• FDA Fast Track designation granted for Telix's BiPASS® program, which is evaluating ⁶⁸Ga-PSMA-PET imaging alongside MRI in the pre-biopsy prostate cancer setting.
• The designation recognizes the program's potential to address an important unmet need by enabling an imaging-first approach to initial prostate cancer diagnosis.
• Fast Track facilitates more frequent engagement with the FDA and may enable expedited review of the planned NDA.

Telix Pharmaceuticals Limited announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation for the Company's BiPASS® program.

BiPASS (Biopsy of the Prostate Avoidance Stratification Study^[1]) is evaluating gallium-68 (⁶⁸Ga) PSMA-PET imaging^[2] in combination with MRI^[3] for the detection of prostate cancer prior to biopsy.

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need^[4], potentially accelerating patient access if approved. More than three million prostate biopsies are performed globally each year^[5], yet up to 75% produce a negative result^[6]. Biopsy can be stressful and painful for patients and may provide no meaningful diagnostic benefit^[7], highlighting the importance of improved diagnostic tools earlier in the patient journey.

Telix recently completed enrollment in the Phase 3 BiPASS study of its proprietary ⁶⁸Ga-PSMA-PET agents, Illuccix® and Gozellix®^[8] for pre-biopsy prostate cancer diagnosis. The Company has positively engaged with the FDA on a new drug application (NDA) pathway and is planning its submission. The NDA pathway supports registration as a new product which, if approved, would broaden access to ⁶⁸Ga-PSMA-PET imaging for a substantially larger patient population.

BiPASS builds on the clinical foundation established by the PRIMARY^[9] and PRIMARY2^[10] studies. These studies demonstrated that combining ⁶⁸Ga-PSMA-PET imaging with MRI can significantly improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50 percent. BiPASS is not intended to replace biopsy when it benefits the patient but rather aims to improve the diagnostic pathway by helping clinicians determine which patients would benefit from biopsy and where biopsy should be targeted.

Dr. David N. Cade, Group Chief Medical Officer at Telix, said, "Fast Track designation reflects the FDA's recognition of the potential for BiPASS to address an important unmet need in the prostate cancer diagnostic pathway. We believe gallium-68 PSMA-PET, used alongside MRI, could help physicians make more informed decisions before biopsy, improve diagnostic confidence and potentially reduce unnecessary invasive procedures for patients. This designation supports continued close engagement with the FDA as we advance BiPASS toward an NDA submission."

Illuccix and Gozellix are approved for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, and in patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Illuccix is also approved for the selection of patients indicated for PSMA-directed therapy. The use of Illuccix and Gozellix in the pre-biopsy setting remains investigational and has not been approved by the FDA or any other regulatory authority.