AIM ImmunoTech Inc.

Hello and welcome to the AIM Immunotech quarterly update conference call and webcast. As a brief reminder, all participants are currently in listen-only mode. If anyone requires operator assistance during the event, please press star zero on your telephone keypad. Following the presentation, there will be a question and answer session. 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 in 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 AEM leadership team are Thomas Eagles, Chief Executive Officer, and Christopher McAleer, PhD Scientific Officer. I would now like to turn the call over to Mr. Eagles. 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 in 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've 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 two 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 top line data, which we hope will be favorable, will be coming out in Q1 of 2024, according to our current best projection. We've published preclinical data as well as clinical data related to pancreatic cancer. It's very, very compelling. And our top line 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 Duvalumab. And all those approvals have been accomplished. We're just waiting to get the party started there, 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 have to go we have to go through it Buffett Cancer Center at the University of Nebraska So you can see based on what we've done over the past two years But 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 in the clinic and 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 are enrolled and dosage has begun. As I mentioned, we expect top-line 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 doesn't mean you're going forward, but here you can see we 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, Chris.

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 the AP in the Netherlands And this has led to additional data beyond what was presented in the cancer's paper. And this data has been analyzed. I do want to caveat that any graphs you'll see comprise data that was collected up until June 12th 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's a four to five month extension over historical control. And 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 a 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 CA-19-9 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, that's 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 these 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 AMP270 trial currently is ongoing and awaiting first patient enrollment. The Gabriel Cancer Center in Ohio and the University of Nebraska are both monitoring multiple patients who are currently undergoing Fulfironox treatment to determine their eligibility to enroll in AMP270. 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 fulfirinox, and that treatment can be extended further depending on clinician observations and the patient's ability to handle fulfirinox therapy, which is helpful but also quite toxic. They must receive a minimum of four months, though, and once they stop treatment, they are given time to recuperate, and then after four to six weeks from treatment stop, they're monitored again, to determine whether the Fulfironox 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 defined 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. To that end, we have identified and contacted over 70 sites. 31 of those sites have expressed interest. Of those 31 sites, we are in 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. The 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 AMP270. So based on what I explained, it does take time, but when the AMP270 data comes in, we believe that based on the data we have from the EAP, including this additional 30 patient data, that it's expected to be well worth the efforts and the wait. In addition to AMP270, we are also working on final European approvals, including QP release to start the DoraPank study in the Netherlands, and that's to investigate Ampligen combined with their Valumab 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 two trial in advance for current ovarian cancer. University of Pittsburgh originally expected that date 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 CITC 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 AMP518 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 top-line data as early as Q1 2024, and we are very excited about this trial. I did want to point out that the last of the, you know, 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 two HIVE 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.