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 | "Clinical Trial Registration Number: NCT05355298 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

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

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

ACCENT TRIAL DATA DEMONSTRATES THAT NARMAFOTINIB + CHEMOTHERAPY COMBINATION SUPERIOR TO CHEMOTHERAPY ALONE (Amplia Therapeutics Press Release) - P1b/2a | N=62 | ACCENT (NCT05355298) | Sponsor: Amplia Therapeutics Limited | "Fifteen (15) confirmed partial responses. (PRs) have now been recorded in the trial, a level of response sufficient to demonstrate that the combination of narmafotinib and chemotherapy is superior to chemotherapy alone. 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. As pancreatic cancer is highly aggressive it is extremely rare for patients to achieve a complete response (CR)....At the outset of the study a statistical analysis was performed which identified that a patient cohort of 50 patients would be sufficient to allow the efficacy of our combination to be ascertained with reasonable confidence if 15 or more responders (confirmed PR or CR) were recorded....Phase 2a ACCENT trial is fully recruited with top-line data expected in mid Q3 2025."

P1/2 data • Pancreatic Cancer

Narmafotinib (AMP945) in combination with gemcitabine and nab paclitaxel in first-line patients with advanced pancreatic cancer (ACCENT trial) a phase 2a study: Interim analysis (AACR 2025) - P1/2 | "Preliminary Part B analysis on the initial 26 patients showed narmafotinib to be safe and well-tolerated with promising signs of efficacy."

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

ACCENT trial data presented at prestigious international conference (Amplia Therapeutics Press Release) - "A poster highlighting key data from Amplia's ongoing ACCENT trial is being presented today at the annual meeting of the American Association of Cancer Research (AACR) in Chicago, USA. The poster, presented by Amplia’s Director of Translational Science, Dr Terrie-Anne Cock, outlines the scientific rationale for the use of FAK inhibitors in pancreatic cancer treatment, describes the clinical design of the ACCENT trial, and presents a detailed analysis of data up to 7 March 2025 for the first 29 patients of the 55 enrolled in the trial."

P1/2 data • Pancreatic Ductal Adenocarcinoma

US clinical trial activities for narmafotinib now underway (Amplia Therapeutics Press Release) - "Amplia has announced that trial initiation activities for the planned pancreatic cancer trial in the US have begun. This new trial will explore the combination of the Company’s best-in-class FAK inhibitor narmafotinib with the chemotherapy FOLFIRINOX in patients with advanced pancreatic cancer."

New trial • Pancreatic Cancer

ENCOURAGING UPDATED DATA FROM PANCREATIC CANCER TRIAL (Amplia Therapeutics Press Release) - P1b/2a | N=62 | ACCENT (NCT05355298) | Sponsor: Amplia Therapeutics Limited | "Amplia Therapeutics Limited...is pleased to report updated data from the Company’s ongoing Phase 2a clinical trial....A total of 55 advanced pancreatic patients have enrolled in the study at the trial sites in Australia and Korea. The trial is fully enrolled and as of 12 March 2025, 29 patients remain on study....At this time, 13 confirmed partial responses (PRs) have been observed (defined as a >30% reduction in tumour size sustained over two months with no new lesions apparent), noting that tumour shrinkage assessments for the majority of patients enrolled since December are yet to be undertaken...Narmafotinib in combination with chemotherapy demonstrates good tolerability, with adverse event profiles similar to chemotherapy alone. Additional ACCENT trial data has been accepted for presentation at the American Association of Cancer Research Annual Meeting in April."

P2a data • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma