Highlights

  • Amplia Therapeutics (ASX:ATX) signed a clinical trial collaboration with Lilly to evaluate narmafotinib in non-small cell lung cancer.
  • The Phase 1b/2b study will combine narmafotinib with Lilly’s KRAS G12C inhibitor olomorasib.
  • Lilly will Supply olomorasib for the study on an in-kind basis.
  • The collaboration expands narmafotinib development beyond existing pancreatic and ovarian cancer programs.

Amplia Therapeutics (ASX:ATX) has expanded the development pathway for its lead oncology candidate narmafotinib through a clinical trial collaboration with Lilly.

The agreement will evaluate narmafotinib alongside Lilly’s KRAS G12C inhibitor olomorasib in non-small cell lung cancer, providing Amplia with access to a large pharmaceutical partner’s investigational therapy while maintaining responsibility for trial funding and execution.

The collaboration represents an important development milestone, although the clinical effectiveness of the combination remains to be demonstrated.

What Happened?

On 4 August 2026, Amplia Therapeutics announced a Clinical Trial Collaboration and Supply Agreement with Lilly to evaluate narmafotinib, also known as AMP945, in combination with olomorasib.

The planned Phase 1b/2b study will assess the combination as a second-line treatment for advanced non-small cell lung cancer (NSCLC), with trial sites expected in Australia and the United States.

Under the agreement, Amplia will conduct and fund the study, while Lilly will supply olomorasib on an in-kind basis.

No upfront payment, milestone payments or total transaction value were disclosed.

The trial protocol remains under development, with the study planned to begin in late 2026.

Why It Matters

The scientific rationale behind the collaboration is based on targeting treatment resistance.

Olomorasib is designed to inhibit mutant KRAS G12C, a genetic alteration associated with a proportion of NSCLC cases. While KRAS inhibitors can produce tumour responses, resistance mechanisms may limit treatment durability.

Narmafotinib targets focal adhesion kinase (FAK), a signalling protein involved in tumour biology and resistance pathways.

The combination aims to evaluate whether FAK inhibition can improve responses to KRAS-targeted therapy.

For Amplia, the collaboration also expands narmafotinib’s potential application beyond pancreatic and ovarian cancer programs.

The Numbers

The disclosed collaboration terms include a Phase 1b/2b trial design, second-line NSCLC indication, planned late-2026 commencement and Lilly supply of olomorasib.

No patient enrolment target, financial payments or milestone structure have been disclosed.

Amplia has previously reported early-stage data from narmafotinib development in pancreatic cancer, including a reported response rate of approximately 36% and median overall survival of around 11 months.

These results are from a different cancer setting and early-stage studies, meaning they do not confirm potential outcomes from the NSCLC combination.

Amplia has referenced the NSCLC market opportunity as approximately US$31 billion currently, with expectations of exceeding US$60 billion by 2033 based on market estimates.

The Bigger Picture

Amplia Therapeutics has primarily advanced narmafotinib through pancreatic cancer research, including the ACCENT program evaluating the drug alongside FOLFIRINOX chemotherapy.

The company has also worked to strengthen its funding position, including a Capital raising initiative to support ongoing clinical development.

The Lilly collaboration broadens the potential application of narmafotinib by testing the drug as a combination therapy across another tumour type.

The agreement also reflects a broader biotechnology model where larger pharmaceutical companies collaborate with smaller developers to evaluate potential treatment combinations.

The Bull Case

The positive case for Amplia Therapeutics (ASX:ATX) is based on expanding narmafotinib into additional cancer indications through combination therapies.

The collaboration with Lilly provides access to olomorasib without Amplia purchasing the investigational drug, reducing one component of trial cost.

The combination approach has a clear biological rationale, as resistance remains a major challenge in targeted cancer therapies.

A successful clinical outcome could increase the development opportunities for narmafotinib and support future partnering discussions.

Risks Investors Should Understand

Amplia Therapeutics (ASX:ATX)’s Business faces risks including clinical trial failure, funding requirements, regulatory uncertainty and limited validation of narmafotinib.

Combination oncology trials may Fail to demonstrate improved patient outcomes despite a supporting scientific rationale.

Narmafotinib remains an investigational therapy and has not received regulatory approval for any indication.

The Lilly agreement does not include disclosed cash payments or guaranteed milestones, meaning the financial benefit depends on future clinical progress.

Amplia remains a clinical-stage company requiring ongoing capital to fund development, and additional funding activities could dilute existing shareholders.

What Comes Next?

The next milestones include finalising the clinical protocol, obtaining regulatory and ethics approvals, activating trial sites and beginning patient dosing.

Investors will monitor safety and tolerability data from the Phase 1b stage, which will determine whether the combination progresses into the Phase 2b portion.

Updates from the ongoing pancreatic cancer program will also remain relevant to the broader narmafotinib development strategy.

Conclusion

Amplia Therapeutics (ASX:ATX) has expanded the development pathway for narmafotinib through a collaboration with Lilly, creating an opportunity to test the drug in combination with olomorasib for non-small cell lung cancer.

The agreement provides access to a major pharmaceutical partner’s investigational therapy and broadens the potential application of Amplia’s lead asset.

However, the collaboration represents an early clinical step rather than confirmation of efficacy. Future value creation will depend on trial execution, clinical outcomes, regulatory progress and the company’s ability to maintain funding.