Delcath Systems, Inc.

Good day and welcome to the DELCAS Systems fourth quarter and full year 2022 financial results conference call. All participants will be placed in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touch-tone phone. To withdraw from the question queue, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to David Hoffman, DelCast General Counsel. Please go ahead.

Thank you. And once again, welcome to DelCast Systems' fourth quarter and full year 2022 earnings call. With me on the call are Gerard Michel, Chief Executive Officer, Dr. Johnny John, Senior Vice President of Medical Affairs and Clinical Development, Kevin Muir, Vice President of Commercial Operations, John Purpura, Chief Operating Officer, and Anthony Diaz, Vice President of Finance. 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 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, events, or circumstances. Now, I would like to turn the call over to Gerard Michel. Gerard, please proceed.

Thank you, everyone, for joining today. We have had a very productive four months since our last earnings call. I'd like to conclude the resubmission of the Hesado NDA on February 14th. and the subsequent receipt of the DUCA date of August 14th from the FDA, the announcement of significant financing with high-quality investors, and the continuation of a steady stream of publication from both commercial usage and clinical investigation of chemosat in Europe. On February 14th, we filed the NDA resubmission for Hipsado, and on March 20th, the FDA determined the resubmission constituted a complete class 2 response and set up the DUCA date of August 14th. We look forward to working with the FDA through the review process of our resubmission. Since I know I will be asked, at this time, we do not know whether the application will be the subject of an adcom, but we will continue to prepare for one unless we receive notification otherwise. Obviously, receiving the FDA acceptance was a major milestone for the company, and it represents a culmination of many, many years of hard work by Delcat employees, our various partners, investigators, and patients. Today, we announced a private investment in public equity, or pipe deal, with healthcare-focused institutional investors as well as existing investors that will provide up to $85 million in gross proceeds, including $25 million in upfront funding upon closing. The financing was led by Bevo Capital, with participation from Logos Capital, BBF Partners, Stone Pine, and Serato Capital, as well as existing investors, including Roslyn Advisors. We are grateful for the participation of our existing investors and are delighted to have the financial backing of an additional set of investors. The new investors are well-known, long-term, healthcare-focused funds who conducted an extended amount of due diligence on clinical, regulatory, commercial, and other topics before deciding to invest in DELCAT. Their support validates the clinical relevance of and the commercial opportunity for Hepsado and metastatic ophthalm melanoma. We believe the aggregate funding will fully support the commercial launch of Pepsado, if approved, and take us to profitability without having to raise additional capital. The structure was designed to remove financing overhang, something that is often an issue in normal economic environments and is greatly exacerbated in the current environment. There is always a trade-off between fully financing a business and dilution. I think it is important to note that we will manage our business prudently with an eye towards building shareholder value through generating and growing cash flows. Given our likely operating margins and the anticipated uptake of Hubsado, we likely can generate positive cash flows within a relatively short period after launch. In addition to the press release on this financing, further details of financing, including the impact on common shares and warrants outstanding upon the conversion of preferred stock, is outlined in our current investor presentation, which can be found on our website. Tony will also cover this in greater detail in his section of the call. On February 16th, we announced that the board of directors voted to appoint John Sylvester as their new chairman of the board. Mr. Sylvester has served as director since July 2019 and has extensive experience building interventional oncology businesses, including senior commercial roles at BTG, and most recently serving as Chief Executive Officer of both Kiram Spec and International Business Units. Mr. Sylvester will replace Dr. Roger Stoll, who has served as Chairman since October 2015, and will continue to serve as an actor member of the Board of Directors and on various committees. We thank Roger for his many years of leadership of the company and are grateful for his continued service with the company. And we look forward to Mr. Sylvester's guidance as the company prepares for a PASO-Hexato launch in the U.S. In the U.S., we currently have enrolled three expanded access program treatment sites, or EAPs. In addition, we have four more sites reviewing their agreements, and Mayo-Jacksonville and Mayo-Rochester are undergoing startup activities. We currently have eight patients at one participating site, which has completed 20 cumulative treatments across the patients. While we have not aggressively pursued EAP sites, or put in place patient referral networks, we are now in the process of hiring a contract MSL team to support our EAP efforts and start building those referral networks. In February, a publication was presented which updated safety and efficacy results from the phase one portion of the Chopin trial. The updated published results for seven patients with advanced serial melanoma treated with chemosat and ipilimumab plus nivolumab showed a median progression pre-survival of 29.1 months and a median follow-up time of 29.1 months. At the time of publication, all patients were still alive, and three of four patients who subsequently experienced progressive disease continued with treatment in the form of repeated melphalan-PHP treatments delivered by chemosat. The ongoing randomized phase two portion of the CHOPAN trial comparing melphalan-PHP alone with melphalan-PHP plus ipinivo, which will include another 76 patients, 38 per arm, is approximately 50% or more enrolled. We eagerly await the publication of interim results potentially late this year from the phase two portion of this study. This should provide critical information about the potential utility of chemoset or Hepsado used in sequence with immune checkpoint inhibitors. Finally, in December, the results of a single center study in the treatment of cholangiocarcinoma were published in the journal Clinical and Experimental Metastasis. The study was a retrospective analysis of 17 patients who underwent a total of 42 procedures of chemosat and melatonin between October 2014 and September 2020 at the Hanover Medical School in Germany. The aim of the retrospective monocentric study was to analyze PHP with chemosat as a palliative treatment for unresectable liver-dominant cholangiocarcinoma. Based on the results of the study, the authors concluded that percutaneous PHP with chemosat is an effective and safe treatment option for patients with advanced cholangiocarcinoma and has the potential to prolong life in patients with inoperable treatment refractory liver metastases. The authors highlighted the increasing importance of local regional forms of therapy in the treatment of cholangiocarcinoma and that the new addition of the German S3 cancer guidelines, Diagnostics and Therapy of Hepatocytic Carcinoma and Biliary Cancer Carcinomas, now includes PHC with melform for the treatment of both inoperable intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma liver metastases. That completes my prepared remarks, and I look forward to taking questions after Tony reviews the financials. Tony?