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 38^th 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^[1]) 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^[2]); 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 SessionTitle: ⁸⁹Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma – results from phase 3 ZIRCON studyDate and Time: 11-Mar-2023, 10:00 AM-10:15 AMPresenter: Prof. P.F.A. Mulders, Radboud UMC, Nijmegen, The Netherlands

Session: Clinical Trials in ProgressTitle: 89Zirconium-labelled girentuximab (⁸⁹Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP) – A phase I trial of a novel staging modality for urothelial carcinomaDate and Time: 12-Mar-2023, 10:45 AM-12:15 PMPresenter: Dr. D. Hayne, University of Western Australia, AustraliaAbstract ID: A0520

Session: Cell biology and novel biomarkers in kidney cancerTitle: Preclinical evaluation of targeted radionuclide therapy combined with immune checkpoint inhibitionDate and Time: 13-Mar-2023, 10:45 AM-12:15 PMPresenter: Ass. Prof. E. Oosterwijk, Radboud UMC, Nijmegen, The NetherlandsAbstract 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^[3] and follow Telix on Twitter^[4] (@TelixPharma) and LinkedIn^[5].

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 WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com^[6]

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References

1. ^{^} NCT03849118 (clinicaltrials.gov)
2. ^{^} NCT05046665 (clinicaltrials.gov)
3. ^{^} www.telixpharma.com (www.telixpharma.com)
4. ^{^} Twitter (twitter.com)
5. ^{^} LinkedIn (www.linkedin.com)
6. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)