narmafotinib (AMP945) / Amplia Therap, Cancer Therapeutics CRC - LARVOL DELTA

Narmafotinib (AMP945) in combination with gemcitabine and nab-paclitaxel as first-line treatment for patients with metastatic pancreatic cancer (ACCENT trial): Phase 2a results. (ASCO-GI 2026) - P1/2 | "Narmafotinib combined with Gem/NabP was associated with manageable toxicity and the P2a study met its primary efficacy endpoint. OS data is awaited and further studies are planned."

Clinical • Combination therapy • Metastases • P2a data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Narmafotinib Large-Scale Manufacture Complete (Amplia Therapeutics Press Release) - "Successful completion of the first large-scale manufacture of narmafotinib which produced approx. 13 kg of drug. Successful transition of process and production from an R&D facility to a commercial manufacturing environment - a key step in Phase-3 readiness. Sufficient drug supply to support Amplia’s pancreatic cancer trials and other planned studies, supporting the Company's clinical development pipeline."

Commercial • Pancreatic Cancer

Phase 1b/2a of narmafotinib (AMP945) in combination with gemcitabine and nab-paclitaxel (Abraxane) standard of care as first-line therapy in patients with advanced pancreatic cancer (ACCENT trial): interim analysis (AACR 2024) - P1/2 | "Based on this promising Phase 1b data, 400 mg of narmafotinib has been selected for RP2D and the trial will proceed through Simon's Two Stage design and enrol up to 50 patients as part of the Phase 2 expansion cohort."

Clinical • Combination therapy • Metastases • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Amplia Showcases Promising Pancreatic Cancer Data for Narmafotinib at ASCO GI (TipRanks) - "The trial, which evaluates narmafotinib in combination with standard chemotherapies gemcitabine and Abraxane, shows a progression-free survival of 7.7 months versus 5.5 months for chemotherapy alone and an overall response rate of 35%, rising to 42% including unconfirmed responses, while maintaining a safety profile comparable to chemotherapy alone."

P2a data • Pancreatic Cancer

Amplia Therapeutics to Present at 2026 ASCO Gastrointestinal Cancers Symposium (The Manila Times) - "The poster, titled Narmafotinib (AMP945) in combination with gemcitabine and nab-paclitaxel as first-line treatment for patients with metastatic pancreatic cancer (ACCENT trial): Phase 2a results, will present updated data from the ongoing ACCENT trial. The full abstract will be published 5pm US ET, January 5th, 2026."

P2a data • Pancreatic Cancer

Amplia has extended its preclinical research collaboration with Korean drug screening specialist Next&Bio, following a successful initial phase of work and promising preliminary data from the study (Amplia Therapeutics Press Release) - "The collaboration has been investigating the ability of Amplia’s FAK inhibitors to suppress the growth of patient-derived pancreatic cancer cells that possess genetic mutations in the kRAS gene known to be present in >90% of pancreatic cancers. Amplia’s best-in-class FAK inhibitor narmafotinib showed promising activity in these initial tests and this data will be presented at a forthcoming scientific conference. Building on these results, the second phase of the collaboration will investigate the potential of combining narmafotinib with experimental kRAS inhibitors..."

Licensing / partnership • Preclinical • Pancreatic Cancer

Amplia Therapeutics Limited…is pleased to announce that an additional confirmed partial response (PR) has been recorded in the ongoing ACCENT trial in metastatic pancreatic cancer. (Amplia Therapeutics Press Release) - "The additional PR brings the confirmed objective response rate (ORR) to 35% (19/55) which compares favourably to the ORR of 23% recorded for gemcitabine and nab-paclitaxel alone in the benchmark MPACT trial upon which ACCENT is based."

P1/2 data • Pancreatic Ductal Adenocarcinoma

Amplia Therapeutics Limited…announces that it has received formal notification from the US Patent and Trademark Office (USPTO) that a key patent titled A salt and crystal form of a FAK Inhibitor has been granted (Amplia Therapeutics Press Release) - "This key patent protects the specific form of narmafotinib being developed clinically by the Company. The patent has already been granted in various important jurisdictions including Europe, Japan, India, Korea and Australia. Granting of this patent extends protection of narmafotinib out to a least 2040 in these jurisdictions."

Patent • Pancreatic Cancer

Amplia Therapeutics Limited announced that positive feedback had been received from the United States Food and Drug Administration (FDA) following a recent Type D meeting, providing support for the company’s planned late-stage clinical trial of narmafotinib for pancreatic cancer (BioMelbourne Network) - "Amplia noted that the FDA had endorsed the proposed two-dose comparison planned for the Phase 2b component of the study, which would precede a pivotal Phase 3 stage....The planned registration-enabling Phase 2b/3 trial is expected to evaluate narmafotinib...in combination with gemcitabine and Abraxane for the treatment of pancreatic cancer....In light of the feedback, a full protocol for the study is being prepared for FDA review in the first half of 2026, aligning with Amplia’s goal to advance to trial initiation later that year."

FDA event • New P2/3 trial • Pancreatic Cancer

AMPLIA RECEIVES R&D TAX REBATE TOTALLING $3.77 MILLION (Amplia Therapeutics Press Release) - "The refund relates to expenditure incurred in R&D activities associated with the Company’s FAK inhibitors, narmafotinib (AMP945) and AMP886....The funds will contribute to the further progression of both the ACCENT and AMPLICITY clinical trials of narmafotinib along with additional supporting R&D activities."

Commercial • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Expansion into FOLFIRINOX Combination (Amplia Therapeutics Press Release) - "In July this year, Amplia received ethics approval in Australia for the new Phase 1b/2a clinical trial combining narmafotinib with FOLFIRINOX chemotherapy....Patient recruitment has commenced at sites in Melbourne and Sydney, with several US sites to begin recruitment later this year. The first participants, of a cohort of up to nine patients, have already started dosing, marking an important milestone for the program."

Trial status • Pancreatic Cancer

Amplia Therapeutics Limited…announces it has initiated a program to expand its presence in the United States with the end goal of expanding investor awareness and engagement (Amplia Therapeutics Press Release) - "IN SUPPORT OF ITS ONGOING PHASE 2A CLINICAL TRIAL IN PANCREATIC CANCER IN U.S. CENTRES, THE COMPANY HAS LAUNCHED A CAPITAL MARKETS CAMPAIGN TO INCREASE INVESTOR AWARENESS, INCLUDING INITIATING AN UPLIST TO THE OTCQB MARKET."

Commercial • Pancreatic Cancer

AMPLIA THERAPEUTICS REPORTS ADDITIONAL RESPONSES IN ACCENT PANCREATIC CANCER TRIAL (Amplia Therapeutics Press Release) - "An updated data analysis of the trial of narmafotinib in combination with chemotherapy to 25 September 2025 is presented. An additional confirmed partial response and unconfirmed partial response have been recorded bringing the Objective Response Rate to 33%, notably superior to 23% recorded for chemotherapy alone. The mean Duration on Trial, a measure of the effectiveness of the drug combination halting cancer progression, is 219 days, substantially better than chemotherapy alone."

P1/2 data • Pancreatic Cancer

PATENT ALLOWANCE FOR KEY NARMAFOTINIB PATENT IN US (Amplia Therapeutics Press Release) - "The patent, titled A salt and crystal form of a FAK Inhibitor, describes the specific chemical form of narmafotinib being utilised in currently ongoing clinical trials. The patent allowance precedes a formal ‘Notification of Grant’ of the patent, which is expected in the coming months....The patent-already granted in Japan, Europe, Australia, India, Korea, Singapore, and New Zealand- extends narmafotinib’s protection to at least 2040."

Patent • Pancreatic Cancer

A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=67 | Recruiting | Sponsor: Amplia Therapeutics Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Solid Tumor

AUSTRALIAN TRIAL SITES OPEN FOR NEW NARMAFOTINIB COMBINATION TRIAL (Amplia Therapeutics Press Release) - "Two clinical trial sites in Australia (Melbourne and Sydney) are now recruiting patients for the Company’s new pancreatic cancer study."

Trial status • Pancreatic Cancer

The United States Adopted Names (USAN) Council has approved the name narmafotinib as the nonproprietary drug name for Amplia Therapeutics' lead FAK inhibitor (Amplia Therapeutics Press Release) - "Amplia has previously reported that the World Health Organization (WHO) approved narmafotinib as the International Non-Proprietary Name (INN) for global use."

Commercial • Pancreatic Cancer

FIRST PATIENT DOSED IN NEW PANCREATIC CANCER TRIAL (Amplia Therapeutics Press Release) - "The trial is being conducted at two (2) sites in Australia that are already open and recruiting patients, and four (4) sites in the US that will shortly be open once final site approvals are obtained....The dose-escalation is anticipated to be completed in Q1 2026."

Trial status • Pancreatic Cancer

Positive ACCENT Trial Topline Data Released (Amplia Therapeutics Press Release) - P1b/2a | N=62 | ACCENT (NCT05355298) | Sponsor: Amplia Therapeutics Limited | "HIGHLIGHTS: (i) Progression Free Survival (PFS) of 7.6 months has been determined with current data which represents a 2-month improvement over chemotherapy alone (benchmark MPACT study); (ii) Days on Trial (DOT) of 202 days is a material improvement on chemotherapy alone (117 days); (iii) Objective Response Rate (ORR) currently at 31%, is significantly better compared to chemotherapy alone (23%), with 17 patients still on study; (iv) Excellent tolerability profile apparent with adverse events being very similar in type and occurrence to those observed for chemotherapy alone; (v) Disease Control Rate (DCR) of 73% is superior to that observed in the MPACT study (50%); (vi) Further patient updates from the ACCENT trial expected in 2H 2025 and mature data expected in Q1 2026; (vii) Company accelerating towards potential initiation of pivotal phase 2b/3 trial in 2H 2026."

New P2/3 trial • P2a data • Pancreatic Cancer

Australian Ethics Clearance for Pancreatic Cancer Trial (Amplia Therapeutics Press Release) - "Therapeutics Limited...is pleased to announce that it has received Australian ethics approval for the Phase 2 clinical trial of narmafotinib in combination with the chemotherapy FOLFIRINOX. The ethics approval received covers two (2) clinical trial sites in Australia and follows US ethics approval received last month."

Trial status • Pancreatic Adenocarcinoma • Pancreatic Ductal Adenocarcinoma

ANOTHER PARTIAL RESPONSE CONFIRMED IN ACCENT PANCREATIC CANCER TRIAL (Amplia Therapeutics Press Release) - P1b/2a | N=62 | ACCENT (NCT05355298) | Sponsor: Amplia Therapeutics Limited | "Amplia Therapeutics Limited...is pleased to announce that an additional confirmed partial response (PR) has been recorded in the Company’s ongoing ACCENT clinical trial in pancreatic cancer. The trial is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane. The additional partial response brings the objective response rate to 31%, namely 17 out of 55 patients enrolled in the trial. This compares very favourably to chemotherapy alone where a 23% response rate was reported in the benchmark MPACT study. A confirmed partial response is a formal designation of response where tumour shrinkage >30% is recorded and sustained for two (2) or more months and where no new cancerous lesions have been detected."

P1/2 data • Pancreatic Cancer

Additional Partial Response in Pancreatic Cancer Trial (Amplia Therapeutics Press Release) - P1b/2a | N=62 | ACCENT (NCT05355298) | Sponsor: Amplia Therapeutics Limited | "Amplia Therapeutics Limited...is pleased to announce that an additional confirmed partial response has been recorded in the Company’s ongoing ACCENT clinical trial in pancreatic cancer. The trial is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane. This additional confirmed partial response brings the objective response rate to 29%, namely 16 out of 55 patients enrolled in the trial. There are 20 patients still enrolled in the trial. A confirmed partial response is a formal designation of response where tumour shrinkage >30% is recorded and sustained for two (2) or more months and where no new cancerous lesions have been detected."

P1/2 data • Pancreatic Cancer

Amplia Gains US Ethics Approval for Pancreatic Cancer Trial (Amplia Therapeutics Press Release) - "Amplia Therapeutics Limited...is pleased to announce that it has received US ethics approval of the protocol for the forthcoming Phase 2 clinical trial of narmafotinib in combination with the chemotherapy FOLFIRINOX. The ethics approval was received from the central US Institutional Review Board (IRB). The Principal Investigators for each selected US site will now submit to their local authorities for final approval to commence the trial at their site....The open-label Phase 2a clinical trial will explore the combination of the Company’s FAK inhibitor narmafotinib with the chemotherapy FOLFIRINOX in first-line patients with advanced pancreatic cancer....The focus of the new trial is identification of the optimal dose of daily, orally-dosed narmafotinib when combined with FOLFIRINOX which is administered intravenously every two (2) weeks. It is anticipated the trial will recruit 60-70 patients, depending on the number of dose-levels explored."

New P2a trial • Pancreatic Cancer

A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=67 | Not yet recruiting | Sponsor: Amplia Therapeutics Limited

New P1/2 trial • Oncology • Pancreatic Cancer • Solid Tumor

PATHOLOGICAL COMPLETE RESPONSE RECORDED IN PATIENT FROM ACCENT CANCER TRIAL (Amplia Therapeutics Press Release) - P1b/2a | N=62 | ACCENT (NCT05355298) | Sponsor: Amplia Therapeutics Limited | "Amplia Therapeutics...is pleased to announce important new data from our ongoing ACCENT clinical trial in pancreatic cancer....A patient from the trial has now recorded a pathological complete response (pCR), an extremely rare observation in this patient population. During routine assessment of tumour burden for the patient in question, it was noted that there had been a significant reduction in the size and number of hepatic metastases (secondary tumours in the liver) and in the primary tumour in the pancreas. The medical team decided that this enabled them to change the treatment plan for this patient, and surgery was performed to remove both the secondary tumours in the liver and the primary tumour in the pancreas. The surgically removed lesions were subjected to pathological examination and were determined to contain no live tumour tissue. This outcome is classified as a pCR."

P1/2 data • Pancreatic Cancer