AIM ImmunoTech Inc (AIM) 2023 Q4 法說會逐字稿

Hello. And welcome to the AIM ImmunoTech Fiscal Year 2023 Update Conference Call and Webcast. (Operator Instructions) 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 AIM 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’s 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.

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’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 Azenova, 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 Azenova, 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 durvalumab, 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 synergy. 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 derisks 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 to 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. 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 Ampligen, the Ampligen pembro containing treatment, had four times 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 two-stage design. The data is very promising. And recruitment rates have also accelerated post-COVID, so all of those are positive. Detailed data from the planned interim report will be disseminated in the upcoming press release.

We reported positive top-line data for the AMP-518 post-COVID trial in February, and I have also recently reviewed the preliminary copy of the complete study report. We are currently working with Amarex 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 2 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 AMP-270 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 DURIPANC study combining Ampligen and durvalumab as therapy post-FOLFIRINOX. The Phase 1 portion of the trial is a 3-in-3 escalation design with fixed durvalumab dosing with escalating Ampligen dose. The first three patients of the 3-in-3 design have been enrolled already and two patients have completed their Ampligen dosing and have received at least two durvalumab 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 1 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 DURIPANC or AMP-270. 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 DURIPANC 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. 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 DURIPANC 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.

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 Azenova and now, we believe is the time to redouble our efforts with their help. The mandate for Azenova 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 a 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 filed. 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 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 Instructions) Jason McCarthy, Maxim Group.

This is Chad, on for Jason. So for AMP-270, 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, anything that would be helpful?

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 US, because there’s a difference in the standard-of-care between Europe and the US that seems to be affecting the ability to get full enrollment in the US, 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 US candidates and subjects recruited and in treatment as well.

Chris, would you like to talk to that a little bit?

Yeah. The Type D 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 was a little more than expected.

And so I assume that after the Type D meeting is over, I hope that the FDA will agree to the changes that we are to be made, and I think that will catapult enrollment in the US. So I expect enrollment in the EU to happen Q3, Q4-ish by the end of the year for sure, and in the US as well.

Okay. Great. Thanks for taking the questions, guys, and congrats again on the quarter.

Thank you.

(Operator Instructions) James Molloy, Alliance Global Partners.

I have a question 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?

Well, we have every expectation of getting the formal interim report on the advanced recurrent ovarian cancer Phase 2. 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?

(multiple speakers) It does. Thank you very much. And then on the 518, the final data set is coming out here in the second quarter. What additional learnings did you anticipate getting with the unfortunate data back in February? What additional data are you hoping to parse out of the final data set going forward, if there’s a go forward for 518?

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 comments. Chris?

So the complete study report will have a 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 did 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? That data is used now to power the study appropriately.

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 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 next trial.

If I might just add, 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 2. 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, the follow-up trial, that we have high confidence that we’ve targeted the zone of the Ampligen responders. And much of that is 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 will just see if Mr. Molloy's --

No. I think that sums it up.

Does that answer your question, Jim?

It does indeed. And don't call me Mr. Molloy, now. I appreciate it. And I guess the last question, housekeeping, G&A, pretty high in the K. You guys talked about the $6.5 million in legal expenses you had to spend in the year. I presume you anticipate, hopefully, that same level of G&A with the legal expenses going forward in 2024?

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 Jorgl, 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.

Thank you for taking the questions.

Ed Woo, Ascendiant Capital Markets.

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?

Certainly, Mr. Woo. 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 persons that will suffer from this going forward in the United States alone. That number is exponentially higher worldwide, of course.

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

Well, thank you very much. We really appreciate your interest.

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.