Telix Joins Thera4Care with TLX400-Tx to Accelerate Translation of Next Generation FAP-Targeting Theranostics

(ASX:TLX, NASDAQ:TLX) Telix Pharmaceuticals Limited has joined Thera4Care, an initiative aimed at establishing an integrated, collaborative ecosystem for theranostics to broaden patient access in Europe. Thera4Care consists of 27 partners from leading European academic centers, healthcare providers, industry stakeholders, and patient advocacy groups. The consortium has selected Telix's fibroblast activation protein (FAP) targeting dimer, DOTAGA.Glu.(FAPi)2, for clinical testing with terbium-161 (161Tb), based on its clinical potential and external scientific interest. This compound has already been validated in several clinical studies. A Phase 1 clinical trial will be conducted to explore the safety profile and preliminary activity of 161Tb-DOTAGA.Glu.(FAPi)2 in patients with FAP-expressing metastatic solid tumors, initially focusing on ovarian and pancreatic cancers and sarcomas. Telix will contribute to both preclinical and clinical activities of the consortium, supporting the clinical evaluation of 161Tb-labelled DOTAGA.Glu.(FAPi)2 and potentially supporting preclinical evaluations in other indications. The consortium will also explore scandium-44 (44Sc), copper-64 (64Cu), and copper-67 (67Cu) labelled compounds. David N. Cade, MBBS, Group Chief Medical Officer of Telix, stated that the collaboration is expected to provide preclinical and clinical data from multiple centers to inform future development directions for this target. Ken Herrmann, MD, Professor of Nuclear Medicine at Universitätsklinikum Essen and Thera4Care clinical lead, highlighted the unique opportunity to study 161Tb-FAPi due to its emission profile and potential applicability in treating micro-metastatic disease. Thera4Care brings together partners from 14 European countries and the United States. The project is coordinated by Università Cattolica del Sacro Cuore and Fondazione Policlinico Universitario Agostino Gemelli in Italy, with GE HealthCare as the industry lead. Thera4Care is co-funded under the Horizon Europe framework and is part of the Innovative Health Initiative (IHI), a public-private partnership between the European Union and the European life science industries. The Joint Undertaking (IHI JU) operates under grant agreement #101172788 and receives support from the European Union's Horizon Europe research and innovation program and several industry organizations and companies. Telix's commercial franchise includes Illuccix®, Gozellix®, and Pixclara®, with approvals in multiple countries and by the U.S. FDA. The company's late-stage therapeutic pipeline includes TLX591-Tx, TLX101-Tx, and TLX250-Tx, all in pivotal-stage trials for various cancers.

Telix Highlights Pivotal Trials in Prostate, Brain and Renal Cancers and Next Generation Theranostics at EANM

(ASX:TLX, NASDAQ:TLX) Telix Pharmaceuticals Limited announces that 20 company-related abstracts will be presented at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM) in Vienna, Austria from October 17-21, 2026. Dr. David N. Cade, Telix Group Chief Medical Officer, states that the selection of 12 abstracts for top-rated oral presentations demonstrates the quality and clinical relevance of Telix's work. Key presentations include the Phase 3 IPAX BrIGHT trial of TLX101-Tx in recurrent glioblastoma, the Phase 3 LUTEON trial of TLX250-Tx in clear cell renal cell carcinoma (ccRCC), and interim results from the PTherpan-Lu trial of TLX597-Tx in metastatic androgen receptor pathway-modified resistant (mAPMR) prostate cancer. Topline Phase 3 data for TLX591-Px (Illuccix) PET imaging of prostate cancer in Chinese men will be presented, along with real-world experience with TLX250-Px (Zircaix) in ccRCC and research from targeted alpha therapy and MedTech programs. Telix will support the EANM Sanjiv Sam Gambhir Young Investigator Award. The company will showcase Illuccix® (kit for the preparation of gallium-68 gozetotide injection), its commercial PSMA-PET imaging agent in Europe, as well as its theranostic pipeline and medical technologies including the SENSEI® miniature drop-in gamma probe and QDOSE® dosimetry software. The sponsored symposium, titled 'The future doesn't wait: The next era of theranostics in urologic oncology,' will be held on 18-Oct-26 from 13:15 to 14:45 in Hall F2, Austria Center Vienna, chaired by J. Calais. Oral presentations include studies such as ELEGANCE (TLX250-Px PET/CT in various cancers, NCT06735560), HIMIKO (TLX591-Px PET/CT in hepatocellular carcinoma, NCT06999837), CAT-VHL Phase 2 trial (TLX250-Px in Von Hippel-Lindau Disease, NCT07171905), LUTEON Phase 3 (TLX250-Tx in ccRCC, NCT07197580), IODO-RISE (TLX101-Tx in recurrent high-grade glioma), IPAX BrIGHT (TLX101-Tx in recurrent glioblastoma, NCT07100730), and PTherpan-Lu (TLX597-Tx in mCRPC). Additional presentations cover radiopharmaceutical therapy traceability, SPECT/CT optimization for alpha emitters, and integration of deep learning for tumor classification. ePosters include preliminary results from the Illuccix China Phase 3 trial (NCT05847348), studies on TLX250-Px in VHL disease and ccRCC, and dosimetric studies of bladder therapy using astatine-211. Telix's commercial franchise includes Illuccix®, available in 22 countries including the U.S., Gozellix®, approved by the FDA for prostate imaging, and Pixclara®, approved by the FDA for glioma imaging. The late-stage therapeutic pipeline features TLX591-Tx in prostate cancer, TLX101-Tx in recurrent glioblastoma, and TLX250-Tx in kidney cancer, with a deep pipeline of next-generation candidates. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America, and Asia-Pacific.

Telix to Host R&D Day in New York City on September 22, 2026

(ASX: TLX, NASDAQ: TLX) Telix Pharmaceuticals Limited announced it will host a Research and Development (R&D) Day on Tuesday, September 22, 2026, from 8:30 a.m. to 12:30 p.m. EDT in New York City. The event will feature a comprehensive overview of Telix's therapeutic and precision medicine pipeline, as well as key scientific, clinical and strategic developments across the portfolio. Members of the Telix leadership team, including Managing Director and Group CEO, Dr. Christian Behrenbruch, will present at the event. Telix will also host a Capital Markets Day in Melbourne on Wednesday, November 4, 2026, where management will provide updates on the Company’s strategy, growth outlook, financial targets and key business priorities. 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 investigational assets in pivotal-stage trials: TLX591-Tx in prostate cancer, TLX101-Tx in recurrent glioblastoma, and TLX250-Tx in kidney cancer. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific.

Telix H1 2026 Results: Investor Webcast Notification

(ASX: TLX, NASDAQ: TLX) Telix Pharmaceuticals Limited today advises that it will release its financial results for the half-year ended June 30, 2026 on Thursday August 20, 2026. An investor webcast and conference call will be held at 9:00 a.m. AEST on Thursday August 20, 2026 (7:00 p.m. EDT Wednesday August 19, 2026). 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 investigational assets in pivotal-stage trials: TLX591-Tx (lutetium-177 ( 177 Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx ( 131 I-iodofalan) in recurrent glioblastoma, and TLX250-Tx (lutetium ( 177 Lu) girentuximab tetraxetan) in kidney cancer. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. The company states that forward-looking statements may include statements about the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs.

TLX591-Tx ProstACT SELECT Study Published in Cancers Journal

(ASX: TLX, NASDAQ: TLX) Telix Pharmaceuticals Limited announced publication of results from the ProstACT SELECT study in Cancers, a peer-reviewed journal. The Phase 1 study evaluated TLX591-Tx (lutetium-177 (177 Lu) rosopatamab tetraxetan), Telix’s first-in-class PSMA-targeting radio antibody-drug conjugate (rADC) therapy candidate. The study reported a median radiographic progression-free survival (rPFS) of 8.8 months in evaluable patients. The publication highlights TLX591-Tx’s differentiated clinical profile, including an intensified dosing schedule, prolonged tumor retention, and low exocrine (salivary) gland irradiation. The authors concluded that TLX591-Tx therapy in combination with standard of care (SOC) demonstrated a manageable and predictable safety profile and indicative efficacy. Telix is further evaluating TLX591-Tx in the international multi-center Phase 3 ProstACT Global study for advanced metastatic prostate cancer. TLX591-Tx has not received a marketing authorization in any jurisdiction.

Telix Doses First Patient in Phase 3 LUTEON Trial of TLX250-Tx for Renal Cancer

(ASX: TLX, NASDAQ: TLX) Telix Pharmaceuticals Limited announced that the first patient has been dosed with TLX250-Tx in the Phase 3 LUTEON study for relapsed or recurrent clear cell renal cell carcinoma (ccRCC). The LUTEON study is the first Phase 3 study of a CAIX 2 -targeted radiopharmaceutical therapy in ccRCC and is a randomized, prospective, open label, multi-center study. The patient was dosed at GenesisCare Murdoch (Western Australia), under the supervision of Dr. Aviral Singh. CAIX is expressed in more than 95% of ccRCC, while demonstrating limited expression in normal tissues, including kidney tissue 4,5. Renal Cell Carcinoma accounts for approximately 9 out of 10 diagnoses of kidney cancer, with ccRCC representing about 85% of all RCC cases and up to 30% of patients presented with metastatic disease at diagnosis, which has a 20% 5-year survival rate 10,11. Telix's commercial franchise includes Illuccix® commercially available in 22 countries including the U.S. and Gozellix® approved by the U.S. Food and Drug Administration (FDA). The company projects that the LUTEON study will play a critical role in evaluating the safety, tolerability and efficacy of this investigational CAIX-targeted radiopharmaceutical for patients globally.

Telix Q2 Revenue US$247M, Strong Momentum and Pipeline Progress

(ASX: TLX, NASDAQ: TLX) Telix Pharmaceuticals Limited reported group revenue of US$247 million for Q2 2026, representing a 7% increase quarter-over-quarter and a 21% increase year-over-year. Precision Medicine revenue was US$202 million, up 9% QoQ and up 30% YoY, while TMS revenue was US$45 million. Telix received an initial non-refundable payment of US$40 million from Regeneron as part of a strategic collaboration to jointly develop and commercialize next-generation radiopharmaceutical therapies. The company issued US$600 million of new convertible bonds due 2031 and repurchased all outstanding 2029 convertible bonds. 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. FY 2026 research and development (R&D) expenditure guidance has been updated to US$230 million to US$270 million.

TLX101-Px (Pixlumi®) MAA Accepted in Europe

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) announced that its marketing authorization application (MAA) for TLX101-Px, a glioma imaging candidate, has been validated and accepted for review in Europe. The application covers commercially significant European markets and has entered a 210-day active assessment phase. There is currently no generally available commercial product for PET imaging of glioma with 18F-FET in Europe, highlighting an acute need for such a product. Approximately 67,500 brain and central nervous system tumors are diagnosed every year in Europe, with gliomas accounting for about 30% of these cases. The acceptance of the MAA is a significant regulatory milestone for Telix and could lead to broader patient access to advanced brain imaging.