How Will Amplia’s $27.5M Raise Accelerate Its Pancreatic Cancer Breakthrough?
Amplia Therapeutics has launched a $27.5 million capital raising to advance its lead drug Narmafotinib, a promising FAK inhibitor showing superior efficacy in pancreatic cancer trials. The funds will support ongoing and new clinical studies, positioning the company for pivotal regulatory milestones.
- Capital raising of approximately AUD 27.5 million via placement and share purchase plan
- Positive Phase 2a ACCENT trial interim data with superior responses over chemotherapy alone
- Lead drug Narmafotinib targets FAK, a validated cancer pathway, with orphan drug and fast track FDA designations
- Funding secured to support Phase 2b/3 pivotal trials and additional studies including ovarian cancer and kRAS inhibitor combinations
- Amplia engaging with potential licensing partners amid increased industry interest
Capital Raising to Fuel Clinical Progress
Amplia Therapeutics Limited (ASX, ATX), a Melbourne-based biotech focused on oncology, has announced a capital raising of approximately AUD 27.5 million. The raise comprises a two-tranche placement and a share purchase plan aimed at sophisticated and professional investors. This infusion of capital is intended to finance the advancement of Amplia’s lead candidate, Narmafotinib, through critical clinical milestones and expand its pipeline into new indications.
The placement price of AUD 0.23 per share represents a discount to recent trading prices, reflecting the typical pricing dynamics of such capital raises. Directors have committed to participate in the raise, signaling confidence in the company’s trajectory. Following the raise, Amplia expects to be funded into 2027, providing runway for multiple clinical programs.
Narmafotinib, A Best-in-Class FAK Inhibitor
Narmafotinib is a small molecule inhibitor targeting Focal Adhesion Kinase (FAK), a protein implicated in cancer progression and fibrosis. Amplia positions Narmafotinib as a best-in-class agent with a compelling safety and tolerability profile, designed to enhance the efficacy of existing chemotherapies. The drug has received orphan drug and fast track designations from the US FDA, underscoring its potential in treating pancreatic cancer and idiopathic pulmonary fibrosis.
Amplia’s ongoing Phase 1b/2a ACCENT trial in advanced pancreatic cancer has delivered encouraging interim results. The combination of Narmafotinib with gemcitabine and nab-paclitaxel chemotherapy has demonstrated a 31% confirmed partial response rate, surpassing historical benchmarks of 23%. Notably, two complete responses, including a rare pathological complete response, have been reported, an exceptional outcome in metastatic pancreatic cancer.
Expanding Clinical Horizons and Regulatory Pathway
Beyond ACCENT, Amplia is initiating the Amplicity Phase 2 trial combining Narmafotinib with FOLFIRINOX, the US standard of care for advanced pancreatic cancer. This trial is expected to commence dosing in Q3 2025. Additionally, plans are underway for investigator-initiated trials exploring combinations with kRAS inhibitors and ovarian cancer therapies, slated for 1H 2026.
Amplia aims to leverage positive ACCENT data to engage with the FDA in a Type C meeting to discuss the design of a pivotal Phase 2b/3 trial, potentially starting in the second half of 2026. The company’s regulatory strategy is informed by precedents such as Verastem’s FDA approval of a FAK inhibitor based on Phase 2 data, suggesting a pathway for accelerated approval.
Partnering and Market Outlook
Amplia reports heightened interest from global pharmaceutical companies following the promising ACCENT trial data. Management is actively pursuing regional licensing agreements with partners specializing in orphan indications, gastrointestinal cancers, and precision medicine. The strengthened balance sheet from the capital raise enhances Amplia’s negotiating position and operational flexibility.
Investors can anticipate a robust news flow through 2025 and 2026, including top-line ACCENT data expected imminently, initial Amplicity trial results, FDA meeting outcomes, and the commencement of new clinical trials. These catalysts will be critical in validating Narmafotinib’s clinical and commercial potential.
Bottom Line?
Amplia’s capital raise and clinical progress set the stage for pivotal data and regulatory milestones that could reshape pancreatic cancer treatment.
Questions in the middle?
- Will the upcoming ACCENT top-line data confirm the early promising efficacy signals?
- How will the FDA respond to Amplia’s proposed pivotal Phase 2b/3 trial design?
- What terms and scope will potential licensing partnerships entail amid growing industry interest?