Aim Immunotech Inc. · AMEX:AIM
Aim Immunotech — Investor Presentation (July 2021)
27 slides from Aim Immunotech's investor presentation, Jul 14, 2021
Slide 1: Company Presentation July 2021
Company Presentation July 2021
Slide 2: Executive Management Team
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 years serv
Slide 3: 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 4: AIM ImmunoTech
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 5: Ampligen is being studied in multiple clinical settings
+ 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 Pp ; [ M n *P1/2 Advanced Recurrent Ovarian Cancer - In Combin
Slide 6: 2021-22 Key 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 an FDA Phase 2 Clinical Trial of Ampligen as a therapy for patients with Long COVID Ini
Slide 7: AIM's Areas of Emphasis
AIM’s Areas of Emphasis —= alas NO0-oncolos,\ y AIM ImmunoTech - Company Presentation - July 2021
Slide 8: AIM and Immuno-oncology
AIM and Immuno-oncology AIM ImmunoTech - Company Presentation - July 2021
Slide 9: Ampligen as a selective activator of the TLR3 pathway
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 10: Ampligen cancer indications studied
AIM Imm Early-Stage Prostate Cancer wunoTach - Company Presentation - July 2024 Stage 4 Stage 4 Metastatic Triple Colorectal Cancer Negative Breast Metastatic to the Cancer Liver Early-Stage Triple Negative Breast Cancer 10
Slide 11: Ampligen Treatment of Advanced Pancreatic Cancer
Ampligen Treatment of Advanced Pancreatic Cancer Increased Survival Compared to Historical Controls Site: Erasmus University, The Netherlands, conducted by Professor Casper van Eijck Eligibility: Adults with metastatic or locally advanced pancreatic carcinoma following FOLFIRINOX Survival Data: Q Me
Slide 12: 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 13: AIM's Planned Next Steps for Cancer Therapy Development
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 results suggest an opportunity for expedited success. These potential trials would FE O ( U S e be AIM-sponsored and AIM
Slide 14: Reprioritization of previously 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 15: AIM and Virology
AIM and Virology AIM ImmunoTech - Company Presentation - July 2021
Slide 16: Ampligen as an immuno-modulator via TLR3 pathways
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 17: 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 18: Human Challenge Trial and Roswell Park COVID-19 trial
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 w
Slide 19: AIM and ME/CFS
AIM and ME/CFS AIM ImmunoTech - Company Presentation - July 2021
Slide 20: AIM and ME/CFS
AIM and ME/CFS Q Over 200 patients with ME/CFS have been treated in randomized, double-blinded, placebo-controlled 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 comm
Slide 21: Ampligen and COVID-Induced Chronic Fatigue (Long COVID)
Ampligen and COVID-Induced Chronic Fatigue (Long COVID or ‘Long Haulers’) AIM ImmunoTech - Company Presentation - July 2021 Oo 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 conside
Slide 22: Headquarters and manufacturing facilities
——— 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 34 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: 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 4 Astrong financial balance sheet and a record of executing effective fiscal strategies Adiverse investor base OQ Aclear strategy to utilize cash resourc
Slide 26: Share Price (6/30/21)
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 (3/31/21) $63.6 M
Slide 27: 2021-22 Key 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 an FDA Phase 2 Clinical Trial of Ampligen as a therapy for patients with Long COVID Ini