AIM ImmunoTech Inc.

Hello and welcome to the AIM Immunotech fiscal year 2023 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. 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. At this time, I'd like to remind our listeners that remarks made during this 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's 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 to differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports aimed 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 review these documents carefully. Additionally, certain information contained in this webcast relates to or is based on studies, publications, surveys, and other data obtained from third-party sources and 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 sources verified any information obtained from third-party sources. Joining us on today's call from AIM leadership team are Thomas Equals, Chief Executive Officer, and Dr. Christopher McAleer, Scientific Officer. I would now like to proceed to turn the call over to Mr. Equals. Please proceed, sir.

Thank you, everyone, for joining us. 2023 was an extremely important year for AIM. We demonstrated progress resulting in significant advancements across our pipelines. showcasing a growing body of highly promising, consistent, positive data with our priority development programs. This data-driven progress drives our firm enthusiasm and belief in Ampligen's long-term potential in these many areas where we have shown clinical therapeutic value through the data. And these are not only unmet medical needs, sometimes lethal unmet medical needs, but also high-value indications, such as advanced local and metastatic pancreatic cancer, advanced recurrent ovarian cancer, post-COVID conditions of chronic fatigue and cognitive dysfunction. These are all important unmet medical needs that we're challenging. On the corporate front, Our positive data in oncology was the catalyst for us to engage as ANOVA, a specialized oncology business development firm. And that is to drive our licensing discussion using skilled experts in the field to engage the negotiation of potentially valuable relationships with qualified partners. We have a robust business development strategy for oncology involving our use of Azanova, and that process is now underway. Importantly, my mandate and strategic imperative for the company early on was to broaden and take steps to secure our patent estate for Ampligen, especially in oncology. As a priority, we successfully continued to do just that. You'll note that we had the issuance of a key U.S. patent, and that's where we were protecting our use of Ampligen in combination with PD-L1 checkpoint inhibitors, such as Dervalumab, the AstraZeneca drug. We've also made tremendous progress in the clinic with Ampligen combined with PD-1 checkpoint inhibitors. So we're trying to establish in many tumors different tumor types, and with different checkpoint inhibitors, Ampligen's ability to create synergy, sometimes massive synergies. Now, I believe that the clinical work that we do is very important, not only for our business development strategy, because for any potential future partner, clinical progress de-risks their investment, but also for our stockholders and investors to understand that all of this work also creates a foundation for long-term value. Through 2023, this time last year to now, we've had tremendous progress. This time last year, we hosted our inaugural earnings call, and quarterly thereafter, we have engaged in similar efforts of updating and providing progress reports to our stockholders. In 2023, we upgraded our website, and we've been extremely effective and active on social media channels. All of this demonstrates our commitment to good communication. Recently, we launched AIM's CEO Corner, to provide a portal on our website to further discuss important topics for the company and areas of interest to you. If you have an area of interest you want to suggest, contact our IR portal and give them your ideas on what we should be talking about on CEO Corner. We are all in this together. I'm a stockholder too. And over the past several years, I have personally invested what I believe is a substantial amount of money in AIM. I believe it is critical for management to stand shoulder to shoulder with our stockholders. And we will lock arms working together to move this company into its next phase of growth and what I believe is a phase that presents great opportunity. It is now my pleasure to turn over this discussion to our science officer, Dr. Chris McAleer. He'll give you a detailed update on our progress in the various clinical trials and also, I hope, broaden your understanding of the mechanism of action of Ampligen, what it's doing in the immune system based upon recent data. Chris? Thank you, Tom.

Ampligen is a treatment for multiple indications from locally advanced and metastatic pancreas cancer to advanced recurrent platinum sensitive ovarian cancer to long COVID. And I will take a few moments to briefly walk through some important aspects of our clinical portfolio. I will start with the study in advanced recurrent platinum sensitive ovarian cancer ongoing at the University of Pittsburgh. I have had an opportunity to review the preliminary data that will be included in the interim report. and we will be releasing a statement in the very near future once the finalized report has been received. What I can say now is that based on the initial data, the safety profile is good. The objective response rate is better than the preliminary data that was reported in the April 2022 AACR abstract. I do remind all shareholders that the data presented at AACR indicated that the Ampligen PEMBRO-containing treatment had a four to five times greater objective response than that seen in the Keynote 100 study of pembrolizumab alone in recurrent ovarian cancer, and the objective response rate being complete in partial tumor responses. The study has moved on to the second stage of the Simon 2 stage design. The data is very promising, and recruitment rates have also accelerated post-COVID, so all of those are positives. Detailed data from the planned interim report will be disseminated in the upcoming press release. We've reported positive top-line data for the AMP518 post-COVID trial in February, and I have also recently reviewed the preliminary copy of the complete study report. We are currently working with AMOREX to finalize that report, at which time we will begin deep analysis of the data and use that information to help inform the design of the next trial. The post-COVID landscape is diverse and information is continually being generated that helps refine the scientific community's understanding of the disease. And the trial was designed to collect preliminary data to appropriately power the next trial, as well as understand and refine inclusion criteria for the design of a successful phase two pivotal study. That analysis will likely take some time based on the over 32,000 pages worth of data listing, but I am optimistic that based on the preliminary review of the data, it is sufficient to design and power the subsequent trial. Concerning our AMP270 trial in locally advanced pancreas cancer, we are currently preparing for a Type D meeting with the FDA to discuss altering inclusion criteria for the IND protocol. If we are successful, it will expand the patient population that would be eligible for enrollment. I will speak further on this in the future after resolution of the Type D meeting. In the interim, we are still recruiting and opening new sites, and the current sites are still open for enrollment and are screening potential candidates. Hopefully, upon successful consultation with the FDA, the revised protocol will allow for faster recruitment of sites and patients in the US. Erasmus Medical Center in the Netherlands should be open for recruitment any day now, and we are engaged in conversations with other sites in the EU. That brings me to the Dorapank study combining Ampligen and Dervalumab as therapy post-Pulverinox. The phase one portion of the trial is a three-in-three escalation design with fixed Dervalumab dosing with escalating Ampligen dose. The first three patients of the three-in-three design have been enrolled already, and two patients have completed their Ampligen dosing and have received at least two Dervalumab doses. The last patient, last Ampligen dose is in mid-April, and thus far there have been no reported adverse events. Once the patient completes the last ampligen dose and finishes the prescribed monitoring period, which should be around the end of April, and assuming the safety profile is consistent as it has been thus far, we can escalate to the next dose. That trial so far is going according to schedule, and if that continues, we expect the phase one portion to be completed in the summer of 2024. I lastly want to address the early access program in pancreas cancer. Enrollment in this program will halt as these patients should be enrolled in either DoraPank or AMP270. And from this program, data was recently published in the Journal of Clinical Cancer Research. And these data highlight aspects of the mechanism by which Ampligen exerts prolonged progression-free and overall survival in pancreas cancer patients. These data were also part of the information used to design the DoraPank study and what gave further confidence that Ampligen would work synergistically with the PD-L1 checkpoint inhibitor, Dervalumab. With that being said, I'd like to take a second and look at Ampligen effects in various different solid tumors. Ampligen works by binding to toll-like receptor 3, which are found on epithelial cells and immune cells in the body. Solid tumors in different parts of the body are similar in that they form from epithelial tissue, and therefore these tumors express Toll-like Receptor 3. Our hypothesis has been that Ampligen will be an effective treatment in multiple solid tumor types, because one, it's binding to Toll-like Receptor 3 found in the solid tumors, no matter where that tumor might be in the body, whether it be pancreas, ovarian, breast, or otherwise. And two, the Ampligen binding to the Toll-like Receptor 3 found on the surface of immune cells that are distributed throughout the body, including the tumor microenvironment. And this chart shows different immune biomarkers. And these are markers of immune cell chemotaxis and dendritic cell or T-cell infiltration in the tumor microenvironment. And this table might seem complicated, so a more relatable analogy might be that ampligen forces the tumor to make a 911 distress call to the immune system against its will, shown here in the table by increases in CXCL9, 10, and CCL5. And subsequently, the immune system infiltrates the tumor and attacks it. shown by upregulation of Granzyme B and CD8 in this chart. And this table shows that the phenomenon happens in multiple different solid tumor types we have investigated. And therefore, we believe that Ampligen has potential not simply as a treatment for one specific form of cancer, but as a treatment for many types. And importantly, I want to highlight that these immune-modulating properties, coupled with other biomarker data we have, suggest that Ampligen would have considerable synergistic effects with immune checkpoint inhibitors. Our data in triple negative breast and ovarian cancer confirm that hypothesis, and I believe this will be confirmed through the DORA-PANK study for pancreas cancer as well. And I'd now like to turn the presentation back over to Tom Eagles to discuss our key recent clinical and business milestones, as well as what to expect in the coming months.