Amplia Therapeutics - Quarterly Activities and Cash Flow Reports - December 2025

Melbourne, Australia, Jan. 30, 2026 (GLOBE NEWSWIRE) -- Key Highlights from the Quarter

• ACCENT Trial Success: The ACCENT trial, testing narmafotinib with gemcitabine and Abraxane®, continues to demonstrate that narmafotinib is well tolerated by patients whilst enhancing the effects of chemotherapy
• AMPLICITY Trial Initiation: The Phase 1b/2a AMPLICITY trial has started, combining narmafotinib with FOLFIRINOX chemotherapy, aiming to determine the optimal daily dose. Patient recruitment is ongoing in Melbourne and Sydney with US sites planned to open imminently
• Regulatory and Commercial Developments: Positive FDA feedback on dose optimization was received; a key patent for narmafotinib was granted; and Amplia successfully uplisted to the US-based OTCQB Venture Market, enhancing its investor reach
• Preclinical Studies: The second phase of a research program evaluating the activity of narmafotinib in patient-derived pancreatic cancer cells carrying specific genetic mutations has been initiated

Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX; OTCQB: INNMF), (“Amplia” or the “Company”), a company developing new approaches for the treatment for cancer and fibrosis, is announces further clinical and preclinical 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 31 December 2025.

Operations Update

Amplia continues to progress the clinical development of narmafotinib, the Company’s best-in-class FAK inhibitor, for the treatment of metastatic pancreatic cancer in two clinical trials. This quarter the Company has reported updated results from the ACCENT trial, as well as important progress in regulatory interactions, intellectual property, investor outreach and preclinical studies.

Clinical Trial Updates

The ACCENT clinical trial is investigating the combination of narmafotinib with standard-of-care chemotherapies gemcitabine and Abraxane®. The Company announced additional confirmed partial responses (PRs) in October, and subsequently December, bringing the overall response rate for the trial to 35% (19 PRs out of 55 patients). A confirmed partial response (PR) is defined as tumour shrinkage exceeding 30%, sustained for at least two months and without the appearance of new cancerous lesions. This ORR (Objective Response Rate) is a considerable improvement over the 23% response rate reported for chemotherapy alone in the clinical study on which we have benchmarked the ACCENT trial¹. Combining both confirmed and unconfirmed responses leads to a response rate of 42%.

In the October release², the Company also reported that the mean duration on trial (a key indicator of the drug combination’s ability to halt cancer progression) was calculated at 219 days from a data cut-off of 25 September. This is substantially better than typically seen for chemotherapy alone. Significantly, at this time seven patients had remained on the study for at least 12 months, and two patients had continued for more than 18 months.

Importantly the combined clinical data continues to show that narmafotinib is generally well tolerated by patients. The adverse event profile for the narmafotinib combination closely mirrors that of the chemotherapy regimen with no other significant toxicities reported.

AMPLICITY Trial

Amplia has begun the Phase 1b/2a AMPLICITY clinical trial, where the combination of narmafotinib with FOLFIRINOX chemotherapy is being investigated. FOLFIRINOX, a more aggressive chemotherapy treatment, is widely used in the treatment of advanced pancreatic cancer in the US and Western Europe. This open-label trial aims to identify the optimal daily dose of narmafotinib, given orally, when paired with FOLFIRINOX, which is administered intravenously every two weeks. Patient recruitment has commenced at sites in Melbourne and Sydney. Five clinical sites, at highly respected tertiary institutions, have been identified and are in the final stages of contracting. Our expectation is these will open in the coming months.

Regulatory and Commercial Progress

This quarter, the Company announced that it had received positive feedback from the US FDA supporting the dose optimisation strategy for narmafotinib in its planned registration enabling Phase 2b/3 trial in pancreatic cancer. Proposed amendments to the trial design are not expected to impact the overall development timeline.

The Company also announced that a key patent covering the specific salt and crystal form of narmafotinib used in clinical trials was granted by the US Patent and Trade Marks Office. The patent extends protection of the developed form of narmafotinib out to at least 2040 in the US and the other jurisdictions (including Europe, Japan, India and Australia) where the patent has been granted.

Amplia also announced this quarter successful completion of the uplisting to the US-based OTCQB. The OTCQB Venture Market is a U.S. trading platform operated by OTC Markets Group where U.S.-based investors can trade in Amplia Therapeutics’ common stock in U.S. dollars during U.S. market hours, while the Company maintains its primary listing on the ASX via codes ATX and ATXOA.

Preclinical Studies

In December, Amplia announced that it had advanced into a second phase of its research collaboration with specialty Korean biotech Next & Bio, following a successful initial program that produced encouraging early data. The collaboration focuses on evaluating Amplia’s FAK inhibitors against patient-derived pancreatic cancer cells carrying specific genetic mutations present in over 90% of pancreatic cancer cases.

Future Outlook

Over the coming months mature data will become available from the ACCENT trial, whilst progress with the AMPLICITY trial will also be announced. Additional preclinical data, including from the Next & Bio collaboration, will also be disclosed demonstrating new opportunities for narmafotinib in the treatment of pancreatic and other cancers.

Financial update

Amplia finished the December 2025 quarter with a cash position of $31.5 million (September 2025: $29.2 million). During the quarter, the Company had net operating cash inflows of $2.4 million in relation to operating activities (September 2025: $3.8 million outflows). Operating cashflows included:

• Inflows of $3.8 million from government grants and tax incentives;
• Outflows of $0.9 million for staff and administration/corporate costs; and
• Outflows of $0.9 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 with gemcitabine and Abraxane® and for its AMPLICITY clinical trial for narmafotinib combined with FOLFIRINOX.

Payments to Related Entities

In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, salaries and superannuation. Total payments made for the quarter equals $112,500 and relate to payments to the CEO/Managing Director in line with employment contracts and payments to the Non-Executive Directors.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

About Amplia Therapeutics Limited

Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on X (@ampliatx) and LinkedIn.

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumors. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently undergoing a clinical trial (the ACCENT trial) where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has already achieved its primary endpoint in achieving a confirmed response rate of 35%, superior to 23% reported in the benchmark MPACT study for gemcitabine and Abraxane alone. An interim median PFS of 7.6 months has also been reported. A second trial – AMPLICITY – has recently opened and is being run under an IND at sites in Australia and the US, investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients.

¹ New England Journal of Medicine 2013; 369: 1691 – 703

² ASX Release 09 October 2025