Hello, and welcome to the AIM ImmunoTech Third Quarter 2024 Update Conference Call and Webcast. As a brief reminder, all participants are currently in a listen-only mode. [Operator Instructions] 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 that 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 these 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 Investors 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 Chief Executive Officer, Thomas Equels, and Scientific Officer Dr. Christopher McAleer. I would now like to turn the call over to Mr. Equels. Please proceed.

Thank you very much, operator, And I'd like to thank everyone for joining us this morning. Throughout the third quarter, we have made solid progress with the advancement of our lead product, Ampligen. By this, I mean our team continued to execute on our clinical and regulatory strategies with our Ampligen development programs across several indications. And I want to remind you that these are areas with critical unmet needs, especially in the high-value pancreatic cancer space. Importantly, we continue to deliver positive clinical trial data across our pipeline, and we believe this progress is driving significant momentum. I'll briefly highlight our progress and then turn the discussion over to our Science Officer, Dr. McAleer, to dive deeper into our programs and our progress. We recently announced positive preliminary data from the Phase 1b/2 study, which we call DURIPANC, evaluating the combination of Ampligen, also known as rintatolimod, and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, Imfinzi, also known as durvalumab, in the treatment of late-stage metastatic pancreatic cancer. During the third quarter, we also announced the great news that the complete clinical patient data from our AMP-518 clinical trial supports our belief in Ampligen as a potential therapeutic for a subset of people with moderate to severe post-COVID conditions of fatigue. These data for that group are statistically significant and allow us to target the subject population for AIM's planned follow-up clinical trial. We are amassing a growing body of data and continue to report as well as publish our data at scientific congresses and prestigious journals and publications supporting Ampligen as both a monotherapy and combination therapy with other approved drugs. During the quarter, we announced official print publication of the data analysis from Erasmus from a long-term early access program studying Ampligen for the treatment of advanced pancreatic ductal…

Thank you, Tom. We have a bit to cover today, and I will start with our programs in pancreatic cancer. DURIPANC is a Phase 1/2 trial to determine the safety and efficacy of combining Ampligen with AstraZeneca's durvalumab in the treatment of metastatic pancreas cancer. We recently announced that the 200-milligram dose was deemed safe, and we were able to proceed to 400-milligram dosing of Ampligen. The study encountered some last-minute screen failures, and there will need to be at least one additional patient enrolled to gather the necessary dose-limiting toxicity data to complete the Phase 1b. The study is on track for the final patient to be enrolled by the end of the calendar year. Thus far, there have been no serious adverse events at either the 200-milligram or 400-milligram doses, and we expect a smooth transition to Phase 2. As we reported earlier, two of the three patients in the low dose cohort had stable disease at the six-month time point, and the higher dose cohorts have yet to reach the six-month assessment. However, of the six valuable patients that have reached the three-month evaluation time point, and this does include both 200-milligram and 400-milligram dosing, five of the six patients, that's 83%, have stable disease at the three-month time point. Erasmus has a large cohort of historical data, and comparably only 20% of historical patients have stable disease at that time point. The first patients in the 400-milligram cohort are approaching the six-month assessment over the next few weeks, and two of the three patients still have stable disease. When evaluating progression-free survival from the start of FOLFIRINOX utilizing the standard Kaplan-Meier time-to-event analysis, and I caveat this by saying these data are preliminary and only from these few DURIPANC patients, the DURIPANC combination has a current…

Thank you very much, Chris. I'd like to direct everybody to Slide number 9, excuse me, Slide number 8, which addresses our audited financials, and state that we've covered a lot of our fundamental progress today. Our priorities, our focus, our enthusiasm, our vision, and our mission have never been clearer. The strength of our growing body of data across multiple indications is both robust and highly encouraging. We are driving significant momentum across multiple clinical programs and studies that are demonstrating Ampligen's significant potential to address high value and high need indications, especially in the pancreatic cancer space. Over the course of 2024, our team has made important progress in executing our clinical strategy, facilitating potential partnerships, including with big pharma, and leveraging commercialization opportunities to create value. The entire AIM team is dedicated to helping patients in need and delivering enhanced value for our shareholders. I would like to inform you that AIM ImmunoTech has found a definitive proxy statement and related proxy materials with the SEC in connection with the 2024 annual meeting of shareholders. And in connection therewith, its directors and executive officers, Peter W. Rodino III and Robert Dickey IV, are participants in the solicitation of proxies from our shareholders in connection with such annual meeting. AIM shareholders are strongly encouraged to read such proxy statement and all other related materials filed with the SEC carefully and in their entirety as they contain important information about the 2024 annual meeting. As you may know, a group of activist investors has nominated four individuals to replace our entire Board. We have issued a detailed public letter on this, but I want to make a few points on this call. For the third year in a row, several individuals of this group are trying to take control…

[Operator Instructions] Our first question comes from the line of [Chad Yahn] (ph) with Maxim Group. Please proceed with your question.

Hi, guys. Thanks for taking the question, and congrats on the progress. I was wondering if you could provide some additional color on the next steps for the Long COVID program and what the potential next studies on there could look like?

Well, thank you very much for the question. And we're utilizing the data that the analysis has just been completed to formulate a profile for inclusion in that next trial. The group that's been identified as having a significant response with statistical significance is in the moderate to severe category of the disease. And I'd like to allow Dr. McAleer to address a few points related to the specifics of the data and also maybe the input that we see generally from the biomarkers.

Thank you for the question. I think The path forward will partially depend on whether Ampligen is chosen in the RECOVER-TLC program. If it's [recovered] (ph) for the TLC program, most of that clinical design will be part of their platform study and the readouts and such will be driven in combination with our input by the NIH, also funded by the NIH. If it's not chosen, we have looked through the data and we found that those who are most severe, the home ambulatory patients, respond best to Ampligen. We've also found blood biomarkers that show those that have markers of anemic events and/or immune cell deprivation seem to respond better to Ampligen as well. And so the design of the trial will incorporate those elements, right? So we're looking at the most severe, moderate to severe patients that have particular biomarkers, that we're looking at that likely the outputs will be something related to fatigue or post-exertional malaise and the design will likely be some sort of Phase 2/3 trial.

And if I might add, the AMP-518 as a part of our concept was to have a relatively broad net for inclusion so we could identify not just who responded well to Ampligen, but where we did not get a significant response in the patient population. So it did its job. We do see a segment of that population, which Chris just described, where there's data that establishes an opportunity to help people move from home ambulatory to community ambulatory, which is a big step in terms of therapeutic improvement. And that data was statistically significant.

That was very helpful. Thanks, gentlemen.

You're welcome.

Thank you. Our next question comes in line of Ed Woo with Ascendiant Capital Markets. Please proceed with your question.

Yeah, congratulations on all the progress. I was curious about, you mentioned that you were able to reduce the cost and time to produce a batch of Ampligen. How much does it cost and how much time does it take to produce the batch? And also, is there any opportunities to improve that going even further?

Ed, we do have plans to continue to work on developing efficiencies in the manufacturing process. And in the bigger picture, if we are able to reach an arrangement with a larger pharma company for development and actual commercial distribution of the drug, that will allow for mass production of the Ampligen rather than production of small lots, which mass production techniques will create tremendous savings on a per-val basis. Chris, do you want to go into some of the things that we're working on right now?

Yes, I don't necessarily want to go into the details of it. We're looking at the patentability of the process that we have ongoing. Right now, the polymer production process is about 400,000 per batch of Poly I, Poly C12U. We have reduced that down to approximately 200,000 with this production. It is still a batch production process. I do believe that we can turn that into a continuous flow process, but we're doing this iteratively. I think when we get that to a continuous flow process, we can probably increase production by three or four-fold for the same production cost. These changes that we've made to the polymer production don't necessarily affect the fill and finish process of taking that API into Ampligen, which currently is in batch production. However, that batch production of Ampligen is currently limited by the quantity of polymer that we can make at any one time. When we go to a continuous flow process of the polymer production and create that into larger quantities, we can increase the batch size production of Ampligen from approximately 9,500 vials to, I believe, somewhere around the 30,000 to 35,000 in production. And in doing so, we can locally project the reduction in cost by about 60% to 70%, which would take us somewhere from the 600,000 down to the 250,000.

Dr. Woo, does that answer your question?

Yes, it does. Thank you very much, and I wish you guys good luck. Thank you.

Thank you. Thank you for your interest.

Thank you. Ladies and gentlemen, this concludes our question-and-answer session, and thus concludes our call today. We thank you for your interest and participation. You may now disconnect your lines.