Nivolumab

QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the acceptance of an oral presentation on results from the investigator-initiated CHOPIN randomized Phase 2 trial at the 2025 European Society for Medical Oncology (ESMO) Annual Congress. Principal Investigator Ellen Kapiteijn, MD, from Leiden University Medical Center’s Department of Medical Oncology, will present data evaluating the safety, tolerability, and efficacy of sequencing systemic ipilimumab and nivolumab with Delcath’s CHEMOSAT® Hepatic Delivery System for percutaneous hepatic perfusion with melphalan in patients with metastatic uveal melanoma. Title: Combined Percutaneous Hepatic Perfusion with Ipilimumab plus Nivolumab in Metastatic Uveal Melanoma: a single center, open-label, randomized, phase 2 study (CHOPIN) Session Title: Melanoma and other skin tumours Session Date and Time: Saturday, October 18, 2025 3:20 p.m. CET / 9:20 a.m. EST Abstract Number: LBA59 Presenter: Ellen Kapiteijn, MD The poster will be available at https://delcath.com/investors/events-presentations/ when the ESMO embargo is released on October 18, 2025. 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 KITTM (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System (HDS) 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 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. Forward-Looking Statements This release contains forward-looking statements, including statements regarding the expected release of clinical trial results, which are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, delays in the presentation of the data, or other unforeseen issues relating to the release of the clinical trial results. For a detailed discussion of these and other risks, please refer to Delcath’s filings with the SEC.

MUNICH & SAN FRANCISCO--(BUSINESS WIRE)--CatalYm, a world-leader in neutralizing GDF-15 in cancer and cachexia, today announced two upcoming oral presentations highlighting the company’s lead-candidate visugromab at the European Society of Medical Oncology (ESMO) Congress, being held October 17th-21st, 2025, in Berlin, Germany. Visugromab is a humanized, monoclonal antibody designed to neutralize the tumor-derived cytokine Growth Differentiation Factor-15 (GDF-15) that plays a central role in immune suppression and anti-PD(L)-1 treatment resistance. A late-breaking abstract featuring first results from the Phase 2 GDFATHER-NEO trial (NCT06059547) was accepted for oral presentation. The trial investigates visugromab as neoadjuvant treatment in combination with nivolumab in patients with muscle-invasive bladder cancer (MIBC) compared to nivolumab administered with placebo. In addition, a second oral presentation will cover long-term follow-up data from the GDFATHER-01 Phase 1/2 trial (NCT04725474) demonstrating deep and durable remissions in heavily pretreated, anti-PD1/-L1 relapsed/refractory non-squamous non-small cell lung cancer (NSCLC), urothelial cancer (UC) and hepatocellular cancer (HCC) patients. Presentation Details Late-breaking Oral Presentation Abstract Title: A blinded, exploratory phase 2 trial of nivolumab and the GDF-15 neutralizing antibody visugromab or placebo as neoadjuvant treatment of patients with muscle-invasive bladder cancer (MIBC): Primary results of the GDFATHER-NEO trial Session Category & Title: Proffered Paper session 1: GU tumours, renal & urothelial Presentation Date & Time: October 17, 2025; 3:00 – 3:10 pm CEST Presenter: Prof. Andrea Necchi, MD, Vita-Salute San Raffaele University, IRCCS San Raffaele Hospital Location: Dortmund Auditorium - Hall 7.1a Proffered Paper Presentation Abstract Title: Long-term follow-up GDFATHER-01 trial: GDF-15 neutralization combined with nivolumab can enable deep, long-term remission in heavily pretreated, anti-PD1/-L1 relapsed/refractory non-squamous non-small cell lung cancer (NSCLC), urothelial cancer (UC) and hepatocellular cancer (HCC) Session Category & Title: Proffered paper session: Investigational immunotherapy Presentation Date & Time: October 20, 2025; 10:55 – 11:05 am CEST Presenter: Prof. Ignacio Melero, MD, PhD, Co-Director of Immunology and Immunotherapy (CIMA) at the Universidad de Navarra, Pamplona/Spain Location: Hanover Auditorium - Hall 7.2c About Visugromab Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients. About CatalYm CatalYm is developing visugromab, a first-in-class anti-GDF-15 antibody, in solid tumors and cachexia. In its first-in-human Phase 1/2a study, visugromab demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. In addition, data from the same study demonstrated that visugromab can significantly counteract the effects of cachexia in these patients. This data was published in Nature and presented at the International Conference on Sarcopenia, Cachexia & Wasting Disorders. CatalYm is now advancing visugromab into multiple Phase 2b studies including first-line metastatic NSCLC (NCT07098988) and cachexia (NCT07112196). Founded in 2016 and based in Munich, Germany and San Francisco, USA, CatalYm is backed by leading international investors including Canaan Partners, Bioqube Ventures, Forbion, Omega Funds, Gilde Healthcare, Jeito Capital, Novartis Venture Fund, Vesalius, Brandon Capital, Bayern Kapital, BioGeneration Ventures, and Coparion.