AIM ImmunoTech Inc. (AIM) Earnings Call Transcript

Essentially, we are working to show that combining Ampligen treatment with an already established cancer treatment could help save even more lives and increasing this potential could have a tremendous impact on long-term stockholder value. So for cancer patients on the one hand and company investors on the other, Ampligen's success could be very important. It could be life-changing for the cancer patients and have tremendous benefits for our investors.

Welcome, everyone, and thank you for joining us today for another Virtual Investor What This Means segment. My name is Jenene Thomas. I am CEO of JTC IR, and I will be the moderator for today's segment. I am very pleased to be joined by Thomas Equels. He's Chief Executive Officer of AIM ImmunoTech. Welcome back to our platform, Tom.

Thank you, Jenene. And it's my pleasure to be here for What This Means.

Before we get started, I just want to remind our audience that AIM 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, so happy to have you with us. You had great announcement with the start of enrollment of your Phase II DURIPANC study for the treatment of pancreatic cancer. So we are here today to get to What This Means. So can you discuss what this means for Ampligen, the patient community and, of course, to AIM investors?

What this means? This is very similar to a question that I ask and answer at the end of most of our AIM ImmunoTech quarterly company updates. Why does this matter? When we talk about the potential, the long-term promise of a cancer drug, we're talking about 2 distinct interest groups, cancer patients on the one hand and company investors on the other, but ultimately, both benefit if we're successful. Today, we're going to discuss the Phase II DURIPANC Study, which we have just opened for enrollment in the Netherlands. This clinical trial combines AIM's Ampligen with AstraZeneca's durvalumab, known as Imfinzi. This is pursuant to a collaboration agreement that AIM entered with AstraZeneca, several months ago, and you can find that press release on our website. Now for cancer patients, the benefits of a successful clinical trial and FDA approval of Ampligen are clear, longer, healthier lives. Pancreatic cancer is a serious unmet medical need that kills approximately 50,000 Americans every year and 500,000 people worldwide. It does so very, very quickly. This grim reality is why our ongoing AMP-270 pancreatic cancer clinical trial in locally advanced pancreatic cancer is looking at Ampligen's effects on a completely different subset of pancreatic cancer between DURIPANC for metastatic pancreatic cancer and AMP-270 for locally advanced pancreatic cancer, we are focused on doing everything we can to find a meaningful therapy for this lethal unmet oncological need. Now we ask ourselves why combine Ampligen with durvalumab. While previous data from more than 50 patients taking Ampligen for pancreatic cancer as a part of the Dutch government approved early access program at Erasmus Medical Center demonstrates Ampligen's clear potential to significantly extend both overall survival and progression-free survival. Now elevated PD-L1 expression known to occur in pancreatic cancer has been associated with increased exhaustion of peripheral and intratumoral T cells. Data suggest that Ampligen has a clear potential to mitigate T cell exhaustion. Ampligen can increase the number and activity of immune cells in the blood and the tumor. Durvalumab can suppress PD-L1 expression. Taken together, it makes clear and logical sense that combining Ampligen with a PD-L1 checkpoint inhibitor, such as durvalumab has great potential for these patients. In the DURIPANC clinical trial, we are starting with those in the worst of the worst condition, late-stage metastatic pancreatic cancer disease. This study would be a win if we just extended the time the tumor is stable for those patients even further than we're doing right now with Ampligen as a single agent therapy. But this combination has an even more important potential, a potential that this trial has the opportunity to prove that in combination that we can achieve a shrinkage of the pancreatic cancer tumor, which would be a major breakthrough. Now we've talked about the importance of Ampligen and its impact in pancreatic cancer and especially the benefits that this combination therapy might have for late-stage pancreatic cancer victims. Nothing could be more important. But also, something that's very important to our investors, to our stockholders is a return on their investment. For our company's stockholders a successful DURIPANC trial could potentially mean making AIM [ any ] Ampligen even more attractive to big pharma companies such as AstraZeneca. We believe that Ampligen has a potential, both as a monotherapy and as a combination therapy. But as a combination therapy, it has enticing aspects that could lead to partnerships or buyout opportunities because we would be enhancing in the already approved cancer drug in an established and successful big pharma market. Essentially, we are working to show that combining Ampligen treatment with an already established cancer treatment could help save even more lives and increasing this potential could have a tremendous impact on long-term stockholder value. So for cancer patients on the one hand and company investors on the other, Ampligen's success could be very important. It could be life-changing for the cancer patients and have tremendous benefits for our investors.

Really appreciate that overview. And you definitely got down to What This Means for us. Appreciate that insight. Congratulations on your progress as this has a potential to provide tremendous hope to the pancreatic cancer patient community and also an exciting opportunity for investors. So I appreciate you sharing that. This does conclude the AIM ImmunoTech What This Means segment. Tom, thank you so much for participating. I can't wait to have you back on the platform. I'd like to thank our participants for joining us today. If you'd like to see other events and other segments go to virtualinvestorco.com. Thanks, everyone.