ASX ANNOUNCEMENT

CMS Grants Transitional Pass-Through Status for Gozellix

Melbourne (Australia) and Indianapolis, IN (U.S.) – 23 September 2025. Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the United States (U.S.) Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next­generation PSMA-PET1 imaging agent for prostate cancer.

This designation enables separate reimbursement for Gozellix® under the Hospital Outpatient Prospective Payment System (HOPPS), effective 1 October 2025, and marks a significant milestone in Telix’s U.S. commercial strategy. Gozellix® has already been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code A9616 to be recognized by CMS and commercial health insurers, effective 1 October 20252 . Additionally, patients are not subject to the 20% patient coinsurance under TPT.

After radiolabelling with 68Ga, Gozellix® is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected biochemical recurrence (BCR) based on elevated serum prostate­specific antigen (PSA) level3.

Gozellix® is a novel imaging agent offering a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based products, helping to overcome many of the logistical barriers that have historically limited access to PSMA-PET imaging 4 . Its innovative formulation enables scalable production, with preparation possible via gallium generators (50mCi and 100mCi) or cyclotron-based methods. This flexibility has the potential to significantly improve efficiency, scheduling flexibility, and throughput for scanning clinics 5 . Cyclotron production of Gozellix® is supported by the GE FASTlab™6 solid and liquid target production system and Telix’s ARTMS QUANTM Irradiation System® (QIS®), the market-leading cyclotron solid target technology, enabling large-scale production across both commercial networks and academic centers.

Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, “Granting TPT status for Gozellix is a strong endorsement of the clinical value of our next-generation imaging agent. Gozellix is already available nationally, and this reimbursement milestone will reduce the out-of-pocket burden for patients, enhance patient access to advanced prostate cancer imaging and simplify payment for providers. As the only provider with two FDA-approved and reimbursed products in this class, we are pleased to make PSMA-PET/CT imaging accessible to more patients and providers across the U.S."

ASX ANNOUNCEMENT

Telix Provides Regulatory Update on TLX250-CDx

Melbourne (Australia) and Indianapolis, IN (U.S.) – 28 August 2025. Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) for the Biologics License Application (BLA) for TLX250-CDx (Zircaix®1, 89Zr-DFO-girentuximab), an investigational PET2 agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma (ccRCC).

The CRL identifies deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package. The FDA has requested additional data to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial and the scaled-up manufacturing process intended for commercial use. Additionally, the FDA has documented notices of deficiency (Form 483) issued to two third-party manufacturing and supply chain partners that will require remediation prior to resubmission.

Telix believes these concerns are readily addressable and submission remediation will begin immediately. The Company will request a Type A meeting with the FDA as soon as practicable to address the deficiencies and determine an appropriate timeframe for resubmission. TLX250-CDx has a Breakthrough Therapy designation and Priority Review status, acknowledging its importance in addressing a significant unmet medical need and clinically demonstrating benefit over available diagnostics.

Dr. Christian Behrenbruch, Managing Director and Group CEO, said, “TLX250-CDx breaks new ground as a highly novel biologic-based PET imaging agent using a first-in-class isotope. Like many radiopharmaceuticals, it has a complex supply chain, and as the field advances this creates new challenges around the regulatory framework applied to these products. We believe the outstanding matters are resolvable and that we can address the remaining FDA requests within a reasonable time frame.”

The CRL does not impact Telix’s stated revenue guidance for 20253, as guidance excludes revenue forecasts from unapproved products. The Company intends to continue to provide patient access to TLX250-CDx through the FDA-approved expanded access program (EAP), subject to consultation with the FDA.