Aim Immunotech Inc. · AMEX:AIM
Aim Immunotech — 8th ESWI Influenza Conference 2021
17 slides from Aim Immunotech's conference presentation, Dec 9, 2021
Slide 1: Safety, tolerability and biological activity of repeated intranasal administration of Ampligen
Safety, tolerability and biological activity of repeated intranasal administration of Ampligen (Poly |:Poly C12U) as potential antiviral treatment in healthy subjects — preliminary results 8th ESWI Influenza Conference — virtual edition, 6 Dec 2021 Johan L. van der Plas'?, Lisanne C.A. Smidt', Alied
Slide 2: Disclosures
Disclosures « Johan L. van der Plas, Lisanne C.A. Smidt, Aliede E. in ’t Veld, Christina Yfanti, Ingrid M.C. Kamerling, Naomi B. Klarenbeek, Manon A.A. Jansen, Matthijs Moerland have nothing to declare ¢ David R. Strayer, Diane L. Young: employees of AIM ImmunoTech + Study was sponsored by AIM Immun
Slide 3: Introduction
Introduction SARS-CoV-2 * COVID-19 therapeutic arsenal limited Epon Nero Spe protein Mprten * Route of infection: upper respiratory tract - Potential target location for early local treatment or post-exposure prophylaxis wa ¢ Intranasal Ampligen® has potential as early treatment or prevention of COV
Slide 4: Innate immune signaling pathways
Innate immune signaling pathways SARS-CoV-: Long dsRNA on Short dsRNA a PRON ne Mitochondria y CHD ‘Source image: Carter-Timofte ME, Jorgensen SE, Freytag MR, Thomsen MM, Brinck Andersen N-S, Al-Mousawi A, Hait AS and Mogensen TH (2020) Deciphering the Role of Host Genetics in Susceptibility to Seve
Slide 5: Ampligen® (rintatolimod)
Ampligen® (rintatolimod) ENDOSOME * Synthetic mismatched double-stranded RNA (Poly |: Poly C12U) ¢ Molecular mimic of viral infection > activation of innate immunity * Selective TLR3 agonist > type 1 interferon production + No NFKB activation saa pee — IRFS. Type | IFNs Image adjusted from: Abouelma
Slide 6: Ampligen® pre-clinical/clinical data
Ampligen® pre-clinical/clinical data * Pre-clinical - Survival SARS-CoV-1 infected mice 100% 14 days post virus exposure! 1. Day CW, Barie R, Cai SX, et al. A new mouse-adapted strain of SARS-CoV as a lethal model for evaluating antiviral agents in vitro and in vivo. Virology. 2009;395(2):210-222. d
Slide 7: Ampligen
100 Ampligen Percent survival 3 rt C) 2 4 6 8 10 12 14 Post Virus Exposure -® Cremaphor control —*- PSS Control —® Ribavirin (75 mg/kg/day) -t- Ampligen (10 mg/kg/day: P<0.001 vs. PSS control) © Urtica doica lectin (5 mg/kg/day) ~® Protease Inhibitor (30 mg/kg/day) ‘Source image: Day CW, Baric R, Ca
Slide 8: Ampligen® pre-clinical/clinical data
Ampligen® pre-clinical/clinical data Pre-clinical - Survival SARS-CoV-1 infected mice 100% 14 days post virus exposure! - Invitro direct antiviral effect against SARS-CoV-2 in human tracheal/bronchial epithelial cells? Clinical - Systemic: clinical trials for several indications (malignancies, chron
Slide 9: Study design
Study design Randomized, double-blind, placebo-controlled, dose-escalation study Healthy subjects (18-70 yr, male/female) Exclusion criteria: recent/current respiratory tract infection, nasal abnormalities, smoking, active allergic or chronic rhinitis Ampligen intranasally every other day (q.o.d.) f
Slide 10: Safety and tolerability of intranasal rintatolimod q.o.d. for 13 days
Safety and tolerability of intranasal rintatolimod q.o.d. for 13 days * Adverse events (AE) + Laboratory values * Solicited local AEs (upper respiratory * Physical examination symptoms) + Integrity of nasal mucosa (anterior + Nasal pain rhinoscopy) + Vital signs Pharmacodynamic endpoint: nasal mucos
Slide 11: Simplified study schedule
Simplified study schedule Nasal swab PCR resp viruses Treatment period Day 3 Day 5 2 ‘, aff Intranasal * ' ‘ . * ™ ' . administration Ce) Mucosal lining fluid (cytokines) - x! lin | x i a i x x i nasosorption = Mucosal immune cells - 1 x x | x x x x x a 2 nasal scrape Safety and local tolerability m
Slide 12: CHDR
CHDR Enrollment a ‘ § = < Analysis Assessed for eligibility (n= 85) Excluded (n=45) + Not meeting inclusion criteria (n=34) + Withdrawal of consent (n=2) + Logistical reasons (n=9) Randomized (n=40) v | t Vv Vv Rintatolimod Rintatolimod Rintatolimod Rintatolimod Placebo (n=8) 75ug (n=8) 200g (n=8) 5
Slide 13: Baseline characteristics
Baseline characteristics * Total: 40 subjects, median age 24 (18-69), 40% male Rintatolimod Placebo 75yug 200ug 500ug 1250 ug N 8 8 8 8 8 Age - median (range) _22(18-33) 24(20-69) 29(19-58) 25(20-51) 23(19-37) Male — N (%) 3 (38%) 4 (50%) 2 (25%) 4 (50%) 3 (38%) CHDR
Slide 14: Safety and Tolerability
Safety and Tolerability Rintatolimod dose administered Total (all 4 ie a 75ug 200 ug 500 ug 1250 ug __ dose levels) iverse events a ae . cot Number of AEs (in % of subjects) No safety or tolerability findings of clinical Darcie . : Gleaa) PERS) FCS concern B| Mild = - 6 (25%) 1 (13%) 7 (9%) 3 | | Mo
Slide 15: Pharmacodynamic outcomes: mucosal immune response
Pharmacodynamic outcomes: mucosal immune response Analysis still pending, results expected soon CHDR
Slide 16: Conclusions
Conclusions ¢ Intranasal Ampligen® q.o.d. for 13 days (7 doses) well tolerated + Analysis of mucosal immune response expected soon * Pending pharmacodynamic analyses in this phase | trial to provide early mechanistic insight in pharmacodynamic effect May aid in dose selection for future trials * Saf
Slide 17: Acknowledgements
Acknowledgements CHDR Centre for Human Drug Research Matthijs Moerland Naomi Klarenbeek Ingrid de Visser-Kamerling Manon Jansen Christina Yfanti Johan van der Plas Eveline In ‘t Veld Sarina de Jonge Annemarie Hoogeboom Alexa Tibboel Study nurses Screening physicians Recruitment officers Data entry o