Delcath Systems, Inc.

Good day, ladies and gentlemen, and welcome to the DELCAS third quarter 2021 earnings call. At this time, all participants have been placed on a listen-only mode, and the floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, James Carbonara. Sir, the floor is yours.

Thank you. And once again, welcome to DELCAS systems third quarter 2021 earnings call. With me on the call are Gerard Michel, Chief Executive Officer, Dr. Johnny John, Senior VP Medical Affairs and Clinical Development, Kevin Muir, VP Commercial Operations, John Purpura, Chief Operating Officer, and Christine Padula, Interim Principal Accounting Officer. 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 21A 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 materially from those expressed or implied in forward-looking statements due to various risks and uncertainties. For discussion of such risks 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 earnings 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. Now, I would like to turn the call over to Gerard Michel. Gerard, please proceed.

Thank you, everyone, for joining today. Eight months ago, we announced that the Phase III focused trial of the Hepsado in patients with liver-dominant metastatic ophthalm melanoma had met its pre-specified endpoint based on an analysis of 87% of the patients. Specifically, in the trial, patients treated with Hepsado had an objective response rate of 29.2%, with a 95% competence interval lower bound of 20%. Given the magnitude by which the lower bound exceeded the 8.3% pre-specified threshold for success, the successful achievement of the primary endpoint could not change, regardless of the outcome of the 11 patients who had not yet been evaluated. Since that time, the clinical teams efforts have been focused on the key tasks required to enable the MBA submission. At this point, 97% of all data has been entered into the electronic database and we have monitored just over 90% of the data. Given the approximately one year pause in data entry and monitoring in 2018 due to company financial difficulties and the unexpected second year of the ongoing pandemic, I am very pleased with this progress. With that said, It is not where I had projected we would be when we started the year, and despite extraordinary and creative efforts by the team, COVID-related site access restrictions for both non-essential internal clinical trial staff and CRO monitors have caused timelines to slip. This has resulted in the delay in sharing the final efficacy data, which we now plan to release at the planned investor day on December 2nd. We are also altering our guidance on the resubmission of the NDA from late in the first quarter to mid-year. While I know investors will be disappointed in this delay, we want to maintain our plan for 100% monitoring and need adequate time for medical writing and quality control. If the FDA allows a rolling submission, we will start submitting the non-clinically related modules earlier in the first quarter. While the HPSADO's fast track status makes the filing eligible for a rolling submission, the FDA generally only accepts responses to CRLs when they are fully complete. Given the six-month BDUCA timeline for a Class 2 resubmission response to a CRL, a rolling submission might be viewed positively by the FDA in that it will give them more review time. This will be one of our questions addressed during the pre-NDA meeting, which we anticipate early in 2022. Our Expanded Access Protocol, or EAP, was submitted to the FDA in August and approved by the FDA in September. To date, five sites have indicated their intention to participate and include Moffitt Cancer Center, University of Tennessee, Duke University, Ohio State University, and Stanford University. We intend to steadily increase the number of sites participating in the EAP throughout 2022 to ensure there is a broad base of trained centers upon commercial launch. Since our last call, the results from a number of single and dual center investigator-initiated retrospective and prospective trials have been published. I would like to ask Dr. Johnny John to give a summary of these publications and presentations. Johnny?