AIM ImmunoTech, Inc.

The CEO Corner platform was launched in March 2024 to provide an additional and in-depth perspective on press releases, corporate developments, and development pipeline progress.

“Keeping our stakeholders well informed is absolutely essential to the future success of AIM ImmunoTech. CEO Corner is a new way for us to connect directly with both current and potential stockholders. CEO Corner segments will provide expanded perspective on press releases, clinical trials and other corporate advancements as we continue to push forward with our development pipeline. We believe in the future of Ampligen and are dedicated to growing value for all stakeholders," said CEO Tom Equels.

March 7, 2024 –
Welcome to the AIM CEO Corner

March 13, 2024 –
Oncology Overview

March 20, 2024 –
Ovarian Cancer

March 20, 2024 –
Virtual Investor Lunch Break: The AIM Opportunity

April 11, 2024 –
Top-line Interim Data from Recurrent Ovarian Cancer Study

April 25, 2024 –
Metastatic Pancreatic Cancer

July 3, 2024 –
Corporate and Clinical Update

July 29, 2024 –
Early Stage Triple Negative Breast Cancer

Videos Source: Company Reports

AIM ImmunoTech has strategically positioned itself as a leader in immunotherapy research and development. With a focus on leveraging the unique properties of its flagship drug candidate, Ampligen, the company is addressing critical unmet needs across multiple therapeutic areas. This comprehensive approach not only diversifies AIM's potential market impact but also maximizes the opportunities for breakthrough treatments in complex diseases.

Source: Company Reports

Ampligen, the lead investigational drug developed by AIM ImmunoTech, is currently being evaluated across various indications in multiple human clinical trials. The drug is under investigation for potential efficacy in several oncology applications, including locally advanced and metastatic pancreatic cancer, as well as advanced recurrent ovarian cancer, both as a standalone treatment and in combination with other therapies. Notably, Ampligen is being studied in combination with established immunotherapies like Durvalumab and Pembrolizumab. The company has also reported positive data from an Early Access Program for late-stage pancreatic cancer in the Netherlands and is investigating Ampligen's potential in treating Long COVID / Post-COVID Conditions. Across these trials, AIM ImmunoTech is actively enrolling and dosing patients, reporting interim results, and progressing through various clinical phases, demonstrating a robust and diverse clinical development program for Ampligen.

AIM ImmunoTech's lead investigational drug, Ampligen® (rintatolimod), stands out as a novel immunotherapeutic agent with a distinctive mechanism of action. As noted below, Ampligen is being investigated for its potential antitumor applications.
Source: Company Reports
Ampligen's safety profile is being continuously evaluated across multiple disease areas. With approximately 100,000 IV doses administered in humans, the drug has demonstrated general tolerability and encouraging results in various preclinical models and clinical studies. Ampligen's potential applications span oncology, COVID-19, ME/Chronic Fatigue Syndrome, and Long COVID conditions, showcasing its versatility as a therapeutic candidate. Ampligen is approved in Argentina for severe chronic fatigue syndrome, and a Phase 3 trial for ME/CFS in the United States has been completed with ongoing analysis.

Source: Company Reports

Next Steps:

AIM ImmunoTech reports ongoing positive developments in its cancer treatment programs with Ampligen. Recent studies continue to explore the potential for enhanced anti-tumor immunity in recurrent ovarian cancer. Recent findings related to Ampligen's study in pancreatic cancer have been reported and are under review for publication. The company continues to explore and expand Ampligen’s therapeutic potential across various oncological applications.

In the video below, CEO Thomas Equels joined Proactive's Stephen Gunnion after the company announced the start of an NCI-funded Phase 2 study of its product candidate, Ampligen, in melanoma. Equels gave an overview of Ampligen and explained the process for the Phase 2 study and the steps AIM will take if it is successful. He also provided an overview of AIM's other programs with Ampligen.

Ampligen's unique mechanism of action in oncology focuses on reprogramming the tumor microenvironment to enhance the immune response against cancer cells. By converting "cold" tumors into "hot" tumors, Ampligen aims to make cancers more responsive to checkpoint blockade therapies. This approach leverages Ampligen's ability to selectively attract cancer-fighting T cells while reducing regulatory T cells that can suppress immune responses, potentially offering a novel strategy to improve cancer treatment outcomes.

Source: Company Reports

Chemokine modulation plays a crucial role in shaping the tumor microenvironment and influencing cancer outcomes. By altering the balance of specific chemokines, such as increasing CXCL10 and decreasing CCL22, therapies like Ampligen can potentially enhance the infiltration of cancer-fighting T cells (Teff) while reducing immunosuppressive regulatory T cells (Tregs). This modulation aims to create a more favorable immune environment within tumors, potentially leading to improved patient survival rates.

Source: Company Reports

Ampligen demonstrates a consistent pattern of immune activation across various solid tumor types, suggesting a broad applicability in oncology. This table illustrates how Ampligen influences key markers associated with T-cell chemotaxis and infiltration in different cancers, including ovarian, colorectal, triple-negative breast, and pancreatic cancers. The similarity in responses across these diverse tumor types underscores Ampligen's potential as a versatile immunotherapy agent.

Source: Company Reports

Ampligen has shown promising results in multiple cancer types, with a particular focus on pancreatic cancer. AIM ImmunoTech is conducting several clinical trials to evaluate Ampligen's efficacy in various stages of pancreatic cancer, as well as in other solid tumors such as ovarian, breast, colorectal, and melanoma.

Source: Company Reports

Pancreatic cancer represents a significant unmet medical need, with approximately 62,000 new cases and 50,000 deaths annually in the United States. The high mortality rate underscores the urgent need for new, effective treatments in this area.

Source: Company Reports

AIM ImmunoTech is pursuing two Phase 2 clinical trials in pancreatic cancer. AMP-270 is evaluating Ampligen following FOLFIRINOX in locally advanced pancreatic adenocarcinoma, while DURIPANC is studying the combination of Ampligen and durvalumab in metastatic pancreatic ductal adenocarcinoma.

Source: Company Reports

AIM ImmunoTech has established strategic collaborations to advance Ampligen's development in oncology. These partnerships leverage the expertise of leading institutions and companies, enhancing the potential for successful outcomes in clinical trials across various cancer types, including advanced and recurrent ovarian cancer.

Source: Company Reports

Ampligen has shown promising results in treating pancreatic cancer, one of the most challenging malignancies. AIM ImmunoTech is pursuing multiple clinical pathways to evaluate Ampligen's efficacy in this critical area of unmet medical need. Promising results from an Early Access Program at Erasmus University showed a statistically significant increase in overall survival for late-stage pancreatic cancer patients treated with Ampligen compared to historical controls.

The Early Access Program for Ampligen in late-stage pancreatic cancer, conducted in partnership with Erasmus MC, has yielded encouraging results. With over 55 subjects enrolled, this ongoing study uses Ampligen as monotherapy. Positive results published in March 2022 indicate a significant improvement in progression-free survival compared to historical controls.

Early Access Program in Late-Stage Pancreatic Cancer - Overall Survival] Further analysis of the Early Access Program data demonstrates promising overall survival outcomes. The graphs show improved survival probabilities for patients treated with Ampligen compared to historical controls, both in the general patient population and in subgroups such as those with CA19.9 levels below 1000. These results suggest Ampligen's potential to extend life in late-stage pancreatic cancer patients.

Source: Company Reports

AIM ImmunoTech's research into Ampligen as a potential treatment for post-COVID conditions focuses on two key areas: fatigue and cognitive dysfunction. The results are summarized below in four slides.

The Phase 2 study (AMP-518) demonstrated promising results in reducing fatigue, with Ampligen outperforming placebo in PROMIS® fatigue measures and the Six-Minute Walk Test. Preliminary data from the Hunter-Hopkins center showed improvements in exercise ability, fatigue levels, and post-exertional malaise over 12 weeks. Additionally, early results indicate potential benefits in cognitive function, with patients reporting improvements in concentration, memory, and overall cognitive performance after 24 weeks of treatment. These findings suggest that Ampligen may offer a comprehensive approach to addressing the complex symptoms of long-COVID, potentially improving both physical and cognitive outcomes for patients.

AIM ImmunoTech conducted a Phase 2 study to evaluate Ampligen's effectiveness in treating post-COVID fatigue. 80 subjects were enrolled in the study, and the preliminary topline data were reported in February 2024.

Source: Company Reports

Preliminary data from the Hunter-Hopkins Center provide encouraging results for Ampligen in treating long-term COVID-19 symptoms. As shown below, patient-reported outcomes demonstrate improvements in exercise ability, fatigue levels, and post-exertional malaise over a 12-week period.

Source: Company Reports

The topline results from the AMP-518 study suggest Ampligen's potential in alleviating post-COVID fatigue. The slide below summarizes key findings, including Ampligen's performance against placebo in PROMIS® fatigue measures and the Six-Minute Walk Test, as well as its safety profile.

Source: Company Reports

Below are preliminary data from the Hunter-Hopkins center on Ampligen's potential to improve cognitive dysfunction in long-COVID patients. The results show improvements in measures of cognitive function, including difficulty concentrating or focusing, memory problems, and impaired memory or concentration. The data compares baseline scores to those after 24 weeks of treatment, suggesting Ampligen may help alleviate these persistent cognitive symptoms associated with long-COVID.

Source: Company Reports

AIM ImmunoTech believes that it has potential solutions for a number of different indications, both for use in isolation as well as in conjunction with another drug.

First, Ampligen is in late-stage trials for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Up to 2.5 million Americans are estimated to suffer from this malady, causing the U.S. economy an estimated $17 to $24 billion per year, according to the CDC.

Additionally, Ampligen is currently being studied for alleviating "long COVID"—the long-term issues some COVID patients suffer from. While there is not much long-term information to draw from, a recent UCLA study implies that around 30% of COVID patients have long-term symptoms.

Lastly, oncology: AIM ImmunoTech believes that it may have therapeutic solutions for numerous types of cancer. As a malady that impacts so many of us, the potential market for these therapeutics is enormous. Precedence Research estimates that the global market will balloon to over $580 billion annually in 2030, with a Compounded Annual Growth Rate (CAGR) of 8.2% this decade.

Source: Precedence Research

Ampligen, the lead investigational drug developed by AIM ImmunoTech, is currently being evaluated across various indications in multiple human clinical trials. The drug is under investigation for potential efficacy in several oncology applications, including locally advanced and metastatic pancreatic cancer, as well as advanced recurrent ovarian cancer, both as a standalone treatment and in combination with other therapies. Notably, Ampligen is being studied in combination with established immunotherapies like Durvalumab and Pembrolizumab. The company has also reported positive data from an Early Access Program for late-stage pancreatic cancer in the Netherlands and is investigating Ampligen's potential in treating Long COVID / Post-COVID Conditions. Across these trials, AIM ImmunoTech is actively enrolling and dosing patients, reporting interim results, and progressing through various clinical phases, demonstrating a robust and diverse clinical development program for Ampligen.

Source: Company Reports

Alferon N Injection® continues to be an FDA-approved treatment for refractory or recurrent external condylomata acuminata. The commercial relaunch is pending the completion of the FDA's manufacturing approval process, including a successful pre-approval inspection. Sales are expected to resume following a successful pre-approval inspection and obtaining the necessary supplemental approvals.

For biotech companies, securing sufficient funding is crucial to sustain development and regulatory approval processes, which are both time-intensive and costly. A lack of adequate funding is a common hurdle that prevents many biotech firms from bringing their candidates to market.

As of Q2 2024, AIM ImmunoTech is in a favorable position compared to many of its peers. With cash and cash equivalents of more than $10.0 million, the company remains strategically poised with enough financial resources to pursue its clinical development goals and move towards the commercialization of its products.

Source: Company Documents

While a strong cash position is no guarantee that its candidates will successfully move through the regulatory approval process, its cash position combined with a strong intellectual property stack puts it in a strong position for future success.

AIM ImmunoTech’s intellectual property portfolio is robust, with 46 patents worldwide, providing strong protection for its drug candidates. Ampligen, the company’s flagship product, benefits from market exclusivity, offering seven years of protection following FDA approval in the U.S. and ten years following EMA approval in Europe. This strategic combination of patents and market exclusivity positions AIM ImmunoTech to capitalize on its innovations, ensuring a competitive edge in the biotech market.

Source: Company Reports

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AIM ImmunoTech Inc. (the “Company”) and its counsel have reviewed the content of this page as well as the accompanying presentation (“Company Presentation”) displayed on this page. To the best of its knowledge, the Company does not believe this content to be misleading or inaccurate in any material respect, nor does it believe there are any material omissions with respect to such content. The Company does not believe the contents of the page or the Company Presentation to contain any non-public material information.

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