Okay, we are ready to get started. So good afternoon, and thank you for joining us for another Virtual Investor Closing Bell segment. Today, we are 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 ImmunoTech. Welcome, Tom. Thank you, Jenene. It's a pleasure to be here, as always. Oh, well, we're always happy to have you, and we're really excited to showcase AIM today on our platform, as well as provide investors the opportunity to connect with you. So for today's event, I think we're just starting, right—we'll jump right in. I think we'll do more of a conversation, and I think we'll focus on your lead product candidate, Ampligen, for the treatment of pancreatic cancer. I know that was a recent strategic decision for you to focus on pancreatic cancer. And if that's okay with you, in just a minute, we'll dive right in. But 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. So, Tom, as I mentioned, I am excited to get right into this, but AIM really has been on our Virtual Investor platform quite a bit over the recent years. For those new and for our audience that are joining us today, I do encourage you to go to the company's website. As I mentioned, I'll give it to you again, aimimmuno.com, for information, and you can access the latest investor presentation. They have a great section on data. The company keeps the website up to date and investors well informed, so I do encourage you to do that. All right, so, Tom, ready to dive right in? Yes, very much so. Okay. Thank you, Jenene. Yeah, absolutely. AIM ImmunoTech has refined its development focus to prioritize pancreatic cancer, an area of significant unmet need, as we all know. Give us some background here, Tom. What led the company to sharpen its focus on this indication at this stage? Well, Jenene, we repurposed Ampligen into oncology, with the first clinical treatments beginning in 2017. We were fortunate in getting industry support, as well as, government grants that allowed us to engage in clinical trials in a number of different tumors. It was our belief, which has been proven correct, that Ampligen, as a mechanism of action, would take tumors that were immunosuppressed or immune-silent, and alter that status, leading to a therapeutic effect in most, if not all, solid tumors. Because solid tumors are comprised of, in large part, of epithelial tissue. Epithelial tissue is rich in Toll-like 3 receptors, and Ampligen activates those Toll-like 3 receptors and the Toll-like 3 pathway, which is an essential and key immune system pathway for anti-tumor and antiviral response. So, we started out with clinical trials in a number of different tumors, all of which resulted in positive data. But we sharpened our focus on pancreatic cancer for a number of reasons. I'm gonna go through the two different thought paths. Both actually work together. First is a moral obligation. Pancreatic cancer, when you have late-stage pancreatic cancer, you know, you're faced with a dire and desperate scenario because it's very fast-acting, and there is no real therapy out there. No, there isn't. ... that's of any significance. And, you know, we're looking at, this is a cancer that kills more than 100,000 people in the United States and European Union every year. Mm-hmm. The action of this is sort of evidenced by the fact that the incidence rate in the United States and Europe is almost the same as the death rate. So it's processing very quickly in a very negative fashion. More than 450,000 people die worldwide of this cancer. So it's a large and highly lethal, fast-acting, unmet medical need. We see that as if we can help make a difference there, which we believe we can. You know, our data, you know, to date, over the past several years, shows that we give an extension of life. We improve overall survival well beyond historical controls that are measuring survival post standard of care. That's important. But what's even more important is that with pancreatic cancer, the quality of life of a late-stage pancreatic cancer patient is horrible. It's extremely painful. The immune system is damaged and suppressed, so they're subject to all kinds of different comorbidities, like respiratory viruses. And then the first-line therapy, the standard of care, is a very harsh chemotherapy, so they're coming out of that, in very rough shape. What Ampligen is showing it can do is to maintain life, create an opportunity for significant extension in overall survival, combined with significant improvements in the quality of life. The stabilization of the tumor is relieving some of the severe pain associated with pancreatic cancer, as well as the antiviral aspects. The immune system boost that Ampligen is giving is helping to protect them from these various infections and health problems that are associated with being in an immunosuppressed state. So that's what we've seen in our clinical trials. You know, we can make a difference there. Now, as to the business model, and this is where, you know, doing the right thing actually is good business in this case, because where you have a large, unmet medical need like that, that you can make a difference in, you have access to a large market where there's limited competition. You know, those hundreds of thousands of people that are facing a painful death with no hope now have an opportunity, you know, to have a therapy. That's a market, and it's a big market. Then additionally, we have been able to achieve a certain level of patent protection that gives us, you know, some market security. But more important than that, we have been granted orphan drug designations by the United States and the European Union, which gives us market exclusivity for an extended period of time after drug approval. These things are all very important to the business model. Now, our business plan, we're a small microcap biotech company that focuses on research and development. We're not out there to become the next Pfizer or Merck. We're out there to develop this drug to a place where it can be acquired, and marketed, and distributed by a big pharma company. Those deals all occur in the stage that we're getting ready to enter, where you move from the Phase 2 into the Phase 3 trials, where you have a background of successful data that continues to flow. Remember, these are cancer studies, because of the nature of the disease, are open label. Everybody knows what's going on as we move forward. The big pharma deals, you know, are in oncology. If you look at 2025, there's probably more than a dozen $1 billion+ oncology deals where R&D products are picked up by big pharma. Now, they do that when you've entered phase III and are producing strong, positive data with safety. You know, we have treated, in pancreatic cancer at this point in time, as we sit here today, approximately 75 subjects. So we've got a safety profile in the disease that is extremely good, and we have efficacy data that is very strong as we move forward. So we're ready to wrap up this Phase 2 over the next year, but we're beginning our planning for the Phase 3. So our next step is to get the very best planning team that the world has to offer to help us design our Phase 3 in pancreatic cancer. And fortunately, even though we, you know, we're not flushed with huge amounts of money, where we can hire whoever we want, the data itself is creating interest on these people, where they want to participate. So I think we're gonna have a great team to design the Phase 3, and we're gonna be very strong coming out of the box. Once we have that plan designed, and we've talked with regulators to make sure that we've got a pathway that's clear, we'll be in the sweet spot for a business deal. Yeah, absolutely. So first, Tom, you know, I'm listening to all of, you know, the business reasons, and I'm, like, thinking of this as, like, a scorecard or a checklist of making that business decision. So you talked about, you know, an area of significant and unmet need, where there's, you know, limitations to therapies. You talked about IP, which is an important component of the overarching strategy, right? Then, you talked about exclusivity. So you have, you know, not only is it covered by IP, but then you've, you know, worked to get these important designations. You know, you talked about a large market opportunity, but, you know, in essence, combined through all the key markets, right, it's a large market. Because I think with the orphan designations, you know, there's limitations with the patient populations, but these are areas where, you know, if successful, I would imagine, you know, the pricing and reimbursement is favorable, not only for, you know, for the patient side, but for the companies as well. So first of all, congratulations, 'cause that's a lot, a lot of accomplishments to secure, I guess, the business mandate there, and I think you're doing a great job there. And then, you know, if you think about it further. I'm getting excited about this discussion. But if you think about it further, you know, then you're working to, you know, have a clear path to your registration study. So you have, you know, consistent data, as you talked about. Now, you have plans to move into, you know, a pivotal study, which then leads to, you know, filing with the FDA, if all goes, you know, as the company planned. And then, even beyond that, you know, interest and discussions and, you know, compelling discussions with pharma. So I think it's—it's exciting overall, so congratulations on all your progress. Well, thank you, Jenene, and I think it's important to note that all of the work that we've done in pancreatic cancer, as well as in these other malignancies, has been with the support of government or industry funding. Yeah ... and at top research institutes in the United States and Europe, and in some instances, with collaboration with big pharma collaborators. For example, in ovarian cancer, we've just finished up a Phase 2 Ampligen plus Keytruda clinical trial. That Phase 2 trial was funded with a Merck grant, conducted with an investigator, a study run at the University of Pittsburgh Medical Center. It was very successful. And the Phase 2 in pancreatic cancer that we're doing right now in the Netherlands at Erasmus, again, we have an industry collaborator, AstraZeneca, that we're working with, and that is moving forward in an extremely positive fashion. Excellent. So we have safety, we have improved quality of life that you see when... And it's not just in pancreatic cancer. In these other cancers as well, Ampligen. It's not that it doesn't have severe adverse events. It is well-tolerated from that perspective, but people feel better when they're using it because it's restoring their immune system as well. Excellent. A lot of these chemotherapies destroy the immune system. Ampligen restores the immune system. In that line of thinking, Tom, so, you know, pancreatic cancer has proven particularly challenging for immunotherapy. So talk about how Ampligen's role as an immune system modulator sets it apart from other potential therapeutic approaches. Well, I think, you know, we have to understand the nature of... and a little bit about the history of cancer treatments. You know, many decades have gone by where chemotherapies that are, you know, extremely toxic and harsh, and but with efficacy, have been used to blunt cancers that were lethal. And I'm not faulting that. I mean, that's the development of something that prevents a greater harm, even though it's very difficult to tolerate the therapy. The advent of immunotherapy in oncology is relatively recent. You know, perhaps 12, 15 years ago, we started to hear about checkpoint inhibitors, and, you know, for the past decade, they've been doing gangbuster business. Why? Because, you're seeing the immune system being utilized to destroy the cancer. That is, while there are side effects to some of these different checkpoint inhibitors, it's nothing like the, you know, systemic impact that some of these, the earlier chemotherapies had. And what we learned from that is you can have a real shift in how therapies work. Now, Ampligen is especially important because it works both as a monotherapy, but it can also be a combination therapy that we believe will enhance the overall effectiveness of checkpoint inhibitors. Now, checkpoint inhibitors, when they work- Mm ... you know, can be very dramatic. They kill tumors. You know, one day you've got non-small cell lung cancer, you know, three weeks later, you don't. You know, now, that's, you know, 30 years ago, people would think that was miraculous, but that's the reality of checkpoint inhibitors. But checkpoint inhibitors only work on what are called hot tumors. Hot tumors are tumors, you know, that are not immune-suppressed. Pancreatic cancer is an archetypical cold tumor, you know, which is why Ampligen's playing a role in pancreatic cancer as both a monotherapy and, we believe, in combination therapies with checkpoint inhibitors. But we have seen in Stage 4 triple-negative breast cancer, Ampligen plus Keytruda, having a dramatic synergy. The recent ovarian cancer trial that just finished up, very successful, Ampligen plus Keytruda. So the ability of Ampligen to convert those refractory patients' cold tumors into hot tumors also leads to a broad platform down the road for we believe all cancers, and we believe it works the same way with checkpoint inhibitors, regardless of which one it is, PD-1, PD-L1. You know, it will have the same effect because the checkpoint inhibitors work the same way, and Ampligen's mechanism of action, you know, will allow those refractory patients to have access to a therapy. Certainly, the data suggests that. Yeah. Do you wanna dive in a little bit on mechanism of action or, you know, the key findings there? Well, certainly, the findings, I think, are probably more important. You know, the data that's coming out of our pancreatic cancer work, the way it works is that it's activating the immune response. You know, the tumor, the pancreatic tumor in the responders is showing stabilization as a result of the progression-free survival data and the overall survival data. And it's improving the quality of life in these pancreatic cancer patients, which is very, very important. Yeah. But why it's doing that is evidenced perhaps best by, you know, the results. As we sit here today, we've, we've treated. Since we started treatment of subjects in a Dutch government-approved Early Access Program, followed by the Phase 2 trial that's underway right now, we've treated, I think, a total of 75 subjects. Treated, and some are still in treatment in this Phase 2. And there are several more that remain to be treated before we complete the Phase 2. But the result of that is we now have data that shows Ampligen's positive therapeutic impact based on well-matched historical controls. And what that shows us is that Ampligen, as compared to those historical controls, is extending overall survival beyond the standard of care for a median of over eight months. Now, that's a lot, you know? And to be able to extend overall survival by a median of eight months, that means there's a lot of people that are living a lot longer than eight months, and that also means that, that, as I said, it's improving the quality of life of those subjects while it does so. So, you know- Right ... typically, late-stage pancreatic cancer patients are elderly, people to begin with. But to be able to give them, you know, extra life span combined with, you know, a better quality of life, makes a real difference. So in that respect, we're doing God's work here, as well as working for our stockholders to create great value. Yeah, absolutely. You know, Tom, you talked about, you know, prior clinical studies and ongoing clinical studies, and the key findings there. Can you discuss how lessons learned from previous studies with Ampligen have informed your current thinking around trial design and patient population in pancreatic cancer, as you're thinking about launching a pivotal program? Well, Jenene, and this is the benefit of being opportunistic. The early access program was for late-stage pancreatic cancer patients, and we were able to move into that program and get Dutch government approval based upon a tremendous safety profile that we have. So we were able to show that what we were gonna do wasn't gonna hurt anybody. We had a very clear theory of why we thought it would be beneficial, and we were allowed to do it. Now, it's an early access program, but we were able to do that without spending... We had very little funds, and they were actually paying us to do the early access program, you know, through the insurance provisions of the Dutch social medicine system. You know, now, but we weren't allowed to do certain types of experimental activities that are often associated with clinical trials. So there, we were administering Ampligen by infusion therapy, and we were seeing, you know, fairly quickly that many of these subjects were reporting significant improvements in quality of life. You know, it was assumed that improvement in quality of life was associated with disease stabilization, because a lot of the pain in pancreatic cancer comes from the tumor infiltrating the nerve bundles surrounding the pancreas, and other comorbidities. But the ability to, you know, get deep into, you know, why it was happening was limited because, you know, it was a compassionate care, so, you know, you weren't allowed to do experimental biopsies and things like that. Our ability to expand our experimental endpoints in this Phase 2 in pancreatic cancer has allowed us to get even further data on the mechanism of action and identify not just that it was working, but getting a very precise idea beyond what we had already seen in the early access program. And that's supported by a number of peer-reviewed publications. But get a precise idea on what was happening and what biomarkers existed to show who the high-level Ampligen responders are. Now, we know that when you look at, for example, one of the archetypal tumor markers for pancreatic cancer is CA19-9. And that biomarker, if it's less than 1,000... I may not be stating the numbers here correctly, but if it's below a certain level, shows a dramatic increase in overall survival when compared to the historical controls, as well as where it's above that level. So we have a biomarker that tells us who the strong Ampligen responders will be. Also, we see the same kind of pattern with the neutrophil/lymphocyte ratios. And there, you know, if it's below a certain level, you know, we have a very different overall survival graph from where it's, it isn't. So these will help us in our planning of the clinical trial, to design a trial that is designed to get approved. You know, we wanna design- Yeah ... this trial in a way that assures success and drug approval. For that reason, we're trying to put together the team starting with the planning and design, which we're doing- Yeah ... right now. Even though we haven't finished the Phase 2, because it's positive enough, we feel confident that we should begin planning now that Phase 3. The good thing about this is, even though, you know, you know, certainly, you know, if we had $1 billion, we could hire whoever we wanted to design the trial. We don't, you know? So, but the data is sufficiently attractive that these top people are excited to find a way to participate with us in that design program. So, I'm looking forward to announcing who our design team will be, and getting this process started, so that- Excellent ... that we come up with a design that's been coordinated with the FDA and the EMA, and you know, move forward with a clinical trial, that we will have a very positive outlook regarding its success. And that is once we get there, once that Phase 3 trial starts, remember, these lethal malignancies, these are you know, sort of open-label-type programs. So, you know, we'll be able to analyze this data periodically in terms of progression-free survival, overall survival, clinical benefit, generally. Progression-free survival and clinical benefit are sort of together in a sense, because stable disease is a part of clinical benefit. when we can show that we're seeing the same results, the same pattern of results that we've seen in the 75 subjects treated so far, and when we can show that we've got safety, and when we can show that we have a good chance of success in that Phase 3, that's when these big pharma companies start looking at acquisition- Absolutely ... either through licensing or acquisition of the drug. Yeah. So, that's our business plan. Perfect. I love it. All right, and so thinking through, some milestones, I know investors love to hear about milestones, and kinda, like, what they can expect that's next. And, so as the pancreatic cancer program advances, what near-term clinical and development milestones do you believe are the most important for demonstrating progress and validating your approach here, Tom? Well, you know, as we've moved into the Phase 2, you know, the one of the problems in pancreatic cancer is that it's sometimes very difficult to predict the level of progress, because it depends on enrollment. And you're talking about a very fast-acting, highly lethal malignancy, so your ability to enroll people, you know, requires... It's not your normal go find, you know, 15 college students that have the flu, right? Mm-hmm. You know, but what's important here is our successes so far, certainly in Europe, have created an impression- Mm ... where we've had no lack of candidates. Enrollment has not been a problem. People want to get into this study, and so it's moving very rapidly. Because we can see, you know, a projected path of being fully enrolled now, in short order, we should be giving a list of milestones for the Phase 2, because we can predict with some level of precision- Yeah ... when we'll hit those milestones over the next year. We're looking at sometime this year being able to wrap up as to the primary endpoint, and sometime next year with the secondary endpoints, which are tied to overall survival, which takes a longer period of time, of course, to analyze. So we'll be determining what those milestones are, and as we do those things, and are comfortable in putting out the milestones, we will share them with the public, of course. Excellent. All right, I do wanna give our audience a chance to ask some questions. Tom, great discussion. Really helpful, excellent background. I think you hit all the key points. So let's see if there are any questions that the audience might have- Thank you ... before we wrap this up. So to our audience, we are gonna open it up for the Q&A portion of this event. So for those interested in asking a question, click the Q&A button at the bottom of your screen, type in your question. And we have enough for just a couple at this point. So let's see what we have here. Maybe I did just a great job with all the questions. I don't know. Let's see. Okay, question right here. So, this one just came in, Tom: "What ultimately drove the decision to concentrate on the company's resources on pancreatic cancer at this point in time? Well, pancreatic cancer was one of our primary targets when we commenced the repurposing into oncology. And in fact, it was that early access program resulted in the first major clinical trial using Ampligen with a large number of subjects. But I wanted to look at as many different solid tumors as possible, so we had the ability to choose. Now, the thing that drove the decision-making in favor of pancreatic cancer was that pancreatic cancer is the fastest-growing, most lethal malignancy that's out there right now. Yeah. You know? Yes. Especially in the United States, Europe, and Japan. Yep. Now, I was able to work and develop a intellectual property portfolio around that work that we were doing in the clinic around our plan, which is helpful. Not, not to say that it's bulletproof, but, you know, but it certainly creates intellectual property positions and rights that, that, you know, help keep the poachers away. But more importantly, unlike the other cancers, even though they were all successful, the, the clinical trials that we had were all very promising results, we have two factors here that are business factors that, that we were able to achieve that made the decision easy to make. Yeah. The first business factor is that it's a huge market, you know? And in terms of the various malignancies that are out there, you know, this is a huge market, and it's an unmet need. And while, you know, a number of companies are trying to move in there, you know, we're certainly in that fight, and the people wanna be there because there's no competition in that market. Now, you know, that's not to say that there won't be others that are doing what we're doing but, you know, for a small biotech company, we're playing a big boy game, and we're making tremendous progress, you know, getting towards the goal line. So, you know, that's important. Mm-hmm. But the key thing that, you know, comes into play is the award of the orphan drug designations from the United States and Europe also puts an imprimatur of security on what we're doing, in the sense that anybody who, you know, wants to come and negotiate a license for Ampligen in pancreatic cancer or oncology generally, you know, can have the assurance that they're doing so in acquiring a drug that has levels of market exclusivity in Europe and the United States, that exist after drug approval. So no matter what happens with the patents, you know, once the drug is approved, in the United States, there's seven years. Europe, there's market protection for 10 years. Yeah ... which gives them time to make the money in that market with the drug. So, that's a very important part of the business decision. So we have- Great ...positive clinical results. We have positive safety. We have, which is truly remarkable, when you're in a maintenance therapy like this, to have extremely, you know, strong indicators of improved quality of life in an environment where we offer to anybody who's in an acquisition mode the orphan drug protection in the two major world markets. Great. All right, we have time maybe for two more here. Several have come in, so our audience always have some good questions. So, oh, next one: "What would you consider the first real validation that this strategic prioritization with pancreatic cancer is working? Well, you know, I know when people are excited when they see our data, and they start to see the path that it creates and the opportunity that it creates for a therapy in an area where so many people have lost so many loved ones, you know, and lost them to, you know, this horrible experience. So, you know, that is clear, but it's also clear, for example, you know, as I'm working to develop the Phase 3 and talking with different parties that you know have been watching Ampligen in pancreatic cancer, at JP Morgan, for example, out in San Francisco. Mm-hmm ... you know, I know now that what we're doing in pancreatic cancer has got people paying attention to Ampligen and the opportunity that it presents. You know, seven years ago, I couldn't get a meeting with anybody. Right. But now they wanna meet with me. Yeah, no, this is great. That's always a good sign, I think, you know? Absolutely. Okay, the last question for today: "So, what would you consider is the most important milestone over the next year that could provide some meaningful impact? Well, we're in a position now, you know, with our focus on pancreatic cancer, that we're gonna be able in a number of different components of this to announce milestones. Yeah. For example, specific milestones for the completion of this Phase 2, at the beginning, you know, we had to be very general because we could not say with any assurance how rapidly we would be able to enroll people- Yeah ... and begin the treatment programs, right? 'Cause as I mentioned, pancreatic cancer, late-stage pancreatic cancer is notoriously difficult to enroll. But our success in the Early Access Program in Europe is sufficiently well known that that and the results are known, so that we haven't had a problem with enrollment. That allows us, now that we know that we have a strong and predictable enrollment, we're gonna be able to give fairly specific milestones as to the completion of that Phase 2. Now, with regard to other things that we're doing, I mean, and we'll be announcing things as they come up. But clearly, you know, as I've said, we intend to develop a design for our pivotal Phase 3. The design of that protocol and the meetings with the regulators will then allow us to come up with milestones for purposes of the Phase 3. I can't be giving you milestones on a Phase 3 that we haven't completed the design for. Right. But- Absolutely, and we're not expecting that. I think, so it's... You know, I think what, you know, basically what you're saying, and just to kind of get right to it, it's most likely, you know, data readout that's going to support a Phase 3 program. So that could happen, you know, like, I believe you said, more data this year. Oh, yeah, but you know, we have in my view the reason we're starting the planning of the Phase 3 is we have in our pocket 75 subjects that have been treated. Yeah. So we have, and for the company's purposes, you know, substantially de-risked things so that we can be confident that the data supports future data that would indicate that it's safe, and future data that would indicate that it has a positive impact on, disease stabilization, progression-free survival, in other words, as well as overall survival. You know, so these are things that we have sufficient data now to project with confidence that that has a future, and we're prepared to invest in that future with this Phase 3 design. And we also have biomarkers that tell us, you know, who the, you know, super responders might be- Yeah ... based upon those biomarkers. So that also allows for design of a study that allows, you know, us to design, you know, to get approved, you know. And that's why I want top people involved in that design process, because, you know, we want this to be something that will be successful. And it's not just for our stockholders. You know, we can't forget the fact that every day, somebody out there, you know, has a friend or a family member, or they themselves are facing, you know, this horrible, you know, announcement that you've got pancreatic cancer, you know. So we intend to make a difference here. This is probably my last rodeo, you know, and you know, I've done things in my life, you know, based on a number of different motivations, but one of them that's consistent is when I do something like this, I'm doing it to make a difference for the good, you know. Excellent. We can make a difference here, and the time is now, and we're getting ready to move forward just as fast as we possibly can. I love it, Tom. I think you and your team are committed. You're leading with your heart here. It's refreshing. And I think this is a perfect place to end. This does conclude our Virtual Investor Closing Bell, featuring AIM ImmunoTech. I love having you on, Tom. Have to have you back soon. It seems like, you know, this year is set up for some good opportunities for progress, so we're gonna want to hear about that. So I want to extend a huge thank you to Tom 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 and 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 Virtual Investor Co.- sorry about that, little tongue twister, VirtualInvestorCo.com for a replay of today's event, as well as our latest segments and events calendar. So Tom, thanks again. Thanks to our audience, and I wish everyone a great rest of your day. Thank you, Jenene. All the best. Thank you.