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. [Operator Instructions] 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 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 and metastatic -- 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 U.S. 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…

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 a 4 times to 5 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 topline 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…

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 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…

Thank you. [Operator Instructions] Our first question today is coming from Jason McCarthy from Maxim Group. Your line is now live.

Hi, guys. Thanks for taking the questions. This is Chad [ph] 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. Does that -- 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 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?

Yeah. The -- I -- 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 U.S. 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 the -- 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 U.S. So I expect enrollment in the EU to happen Q3, Q4-ish by the end of the year for sure and in the U.S. as well.

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

Thank you.

Thank you. [Operator Instructions] Our next question is coming from James Molloy from Alliance Global Partners. Your line is now live.

Hey, guys. Good morning. Thank you very much for taking the questions. I have 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?

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, it -- 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?

On the -- 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 topline 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 breakdown of all the secondary endpoints that weren’t part of the topline data. We’ve seen those and there are positive improvements in quite a few of those. The -- 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. 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, 6-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, this follow-up trial, that we have high confidence that we’ve targeted the zone of the amylogen 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?

No. I think that sums it up.

Does that answer your question, Jim?

It does indeed. No, 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 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.

Thank you. The next question is coming from Ed Woo from Ascendiant Capital Markets. Your line is now live.

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?

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 questions 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.