Okay, we are ready to get started. Good afternoon, and thank you for joining us today for a 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 ImmunoTech. Welcome, Tom.
Hey, Jenene. Thank you for having me.
Oh, always happy to have you, and 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, and 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, it's great to have you back on our platform. We're going to do more of a little fireside chat format for this event, so I have prepared a few questions for you.
I should have worn my plaid shirt then, you know.
You should have.
Lumberjack style.
I'll give you more of a heads up. Perfect. So, to set the stage for our audience, for those that have been following AIM, as well as those new to the story, if you can provide a brief overview of your lead asset, Ampligen.
It'd be a pleasure. Ampligen is not just an asset. It's a drug that the data has demonstrated has tremendous potential in immuno-oncology, both as a monotherapy and as an enhancer, synergistic enhancer to checkpoint inhibitors. And it's across a broad spectrum of solid tumors. So, it's more of a platform asset in that you have multiple potential indications, and you have a huge market of refractory patients who haven't responded to checkpoint blockade therapy, which very often in immuno-oncology is at the end of the line. And Ampligen, the data is showing, has a strong impact in improving the response rate after these patients have been refractory to the checkpoint inhibitor alone. So, we're very happy that data over the past several years, since we repurposed into immuno-oncology as our focus, is meeting the expectations that we had in planning this effort and also the market's expectations.
Excellent. I want to dive more into something that you just said. So, can you talk about Ampligen and checkpoint inhibitors? I know there was a recently completed Phase II clinical trial in ovarian cancer performed in collaboration with Merck and its drug Keytruda.
Yes, I'd be happy to. First of all, for those who aren't familiar with what a checkpoint inhibitor is, checkpoint inhibitors operate to alter a mechanism that allows tumors to avoid these therapies that then allow the immune system to destroy the tumor. Checkpoint inhibitors, when they work, can be extremely effective. In some instances, not just creating a state of remission and not just extending survival, but actually destroying the tumor, its metastatic activity, and creating a cure. The problem with checkpoint inhibitors is typically there are two types, PD-1 and PD-L1, but they operate very much the same way in solid tumors. Typically, there are large percentages of refractory subjects. That means they don't respond. The reason they don't respond is because they have tumors that are immunosilent. The oncologists call them cold tumors.
What Ampligen does is alters the microenvironment of the tumor and the immune setup of the tumor so that the tumor is basically lit up, is a hot tumor now that the checkpoint inhibitors can see for once and begin the process of destroying it. We see this as very important. It has the potential to save lives. From a business standpoint, this is a huge potential market.
Excellent. You know, I think about the evolution of AIM. You had many clinical trials ongoing. You talked about your shift to really focusing the company to immuno-oncology company, and even further evolution of this story, you recently announced that the company made the strategic decision to prioritize pancreatic cancer as your lead indication. Walk us through that decision, specifically the why and what that means.
You know, not to be too homespun about it, but there's an old saying, if you're a fisherman and you want to catch fish, you got to go where the fish are. Now, we're a small biotech company involved in drug development, and the reality is, oncology is the area where most of the deals are. We've been able to, we had a theory as to why we would be effective in oncology, but now we've been able to have numerous clinical trials in numerous solid tumors demonstrating Ampligen's potential as a monotherapy, as well as an enhancer to checkpoint blockade therapies. That's where the big deals in biotech are, and these are billion-dollar deals. If you're in Phase III and producing good data, it creates tremendous opportunity. That's the business part of it.
But the other part of it is, for example, in pancreatic cancer, everybody knows what happens when you have a diagnosis of late-stage pancreatic cancer. So, here's a place where we can make a big difference in people's lives because the data so far shows that Ampligen has a meaningful and significant data-driven ability to extend overall survival as a monotherapy. And the data developing in our Phase II in conjunction with AstraZeneca and their drug durvalumab, also known as Imfinzi, is showing that there's a synergistic impact, Ampligen with durvalumab, in even further extending those opportunities for overall survival. And one of the things about Ampligen that is clinically consistent is that Ampligen, unlike many of these other therapies, which have horrible side effects and make life almost not worth living, is Ampligen seems to consistently improve the quality of life of the subjects during the therapy.
This is very important for somebody that's facing a lethal malignancy with no hope, so we're here to address that problem first and foremost, because it's such a big problem in pancreatic cancer, it's also a big business opportunity, and that business opportunity is enhanced by our patent estate and the orphan drug designations that we've received over the past couple of years, like a U.S. patent specifically for Ampligen plus PD-L1 checkpoint inhibitors. That's what AstraZeneca's drug, Imfinzi, is, and orphan drug designations for the use of Ampligen in pancreatic cancer. Orphan drug designations give market exclusivity, and we have them both in the United States and Europe and the European Union.
So, that makes pancreatic cancer a big market, big health problem, lethal unmet medical need, and market exclusivity that extends out into the future so that any large company that wants to acquire rights to Ampligen in oncology, specifically pancreatic cancer, has certainly the indication that it will have control of a market for enough time to make a good profit.
Excellent. That's helpful background, Tom. So, if you think with pancreatic cancer, top of mind, can you walk us through AIM's clinical and regulatory strategy for Ampligen in the treatment of metastatic pancreatic cancer?
Certainly. One of the things I'd like to mention first, and I touched on it, is worldwide, we're looking at over 500,000 people dying every year from pancreatic cancer, and the survival rate is extremely low. Between the United States and Europe, over 100,000 people will die this year alone from pancreatic cancer, so it's not just an important market from a business standpoint. From what medicine is supposed to be about, it's extremely important, saving lives, helping people to have a better life, a longer life. Now, the rationale for what we're doing in pancreatic cancer is driven partly by the altruistic aspects and partly by the business aspects, but here, they both go together. This is one of those places where good science equals good medicine. Good medicine ultimately equals saving lives in this instance, and that equals good business.
Excellent.
I used a lot of equals there because my name is Equels.
Equels. That makes sense. Can you talk further about the durvalumab? And as you said, definitely publicly available information. So, for your mid-year safety and efficacy data, can you just talk about what you shared publicly with respect to that?
Well, certainly. First of all, these studies are open-label studies, but the information is not publicly available. But in order to have transparency, we've committed to a mid-year and year-end report as we go forward. Now, this study will be over probably by the end of next year. But it's important for people interested in AIM and Ampligen to understand what's going on, I believe. And the mid-year report was extremely positive. It gives every suggestion that data that Ampligen is having a synergistic effect with durvalumab that certainly exceeds durvalumab's individual capacity in pancreatic cancer and in all probability substantially exceeds what Ampligen would have been able to do as a monotherapy. So, that's extremely important. But the other aspect of it is that, as I said, we've committed to mid-year and year-end reports. We have a report coming out soon.
I haven't seen the report yet because it comes from our lead investigators at Erasmus Medical Center. Data is also being collected and reviewed by AstraZeneca as well. Once we have that report in a format where we can share it, we will be sharing it probably before the end of the year.
Excellent. So, as you think about Ampligen in pancreatic cancer, how do you kind of put out the breadcrumbs for us as you think about the overall development and commercialization strategy? How are you viewing that?
As I mentioned at the beginning of this talk, and I know it's a little unstructured, so we may have been bouncing around a little bit, but at the very beginning, I mentioned the idea that oncology is where the big biotech deals, licensing deals from the smaller companies that are developmental companies are taking place. Our strategy for pancreatic cancer is to reach a data point where we're able to get into a Phase III trial, preferably in conjunction with a checkpoint inhibitor such as AstraZeneca's durvalumab, or it could even be Merck's Keytruda. We've done a number of studies in collaboration with Merck in other solid tumors with Ampligen plus Keytruda that have been very successful.
We get into a Phase III trial where we're able to establish the positive therapeutic impact of this combination and how we believe we'll have the opportunity to exceed any expectations in performance of anything that's on the market and approved right now because we already know that we are, as a monotherapy, able to extend overall survival well beyond the standard of care. We had treated 57 subjects and demonstrated that with that data. We're taking that data-driven point to the next step with the Phase II that we're doing with the checkpoint drug. We believe that will give us enough to get started in a Phase III. We're trying to design that Phase III as we speak. Now, Phase III are very expensive.
So, I'm looking to have a big pharma partner to work with us to take us to that next step to achieve not just the business opportunity, but also the humanitarian opportunity that comes with our success.
Excellent. Well, Tom, I know the goal for this discussion from when you and I chatted was you stated in a couple of public documents the fact that pancreatic cancer was your lead indication, that you're really putting the focus there, that that's where you have the most momentum. And you described all of those things. So, I think the mission was accomplished here. Sometimes it makes it better to hear it just directly from the CEO. And so, I guess before we close, everything that you described, I mean, there's certainly exciting times ahead, especially as you look to advancing to really shifting like a strategic shift or an important catalytic shift into a late-stage clinical development company as you embark on a Phase III or pivotal study. What should investors look for as the next important set of milestones from AIM?
I think clearly the next milestone, which I think will be an inflection point, is the data that's coming at our year-end report. Like I said, I haven't seen it yet because I'm waiting to receive it from Erasmus. But I have every expectation that it will be positive and, I hope, significantly positive. That will take us step by step through 2026 towards the goal that I have of finding a partner to begin our Phase III activities in pancreatic cancer in a way that will allow us to monetize all this research and development in one of those biopharma oncology deals that we see. There's probably been $10+ or $12+ billion deals in 2025 involving Phase III products that show promise in oncology. That's where we want to be from a business standpoint. From a humanitarian standpoint, that's where we want to be.
And it's not just pancreatic cancer. Something I feel it's important to mention, we just had a paper published from a Merck collaboration, and it was funded with a Merck grant, which is a Phase II in advanced recurrent ovarian cancer. Very strong activity. The paper that was published is available online. But it's not just ovarian cancer. With Merck's drug Keytruda, we had several different solid tumors where we worked together in collaboration to see the synergistic impact of Ampligen with Keytruda. So, we're talking, as I started, about a platform in oncology, not just a drug that works on one aspect of pancreatic cancer. So, pancreatic cancer is our lead because I believe pancreatic cancer is the quickest and most lucrative and most needed thing that we can do right now to get this drug approved. But these other cancers and opportunities fall in line right behind it.
Excellent. Well, Tom, any closing remarks? I think that you ended on a good note there. But before we close, we are at that point. So, anything to tell investors before we close out for the day?
Yes. The advances that we've made are demonstrated by the data that's been published. This data is independent data from top research institutions, some of the finest cancer research facilities in the world, the top investigators, the doctors, or the tops in their field, whether it's ovarian cancer or pancreatic cancer. I want to thank our collaborators. I want to thank those doctors and research facilities because much of the work they've done, they've done without charge to AIM because they're excited about the opportunity to make a difference. I also want to thank Merck and AstraZeneca. Our collaborations with these big pharma companies have allowed us to move forward in this exploration of the benefits of Ampligen as a synergistic agent in oncology. The data, again, has supported all of their faith. I'm glad that it's working out.
And I want to thank our team here. We're a very small company. You see these companies that have spent billions of dollars trying to develop a cancer drug, and they've got 500 people as a part of the company. We're a small company with limited resources, but sometimes I feel like Thomas the Train. I think I can. I think I can because we're working, doing great things with a very small and dedicated group. So, I want to thank everybody that's a part of that group as well. And I want to thank you, Jenene, for the opportunity to share all this at our fireside chat.
Absolutely, Tom. And I want to thank you for participating in our closing bell segment. I'd also like to thank our audience for your time and attention. Tom, exciting times ahead. You had mentioned next big milestone before the end of the year. We are in December. So, I'm sure just a few short weeks away before we see the latest information from the clinical study report, right?
Like I said, I haven't received it yet. It might be January, but I think we're going to be on target.
Excellent. Perfect. Well, can't wait to have you.
Some of these things where you're using independent research organizations as your collaborator, you don't have complete control of the timing.
No, absolutely. And we actually see that more often than not. So, with that, though, Tom, can't wait to have you back. Would love to hear more about the advancements with the program. Definitely will have you back on our platform in 2026. So, this does conclude our Virtual Investor Closing Bell featuring AIM ImmunoTech. Again, I'd like to thank Tom. I'd like to thank our audience. As a reminder, AIM trades on the NYSE American under the ticker AIM. And if you like what you saw today, I encourage you to visit aimimmunotech.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. And you can also visit virtualinvestorco.com for a replay of today's segment, as well as our latest events and event calendar. Tom, thanks again.
We look forward to having you back.
Jenene, if I may, just one final thank you. Okay?
Yeah.
I want to thank everybody that's attending this and that has supported us, our stockholders, our investors, because we can't get across the finish line without that kind of support. And there's a big thank you, a big shout-out to them for the support we've received because without them, the successes that we're demonstrating with the data would never have occurred. So, thank you for your faith in us.
Excellent. I'm glad you interrupted for that because that is so important. So, with that, I think we're going to end on that note. So, thanks to everyone. Tom, hope to have you back soon, and we'll see everyone back on our platform in the near term.
Best regards.
Bye, everyone.
Bye.