Telix to Showcase Additional ZIRCON Phase III Data in Kidney

Telix to Showcase Additional ZIRCON Phase III Data in Kidney Cancer Imaging and Theranostic Pipeline Developments at EAU

MELBOURNE, Australia, March 9, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces presentations from the Company's carbonic anhydrase IX (CAIX) targeting kidney and bladder cancer programs at the 38th Annual European Association of Urology (EAU) Congress to be held in Milan from 10 - 13 March 2023. Further data from Telix's completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) will be presented in a "Game Changing" oral session. Game Changing sessions are reserved for Phase III trials or other developments that the EAU's Scientific Congress Office believes will have a large impact on daily practice. In addition, presentations will report on the potential utility of TLX250-CDx in urothelial carcinoma or bladder cancer (ZiPUP study, ClinicalTrials.gov Identifier: NCT05046665); and a preclinical evaluation of a Telix targeted radionuclide therapy candidate in combination with an immune checkpoint inhibitor. Dr Colin Hayward, Telix Chief Medical Officer, said, "In support of Telix's vision to drive innovation in urologic oncology, we are pleased that our programs in renal and bladder cancer will be presented at EAU 2023, the largest urological event in Europe. Notably, Professor Peter Mulders from Radboud UMC will be presenting further data from the Phase III ZIRCON study of TLX250-CDx, our investigational renal cancer imaging agent, which is generating significant interest in the medical community, following a highly positive result. We are also excited to announce two additional presentations on Telix's CAIX-targeting candidates further exploring potential theranostic applications beyond ccRCC." EAU presentation details are as follows: Session:Game Changing Session Title:89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma - results from phase 3 ZIRCON study Date and Time: 11-Mar-2023, 10:00 AM-10:15 AM Presenter: Prof. P.F.A. Mulders, Radboud UMC, Nijmegen, The Netherlands Session:Clinical Trials in Progress Title: 89Zirconium-labelled girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP) - A phase I trial of a novel staging modality for urothelial carcinoma Date and Time: 12-Mar-2023, 10:45 AM-12:15 PM Presenter:Dr. D. Hayne, University of Western Australia, Australia Abstract ID: A0520 Session:Cell biology and novel biomarkers in kidney cancer Title:Preclinical evaluation of targeted radionuclide therapy combined with immune checkpoint inhibition Date and Time: 13-Mar-2023, 10:45 AM-12:15 PM Presenter:Ass. Prof. E. Oosterwijk, Radboud UMC, Nijmegen, The Netherlands Abstract ID: A1032 About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. 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-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn. TLX250-CDx has not received a marketing authorisation in any jurisdiction. Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[1] and by the Australian Therapeutic Goods Administration (TGA),[2] and by Health Canada.[3] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: kyahn.williamson@telixpharma.com Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include 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", "outlook", "forecast" and "guidance", or other similar words. 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 the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company'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 studies, 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, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; 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. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website. 2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). [1]ASX disclosure 20 December 2021. [2]ASX disclosure 2 November 2021. [3]ASX disclosure 14 October 2022.

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Australia , Oosterwijk , Noord Brabant , Netherlands , Japan , Milan , Lombardia , Italy , United States , United Kingdom , Belgium , Melbourne , Victoria , Canada , Switzerland , Nijmegen , Gelderland , Australian , Kyahn Williamson , Colin Hayward , Peter Mulders , European Association Of Urology , Telix Pharmaceuticals , Linkedin , Drug Administration , Australian Securities Exchange , University Of Western Australia , Prnewswire Telix Pharmaceuticals Limited , Australian Therapeutic Goods Administration , Corporate Communications , Scientific Congress Office , Health Canada , Pharmaceuticals Limited , Annual European Association , Congress Office , Telix Chief Medical Officer , Professor Peter Mulders , Game Changing , Clinical Trials , Urothelial Cancer Patients , Western Australia , Telix Pharmaceuticals Limited , March 9 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , Felix , He Company Today Announces Presentations From The 39s Carbonic Anhydrase Ix Caix Targeting Kidney And Bladder Cancer Programs At 38th Annual European Association Of Urology Eau Congress To Be Held In Milan 10 13 March 2023 Further Data Telix Completed Pivotal Phase Iii Zircon Study Tlx250 Cdx 89zr Dfo Girentuximab Clear Cell Renal Carcinoma Ccrcc Clinicaltrials Gov Identifier Nct03849118 Will Presented Ina Quot Game Changing Oral Session Sessions Are Reserved For Trials Or Other Developments That Scientific Office Believes Havea Large Impact On Daily Practice Addition , Resentations Will Report On The Potential Utility Of Tlx250 Cdx In Urothelial Carcinoma Or Bladder Cancer Zipup Study , Linicaltrials Gov Identifier Nct05046665 Anda Preclinical Evaluation Ofa Telix Targeted Radionuclide Therapy Candidate In Combination With An Immune Checkpoint Inhibitor Dr Colin Hayward , Aid , Uot In Support Of Telix 39s Vision To Drive Innovation Urologic Oncology , E Are Pleased That Our Programs In Renal And Bladder Cancer Will Be Presented At Eau 2023 , He Largest Urological Event In Europe Notably , Rofessor Peter Mulders From Radboud Umc Will Be Presenting Further Data The Phase Iii Zircon Study Of Tlx250 Cdx , Ur Investigational Renal Cancer Imaging Agent , Hich Is Generating Significant Interest In The Medical Community , Ollowinga Highly Positive Result We Are Also Excited To Announce Two Additional Presentations On Telix 39s Caix Targeting Candidates Further Exploring Potential Theranostic Applications Beyond Ccrcc Quot Eau Presentation Details As Follows Session Game Changing Title 89zr Dfo Girentuximab For Pet Ct Imaging Of Clear Cell Renal Carcinoma Results From Phase 3 Zircon Study Date And Time 11 Mar 2023 , 0 00 Am 10 15 Presenter Profp Fa Mulders , Adboud Umc , He Netherlands Session Clinical Trials In Progress Title 89zirconium Labelled Girentuximab 89zr Tlx250 Pet Urothelial Cancer Patients Zipupa Phasei Trial Ofa Novel Staging Modality For Carcinoma Date And Time 12 Mar 2023 , 0 45 Am 12 15 Pm Presenter Drd Hayne , Ustralia Abstract Id A0520 Session Cell Biology And Novel Biomarkers In Kidney Cancer Title Preclinical Evaluation Of Targeted Radionuclide Therapy Combined With Immune Checkpoint Inhibition Date Time 13 Mar 2023 , 0 45 Am 12 15 Pm Presenter Ass Profe Oosterwijk , He Netherlands Abstract Id A1032 About Telix Pharmaceuticals Limited Isa Biopharmaceutical Company Focused On The Development And Commercialisation Of Diagnostic Therapeutic Radiopharmaceuticals Is Headquartered In Melbourne , Ustralia With International Operations In The United States , Urope Belgium And Switzerland , Nd Japan Telix Is Developinga Portfolio Of Clinical Stage Products That Aims To Address Significant Unmet Medical Need In Oncology And Rare Diseases Listed On The Australian Securities Exchange Asx Tlx For More Information Visit Www Telixpharma Com Follow Twitter Linkedin Tlx250 Cdx Has Not Receiveda Marketing Authorisation Any Jurisdiction 39s Lead Product , Allium 68 68ga Gozetotide Also Known As Psma 11 Injection , As Been Approved By The Us Food And Drug Administration Fda , And By The Australian Therapeutic Goods Administration Tga , And By Health Canada 3 Telix Investor Relations Ms Kyahn Williamson Pharmaceuticals Limited Svp Corporate Communications Email Telixpharma Com Legal Notices This Announcement Is Not Intended As Promotion Or Advertising Directed To Any Healthcare Professional Other Audience In Country Worldwide Including Australia , Nited States And The United Kingdom This Announcement May Include Forward Looking Statements That Relate To Anticipated Future Events , Financial Performance , Plans , Trategies Or Business Developments Forward Looking Statements Can Generally Be Identified By The Use Of Words Such As Quot May , Uot Expect Quot , Uot Intend Quot , Uot Plan Quot , Uot Estimate Quot , Uot Anticipate Quot , Uot Outlook Quot , Uot Forecast Quot And Guidance , R Other Similar Words Forward Looking Statements Involve Known And Unknown Risks , Ncertainties And Other Factors That May Cause Our Actual Results , Evels Of Activity , Erformance Or Achievements To Differ Materially From Any Future Results , Erformance Or Achievements Expressed Implied By These Forward Looking Statements Are Based On The Company 39s Good Faith Assumptions As To Financial , Market , Egulatory And Other Risks Considerations That Exist Affect The Company 39s Business Operations In Future There Can Be No Assurance Any Of Assumptions Will Prove To Correct Context Telix , Orward Looking Statements May Include , Ut Are Not Limited To , Tatements About The Initiation , Timing , Rogress And Results Of Telix 39s Preclinical Clinical Studies , Nd Telix 39s Research And Development Programs Ability To Advance Product Candidates Into , Nrol And Successfully Complete , Linical Studies , Ncluding Multi National Clinical Trials The Timing Or Likelihood Of Regulatory Filings And Approvals , Anufacturing Activities And Product Marketing The Commercialisation Of Telix 39s Candidates , F Or When They Have Been Approved Estimates Of Telix 39s Expenses , Uture Revenues And Capital Requirements Telix 39s Financial Performance Developments Relating To Competitors Industry The Pricing Reimbursement Of Product Candidates , F And After They Have Been Approved Telix 39s Actual Results , Erformance Or Achievements May Be Materially Different From Those Which Expressed Implied By Such Statements , Nd The Differences May Be Adverse Accordingly , Ou Should Not Place Undue Reliance On These Forward Looking Statements Except As Required By Applicable Laws Or Regulations , Elix Does Not Undertake To Publicly Update Or Review Any Forward Looking Statements Past Performance Cannot Be Relied On Asa Guide Future Readers Should Read This Announcement Together With Our Material Risks , S Disclosed In Our Most Recently Filed Reports With The Asx And On Website 2023 Telix Pharmaceuticals Limited Illuccix Name Logo Are Trademarks Of Its Affiliates All Rights Reserved 1 Disclosure 20 December 2021 2 November 3 14 October 2022 ,

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