Company

Presentation

September 2021

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, we claim 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. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. We are in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and the presentation sets forth our current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not 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, we cannot assure that the clinical studies will be successful or yield any

useful data or require additional funding. Some of the world's largest pharmaceutical companies and medical institutions are

racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. We recognize that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies. 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. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. In addition, many countries, including Argentina, are dealing with COVID-19 outbreaks and have made that their primary focus. We believe that this may be delaying our commercialization of Ampligen in Argentina until COVID-19 is more under control. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

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

AIM ImmunoTech - Company Presentation - September 2021

2

AIM is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of viral diseases, cancers, and immune-deficiency disorders.

AIM's flagship products are Ampligen (rintatolimod) and Alferon N Injection.

Ampligenis being evaluated as a potential treatment for myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS), COVID-19 in cancer patients, Long COVID-19,Post-COVID-19 Cognitive Dysfunction (PCCD), and multiple types of cancers.

Alferonis a natural interferon that is approved in the U.S. for the treatment of refractory or recurrent external genital warts in patients ages 18 or older.

3

AIM ImmunoTech - Company Presentation - September 2021

Product Pipeline

of FDA- and

EMA-Authorized

Trials

Ampligen is being studied in multiple clinical settings with human subjects in the United States and the European Union. Additionally, it is approved as a treatment for ME/CFS in Argentina.

Phase 1

  • P1 Early-StageTriple-Negative Breast Cancer - Chemokine Modulatory Regimen plusNeoadjuvant Chemo
  • P1 Intranasal Administration of Ampligen in Healthy Volunteers

Phase 2

  • P1/2 Advanced Recurrent Ovarian Cancer - Chemokine Modulatory Regimen
  • P1/2 Advanced Recurrent Ovarian Cancer - In Combination w/Pembrolizumab
  • P1/2 Cancer with COVID-19 - In combination w/Interferon Alpha-2b, and as Ampligen alone
  • P1/2 Metastatic Triple-Negative Breast Cancer - Chemokine Modulatory Regimen
  • P2 Early-Stage Prostate Cancer - In Combination w/Intron A
  • P2a Human Challenge Study - Respiratory Viral Prophylaxis
  • P2a Metastatic Colorectal Cancer - Chemokine Modulatory Regimen

Phase 3

  • ME/CFS - AMP-516 - Single Agent Ampligen

EAP

• EU - Pancreatic Cancer (Early Access Program)

• US - AMP-511 - Single Agent Ampligen - Compassionate Care for ME/CFS including chronic

fatigue associated with Long COVID (Expanded Access Program)

4

AIM ImmunoTech - Company Presentation - July 2021

AIM ImmunoTech - Company Presentation - September 2021

2021-22

  • Seek FDA authorization for a confirmatory trial in ME/CFS based upon our existing New Drug Application and then file the response to Complete Response Letter with data from the confirmatory trial
  • Initiate Phase 2 Clinical Trials of Ampligen as intranasal and intravenous therapies for Post-COVID-19 Cognitive Dysfunction (PCCD)
  • Initiate Phase 2 Clinical trials of Ampligen as intranasal and intravenous therapies for early-onsetCOVID-19
  • Report initial Long COVID results from AMP-511 study
  • Publication of Phase 1/2 data in Advanced Recurrent Ovarian Cancer
  • Report detailed intranasal safety data on Ampligen in healthy volunteers
  • Initiate Phase 2a Human Challenge Trial of Ampligen as a potential broad-spectrum respiratory virus prophylaxis
  • Publication of detailed data from Pancreatic Cancer EAP
  • Seek FDA IND authorization of a Phase 2 Pancreatic Cancer Clinical Trial, and then initiate trial; Seek equivalent from EMA
  • Seek FDA IND authorization of a Phase 2 Advanced Recurrent Ovarian Cancer Clinical Trial, and then initiate trial
  • U.S. Phase 2 interim report on the combination treatment of Ampligen and pembrolizumab in Advanced Recurrent Ovarian Cancer
  • Expand Phase 2 Cancer with COVID-19 Clinical Trial for Ampligen as a treatment for Acute COVID-19 to broaden patient population
  • Seek Ampligen FDA fast-track or breakthrough status in Pancreatic Cancer
  • Seek Ampligen FDA fast-track or breakthrough status in Advanced Recurrent Ovarian Cancer
  • Publication of data from Clinical Trial of Metastatic Triple Negative Breast Cancer
  • Publication of data from Clinical Trial of Metastatic Colorectal Cancer

2022-24

  • If data supports, seek New Drug Application approvals in ME/CFS, COVID-induced CF, Advanced Pancreatic Cancer, Advanced Ovarian Cancer, and PCCD

Upcoming Milestones and

Value Drivers

5

AIM ImmunoTech - Company Presentation - September 2021

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

Attachments

  • Original document
  • Permalink

Disclaimer

AIM ImmunoTech Inc. published this content on 17 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 September 2021 13:21:01 UTC.