Nuclear Medicine Technologist

Telix announces collaborations to explore PSMA-PET imaging in emerging prostate cancer treatment approaches. Melbourne (Australia) and Indianapolis, IN (United States) | May 15, 2026 * Telix to partner with companies developing advanced minimally invasive and image-guided ablative technologies for prostate cancer. * Initial focus on patient selection, treatment planning and post-treatment monitoring; evidence generation to inform best practice. * Aim to accelerate adoption of novel therapeutic workflows to enhance clinical decision making and patient outcomes. Telix today announces that it has entered into letters of intent to pursue collaborations with EDAP TMS S.A.(NASDAQ: EDAP, "EDAP") and Profound Medical Corp. (NASDAQ: PROF, TSX: PRN, "Profound"), leading companies developing advanced minimally invasive and image-guided treatment ablative technologies for prostate cancer, including focal, subtotal, and whole-gland treatment approaches. These initiatives reflect Telix's commitment to advancing the integration of molecular imaging into the evolving prostate cancer treatment landscape to help inform clinical decision-making. The collaborations will explore the investigational use of Telix's PSMA-PET[1] imaging agents Gozellix(R)(kit for the preparation of gallium Ga 68 gozetotide) and Illuccix(R)(kit for the preparation of gallium Ga 68 gozetotide) with robotic high-intensity focused ultrasound (HIFU), and other image-guided therapies designed to treat localized prostate cancer, such as transurethral ultrasound ablation (TULSA). Telix's intention is to work with select partners to explore how PSMA-PET imaging may support emerging therapy workflows, which aim to preserve healthy tissue and minimize the risk of side effects such as incontinence and impotence. Collaborative activities will focus on non-promotional scientific, educational, and research engagement[2]. "We are uniquely designed to enable the integration of PSMA-PET imaging with Focal One's real-time ultrasound and fully robotic energy delivery to optimize treatment efficacy while minimizing side effects," said Ryan Rhodes, EDAP Chief Executive Officer. "As the market leader in robotic focal therapy, with a growing global installed base, this collaboration will accelerate the development and standardization of treatment strategies to further personalize focal therapy treatments using Telix's PSMA-PET imaging agents and Focal One Robotic HIFU." "Emerging clinical evidence suggests PSMA imaging may support prostate whole-gland, partial-gland, and focal ablation workflows, from treatment planning through post-treatment monitoring," said Arun Menawat, Profound's Chief Executive Officer and Chairman. "In collaboration with Telix, we look forward to exploring optimized workflows and generating clinical evidence that may help establish best practices and accelerate adoption of PSMA-PET imaging and the MRI-guided TULSA Procedure." "Precision medicine requires precision treatment strategies," said Kevin Richardson, CEO, Telix Precision Medicine. "As disruptive technologies continue to transform prostate cancer care, we believe PSMA-PET imaging has the potential to play an important role in helping inform clinical decision-making across a range of minimally invasive and image-guided treatment approaches. We are excited to explore collaborations with market leaders in EDAP and Profound that may further advance personalized care for patients." Read the full media release here [1] Imaging of prostate-specific membrane antigen. [2] PSMA-PET imaging is not currently approved for specific treatment-planning indications associated with these emerging therapies. IMPORTANT SAFETY INFORMATION (GOZELLIX) WARNINGS AND PRECAUTIONS Risk for Misinterpretation Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Imaging Prior to Initial Definitive or Suspected Recurrence Therapy The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Radiation Risks Gallium Ga-68 gozetotide contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration. Hypersensitivity Reactions to Sulfites Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. ADVERSE REACTIONS The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 +/- 40.7 MBq (5.1 +/- 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%. DRUG INTERACTIONS Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established. Please note that this information is not comprehensive. Please see the Full Prescribing Information here. IMPORTANT SAFETY INFORMATION (ILLUCCIX) WARNINGS AND PRECAUTIONS Risk for Misinterpretation Image interpretation errors can occur with Illuccix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Imaging Prior to Initial Definitive or Suspected Recurrence Therapy The performance of Illuccix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Illuccix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Radiation Risks Gallium Ga 68 gozetotide contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration. ADVERSE REACTIONS The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 +/- 40.7 MBq (5.1 +/- 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%. In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 +/- 23.1 MBq (4.52 +/- 0.62 mCi). Adverse reactions occurring at >=0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%). Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills. DRUG INTERACTIONS Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established. Please note that this information is not comprehensive. Please see the Full Prescribing Information here. You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing: [email protected].

TLX101-Px (pixlumi(r) MAA accepted in Europe. Melbourne (Australia) and Indianapolis, IN (United States) | May 1, 2026 Telix today announces that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[[18] F]fluoroethyl)-L-tyrosine, [18] F-FET), its glioma (brain cancer) imaging candidate[1], has been validated and accepted for review. The application, covering commercially significant European markets[2], has now moved into a 210-day active assessment phase[3]. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines[4]. Assuming a positive outcome from the application at Day 210, national marketing authorizations are expected to follow shortly after. In Europe, there is currently no generally available commercial product for PET[5] imaging of glioma with [18] F-FET ("FET-PET"), resulting in an acute and immediate need for a consistent, high-quality product [6]. Through this MAA, Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications. TLX101-Px is also being developed as a patient selection and response assessment tool for Telix's glioblastoma therapy candidate TLX101-Tx (iodofalan [131] I), which has been granted orphan drug designation in Europe and the U.S. The Phase 3 IPAX-BrIGHT[7] trial of TLX101-Tx in patients with recurrent glioblastoma has commenced patient dosing internationally[8] and is launching in multiple European countries. Sied Kebir, MD, Head of Clinical Neuro-Oncology, University Hospital Essen, said: "In our day-to-day practice, one of the hardest questions we face is whether a change on conventional imaging reflects tumor progression or a treatment-related effect. PET imaging with 1[8]F-FET can be used to help resolve this dilemma. The acceptance of this application is a welcome step toward broader, standardized patient access across Europe, and more timely and accurate decision-making." Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "The acceptance of our European MAA represents a significant regulatory milestone for Telix and for TLX101-Px. It supports a critical unmet need for widely accessible glioma imaging for both diagnostic evaluation and therapeutic decision-making. Subject to regulatory approval, we are preparing to bring this powerful precision medicine product to market in both Europe and the United States, where our new drug application has recently been accepted[9]." About glioma in Europe In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year[10], with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors[11]. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors of the central nervous system, particularly in the post-treatment setting[4]. Conventional MRI imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions[12]. With low survival rates and the need to make rapid decisions, precision imaging is paramount[6]. Subject to regulatory approval, TLX101-Px has the potential to address this need, enabling patients in Europe and worldwide to receive greater clarity in their diagnosis and treatment decision making. About TLX101-Px TLX101-Px (O-(2-[[18] F]fluoroethyl)-L-tyrosine) is Telix's PET imaging candidate for the characterization of glioma. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a a patient selection and response assessment tool for TLX101-Tx (iodofalan [131] I), Telix's LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in Telix's IPAX-2[13] and IPAX-BrIGHT studies. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction. In relevant European markets, the proposed brand name for TLX101-Px is "Pixlumi(R)". Brand name and commercial launch are subject to final regulatory approval. [1] Telix ASX disclosure February 18, 2026. [2] The French National Agency for Medicines and Health Products Safety (ANSM), in its capacity as Reference Member State, is responsible for coordinating and leading the scientific evaluation of the dossier, in collaboration with the concerned Member States, nominated by Telix and representing the major European markets for Telix's brain cancer imaging product. [3] 210-day assessment phase excludes clock-stop. [4] Galldiks et al. Lancet Oncol. 2025 (Joint guidelines from the European Association of Nuclear Medicine (EANM), European Association of Neuro-Oncology (EANO), Society of Nuclear Medicine and Molecular Imaging (SNMMI), Response Assessment in Neuro-Oncology (RANO), The European Society for Pediatric Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients); National Comprehensive Cancer Network(R)("NCCN") Clinical Practice Guidelines in Oncology ("NCCN Guidelines(R)") for Central Nervous System Cancers V1.2025. [5] Positron emission tomography. [6] Albert et al. Lancet Oncol. 2024. [8] Telix media release April 15, 2026. [9] Telix ASX disclosure April 10, 2026. [10] Frosina et al. Sci Rep. 2024. [11] Goodenberger et al. Cancer Genetics. 2012. [12] Smith et al. J Nucl Med. 2023.

OPTIMAL-PSMA trial of TLX597-Tx next generation RLT presented at IPCS 2026 highlighting therapeutic potential in Prostate Cancer. Melbourne (Australia) and Indianapolis, IN (United States) | April 30, 2026 * TLX597-Tx is a PSMA[1]-targeting small molecule radioligand therapy (RLT) candidate, designed to improve quality-of-life and efficacy in earlier-stage prostate cancer. * OPTIMAL-PSMA[2] initial dosimetry data demonstrate low salivary gland and kidney uptake, supporting dose intensification. * Telix is developing two distinct prostate therapeutic programs, tailored to disease stage and patient condition: TLX591-Tx radio antibody-drug conjugate (rADC) in combinations with standard of care (Phase 3 in mCRPC[3]) and TLX597-Tx intended for earlier-stage mHSPC[4]. * Webcast today: Thursday, April 30, at 9:30 a.m. AEST (Wednesday, April 29, at 7:30 p.m. EDT). Register here: https://s1.c-conf.com/diamondpass/10053985-675tre.html Telix today announces dosimetry results from the randomized Phase 2 OPTIMAL-PSMA trial of TLX597-Tx in metastatic castration-resistant prostate cancer (mCRPC), presented at the 2026 International Prostate Cancer Symposium (IPCS 2026) held in Lugano, Switzerland. These findings support TLX597-Tx's potential to deliver a treatment that overcomes quality-of-life challenges that currently limit the clinical utility of existing RLTs in earlier-stage metastatic prostate cancer. TLX597-Tx ([177] Lu-DOTA-HYNIC-panPSMA) is a novel PSMA-targeting small molecule RLT candidate with a highly favorable dosimetry profile. Significantly reduced radiation exposure to healthy organs, including the salivary glands and kidneys[5], may lower the incidence of xerostomia (dry mouth) and renal toxicity and support better tolerability for patients. This dosimetry profile combined with higher tumor uptake compared to existing PSMA RLTs may deliver a wider therapeutic window and enable dose intensification to maximize tumor control while preserving patient quality-of-life. OPTIMAL-PSMA is an open-label, multi-center, randomized, Phase 2 investigator-initiated trial (IIT) led by Professor Louise Emmett at St Vincent's Hospital in Sydney, Australia. The study is evaluating the safety, dosimetry, and efficacy of an intensified dosing regimen of TLX597-Tx compared with a standard dose schedule in 120 men with advanced mCRPC, randomized on a 2:1 basis. The novel dose-intensification regimen delivers higher activity per cycle (8.5 GBq), delivered on day 1, day 3 and day 15, followed by 10-weekly dosing for three further cycles. The study aims to confirm that a dose intensified TLX597-Tx regimen will maximize the radiation dose to cancerous lesions when they are most vulnerable to damage and therefore improve overall response to treatment. Telix believes these dosimetry data support further evaluation of TLX597-Tx in earlier-stage disease and is initiating OPTIMAL-E, a Phase 2 study in androgen pathway-sensitive prostate cancer (mHSPC). Principal Investigator for OPTIMAL-PSMA, Professor Louise Emmett, commented, "The goal of OPTIMAL-PSMA is to identify a dose regimen for TLX597-Tx that leads to deeper and longer responses without increasing toxicity for men with metastatic prostate cancer. We look forward to starting the Phase 2 OPTIMAL-E trial soon." Dr. David N. Cade, Group Chief Medical Officer at Telix, added, "These encouraging dosimetry results from OPTIMAL-PSMA, combined with earlier exploratory work[6], are very promising and highlight TLX597-Tx's potential to substantially increase the tumor dose while minimizing radiation to sensitive organs. For people living with earlier-stage metastatic disease, preserving quality-of-life alongside effective cancer control is mandatory. These findings support further study in mHSPC and reinforce Telix's strategy to develop differentiated PSMA-targeting therapies, so clinicians may be able to tailor treatment choice to the patient's disease stage and individual condition." TLX597-Tx is being developed alongside TLX591-Tx (lutetium-177 ([177] Lu) rosopatamab tetraxetan), Telix's lead antibody-based prostate cancer therapy candidate, currently the subject of the Phase 3 ProstACT Global[7] trial in mCRPC, which is actively dosing patients in jurisdictions with regulatory approval and recently reported data from a safety and dosimetry lead-in[8]. TLX591-Tx and TLX597-Tx exhibit complementary modes-of-action, suggesting the potential for distinct applications in mCRPC and mHSPC settings as part of Telix's portfolio approach to treating prostate cancer. TLX591-Tx and TLX597-Tx have not received marketing authorization in any jurisdiction. [1] Prostate-specific membrane antigen. [2] Australian New Zealand Clinical Trials Registry ID: ACTRN12625000971437. [3] Metastatic castration-resistant prostate cancer. [4] Metastatic hormone-sensitive prostate cancer. [5] Steinhelfer et al. J Nucl Med. 2024. [6] Omar et al., presented at the European Association of Nuclear Medicine 2025 Annual Congress. [8] Telix ASX disclosure March 10, 2026.