MELBOURNE, Australia and INDIANAPOLIS, Jan. 16, 2026 -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that the first patient in the United States (U.S.) has been dosed in BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study), a Phase 3 trial to evaluate the use of Telix's commercial PSMA-PET^[1] imaging agents, Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection) in the initial prostate cancer diagnosis setting. The dose was administered under the supervision of Dr. Brian Mazzarella at Urology Austin and supplied by RLS Radiopharmacies.

BiPASS™ is the first study designed to gain marketing authorization for ⁶⁸Ga-PSMA-PET^[2] imaging in the pre-biopsy setting. The prospective, open-label Phase 3 trial will enroll 250 patients across sites in the U.S. and Australia. The study aims to determine whether combining MRI^[3] with Illuccix/Gozellix ⁶⁸Ga-PSMA-11 PET can improve diagnostic accuracy and reduce unnecessary biopsies compared to current standard practice. Men with elevated PSA^[4] often proceed from an inconclusive MRI to template prostate biopsy. This procedure is stressful and unpleasant, can lead to complications^[5] and frequently proves to be of no benefit to the patient^[6].

In the U.S., more than one million prostate biopsies are performed annually, yet up to 75% are negative^[6], and one in four patients declines the physician recommendation of receiving a biopsy^[7]. The objective of BiPASS™ is to demonstrate improved lesion detection and patient stratification by integrating non-invasive molecular Illuccix/Gozellix ⁶⁸Ga-PSMA-11 PET imaging early in the diagnostic pathway, to enable biopsy de-escalation or, alternatively, greater biopsy precision when administered.

If the BiPASS™ study achieves its primary objectives, it could lead to a reduction in unnecessary biopsies, improved patient experience, and a significant expansion of access to precision imaging for patients with suspected prostate cancer, potentially increasing the use of ⁶⁸Ga-PSMA-11 PET in a large new patient population.

Dr. Mazzarella, Vice President of Research for Urology America, said, "We're excited to participate in the BiPASS trial at Urology Austin, which brings together promising technologies and emerging trends in patient care. 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, Telix Precision Medicine, added, "Illuccix and Gozellix are already transforming how clinicians treat and manage prostate cancer. 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."

About BiPASS™

BiPASS™ (ClinicalTrials.gov ID: NCT07052214) leverages promising clinical findings from the PRIMARY^[8] and PRIMARY2^[9] studies, which demonstrated that MRI combined with ⁶⁸Ga-PSMA-11 PET can better define or rule out prostate cancer and guide active surveillance before invasive biopsy. Professor Louise Emmett, Principal Investigator for PRIMARY, serves on the BiPASS™ Steering Committee and as an Investigator on the study.

About Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection)

Illuccix, after radiolabeling with ⁶⁸Ga, 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, those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level, and for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products.

About Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection)

Gozellix, after radiolabeling with ⁶⁸Ga, 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 recurrence based on elevated serum prostate-specific antigen (PSA) level.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address 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 been approved in multiple markets globally. Gozellix has been approved by the U.S. FDA^[10]. Illuccix and Gozellix have not received regulatory approval for initial diagnosis of prostate cancer in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.) 

Annie Kasparian 
Telix Pharmaceuticals Limited 
Director Investor Relations and Corporate Communications 
Email: annie.kasparian@telixpharma.com

Media Contact

Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

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