Amplia Therapeutics Limited

Release Highlights:

• Amplia successfully completes its $4.27 million fully underwritten Entitlement Offer.
• The fully underwritten Entitlement Offer announced 16 April 2024 was well supported by
  existing shareholders and new institutional and sophisticated investors.
• Recruitment in the ongoing Phase 2a ACCENT trial is on track for 19 patients with advanced pancreatic cancer that have been recruited to date.

Report Highlights:

• Amplia was pleased to initiate Phase 2a of its ACCENT clinical trial, which aims to explore the safety, tolerability and efficacy of its best-in-class FAK inhibitor narmafotinib combined with chemotherapy drugs gemcitabine and Abraxane®.
• First patient dosing in January 2024, with South Korean sites for the ACCENT trial now recruiting patients. Investigational New Drug (IND) application cleared by US FDA for a trial of narmafotinib in the USA.
• Entitlement offer announced to fund Amplia through to Interim Anaylsis of ACCENT’s Phase 2a. The trial seeks to treat first-line patients with advanced pancreatic cancer.

Presentation Highlights:

• Amplia is developing a pipeline of small moleclue inhibitors of Focal Adhesion Kinase (FAK) – a clinically validated target in cancer. ATX’s lead compound narmafotinib is the best-in-class FAK inhibitor in development.
• Promising clinical safety and tolerability data positions narmafotinib as the preferred agent to enhance the activity of drugs that are currently standard-of-care, for the treatment of pancreatic cancer and other solid tumours.
• The company is raising AUD 4.27M by way of a fully underwritten non-renounceable entitlement offer to existing shareholders on a two (2) for five (5) basis resulting in the issue of 77.6 million new shares.

Release Highlights:

• Amplia is raising capital to develop a pipline of small molecule inhibitors of Focal Adhsion Kinase (FAK) – a clinically validated target in cancer. Amplia’s lead compound narmafotinib (AMP945) is the best-in-class FAK inhibitor in development.
• Promising clinical safety and tolerability data positions narmafotinib as the preferred agent to enhance the activity of drugs that are currently standard-of-care, for the treatment of pancreatic cancer and other solid tumours.
• The capital raising consists of a two (2) for five (5), fully underwritten pro-rata non renounceable Entitlement Offer to raise AUD 4.27M. Proceeds will be used to provide sufficient funding to undertake the Interim Analysis for the ongoing Phase 2a ACCENT trial.

Release Highlights:

• Amplia Therapeutics Limited is pleased to announce that key data from the Phase 1b ACCENT trial was presented at the annual meeting of the American Association of Cancer Research.
• The ACCENT trial is the company’s lead clinical program, exploring the activity of best-in-class FAK inhibitor narmafotinib, in combination with standard-of-care chemotherapy for advanced pancreatic cancer patients.
• Excellent demonstration of pharmacokinetics of the drug in patients, supporting once-a-day daily dose and a promising duration, showing 9 of 14 patients stayed on trial for over 5 months.

Update Highlights:

• The ACCENT trial explores the activity of narmafotinib, in combination with standard-of-care chemotherapy, in advanced pancreatic cancer patients.
• Response rates from the Phase 1b portion of the trial continue to be substantially better in
  terms of clinical response and duration on trial, when compared to treatment with
  chemotherapy alone.
• There are now 11 patients enrolled in the Phase 2a portion of the trial.

This is an executive summary on Australia-based and ASX-listed biotech company Amplia Therapeutics Limited from CEO and MD Chris Burns, who will run you through Amplia’s slide deck.

Presentation Highlights:

• Developing best-in-class FAK inhibitor narmafotinib for cancer and fibrosis indications
• Clinical trial in advanced pancreatic cancer underway
  • Interim readout planned for mid-2024
  • Preliminary signs of efficacy
• Lean team of experienced drug development staff
  • Network of experienced consultants and CROs
• Open IND for narmafotinib trial in pancreatic cancer
• Orphan Drug Designation for pancreatic cancer and IPF
• Compelling preclinical data in pancreatic cancer, combinations with
  • Gemcitabine and Abraxane
  • FOLFIRINOX
• Efficacy demonstrated in ovarian cancer and IPF models