Gallium GA-68 Gozetotide

Melbourne (Australia) and Indianapolis, IN (United States) | July 21, 2026 Telix provides a market update on its commercial and operational performance for the quarter ended June 30, 2026 (Q2 2026). Q2 2026 Highlights[1] Group revenue of US$247 million, up 7% quarter-over-quarter (QoQ) and up 21% year-over-year (YoY). Precision Medicine continues to deliver strong growth, revenue of US$202 million, up 9% QoQ and up 30% YoY. Telix expects FY 2026 revenue and other income to be in excess of US$1 billion, with revenue tracking in line with the upper end of FY 2026 guidance of US$950 million to US$970 million plus US$40 million non-refundable other income received from Regeneron. United States (U.S.) Food and Drug Administration (FDA) alignment on ProstACT Global Phase 3 study of TLX591-Tx in mCRPC[2] to advance to Part 2 in the U.S.[3] BiPASSTM, patient enrollment nearing completion for study of Illuccix® and Gozellix® for initial prostate cancer diagnosis in the pre-biopsy setting[4]. Regeneron (NASDAQ: REGN) strategic collaboration to jointly develop and commercialize next generation radiopharmaceutical therapies, initially focused on lung cancer. FY 2026 research and development (R&D) expenditure guidance updated to US$230 million to US$270 million, enabled by the Company’s strong commercial performance and the non-refundable payment of US$40 million received from Regeneron. Q2 2026 Revenue Executive Commentary Dr. Christian Behrenbruch, Managing Director and Group CEO, stated, “We delivered another quarter of growth with U.S. dose volumes increasing 7% during the quarter, driven by growing demand for Gozellix and continued strength across our PSMA[7] imaging portfolio. This performance underscores the strength of our differentiated two-product PSMA imaging strategy and reinforces Telix’s market leadership, built on clinical differentiation, supply chain resilience and commercial execution. During the quarter, we achieved key regulatory, commercial and clinical milestones across both our Precision Medicine and Therapeutics businesses. We are tracking in line with the upper end of our FY 2026 revenue guidance and are investing further in R&D to accelerate a number of high-value programs that have the potential to create significant future growth and shareholder value.” Therapeutics Business Unit Telix continues to progress its industry-leading Therapeutics pipeline, which spans multiple product candidates and disease areas. Q2 2026 highlights include: TLX591-Tx (lutetium (177Lu) rosopatamab tetraxetan): Achieved key regulatory milestone for ProstACT Global Phase 3 trial, with the FDA confirming that the safety data from Part 1 of the study of Telix’s lead prostate cancer therapy candidate is sufficient to enable progression of Part 2 in the U.S. The FDA and Telix also achieved alignment on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan. Initiation of Part 2 in the U.S. remains subject to the FDA’s review of an Investigational New Drug (IND) amendment[8]. Part 2 continues to enroll strongly in regions where recruitment is open including Australia, New Zealand, Canada, Türkiye, the United Kingdom, Singapore and South Korea and has also received regulatory approval to commence in China. TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA): OPTIMAL-PSMA study evaluatingTLX597-Tx for mCRPC has recently completed patient enrollment of 120 patients[9]. Building on initial findings of the OPTIMAL-PSMA study, the first patients have been dosed in the OPTIMAL-e Phase 2 study, evaluatingTLX597-Tx for metastatic hormone sensitive prostate cancer[10]. TLX597-Tx is a next generation small molecule PSMA-targeting prostate cancer radioligand therapy (RLT) candidate designed to improve efficacy and quality of life in earlier-stage metastatic prostate cancer. TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan): Dosed first patient in LUTEON[11], a pivotal trial of TLX250-Tx as a monotherapy in advanced ccRCC[12]. LUTEON will evaluate the efficacy of TLX250-Tx compared with investigator’s choice of monotherapy consistent with standard of care. LUTEON forms part of Telix’s global development program[13] for TLX250-Tx, Part 1 is expected to enroll up to 40 patients. TLX101-Tx (131I-iodofalan): Enrolled first patient cohort in Part 1 (assessing safety and dose optimization) of IPAX BrIGHT, an international, multi-center pivotal trial of TLX101-Tx in patients with recurrent glioblastoma[14]. The trial is open for enrollment in Australia, Austria, the Netherlands and Belgium, with approval being sought in additional jurisdictions. Completed patient enrollment in IPAX-2[15], a Phase 1 study evaluating TLX101-Tx in patients with newly diagnosed glioblastoma, with no dose-limiting toxicities observed to date[16]. Precision Medicine Business Unit PSMA imaging portfolio: Telix’s Precision Medicine business continues to expand its commercial reach and support broader patient access to PSMA-PET/CT imaging[17]. Q2 2026 highlights include: Rapid enrollment of 338 patients in BiPASS™ Phase 3 study of Illuccix and Gozellix for the initial diagnosis of prostate cancer, integrating non-invasive 68Ga-PSMA-11 PET imaging prior to biopsy. Building on the clinical foundation established by the PRIMARY[18] and PRIMARY 2[19] studies, BiPASS™ is intended to support regulatory submissions in major markets, including the U.S., Europe and Australia. Completed patient enrollment in Japan in Phase 3 registrational study of TLX591-Px (Illuccix)[20]. Telix is preparing a New Drug Application (NDA) for submission in Japan, with clinical data from the Phase 3 local study intended to support the application. In parallel, Telix’s application for Conditional Approval is under review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). If granted, Conditional Approval will enable an expedited NDA review process while the final study clinical dataset is prepared. TLX101-Px, (Floretyrosine F 18 or 18F-FET) for brain cancer imaging: Submitted an IND application to the FDA for Pixclara®, a Phase 3 registrational study for indication expansion for the diagnosis of brain metastases. The FDA has accepted Telix’s resubmitted NDA for Pixclara®[21] and has granted a PDUFA[22] goal date of September 11, 2026[23]. Telix’s Marketing Authorization Application (MAA) for Pixlumi®21 in Europe has been validated and accepted for review[24]. Zircaix®21 (TLX250-Px, 89Zr-DFO-girentuximab) for kidney cancer imaging: Telix continues to make good progress on its Biologics License Application (BLA) resubmission for Zircaix®21in the U.S. Final Chemistry, Manufacturing and Controls (CMC) documentation is nearing completion. Consistent with TLX250-Px’s Breakthrough Therapy designation, Telix has maintained regular consultation with the FDA and expects to resubmit the application shortly. Telix Manufacturing Solutions (TMS): Expanded global operations TMS continues to expand its global operations which are fundamental to Telix’s future growth, supporting supply chain resilience. Q2 2026 highlights include: Opened TMS North Melbourne, in partnership with the Melbourne Theranostic Innovation Centre (MTIC)[25]. The purpose-built facility combines radiochemistry laboratories, clinical product manufacturing, patient dosing and imaging that aims to provide advanced clinical infrastructure and R&D capabilities to accelerate the development of targeted radiopharmaceuticals. TMS Brussels South successfully completed its first Good Manufacturing Practice (GMP) production run of a lutetium-based therapeutic candidate, representing a significant operational milestone and further validating the facility’s capabilities to support the manufacture of Telix’s next-generation therapeutics. Installed ARTMS’ QUANTM® Irradiation System (QIS®) at TMS Yokohama, expanding isotope production capabilities and enabling local Zirconium-89 (89Zr) manufacturing to support Telix’s portfolio. The installation represents further progress in scaling the ARTMS network and advancing toward the Company’s target of 50 QIS® installations globally by the end of 2026. Corporate Updates Telix entered into a strategic collaboration with Regeneron to jointly develop and commercialize next-generation radiopharmaceutical therapies[26]. The strategic partnership combines Telix’s radiopharmaceutical development, manufacturing and supply chain capabilities with Regeneron’s leading antibody discovery and development platforms, creating a framework to advance multiple novel oncology programs and further strengthen Telix’s position in Precision Medicine. On execution of the agreement, Telix has received an initial non-refundable payment from Regeneron of US$40 million. Telix also completed a refinancing of its existing convertible bond structure, issuing US$600 million of new convertible bonds due 2031 and repurchasing all outstanding 2029 convertible bonds[27]. The transaction extends debt maturities, enhances financial flexibility and further strengthens the Company’s capital structure, supporting the execution of Telix’s long-term growth strategy, including developing its late-stage therapeutics pipeline. Three new Non-Executive Directors were appointed during the quarter as part of Telix’s Board expansion and succession planning. Effective May 11, 2026, David Gill, Maria Rivas, MD, and William Jellison[28] joined the Board, further strengthening the Board’s clinical, commercial, financial and governance expertise, enhancing the Company’s capabilities as a dual-listed, commercial stage biopharmaceutical company. FY 2026 guidance Telix expects FY 2026 revenue and other income to be in excess of US$1 billion, with revenue tracking in line with the upper end of FY 2026 guidance of US$950 million to US$970 million plus US$40 million non-refundable other income from Regeneron. Revenue guidance reflects product sales in jurisdictions with a marketing authorization, and a full year of revenue contribution from RLS. Telix has updated FY 2026 R&D expenditure guidance to US$230 million to US$270 million, subject to achieving ongoing global clinical data outcomes and development milestones. The additional investment will support the advancement of high-value clinical programs beyond the Company’s original R&D forecast, including acceleration of the TLX597-Tx program and label expansion for Pixclara®, and progression of the Regeneron strategic collaboration. Illuccix® (kit for the preparation of gallium-68 gozetotide injection) is commercially available in 22 countries including the U.S. Gozellix® (kit for the preparation of gallium-68 gozetotide injection) is approved in the U.S. No other Telix product mentioned in this announcement has received a marketing authorization in any jurisdiction. [1] The financial information for the quarter ended June 30, 2026 is unaudited. [2] Metastatic castration-resistant prostate cancer. [3] Telix ASX disclosure July 2, 2026. ClinicalTrials.gov ID: NCT06520345. [4] ClinicalTrials.gov ID: NCT07052214. [5] Primarily sales of Illuccix and Gozellix in our Precision Medicine business. [6] Telix Manufacturing Solutions (TMS) third-party revenue predominantly driven by RLS Radiopharmacies (RLS), excludes Illuccix and Gozellix sales and TMS inter-segment revenue. [7] Prostate-specific membrane antigen. [8] Telix ASX disclosure July 2, 2026. [9] Telix LinkedIn June 25, 2026. Australian New Zealand Clinical Trials Registry ID: ACTRN12625000971437. [10] Telix media release July 16, 2026. Australian New Zealand Clinical Trials Registry ID: ACTRN12626000034336. [11] Telix media release July 21, 2026. ClinicalTrials.gov ID: NCT07197580. [12] Clear cell renal cell carcinoma. [13] Telix’s global development program for TLX250-Tx includes the separate LUTEON ATLAS study in the U.S. and Europe. [14] ClinicalTrials.gov ID: NCT07100730. [15] ClinicalTrials.gov ID: NCT05450744. [16] Telix media release May 19, 2026. [17] Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography. [18] Emmett et al. Eur Urol. 2021. [19] Buteau et al. Lancet Oncol. 2026. ClinicalTrials.gov ID: NCT05154162. [20] Telix media release July 17, 2026. Japan Registry of Clinical Trials identifier: JRCT2031250473. [21] Brand name subject to final regulatory approval. [22] Prescription Drug User Fee Act. [23] Telix ASX disclosure April 10, 2026. [24] Telix media release May 1, 2026. [25] Telix media release July 16, 2026. [26] Telix ASX disclosure April 13, 2026. [27] Telix ASX disclosure April 23, 2026. [28] Telix ASX disclosure April 2, 2026. Telix ASX disclosure April 9, 2026.

First patient dosed in Phase 3 LUTEON 1 trial evaluating TLX250-Tx in relapsed or recurrent clear cell renal cell carcinoma (ccRCC). LUTEON is the first Phase 3 study of a CAIX 2 -targeted radiopharmaceutical therapy in ccRCC. MELBOURNE (Australia) and INDIANAPOLIS, July 21, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announced that the first patient has been dosed with TLX250-Tx (lutetium-177 ( 177 Lu) girentuximab tetraxetan) in the LUTEON study, the first radiopharmaceutical therapy to enter Phase 3 development for ccRCC. LUTEON is a randomized, prospective, open label, multi-center study evaluating a CAIX-targeting radionuclide therapy in patients with relapsed or recurrent ccRCC. The patient was dosed at GenesisCare Murdoch (Western Australia), under the supervision of Dr. Aviral Singh. Dr. Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at GenesisCare Murdoch and Principal Investigator on the LUTEON trial, commented, “Dosing the first patient in the LUTEON study marks an important milestone in the development of potential new treatment options for patients with relapsed or recurrent clear cell renal cell carcinoma. Despite advances in care, outcomes remain poor for many patients, underscoring the need for innovative therapeutic approaches. This study will play a critical role in evaluating the safety, tolerability and efficacy of this investigational CAIX-targeted radiopharmaceutical for patients globally, and we look forward to helping advance the clinical evidence for this promising therapeutic candidate.” Dr. David N. Cade, Telix Group Chief Medical Officer, added, “LUTEON represents the next stage in Telix’s global clinical development of TLX250-Tx and reflects our commitment to developing precision radiopharmaceuticals for patients with difficult-to-treat cancers. We aim to further evaluate the potential of TLX250-Tx that is designed to utilize the high prevalence of CAIX expression in ccRCC to deliver targeted radiation directly to tumor sites, while limiting exposure to healthy tissue.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); About TLX250-Tx TLX250-Tx is a first-in-class CAIX-targeting rADC 3 therapy candidate composed of a high-specificity monoclonal antibody chelated to the therapeutic radionuclide lutetium-177. CAIX is an attractive therapeutic target because it is expressed in more than 95% of ccRCC, while demonstrating limited expression in normal tissues, including kidney tissue 4,5 . LUTEON is being run under a Phase 3 protocol in Australia and forms part of Telix's global development program for TLX250-Tx, which includes the separate Phase 2a LUTEON ATLAS study in the United States and Europe. The LUTEON study utilizes Telix’s investigational PET 6 imaging agent, TLX250-Px (Zircaix® 7 , zirconium-89 ( 89 Zr) girentuximab senvedoxam), to identify eligible patients with CAIX-positive tumors. About clear cell Renal Cell Carcinoma Renal Cell Carcinoma, RCC, is the most common form of kidney cancer, accounting for approximately 9 out of 10 diagnoses 8 . Within this category, ccRCC is the most common and often the most aggressive subtype, representing about 85% of all RCC cases 9 with up to 30% of patients presented with metastatic disease at diagnosis, which has a 20% 5-year survival rate 10,11 . About Telix Pharmaceuticals Limited Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. Telix's commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix® (kit for the preparation of gallium-68 gozetotide injection), approved by the U.S. Food and Drug Administration (FDA). The Company's late-stage therapeutic pipeline includes three assets in pivotal-stage trials - TLX591-Tx (lutetium-177 ( 177 Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx ( 131 I-iodofalan) in recurrent glioblastoma, TLX250-Tx (lutetium ( 177 Lu) girentuximab tetraxetan) in kidney cancer, complemented by a deep pipeline of next generation assets. TLX250-Tx and TLX250-Px have not received a marketing authorization in any jurisdiction. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit or follow Telix on LinkedIn , X and Facebook . Investor Relations Annie Kasparian Annie.kasparian@telixpharma.com Charlene Jaw Charlene.jaw@telixpharma.com Media Eliza Schleifstein Eliza@schleifsteinpr.com 1 ClinicalTrials.gov ID: NCT07197580 . 2 Carbonic Anhydrase IX. 3 Radio antibody-drug conjugate. 4 Luong-Player A, et al. Am J Clin Pathol. 2014. 5 Kleinendorst SC, et al. Theranostics. 2024. 6 Positron emission tomography. 7 Brand name subject to final regulatory approval. 8 Bukavina, L, et al. Eur Urol . 2022. 9 Alchahin AM, et al. Nat Commun. 2022. 10 National Cancer Institute. Cancer stat facts: kidney and renal pelvis cancer. Updated 2025. Accessed May 1, 2026. . 11 Vento JA, et al. Cancers (Basel) . 2022. Legal Notices Cautionary Statement Regarding Forward-Looking Statements. 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. 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