Participants

Thomas Equels; President, Chief Executive Officer, Executive Vice Chairman; AIM ImmunoTech Inc

Edward Woo; Analyst; Ascendiant Capital Markets

Presentation

Operator

Hello and welcome to the AIM ImmunoTech fourth-quarter and full-year 2024 update conference call and webcast. (Operator Instructions) 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.
At this 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 and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and are based on AIM ImmunoTech current expectations and 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 of different materially from these contemplated by such forward-looking statements are discussed in the periodic reports AIM ImmunoTech's files with the Securities and Exchange Commission.
These documents are available in 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. 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 the third-party sources to be reliable as of the date of this presentation, it has 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.
Joining us on today's call from the AIM ImmunoTech leadership team is Thomas Equels, Chief Executive Officer. I'd like to now turn the call over to Mr. Equels. Please proceed.

Thomas Equels

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.
This study will explore this combination as a potential intranasal vaccine for influenza, including avian flu. We're honored that Dr. Paul Goepfert of the University of Alabama-Birmingham Medical Center will serve as principal investigator for this important study.
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 Chemerow, 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 2 portion of the DURIPANC pancreatic cancer trial. This is the ongoing Phase 1b/2 study evaluating Ampligen in combination with AstraZeneca's drug Imfinzi, an anti-PD-L1 checkpoint inhibitor for the treatment of late-stage metastatic pancreatic cancer.
Dosing has commenced for the Phase 2 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 and Ampligen'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 US 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.
And lastly, we announced the publication of new data from a Phase 1 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 programs.
As you can see, we 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.
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 DURIPANC study is a Phase 1b/2 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 2 dosing, we anticipate enrollment of the final patient in the study during the second or third quarter of 2026.
In advanced ovarian cancer, we have a Phase 2 study evaluating Ampligen 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 Ampligen, 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. 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 AMP-518 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. Each of these programs is targeted to address areas of high unmet medical need, and we believe this continued clinical progress combined with growing external validation and strategic collaboration positions AIM for an exciting year ahead.
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, 2023. 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.
Now, I'd like to take a moment to address our continued listing on the New York Stock Exchange American. Maintaining our listing is a major priority frame and we believe it's essential for our long term success. 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 listing requirements and are actively evaluating all available options to maintain compliance.
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 affect the 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 listing, and we will continue to act in the best interests of the company and our stockholders as we move forward. 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 the Ampligen and our commitment to advancing this important asset so it can make a real difference in patients' lives.
With that operator, we're ready to take questions, and thank you very much.

Question and Answer Session

Operator

(Operator Instructions) Ed Woo, Ascendiant Capital Markets.

Edward Woo

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?

Thomas Equels

Well, thank you, Dr. Woo. We have a Ampligen budget that's tied to our ongoing clinical activity 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 the 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 Ampligens 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.
So we don't anticipate a problem of running out of Ampligen absent some unforeseen circumstances.

Edward Woo

Great. Well, thank you for answering my questions, and I wish you guys good luck. Thank you.

Operator

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