AIM ImmunoTech Inc. (NYSE American: AIM) is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases. The company's lead product is Ampligen (rintatolimod), a first-in-class investigational drug that has shown promise across a range of important indications.

Business Overview

AIM ImmunoTech is headquartered in Ocala, Florida, and has established a strong foundation of laboratory, pre-clinical, and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body. The company's primary focus involves Ampligen, a double-stranded RNA (dsRNA) molecule being developed for globally important cancers, viral diseases, and disorders of the immune system.

The company is currently proceeding in four key areas with Ampligen: 1) Conducting a randomized, controlled study to evaluate the efficacy and safety of Ampligen compared to a control group in treating locally advanced pancreatic cancer patients; 2) Evaluating Ampligen in other cancers as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor responses to checkpoint inhibitors; 3) Exploring Ampligen's antiviral activities and potential use as a prophylaxis or treatment for existing viruses, new viruses, and mutated viruses; and 4) Evaluating Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and fatigue and/or Post-COVID conditions.

Immuno-Oncology Developments

AIM's focus on pancreatic cancer is driven by promising testing results primarily conducted in the Netherlands, which generated statistically significant data indicating that Ampligen extended survival well beyond the standard of care when compared to well-matched historical controls. These data support the proposition that Ampligen, when administered to patients with locally advanced or metastatic pancreatic cancer after systemic chemotherapy, showed a statistically significant increase in survival rate.

In addition to pancreatic cancer, Ampligen has demonstrated potential standalone efficacy in a number of other solid tumors. AIM has also seen success in increasing survival rates and efficacy in the treatment of animal tumors when Ampligen is used in combination with checkpoint blockade therapies. For example, in a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer, the combination of Ampligen, pembrolizumab (Keytruda), and cisplatin demonstrated an objective response rate of 45%, which compares favorably to the 8% objective response rate seen with pembrolizumab alone in the KEYNOTE-100 study.

Antiviral Potential

AIM has a research and pre-clinical history indicating broad-spectrum antiviral capability of Ampligen in animals, and the company hopes to demonstrate the same effect in humans. Previous animal studies have yielded positive results utilizing Ampligen to treat numerous viruses, such as Western Equine Encephalitis Virus, Ebola, Vaccinia Virus, and SARS-CoV-1. The company has also conducted experiments showing Ampligen has a powerful impact on SARS-CoV-2 viral replication.

While there are approved therapies for COVID-19, AIM believes that if Ampligen has the broad-spectrum antiviral properties the company believes it has, it could be a valuable tool in treating variants of existing viral diseases, including COVID-19, or novel ones that arise in the future. Unlike most developing therapeutics that attack the virus, Ampligen works differently by activating antiviral immune system pathways that fight not just a particular virus or viral variant, but other similar viruses as well.

ME/CFS and Post-COVID Conditions

AIM has long been focused on seeking FDA approval for the use of Ampligen to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). In 2016, the company received approval of an NDA from ANMAT in Argentina for the commercial sale of Ampligen for the treatment of severe CFS. AIM also has an open-label treatment protocol (AMP-511) allowing patient access to Ampligen for the treatment of CFS in the U.S.

In October 2020, AIM received IRB approval to expand the AMP-511 protocol to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms, referred to as Post-COVID conditions. Preliminary data from this study has shown that Ampligen treatment led to clinically significant decreases in fatigue-related measures for these patients.

Financials

For the full year 2023, AIM reported annual net income of -$28,962,000, annual revenue of $202,000, annual operating cash flow of -$21,267,000, and annual free cash flow of -$21,852,000.

In the first quarter of 2024, the company reported revenues of $40,000, down from $49,000 in the prior-year period, primarily due to fluctuations in patient participation in the Ampligen cost recovery program. The net loss for Q1 2024 was $5,817,000, compared to a net loss of $3,661,000 in Q1 2023, representing a 59% increase in losses. This was driven by a decrease in gain from the sale of income tax operating losses, a decrease in interest and other income, an increase in loss on investments, and increases in general and administrative expenses and interest expense.

Research and development costs for Q1 2024 were $1,951,000, down slightly from $2,052,000 in the prior-year period, while general and administrative expenses increased to $3,815,000 from $2,292,000, primarily due to higher legal and professional fees.

As of March 31, 2024, AIM had $10.9 million in cash, cash equivalents, and marketable investments, which the company believes is sufficient to fund operations through several key potentially value-driving milestones.

Outlook

AIM remains focused on advancing its pipeline of Ampligen programs across oncology, antiviral, and immune disorder indications. Key upcoming catalysts include:

• Completion of the Phase I portion of the DURIPANC study evaluating Ampligen in combination with AstraZeneca's Imfinzi (durvalumab) for metastatic pancreatic cancer this summer.

• Reporting of full data from the AMP-518 study evaluating Ampligen as a potential therapy for post-COVID conditions, which the company expects will help inform the design of a larger, statistically powered trial.
• Potential partnerships or licensing agreements for the commercialization of Ampligen, particularly in oncology indications where the data continues to be highly encouraging.

The company believes the depth, breadth, and potential of Ampligen provide a meaningful therapeutic solution in many high-value indications with significant unmet medical needs. AIM remains committed to advancing its pipeline and unlocking the full potential of Ampligen and the company as a value driver for investors.

Risks and Challenges

While AIM has made significant progress with Ampligen, there are risks to consider. These include the inherent uncertainties of drug development, the potential for clinical trial failures, regulatory hurdles, and the company's ability to secure partnerships or additional financing to support its programs. Additionally, AIM faces competition from larger pharmaceutical companies also working on treatments for cancer, viral diseases, and immune disorders.

Conclusion

Overall, AIM ImmunoTech's focus on advancing Ampligen across multiple high-value indications, coupled with its encouraging clinical data and manufacturing capabilities, position the company as an intriguing player in the immuno-pharma space. Investors will want to closely monitor the company's progress on its key pipeline programs and its ability to forge strategic partnerships to unlock the full potential of Ampligen.