Delcath Systems, Inc.

Greetings and welcome to the DelCast Business Update Call. At this time, all participants are in a listen-only mode. A 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, Mr. James Carbonara, Investor Relations. Please go ahead. Thank you.

And once again, welcome to Delcath Systems' fourth quarter 2020 business update call. 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 a 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 Thank you, everyone, for joining today.

This morning we released preliminary data from the FOCUS trial, a global registration clinical trial investigating the safety and efficacy of Hepsado to treat metastatic ocular melanoma patients. Due to the importance of those data, we will focus this call on those results and not discuss in detail the financial results for the quarter, which were also released this morning in our fourth quarter earnings release. Of course, I and the team are available later to answer any questions about our financial results. and anything else covered in the earnings release or 2020 10-K, which will be filed later today. With me on the call today are John Purpura, Chief Operating Officer, Dr. Johnny John, our Senior Vice President of Clinical and Medical Affairs, and Dr. Jonathan Zager, Lead Investigator of the FOCUS Study, Senior Member and Director of Regional Therapies at Moffitt Cancer Center, who has kindly joined us to answer questions about their experience treating patients with Hevzato and his perspective on the preliminary results. Before handing the call over to Johnny, who will review the preliminary content, I want to share my perspective on the data and put it in context. As most listeners know, the FOCUS trial is the second pivotal trial studying a DelCap percutaneous hepatic perfusion system with Melklin to treat metastatic ocular melanoma patients. The first trial used an earlier generation device as well as a somewhat different procedure and patient selection criteria. and NDA submission based on data from that trial led to a complete response letter or CLL, CRL. Leading up to the CRL, an oncologic drug advisory committee or ODAC panel voted against supporting approval based on an assessment that the benefits of treatment with an earlier version of the system did not outweigh the risks associated with the procedure. A significant portion of FDA's presentation to the ODAC panel was focused on the FDA's assessment of treatment related risks including the analysis of treatment-related deaths that occurred during the clinical trial. Therefore, the critical objective of the FOCUS trial was to maintain or improve the efficacy seen in the earlier pivotal trial while dramatically improving the safety profile. I believe we have accomplished this. There is no standard of care for metastatic ocular melanoma, and we chose to power the single-arm trials who, at a minimum, achieve a higher overall response rate versus checkpoint inhibitors one of the few metastatic octomelanoma treatment categories with a significant amount of peer-reviewed publications which enabled a meta-analysis from which to estimate an overall response rate as a threshold for success. As Dr. John will present shortly, the preliminary data does yield an overall response rate which well exceeds the threshold. The single arm trial was initially designed and conducted as a randomized control study with a best alternative care comparator arm before being amended to a single arm trial. While the amended trial was not powered to test superiority versus best alternative care, or BAC, comparative analyses against the back arm were included in the revised statistical analysis. It is very exciting that based on the data available, patients in the Hepsado arm had statistically significant improvements over back on a number of important endpoints, including ORR, PFS, and DCR. Since most of the patients in the back arm were treated with TACE, This trial provides a strong signal that Hepsado may have advantages over both checkpoint inhibitors and TACE in the treatment of metastatic ophthalm melanoma patients. Of course, we all must recognize that not all of the data are available for analysis and therefore results are subject to change. Nevertheless, the results to date are very encouraging. I recognize that preliminary overall response rates released today is somewhat lower than the range of efficacy results reported from a variety of non-sponsor studies in Europe over the past few years. The use of an independent review committee, patient selection, and likely most importantly, scan frequency may account for most of these differences. The focus study, which was initially designed as an RCT, used the common 12-week scan used in most RCTs, which the focus trial was originally designed as. All of the European studies scan patients more frequently with some intervals as short as six weeks. Since the confirmed response per resist criteria requires two sequential scans showing a response, a six or nine week schedule would likely be more likely to capture a shorter duration response at a 12 week schedule. But we must keep in mind that we have easily cleared the pre-specified target of 21%, which is based on the checkpoint inhibitor meta-analysis, and even more compelling, The evaluable data are incredibly strong when compared to the BAC arm, which is really the most pertinent comparison. We will not be sharing all pre-specified analyses, since the data is not yet mature enough for each analysis to provide any meaningful information. Specifically, we will not yet be sharing overall survival or duration of response, primarily because for the former, there are too many patients for which the EDC has not been updated with date of death or confirmation that the patient is still living, and for the latter, there are too many later scans of both arms which need review by the IRC. But we are very confident on the data points we are releasing today. The most significant question is whether the efficacy shown, combined with the improved safety profile, meaningfully improves the overall benefit-risk profile over what was seen in the earlier study. The preliminary safety results are consistent with what we have seen in the over 1,000 commercial treatments that have occurred in Europe in 2015 and have been reported in the four publications from Europe. In short, the adverse events of the study were well manageable or self-limiting and there were no treatment-related deaths and the hematologic and hepatic toxicity percentages were significantly lower compared to studies using the early generation of the device, which utilized a different filter system. While the trial is still ongoing and final and complete data will not be available until later in the year, We believe these results strongly suggest that the focused trial data will demonstrate a significantly improved benefit-risk profile that warrants forming the basis of our NDA resubmission to the FDA. I will now call the turn over to Dr. John to review the preliminary focused data.