AIM ImmunoTech Inc. ($AIM)

Welcome back, 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 I'm very pleased to be joined by Tom Equels, he is Chief Executive Officer. We also have Dr. Charles Lapp. He's the company's consulting Medical Officer; and Dr. Christopher Nicodemus. He's the company's Consulting Science Officer of Amimmunotech. Welcome gentlemen.

Very much, Jenene. On behalf of our medical and scientific team, we're very grateful for this opportunity to discuss this important issue.

Well, I'm a grateful one. So happy to have you guys here. And 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. Okay. So we're going to dive right in. So Tom, today's virtual investor Ebola, what this means segment focuses on Ampligen's potential role in Ebola virus disease amid the current World Health Organization, public health emergency declaration.

So I have to ask, why is AM addressing a bullet now? And why is this important for both public health and strategic perspective.

Jenene, the current situation with the outbreak of the BundiBugyo variant of Ebola is very serious because unlike the prior dominant strain that we've seen in outbreaks over the past several years, which are very close to or clearly in the space of the Zaire variant. The BundiBugyo variant does not have a therapeutic or a vaccine or any kind of a prophylactic that helps to prevent infection for those people who are exposed to the virus. So that's why it is a serious and dangerous public health emergency and spreading very, very rapidly in Central Africa, so you're talking about a disease that is deadly, 40% to 50% mortality rate they're estimating and it's spreading fast. So the work that we can do in this space is amplified by prior work that we've done in Ebola generally, which establishes our ability in the Zier variant to create a prophylactic or early onset therapeutic response. It's very, very powerful. Combined with studies, including a peer-reviewed journal article, which outlines the mechanism of action of Ampligen clearly and the stands with a proposition that, that mechanism of action preventing viral replication would be a broad spectrum across these different Ebola variants. So we have a tremendous need due to a lethal public health emergency, and we have research that we've done so far that helps us to believe that we can make a difference in preventing infections or helping to resolve early onset infections, which is critical in stemming the spread of such ambitious and deadly virus.

So Dr. Lapp, over to you. So for viewers less familiar with Ebola, can you provide some background and explain why the current outbreak remains such an important public health concern?

Surely. Ebola is a highly infectious and dangerous RNA virus that causes hemorrhagic fever, which is often fatal. It's endemic in Central Africa. -- where it has triggered large outbreaks in the past, the largest of which was in 2004 to 2016, and claimed over 11,000 lives Bundy bogo is a fatal rate -- fatality rate rather of 40% to 50%, while other strains have a fatality rate of 90%. There's a Tom Equels, as pointed out, there's no approved treatment for Bendigo. As of May 26, just 3 days ago, the CDC reported 764 suspected cases of Bendigo and 176 deaths. This morning, I was listening to the radio, and they're saying that there's over 1,000 in just 3 days, so the illness starts as a simple flu-like illness with fever, chills, sore throat, headache akiness. But within days evolves to the so-called wet phase which is intractable nausea, vomiting, diarrhea, followed by an inability to clot the blood, widespread hemorrhage, organ failure and then eventually death. And it's easily spread by contact from any bodily fluid. So that makes it -- containment a very difficult job, particularly when medical facilities are strained or there's a lot of adequate resources there. Now the current outbreak of Ebola is a significant public health concern because the Bundibugyo strain has a high fatality rate and it lacks an approved treatment, as Tom has pointed out, Additionally, it's difficult to diagnose this strain, the inability to accurately diagnose means that the actual number of infections would be much higher than reported and it makes it more easily to spread within communities. There are no known treatments, as we've said, but there are also no vaccines that can help prevent Bundibugyo. So management is all supportive. That means IV fluids, nutrition, symptomatic therapy, continue teboteluids, and proper burial techniques. The rapid spread of this illness, the fatality rate, the difficulty in diagnosis and the lack of treatment of vaccine, these all collectively make this outbreak a public health emergency of international concern.

Thank you, Dr. Lapp. Extremely helpful background there. So Dr. Nicodemus would you like to bring the company's lead product candidate Ampligen into this conversation and specifically the mechanism of action of Ampligen. Can you explain in simple terms why the company believes Ampligen may have broad applicability or utility across the Ebola variants?

Yes, absolutely. So I guess the key to host defense for anyone who's exposed to a new infectious agent is what we call the innate part of the immunity. So that's the first -- the first part of immunity before you've had a chance to educate yourself about what it is that you're up against. And in the case of Ebola and then these various strands of ebola that are just slight variants that behave ever so slightly differently. The virus has managed to develop its ability to be lethal because kind of hides itself from the innate immune response when it gets processed. So that if you get exposed to a fluid, maybe fruit from a bat that had been -- had saliva on it from the footbed, maybe that's how it got to you in some rural district, you become ill. The virus goes into the scavenger part of your early immune response, the part that is looking for fine agents. And manages to hide itself so that it is able to proliferate. And by the time your body becomes aware of the fact that it's infected, you already have a very widespread and dramatic disease, just as Dr. Lapp was describing. So patients rapidly succumb with bleeding and all of the symptoms that he described. And there's very little time. In fact, by the time it present, it's almost too late to even know that you need to have an intervention. Now for the earlier spins, there were specific treatments that interfered with their ability to spread and that kind of stopped those prior pandemics. The current one, as we mentioned, is with a new strain and we do not have any existing treatments. So why would Ampligen be useful, it turns out that Ampligen is focused on this very same part of the early immune response, innate immunity. And in fact, shares a feature, which is that it is actually a double-stranded RNA form. So that is actually what Ampligen is, is essentially a variation of the of the RNA that is central to the virus itself. So when the virus in made, it would normally trigger a late immunity, but since it hides itself from those pathways, it just proceeds. By being exposed in the presence of Ampligen 1 has an ability to alter the way the virus is being perceived within that infected cell and actually to start triggering an innate immune response. So by the very nature of Ampligen as an interferon inducer, which is what it's original research purpose was happens to line up very much with the very mechanism of how this virus grows and spreads within the body, and it will interfere with that in ways that we still do not fully understand. But there has been research that has gone on over time, periodically looking at these pathways and trying to better understand immunology. And so we're very aware that Ampligen and Ebola are in the same set of pathways. And as -- as has been mentioned, there have been studies that have been previously done that have shown that Ampligen can interfere with infections in a variety of systems, either cellular systems in various animal models of pole infection and in fact, can have pretty dramatic effects on the outcomes of otherwise litho infections. So for that reason, it makes sense that Ampligen is something that could be useful as I would say, is a tool in the toolkit as one is attempting to support these patients as they come in whatever location they might be. Right now, the infection is primarily confined to rural areas with limiting access to facilities. If it does start just to be spread into more developed areas, perhaps containment can work. But nevertheless, exposures do occur and then how to interfere with the rapid spread of the virus is the question of the hour and what tools are available. I don't know if that answered your question, but it's not simple biology, but in many ways, the way that Ampligen works and the way that the virus is working are related to each other. So it does make sense that this could be a useful intervention that might be a benefit to field workers.

Well, that makes absolute perfect sense. And from my point of view, it makes all the difference in on helping us understand why we're even all here together for this segment today. So extremely, extremely helpful. Tom, on top of this here, how does AIM's position differ from companies that may only now be beginning to explore Ebola-related opportunities?

Jenene, it's important to understand the testing regimen for a disease like this. Ebola is a virus that is so lethal, generally Ebola is so lethal that you don't have clinical trials in humans. So all of the experimentation that's done to establish efficacy is done typically in government-controlled biosafety level IV labs that are designed for testing of extremely lethal viruses. So the ability to even test in this space is challenging to have access to those labs to get the government support to allow the testing to take place. Now we've been very fortunate in some of these prior outbreaks before vaccines and everything were developed for the variance that we're challenging the health organizations to have had access to government studies by the United States at usamarid. -- that's the United States Army Medical Research investigative facility. which is a biosafety level 4 lab as well as in Canada by the government of Canada. And there have been 2 studies in animal models, testing Ampligen's potential in the -- in these studies, Ampligen in both studies showed a dramatic impact on infection and survival depending on the structure of the study, but in the U.S. government study, we saw -- and this is clearly a prophylactic or early onset effect because the rodents were infected with Ebola and then in a very short space treated with Ampligen. but there was 100% survival in the low-dose Ampligen cohort with virtually no symptoms of Ebola. So that shows a dramatic impact. In another study were conducted in Canada, -- there was a very significant survival advantage of, I believe it was slightly over 50%. But that was in a study where the infection -- the exposure to infection continued for several days beyond the administration of the Ampligen. So it was showing a survival impact, but arguably one that as the effect of the Ampligen we're off could lead to additional infections and deaths in the animals. But it was still a very significant survival advantage, 100% mortality compared to 50-plus percent survival. So those studies have already been done by these government labs. And so that's the springboard that we launched from here. And on top of that, we have a peer-reviewed study at 1 of Italy's top research universities that's been published that outlines not just the survival data that we're talking about, but also in vitro testing, establishing a mechanism of action that should have meaningful broad-spectrum impact on any Ebola variant, including the Bundibugyo variant. Now that takes us to the place we are right now. And we have a very strong commitment. And we've, in fact, said that our sole priority is the progression of our clinical trials that have thus been very powerful drivers for us getting into a Phase III pancreatic cancer trial. And we're still doing that. But this current variant because it's such a lethal health emergency and there are lives in the balance, we believe we have to step in and try to offer whatever help Ampligen can provide because I think we all agree that it has the potential to protect not only health workers, these volunteer doctors and nurses and other associated health workers, not only first responders who may be going into secure an area where there's an outbreak to prevent people from coming in and getting exposed. But also -- and this is so vitally important because if you have, as we believe we may a prophylactic or early onset therapeutic, what does that mean if you're in an apartment building where 2 people have come down with the Ebola variant. It means that those people who are not yet showing symptoms or may have just been exposed or potentially exposed, have some hope of preventing infection. What does that mean for the health care worker who, even though wearing hazmat or protective clothing is working every day, long hours in an environment where you're clearly exposed to high levels of this virus, what it means is, is if there's a mistake in the tear in the suit or somehow you're exposed to these fluids, you have hope of blunting that infection by keeping viral infection from being totally out of control. So we're talking about not just giving hope but hope that's based upon these meaningful governmental studies that precede us and taking advantage of those studies and making Ampligen available to governments for development to protect health care workers, first responders and more importantly, the people, the broader population who could be exposed because if you have 2 people in an apartment building or a family into a village being able to treat those other people and prevent their infection also prevents the infection from spreading. It gives hope and protection. What happens if you don't have something like that, people flee those areas and potentially spread the disease in an ever broader expanding circle.

Well, Tom, I have to say 1 of the things that I feel like you always bring to our conversations is the human element. And most of this discussion in this segment was about hope and helping people and just this broader theme here. And so I commend you and the team for that. I think the second thing is that was important to note from what you said is you're not jumping on this bandwagon in a disingenuous way. You have data, you have sound data publications. And so you have -- you're 10 steps ahead of many that would even consider looking into a way in which their potential product candidate can have an impact. So it almost feels like there is a race, though, right?

The race is not a race against other companies. We -- this is a horrible disease. It's a deadly fast-spreading disease, and it has to be contained. And we have to develop therapies, vaccines, so we want everybody else who might have something to offer to be successful because the humanitarian issue here is what's important. And I think I can speak for Dr. Nicodemus and Dr. Lapp is we're here to make a difference. This is 1 of those instances where we, in our role in immunology and medicine have an opportunity to save lives in real terms. This is a lethal unmet medical need. And if we can make a difference, we have a duty to make a difference. A professional and a moral duty to make that difference. So that's what we're trying to do here.

Excellent. Makes perfect sense, and thanks for that. So Dr. Nicodemus, over to you beyond bolaself, what broader message does this initiative send about preparedness for emerging viral threats.

Well, for emerging barrel threats or actually any kind of microbial threat that hasn't been encountered before, you never know what you're up against, and it's a matter of A little bit of luck along with making appropriate moves to try to bring whatever the circumstance would be in the future under control. And again, since Ampligen is if this core of the nat immunity at the very start of stimulating an immune response. There's every reason to believe even if that the disease is different than the Ebola, which happens to be kind of mimicking the very structure of Ampligen in the way that it works. But in other diseases where an early immune response might alter amplified early immune response might alter the downstream effect for better or worse. It would be a useful agent to have available and to try in carefully controlled settings. And again, going back to the toolkit analogy, when you have to be prepared to deal with the unknown, you want to have a set of tools that will be useful and make a difference on what you're up against. And for the -- for the case of Ampligen, it is a tool that is very active and does alter the way immune responses progress. So therefore, not knowing what such a future disease would be still, if I have to have a toolkit, I would prefer to have Ampligen available to me in that tool kit assuming I was up against the unknown.

Appreciate that. And Tom, you and the team have been talking about this prior data. And I do want to make a note here that you have posted the data to the website for those that are interested in seeing that at aimimmuno.com. So just wanted to make that important note because I know we're having this segment here, and there aren't slides involved. This is more of a conversation, but the fact that people can reference that data All right. So Tom, as we think about closing this discussion, which has been absolutely helpful and certainly important and timely. Looking ahead, what should investors and public health stakeholders watch for net from AIM regarding initiative and the broader Ampligen platform?

Well, at this point in time, AIM is taking next steps, which involve reaching out to different governmental entities and agencies like the World Health Organization in order to let them know or remind them of the positive data that's been accumulated in these other variants and the analysis of that data that's set forth in the peer-reviewed article I mentioned, but also to let them know that we will cooperate fully in doing what needs to be done to move forward. It's important to note that both the United States as well as the European Union have granted AIM and Ampligen orphan drug designations for ebolavirus disease. And those orphan drug designations carry certain benefits and acknowledgments with them, one of which being recognizing the danger of this particular disease that we do have sort of maybe a little bit of an edge in saying, we'd like your help in designing fast track status, things like that. But also remember, any testing that has to be done in these biosafety level for facilities. Almost all of those facilities are government-controlled facilities. I'm not saying all of them are, but -- but typically, it's some form of government-controlled facility. So getting access for the additional testing that might need to be done is extremely important, too. So the work we've done in front of this problem lends itself to opening those doors. And I want to make a point, too, because we -- there are 2 areas that we're working in now that involve highly deadly diseases. And we've committed ourselves to move forward in late-stage pancreatic cancer our metastatic pancreatic cancer trial is ongoing in the Netherlands at a Rasmus Medical Center right now, and we're not backing off of that. We're pushing forward there as well because between the United States and Europe, over 100,000 people a year dying of late-stage cancer, pancreatic cancer, worldwide, almost 0.5 million. So this is again an area where we have an obligation to keep the ball moving forward.

Tom Excellent. Gentlemen, this has been such an important discussion. I really appreciate your time. And with that, this does conclude the AIM ImmunoTech what this means segment. I'd like to thank Tom Equels, Dr. Lapp and Dr. Nicodemus for joining us today. I'd also like to thank our audience for your time and attention. And if you like what you saw today, I encourage you to visit as website at aimmune.com and follow their social channels on X LinkedIn and Facebook to stay current on the latest information. gentlemen, such an important discussion. Thank you for your time and wish everyone a great rest of your day.