Amplia Therapeutics Ltd.

Release Highlights:

• Amplia Therapeutics Ltd. (ASX: ATX) has received feedback from the US Food and Drug Administration (FDA) regarding modifications to its planned clinical trial of narmafotinib, the company’s proprietary FAK inhibitor, in combination with FOLFIRINOX for advanced pancreatic cancer and annotated the proposed changes as reasonable after inspection, allowing Amplia to proceed with finalizing the study protocol and trial planning for the Phase 2a study.
• Narmafotinib holds significant potential as a highly selective FAK inhibitor drug candidate, having shown promising results in preclinical pancreatic cancer studies and is currently being evaluated in the ACCENT trial where it is combined with gemcitabine and Abraxane Positive data from both trials, which could position narmafotinib as a key component of pancreatic cancer treatment worldwide.
• The ACCENT trial, conducted in Australia and South Korea, is assessing narmafotinib’s safety and efficacy in combination therapy Amplia aims to establish the drug as a preferred addition to standard chemotherapy regimens advancing treatment options for pancreatic cancer patients.

Release Highlights:

• Amplia Therapeutics Ltd. (ASX: ATX) has announced the successful completion of patient recruitment for its ACCENT Phase 2a clinical trial, which has evaluated the efficacy of narmafotinib in combination with standard chemotherapy for advanced pancreatic cancer. The trial reached full enrollment ahead of schedule, with a total of 53 patients recruited since January 2024, including three additional patients to replace non-evaluable cases. The company now expects to release top-line data from the study in mid-Q3 2025​.
• Preliminary results from the first 26 patients enrolled in the Phase 2a portion of the ACCENT trial have shown promising efficacy, with an additional confirmed partial response (PR), bringing the total to 10 confirmed PRs and achieving an objective response rate of 38.5%, which is significantly higher than the 23% observed in the historical benchmark trial. Additionally, the median duration on trial for these patients has reached 197 days, marking a 68% improvement over historical data, while narmafotinib continues to demonstrate a favorable safety and tolerability profile​.
• The ACCENT trial, which is being conducted at twelve sites across Australia and South Korea, consists of two stages: the completed Phase 1b stage, which determined the optimal dose of narmafotinib, and the ongoing Phase 2a stage, which is assessing its efficacy in combination with chemotherapy. The trial’s primary endpoints include objective response rate and duration on trial, with secondary measures such as progression-free survival and overall survival. Amplia’s CEO, Dr. Chris Burns, emphasized that the early completion of recruitment was a result of dedicated efforts by the company and its clinical partners, and he reiterated the company’s commitment to providing timely updates as the study progresses​.

Report Highlights:

• Amplia Therapeutics Ltd. (ASX: ATX) has made significant progress in its Phase 2a ACCENT trials for pancreatic cancer treatment, recruiting 12 patients for the second and final cohort, bringing the total to 50 patients. The company also recorded three additional confirmed partial responses in the initial 26-patient cohort, increasing the total to 9 confirmed partial responses and achieving an objective response rate of 35%, which is notably higher than the historical benchmark of 23%​.
• The company strengthened its research and development efforts by initiating a preclinical collaboration with Korean biotechnology company Next&Bio to evaluate the effectiveness of Amplia’s FAK inhibitors in combination with kRas inhibitors for pancreatic cancer treatment. This partnership aims to explore the potential of these inhibitors in treating pancreatic, lung, and colorectal cancers, reinforcing Amplia’s commitment to expanding its therapeutic pipeline​.
• Amplia concluded the quarter with a strong cash position of USD 8.6MM / AUD 13.7 MM, significantly bolstered by the recent capital raise USD 8.1MM / AUD 13MM to support the completion of the Phase 2a ACCENT trial and the newly approved U.S.-based trials. The company recorded a net operating cash outflow of USD 1.9MM / AUD 3MM, primarily allocated to R&D and corporate expenses, while also settling payments to related entities.

Release Highlights:

• Additional data analysis from Amplia Therapeutics’ (ASX: ATX) Phase 1b/2a ACCENT trial in pancreatic cancer has been presented at the specialist scientific conference – the Keystone Meeting on the Tumor Microenvironment.
• The data analysis further confirms the promising activity of narmafotinib at the 400 mg dose.
• New preclinical data shows that narmafotinib enhances the activity of a drug that is used
  clinically to block the cancer-driving protein kRas in difficult-to-treat cancers, such as
  pancreatic cancer, lung cancer and colorectal cancer.

Release Highlights:

• A preclinical research collaboration with specialist drug screening company Next & Bio has been established.
• The collaboration explores the effect of Amplia’s FAK inhibitors in combination with experimental drugs called kRas inhibitors.
• kRas inhibitors are being developed for the treatment of pancreatic cancer.

Release Highlights:

• Amplia Therapeutics Limited (“ATX” or “the Company”) has today completed an allotment of 67,723,015 ordinary fully paid shares at the Offer Price of $0.115 per share in completion of an institutional placement (Placement) as part of a $13m Capital Raise announced 30 October 2024.
• All of the shares issued will rank pari-passu with existing ATX ordinary shares.
• In accordance with Section 708A(5)(e) of the Corporations Act 2001 (Act), Amplia gives notice that it has issued these shares without disclosure to investors under Part 6D.2 of the Act, and Amplia has complied with the provisions of Chapter 2M of the Act as they apply to the Company as well as Sections 674 and 674A of the Act. Additionally, there is no excluded information (as defined in Sections 708A(7) and 708A(8) of the Act) that is required to be disclosed by the Company.