AIM ImmunoTech Inc (AIM) 2023 Q2 法說會逐字稿

Hello and welcome to the AIM ImmunoTech quarterly 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 those 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, public stations, 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 has not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of or that any independent source has verified any information obtained from third-party sources.

Joining us on today's call from the AIM leadership team are Thomas Equels, Chief Executive Officer; and Christopher McAleer, PhD, Scientific Officer.

I would now like to turn the call over to Mr. Equels. Please proceed.

I'm extremely pleased with the progress we have made for the first half of this year. We are meeting and, in many cases, exceeding our expectations on timing and execution related to our clinical programs. Fundamentally, the company has never been stronger, and we are clearly in line with what our belief is and the vast potential of Ampligen. It's a belief that's shared by me, the team at AIM, and our many collaborators.

And I want to take just a moment now to thank my team at AIM. Both our Florida and New Jersey operations deserve a big thank you for they made incredible strides over the past two years, including in this last quarter in developing our clinical programs and achieving fantastic clinical progress.

Now, at AIM, we are focused. Execution in the clinical trials is our priority, and we have a number of important trials going forward. But let's take a look at what we accomplished in this past quarter.

In our Phase 2 trial in long COVID or post-COVID chronic fatigue like conditions, we have met and exceeded our milestones by not only enrolling all of the subjects, but as of just a day or two ago, we've begun treatment of all subjects that have been enrolled. So dosages is underway, and that study is expected to end by the end of Q4. And topline data, which we hope will be favorable, will be coming out in Q1 of 2024 according to our current best projection. And we published preclinical data as well as clinical data related to pancreatic cancer, very, very compelling. And our topline data from the early access program where we've treated over 50 subjects is extremely positive.

Furthermore, we are working with one of our top collaborators, AstraZeneca, to do a metastatic pancreatic cancer -- advanced metastatic pancreatic cancer program at Erasmus MC, one of Europe's top research facilities in pancreatic cancer. And that's combining our drug, Ampligen, with their drug, durvalumab. And all those approvals have been accomplished. We're just waiting to get the party started. They're finishing some of the numerous things that have to be done in a complicated cancer protocol.

Finally, we are opening sites and recruiting new sites for our locally advanced pancreatic cancer program in the United States, we just signed up and -- and when we say signed up, it's not as simple as signing a paper, but there are a lot of steps that we have to go through at Buffett Cancer Center at the University of Nebraska.

So you can see, based on what we've done over the past two years and just looking at what we've done in this past quarter, that the team at AIM gets things done. And when it comes to our goals, we deliver.

Now let's look at our broad pipeline. And we have a broad pipeline because Ampligen has a broad-spectrum impact in oncology in diseases like long COVID or the actual COVID as an antiviral and the actual COVID infection. And because it's broad spectrum, we cover a lot of ground, and we're working hard developing that.

Now you see here that we're doing work in the clinic in locally advanced pancreatic cancer, metastatic pancreatic cancer, advanced recurrent ovarian cancer. This is the type of work in Oncology that's cutting edge because these are highly lethal malignancies with clear unmet medical needs. In long COVID, all of the subjects were enrolled, and dosage has begun. As I mentioned, we expect topline data in Q1. So there's a lot of activity going on, but it all involves progress.

You've heard the saying that just because the wheels are turning, doesn't mean you're going forward. Well, it's the same thing with progress. Just because it looks like there's a lot of activity, it doesn't mean you're going forward. But here you can see we're not only have the wheels turning, but we're traveling at 90 miles an hour in the right direction.

Now with regard to the last thing on this list, chronic fatigue syndrome, we are going to be guided in chronic fatigue syndrome very much by the results that we'll see in Q1 next year from our post COVID with chronic fatigue-like conditions data. So all of these programs are moving forward.

Now with that, I want to go into the scientific detail. And our Science Officer, Dr. Christopher McAleer is here to talk with you today on those points.

Thank you, Tom. As Tom pointed out, we have a broad pipeline across multiple unmet needs, and our primary focus area is cancer specifically our lead indication in pancreas cancer. As discussed in the last earnings call, we have continued to enroll patients in EAP in the Netherlands, and this has led to additional data beyond what was presented in the Kansas paper. And this data has been analyzed. I do want to caveat that any graph you see comprise data that was collected up until June 12 of this year.

But the addition of 30 patients for 57 total confirms the improvements in the progression-free survival that we're seeing in the original cohort of patients, and that improvement four or five months of extension over historical control. Then the analysis of the overall survival confirms the improvements in patient survival in comparison to those historical controls.

In fact, if you look at the graph on the left, there appears to be improvements in short- and long-term survival with the addition of these 30 patients, and that's the comparison of the red and green Kaplan-Meier curves. We are also doing further analysis of data to help determine subsets of populations that might respond better to Ampligen. As an example, if you look at a subset of patients whose CA19-9 levels are less than 1,000, which encompasses 49 of those 57 patients, there are further increases in progression-free survival. That's an additional one month beyond the four to five months and also in overall survival as an additional four months beyond the previous data.

And those data are compelling, but if the control data in the AMP-270 compares to the data in the EAP, which we have no reason to believe that it won't as these additional 30 patients only confirms the original data we had, the improvements we see in progression-free and overall survival should be sufficient for regulators. So it may be unlikely that the subset analyses will be necessary for moving forward and for future approval for that matter. But they are good to have, and they help further our understanding of Ampligen's multifaceted effects.

The AMP-270 trial currently is ongoing and awaiting first patient enrollment. The Gabrail Cancer Center in Ohio and the University of Nebraska are both monitoring multiple patients who are currently undergoing FOLFIRINOX treatment to determine their eligibility to enroll in AMP-270.

I wanted to take a moment to discuss the trial design and what that means for patient enrollment. The timeline from patient identification to enrollment depends on where the patient is on their journey when the site opens, and that can take up to several months. Each patient must be treated for at least four months with FOLFIRINOX, and that treatment can be extended further depending on clinician observation, and the patient's ability to handle FOLFIRINOX therapy which is helpful but also quite toxic.

They must receive a minimum of four months, though. And once they stop treatment, they're given time to recuperate. And then after four to six weeks from treatment stop, they're monitored again to determine whether the FOLFIRINOX treatment worked in stabilizing their disease. If they are stable, they would need to be evaluated and consented before they could enroll, which will take about a week or two, and then they'd be randomized and receive treatment.

The clinical sites focus is on patient enrollment, and our focus is on opening more clinical sites. These large institutional sites have to find controls and processes in place that must be followed. For example, their IRB only meets once a month. Cancer committees can meet every one or two months. And we sent a site invitation letter to a proposed site, and it took several weeks until the hospital had finalized its internal review processes to begin screening patients. And these timelines are just realities of the clinical trial process and large institutional sites.

But we have some degree of control in identifying and opening additional sites, and that must be our focus. And to that end, we have identified and contacted over 70 sites. 31 of those sites have expressed interest. Of those 31 sites, we are an ongoing contract and/or budget negotiations with almost half of them. We are also working with centers like Allegheny Hospital in Western Pennsylvania and Sarah Cannon Research Institute, who have multiple clinical trial sites. And simple logistics suggest that the more sites we open, the faster we can enroll patients and hopefully receive data that resembles that of the EAP. And that is our focus for AMP-270.

So based on what I explained, it does take time. But when the AMP-270 data comes in, we believe that based on the data we have from the EAP, including this additional 30 patient data, that is expected to be well worth the efforts and the wait.

In addition to AMP-270, we are also working on final European approvals, including QP release to start the DURIPANC study in the Netherlands. And that's to investigate Ampligen combined with durvalumab for metastatic pancreas cancer patients.

That study is still on track to open for patient enrollment in Q4 of this year. We are still awaiting interim results for the Phase 2 trial in advanced recurrent ovarian cancer. University of Pittsburgh originally expected that data to come in June, and that was amended to be in September. But the conversations we've had indicate that the data is as good or better than that what was published in AACR.

In addition, they are expecting to present data at the 2023 SITC conference concerning immune marker changes and Ampligen's ability to modulate cytokine release and immune function such as differential T cell changes and cytotoxic T cell upregulation. That data is similar to data we've seen in other cancers, but specifically for ovarian, which in our opinion further illustrates the broad applicability of Ampligen in solid tumors.

We are also working diligently on our study of Ampligen to treat post-COVID conditions, also known as our AMP-518 study. Site initiation and recruitment went very fast for this study, and we announced just recently that we hit our target enrollment of 80 patients. The treatment regimen is for 12 weeks with follow ups for two weeks thereafter. This means that the last patient dose will be in mid-November, and we are expecting topline data as early as Q1 2024. And we are very excited about this trial.

I do want to point out that the last of the -- as of the latest update I received, which was Thursday of last week, between all of the doses, both Placebo and Ampligen, which at this point numbers in the hundreds, there had only been one adverse event, which was a case of a grade 2 hives that was remedied by Benadryl treatment. And we think that attests to the overall safety profile of Ampligen. And we are advancing our clinical agenda and from the scientific and clinical perspective from my desk, I think stockholders should be excited about the short and long-term future of AIM.

And I'll hand it back to Tom to discuss the future of AIM from a financial perspective.

Thank you very much, Chris. As Chris was mentioning, we have a well-developed safety profile. We have 100,000-plus doses IV in humans. We've had findings that Ampligen is generally well tolerated, not only IV, but also intraperitoneally and intranasally in Phase 1 and Phase 2 and Phase 3 testing.

So we have a drug that is generally well tolerated, and that allows us to springboard into multiple clinical programs because the safety aspect of that is not a major issue in consideration. Now I'd like to address our milestones and how we've achieved our milestones and the milestones that are coming up.

We're in the third quarter right now. In the third quarter, we had projected that we would open numerous additional sites in our locally advanced pancreatic cancer program. We have projected that the protocol planned interim results will be published in our advanced recurrent ovarian cancer program. And with post-COVID conditions, we had projected that we would enroll patients, dose patients. And in fact, we have enrolled our last patient in this Phase 2 trial, and we have begun dosing all of the subjects in this Phase 2 trial.

So many of the milestones for the third quarter have already been accomplished. With regard to the fourth quarter, we have every hope that we will begin dosing in metastatic pancreatic cancer, certainly begin enrollment by the fourth quarter. And with regard to post-COVID conditions, we have every hope that we will have enrolled and treated our last subject in that Phase 2 study. So with the final patient complete, we move into the first quarter of 2024. And in the first quarter of 2024, our big thing that we believe will be a milestone will be the publication of the topline data from the Phase 2 long COVID study.

Now I'd like to take just a moment to talk about who we do business with. We've all heard the old wisdom that you can sometimes be measured by the company that you keep. And we are very fortunate to be in good company here. We're working in metastatic pancreatic cancer with AstraZeneca in combination with their drug durvalumab. We've done a number of different studies with Merck as a collaborator using Ampligen and their drug pembrolizumab or KEYTRUDA.

Our investigator-sponsored studies and the locations where we're conducting these trials are top world-class cancer centers: Erasmus in the Netherlands, Roswell Park in New York, University of Pittsburgh in Pittsburgh, and The Buffett Cancer Center in Nebraska are the crème de la crème of cancer centers for cancer research in the areas where we're working.

I'd like to now talk a little bit about our position in terms of cash or financial snapshot. As you can see, we're in an extremely robust position. And over the course of the second quarter, our team continued to deliver on timelines and made significant progress advancing Ampligen through our clinical trial studies in multiple indications.

We continue to be encouraged by the growing body of positive and consistent data and believe Ampligen will be a meaningful treatment option in the future. And in support of that, our operational execution remains fully supported by a strong cash position, and we are steadfast in our mission to advance the clinical development of our oncology pipeline. I think that the numbers speak for themselves in that respect.

So we come to what's, maybe for some, the important question. Why AIM? Why now? When you look at what's happened in the biotech sector, especially the small-cap biotech, a lot of these companies have been wiped out over the past two years. But we've achieved clinical progress, we've stayed true to our goals and milestones, and we've done it all the while by being good stewards of our cash position.

So we're in a strong cash position. We've got a lot of very positive activity going on. It's the type of activity that can translate into superior development of stockholder value. On behalf of the team at AIM, I want to thank you very much for being interested in Ampligen and AIM ImmunoTech.

At this time, I'd like to turn the presentation over to the operator so that we can have Q&A.

Thank you. The floor is now open for questions. (Operator Instructions) Jim Molloy, Alliance Global Partners.

I want to follow up on the AMP-518. Could you walk through, please, what data we should anticipate to see here in first quarter? What's the primary, secondary? And what's the dosing schedule? And walk through sort of the -- and walk through the rationale of the trial as well that would be great.

Thank you, Jim. Good to talk to you again. We had a pilot program in AMP-511 that gave us preliminary data not in a controlled setting, but we hit with a positive response, four out of four of the subjects, three with fairly significant positive results. So we use that to derisk, in a sense, the activities that we were planning for AMP-518. I'm going to hand this over to our Scientific Officer, Dr. McAleer, to discuss the actual elements of the protocol and the stages that you'll see.

This is different from a cancer study, which the protocols are long and drawn out. Everything moves pretty quick here, and he'll go through that. And our hope is that in the first quarter of next year, not only will we have the topline data, but it will be consistent with the pilot study we did, which would be extremely favorable.

Thank you for the question, Jim. It was multifaceted. So I hope I answer all of it. The trial design is a double-blind, placebo controlled. There are 40 controlled patients, 40 Ampligen-treated patients. The primary endpoint is a PROMIS Fatigue Score, Short Form 8a. But the secondary outcomes will be brain fog that's from a PROMIS Fatigue -- or PROMIS score as well, six-minute walk test. We also have a MoCA exam for cognitive function. There's also some exploratory biomarker analysis, and we expect that data on top line.

I'm sorry, the other part of your question were?

That was most of it. I just want to get the trial design, and so there's dosing, and then what do you anticipate to get out of this to go into the -- I presume a Phase 3 confirmatory trial?

Yeah. So the trial is 12-week dosing with two weeks follow-up. If the data depending -- what we do next depends on the quality of the data, and we presume that the next is a Type B meeting with the FDA to go to a Phase 3 confirmatory trial. But that will depend on how well the treatment works, right? That is our topline expectation.

Yeah, and remember, in order to move forward with the FDA, we need this placebo-controlled Phase 2 data, not just to move into Phase 3, but also to the extent that there are fast track and breakthrough-type opportunities, similar to what you see in cancer, that may arise with long COVID, which is, right now, afflicting in a very serious way, disabling 4 million Americans. This is not an insignificant market and not an insignificant public health impact.

So there may be things that we can take advantage of with this data moving forward, but we have to have this type of placebo-controlled trial in order to present that to the FDA and take advantage of the opportunities for the next steps.

Well, Jim, we do -- the 80 patients is small for a Phase 2 with no current therapies, if the data comes out the way we expect it based on the preliminary data and our understanding of Ampligen's mechanism and things like fatigue and brain fog. I expect that -- I hope that will be sufficient for the Phase 3.

What's the entry criteria? Is it change in PROMIS score from baseline for fatigue and brain fog? What's the entry criteria to get into the trial?

So we're measuring both change from control to -- for the PROMIS fatigue score and a secondary measure of change from baseline in individual patients.

Okay. Great. And then you guys have always been excellent stewards of shareholder capital and a lot of your trials being run in partnerships and ISTs. To the -- it's the 518 and 270, those are the only two that are -- if I understand correctly, those are the only two that are under your control and that AIM is currently paying for?

That's correct. Well, I mean, we provide financial support to some of these other investigator-sponsored trials, including the primary component, the supply of drug. However, for purposes of AMP-518 and AMP-270, it was important that these be AIM-sponsored trial. So we control the data, and we're able to fund those items that are necessary to moving forward rapidly because in pancreatic cancer, just like in long COVID, we're dealing with large unmet medical needs.

The advanced pancreatic cancer is a horrible lethal malignancy for which there is no therapy currently that provides extended survival or progression-free survival. So what we perceive that we're doing there is obviously important from a financial potential, but it's even more important in terms of our ability to deliver an immunological solution that may save lives.

And similarly with long COVID where people have post-COVID severe chronic fatigue syndrome, these people are disabled and in many cases bedridden and unable to function to take care of themselves, to participate in their family, or go to work. So our ability to provide a therapy there is also extremely important to us because they don't have any options. And if we're able to show that we have a significant therapeutic impact in this Phase 2, we intend to move forward rapidly with a Phase 3, if the FDA will allow it, because people deserve more than just being a prisoner in bed and not having the option of a therapeutic alternative that might help them have a better life.

So we're doing very important things here in these two areas. And these are controlled by AIM so that we can control the pace. And it's our intention to move as fast as we possibly can because the subjects of those trials will provide the proof we need in order to show the FDA and the EMA that we have a significant therapeutic opportunity for these people to have a better life.

Maybe last question. You mentioned Pittsburgh advanced recurrent ovarian cancer interim data that will be coming out third quarter, what should we anticipate to see there? And what's good data, bad data, what's the clinical data? What are you guys anticipating to see?

Well, we don't know exactly what that data is right now. But every indication suggests that it will be consistent with the preliminary data that was published at the AACR in April of 2020, which was extremely positive. If you remember that abstract was a late-breaking abstract that was published because it's not normal to see a publication of preliminary data, but it was filed as an abstract because the data was so powerful in a cancer where there are a few alternatives. Advanced recurrent ovarian cancer, somewhat like late-stage pancreatic cancer, is almost like a death sentence unfortunately.

So what was shown in that AACR abstract, in addition, I mean, it was focused on showing the immunological impact of Ampligen plus pembrolizumab, but also it had survival data. And it showed in advanced recurrent ovarian cancer, there was a 60% plus clinical benefit by combining Ampligen with pembrolizumab, far in excess of what was seen in KEYNOTE-100 with pembrolizumab alone. And then additionally, this was not just disease stabilization with pembrolizumab, we were seeing an ORR of over 35% with 15%-plus complete response and another 20%-plus significant partial responses. So that data was very powerful, assuming it's interim analysis, it's a part of the program of the protocol is similar and we're operating based on that assumption, we think that interim data will be similarly powerful.

Excellent. And I'm looking at the AACR from 2022 right now, yeah, 61.8%, I think it was 61.6 % clinical benefit rate. Will there be -- did they present any data at AACR this year, or do you anticipate something perhaps next year?

I think they're going to present this interim program data at SITC this year. That's assuming they're able to wrap everything up in a timely fashion and present it. But we don't know for sure.

Of course, out of your hands. All right.

Ed Woo, Ascendiant Capital.

Yeah, congratulations on the progress you made. My question is on the long COVID study. Was that only a US study? And is there any plans to do studies internationally especially in the EU?

Yeah. I'll address that, Ed, if I may. Right now, it's only taking place in the US. And the AMP-518 is an FDA-authorized study. However, we are working to conduct a similar, non-identical study in Europe, probably in the Netherlands.

Great. That sounds good.

But that's on the drawing board because -- excuse me, Ed, that's on the drawing board somewhat because there's a lot of bureaucracy that you have to go through in order to get one of these things started, but we're working on it.

Great. No problem. And then you guys have a pretty big cash balance. Is there any considerations to potentially do any acquisitions, or are you going to just focus on what you have now?

Well, my father taught me when I was learning baseball as a boy, keep your eye on the ball, okay? If you want to hit it, right? So we've got a lot of things that we're working on right now that are extremely important, and I don't want to lose our focus by moving into a merger or acquisition mode, where we're trying to acquire other technology. Now that's not to say if an opportunity presented itself, which was compelling -- and the biotech sector for the past two years has been a bit of a slaughterhouse. So there's probably things out there that we could take advantage of.

But we want to use the cash we have and the team we have to make sure that as our first priority, we deliver on the clinical progress that's underway, and we meet those milestones, which I think are very important milestones for our stockholders down the road without being diverted. So that sounds like a politician's answer in a way. But our first priority is the clinic. And only if something was so compelling that we couldn't turn it away would we do an acquisition.

Great.

Thank you. At this time, I'd like to turn the floor back over to Mr. Equels for closing comments.

Well, I want to thank everybody very much and thank you, Donna. In closing, I'm extremely pleased with our progress this year and believe we are very well positioned to achieve important operational and clinical milestones throughout the remainder of this year and beyond. This is a very exciting time for AIM. And on behalf of team AIM and myself, I want to thank you for your continued support.

Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines at this time or log off the webcast and enjoy the rest of your day.