Core Viewpoint - Telix Pharmaceuticals has resubmitted a New Drug Application (NDA) for TLX101-Px, an investigational PET imaging agent for glioma characterization, to the U.S. FDA, addressing previous feedback and aiming for expedited review due to significant unmet medical needs [1][2][3]. Group 1: Product Information - TLX101-Px is a PET imaging agent targeting LAT1 and LAT2 membrane transport proteins, potentially serving as a companion diagnostic for TLX101-Tx, a glioblastoma therapy candidate [5]. - The agent has received Orphan Drug and Fast Track designations from the FDA, highlighting its potential to meet critical medical needs in glioma diagnosis and management [3][5]. Group 2: Clinical Context - Gliomas account for approximately 30% of all brain and CNS tumors and 80% of malignant brain tumors, with an annual diagnosis rate of six cases per 100,000 people in the U.S. [6]. - GBM, a high-grade glioma, is the most aggressive form of primary brain cancer, with around 22,000 new cases diagnosed each year in the U.S. [6]. Group 3: Company Overview - Telix Pharmaceuticals is a global biopharmaceutical company focused on developing therapeutic and diagnostic radiopharmaceuticals, headquartered in Melbourne, Australia, and listed on both the ASX and NASDAQ [7].

Core Viewpoint - Telix Pharmaceuticals Limited has successfully achieved the primary objectives of Part 1 of the ProstACT Global Phase 3 study for its therapeutic candidate TLX591-Tx, demonstrating an acceptable safety and tolerability profile with no new safety signals observed [1][5]. Study Findings - Part 1 confirmed the safety profile, biodistribution, and dosimetry of TLX591-Tx administered in two doses, 14 days apart, in combination with standard of care therapies: abiraterone, enzalutamide, or docetaxel [2][5]. - The patient population consisted of prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC) patients previously treated with one androgen receptor pathway inhibitor (ARPI) [2][5]. Trial Design - ProstACT Global is a differentiated Phase 3 trial comparing PSMA-targeted 177Lu-rADC therapy administered with standard of care versus standard of care alone, reflecting current global clinical practice [3]. - The study has advanced into Part 2, a 2:1 randomized treatment expansion, in regions where clinical trial approval has been obtained [3]. Expert Commentary - Neeraj Agarwal, MD, noted that the results support the feasibility of integrating TLX591-Tx with current standard therapies for mCRPC, with hematologic events aligning with expectations and resolving quickly [4]. - David N. Cade, MD, emphasized the need for improved treatment options for advanced prostate cancer and highlighted the potential of TLX591-Tx to become a new first-line option [4]. Summary Results - A total of 36 patients were dosed in Part 1, with an acceptable safety profile observed across combination cohorts [5][6]. - The tolerability profile was supported by dosimetry and low-grade non-hematologic events, with no adverse drug-drug interactions observed [6][15]. Dosimetry and Biodistribution - Lesion dosimetry indicated no difference in absorbed dose profile across cohorts, and radiation exposure to key organs was well below established safety limits [6][15]. - Pharmacokinetics demonstrated sustained activity at 15 days, corroborated by imaging showing prolonged tumor retention [15]. Additional Information - ProstACT Global is an international, multicenter trial with an overall target enrollment of approximately 490 patients, focusing on confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET imaging agent [9][24]. - TLX591-Tx has not yet received marketing authorization in any jurisdiction [12].

Core Insights - Telix Pharmaceuticals Limited has announced that Part 1 of the ProstACT Global Phase 3 study for TLX591-Tx has met its primary objectives, showing an acceptable safety and tolerability profile with no new safety signals observed [1][4]. Study Findings - Part 1 confirmed the safety profile, biodistribution, and dosimetry of TLX591-Tx administered in two doses, 14 days apart, alongside standard of care therapies: abiraterone, enzalutamide, or docetaxel, in patients with metastatic castration-resistant prostate cancer (mCRPC) [2][6]. - The study dosed 36 patients across three cohorts, with no adverse drug-drug interactions observed in TLX591-Tx combinations [5][6]. - Hematologic events were transient and manageable, aligning with expectations for this therapeutic class, with Grade 3 thrombocytopenia at 14% and neutropenia at 22% [14]. Trial Design and Progress - The ProstACT Global trial is a differentiated Phase 3 study comparing PSMA-targeted Lu-rADC therapy with standard of care versus standard of care alone, reflecting current clinical practices [3]. - Telix has advanced to Part 2 of the study, which involves a 2:1 randomized treatment expansion, pending regulatory approval in various jurisdictions [3][23]. Expert Commentary - Dr. Neeraj Agarwal emphasized the feasibility of integrating TLX591-Tx with current therapies for mCRPC, noting that adverse events were consistent with the patient population and resolved quickly [4]. - Dr. David N. Cade highlighted the need for improved treatment options for advanced prostate cancer and expressed optimism about TLX591-Tx's potential as a first-line option [4]. Dosimetry and Pharmacology - The dosimetry profile indicated no significant acute or delayed kidney toxicity, as TLX591-Tx is primarily cleared through the liver, minimizing adverse effects commonly associated with other PSMA-targeted therapies [10]. - The pharmacokinetics demonstrated sustained activity at 15 days, corroborated by imaging showing prolonged tumor retention [14].

The future of prostate cancer imaging: What do physicians want? March 5, 2026 ASX: TLX | Nasdaq: TLX Forward looking statement This presentation should be read 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 presentation is not intended to be an offer for subscription, in ...

Core Insights - Telix Pharmaceuticals Limited has announced a research collaboration with University Hospital Essen to explore the prognostic value of PSMA-PET imaging through artificial intelligence [1][4]. Group 1: Research Collaboration - The PROMISE-PET registry is a multi-center, prospective, observational study aimed at assessing the prognostic value of PSMA-PET imaging and comparing it with established clinical risk scores [2]. - The registry has been collecting data since 2018, standardizing PET readings from over 15,000 patients across more than 50 institutions globally [2]. Group 2: AI and Imaging Technology - The collaboration aims to develop AI-based prediction models for survival using gallium-68 (Ga)-PSMA-11-PET imaging data, leveraging Telix's automated machine learning platform [3]. - PSMA-PET imaging is now considered a standard of care in prostate cancer management, offering greater accuracy than conventional imaging methods [3]. Group 3: Expert Commentary - Wolfgang Fendler, MD, emphasized the importance of Telix's involvement in enhancing risk stratification and informing future clinical guidelines [4]. - Simon Wail from Telix highlighted the significance of accessing a large, standardized PSMA-PET dataset for developing clinically relevant prognostic models [4]. Group 4: Company Overview - Telix Pharmaceuticals is focused on developing therapeutic and diagnostic radiopharmaceuticals, with operations in multiple countries including the U.S., U.K., and Japan [5]. - The company has received approvals for its first-generation PSMA-PET imaging agent, Illuccix®, in various global markets [6].

Core Insights - Telix Pharmaceuticals reported a revenue of US$803.8 million for FY 2025, marking a 56% increase compared to FY 2024, and exceeded its full-year guidance [6][25] - The company achieved positive adjusted EBITDA of US$39.5 million, despite a non-material loss before tax of US$5.3 million due to increased operating expenditures [6][8] - Telix is focusing on expanding its Precision Medicine segment and has prioritized R&D investments towards late-stage assets, with US$98 million allocated to therapeutics [5][7] Financial Performance - Total revenue for FY 2025 was US$803.8 million, up from US$516.6 million in FY 2024 [8] - Gross profit increased to US$426.4 million, with a stable gross margin of 64% [8] - Research and development expenses rose to US$171.2 million from US$127.9 million in the previous year [8] - Selling and marketing expenses increased to US$96.8 million, reflecting investments in global commercial infrastructure [8] Segment Performance - The Precision Medicine segment saw a revenue increase of 22% year-over-year, driven by higher volumes of Illuccix® and the successful launch of Gozellix® in the U.S. [6][8] - The Telix Manufacturing Solutions (TMS) segment reported total revenue of US$238.4 million, with a positive adjusted EBITDA contribution of US$1.2 million from RLS [6][8] - RLS's revenue included US$170.1 million from third-party product sales and service fees, indicating strong growth in sales [6][8] R&D and Regulatory Developments - Telix invested US$98 million in its therapeutics pipeline, achieving significant milestones in clinical trials for prostate, kidney, and brain cancer treatments [5][9] - Regulatory approvals were received for multiple trials, including TLX250-Tx for metastatic clear cell renal cell carcinoma and TLX101-Tx for recurrent glioblastoma [9] - The company plans to continue expanding its product pipeline and has filed for marketing authorization for TLX101-Px in Europe and is finalizing the NDA for the U.S. [6][9] Future Guidance - For FY 2026, Telix projects revenue between US$950 million and US$970 million, reflecting confidence in sustaining growth momentum [7][9] - The company anticipates R&D expenditures of US$200 million to US$240 million to support its therapeutic pipeline [9]

This presentation should be read 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 presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the U ...

Core Insights - Telix Pharmaceuticals has announced a strategic clinical collaboration with Varian, a Siemens Healthineers company, to develop novel clinical applications that integrate Telix's theranostic products with external beam radiation therapy (EBRT) [1][2]. Group 1: Collaboration Details - The collaboration aims to enhance the role of EBRT in cancer treatment by integrating therapeutic radiopharmaceuticals and precision diagnostics, potentially improving patient selection and targeted treatment delivery [2][4]. - The initial focus will be on PSMA-PET imaging for prostate cancer radiotherapy patients, utilizing Telix's Gozellix® and Illuccix® products to develop personalized treatment plans and monitor treatment responses [3][4]. Group 2: Future Opportunities - The partnership is structured as a general framework for future co-development opportunities, which may include other PET imaging candidates in Telix's pipeline, such as TLX250-CDx and TLX101-CDx, as well as future therapeutic radiopharmaceuticals [4]. - By combining Telix's expertise in molecular imaging with Varian's leadership in radiation therapy, the collaboration aims to advance personalized cancer care and improve patient outcomes [5]. Group 3: Company Background - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals, headquartered in Melbourne, Australia, with operations in multiple countries [20]. - Varian, as a Siemens Healthineers company, has over 75 years of experience in developing technologies for cancer treatment, supporting various stages of the cancer care journey [22].

Core Insights - Telix Pharmaceuticals has received recognition for its investigational PET agent TLX250-CDx in updated clinical guidelines for molecular imaging of renal masses, marking a significant advancement in precision medicine for renal cancer [1][5][6] Group 1: Clinical Guidelines and Implications - The updated guidelines from SNMMI, EANM, and ACNM highlight the potential of molecular imaging for risk stratification of indeterminate renal masses, which can enhance patient management decisions [2] - The guidelines endorse TLX250-CDx PET as a well-tolerated and accurate method for non-invasive identification of clear cell renal cell carcinoma (ccRCC), contrasting with traditional F-FDG PET methods that have high renal excretion rates [3][4] Group 2: Clinical Trial Data - Data from Telix's pivotal Phase 3 ZIRCON trial demonstrated that TLX250-CDx met all primary and secondary endpoints, achieving a sensitivity of 86%, specificity of 87%, and a positive predictive value (PPV) of 93% for ccRCC, including small lesions [4][6] - TLX250-CDx specifically binds to carbonic anhydrase IX (CAIX), a target protein present in over 95% of ccRCC cells, resulting in high tumor-to-background ratios and consistent imaging results [4][6] Group 3: Company Statements and Future Outlook - Experts, including Professor Brian Shuch, emphasize that the inclusion of TLX250-CDx PET in clinical guidelines represents a shift towards precision medicine, providing clinicians with improved diagnostic tools for individualized treatment planning [5] - Telix's CEO, Kevin Richardson, noted that this endorsement by a global expert panel is expected to drive adoption and implementation of TLX250-CDx in clinical workflows, ultimately enhancing patient outcomes [5]

Core Insights - The U.S. Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix®, a next-generation PSMA-PET imaging agent for prostate cancer, marking a significant milestone in Telix's U.S. commercial strategy [1][2] Group 1: Product and Market Impact - Gozellix® will have separate reimbursement under the Hospital Outpatient Prospective Payment System (HOPPS) starting October 1, 2025, and has been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code A9616 [2] - The TPT status will reduce the out-of-pocket burden for patients and enhance access to advanced prostate cancer imaging [5] - Gozellix® offers a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based products, addressing logistical barriers to PSMA-PET imaging [4] Group 2: Production and Technology - The innovative formulation of Gozellix® allows for scalable production via gallium generators or cyclotron-based methods, improving efficiency and scheduling flexibility for scanning clinics [4] - Cyclotron production is supported by GE FASTlab™ and Telix's ARTMS QUANTM Irradiation System® (QIS®), enabling large-scale production across commercial networks and academic centers [4] Group 3: Clinical Application - Gozellix® is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and those with suspected biochemical recurrence based on elevated serum prostate-specific antigen (PSA) levels [3]