Earnings Labs

AIM ImmunoTech Inc. (AIM)

Q2 2024 Earnings Call· Fri, Aug 16, 2024

$0.52

+0.81%

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Transcript

Operator

Operator

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. [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 that 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 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 Investors 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 studies, publication, 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 of 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, Ph.D. Scientific Officer. I'd now like to turn the conference call over to Tom Equels, CEO. Please proceed.

Thomas Equels

Analyst

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. 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 manufacturer of approximately 9,000 clinical valves of Ampligen. Additionally, earlier this year, we made a commitment to all of our stakeholders, the 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.

Christopher McAleer

Analyst

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 1/2 trial to determine the safety and efficacy of combining Ampligen with AstraZeneca's durvalumab in the treatment of metastatic pancreas 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 3+3 design has 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 1,500 milligrams durvalumab and 400-milligram Ampligen. And these are the last three patients of the Phase 1 portion and together with the other three already receiving this dose will be included as the first patients of the Phase 2 efficacy evaluation. The first patients of the initial 200-milligram dose level are reaching the next efficacy evaluation, which is set for week 24. And I want to remind everyone that the initial data indicated two stable disease and one minor progression at week 12 and the first patient continues to have stable disease at week 24. And 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. And this has us excited. And as of our last update earlier this week, two of those patients still have stable disease. And we're hopeful that we will see responses from these patients even at that lower Ampligen dose. The time to response of immunotherapies is…

Thomas Equels

Analyst

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're fortunate that we can announce that we have cash position, which we believe is sufficient to fund operations through multiple key milestones that are coming up. Our cash, 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. 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 the Ampligen has the potential to unlock tremendous value for all stakeholders. And when I say stakeholders, I'm not just talking about investors but the patient populations that we hope to serve also. And 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're collaborating with big pharma companies, for example, the advanced recurrent ovarian cancer study at Pit. We collaborate, if you look at the clinicaltrial.gov filing with Merck and Erasmus in the Netherlands, our DURIPANC studies 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

Operator

Thomas Equels

Analyst

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

Operator

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.