TLX Telix Pharmaceuticals Ltd

 Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces presentations featuring the Company’s late-stage and next generation therapeutic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2025) to be held in San Francisco, CA (US) from 13 – 15 February 2025.

Dr. David N. Cade, Telix Group Chief Medical Officer, said, “Telix will feature in four presentations at this year’s ASCO GU, which showcase the depth and differentiation of our therapeutic urologic pipeline, alongside our industry-leading precision medicine portfolio. For the first time at a medical congress, preliminary data will be presented from the CUPID study of TLX592, which was successful in demonstrating clinical proof-of-concept of Telix’s alpha therapy candidate for prostate cancer1.”

ProstACT GLOBAL, the first Phase 3 trial to evaluate Telix’s lead rADC2 therapy candidate, TLX591, in patients with PSMA3-positive mCRPC4 who have progressed while receiving a prior androgen receptor pathway inhibitor (ARPI) drug, is actively dosing patients in the United States and the Asia Pacific region and will be highlighted during a ‘Trials In Progress’ presentation.

In kidney cancer, Principal Investigators of the STARLITE-1 and -2 investigator-initiated trials will provide an update on design and status of these trials in progress. These groundbreaking studies are investigating Telix’s therapeutic candidate TLX250 in combination with immunotherapy in treatment-naïve and late-stage patients, respectively. TLX250 is positioned to be the first carbonic anhydrase IX (CAIX)- targeting rADC to market and is progressing toward a pivotal trial in clear cell renal cell carcinoma (ccRCC).

ASCO GU 2025 presentation details are listed below: Title: A Phase 3 Study of 177Lu-rosoptamab Tetraxetan Plus Standard of Care vs. Standard of Care Alone in Patients with Metastatic Castration-Resistant Prostate CancerClinicalTrials.gov ID: NCT06520345Date and Time: February 13, 2025 | 11:25 AM – 12:45 PM (PST)Presenter: Oliver Sartor, MD, Mayo ClinicType: Trials in Progress Poster SessionLocation: Level 1, West Hall | On DemandAbstract: TPS303Poster Bd: M22

Title: CUPID (64Cu-TLX592 Phase 1 PK, Biodistribution & Dosimetry): A Proof-of-Concept Study of TLX592 Targeted Alpha Therapy in Prostate CancerClinicalTrials.gov ID: NCT04726033Date and Time: February 13, 2025 | 11:25 AM – 12:45 PM (PST)Presenter: David N. Cade, MD, Telix PharmaceuticalsType: Poster SessionLocation: Level 1, West Hall | On DemandAbstract: 177Poster Bd: E16

Title: STARLITE-2: Phase 2 Study of Nivolumab plus 177Lutetium-labeled Anti–Carbonic Anhydrase IX (CAIX) Monoclonal Antibody Girentuximab (177Lu-girentuximab, TLX250) in Patients with Advanced ccRCCClinicalTrials.gov ID: NCT05239533Date and Time: February 15, 2025 | 7:10 AM – 8:10 AM (PST)Presenter: Darren Feldman, MD, Memorial Sloan Kettering Cancer CenterType: Trials in Progress Poster SessionLocation: Level 1, West Hall | On DemandAbstract: TPS608Poster Bd: K9

Title: STARLITE-1: Phase 1b/2 Study of Combination 177Lu Girentuximab (TLX250) Plus Cabozantinib and Nivolumab in Treatment Naive Patients with Advanced ccRCCClinicalTrials.gov ID: NCT05663710Date and Time: February 15, 2025 | 7:10 AM – 8:10 AM (PST)Presenter: Eric Jonasch, MD, The University of Texas, MD Anderson Cancer CenterType: Trials in Progress Poster SessionLocation: Level 1, West Hall | On DemandAbstract: TPS614Poster Bd: K15

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, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX).

Telix’s lead prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)5, by the Australian Therapeutic Goods Administration (TGA)6, by Health Canada7, by the Danish Medicines Agency8 and by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA)9. Illuccix is currently in national approval review in 18 European countries following a positive decentralized procedure (DCP) opinion by BfArM10.

Telix’s osteomyelitis (bone infection) imaging agent, technetium-99m (99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix’s miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and 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

Legal Notices

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 registration statement 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 commercialisation 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; 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.

©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country.

1 Telix ASX disclosure 21 May 2024.2 Radio antibody-drug conjugate.3 Prostate-specific membrane antigen.4 Metastatic castrate-resistant prostate cancer.5 Telix ASX disclosure 20 December 2021.6 Telix ASX disclosure 2 November 2021.7 Telix ASX disclosure 14 October 2022.8 Telix media release 11 February 2025.9 Telix ASX disclosure 13 February 2025.10 The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Telix ASX disclosure 17 January 2025.