Delcath Systems, Inc.

Good day and welcome to the Delcath Systems Reports third quarter fiscal year 2023 financial results. All participants will be 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 a touch-tone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to David Hoffman, General Counsel. Please go ahead, sir.

Thank you. And once again, welcome to DelCast Systems 2023 Third Quarter Earnings and Business Update Call. With me on the call are Gerard Michel, Chief Executive Officer, Sandra Pinnell, Senior Vice President of Finance, Kevin Muir, General Manager, Interventional Oncology, Boyle Vukovic, the Chief Medical Officer, and John Purpora, Chief Operating 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 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 forward-looking statements, please see risk factors detailed in the company's annual report on Form 10-K, Those contained and subsequently filed quarterly reports on Form 10Q, 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. Now, I would like to turn the call over to Gerard Michel. Gerard, please proceed.

Thank you, everyone, for joining today. Since the FDA approval of hep-saddle kit on August 14th for patients with metastatic uveal melanoma, we have been focused on outreach to potential treating sites and building our commercial team in preparation for commercial launch, which is now anticipated for January. While it has taken slightly longer than expected to work with our CMOs to finalize and produce QC-released, labeled, and packaged melt ones specific to Hepzato, we have been productively using the time between approval and launch to expand the number of treatment teams that have undergone didactic training and attended a preceptorship, both of which require before a new treating team can perform their first proctored case. Since Hepzato kits FDA approval, we have been encouraged by both the medical oncologists and interventional radiology communities' motivation and stated commitment to incorporate Hepzadokit into their practices treating patients with metastatic uveal melanoma. While we are fielding interest from more than 20 sites, we are primarily focused on a subset of these to ensure that we achieve our planned activation targets throughout the year. In conjunction with the local medical oncologists at each of our target sites, we have been working with the site's intervention radiologists to identify and train hep-sado kit treatment teams. In addition to training the treatment teams at each site, we are also working to get hep-sado kit approved through the various traditional hospital formulary and value analysis committees, and we have started that process in 13 hospitals. Currently, we have three EAP sites, Moffitt Cancer Center, Duke University, and the University of Tennessee, which are fully trained and can start treating commercial patients upon the availability of commercial product. In addition, we now have a further four sites, Mayo Clinic, Thomas Jefferson, Ohio State University, and Stanford University, that have completed the necessary steps to conduct their first commercial treatment under the guidance of a proctor once commercial product is available and formulary and value analysis committee approvals are obtained. Beyond those seven sites, another four sites, UCLA, Providence St. John's, Mass General, and Piedmont Hospital, currently have their preceptorship scheduled in November or December. In total, we expect at least 10 sites will have completed the required training to treat a commercial case by the end of January, contingent on scheduling a proctor chain for that first case and a successful completion of the various value analysis committee processes. Given the need for the first case to be proctored and the required committee approvals, I don't expect all of the 11 previously mentioned sites to be actively treating patients in the first quarter. However, based on interest and progress today, I am confident that we will achieve at least five active treatment sites sometime in the first quarter, 10 by the end of the second quarter, and 15 treating centers by the end of 2024. We expect treatments per site to start out at approximately one per month and end the year at approximately two per month. Simcepzadokid is a liver-directed interventional radiology procedure and not an effused drug. We are focused on medical centers, as currently mentioned, that currently offer liver-directed therapies for metastatic uveal melanoma patients and currently treat a meaningful number of patients with liver-directed therapy. Noteworthy centers include Thomas Jefferson University, led by uveal melanoma oncologist thought leader Marlena Orloff, and interventional radiologist David Eshelman, a leader in liver-directed therapy. Thomas Jefferson by far treats the largest number of metastatic uvea melanoma patients in the country. Other note-weather centers include UCLA, with the uvea melanoma thought leader, medical oncologist Bartosz Cimilowski, and interventional radiologist Sid Pavia. Mayo Clinic, with medical oncologist Roxanne Dronka and Yiyi Yan, interventional oncologist Charles Ritchie and Bo Toskis. Moffitt Cancer Center with the focused trial principal investigator, John Zager, and Stanford University with medical oncologist, Sunil Reddy, and interventional radiologist, Gloria Huang. Since approval, Kevin Muir, DelCast General Manager, Interventional Oncology, has been busy building the commercial organization. Kevin has made a point of bringing on team members that have deep experience in launching complex therapies that require multiple stakeholders in the hospital setting. For example, our new Director of Sales, Zach McLean, comes from Boston Scientific and has over 20 years' experience leading teams in bringing new liver-based interventional procedures to market. Under Zach's guidance, we have divided the U.S. into four regions, each of which will be served by a commercial team comprised of a liver-directed therapy representative and two oncology managers. The liver-directed therapy representative will manage the hospital approval process and ensure that the Hopsado kit procedure team is trained and supported while performing the procedures. The oncology managers will engage community-based medical oncologists outside of our treating centers with the goal of building referral networks to the oncologists within the treating centers. In addition, each team will be supported by a clinical specialist who will support the treatment teams in preparation for and during the treatment with the goal of ensuring patient safety and improving patient outcomes. To ease patient access, Kevin's team has been working with market access consultants to submit the required applications to obtain the C code, J code, and NTAP from CMS. Given the nature of HepsadoKit, we anticipate all codes and add-on payments to be granted. We are in the final stages of designing a patient access program called HepsadoKit Access, designed to assist patients and hospitals in numerous aspects of treatment planning, including prior authorization. We are working with a well-established hub service with significant experience in both ultra-orphan diseases and oncology to design and manage this program. We continue to support both internal and external efforts to add to a growing body of evidence that the PHP procedure, whether utilizing Melquin delivered by Stelcast ChemoSac or the HepCytoKit, is an important treatment option for patients with liver-dominant uveal melanoma. We recently announced the publication of results from a retrospective comparative study of chemosat and selective internal radiation, or CERT, published in the Journal of Cancers. The independent investigator study from the University Hospital Tübingen, Germany, compared two liver-directed therapies, multiple cycles of CERT versus two treatments of percutaneous hepatic perfusion with chemosat in patients with liver-dominant metastatic uveal melanoma. Median overall survival was 301 days for the 34 patients treated with SIRT and 516 days for the 28 patients treated with chemoset. In an adjusted COX regression model, there was a significant difference between SIRT and chemoset with a hazard ratio of 0.32, an associated 95% competence interval of 0.14 to 0.73, and a p-value of 0.006. The overall survival results clearly demonstrate the positive impact of treating liver metastases on patient outcomes with chemoSAT. As a reminder, there is an ongoing investigator-initiated randomized Phase II trial in Europe, the CHIPAN trial, evaluating the effect of adding immunotherapy to chemoSAT liver-directed therapy. The trial has enrolled 55 of the planned 76 patients, and the investigators expect the trial to be fully enrolled mid-2024. The primary objective of the trial is to determine the efficacy of combination treatment of immunotherapy with ipilimumab and nivolumab with chemostat treatment versus chemostat alone, defined by progression-free survival at one year. Secondary objectives include overall survival and overall response rate. An interim futility analysis conducted in September resulted in the independent data monitoring committee recommending the continuation of the study without modification. As mentioned earlier, we now expect to start commercial sales in January 2024, We have been utilizing the time between approval and launch to increase the number of trained training centers and initiating the formulary approval process in numerous institutions. The feedback and progress today gives us confidence that HepsadoKit will become the standard of liver-directed therapy care for metastatic uveal melanoma patients quickly after launch. I will now hand the call over to Sandra to share some details on her financial position. Sandra?