Good afternoon, and welcome, everyone, to the GeoVax Fourth Quarter 2023 Corporate Update Call. My name is Desiree, and I will facilitate today's call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Chief Financial Officer; Dr. Mark Newman, Chief Scientific Officer; Dr. Kelly McKee, Chief Medical Officer; and Dr. John Sharkey, Vice President, Business Development. As a reminder, this conference is being recorded. At this time, I am turning the call over to Max Gadicke of SternIR.

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 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 and necessaries to be licensed and marketed. GeoVax raises the required capital to complete the 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'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.

Good afternoon, and thank you for joining the GeoVax corporate update call. Last year, particularly in the fourth quarter, we made significant progress in our developments, concentrating on two Phase 2 clinical stage products while also advancing other vital initiatives. Today, we will review the status and plans for Gedeptin, which is being developed as a treatment for advanced head and neck cancer, as well as GEO-CM04S1, our next-generation COVID-19 vaccine. Our objective is to create innovative therapies for cancer and vaccines for infectious diseases, addressing critical unmet medical needs while targeting initial indications that facilitate expedited registration pathways. We foresee worldwide development, commercialization, and distribution through business partnerships and collaborations. After my remarks, Mark Reynolds, our CFO, will provide a financial update, followed by a Q&A session. By the end of the year, we announced the completion of enrollment for the Phase 1/2 trial of Gedeptin among patients with advanced head and neck cancer. This specific group of patients includes those in end-stage care, comprising approximately 15,000 individuals in the U.S. and around 400,000 globally, representing a significant unmet medical need. Many of these patients struggle with swallowing and speaking, having often exhausted existing therapies and standard care options, and are currently receiving palliative treatment. Our aim is to enhance their quality of life by shrinking or eliminating targeted tumors and to provide clinical evidence supporting the advancement of this therapy for earlier-stage diseases. The trial was funded by the FDA through the Orphan Drugs clinical trials program. Last July, we presented initial clinical data at the AACR AHNS Conference in Montreal, highlighting that Gedeptin was shown to be safe and feasible, resulting in the stabilization and/or reduction of treated tumors. We expect to share final results from this trial in the first half of 2024, along with our plans for further evaluation of Gedeptin in patients with advanced head and neck cancer. Our approach also includes the use of Gedeptin therapy for earlier-stage HNSCC with less tumor burden, potentially in a role similar to neoadjuvant or cytoreductive radiotherapy combined with checkpoint blockade inhibition. We anticipate discussions with the FDA in 2024 regarding a faster path to registration. The extensive range of unmet medical needs in oncology provides significant opportunities for GeoVax to implement innovative approaches to meet various cancer patient requirements globally. We characterize Gedeptin as tumor-agnostic, meaning its mechanism of action allows us to address various solid tumors, whether malignant or benign. We hold global rights to all indications of this technology and are engaging in various oncology and partnering conferences to present clinical data and pursue potential collaborations. The GEO-CM04S1 COVID-19 vaccine is designed to offer a more practical, public health-friendly solution compared to currently approved vaccines by prompting a robust and lasting immune response across multiple virus variants. It targets both antibody and cellular immune responses, utilizing a proven safe and effective replication-deficient vaccine delivery system. This aspect is especially critical for high-risk immunocompromised populations who may not be sufficiently covered by existing vaccines and monoclonal antibody therapies. The immune profile elicited by GEO-CM04S1 also makes it a promising heterologous booster for existing mRNA vaccines, potentially providing a stronger response against emerging variants without the need for constant reconfiguration that mRNA vaccines require. We currently have three Phase 2 clinical trials underway for CM04S1, two of which focus on high-risk immunocompromised patients. The third trial evaluates our vaccine as a booster after prior mRNA vaccination. We aim to show that our COVID-19 vaccine addresses the urgent unmet needs of millions of immunocompromised individuals while proving to be a more effective and long-lasting universal booster for authorized vaccines. In September, we completed enrollment in our Phase 2 trial evaluating CM04S1 as a booster for mRNA vaccines, which involves 63 healthy adults who had previously received either the Pfizer or Moderna vaccine. The study measures immunological responses, including neutralizing antibodies against various SARS-CoV-2 variants and specific T-cell responses. Earlier this month, we reported positive interim findings from this trial, indicating no serious adverse events and statistically significant increases in neutralizing antibodies against multiple variants of SARS-CoV-2, from the original Wuhan strain to the highly virulent Omicron SBB 1.5, as well as strong cellular immune responses. Additional testing against the JN 1 variant, the current variant of concern, is already underway. We expect the final results from this trial in the fourth quarter of this year, reflecting the 12-month monitoring of the participants. In the U.S., approximately 15 million individuals are immunocompromised, but recent reports from JAMA indicate this number has risen to 23 million. Worldwide, estimates surpass 240 million. This population includes individuals with various blood cancers, renal diseases, autoimmune disorders like lupus, transplant patients, and others facing disease or therapy-induced immunosuppression. Many cannot adequately respond to approved mRNA vaccines, which places them at a higher risk of severe COVID-19 infections, hospitalization, and death. In 2023, initial data from our stem cell transplant trial were shared at several international conferences, including the World Vaccine Congress in Washington, D.C. We also published results in the peer-reviewed journal Vaccines in September, showcasing the vaccine's strong immunogenicity and ability to induce significant antibody and T-cell responses crucial for ensuring protection, particularly among immunocompromised individuals. Our findings emphasized CM04S1's capability to maintain protective immune levels from the Wuhan strain to the Omicron XBB1.5 variant. We started patient enrollments for this trial at the City of Hope Medical Center in California and have recently added more sites to accelerate recruitment. In addition to City of Hope, we now have four other actively recruiting sites, including the Fred Hutchinson Cancer Center in Seattle, University of Massachusetts Medical Center in Worcester, Wake Forest Baptist Medical Center in North Carolina, and Eastern Carolina Medical Center in Benson, North Carolina. While we are focusing on optimizing patient enrollment at these locations, we've observed significant interest domestically and internationally in participating in this study. Since the start of patient enrollment in the immunocompromised CLL trial last August, this investigator-initiated trial is continuing to recruit patients and has recently expanded to additional City of Hope locations. The trial aims to evaluate CM04S1 among around 80 CLL patients, directly comparing it with the Pfizer-BioNTech mRNA vaccine. Typically, these patients struggle to produce adequate protective antibodies following mRNA vaccination due to their underlying hematologic malignancy, leaving them at extreme risk of severe COVID-19. Many have been homebound for over three years since the pandemic began. We are hopeful that CM04S1 can provide these individuals the protection they urgently need from viral infections. Interim results from this ongoing trial are expected in the first half of 2024. In relation to developing CM04S1 for immunocompromised patients, we see an opportunity for an expedited regulatory path due to our focus on these high-risk, underserved populations. Now, let's discuss Project NextGen. In April, the White House launched a $5 billion initiative to build on Operation Warp Speed, seeking COVID-19 vaccines with improved variant protection and durability, particularly in novel candidates already in clinical trials. We believe CM04S1 exemplifies the next-generation COVID-19 vaccine that Project NextGen is focusing on. We are actively engaged in discussions concerning our formal participation in this program. From the $5 billion allocated for funding, over $3 billion remains unawarded. While we can’t provide details at this time, we assure you that we are in ongoing discussions and negotiations about the involvement. Lastly, concerning CM04S1, we are exploring partnerships and collaborations, along with additional clinical and research efforts to support worldwide commercialization and distribution. A number of active initiatives are underway in this area. Overall, we are addressing opportunities that could establish leadership in the targeted patient sectors and commercial markets. Our current clinical stage products, Gedeptin and CM04S1, focus on patient populations not served by existing therapies or vaccines. We are dedicated to achieving product leadership in meeting the therapeutic and vaccine needs of these groups. Additionally, our MVA vaccine against Mpox and smallpox aims to disrupt the existing global monopoly in this critical area, positioning us as the first U.S.-based supplier of such a vaccine. We are confident that we are on a path to generate significant value for our shareholders and stakeholders while delivering essential differentiated products to enhance lives around the world. Throughout this year, we will continue to provide updates on the progress and results of our CM04S1 Phase 2 programs. For Gedeptin, we expect to share final results from the current trial and outline our plans for an expanded Phase 2 trial. We also anticipate further plans related to evaluating Gedeptin in combination with immune checkpoint inhibitors. Regarding our MVA vaccine against Mpox and smallpox, we look forward to reporting our regulatory pathway and plans related to advancing that product toward registration. Additionally, we expect to share updates on our advanced MVA manufacturing process, aimed at enabling GeoVax to effectively produce and distribute MVA-based vaccines in response to real-time global market demands. In summary, our clinical stage products, Gedeptin, CM04S1, and MVA, address significant, unmet medical needs largely not served by current products and standard treatments. We are encouraged by the consistent positive results we are observing in our clinical trials. Furthermore, we believe that feasible expedited paths to registration exist for these products. From a commercial viewpoint, these opportunities represent an estimated annual revenue potential of nearly $30 billion in the U.S. This figure reflects the importance of addressing these critical needs rather than a sales forecast. Expanding these opportunities globally, through partners and collaborators, reinforces our confidence in the outlook for GeoVax, our shareholders, and stakeholders. Now, I will turn the presentation over to Mark Reynolds, GeoVax's Chief Financial Officer, to review our recent results and financial status.

Thank you, David. I'll start the financial review with our income statement. We had no active grants during 2023, so we reported no grant revenues this year compared to a small amount in 2022. However, as David has noted, we are having ongoing discussions with BARDA relative to Project NextGen. If an award were to be made, this would become a very important component of our financing mix going forward as well as a catalyst for other financing efforts, but there is no award to date, so these are definitely forward-looking statements. Research and development expenses were $20.7 million in 2023 versus $9.1 million in 2022, an increase of $11.6 million. This increase is primarily associated with the accelerated clinical trial activity for our CM04S1 and Gedeptin programs, including manufacturing costs for clinical trial materials. The increase also includes costs associated with the AGE1 cell line manufacturing technology licensed from ProBiogen, which will be important to the future commercialization and partnering activities for all of our MVA-based vaccines. General and administrative expenses were $6 million in '23 versus $5 million in 2022, with the increase mostly associated with higher legal and patent costs, investor relations expenses, consulting fees, and personnel costs. Interest income was $776,000 in '23 versus just $7,000 in '22 reflecting increasing interest rates available through our money market accounts. So overall, the net loss for '23 was $26.5 million or $14.29 per share versus $14 million in 2022 or $12.36 per share, again, with the increase being driven by clinical trial programs. Now to the balance sheet. Our cash balances at December 31 of '23 were approximately $6.5 million compared to $27.6 million at the end of 2022. The change in the cash loss is reflective of $25 million used in operating activities, partially offset by $4.1 million in net proceeds from the exercise of warrants in this past December. Outstanding common shares currently stand at 2.2 million following the reverse split we executed in January this year, which brings us back into full NASDAQ compliance. Funding our ongoing Phase 2 clinical programs for CM04S1 and Gedeptin will continue to be the most significant use of our cash for 2024. We don't expect this prioritization of our spending to change if we receive a Project NextGen award from BARDA as any incremental spending for that program will be funded by the award. We do expect to raise additional capital to fund programs in 2024, and we intend to do that in conjunction with positive news flow. I'll be happy to answer questions during the Q&A, and I'll turn the call back to David now.

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.

The first question comes from the line of James Molloy with Alliance Global Partners. Your line is open.

Hello. This is Laura Suriel on for Jim Molloy. Thank you for taking the question. So with the positive interim results that you already gathered for the Phase 2 trial of your COVID booster vaccine in healthy volunteers, do you anticipate similar efficacy against the newer JN.1 COVID variant? And what other findings might you be expecting from this trial once full top-line results are gathered?

Sure. Thank you. This is David Dodd. Thank you for your question, and I'll make some comments, and then I'll ask Kelly McKee, our Chief Medical Officer, if he'd like to add. But we're very pleased with the initial results that we've seen. The trial is fully enrolled. It will be tracking these patients through September of this year, and then we'll see the final result. Right now, we have no reason to believe that our vaccine would not continue to address the variants, including JN.1, as it has all the others. But until our testing is completed, we have no data to support that statement. But we are very pleased that whereas the mRNA vaccines have had to be reconfigured as new variants of concern have emerged, such as Delta, the various Omicron, the XBB.1.5, etc., our vaccine, without any reconfigurations, continued to demonstrate strong protective immunity. We believe that's because of the dual approach of targeting both the antibody as well as the cellular immunity. But I'll ask Kelly if he'd like to add anything to that.

Thanks, David. I think you pretty much covered the waterfront on that one. Yes, we don't have any reason to expect that neutralization of JN.1 will be significantly different from anything that we've seen with the other Omicron variants we've tested. But the proof is going to be in the testing, and we'll have to wait until those test results come back.

Got it. And then also for your Gedeptin candidate, what additional indications might you consider for a combination therapy alongside immune checkpoint inhibitors? And do you currently have any clinical development plans for this program?

Kelly, would you like to address that?

This technology is expected to be effective across various tumor types. The way it works suggests that it should be applicable to any solid tumor. We are currently investigating which additional tumor types could be suitable for this treatment approach, extending beyond just head and neck cancer. We initially selected head and neck cancer due to several factors, including the ease of accessing these tumors for needle injections, which is an essential initial step in these treatment protocols. As we consider other tumors that might be suitable for needle injection, advanced breast tumors emerge as strong candidates. We are actively engaged in discussions with a team at Emory regarding a trial for Gedeptin in specific advanced breast tumor types. The design of the trial is still being discussed and any timeline for its commencement is still far off, but we are in conversations about it.

Got it. Thank you for taking the questions.

Thank you. Our next question comes from the line of Jeffrey Kraws with Crystal Research. Your line is open.

Thank you very much. The BARDA agreement for other companies has been extremely valuable in terms of market cap appreciation. When we looked at some of those other companies, the additions to their market capitalization based just on the increase in the stock price has been very powerful for them. How are things proceeding on that front, and do you believe they continue to proceed in the direction you would like them to?

Thus far, we're very pleased with the discussions. We'd love to have received an award letter yesterday or even today. That hasn't occurred. But they are very positive. They're encouraging. And we try not to speculate or give out specifics, but we certainly think that receiving an award will be very positive, and it certainly won't be negative. But we're not speculating what the range of that might be. But like everyone else, we're aware of the value of participating in and being selected for that program. And I'll just say that we have had continued ongoing discussions that, by and large, are most encouraging.

Okay. Thank you very much. And with regard to Gedeptin, we have not seen any other trials significantly advance in that area ahead of providing results that we've seen from your product. Is there any new technology that you see on the horizon that you feel poses additional threats? Or do you still feel as confident with your technology, as you have been, given the results you've been able to achieve so far?

I would say, and then I'll ask if either Kelly or Mark Newman wish to add anything, but I'm not aware of any other. There's a lot of work going on for head and neck cancer because that's an important area. There are over 70,000 new cases every year now, and we're seeing now 16,000 deaths. That latter is what we're addressing, at least, as our initial indication. I would say the advanced technology may well be the combination therapy of the Gedeptin technology in conjunction with the immune checkpoint inhibitors, that may be what would be the next-stage advanced technology. But our goal right now is to complete the evaluation of what we hope to be able to announce until yet this half and then to lay out our plans for moving forward and keep everybody updated. But we're not aware of any other technology that's directly competing with what we're focusing on right now. We see a lot of good ideas and approaches for earlier-stage solid tumors. In the end, they may very well be highly complementary. There may be synergy between those technologies and Gedeptin. If not, we can go to the next question.

Next question comes from the line of Robert LeBoyer with NOBLE Capital Markets. Your line is open.

I had a question on Gedeptin and the clinical trials. I was hoping you could just clarify a little bit of the plans. You had mentioned the expansion of the Phase 2 neoadjuvant and combinations with checkpoint inhibitors. Are these going to be separate trials that begin in sequence or arms of one trial? Or just any clarification on how you're looking at all of these potential combinations of Gedeptin?

Sure. I'll ask Kelly to pick up on this one.

Yes, you're highlighting the dilemma we face, and it's a topic currently under active discussion. We are encouraged by the results of our Phase 1 and Phase 1/2 trials so far, especially regarding the mechanism of action and how that translates into the responses we anticipated in these patients. The next question is what our next steps should be. We have formed an advisory committee made up of several head and neck cancer oncologists and surgeons, with whom we plan to meet at the end of April to discuss the most logical next steps. While, as David mentioned, there's not much competition related to our specific technology, this is still a very important issue.

I think Kelly is having some phone difficulties, but I believe he was indicating that, specifically with our technology, we don't see a lot of competition. But there is a lot going on that addresses solid tumors, and I would say, they're all novel, all good ideas.

With checkpoint inhibitors, should this be an add-on? Should this be a monotherapy to which we then overlay a checkpoint inhibitor? Should we progress into earlier-stage disease? All of these questions, I think, they're sort of interrelated, and we're going to be heavily reliant on the advice of our Advisory Committee to guide us into where we go next. But the short answer to your question is, we don't really know at this point in time.

Okay. Yes, that's totally fair. Relying on the head and neck surgeons who advise you is a good course of action. So I won't ask you to speculate, and I'll just wait for the update after you have that meeting with them.

Okay. Thanks.

In terms of the Mpox and the MVA manufacturing process, since that's not something where you have a clinical trial or presentation at the conference, are there any milestones or announcements that we should be looking for that would signal progress in the manufacturing process or toward the market in that program?

Yes. John Sharkey, would you pick up on that, please?

Sure. Robert, nice talking with you again. Yes, remember, MVA in our manufacturing environment is like a lot of our other vaccines. So as we move forward to implement our MVA production for our different vaccine candidates, such as CM04S1 and others at ABL, that platform will also be useful for MVA. Regarding specific MVA milestones, we remain highly confident and optimistic that there is an expedited pathway forward to bring an MVA vaccine for smallpox to the marketplace. We are advancing our discussions with regulators to map that out. I would expect that we would be updating the market once we have agreement on the plan towards registration. As always, you never get a yes, do this, and you'll get it, but you get agreement on how to move something forward. I would expect we would be bringing that forward and sharing with the market this year, probably even later.

Next question comes from the line of Jason Kolbert with Dawson James. Your line is open.

Hi, guys. Good seeing you recently. I'd like to ask you a little bit about financing. We're in a very tough environment for micro caps. They've been under a lot of pressure. How do you anticipate raising capital over the coming year?

I'll ask Mark Reynolds. I'll toss that easy-answer question to him.

The simple answer, Jason, is we'll raise funds opportunistically. Every biotech CEO will tell you we'll raise as much money when and wherever we can. We have said in our public filings that we've got cash runway through into Q2 of this year. So you could expect to see some fundraising activity within that time frame.

Can you narrow in with me on that time frame what you think might be catalysts that could help drive the stock?

It's going to be some continued data flow from the trials. It's going to be the most significant item, which is the elephant in the room: the Project NextGen award from BARDA. We can't count on that because that's definitely a forward-looking statement to say that we are contemplating that award, but we're very confident in that regard. I think that would be a significant catalyst for us to look at fundraising upon.

And remind me how big that award could be and whether that award goes beyond just like time and materials or if it's supply? Just can you go into that a little bit?

David, would you like to address that question?

No, you can go ahead with it. Thanks.

Yes. The type of award we anticipate may be a modest amount payable directly to the company. However, the overall value of the award could far exceed the direct amount we receive. You might refer to it as bio bucks. The benefit to the company could reach hundreds of millions of dollars. That said, this is a forward-looking statement, and we will need to wait and see when and if the award is granted and how it is structured.

It looks like a pretty important catalyst.

Yes, very much.

It is, Jason. Let me just add on. The way that these awards have been coming is that there's a direct award to the company, and that's for the planning of a Phase 2. And then if there will be a direct payment to the CRO that's going to be supporting the clinical program, and that can be $300-plus million in value. So when you see these awards announced, you'll see some of them will announce what they've received this initial award of $10 million directly, but the value that they're receiving is $350 million. So that's how it's been reflected in various press releases.

Next question comes from the line of Vernon Bernardino with H.C. Wainwright. Your line is open.

Hi, David and team. Thanks for taking my question. You probably saw that ACIP recommended persons over 65 years of age should receive an additional dose of COVID vaccine. Does the recommendation or any of the language from the meeting change your thinking as far as strategy, market opportunity, or priorities?

Not at all. If anything, it underscores where we differentiate. Because what has been going on is we've all noticed, and we're seeing reports from the CDC and others, that the famous efficacy of 95%, etc., seems to be more like about 50%, depending on how you measure efficacy. We're also seeing the durability, which is why we're having to see so many boosters continuously being added; the durability of the existing vaccines appears to be somewhere between two to four or two to six months. I mean, it just is not the durability versus what was originally communicated, which was that they would be good for a year. And yet, we're seeing right now, with the data that we're getting out of our trials, durability in excess of eight months. So we, right now, are seeing data that demonstrate that our durability is about twice that of what is being noted in the clinical use of the current vaccines. There are increasingly more and more publications and statements in addressing the needs of the elderly, depending on how you define the elderly, but also those with compromised immune systems. It's well accepted that that latter group of people have depleted immune systems because of various medical conditions, and they are at the highest risk of severe disease, hospitalization, and the risk of death. This is, again, where we see with our construct of coming in and having a strong focus on not only the antibody side, but also on the cellular side, given what we're seeing right now gives us a broader, almost very agnostic immune response but also greater durability. We think that as our product is progressing through its clinical trials, there is increasingly more and more evidence of why Project NextGen is such a critical program that the White House announced last year, because it recognizes that what is out there is inadequate in many ways.

Now as a follow-up, I didn't attend or view the proceedings. I didn't see any mention regarding immunocompromised individuals. Did you get any insight from the ACIP meeting about immunocompromised individuals and booster shots?

Not in the recent meeting, but it's been so well underscored by the CDC, WHO, and others that the highest-risk groups are those with compromised immune systems.

Okay. Yes. I'm definitely excited for that kind of clinical trial as well. Thanks for taking my question and my follow-up. Looking forward to the progress this year.

Thank you so much.

There are no further questions at this time. 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. We really appreciate your participation in this corporate update call and in joining us in sharing the achievements, progress, and our outlook. Indeed, your interest is greatly appreciated. I want to especially acknowledge and thank our Board of Directors and advisers and our GeoVax staff and many other parties that continue to support and advise us towards achieving success. In achieving our success, we're committed to providing meaningful career development opportunities for highly competitive, quality-oriented individuals seeking to disrupt the current paradigm with cancer therapies, infectious disease vaccines and redefining how success is defined in addressing various patient populations. For all of us, it's been a great pleasure serving our shareholders, our stakeholders and being part of this team. I wish everyone a safe evening and a wonderful rest of the week. Thank you.

It's now concluded. Thank you for attending today's presentation. You may now disconnect.