results and financial status. Mark?

Thank you, David. And the details of our third quarter financial results are summarized in today's press release. I'll start the review with our income statement. During the 9 months ended September 30, 2025, we reported revenues of $2.5 million versus $3.1 million in 2024. This relates to the BARDA Project NextGen contract that began in June 2024. And as we previously discussed in our Q1 earnings call this year, in April, the contract was terminated along with other Project NextGen funded contracts as part of the government's efficiency program, so there were no contract revenues reported during Q3. Research and development expense for the quarter was $5 million versus $7.4 million in 2024. For the 9-month period, R&D expense was $15.1 million versus $16.1 million in 2024. The decrease during 2025 is primarily related to discontinued costs associated with the termination of the BARDA contract as well as lower costs for the CM04S1 clinical trials and manufacturing costs associated with the CM04S1 and Gedeptin programs. These lower costs were partially offset by higher personnel and consulting costs and manufacturing costs associated with the GEO MVA development program in preparation for initiating clinical trials in 2026. General and administrative expense was $1.3 million for the third quarter of '25 versus $1.2 million in '24. For the 9-month period, G&A expense was $4.6 million versus $3.8 million in '24. The overall increase during 2025 is associated with higher personnel costs, investor relations consulting and other programmatic expenses and stock-based compensation expense. Other income expense was $151,000 for the year-to-date period in '25 as compared to $70,000 in '24, primarily reflecting higher interest income. So overall net loss for the quarter was $6.3 million versus $5.8 million in '24 and $17 million for the year-to-date period versus $16.7 million in '24. Turning now to the balance sheet. Our cash balances at September 30 were $5 million as compared to $5.5 million at December 31, '24, reflective of $16.5 million used in operating activities, offset by $16 million in financing transactions. Our outstanding common shares currently stand at $27.7 million. Supporting our clinical programs for the priority programs at CM04S1, GEO-MVA and Gedeptin will be the most significant use of our cash for the foreseeable future. We continue to explore various strategies to fund these programs through several valuation inflection points and also to extend our cash runway. These could include strategic partnerships, nondilutive funding or additional offerings of our common stock. And I'll be happy to answer any questions during the Q&A, 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 Dr. Mark Newman, Kelly McKee and John Sharkey, our Chief Scientific Officer, Chief Medical Officer and Vice President of Business Development, respectively. I'll now turn the call over to the operator for instructions on the question-and-answer period.

[Operator Instructions] And our first question will come from the line of Jonathan Aschoff with ROTH Capital Partners.

I was kind of curious, can you envision any kind of scenario, an outbreak type of scenario that would get MVA into the hands of governments? Is there anything that you can think of that would make that go commercial at least temporarily way before you would do any sort of clinical trials with it?

This is David, Jonathan. I wouldn't anticipate that prior to any clinical evaluation that such a situation would occur. We do believe there may be an opportunity as well as a significant need for emergency use licensing, which would come through WHO based on certain situations occurring. And some of those types of discussions were part of our recent trip in Europe that we had with WHO and other parties.

Okay. I think that's really all that I had. The Q will come out soon, yes.

Yes.

The 10-Q.

Yes, the Q is [Technical Difficulty].

Yes, I think came out at 4.

One moment for our next question -- and that will come from the line of Robert LeBoyer with NOBLE Capital Markets.

Congratulations on all the progress you've been making. I know it's probably a little early to talk about the collaborations specifically. But on the broad strategic level, is there anything that you can tell us about what you're thinking in terms of the collaborations or partnerships or anything like that, that would be helpful in determining what the prospects are for kind of business combination or partnership?

Sure, Robert. This is David. We hold worldwide rights for all of our product assets. And our plan and our focus is to register broadly on a global basis. It doesn't mean every single country, as you know, but broadly to register on it. And our initial thinking is that we would be able to handle North America, which would be the U.S. and Canada, but I would also underscore that we'll always listen to any proposal that a potential partner has. We are quite active in attending various conferences as we just did, both World Vaccine Congress Europe as well as BIO-Europe. BIO-Europe is largely a partnering-oriented conference. We attend that every fall as well as in the spring as well as obviously U.S. based similar types of conferences. So increasingly, our discussions related to potential partnering or collaboration, which would entail involvement of a partner as we develop it for a particular region, and you can sort of think through how certain rights would be distributed if someone was heavily focused in a certain region, the Pacific region, then they might be assisting us in the development process for their regulatory process, et cetera. So all of those types of concepts are actively discussed in meetings that we continue to have and have been having. And we're open to whatever makes sense from a win-win and from the basis of value for our shareholders as well as the stakeholders who are out there.

One moment for our next question. And that will come from the line of Jim Molloy with Alliance Global Partners.

This is Laura Suriel on for Jim Molloy. So for GEO-MVA, can you just talk a bit more about the collaboration you have in place with the University of Queensland and UniQuest for the needle-free administration method that you have for this vaccine? And also any research or manufacturing plans that you have in place here as well?

So we announced not too long ago that we were doing an evaluation in conjunction with the technology out of out of Vaxxas. And we believe it's very important and in fact, critically important for certain regions of the world to look at nontraditional delivery methods. And as you know, Vaxxas is a leader in the area of microarray patches. There's someone we've known for several years as well as other very good players in those delivery areas. And so we're evaluating it to see what the feasibility is relative to GEO-MVA. And as information comes actively -- in evaluation now, as information comes forward, we will make appropriate announcements of that. And so that's what we're doing within that realm of it. You asked a question, I think, about manufacturing. What was that? I didn't quite get it, please.

Just the manufacturing that you might have for this particular program for GEO-MVA?

GEO-MVA, I'm going to ask our executive lead for our GEO-MVA program, John Sharkey to address that. John?

So in regards to our manufacturing, as we've explained before, our lead here is to manufacture on the CEF platform, Chicken Embryo Fibroblast. That is the fastest pathway to registration and EMA has understood this. Our partner is, as we do with all our programs, we use CDMOs. And so we're partnered with Oxford Biomedica in the U.K. We are -- as David mentioned in the presentation, we're in the process of packaging our clinical supplies, and we are in active discussions with OXB to how we can expand the supply out of their facility as well in discussions with other potential manufacturers to add additional supply as we move -- when we move forward to commercialization.

[Operator Instructions] And our next question will come from the line of John Vandermosten with Zacks.

So you guys are working with CEPI, Africa CDC, WHO and others. What regions of the world are looking most supportive for your vaccine programs? And then what are their pathogens of greatest concern?

I think clearly -- and John, that from the perspective of GEO-MVA, it's obviously in the Southern Hemisphere, where you see endemic outbreaks. But then we're also seeing increasingly reports of Mpox and the new strain Mpox becoming evident not only in the U.S. but throughout Europe. But certainly, the concentration is in the Southern Hemisphere. And there's a significant interest from parties that relate to that. I mean we keep being encouraged and told by WHO leaders that this is not going away. It's going to continue to evolve. It's not going to get any better and that they really are in need of our supply contribution as well as the eventual shift to our AGE1, our suspension cell line, continuous manufacturing process for that. So I think from that standpoint, that's where that one is heavily concentrated, which sort of is intuitive. But it's on a broader basis. It's not just the stockpile needs, it will eventually also include the response in a more timely manner to endemic needs also. So we believe that. When it comes to our CM04S1, clearly, the most significant need are among those populations who have inadequate -- they have medical conditions that have rendered their immune systems, basically inability to appropriately respond to antibody stimulation. And for these people, as I mentioned, the pandemic continues. I mean, these 40-plus million adults in the United States, the estimated 400 million worldwide who have various medical conditions, blood cancers, kidney disease, diabetes, multiple sclerosis, lupus, et cetera, it goes on and on. These are individuals that their risk is not so much, for instance, to die of the blood cancer that they have or to be hospitalized from, it's more from an infection. That's where they're risk. And so that's where we see a broad interest for those parties that are caring for individuals who have such medical conditions. These medical practitioners, these medical health care groups, they are very interested in what our vaccine has the capability or potential to do and how can we move it faster. That's what we're always asked. And the answer is as a pre-revenue company, it's all about the balance sheet. The stronger our balance sheet is, the faster we can move something forward. Obviously, we're all looking forward to the Phase II trial with Gedeptin. And as we go forward with the implementation of that, evaluating Gedeptin along with pembro in first-line therapy, you're following mimicking the KEYNOTE-689 trial. So there's a lot of interest in that related to any parties that are following solid tumor cancers. So we get a question on all of these at various meetings. I would say right now, we have many more questions and interest because of the sense of urgency related to GEO-MVA. We spent a lot of time addressing that as well as opportunities with Gedeptin.

Okay. And my next question is on Gedeptin actually and the use of -- you mentioned that you're going to have it in combination with pembro. Do you think by the time this is approved, there'll be a biosimilar version of that available? And do you think that will help adoption?

I would say I really don't know because we may very well continue to develop Gedeptin across various immune checkpoint inhibitors. We have other players who have checkpoint inhibitors are interested in what we're doing. Obviously, we don't have the resources to do a blanket testing across all immune checkpoint inhibitors, but we do have potential interest, and that may evolve into some collaborative development opportunities. We've had some discussions, but I would be -- it would be incorrect for me to suggest that we're actively in discussions that are going to, within a reasonable time period, expand it to other ICIs. We have interest that's been expressed. We've had a few discussions, and we're certainly open to that and would encourage such discussions. But we'll just see how those discussions continue to evolve.

This concludes our question-and-answer session. I would like to turn the conference back over to David Dodd for any closing remarks.

Well, thank you, everyone, for participating in today's update. We really appreciate your interest, and we look forward to ongoing interactions. As always, I wish to acknowledge and thank the GeoVax Board of Directors and advisers -- certainly, our GeoVax staff and the many other parties who contribute toward our success. We're 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 welcome any and continued inquiries about opportunities at GeoVax. We're a small company, so we received many more inquiries than we have availability for, but we thank you for your interest. We're most proud and appreciative of our team, including those external partners who continue to contribute to the progress and success underway at GeoVax. For all of us, it's 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. And with that, I want to wish everyone a safe and enjoyable day. And again, thank you for your time and attention.

This concludes today's program. Thank you for participating. You may now disconnect.

Good afternoon, and welcome, everyone, to the GeoVax Second Quarter 2025 Corporate Update Call. My name is Michelle, and I'll facilitate today's call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Vice President, 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. Please note the following: Certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether GeoVax can develop and manufacture its product candidates with the 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 the development of its products. There is development of competitive products that may be more effective or easier to use then 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 and GeoVax's Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.

Thank you. Welcome to the Second Quarter 2025 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 that you may have. We remain confident in the continued progress and compelling outlook for our portfolio of GEO-MVA, GEO-CMO4S1, Gedeptin and the advanced MVA manufacturing process. Each of our product development candidates addresses critically important unmet health care needs, providing opportunities for expedited registration paths and strong opportunities to commercialize differentiated solutions supporting patient needs worldwide. We also anticipate that the advanced MVA manufacturing process will provide a game-changing advantage in production of MVA-based vaccines and therapies. Today, I'll start with the recent exciting updates regarding GEO-MVA, our vaccine candidate against Mpox and smallpox. In June, we announced the receipt of guidance from the European Medicines Agency referred to as the EMA, providing an expedited development path for GEO-MVA. This is most encouraging news and that it provides the potential for GeoVax to achieve marketing authorization and revenue generation sooner, allowing us to bypass Phase I and Phase II clinical trials and proceed directly to a Phase III immunobridging trial. In addition, we continue to engage in dialogue with various stakeholders that may result in emergency use distribution of GEO-MVA, prior to formal market authorization. Relative to GEO-MVA, we recently completed cGMP production and quality release of the clinical batch of vaccine material. We anticipate having vaccine available for clinical evaluation later this year. We are pleased to note that in addition to product in support of our clinical evaluation we plan to produce additional product in support of a potential additional use in conjunction with various stakeholder discussions that are underway. We believe that GEO-MVA provides the potential to end the current monopoly of MVA vaccine supply, expanding the global supply of this critically needed vaccine, addressing both the needs resulting from epidemic outbreaks as well as the various stockpile opportunities worldwide. I'll note the significant governmental interest exists relative to U.S.-based supply chains versus the current overdependence on non- U.S. suppliers. The strong sentiment in favor of such onshoring initiative is a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders, such as the White House, Congressional Representatives, HHS, WHO, the Africa CDC and others regarding our progress relative to cGMP clinical inventory of GEO-MVA. Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. We remain committed to GEO-CMO4S1, our multi-antigen vaccine against COVID-19, especially as a critically needed vaccine for use among the over 40 million immunocompromised adults in the U.S. as well as the over 400 million worldwide. Based on the clinical data results thus far, we believe that GEO-CMO4S1 provides potential for a more robust immune response against emerging variants, improved durability versus the first-generation single antigen COVID-19 vaccines and especially in addressing the immune protection among those patients with compromised immune systems. Our current CMO4S1 studies are progressing, especially our focus on continued enrollment of severely immunocompromised patients with blood cancers who have received stem cell transplants and on completion of the investigator-initiated Phase II trial among chronic lymphocytic leukemia or CLL patients, one of the highest risk groups in need of reducing the risk of severe infection, hospitalization and the risk of death. Demonstrating the potential superior value of CMO4S1 among immunocompromised patients remains our focus for development of differentiation from the first generation and other single antigen-focused COVID-19 vaccines. The medical need for a COVID-19 vaccine, such as CMO4S1 remains substantial for those with medical conditions rendering their immune systems inadequately responsive to the first generation and other single antigen vaccines, placing them at a continued risk for the severe disease, hospitalization and the risk of death. In fact, during second quarter, a second site located at the City of Hope facility in Orange County, California, the Lennar Foundation Cancer Center initiated CLL patient enrollment into this trial. We also believe that CMO4S1 provides the potential for a better booster to the first-generation single antigen vaccines. During the remainder of 2025, multiple presentations of clinical results for CMO4S1 will continue, including the recent presentations at the World Vaccine Congress, The Keystone Symposia and The European Hematology Association. Upcoming presentations in the remainder of this year include the International Workshop on chronic lymphocytic leukemia, The World Vaccine Congress Europe, The European Society of Clinical Microbiology and Infectious Disease and additional conferences underscoring the important potential medical value of this unique next-generation COVID-19 vaccine. We also expect that these presentations will continue to provide important catalysts for strategic partnership discussions. Relative to our plans for a Phase II Gedeptin trial in head and neck cancer the clinical operations plans, product manufacturing in support of the trial and the necessary regulatory aspects continue. During second quarter, Dr. Marc Pipas presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the Phase II study. Following the recent impressive results of the KEYNOTE-689 study presented at ASCO, we have modified the Gedeptin Phase II study protocol, changing the target population to first-line therapy, mimicking KEYNOTE-689 trial as historical control. As such, our focus will be on evaluating neoadjuvant Gedeptin and pembro, offering meaningful efficacy and tolerability in patients with primary squamous cell carcinoma of the head and neck who are being considered for surgical resection with curative intent. Our primary endpoint will be major pathological response. Relative to the initiation of this study, we anticipate that this protocol modification will still allow us to initiate the trial during second half 2026. We believe that Gedeptin has the potential to address multiple solid tumors, especially via combination therapy, providing significant value long term. We also plan additional studies of Gedeptin addressing other solid tumors beyond head and neck cancer. We are also engaging in various discussions related to potential collaborations in the long-term development and commercialization of Gedeptin. Overall, 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, registration, commercialization and distribution. Our priorities and anticipated milestones for 2025 remain focused on advancing GEO-MVA to clinical evaluation readiness, advancing GEO- CMO4S1 for immune-compromised patients, advancing the progress of the advanced MVA manufacturing process and on our focus on oncology, specifically related to Gedeptin, this is a major priority for the future of GeoVax. We hold high expectations for the potential broad utilization of Gedeptin against various solid tumors, especially in combination with immune checkpoint inhibitors. 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. 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 second quarter 2025 financial results are summarized in today's press release. I'll start the review with our income statement. During the 6 months ended June 30, 2025, we reported revenues of $2.5 million versus $301,000 in 2024. This relates to the BARDA project NextGen contract that began during June 2024. As we previously discussed during our Q1 earnings call in April of this year, the contract was terminated as part of the government's efficiency program, or DOGE, so we won't report any further revenues from this contract beyond Q2. But as a reminder, this is a cost reimbursement contract, with the majority of the contract earmarked for incremental spending. So the net impact of termination on our overall cash flow projection is less than $750,000 annual. Research and development expense was $10 million during the 6-month period in 2025 versus $8.7 million in 2024, representing an increase of roughly $1.4 million or 16%. This increase during 2025 is primarily associated with costs for the BARDA contract as well as our Gedeptin and GEO-MVA programs. Costs were partially offset by lower costs related to the GEO-CMO4S1 clinical trials. General and administrative expense was $3.2 million for 2025 versus $2.5 million in 2024, representing an increase of $686,000 or 27% associated primarily with higher investor relations consulting costs and stock-based compensation expense. Other income and expense was $96,000 in 2025 as compared to $31,000 in 2024, primarily reflecting lower interest income due to lower cash balances. So overall, net loss for the 6-month period in 2025 was approximately $10.7 million or $0.79 per share versus $10.9 million in 2024 or $4.68 per share. Turning now to the balance sheet. Our cash balances at June 30, 2025, were $3.1 million as compared to $5.5 million at December 31, 2024, reflective of $10.3 million used in operating activities, offset by $7.9 million in financing transactions. I'll note also that subsequent to June 30, we concluded a follow-on public offering in July of almost $6 million in net proceeds that bolstered our cash balances. Our outstanding common stock -- common shares currently stand at $25.2 million, reflecting the recent financing activity. Including our ongoing CMO4S1 clinical trials continues to be a top priority in terms of our operational focus. We've also accelerated plans for clinical trials associated with the GEO-MVA and Gedeptin programs. Supporting these clinical programs will be the most significant use of our cash for the foreseeable future. We continue to explore various strategies to fund the development programs through several valuation inflection points and extend our cash runway. These could include strategic partnerships, non-dilutive funding and additional offerings of our common stock. I'll be happy to answer any questions during the Q&A. And now I'll 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 Dr. Mark Newman, Kelly McKee and John Sharkey, our Chief Scientific Officer, Chief Medical Officer and Vice President of Business Development, respectively, I'll now turn the call over to the operator for instructions on the question-and-answer period.

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

I was wondering, regarding the new patch method to administer the MVA vaccine, is this what you now intend to use for the pivotal trial starting in the second half of '26? And the second part of that question is, is the making of enough vaccine product a limiting step that necessitates a 2H '26 start?

Jonathan, thanks for your questions. We do not intend to use the patch for the clinical program. It's a valuation of the micro array patch that we believe could potentially be a very important manner of delivering the vaccine in certain parts of the world, specifically obviously in the African continent regions. But we plan to utilize the standard vaccine and delivery of it. And that's why the vialing should be completed or were targeted to complete in the fourth quarter of this year.

Okay. And the 2H '26 start time, that's largely because you have to make the vaccine product itself, correct? That's the major step.

The vaccine is largely manufactured, I'll -- let me ask John Sharkey and perhaps, Kelly, if he'd like to add on, just to update you on the status of that, but we have product already produced. John?

Jonathan, thanks for the question. Yes. So I mean, what we announced in June is EMA, we presented to them a proposal that if we based on MVA being highly similar to the Bavarian Nordic, if we were to do an immunobridging study could -- and appropriate [ work ] could we bypass and they agreed. So we are now -- the statisticians are powering the study to what we would need to show noninferiority. We will prepare the clinical trials. We then need to submit the dossier to Europe to get approval to the CTAs to get them running. So I wouldn't say it's just drug availability, it's all the parts together to get that trial started in the second half of 2026. As you all know, there's a lot of moving parts that need to come together before you can inject your first volunteer.

Certainly. Mark, did you say $10 million R&D for the quarter? Did I hear that correctly? Is Mark there or anybody that can take that?

Yes, it was $10 million for the 6-month period.

Six months. Okay. I definitely did not hear that correctly. Then I don't have a follow-up on that, that's in line. When will you file the Q, guys?

The 10-Q was filed about 20 minutes ago.

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

Good afternoon, everybody. I had a question about the MVA trials. And in June when you announced that you would not need to do Phase I and Phase II and you would just do an immunobridging study. That was great news. And then you just recently made an announcement that mentioned a start in 2026, also great news. And my understanding, which was partially answered was that this was going to be compared against a Bavarian Nordic on the immunotherapy. And this was not this was not an immune response under the animal rule or anything like that. So it's going to be against the standard vaccine. Is that correct?

Sharkey, would you like to answer that?

Sure, I'll take it. Yes, you're right. So what we have proposed to EMA, and we have agreement with is we will do an immunobridging trial in otherwise healthy volunteers, comparing the immune response, non-inferiority of the immune response to GEO-MVA to the MVA-BN. The -- and we'll have supporting preclinical animal toxicology and other studies to support the equivalents. What we're not required to do is normally under the animal rules, one, demonstrate efficacy in an animal model, and we're not going to be required to do that. If we show equivalent immune response, the EMA has indicated that, that would be sufficient for consideration of the MAA.

Great. And since you're running the trial in the second half of '26, is there any U.S. action that could be taken as a result of the data from this? Or is this strictly for Europe?

David, do you want me to take that?

Yes, please.

Sure. So the data we have filed with the EMA, we will be running the trial in Europe and some African sites also to support discussions with the WHO. That data would be sufficient to have discussions with the FDA about approval. The other thing to always keep in mind and BARDA has said more than once in the presentation that when times are needed, they don't necessarily need a vaccine to be approved depending on what's going on in the world at any time. So would they consider using a vaccine that was approved in Europe and not the U.S.? You'd have to ask them, but they've indicated that if there was a pressing need, they would. But in regards to FDA that once we have agreement on all the final components of the clinical trial and everything else with EMA, our plans would be to engage with FDA and see where they would be willing to go with us, whether they would accept an immunobridging approach for approval in the U.S.

Okay. Great. And also had a follow-up question on Gedeptin. And the press release mentioned after the Keynote-689, you've made some changes and David mentioned some of those in the prepared remarks. One of the end points is going to be major pathological response. Can you elaborate on what those responses are and if there's a primary endpoint selected yet?

Let me ask Kelly to give you update on that trial and the plans for it. Kelly?

Yes. So with the caveat that I'm not an oncologist, so I'm going to sort of stumble my way through this a little bit. But major pathologic response is defined -- has been defined for the 689 study and it has to do with the -- obviously, the extent of response in the resected tumor tissue that's obtained during the trial. And for the standard of care and for the pembro alone, the major pathologic response was not very impressive. It was in the 0 to 40% to 20%, 30% range. So we think we've got a pretty good shot at bettering that with Gedeptin as an add-on to pembro in the neoadjuvant space. But our primary endpoint is going to be pathological, okay? We have a secondary endpoint that's going to be disease-free event-free survival after a year which we'll also be able to compare with the data from the 689 study. But that's kind of our overall plan.

Okay. And could you just repeat the changes that you made to the protocol. There was a mention of moving to first-line patients, and I didn't catch the rest of that sentence?

Yes. So the way that the study was originally designed was to treat sort of patients that had already sort of failed a first-line therapy and had recurrent disease after treatment. So this -- we're sort of moving up in the evolution of the disease in an individual patient, such that these are patients that essentially are getting treated for lesions that appear primarily as a result of the tumor. So it's first-line therapy that they've not received other treatments, except for the standard of care, which is post resection.

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

On the Gedeptin, is the start date for that second half '266 as well or is that...

That's correct. Yes, second half of 2026 is what we're targeting.

And what should we look for? I think the 36 is the -- looking like 36 patients before for the endpoint? And what's the sort of -- what's the thinking on the design of the trial at this point for size and duration and this sort of thing?

Kelly, do you want to take that?

Yes. We're still sort of refining those estimates, but we think it's going to be in the same range, 36 to 40 patients that will allow us to sort of demonstrate statistically improved performance over the pembro alone in the neoadjuvant space. And we think it's going to enroll fairly quickly, especially for first-line therapy. And we think that because, again, it's a pathologic endpoint, once these tumors are resected and examined, we'll have readouts. So we should have readouts from this trial fairly quickly after it begins enrolling.

All right, great. And how come not overall survival on the endpoint?

Well, I mean overall survival is a long-term follow-up. So that's [indiscernible] we will have 1-year event-free survival as a secondary endpoint.

And then what's the expectations for potential interim looks? Trying to get an idea of how to thinking about these trial -- this one in MVA, MVA starting in second half of '26 as well, what's the expectation for sort of getting to either an interim or a final look on that trial, too?

Well, so start off with Gedeptin, it's a Simon 2-stage design. So after the first stage, we'll have a statistical look to see where we are with that. So that's an interim look. And again, we are expecting this trial to enroll fairly quickly. So I can't give you a time estimate, but it should be a matter of a few months, we think. For the GEO-MVA, we won't look at that until we won't have an interim look at that until all of the patients are enrolled in the non-inferiority study. However, we also are going to be required to provide a number of subjects to expand the safety database. And so we'll be looking at the non-inferiority results in conjunction with enrolling -- starting the enrollment in the safety database portion of the trial. So again, depending on how quickly that enrolls, we'll have sort of an early look, if you will, before the entire study is completed.

Is there an expectation on '26 -- second half '26 start date potential, are we talking in 2029, 2030? I was just going to get an idea for what should be looking at as the outsider looking in here?

For the GEO-MVA study?

Yes, please.

Again, it all depends on the rapidity of enrollment. We -- because these are healthy volunteer subjects, we don't think it's going to take a long time to enroll. But there's so many variables out there that impact enrollment is really going to be hard to say. We are including a couple of African sites that we have confidence are going to enroll very quickly, so that's going to help our case. But I'm hesitant to give you a projected time line for that.

[Operator Instructions] Our next question comes from John Vandermosten with Zacks.

You guys have the COVID vaccine program with BARDA, which was set aside. But recently, you mentioned that there was a manufacturing proposal that's under active review with BARDA, what does this mean for your work with them?

I'll answer. So John, in 2024, BARDA announced through their RRPV program, a project next-gen clinical manufacturing program. We responded to that. That was in March of 2024. In the beginning of this year, we were notified that they hit -- between March and the beginning of 2025, there were no awards and basically no real response from BARDA. But in January, they informed some companies, thanks, but no thanks, didn't qualify. And then for others, such as ourselves, we were informed that they liked our proposal, it qualified for funding, but it would be dependent on funding becoming available. So that it would be placed and what they refer to as a basket, I'll call it a holding basket for 2 years, depending on funding availability. And that was intended to fund our AGE1 continuous cell line manufacturing process that we have underdeveloped. And our candidate product at that time was for the CM04S1, our COVID-19 vaccine. So that continues to be in the basket. And so it has been selected, but it's dependent on funding availability. And that's not just true for us, but none of them have been funding. And as you know, the early part from January of this year until -- through April, we saw the activities that have eliminated most of the products that were in for the Phase IIb clinical trial, ours being included, which we announced in April and all. So right now, the status of it is that we were awarded and selected for the manufacturing process to be funded. That's great news. The challenge is that they don't have the necessary funding at this stage. It's in this basket for a 2-year process. So that would be 2 years from January of this year. So we'll keep you appraised of it, but that's where it stands for us and everyone else that was in that program.

Okay. And then looking at the Gedeptin trial, you cited the recent study with KEYTRUDA and then successful in head and neck. And I wasn't quite sure if you had selected a checkpoint inhibitor to be in combination with. Is it going to be pembro? Or are you guys still considering which checkpoint inhibitor to combine with?

We're planning to use pembro.

Okay. And then shifting once again back to the COVID vaccine. With all the changes from -- in guidance for who and how to use the vaccine, how has that changed your efforts with your clinical trials and perhaps endpoints and design and things like that and how you interact with the agencies going forward with your COVID program?

Yes. Excellent question. We're asked that all the time. And our belief and our answer is that we actually think that what is coming out of HHS and what's being communicated relative to the targeted audiences for whom COVID-19 vaccines might be most appropriate, et cetera. It fits with us because it's clearly those who have compromised immune systems, from a variety of reasons. So we remain most focused on those populations. As you know, we have 2 Phase II trials. One is the investigator initiated. And as I mentioned during second quarter, the investigator initiated trial the CLL trial opened another site there in the Orange County, Lennar Cancer Institute part of City of Hope. So we think that increasingly, what we are hearing coming out of HHS, FDA, et cetera, in terms of utilization of COVID-19 vaccines and where they're most needed fits ideally, we're well aligned with what we're hearing. So we're continuing to focus on that, continuing to expand enrollment in our immunocompromised stem cell transplant patient population and adding more patients. Recall that we -- last fall, we announced the interim results for the CLL trial where they halted the Pfizer arm and have just continued with only ours. So the remainder of that trial is only utilizing a CM04S1. And our goal is to see that completed and it's around -- I don't have the latest update, but it's around 20 to 22, something like that, around 20 patients remaining to complete that trial. Our interest is seeing that completed as soon as possible. And then we'll evaluate it and depending on the data, we may sit down with regulatory agencies to discuss an expedited path for -- specifically for CLL patients.

I might also add that our vaccine is a 2-antigen vaccine, it's a multi-antigen vaccine, which is different from those that are currently available on the market.

Kelly makes an excellent point because we heard Secretary Kennedy in April acknowledge and discuss his preference or his belief that multi-antigen vaccines in particular areas of infectious disease needs are more appropriate than single antigen vaccines. And again, that aligns very well with us since we have a multi-antigen in this case, a dual antigen approach. And we believe that's what contributes to the performance of our vaccine, both in terms of breadth of protection, durability and also a utilization among immunocompromised populations.

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, everyone. Good questions for participating in today's update. Your interest is greatly appreciated, and we look forward to ongoing interactions. I want to acknowledge and thank the Board of Directors of GeoVax and our advisers, our GeoVax 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 are most proud and appreciative of our team, including those external contributors who continue to assist in the progress and success underway at GeoVax. For all of us, it is a great pleasure serving our shareholders and being a part of this team. Our overriding goal is to improve lives worldwide by our development and commercialization of novel critically needed cancer therapies and infectious disease vaccines. With that, I wish everyone to have a safe and enjoyable day. Thank you.

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