GeoVax Labs, Inc.

Good afternoon and welcome everyone to the GeoVax first quarter 2024 corporate update call. My name is Mark 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, MPA, Chief Medical Officer, and John Sharkey, PhD, Vice President, Business Development. At this time, all participants are in listen-only mode and a question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. At this time, I am turning the call over to Matthew Adiki of Stern IR.

Thank you. Please note the following. Certain statements in this presentation 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 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'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.

Thank you, Max. Good afternoon and thank you for participating in the first quarter 2024 GeoVax corporate update call. During the first quarter, we successfully advanced our developments focused on our two Phase II status products, Godeptin, a unique therapy against solid tumors, and GEO CMO4S1, a next-generation COVID-19 vaccine. In addition, we also advance other critically important initiatives. Today, we'll discuss the progress, status, and plans related to Godeptin and CMO4S1. Our goal is to 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. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then your questions will be addressed. At year-end, we announced the closure of enrollment for the Phase 1-2 trial of gadeptin among advanced head and neck cancer patients. This initial targeted patient population represents those who are in end-stage care, the 17,000 in the U.S. and over 400,000 worldwide who unfortunately die each year as a result of head and neck cancer. Our goal is to obtain clinical evidence supporting advancement of this therapy including in patients with earlier stage disease. You'll recall this trial was funded by the FDA under the Orphan Drugs Clinical Trials Program. We expect to report the trial final results during this first half of 2024, followed by discussing our plans for further evaluation of gadeptin in patients with head and neck cancer, including a role similar to neoadjuvant or cytoreductive radiotherapy in combination with checkpoint blockade medications. We refer to Godeptin as tumor agnostic, meaning that its mechanism of action will enable us to address a variety of solid tumors, both cancerous and benign. We hold worldwide rights for all indications of this technology, and we're participating in various oncology and partnering conferences, and some of which we will present Godeptin clinical data with others to conduct partnering discussions. We recently convened our oncology advisors reviewing the clinical results to date, as well as further opportunities related to gadeptin and other monotherapy indications. Also addressed were combination therapy indications, gadeptin in conjunction with immune checkpoint inhibitors. We continue to anticipate discussions with the FDA related to a potential expedited path to registration. CMO4S1, our next generation COVID-19 vaccine, aims to provide a more practical, public health-friendly vaccine solution than that offered from the currently approved vaccines. We believe that this is achieved by stimulating a robust and durable immune response across multiple virus variants as a result of the induction of both the antibody and cellular arms of the immune system against multiple virus antigens. This is the key differentiation of our vaccine and the current authorized vaccines. Our vaccine utilizes a proven safe and efficient delivery platform, Modified Vaccinia Ancora, or MVA, which does not replicate in mammalian cells. This distinction is critically important in addressing the high-risk populations of immune-compromised individuals, for whom the current vaccines and monoclonal antibody therapies focused only on blocking or reducing virus infection are often inadequate. that our vaccine platform, MVA, is also a standalone vaccine authorized for protection against mpox and smallpox is a unique feature with critically important clinical benefits providing a significant differentiation for CMO4S1. In addition, we believe that CMO4S1 offers an immune profile optimal for more general use as a heterologous booster to current mRNA vaccines. providing a more robust, durable, and broadly functional immune response against emerging variants, potentially without the need for the continuous vaccine reconfiguration that appears necessary with the mRNA vaccines. Relative to CMO4S1, we anticipate partnering and collaborations and additional clinical and research efforts, and in support of worldwide commercialization and distribution. Active initiatives are underway in these areas. Let me now address our various clinical trials underway with this promising product. Three Phase II clinical trials are underway with CMO4S1, two of which address the high-risk populations of immunocompromised patients. The other Phase II trial evaluates our vaccine as a heterologics booster among healthy adults following prior receipt of an mRNA vaccine. Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the millions of immunocompromised patients while also demonstrating the vaccine is a more robust, durable booster vaccine when used in conjunction with mRNA vaccines. Starting with our healthy adult booster trial, last September we completed enrollment in this trial. The trial involves 63 healthy adults who had previously received the Pfizer and Moderna mRNA vaccine. The immunological responses measured throughout the year-long study provide both neutralizing antibodies against multiple SARS-CoV-2 variants as specific T cell responses. This past February, we reported positive interim data from this trial, indicating no serious adverse events and statistically significant increases in neutralizing antibodies against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5, as well as robust cellular immune responses. We plan to perform additional testing against the current JN1 variant. Final results from this heterologics booster trial are anticipated during fourth quarter of this year, reflecting the 12-month monitoring of these patients. In the U.S., there are approximately 20 to 25 million immune-compromised adults. Worldwide, there are an estimated 250-plus million. Such populations include those with various blood cancers, renal disease, autoimmune diseases such as lupus, transplant patients, and others with disease or therapy-induced immunosuppression. Many of these patients are limited in their ability to respond adequately to the approved mRNA vaccines. placing them at significant increased risk of severe COVID-19 infection, hospitalization, and potentially death. This is well documented in the medical literature, highlighting the need of a next-generation vaccine that addresses this critically important medical area. We believe that CMO4F1 is the leading next-generation vaccine in clinical development in support of the needs of immunocompromised patients. Also, we believe that an opportunity for an expedited regulatory path likely exists due to our focus on such high-risk, unserved and underserved immunocompromised patient populations. Encouraging data from our phase two stem cell transplant immunocompromised randomized trial comparing CMO4S1 against an mRNA vaccine have been presented at several international conferences. Preliminary results were published last September in the peer-reviewed journal Vaccines. The findings demonstrated robust immunogenicity, illustrating the vaccine's ability to strongly induce both antibody and T-cell responses, essential for conferring protection, particularly in immunocompromised individuals. The vaccine article also highlighted the unique feature of CMO4S1, providing immune responses across a spectrum of viral variants, again from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB 1.5 variant. We're continuing to expand this study to additional sites. Thus far, the data continue to demonstrate increased robust protective immunity and increased durability. This patient population represents one of the highest at-risk patient populations for severe disease, hospitalization, and the risk of death. Following the initiation of patient enrollment in the chronic lymphocytic leukemia immunocompromised patient trial last August, this investigator-initiated trial has continued to recruit and enroll patients. The trial is designed to evaluate CMO4S1 among approximately 80 CLL patients, directly comparing it to the Pfizer-BioNTech mRNA vaccines. Typically, these patients are unable to generate protective antibody responses following mRNA vaccine due to their underlying hematologic malignancy, placing them at extreme risk of developing clinically severe COVID-19. As a consequence, many of these patients remain homebound more than four years since the pandemic began. We are optimistic the CMO4S1 can offer these individuals the protection from this virus that they so desperately need. We anticipate that the required number of patients in support of an interim analysis will soon be reached and that the interim results will be available yet this year. Finally, I'd like to address Project NextGen. This $5 billion initiative to follow on from Operation Warp Speed is focused on accelerating the clinical development of COVID-19 vaccines with the potential for enhanced breadth of protection against variants and improved durability. being particularly interested in novel vaccine candidates already in clinical trials. CMO4S1 is a prime example of the desired next generation COVID-19 vaccine. We continue to have active advancing negotiations regarding the inclusion of CMO4S1 in Project NextGen, and we look forward to further updating you in the near future. We're addressing opportunities that provide us a basis for achieving leadership within differentiated patient areas and commercial markets. Our current clinical stage products, Godeptin and CMO4S1, are focused on patient populations currently underserved or unserved by existing vaccines and or therapies. GeoMVA, our vaccine against mpox and smallpox, is intended to disrupt the current global monopoly in that important area. providing us a leadership position as the first U.S.-based supplier of such a vaccine. This may also provide GeoVax our initial step into revenue generation due to the significant government interest in U.S.-based supply chains versus over-dependence on non-U.S. suppliers. The strong sentiment in favor of such on-sourcing initiative remains a major national legislative focus and interest, and we're well aware of it and very much involved in it. 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. During the remainder of this year, we'll continue to report progress and results from our CMO4S1 Phase 2 programs. For Godepton, we expect to report the final results from the recently completed trial and our plans for the expanded Phase 2 trials. We also expect to report further plans regarding next steps related to evaluating gadeptin as combination therapy used in conjunction with immune checkpoint inhibitors. Relative to our MVA vaccine against mpox and smallpox, we anticipate reporting our regulatory path and plans related to advancing that product towards registration. Finally, we anticipate further updates related to our advanced MVA manufacturing process targeted to enable Geovax to effectively produce and distribute MVA-based vaccines in response to real-time market needs. To summarize, our various clinical stage products, Godeptin, CMO4S1, and MVA represent critically important areas of medical needs, largely unserved or underserved by current products and standard of care. We are pleased with the consistent encouraging results we're seeing from our clinical study. Moreover, we believe that expedited paths to registration are feasible for these products. From a potential commercial perspective, these product opportunities represent an estimated annual U.S. revenue potential of almost $30 billion. I'll underscore that this isn't a sales forecast, but rather a reflection of the significance of the need to address these critically important areas of healthcare, both clinically and commercially. Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence we have relative to the outlook for GFX, our shareholders and stakeholders. Now I'd like to turn the presentation over to Mark Reynolds, GFX Chief Financial Officer, for a review of our recent results and financial steps. Mark?

Thank you, David. I'll begin with a brief review of our income statement. The first thing to comment on is we had no grant revenues or government contracts during the first quarter as we've reported in the past years. However, we are having advanced discussions with BARDA related to Project NextGen, and we are highly encouraged by the status of these negotiations. If an award were to be made through this program, this would be a significant catalyst for fundraising and will become an important component of our financing mix going forward. but I will emphasize that this is a forward-looking statement. There can be no assurance that such an award will actually be made. Research and development expenses were $4.4 million in the first quarter of 24 versus $2.8 million in 23, representing an increase of $1.6 million, or 57%. The year-over-year increase is primarily associated with the cost of conducting our clinical trials, including manufacturing costs for clinical trial materials currently being used and being used in the future. General administrative expenses were $1.5 million in the first quarter of 24, and were relatively unchanged from the amount reported last year. Interest income was $33,000 in the first quarter of this year, compared to $232,023, reflecting lower cash balances invested through our money market accounts. So overall net loss for the first quarter of 2024 was $5.9 million, or $2.5 $2.47 per share, versus $4 million in 2023, or $2.30 per share. Again, with the increase primarily being driven by the CMO4S1 and the Adeptum clinical trial programs. Turning now to the balance sheet, our cash balances at March 31st were $769,000 as compared to $6.5 million at the end of 2023, reflective of $5.7 million used in operating activities. There were no financing activities in the first quarter, but we do expect to raise capital in the very near future. I'll also note that as disclosed in our 10Q being filed today, our management team and board recently provided a modest amount of capital to the company through a straight debt structure in order to help bridge to our next capital raise. Our outstanding common shares stand at $2.3 million following the reverse split we exercised at the end of January this year, which brought us, the intention of that was to bring us back into full compliance with NASDAQ. Funding our ongoing Phase II clinical programs for CMO4S1 and Gideptin will continue to be the most significant use of our cash for the foreseeable future. We don't expect this prioritization of spending to change if we receive a Project NextGen award from BARDA as any incremental spending for that program will be funded completely by the award. Now, I'm happy to answer any questions during the Q&A, and 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 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 answer period.

We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before depressing the keys. To withdraw your question, please press star, then 2. At this time, we will pause momentarily to assemble our roster. Her first question comes from the line of Robert LeBoyer with Noble Capital Markets. Please go ahead.

Good afternoon. And my first question has to do with Gideptin. And you mentioned that there would be a data update coming shortly, and you had been in consultation with your advisors about the path forward with combinations of checkpoint inhibitors or monotherapy. Were there any other options that you mentioned? There were a few things that I thought I heard but wasn't exactly certain as to what pathway you were thinking about that.

So, Robert, I'll answer and then I'll ask Dr. McKee to step in. So, we recently met with our advisors, and thank you for your question, first of all, and that was to go through the, you know, the final results, et cetera, from the trial that was completed last year, year in. The focus that we have going forward initially will be on head and neck cancer, as we've done in that initial trial, and looking at it perhaps even an earlier stage. The combination therapy is when it definitely will be combined with the immune checkpoint inhibitors, but we will be looking at other monotherapy uses of adaptant against standalone solid tumors. Kelly, would you like to step in now?

Well, sure. I mean, I think you sort of hit the nail on the head. You know, our advisory committee sort of recommended a sort of a next step forward for the head and neck cancer program, sort of by focusing on a on a target population that they thought would yield more meaningful data in terms of sort of where we go. We would go beyond that in the head and neck cancer treatment population. At the same time, we're looking at other solid tumor types. I mean, we've got some discussions underway a group at Emory that's interested in looking at this in triple negative breast cancer patients. And we will be speaking with some people at Oxford University next week, in fact, about the potential for a study, so the basket trial and other solid tumor types. But those discussions are all very early on, early at this point, and probably no details worth sharing at this time.

Okay, well, thank you. That's very helpful. I also had a question on the MVA for smallpox and monkeypox and was wondering if there were any details that you could share about the steps or milestones between where you are today and potential revenues down the road.

Sure. I'll call on Jonathan. Sharkey to address that. He's leading our MBA program, standalone vaccine.

Oh, hey, Robert. Thanks for the question. So we continue to progress our MBA. We have begun the process of preparing the master seed banks and the working viral seed banks with our partner, Oster Biomedica, formerly was ABL in France prior to the merger. We are finalizing the submission to the appropriate regulatory agency. We've not disclosed our regulatory strategies just yet. With some additional questions on the process forward, we remain optimistic. There is an accelerated pathway forward for this program, but we have not at this point projected any final registration date or anything else. But we continue, as I said, to move efforts forward on both the supply front to have material available for any work, clinical work we have to do, as well as initial commercial launch supplies, as well as discussions with a regulatory authority to finalize any last questions that we have. Hopefully that helps.

Yes, that does help. Thank you very much.

I'll add on a Robert, you're probably familiar with there have been major outbreaks of MPOCs throughout Africa and even in locations in major cities throughout the United States. So this isn't going away, and there's a great interest in a U.S.-based supplier so that we're able to respond in meeting the full global needs and doing that in a rapid time period.

Yes, and as you mentioned, the national stockpile is a definite customer for smallpox vaccines and other things that can be produced through that method. So thank you. Sure, thank you.

Again, if you would like to ask a question, please press star 1. There are no more questions coming at this time. This concludes our question and answer session. I would like to turn the conference back over to David Dudd for any closing remarks.

Sure. Thank you, everyone, for participating in today's update and sharing in our achievements, progress, and outlook. We really appreciate your interest. I want to acknowledge and thank the Board of Directors and Advisors and our GFAC staff and the many other parties that continue to support us towards achieving success. Additionally, 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'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 is a great pleasure serving our shareholders and being 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. Have a safe and enjoyable day. Thank you.

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