Q4 2024 AIM ImmunoTech Inc Earnings Call

Operator: Hello and welcome to the AIM ImmunoTech fourth quarter and full year 2024 update conference call and webcast. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the event, please press star zero on your telephone keypad.

Hello, and welcome to the aim of Eurotech fourth quarter and full year 2024 update conference call and webcast.

As a brief reminder, all participants are currently in a listen only mode.

If anyone requires operator assistance thrown their event.

Press Star Zero under your telephone keypad.

Operator: Following the presentation will be a question and answer session. Note that this webcast is being recorded at the company's request and a replay will be made available on the company's website following the end of the event.

Following the presentation there'll be a question answer session.

This webcast is being recorded at the company's request and a replay will be made available on the company's website. Following me into the event.

Operator: Next time I'd like to remind our listeners that remarks made during the webcast may state management's intentions, beliefs, expectations, or future projections. These are forward-looking statements that involve risks and uncertainty. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the Federal Securities Law Center based on AIM ImmunoTech's current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statement. Some of the factors that could cause actual results of different material from these contemplated by such forward-looking statements are discussed in the periodic reports in ImmunoTech files with the Securities and Exchange Commission.

At this time I'd like to remind our listeners that remarks made during the webcast may state managements intentions beliefs expectations or future projections. These are forward looking statements and involve risks and uncertainties forward looking statements on this call are made pursuant to the safe Harbor provisions of the Federal Securities laws are based on current expectations.

Actual results could differ materially.

As a result, you should not place undue reliance on any forward looking statements.

Some of the factors that could cause actual results to differ materially from these contemplated.

Such forward looking statements are discussed in the periodic reports immuno take files with the Securities and Exchange Commission.

Operator: These documents are available on the Investor section of the company's website and on the Securities and Exchange Commission's website. We encourage you to view these documents carefully.

These documents are available on the investors section of the company's website and on the Securities and exchange Commission's website.

We encourage you to view these documents carefully.

Operator: Additionally, certain information contained in the webcast relates to or is based on studies, publications, surveys, and other data obtained from third-party sources of the company's own estimates and research. While the company believes these third-party sources to be reliable, as of the date of this presentation, it is not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of, or that any independent source has verified any information obtained from third-party sources.

Additionally, certain information contained in the webcast relates to or is based on studies publications surveys and other data obtained from third party sources of a company's own estimates in research.

While the company believes he started party sources to be reliable as of the June of this presentation and its not independently verified. It makes no representation as to the adequacy of fairness accuracy or completeness of or that any independent sources verified any information of changes on third party sources.

Operator: joining us on today's call from the AIM ImmunoTech leadership team. Thomas Equels, Chief Executive Officer.

Speaker Change: Joining us on today's call from the aim of immuno Tech leadership team.

Thomas Echoes: Thomas Echoes Chief Executive Officer of.

Thomas Equels: I would like to now turn the call over to Mr. Equels. Please proceed. Thank you, operator. I'd like to thank everyone for joining us this morning. I've been looking forward to this call because the progress we've made in the last several months underscores our commitment to advancing Ampligen across multiple areas of significant medical need. We're continuing to build meaningful momentum, both clinically and strategically. And I'm excited to walk through some of the recent highlights. To start, we recently announced plans to conduct a new clinical study evaluating Ampligen in combination with AstraZeneca's intranasal influenza vaccine, Flumist.

Speaker Change: I'd like to turn the call over to MS cycles. Please proceed thank.

Speaker Change: Thank you operator.

Speaker Change: I'd like to thank everyone for joining us this morning.

Speaker Change: I've been looking forward to this call because of the progress we've made in the last several months underscores our commitment to advancing ampligen.

Speaker Change: Multiple areas of significant medical need.

Speaker Change: We're continuing to build meaningful momentum, both clinically and strategically and I'm excited to walk through some of the recent highlights.

Speaker Change: To start we recently announced plans to conduct a new clinical study evaluating <unk> in combination with Astrazeneca as intranasal influenza vaccine luminaire. This.

Thomas Equels: This study will explore this combination as a potential intranasal vaccine for influenza, including avian flu. We're honored that Dr. Paul Gupfert of the University of Alabama Birmingham Medical Center will serve as principal investigator for this important study.

Speaker Change: This study will explore this combination as a potential intranasal vaccine for influenza, including avian flu.

Speaker Change: We're honored that Dr. Paul good for the University of Alabama, Birmingham, a medical center will serve as principal investigator for this important study.

Thomas Equels: From a corporate standpoint, we further strengthened our leadership with the addition of two board members, Ted Kellner, who has 50 years of investment experience and was previously a portfolio manager at Fiduciary Management, and David Chemero, who brings more than 40 years of finance, accounting, and operations leadership across multiple industries, Their experience and guidance will be instrumental as we move forward to execute on our strategy. On the clinical front, we're pleased to report that the Erasmus Medical Center Safety Committee has approved the continuation into the phase two portion of the DuraPanc pancreatic cancer trial. This is the ongoing phase one B slash two study evaluating Ampligen in combination with AstraZeneca's drug MFIZI, an anti-PDL1 checkpoint inhibitor for the treatment of late stage metastatic pancreatic cancer.

Speaker Change: From a corporate standpoint, we further strengthened our leadership with the addition of two board members. Ted Kellner was 50 years of investment experience and was previously a portfolio manager at.

Speaker Change: Baidu sharing management and David Jim Rowe, who brings more than 40 years of finance accounting and operations leadership across multiple industries their experience and guidance will be instrumental as we move forward to execute on our strategy.

On the clinical front, we're pleased to report that the Erasmus Medical Center Safety Committee has approved the continuation into the phase II portion of the door of Pink pancreatic cancer trial. This is the ongoing phase one b slash two study evaluating <unk> in combination with <unk>.

Speaker Change: Zeneca's drug in busy and anti PDL, one checkpoint inhibitor for the treatment of late stage metastatic pancreatic cancer dosing has commenced for the phase II portion of the trial, which is a key step forward in this critical program.

Thomas Equels: Dosing has commenced for the phase two portion of the trial, which is a key step forward in this critical program. We also announced final clinical results from our AMP 518 study, evaluating Ampligen in the treatment of patients with post-COVID conditions. This data represents a culmination of our efforts in this space and reinforces our belief in Amblogen's potential to help address the persistent fatigue experienced by so many people post-COVID. In parallel, we continue to expand our intellectual property estate. We were recently granted a U.S. patent covering compositions and methods for the treatment of endometriosis. as well as a Netherlands patent protecting the use of Ampligen for the post-COVID condition of fatigue.

Speaker Change: We also announced final clinical results from our Amp 518 study evaluating ampligen in the treatment of patients with post COVID-19 conditions.

Speaker Change: This data represents a culmination of our efforts in this space and reinforces our belief in <unk> potential to help address the persistent fatigue experienced by so many people post COVID-19.

Speaker Change: In parallel we continue to expand our intellectual property estate, we were recently granted and a U S patent covering compositions and methods for the treatment of endometriosis.

Speaker Change: As well as a Netherlands patent protecting the use of ampligen for the post COVID-19 condition of fatigue.

Thomas Equels: And lastly, we announced the publication of new data from a phase one study conducted at Roswell Park Comprehensive Cancer Center. This study evaluated Ampligen as part of a combination therapy in early stage triple negative breast cancer. And the data was published in the Journal for Immunotherapy of Cancer, further strengthening the clinical foundation and broad spectrum capabilities and potential of our immuno-oncology program. As you can see, we've maintained strong momentum and continue to execute across multiple programs. I'm very proud of our team's progress. And I believe this growing body of clinical evidence reinforces Ampligen's broad potential and positions us as a company for the next phase of our journey.

Speaker Change: And lastly, we announced the publication of new data from a phase one study conducted at Roswell Park comprehensive cancer Center. This study evaluated the ampligen as part of a combination therapy in early stage triple negative breast cancer and the data was published in the journal for immunotherapy of cancer.

Speaker Change: Further strengthening the clinical foundation, and broad spectrum capabilities and potential of our immuno oncology programs.

Speaker Change: As you can see we maintained strong momentum and continued to execute across multiple programs I'm very proud of our team's progress and I believe this growing body of clinical evidence reinforces ampligen broad potential input positions us as a company for the next phase of our journey.

Thomas Equels: Now I'd like to walk through our pipeline to provide a snapshot of where we stand across each of our active clinical programs, as well as highlight some upcoming value driving milestones that we feel have great potential. Starting with metastatic pancreatic cancer, the DuraPanc study is a phase 1B2 trial evaluating the combination of Ampligen with AstraZeneca's checkpoint inhibitor, Durvalumab. This study is being conducted in collaboration with Erasmus Medical Center and is fully funded through that partnership and collaboration agreement entered into with Erasmus Medical Center and AstraZeneca. Following the recent start of the phase two dosing, we anticipate enrollment of the final patient in this study during the second or third quarter of 2026.

Speaker Change: Now I'd like to walk through our pipeline to provide a snapshot of where we stand across each of our active clinical programs as well as highlight.

Speaker Change: Some upcoming value driving milestones that we feel have great potential.

Speaker Change: Turning with metastatic pancreatic cancer. The European study is a phase one b two trial evaluating the combination of ampligen with Astrazeneca is checkpoint inhibitor or value map. This study is being conducted in collaboration with Erasmus Medical Center and is fully funded through that partnership and collaboration.

Speaker Change: Asian agreement entered into with Erasmus Medical Center in Astrazeneca.

Speaker Change: Following the recent start of the phase II dosing, we anticipate enrollment in the final patient enrollment of the final patient in this study during the second or third quarter of 2026.

Thomas Equels: In advanced ovarian cancer, we have a phase two study evaluating amplogen and pembrolizumab, and it is nearing completion. The study is grant funded by Merck. It's expected to be completed in the first half of 2025, with data anticipated soon thereafter. For refractory melanoma, we have a phase 2 study evaluating a combination regimen that includes Amblygine, Interferon Alpha, Celecoxib, and a polarized dendritic cell vaccine in HLA-A2 positive patients. This study is funded by the National Cancer Institute, and we expect the first patient to be dosed in the first half of 2025. There is also a phase 1-2a trial in stage 4 triple negative breast cancer that combines Ampligen with Celecoxib, Interferon Alpha, and Pembrolizumab.

Speaker Change: And at advanced in advanced ovarian cancer, where we have a phase II study evaluating ampligen and pember Elysium Mab and is nearing completion. This study is grant funded by Marc it's expected to be completed in the first half of 2025.

Data are anticipated soon thereafter.

Speaker Change: Were refractory melanoma, we have a phase II study evaluating a combination regimen that includes ampligen interferon alpha celecoxib and a polarized dendritic cell vaccine in H L. A dash eight two positive patients there.

Speaker Change: This study is funded by the National Cancer Institute, and we expect the first patient to be dosed in the first half of 2025.

Speaker Change: There is also a phase one slash Iia trial are in stage for triple negative breast cancer that combines ampligen with Celecoxib interferon Alpha and Pember Elysium map. This program is also grant funded with support from Merck and the National Cancer Institute enrollment is underway.

Thomas Equels: This program is also grant funded with support from Merck and the National Cancer Institute. Enrollment is underway and the study is expected to complete enrollment in the second quarter of 2026. We also remain committed to advancing Ampligen in long COVID, where we've completed our AMP518 trial and are actively planning a follow-up study to build on the encouraging data generated today. Additionally, we're preparing a new clinical study, which I mentioned earlier, evaluating Ampligen in combination with Flumist as a potential intranasal vaccine for influenza, including avian influenza, in collaboration with the University of Alabama, Birmingham. As you can see, our pipeline continues to advance with multiple programs nearing key inflection points.

Speaker Change: And the study is expected to complete enrollment in the second quarter of 2026.

Speaker Change: We also remain committed to advancing ampligen and long Covid, where we've completed our amp 18 trial and are actively planning a follow up study to build on the encouraging data generated to date.

Speaker Change: Additionally, we are preparing a new clinical study, which I mentioned earlier evaluating ampligen in combination with flu mist is it potential intranasal vaccine for influenza, including avian influenza in collaboration with the University of Alabama Birmingham.

Speaker Change: As you can see our pipeline continues to advance with multiple programs nearing key inflection points. Each of these programs has targeted a.

Thomas Equels: Each of these programs is targeted to address areas of high-end medical need. And we believe this continued clinical progress, combined with growing external validation and strategic collaboration.

Speaker Change: To address areas of high unmet medical need and we believe this continued clinical progress combined with growing external validation and strategic collaborations positions aim for an exciting year ahead.

Thomas Equels: Positions AIM for an exciting year ahead.

Thomas Equels: I want to touch briefly now on our financial position. In terms of cash, cash equivalents, and marketable securities, and we need to address this based on the last audited numbers, we had $4 million approximately as of December 31, 2024. Research and development expenses for the year ended December 31, 2024, were $6.2 million as compared to $10.9 million for the year, which ended on December 31, 2022. and General and Administrative expenses for the year ended December 31, 2024 were $13.7 million as compared to $21.1 million for the year ended December 31, 2020.

Speaker Change: I wanted to touch briefly now on our financial position.

Speaker Change: In terms of cash cash equivalence and marketable securities and we need to address this based on the last audited numbers, we had $4 million approximately as of December 31 2024.

Speaker Change: Research and development expenses for the year ended December 31, 2024 were $6 2 million as compared to $10 9 million for the year, which ended on December 31 2023.

Speaker Change: And general and administrative expenses for the year ended December 31, 2024 were $13 7 million as compared to $21 1 million for the year ended December 31 2023.

Thomas Equels: Now I'd like to take a moment to address our continued listing on the New York Stock Exchange America. Maintaining our listing is a major priority frame, and we believe it's essential for our long term. Being listed on a national exchange provides access to capital, enhances our credibility and visibility in the market, and supports stockholder and partner confidence. It also helps ensure liquidity for our stockholders, which is a critical consideration as we continue to build momentum across our pipeline. We understand the importance of meeting the exchange's listing requirements and are actively evaluating all available options to maintain compliance.

Speaker Change: Now I'd like to take a moment to address our continued listing on the New York Stock Exchange American.

Speaker Change: Maintaining our listing is a major priority frame and we believe it is essential for our long term success.

Speaker Change: Being listed on a national exchange provides access to capital enhances our credibility and visibility in the market and supports stockholder and partner count competence. It also helps ensure liquidity for our stock holders, which is a critical consideration as we continue to build momentum across our pipeline.

Speaker Change: We understand the importance of meeting the exchange's listing requirements and are actively evaluating all available options to maintain complaint.

Thomas Equels: This includes a potential reverse stock split, among other strategic alternatives. We will be holding a special meeting of stockholders within the next month or so to authorize our board to effect a reverse stock split at that time and at a ratio that should avoid delisting. We are committed to taking the necessary steps to preserve our list. and will continue to act in the best interest of the company and our stockholders as we move forward.

Speaker Change: <unk> the potential reverse stock split among other strategic alternatives.

Speaker Change: We will be holding a special meeting of stockholders within the next month or so to authorize our board to effect a reverse stock split at that time and at a ratio that should avoid delisting.

Speaker Change: We are committed to taking the necessary steps to preserve our listing.

Speaker Change: And we'll continue to act in the best interest of the company and our stockholders as we move forward.

Speaker Change: Yeah.

Thomas Equels: Before I turn it over to the operator for questions and answers, I want to take a moment to center on what drives everything we do here at AIM. It is our mission, immunology for a better future. And that is more than just a tagline. It reflects our deep belief in the potential of ampligens and our commitment to advancing this important asset so it can make a real difference in patients' lives.

Speaker Change: Before I turn it over to the operator for questions and answers I want to take a moment to center on what drives everything we do here at Ing.

Speaker Change: It is our mission immunology for a better future and that is more than just a tagline. It reflects our deep leaf and the potential of ampligen and our commitment to advancing this important asset. So it can make a real difference in patients' lives.

Thomas Equels: With that, Operator, we're ready to take questions, and thank you very much. Thank you.

With that operator, we're ready to take questions and thank you very much.

Operator: We will now be conducting the question and answer session. If you would like to ask a question, please press star one on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star 2 to remove yourself. Participants using speaker equipment, it may be necessary to pick up your hands before pressing the star key. One moment, please, while we poll for your question.

Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.

Speaker Change: A confirmation tone will indicate your line is in the question queue.

Speaker Change: Press Star two to remove yourself from the queue.

Speaker Change: Participants using speaker equipment may be necessary to pick up your handset before pressing the star keys.

Speaker Change: One moment, please while we poll for your questions.

Edward Woo: Our first questions come from the line of Ed Woo with Ascendian Capital Markets. Please proceed with your question. Yeah, congratulations on all the progress. My question is on your current inventory of Ampligen. Do you have adequate supply for all your clinical trials this year? And how easy would it be for you to get new supply?

Speaker Change: Our first questions come from the line of Ed Woo with <unk> capital markets. Please proceed with your questions.

Ed Woo: Yeah. Congratulations on all the progress my question is on your current inventory Apple Jim do you have adequate supply for all your clinical trials this year and how easy would it be for you to get new supply.

Thomas Equels: Well, thank you, Dr. Woo. We have an Ampligen budget that's tied to our ongoing clinical activities so that we make an effort and certainly our collaborators, especially the research institutes that we work with, consider it very important that we budget sufficient Ampligen for the trials that are ongoing. So I believe, absent some unanticipated or extraneous event, that there should be no problem supplying Ampligen for the ongoing clinical trials. For future clinical trials, we will have to manufacture more Ampligen, and that requires capital, but the process for manufacturing additional Ampligen is being analyzed, and the work that we're doing with polymer manufacturers and other vendors that are essential to the manufacturing process is a part of our constant operational activity.

Speaker Change: Well thank.

Speaker Change: Thank you Dr. <unk>, we have ampligen budget, that's tied to our ongoing clinical activities. So that we.

When you make an effort in and certainly our collaborators, especially the research institutes that we work with our consider it very important that we budget sufficient ampligen for the trials that are ongoing so so I believe absent some.

Speaker Change: The unanticipated or extraneous events that are there should be no problem supplying ampligen for the ongoing clinical trials.

Speaker Change: For future clinical trials, we will have to manufacture more ampligen and that requires capital are but the process for manufacturing additional ampligen is being analyzed and the work that we're doing with the polymer manufacturers and other vendors that are essential to the <unk>.

Speaker Change: Manufacturing process is a part of our constant operational activity.

Edward Woo: So we don't anticipate a problem of running out of ampligen absent some unforeseen circumstance. Great.

Speaker Change: So we don't anticipate a problem I'm running out of ampligen absent some unforeseen circumstance.

Edward Woo: Well, thank you for answering my questions and I wish you guys good luck. Thank you. Thank you very much. Thank you.

Speaker Change: Great well. Thank you for answering my questions and I wish you guys. Good luck. Thank you.

Speaker Change: Thank you very much.

Speaker Change: Thank you we have reached the end of our question and answer session.

Operator: We have reached the end of our question and answer session. And with that, that does bring this call to a close. We appreciate your participation today. You may now disconnect.

Speaker Change: And with that that does bring this call to a close we appreciate your participation today you may now disconnect.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Uh huh.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.