Slide 1: Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer
Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer Presentation by AIM CEO Thomas K. Equels, MS, JD
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: AIM ImmunoTech is a U.S.-based clinical immuno-pharma company
AIM ImmunoTech is a U.S.-based, clinical immuno-pharma company focused on developing therapeutics in immuno- oncology, immune disorders and viral diseases. Our lead program, Ampligen, is an immuno-modulator that has shown broad spectrum activity in clinical trials with significant positive data publ
Slide 4: Lead Program Ampligen (rintatolimod)
Pancreatic Cancer Lead Program Ampligen (rintatolimod) Ampligen is unique among TLR agonists in its mechanism of action, specificity and safety profile. As a TLR3 agonist, it activates the TRIF adaptor pathway, which avoids the systemic inflammatory MyD88 pathway used by all Induces wide range of ot
Slide 5: Mechanism of Action in Oncology
Pancreatic Cancer Mechanism of Action in Oncology The goal is to unleash the cellular immune response to attack and destroy cancer cells and increase survival1 Ampligen “reprograms” the Ampligen is the only known TLR3 agonist to tumor microenvironment to promote selective attraction of CTLs (Teff) w
Slide 6: Why late-stage metastatic pancreatic cancer is a primary focus
Late-stage metastatic pancreatic cancer is a primary focus for Ampligen’s development given… • The lethal malignancy’s high unmet need • The large potential market • AIM’s U.S. patent for Ampligen in combination with PD-L1 drugs for the treatment of cancers, including pancreatic cancer • AIM’s grant
Slide 7: Pancreatic Cancer – Global Snapshot
Pancreatic Cancer – Global Snapshot ~510,000 news cases worldwide (2022)1 ~467,000 deaths worldwide (2022)1 12th-most common cancer worldwide1 Pancreatic cancer is expected to be the 2nd-leading cause of cancer deaths by 20302 1 - World Cancer Research Fund, wcrf.org 2- Pancreatic Cancer Action Netw
Slide 8: Early Access Program - Statistically Significant Increased Overall Survival
Pancreatic Cancer Early Access Program (EAP) - Statistically Significant Increased Overall Survival Compared to Historical Controls in Treatment of Late-Stage Pancreatic Cancer Adults with metastatic or locally advanced unresectable pancreatic carcinoma following first-line FOLFIRINOX received Ampli
Slide 9: EAP - Well-matched historical control group
Pancreatic Cancer EAP - A well-matched historical control group (established by the below p-values) was used to compare outcomes in the single-arm study Control Group Ampligen® Group Variable p-value (n=27) (n=57) Age, Mean (SD) 64.5 8.4 64.6 8.1 0.9 FOLFIRINOX cycles, 7.7 3.3 9.1 3.1 0.108
Slide 10: Ampligen demonstrated significant improvement in OS and PFS
Pancreatic Cancer Ampligen demonstrated significant improvement in OS and PFS as compared with historical controls Progression-Free Survival (PFS) Overall Survival (OS) Ampligen n=57 100 100 Ampligen n=57 Control n=27 Control n=27 % Survival % Survival 50 50 0 0 0 20 40 60 0 20 40 60 80 Months From
Slide 11: Baseline Neutrophil/Lymphocyte ratio predictive of Ampligen response
Pancreatic Cancer Baseline Neutrophil/Lymphocyte (N/L) ratio appear to be predictive of Ampligen response Progression-Free Survival (PFS) Overall Survival (OS) N/L < 4.5 (n=39) 100 N/L < 4.5 (n=39) 100 N/L > 4.5 (n=9) N/L > 4.5 (n=9) Control (n=27) Control (n=27) % Survival % Survival 50 50 0 0 0 20
Slide 12: CA19-9 tumor marker levels predictive of Ampligen response
Pancreatic Cancer CA19-9 tumor marker levels appear to be predictive of Ampligen response Progression-Free Survival (PFS) Overall Survival (OS) CA19-9 <1000 (n=49) CA19-9 <1000 (n=49) 100 CA19-9 >=1000 (n=8) 100 CA19-9 >=1000 (n=8) Control (n=27) Control (n=27) % Survival % Survival 50 50 0 0 0 20 4
Slide 13: DURIPANC Clinical Trial
DURIPANC Clinical Trial Sponsor: Erasmus University Medical Center Collaborators: AIM ImmunoTech and AstraZeneca Study Title: Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy
Slide 14: DURIPANC – End Points
DURIPANC – End Points The primary objective of the safety run-in (Phase 1b) is to determine the safety of combination therapy with durvalumab and rintatolimod. The primary objective of the Phase 2 trial is to determine the clinical benefit rate of combination therapy with durvalumab and rintatolimod
Slide 15: DURIPANC – Patient Enrollment and Treatment
DURIPANC – Patient Enrollment and Treatment Total Patients Enrolled to Date: 14 Eligibility Criteria: Confirmed PDAC, radiographically stable disease post-standard of care FOLFIRINOX x8 cycles, ECOG status:0–1 Treatment: Durvalumab 12 doses administered once every 28 days and Rintatolimod administer
Slide 16: DURIPANC – Mid-Year Results (Cutoff: 7/1/25)
DURIPANC – Mid-Year Results (Cutoff: 7/1/25) Safety • Toxicity - No grade ≥2 immune-related or systemic toxicities reported to date Efficacy • Progression-Free Survival (PFS) - Among the 14 patients evaluable for progression- free survival, eight patients experienced disease progression within 6 mon
Slide 17: DURIPANC – Quality of Life
DURIPANC – Quality of Life Patient-reported outcomes indicated a consistently high level of quality of life (QoL) throughout the treatment period. This is particularly notable given that patients with advanced disease typically experience substantial symptom burden and functional decline. In the con
Slide 18: Ampligen vs. Other Trials
Ampligen vs. Other Trials Others: Ampligen: Pancreatic ductal cancer has limited immunotherapy Compared to these data, the DURIPANC study Mid-Year responsiveness, particularly in unselected PDAC interim data shows promising early signs of no populations. Following FOLFIRINOX, maintenance or signific
Slide 19: DURIPANC – Conclusions and Next Steps
DURIPANC – Conclusions and Next Steps • Durvalumab (Imfinzi) + Rintatolimod (Ampligen) is well-tolerated in post- FOLFIRINOX PDAC patients • Preliminary survival data are encouraging, especially given the historical difficulty of improving outcomes in this setting • Immunologic correlatives and furt
Slide 20: Intellectual Property Portfolio
Intellectual Property Portfolio Patent protection regarding pancreatic cancer and oncology development • United States - Methods involve the administration of a unique synergistic combination of Ampligen and an anti-PD-L1 in the treatment of pancreatic cancer, renal cell carcinoma, colorectal cancer
Slide 21: Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer
Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer Presentation by AIM CEO Thomas K. Equels, MS, JD