• ACCENT Trial Success: Narmafotinib enhances chemotherapy effects
• AMPLICITY Trial Initiation: Combination with FOLFIRINOX ongoing
• Regulatory and Commercial Developments: Positive FDA feedback, key patent granted, uplisting to OTCQB

Amplia Therapeutics announces further clinical and preclinical progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report for the quarter ending 31 December 2025. The ACCENT clinical trial investigating the combination of narmafotinib with standard-of-care chemotherapies gemcitabine and Abraxane has reported additional confirmed partial responses, bringing the overall response rate to 35%. The company has also begun the Phase 1b/2a AMPLICITY clinical trial, where the combination of narmafotinib with FOLFIRINOX chemotherapy is being investigated. Amplia received positive feedback from the US FDA supporting the dose optimization strategy for narmafotinib and was granted a key patent covering the specific salt and crystal form of narmafotinib. The company also successfully uplisted to the US-based OTCQB Venture Market. In preclinical studies, Amplia has advanced into a second phase of its research collaboration with Next & Bio, evaluating its FAK inhibitors against patient-derived pancreatic cancer cells. The company finished the quarter with a cash position of $31.5 million.

Amplia expects to report mature data from the ACCENT trial and progress with the AMPLICITY trial over the coming months. Additional preclinical data, including from the Next & Bio collaboration, will also be disclosed.