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Telix FAP-targeting Therapeutic Published in Thyroid Journal: Demonstrates Encouraging Efficacy

1. TLX400 shows promising safety in radioiodine-resistant thyroid cancer treatment. 2. Median overall survival achieved is 32 months, with manageable adverse effects. 3. Research validates FAP-targeting therapy as significant in thyroid cancer treatment. 4. Telix explores TLX400's potential in various oncology indications. 5. Publication enhances clinical credibility for Telix's next-generation therapeutic portfolio.

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Why Bullish?

TLX400's positive data may enhance investor confidence, reminiscent of past successes in oncology treatments, such as Kalydeco for cystic fibrosis, which boosted Vertex Pharmaceuticals' stock after positive results.

How important is it?

The detailed publication of TLX400's results enhances Telix's market position and investor interest, indicating strong growth potential.

Why Long Term?

Increasing acceptance and potential regulatory approvals for TLX400 could expand market opportunities, similar to the trajectory seen with Novartis' Kymriah in CAR-T cell therapy.

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MELBOURNE, Australia and INDIANAPOLIS, May 08, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its Fibroblast Activation Protein (FAP)-targeting therapy candidate, TLX400, has been published in Thyroid, the official journal of the American Thyroid Association. The candidate demonstrated an encouraging safety profile and efficacy in aggressive, radioiodine-resistant (RAI-R) thyroid cancer1. TLX400 (177Lu-DOTAGA.Glu.(FAPi)2) has been in-licensed by Telix as part of a portfolio of next-generation therapeutic and diagnostic (“theranostic”) radiopharmaceutical candidates2. TLX400 has potential clinical utility in several oncology indications. The publication provides further validation of the safety profile and potential efficacy of Telix’s lead FAP therapeutic candidate. In this peer-reviewed manuscript, Dr. Sanjana Ballal and colleagues report results from 73 heavily pre-treated patients with RAI-R follicular thyroid carcinoma3. The authors conclude that TLX400 therapy demonstrated a promising safety profile and efficacy in aggressive, RAI-R thyroid cancer, achieving a median progression-free survival (PFS) and overall survival (OS) of 29 and 32 months, respectively, with a manageable adverse event profile. The therapeutic approach to radioiodine-refractory thyroid cancer has advanced with tyrosine kinase inhibitors (TKIs) such as sorafenib and lenvatinib, supported by the DECISION trial4 and SELECT study5 results. However, their potential risks, including significant side effects, require careful management, particularly in patients with comorbidities such as cardiac issues, hypertension, stroke, and kidney dysfunction, who may not be optimal candidates for TKI therapy. Lutetium-177 (177Lu)-FAP inhibitor therapy marks a significant advancement in thyroid cancer theranostics, where FAP in cancer-associated fibroblasts (CAFs) influences the tumor microenvironment (TME), angiogenesis, and chemotherapy resistance. CAFs interact with cancer cells, fostering tumor growth and aggressiveness, highlighting their significance as therapeutic targets and in elucidating tumor progression mechanisms. Dr. Sanjana Ballal, Senior Researcher at the All India Institute of Medical Sciences (AIIMS, New Delhi), investigator and lead author, commented, “This preliminary study highlights the promising safety profile and efficacy of TLX400 therapy in aggressive radioiodine-resistant thyroid cancer, including refractory cases. Notably, in the cohort of patients with reported efficacy, the treatment demonstrated median OS and PFS durations of 32 and 29 months, with a promising 50% partial response rate. Adverse events, primarily hematotoxicity – typical of radiopharmaceuticals – were manageable, emphasizing potential as a promising treatment option for this challenging patient population.” TLX400 is differentiated by a novel structure that drives prolonged tumor retention while minimizing off-target uptake, designed to overcome the limitations seen with first-generation FAP-targeting compounds. These candidates have extensive pre-clinical and clinical data covering a range of tumors6. Telix is exploring the clinical utility of the FAP portfolio across a range of solid tumors, including bladder cancer. Dr. David N. Cade, Group Chief Medical Officer, Telix, added, “We are highly encouraged by these data for TLX400, which compare favourably to TKIs – the standard of care treatment in patients with thyroid cancer – for OS and PFS. This provides further validation of the safety profile and efficacy potential enabled by the novel design of these FAP-targeting therapeutic candidates.” The Thyroid publication is available online at: https://www.liebertpub.com/doi/10.1089/thy.2024.0229 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, 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. 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). 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. TLX400 has not received a marketing authorization in any jurisdiction. 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 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 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. 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 Ballal et al. Thyroid. 2025. https://www.liebertpub.com/doi/10.1089/thy.2024.0229 2 Telix ASX disclosure 12 March 2025.3 The data were collected as part of a compassionate use program covered by an overarching protocol, approved by the institutional ethics board.4 Brose et al. Lancet. 2014.5 Schlumberger et al. N Engl J Med. 2015.6 See Telix investor presentation lodged with the ASX on 19 November 2024.

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