AIM ImmunoTech Inc.

Hello and welcome to the AIM Immunotech first quarter 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 this event, please press star zero on your telephone keypad. Following the presentation, there 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 Immunotech'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 those contemplated by such forward-looking statements are discussed in the periodic reports AIM Immunotech 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 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 are Thomas Equals, Chief Executive Officer, and Dr. Christopher McAleer, Scientific Officer. I will now turn the call over to Mr. Equals. Please proceed.

Thank you, operator. Welcome, everyone, and thank you very much for your interest in AIM Immunotech. I'm very pleased with our progress over the past several months. To summarize, on the clinical front with our DuraPank study, we took an important step forward in the testing of the combination of Ampligen with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, Mphysi, also known as Dervalumab, for the treatment of late-stage metastatic pancreatic cancer. This is pursuant to a collaboration agreement that we have with AstraZeneca and Erasmus Medical Center, and it is moving at full speed ahead. As we reported, the investigator at Erasmus Medical Center in the Netherlands completed the safety evaluation of patients enrolled in the first dose level of the dose escalation design in the Phase 1b-2 study. The combination of Ampligen and mFSI was found to be generally well-tolerated with no severe adverse events or dose-limiting toxicities. We are very encouraged as we continue to see a consistent safety profile across our oncology pipeline in multiple indications. Based on these positive results, escalation to the next dose level in Durapank will occur according to the protocol design and we expect the next cohort of patients to begin dosing very soon. We also announced the top line interim data indicating that the combination of Ampligen with Keytruda also known as pembrolizumab, in the treatment of recurrent ovarian cancer may have a very powerful synergistic effect. The investigator concluded the combination therapy could be far more effective than pembrolizumab alone as a therapy for this dread disease. These interim data clearly suggest that there may be a massive positive impact on efficacy when Ampligen is combined with pembrolizumab for the treatment of recurrent ovarian cancer. Other research suggests a similar effect on other solid tumor types. This means we can see an ampligen as a potential combination therapy, having therapeutic potential across multiple types of solid tumors and possibly even with different checkpoint inhibitors. Now, Dr. Chris McAleer, our science officer, will be talking in more depth about our lead clinical programs in just a few minutes. On the operational front, we have successfully completed CGMP manufacturing of 9,042 clinical valves of Ampligen. This repeatable manufacturing expertise represents a critical component of our overall commercial and business development strategies. Our record of successful manufacturing is important as we seek commercial partners as well as for establishing Ampligen reserves for ongoing and upcoming clinical trials. And finally, on the corporate front, Dr. Charles Lapp recently joined the company's medical and scientific team. Dr. Lapp is a very well-respected and well-known, world-class player in the disease of ME-CFS. He played a key role in our longstanding AMP511 expanded access program for the treatment of ME-CFS and long COVID. Of note, he founded and led one of the clinical trials key sites, the Hunter Hopkins Center in Charlotte, North Carolina, from which he recently retired. As a consulting medical officer and an independent contractor, he will help manage the company's research programs related to ME-CFS and Long COVID, including the development of protocols and new clinical trials. All of this progress in just a few short months continues to demonstrate our commitment to advancing our pipeline and operational execution. I now turn over the call to Dr. McAleer, our science officer, to discuss our priority pipeline programs. Chris, please.

Thank you, Tom. I'd like to give a brief status update on our lead programs. The FDA has granted our Type D meeting request regarding the AMP270 study in locally advanced pancreas cancer, and according to their proposed timeline, we should have preliminary answers in late June. Assuming that AIM and the FDA are in agreement, we will then be able to move forward with expanding the patient population that would be eligible for enrollment. I will be able to speak further on this once we have a resolution from the Type D meeting. In the interim, there are open sites that are screening potential candidates, and we are also working to recruit and open new sites. Hopefully, upon successful consultation with the FDA, the revised protocol will allow for faster recruitment of sites and patients. The DORPANK study combining Ampligen and Dervalumab as therapy post-Pulverinox in metastatic pancreas cancer is proceeding according to schedule. The phase one portion of the trial is a three-in-three escalation design with fixed Dervalumab dosing and escalating Ampligen dose. As we recently reported, the first three patients of the three-in-three design have completed the safety evaluation, and the few adverse events observed were only grade one with no serious adverse events. The internal evaluation committee at Erasmus has approved the escalation to the next dose, and patients have already begun the evaluation and enrollment process. We expect the phase one portion of DoraPank to be completed this summer. As promised in the last update call, we have announced the efficacy data of Ampligen, Pembrolizumab, and Cisplatin in the ongoing trial in advanced recurrent platinum-sensitive ovarian cancer at the University of Pittsburgh. The data indicated an objective response rate of 45%. When you compare this to the OR or objective response rate of 39% in the preliminary data published in 2022, or the objective response rate of about 8% in the Keynote 100 study of pembrolizumab alone, you can see the potential positive impact that this trial could have for women with recurrent ovarian cancer. We are currently working through the data for the AMP518 trial for Ampligen as a potential therapy for the post-COVID condition of fatigue. We are also consulting with patient advocacy groups to further understand the symptomatology of patients to help further refine and design the follow-on trial. We are waiting for the results of the exploratory biomarker analysis to finalize the data. And as such, I do not currently have an estimate of when the next IND will be submitted, but we will keep stockholders and others advised as we proceed. And as you can see, we are advancing in our clinical agenda, and I look forward to being able to announce new progress throughout 2024. And I'll hand it back to Tom to discuss the company financials. Thank you very much, Chris.