This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
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 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'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 aimed files with the Securities and Exchange Commission. These documents are available in 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 sources to be reliable as of the date of this presentation, it is not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of or that any independent sources verified any information obtained from third-party sources. Joining us on today's call from AIM leadership team are Thomas Equals, Chief Executive Officer, and Dr. Christopher McAleer, Scientific Officer. I would now like to proceed to turn the call over to Mr. Equals. Please proceed, sir.
Equals
Thank you, everyone, for joining us. 2023 was an extremely important year for AIM. We demonstrated progress resulting in significant advancements across our pipelines. 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's long-term potential in these many areas where we have shown clinical therapeutic value through the data. And these are not only unmet medical needs, sometimes lethal unmet medical needs, but also high-value indications, such as 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 we're challenging. On the corporate front, Our positive data in oncology was the catalyst for us to engage as ANOVA, a specialized oncology business development firm. And that is to drive our licensing discussion using skilled experts in the field to engage the negotiation of potentially valuable relationships with qualified partners. We have a robust business development strategy for oncology involving our use of Azanova, 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 U.S. patent, and that's where we were protecting our use of Ampligen in combination with PD-L1 checkpoint inhibitors, such as Dervalumab, the AstraZeneca drug. We've also made tremendous progress in the clinic with Ampligen combined with PD-1 checkpoint inhibitors. So we're trying to establish in many tumors different tumor types, and with different checkpoint inhibitors, Ampligen's 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 to 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 reports 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 AIM's CEO 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 area of interest you want to suggest, contact our IR portal and give them your ideas on what we should be talking about on CEO Corner. We are 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 AIM. 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. He'll give you a detailed update on our progress in the various clinical trials and also, I hope, broaden your understanding of the mechanism of action of Ampligen, what it's doing in the immune system based upon recent data. Chris? Thank you, Tom.
Chris
Ampligen is a treatment for multiple indications from locally advanced and metastatic pancreas cancer to advanced 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 AACR abstract. I do remind all shareholders that the data presented at AACR indicated that 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 in partial tumor responses. The study has moved on to the second stage of the Simon 2 stage design. The data is very promising, and recruitment rates have also accelerated post-COVID, so all of those are positives. Detailed data from the planned interim report will be disseminated in the upcoming press release. We've reported positive top-line data for the AMP518 post-COVID trial in February, and I have also recently reviewed the preliminary copy of the complete study report. We are currently working with AMOREX 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 AMP270 trial in locally advanced pancreas cancer, we are currently preparing for a Type D meeting with the FDA to discuss altering inclusion criteria for the IND protocol. 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 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 US. 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 Dorapank study combining Ampligen and Dervalumab as therapy post-Pulverinox. The phase one portion of the trial is a three-in-three escalation design with fixed Dervalumab dosing with escalating Ampligen dose. The first three patients of the three-in-three design have been enrolled already, and two patients have completed their Ampligen dosing and have received at least two Dervalumab doses. The last patient, last Ampligen dose is 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. I lastly want to address the early access program in pancreas cancer. Enrollment in this program will halt as these patients should be enrolled in either DoraPank or AMP270. And from this program, data was recently published in the Journal of 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 DoraPank study and what gave further confidence that Ampligen would work synergistically with the PD-L1 checkpoint inhibitor, Dervalumab. With that being said, I'd like to take a second and look at Ampligen effects in various different solid tumors. Ampligen works by binding to toll-like receptor 3, 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 form from epithelial tissue, and therefore these tumors express Toll-like Receptor 3. 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 3 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 3 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 chemotaxis 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 911 distress call to the immune system against its will, shown here in the table by increases in CXCL9, 10, and CCL5. And subsequently, the immune system infiltrates the tumor and attacks it. shown by upregulation of Granzyme B and CD8 in this chart. And this 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 DORA-PANK study for pancreas cancer as well. And I'd now like to turn the presentation back over to Tom Eagles to discuss our key recent clinical and business milestones, as well as what to expect in the coming months.
Equals
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've followed a wave going back over two years of positive data, data published in top journals and abstracts at major meetings, especially in oncology. For Q2, we are planning for an action-packed quarter. Now regarding our business development strategy, as I mentioned, we hired Azanova. And now, we believe, is the time to redouble our efforts with their help. The mandate for Azanova 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 is in oncology. That's where the most deals are, and that's where the most money is. Business development takes time. It 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 to 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 integral 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. 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 the The answer, when you look at 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. Now, Chris and I believe the future is bright for both AIM and Ampligen. The entire AIM team 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's opportunity to provide therapeutic value. Our medical and scientific 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. Now at this time, I'd like to open the floor for questions.
Operator
Thank you. And I'll 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 a question from the queue. For participants using speaker equipment, it may be necessary to pick up her handset before pressing star one. One moment, please, while we poll for questions. Our first question today is coming from Jason McCarthy from Maxim Group. Your line is now live.
Jason McCarthy
Hi, guys. Thanks for taking the questions. This is Chad on for Jason. So for AMP270, I was just wondering if you could give a bit more clarity on timing for first patient dose. Do you guys think of that as a 3Q event, 4Q event? I think that would be helpful.
Equals
Well, we certainly have every expectation that in Europe we will certainly by the end of the year have people not only enrolled but in treatment. 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 be affecting the ability to get full enrollment in the U.S., which is why we're having the meeting with the FDA. Can't go into the details of that ahead of time, but we hope with some amendments to the protocol to broaden the inclusion criteria, we'll also start to get the kind of U.S. candidates and subjects recruited and in treatment as well. Chris, would you like to talk to that a little bit?
Chris
The Type D meeting should be scheduled here shortly. When we have that conversation with the FDA, it's about altering the inclusion criteria. The U.S. does things a little bit differently than Europe does in terms of how they treat patients with locally advanced pancreas cancer. 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 was a little more than expected. I assume that after the Type D meeting is over, I hope that the FDA will agree to the changes that we already made, and I think that will catapult enrollment in the US. enrollment in the EU to happen Q3, Q4-ish, by the end of the year for sure, and in the U.S. as well.
Jason McCarthy
Okay, great. Thanks for taking the questions, guys, and congrats again on the quarter. Thank you.
Operator
Thank you. As a reminder, that's star one to be placed at the question queue. Our next question is coming from James Malloy from Alliance Global Partners. Your line is now live.
James Malloy
Hey, guys. Good morning. Thank you very much for taking the questions. I had a question sort of on the investigator-sponsored trials. You've got a variety of metastatic prostate, triple negative, ovarian cancer, a variety of ISTs ongoing. I know they're outside of your control, but any insight you could give us on to when you think we might be seeing some potential data out of any of those ISTs?
Equals
Well, we have every expectation of getting the formal interim report on the Advanced Recurrent Ovarian Cancer Phase II. That's the program that was started in Pittsburgh with a Merck grant and combining Ampligen with Pembrolizumab to see if it improved 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 ORR. 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. Does that answer your question?
James Malloy
It does. Thank you very much. And then on the 518, I know the final data sets are going to be coming out here second quarter. What additional learnings did you anticipate getting with the unfortunate data back in February? What additional data are you hoping to sort of parse out of the final data set potentially going forward if it doesn't go forward for 518?
Equals
Well, the data we received in February had a lot of very positive points in that top-line report and the complete data set. 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. McAleer for any detailed comment. Chris?
Chris
So, the complete study report will have breakdown of all the secondary endpoints that weren't part of the top line data. We've seen those and there are positive improvements in quite a few of those. It'll also give us the individual data points for a statistical analysis and power analysis to be done. I'm also hoping that we have to wait for the biomarker analysis to come in, but it's clear from the initial review of the data that there are responders and non-responders as we would expect. And the understanding of the inclusion criteria and the initial baseline data of those individual patients who responded versus those who are not will give us an indication of how we want to design the study in the future. Secondary to that, I remind everyone that the landscape of post-COVID and how you use statistical analysis and standard deviation to power 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 exists, 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 tests, 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 next trial.
Equals
If I might just add, you know, the point of this was it was called a proof of concept because of the small number of subjects. 80 subjects is a very small phase, too, and it's usually designed for exactly the purpose that we've just articulated. But what we intend to do is take that data and refine our inclusion criteria so that we're focused on bringing subjects into this trial, this follow-up trial, that we have high confidence that we've targeted the zone of the 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, Chris, anything you want to add to that? And we'll just see if Mr. Malloy's
Chris
No, I think that sums it up.
Equals
Does that answer your question, Jim?
James Malloy
It does indeed. And don't call me Mr. Malloy now. I appreciate it. And I guess the last question, housekeeping, G&A, pretty high. I see in the K you guys talk about the $6.5 million in legal expenses you had to spend in the year. I presume you don't just pay hopefully that same level of G&A with legal expenses going forward in 2024?
Equals
Well, we hope that we don't have those expenses again for 2024. We've, in the Chancery Court, defeated this group on, I think, related group on three separate occasions. It's up in the Delaware Supreme Court right now after our last trial. 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 second attack with Jorgel, that this whole thing was orchestrated by a securities law felon 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.
James Malloy
Thank you for taking questions.
Operator
Thank you. Next question is coming from Ed Wu from Ascendian Capital Markets. Your line is now live.
Ed Wu
Yeah, 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 the initial start of the pandemic. Can you talk about the market opportunity for long COVID today?
Equals
Certainly, Mr. Wu. 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 that are expected to have serious post-COVID chronic fatigue-like conditions. which is post-exertional malaise, debilitating fatigue, cognitive dysfunction, sleep interruption, and severe joint pain. So that's a disabling disease that's ever-growing, and it's, I believe right now, estimated at about 4 million potential patients. persons that will suffer from this going forward in the United States alone. That number is exponentially higher worldwide of course.
Ed Wu
Great. Well, thanks for answering my questions and I wish you good luck.
Equals
Well, thank you very much. We really appreciate your interest.
Operator
Thank you. We've 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.
Disclaimer