Immunology for a Better Future

Ampligen: A General Overview and the Plan for

ME/CFS and Long Covid

January 27, 2022

Forward-Looking Statements

Some of the statements included in this presentation may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, AIM claims the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. AIM does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This presentation relates to clinical development plans for AIM's Ampligen for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Long COVID. These developments are subject to change for a number of reasons. AIM has been focusing on the use of Ampligen for the treatment of ME/CFS for a number of years. Ampligen is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome, but commercial sales have not yet begun. In the U.S., the FDA issued a complete response letter ("CRL") in 2013 to AIM's New Drug Application and has requested additional trials and other information before it can proceed. AIM is working on a comprehensive follow through with the FDA. AIM learned a great deal since the FDA's CRL and plans to adjust its approach to concentrate on specific ME/CFS symptoms. Responses to the CRL and a proposed confirmatory trial are being worked on now by AIM's R&D team and consultants. The FDA authorized an open-label treatment protocol ("AMP-511") in a study under which severely debilitated CFS patients have the opportunity to be on Ampligen to treat this very serious and chronic condition. The AMP-511 protocol is ongoing. In October 2020, AIM received Institutional Review Board approval for the expansion of 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 (Long COVID). Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of Long COVID. In addition, results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, AIM cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the presentation.

Please review the "Risk Factors" section in AIM's latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. AIM'S filings are available at www.aimimmuno.com. The information found on AIM's website is not incorporated by reference into this presentation and is included for reference purposes only.

2

Ampligen (Rintatolimod) is a Broadly Applicable Immune Therapy

  • Ampligen is a broadly applicable immune therapy that has the potential to be used in a wide range of indications
  • Generally well-tolerated with over 100,000 IV doses in humans
  • Ampligen has Orphan Drug Status in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Metastatic Melanoma, Renal Cell Carcinoma, and HIV in the US and Pancreatic Cancer and Ebola Virus Disease in the EU

Ampligen

Immuno-

ME/CFS

Vaccine

Oncology

Enhancer

Combination

Single Agent

Phase III

Therapy

Approved in

Phase I/II

EAP

Phase I/II

Argentina

3

Ampligen (Rintatolimod) Development Pipeline

Phase

Disease / Indication

Pre-

Phase

NDA

Approved

EAP1

clinical

I

II

III

Myalgic Encephalomyelitis/

US

Argentina

Chronic Fatigue Syndrome*

Ovarian, Colorectal, Renal

Cell Carcinoma*, Prostate,

and Melanoma* Cancers

Breast Cancer

Pancreatic Cancer

Bladder Cancer

Vaccine Adjuvant (Influenza

including highly pathogenic)

HIV Disease*

1 EAP = Expanded Access Program / Early Access Program * Orphan Drug Indications in US

4

Clinical Safety Profile Related to Molecular Structure of Ampligen (Poly I: Poly C12U)

  • Mis-pairedregions of base pair hydrogen bonding accelerate chain hydrolysis while preserving biological activity
  • Decreased toxicity and improved safety compared to the absence of mis-pairing
  • No development of antibodies to Ampligen - In contrast to 40-60% antibody formation with poly ICLC and poly ICL [J. of IFN Research3,281 (1983)]
  • Ampligen is a selective TLR3 agonist compared to poly IC which also activates helicases (i.e. MDA-5)

5

This is an excerpt of the original content. To continue reading it, access the original document here.

Attachments

  • Original Link
  • Original Document
  • Permalink

Disclaimer

AIM ImmunoTech Inc. published this content on 27 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 January 2022 21:49:11 UTC.