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Telix Announces First Patient Dosed in First-in-Human ZOLAR Trial of TLX300-CDx in Advanced Soft Tissue Sarcoma

1. Telix begins Phase 1 ZOLAR trial for TLX300-CDx targeting soft tissue sarcoma. 2. First patient dosed in trial to evaluate safety and efficacy of TLX300-CDx. 3. Olaratumab targets PDGFRα; promising approach for disseminated STS treatment. 4. Telix holds exclusive rights to develop and commercialize radiolabelled olaratumab. 5. Current treatments for STS show poor prognosis, heightening need for new therapies.

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Why Bullish?

Starting the Phase 1 trial suggests progress toward product approval. Historical examples, such as previous successful trials in oncology, indicate potential for stock price appreciation.

How important is it?

Introduction of TLX300-CDx is crucial for addressing unmet medical needs and improving overall stock perception.

Why Long Term?

Successful trial results could lead to product approval and revenue generation, impacting TLX's stock over time.

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MELBOURNE, Australia, April 02, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; NASDAQ: TLX, Telix, the Company) today announces that a first patient has been dosed in the Phase 1 ZOLAR1 trial of TLX300-CDx (89Zr-olaratumab) in patients with advanced, metastatic soft tissue sarcoma (STS) at the Melbourne Theranostic Innovation Centre (MTIC) in Melbourne, Australia. ZOLAR is a first-in-human, proof-of-concept and biodistribution trial that uses positron emission tomography (PET) to evaluate olaratumab, a monoclonal antibody, as a therapeutic radiopharmaceutical targeting platform. Olaratumab targets platelet-derived growth factor receptor alpha (PDGFRα) a cell surface protein often over-expressed in STS. The aim of the trial is to evaluate the safety, pharmacokinetics, biodistribution and dosimetry, and establish the optimal dose of TLX300-CDx in patients with advanced STS, prior to therapeutic studies, based on a theranostic approach. As part of the study, it is also expected that the patient dosimetry and target expression characteristics will inform the final selection of therapeutic radionuclide for this candidate, in conjunction with currently active non-clinical radiation biology studies. Telix intends to develop a novel targeted radionuclide therapy, specific for PDGFRα, which could be used to treat patients with STS. Telix holds the exclusive worldwide rights to develop and commercialize radiolabelled forms of olaratumab, which was originally developed by Eli Lilly and Company (Lilly). Professor Rodney Hicks AM, Founder, Chair, and Chief Medical Officer at MTIC, and Principal ZOLAR Investigator, said, “Sarcomas are individually very rare and they can arise from a variety of different tissues. Unfortunately, they tend to respond rather poorly to chemotherapy. While localized STS generally responds to radiotherapy, it is challenging to treat once it has spread. Targeted radionuclide therapy, which targets cancer cells throughout the body, is therefore an attractive option to treat disseminated disease. At MTIC, we're fortunate to be the first site validating this investigational agent as a precision diagnostic and to inform the design of future therapeutic studies.” Dr. David N. Cade, Telix Group Chief Medical Officer, added, “We are pleased that a first patient has been imaged in the first-in-human ZOLAR trial, which is designed to inform both the potential efficacy (dosimetry) and safety profile of this research candidate as a therapeutic, based on a theranostic approach. We would like to thank Professor Hicks and his team at MTIC for their commitment to addressing unmet medical need in STS, as well as the patients who will contribute to this important trial.” Visit the Telix website to view a short video of Professor Hicks explaining the theranostic approach in soft tissue sarcoma here. TLX300-CDx has not received a marketing authorization in any jurisdiction. About Soft Tissue Sarcoma (STS) Soft tissue sarcoma is a complex disease that encompasses a diverse group of relatively rare cancers, with more than 50 malignant histological subtypes. In the United States (U.S.), it is estimated that there will be approximately 13,520 new diagnoses and 5,420 deaths from STS in 2025, representing 0.66% of overall cancer incidence and 0.88% of overall cancer mortality2. Standard treatment for soft tissue sarcoma includes surgery, radiation therapy and/or chemotherapy. For patients with advanced, unresectable, or metastatic disease, treatment typically involves chemotherapy with single agents (e.g., doxorubicin) or anthracycline-based combination regimens. However, the prognosis for these patients remains poor, with treated patients with metastatic disease having a median overall survival of around 12–18 months3. About olaratumab Olaratumab (previously marketed under the brand name, Lartruvo®) was originally developed by Lilly as a monoclonal antibody targeting PDGFRα. Olaratumab was granted "Accelerated Approval" in the U.S. and "Conditional Approval" in the EU based on Phase 2 trial data. Olaratumab was voluntarily withdrawn from the market by Lilly following the failure of the Phase 3 ANNOUNCE clinical trial, in which olaratumab in combination with standard chemotherapy did not improve survival for patients compared to chemotherapy alone. In April 2022, Telix secured the exclusive worldwide rights to develop and commercialize radiolabelled forms of olaratumab for the diagnosis and treatment of human cancers4. Olaratumab has a well-established clinical safety profile and a favorable toxicology dataset, which Telix is leveraging for radiopharmaceutical development. 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). 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 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 ClinicalTrials.gov ID: NCT06537596.2 American Cancer Society 2025.3 In et al. Ther Adv Med Oncol. 2017.4 Telix ASX disclosure 11 April 2022.

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