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Telix Doses First Patient in Phase 3 BiPASS Trial: PSMA-PET Imaging for Prostate Cancer Diagnosis

1. Telix doses first patient in Phase 3 trial for prostate cancer. 2. Combination of MRI and PSMA-PET aims to optimize biopsy processes. 3. Potential market for imaging agents could expand by 800,000 scans. 4. Study leverages previous successful trials to improve diagnostic accuracy. 5. Innovative techniques may transform prostate cancer diagnosis and treatment.

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FAQ

Why Very Bullish?

The Phase 3 trial's success could significantly expand market potential for TLX's products, driving revenue growth as seen historically with successful clinical trials in this sector, which have resulted in stock price increases.

How important is it?

The announcement correlates with significant potential revenue growth, making the trial's progress crucial for investor sentiment and stock performance in TLX.

Why Long Term?

If successful, the trial could lead to FDA approvals and market launches, creating sustained revenue streams over many years, similar to impacts seen historically with other successful clinical trials leading to product approval.

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MDGLDYNEXAS
MELBOURNE, Australia and INDIANAPOLIS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix® and Gozellix® (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis. BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study1) is the first registration-enabling study to evaluate whether the combination of MRI2 and PSMA-PET3 imaging can improve sensitivity, specificity, and positive and negative predictive values in diagnosing prostate cancer. The aim of the study is to demonstrate that some patients can be effectively stratified to either avoid a biopsy altogether or undergo a single PSMA-PET guided biopsy instead. Telix plans to enrol 204 patients in Australia and the United States (U.S.) for the single arm, multicenter, prospective, open label, longitudinal Phase 3 study. The first BiPASS™ patient was dosed under the supervision of Principal Investigator Professor Tony Costello AM at the Australian Prostate Centre (APC), and imaged by Professor Rodney Hicks AM, at the Melbourne Theranostic Innovation Centre (MTIC). The first patient biopsy was performed by BiPASS™ Investigator and Clinical Director at APC, Mr. Phil Dundee. Prof. Costello, Founder and Director, APC said, “Urologists are often faced with the dilemma of whether or not to biopsy. This invasive and often painful procedure carries risks, with many men refusing it altogether. From a clinical perspective, when the biopsy shows low to intermediate risk cancer, it’s unclear whether this represents the true burden of disease or sampling error. Combining MRI and PSMA-PET imaging has the potential to improve both the patient experience and diagnostic accuracy. As such, being part of this study is very important to the APC and our patients.” Prof. Hicks, Founder, Chair and Chief Medical Officer, MTIC added, “PSMA-PET plus MRI has the potential to fundamentally change prostate cancer diagnosis. Using existing technologies with proven performance in lesion detection at the start of the patient journey could improve the way we stratify patients – safely de-escalating treatment or using a single precision biopsy for diagnosis.” In the current diagnosis pathway, men with elevated PSA4 values can be recommended for MRIs which are often inconclusive. A prostate template biopsy, which typically involves 12 – 20 needle biopsies, is commonly the next step, even in patients deemed as low risk on MRI. However, this non-specific procedure can still miss significant prostate cancer, and can be painful and subject to complications, with many found to be unnecessary. While more than 1 million biopsies are performed in the U.S. each year, up to 75% are negative5. Moreover, one in four patients refuse a recommended biopsy6. Adding an indication for prostate cancer diagnosis has the potential to significantly expand the U.S. market for Telix’s twin commercial PSMA-PET imaging agents by approximately 800,000 scans7. BiPASS™ builds on a promising body of research, including the PRIMARY8. and PRIMARY29 studies, which demonstrated the advantages of MRI + PSMA-PET imaging in defining or ruling out prostate cancer, or in recommending participants undergo active surveillance before an invasive biopsy is performed. Professor Louise Emmett, Principal Investigator for PRIMARY, will continue her pioneering work as a BiPASS™ Steering Committee member and an Investigator on the study. Prof. Emmett, Director of Theranostics and Nuclear Medicine, St Vincent’s Hospital, said, “My colleagues and I have built a significant body of research on the benefits of PSMA-PET and MRI, documented in the PRIMARY studies and we are pleased to see Telix expand on this research with this registration-enabling study. BiPASS™ has the potential to positively impact all men by changing clinical practice and guidelines to facilitate earlier, more accurate prostate cancer diagnosis.” 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® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA10. 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 WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: 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 ContactEliza Schleifstein917.763.8106 (Mobile)Eliza@schleifsteinpr.com Legal Notices  Cautionary Statement Regarding Forward-Looking Statements   You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.   The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.   This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.   Trademarks and Trade Names All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.   ©2025 Telix Pharmaceuticals Limited. All rights reserved.  _______________ 1 ClinicalTrials.gov ID: NCT07052214.2 Magnetic resonance imaging.3 Imaging of prostate-specific membrane antigen with positron emission tomography.4 Prostate-specific antigen.5 Vickers et al. J Clin Oncol. 2010.6 Schaufler C et al. Urologic Oncology: Seminars and Original Investigations. 2022.7 Based on positive scans for PI-RADS (Prostate Imaging Reporting and Data system) scores 2-4 (NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2025), includes negative scans at a ratio of 3.1 scans per positive case (Landa et al. PLOS ONE. 2024)​.8 Emmett et al., Eur Urol. 2021. 9 ClinicalTrials.gov ID: NCT05154162. Sponsor: Peter MacCallum Cancer Centre, Australia.10 Telix ASX disclosure 21 March 2025.

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