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, Ph.D., Chief Scientific Officer; Kelly McKee, MBA, Chief Medical Officer; and John Sharkey, Ph.D., Vice President, Business Development. [Operator Instructions] 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 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 vaccines will effectively prevent targeted infections in humans. GeoVax 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 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. .

Gedeptin, a unique therapy against solid tumors, and GEO-CM04S1, a next-generation COVID-19 vaccine. .

In addition, we also advanced other critically important initiatives. Today, we'll discuss the progress status and plans related to Gedeptin and CM04S1..

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 that support a 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 I/II trial of Gedeptin 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 will 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 trial program.

We expect to report the trial final results during this first half of 2024, followed by discussing our plans for further evaluation of Gedeptin 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 Gedeptin 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 are participating in various oncology and [ partnering ] conferences and some of which we will present Gedeptin clinical data with others to conduct partnering discussions. .

We recently convened our oncology advisers reviewing the clinical results to date as well as further opportunities related to Gedeptin and other monotherapy indications, also address recombination therapy indications, Gedeptin in conjunction with immune checkpoint inhibitors.

We continue to anticipate discussions with the FDA related to a potential expedited path to registration..

CM04S1, 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 in the current authorized vaccines..

Our vaccine utilizes a proven safe and efficient delivery platform, modified vaccinia Ankara, 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 focus only on blocking or reducing virus infection are often inadequate.

That our vaccine platform, MVA, is also a stand-alone vaccine authorized for protection against Mpox and smallpox is a unique feature, with critically important clinical benefits providing a significant differentiation for CM04S1. .

In addition, we believe that CM04S1 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 vaccine.

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Relative to CM04S1, we anticipate partnering and collaborations in 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. 3 Phase II clinical trials are underway with CM04S1, 2 of which address the high-risk populations of immunocompromised patients. The other Phase II trial evaluates our vaccine as a heterologous booster among healthy adults following prior receipt of an mRNA vaccine. .

Overall, we hope to demonstrate that our COVID-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 and specific T cell responses. .

This past February, we reported positive interim data from this trial, indicating no serious adverse defense 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 JN.1 variant. Final results from this heterologous booster trial are anticipated during fourth quarter this year, reflecting the 12-month monitoring of these patients..

In the U.S., there are approximately 20 million, 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 CM04S1 is the leading next-generation vaccine in clinical development that 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 II stem cell transplant/immunocompromised randomized trial comparing CM04S1 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 confirming protection, particularly in immunocompromised individuals..

The vaccine article also highlighted the unique feature of CM04S1 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 debt..

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 CM04S1 among approximately 80 CLL patients directly comparing it to the Pfizer-BioNTech mRNA vaccine. .

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 4 years since the pandemic began. .

We are optimistic the CM04S1 can offer these individuals the protection from this virus that they still 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, the follow-on from Operation Warp Speed, is focused on accelerating the clinical development of COVID-19 vaccine with the potential for enhanced breadth of protection against variants and improved durability being particularly interested in novel vaccine candidates already in clinical trials.

CM04S1 is a prime example of the desired next-generation COVID-19 vaccine. .

We continue to have active advancing negotiations regarding the inclusion of CM04S1 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, Gedeptin and CM04S1, are focused on patient populations currently underserved or unserved by existing vaccines and/or therapies. .

GEO-MVA, 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 overdependence 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 we'll 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 CM04S1 Phase II programs. .

For Gedeptin, we expect to report the final results from the recently completed trial and our plans with the expanded Phase II trial. We also expect to report further plans regarding next steps related to evaluating Gedeptin 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, Gedeptin, CM04S1 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 studies. .

Moreover, we believe the expedited path 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 health care, 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 GeoVax, our shareholders and stakeholders..

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. 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 [Technical Difficulty] 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, and 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 and administrative expenses were $1.5 million in the first quarter of '24 and relatively unchanged from the amount reported last year. Interest income was [ $33,000 ] in the first quarter of this year compared to $232,000 in '23, reflecting lower cash balances invested through our money market accounts. .

So overall net loss for the first quarter of 2024 was $5.9 million (sic) [ 5.6 million ] or $2.47 per share versus $4 million in 2023 or $2.30 per share, again, with the increase primarily being driven by the CM04S1 and Gedeptin clinical trial programs..

Turning now to the balance sheet. Our cash balances at March 31 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. .

And I'll also note that, as disclosed in our 10-Q 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 share stands at 2.3 million, following the reverse split we exercised at the end of January this year, which brought us that [indiscernible] that was to bring us back into full compliance with NASDAQ..

Funding our ongoing Phase II clinical programs for CM04S1 and Gedeptin 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 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 doctors, Mark Newman, Kelly McKee and John Sharkey, our Chief Scientific Officer, Chief Medical Officer and Vice President of Business Development, respectively.

I'll now turn the call over to the operator for instructions on the question-and-answer period. .

[Operator Instructions] Our first question comes from the line of Robert LeBoyer with NOBLE Capital Markets. .

And my first question has to do with Gedeptin. And you mentioned that there would be a data update coming shortly, and you had been in consultation with your advisers 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 advisers. And thank you for your question, first of all. And that was to go through the final results, et cetera, from the trial that was completed at last year, year-end. .

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 in earlier stage.

The combination therapy is when it -- Gedeptin will be combined with the immune checkpoint inhibitors, but we will be looking at other monotherapy uses of Gedeptin against stand-alone 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.

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 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 are looking at other solid tumor types. I mean we've got some discussions underway with 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 in other solid tumor types. But those discussions are all very early on -- early at this point and probably no details we're sharing it at this time. .

Okay. Well, that's very helpful. I also had a question on the MVA for smallpox and monkeypox.

And I 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 John Sharkey to address that. He's leading our MVA program stand-alone vaccine. .

Robert, thanks for the question. So we continue to progress our MVA. We have begun the process of preparing the [ master seed banks ] and the working viral [ seed ] banks with our partner, Oxford 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 strategy as yet. .

With some additional questions on the process forward, we remain optimistic. There is an accelerated pathway 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 [ seed ] 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. .

And I'll add on, Robert, that you're probably familiar with, there have been major outbreaks of Mpox 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. .

[Operator Instructions] 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 Dodd for any closing remarks. .

Sure. Thank you, everyone, for participating in today's update and sharing on our achievements, progress and outlook. We really appreciate your interest. I want to acknowledge and thank the Board of Directors and advisers, our GeoVax 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 are 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 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..