• Received Complete Response Letter from FDA for TLX101-CDx NDA
• FDA requires additional confirmatory clinical evidence to progress application
• No safety concerns raised, will request hearing with FDA to review decision

Telix Pharmaceuticals Limited has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara®), an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer. The CRL states that the FDA has completed its review of the application and has ruled that the NDA cannot be approved in its current form. The FDA stated that additional confirmatory clinical evidence is required to progress the application, despite a robust consultation process prior to submission and during review of the NDA. The FDA has not raised any concerns regarding product safety. The Company will be requesting a hearing with the FDA to review the basis for the decision and is assessing clinical strategies available to augment the package in the near term. This is a disappointing outcome for American glioma patients, as FET-PET is recommended medical best practice in relevant international oncology practice guidelines and is used extensively in other parts of the world. The FDA has granted TLX101-CDx Orphan Drug and Fast Track designation, a tacit acknowledgement of the drug candidate's importance in addressing a significant unmet medical need and clinically demonstrating benefit over existing medical solutions.

The Company remains committed to commercializing TLX101-CDx and fulfilling the unmet need to improve imaging to enable timelier and more accurate decisions for the clinical management of glioma. The Company has multiple go-forward pathways available, such as providing additional confirmatory data through several active clinical programs, including Company-led studies. The immediate focus is understanding the FDA's feedback and augmenting the submission with additional data to satisfy the Agency as soon as possible.