University Hospital Southampton NHS Foundation Trust

MELBOURNE, Australia, Oct. 16, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces thirteen abstract presentations featuring the Company's ongoing theranostic development, medical technologies (MedTech), and research and innovation (R&I) programs at the 37th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Hamburg from 19 – 23 October 2024. Telix's extensive theranostic pipeline will be showcased in presentations covering: TLX250-CDx (Zircaix®[1], 89Zr-girentuximab) kidney cancer imaging, including first real-world clinical experience; TLX101 (131I-iodofalan or 131I-IPA) glioblastoma therapy; TLX66 (90Y-besilesomab) bone marrow conditioning therapy; TLX252 (225Ac-girentuximab) carbonic anhydrase IX (CAIX)-targeted alpha therapy; and SENSEI®, Lightpoint's robotic-assisted gamma probe. Dr. David N. Cade, Telix Group Chief Medical Officer, said, "We are pleased to be able to so comprehensively showcase our pipeline at EANM – the largest gathering of nuclear medicine professionals worldwide – with a sponsored symposium, and abstracts accepted across Telix's late-stage theranostic programs in kidney and brain cancers, and in bone marrow conditioning. As in previous years, it is an honour for us to support the EANM Sanjiv Sam Gambhir Young Investigator Award. This is an exciting opportunity for a junior physician or scientist to further develop their career in radiopharmaceuticals, in memory of an extraordinary man and an inspiring educator." We look forward to seeing delegates at Telix's booth in Hall H, Stand H29 to discuss Telix's industry leading theranostic pipeline in urologic oncology (prostate, kidney and bladder cancers), neuro-oncology (glioma), musculoskeletal oncology (sarcoma) and hematology, our associated medical devices, and opportunities for collaboration. EANM presentation details are as follows: Sponsored Symposium: Does size matter in targeted radionuclide therapies? Chairperson: Professor Viktor Grünwald, University Hospital Essen, Essen, Germany. Why size matters: The relative benefits of antibodies vs. small molecules in oncology Prof. Arturo Chiti, IRCCS San Raffaele Hospital, Milan, Italy When small may be smart: The role of small molecules in neuro-oncology Prof. Nathalie Albert, Ludwig-Maximilian's-University of Munich, Munich, Germany Where big may be best: The power of antibodies in onco-hematology Prof. Stefano Fanti, University of Bologna, Bologna, Italy How size will shape the future: The choice between antibodies and small molecules in uro-oncology Prof. Karolien Goffin, University Hospital Leuven, Leuven, Belgium Date & Time: Sunday, 20 October, 2024, 13:15 – 14:45 CEST Location: Hall G1, Congress Center Hamburg Abstract presentations Title: Unravelling radiobiological and immunological mechanisms driving effective CAIX-TRT and ICI combination therapy Presenter: S. Kleinendorst, RadboudUMC, Netherlands Date and Time: 20-Oct-24, 08:00 – 09:30 Session: Cutting Edge Science Track - TROP Session: Dosimetry Committee: Preclinic and Radiobiology Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-022 Title: Accuracy of personalised single time point dosimetry for bone marrow and liver dosimetry in TLX66 (90Y-Anti CD66) radioimmunotherapy Presenter: A. Nautiyal, University Hospital Southampton, United Kingdom Date and Time: 20-Oct-24, 15:00 – 16:30 Session: Cutting Edge Science Track - TROP Session: Dosimetry Committee: Dosimetry: A Question of Time Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-158 Title: Tumour margin thickness inference for 99mTc radio-guided surgery using internal conversion electrons Presenter: J. Moo, Telix Date and Time: 21-Oct-24, 08:00 – 09:30 Session: Cutting Edge Science Track - TROP Session: Physics Committee: Data Corrections / Image Enhancement Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-289 Title: Radiation protection considerations with TLX250-CDx (89Zr-girentuximab) PET/CT experience in France Presenter: C. Morgat, Department of Nuclear Medicine, University Hospital of Bordeaux, France Date and Time: 21-Oct-24, 15:00 – 16:30 Session: TROP Session: Radiation Protection Committee: Radiation Protection in Diagnostic Imaging Procedures Format: Oral Location: Hall Y1-Y3 Presentation ID: OP-452 Title: Correlation of tracer uptake in sentinel lymph nodes as measured on SPECT/CT and during intraoperative gamma tracing with the SENSEI drop in gamma probe: the UZ Leuven experience Presenter: M. Manley, Nuclear Medicine, University Hospitals Leuven, Belgium Date and Time: 22-Oct-24, 08:00 – 09:30 Session: Cutting Edge Science Track – TROP Session: Physics Committee: SPECT/CT Quantification Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-543 Title: Development of 161Tb-DOTA-HYNIC-panPSMA for targeted radionuclide therapy of prostate Cancer Presenter: C. Morgat, Department of Nuclear Medicine, University Hospital of Bordeaux, France Date and Time: 22-Oct-24, 08:00 – 09:30 Session: M2M Track - TROP Session: Radiopharmaceutical Sciences + Translational Molecular Imaging & Therapy Committee: From Radionuclide to Clinical Translation Format: Oral Location: Hall X1-X4 Presentation ID: OP-532 Title: Feasibility and tolerability of TLX101 (¹³¹I-IPA) monotherapy in progressive and recurrent high grade gliomas; an ongoing single institution case series Presenter: N. Tolboom, University Medical Centre Utrecht, Netherlands Date and Time: 22-Oct-24, 16:45 – 18:15 Session: TROP Session: Neuroimaging Committee: Neuro-Oncology Format: Oral Location: Hall Y10-Y12 Presentation ID: OP-758 Title: The emerging role of TLX250-CDx (89Zr-girentuximab) PET/CT in accurate characterisation and staging of ccRCC: early experience with three patients Presenter: F. Gelardi, Università Vita-Salute San Raffaele, Italy Date and Time: 23-Oct-24, 08:00 – 09:30 Session: TROP Session: Case Report Session 2: You Won't Believe the Things I've Seen! Format: Oral Location: Hall Y1-Y3 Presentation ID: OP-824 Title: Development of girentuximab as a theranostic tool in non-renal indications Presenter: A. Ivashkevich, Telix Date and Time: 23-Oct-24, 08:00 – 09:30 Session: e-Poster Presentations Session 13: Translational Molecular Imaging & Therapy Committee: Molecular Imaging & Therapy Format: Oral ePoster Location: Hall F Presentation ID: EPS-270 Title: Preclinical evaluation of DNA damage response inhibitors and TLX252 (225Ac-DOTA-girentuximab) combination therapy Presenter: Z. Cao, Olivia Newton-John Cancer Research Institute, Australia Date and Time: 23-Oct-24, 08:00 – 09:30 Session: e-Poster Presentations Session 13: Translational Molecular Imaging & Therapy Committee: Molecular Imaging & Therapy Format: Oral ePoster Location: Hall F Presentation ID: EPS-269 Title: Development of Kit-Composition for the Preparation of 99mTc-PSMA-GCK01 / RHN001-Dx Presenter: J. Cardinale, University Hospital Duesseldorf, Germany Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D57 Radiopharmaceutical Preparation and Quality Control Format: e-Poster Location: e-Poster Area Presentation ID: EP-1037 Title: Development of 18F-labelled lactate for oxidative cancer imaging Presenter: M. da Silva Morais, Pole of Pharmacology, Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain (UCLouvain), Belgium Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D55 Radiopharmacokinetics and Drug Development Format: e-Poster Location: e-Poster Area Presentation ID: EP-1010 Title: Radiolabelling DOTA-HYNIC-panPSMA with actinium-225 for in vivo studies Presenter: K. Attia, Telix Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D53 New Radiopharmaceuticals - Therapy Format: e-Poster Location: e-Poster Area Presentation ID: EP-0985 About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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. Telix is listed on the Australian Securities Exchange (ASX: TLX). Telix's lead 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)[2], by the Australian Therapeutic Goods Administration (TGA) [3], and by Health Canada [4] . No other Telix product has received a marketing authorisation in any jurisdiction. Visit for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. 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) 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. 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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. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix®, SENSEI® and Zircaix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

QUEENSBURY, N.Y.--( BUSINESS WIRE )--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, today announced the presentation of new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) in patients with metastatic uveal melanoma (mUM). The data were presented by Dr. Matthew Wheater from University Hospital Southampton at the European Society for Medical Oncology (ESMO) Congress in Barcelona. The FOCUS trial was a pivotal Phase 3 study designed to evaluate the efficacy and safety of HEPZATO KIT™ in patients with unresectable hepatic metastases from mUM. The primary endpoint of the study was objective response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS). The trial enrolled 102 patients, of whom 91 received treatment. The full results of the FOCUS trial were published on May 4, 2024, in the Annals of Surgical Oncology. The subgroup analysis evaluated patients with and without extrahepatic disease, treatment-naive versus previously treated patients, and those with low (1-25%) versus high (26-50%) liver tumor burden. There were no significant differences in OS, ORR, or PFS between patients with and without extrahepatic lesions or based on prior therapy. While ORR and PFS remained consistent regardless of liver tumor burden, more extensive liver involvement was associated with worse OS outcomes. Objective tumor responses were observed throughout the entire treatment period; the earliest following completion of the first treatment cycle, and the latest following treatment cycle 6. This result supports the strategy to continue treatment until best response is achieved. Rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs) remained consistent, indicating an absence of cumulative toxicity. These findings underscore the favorable benefit-risk profile of HEPZATO KIT™ in this patient population, offering a meaningful option for patients who typically have limited treatment options. Dr. Wheater commented, "The lack of significant differences in outcomes between patients with and without extrahepatic disease is encouraging, particularly for a liver-directed therapy like Melphalan/HDS. Additionally, the fact that responses were observed through all six treatment cycles supports the strategy of continuing treatment beyond two cycles in patients with stable disease." About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT ® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information , including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.

VADUZ, Liechtenstein, Aug. 21, 2024 /PRNewswire/ -- RefluxStop™ is on a wave of success - carried by a multitude of published studies with excellent outcomes from leading European Reflux-centers Significant events in the second quarter of 2024 Module 1 review of Premarket Approval (PMA) application for RefluxStop™ completed by US FDA Findings presented, all of which Implantica considers to be minor Decided to submit response to Module 1 together with Module 2 submission NHS Trust University Hospital Southampton started performing the RefluxStop™ procedure NICE IPAC evaluation process assessing reimbursement of RefluxStop™ within NHS continues with the submission of our clinical and regulatory dossier. This is the support organisation of the National Health Services (NHS, in charge of the public healthcare in UK) which evaluates new technologies. RefluxStop™ advanced education program launched in Spain with more than 15 anti-reflux surgeons and gastroenterologists from seven leading reflux hospitals across Spain participating Selected new centers started during period: Herzogin Elisabeth Hospital, Germany Cirugía Laparoscopica Madrid, Spain Hospital Clínico University, Valencia, Spain Significant events after the end of the period 4-year results from our CE-mark study published in Surgical Endoscopy showcasing continued excellent results up until 4-year follow-up Investigator-initiated study led by Prof. Schoppmann, AKH Vienna, on 40 ineffective esophageal motility (IEM) patients treated with RefluxStop™ published in Scientific Reports, a Nature journal IEM patients represent approx. 30% of reflux sufferers with no ideal treatment available until now Ethics Committee (EC) approval confirmed in August for first-ever randomized clinical trial of its kind comparing RefluxStop™ to Nissen fundoplication Independent study by Dr. med. Zehetner (Prof. USC) on his first 40 patients who underwent RefluxStop™ procedure published in prestigious Swiss Medical Weekly Further confirming the excellent results with RefluxStop™ in patients suffering from IEM and large hernia Financial summary second quarter 2024 Net sales increased 59% to TEUR 554 (349). Adjusted gross margin amounted to 91% (94%). Operating loss (EBIT) increased to TEUR 5,869 (4,276). Loss after tax amounted to TEUR 6,431 (5,311). Basic and diluted loss per Class A share amounted to EUR 0.09 (0.07). Cash as at the end of the period amounted to MEUR 74.0. First six months Net sales increased 75% to TEUR 1,150 (656). Adjusted gross margin amounted to 91% (94%). Operating loss (EBIT) increased to TEUR 12,956 (9,146). Loss after tax amounted to TEUR 9,903 (10,069). Basic and diluted loss per Class A share amounted to EUR 0.14 (0.14). Telephone conference Implantica will hold a teleconference on 21 August 2024 at 15:00 (CEST) with Peter Forsell (CEO), Andreas Öhrnberg (CFO), and Nicole Pehrsson (Chief Corporate Affairs Officer). Please see the dial-in details below to join the conference: Webcast If you wish to participate via webcast, please use the following link: Dial-in Dial-in numbers to the teleconference will be received by registering on the link below. After the registration, you will be provided phone numbers and a conference ID to access the conference. For further information, please contact: Nicole Pehrsson, Chief Corporate Affairs Officer Telephone (CH): +41 (0)79 335 09 49 [email protected] Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. The company's Certified Adviser is FNCA Sweden AB, [email protected] This information is information that Implantica AG is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-21 08:00 CEST. About Implantica Implantica is a medtech group dedicated to bringing advanced technology into the body. Implantica's lead product, RefluxStop™, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energising platform designed to power remote controlled implants wirelessly through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB). Visit for further information. This information was brought to you by Cision The following files are available for download: