Q3 2025 GeoVax Labs Inc Earnings Call

Right.

Good afternoon, and welcome everyone to the <unk> third quarter 2025, corporate update call. My name is Sherry and I will facilitate todays call.

With me are David Dodd, Chairman and CEO, Mark Reynolds, Vice President Chief Financial Officer, Mark Newman Ph D. Chief Scientific Officer, Kelly Mckee M. D N P H, Chief Medical Officer, and John Sharkey Ph D Vice President.

Business development 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.

Note the following.

Certain statements in this presentation may constitute forward looking statements within the meaning of the private Securities Litigation Reform Act.

These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances.

Actual results may differ materially from those included in these statements due to a variety of factors, including whether Geo Vax can develop and manufacture its product candidates with the desired characteristics in a timely manner and such products will be safe for humans.

G O vaccines vaccines will effectively prevent targeted infections in humans, Gilles DOCSIS products candidates, well received regulatory approvals necessary to be licensed and marketed.

Operator: Good afternoon, and welcome everyone to the GeoVax Q3 2025 corporate update call. My name is Cherie, and I will facilitate today's call. With me are David Dodd, Chairman and CEO, Mark Reynolds, Vice President, Chief Financial Officer, Mark Newman, PhD, Chief Scientific Officer, Kelly McKee, MD, MPH, Chief Medical Officer, and John Sharkey, PhD, Vice President, Business Development. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. Please note the following. Certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances.

G box raises required capital to complete development of its products. There's a development of competitive products that may be more effective or easier to use and geo abaxis products G box will be able to enter into favorable manufacturing and distribution agreements and other factors over which.

G box has no control.

<unk> assumes no obligation to update these forward looking statements and does not intend to do so.

More information about these factors isn't is contained in <unk> filings with the <unk>.

Securities and Exchange Commission, including those set forth at risk factors and Geo Vaxes Form 10-K. It is now my pleasure to introduce the chairman and CEO of Geovax David Dodd. Please go ahead.

Thank you.

Welcome to the third quarter 2025, <unk> corporate update.

Following my comments Mark Reynolds, our CFO will provide an update of our financials and then we will address any questions that you may have.

Operator: Actual results may differ materially from those included in these statements due to a variety of factors, including whether GeoVax can develop and manufacture its product candidates with the desired characteristics in a timely manner, and such products will be safe for human use. GeoVax's vaccines will effectively prevent targeted infections in humans. GeoVax's products candidates will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises required capital to complete development of its products. There is a development of competitive products that may be more effective or easier to use than GeoVax's products. GeoVax will be able to enter into favorable manufacturing and distribution agreements and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements and does not intend to do so.

We remain confident in the continued progress and compelling outlook for our portfolio of Geo MBA GL CMO for US one that's been in the game changing NVA vaccine manufacturing process.

Each of our product development candidates address critically important unmet healthcare needs, providing opportunities for expedited registration paths and strong opportunities to commercialize differentiated solutions supporting patient needs worldwide.

We also anticipate that the advanced N V. A manufacturing process, we will provide a game changing advantage in production or in VA based vaccines and therapies.

We're experiencing increased partnering and collaboration interest from established industry players as well as increased interest from non dilutive funding organizations, including stakeholders addressing various areas worldwide vaccine needs.

Operator: More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission, including those set forth at Risk Factors in GeoVax's Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. Please go ahead.

In June we announced the receipt of guidance from the European Medicines agency referred to as the <unk>, providing an expedited development path for Geo MBA or a vaccine candidate against imports in smallpox.

This is most encouraging news in that it provides the potential for <unk> to achieve marketing authorization and revenue generation sooner, allowing us to bypass phase one and phase two clinical trials and proceed directly to a phase III immuno bridging trial.

David Dodd: Thank you. Welcome to the Q3 2025 GeoVax corporate update. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then we will address any questions that you may have. We remain confident in the continued progress and compelling outlook for our portfolio of GEO-MVA, GEO-CM04S1, Gedeptin, and the game-changing MVA vaccine manufacturing process. Each of our product development candidates address critically important unmet healthcare needs, providing opportunities for expedited registration paths and strong opportunities to commercialize differentiated solutions supporting patient needs worldwide. We also anticipate that the advanced MVA manufacturing process will provide a game-changing advantage in production of MVA-based vaccines and therapies.

As a result of this news we're experiencing increased interest in dialogue with various industry colleagues and stakeholders regarding potential partner collaboration and funding.

Relative to <unk>, we have initiated the fill finished with clinical batch vaccine mature.

We anticipate having a vaccine available for clinical valuation early next year.

We're pleased to note that in addition to product in support of our clinical evaluation, we plan to produce additional product in support of potential use in conjunction with various stakeholder discussions that are underway.

We believe that Geo NBA provides the potential to end the current monopoly MBA vaccine supply expanding the global supply of this critically needed vaccine addressing both their needs, resulting from epidemic outbreaks as well as the various stockpile opportunities worldwide.

David Dodd: We're experiencing increased partnering and collaboration interest from established industry players as well as increased interest from non-dilutive funding organizations, including stakeholders addressing various areas of worldwide vaccine needs. In June, we announced the receipt of guidance from the European Medicines Agency, referred to as the EMA, providing an expedited development path for GEO-MVA, our vaccine candidate against mpox and smallpox. This is most encouraging news in that it provides the potential for GeoVax to achieve marketing authorization and revenue generation sooner, allowing us to bypass phase I and phase II clinical trials and proceed directly to a phase III immunobridging trial. As a result of this news, we're experiencing increased interest and dialogue with various industry colleagues and stakeholders regarding potential partnering, collaboration, and funding. Relative to GEO-MVA, we have initiated the fill finish of clinical batch vaccine material. We anticipate having vaccine available for clinical evaluation early next year.

Significant government interest exists relative to the U S based supply chain versus the current overdependence on non U S suppliers.

Sentiment in favor of such onshoring initiatives as a major national legislative focus and interest.

We remain in active discussions and briefings with various stakeholders, including the White House Congressional Representatives HHS designate Joe the International vaccine Institute, the Africa, CDC and others regarding our progress relative to cgmp clinical inventory of G. O N E.

In fact this was the subject of numerous discussions during our recent series of meetings in Europe in conjunction with the World vaccine Congress Europe, Bio Europe, and individual meetings held in Geneva and elsewhere.

Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine.

GL CMO for US one our multi antigen vaccine against COVID-19 is increasingly recognized as a critically needed vaccine for use among the over $40 million immuno compromised adults in the U S as well as the over 400 million worldwide based.

David Dodd: We're pleased to note that in addition to product in support of our clinical evaluation, we plan to produce additional product in support of potential use in conjunction with various stakeholder discussions that are underway. We believe that GEO-MVA provides the potential to end the current monopoly of MVA vaccine supply, expanding the global supply of this critically needed vaccine, addressing both the needs resulting from epidemic outbreaks, as well as the various stockpile opportunities worldwide. Significant government interests exist relative to US-based supply chains versus the current overdependence on non-US suppliers. The strong sentiment in favor of such onshoring initiatives is a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders, including the White House, congressional representatives, HHS, WHO, the International Vaccine Institute, the Africa CDC, and others regarding our progress relative to cGMP clinical inventory of GEO-MVA.

Based on the clinical data results. Thus far we believe that CMO forest, one provides potential for demonstrating a more robust immune response against emerging variants.

Improved durability versus the first generation single antigen COVID-19 vaccine.

And especially in addressing the immune protection among those patients with compromised immune systems.

Our current CMO for echelon studies are progressing, especially our focus on continued enrollment of severely immunocompromised patients with blood cancers, who have received cell transplants and towards completion of the investigator initiated phase II trial, among chronic lymphocytic leukemia patients.

Both the hematologic cell therapy patients out of the CML patients represent the highest risk groups and need of reducing the risk of severe infection hospitalization and a risk of death, resulting from COVID-19 infection.

David Dodd: In fact, this was the subject of numerous discussions during our recent series of meetings in Europe in conjunction with the World Vaccine Congress Europe, BIO-Europe, and individual meetings held in Geneva and elsewhere. Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. GEO-CM04S1, our multi-antigen vaccine against COVID-19, is increasingly recognized as a critically needed vaccine for use among the over 40 million immunocompromised adults in the US as well as the over 400 million worldwide. Based on the clinical data results thus far, we believe that CM04S1 provides potential for demonstrating a more robust immune response against emerging variants, improved durability versus the first-generation single-antigen COVID-19 vaccine, and especially in addressing the immune protection among those patients with compromised immune systems.

For these individuals the pandemic continues demonstrating the critically important values CMO fourth one amongst such immune compromised patients remains our focus for differentiation from the first generation COVID-19 vaccine.

The medical need for a vaccine such as CMO Forest, one remains substantial for those with medical conditions that render their immune systems and adequate and responding to the referral generation vaccines.

It's noteworthy that just recently the infectious disease Society of America, known as IBSA issued updated guidelines regarding COVID-19 vaccine among immuno compromised patients.

Critically important guidelines are well exceedingly well with our development of CMO for Us law.

During the third quarter multiple presentations of clinical results for <unk> for US one we're provided that the international workshop on chronic lymphocytic leukemia.

David Dodd: Our current GEO-CM04S1 studies are progressing, especially our focus on continued enrollment of severely immunocompromised patients with blood cancers who have received cell transplants and towards completion of the investigator-initiated phase II trial among Chronic Lymphocytic Leukemia patients. Both the hematologic cell therapy patients and the CLL patients represent the highest risk groups in need of reducing the risk of severe infection, hospitalization, and the risk of death resulting from COVID-19 infection. For these individuals, the pandemic continues. Demonstrating the critically important value of GEO-CM04S1 among such immune-compromised patients remains our focus for differentiation from the first-generation COVID-19 vaccines. The medical need for a vaccine such as GEO-CM04S1 remains substantial for those with medical conditions that render their immune systems inadequate in responding to the first-generation vaccines.

World Vaccine Congress, Europe, and the European Society of clinical microbiology and infectious disease.

Each of these presentations resulted in additional and expanded discussions regarding potential partnering and collaborative developments.

Let me point out while such discussions tend to follow a somewhat tedious due diligence process.

We are encouraged by the continued interest in <unk>, one as the leading multi antigen COVID-19 vaccine in clinical development.

Relative to our plans for our phase III <unk> trial in head and neck cancer. The primary determinant of the timing to initiate the phase II trials, the completion of necessary product manufacturing.

That is underway along with the continued clinical operations plans and the necessary regulatory aspects.

Earlier this year, Dr. Mark pipe as presented at the ACR meeting in Chicago, reviewing the clinical results, thus far and our plans for the phase III study.

David Dodd: It's noteworthy that just recently, the Infectious Diseases Society of America, known as IDSA, issued updated guidelines regarding COVID-19 vaccine among immunocompromised patients. These critically important guidelines are well exceedingly well with our development of CM04S1. During Q3, multiple presentations of clinical results for CM04S1 were provided at the International Workshop on Chronic Lymphocytic Leukemia, the World Vaccine Congress Europe, and the European Society of Clinical Microbiology and Infectious Diseases. Each of these presentations resulted in additional and expanded discussions regarding potential partnering and collaborative developments. Let me point out, while such discussions tend to follow a somewhat tedious due diligence process, we are encouraged by the continued interest in CM04S1 as the leading multi-antigen COVID-19 vaccine in clinical development.

Peer reviewed publication of this work is forthcoming in <unk> oncology advances so beyond the outlook for this.

Following the impressive results of the keynote 289 study presented at <unk> with modified the good depth in phase III study protocol changing the target population of first line therapy Amendment in keynote 689 trials historical control.

As such our focus will be on evaluating neo adjuvant, good depth and in turn grow offering meaningful efficacy and tolerability in patients with primary squamous cell carcinoma head and neck were being considered for surgical resection with curative intent.

Our primary end point will be major pathological response.

We believe that <unk> has the potential to address multiple solid tumors, especially via combination therapy, providing significant value long term. We also plan additional studies of good depth in addressing other solid tumors beyond head and neck cancer and in addition, we are engaging in various discussions related to potential collaboration.

David Dodd: Relative to our plans for a phase II Gedeptin trial in head and neck cancer, the primary determinant of the timing to initiate the phase II trial is the completion of necessary product manufacturing. That is underway, along with the continued clinical operations plans and the necessary regulatory aspects. Earlier this year, Dr. Marc Pipas has presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the phase II study. Peer-reviewed publication of this work is forthcoming in JCO Oncology Advances, so be on the outlook for this.

In the long term development and commercialization of <unk>.

Overall, our goal is successfully develop innovative cancer therapies in infectious disease vaccines addressing critically important unmet medical needs pursuing initial indications.

Port expedited registration pathways.

We anticipate business partnerships and collaborations in support of worldwide development commercialization and distribution.

Our priorities and anticipated milestones for 2025 through 2026 remain focused on advancing Jill NVA to clinical evaluation.

David Dodd: Following the impressive results of the KEYNOTE-689 study presented at ASCO, we have modified the Gedeptin phase II study protocol, changing the target population to first-line therapy, mimicking KEYNOTE-689 trial's historical control. As such, our focus will be on evaluating neoadjuvant Gedeptin and pembro, offering meaningful efficacy and tolerability in patients with primary squamous cell carcinoma head and neck who are being considered for surgical resection with curative intent. Our primary endpoint will be major pathological response. We believe that Gedeptin has the potential to address multiple solid tumors, especially via combination therapy, providing significant value long term. We also plan additional studies of Gedeptin addressing other solid tumors beyond head and neck cancer. In addition, we are engaging in various discussions related to potential collaborations in the long-term development and commercialization of Gedeptin.

Advancing Jill CMO for us one for immune compromised populations.

Advancing the progress of the advanced N V a manufacturing process.

And our focus on oncology, specifically related to adapt and is a major priority for the future of <unk>, we have high expectations for the potential broad utilization of good depth when it gets various solid tumors, especially in combination with immune checkpoint inhibitors.

We also are focused on progressing various partnering and collaboration discussions in support of these developments with the potential to accelerate the pace of these programs.

We're confident that we're on a course that will build significant shareholder and stakeholder value, while delivering critically important differentiated products to improve lives worldwide.

Now I'd like to turn the presentation over to Mark Reynolds <unk>, Chief Financial Officer for a review of our recent result and financial status Mark.

David Dodd: Overall, our goal is to successfully develop innovative cancer therapies and infectious disease vaccines addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate business partnerships and collaborations in support of worldwide development, commercialization, and distribution. Our priorities and anticipated milestones for 2025 through 2026 remain focused on advancing GEO-MVA to clinical evaluation, advancing GEO-CM04S1 for immunocompromised populations, advancing the progress of the advanced MVA manufacturing process, and our focus on oncology, specifically related to Gedeptin, is a major priority for the future of GeoVax. We have high expectations for the potential broad utilization of Gedeptin against various solid tumors, especially in combination with immune checkpoint inhibitors. We also are focused on progressing various partnering and collaboration discussions in support of these developments with the potential to accelerate the pace of these programs.

Thank you David and the details of our third quarter financial results are summarized in today's press release.

I'll start the review with our income statement.

During the nine months ended September 32025, we reported revenues of $2 5 million versus $3 1 million in 2024.

This relates to the BARDA project Nexgen contract that began in June 2024, and as we did previously discussed in our Q1 earnings call. This year in April contract was terminated along with other project Nextgen funded contracts as part of the government Sufficiency program. So there were no contract revenues reported during Q.

Three <unk>.

Research and development expense for the quarter was 5 million versus $7 4 million in 2024.

For the nine month period, R&D expense was $15 1 million versus $16 1 million in 2024.

The decrease during 2025 is primarily related to discontinued costs associated with the termination of the BARDA contract as well as lower costs for the CMO Forest one clinical trials.

In manufacturing costs associated with the CMO for us one and good depth in programs.

David Dodd: We're confident that we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. Now I'd like to turn the presentation over to Mark Reynolds, GeoVax Chief Financial Officer, for a review of our recent results and financial status. Mark?

Lower costs were partially offset by higher personnel and consulting costs and manufacturing costs associated with the <unk> development program and preparation for initiating clinical trials in 2026.

General and administrative expense was $1 3 million for the third quarter of <unk> 25 versus $1 2 million and 24 for.

Mark Reynolds: Thank you, David. The details of our Q3 financial results are summarized in today's press release. I'll start the review with our income statement. During the nine months ended 30 September 2025, we reported revenues of $2.5 million versus $3.1 million in 2024. This relates to the BARDA Project NextGen contract that began in June 2024. As we previously discussed in our Q1 earnings call this year, in April, the contract was terminated along with other Project NextGen funded contracts as part of the government sufficiency program, so there were no contract revenues reported during Q3. Research and development expense for the quarter was $5 million versus $7.4 million in 2024. For the nine-month period, R&D expense was $15.1 million versus $16.1 million in 2024.

For the nine month period, G&A expense was $4 6 million versus $3 8 million and 24.

The overall increase during 2025.

Associated with higher personnel costs, and Investor relations consulting and other programmatic expenses and stock based compensation expense.

Other income expense was 151000 for.

Year to date period, and 25 as compared to 70024, primarily reflecting higher interest income.

So overall net loss for the quarter was $6 3 million versus $5 8 million in 'twenty, four and $17 million for the year to date period versus $16 7 million from 24.

Turning now to the balance sheet, our cash balances at September 30 were $5 million as compared to $5 5 million at December 31, 24 reflective of $16 5 million used in operating activities offset by $16 million in financing transactions.

Mark Reynolds: The decrease during 2025 is primarily related to discontinued costs associated with the termination of the BARDA contract, as well as lower costs for the GEO-CM04S1 clinical trials and manufacturing costs associated with the GEO-CM04S1 and Gedeptin programs. These lower costs are partially offset by higher personnel and consulting costs and manufacturing costs associated with the GEO-MVA development program in preparation for initiating clinical trials in 2026. General administrative expense was $1.3 million for Q3 of 2025 versus $1.2 million in 2024. For the nine-month period, G&A expense was $4.6 million versus $3.8 million in 2024. The overall increase during 2025 is associated with higher personnel costs, investor relations consulting, and other programmatic expenses and stock-based compensation expense.

Our outstanding common shares currently stand at $27 7 million.

Supporting our clinical programs for the priority programs at CMO for Us one.

<unk> and good afternoon.

The most significant use of our cash for the foreseeable future.

We continue to explore various strategies to fund these programs for several valuation inflexion points and also to extend our cash runway. These could include strategic partnerships non dilutive funding for additional offerings of our common stock.

And I'll be happy to answer any questions during the Q&A and I'll now turn the call back to David.

Thank you Mark My colleagues and I will now answer your questions joining us for the Q&A session are doctors, Mark Newman, Kelly Mckee and John Sharkey, Our Chief Scientific Officer, Chief Medical Officer, and Vice President of business development, respectively. I will now turn the call over to the operator for instructions on the question and answer.

Mark Reynolds: Other income expense was $151,000 for the year-to-date period in 2025 as compared to $70,000 in 2024, primarily reflecting higher interest income. Overall net loss for the quarter was $6.3 million versus $5.8 million in 2024, and $17 million for the year-to-date period versus $16.7 million in 2024. Turning now to the balance sheet. Our cash balances at 30 September were $5 million as compared to $5.5 million at 31 December 2024, reflective of $16.5 million used in operating activities, offset by $16 million in financing transactions. Our outstanding common shares currently stand at 27.7 million. Supporting our clinical programs for the priority programs, that's GEO-CM04S1, GEO-MVA, and Gedeptin, will be the most significant use of our cash for the foreseeable future.

Sure.

Thank you to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw your question Press Star one again due to time restraints. We ask that you. Please limit yourself to one question and one follow up question. You May then return to the queue. Please standby, while we compile the Q&A roster.

Sure.

And our first question will come from the line of Jonathan Aschoff with Roth Capital Partners. Your line is open.

Thank you guys.

Good afternoon, I was kind of curious can.

Can you envision any kind of scenario.

An outbreak type of scenarios that would get MBA.

Into the hands of <unk>.

Government is there anything that you can think of that would make that.

Mark Reynolds: We continue to explore various strategies to fund these programs through several valuation inflection points and also to extend our cash runway. These could include strategic partnerships, non-dilutive funding, or additional offerings of our common stock. I'd now be happy to answer any questions during the Q&A, and I'll now turn the call back to David.

Go commercial at least temporarily way before you would do any sort of clinical trials with it.

This is David Jonathan Thank you for your question.

Wouldn't anticipate the prior to any clinical evaluation that such a situation would occur.

David Dodd: 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.

We do believe there may be an opportunity as well as a significant need for emergency use licensing, which would come through <unk> based on certain situations occurring in some of those types of discussions.

Part of our recent.

Operator: Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, press star one one again. Due to time restraints, we ask that you please limit yourself to 1 question and 1 follow-up question. You may return to the queue. Please stand by while we compile the Q&A roster. Our first question will come from the line of Jonathan Aschoff with Roth Capital Partners. Your line is open.

Trip in Europe that we have with <unk> and other parties.

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

Yes, the 10-Q, okay. Thank you.

Hi.

Yes, I think it came out at four.

Thank you one moment for our next question.

And that will come from the line of Robert Leboyer with Noble capital markets. Your line is open.

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

Good afternoon, and congratulations on all the progress you've been making.

I know, it's probably a little early to talk about the collaborations.

Specifically, but.

Sure.

<unk>.

Broad strategic level is there anything that you can tell us about what youre thinking in terms of the collaborations or partnerships or anything like that that would.

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

Be helpful in determining what the prospects are for.

In a business combination or partnership.

Sure. Robert This is David and thank you for your questions and participation.

We hold worldwide rights for all of our product assets and our plan and our focus is to register a broadly owner on a global basis doesn't mean every single country as you know, but broadly to register on it and are.

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

Initial thinking is that we would be <unk>.

David Dodd: Yes.

Jonathan Aschoff: The 10-Q? Okay. Thank you.

Well to handle North America, which would be the U S and Canada, but I would also underscore that we will always listen to any proposal that a potential partner has.

David Dodd: Yeah.

Mark Reynolds: Yeah. The Q is live right now, Jonathan.

David Dodd: Yeah.

Jonathan Aschoff: Thank you.

David Dodd: I think it came out at four.

Operator: Thank you. One moment for our next question. That will come from the line of Robert LeBoyer with Noble Capital Markets. Your line is open.

We're quite active in <unk>.

Pending various conferences as we just did both world vaccine Congress Europe as well as bio Europe Bio Europe is largely a partnering oriented conference.

Tim that every fall as well as in the spring as well as obviously U S based similar types of conferences. So.

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

Recently, our discussions.

Related to potential partnering or collaboration which would entail.

Involvement.

Of our partner as we develop that for a particular region and you can sort of think through how.

Certain rights would be distributed if someone was heavily focused in a certain region in the Pacific region than they might be assisting us in the development process for their regulatory process et cetera. So all of those types of concepts are actively discussed.

David Dodd: Sure, Robert. This is David. Thank you for your question and participation. We hold worldwide rights for all of our product assets. Our plan and our focus is to register broadly on a global basis. Doesn't mean in every single country, as you know, but broadly to register on it. Our initial thinking is that we would be able to handle North America, which would be the US and Canada, but I would also underscore that we'll always listen to any proposal that a potential partner has. We are quite active in attending various conferences as we just did, both World Vaccine Congress Europe as well as BIO-Europe. BIO-Europe is largely a partnering-oriented conference. We attend that every fall as well as in the spring, as well as obviously US-based, similar types of conferences.

In meetings that we continue to have and have been having and we're open.

To whatever makes.

From a win win from the basis of.

Value for our shareholders as well as the stakeholders who are out there.

Okay, Great. That's helpful. Thank you very much.

Youre welcome.

One moment for our next question.

And that will come from the line of Jim Molloy with Alliance Global Partners. Your line is open.

Hello. This is <unk> on for Jim Malloy. Thank you for taking my questions.

So for <unk> NDA can you just talk a bit more about the collaboration you have in place with the University of Queensland.

For after the needle free administration method that you have with the vaccine and also any replay tremendous tax policy in place here as well.

David Dodd: Increasingly, our discussions related to potential partnering or collaboration, which would entail involvement of a partner as we develop it for a particular region. You can sort of think through how certain rights would be distributed. If someone was heavily focused in a certain region, a specific region, then they might be assisting us in the development process for there and regulatory process, et cetera. All of those types of concepts are actively discussed in meetings that we continue to have and have been having. We are open to whatever makes sense from a win-win and from the basis of value for our shareholders as well as the stakeholders who are out there.

So we announced.

Not too long ago that we were doing.

An evaluation in conjunction with the technology out of.

Out of Abaxis, and we believe it's very important in fact critically important for certain regions of the world to look at non traditional delivery methods.

Access is a leader in the area of micro Ray patches.

There is someone we've known for several years as well as other very good players in and those delivery area and so we're evaluating it to see what the feasibility is relative to GL MVA and as information credits actively in evaluation now as information comes forward we will.

Make appropriate announcements of that and so that's what we're doing within that realm of it.

Robert LeBoyer: Okay, great. That's helpful. Thank you very much.

David Dodd: You're welcome.

You asked a question I think about manufacturing what was that it didn't quite get it. Please.

Operator: One moment for our next question. That will come from the line of James Molloy with Alliance Global Partners. Your line is open.

Just the manufacturing that you might have for that.

This particular program.

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

<unk> MBA I'm going to ask our executive lead for our Geo MBA program.

John Sharkey too to address that John.

So in regards to our manufacturing as we've explained before our lead here as the manufacturer on the set platform took an embryo fiberglass that is the fastest pathway to registration and EMA has understood. This.

David Dodd: We announced, you know, not too long ago that we were doing an evaluation in conjunction with the technology out of Vaxess. We believe it's very important and in fact critically important for certain regions of the world to look at non-traditional delivery methods. As you know, Vaxess is a leader in the area of microarray patches. They're someone we've known for several years as well as other very good players in those delivery areas. We're evaluating it to see what the feasibility is relative to GEO-MVA. As information comes forward, we will make appropriate announcements of that. That's what we're doing within that realm of it. You asked a question, I think, about manufacturing.

Our partner as we do with all our programs with <unk> and so we are partnered with Oxford Biomedical Oxford.

Biomedical and the U K.

We are.

David Madge, our as I've mentioned in the presentation, we're in the process.

Packaging, our clinical supplies and we are in active discussions with OSB to how we can expand the supply out of their facility as well in discussions with other potential manufacturers to add additional supply as.

As we move when we move forward to commercialization.

It sounds good thank you for taking the question.

Youre welcome. Thank you as a reminder, if you would like to ask a question. Please press star one one and our next question will come from the line of Jon Vander motion with Zacks. Your line is open.

David Dodd: What was that? I didn't quite get it. Please.

Laura Suriel: Oh, just the manufacturing that you might have for this particular program, for GEO-MVA.

Thank you and good afternoon. So you guys are working with Sappy Africa, CDC WHI with others what regions of the World are looking less supportive for your vaccine programs and then what are their pathogens are would be great.

David Dodd: For GEO-MVA? I'm gonna ask our executive lead for our GEO-MVA program, John Sharkey to address that. John?

This concern.

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

I think clearly thank you John.

From the perspective of Geo MBA, it's obviously in the southern hemisphere.

And then back out breaks, but then we're also seeing increasingly reports of <unk> and the new strain impacts.

<unk> evident not only in the U S, but throughout Europe, but certainly the concentration is in the southern hemisphere and Theres a significant interest from parties that relate to that I mean, we keep being encouraged and told by <unk> leaders that this is not going away it's going to.

<unk> to evolve it is not going to get any better than that.

Really are are in need of our supply cost contribution as well as the eventual shift to our to our AG one our suspension cell line and continuous manufacturing process for that so I think from that standpoint.

Laura Suriel: All right. Sounds good. Thank you for taking the question.

John Sharkey: You're welcome.

Operator: Thank you. As a reminder, if you would like to ask a question, please press star one one. Our next question will come from the line of John Vandermosten with Zacks. Your line is open.

Where would that one is heavily concentrated which sort of is intuitive, but but on a broader basis.

Just the stockpile needs. It will eventually also include <unk>.

John Vandermosten: Thank you, good afternoon. You guys are working with CEPI, Africa, CDC, WHO, and others. What regions of the world are looking most supportive for your vaccine programs? What are their pathogens of greatest concern?

Response in a more timely manner to endemic needs also so we believe that when it comes to our.

CMO for us one.

Clearly the most significant need are among those populations, who who have inadequate.

They have medical conditions that have rendered their immune systems.

David Dodd: Well, I think clearly, and thank you, John, that, from the perspective of GEO-MVA, it's obviously in the Southern Hemisphere where you see endemic outbreaks. We're also seeing increasingly, reports of mpox and the new strain of mpox, becoming evident not only in the US, but throughout Europe. Certainly the concentration is in the Southern Hemisphere. There's a significant interest from parties that are relate to that. I mean, we keep being encouraged and told by WHO leaders that this is not going away. It's going to continue to evolve. It's not gonna get any better and that they really are in need of our supply contribution, as well as the eventual shift to our, to our AGE1, our suspension cell line continuous manufacturing process for that.

<unk> inability to appropriately respond to antibiotics stimulation.

For these people as I mentioned the pandemic continues I mean, these 40 plus million adults in the United States. The estimated 400 million worldwide, who have various medical condition blood cancers, kidney disease diabetes, multiple sclerosis, lupus et cetera. It goes on and all these are individuals that.

Their risk is not so much for instance to die of the blood cancer.

They have are to be hospitalized front its more from an infection, that's where their risk and so that's where we see a broad interest for those parties that are carrying for individuals who have such medical condition. These medical practitioners medical.

Healthcare groups they are very interested in what our vaccine.

Has the capability of potential to do and how can we move it faster that's what we're always asked and the answer is as a pre pre revenue company. It's all about the balance sheet the stronger our balance sheet is the faster we can move something forward.

David Dodd: I think from that standpoint, that's where that one is heavily concentrated, which sort of is intuitive. It's on a broader basis. It's not just the stockpile needs. It will eventually also include the response in a more timely manner to endemic needs also. We believe that. When it comes to our GEO-CM04S1, clearly the most significant need are among those populations who have inadequate response. They have medical conditions that have rendered their immune systems inability to appropriately respond to antibody stimulation. For these people, as I mentioned, the pandemic continues. These 40-plus million adults in the United States, the estimated 400 million worldwide who have various medical conditions, blood cancers, kidney disease, diabetes, multiple sclerosis, lupus, etc.

Obviously, we're all in.

Looking forward to the phase two trial with good depth.

And as we go forward with the implementation of that evaluating good depth and along with <unk>.

First line therapy following mimicking the keynote 689 per ounce or Theres a lot of interest.

That related to any parties that are that are following solid tumor cancers. So so we get a question on all of these at various meetings I would say right now we have many more questions and interest because the sense of urgency related to GL MBA.

We spent a lot of time addressing that as well as opportunities with good afternoon.

David Dodd: It goes on and on. These are individuals that their risk is not so much, for instance, to die of the blood cancer that they have or to be hospitalized from. It's more from an infection. That's where their risk is. That's where we see a broad interest for those parties that are caring for individuals who have such medical conditions. These medical practitioners, these medical healthcare groups, they are very interested in what our vaccine has the capability or potential to do and how can we move it faster. That's what we're always asked. The answer is, as a pre, you know, as a pre-revenue company, it's all about the balance sheet. The stronger our balance sheet is, the faster we can move something forward.

Okay and.

My next question is on <unk>.

And actually and the use of you mentioned that youre going to have it in combination with <unk> do you think by the time. This is approved there'll be a biosimilar version of that available and do you think that will help adoption.

I would say I really don't know because we may very well continue to develop good depth.

Across various.

Immune checkpoint inhibitors, we have other other players who have.

Checkpoint inhibitors are interested in and what we're doing obviously, we don't have the resources to do a blanket testing across all of immune checkpoint inhibitors, but we do have.

David Dodd: Obviously, we're all looking forward to the phase II trial with Gedeptin. As we go forward, with the implementation of that, evaluating Gedeptin along with pembrolizumab in first-line therapy, you know, following mimicking the KEYNOTE-689 trial. There's a lot of interest in that related to any parties that are following solid tumor cancers. We get to question on all of these at various meetings. I would say right now we have many more questions and interest because the sense of urgency related to GEO-MVA. We've spent a lot of time addressing that as well as opportunities with Gedeptin.

Potential interest in that may evolve into some collaborative development.

Opportunities, we've had some discussions but.

I would be.

It would be incorrect for me.

To suggest that we're in.

<unk>.

And discussions that are going to within a reasonable time period expand it to other ICIS. We have interest that's been expressed we've had a few discussions and we're certainly open to that and would encourage such discussions.

But we'll just see how those discussions continue to evolve.

Okay. Thanks, David.

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.

John Vandermosten: Okay. My next question is on Gedeptin, actually, and the use of You know, you mentioned that you're gonna have it in combination with the pembrolizumab. Do you think by the time this is approved, there'll be a biosimilar version of that available, and do you think that will help adoption?

Well. Thank you everyone for participating in today's update we really appreciate your interest and we look forward to ongoing interactions as always I wish to acknowledge and thank the <unk> board of directors and advisors, certainly our <unk> staff and the many other parties who contribute toward our success.

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

We're committed to providing meaningful career development opportunities for highly competitive quality oriented individuals seeking to disrupt the current paradigm of cancer therapies.

<unk> disease vaccines.

We welcome any in <unk>.

Inquiries about opportunities at <unk>, where a small company. So we are seeing many more inquiries than we have availability for but we thank you for your interest we're most proud and appreciative of our team, including those external partners, who continue to contribute to the progress and success underway at GFS.

For all of US, it's a great pleasure, serving our shareholders and being a part of this team. Our overriding goal is to improve lives worldwide through our development and commercialization of novel critically needed cancer therapies, and infectious disease vaccine and with that I want to wish everyone, a safe and enjoyable day and again. Thank you for your time and attention.

David Dodd: We've had a few discussions, and we're certainly open to that and would encourage such discussions. We'll just see how those discussions continue to evolve.

John Vandermosten: Okay. Thanks, David.

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

David Dodd: You're welcome. Thank you.

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

Okay.

[music].

David Dodd: Well, thank you everyone for participating in today's update. We really appreciate your interest, and we look forward to ongoing interactions. As always, I wish to acknowledge and thank the GeoVax Board of Directors and Advisors, certainly our GeoVax staff and the many other parties who contribute toward our success. We're committed to providing meaningful career development opportunities for highly competitive, quality-oriented individuals seeking to disrupt the current paradigm of cancer therapies and infectious disease vaccines. We welcome any and continued inquiries about opportunities at GeoVax. We're a small company, we receive many more inquiries than we have availability for, but we thank you for your interest. We're most proud and appreciative of our team, including those external partners who continue to contribute to the progress and success underway at GeoVax.

Okay.

Okay.

[music].

Okay.

[music].

David Dodd: For all of us, it's a great pleasure serving our shareholders and being a part of this team. Our overriding goal is to improve lives worldwide through our development and commercialization of novel, critically needed cancer therapies and infectious disease vaccines. With that, I want to wish everyone a safe and enjoyable day. Again, thank you for your time and attention.

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