AIM ImmunoTech Inc. (AMEX:AIM) Q1 2024 Earnings Call Transcript

AIM ImmunoTech Inc. (AMEX:AIM) Q1 2024 Earnings Call Transcript May 16, 2024

AIM ImmunoTech Inc. misses on earnings expectations. Reported EPS is $-0.12 EPS, expectations were $-0.11.

Operator: Hello, and welcome to the AIM ImmunoTech First Quarter 2024 Update Conference Call and Webcast. As a brief reminder, all participants are currently in a listen-only mode. [Operator Instructions] Following the presentation, there 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 ImmunoTech’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 ImmunoTech 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 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 ImmunoTech leadership team are Thomas Equels, Chief Executive Officer; and Dr. Christopher McAleer, Scientific Officer. I will now turn the call over to Mr. Equels. Please proceed.

Thomas Equels: Thank you, operator. Welcome, everyone, and thank you very much for your interest in AIM ImmunoTech. I’m very pleased with our progress over the past several months. To summarize, on the clinical front with our DURIPANC study, we took an important step forward in the testing of the combination of Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, Imfinzi also known as durvalumab, for the treatment of late-stage metastatic pancreatic cancer. This is pursuant to a collaboration agreement that we have with AstraZeneca and Erasmus Medical Center, and it is moving at full speed ahead. As we reported, the investigator at Erasmus Medical Center in the Netherlands completed the safety evaluation of patients enrolled in the first dose level of the dose escalation design in the Phase Ib/II study.

The combination of Ampligen and Imfinzi was found to be generally well tolerated with no severe adverse events or dose limiting toxicity. We are very encouraged as we continue to see a consistent safety profile across our oncology pipeline in multiple indications. Based on these positive results, escalation to the next dose level in DURIPANC will occur according to the protocol design and we expect the next cohort of patients to begin dosing very soon. We also announced the top line interim data indicating that the combination of Ampligen with Keytruda, also known as pembrolizumab, in the treatment of recurrent ovarian cancer may have a very powerful synergistic effect. The investigator concluded the combination therapy could be far more effective than pembrolizumab alone as a therapy for this dread disease.

These interim data clearly suggest that there may be a massive positive impact on efficacy when Ampligen is combined with pembrolizumab for the treatment of recurrent ovarian cancer. Other research suggests a similar effect on other solid tumor types. This means we can see in Ampligen as a potential combination therapy, having therapeutic potential across multiple types of solid tumors and possibly even with different checkpoint inhibitors. Now Dr. Chris McAleer, our Science Officer, will be talking in more depth about our lead clinical programs in just a few minutes. On the operational front, we have successfully completed cGMP manufacturing of 9,042 clinical valves of Ampligen. This repeatable manufacturing expertise represents a critical component of our overall commercial and business development strategies.

Our record of successful manufacturing is important as we seek commercial partners as well as for establishing Ampligen reserves for ongoing and upcoming clinical trials. And finally, on the corporate front, Dr. Charles Lapp recently joined the company’s medical and scientific team. Dr. Lapp is a very well respected and well-known world-class player in the disease of ME/CFS. He played a key role in our long standing AMP-511 expanded access program for the treatment of ME/CFS and Long COVID. Of note, he founded and led one of the clinical trials key sites, The Hunter Hopkins Center in Charlotte, North Carolina from which he recently retired. As a consulting medical officer and an independent contractor, he will help manage the company’s research programs related to ME/CFS and Long COVID, including the development of protocols and new clinical trials.

All of this progress in just a few short months continues to demonstrate our commitment to advancing our pipeline and operational execution. I now turn over the call to Dr. McAleer, our Science Officer to discuss our priority pipeline programs. Chris, please?

Christopher McAleer: Thank you, Tom. I’d like to give a brief status update on our lead programs. The FDA has granted our Type D meeting request regarding the AMP-270 study in locally advanced pancreas cancer, and according to their proposed time line, we should have preliminary answers in late June. Assuming that AIM and the FDA are in agreement, we will then be able to move forward with expanding the patient population that would be eligible for enrollment. I will be able to speak further on this once we have a resolution from the Type D meeting. In the interim, there are open sites that are screening potential candidates, and we are also working to recruit and open new sites. Hopefully, upon successful consultation with the FDA, the revised protocol will allow for faster recruitment of sites and patients.

The DURIPANC study combining Ampligen and durvalumab as therapy post-FOLFIRINOX in metastatic pancreas cancer is proceeding according to schedule. The Phase I portion of the trial is a 3-in-3 escalation design with fixed durvalumab dosing and escalating Ampligen dose. As we recently reported, the first three patients of the 3-in-3 design have completed the safety evaluation and the few adverse events observed were only Grade 1 with no serious adverse events. The internal evaluation committee at Erasmus has approved the escalation to the next dose and patients have already begun the evaluation and enrollment process. We expect the Phase I portion of DURIPANC to be completed this summer. As promised in the last update call, we have announced the efficacy data of Ampligen, pembrolizumab and cisplatin in the ongoing trial in advanced recurrent platinum sensitive ovarian cancer at the University of Pittsburgh.

The data indicated an objective response rate of 45%. When you compare this to the ORR or a death response rate of 39% in the preliminary data published in 2022 or the objective response rate of about 8% in the KEYNOTE-100 study of pembrolizumab alone, you can see the potential positive impact that this trial to have for women with recurrent ovarian cancer. And we are currently working through the data for the AMP-518 trial for Ampligen as a potential therapy for the post-COVID condition of fatigue. We are also consulting with patient advocacy groups to further understand the symptomatology of patients to help further refine and design the follow-on trial. We are waiting for the results of the exploratory biomarker analysis to finalize the data.

And as such, I do not currently have an estimate of when the next IND will be submitted, but we will keep stockholders and others advised as we proceed. And as you can see, we are advancing in our clinical agenda, and I look forward to being able to announce new progress throughout 2024. And I’ll hand it back to Tom to discuss the company financials.

Thomas Equels: Thank you very much, Chris. Now for a brief summary of our first quarter financials. As you can see, the audited information is on the slide, but we share our operational and clinical execution with you. Now I want to touch on our financials, so you can understand where we are in that respect. We ended the first quarter with $10.9 million. Our R&D expenses were consistent, while our G&A expenses were up from the same period last year. Importantly, we believe we have enough cash available to fund our operations through several key potentially value driving milestones. Please take your time going through the full 10-Q for a complete picture of the company’s financials. Now we believe very much in the depth, breadth and potential of the Ampligen to provide a meaningful therapeutic solution in many high-value indications where there are high, even legal unmet medical needs.

Our data continues to be highly encouraging and it supports further development of our multiple ongoing studies, as well as the next phase of development. Our success in the clinical trials leads us to believe that there will be a continuing developing body of positive safety and efficacy data, and we believe that data because these are data-driven decisions will help us to drive advanced discussions with potential commercial partners that are interested in the commercialization of Ampligen, especially in oncology. And finally, we believe all of our work and progress will ultimately unlock the full potential of Ampligen and AIM ImmunoTech as a value driver for investors and also as an important therapeutic solution for those suffering from these drug diseases.

I very much appreciate your time, and we’ll turn it back to the operator now for a question-and-answer session. Thank you.

Q&A Session

Operator: Thank you. The floor is now open for questions. [Operator Instructions] Today’s first question is coming from Jason McCarthy of Maxim Group. Please go ahead.

Unidentified Participant: Hi, guys. This is Chad (ph) on for Jason. Congrats on the progress and thanks for taking the question. So firstly, for the — on the interim ovarian readout, we were just wondering how many patients were evaluated? It would be helpful in comparing the data versus KEYNOTE, and also just general next steps for the program? Thanks.

Thomas Equels: Chad, I believe — this is Tom. I believe approximately 27 subjects were evaluated. Chris might have the number, they are in front of them here.

Christopher McAleer: There are 26 patients enrolled. The evaluation comes from 21 evaluable patients.

Unidentified Participant: Okay. Thank you.

Thomas Equels: Now this is the interim report that’s called for by the protocol. So there will be additional patients. But the data is extremely strong, indicating that Ampligen enhances the therapeutic impact of the cisplatin, pembrolizumab program so significantly that we can see a very, very strong synergy from the combination of those drugs.

Unidentified Participant: Got it. Appreciate the color there. And then, yeah, in post-COVID conditions, I mean, I know that, that data again was very strong. And I was just wondering, you couldn’t comment too much on next steps, but we can still expect that full study data soon. And then, that will help inform the potential larger static powered trial, is that right?

Thomas Equels: That’s correct. The data that has to be evaluated consists of tens of thousands of pages of information. So we’re going through that now very carefully and rooting out any issues that flag signals as to where the parameters should be for inclusion data in our next step here. We kept the, let’s say, the gate very wide in terms of inclusion for the study so that we could determine from onset of disease, severity of disease, a number of different criteria where Ampligen works best in the treatment of lung, COVID, or post-COVID exhibiting clinic fatigue like conditions. Chris, do you have anything to add to that?

Christopher McAleer: So the last piece that we need before we can proceed is the exploratory biomarker analysis. I believe there will be data in there that helps pinpoint responders versus non-responders. And so that data we expect to have in the next three months or so. And so, the generality of the inclusion criteria that we’re looking to do, we’re working with the patient advocacy groups to get their input as the FDA has requested so that we can best monitor the symptoms of the patients. And when we combine that with the data we currently have in the exploratory biomarkers, I think we’ll be prepared to launch the next trial but that will take some time based on our waiting for the results of that.

Thomas Equels: But this is one of those instances where haste makes waste. We did this so that we could have a very refined view of what the next trial should look like, which will make an effort to identify those persons with this syndrome most likely to respond to Ampligen as a therapeutic.

Unidentified Participant: Got it. Thanks. And then just lastly, going back to the ovarian program. I know it’s an IST, but I guess what are your expectations in terms of a next step there after this positive interim data?

Thomas Equels: Well, the data has impact in a number of respects. This is a Phase II trial that was principally funded through a Merck grant. We supply the Ampligen for the trial and of course, technical assistance at our end. And it’s an investigator sponsored trial. When it’s over and we have the final publication of the investigators reports related to the study. Clearly, there is an opportunity to move forward. But we use this in combination with some of the other clinical trials where we’ve combined Ampligen with pembrolizumab, so that we can see that, that combination has the potential to be a powerful synergistic combination in a number of different solid tumors, which means that Ampligen’s role, much like pembrolizumab or KEYTRUDA’s role, is broad spectrum across the arena of solid tumors in oncology.

So that’s what we’re working to prove long term. And that’s the kind of data that we hope to use as a part of our commercialization pitch to well-developed oncology companies that might have an interest in the Ampligen.

Unidentified Participant: Okay. Great. Thanks for taking the questions and congrats on all the progress.

Thomas Equels: Well, thank you very much.

Operator: Thank you. Our next question is coming from James Molloy of Alliance Global Partners. Please go ahead.

James Molloy: Hey, guys. Thanks for taking my question. I just had a question on — you have a variety of ISTs ongoing triple-negative breast, metastatic colorectal, prostate cancer. Can you — any sort of expectations for another outside of your control for near-term catalysts or potential catalysts upcoming on the broad range of ISTs, you guys are ongoing?

Thomas Equels: As you mentioned, the good part about investigator sponsored trials, and we’ve had a number of them that have advanced our position in oncology because it is that they’re typically funded by others, but they also are controlled by others in terms of the timing and the release of data and everything. But thus far, in all of these trials that we’ve done, the initial reports of data and the publications. We have a host of publications now over the past two years that indicate that Ampligen has the potential to be a very powerful therapeutic agent in a wide range of tumors. So we look forward to the reports as these trials — these investigator-sponsored trials come to an end. Most of this information will probably be published in some form, either as an abstract or a peer-reviewed paper.

We have a number of very strong peer-reviewed papers in extremely well respected journals that are out there right now. If you go to our website, you can see a list of recent publications probably over the past 2.5 years. So our feeling is very positive about the future from these trials. And it’s instructive as to next steps because this is the kind of information that derisks a major oncology trial, which can cost very large amounts of money.

James Molloy: To that — follow-up on that, can you talk a little bit about how the partnership environment? Any thoughts on how that environment looks and what the potential partners for your variety of programs might be waiting on as you see it? And how does that…

Thomas Equels: I’m sorry, go ahead.

James Molloy: And if you can break it down between self-funding versus finding a partner to carry on some of these trials, obviously, these very expensive trials to run. What are your thoughts on that?

Thomas Equels: Well, our thought is that this is an opportune time to reach out. We’ve engaged a highly skilled B&D oncology group with Azenova, and we’ve targeted companies that we think that may have an interest in what we’re doing as a part of their strategic development. We have two major pharma companies that are involved in research combining Ampligen with their drug. We have a collaboration agreement, which if you go to our website, there’s a press release from almost two years ago, I guess, related to the collaboration agreement we entered into with AstraZeneca. We also are moving forward in a number of investigator-sponsored trials with the assistance of Merck as a participant and named collaborator. And for example, advanced recurrent ovarian cancer is probably the best example.

So we have to presume that those companies are doing this because of some interest. And there are other companies that this might enhance especially those companies with underperforming checkpoint inhibitor drugs might enhance their overall picture by creating a boosting efficacy down the road through a combination therapy. Also, we recently had a U.S. patent issued for our combination therapy synergistic approach with Ampligen combining it with PD-L1 checkpoint inhibitors, a little over 1.5 years ago, my timing may be off this is off the top of my head. We started to receive approvals of our general synergistic patent approach for Ampligen with checkpoint inhibitors generally. And we’re looking to create patent protection with Ampligen with PD-1 type checkpoint inhibitors as well.

James Molloy: Great. Thank you for taking my questions.

Thomas Equels: Well, thank you, James.

Operator: Thank you. The next question is coming from Ed Woo of Ascendiant Capital Markets. Please go ahead.

Ed Woo: Yeah. Congratulations on all the progress. My question is on the recent manufacturing of Ampligen. How much difficult or easy was it compared to the last batch you did? And in terms of also — is there any difference in the cost and your outlook for producing more going forward? Thank you.

Thomas Equels: Thank you, Dr. Woo. The recent manufacturing process went well. We aren’t there to watch it. So all I can say is, there were no reports of problems or anything like that because we use a contract — a well-established contract manufacturer that has worked for us over several years, that’s Jubilant HollisterStier, they’re out in Spokane, Washington. They costs like much, especially in this medical R&D space have all increased over time. But we see that in our clinical trials, everything is significantly more expensive than it was five years ago. Does that answer your question, Ed?

Ed Woo: Yes, it does. And do you anticipate if you do need another batch that it will be the similar process?

Thomas Equels: Well, we’re anticipating that in the next two years, we probably don’t need another. But one of the reasons we did this is to make sure that we had adequate reserves, not just for what we’re doing but for future activity. However, if we were to launch into a large scale oncology trials, say, for new drug approval purposes with a commercial partner, there would be a need to manufacture more Ampligen. We believe this is a reproducible, repeatable process that we’ve been using. And we’re doing work on manufacturing processes from start to finish, including all the components that go into Ampligen so as to create an efficient, reproducible and cost-effective approach to the Ampligen manufacturer. And when we manufacture commercial lots, because these are smaller lots, it’s very expensive. But mass produced Ampligen has the potential to be manufactured at much lower cost than what we’re seeing right now.

Ed Woo: Great. Well, thanks for answering my questions and I wish you good luck. Thank you.

Thomas Equels: Well, thank you.

Operator: Thank you. This brings us to the end of the question-and-answer session. I would like to turn the floor back over to Mr. Equels for closing comments.

Thomas Equels: Well, thank you very much, operator. And I want to thank all of the analysts that participated today in the question-and-answer session. We at AIM ImmunoTech are very pleased with the progress that we’re making and our hopes for the future are high. We also appreciate the support that we’ve had from shareholders, the investment community, and we look forward to serving them well, as well as what is our most important stakeholder population. These people who are suffering from lethal unmet medical needs in oncology where we can see a real opportunity to make a difference. Our motto is immunology for a better future, and we strive to create that future today.

Operator: Ladies and gentlemen, thank you for your interest in AIM ImmunoTech. 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.