Amplia Therapeutics Announces Opening of US Sites for Amplicity Pancreatic Cancer Trial

Rhea-AI Summary

Amplia Therapeutics (OTCQB:INNMF) opened two US sites for the AMPLICITY pancreatic cancer trial: University of California, Irvine and The Cleveland Clinic.

These join two Australian sites (Epworth Hospital and Genesis Care). Three more US sites are expected to open in the coming weeks as recruitment continues for narmafotinib plus FOLFIRINOX.

Melbourne, Australia, Feb. 11, 2026 (GLOBE NEWSWIRE) -- HIGHLIGHTS

• Two US-based sites have completed trial initiation activities for the AMPLICITY trial in pancreatic cancer

• These sites join the two Australian sites already open and recruiting patients

• Three additional US sites are expected to be open in the coming weeks

Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), announces that two (2) sites in the US have been initiated and will shortly be commencing recruitment activities for the AMPLICITY trial.

The two sites – University of California, Irvine (Irvine, Calif.) and The Cleveland Clinic (Cleveland, Oh.) – join the two (2) sites already open in Australia as part of the Company’s AMPLICITY trial, which is investigating Amplia’s lead drug, narmafotinib, in advanced pancreatic cancer patients. An additional three (3) sites in the US will be initiated in the near future as recruitment to the trial continues.

Dr Chris Burns, CEO of Amplia, commented, “These two excellent clinical trial sites in the US help to significantly expand our potential patient base for the AMPLICITY trial, while also contributing to enhancing our presence in the United States both from a clinical and investor perspective. With these two sites, and shortly an additional three sites, we expect to be able to enroll the ongoing study as efficiently as possible. We thank the trial sites and clinical teams for their diligent efforts in completing the pre-trial activities.”

The AMPLICITY trial is investigating narmafotinib, the Company’s best-in-class FAK inhibitor, in combination with the chemotherapy FOLFIRINOX in advanced pancreatic cancer. The trial is already open at two sites in Australia, at the Epworth Hospital (Melbourne) and Genesis Care (Sydney). Further information regarding the AMPLICITY trial can be found at the trial website amplicitytrial.com.

This ASX announcement was approved and authorized for release by the Board of Amplia Therapeutics.

ABN 16 165 160 841
+61 (0) 3 9123 1140 | info@ampliatx.com
Level 5, 90 William Street, Melbourne VIC 3000 Australia
www.ampliatx.com

Investor Contact: Dr Chris Burns Chief Executive Officer chris@ampliatx.com U.S. Contact: Robert Giordano rjgiordano@ggrouplifesciences.com +1 917 327 3938

Media Contact: H^CK Director, Haley Chartres haley@hck.digital +61 423 139 163 U.S. Media: media@ampliatx.com

About Amplia Therapeutics Limited

Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on X (@ampliatx) and LinkedIn.

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently being investigated in two clinical trials in pancreatic cancer. The most advanced clinical trial (ACCENT) investigates a combination with the chemotherapies gemcitabine and Abraxane® in first-line patients with advanced pancreatic cancer. The trial has already achieved its primary endpoint in achieving a confirmed response rate of 35%, superior to 23% reported in the benchmark MPACT study for gemcitabine and Abraxane alone. An interim median PFS of 7.7 months has also been reported.

About AMPLICITY

The AMPLICITY trial explores the safety, tolerability, efficacy and pharmacokinetics of the combination of narmafotinib with the chemotherapy regimen known as modified FOLFIRINOX in newly-diagnosed patients with advanced pancreatic cancer. The trial is entitled A Phase 1b/2a, Multicenter, Open Label Study of the Safety, Efficacy and Pharmacokinetics of narmafotinib in Combination with modified FOLFIRINOX in Pancreatic Cancer Patients and is being conducted under an open IND from the US FDA.

Designed as a single-arm, open-label study, the trial will proceed in two parts, incorporating the principles of the FDA's Project Optimus guidance for developing new oncology therapies. Part A will explore a range of oral daily doses of narmafotinib in combination with modified FOLFIRINOX (administered every 14 days), for safety, tolerability, and pharmacokinetics.

Part B of the trial is designed to identify the optimal daily dose of narmafotinib for future studies, by comparing two (2) doses identified from Part A, for safety, tolerability and efficacy.

The trial is being conducted initially at sites in Australia and the US. More information about the trial can be found at the Amplia Therapeutics website; ClinicalTrials.gov under the identifier NCT07026279; and at amplicitytrial.com.

The Company has previously presented data from preclinical studies demonstrating that the addition of narmafotinib to FOLFIRINOX significantly improves survival in animal models of pancreatic cancer compared to animals treated with FOLFIRINOX alone.

FAQ

Which US sites did Amplia (INNMF) initiate for the AMPLICITY pancreatic cancer trial on Feb 11, 2026?

Two US sites were initiated: University of California, Irvine and The Cleveland Clinic. According to the company, these sites will shortly begin recruitment and join two Australian sites already open for the AMPLICITY trial.

How many total clinical sites will be open soon for Amplia's (INNMF) AMPLICITY trial and where are they located?

Four sites are currently open: two in Australia and two in the US, with three additional US sites expected soon. According to the company, recruitment will continue across these Australian and US locations to enroll patients.

What treatment is being tested in Amplia's (INNMF) AMPLICITY pancreatic cancer trial?

The trial is testing narmafotinib combined with the chemotherapy regimen FOLFIRINOX in advanced pancreatic cancer patients. According to the company, narmafotinib is a FAK inhibitor being evaluated in combination therapy in this study.

When will the additional US sites for Amplia's (INNMF) AMPLICITY trial be opened?

Three additional US sites are expected to be initiated in the coming weeks. According to the company, these sites are planned to expand the trial's US footprint and support ongoing patient recruitment shortly.

How can investigators or patients find more information about the AMPLICITY trial (INNMF)?

Further trial details and site information are available at amplicitytrial.com. According to the company, the trial website provides enrollment criteria, site contacts, and updates on recruitment status for interested patients and investigators.

What did Amplia's management say about opening US sites for the AMPLICITY trial (INNMF)?

Management said the US sites expand the potential patient base and US presence while supporting efficient enrollment. According to the company, the sites and clinical teams completed pre-trial activities and will commence recruitment shortly.