Telix Doses First Patient in Phase 3 LUTEON Trial of TLX250-Tx for Renal Cancer

•  First patient

dosed in Phase 3 LUTEON^[1] trial evaluating TLX250-Tx in relapsed or recurrent clear cell renal cell carcinoma (ccRCC).
•  LUTEON is the first Phase 3 study of a CAIX^[2]-targeted radiopharmaceutical therapy in ccRCC

MELBOURNE, Australia and INDIANAPOLIS, July 21, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announced that the first patient has been dosed with TLX250-Tx (lutetium-177 (¹⁷⁷Lu) girentuximab tetraxetan) in the LUTEON study, the first radiopharmaceutical therapy to enter Phase 3 development for ccRCC. LUTEON is a randomized, prospective, open label, multi-center study evaluating a CAIX-targeting radionuclide therapy in patients with relapsed or recurrent ccRCC.

The patient was dosed at GenesisCare Murdoch (Western Australia), under the supervision of Dr. Aviral Singh.

Dr. Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at GenesisCare Murdoch and Principal Investigator on the LUTEON trial, commented, "Dosing the first patient in the LUTEON study marks an important milestone in the development of potential new treatment options for patients with relapsed or recurrent clear cell renal cell carcinoma. Despite advances in care, outcomes remain poor for many patients, underscoring the need for innovative therapeutic approaches. This study will play a critical role in evaluating the safety, tolerability and efficacy of this investigational CAIX-targeted radiopharmaceutical for patients globally, and we look forward to helping advance the clinical evidence for this promising therapeutic candidate."

Dr. David N. Cade, Telix Group Chief Medical Officer, added, "LUTEON represents the next stage in Telix's global clinical development of TLX250-Tx and reflects our commitment to developing precision radiopharmaceuticals for patients with difficult-to-treat cancers. We aim to further evaluate the potential of TLX250-Tx that is designed to utilize the high prevalence of CAIX expression in ccRCC to deliver targeted radiation directly to tumor sites, while limiting exposure to healthy tissue."

About TLX250-Tx

TLX250-Tx is a first-in-class CAIX-targeting rADC^[3] therapy candidate composed of a high-specificity monoclonal antibody chelated to the therapeutic radionuclide lutetium-177. CAIX is an attractive therapeutic target because it is expressed in more than 95% of ccRCC, while demonstrating limited expression in normal tissues, including kidney tissue^[4],[5].

LUTEON is being run under a Phase 3 protocol in Australia and forms part of Telix's global development program for TLX250-Tx, which includes the separate Phase 2a LUTEON ATLAS study in the United States and Europe.

The LUTEON study utilizes Telix's investigational PET^[6] imaging agent, TLX250-Px (Zircaix®^[7], zirconium-89 (⁸⁹Zr) girentuximab senvedoxam), to identify eligible patients with CAIX-positive tumors.

About clear cell Renal Cell Carcinoma

Renal Cell Carcinoma, RCC, is the most common form of kidney cancer, accounting for approximately 9 out of 10 diagnoses^[8]. Within this category, ccRCC is the most common and often the most aggressive subtype, representing about 85% of all RCC cases^[9] with up to 30% of patients presented with metastatic disease at diagnosis, which has a 20% 5-year survival rate^[10],[11]. 

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. 

Telix's commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix® (kit for the preparation of gallium-68 gozetotide injection), approved by the U.S. Food and Drug Administration (FDA). The Company's late-stage therapeutic pipeline includes three assets in pivotal-stage trials - TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (¹³¹I-iodofalan) in recurrent glioblastoma, TLX250-Tx (lutetium (¹⁷⁷Lu) girentuximab tetraxetan) in kidney cancer, complemented by a deep pipeline of next generation assets. TLX250-Tx and TLX250-Px have not received a marketing authorization in any jurisdiction.

Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit www.telixpharma.com or follow Telix on LinkedIn, X and Facebook.

 

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, completion and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, including TLX250-Px, 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, including as a result of war or other geopolitical conflicts; 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.

©2026 Telix Pharmaceuticals Limited. All rights reserved.