Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — AACR 2026
17 slides from Amplia Therapeutics's conference presentation, May 12, 2026
Slide 1: Narmafotinib in combination with gemcitabine and nab-paclitaxel: ACCENT trial interim analysis
Narmafotinib (AMP945) in combination with gemcitabine and nab-paclitaxel in first-line patients with advanced pancreatic cancer (ACCENT trial) a Phase 1b/2a study: Interim analysis Terrie-Anne Cock PhD Amplia Therapeutics Australia ASX:ATX | OTCQB:INNMF
Slide 2: Focal adhesion kinase inhibition in cancer
FOCAL ADHESION KINASE INHIBITION IN CANCER FAK enzyme overactive in pancreatic cancer 2 FAK levels are elevated in pancreatic cancer • Correlate with worse patient outcomes FAK is a cellular stress-buffer that sustains tumor survival especially under therapeutic stress FAK overactivity in both cance
Slide 3: Narmafotinib: A Potent and Selective FAK Inhibitor
NARMAFOTINIB A Potent and Selective FAK Inhibitor 3 Drug-like small molecule • Highly potent and highly selective FAKi • Pharmacokinetic (PK) profile supports oral once-a- day dosing (t½ ~20 h) • Dose-proportional PK • Patient population not limited by genetics Safe to combine with other medicines •
Slide 4: ACCENT Trial in Pancreatic Cancer: Phase 1b/2a study design
ACCENT TRIAL IN PANCREATIC CANCER Phase 1b/2a study in Australia and Korea 4 OBJECTIVE • To determine safety and efficacy of narmafotinib in combination with gemcitabine and nab- paclitaxel (Gem/nab-P) • Patients with newly diagnosed metastatic disease PRIMARY ENDPOINTS ADDITIONAL ENDPOINTS • Safety
Slide 5: ACCENT Trial: dosing schedule
ACCENT TRIAL IN PANCREATIC CANCER Phase 1b/2a study in Australia and Korea 5 7 days priming prior to Gem/nab-P on Cycle 1 Day 1 4 days of dosing prior to each Gem/nab-P thereafter 12 days out of 28-day cycle 43% coverage after cycle 1
Slide 6: ACCENT Trial: patient demographics
ACCENT TRIAL IN PANCREATIC CANCER Phase 1b/2a study in Australia and Korea 6 Demographics All 400 mg patients Part A: Dose escalation to select dose for Part B Patient # (total study) 64 Australia (52%) / • 3 patients at 100 mg Geographic area (%) Korea (48%) • 3 patients at 200 mg Female (%) 32 (50
Slide 7: RECIST 1.1 analysis: investigator vs independent central read
ACCENT TRIAL IN PANCREATIC CANCER RECIST 1.1 analysis ACCENT 7 Abstract data Data presented today • Investigator read • Independent review (central read) performed by • Requested in real time to assess specialist global contract patient progress organization • RECIST 1.1 analysis standard in • Two i
Slide 8: Narmafotinib treatment results in negligible extra patient burden
ACCENT TRIAL IN PANCREATIC CANCER Narmafotinib treatment results in negligible extra patient burden 8 PIVOTAL STUDY Narmafotinib Gem/nab-P Gem/nab-P Adverse Event (AE) Grade ≥ 3 +Gem/nab-P (NAPOLI 3; (ACCENT N=64) (MPACT; N=421) N=379) Neutropenia 39% 38% 39% Anemia 17.2% 13% 18% Diarrhea 6.3% 6% 5%
Slide 9: Narmafotinib-related adverse events mostly gastrointestinal and mild to moderate
ACCENT TRIAL IN PANCREATIC CANCER Narmafotinib treatment results in negligible extra patient burden 9 Narmafotinib-related TEAEs in were mostly gastrointestinal events predominately mild to moderate Narmafotinib Related Adverse Events Narmafotinib 400 mg Any grade ( ≥ 5%) (N=64) N (%) Nausea 19 (29.
Slide 10: Exceptional complete response rate
ACCENT TRIAL IN PANCREATIC CANCER Exceptional complete response rate 10 Excellent response rate observed ACCENT Trial MPACT Trial (Narmafotinib/ (Gem/nab-P) • 5 confirmed Complete Responses (CR) Gem/nab-P) (N=64) CR 5 (8%) 0.2% • 18 confirmed Partial Responses (PR); Incl. 1 patient with pathological
Slide 11: Enhanced depth of response
ACCENT TRIAL IN PANCREATIC CANCER Enhanced depth of response 11 30 20 10 Best change from baseline (%) 0 -10 -20 (target lesions) -30 -40 Progressive Disease -50 Stable Disease -60 Partial Response -70 Complete Response -80 Pathological Complete Response -90 Patient still on study -100 Individual pa
Slide 12: Early and sustained deep tumor shrinkage
ACCENT TRIAL IN PANCREATIC CANCER Early and sustained deep tumor shrinkage 12 60 Key for overall response Black = PD 40 Grey = SD Blue = PR change from baseline (%) 20 Orange = pCR Purple = CR Target lesion: 0 Open circles = patient still on study -20 -40 -60 -80 -100 0 60 120 180 240 300 360 420 48
Slide 13: Improved PFS over chemotherapy alone
ACCENT TRIAL IN PANCREATIC CANCER Improved PFS over chemotherapy alone 13 Median Progression Free Survival (mPFS) • Currently determined at 7.7 months - 100 substantially better than Gem/nab-P Progression free survival (%) 90 chemotherapy alone (5.5 months) 80 70 • Improvement over FOLFIRINOX chemot
Slide 14: Improved overall survival – sustained response
ACCENT TRIAL IN PANCREATIC CANCER Improved overall survival – sustained response 14 Median Overall Survival (mOS) data • Currently determined at 11.1 months - 100 substantially better than Gem/nab-P 90 chemotherapy alone (8.5-9.2 months) 80 Overall survival (%) 70 • Comparable to FOLFIRINOX chemothe
Slide 15: Improved overall survival – sustained response
ACCENT TRIAL IN PANCREATIC CANCER Improved overall survival – sustained response 15 Median Overall Survival (mOS) data PD • Currently determined at 11.1 months - substantially better than Gem/nab-P chemotherapy alone (8.5-9.2 months) SD • Comparable to FOLFIRINOX chemotherapy PR (11.1 months) CR ACC
Slide 16: Summary
ACCENT TRIAL IN PANCREATIC CANCER Summary 16 Deep and fast Durable and sustained Demonstrated response response tolerability 64 patients 400 mg 12 patients on trial Good tolerability profile • 5 CR >12 months • 18 PR (incl. 1 pCR) Minimal additional burden Improved OS (11.1 mo) over on patients abov
Slide 17: Acknowledgments
ACKNOWLEDGMENTS Co-authors: S. Ananda, C. Lee, N. Pavlakis, J. Park, J. Kim, D. Lau, L. Lipton, A. Nagrial, W. Lee, H. Chan, D. Oh, W. Joubert, S. Kinkel, N. Kruger, C. Mulder, J. Lickliter, C. Burns We thank all investigators and site staff involved in the ACCENT trial We gratefully acknowledge the