Highlights

  • Amplia held A$20.8 million cash at 30 September 2026, or pro forma A$25.6 million including an October tax refund.
  • The ACCENT trial reported a 36 per cent overall response rate and median overall survival of 11.1 months.
  • Amplia is starting up three Australian sites for ACCENT-MINI, with ethics approval expected imminently and an FDA meeting planned.
  • Quarterly net operating cash outflow fell to A$3.1 million, and the company estimates a runway of about 6.7 quarters.

Amplia Therapeutics (ASX:ATX) is edging toward a pivotal moment for its pancreatic cancer drug. The Australian clinical-stage company said its ACCENT trial of narmafotinib is nearing completion, while preparations are under way for the first stage of a registrational program. Alongside a quarterly report and Appendix 4C, it also pointed to a collaboration with Eli Lilly.

ACCENT trial nearing completion

ACCENT tests narmafotinib combined with the chemotherapy drugs gemcitabine and Abraxane in pancreatic cancer. The company cited an overall response rate of 36 per cent, or 42 per cent when unconfirmed responses are counted, and a complete response rate of 7.8 per cent.

Amplia said median progression-free survival and median overall survival improved by two to three months compared with chemotherapy alone. It put median overall survival at 11.1 months.

Follow-up continues. One patient remains on study after 19 months, while two patients completed 24 months of treatment and moved on to narmafotinib under a compassionate access scheme. These are company-reported results from a study that has not yet concluded, and they do not establish regulatory approval or commercial outcomes.

The registrational step and the Lilly link

The next step is ACCENT-MINI, described as the first stage of the registrational program. It will explore safety, tolerability and pharmacokinetics at two to three dose levels. Three Australian sites are being started up, and ethics approval is expected imminently. A meeting with the US Food and Drug Administration is planned for the second quarter of 2027 to agree the final design.

Separately, Amplia noted the collaboration and clinical trial supply agreement with Eli Lilly announced in August 2026. Under it, narmafotinib will be tested with Lilly's olomorasib in non-small cell lung cancer. The report set out no financial terms, and it did not say whether the lung cancer work would affect spending plans or the runway estimate.

Cash position and runway

Cash at 30 September 2026 was A$20.8 million, compared with A$24.0 million at 30 June 2026. Including a Research and Development Tax Incentive refund of A$4.8 million received in October, pro forma cash was A$25.6 million. The refund relates to the year ended 31 March 2026 and was the only government funding noted. No grants were reported.

Net operating cash outflow was A$3.1 million, down from A$3.9 million in the June quarter, and A$7.0 million year to date. Research and development outflows were A$2.1 million, staff costs A$0.5 million, and administration and corporate costs A$0.7 million, offset by interest received of A$0.2 million. Investing outflows for property, plant and equipment were A$66,000, and lease repayments were A$28,000. Payments to related parties, covering directors' fees and the chief executive's salary, totalled A$157,500.

The company raised no equity, drew no debt and had no financing facilities during the quarter. At the current rate of operating spending, it estimated a runway of about 6.7 quarters.

What to watch

Confirmed milestones include ethics approval and site activation for ACCENT-MINI, completion of the ACCENT trial and the planned FDA meeting. Amplia remains pre-revenue, and the runway estimate depends on spending staying near current levels as registrational work begins. Additional funding, trial delays or regulatory feedback that differs from the company's plans could change that picture, and the report gives no assurance on those points.