KLK3

OXFORD, UK I May 1, 2025 I Blue Earth Therapeutics today announced further progress in development of its radiohybrid, lutetium-labelled, PSMA targeted, investigational radioligand therapy, with enrolment of the first two patients in a Phase 2 clinical trial. The primary measure of efficacy in the study will be the proportion of patients achieving a ≥50% reduction in PSA levels, as well as assessing radiographic progression-free survival and patient safety (NCT05413850). The study is testing multiple dosing regimens that focus on delivering higher radiation doses when tumor burden is usually highest, at the beginning of treatment. This approach contrasts to pivotal studies of earlier radioligand therapies where the same dose was administered in every cycle 2 regardless of tumor burden. The study design aligns with the US FDA Project Optimus initiative where the goal is that drug developers optimize dosing early in a product’s development to deliver the best possible benefit risk profile. Loading doses will be delivered by either a) giving a higher dose in the first two treatment cycles, or b) shortening the time between administration of the first three doses to three weeks from the usual six weeks. The study is also designed to test the clinical benefit of administration of high total doses of administered radioactivity, up to 60GBq. The Phase 1 data confirmed a high ratio of uptake in tumor tissues vs. uptake in healthy tissues such as kidneys and salivary glands 1 . David Gauden DPhil, CEO of Blue Earth Therapeutics said, “This is an important step forward in the development of Lutetium ( 177 Lu) rhPSMA-10.1 injection and builds on the strong data seen in the Phase 1 clinical trial. Commencement of treatment of patients at full intended therapeutic dosing levels provides a great opportunity to assess the benefit this therapy can bring to patients. With up to 20 sites enrolling patients, we expect to see first results from the study early next year. We are grateful to the physicians and patients of Biogenix Molecular in Florida, who have just recruited the first patients for the study.” About metastatic prostate cancer In 2025 it is estimated that there will be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses). 3 Five-year survival for newly diagnosed metastatic prostate cancer is low, 36.6%. 4 While death rates from prostate cancer have declined over the past three decades 4 , there is still considerable room to improve patient outcomes. About Radiohybrid Prostate–Specific Membrane Antigen (rhPSMA) rhPSMA compounds are referred to as radiohybrid (“rh”), as each molecule possesses four distinct domains. The first consists of a Prostate–Specific Membrane Antigen–targeted receptor ligand. It is attached to two labelling moieties which may be radiolabelled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. About Blue Earth Therapeutics Blue Earth Therapeutics is a clinical stage company dedicated to advancing next-generation targeted radiotherapeutics to treat patients who have cancer and has been incubated within the Bracco family of companies. Other investors joined with Bracco in a $76.5M Series A financing round in 2024. With proven management expertise across the spectrum of radiopharmaceutical and oncology drug development, as well as biotechnology start–up experience, the Company aims to innovate and improve upon current technologies and rapidly advance new targeted therapies for serious diseases. Blue Earth Therapeutics has an emerging pipeline initially focused on prostate cancer. For more information, please visit: https://www.blueearththerapeutics.com . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world–leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X–ray imaging (including Computed Tomography–CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose–management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting–edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com . SOURCE: Blue Earth Therapeutics

– First Level 1 study comparing an emerging technology head-to-head with RP in men with prostate cancer – – TULSA had no blood loss and no overnight stay, along with reduced post-procedure pain, and more rapid recovery to baseline activities and overall health – TORONTO, April 29, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, AI-powered, incision-free therapies for the ablation of diseased tissue, is pleased to announce initial perioperative data from the Level 1 post-market CAPTAIN trial comparing the safety and efficacy of the TULSA procedure with radical prostatectomy (“RP”) in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. The positive perioperative results were presented yesterday by Xiaosong Meng, M.D., Ph.D., an Assistant Professor in the Department of Urology at UT Southwestern Medical Center, at the American Urological Association (“AUA”) Annual Meeting. Starting in 2022, CAPTAIN patients were recruited at 20 sites in the United States, two in Canada and one in Europe. As of January 2025, 201 patients were randomized and, to-date, 194 have been treated or scheduled for treatment (69% TULSA, 31% RP). Baseline patient characteristics are balanced for TULSA vs RP, with median (IQR) age 63 (58-68) vs. 64 (59-68) years, proportions with PSA ≤10ng/mL 77% vs. 74%, and 23% vs 26% with PSA>10ng/mL. Proportions of TULSA vs. RP patients with GG2/3 disease were 76%/24% vs. 74%/26%. All patients were EPIC pad-free at baseline. Dr. Meng’s AUA presentation highlighted that TULSA provided statistically significant improvement in all assessed perioperative measures: Blood loss: TULSA median 0 (IQR 0-0) mL vs. RP 100 (100-200) mL, p<0.001.Length of stay: TULSA median 0.29 (IQR 0.27-0.32) days vs. RP 1.24 (1.12-1.36) days, p<0.001.NRS (Numeric Rating Scale) pain: Significantly lower post-operative pain after TULSA procedure vs. RP through to post-treatment day 6, p<0.05.Patient-reported health-related QOL: Significantly higher overall health on the EQ-5D-5L 0-100 VAS (Visual Analog Scale) after TULSA vs. RP for all 30 days measured after treatment, p<0.05.During the first month post-treatment, significantly fewer TULSA patients reported experiencing extreme problems or inability with mobility (0% for TULSA vs. 12% for RP, p=0.001), self-care (3% for TULSA vs. 17% for RP, p=0.005), and usual activities (17% for TULSA vs. 40% for RP, p=0.008). Dr. Meng commented, “I commend the Sponsor and the Study Investigators for taking on this audacious study, as CAPTAIN is the fist randomized controlled trial comparing a new technology to the standard of robotic radical prostatectomy to successfully recruit to target enrollment. In addition to including some of the most talented and high volume surgeons from academic hospitals and private practice, I believe successful randomization was in large part due to TULSA’s proven safety and efficacy for whole-gland ablation in intermediate-risk prostate cancer patients, which fostered equipoise between both arms. While TULSA already has a well-established body of clinical evidence, it now has hard data that shows quantitatively in a head-to-head fashion significantly superior post-treatment patient experience compared to robotic prostatectomy.” “Zero blood loss and nearly a full 24 hours less at the hospital or clinic. Dramatic reduction in post procedure pain and significant improvement with patient mobility, self-care and ability to perform usual activities,” said Arun Menawat, Profound’s CEO and Chairman. “When we see the data that says that robotic prostatectomy patients take over two weeks of recovery, on average, to feel like a TULSA patient does the day after their procedure, we can understand how TULSA patients are often out at the restaurant with their families the night of their procedure rather than laying in a hospital bed. This superior patient experience leads to high patient satisfaction and patient demand, which interestingly is the same axis that drove adoption of the surgical robot in its early days.” Dr. Menawat added, “We believe the CAPTAIN perioperative outcomes are not only central to patient demand, but are also important for insurance companies who consider Level 1 randomized controlled trials the gold standard in evidence-based research for establishing the effectiveness of interventions and making their coverage policies. We look forward to continue reporting CAPTAIN follow-up data, adding to the growing body of clinical evidence that demonstrates the unrivaled precision and flexibility of TULSA with consistent safe and effective outcomes across the full spectrum of prostate disease states.” About CAPTAIN CAPTAIN (A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants with Localized Prostate Cancer) is a prospective, multi-center randomized controlled trial aimed at comparing the safety and efficacy of the TULSA procedure (performed with the TULSA-PRO® system) with RP in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. The goal of CAPTAIN is to demonstrate that the efficacy of the TULSA procedure is not inferior to RP, while demonstrating superior quality of life outcomes. The primary safety endpoint is the proportion of patients who preserve both erectile potency and urinary continence at one year after treatment. The primary efficacy endpoint is the proportion of patients who are free from any additional treatment for prostate cancer, free of metastases or prostate cancer related death by three years after treatment. Secondary endpoints include comparison of rates of complications, cost effectiveness, as well as histologic and biochemical failure. About Profound Medical Corp. Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue. Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control. The TULSA procedure, performed using the TULSA-PRO® system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. TULSA employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO® is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”). Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy. Forward-Looking Statements This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; and the success of Profound’s U.S. commercialization strategy and activities for TULSA-PRO®. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound's Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.ca and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. For further information, please contact: Stephen KilmerInvestor Relationsskilmer@profoundmedical.com T: 647.872.4849 Susan ThomasPublic Relationssthomas@profoundmedical.com T: 619.540.9195

New approval provides French hospitals and clinics with access to a proven PSMA-PET imaging agent MELBOURNE, Australia, April 29, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its prostate cancer PET[1] imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in France by ANSM[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. Illuccix, after radiolabelling with gallium-68, is indicated in France for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated. PSMA-PET[3] imaging represents a significant advancement in prostate cancer management, providing clinicians with more information than conventional imaging methods (bone scan, CT[4] scan) thereby offering a new standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognise its superior accuracy in staging primary disease and assessing BCR/biochemical persistence (BCP)[5]. Illuccix® PSMA-PET will help address an important clinical need by supporting timely and effective diagnosis, as well as identifying patients who may benefit from PSMA-targeted therapy. Illuccix's broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial[6]. The approval of Illuccix® in France has the potential to resolve access challenges by enabling hospitals and clinics to prepare PSMA-PET scans on-site, offering physicians a quicker, more accessible solution. Professor Frédéric Courbon, Head of the Medical Imaging Department - University Cancer Institute of Toulouse – Oncopole, commented, "PSMA-PET imaging is dramatically changing prostate cancer patient management. Thus, equitable and reliable access to PSMA-PET across France is essential. The approval of Illuccix® in France will address some of the access challenges, and reduce the risk of delayed diagnosis, with a readily available option for effective disease management." With its broad indication and ready-to-use formulation, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe, reinforcing the need for solutions that fit within existing hospital workflows. "The approval of Illuccix in France will enable a clinically validated PSMA-PET product to be more widely available, allowing healthcare providers to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces our ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe," said Raphaël Ortiz, Chief Executive Officer, Telix International. Telix will partner with IRE ELiT S.A. (the radiopharmaceutical subsidiary of IRE Group), a leading provider of radioisotopes and radiopharmaceuticals for nuclear medicine, for the marketing and promotion of Illuccix® to healthcare professionals in France. Jean Bonnet, Head of Strategy, Sales and Marketing, IRE EliT added: "We are pleased to collaborate with Telix and bring our expertise to expanding the availability of Illuccix throughout France. We are committed to ensuring that clinicians have access to reliable PSMA-PET imaging technologies to improve the lives of people living with prostate cancer." - ENDS - Notes to editors French healthcare professionals interested in ordering Illuccix® or learning more about availability can contact Eric Rizzo: [email protected] Prostate Cancer in France Prostate cancer is the most common cancer in men in France, with over 57,000 new cases diagnosed annually, and a significantly higher incidence in men than either lung cancer (32,800 new cases) or bowel cancer (27,000 new cases). Prostate cancer is also a common cause of cancer death in men, with over 9,200 men dying from their disease in France in 2022[7]. About Illuccix®  Telix's prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)[8], by the Australian Therapeutic Goods Administration (TGA)[9], by Health Canada[10], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[11], by the French ANSM, and in multiple other European Economic Area (EEA) Member States[12]. Illuccix® is currently in national approval review across the European Economic Area following a positive decentralized procedure (DCP) opinion by BfArM[13]. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Telix's osteomyelitis (bone infection) imaging agent, technetium-99m (99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix's miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction. Visit for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] Legal Notices 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. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED