AIM ImmunoTech Inc. (AIM) Earnings Call Transcript & Summary

Okay. We are ready to get started. Good afternoon, everyone, and thank you for joining us for another virtual investor lunch break segment featuring AIM ImmunoTech. My name is Jenene Thomas. I'm CEO of JTC IR, and I will be The moderator for today's event. I am very pleased to be joined by Thomas Equels. Tom is Chief Executive Officer of AIM ImmunoTech. Welcome back to our platform, Tom.

Thank you, Jenene. It's always a pleasure, and thank you for having me.

Absolutely. So I hope everyone has had a chance to grab your lunch. We are very excited to showcase AIM today on our platform and share their story with our virtual investor audience. So for today's event, we will start with the corporate overview from Tom followed by questions from myself, and then we will open the floor to our audience for questions. 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. 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, we're here to hear the story. So why don't we dive right in, and I'm going to turn it over to you.

Thank you, Jenene, and thank you, everyone out there who's here today for your interest in AIM and your support of AIM as we move forward on what we think are very important paths for the development of therapeutics and lethal and debilitating unmet medical needs. Our primary experimental drug is Ampligen, also known as rintatolimod. Ampligen is a very broad spectrum, immunomodulator and it -- being broad spectrum as an immune drug, it has an impact in oncology and immune disorders, as well as viral diseases because it's operating through its mechanism of action as an antitumor agent as well as an antiviral agent. And it does modulate the immune system in a fashion that also, we believe, has a tremendous impact on certain immune disorders. Now, unlike many small biotech companies, we are very active with human clinical trials that are underway, and we have human clinical data especially in oncology, where we've not only reported strong results from the company, but there are peer-reviewed medical journal publications and clinical research publications, highly esteemed by independent collaborators, top cancer centers and top cancer researchers that have been published, and you can look at these publications on our website. Our collaborators are perhaps one of our strongest points because we're working in these cancer trials, especially with industry collaboration and advanced recurrent ovarian cancer with Merck in the University of Pittsburgh, with Roswell Park Comprehensive Cancer Center in certain trials, Erasmus Medical Center and Buffett Cancer Center. So these collaborations with these top institutions and top research experts make a big difference in the progress we're making, but also in derisking what we're doing. The fact that this is being done independently and Ampligen has the eye of these top institutions takes a lot of the risk out of the financial equation down the road. Now our clinical trials are here on this slide, and we have made a tremendous amount of progress in a few of these areas. Some of these areas are in the early stages, the AMP-270, we're commencing patient recruitment and going through a number of different regulatory processes to get our European part of the study up and running. That's in pancreatic cancer, locally advanced late stage, and that's Ampligen alone, is very similar to the work that we've done in the early access program with a program where we treated based on a Dutch government authorization over 50 subjects and got tremendous positive data resulting in a number of very significant publications. We've also started in the Netherlands, a Phase I/II study in collaboration with AstraZeneca. This collaboration is at a Erasmus Medical Center. And that's combining Ampligen with AstraZeneca's drug durvalumab, and that's in late-stage metastatic pancreatic cancer. That is a Phase I/II because we never used Ampligen in conjunction with Imfinzi, the durvalumab drug of AstraZeneca. So there is a dose escalation safety component to it. Patients have been dosed. The first tranche of that dose escalation study is moving forward with no serious adverse events, and we moved into the second tranche of that and we expect that to move very rapidly. In advanced recurrent ovarian cancer, we have 2 trials underway. Both of those are combination trials at The University of Pittsburgh. We have Ampligen combined with KEYTRUDA. That's a Phase II that has produced tremendously positive results showing Ampligen enhances the impact of KEYTRUDA in these advanced recurrent ovarian cancer patients by several hundred percent over KEYTRUDA alone. And that study will have publications forthcoming related to the complete data from a protocol programmed interim report, and it's moving forward. And similarly, we are doing a pit also in collaboration with The University of Pittsburgh Medical Center, and the other collaborator there is National Cancer Institute combining Ampligen with a dendritic cell therapeutic vaccine. Now that study is just starting, but we have high hopes that it too will produce good data based on Ampligen's proven mechanism of action and how it interacts with certain immunotherapies. The early access program which you see down towards the bottom of this page is completed over 50 patients were treated. Again, the data coming out of that program, as compared to historical controls was extremely positive, showing significant impact on progression-free survival and even more so in overall survival. And finally, out of the oncology that's in pancreatic cancer that early access program. But finally out of the oncology world for a moment, we have completed a study called AMP-518 in long COVID where post-COVID in patients who are exhibiting chronic fatigue like conditions, that study is complete. The data there is generally positive. But we haven't done the complete data analysis, which is underway right now based on the clinical study report. I'd like to go now into our oncology program. I'm just going to touch on the top priority programs. I mentioned AMP-270. Now AMP-270 basically replicates for locally advanced cancer, pancreatic cancer. The program in the Netherlands where we had such success. We are working to open up European clinics for AMP-270 as well as we have recruitment underway at a few U.S. sites. The standard of care in Europe is more suited for this protocol. So we believe that once we get the European sites up and running, that this will move much faster. And we're also seeking modification to the protocol to allow certain nuances that will enhance it recruitment and enrollment in the United States. Now in -- also in pancreatic cancer, the DURIPANC study, which I mentioned, we believe this is an extremely important study. First of all, we're collaborating with the Erasmus, which is perhaps in pancreatic cancer one of the finest research centers in the world and certainly the top research center in Europe. And it's in conjunction with one of the world's top pharma companies, AstraZeneca, which is -- we got a big European operation and a big focus on oncology in Europe. So the endpoints there are safety and efficacy. We have every hope that this combination therapy will enhance the progress that Ampligen by itself has already demonstrated in terms of extension of progression-free survival and overall survival in the early access program and to the extent that adding durvalumab does that -- that's a big step because late-stage pancreatic cancer is a disease that's highly lethal with a short fuse and we're also hopeful that we'll see some of the dramatic impacts on ORR, objective response rates, like clinical complete responses and significant partial responses in tumor reduction, as we're seeing when we combine Ampligen with KEYTRUDA in ovarian cancer. Now moving to ovarian cancer. I've talked a bit about both of these studies already, but the impact that Ampligen is having in enhancing this PD-1 checkpoint drug, KEYTRUDA, and the mechanism of action generally suggest to us that it may have not only a broad spectrum effect on a number of different solid tumors, but also be useful as an enhancer of the effectiveness of a wide range of checkpoint blockade therapies. Now, we are starting this dendritic cell combination therapy under the same theory, but we don't have the clinical data at this point. So we have to wait and see how that develops. But we have positive hopes for the same kind of dramatic synergies seen with checkpoint inhibitors being replicated in the dendritic cell combination therapy programs. Advanced recurrent ovarian cancer and pancreatic cancer are just a few of the cancers where we are doing work, but it is important to note that those are our priorities. Now I'd like to touch on immune disorders, immune system disorders for just a moment. Ampligen was originally developed as a therapy for a disease called chronic fatigue syndrome or ME/CFS and the conditions of chronic fatigue syndrome are a mirror of certain -- suffers post-COVID or long COVID. And so we focused on using Ampligen to look at its therapeutic impact on long haulers who are showing fatigue, brain fog or cognitive dysfunction, sleep disorders and joint pain. Now that study is completed. There were no safety-related issues. The study was a proof-of-concept. Phase II is very small for a Phase II, but it's big enough to allow us to create The criteria for the design of a bigger and more successful Phase II, Phase III type study because we'll know the parameters where we can better identify the inclusion criteria that focuses on Ampligen responders. So we need this information and was -- we cast a very broad net of who came in, but we'll be able to sift through that and create an inclusion criteria for our next step in this important disease. Now you may be asking yourself, why AIM and why now? Well the reason why AIM is important right now is because we have been focused on clinical execution. And our clinical execution over the past 3 years, especially in oncology has been spectacular in my opinion. I believe that the data that we're generating strongly suggests a long-term potential for success of Ampligen, our drug Ampligen, in oncology, both as a single agent and as a combination therapy with checkpoint blockade drugs and perhaps even dendritic cell therapies. So we're unlocking the value of Ampligen, not just our stockholders. That's, of course, very important. And our clinical successes have a direct relationship to value. But also, and what is our top priority is creating a clinical base that will allow us to move forward in these dread unmet medical situations like late-stage pancreatic cancer, advanced recurrent ovarian cancer, Stage IV triple-negative breast cancer, where people's lives are on the line. And we want to be there to help them not just to give hope, but to give extensions of life and health. We're here to serve those people. And like our motto said, AIM ImmunoTech's motto is immunology for a better future. It's not just a better future for the stockholders, it's a better future for the people in need of therapies. So with that I want to end by saying that when you look at our data and you can go to our website to see that data, you'll see that we have especially in oncology, some of the strongest human data for a company of our size and our stage that's out there right now, just read the publications, see what's going on. we have ongoing studies, multiple studies, human studies and respected institutions by independent investigators that in the future could very well if it's consistent with past performance, generate important inflection points. And finally, something that very few companies can boast, we have big pharma collaborators both in ovarian cancer and pancreatic cancer that are providing a collaboration arrangement to support that study moving forward. So with that, I thank you very much. And I want to take this time to open the floor to questions.

Excellent. Tom, thank you so much. Congratulations on all of your progress. Really great work that you and the team are doing and definitely felt your passion at the end there just on the possibility of having a potential to help people that are in desperate need. So love hearing that. We are, as you said, going to transition over to our Q&A. So for our audience, I'm sure you have questions for Tom. [Operator Instructions]. And Tom, so while our audience is thinking of questions, I have a few to get us started. When listening to your presentation, you have built a robust data set with Ampligen in multiple indications. So I know your focus is oncology. Can you discuss what you consider your lead indication?

We began our repurposing of Ampligen into oncology in 2016. The pancreatic cancer early access program that we've just completed was our first step in oncology in any significant way. And we've been very fortunate because that repurposing was followed by positive data being collected as a result of these studies step by step. We haven't had any setbacks of any significance whatsoever in oncology. Again, I ask anybody who wants to see our oncology program, you don't have to listen to what I'm saying. You don't have to look at what we see on our website about ourselves, go to those publications and read what these independent clinical and medical journals are saying, these are peer-reviewed by top experts in those cancers and the data is being generated by top cancer centers with world-class researchers writing those papers. So that shows you where we're at and that shows you where we're going.

Great. Okay. We have had a bunch of questions come in, so we're going to get right into it. Our first question comes in says, hi, Tom. Dr. [ Murray ] here. Can you provide a rough time line for the work of Azenova? And what is evolved in their work?

First of all, in answering that question, the conversations that we might be having as a result of Azenova are typically confidential. So I'm not going to be able to go into anything that, but let me just give an overview of what we're doing. We hired Azenova because they specialized in business development in oncology. That's their area of specialty. Azenova has helped us create a database presentation, based upon the data that we have collected through the research and development work over the past 6 years, much of which has just come in over the past 1.5 years. We couldn't begin this process until we had sufficient data to have something meaningful to discuss with these larger companies. Now part of the reason why I repurposed this company into oncology was because there is a tremendous unmet medical need in certain solid tumors. And we had a theory about how Ampligen might work in that respect that's being proven out. So it's to help people in need. But the other part of our reason for repurposing into oncology, unlike some of these chronic diseases, where you have very little big pharma interest, aggressive interest anyway. In oncology, once you reach a certain inflection point with your data, then there is a lot of deal activity in oncology. And typically, those deals involve significant sums of money. So in that respect, we're trying to work and focus on where the money is. Now Azenova as identified candidates, approximately 20 candidates for conversations, and is in the process and has initiated such conversations. Now as I said, those conversations are confidential and in many respects right now, preliminary because we're in that stage of the game. If there's any follow-up question there, I'm happy to answer it, but I hope I've addressed the question, Dr. [Murray].

Thank you, Tom. So our next question that comes in, where do you see the most potential for Ampligen given the compelling combination therapy data?