Slide 1: Oncology Presentation
aimimmuno.com NYSE American: AIM S AIM ImmunoTech Oncology Presentation
Slide 2: Forward Looking Statements
Forward Looking Statements ‘Some of the statements included in this presentation may be forward-looking statements that involve @ 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 Privat
Slide 3: Ampligen (Rintatolimod) Highlights
Ampligen (Rintatolimod) Highlights Combination Broadly applicable immune therapy with the Immuno- Therapy Phase I/II potential to be used in a wide range of indications Oncology |_ single Agent EAP Six Orphan Drug indications (Pancreatic cancer (EU and US), Chronic Fatigue Syndrome (CFS), Phase Ill
Slide 4: Ampligen (Rintatolimod) in Immuno-Oncology
Ampligen (Rintatolimod) in Immuno-Oncology Pre-clinical data demonstrates Ampligen’s ability to boost the activity of PD-1/PD-L1 checkpoint Investigated in a variety of cancers as either a standalone agent or in combination with chemotherapeutics Pancreatic cancer clinical program underway in Europe
Slide 5: Priority Oncology Pipeline
Priority Oncology Pipeline Indications Approach Preclinical Phase1 Phase 2 Highlights Pancreatic: ‘Ampligen® following Patient Recruitment Underway Locally Advanced Adenocarcinoma | FOLFIRINOX 1 Patient Enrolled Expected 2023 pancreas Single Agent Early Access Program Late-Stage; Early Access Progra
Slide 6: Clinical Safety Record of Ampligen (dsRNA)
Clinical Safety Record of Ampligen (dsRNA) Generally well-tolerated, with | Serious adverse event (SAE) —_— FDA Advisory Committee approximately 100,000 IV doses | profile shows no clinically Pantolranianity voted in majority that the administered in humans significant differences safety profile of
Slide 7: Ampligen (Rintatolimod) Mechanism of Action
Ampligen (Rintatolimod) Mechanism of Action Unique among 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 “4 a e5 which avoids the systemic inflammatory MyD88 immunologic / antitumor pathway used by
Slide 8: 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 Only TLR3 agonist to promote selective attraction of CTLs (Teff) with concomitant reduction in Treg attraction in the TME Increases Natural Killer (NK) cell activity Phase I/II colorectal
Slide 9: 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 Immunological Activity Promotes optimal dendritic cell maturation and Th1-type responses of healthy donors and cancer patients Induces epitope spreading and cross-protective immunity in mice Increases
Slide 10: Increased IL-12, HLA Class and II, CD83, CD86, CD40, CCR7
Increased IL-12, HLA Class 1 and II, CD83, CD86, CD40, CCR7 = —_—— — cD14_— CD86 Class CD40 " pe 2, ots] [8 03% | [8 96% | 51% | — Isotype # E120 — Antibody ‘Class | i Bice. ol eh, goo SioaTET| [NTO | [oso : be AAAI naa 5 Phenotypic maturation of DC treated with poly(I:C, U}: Immature monocyte- sy d
Slide 11: Ampligen Induces Dendritic Cell Maturation and Enhances T-cell Activation
un Ampligen Induces Dendritic Cell Maturation and Enhances T-cell Activation OTNF@/IEN«. 1m PolylC,,U lil LS LAO AZ (p70) IFNy = MCP-4 MP4 TNFa Above: Supernatants from dendritic cell cultures that were matured with polyl:C,,U (25 ug/ml) or TNF-a/IFN-a. were assayed for a panel of cytokines by Multi
Slide 12: Ampligen Increases NK and Mφ Activity
Ampligen Increases NK and Mé Activity NK Activity Mo antitumor activity * * | | 0 1 2 4 8 % Lysis LL target 86s * * * * ° 1 2 4 8 Ampligen (mg/kg) Ampligen (mg/kg) Dose - response effect of Ampligen on splenic NK activity and peritoneal Md antitumor activity. * p < 0.05 in https://doi.org/10.1016/01
Slide 13: Early Pre-Clinical and Clinical Studies Indicated the Potential of Ampligen in Oncology
Early Pre-Clinical and Clinical Studies Indicated the Potential of Ampligen in Oncology Human Tumor Xenografts Show Bladder Carcinoma, Melanoma, Antitumor Activity of Ampligen in — genai cell Carcinoma (RCC) Nude Mouse Models B
Slide 14: Early Pre-Clinical and Clinical Studies Indicated the Potential of Ampligen in Oncology
Volume of Right Axillary Tumor Mass 4 Sam Early Pre-Clinical and Clinical Studies Indicated the Potential of Ampligen in Oncology Melanoma 30-28 5 Days on Ampligen Source: Strayer DR, unpublished data 50 Partial Response Complete Response Ampligen (300mg twice weekly) eee 5 Renal Cell Carcinoma Resp
Slide 15: Recent Pre-Clinical Advances of Ampligen
Recent Pre-Clinical Advances of Ampligen Melanoma Ampligen + Anti PD-L1 15 as Pancreatic Cancer Ampligen + Anti PD-L1 Colorectal Carcinoma Ampligen + Anti PD-1.
Slide 16: Ampligen Induced Anti-Tumor Synergy with Checkpoint Blockage
Ampligen Induced Anti- Tumor Synergy with Checkpoint Blockage* Synergistic with anti-PD-L1, yielding an increased anti-tumor response in a B16 mouse melanoma model _~»~ Addition of Ampligen to anti-PD-L1 increased the objective LV, response rate 3-fold, from 10% with anti-PD-L1 alone to 30% with ~~
Slide 17: Synergistic Effects in Combination with Checkpoint Inhibitor, Anti-PD-L1
Synergistic Effects in Combination with Checkpoint Inhibitor, Anti-PD-L1 Synergistic Increase in Median Survival Percent survival 1004 Ea = Gated! > Control ~ alae oy moro 3 ol 5 x é ° sate ao > oa oof dps catenge Noo day postenaenge — cont 156 Anth-PD-LL+Amp_ 2 2 oy Bs : é 4 160 tbo No.of days post
Slide 18: Increase in Median Survival Combining Ampligen with Anti-PD-1
Increase in Median Survival Combining Ampligen® with Anti-PD-1 UPMC LIFE CHANGING MEDICINE 100 —@>- Ampligentanti-po-1 80 =O Anti-po-1 -O- control 3 zg 0 5 a = g 40 é 20 ° ° 20 40 60 20 Days 18 Sam
Slide 19: Recent Clinical Advances of Ampligen in Oncology, Immuno-Oncology, and Checkpoint Blockade Therapy
Recent Clinical Advances of Ampligen in Oncology, Immuno-Oncology, and Checkpoint Blockade Therapy FOLFIRINOX followed by Ampligen + ‘Ampligen + Celecoxib Ampligen + ‘Ampligen + NCTO3899987) | (NCTO4093323) Ampligen in metastatic Celecoxib + Intron- +Intron-A + Celecoxib + Intron-A Celecoxib + Intro
Slide 20: Objectives of These Studies
Objectives of These Studies 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 survival 4 Intratumoral Teff Cells WV Intr
Slide 21: Ensuring Effective Chemokine Modulation in Tumors
Ensuring Effective Chemokine Modulation in Tumors is Important for Teff Cell Infiltration and Increased Survival + |e In contrast, high levels of CCL22 x associated with enhanced infiltration of eR Ore rental etisera aia Va CTLs (Teff) cells and increased survival in 2 Y es _—_— is associated with r
Slide 22: Metastatic Triple Negative Breast Cancer
Metastatic Triple Negative Breast Cancer CKM (Ampligen + Intron-A + Celecoxib) Followed by Pembrolizumab (NCT03599453) Waterfall Plot Swimmer’s Plot igo Best Response IPD MSD oly x 19 Increase in non-target lesions 024 % io **PD per RECIST v1.1, continued z = 100 tohave partial response later Sos GS
Slide 23: Advanced Recurrent Ovarian Cancer
Advanced Recurrent Ovarian Cancer IP cisplatin with IV pembrolizumab and IP Ampligen Phase Il, single arm, efficacy/safety trial (NCT03734692) Percent Survival Months until progression —L— Responders —L_ Nonresponders 40 Evaluable Response Progression 38% "Complete = Partial Stable = Progression
Slide 24: Promising Late-Stage Pancreatic Cancer Results From Early Access Program
Promising Late-Stage Pancreatic Cancer Results From Early Access 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 es Eligibility: Adults with metastatic N
Slide 25: Ampligen Maintenance Therapy after FOLFIRINOX
Ampligen Maintenance Therapy after FOLFIRINOX Improves Overall and Progression-Free Survival 100: —L= Rintatolimod —L— subset matched controls —L— Rintatolimod —L— Subset matched controls 0 2 24 36 43, 0 2 24 36 Time in months since start FOLFIRINOX Time in months since start FOLFIRINOX Study popula
Slide 26: Long-Term Survivors Exhibit Decreased SIII and NLR as well as Increased B-Cell Counts
Long-Term Survivors Exhibit Decreased SIII and NLR as well as Increased B-Cell Counts 26 am sill ) Neutrophils to Lymphocytes Ratio 8 3 g oe > oe Systemic Immune Inflammation Index NLR B-Cells 800 EB 3m y § 400 a i 8 200 é * Pipe ¥ ¢ og SF € § & & e we ‘elHaddaoui Cancers 2022, 14, 1377. https {(n=8
Slide 27: Upcoming Oncology Trials of Ampligen
Upcoming Oncology Trials of Ampligen 27 Phase 2 Study FOLFIRINOX followed by Ampligen for locally advanced pancreas cancer (AMP-270) (NCT05494697) Sites currently open and recruiting patients
Slide 28: Summary of Recent Ampligen Data Publications
Summary of ANNUAL AACS MEETING cancers ON LOW urnal for munoTherapy of Cancer 1st IHPBA & World Congress Recent Ampligen Data Publications Initial results of a phase II study evaluating a chemokine-modulatory (CKM) regimen in patients with colorectal cancer metastatic to theliver ‘Systemic Rintatoli
Slide 29: Priority Oncology Pipeline
Priority Oncology Pipeline Pancreatic: Locally Advanced Adenocarcinoma Ampligen” following, FOLFIRINOX Patient Recruitment Underway 1 Patient Enrolled Expected Q2 2023 Pancreati Late-Stage; Early Access Program Single Agent Early Access Program. Pancreati Metastatic Ductal Adenocarcinoma Ampligen* a
Slide 30: Conclusion
Conclusion Data indicate potential to extend time to progression and death as well as modulate the immune response both systemically and in the tumor microenvironment Shown potential in a variety of cancers as either a standalone agent or in combination with chemotherapeutics and/or checkpoint inhib
Slide 31: AIM ImmunoTech
SS AIM ImmunoTech