• Completed patient enrolment into Part 1 of the ProstACT Global Phase 3 study
• Preparing to complete data lock and read-out for Part 1
• Part 2 of the study has been initiated in several countries

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) has provided an update on the status of the ProstACT Global Phase 3 study of its lead prostate cancer therapy candidate TLX591 (lutetium (177Lu) rosopatamab tetraxetan). The company has confirmed that it has completed patient enrolment into Part 1 of the study, a safety and dosimetry lead-in, in accordance with the study protocol. Preparation is now underway to complete data lock and read-out, including data from each of the three cohorts in Part 1, which will be presented to the FDA to ascertain eligibility for U.S. patients to participate in the Part 2 (randomized treatment expansion) portion of the study. Preliminary results from Part 1 will be publicly disclosed at the time of readout and engagement with the FDA. An Independent Data Monitoring Committee has reviewed the available data in Part 1 and recommended that the study proceed to Part 2. Accordingly, Telix has advanced the study into Part 2, which has been initiated in Australia, New Zealand, Canada, China, Singapore, Türkiye, the United Kingdom, South Korea and Japan. The company also intends to file a clinical trial application with the EMA to enable expansion into EU sites.