Slide 1: Investor Presentation Q1 2023
NYSE American: AIM aimimmuno.com Investor Presentation 1 Q1 2023
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: Investor Highlights
Investor Highlights 1 Important Clinical Asset Ampligen® - Fueling a Broad Pipeline in Multiple Indications Late-stage clinical immuno-pharma company focused Disease Areas on developing therapeutics across a number of disease areas 3 Immuno-Oncology | Immune Disorders | Viral Diseases Our lead progr
Slide 4: Broad Pipeline Across Multiple Unmet Needs
Broad Pipeline Across Multiple Unmet Needs Priority Development Programs Indications Approach Preclinical Phase 1 Phase 2 Phase 3 Highlights Locally Advanced Ampligen® Following First Patient Expected in Q1 2023 Pancreatic Adenocarcinoma FOLFIRINOX Early Access Program Single Agent Early Access Prog
Slide 5: Lead Program Ampligen (rintatolimod)
Lead Program Ampligen® (rintatolimod) Unique amongst TLR agonists in its mechanism of action, specificity and safety profile Induces wide range of As a TLR3 agonist it activates the TRIF adaptor pathway, which avoids the systemic inflammatory immunologic / antitumor MyD88 pathway used by all other T
Slide 6: Ampligen Has Significant Opportunity Across High-Value Multiple Disease Areas
® Ampligen Has Significant Opportunity Across High-Value Multiple Disease Areas ~100,000 Clinically Demonstrated Demonstrated clinical potential IV doses in humans, / encouraging results in multiple generally well-tolerated Disease preclinical models and clinical Area Focus studies Positive Phase 3
Slide 7: Our Oncology Programs
Our AIM Oncology Programs Immuno-Therapy Targeting Multiple Cancers with High-Unmet Need 7
Slide 8: Ampligen: Mechanism in Oncology
Ampligen®: Mechanism in Oncology Reprogramming of the Tumor Microenvironment to Convert “Cold” Tumors Into “Hot” Tumors that will be Responsive to Checkpoint Blockage Goal is to unleash the cellular immune response to attack and destroy cancer cells and increase survival1 ↑ Intratumoral Teff Cells A
Slide 9: Ensuring Effective Chemokine Modulation in Tumors
Ensuring Effective Chemokine Modulation in Tumors is Important for Teff Cell Infiltration and Increased Survival + High levels of CXCL10 in tumors is associated with enhanced infiltration of CTLs (Teff) cells and increased survival in - In contrast, high levels of CCL22 which preferentially attracts
Slide 10: Pancreatic Cancer Market Opportunities
Pancreatic Cancer Market Opportunities 62,210 New Cases Annually1 49,830 Deaths Annually1 10 1. National Cancer Institute: Surveillance, Epidemiology and End Results - Ovarian Cancer; Pancreatic Cancer; Breast Cancer; Melanoma
Slide 11: Promising Results From Early Access Program Published in Cancers
Pancreatic Promising Results From Early Access Cancer Program (EAP) Published in Cancers Statistically Significant Increased Overall Survival Compared to Historical Controls in Treatment of Late-Stage Pancreatic Cancer Site: Erasmus University, The Eligibility: Adults with metastatic Netherlands, co
Slide 12: Ampligen Maintenance Therapy after FOLFIRINOX Improves Survival
Pancreatic Ampligen® Maintenance Therapy after FOLFIRINOX Cancer Improves Overall and Progression-Free Survival Progression-free survival Overall survival 100 100 Ampligen Ampligen Subset matched controls Subset matched controls PFS (%) OS (%) 50 50 p=0.0069 p=0.0157 0 0 0 12 24 36 0 12 24 36 48 Tim
Slide 13: Long-Term Survivors Exhibit Decreased SIII and NLR
Pancreatic Long-Term Survivors Exhibit Decreased SIII Cancer and NLR as well as Increased B-Cell Counts (A) (B) (C) SIII NLR B-Cells Systemic Immune Inflammation Index 5000 15 Neutrophils to Lymphocytes Ratio 800 4000 Counts per microLiter 600 10 3000 400 2000 5 200 1000 0 0 0 13 A. Systemic immune
Slide 14: Pancreatic Cancer Clinical Activity
Pancreatic Cancer Pancreatic Cancer Clinical Activity Locally Advanced Pancreatic Early Access Investigator Phase 2 Late-Stage Pancreatic Cancer Metastatic Pancreatic Ductal Adenocarcinoma Initiated Program Adenocarcinoma Program Status Study Launch Expected in Q1 2023 Status Early Access Program On
Slide 15: Additional Target Oncology Indications Represent Significant Unmet Need
Additional Target Oncology Indications Represent Significant Unmet Need Ovarian Cancer Breast Cancer Colorectal Cancer Melanoma Market Opportunities Market Opportunities Market Opportunities Market Opportunities 19,880 287,850 151,030 99,780 New Cases Annually1 New Cases Annually1 New Cases Annually
Slide 16: Additional Ongoing Oncology Development Programs
Additional Ongoing Oncology Development Programs Advanced, Recurrent Interim Data Published April 2022 Study Details: NCT02432378; Phase 1/2 Ovarian Cancer (NCT02432378) NCT03734692 Metastatic Triple Negative Phase 1 Data Published April 2022 Study Details: NCT03599453 Breast Cancer Early-Stage Trip
Slide 17: Our Immune System Disorder Programs
Our AIM Immune System Disorder ME/CFS | Long COVID 17
Slide 18: Ampligen for the Treatment of ME/CFS
Ampligen® for the Treatment of ME/CFS Myalgic Encephalomyelitis (Chronic fatigue syndrome or ME/CFS) Approved for the treatment of Complex chronic disease that presents with Severe CFS in Argentina symptoms in multiple body systems Only late-stage program in development Symptoms include problems wit
Slide 19: Ampligen as a Potential Treatment of ME/CFS
Ampligen® as a Potential Treatment of ME/CFS Positive Results from Phase 3 Study Demonstrated Significant Improvement in the Primary Endpoint, Exercise Treadmill Tolerance (ETT) 60.0% 51.2% 50.0% 39.0% 40.0% p=0.0131 p=0.0031 p=0.511 (∆=15.9%) (∆=33.6%) 30.5% (∆=4.8%) 30.0% Ampligen 25.7% 23.1% Plac
Slide 20: Ampligen as a Potential Treatment of Post-COVID Conditions
Ampligen® as a Potential Treatment of Post-COVID Conditions Chronic Illness Following COVID-Induced Chronic Fatigue COVID-19 Shares Similar Phase 2 Study (Post-COVID Conditions or ‘Long Haulers’) Characteristics to ME/CFS Status Study Launch Expected Q1 2023 ! Number of Subjects Up to 80 Fatigue Bra
Slide 21: Our Viral Disease Programs
Our AIM Viral Disease Programs SARS-CoV-2 (COVID-19) 21
Slide 22: Ampligen as a Potential Treatment of SARS-CoV-2
Ampligen® as a Potential Treatment of SARS-CoV-2 Ampligen Demonstrated 100% Survival in SARS-CoV Infected Mice 100 Potentially broad-spectrum immune system 90 response against SARS-CoV-2 (COVID-19) 80 70 Percent survival Uniquely targets TLR3 without activation of 60 the inflammatory cytosolic helic
Slide 23: Ongoing Phase 1/2 Study for Treatment of COVID-19 in Cancer Patients
Ongoing Phase 1/2 Study for Treatment of COVID-19 in Cancer Patients Phase 1/2 COVID-19 in Cancer Patients Status Recruiting Number of Subjects Up to 64 Study Drug Ampligen® and IFN alpha-2b Primary Endpoint Incidence of AEs, Kinetics of Viral Load Study Partner Roswell Park Clinical Trials NCT# NCT
Slide 24: Our Corporate Overview
Our AIM Corporate Overview 24
Slide 25: Intellectual Property Portfolio – Market Exclusivity
Intellectual Property Portfolio – Market Exclusivity 44 7 year market exclusivity following FDA approval Ampligen® 10 year market exclusivity following EMA approval Patents Worldwide 39 U.S. – pancreatic cancer, melanoma, ME/CFS, renal Indications cell carcinoma, AIDS Europe – pancreatic cancer, Ebo
Slide 26: Financial Snapshot
Financial Snapshot Sufficient Capital to Fund Operations Through End of 2023 and Multiple Key Clinical Milestones ~$37M ~$25M Cash, Cash Equivalent and ~203K 48M Marketable Securities1 Market Cap2 Average Volume2 Shares Outstanding3 26 1: As of September 30, 2022; 2: As of February 28, 2023 with a c
Slide 27: Proven Management Team
Proven Management Team Thomas K. Equels, M.S., J.D. Chief Executive Officer David R. Strayer, M.D. Chief Scientific & Medical Officer Peter W. Rodino III, J.D. Rodino Consulting; Rodino & Rodino; Chief Operating Officer, Executive Director for Governmental Rodino & Scalera Inc.; Relations, General C
Slide 28: 2023 Milestones
2023 Milestones Publications for pipeline data expected throughout 2023 Q1 Q2 Q3 Q4 Post-COVID Conditions Locally Advanced Pancreatic Advanced Recurrent Ovarian Metastatic Pancreatic Cancer Commence Phase 2 study Cancer Cancer Begin clinical trial Locally Advanced Pancreatic Dose first patient in Ph
Slide 29: Investment Summary
Investment Summary Advancing Lead Program Ampligen®, for the Potential Treatment of Multiple High-Value Oncology, Viral and Immune-System Disorders Indications Demonstrated safety and Approved for the potential clinical benefit in Multiple value-driving treatment of severe milestones expected over m
Slide 30: Thank you!
NYSE American: AIM aimimmuno.com Thank you! 30