AIM ImmunoTech Inc.

Hello, and welcome to the AIM Immunotech inaugural fiscal year 2022 update conference call and webcast. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the event, please press star zero on your telephone keypad. Following the presentation, there will be a question and answer session. Note that this webcast is being recorded at the company's request, and a replay will be made available on the company's website following the end of the event. At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations, or future projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and are based on AIM Immunotech's current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports AIM Immunotech files with the Securities and Exchange Commission. These documents are available on the investor section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast relates to or is based on studies, publications, surveys, and other data obtained from third-party sources. and the company's own estimates and research. While the company believes these third-party resources to be reliable as of the date of this presentation, it's not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of or that any independent source has verified any information obtained from third-party sources. Joining us on today's call from the AIM Immunotech leadership team are Thomas Equals, Chief Executive Officer, and Christopher McClure, PhD Scientific Officer. I'd now like to turn the conference over to Thomas Equals, Chief Executive Officer. Mr. Equals, please go ahead.

Thank you, everyone, for your interest in AIM Immunotech, and welcome to our inaugural earnings call. Today marks an important time in our evolution. We look forward to reviewing today's our many achievements on the operational, clinical, and regulatory fronts. As a reminder, our motto at AIM Immunotech is Immunology for a Better Future. And we look forward to showing you today how, over the past year and going forward, we intend to live up to that motto by developing immunological solutions for serious unmet medical needs. Now, you'll see that we have made tremendous progress over the course of 2022 as we go forward. But you will also see how we are transitioning ourselves into late stage clinical immunopharma development utilizing our lead program, Ampligen. We have built an extremely robust pipeline in high value indications. These are lethal unmet medical needs some of which are in extremely large market opportunities. In addition to this progress, our outreach and our desire to properly communicate our progress as well as our plans is enhanced by the launch of our new website. We invite all of you to come and visit our website and see what we've done and where we're going. Over the course of 2022, we focused on improving communications. Communicating frequently with our stockholders remains a top priority. And we intend, starting with this presentation today and quarterly hereafter, to have earnings calls to discuss our progress as well as our plans for the future. You also see that our social media imprint is stronger and being expanded, consistent with the work we're doing on our website. Now, we are unique in many respects for a company of our size because we have an extremely robust pipeline. We have had a large number of material and significant accomplishments. Our progress is evidenced by the 20-some things you see referenced here that have occurred in 2022. When you go to publications regarding Ampligen or Rintitolamide, you'll see we are regularly publishing papers through independent researchers and top institutions outlining data that shows the potential, the great potential for Ampligen. So this 2022 activity that's referenced here is our foundation for springing forward in 2023. Our pipeline is extremely robust. For a company of our size, very few can boast of the accomplishments that we've made as well as the pipeline that we have in place right now. And this pipeline is addressing clinical activity in serious unmet medical needs. advanced pancreatic cancer, long COVID, advanced recurrent ovarian cancer, stage four triple negative breast cancer. The data on these clinical trials is evolving, and it's been evolving in a very positive fashion. You can read about it in these papers and abstracts that have been published, and you can see that we are in the game, working hard to move our product Ampligen forward along this developmental path. Now, you will find that we also have an extremely well-developed safety profile with the Ampligen, and that safety profile has allowed us to move into clinical trials in multiple high-value disease areas. We have a profile for intravenous use that involves 100,000 doses approximately in humans, and the drug has been found to be generally well tolerated. We have done, as a part of our advanced recurrent ovarian cancer studies, human safety trials to establish intraperitoneal safety for purposes of going forward with those clinical trials, and have successfully done so. Further, we have accomplished what I think in the future will be a major foundation for our clinical activity with an intranasal safety study utilizing Ampligen over a prolonged period of time with doses every two weeks at different dosage levels. Again, it being found generally well tolerated in that study allowing us a basis for going forward into clinical trials related to efficacy. So with that safety foundation, you'll see that we've moved forward with ME-CFS, long COVID, oncology, a number of different solid tumors in oncology, and as an antiviral. And this allows us a very broad spectrum approach for a drug that has, as its mechanism of action, naturally broad spectrum implications. Now, I'd like to discuss what I have prioritized as the company's top program. We have placed our work in pancreatic cancer at the very top of our list, and there's a reason for that. Late-stage pancreatic cancer is basically a death sentence and sometimes with a very short fuse, oftentimes. We first started our program in pancreatic cancer in late 2016 with a Dutch government-approved early access program. And there it was Ampligen as a single agent treating late-stage pancreatic cancer patients. The results of that study were, as of today, we've treated over 40 subjects. is to show with well-established data that Ampligen significantly extends both progression-free survival and overall survival over the standard of care. Now, based on that, we've gotten FDA authorization and commenced a phase two study with Ampligen as a therapy for locally advanced pancreatic cancer. And we are working now to launch another phase two study combining Ampligen with AstraZeneca's drug Dervalumab. And the goal of that is to heighten and even possibly destroy these pancreatic tumors through the combination therapy. That potential is a potential that we have to experiment with as a part of this clinical trial. But we've seen in our other clinical trials that checkpoint blockade therapies in Ampligen can lead to tremendous enhancements in efficacy over the checkpoint blockade drug alone, and in many instances, create complete responses in diseases where few, if any, complete responses are ever seen. If we look at our ongoing clinical programs, I'd like to talk first about our advanced recurrent ovarian cancer program. We had two trials that were started at the University of Pittsburgh's medical school. The first one was phase one to establish intraperitoneal safety. Ampligen was injected into the peritoneal cavity as a part of the protocol in order to better attack these tumors. where they're located. But the second trial, which is a phase two, is funded by a Merck grant principally. And that is a phase two trial where we're using in cisplatin sensitive subjects, Ampligen plus the Merck drug Keytruda or Pembrolizumab. Now, there was initial data published because The progress was extremely dramatic at the American Association of Cancer Research convention in April of 22 by an abstract, a late-breaking abstract, which showed that the ampligen combined with pembrolizumab was achieving, in these initial subjects, tremendous results. They were seeing complete responses slightly in excess of 15%. an additional 20 plus percent of significant partial responses, and a balance going up to 60% for the total clinical benefit related to disease stabilization. What this shows us, especially when we look at the abstract that was published through Roswell Comprehensive Cancer Center in stage four triple negative breast cancer, again, combining Ampligen with Pembrolizumab, is that Ampligen has tremendous potential to create a strong synergistic effect when combined with these checkpoint blockade drugs. So with pancreatic cancer, which tends to express PD-L1, that's why we're working with Dervalumab as the combination therapy in pancreatic cancer, hoping to see the same type of synergy that we saw with Keytruda in these tumors that tend to express PD-1. Now, we also have done a tremendous amount of work in a disease called chronic fatigue syndrome, and the work that we've done in chronic fatigue syndrome led us to believe that Ampligen would have some potential as a therapy in what's called long COVID or post-COVID with chronic fatigue-like conditions. And the reason being is there are a lot of similarities and in many respects, there's almost a complete identity. Now, in chronic fatigue-like conditions post-COVID, you see the exact same symptoms that you see in traditional ME-CFS. Fatigue, and this is profound fatigue, including post-exertional malaise. Brain fog, which is a serious form of cognitive dysfunction, and sleep disorders, as well as joint pain. Now, the phase two study for that has been authorized by the FDA, and we are in the process of commencing that study, but we began that in utilizing a pilot program that was associated with a compassionate care early access program that the FDA authorized for ME-CFS. We have two clinics in the U.S. that are treating severe ME-CFS subjects with Ampligen. And the protocol for that was modified and approved to allow us to begin treating people with those same symptoms where the symptoms arrived post-COVID. So the initial work that we did very strongly suggested that Ampligen might have a positive therapeutic effect. With utilizing that data, we were able to get the phase two authorized. and we intend in Q2 of 2023 to be moving full speed ahead in that program. Now, I'd like to just show you a little bit about Ampligen's efficacy in ME-CFS. This is phase three data that we have, and it's very important to understand why it might be of importance in post-COVID chronic fatigue-like syndrome. Now, you'll see here two graphs. The first one is for the entire population of this Phase III study. And Ampligen was showing a 39% response rate, which is very significant. And you have about a 15% improvement with Ampligen as compared to the placebo control group. But The subjects in this study, some of whom had, not some, many of whom had the disease for more than 10 years, were subjects that we took because it was many, many years before this disease was even recognized to the point that we could move forward with clinical activity. When we wanted to see what kind of subset might be more responsive to Ampligen, we took a midpoint, which is eight years or less from the onset of symptoms, and we see a significant improvement where the Ampligen responders were at 51% compared to a placebo at 17%, which is a 33% improvement. between the ampligen group and the placebo control. So that tells us that in the earlier stages of the disease, from the onset of these chronic fatigue-like syndrome conditions, we are in a position, if treated early, to see a greater improvement or a greater response. Of course, with post-COVID chronic fatigue-like conditions, we have the benefit of being able to catch these people early in the syndrome. So that's why we're moving as fast as possible to get this clinical trial started and see what the data has in store. Now, I'd like to talk a little bit about our finances and our plans. You can see we have great plans based upon the foundation that we've established in 2022. But those plans also include two major Phase II clinical trials, which are going to be fully funded by AIM Immunotech. So we have to look at where we are with cash. And we believe that we have sufficient cash to take us through many of these key clinical milestones. And we're very comfortable in approaching this aggressively utilizing judiciously the cash that we have in place. Now 2023 is clearly poised to be a transformational year for AIM Immunotech. The successes we had in 2022, if the data continues to be so positive, will make big changes in our company and where we're going, and also create opportunities for long-term increases in stockholder value. For Q2, you'll see we have a number of different milestones that we expect to achieve, similarly in Q3 and Q4. These milestones are in collaboration with some of the top big pharma companies and university research centers in the world. The work that we're doing will also be advanced because we expect numerous publications to occur during 2023 that relate to the work that is going on now and is recently, in some instances, recently completed and the data is being compiled. So look forward to a number of important publications and look forward to us achieving these milestones in 2023. We're going to do our very best to hit each and every one of these and, if possible, advance other milestones that may become available during the course of 2023. The work that we're doing here is extremely important, and we appreciate your interest, especially for our stockholders, We appreciate the fact that you are a part of our company, and the work that we're doing, we're doing for you, but we're also doing it for people in these disease areas that really need an immunotherapy, especially in immuno-oncology, that creates hope, not just for a better future, but for life itself. So we've achieved and intend to continue achieving our clinical and regulatory milestones. We hope to continue to establish our growing body of data and expand our clinical opportunities. We are going to work as a company with programs such as the one that we're launching today to elevate the AIM story so that more people have an opportunity to understand what we're doing and why we're doing it. We intend to bring in to our program key opinion leaders, doctors who are doing the research so you can hear from the horse's mouth, so to speak, what we're doing from the people who are doing the actual clinical work. And we are making the changes that we think are necessary to make our stock more attractive to fundamental institutional investors. So all of these things are in progress. The evidence of what we've done, I think, allows you to see that we have a reasonable expectation of progress in the future, and we're going to work very hard for that success. All that having been said, it's important for you to understand the why behind Team AIM. We get up every day. Our passion is that we have an opportunity to make a difference in people's lives by providing a therapy and the hope of a meaningful cure to people who exist under the fear of a wide range of unmet medical needs, especially in oncology. Some of these cancers Where we're making progress are cancers that are extremely lethal, basically a death sentence. So to us, this is very, very important. That's, again, our passion. And it also is good business because we believe that good medicine and good science, where we can accomplish things in these areas where there's a tremendous need, ultimately equates to good business. Again, thank you very much for your interest. I'm ready to open up the program to questions and answers at this time. I have with me Dr. Chris McClure, our science officer. Between the two of us, we hope we can answer any questions you may have. And again, thank you.

Thank you. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star 1. One moment, please, while we poll for questions. Our first question today is coming from Jason McCarthy from Maxim. Your line is now live.