Q4 2023 AIM ImmunoTech Inc Earnings Call

Participants

Thomas Equels; President, Chief Executive Officer, Executive Vice Chairman; AIM ImmunoTech Inc

Christopher McAleer; Scientific Officer; AIM ImmunoTech Inc

James Molloy; Analyst; Alliance Global Partners

Ed Woo; Analyst; Ascendiant Capital Markets LLC

Presentation

Operator

Hello, and welcome to the AIM ImmunoTech fiscal year 2023 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 and 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 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 Aames 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 files with the Securities and Exchange Commission. These documents are available in the Investors 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 of the company's own estimates and research. While the Company believes the third party sources to be reliable as of the date of this presentation, it is not independently verified and makes no representation as to the adequacy of fairness accuracy or complete completeness of or that any independent sources verified any information obtained from third-party sources.
Joining us on today's call from a leadership team are Thomas Equels, Chief Executive Officer; and Dr. Christopher McAleer, Scientific Officer. I would now like to proceed to turn the call over to Mr. Equels. Please proceed, sir.

Thomas Equels

Thank you, everyone, for joining us. 2023 was an extremely important year for AIM. We demonstrated progress resulting in significant advancements across our pipeline, showcasing a growing body of highly promising, consistent positive data with our priority development programs. This data-driven progress drives our firm enthusiasm and belief in Ampligen has long-term potential in these many areas where we have shown clinical therapeutic value through the data. And these are not only unmet medical need, sometimes lethal unmet medical needs, but also high value indications such as advanced and metastatic advanced local and metastatic pancreatic cancer, advanced recurrent ovarian cancer, post-COVID conditions of chronic fatigue and cognitive dysfunction.
These are all important unmet medical needs that were challenging on the corporate front, our positive data in oncology was the catalyst for us to engage as Inova a specialized oncology business development firm. And that is to drive our licensing discussion using skilled experts in the field to engage in negotiation of potentially valuable relationships with qualified partners. We have a robust business development strategy for oncology involving our use of as Enova, and that process is now underway.
Importantly, my mandate and strategic imperative for the Company, early on was to broaden and take steps to secure our patent estate for Ampligen, especially in oncology as a priority. We successfully continued to do just that you'll note that we had the issuance of a key US patent. And that's where we were protecting our use of Ampligen in combination with PD-L1 checkpoint inhibitors such as their value MAM, the AstraZeneca drug and we've also made tremendous progress in the clinic with Ampligen combined with PD one checkpoint inhibitor. So we're trying to establish in many tumors, different tumor types and with different checkpoint inhibitors Ampligen, the ability to create synergy, sometimes massive synergies.
Now I believe that the clinical work that we do is very important not only for our business development strategy because for any potential future partner, clinical progress, de-risks their investment, but also for our stockholders and investors to understand that all of this work also creates a foundation for long-term value through 2023 this time last year for now, we've had tremendous progress this time. Last year we hosted our inaugural earnings call and quarterly thereafter. We have engaged in similar efforts of updating and providing progress report to our stockholders in 2023, we upgraded our website, and we've been extremely effective and active on social media channels. All of this demonstrates our commitment to good communication.
Recently, we launched a MCEO. corner to provide a portal on our website to further discuss important topics for the Company and areas of interest to you if you have an interest area of interest, do you want to suggest contact our IR portal and give them your ideas on what we should be talking about on CYO. corner. We're all in this together. I'm a stockholder too. And over the past several years, I have personally invested what I believe is a substantial amount of money in I believe it is critical for management to stand shoulder to shoulder with our stockholders, and we will lock arms working together to move this Company into its next phase of growth and what I believe is a phase that presents great opportunity.
It is now my pleasure to turn over this discussion to our Science Officer, Dr. Chris McAleer, who will give you a detailed update on our progress in the various clinical trials. And also, I hope broadened your understanding of the mechanism of action of Ampligen, what it's doing in the immune system based upon recent data. Chris?

Christopher McAleer

Thank you, Tom. Ampligen is a treatment for multiple indications from locally advanced and metastatic pancreas cancer to advance recurrent platinum-sensitive ovarian cancer to Long COVID and I will take a few moments to briefly walk through some important aspects of our clinical portfolio. I will start with the study in advanced recurrent platinum-sensitive ovarian cancer ongoing at the University of Pittsburgh. I have had an opportunity to review the preliminary data that will be included in the interim report, and we will be releasing a statement in the very near future once the finalized report has been received. What I can say now is that based on the initial data, the safety profile is good. The objective response rate is better than the preliminary data that was reported in the April 2022, ACR abstract, and you remind all shareholders that the data presented at ACR indicated that Ampligen and the Ampligen pembro containing treatment had a four to five times greater objective response than that seen in the KEYNOTE 100 study of pembrolizumab alone in recurrent ovarian cancer and the objective response rate being complete and partial tumor responses. The study has moved on to the second stage of the Simon two-stage design. The data is very promising, and recruitment rates have also accelerated post COVID.
So all of those are positives as detailed data from the planned interim report will be disseminated in the upcoming press release, we reported positive top line data for the AMP5 18 post COVID trial in February. And I have also recently reviewed the preliminary copy of the complete study report. We are currently working with Amrix to finalize that report at which time, we will begin deep analysis of the data and use that information to help inform the design of the next trial. The post-COVID landscape is diverse and information is continually being generated that helps refine the scientific community's understanding of the disease. And the trial was designed to collect preliminary data to appropriately power the next trial as well as understand and refine inclusion criteria for the design of a successful Phase two pivotal study. That analysis will likely take some time based on the over 32,000 pages worth of data listing, but I am optimistic that based on the preliminary review of the data, it is sufficient to design and power the subsequent trial concerning our and through 70 trial in locally advanced pancreatic cancer. We are currently preparing for a Type B meeting with the FDA to discuss altering inclusion criteria for the I&D vertical. If we are successful, it will expand the patient population that would be eligible for enrollment. I will speak further on this in the future after a resolution of the Type D meeting.
In the interim, we are still recruiting and opening new sites and the current sites are still open for enrollment and are screening potential candidates. Hopefully, upon successful consultation with the FDA, the revised protocol will allow for faster recruitment of sites and patients in the EU. Erasmus Medical Center in the Netherlands should be open for recruitment any day now. And we are engaged in conversations with other sites in the EU that brings me to the DORA Panc study combining Ampligen and their value mAb therapy post full.
Fair enough. The Phase one portion of the trial is a three and three escalation design was fixed or value MAD dosing with escalating Ampligen dose. The first three patients of the three and three design have been enrolled already, and two patients have completed their Ampligen dosing and have received at least two doValue MAD doses, the last patient last Ampligen doses in mid April and thus far, there have been no reported adverse events once the patient completes the last Ampligen dose and finishes the prescribed monitoring period, which should be around the end of April. And assuming the safety profile is consistent as it has been thus far we can escalate to the next dose. That trial so far is going according to schedule. And if that continues, we expect the Phase one portion to be completed in the summer of 2024. And lastly, once you address the early access program in pancreas cancer, enrollment in this program will halt as these patients should be enrolled in either door bank or add to 70 from this program. Data was recently published in the journal Clinical Cancer Research. And these data highlight aspects of the mechanism by which Ampligen exerts prolonged progression-free and overall survival in pancreas cancer patients. These data were also part of the information used to design the door Panc study and what gave further confidence that Ampligen would work synergistically with the PD-L1 checkpoint inhibitor durvalumab.
With that being said, I'd like to take a second and look at Ampligen effects in various different solid tumors. Amergen works by binding to Toll-Like Receptor three, which are found on epithelial cells and immune cells in the body. Solid tumors in different parts of the body are similar in that they formed from epithelial tissue and therefore, these tumors express Toll-Like Receptor three, our hypothesis has been that Ampligen will be an effective treatment in multiple solid tumor types because one, it's binding to Toll-Like Receptor three found in the solid tumors, no matter where that tumor might be in the body, whether it be pancreas, ovarian, breast or otherwise. And two, the Ampligen binding to the toll-like receptor three, three found on the surface of immune cells that are distributed throughout the body, including the tumor microenvironment. And this chart shows different immune biomarkers, and these are markers of immune cell chemo taxes and dendritic cell or T cell infiltration in the tumor microenvironment.
And this table might seem complicated. So a more relatable analogy might be that Ampligen forces the tumor to make a nine one one distress call to the immune system against its will shown here in the table by increases in CXCL. nine 10 and CCL. five and subsequently, the immune system infiltrate the tumor and taxes shown by upregulation of granzyme B and CDA. in this chart. And the table shows that the phenomenon happens in multiple different solid tumor types we have investigated. And therefore, we believe that Ampligen has potential not simply as a treatment for one specific form of cancer. But as a treatment for many types. And importantly, I want to highlight that these immune modulating properties, coupled with other biomarker data, we have suggest that Ampligen would have considerable synergistic effects with immune checkpoint inhibitors our data in triple-negative breast and ovarian cancer confirm that hypothesis. And I believe this will be confirmed through the door Panc study for pancreas cancer as well.
And I'd now like to turn the presentation back over to Tom Equels to discuss our key recent clinical and business milestones, as well as what to expect in the coming months.

Thomas Equels

Thank you, Chris. I too, am very excited about the opportunities that these clinical successes provide. This year, we've hit milestone after milestone in 2023. We have followed away going back over two years of positive data published in top journals and abstracts at major meetings, especially in oncology. For Q2, we are planning for an action-packed quarter. And regarding our business development strategy, as I mentioned, we hired as Inova and now we believe in time to redouble our efforts with their health to mandate for as Inova is to drive our process for conversations with targeted potential sponsors partners and create the value that comes in oncology from such deals.
If you look, you'll see that the richest area of deal-making for biotech and oncology, that's where the most deals are, and that's where the most money is. Business development takes time and begins with the creation of a sufficient database to support the discussion. That's where we're at now from that point forward the cycle from introduction to a potential partner. So the negotiation of a valuable transaction doesn't just happen overnight or with a few conversations. It's a long term process taking months, sometimes a year or more. We do believe, however, that we have the right team and process in place to ensure we maximize the value of Ampligen. We also believe, and this is why we're taking this step at this time is that these decisions by the bigger pharma companies to acquire rights in a drug in an oncology drug are data-driven decisions and we are now sitting on data that allows us to have that discussion. And we have additional data coming in, we think will amplify this point.
Now what are we trying to do? There are a number of different things that are possible if we have an interested business partner, partnering, traditional partnering, co-development licensing deals, even M&A opportunities might appear, we believe 2024 is an full year for this process. We have the data, we have the team and we intend to make important strides with our discussions with these potential partners over the course of this year.
Thanks. Now let's take a look at our financial snapshot. The numbers are there. The details are in the 10 K that we just found. But the important thing to take from this is we have the wherewithal to go forward with our programs for the next year and a half or longer. So this is this is the answer. When you look at it, what you're seeing here is we have the ability to continue our programs into the future, and we have important programs that are underway. But Chris and I believe the future is bright for both AIM and Ampligen. The entire 18 is behind us driving this strategy forward. Our programs, our operational activities and our clinical execution has been superb. We believe we will continue to deliver promising data across several important indications, all of which have the potential to create huge market opportunities.
Now all of this is done to drive forward AIM and Ampligen and unlock Ampligen of opportunity to provide therapeutic value. Our medical and scientific success success, though, is not just good medicine I firmly believe that good medicine equals good business and our strong clinical showings that we've posted over the past two years as well as what we expect in the future is a basis for driving stockholder value.
At this time, I'd like to open the floor for questions.

Question and Answer Session

Operator

(Operator Instructions) Jason McCarthy, Maxim Group.

Hi, guys. Thanks for taking the questions. This is Chad on for Jason. So for AMP two 70. I was just wondering if you could give a bit more clarity on timing for first patient dosed as that I'm guessing that as a 3Q event, 4Q event or anything there would be helpful.

Thomas Equels

Well, we certainly have every expectation that in Europe we will serve certainly by the end of the year, have people not only enroll, but in treatment. And that's not something we can say in the U.S. because there's a difference in the standard of care between Europe and the U.S. That seems to we are affecting the ability to get full enrollment in the U.S., which is why we're having the meeting with the FDA. I can't go into the details of that ahead of time, but we hope with some amendments and the protocol to broaden the inclusion criteria will also start to get the kind of U.S. candidates in subjects recruited and in treatment as well. Chris, would you like to that, talk to that a little bit?

Christopher McAleer

Indeed, a Type B meeting should be scheduled here shortly. And when we have that conversation with the FDA, it's about altering the inclusion criteria. The US does things a little bit differently than Europe does in terms of how they treat patients with locally advanced pancreas cancer. And we need to take that further into account. We understood that when the trial was designed, but perhaps to the extent that they want to include radiotherapy is that it was a little more than expect. And so the I assume that after the Type B meeting is over, I hope that the FDA will agree to the changes that we are going to be made. And I think that will catapult enrollment in the US. So I expect enrollment in the EU to happen Q. three Q. fours by the end of the year, for sure. And in the U.S. as well.

Okay, great. Thanks for taking the questions, guys, and congrats again on the quarter and thinking. Thank you.

Operator

James Molloy, Alliance Global Partners.

James Molloy

Yes, good morning. Thank you very much for taking the questions. And I had a question sort of on the or the investigator-sponsored trials, you've got a variety of metastatic prostate, triple negative ovarian cancer. A variety of IST. is ongoing and of their outside of your control, but would any any insight you could give us on when you think we might be seeing some uptake data and in and out of the new Desire series?

Thomas Equels

Well, we have every expectation of getting the formal interim report on the advanced recurrent ovarian cancer Phase two. That's the program that was started in Pittsburgh with Merck grant. And I combining Ampligen with pembrolizumab to see if it improve the therapeutic efficacy over and above what pembrolizumab alone was able to do, that should be extremely positive data because we've seen preliminary data come in consistently positive and showing a massive increase in therapeutic impact, especially with regard to our. So I think that's going to be very powerful. These investigator-sponsored trials are extremely important because while we're supplying the Ampligen and everything for the most part, the big part of the expenses in those trials is covered by various grants, either industry grants or governmental grants typically then in terms of when does it does.

James Molloy

Thank you very much. And then on the 5.8 times, the final datasets can become And I hear second quarter, what's the what does it what does the learnings you to just be getting out of it with the unfortunate data back in February of what additional data you hoping to sort of parse out of the final dataset that potentially going forward, it doesn't go for the five one eight?

Thomas Equels

Well, the data we received in February had a lot of very positive points in the top line report and the complete dataset has come in, but I think it's tens of thousands of pages. So our ability to do that analysis will take some time but it's underway. I'll turn this over to Dr. Meckler for any detailed comments, Chris?

Christopher McAleer

So the complete study report will have a break down of all the secondary endpoints that were in part of the top line data. We've seen those and there are positive improvements in quite a few of those. The It also gives us the individual data points for a statistical analysis and power analysis to be done. I am also hoping that would be you have to wait for the biomarker analysis come in, but it's clear from the initial review of the data that there are responders and nonresponders as we would expect and the understanding of the inclusion criteria and the initial baseline data of those individual patients who responded versus or not will give us an indication of how we want to design this study in the future.
Secondary to that, you I remind everyone that you the landscape of post COVID and how you use statistical analysis and standard deviation. The power of the study didn't necessarily exist for us. So we chose 80 patients as a clinical judgment, right? And that data is used now to power the study appropriately. If even the data that currently exist, I believe powered properly would have given us statistical significance over the course of the study as the data would suggest there are improvements in both cognitive function, fatigue, six minute walk test and sleep as well in these patients. And so I believe the data will give us enough information for us to design the trial to be successful with high level of power for the Nextra.

Thomas Equels

If I might just add the the point of this was the move is called a proof of concept because of the small number of subjects, 80 80 subjects is a very small Phase two, and it usually designed for exactly the purpose that we've just articulated. But but what we intend to do is take that data and refine our inclusion criteria so that that we're focused on bringing subjects into this trial.
This follow-up count that we have high confidence that we've targeted the zone of Ampligen responders and much of that's going to be based upon the onset of disease. And we believe that the longer they've had post-COVID chronic fatigue like symptoms, the more likely we'll see statistically significant responses, especially with severe disease, which is much easier to measure than people with mild or moderate disease so So Chris, anything you want to add to that and we'll have to see if Mr. Moyes, I think that sums it up it. Does that answer your question?

James Molloy

I appreciate it. And I guess last question, a housekeeping of G&A, pretty high in the K. You guys talk about the $6.5 million legal expenses you had to spend in the year. I presume you anticipate, hopefully at that same level of G&A with the with legal expenses going forward in 2024 well or we hope that we don't have those expenses again for 2024.

Thomas Equels

We in the Chancery Court defeated this group on thing related group from on three separate occasions it's up and the Delaware Supreme Court right now after our last trial of B., we have we have to take a stand though, if it's this particular group because as the Chancery Court in one of its orders related to the the second attack withdrawal from that, the whole thing was orchestrated by a securities law, Alan, and then the payment and funding of it was managed by another financial fraudster convicted felon. So you can't allow that to go forward without addressing those issues. Thank you for your questions.

Operator

Ed Woo, Ascendiant Capital Markets.

Ed Woo

Yes. Congratulations on all the progress that you're doing. My question is the COVID landscape has changed significantly. Obviously, as we move further and further away from initial start of the pandemic. Can you talk about the market opportunity for long COVID today?

Thomas Equels

It certainly is to we've got a situation in the United States that is ever increasing in terms of its social impact, we're looking at millions of Americans, and they're expected to have a serious post COVID chronic fatigue like conditions, which is a potent exertional malaise, debilitating fatigue, cognitive dysfunction, sleep interruption and severe joint pain. So the so that's a disabling disease that's ever growing. And it's I believe right now estimated at about 4 million potential persons that will suffer from this going forward in the United States alone. The numbers are exponentially higher worldwide, of course.

Ed Woo

Great. Well, thanks for answering my questions, and I wish you good luck.

Thomas Equels

We'll thank you very much. We really appreciate your interest.

Operator

Thank you. We reached the end of our question-and-answer session. And ladies and gentlemen, that does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.