Delcath Systems, Inc.

Greetings and welcome to the DelCast Systems Business Update Call. At this time, all participants are in a listen-only mode. Question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, David Hoffman, General Counsel for DelCast Systems. Thank you. You may begin.

Thank you, and welcome to DelCast Systems Business Update Call. With me on the call are Gerard Michel, Chief Executive Officer, Sandra Pinnell, Chief Financial Officer, and Voyo Vukovic, DelCast Chief Medical Officer. In addition, we will share a prerecorded conversation between Dr. Vincent Timah, Assistant Professor and Medical Oncologist at the University of Wisconsin's Department of Medicine, and Dr. Vukovic. I'd like to begin the call by reading the safe harbor statement. This statement is made pursuant to the safe harbor for forward looking statements described in the private securities litigation reform act of 1995. All statements made on this call with the exception of historical facts may be considered forward looking statements within the meaning of section 27A of the securities act of 1933 and Section 21E of the Securities Exchange Act of 1934. Although the company believes that expectations and assumptions reflected in these forward-looking statements are reasonable, it makes no assurance that such expectations will prove to have been correct. Actual results may differ in a material manner from those expressed or implied in forward-looking statements due to various risks and uncertainties. The preliminary estimated financial results for the quarter ended September 30th of 2025 included in this call have not been reviewed by DELCAS independent auditors and may change as a result of the continued review. Such preliminary results are subject to the finalization of quarter end financial and accounting procedures. For a discussion of such risk and uncertainties, which could cause actual results to differ from those expressed or implied in the forward-looking statements, please see risk factors detailed in the company's annual report on Form 10-K, those contained in subsequently filed quarterly reports on Form 10-Q, as well as in other reports that the company files from time to time with the Securities and Exchange Commission. Any forward-looking statements included in this call are made only as of the date of this call. We do not undertake any obligation to update or supplement any forward-looking statements to reflect subsequent knowledge, events, or circumstances. Our press release with a summary of the Chopin trial results And our press release containing preliminary 2025 Q3 financial results are available on our website under the investor section. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website. Now, I would like to turn the call over to Gerard Michel. Gerard, please proceed.

Thank you for joining us today to review the Chopin trial results and a summary of preliminary third quarter 2025 financial results. Yesterday, DelCast's chief medical officer, Boya Lukavich, had an opportunity to discuss the Chopin trial results with Dr. Vincent Ma, a current user of HepCytoKit for the treatment of metastatic uveal melanoma patients. Dr. Ma is an assistant professor, medical oncologist, and the immuno-oncology therapeutics director of the Phase I program at the University of Wisconsin Carbone Cancer Center. He is a clinical investigator and translational scientist with a research program dedicated to melanoma and advanced cutaneous malignancies. Recognized as an emerging national expert in using melanoma, he leads and collaborates on multiple grants, clinical trials, and scholarly publications focused on improving outcomes for patients with this disease. Delcoff retained Dr. Ma to review the Chopin trial results and provide his feedback. Dr. Ma's comments are his own and do not constitute medical advice. Let me first recap the trial results that were presented Saturday by principal investigator and lead author, Professor Ellen Capitan from Leiden University. The Chopin trial randomized 76 patients one-to-one to receive PHP alone at weeks one and seven or four cycles of ipilimumab and nivolumab every three weeks over approximately nine weeks with two PHP treatments at weeks one and seven. The trial protocol did not include additional PHP treatments beyond two treatments or nevalumab maintenance monotherapy. Once the nine-week treatment period was completed, patients were monitored without further treatment until progression. Key eligibility criteria included unresectable hepatic metastases with 50% or less unresectable disease and limited extra hepatic disease. The primary endpoint was one-year progression-free survival. Secondary influence included safety, best overall response rate, and overall survival, and hepatic progression-free survival. The primary endpoint was MEP, with one-year progression-free survival of 54.7% in the combination group versus 15.8% in the perfusion group. The combination also significantly improved overall survival, 23.1 versus 19.6 months, and best overall response rates, 76.3% versus 39.5%. All of these efficacy advantages were statistically significant. Grade 3 or higher treatment-related adverse events were more frequent in the combination group, 81.6% versus 40.5%, but most were manageable with standard care. Interestingly, this rate of adverse events in the combination arm were consistent with those seen in the FOCUS pivotal trial. To better explore the importance of the results, I will now share the prerecorded discussion between Dr. Vukovic and Dr. Ma. I will then discuss the implications of these results for DELCAP, as well as share preliminary third quarter 2025 financial results and full year guidance, and open the floor for questions.