• Generally well-tolerated with over 100,000 IV doses in humans

• Clinically tested in oncology as a single-agent therapeutic and in combination with other agents

• Potential in oncology to enhance efficacy of PD-1 and PD-L1 checkpoint inhibitors¹

• Phase 3 in ME/CFS completed in U.S. – NDA filing pending confirmatory Phase 3 following complete response letter; Approved for the treatment of severe CFS in Argentina

1: Animal experiments support expectations of human responses

Additionally, Ampligen^® induces a wide range of immunologic and anti-tumor activities, making it a potentially useful immuno-therapy targeting multiple cancers with high unmet needs.

Site: Erasmus University, The Netherlands, conducted by Professor CHJ van Eijck, MD, PhD

Eligibility: Adults with metastatic or locally advanced pancreatic carcinoma following FOLFIRINOX

Survival Data: Median overall survival (OS) was 19 months in the Ampligen® cohort compared to 12 months for a well-matched historical control group (p=0.035) 19 months OS in Ampligen® cohort represents 7.9 month increase survival benefit compared to current standard of care (FOLFIRINOX followed by gemcitabine), which yields 11.1 months OS

Received IND clearance from the U.S. FDA and IRB approval to initiate Phase 2 study in locally advanced pancreatic cancer patients

Lastly, Ampligen^® may mount a potentially broad spectrum immune system response against SARS-CoV-2 (COVID-19)

Next Steps: Planning intranasal study of Ampligen® to potentially enhance and expand natural immunity

The Alferon N Injection^® is currently an approved treatment of refractory or recurrent external condylomata acuminata. Commercial launch is pending FDA manufacturing approval, and sales are anticipated to resume upon successful pre-approval inspection and supplemental approval by FDA.

AIM ImmunoTech has developed strategic partnerships with groups such as the University of Pittsburgh Medical Center as well as Erasmus MC in Rotterdam for their oncology treatment trials.

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 treatment for 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 alleviation of "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, obviously 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.

For biotech companies, having enough runway to develop their candidates and get through the regulatory process takes an incredible amount of cash and time. Many are not able to see their candidates through because of a shortage of cash.

AIM ImmunoTech is currently in a very advantageous position in this regard. Its cash and cash equivalents position as of the end of Q3 2023 sat at about $22 million, offering it a lengthy runway to achieve its goals and reach commercialization.

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.

NOTE: since the creation of the above graphic, AIM ImmunoTech has also earned the FDA Orphan Drug Designation

AIM ImmunoTech Virtual Investor Video: Aug 3, 2022

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