Aim Immunotech Inc. · AMEX:AIM
Aim Immunotech — Investor Presentation (January 2022)
34 slides from Aim Immunotech's investor presentation, Jan 27, 2022
Slide 1: Ampligen: A General Overview and the Plan for ME/CFS and Long COVID
Dal M Immunology for a Better Future ImmunoTech ad = we aaa :Ampligen: A General Overview and the:Plan for 2 "elVIE/GES and Long,Covid i ay
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, AIM claims the protection of safe harbor for forward-looking statements contained in the Priva
Slide 3: Ampligen (Rintatolimod) is a Broadly Applicable Immune Therapy
Ampligen (Rintatolimod) is a Broadly Applicable Immune Therapy e Ampligen is a broadly applicable immune therapy that has the potential to be used in a wide range of indications e Generally well-tolerated with over 100,000 IV doses in humans ¢ Ampligen has Orphan Drug Status in Myalgic Encephalomyel
Slide 4: Ampligen (Rintatolimod) Development Pipeline
Ampligen (Rintatolimod) Development Pipeline = oes : nieve rr ign! Ga Myalgic Encephalomyelitis/ Argentina Chronic Fatigue Syndrome* 8 Ovarian, Colorectal, Renal Cell Carcinoma*, Prostate, e @ @ and Melanoma* Cancers Breast Cancer e e Pancreatic Cancer 8 e Bladder Cancer e Vaccine Adjuvant (Influenz
Slide 5: Clinical Safety Profile Related to Molecular Structure
Clinical Safety Profile Related to Molecular Structure of Ampligen (Poly I: Poly C,,U) Mis-paired regions of base pair hydrogen bonding accelerate chain hydrolysis while preserving biological activity Decreased toxicity and improved safety compared to the absence of mis-pairing No development of ant
Slide 6: Drug Product Characteristics
Drug Product Characteristics Ampligen (Poly I : Poly C,,U) 6 Preparation: Liquid ready for Infusion ° Routes of Administration: intravenous (IV) infusion (over 30 minutes), intraperitoneal (IP), and intranasal (IN) e Half-life: approximately 40 minutes (IV) ° Dose regimen: 400 mg twice weekly (IV) e
Slide 7: Ampligen Exposure
Ampligen Exposure e Ampligen has been generally well-tolerated in clinical trials enrolling: — >1200 patients total (all indications) — >800 patients with CFS, and — Over 100,000 doses administered: no drug related deaths, no treatment emergent clinical or lab evidence of new autoimmune signals — >2
Slide 8: Ampligen (Rintatolimod) Mechanism of Action
Ampligen (Rintatolimod) Mechanism of Action Oe Ampligen is unique amongst TLR agonists in its mechanism of action, specificity and safety profile Only TLR to exclusively activate the TRIF adaptor and avoids the more inflammatory MyD88 pathway used by all other TLR agonists Ampligen is the only TLR3
Slide 9: The Immunological Activity of Ampligen has been Demonstrated in a Wide Body of Literature
The Immunological Activity of Ampligen has been Demonstrated in a Wide Body of Literature Immunological Activity Reference(s)* Only TLR3 agonist to promote selective attraction of CTLs (Teff) Theodoraki, et al. (2018) with concomitant increase in Teff/Treg ratio in the TME Ampligen induces desirable
Slide 10: The Immunological Activity of Ampligen has been Demonstrated in a Wide Body of Literature — cont'd
The Immunological Activity of Ampligen has been Demonstrated in a Wide Body of Literature — cont’d ical Activity Reference(s)* Induces dendritic cell maturation: Enhances bioactivity of cancer Nicodemus, et al. (2010) immunotherapy Promotes optimal dendritic cell maturation and Th1-type Navabi, et a
Slide 11: Overview of Chronic Fatigue Syndrome
Overview of Chronic Fatigue Syndrome ° Severely debilitating, progressive disease ° Effects multiple organ systems - >1 million diagnosed cases in U.S. - ™~60-80% severely afflicted (~700,000) ¢ CDC: Chronic Fatigue Syndrome (CFS) is as debilitating as Multiple Sclerosis (MS), Systemic Lupus Erythem
Slide 12: Overview of Ampligen's Safety Profile
Overview of Ampligen’s Safety Profile e Administered by intravenous (IV) infusion over 30 to 60 minutes e Generally well-tolerated e Extensive exposure to drug (>600 patient treatment years), including two placebo-controlled pivotal studies e Favorable safety profile overall and specifically for the
Slide 13: Clinical Safety Record of Ampligen (dsRNA)
Clinical Safety Record of Ampligen (dsRNA) e The Ampligen serious adverse event (SAE) profile shows no difference compared to placebo e An FDA CFS Advisory Committee voted in favor of its clinical safety for commercial use e No evidence of autoimmunity in >100,000 drug administrations 13) Oe
Slide 14: AMP 516 & AMP 516: No Significant Difference in SAEs
AMP 502 & AMP 516: No Significant Difference in the Number or Relationship of SAEs to Study Drug as Determined by Blinded Investigators Relationship Number of Serious Adverse Events to Study Drug Ampligen Placebo Not Related 16 16 Remote 4 3 Possible 2 2 Probable 0 1 Definite 0 0 Total 22 22 Note: D
Slide 15: All SAEs in the Ampligen CFS Program
All SAEs in the Ampligen CFS Program — No Significant Difference’ Between Ampligen and Placebo Groups in Relationship of SAEs to Study Drug All CFS Studies? Ampligen Group Placebo Group ™@ 1=None ~ 2=Remote ™ 3=Possible @ 4=Probable @ 5=Definite Percent of Patients with 7.7% <—— SAEs —> 8.6% 1Fisher
Slide 16: Safety Findings from Two Well-Controlled Pivotal Studies (502 and 516)
Safety Findings from Two Well-Controlled Pivotal Studies (502 and 516) Oe No Evidence of new Autoimmune Disease No Evidence for Induction of Autoantibodies No Increase of Treatment Emergent Depression or Suicide Attempts No Increase Incidence of Cancer 5.6 % increase in SGOT (AST) or SGPT (ALT) >3 t
Slide 17: Overview of Ampligen's Efficacy in ME/CFS
Overview of Ampligen’s Efficacy in ME/CFS 1. Phase Ill Study (AMP-516) ¢ Primary endpoint: Exercise Treadmill Tolerance (ETT) was met ¢ 25% increase in ETT is clinically meaningful ¢ Greater percentage of Ampligen patients increased ETT by 225% than placebo ¢ Concomitant medication use was decreased
Slide 18: AMP-516 Phase III Study Design
AMP-516 Phase Ill Study Design Randomized, Placebo-controlled 40 weeks of Double-Blinded Treatment (Stage 1) Ampligen Dose = 400 mg or placebo * Twice weekly IV infusions « Primary Endpoint: Exercise Treadmill Tolerance (ETT) ° The two exercise strata ($9 vs. >9 minutes) were pre-declared subsets fo
Slide 19: AMP-516 Primary Efficacy Endpoint: Change from Baseline in Mean ETT Duration
AMP-516 Primary Efficacy Endpoint: Change from Baseline in Mean ETT Duration at Week 40 is Statistically Significant for the ITT Population Week Exercise Duration Mean seconds Ampligen Increase from Baseline seconds Ampligen Improvement Over Placebo seconds Baseline 40 576.3 n=100 672.0 616.3 n=100
Slide 20: AMP-516: Baseline ETT Stratification Added to the ANCOVA Model
AMP-516: Baseline ETT Stratification Added to the ANCOVA Model Week 40 Minus Baseline (ITT Population) Statistic Ampligen Placebo Number of Patients n=100 n=108 Mean Change (seconds) 95.65 28.25 Paired-difference t-test <0.001 0.20 ANCOVA Untransformed Data p=0.047 ANCOVA with 9 Minutes in p=0.033*
Slide 21: Increase in Placebo-Adjusted Intra-Group Mean ETT Duration with Ampligen
Increase in Placebo-Adjusted Intra-Group Mean ETT Duration with Ampligen: the ITT and Pre-Declared Subsets Shows Greater Improvement with Ampligen Increase from Improvement Efficacy Population (ETT) Baseline - seconds Over Placebo | p-value Ampligen | Placebo -seconds ITT Populati opu aver 0.0471 (F
Slide 22: AMP-516 Met Primary Endpoint: Exercise Treadmill Tolerance (ETT)
AMP-516 Met Primary Endpoint: Exercise Treadmill Tolerance (ETT) e Statistical Significance - ANCOVA untransformed Data p=0.047 ANCOVA with Baseline <9 minutes and >9 minutes included in the model p=0.033 22
Slide 23: AMP-516: Clinical Relevance of at Least a 25% Increase in ETT
AMP-516: Clinical Relevance of at Least a 25% Increase in ETT from Baseline. Greater Improvement with Ampligen Compared to Placebo 45 p=0.0131 p=0.004! 39.0% (1.69 Fold Increase) (2.75 Fold Increase) Ampligen | Placebo Ampligen Percent of Patients ITT Population Baseline >9 Minute Population 1 Proba
Slide 24: Continuous Analysis of 5% Response Increments Shows a Sustained Ampligen Effect
Continuous Analysis of 5% Response Increments Shows a Sustained Ampligen Effect at Each Interval from 225% to 250% and Illustrates the Robustness of the Results for the AMP-516 (ITT) (n=208) Week 40 p=0.013 =0.018 35 . p=0.037 p=0.023 30 p=0.032 p=0.028 25 20 @ Improved Ampligen 15 ™ Improved sal Pl
Slide 25: Dichotomizing the Ampligen Treated ITT Population Based on Clinical Improvement
Dichotomizing the Ampligen Treated ITT Population Based on Significant Clinical Improvement (225%) at Week 40 in ETT Duration Shows There is Corresponding Clinically Significant Improvements in Secondary Endpoints, KPS and Vitality (SF-36) for the 225% ETT Improving Ampligen Cohort Secondary Endpoin
Slide 26: AMP-516: Ampligen Treated Patients by ETT Response
AMP-516: Ampligen Treated Patients by ETT Response (225% vs. <25%) Comparison of Change from Baseline in Vertical Rise During ETT at Week 40 for ITT Population 7. Flights of Stairs Vertical Feet (Week 40 — Baseline) LS is) Mean Increase in Equivalent Rise in ITT Population? 1 In the ITT population,
Slide 27: Identification of a Subset of AMP-516 CFS Patients with Twice the Response Rate
Identification of a Subset of AMP-516 CFS Patients with Twice the Response Rate with Regard to the Primary Endpoint Exercise Treadmill Tolerance (ETT) Compared to the ITT Population 27
Slide 28: Definition of the AMP-516 Target Subset
Definition of the AMP-516 Target Subset (n=75) Target Population consists of the subset of the AMP-516 ITT Population (n=208) with: 1. Onset of symptoms of CFS between 2 and 8 years before enrollment into the trial 2. Post-exertional malaise (PEM) lasting 224 hours 3. Ability to walk on moving tread
Slide 29: Definition of Non-Target Subset (n=133)
Definition of Non-Target Subset (n=133) Non-Target Population consists of the subset of the AMP-516 ITT Population that did not meet the definition of the Target Subset. Note: Total ITT Population (n=208). C—O 29
Slide 30: AMP-516: Percent of Patients with at Least a 25% Increase in ETT
AMP-516: Percent of Patients with at Least a 25% Increase* in ETT from Baseline; Greater Improvement with Ampligen Compared to Placebo 60 51.2% 50 | — - = p=0.0131 p=0.0031 =0.541 a 39.0% (A=15.9%) (A=33.6%) (A=4.8%) 30 20 Percent of Patients 10 ITT Population Target Subset Non-Target Subset 1 p-val
Slide 31: Ampligen (rintatolimod) for CFS: Summary
Ampligen (rintatolimod) for CFS: Summary ¢« Ampligen (rintatolimod) is the only investigational drug treatment for CFS which has completed two pivotal Clinical trials and has an active CFS NDA with FDA ¢ Has Orphan Drug Designation for CFS and an ongoing Treatment Protocol (CFS) authorized by the FD
Slide 32: Post-COVID Conditions
Post-COVID Conditions* ¢ Other names for Post-COVID Conditions ¢ Long COVID ° Long-haul COVID - Post-acute COVID-19 ° Long-term effects of COVID * Chronic COVID * CDC Website September 16, 2021 Post Covid Conditions C—O 32
Slide 33: Post-COVID Conditions
Post-COVID Conditions* ¢ Characteristics of Post-COVID Conditions ° Most people with COVID-19 get better within weeks of illness onset ° However, some experience “Post COVID Conditions” ° Even asymptomatic people with COVID-19 can develop Post-COVID conditions * CDC Website September 16, 2021 Post C
Slide 34: What are Post-COVID Conditions?
What are Post-COVID Conditions? e« Post-COVID conditions are a wide range of new ongoing health problems experienced four or more weeks after the initial infection with the SARS- CoV-2 virus e Current list of CDC Post-COVID Conditions: © Difficulty breathing or shortness of o Joint or muscle pain br
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