Aim Immunotech Inc. · AMEX:AIM
Aim Immunotech — Investor Presentation (March 2021)
25 slides from Aim Immunotech's investor presentation, Mar 10, 2021
Slide 1: AIM ImmunoTech: Ampligen
SAM ImmunoTech Ampligen “Immunology for a better future”
Slide 2: Forward-Looking Statements
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
Slide 3: AIM ImmunoTech Inc.
AIM ImmunotTech Inc. We are 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. Ampligen is being evaluated
Slide 4: Robust Pipeline for Ampligen in Oncology, COVID-19 and ME/CFS
Robust Pipeline for Ampligen in Oncology, COVID-19 and ME/CFS ME/CFS od > Amobean ‘Approved in Argentina P1/2 Ovarian Cancer proce > Advanced, Recurrent ‘Regimen im iC P2a Colorectal Cancer Modutacory frosw | Metastatic same | ec “homotine Hates ot Noga eee | EL ———) iple-Negative “pemivolicamab PAR
Slide 5: Ampligen and COVID-19
Ampligen and COVID-19 ..a potential Prophylaxis for first responders and other medical professionals to essentially armor themselves against the virus before treating new and potential patients ..a potential Early-onset Therapeutic for people who have been exposed to the coronavirus so that they can
Slide 6: AIM's Current COVID-19 Efforts
AIM’s Current COVID-19 Efforts On August 27, 2020, AIM announced that it had identified an effective in vitro model at The Institute for Antiviral Research at Utah State University for testing Ampligen, a dsRNA TLR3 agonist, with the results showing that Ampligen was able to decrease SARS-CoV-2 infe
Slide 7: Potential Government Funding for COVID Long Haulers
Potential Government Funding for COVID Long Haulers While we believe our current level of funding is sufficient to support all our ongoing and currently proposed clinical work — including as it relates to COVID-19 — we are also exploring the possibility of federal funding of research and have retain
Slide 8: Ampligen in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Ampligen in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) ME/CFS was originally considered a psychiatric based illness. Current medical opinion considers ME/CFS to be a physically based illness of unknow etiology. Peer-reviewed medical journal articles now support the proposition that
Slide 9: Ampligen and COVID-Induced CFS: 'COVID Survivor Syndrome'
Ampligen and COVID-Induced CFS: ‘COVID Survivor Syndrome’ "It is anticipated that COVID-19 will trigger a large number of CFS cases, providing an opportunity for the medical community to learn more about the onset and pathogenesis of CFS. The investigational immune-modulating antiviral drug Ampligen
Slide 10: Ampligen and Cancer: Animal Experiments
Ampligen and Cancer: Animal Experiments Ampligen + Checkpoint Blockade Synergistically Increased Survival/Anti-tumor Response Synergistic/anti-tumor responses have led to clinical trials in oncology. For example: e AnAIM grant-supported experiment at the University of Nebraska, in a pancreatic cance
Slide 11: Ongoing Clinical Trial Objective: Show Ampligen Converts 'Cold' Tumors Into 'Hot'
Ongoing Clinical Trial Objective: Show Ampligen Converts ‘Cold’ Tumors Into ‘Hot’ Tumors that will be Responsive to Checkpoint Inhibitors e Increase Intratumoral Effector T (Teff) cells e Decrease Intratumoral Regulatory T (Treg) cells e Goal is to unleash the cellular immune response to attack and
Slide 12: Ampligen and Cancer: Immuno-Oncology Thought Leaders
Ampligen and Cancer: Immuno-Oncology Thought Leaders Pawel Kalinski, MD, PhD, Vice Chair for Translational Research at Roswell Park Comprehensive Cancer Center, Buffalo, NY. “Ampligen is a selective activator of the TLR3 pathway, which selectively increases the production of factors which attract cy
Slide 13: Ampligen and Cancer: Immuno-Oncology Clinical Trials Initiated / Ongoing in the U.S.
Ampligen and Cancer: Immuno-Oncology Clinical Trials Initiated / Ongoing in the U.S. e Advanced Recurrent Ovarian Cancer - This Phase 1/2 study of Ampligen as an intraperitoneal UPMC therapy in advanced recurrent ovarian cancer has completed 12 subjects in Phase 1; the Phase 1 portion established in
Slide 14: Ampligen and Cancer: Immuno-oncology Clinical Trials Initiated / Ongoing in the U.S.
Ampligen and Cancer: Immuno-oncology Clinical Trials Initiated / Ongoing in the U.S. e Stage 4 Colorectal Cancer Metastatic to the Liver - Phase 2a study of Ampligen as a component of chemokine modulatory regimen on colorectal cancer metastatic to liver; the majority of the 12 planned patients enrol
Slide 15: Early Access Program with Ampligen in Late-stage Pancreatic Cancer
Early Access Program (EAP) with Ampligen as a Treatment in Late-stage Pancreatic Cancer Shows Increased Overall Survival Compared to Historical Controls Site: Erasmus University, The Netherlands, conducted by Professor Casper van Eijck Eligibility: Adults with metastatic or locally advanced pancreat
Slide 16: AIM's Next Steps for Pancreatic Cancer Therapy Development
AIM’s Next Steps for Pancreatic Cancer Therapy Development e Proposed Phase 2/3 Follow-up Study 1) Develop a protocol design and schema in consultation with Buffet Cancer Center and Erasmus Medical Center 2) Develop a full protocol with Amarex Clinical Research and obtain regulatory approval to init
Slide 17: Alferon N Injection (interferon alfa-n3)
Alferon N Injection (interferon alfa-n3) Approved in the U.S. for the treatment of refractory or recurrent external genital warts in patients ages 18 or older. Approved in Argentina for the treatment of patients refractory to or intolerant to recombinant interferon alpha. Global market is open, as t
Slide 18: Alferon N Injection Development Pipeline
Alferon N Injection Development Pipeline Pre; Di: Indicati A d Genital HPV (condylomata acuminata) Refractory to Recombinant IFN Intolerant to Recombinant IFN MERS* Influenza A (H7N9) Virus * Orphan Drug Indication in EU he. S BS S Bs ns. S BS US and Argentina Argentina Argentina Salm ImmunoTech NYS
Slide 19: IP Protection and Growing Patent Estate
IP Protection and Growing Patent Estate * 43 patents worldwide with 10 additional pending patent applications underway ° FDA has granted Ampligen “orphan drug status” for CFS, HIV/AIDS, renal cell carcinoma, malignant melanoma and pancreatic cancer * Grants protection against potential subsequent ap
Slide 20: AIM's Executive Management Team
AIM’s Executive Management Team ° Thomas K. Equels, M.S., J.D. / Chief Executive Officer — Equels was named Chief Executive Officer in February 2016 and has served as President since August 2015. Equels’ successful legal career included extensive experience in the pharma sector. He has over the year
Slide 21: Investment Highlights
Investment Highlights Y Advancing clinical trials of Ampligen as a potential protective prophylaxis and an early-onset treatment for COVID-19 Y Ampligen believed to be the world’s only approved therapeutic for ME/CFS (first approval in Argentina) ) Potential surge in COVID-induced CFS-like cases wor
Slide 22: Key Statistics
Key Statistics * Ticker AIM - Exchange NYSE American » Share Price (2/26/21) $2.26 « Shares Outstanding (2/26/21) 47.8M « Market Cap (2/26/21)* $108.1 M * Cash, Cash Equivalents & Marketable Securities (09/30/20): $39.6 M * Market Cap calculated using Shares Outstanding and Share Price from 2/26/21
Slide 23: Supplemental Data
Supplemental Data: Aci 'y Only TLR3 agonist to promote selective attraction of CTLs (Teff) with concomitant increase in Teff/Treg ratio in the TME Reference(s)* Theodoraki, et al. (2018) Ampligen induces desirable chemokines in the TME, while other TLR3 agonists, such as poly IC, by activating helic
Slide 24: Supplemental Data
Supplemental Data: Activity Reference(s)* Induces dendritic cell maturation: Enhances bioactivity of cancer immunotherapy Nicodemus, et al. (2010) Promotes optimal dendritic cell maturation and Th1-type responses of healthy donors and cancer Navabi, et al. (2009) patients in vivo Induces epitope spr
Slide 25: Supplemental Data
Supplemental Data: Activity References Ampligen increases exercise performance in ME/CFS in Phase Ill, placebo-controlled trial Strayer, et al. (2012) Review of Ampligen clinical activity in ME/CFS Mitchell (2016) Low NK cell activity in ME/CFS increased by Ampligen (in vitro) Strayer, et al. (2015)