Preliminary Final Report and Annual Report YE 31 March 2025

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Stock Amplia Therapeutics Ltd (ATX.ASX)
Release Time 30 May 2025, 3:13 p.m.
Price Sensitive Yes
 Amplia Therapeutics Reports FY 2025 Results
Key Points
  • Positive data from ACCENT trial in advanced pancreatic cancer
  • Accelerated US approval of FAK inhibitor for ovarian cancer
  • Initiation of second US-based pancreatic cancer trial planned
Full Summary

Amplia Therapeutics has made significant progress with its FAK inhibitor program over the past year. The company's lead asset, narmafotinib, demonstrated promising results in the ongoing ACCENT trial in advanced pancreatic cancer. By the end of the fiscal year, the trial had enrolled 55 patients, with 15 confirmed partial responses observed. The company plans to report additional data as it becomes available. Amplia also announced plans to initiate a second clinical trial in pancreatic cancer in the US, which will investigate narmafotinib in combination with a different chemotherapy regimen. This trial is an important strategic move to position narmafotinib as a drug that can be combined with the two main chemotherapy regimens used to treat advanced pancreatic cancer. The company highlighted the accelerated US approval of a first-generation FAK inhibitor, defactinib, for the treatment of low grade serous ovarian cancer as an important milestone for the development of FAK inhibiting drugs. Amplia also reported on preclinical studies demonstrating that narmafotinib can enhance the activity of a new class of drugs called kRas inhibitors, which are being developed for various cancers including pancreatic cancer. The company successfully raised capital twice during the year, securing support from both existing and new investors. Amplia's chairman and CEO both expressed confidence in the company's progress and the potential of narmafotinib to deliver increasing shareholder value as the clinical dataset matures.

Outlook

Amplia remains focused on driving the development of narmafotinib forward to clinical success, with the goal of adding commercial potential to the company and driving shareholder value.