Q1 2024 GeoVax Labs Inc Earnings Call

Mark: Good afternoon, and welcome everyone to the GeoVax First Quarter 2024 Corporate Update Call. My name is Mark, and I will facilitate today's call. With me are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, Mark Newman, PhD, Chief Scientific Officer, Kelly McKee, MD, MPH, Chief Medical Officer, and John Sharkey, PhD, Vice President, Business Development. At this time, all participants are in a listen-only mode, and a question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. At this time, I am turning the call over to Max Gadicke of Stern IR.

Good afternoon, and welcome everyone to the <unk> first quarter trying to bring up our corporate update call. My name is Mark and I will facilitate todays call with me are David Dodd, Chairman and CEO, Mark <unk>, Chief Financial Officer, Mike Newman H D chips, Andi think officer, Kelly Mcgee M. D M D Chief Medical Officer.

And John Sharp Phd Vice President of business development.

All participants: All participants are in a listen only mode and a question and answer session will follow the formal presentation.

All participants: As a reminder is conference is being recorded.

Speaker Change: At this time I am turning the call over to Jim Muskogee Ausberry Nair.

Speaker Change: Thank you.

Max Gadicke: 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.

Speaker Change: Please note the following.

Speaker Change: Certain statements in this presentation constitute forward looking statements.

Speaker Change: Private Securities Litigation Reform Act.

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

Speaker Change: Actual results may differ materially from those included in these statements due to a variety of factors including weather.

Unknown Executive: GeoVax can develop and manufacture its product candidates with the desired characteristics in a timely manner, and such products will be safe for human use. GeoVax's vaccines will effectively prevent targeted infections in humans. GeoVax's product candidates will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises the required capital to complete the development of its products. There is the development of competing products that may be more effective or easier to

Speaker Change: <unk> can develop and manufacture its product candidates with the desired characteristics in a timely manner and.

Speaker Change: Such products will be safer.

Speaker Change: G O abaxis vaccines will effectively prevent targeting infections in humans.

Abaxis: Sure the Abaxis product candidates will receive regulatory approvals necessary to be licensed and marketed.

Abaxis: So you go backs raises required capital to complete development of its products.

Speaker Change: There is development of competitive products that may be more effective are easier to use and <unk> products.

Speaker Change: <unk> will be able to enter into a favorable manufacturing and distribution agreements.

Speaker Change: And other factors over which the Opex has no control.

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

Ngos: More information about these factors is contained in <unk> filings with the Securities and Exchange Commission, including those set forth at risk factors Ngos's forms that okay.

Unknown Executive: GeoVax will be able to enter into favorable manufacturing and distribution agreements and other factors over which it 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 as risk factors in GeoVax's Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.

David Alan Dodd: It is now my pleasure to introduce the chairman and CEO Geovax David Dodd.

David Alan Dodd: Thank you, Max. Good afternoon, and thank you for participating in the first quarter 2024 GeoVax Corporate Update Call. During the first quarter, we successfully advanced our developments, focused on our two phase two status processes: GADEPTEN, a unique therapy against solid tumors, and GEO-CM04S1, a next-generation COVID-19 vaccine. In addition, we also advanced other critically important initiatives.

Matt: Thank you Matt good afternoon, and thank you for participating in the first quarter 2024, <unk> corporate update call.

David Alan Dodd: During the first quarter, we successfully advanced our developments focused on our two phase two status products. Good depth in a unique therapy against solid tumors and G. E O CMO for S. One our next generation COVID-19 vaccine and.

S. One: In addition, we also advanced other critically important initiatives today, we will discuss the progress status and plans related to good depth in N CMO for his work.

David Alan Dodd: Today, we'll discuss the progress, status, and plans related to GDEPM and CMO-4S1. Our goal is to develop innovative cancer therapies and infectious disease vaccines addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate establishing business partnerships and collaborations in support of worldwide development, commercialization, and distribution. Following my comments, Mark Reynolds, our CFO, will provide an update on our financials, and then your questions will be addressed.

Speaker Change: Our goal is to develop innovative cancer therapies in infectious disease vaccines addressing critically important unmet medical needs pursuing initial indications that support expedited registration pathways.

Speaker Change: We anticipate establishing business partnerships and collaborations in support of worldwide development commercialization and distribution.

Speaker Change: Following my comments Mark Rumbles, our CFO will provide an update of our financials and then your questions will be addressed.

Speaker Change: Okay.

David Alan Dodd: At year-end, we announced the closure of enrollment for the Phase 1, Slice 2 trial of Gadeptin among advanced head and neck cancer patients. This initial targeted patient population represents those who are in end-stage care. There are 17,000 in the U.S. and over 400,000 worldwide who unfortunately die each year as a result of head and neck cancer.

Speaker Change: At year end, we announced the closure of enrollment for the phase one slice to trial a good depth in a moment advanced head and neck cancer patients. This initial targeted patient population represents those who are in stage care 17000 in the U S and over 400000 worldwide, who unfortunately die each year.

Speaker Change: As a result of head and neck cancer.

David Alan Dodd: Our goal is to obtain clinical evidence supporting the advancement of this therapy, including in patients with earlier stage disease. You'll recall this trial was funded by the FDA under the Orphan Drugs Clinical Trials Program. We expect to report the final results of the trial during this first half of 2024, followed by discussing our plans for further evaluation of gadeptin in patients with head and neck cancer, including a role similar to neoadjuvant or cytoreductive radiotherapy in combination with checkpoint blockade medication. We refer to godemptin as tumor agnostic, meaning that its mechanism of action will enable us to address a variety of solid tumors, both cancerous and benign.

Speaker Change: Our goal is to obtain clinical evidence supporting advancement of this therapy, including in patients with earlier stage disease.

FDA: You'll recall this trial was funded by the FDA under the orphan drugs clinical trials program.

Speaker Change: We expect to report the trial final results. During this first half of 2024, followed by discussing our plans for further evaluation of good depth and in patients with head and neck cancer, including a role similar to Neil Adjuvant Rosado reductive radio therapy in combination with checkpoint blockade medications.

Speaker Change: We refer to good depth in his tumor agnostic, meaning that its mechanism of action will enable us to address a variety of solid tumors, both cancers and benign.

David Alan Dodd: We hold worldwide rights for all indications of this technology, and we're participating in various oncology and partnering conferences, at some of which we will present cadet and clinical data with others to conduct partnering discussions. We recently convened our oncology advisors to review the clinical results to date as well as further opportunities related to gadeptin and other monotherapies. Also addressed were combination therapy indications conducted in conjunction with immune checkpoint inhibitors. We continue to anticipate discussions with the FDA related to a potential expedited path to registration.

Speaker Change: 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, good depth and clinical data with others to conduct partnering discussions.

Speaker Change: We recently convened our oncology advisors reviewing the clinical results to date as well as further opportunities related to good depth and other monotherapy indications.

Speaker Change: Also address where combination therapy indications good depth and in conjunction with immune checkpoint inhibitors.

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

Speaker Change: CMO for S. One our next generation COVID-19 vaccine aims to provide a more practical public health friendly vaccine solution that offered from the currently approved vaccines.

David Alan Dodd: CMO4S1, our next generation COVID-19 vaccine, aims to provide a more practical, public health-friendly vaccine solution than that offered by the currently approved vaccine. 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 between our vaccine and the current authorized vaccine.

Speaker Change: 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 allergens.

Speaker Change: This is the key differentiation of our vaccine in the current authorized vaccines.

David Alan Dodd: Our vaccine utilizes a proven, safe, and efficient delivery platform, the Modified Vaccinia Anchora, or MVA, which does not replicate in mammalian cells. This distinction is critically important in addressing the high-risk populations of immune-compromised individuals for whom the current vaccines and monoclonal antibody therapies focused only on blocking or reducing virus infection are often inadequate. That our vaccine platform, MVA, is also a standalone vaccine authorized for protection against mPox and smallpox is a unique feature with critically important clinical benefits providing a significant differentiation for CMO4S1.

Speaker Change: Our vaccine utilizes a proven safe and efficient delivery platform modified vaccinia anchor or M. B, a 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 a monotone and.

Speaker Change: Body therapies focused only on blocking of reducing virus infection are often inadequate.

Speaker Change: That our vaccine platform MVA is also a standalone vaccine authorized for protection against and Fox in smallpox is a unique feature with critically important clinical benefits, providing a significant differentiation for C. M O four S. One.

David Alan Dodd: In addition, we believe that CMO4S1 offers an immune profile optimal for more general use as a heterologous booster to current mRNA vaccines, providing a more robust, durable, and broadly functional immune response against emerging variants, potentially without the need for the continuous vaccine reconfiguration that appears necessary with the mRNA vaccine. Relative to CMO4S1, we anticipate partnering and collaborations and additional clinical and research efforts and in support of worldwide Active initiatives are underway in these areas.

Speaker Change: In addition, we believe that CMO for US one all person immune profile optimal for more general use as a head or logical booster to current mrna vaccines, providing a more robust durable and broadly functional immune response against emerging variants, particularly without the need for the continuous vaccine reconfiguration.

Speaker Change: And it appears.

Speaker Change: Appears necessary with the mrna vaccines rare.

Speaker Change: Relative to CMO for US one we anticipate partnering collaborations in additional clinical research efforts and in support of worldwide commercialization of distribution.

Speaker Change: Active initiatives are underway in these areas.

David Alan Dodd: Let me now address our various clinical trials underway with this promising product. Three phase two clinical trials are underway with CMO4S1, two of which address the high-risk populations of immunocompromised patients. The other Phase 2 trial evaluates our vaccine as a heterologic 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.

Speaker Change: Let me now address our various clinical trials underway with this promising product.

CMO: Three phase II clinical trials are underway with see a move for us one.

Speaker Change: Two of which address the high risk populations of immuno compromised patients. The other phase II trial evaluates our vaccine as a hydrological booster among healthy adults following prior receipt of an mrna vaccine.

Speaker Change: Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the millions of immuno compromised patients. While also demonstrating the vaccine is a more robust durable booster vaccine when used in conjunction with mrna vaccines.

David Alan Dodd: 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 provided both neutralizing antibodies against multiple SARS-CoV-2 variants, and a specific T cell response. This past February, we reported positive interim data from this trial, indicating no serious adverse events and statistically significant increases in neutralizing antibodies against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5, as well as robust cellular immune We plan to perform additional testing against the current JN1 variant.

Speaker Change: With our healthy adult booster trial last September we completed enrollment in this trial.

Speaker Change: The trial involves 63 healthy adults, who had previously received the Pfizer of Madonna mrna vaccine the.

Speaker Change: The immunological responses measured throughout the year long study provide both neutralizing antibodies against multiple Sars Covid two variances specific T cell responses.

Pfizer: This past February we reported positive interim data from this trial, indicating no serious adverse events as statistically significant increases in neutralizing antibodies against multiple Sars Covid two variants ranging from the original Wuhan strain through Delta and Omicron ex VB, one five as well as robust.

Pfizer: <unk> cellular immune responses.

Speaker Change: We plan to perform additional testing against the current J N one variant.

David Alan Dodd: Final results from this Heritologicus booster trial are anticipated during the fourth quarter of this year, reflecting the 12-month monitoring of these patients. In the U.S., there are approximately 20 to 25 million immune-compromised adults. Worldwide, there are an estimated 250-plus million.

Speaker Change: Final results from this higher larger 'cause booster trial are anticipated during the fourth quarter of this year, reflecting the 12 month monitoring of these patients.

Speaker Change: In the U S. There are approximately 20 to 25 million immune compromised adults worldwide. There are an estimated 250 plus million.

David Alan Dodd: 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 significantly increased risk of severe COVID-19 infection, hospitalization, and potentially death. This is well documented in the medical literature, highlighting the need for a next generation vaccine that addresses this critically important medical area.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: This is well documented in the medical literature, highlighting the need of a next generation vaccine that addresses is critically important medical area.

David Alan Dodd: We believe that CMO4F1 is the leading next-generation vaccine in clinical development in support of the needs of immunocompromised patients. Additionally, 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 2 stem cell transplant immunocompromised randomized trial comparing CMO4S1 against an MRA vaccine have been presented at several international conferences. Additionally, preliminary results were published last September in the peer-reviewed journal Vaccines.

Speaker Change: We believe the CMO for US that's one is the leading next generation vaccine in clinical development in support of the needs of immuno compromised patients.

Speaker Change: Also we believe that an opportunity for an expedited regulatory path likely exist due to our focus on such high risk Unserved and underserved immuno compromised patient populations.

Speaker Change: Encouraging data from our phase II stem cell transplant, and immuno compromised randomized trial comparing CMO forests won against an mrna vaccine has been presented at several international conferences.

Speaker Change: Preliminary results were published last September in the peer reviewed journal vaccines.

David Alan Dodd: The findings demonstrated robust immunogenicity, illustrating the vaccine's ability to strongly induce both antibody and T cell responses, essential for conferring protection, particularly in immunocompromised individuals. The article also highlighted the unique feature of CMO4S1 providing immune responses across a spectrum of viral variants, again, from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB1.5 variant. We're continuing to expand this study to additional sites, and thus far, the data continue to demonstrate increased, robust, protective immunity and increased durability.

Speaker Change: The findings demonstrated robust image justy illustrating the vaccine's ability to strongly induced both antibody and T cell responses.

Speaker Change: Central for conferring protection, particularly in immuno compromised individuals.

Speaker Change: The vaccine article also highlighted the unique feature of CMO for us one providing immune responses across a spectrum of viral variance again from the ancestral Wuhan strained through delta in the highly barrel omicron SBB, one five very well.

Speaker Change: We're continuing to expand this study to additional sites. Thus far the data continue to demonstrate increased robust protective immunity and increased durability.

David Alan Dodd: This patient population represents one of the highest at-risk patient populations for severe disease, hospitalization, and the risk of death. Following the initiation of patient enrollment in the chronic lymphocytic leukemia immunocompromised patient trial last August, this investigator-initiated trial has continued to recruit and enroll patients. The trial is designed to evaluate 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 the 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 have remained homebound more than four years since the pandemic began.

Speaker Change: This patient population represents one of the highest at risk patient populations, where severe disease hospitalization and the risk of death.

Investigator: Following the initiation of patient enrollment in the chronic lymphocytic leukemia immuno compromised patient trial last August. This investigator initiated trial has continued to recruit and enroll patients.

Pfizer: The trial is designed to evaluate CMO for echelon, among approximately ADC L. L patients directly comparing it to the Pfizer <unk> mrna vaccine.

Pfizer: 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.

Speaker Change: As a consequence many of these patients remain homebound more than four years since the pandemic began.

David Alan Dodd: We are optimistic that CMO4S1 can offer these individuals the protection from this virus that they so desperately need. We anticipate that the required number of patients in support of an interim analysis will soon be reached, and that the interim results will be available this year. Finally, I'd like to address Project NextGen. This $5 billion initiative to follow on from Operation Warp Speed is focused on accelerating the clinical development of COVID-19 vaccines with the potential for enhanced breadth of protection against variants and improved durability, being particularly interested in novel vaccine candidates already in clinical trials. CMO4S1 is a prime example of the desired next-generation COVID-19 vaccine.

Speaker Change: We are optimistic the CMO for US one can offer these individuals the protection from this virus that they so desperately need.

Speaker Change: 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.

Speaker Change: Finally, I'd like to address project Nextgen.

Speaker Change: This $5 billion initiative the follow on from Operation Warped speed is focused on accelerating the clinical development of COVID-19 vaccines with the potential for enhanced breadth of protection against variants and improved durability.

I: Your ability being particularly interested in novel vaccine candidates already in clinical trials.

Your ability: <unk> for US one is a prime example of the desired next generation COVID-19 vaccine.

David Alan Dodd: We continue to have active negotiations regarding the inclusion of CM04-S1 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, GADEPTIN and CMO4S1, are focused on patient populations currently underserved or unserved by existing vaccines and or therapies. GeoMVA, our vaccine against mumps 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.

US one: We continue to have active advancing negotiations regarding the inclusion of CMO for S. One project Nexgen and we look forward to further updating you in the near future.

Speaker Change: We're addressing opportunities that provide us a basis for achieving leadership within differentiated patient areas and commercial markets.

CMO Forests: Our current clinical stage products good depth in the CMO for US one our focus on patient populations currently underserved or unserved by existing vaccines <unk> therapies.

GL MBA: GL MBA, our vaccine against and Pax in smallpox is intended to disrupt the current global monopoly and that important area, providing us a leadership position as the first U S based supplier of such a vaccine.

David Alan Dodd: This may also provide GeoVax our initial step into revenue generation due to the significant government interest in U.S.-based supply chains versus over-dependence on non-U.S. suppliers. The strong sentiment in favor of such an on-sourcing initiative remains a major national legislative focus and interest, and we're well aware of it and very much involved.

GL MBA: This may also provide <unk>, our initial step into revenue generation due to the significant government interest at U S based supply chains versus Overdependence on non U S suppliers.

Speaker Change: The strong sentiment in favor of such one sourcing initiative remains a major national legacy legislated focus and interest and we are well aware of it and very much involved in it.

David Alan 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. During the remainder of this year, we'll continue to report progress and results from our CMO4S1 Phase 2 program. For Goodafton, we expect to report the final results from the recently completed trial and our plans for the expanded Phase 2 trial. We also expect to report further plans regarding next steps related to evaluating gadeptin as combination therapy used in conjunction with an immune checkpoint inhibitor.

Rob: 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 world Rob.

Rob: During the remainder of this year, we will continue to report progress and results from our CMO for US one phase II programs for good depth and we expect to report the final results from the recently completed trial and our plans for the expanded phase II trial.

Robert Michael LeBoyer: We also expect to report further plans regarding next steps related to evaluating good depth and as combination therapy used in conjunction with immune checkpoint inhibitors.

David Alan Dodd: Relative to our MVA vaccine against mumps 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 marketing. To summarize, our various clinical stage products, GADEPTIN, CMO4S1, and MVA, represent critically important areas of medical needs that are largely unserved or underserved by current products and standards of care.

M. B: Relative to our M. B, a vaccine against <unk> smallpox, we anticipate reporting our regulatory path and plans related to advancing that product towards registration.

M. B: Finally, we anticipate further updates related to our advanced MBA manufacturing process targeted that enabled <unk> to effectively produce and distribute NBA base back scenes in response to real time market needs.

CMO Forests: To summarize our various clinical stage products, good depth and CMO for US one an MBA represent critically important areas of medical needs, largely unserved or underserved by current products and standard of care.

David Alan Dodd: We are pleased with the consistent, encouraging results we're seeing from our clinical studies. Moreover, we believe that expedited paths to registration are feasible for these products. From a potential commercial perspective, these product opportunities represent an estimated annual U.S. revenue potential of almost $30 billion. I'll emphasize that this isn't a sales forecast but rather a reflection of the significance of the need to address these critically important areas of healthcare, both clinically and commercially.

Speaker Change: We are pleased with the consistent encouraging results, we're seeing from our clinical studies. Moreover, we believe that expedited path to registration are feasible for these products.

Speaker Change: From a potential commercial perspective, these product opportunities represent an estimated annual U S revenue potential almost $30 billion.

Speaker Change: 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.

David Alan Dodd: 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's Chief Financial Officer, for a review of our recent results and financial stats.

Speaker Change: Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence we have relative to the outlook for <unk>, our shareholders and stakeholders.

Speaker Change: Now I'd like to turn the presentation over to Mark rentals, <unk>, Chief Financial Officer for a review of our recent results and financial steps Mark.

Mark W. Reynolds: Thank you, David. I'll begin with a brief review of our income statement. The first thing to comment on is that we had no grant revenues or government contracts during the first quarter, as we've reported in previous 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...

Mark W. Reynolds: Thank you David.

Mark W. Reynolds: I'll begin with a brief review of our income statement.

Mark W. Reynolds: The first thing to comment on is we had no grant revenues or government contracts during the first quarter as we reported in past years. However, we are having advanced discussions with BARDA related to project Nexgen and we are highly encouraged by the status of these negotiations.

BARDA: If an award would have been made through this.

Mark W. Reynolds: 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.

BARDA representative: This would be a significant catalyst for fundraising and will become an important component of our financing mix going forward, but I will emphasize that this is a forward looking statement there can be no assurance that such an award will actually be made.

Mark W. Reynolds: Research and development expenses were $4.4 million in the first quarter of 2014 versus $2.8 million in 2023, representing an increase of $1.6 million, or 57%. The year-over-year increase is primarily associated with the cost of conducting our clinical trials, including manufacturing costs for clinical trial materials currently being used and being used in the future. General Administrative Expenses were $1.5 million in the first quarter of 2024, relatively unchanged from the amount reported last year.

Mark W. Reynolds: Research and development expenses were $4 4 million in the first quarter of <unk> 24 versus $2 8 million and 23, representing an increase of $1 6 million or 57%.

Mark W. Reynolds: The year over year increase was 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 generally.

Speaker Change: General and administrative expenses were $1 5 billion in the first quarter of 'twenty, four and relatively unchanged from the amount reported last year.

Mark W. Reynolds: Interest income was $33,000 in the first quarter of this year compared to $232,023, reflecting lower cash balances invested through our money market account. So overall net loss for the first quarter of 2024 was $5.9 million or $2.47 per share versus $4 million in 2023 or $2.30 per share, again with the increase primarily being driven by CMO4S1 and the ADEPTEN clinical trial program.

Speaker Change: Interest income was 33000 in first quarter of this year compared to 232023, reflecting lower cash balances invested through our money market accounts. So overall net loss for the first quarter of 2024 was $5 9 million or 2.2.

Speaker Change: $2 47 per share versus $4 million in 2023, or $2 30 per share again with the increase primarily being driven by the CMO Forest, one and you can adapt in clinical trial programs.

Mark W. Reynolds: Turning now to the balance sheet, our cash balances at March 31st were $769,000 as compared to $6.5 million at the end of 2023, reflective of $5.7 million used in operating activity. There were no financing activities in the first quarter, but we do expect to raise capital in the very near future. I'll now also note that, as disclosed in our 10Q being filed today, our management team and board recently provided a modest amount of capital to the company through a straight debt structure in order to help bridge to our next capital raise.

Speaker Change: Turning now to the balance sheet, our cash balances at March 31 for.

Speaker Change: Our 769000 as compared to $6 5 million at the end of <unk>.

I'll: 2023 reflective of $5 7 million used in operating activities. There were no financing activities during the first quarter, but we do expect to raise capital in the very near future. I'll. Now know also note that as disclosed in our 10-Q being filed today and our management team and board recently provided a modest.

Speaker Change: Mountain capital to the company through a straight debt.

Speaker Change: So with that straight debt structure in order to help bridge to our next capital raise.

Mark W. Reynolds: Our outstanding common shares stand at $2.3 million following the reverse split we exercised at the end of January this year, which brought us, the intention of that was to bring us back into full compliance with NASDAQ. The funding of our ongoing Phase II clinical programs for CMO4S1 and GADEPTIN will continue to be the most significant use of our cash for the foreseeable future. We don't expect this prioritization of spending to change if we receive a Project NextGen award from BARDA, as any incremental spending for that program will be funded completely by the award. Now, I'll be happy to answer any questions during the Q&A, and I'll turn the call back to David.

Speaker Change: Our outstanding common shares stands at $2 3 million following the reverse split we exercised at the end of January this year, which brought us that Nick mentioned that was brings back in full compliance with Nasdaq.

I'll: Funding, our ongoing phase II clinical programs for CMO forests, one and get up to and we will continue to be the most significant use of our cash for the foreseeable future.

Nick: We don't expect this prioritization of spending to change if we receive a project next Gen Award from BARDA is any incremental spending for that program will be funded completely by the award.

Nick: Now happy to answer any questions during the Q&A and I'll turn the call back to David.

David: Thank you Mark.

David Alan Dodd: 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, Business Development, respectively. I'll now turn the call over to the operator for instructions on the question-answer period.

Operator: 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 business development respectable I will now turn the call over to the operator for instructions on the question and answer period.

Operator: We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad.

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

Operator: Using a speakerphone please pick up your handset before pressing the keys.

Operator: Draw your question based press Star then two.

Operator: At this time, we will pause momentarily to assemble our aerostar.

Operator: Our first question comes from the line up Robert buyer with Noble capital markets. Please go ahead.

Robert Michael LeBoyer: Good afternoon. And my first question has to do with GADEPTAN. And you mentioned that there would be a data update coming shortly, and you had been in consultation with your advisors about the path forward with combinations of. Checkpoint inhibitors or monotherapy, and 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.

Robert Michael LeBoyer: Good afternoon, and my question. My first question has to do with the depth and you mentioned that it would be a data update coming shortly and you had been in consultation with your advisors about the path forward with.

Speaker Change: Combinations of.

Robert Michael LeBoyer: Checkpoint inhibitors or mono therapy and were there any other options that you mentioned there were few things that I thought I heard but wasn't exactly certain as to what path, where you're thinking about that.

Dr. <unk>: So Robert I'll answer and then I'll ask Dr. <unk> to step in so we recently met with our advisors and thank you for your question first of all.

David Alan Dodd: So, Robert, I'll answer and then I'll ask Dr. McKee to step in. So, we recently met with our advisors, and thank you for your question, first of all. That was to go through the, you know, the final results, et cetera, from the trial that was completed last year. The focus that we have going forward initially will be on head and neck cancer, as we did in that initial trial, and we will look at it perhaps even at an earlier stage.

Dr. <unk>: And that was to go through the.

Dr. <unk>: Final results et cetera from the trial that was completed that last year you are in.

Dr. <unk>: The focus that we have going forward initially will be one the head and neck cancer as we've done in that initial trial and looking at it perhaps even at an earlier stage.

David Alan Dodd: Combination therapy is when it could definitely be combined with immune checkpoint inhibitors. But we will be looking at other monotherapies uses of gadaptin against standalone solid tumors. Kelly, would you like to step in now?

Speaker Change: <unk> combination therapy is when it good definitely will be combined with <unk>.

Kelly T. McKee: With the immune checkpoint inhibitors, but we will be looking at other model therapy uses of good depth and against Standalone solid tumors Kelly would you like to step in.

Kelly T. McKee: Well, sure. I mean, I think you sort of hit the nail on the head.

Kelly T. McKee: Well.

Kelly T. McKee: Sure.

Kelly: I mean, I think you sort of hit the nail on the head.

Kelly T. McKee: You know, our advisory committee sort of recommended a sort of 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're 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.

Kelly T. McKee: Yes.

Kelly T. McKee: Advisory Committee.

Advisory Committee: Sort of recommended a sort of a next step forward for the head and neck cancer program.

Advisory Committee: Sort of.

Speaker Change: And focusing on it on a target population that they thought would.

Kelly T. McKee: Neil.

Kelly T. McKee: More.

Neil: Meaningful data in terms of.

Neil: So where we go we would go.

Speaker Change: Beyond that.

Speaker Change: In the head and neck cancer.

Speaker Change: Treatment.

Neil: Population.

Speaker Change: At the same time, where we're looking at.

Speaker Change: Other solid tumor types I mean, we've got some discussions underway with.

Speaker Change: Our group at Emory that's interested in looking at this in a triple.

Kelly T. McKee: And we will be speaking with some people at Oxford University next week, in fact, about the potential for a study, so the BASTA trial and other solid tumor types. But those discussions are all very early on, very early at this point, and probably not worth sharing.

Emory Group: Triple negative breast cancer.

Emory Group: <unk> and <unk>.

Emory Group: And we will be speaking with some people in Oxford University next week and think about the potential for <unk>.

Oxford University: Our study so the basket trial and other solid tumor types, but those discussions are all very early on early at this point.

Speaker Change: Probably no no detailed fourth we're sharing it at this time.

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

Speaker Change: Okay well. Thank you that's very helpful.

Robert Michael LeBoyer: Also had a question on the.

Speaker Change: On the MBA for smallpox and Monkey pox and was wondering if there were any details.

Speaker Change: You could share about the steps or milestones between where you are today and potential revenues down the road.

John Sharkey: Sure. I'll call on John Sharkey to address that. He's leading our MBA program stand-alone.

Speaker Change: Sure.

Speaker Change: Column, John Sharkey to address that he's leaving our.

John Sharkey: NBA program Standalone vaccine.

John Sharkey: Oh, hey, Robert, thanks for the question. So we continue to progress with our MBA. We have begun the process of preparing the master seed banks and the working viral seed banks with our partner Oxford Biomedica, which was ABL in France prior to the merger. We are finalizing the submission to the appropriate regulatory agency. We've not disclosed our regulatory strategies just yet. However, with some additional questions on the process forward, we remain optimistic there is an accelerated pathway forward for this program.

Robert Michael LeBoyer: Hey, Robert Thanks for the question. So we continue to progress our NDA.

Speaker Change: We have begun the process of preparing the master seed bank and the working <unk> banks.

John Sharkey: With our partner.

Oxford Biomedical: Oxford Biomedical formerly.

Robert: Was ABL in France prior to the merger.

John Sharkey: We are finalizing the submission too.

Speaker Change: The appropriate regulatory agency, we have not disclosed our regulatory strategy just yet with some additional questions on the process forward remain optimistic there is an accelerated pathway forward for this program.

Speaker Change: But we have not at this point projected any final registration data or anything else, but we continue as I said to move efforts forward on both the the supply front to have material available for any work clinical work, we have to do as well as initial commercial launch supplies as well as discussions with.

John Sharkey: But we have not at this point projected any final registration date or anything else. But we continue, as I said, to move efforts forward on both the supply front to have material available for any work, clinical work we'd have to do, as well as initial commercial lawn supplies, as well as discussions with a regulatory authority to finalize any last questions that we have. Hopefully, that helps.

Unknown Executive: A regulatory authority to.

John Sharkey: To finalize any last questions that we have hopefully that helps.

Robert Michael LeBoyer: Yes, that does help. Thank you very much.

John Sharkey: Yes that does help thank you very much.

Operator: And I'll add, Robert, that you're probably familiar with, there have been major outbreaks of MPOGS 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 to meeting the full global needs and doing that in a rapid time period.

Robert Michael LeBoyer: And I'll add I'll add on the Robert.

Speaker Change: Familiar with there have been major outbreaks of impulse throughout Africa, even in locations in major cities throughout the United States. So this isn't going away.

Speaker Change: There is a great interest in a U S based supplier so that we're able to respond.

Operator: In meeting the full global needs and doing that in a in a rapid time period.

David Alan Dodd: 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.

Robert: Yes, and as you mentioned the national stockpile.

David Alan Dodd: A definite customer for for smallpox vaccines and other things that can be produced through that method. So thank you.

David Alan Dodd: Sure. Thank you.

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

David Alan Dodd: Again, if you would like to ask a question. Please press star one.

Operator: Okay.

Operator: 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 <unk> for any closing remarks.

David Alan Dodd: Sure. Thank you, everyone, for participating in today's update and sharing our achievements, progress, and outlook. We really appreciate your interest. I want to acknowledge and thank the Board of Directors and Advisors, and 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 therapy and infectious disease vaccines.

David Alan Dodd: Sure. Thank you everyone for participating in today's update and sharing what our achievements progress and outlook. We really appreciate your interest.

David Alan Dodd: I want to acknowledge and thank the board of directors and advisers and our <unk> 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.

David Alan Dodd: Infectious disease vaccines.

David Alan Dodd: We're most proud and appreciative of our team, including those external partners who continue to contribute to the progress and success underway at GeoVax. For all of us, it is a great pleasure serving our shareholders and being part of this team. Our overriding goal is to improve lives worldwide through the development and commercialization of novel, critically needed cancer therapies and infectious disease vaccines. Have a safe and enjoyable day. Thank you.

GeoVax CEO: We are most proud and appreciative of our team, including those external partners, who continue to contribute to the progress and success underway at <unk> for all of US. It is a great pleasure, serving our shareholders and being part of this team. Our overriding goal is to improve lives worldwide by our development and commercialization of novel Chris.

David Alan Dodd: <unk> needed cancer therapies infectious disease vaccines have a safe and enjoyable day. Thank you.

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

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

Operator: [music].

Operator: Yes.

Operator: Okay.

Operator: [music].

Operator: Sure.

Operator: [music].