Okay, we're ready to get started. Good afternoon, everyone, and thank you for joining us today for our Virtual Investor Closing Bell segment, featuring AIM ImmunoTech. My name is Jenene Thomas. I am CEO of JTC IR, and I will be the moderator for today's event. I am very pleased to be joined by Thomas Equels. He is Chief Executive Officer of AIM. Welcome, Tom. Good to be here, Jenene. Thank you very much for having me. Happy to have you back on our platform, and we're really excited to showcase AIM today on our platform to provide investors the opportunity to connect with you. For today's event, we'll start with a discussion between Tom and I, kind of like a little bit of a fireside chat, and then we'll open it up for Q&A with our attendees. Before we get started, I just want to remind our audience that AIM ImmunoTech is publicly listed on the NYSE American and trades under the ticker AIM. During today's discussion, the company will be making forward-looking statements, and I encourage everyone to view the company's latest SEC filings on their website at aimimmuno.com for the latest information. Also, we're not going to be doing a formal presentation. If you're new to AIM, if you're new to the Virtual Investor platform, in the AIM discussion, I do encourage you to go to their website. Lots of information. There's data, publications, press releases, information on the management team, so aimimmuno.com for that information. Tom, as I mentioned, we're going to do a little bit of a fireside chat, so we'll dive right in. You recently shifted your primary focus to Ampligen for the treatment of pancreatic cancer. Can you give an overview for the audience as to why you did this? Certainly, Jenene. This program goes back several years, when we repurposed Ampligen into oncology and began a concerted effort engaging in clinical trials in multiple different solid tumors. Now, fortunately, the data from those clinical trials, conducted at top research institutions by top investigators, all produced favorable data. At some point, we had to pick a target that presented the best business opportunity. Now, one of the first programs that we initiated was in late-stage pancreatic cancer. We treated our first subject with Ampligen in a monotherapy program that was approved by the Dutch government. It's called a named patient program or early access program. By the end of it, we got some of the final data has come in, 82 different subjects. That data was very compelling, because what it showed when compared to well-matched historical controls, that we produced a distinct and significant extension of both progression-free survival and, most importantly, overall survival beyond the standard of care. Now, we also have another element that we drew from that early access program that is very important. Consistently, patients were reporting significant improvements in their quality of life. For late-stage cancer patients with pancreatic cancer, that is very, very important. Many of those therapies that are out there and in development have very harsh and painful, sometimes, side effects that they have to deal with. We moved from the early access program into a phase II, which is underway right now, and we see that same quality of life, as well as making similar progress. That's Ampligen in conjunction with AstraZeneca's checkpoint inhibitor called durvalumab. That's a program at Erasmus University in the Netherlands, collaborating with AstraZeneca and Erasmus. Now, from a business standpoint, the medical ethics of it are crystal clear. There's 150,000 people dying every year, horrible, painful deaths from late-stage pancreatic cancer, and it's a serious unmet medical need. From a business standpoint, we have to look at where we're at. This is the largest market of any of those cancers that we were working in. It's a market where there is little or no competition. It's also a market where we've been able to develop both intellectual property through patent achievements, as well as orphan drug designations for Ampligen and pancreatic cancer that allows us levels of market exclusivity, which down the road, if we're able to get into a position where we're negotiating licensing or takeover of Ampligen for pancreatic cancer with one of the big pharma companies, that intellectual property protection is very, very valuable, I believe, and creates long-term stockholder value. That's why we made our choice amongst all those solid tumors and said, the place we need to be because people need it the most, the place we need to be because it's the best business plan for our stockholders, is late-stage pancreatic cancer. Excellent. Of course, you have a lot of data there. You currently have your ongoing phase II study, what you call DURIPANC, and this is in collaboration with the big pharmaceutical company, AstraZeneca. We've seen some important advancements from this study. Can you summarize the data so far and what we can expect next? Certainly. Well, one of the things I would ask people to do so they can read it for themselves is go to our website, look at some of the slide decks on our cancer programs, our pancreatic cancer program specifically. But also, one of the things when we set up DURIPANC that we sort of reached agreement on, is that we would get information from the study. It's an open label study, from Erasmus and the team in charge of the study, so that we could do mid-year and year-end reports as the study went on. Now, when you look at the first mid-year report and the follow-up year-end report for year-end 2025, you see that we've got a good safety profile, quality of life is good, and importantly, we're seeing positive results in terms of disease stabilization, which is what leads to extended overall survival. Everything so far is very positive, but the study's not over. What is good, and this is something that is somewhat unique to late stage pancreatic cancer, because the disease mortality comes very quickly, and it's a very aggressive cancer when it's typically diagnosed late stage. We're able to achieve meaningful analyses of overall survival very quickly. Our primary endpoint, we'll have all of the data we need from that end. Everything's moving according to plan, by the end of the year. We will have enrollment completed mid-year this year, sometime in June, probably, perhaps July. We'll have achieved the necessary data collection to address whether or not we've achieved our primary endpoint right around year-end. We have secondary endpoints to deal with longer term overall survival that, of course, we have to wait longer, and that would be mid-year of 2027. The important thing to note, and this is one of the things in pancreatic cancer that sometimes makes clinical trials difficult, is because of the aggressiveness of the disease and the fast-acting nature, is that we have basically stayed on track with our enrollment. We believe that we have candidates so that we'll achieve full enrollment in the very near future, and that's an important endpoint, because all the final data follows on that completion of enrollment. Excellent, Tom. The mid-year and year-end reports for the DURIPANC study mentioned improvements in quality of life for the pancreatic cancer patients in the study. Can you tell us why you're seeing that and why it's important? Well, it's extremely important, because if you look at the approved therapies for pancreatic cancer, like FOLFIRINOX, as the first line therapy, the side effects of that chemotherapy are very burdensome on the subjects. You're dealing with a cancer which, in and of itself, without even the impact of a difficult to address from a side effect chemotherapy. That cancer by itself is extremely painful, and because it creates a highly immune suppressed state, leads to comorbidities, which are only exacerbated by the first line of therapy. The typical late stage pancreatic cancer patient does not have a good quality of life. Many of the drugs in development have severe side effects and high levels of side effects, so that even though they're extending life by perhaps an additional six or 10 months, it may come with the trade-off of those side effects. We're very fortunate because what we've been seeing, and at this point between the early access program, or named patient program, and DURIPANC, we've probably treated close to 100 people, and with the Ampligen. What we see consistently is not only the disease stabilization leading to the extension of overall survival, but we're also seeing consistently high levels of quality of life as compared to what they were dealing with before. Which, when you're in that state, being able to have a therapy that extends your life, but a life that you can enjoy living and make the most of, is very, very important, we believe, to the patients who need this drug. Absolutely. You mentioned in your opening response to my question, the market, the business piece of your decision, so I wanted to dive a little bit further into that. What makes the market for pancreatic cancer attractive to AIM? It's been a difficult area, as we know, for drug development. Can you discuss this market and the unmet need? Well, the unmet medical need is what drives the market. This is one of those instances where, for example, we've gotten orphan drug designations, but it's based upon the fact that there is no drug that really positively addresses the problem. It's an orphan drug designation. In this instance, it doesn't mean it's a rare disease. This is a disease that kills, in the three major markets, approximately 150,000 people every year. The time from diagnosis to mortality is very, very quick. You're talking about a large market. It's a market where there is some competition, but it's open to a drug like Ampligen as we move forward. If we continue to develop positive data through this phase II program, that adds on top of our monotherapy data, which was extremely positive. It is our hope that as we move into a phase III, that data helps to de-risk the phase III, but also lets us know that we can have an opportunity to do a pivotal trial supporting a new drug application, which will not only provide a positive therapeutic impact, extend life, but do so in a way that it creates a life that people want to live as they end their days. Excellent. I'm going to preface my next question. It's hard, in a lot of ways, to compare apples- to- apples when you're talking about different companies and different programs. I want to provide that kind of context before I ask the next question. We have seen some advancements in the pancreatic cancer space. I know Revolution Medicines put out exciting data earlier this week. Given that pancreatic cancer is your strategic focus, what are your thoughts on this advancement? Well, I'm excited about it because Revolution Medicines is a multibillion-dollar company with hundreds and hundreds of employees. We're a small company, and I think we've accomplished a lot with what we've got. Having them clear the path for us is something that I appreciate, because the common thought is that pancreatic cancer can't be cured. There's a lot of negativism, and especially when we were starting our program years ago. We've demonstrated that we can make a difference. When you have 100 subjects, you have enough information, enough data to know whether or not you're making a positive difference in overall survival, and to know whether or not the quality of life impact is positive, as we've seen. We're very excited about that, and we wish Revolution Medicines the best as they move forward. A little bit like a water ski boat, we're the water skier. We'll just follow along as best we can and move forward as rapidly as possible, because this is a market that's very big, very important, and at the end of the day, we're willing to stand up in a comparison with any of our competitors. Great. I'm not asking, for my next question, for a comparison with respect to their data or a comparison, apples- to- apples, between Ampligen and their program. I am inclined to see if there are some parallels that we can draw here. If you look at their recent news and relate that to what AIM is doing now, and the fact that you're completing your phase II study, you're entering a phase of the prepping and preparing for your pivotal study. Is there a parallel that you can draw where investors can tie, almost like a value indicator, of what Revolution has done, and tie that to AIM, given that you are ready to start embarking on the preparation phase of your pivotal study? Oh. Revolution's drug and ours are not necessarily apples- to- apples, but in many respects, in terms of where we're at and what we're doing and what we're accomplishing, and what disease sector we're in, there are similarities. What we see as they've moved into this phase III, and they start to produce positive phase III data that's available, it's created a tremendous impact on the value of that company. Now, as I mentioned, they started out as a well-funded company. I can't say that we had that privilege when I became CEO. We work hard with the money we've got. The idea of just the mushroom, if you look at the mushroom in market cap for Revolution Medicines, that's an indicator that the market understands how important therapies in this disease sector are. Now, I don't know that we can replicate that. What I do know is we're on the same path. We have, thus far, had positive data from a safety standpoint, from a quality of life standpoint, and most importantly, from an overall survival standpoint. I'm very happy to be where we're at. I have to say, I appreciate the work that they've done, because anything that can be done to provide a therapy for this horrible unmet medical need, this lethal malignancy, is an extremely important public service in my opinion as well. Agree. Okay. I appreciate that. I think a great way to answer that question, Tom. Speaking of your pivotal study, you announced that you're in the planning stage for that, and recently announced, actually, a relationship with Thermo Fisher Scientific. What are the next steps with regard to your phase III program in pancreatic cancer? Well, probably the most recent, most important step is we've entered into a contractual relationship with Thermo Fisher Scientific. That contractual relationship is for the design of this phase III. I'm honored to have been able to work this out with Thermo Fisher Scientific because, in my opinion, in this space, they are clearly the top shelf firm. Agreed. Yeah. That's PPD, Thermo Fisher Scientific. You can't find a better company to design what we need to do in late-stage pancreatic cancer. I'm very happy about that, and that's a major step. Now, of course, we need to wrap up this phase II. The data that we've got so far has been good. We need to see where we're at the end of the phase II. If the data is still strong, that gives us the opportunity to be able to move into that phase III pivotal study, with an element of de-risking the expenses for the phase III. Because when you have positive data, not from everyone, but of a significant part of 100 subjects are reporting positive overall survival, positive quality of life, good safety profile, that de-risks the project going forward, I believe. That's a lot of free phase III data to support that next step. Great. It sounds like it's going to be an action-packed next three, six, nine, 12 months. You had talked about the first, I guess, the mid-year report for DURIPANC. Then you talked about the completion of enrollment mid-year as well. Also, towards the end of the year, first set of data, and then additional data into 2027. With all of that going on, which is a lot, what is the expected timing, and when do you think you'll start the pivotal program with Ampligen in pancreatic cancer? I don't think we're going to move into the commencement of the phase III until we've completed the phase II. Right. That data, in terms of the treatment, will be, for the primary endpoint, wrapping up at the end of this year, and for the secondary endpoint, which is long-term overall survival, in the middle of next year. That just means that everybody has been treated and the amount of months have passed to allow the valuation. There could be several months involved in collecting the data, analyzing the data. Something also very important about this phase II that's underway, and I can't overemphasize this, when the Dutch government authorized our named patient program, the early access program, that was a compassionate care therapeutic program where we were allowed to treat these late-stage patients. Of course, we could collect progression-free survival, and overall survival data, because that's obvious. We weren't allowed to engage in exploratory endpoint-type procedures, like biopsies and things like that, because it's a compassionate care. Now in the phase II program that's underway, we're collecting a lot more data to support Ampligen's mechanism of action so that it's very clear why we're getting these positive responses, why we're getting a response in conjunction with the PD-L1 checkpoint inhibitor, AstraZeneca's drug, durvalumab. The answers to those questions come out of this phase II. Those answers could also be very instructive for the design of the phase III. We don't want to be jumping into a phase III when we don't have all the answers that we've set up this phase II to address. We want to be very careful. I want to just make it clear, the idea behind having top scientists like Erasmus, and a top CRO like Thermo Fisher Scientific PPD, is not just for show. It's so that I have people that I can listen to, rely upon, and allow them to help me design this path forward so that we do it correctly. Absolutely. Okay. I do have one more question before we open up to the audience for our Q&A. You did put out a press release this morning. What are the key takeaways you think investors should focus on from that press release? I think the key takeaway here is that we're moving into a stage where I don't mean to be crass about this, from a scientific standpoint to a financial standpoint, but this is where we're moving into the money play that's a part of the life of a small biotech research and development company. We're moving into that pivotal trial, and that pivotal trial generates the foundation for the acquisition or licensing of Ampligen for pancreatic cancer, or oncology generally, that is the payday for our stockholders. We've worked very hard to get here. This next step is extremely important. There's no guarantees that we'll be successful. I think the data that we've accumulated so far does present a de-risking factor, and suggests that we have a good chance. With that in mind, we have to make that money play. Yep. Great. All right. We are going to open it up to the audience for a few questions. If you click on the Q&A button at the bottom of your screen, type in your question, and we will get to as many as time allows here today. All right. Let's see. Our first question is, Hi, I invested thousands of dollars here. Will this ever return? And why is there seem to be a falling trend at the moment? Well, I can't make any guarantees about returns. As I've explained, we're moving into the final stages of the research and development life cycle. We've got a disease, late stage pancreatic cancer, where there's not a lot of competition. We have a disease where it's a highly lethal malignancy, that has huge market potential. Like I say, between the three major markets, Europe, America, and Japan, developed markets where we can get paid. 150,000 people approximately die every year. We're moving towards the end game, in this plan. Presumably, if we're successful, that's where the payoff is. It has the potential to be a big payoff. As you can see, anytime you look at these small biotechs that get picked up in oncology by big pharma, the amounts involved are typically very significant. Great. That's our plan anyway. I can't guarantee it'll be successful, but I think it's a good plan, and I think we're working with good partners, and we just have to see what happens. Great. All right. Our next question is, The global IP estate now extends through 2039 across major markets, how important is that level of protection when thinking about long-term commercial value and potential partnerships? Well, it is very important because without a runway to acquire the drug from us and then develop it commercially, it's very hard for a big company to make money. Having that patent runway is important, but perhaps, and this is a driving factor in our focus on pancreatic cancer, is perhaps the most important thing here is that the European Union, as well as the United States, have granted us orphan drug designation for Ampligen in pancreatic cancer, and we intend to seek that in Japan as well. Orphan drug designation provides for, in the United States, it's seven years, it's approximately 10 years in Europe, but elements of market exclusivity and protection of the market for Ampligen, and that's after the drug has been approved. That's like icing on a cake. Even if it took you till 2035 to get an approval, you still have the exclusivity components that orphan drug designations provide to have a market that allows whoever's acquiring the drug to not only develop the drug finally and commercialize it, but get their payday over a seven to 10-year period. Great. Our next question. Pancreatic cancer trials are notoriously difficult with small data sets, often producing variability. What gives you confidence that the signals that you're seeing in DURIPANC are real and reproducible? Well, the signal that we're seeing in DURIPANC is preliminary. We need to wait till the end of the study. That's the whole point of doing a study that is designed to allow for statistical significance. When we look at the early access program and the well-matched historical controls, these extensions of overall survival, especially when you look at the stratifications, were statistically significant, very strong, and very important extensions of overall survival. If we continue to see that in the phase II, we just have to rely upon the results. Okay. Our next question, "If Ampligen is successful in pancreatic cancer, how do you think about its commercial positioning? Is this a niche therapy, or do you see it becoming part of standard of care regimens? Well, I believe if we're successful, and we get approved in pancreatic cancer, based upon the, and this is a generalization of both the early access program data and what we hope to see at the end of the phase II, we probably will be in a position where we're very competitive in terms of extensions of overall survival with any of our competitors. Certainly vastly exceeding the overall survival provided by the standard of care, the FOLFIRINOX treatment, without the horrible side effects and with good quality of life. We think that positions Ampligen well in this space. As I mentioned several times in this interview, this is not a niche or small market. This is a big market. It's a market where anybody who can break through and provide a major therapeutic impact, extending life, and doing so where the life of these people who has been at risk is extended with good quality of life will make a difference and be a player in that market, I believe. Now, I want to say this because it addresses your question. Our focus on pancreatic cancer is driven by the size of the market, by the lack of competition, by the protection that we have in terms of patent and orphan drug protection to create market exclusivity. As we launched our oncology program in 2017, we did studies in numerous other solid tumors where Ampligen was shown to have a very positive effect. We just wrapped up a major study funded by a Merck grant at the University of Pittsburgh Medical Center in advanced recurrent ovarian cancer. We're expecting, at some point in time, that final data to be published. But what that shows us is that Ampligen is not a rifle shot type drug. It's not a one-and-done type drug in a particular disease in a particular niche. Ampligen has the potential to be a platform drug unto itself, crossing the boundaries of multiple different solid tumors and enhancing the effectiveness of checkpoint inhibitors, generally PD-1 and PD-L1. That, I think, answers your question as far as it being a niche type approach. Great. All right. We have time for a couple more questions here, Tom. Next question that came in. You mentioned that phase III planning is now underway with Thermo Fisher’s PPD group. Can you give us more detail on actually what that means in practice, and how that partnership will help de-risk execution of the trial, as you had mentioned? Well, we've just started that contractual relationship. Mm-hmm. Obviously, they have to design the phase III around the data that we've accumulated so far and the data that's coming in from the phase II. Now, what that means, we can't be specific about at this point in time because they've just started. The idea that I had was to acquire the CRO that I believe could best address this type of major oncology effort, and for purposes of the global impact. Because we're trying to get ourselves set up so that we're a player in Europe. In Europe, they very much know about the issues of Ampligen's safety, quality of life, and efficacy. That's a little bit easier. The United States as well, and Japan. Because these are the three major paying markets in the world, and we want to be a player in each of those markets. Great. All right. Time for one more question. Several people asked the same question in one way, shape, or form, so I'm going to kind of summarize it to try and get everyone's point in. Everything that you're talking about is exciting. Everything sounds very positive, and a lot of momentum seems to be building. What are the most important milestones over the next six to 12 months that could meaningfully change the trajectory of AIM and value creation? Oh, I believe as we move forward with the phase II, and for example, we have a mid-year report that's coming out. If it continues to show progress in terms of safety, quality of life, and probably most importantly, that positive trend related to efficacy. The investigators aren't going to give a report on efficacy until the study's over. That's their obligation to complete the study. But they do know what the trend is. So if it continues to do that mid-year report will support what we've done, and we should look out for that. Sometime plus or minus June 1st. Now, perhaps the most important thing here, though, I believe, is going to be the fact that once it is clear that we're moving into that space, anybody who looks at the kind of deals that evolve from microcap biotech R&D being acquired for this type of large market cancer with strong data, can look at those numbers and do the math. That's what our plan is. That's what I'm trying to do. I can't make any promises about how that's going to end up, but I think it's a good plan. Fortunately, our clinical execution has supported that plan consistently since 2017, when we dosed the first late-stage pancreatic cancer patient. Great. All right. I think we're ready to wrap this up, Tom. Any closing remarks before we end? Well, yes. What we're doing here, to me, is extremely important. There aren't too many times that you can have something that makes sense as good business, but also know that you're providing hope for people who don't have a clear idea of how they can survive a late-stage pancreatic cancer diagnosis. We believe that if we're successful, we're going to improve lives, but also save lives by extending overall survival by a meaningful amount. Now, that's our goal, that's our plan, and our heart's in the right place. We think we're doing the right thing here to help people. For us, that's the most important part of what we're doing. Excellent. Well, Tom, certainly providing hope for so many patients that have limited options here. Congratulations on all your progress. I really appreciate you sitting down with me today, going through your program, your priorities, and what's to come. With that, this does conclude our Virtual Investor Closing Bell, featuring AIM ImmunoTech. I'd like to extend a huge thank you to Thomas Equels for joining us today. I'd also like to thank our audience for your participation and great questions, as always. As a reminder, AIM trades on the NYSE American under the ticker AIM. If you like what you saw today, I encourage you to visit aimimmuno.com for more information on the company, to sign up to follow the company to receive their alerts, as well as follow their social channels to stay current on the latest information. You can also visit virtualinvestorco.com for a replay of today's segment, as well as our latest events calendar. Tom, thanks again. Hope to have you back when you make more progress [crosstalk] here in the near term. Thanks again, and I wish everyone a great rest of your day. Bye