Amplia Therapeutics Ltd.

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.
  
  
  
  
  
  
  

Report Highlights:

• Amplia Therapeutics Ltd. (ASX: ATX) is pleased to announce the successful completion of the first patient cohort in its Phase 2a clinical trial of narmafotinib targeting pancreatic cancer, reporting six confirmed partial responses out of 26 patients. As a result, recruitment has resumed to enroll an additional 24 patients, aiming to reach a total of 50 participants by the end of Q1 2025.
• The U.S. FDA granted Fast Track Designation to narmafotinib, recognizing its potential as a treatment for advanced pancreatic cancer. This designation will facilitate an accelerated development process, providing Amplia with enhanced opportunities to interact with the FDA and opening the potential for Priority Review or Accelerated Approval, which could bring the drug to patients sooner.
• Amplia reported a closing cash balance of AUD 4.6M (USD 3.02M) for the quarter ending September 30, 2024, and achieved net cash inflows of AUD 1.3M (USD 855K) during the period. These inflows were primarily bolstered by an AUD 3.2M (USD 2.1M) R&D Tax Incentive refund, which enabled the company to fully repay its AUD 1.47M (USD 967K) R&D funding loan, strengthening its financial position for continued trial activities.

Presentation Highlights:

• Amplia Therapeutics Ltd. (ASX: ATX) is advancing its lead propietary compound, narmafotinib, a best-in-class FAK inhibitor drug in the treatment of pancreatic and other solid tumors, with its ACCENT Phase 2a clinical trial demonstrating highly positive efficacy signals while nearing completion for full enrollment.
  The trial has already achieved its initial activity threshold, and full enrollment of the planned 50 patients is expected soon, with topline results anticipated by Q3 FY25.
• The U.S. FDA has granted narmafotinib for both Orphan Drug and Fast Track designations, positioning Amplia with approvals for 7 years of market exclusivity, tax credits eligibility, and an expedited pathway for regulatory reviews, preparing its market entry for pancreatic cancer treatment.
• To fund its expanding clinical program, Amplia is organizing a capital raise of approximately AUD 13.0M (USD 8.55M) through a combination of a Placement, Director Placement, and Entitlement Offer to support its clinical program. This includes the completion of the ACCENT Phase 2a trial, a new U.S.-based dose-escalation study using FOLFIRINOX for patients with advanced pancreatic cancer, as well as additional preclinical and manufacturing research from future studies.

Release Highlights:

• Amplia Therapeutics Ltd. (ASX: ATX) has released interim data from its ACCENT trial, which combines its proprietary drug, narmafotinib, with chemotherapy for treatment of advanced pancreatic cancer. Data shows six patients with confirmed partial responses (PRs), indicating a sustained 30% or greater reduction in tumor size, while 19 of the 24 evaluable patients in total have recorded tumor shrinkage.
• Narmafotinib has demonstrated a favorable tolerability profile in this study, with no required dose reductions, allowing patients to safely continue on their initial dosing schedule. Patients in the trial have had a median duration on treatment of 136 days, notably longer than the 117-day average seen in historical chemotherapy-only data.
• Initial findings suggest that narmafotinib may enable a more thorough and non-invasive tumor reduction treatment than chemotherapy alone. Recruitment has resumed for the final trial cohort of 24 patients, with three already enrolled as of October 24, 2024. Amplia expects to complete this final phase of enrollment by the end of Q1 FY2025.

Release Highlights:

• Recruitment of the final cohort of patients in the ACCENT clinical trial has begun with the first patient having started on trial this week.
• The final cohort of 24 patients adds to the 26 patients already enrolled on the trial
• The ACCENT trial explores the activity of narmafotinib, in combination with standard-of-care chemotherapy, in advanced pancreatic cancer patients