AIM ImmunoTech - Q2 2024

Transcript

Operator (participant)

Hello, and welcome to the AIM ImmunoTech second quarter 2024 update conference call and webcast. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the event, please press star zero on your telephone keypad. Following the presentation, there'll 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.

Christopher McAleer (Scientific Officer)

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 ImmunoTech 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 view these documents carefully. Additionally, certain information contained in this webcast relates to or is based on the studies, publications, surveys, and other data obtained from third-party sources and the company's own estimates and research.

While the company believes 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 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 Christopher McAleer, PhD, Scientific Officer. I'd now like to turn the conference call over to Tom Equels, CEO. Please proceed.

Thomas Equels (CEO)

Thank you, operator. To get started, I'd like to say that I cannot be more proud, not just of our team at AIM, but of our key clinical partners at Top Cancer Research Centers for their hard work and continued focus on execution of clinical trials demonstrating Ampligen's potential. Over the past quarter, we have been working diligently to advance Ampligen across all of our development programs. Of note, over the past quarter, we continue to generate data that demonstrates the potential of Ampligen in oncology. These new positive data showed that in combination with dendritic cell vaccines, including anti-PD-1, PD-L1 checkpoint inhibitors, Ampligen slowed tumor growth with improved survival in a preclinical model. This encouraging data was published in the prestigious peer-reviewed journal vaccines.

Christopher McAleer (Scientific Officer)

While preclinical, these data do give us confidence as we advance our active, ongoing clinical oncology programs in pancreatic and ovarian cancer. I'd also like to point everyone toward our last quarterly update call in May, which, because of timing, covered many of our accomplishments in the second quarter. Those included updates in both our pancreatic cancer and ovarian cancer work, as well as the GMP manufacture of approximately 9,000 clinical vials of Ampligen. Additionally, earlier this year, we made a commitment to all of our stakeholders that transparency would be at the forefront of what we do. We believe we are holding true to this commitment and continue to be active on the CEO Corner program, which we launched earlier this year.

Through this platform, which can be found on our website and posted on social media, we strive to provide information and access, and I invite all of you to go to the CEO Corner on our website, sign up for the alerts, and also submit topics of interest that you would like us to cover. Now, to go into the details of our recent clinical advancements, I'd like to turn this call over to our Science Officer, Dr. Chris McAleer.

Thank you, Tom. I will give a brief overview of the clinical status of our priority development programs, and I'll start with DURIPANC. DURIPANC is a phase I/II trial to determine the safety and efficacy of combining Ampligen with AstraZeneca's durvalumab in the treatment of metastatic pancreatic cancer. We announced recently that the first cohort of the dose escalation had completed the safety evaluation, and the Medical Review Committee agreed to move forward with the next dosing level. The three patients to be evaluated in the second grouping of the three and three design have since finished the safety evaluation, and this dose level was also deemed safe.

Additional patients are being enrolled at this highest dose level, which is 1500 milligrams durvalumab and 400 milligram Ampligen, and these are the last three patients of the phase I portion, and together with the other three already receiving this dose, will be included as the first patients of the phase II efficacy evaluation. The first patients of the initial two hundred milligram dose level are reaching the next efficacy evaluation, which is set for week 24. I want to remind everyone that the initial data indicated two stable disease and one minor progression at week twelve, and the first patient continues to have stable disease at week 24.

While this is preliminary data from three patients at the lowest dose level, these patients already have average stable disease time that is similar to the median progression-free survival we saw with Ampligen alone in the EAP conducted at Erasmus. This has us excited. As of our last update earlier this week, two of those patients still have stable disease. We are hopeful that we will see responses from these patients, even at that lower Ampligen dose. The time to response of immunotherapies is in the weeks to months range, depending on the tumor type. Also, we expect the response to be slower than might be seen in other tumor types based on the fact that pancreatic tumors have a thick, fibrous desmoplastic nature, which makes immune infiltration more difficult.

That is where we stand with our clinical progress in metastatic pancreatic cancer. But in regards to our work in locally advanced pancreatic cancer, we have received the FDA's written response to our Type D meeting package in June. The FDA has agreed in principle with our proposed changes to the inclusion criteria and treatment arms, and we are working on finalizing approval of the protocol changes. While our progress might seem slow from the outside looking in, this is a complex disease with a range of treatment standards across different U.S. institutions, so it is important that the trial be managed so as to maximize the usefulness of the data we receive, while keeping trial costs within reason. This is especially important when it comes time to consider future steps in the development of a treatment.

When we have full regulatory go-ahead to proceed, we believe this new protocol will allow for greater site and patient recruitment in the U.S. Our last oncology update relates to the advanced recurrent ovarian cancer trial using Ampligen plus pembrolizumab and cisplatin in platinum-sensitive ovarian cancer. Based on conversations with Dr. Robert Edwards at the University of Pittsburgh, we know that the results thus far are better than he had expected, and patients have seen a clinical benefit rate of greater than 60%. In addition, he was also quite impressed with the immune changes to the tumor microenvironment, and the trial was proceeding so well that he feels there is no need to enroll the total 45 patients as originally planned.

And therefore, the trial is wrapping up enrollment and future steps are being planned, and you should see manuscripts highlighting the data coming from the University of Pittsburgh as early as the end of the year. As great as the initial response data is, I am personally the most interested in seeing the follow-up data with the duration of response. As you know, chemotherapy regimens have been effective in generating response data in these patients. But unfortunately for those who are afflicted, the sad reality is ovarian cancer notoriously comes back with a recurrence rate of approximately 80% for Stages III and IV patients. We believe the immune-modulating properties of this treatment and Ampligen's potential to modulate the immune milieu of the tumor microenvironment might help in this regard.

We are also eager to see preliminary data in the phase II study of advanced recurrent ovarian cancer, combining the Ampligen-containing chemokine modulation therapy with cisplatin and a dendritic cell vaccine, which is now open for recruitment. Lastly, I want to update you on the progress of Ampligen for the post-COVID condition of fatigue. We have done a thorough analysis of the data, and we have identified certain inclusion criteria that can help delineate the high responders. We are awaiting the biomarker data necessary to complete our analysis and expect to receive this data in mid-September. We have also been working with patient advocacy groups to better understand the patient journey and solicited their input on the subsequent trial design.

While we are still awaiting biomarker data, we believe we have a patient population we can target that will be high responders and that will minimize the size of the subsequent trial. We are drafting a preliminary regulatory package that we aim to submit to the FDA in Q4. And that is a brief overview of our priority clinical pipeline, and I'll hand it back to Tom to discuss the company financials.

Thomas Equels (CEO)

Good job. Thank you very much, Chris. Now I'd like to go into the financial picture. For those of you familiar with the micro-cap biotech sector, it's a rough area over the past couple of years. But we are fortunate that we can announce that we have cash position, which we believe sufficient to fund operations through multiple key milestones that are coming up. Our cash equivalents and marketable securities are $10.1 million as of June 30, 2024. Our research and development expenses for the three months and six months ending in June 30, 2024, were $1.1 million and $3.1 million, respectively, and that's compared to $3 million and $5 million for the same period of 2023.

Christopher McAleer (Scientific Officer)

General and administrative expenses for the three months and six months that ended June 30, 2024, were $2.6 million and $6.4 million, respectively, compared to $2.6 million and $4.8 million for the same period of 2023. Now, as we reflect on our progress, and the data is what tells the story of the progress that we've made over the past couple of years, you'll see that there are numerous articles, various peer-reviewed publications that are publishing data that show a bright future for Ampligen. And we are not only excited for the future of the company, but we believe that Ampligen has the potential to unlock tremendous value for all stakeholders.

When I say stakeholders, I'm not just talking about investors, but the patient populations that we hope to serve also. When you look at our company, you may ask: Well, why AIM? Why now? The reason is, we have encouraging data that drives our programs. We have multiple ongoing clinical studies at top cancer research institutions. And with regard to two of these studies, we are collaborating with big pharma companies. For example, the advanced recurrent ovarian cancer study at Pitt. We collaborate, if you look at the ClinicalTrials.gov filing with Merck, and in Erasmus in the Netherlands, our DURIPANC study is in collaboration with AstraZeneca. So we have all the ingredients, we believe, for a bright future. Thank you very much, everybody, for your interest. At this point, I'd like to open up the floor for questions. Operator?

Operator (participant)

Thank you. We're now conducting a question-and-answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. Once again, if you'd like to be placed in the question queue at this time, please press star one on your telephone keypad. One moment, please, while we pull for questions. We've reached the end of our question-and-answer session, and at this point, I'd like to turn the floor back over for any further closing comments.

Thomas Equels (CEO)

Again, I just want to thank everybody for their interest, and, we're working very hard, to fulfill AIM's motto, Immunology for a Better Future. Thank you very much.

Operator (participant)

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.