On July 31, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 30 June 2025 (Press release, Amplia Therapeutics, JUL 31, 2025, View Source [SID1234654649]).
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Key Highlights
• The ACCENT trial achieved a key activity threshold with 17 confirmed partial responses (PRs), showing a 31% response rate for narmafotinib combined with chemotherapy, which is superior to chemotherapy alone (23%).
• Two patients achieved complete responses, including one patient with undetectable cancer lesions for over two months and another with a rare pathological complete response in metastatic pancreatic cancer, garnering significant media attention.
• Progress has been made in initiating a second trial of narmafotinib, combining it with FOLFIRINOX chemotherapy in the USA and Australia, with ethics approvals now secured for both regions.
• Dr Jason Lickliter was appointed Chief Medical Officer in May, bringing extensive experience as a medical oncologist and clinical triallist, having advised Amplia since 2021.
• ACCENT trial data was presented for the initial 26-patient cohort at the prestigious American Association of Cancer Research annual meeting in April. • $27.5m capital raise announced in July 2025, funding the company into 2027
Operations Update
Significant developments in the ACCENT trial were achieved over this quarter. In May we reported that we had achieved the key activity threshold of 15 confirmed partial responses (PRs), demonstrating that the combination of our best-in-class FAK inhibitor narmafotinib with chemotherapy was superior to chemotherapy alone. At the time of writing we now have reported 17 confirmed PR’s, which equates to a response rate of 31%, superior to the 23% response rate observed for chemotherapy alone.
In June we announced that two (2) patients from the trial had achieved complete responses. In one patient, the cancer lesions had decreased in size over the course of treatment to become no longer detectable for over a 2-month period. In the second patient, surgical removal of tissue that appeared to be residual tumour was shown by pathology to be non-malignant tissue, meaning that the patient had achieved a pathological complete response. This latter finding is extremely rare in metastatic pancreatic cancer and resulted in significant media attention for the patient and the hospital where the treatment was delivered.
Further progress has been made towards initiation of the second trial of narmafotinib in pancreatic cancer, this time combining the drug with a different chemotherapy called FOLFIRINOX. This trial, to will be conducted in the USA and Australia, is designed to demonstrate that narmafotinib can also improve the response to FOLFIRINOX. In June we announced that ethics approval had been received from the central US Institutional Review Board (IRB), a critical approval required before sites can initiate patient recruitment. We have now also received similar ethics approval for the Australian sites. The first stage of the trial, where different doses of narmafotinib will be trialled in combination with FOLFIRINOX, is due to start imminently.
In May, the Company announced the appointment of Dr Jason Lickliter as Chief Medical Officer. Dr Lickliter is a highly experienced medical oncologist and clinical triallist and joins the Company in a part- time capacity, whilst retaining a CMO role at clinical trials organisation Nucleus Network. Dr Lickliter has been acting in the role of clinical adviser to Amplia since 2021 and has a deep knowledge of our clinical program and data.
In April, the Company presented ACCENT trial data for the initial cohort of 26 patients at the American Association of Cancer Research annual meeting, a highly prestigious cancer meeting that attracts scientists, clinicians and representatives from pharma and biotech from across the globe.
Outlook and future activities
The Company will continue to collect, analyse and report data from the ongoing ACCENT trial over the coming months. Initiation and progression of the FOLFIRINOX and narmafotinib combination trial, being conducted in the USA and Australia, will also be a major focus of the Amplia team. Interactions with regulatory agencies, in particular the US FDA, is also planned in the coming months.
Capital Raise
On 23 July the Company announced a capital raise of $27.5 million (before costs) to support the ongoing clinical activities and additional planned activities, funding the Company into 2027. The capital raise comprises a successful institutional placement raising $25.0 million (before costs) and a Share Purchase Plan seeking to raise an additional $2.5 million. The Placement was strongly supported by existing and new institutional and sophisticated investors in Australia and offshore.
Financial update
Amplia finished the June 2025 quarter with a cash position of $7.0 million (March 2025: $10.9 million).
During the quarter, the Company had net operating cash outflows of $3.8 million in relation to operating activities (March 2025: $2.7 million). Operating cashflows included:
• Outflows of $0.9 million for staff and administration/corporate costs; and • Outflows of $3.0 million for research and development costs, which primarily related to trial costs, Contract Research Organisation (CRO), manufacturing and other CMC related costs incurred in relation to the ACCENT Phase 2 clinical trial for narmafotinib (AMP945) with gemcitabine and Abraxane and initiation costs with its AMPLICITY Phase 2 study clinical trial for narmafotinib (AMP945) with FOLFIRINOX.
The Company is also expecting to receive its Research and Development Tax Incentive refund for the year ended 31 March 2025 of $3.8m in the September 2025 quarter.