Gallium GA-68 Gozetotide

MELBOURNE, Australia, Nov. 19, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces it will expand its theranostic pipeline with new assets targeting Fibroblast Activation Protein (FAP), one of the most promising pan-cancer targets in nuclear medicine. Telix's development program will initially focus on the treatment of bladder cancer, rounding out its urology franchise, which includes late-stage therapeutic programs for kidney and prostate cancers. FAP is a pan-cancer marker expressed in the tumour microenvironment of epithelial cancers and on the surface of some specific cancer types, including sarcomas and mesotheliomas. Telix has entered into asset purchase and exclusive worldwide in-licence agreements for a suite of clinically validated FAP-targeting therapeutic and precision medicine (diagnostic) radiopharmaceutical candidates developed by Professor Frank Roesch and his collaborators at the Institute of Nuclear Chemistry at the Johannes Gutenberg-Universität Mainz, Germany. The next-generation therapeutic assets are differentiated by a novel structure that drives extended tumour retention while minimising off-target uptake, potentially overcoming the limitations seen with first-generation compounds. The diagnostic and therapeutic compounds have been clinically validated in over 500 patients across a variety of solid tumours and are the subject of multiple peer-review publications[1]. Richard Valeix, Chief Executive Officer, Telix Therapeutics, said, "We are delighted to partner with Professor Roesch and his team on this exciting frontier of radiopharmaceuticals. Telix will gain access to assets that are already significantly de-risked, with clinically demonstrated safety profile and efficacy. We will develop these assets in bladder cancer as a primary indication, in line with our focus on urological cancers, and explore the potential of FAP as a pan-cancer target, adding significant value to our pipeline." Frank Roesch, professor emeritus, said, "Over the past two years, our FAP inhibitor-based theranostic candidates have seen extensive preclinical and clinical evaluation. Collaboration has been very important, and I am grateful to many colleagues around the world who have contributed to advancing the molecules to this point. We are excited to be working with Telix as a leader in radiopharmaceutical innovation, development and commercialisation, to further develop and bring these drug candidates to regulatory approval. The ultimate goal is to improve the diagnostic precision and therapeutic outcomes of cancer patients in need." Visit the Telix corporate website to view an interactive explainer on FAP: Attack on Stroma Deal terms and conditions Under an exclusive worldwide licence agreement with a German company controlled by Professor Roesch, SCV GmbH, and a concurrently-signed asset purchase agreement with German company Medianezia GmbH, which collectively hold the intellectual property rights to the FAP assets, Telix will pay €7 million in cash as of closing (inclusive of €700,000 paid at or prior to the signing of the agreements) and a further €3 million in 12 months' time subject to any potential indemnity setoff. Telix will pay up to a further €132 million contingent upon achievement of certain clinical development and regulatory milestones related to both the diagnostic and therapeutic products under both agreements. An additional €20 million will be payable under the licence agreement on achievement of certain commercial milestones related to the diagnostic product; as well as royalties on net sales in the low to mid-single digits on the diagnostic product and an earlier formulation of the therapeutic product, if used. Closing of the licence agreement and asset purchase agreement is expected to occur simultaneously and is subject to customary closing conditions including, with respect to the acquisition of assets, assignment of patents rights and foreign direct investment (FDI) approval of Germany's Ministry for Economic Affairs and Climate Action. Telix cannot guarantee these transactions will close in any specific timeframe or upon the terms summarised herein, if at all. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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). Telix's lead 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)[2], by the Australian Therapeutic Goods Administration (TGA) [3], and by Health Canada[4]. No other Telix product has received a marketing authorisation in any jurisdiction. Visit for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. 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. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MELBOURNE, Australia and BERLIN, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into a technology collaboration and licence agreement with Berlin-based Eckert & Ziegler SE (EZAG) for the use of EZAG’s cyclotron-based systems to produce the alpha-emitting isotope, actinium-225 (225Ac). This provides Telix with both an additional commercial source of 225Ac and access to a platform technology that enables highly efficient, scalable isotope production for use in the development of next generation targeted alpha therapies (TATs), a strategic focus for Telix. EZAG is one of the world’s largest providers of isotope technology for medical, scientific and industrial use and a long-term partner of Telix. By combining EZAG’s technology with Telix’s rapidly expanding global manufacturing footprint, the collaboration will enhance capacity to produce 225Ac, to accelerate the development of Telix’s alpha therapy candidates and support eventual commercial demand. “This new collaboration is a significant step in the implementation of our actinium strategy,” said Dr. Harald Hasselmann, Chief Executive Officer of Eckert & Ziegler. “Eckert & Ziegler and Telix have a long-standing and multi-faceted business relationship. Combining the strengths of two leading players in radiopharmaceuticals and isotopes will create a collaboration for the supply of actinium-225-based radiotherapeutics, that are of high interest worldwide.” Raphaël Ortiz, Chief Executive Officer, Telix International, added: “Targeted alpha therapy is regarded as the next frontier in the field of radiopharmaceuticals and is a priority R&D focus for Telix. This collaboration will enable us to unlock the early investment we have made in alpha therapy candidates and further leverage our manufacturing facilities worldwide, including in Brussels South, for the production of this important alpha emitting isotope.” Alpha emitters such as 225Ac have the potential to deliver high amounts of energy to cancer tissue, while their short range can reduce the risk of damage to surrounding healthy cells, increasing the selectivity and potency of radiation treatment. In contrast, beta emitters such as lutetium-177 (177Lu) and iodine-131 (131I) have a longer penetration, which may suit bulky metastatic disease. The development of TATs is a priority research and development focus area for Telix and is highly complementary to the Company’s existing late-stage therapeutic pipeline. Experts believe the demand for 225Ac will increase significantly over the next decade. Telix’s R&D commitment to TAT is demonstrated in an extensive clinical-stage TAT pipeline: TLX592, a PSMA1-targeting prostate cancer therapy candidate based on the Company’s proprietary RADmAb® engineered antibody technology;TLX252, a CAIX2-targeting radio antibody-drug conjugate (rADC) under development as a potential complement to the TLX250 (beta) program;TLX1023, a LAT14-targeting small molecule-based candidate under development as a potential complement to the TLX101 and TLX101-CDx brain cancer programs; andTLX300, a radiolabelled form of a naked antibody in-licensed from Eli Lilly & Company under investigation in soft tissue sarcoma5. In addition, the completed OPALESCENCE6 and PERTINENCE7 investigator-initiated trials have demonstrated CAIX-targeting and dosimetry proof-of-concept for alpha therapy in triple-negative breast cancer, and non-muscle-invasive bladder cancer, respectively, using TLX250-CDx PET8. About Eckert & Ziegler SE Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse. For more information visit: www.ezag.com Contributing to saving lives. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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). Telix’s lead 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)9, by the Australian Therapeutic Goods Administration (TGA) 10, and by Health Canada11. 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, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. 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) 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 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. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. _____________________________1 Prostate-specific membrane antigen.2 Carbonic anhydrase IX.3 TLX102 labelled with astatine-211. All other listed alpha therapies labelled with actinium-225.4 Large amino acid transporter 1.5 Telix ASX disclosure 17 April 2023.6 ClinicalTrials.gov ID NCT04758780. Positive topline results presented at SABCS in December 2023, Telix media release 7 December 2023. 7 ClinicalTrials.gov ID NCT04897763.8 Positron emission tomography.9 Telix ASX disclosure 20 December 2021.10 Telix ASX disclosure 2 November 2021.11 Telix ASX disclosure 14 October 2022.