Key Highlights

  • Amplia announced a collaboration and clinical trial supply agreement with Eli Lilly to test narmafotinib with the kRAS G12C inhibitor olomorasib in non-small cell lung cancer.
  • ACCENT trial data show an overall response rate of 36% and a complete response rate of 7.8%, with median progression-free and overall survival 2 to 3 months above chemotherapy alone.
  • Cash stood at $20.8 million at 30 September 2026, rising to a $25.6 million pro forma balance after a $4.8 million R&D tax incentive refund.
  • Net operating outflows were $3.1 million for the quarter, down from $3.9 million in the June 2026 quarter.

Amplia Therapeutics Limited (ASX:ATX) used its quarterly activities report for the period ended 30 September 2026 to set out progress on narmafotinib, its focal adhesion kinase (FAK) inhibitor, and to lodge its Appendix 4C. The quarter included an August collaboration with Eli Lilly, continued follow-up of patients in the ACCENT pancreatic cancer trial and planning for a registrational study. Amplia closed the quarter with $20.8 million in cash after net operating outflows of $3.1 million.

ACCENT Trial Results and Registrational Planning

The mature ACCENT data, presented at the annual meeting of the American Association for Cancer Research, show improvements of 2 to 3 months in both median progression-free survival and median overall survival over chemotherapy alone. The overall response rate is 36%, or 42% when unconfirmed responses are included, and the complete response rate is 7.8%. Amplia said chemotherapy tolerability did not worsen significantly. A median overall survival of 11.1 months has been reported.

One patient remains on study after 19 months, while two others completed 24 months and moved to narmafotinib under a special compassionate access scheme.

The company is in late-stage planning for a registrational study of narmafotinib with gemcitabine and Abraxane. Its first stage, ACCENT-MINI, will assess safety, tolerability and pharmacokinetics of daily narmafotinib across two to three dose levels. Three Australian sites are proceeding with start-up activities and ethics approval is expected imminently. The final design is to be agreed with the US FDA in a meeting planned for the second quarter of 2027.

Lilly Collaboration and the kRAS Programme

In August, Amplia announced a collaboration and clinical trial supply agreement with Eli Lilly to explore narmafotinib alongside olomorasib, Lilly's experimental kRAS inhibitor. The study focuses on non-small cell lung cancer because olomorasib selectively inhibits the kRAS G12C mutation, which is more prevalent there than in other cancers. Approximately 23,000 patients with G12C-mutated disease are estimated to be diagnosed in the United States in 2026.

Mutant kRAS occurs in about 85% of pancreatic cancers, 30% of non-small cell lung cancers and 45% of colorectal cancers. Three kRAS-targeting drugs have FDA approval and more than 80 others are in development. Resistance can appear within 2 to 4 months of treatment, and preclinical data presented in March indicated that narmafotinib enhances selected kRAS inhibitors in pancreatic and lung cancer models by blocking resistance mechanisms.

Collaborators at the Garvan Institute in Sydney, led by Professor Paul Timpson, have also posted preclinical pancreatic cancer studies on BioRxiv describing reduced tumour fibrosis and increased immune reactivity, with improved responses when combined with chemotherapy. A second trial, AMPLICITY, is testing narmafotinib with FOLFIRINOX in first-line advanced pancreatic cancer.

Cash Flow for the September Quarter

Cash fell to $20.773 million from $23.984 million at the end of June 2026. Net operating outflows of $3.087 million comprised $2.149 million for research and development, mainly ACCENT Phase 2 trial, contract research and manufacturing costs, $504,000 for staff and $700,000 for administration and corporate costs, partly offset by $203,000 of interest. Equipment outflows were $66,000 and financing outflows $28,000.

A Research and Development Tax Incentive refund of $4.8 million for the year ended 31 March 2026 was received in October 2026, giving a pro forma balance of $25.6 million at 30 September. The Appendix 4C estimates 6.7 quarters of funding. Payments to related parties were $157,500, covering the managing director's remuneration and non-executive director fees.

Closing Position for the Quarter

Amplia reported ACCENT response data, a signed supply agreement with Eli Lilly, ACCENT-MINI start-up at three Australian sites and a quarter-end cash balance of $20.8 million.