Delcath Systems, Inc.

Good day, ladies and gentlemen, and welcome to the Delcath Second 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, Investor Relations. Sir, the floor is yours.

Thank you. And once again, welcome to Delcath Systems' Second 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, 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 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 assurances 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 Forms 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. One of the major highlights of the quarter was the presentation at the 2021 ASCO Annual Meeting, which reviewed both previously announced and new efficacy data from our Phase III focused trial of Hepsado kit in patients with liver-dominant metastatic ocular melanoma. The oral presentation by the study's lead investigator, Dr. Jonathan Zager, Chief Academic Officer, Chair, USF Department of Oncological Sciences at the Moffitt Cancer Center, included data based on 79 of 91 treated Hepsado patients, which showed an overall response rate of 29.2%, with a 95% competence interval lower bound of just over 20%. Given the magnitude by which the lower bound exceeded the 8.3% pre-specified threshold for success, the primary endpoint of the trial has been met regardless of the outcome of patients who have not yet been evaluated. Patient-level response data were also presented for this same patient set, indicating that 44% of evaluable patients in the hep-sato arm had a 30% or greater reduction in tumor target lesions at one or more time points versus 17% for patients enrolled in the best alternative care arm. Importantly, the safety data presented was well in line with previously reported data from single-center European studies. These data, combined with the previously disclosed statistically significant improvement over best alternative care and progression-free survival and disease control rate, further strengthens the case that Hepzada would offer a compelling clinical benefit to patients were it approved by the FDA. The resurgence in COVID is impacting both our clinical sites and vendors, Due to that, final focus data is going to be released somewhat later than we projected three months ago, and we are now targeting October instead of ESMO in September. Given the importance of these data to investors, we will likely present these data as part of an investor day instead of waiting for the next scientific conference. Despite that slight delay, we are still targeting the end of Q1 2022 for the filing of the NDA with the FDA. Despite the disruptions at the clinical sites due to COVID, we continue to try everything possible to get the sites to enter all the data into the electronic data capture or EDC database and get all the scans over the independent radiology committee reviewing the scans. The gating item for final submission will be monitoring, an activity that for most sites requires multiple physical on-site visits. We are pursuing a 100% data monitoring effort. Our efforts to ensure timely access to data and monitoring include lobbying sites to get extra monitoring days on-site each month adding co-monitors to monitoring visits, working with sites to improve the use of remote monitoring in cases where that has never been done before, and paying for supplemental staff at sites to assist in data entry, monitoring visits, and answering queries. All NDA resubmission and CRL response accountabilities, writing and data compilations, are ongoing to the extent possible without finalized clinical data. We have chosen to reprioritize some activities as the clinical team has been working with the sites on the above-mentioned activities. We are submitting the expanded access protocol this week to the FDA instead of earlier this summer as originally planned. That was a difficult tradeoff because we know patients desperately need treatment options, but we thought it more important to focus resources on compiling the NDA so that Hepzada becomes commercially available as soon as possible. We are also well on our way to prelaunch planning. ranging from accessing data to better understanding treatment pathways for metastatic ocular melanoma patients, building out our marketing group with additional hires, including recently adding a new product manager to the team, and starting to compile a global value dossier, which will be the core document used to communicate Hapsado's kit's value to both payers in the US and Europe, and in the European case, of course, Chemosat. Turning to Europe, another important commercial development in the second quarter has been the change in guidance from the United Kingdom's National Institute for Health and Care Excellence, or NICE, for chemosat and the treatment of patients with metastatic ocular melanoma. Previously, the NICE guidance recommended chemosat only be used in the context of formal research studies. Due to that guidance, both private insurance and regional funding were generally not available for treatment of chemosat, nor was it possible to apply for national coverage. Under the revised NICE guidance, Chemosat has been categorized under a special arrangement designation. Under this designation, private insurance may be more likely to fund treatment with Chemosat, some regional funding may be more accessible, and a process is now available to seek national reimbursement. We are continuing our analysis to prioritize the next set of indications we will study in the clinic. This effort is being led by our new EMEA Medical Director, Dr. Stephan Shakar. Dr. Shakar was most recently Global Medical Affairs Director at Gilead Kite Pharma, and prior to that was EMEA Medical Director Oncology at Astellas. He has 20 years of experience in the pharmaceutical industry at national and regional levels, leading the development, rollout, and execution of several pre- and launch medical campaigns for a dozen launches. We have concluded that metastatic colorectal cancer and interhepatic cholangiocarcinoma or MCRC and ICC, will be the focus of our expanded development activities. We currently have an open IND for ICC, but paused the trial due to lack of enrollment owing to both a small number of sites being open and the requirement that patients be treatment naive. We are now investigating changes to the protocol to increase the pace of enrollment. At this point, I can't go into what those changes might be, but I can state the clinicians have been very consistent in their feedback that existing therapies for ICC have limited efficacy and poor tolerability, and there is strong interest in trying percutaneous hepatic perfusion, or PHP, in ICC patients. Unlike ICC, metastatic colorectal cancer is a crowded field, both in terms of approved products and clinical trials. However, we are viewing Hepsado as an additive agent and not as a replacement for an existing systemic therapeutic. We believe there is a role for Hepsado in stage three and four patients, either as a complement to other therapies or for use in patients at higher risk for recurrence as an adjuvant therapy. We hope to have further detail on this in October when we present the final HPSADO data. In summary, this past quarter we've taken important steps towards commercialization of our PHP system in our initial indication and expansion into new areas. The release of positive preliminary results from the FOCUS trial, which with new patient data presented at ASCO this quarter, Sterling indicates that Hepsado's risk-benefit ratio is a significant improvement versus an earlier generation of Delft-Cast proprietary PHP system. In addition, there is significant physician interest in utilizing PHP in a broader range of tumor types, and we are actively in discussions with KOLs regarding both setting and protocols. We look forward to continued progress with the balance of the year as we prepare both to file an NDA in early 2022 and expand the development of Hepsado into additional areas of high unmet need. I look forward to taking questions, but first we'll turn the call over to Christine to review the financials.