Highlights

  • Amplia Therapeutics entered a clinical trial collaboration with Eli Lilly to evaluate narmafotinib with olomorasib in advanced non-small cell lung cancer.
  • The Phase 1b/2b trial is planned to begin in late 2026 across Australia and the United States, subject to protocol finalisation.
  • Eli Lilly will provide olomorasib for the study, while Amplia retains ownership of narmafotinib and trial data.
  • Amplia's lead drug candidate is also being developed in pancreatic cancer, with ACCENT trial completion expected around Q3'2026.

Amplia Therapeutics (ASX:ATX) has signed a Clinical Trial Collaboration and Supply Agreement with Eli Lilly to evaluate its oral FAK inhibitor narmafotinib in combination with Lilly's KRAS G12C inhibitor olomorasib in advanced non-small cell lung cancer (NSCLC).

Announced to the ASX on 4 August 2026, the collaboration expands narmafotinib's development beyond its original pancreatic cancer focus and introduces the drug candidate into another oncology setting. The agreement provides access to Lilly's olomorasib for the planned study, while Amplia retains ownership of narmafotinib and the resulting clinical data.

The arrangement is a collaboration and supply agreement rather than a licensing transaction, with no upfront payments, milestone payments or Royalty terms disclosed.

What Was Announced?

Under the agreement, Amplia (ASX:ATX) will conduct a Phase 1b/2b clinical trial evaluating narmafotinib combined with olomorasib as a second-line treatment for patients with advanced NSCLC carrying KRAS G12C mutations.

The trial is planned to commence in late 2026 across clinical sites in Australia and the United States, subject to finalisation of the clinical protocol.

Lilly's contribution will involve supplying olomorasib for the trial. Amplia will continue to control the development and ownership of narmafotinib.

The study will assess the safety and early efficacy signals of combining FAK inhibition with KRAS G12C inhibition. It remains an early-stage clinical study and is not a registration trial or an indication of regulatory approval.

Why This Matters

KRAS G12C mutations occur in a subset of NSCLC patients, and while KRAS-targeted medicines have changed treatment approaches in some lung cancer patients, resistance development remains a challenge.

The scientific rationale behind combining narmafotinib with olomorasib is based on the potential role of FAK inhibition in reducing adaptive resistance mechanisms that allow tumours to evade targeted therapies.

For Amplia (ASX:ATX), the collaboration broadens narmafotinib's development pathway beyond pancreatic cancer and provides access to a combination partner supplied by a global pharmaceutical company.

However, the study remains at an early development stage and will primarily provide safety and initial efficacy information rather than confirm the long-term clinical benefit of the combination.

Company Background

Amplia Therapeutics (ASX:ATX) is an Australian clinical-stage biotechnology company developing narmafotinib, an oral once-daily small-molecule FAK inhibitor.

The company's most advanced program has focused on advanced pancreatic cancer, where narmafotinib is being evaluated alongside standard chemotherapy.

Data from the ACCENT trial, a single-arm study, showed that at the 400mg dose in evaluable patients, narmafotinib recorded an objective response rate of approximately 35.9%, a complete response rate of about 7.8%, median progression-free survival of approximately 7.6–7.7 months and median overall survival of approximately 11.1 months.

Amplia has stated these findings are from an early-stage single-arm study requiring confirmation through larger controlled trials.

The company has also commenced work on registration-enabling pancreatic cancer studies and has disclosed development activity in ovarian cancer.

Financial Position

Amplia reported cash of $31.5 million at the end of the December 2025 quarter, compared with $29.2 million at the end of the September 2025 quarter.

The company completed a $27.5 million Capital raise in July 2025, consisting of a $25 million institutional Placement and a $2.5 million share purchase plan before costs.

During the December 2025 quarter, Amplia recorded net operating cash inflow of $2.4 million, supported by $3.8 million in government grants and Research and Development tax incentive receipts, which exceeded staff, administration and research and development expenditure.

As a pre-revenue biotechnology company, Amplia continues to rely on available cash, grants and future capital management activities to support its clinical programs.

What Comes Next?

The next disclosed milestones include completion of the ACCENT pancreatic cancer trial, expected around the third quarter of 2026, and commencement of the narmafotinib-olomorasib NSCLC trial planned for late 2026.

The NSCLC study remains subject to final protocol discussions, and Amplia has not disclosed timing for interim data updates from the trial.

Future clinical updates will likely focus on trial commencement, patient enrolment progress and early safety or efficacy observations from the combination program.

Risks

Amplia (ASX:ATX) remains a pre-revenue biotechnology company dependent on the clinical performance of narmafotinib across multiple tumour types. Existing pancreatic cancer data comes from an early-stage single-arm study without a randomised control, and early clinical signals may not translate into later-stage success. The Eli Lilly agreement does not include disclosed milestone or royalty payments, meaning Amplia remains responsible for broader development costs. Running multiple clinical programs may also require additional funding and create potential dilution risk.

Investor Takeaway

The Eli Lilly collaboration expands Amplia's narmafotinib development strategy into advanced NSCLC and provides access to olomorasib through a supply arrangement. The agreement allows Amplia to test a new combination approach while retaining ownership of its lead asset and trial data.

However, the NSCLC program remains in early development, with the trial yet to begin and no disclosed commercial Economics attached to the collaboration. Amplia's ability to progress multiple clinical programs while managing funding requirements will remain an important Factor as narmafotinib development continues.