GeoVax Labs Q1 2025 Earnings Report

GeoVax Labs EPS Results

• Actual EPS: -$0.45
• Consensus EPS: -$0.59
• Beat/Miss: Beat by +$0.14
• One Year Ago EPS: N/A

GeoVax Labs Revenue Results

• Actual Revenue: $1.64 million
• Expected Revenue: $0.75 million
• Beat/Miss: Beat by +$890.00 thousand
• YoY Revenue Growth: N/A

GeoVax Labs Announcement Details

• Quarter: Q1 2025
• Date: 5/1/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, May 1, 2025
• Conference Call Time: 4:30PM ET

GeoVax Labs (NASDAQ:GOVX), Inc., a clinical-stage biotechnology company, develops human vaccines and immunotherapies against infectious diseases and solid tumor cancers using modified vaccinia ankara virus-like particle vaccine platform. It is developing various preventive vaccines against (COVID-19), human immunodeficiency virus (HIV); Zika virus; malaria; and hemorrhagic fever viruses, such as Ebola, Sudan, Marburg, and Lassa, as well as therapeutic vaccines for HIV, chronic Hepatitis B infections, and solid tumor cancers. The company is developing GEO-CM04S1, a vaccine candidate that is in Phase 2 clinical trial for the treatment of preventive COVID-19; Gedeptin, a novel patented product/technology for the treatment of solid tumors, and Phase 1/2 clinical trial for the treatment of advanced head and neck squamous cell carcinoma; and GEO-CM02, a pan-coronavirus vaccine. In addition, it is developing GEO-ZM02, a vaccine candidate, which is in preclinical trial for the treatment of GEO-ZM02, a vaccine candidate, which is in preclinical trial for the treatment of Zika; GEO-MM02 treatment for malaria; other infectious disease vaccines for the treatment of fever viruses, such as Ebola, Sudan, and Marburg; GEO-LM01 for the treatment of Lassa fever. It has collaboration and partnership agreements with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health; U.S. Department of Defense; Emory University; and the Burnet Institute. GeoVax Labs, Inc. was incorporated in 1988 and is headquartered in Smyrna, Georgia.

GeoVax Labs Q1 2025 Earnings Call Transcript

Key Takeaways

• GeoVax unexpectedly received a stop work order from BARDA for the Project NextGen contract, leading to its termination for convenience and an estimated annual impact of under $750,000.
• The GEO-CM04S1 multi-antigen COVID-19 vaccine continues Phase 2 trials in immunocompromised populations, with investigator-initiated CLL studies nearing completion and multiple conference presentations planned.
• GeoVax completed cGMP production of its GEO-MVA mpox/smallpox vaccine batch, expecting clinical material later this year and aiming to expand U.S.-based MVA supply to break current monopolies.
• The Gideptin oncology program is preparing for a Phase 2 head and neck cancer trial with regulatory and manufacturing activities underway, and additional solid tumor combination studies planned following AACR data presentations.
• In Q1 2025 GeoVax posted a $5.4 million net loss versus $5.9 million a year ago, held $7.4 million in cash, and is exploring strategic partnerships and funding options to support its clinical pipeline.

Presentation

[Operator]

Good afternoon, and welcome everyone to the GeoVax First Quarter twenty twenty five Corporate Update Call. My name is Michelle, and I will facilitate today's call. With me are David Dodd, Chairman and CEO Mark Reynolds, Chief Financial Officer Mark Newman, Ph. D. Chief Scientific Officer Kelly McKee, MD, Miles per hour, Chief Medical Officer and John Sharkey, PhD, Vice President, Business Development.

[Operator]

At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. At this time, I'm turning the call over to Max Gattaca of PrecisionAQ.

[Operator]

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 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.

[Operator]

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.

[Operator]

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 ks. It is now my pleasure to introduce the Chairman and CEO of Geovax, David Dodd.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Thank you. Welcome to the first quarter twenty twenty five 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 CMOS-four S1, GEO MVA, Gideptin, and the advanced MVA manufacturing process. Each of our product development candidates addresses critically important unmet healthcare needs providing opportunities for expedited registration paths and strong opportunities to commercialize differentiated solutions supporting patient needs worldwide.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

We also anticipate that the advanced MVA manufacturing process will provide a gain advantage in production of MVA based vaccines and therapies. We also wish to welcome doctor Senthil Raganathan to GIVX as our vice president Technical Development and CMC Operations, joining our team to guide our transition to the next phase for registration and commercialization of our exciting portfolio. Before going any further, let me first address the recent Project NextGen stop work order. Following the close of first quarter, on April, we unexpectedly received the stop work order notice relative to the BARDA Project NextGen program. The notice indicated that BARDA has decided to terminate the contract for convenience to the government pursuant to the terms of the project agreement.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

We can only assume this relates to the ongoing government efficiency efforts. We had no prior indication that the notice was forthcoming and were surprised by the notice as both the GFX internal team, our external contractors and consultants were making good progress and had a very good productive working relationship with the technical team at BARDA. The termination in no way implies any concerns as to the safety or potential efficacy of GOCM o four s one or the underlying NBA vaccine vector technology, nor will the termination impact the ongoing phase two clinical trials of CMOS4S1, primarily investigating our vaccine in immunocompromised patient populations. The funding from BARDA pursuant to the project agreement was mostly earmarked for incremental spending with a large portion going directly to the external clinical research organization to conduct the clinical trial. Given the structure of the award, the financial impact to GIVACS is estimated at less than $750,000 annually toward reimbursement of existing personnel overhead costs.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

As a result, we don't anticipate any significant changes to our ongoing operations. The decision by BARDA to terminate our contract is very disappointing to GFX and our stakeholders. However, we remain committed to c m o four s one as a critically needed next generation multi antigen COVID nineteen vaccine, providing the potential for a more robust immune response against emerging variants, improved durability versus the first generation single antigen COVID -nineteen vaccine and especially in addressing the immune protection among those patients with compromised immune system. During the Q and A session, we welcome the opportunity to address any further questions that you may have. Our current CMO4S1 studies will continue especially our focus on achieving the completion of the investigator initiated phase two trial among chronic lymphocytic leukemia patients, one of the highest risk groups in the need of reducing the risk of severe infection, hospitalization, and risk of death coming from COVID-nineteen.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Demonstrating the potential superior value of CML4S1 among immunocompromised patients remains our focus for the development of differentiation for the first generation and other single antigen focused COVID-nineteen vaccines. The medical need for a COVID-nineteen vaccine such as cmo4s1 is substantial given that we estimate over forty million adults in The United States have medical conditions rendering their immune systems inadequately responsive to the first generation and other single antigen vaccine. Worldwide, we estimate over four hundred million at such risk. In addition, we believe the c m o four s one provides the potential for a better booster for the first generation single antigen vaccines. During 2025, we anticipate multiple presentations of clinical results for c m o four s one, including the World Vaccine Congress presentation last week.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

In addition, presentations are scheduled for the European Hematology Association, the International Workshop on Chronic Lymphocytic Leukemia, American Association of Immunologists, the Keystone Vaccinology, and a different additional conferences underscoring the important potential medical value of this unique next generation COVID nineteen vaccine. These presentations will undoubtedly also serve as important catalysts for ongoing strategic partnership discussions. Relative to Geo MVA, our vaccine candidate against MPOXX and smallpox, 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're pleased to state that we have produced sufficient amount of product to support the anticipated clinical evaluation as well as additional product in support of additional clinical use in conjunction with various stakeholder discussions that we have underway.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

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 need resulting from epidemic outbreaks as well as the various stockpile opportunities worldwide. Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. Relative to our plans for a phase two Gadeptin trial in head and neck cancer, the clinical operations plans are underway as we complete the necessary regulatory aspects of product manufacturing in support of the trial. Just this week, Doctor. Mark Pipes presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the Phase two study.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

In addition to the upcoming Phase two trial, we also plan additional studies of Gideptin addressing other solid tumors beyond head and neck cancer. We believe that the Gideptin has the potential to address multiple solid tumors, especially via combination therapy providing significant value long term. Overall, 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 the worldwide development, commercialization, and distribution of our portfolio of products. Our priorities and anticipated milestones for 2025 remain focused on: or first advancing GEO CM04S1 for immune compromised populations.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Secondly advancing GEO MVA to clinical evaluation. I'll note the significant governmental interest exists relative to The US based supply chain versus the current overdependence on non US suppliers. The strong sentiment in favor of such onshoring initiatives remains a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders such as the White House, congressional representatives, HHS, BARDA, WHO, the Africa CDC, and others regarding our having produced a cGMP clinical batch of GL MVA vaccine planned for use in the upcoming clinical study as well as other potential uses. In fact WHO and other stakeholders have underscored the critical need for expanded MPOXX vaccine supply as a priority for WHO and other public health agencies worldwide.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Lastly, our focus on oncology specifically related to Gideptin is a major priority for the future of GIVAC. We have high expectations for the potential broad utilization of Gideptin against various solid tumors, especially in combination with immune checkpoint inhibitors. We continue to progress towards the invitation of our phase two study to evaluate gideptin in combination with immune checkpoint inhibitor among patients with locally recurrent head and neck squamous cell carcinomas following primary therapy and for whom resection with curative intent is planned. Our clinical operations plans for this trial as I mentioned are coming together nicely along with the regulatory aspects and necessary product manufacturing in support of the phase two study. As I previously noted this week Doctor.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Pike has provided an overview of the Gideptin of American Association of Cancer Research. In addition we're planning various animal validation studies further building a compelling basis of the potential value of Gideptin addressing various solid tumors. Overall, 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, GFX Chief Financial Officer, for a review of our recent results and financial status. Mark?

[Mark Reynolds, CFO at GeoVax Labs]

Thank you, David. The details of our first quarter twenty twenty five financial results are summarized in I'll start my review with our income statement. Revenues associated with the BARDA contract were $1,600,000 in 2025 versus zero in 2024 as the contract began during June of last year. As David mentioned, we received a stop work order from BARDA in April with the expectation that the contract is to be terminated.

[Mark Reynolds, CFO at GeoVax Labs]

So there will be a final settlement amount built to BARDA during Q2 of this year and then nothing more going forward. But as a reminder, this is a cost reimbursement contract with the vast majority of the contract earmarked for new incremental spending. So the net financial impact to GIVAC is expected to be less than $750,000 annually for billable personnel time and overhead. Research and development expenses were $5,400,000 in 2025 versus $4,400,000 in 2024, representing an increase of roughly $1,000,000 or 21%. The increase during 'twenty five is primarily related to costs associated with the BARDA contract as well as our Gideptin and GEO MVA programs.

[Mark Reynolds, CFO at GeoVax Labs]

These costs were partially offset by lower costs related to the CMOS-four S1 clinical trial. General and administrative expenses were $1,700,000 in 2025 versus $1,500,000 in 2024, representing an increase of $200,000 or 16% associated with higher investor relations consulting costs and stock based compensation expense. Interest income was $47,000 in 2025 compared with $33,000 in 2024. So overall net loss for the first quarter of twenty twenty five was approximately $5,400,000 or $0.45 per share versus $5,900,000 in 2024 or $2.47 per share. Turning now to the balance sheet.

[Mark Reynolds, CFO at GeoVax Labs]

Our cash balances at March 31 were $7,400,000 as compared to $5,500,000 at December 31, reflective of $6,000,000 used in operating activities, offset by 7,900,000.0 in financing transactions. Our outstanding common shares currently stand at 15,200,000 following recent financing activity. Including the ongoing GEO CMOS-four S1 clinical trials continues to be a top priority for us in terms of our operational focus. These trials were unaffected by the BARDA stop work order. We also expect to accelerate our plans for clinical trials associated with the GEO MVA and Gideptin programs.

[Mark Reynolds, CFO at GeoVax Labs]

Supporting these clinical programs will be the most significant use of our cash in the foreseeable future. We continue to explore various strategies to fund our development programs through several valuation inflection points and to extend our cash runway. These could come in the form of strategic partnerships, non dilutive funding and additional offerings of our common stock. I'll be happy to answer any questions during the Q and A. And now I'll turn the call back over to Dave.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q and 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]

Thank you. We will now begin the question and answer session. And our first question comes from James Malloy with Alliance Global Partners. Your line is open.

[James Molloy, Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals at Alliance Global Partners]

Hey guys, thank you very much for taking my question. I want to try to address I'm sure you saw that Vaxart recently got their hold lifted. I was wondering if you could talk a little bit about that, any compare or contrast potentially between their program, your program? Is that a hopeful sign for potentially a change in administration with the stop work order?

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Jim, thank you. This is David. I'll be happy to address that. There are some distinct differences between their program and ours. First of all, Vaxart had already dosed 400 patients, if you may recall that.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

So they had a 400 patient sentinel group out of the 10,000. That was what was halted in February, they received notice I believe it was February 21. And so the situation they had was you had a group of patients out there already dose. This was also true with another company, which is a private company that had just started their clinical trial. There are actually two such holds issued back, stopped work orders in February.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

'1, we know much more about because it's a public company, that's Vaxart. So the challenge that they had and that the government had is you've got patients of the trials who've been dosed and you can't just leave them out there necessarily without doing something and so they took the time they evaluated that you may recall that stop work order indicated there would be a ninety day pause in which the government would review the situation and get back by the end of the ninety days. That would have been around the twentieth or thereabouts of May. As it was the termination was made to then reinstitute and start that program over. So I just want to underscore that in the case of two of the companies of the six vaccines that were in Project NextGen, two of them were already dosing patients and both of them were received a stop work order.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

At least one of them that we know about because they made the public disclosure has it has been lifted and they'll then go forward. I'll also point out that of the six vaccines that had been given the Project NextGen award of those you had Vaxar, the other private company, CastleVax is a private company. It remains on a stop work order as we do. And also, you had Gritstone, which ended up filing bankruptcy, so it's no longer in the program. The only one in which there's little information that we've been able and others have been able to find is Cotagenyx which is again a private company.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

So it's hard to find out what I I I don't I would not try to guide anyone on what to read into this. We posted our statement on our website. I commented some today. We believe some element of government efficiency because there were no negative reasons that we could determine or that were conveyed to us of of why the stop work order occurred. Of course, we have seen the announcement of of $500,000,000 going from BARDA now for a work towards a universal influenza vaccine and a universal coronavirus vaccine.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

We don't know if some of that money came from what was in our award or what. I I would point out that in September of twenty twenty, '3 vaccines insights was a very well received publication from our r and d team of the universal coronavirus vaccine, and and certainly we have been positioning that, and and more recently, there was a publication in vaccines peer reviewed journal of a multi antigen couple of additional constructs we have that are multi antigens that that could be the candidates for universal pan coronavirus vaccine. So I would just leave it that but I can't really guide you on on what to read into this. We made our announcement. All we know is what has been communicated to us, and we're focused on running the company and not trying to read too much into to events that may happen.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

I hope that helps answer your question. If you have any follow-up, just go ahead and ask that.

[James Molloy, Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals at Alliance Global Partners]

Absolutely, of course. Let's see what happens. Maybe just one quick comment as well on recent comments by the head of HHS about placebo controlled vaccine trials. Does that impact your thoughts for your trials going forward? Any change to design or we'll see if it even comes to pass?

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Well, we have three phase two trials underway. One has been completed, is the healthy volunteers where we're evaluating, two different doses of our vaccine among healthy adults who had previously been, been vaccinated with mRNA vaccine. Those results, the readout, we believe will be around the middle of thereabouts June. That's that's what the statisticians telling us because they told us other dates previously, but they're they're crunching it out, and we we're getting there, so we hope to be making an announcement within, you know, you know, before the end of next month. So that would be there.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

We have the CLL trial, which we announced, very promising encouraging results in November. That was the, the randomized comparison of our vaccine to the Pfizer vaccine among CLL patients. You may recall that the at the interim review, the Pfizer arm did not meet its endpoint. It was subsequently halted on the recommendation of the data safety monitoring board. The study continues as an investigator initiated study.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

It continues towards completion. I think there remains about approximately 24 more patients to complete that trial. We're hoping they will be completed yet this year. Again, we don't it's not our sponsored study, we have less control and influence over it, but we work as close as we can with the investigator. That's one that we believe demonstrates very nicely and encouragingly that our vaccine is apparently doing something which we would like to see that is doing providing value to patients with compromised immune systems.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

We're not seeing that being validated in various studies, but certainly in this in this study, and then we have the immune the hematologic cancer patients who are being prepped for stem cell transplantation or CAR T therapy, and that study contends to enroll patients in the preliminary data that have been coming out, including what was presented last week at the World Vaccine Congress, but continue to be very encouraging on that. That's also randomized comparison that this case between our between our vaccine and the mRNA vaccine. The patients and the other in the non GIVX arm are either receiving Pfizer or Moderna. So, we were looking and monitoring the statements and certainly we saw the recent statement that the Secretary of HHS came out indicating his preference for multi antigen vaccines versus single antigen vaccines related to to use within certain infectious disease categories. We obviously believe very strongly that there is a enhanced value by a multi antigen vaccine.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

I'll also point out that we do have an active BARDA proposal for moving forward with our advanced in the a base manufacturing process that that was deemed worthy we received knows that was deemed worthy of funding by barter but right now they've made no awards because of funding or financial funding levels and considerations that are all that are going on, but they have they have indicated in some instances proposals that were not acceptable ours has been placed into a two year basket for funding as the money becomes available and we're quite encouraged and excited about that also. So we remain with our MBA vaccine CMO for us one as well as our overall MBA advance MBA manufacturing process and our dealings with the government. Remain optimistic and very positive in that regard.

[James Molloy, Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals at Alliance Global Partners]

Well, I thank you. There's certainly a lot of moving parts. I appreciate your input.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Thank you.

[Operator]

Thank you. Our next question comes from Robert LeBoyer with Noble Capital Markets. Your line is open.

[Robert Leboyer, Senior Biotechnology Analyst at Noble Capital Markets]

Good afternoon. And based on the upcoming results in the healthy volunteers trial, what are you thinking in terms of the next steps for a trial in terms of size, funding, and just length of trial, any thoughts or guidance that you can share with us?

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Sure, our focus is not primarily on otherwise healthy individuals. It has always been focused on the immunocompromised populations for the simple reason that these are individuals who do not respond to antibody stimulation, which is the basis or the target for the single antigen vaccines, those that are authorized as well as others in development. And we believe that this provides us in the case of United States, Forty Plus Million population that currently remain in a pandemic state because they don't respond to the current vaccines either the mRNAs or the protein adjuvant So we continue to feel very strongly that this is an ideal point of differentiation for fulfilling an unmet medical need and making a real difference. So our goal has never been to go further with towards registration in a healthy volunteer population.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

One, it require a much larger type of clinical trials you're hearing in discussions with the current vaccines, Novavax is a prime example of going after that population. So it's looking for taking market share away from Pfizer and Moderna. We've always looked at it as we would be creating a new submarket because it's currently not being addressed. So we would have the opportunity for a leadership position in there. We believe that by this trial, it would give us some good indication of data that would be reflective of how our vaccine operates within an otherwise healthy population.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

That was also our focus for Project NextGen. We were not looking to go forward after doing 10,000 patients, 5,000 each arm, and doing a much larger study in otherwise healthy volunteers. It would have generated for us a very strong database of how our vaccine works in otherwise healthy individuals, which would then be the basis for comparison of how our vaccine works in otherwise healthy patients versus immunocompromised populations, be it CLL patients, be it people with renal disease, whatever the target audience was. So that's how we're looking for. Our focus going forward is going to be a couple fold.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

One is going to be look at the results that come out of the current investigator initiated trial for CLL patients. If the results of that trial continue to be encouraging, we'll look at doing an expanded trial that will be a company sponsored trial that would feed into a dossier that would be developed for registration. We would also utilize that as a as a initial entry point of discussion for expedited review with regulatory authorities because there is nothing else for these patients from a vaccine standpoint. So that's our general approach of developing CMOS1 is around the immunocompromised looking and fulfilling the opportunities where patients otherwise do not have vaccine to help prevent. And remember that our vaccine has shown much more robust in terms of protection against variants.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

If you recall, we've demonstrated protective immunity from the original Wuhan strain through the Omicron XBB 1.5 without having to reconfigure. That in and of itself is a major deficiency and that's part of the problem that Novavax is dealing with is they're being asked to do a full clinical trial to show that that an updated construct is worthy of signing off by the FDA and what the FDA and not the FDA what HHS is really looking for as they iterated in the announcement about the universal one is something that works across multiple, multiple generations of variants. So far, the only vaccine we've seen that has consistently shown that has been geo geo centimeters four S one. So that's where our focus is and where we think we will have a major difference by taking the approach we have of a multi antigen approach, targeting and applying it to populations for whom current existing vaccines, they all happen to be single antigen or simply inadequate.

[Robert Leboyer, Senior Biotechnology Analyst at Noble Capital Markets]

Okay, thank you very much.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Thank you. Appreciate your interest.

[Operator]

Thank you. Our next question comes from Jeffrey Krause with Crystal Research Associates. Your line is open.

[Jeffrey Kraws, Co-Founder & CEO at Crystal Research Associates]

Thank you very much. David, several of my questions were answered, but two remaining questions. You haven't seen anything contrary to your balanced safety and efficacy with your MPOXX vaccine that is you haven't seen any of the challenges and the complications that people are seeing with the myocarditis encephalitis or other complications, correct?

[David Dodd, Chairman, President & CEO at GeoVax Labs]

No, not at all. Know, MVA was developed in the late 60s, early 70s, specifically to be utilized among people who have compromised immune systems, pregnant women and children. The fact that it does not replicate in humans or mammals, humans, means it has been recognized for being exquisitely safe, and that is one thing you can count on with MVA. It has always been shown to be extremely safe. We've mentioned in the past that we received an exemption from the EA to not have to do the animal toxicology studies because with MVA it's recognized for its safety by regulatory authorities worldwide.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

One thing that most people recognize with MVA has always been its safety because it was specifically developed for patients for whom the traditional vaccinia was contraindicated. We would not have been able to rid itself of smallpox otherwise. So we feel very strongly about that. The challenge with MVA and hurdle has always been the complicated cumbersome manufacturing process because it's very slow, it's very cumbersome, and that's why typically products are stockpiled, but that's why we went forward four and a half plus years ago towards this advanced MBA manufacturing process, which now we have in process development. But we have not seen those types of side effects in any of our MBA based products.

[Jeffrey Kraws, Co-Founder & CEO at Crystal Research Associates]

Great, and that is helpful because the rumor mill out there, of course, runs wild with both those issues. So thankful. Thank you for confirming what our beliefs were. The second question relates around the backbone of vaccine manufacturing. You indicated in the call here that obviously there's a move underway to sort of move from having vaccines and all the constructs of vaccines manufactured outside this country as many of the bases are in China right now.

[Jeffrey Kraws, Co-Founder & CEO at Crystal Research Associates]

Are you receiving support or indications of support in your conversations with the government for having a US based manufacturing piece? I would think that would be something that they're involved in. I know you brought up BARDA and you said funding is all halted right now on that construct, but would you expect significant movement there given your proclivity for manufacturing here?

[David Dodd, Chairman, President & CEO at GeoVax Labs]

Well everybody right now there's not an MVA manufacturer or contract CDMO manufacturer in The United States. So if you're doing MVA, you have to go, and that's why we're working with Oxford Biomedica and the manufacturing for us right now is being done outside The US and France specifically. However, helping this new method and all in our relationship with Oxford Biomedical, we would anticipate as we go forward with the advanced MVA manufacturing that that will be manufactured in The United States. And we do, as I mentioned, we we submitted a proposal a little over a year ago when that RFP came out from from Florida. They made no awards on it, but, we recently were informed that that our proposal was deemed appropriate for funding, passed the mustard there, and it's been placed in a two year, what they call it, basket, that as funding occur and come forward, of course, that will be competing with whatever alternative options people are looking at, this and that to utilize the funding from the government.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

We discussed this with legislators, with congressmen, with representatives, our senators, we discussed it with other representatives that would have an interest in that. So we believe that what we will migrate towards will be US based manufacturing of our MVA based vaccines. Can I have been asked by a couple of, let's say stakeholders, what would it take to go even faster? And the answer is very simple. It's your balance sheet drives that.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

And I usually point out to them that I'm having to to sit across happen to be sitting across from a person that could make a difference there. So those discussions so far no one has has handed me a check, but so far handed us a check, should say. But so far, those discussions continue. Week after next, I'll be briefing people in Washington, DC, you know, legislator, their staffs, etcetera, and decision makers, influencers, and all of that. So I'll I'll be doing that both as as part of a a group and as well as individually.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

So we continue to go forward with that because our commitment is to establish US based manufacturing even if it's using a CDMO and that's what we're working toward with our relationship with Archer Biomedical.

[Jeffrey Kraws, Co-Founder & CEO at Crystal Research Associates]

Perfect. Thank you very much, David.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

You're welcome. Thank you.

[Operator]

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

[David Dodd, Chairman, President & CEO at GeoVax Labs]

All right. Thank you, everyone. Really appreciate your interest. Let me just say that, as always, I like to acknowledge the ongoing support and thank our board of directors and advisors and especially our staff and the many others, either consultants, contractors, but many other parties who continue to support us towards achieving the success we believe that we have underway here. We indeed remain committed to providing meaningful career development opportunities for what we consider highly competitive, quality oriented individuals who want to be part of the disruption of the current paradigm of cancer therapies and infectious disease vaccines.

[David Dodd, Chairman, President & CEO at GeoVax Labs]

And we are most proud and appreciative of our team, including those external partners because they are dedicated to us, are supportive of us, and they're part of our ongoing success. So for those of you who have taken the time to participate in this, we especially want to thank you because you're not only interested, sometimes you may have been assigned to listen to this broadcast, but we know that you you are sincere. You give us good counsel, good guidance, and we appreciate that. Just lastly, I would just underscore that our our overriding goal is to drive products through the to the registration point to improve lives worldwide through these efforts and especially in these two areas. So with that, I look forward to keeping you updated, hopefully in between the next call, but also at the next call. So thank you, and have a wonderful day.

[Operator]

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

Participants

Executives

• David Dodd, Chairman, President & CEO
• Mark Reynolds, CFO

Analysts

• James Molloy, Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals at Alliance Global Partners
• Robert Leboyer, Senior Biotechnology Analyst at Noble Capital Markets
• Jeffrey Kraws, Co-Founder & CEO at Crystal Research Associates