Aim Immunotech Inc. · AMEX:AIM
Aim Immunotech — Investor Presentation (September 2021)
27 slides from Aim Immunotech's investor presentation, Sep 17, 2021
Slide 1: Company Presentation September 2021
Company Presentation September 2021
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 company overview
SS AIM ImmunoTech 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. Ampligen is being evaluated as a
Slide 4: Ampligen clinical studies
+ P1 Early-Stage Triple-Negative Breast Cancer - Chemokine Modulatory Regimen plus Neoadjuvant Chemo * P1 Intranasal Administration of Ampligen in Healthy Volunteers + P1/2 Advanced Recurrent Ovarian Cancer - Chemokine Modulatory Regimen + P1/2 Advanced Recurrent Ovarian Cancer - In Combination w/Pe
Slide 5: 2021-22 planned milestones
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-CO
Slide 6: AIM's Areas of Emphasis
AIM ImmunoTech - Company Presentation - September 2021 AIM’s Areas of Emphasis —= alas NO0-oncolos,\ y
Slide 7: AIM and Immuno-oncology
AIM and Immuno-oncology AIM ImmunoTech - Company Prasontation - September 2021
Slide 8: Ampligen TLR3 pathway and mechanism in cancer
Ampligen is a selective activator of the TLR3 pathway. Ampligen has great potential as a single-agent therapeutic and may potentially enhance the performance of checkpoint inhibitors, How cana and the drug’s “mechanism of action” appears ideally suited to boost the efficacy of PD-1 and PD-L1 checkpo
Slide 9: Cancer stages and indications studied
Stage 4 Stage 4 Metastatic Triple Colorectal Cancer Negative Breast Metastatic to the Cancer Liver Early-Stage Early-Stage Triple Prostate Cancer Negative Breast Cancer AIM ImmunoTech - Company Presentation - September 2021
Slide 10: Early Access Program in late-stage pancreatic cancer
Early Access Program (EAP) with Ampligen as a Treatment in Late- Stage Pancreatic Cancer Shows Statistically Significant Increased Overall Survival Compared to Historical Controls AIM ImmunoTech - Company Presentation - September 2021 Site: Erasmus University, The Netherlands, conducted by Professor
Slide 11: Orphan Drug Designation, FDA and EMA
United States - U.S. Food and Drug Administration The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in th
Slide 12: Focus: Planned next steps for cancer therapy development
FOCUS: AIM’s Planned Next Steps for Cancer Therapy Development AIM ImmunoTach - Company Presentation - September 2021 AIM intends to narrow its focus to trials and activities that have the shortest path to FDA and EMA drug approval - in other words, to put its energy into the tasks where clinical re
Slide 13: Reduced priority for some planned trials
After internal discussions with investigators, AIM has determined that it will reduce priority at this time for some of our previously planned, but not yet initiated, trials: 1. Acolorectal carcinoma trial 2. Aproposed brain metastatic triple-negative breast cancer trial 3. Aproposed non-small cell
Slide 14: AIM and Virology
AIM and Virology AIM ImmunoTech - Company Presentation - September 2021
Slide 15: Ampligen as immuno-modulator, broad-spectrum antiviral
Ampligen is an immuno-modulator that can help the body mount a potentially broad-spectrum immune system response through the toll-like receptor 3 (TLR3) pathways, which are among the primary pathways for antiviral protection. How cana ° Ampligen does not work directly on a virus. Instead, it works s
Slide 16: Ampligen is a broad-spectrum antiviral
Ampligen is a broad-spectrum antiviral. In animal studies, Ampligen demonstrated complete protection (100% survival) against SARS- CoV-1, Ebola virus, Western Equine Encephalitis virus and Herpes Simplex virus. The SARS-CoV-2 virus - the cause of the ongoing COVID-19 pandemic - shares important and
Slide 17: Human Challenge Trial and COVID-19 in cancer patients
In addition to the planned Human Challenge Trial, AIM is working with Roswell Park Comprehensive Cancer Center on a Phase 1/2 clinical trial of Ampligen (clinicaltrials. gov/NCT04379518) to test the safety and effectiveness of Ampligen to clear the SARS-CoV-2 virus from the upper airway in patients
Slide 18: AIM and ME/CFS
AIM and ME/CFS AIM ImmunoTech - Company Presentation - September 2021
Slide 19: AIM and ME/CFS
AIM and ME/CFS Q Over 500 patients with ME/CFS have been treated in clinical trials evaluating the activity and safety of Ampligen. These safety data show Ampligen to be generally well- tolerated. Q_ Based upon Phase 2 and 3 clinical trial data, AIM received commercial approval for Ampligen in the t
Slide 20: Ampligen and COVID-induced chronic fatigue
Ampligen and COVID-Induced Chronic Fatigue (Long COVID or ‘Long Haulers’) AIM ImmunoTech - Company Presentation - September 2021 Like the SARS coronavirus epidemic before it, COVID-19 is triggering many CFS-like cases (JAMA 1, 2). The high number of younger people contracting COVID-19 suggests consi
Slide 21: Ampligen and Post-COVID-19 Cognitive Dysfunction
Ampligen and Post-COVID-19 Cognitive Dysfunction (PCCD) In August 2021, AIM filed a provisional patent application for Ampligen as both an intranasal and an intravenous therapy for Post-COVID-19 Cognitive Dysfunction (PCCD) » The people suffering from PCCD, including children and young adults, are a
Slide 22: Headquarters, facility and manufacturing plan
——— AIM’s corporate headquarters is in Ocala, Fla. The Company also owns and operates a 30,000-sq.-ft. facility in New Brunswick, N.J., and is in the process of updating the manufacturing and laboratory suites with state-of-the-art, mobile-ready equipment that can be used either there or in future a
Slide 23: Government affairs initiatives
AIM has engaged the government affairs expertise of Buchanan Ingersoll & Rooney PC to execute the company’s regulatory initiatives. We are working closely with U.S. Senate offices in New Jersey and Florida on the possibility of appropriation requests for federal grants. Our team will be focused on t
Slide 24: Patents and orphan drug status
Q AlMholds 44 patents worldwide, with 35 additional pending patent applications underway. Q Ampligen has been granted what is referred to as “orphan drug status” (ODD) for a variety of disorders in the U.S. and Europe. ODD status grants protection against potential subsequent approval of other versi
Slide 25: Executive Management Team
Executive Management Team a 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 years serv
Slide 26: Financial and Investment Highlights
| Financial and | Investment Highlights | 4 Careful cash utilization has the Company well positioned to maintain business health and | fund future growth . A strong financial balance sheet and a record of executing effective fiscal strategies Adiverse investor base OQ Aclear strategy to utilize cash
Slide 27: Share price, shares outstanding, market cap and cash
NYSE American: AIM Share Price (6/30/21) $2.16 Shares Outstanding (6/30/21) 47.8 M Market Cap (6/30/21) $103.2 M Cash, Cash Equivalents & Marketable Securities (6/30/21) $57.3 M
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