Amplia Therapeutics reported a $4.18 million half-year loss but bolstered its cash reserves with a $27.6 million capital raise to advance clinical trials of its lead drug narmafotinib, showing encouraging interim data in pancreatic cancer.
- Half-year net loss widened to $4.18 million
- Raised $27.6 million through equity placement and share purchase plan
- Promising ACCENT trial interim results – 33% objective response rate, 7.6 months progression-free survival
- Initiated second AMPLICITY trial combining narmafotinib with FOLFIRINOX
- Secured key patents and USAN drug name adoption for narmafotinib
Financial Performance and Capital Raise
Amplia Therapeutics Limited (ASX, ATX) has released its half-year financial results for the period ending 30 September 2025, reporting a net loss of $4.18 million, up from $2.81 million in the prior corresponding period. Despite the widening loss, the company strengthened its balance sheet significantly, raising $27.6 million through a combination of a $25.1 million institutional placement and a $2.5 million share purchase plan. This capital injection boosts Amplia’s cash position to over $29 million, providing a solid runway to fund ongoing clinical development activities through 2027.
Clinical Progress with Narmafotinib
Amplia’s lead drug candidate, narmafotinib (AMP945), a selective Focal Adhesion Kinase (FAK) inhibitor, continues to show promise in the treatment of advanced pancreatic cancer. Interim data from the Phase 1b/2a ACCENT trial revealed an objective response rate (ORR) of 33%, outperforming the 23% benchmark established by chemotherapy alone in the MPACT study. Additionally, the median progression-free survival (PFS) was reported at 7.6 months, representing a meaningful two-month improvement over standard chemotherapy regimens. Importantly, narmafotinib was generally well tolerated, with no significant exacerbation of chemotherapy side effects observed.
Expansion of Clinical Trials and Regulatory Milestones
Building on the ACCENT trial, Amplia has launched a second clinical study, AMPLICITY, investigating narmafotinib in combination with the chemotherapy FOLFIRINOX regimen. This trial is underway at sites in Australia and the United States, marking a strategic expansion of the drug’s clinical evaluation. The company also secured key intellectual property protections, with patents granted across multiple jurisdictions including the US, Australia, Europe, Japan, India, Korea, Singapore, and New Zealand. Furthermore, the United States Adopted Names (USAN) Council has officially adopted the drug name narmafotinib, a critical step towards regulatory approval and commercialisation in the US market.
Operational and Strategic Considerations
Amplia continues to invest heavily in research and development, supported by government R&D tax incentives, which contributed $2.63 million in revenue for the half-year. The company’s operating expenses reflect ongoing clinical trial costs and administrative overheads. While the company remains loss-making, its strengthened cash position and clinical progress underpin a positive outlook. Amplia’s management acknowledges the inherent risks in drug development, including clinical trial recruitment, regulatory approvals, and competitive pressures, but remains confident in its strategy and pipeline potential.
Outlook
With robust interim clinical data, a strong cash buffer, and expanding trial programs, Amplia Therapeutics is well positioned to advance narmafotinib through critical development milestones. The next 12 to 18 months will be pivotal as the company seeks to validate efficacy outcomes, navigate regulatory pathways, and explore commercial partnerships. Investors will be watching closely for further clinical updates and progress towards potential market approval.
Bottom Line?
Amplia’s clinical momentum and fresh capital set the stage for a critical phase in its pancreatic cancer drug development journey.
Questions in the middle?
- Will the promising interim ACCENT trial results translate into final clinical success and regulatory approval?
- How will Amplia manage the risks of clinical trial recruitment and potential delays in its expanding pipeline?
- What commercial partnerships or licensing deals might Amplia pursue to maximise narmafotinib’s market potential?