BiPASS Phase 3 Study: First U.S. Patient Dosed for Prostate Cancer

Telix Pharmaceuticals Doses First U.S. Patient in Phase 3 BiPASS Trial for Prostate Cancer Diagnosis

MELBOURNE, Australia, Jan. 17, 2026 – Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) has announced a significant milestone in its prostate cancer diagnostic pipeline with the dosing of the first U.S. patient in its Phase 3 BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study) trial. This pivotal study is designed to evaluate the efficacy of Telix’s commercial PSMA-PET imaging agents, Illuccix® and Gozellix®, in the initial diagnosis of prostate cancer, aiming to reduce the reliance on invasive biopsies.

The BiPASS™ trial represents a novel approach, being the first study seeking marketing authorization for ⁶⁸Ga-PSMA-PET imaging in the pre-biopsy setting. The prospective, open-label study will enroll 250 patients across clinical sites in the United States and Australia. Its core objective is to assess whether combining Magnetic Resonance Imaging (MRI) with Illuccix/Gozellix ⁶⁸Ga-PSMA-11 PET imaging can enhance diagnostic accuracy and, crucially, decrease the number of unnecessary prostate biopsies.

The current diagnostic pathway often involves patients with elevated Prostate-Specific Antigen (PSA) levels proceeding from an inconclusive MRI to a prostate biopsy. This invasive procedure, while sometimes necessary, carries inherent risks, can lead to complications, and frequently yields negative results. In the U.S. alone, over one million prostate biopsies are performed annually, with a significant proportion—up to 75%—reported as negative. Furthermore, approximately one in four patients decline a recommended biopsy, highlighting a potential unmet need for less invasive and more definitive diagnostic tools.

By integrating non-invasive molecular imaging with Illuccix/Gozellix ⁶⁸Ga-PSMA-11 PET early in the diagnostic process, the BiPASS™ study aims to demonstrate improved lesion detection and patient stratification. Success in this trial could lead to a reduction in unnecessary biopsies, an improved patient experience, and a substantial expansion of precision imaging access for individuals suspected of having prostate cancer, potentially widening the application of ⁶⁸Ga-PSMA-11 PET in a large, new patient cohort.

Dr. Brian Mazzarella of Urology Austin, where the first dose was administered, expressed enthusiasm for the trial’s potential. “We’re excited to participate in the BiPASS trial at Urology Austin, which brings together promising technologies and emerging trends in patient care,” Dr. Mazzarella stated. “If BiPASS is successful in meeting its primary endpoint, it could eliminate the need for biopsy—reducing risks, side effects, and costs—and improve decision-making for providers and patients.”

Kevin Richardson, Chief Executive Officer of Telix Precision Medicine, echoed this sentiment, emphasizing Telix’s commitment to innovation. “Illuccix and Gozellix are already transforming how clinicians treat and manage prostate cancer,” Richardson commented. “By initiating this trial, we are reinforcing Telix’s commitment to patient centricity, clinical innovation, and industry leadership—with the goal of eliminating invasive biopsy.”

The BiPASS™ trial builds upon promising clinical findings from earlier studies, including PRIMARY and PRIMARY2, which indicated that a combination of MRI and ⁶⁸Ga-PSMA-11 PET could more effectively identify or rule out prostate cancer, guiding active surveillance strategies prior to biopsy. Professor Louise Emmett, a key investigator from these prior studies, is contributing to the BiPASS™ Steering Committee.

**About Illuccix® and Gozellix®**
Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection), after radiolabeling with ⁶⁸Ga, are indicated for PET scanning of PSMA-positive lesions in men with prostate cancer. This includes patients with suspected metastasis who are candidates for initial definitive therapy, those with suspected recurrence based on elevated serum PSA levels, and for selection of patients indicated for PSMA-directed therapy.

**Important Safety Information for Illuccix® and Gozellix®**
Image interpretation errors can occur. Negative scans do not rule out prostate cancer, and positive scans do not confirm it. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur in other cancers or non-malignant processes. Clinical correlation, including histopathological evaluation, is recommended. The performance of these agents for imaging recurrent prostate cancer may be affected by PSA levels and disease site, and for imaging metastatic pelvic lymph nodes prior to initial therapy, by Gleason score.

Patients receive radiation exposure from gallium Ga 68 gozetotide, which is associated with an increased long-term cancer risk. Patients should be advised to hydrate and void frequently after administration to minimize radiation exposure. Commonly reported adverse reactions in clinical studies include nausea, diarrhea, and dizziness, occurring at a rate of approximately 1%. Other adverse reactions may include fatigue, constipation, and vomiting. Androgen deprivation therapy (ADT) and other androgen pathway therapies may affect gallium Ga 68 gozetotide uptake, though the clinical impact remains to be established.

**About Telix Pharmaceuticals Limited**
Telix is a biopharmaceutical company dedicated to the development and commercialization of innovative therapeutic and diagnostic radiopharmaceuticals and related medical technologies. Headquartered in Melbourne, Australia, Telix has a global presence with operations in the United States, United Kingdom, Brazil, Canada, Europe, and Japan. The company is building a portfolio of products aimed at addressing significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Illuccix, Telix’s first-generation PSMA-PET imaging agent, has received regulatory approval in multiple global markets. Gozellix has been approved by the U.S. FDA. Neither Illuccix nor Gozellix has received regulatory approval for initial prostate cancer diagnosis in any jurisdiction to date.

For further information, visit [www.telixpharma.com](http://www.telixpharma.com) or follow Telix on LinkedIn, X, and Facebook.

**Investor Relations**
Ms. Kyahn Williamson
SVP Investor Relations and Corporate Communications
Telix Pharmaceuticals Limited
Email: [email protected]

Annie Kasparian
Director Investor Relations and Corporate Communications
Telix Pharmaceuticals Limited
Email: [email protected]

**Media Contact**
Eliza Schleifstein
Email: [email protected]

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*This announcement contains forward-looking statements. Investors should refer to Telix’s SEC filings and risk factors for a comprehensive understanding of potential risks and uncertainties.*