Delcath Systems, Inc.

Good day, ladies and gentlemen, and welcome to the Delcath fourth quarter 2021 earnings call. At this time, all participants have been placed on a listen-only mode. 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, David Hoffman, Delcath General Counsel. Sir, the floor is yours.

Thank you. And once again, welcome to DelCast Systems' fourth quarter 2021 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 Pappora, 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 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 or a discussion of such risks and uncertainties which could cause actual results to differ from those expressed or implied in the forward-looking statement, 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. Since that call, we've released additional secondary and exploratory efficacy endpoints from the phase three focus study. hosted a comprehensive virtual investor update meeting, made important strides towards filing our NDA for the treatment of metastatic ocular melanoma, and continued our discussions with medical oncologists regarding further development and additional indications. Starting with focus study data, we believe the totality of the efficacy data we released last year provides strong support for the clinical benefit of Hipsado for patients with metastatic ocular melanoma. The 31.4% objective response rate in the intent to treat population, including a 6.9% complete response rate, meaningfully exceeds response rates reported in published studies in this difficult-to-treat disease. Notably, it far exceeds the 5.5% objective response rate from the meta-analysis of immune oncology agents, which we used to power the study. Importantly, the responses seen in the trial are durable. with a clinically meaningful duration of response of 14 months. And the categories of response ranging from progression of disease to complete response correlate with increased median overall survival. The overall survival of 20.5 months in this patient population compares favorably to published studies in metastatic doctor melanoma. As we have previously reported, supportive, predefined exploratory analyses were conducted comparing patients in the hep-sato arm versus a best alternative care or BAC arm. As a reminder, the BAC arm was comprised of 42 patients originally randomized in the FOCUS trial prior to its amendment in consultation with FDA through a single arm pivotal study in 2018. These predefined exploratory analyses between the BAC arm and Hopsado show statistically significant treatment advantages and objective response rate, disease control rate, and progression-free survival. Specifically, in patients who received one or more treatments, objective response rate was almost triple BAC at 35.2% versus 12.5%, almost double the disease control rate at 73.6% versus 37.5%, and almost triple the progression-free survival at nine months versus 3.1 months. Further, while survival data has not fully matured, a six-month median overall survival trend in favor of Lepsado is observed In an important post-hoc analysis, survival at 12 months in the evaluable patients was 75% in the hips out of arm versus 47% for BAC, a statistically significant and clinically meaningful difference. Per the statistical plan, a predefined exploratory survival analysis versus BAC will be conducted at 24 months after last patient, last treatment, which occurred in May of last year. We will provide future overall survival analysis updates as patient follow-up continues and the capillary viral analysis matures. In the hepato-safety population, the most commonly reported treatment emergent serious adverse events were anemia, 29.7% of patients, thrombocytopenia, 26.4% of patients, and neutropenia, 19.8% of patients, which were well manageable and transient. 5.3% of patients experienced a treatment of emergency serious cardiac adverse events. All of those events resolved with no ongoing complications. There were no treatment related deaths in the trial. This adverse event profile is similar to many commonly prescribed cytotoxic agents. We are excited to share these and other data with the FDA and are on track to submit the class two resubmission to the agency in mid-year. I'm glad to be able to announce that we're close to having 1% of the patient data monitored. We have requested a pre-NDA meeting with the FDA and are scheduled to meet with the agency in late April. Last year, an outside firm completed a mock audit of our Queensbury, New York medical device manufacturing facility in anticipation of the submission and of an eventual FDA pre-approval inspection. While we recently achieved a medical device regulation or MDR certification from our notified body for chemosat under the new European medical devices regulation, We recognize that an FDA pre-approval inspection has a distinct set of standards and therefore hired this outside firm to conduct the mock audit. I am pleased to announce that based on the findings from the audit and our ongoing activities, we are confident that we will be well prepared for the anticipated FDA inspection, hopefully sometime in late summer or fall. We announced last month that we were resuming direct responsibility for sales, marketing, and distribution activities of Chemostat in all of Europe. Since December 2018, Mediac, a privately held company based in Germany, has been the licensee for ChemoSat in the EU, the UK, Norway, and Switzerland. We resumed direct sales, marketing, and distribution earlier this month and currently have four customer-facing employees in sales, marketing, and medical affairs working with healthcare providers in the UK, Germany, and Netherlands and anticipate hiring several more this year to further support healthcare providers and patients in those markets as well as expand use throughout broader Europe. Importantly, we anticipate our first submissions for national coverage will occur by the end of the year, including in the United Kingdom. In December, we hosted a distinguished panel of 12 U.S. and European physicians who discussed their respective experience with Hepsado in the FOCUS trial, commercial experience with Chemostat in Europe, and the unmet need in the treatment of liver metastases and the possible role of Chemostat and Hepsado, if approved, to treat those patients. We were able to gather this large group of distinguished experts for three reasons. First, the compelling nature of the FOCUS trial results for Hepsados treatment of metastatic octomelanoma patients. Second, the existence of approximately 10 years of real-world experience in the EU demonstrated the utility of the PHP platform. And finally, the large unmet need for improved treatments for patients with hepatic-dominant disease. If you haven't had a chance to watch the December 2nd Virtual Investor Update presentation, I recommend you take the time to get a treating physician's view on Hep Ceto and ChemoSat, as well as their perspective on the need for better treatments for patients suffering from liver-dominant cancers. Related to the real-world experience shared during that Virtual Update presentation by some of the European KOLs, last month we were pleased to see results from a single institution retrospective study published in the journal Melanoma Research. The study was conducted by University Hospital Southampton NHS Foundation Trust in England on the use of chemosat for the treatment of patients with liver-dominant metastatic uveal melanoma and was authored by Dr. Sachin Modi and his colleagues. The study evaluated the safety and efficacy of chemosat in 81 patients with liver-dominant metastatic uveal melanoma treated with chemosat between 2012 and 2020. Approximately half of the patients had received other treatments, either systemic or liver-directed, before chemosat treatment, similar to the FOCUS trial that included first-line patients and patients who had failed prior lines of therapy. 250 PHP procedures were performed in 81 patients with a median of three per patient. The analysis demonstrated a hepatic disease control rate of 88.9%, a hepatic response rate of 66.7%, which included a hepatic complete response rate of 12.3%, and an overall response rate of 60.5%. After a median follow-up of 12.9 months, median overall progression-free survival and median overall survival were 8.4 and 14.9 months, respectively. Treatment of emergent adverse events of grade three or four occurred in 27.7% of the patients. The most common grade three or four hematological toxicities where anemia observed in 13.3% of patients and thrombocytopenia observed in 12% of patients. There were no fatal treatment-related adverse events. The authors concluded that ChemoSaf provides excellent response rates and progression-free survival compared with other available treatments and noted that combination therapy with systemic agents may be viable to further advance overall survival. These results are consistent with numerous other publications out of Europe and as the growing body of published research documenting the efficacy of our PrimaSat system in the European commercial setting. Shifting gears, we also strengthened our leadership team with two appointments in early 2022. We announced Anthony Diaz as our new Vice President of Finance. Tony brings over 20 years of experience leading finance and operational teams of pharmaceutical, medical device, and technology companies. Tony will oversee all financial aspects of the company, including financial planning and analysis, financial reporting, accounting and control, tax and treasury. We also announced David Hoffman as General Counsel and Corporate Secretary. David will also serve as DELCAP's Chief Compliance Officer. He brings over 20 years of experience advising biotechnology companies with a focus on the commercialization of therapies. Most recently, he served as Associate General Counsel and Chief Compliance Officer at Barrasoft Corporation. where he was responsible for legal and compliance matters in support of the launching growth of products in the advanced cell therapy and biologic space. David has considerable expertise in pharmaceutical law and regulation, business development, commercial business transactions, IT, and compliance. Both hires bolster our management team at a critical juncture as we approach commercialization in the US and resume direct commercial operations in the EU. Regarding US commercialization, A key goal is to have 10 expanded access sites open by the time of launch and to ensure that the mix of sites are appropriately located to enable reasonable access regardless of a patient's location. To date, well over 10 sites have expressed interest in participating, and we should have two sites in a position to start accepting patients within a month. In addition, we are actively developing key documentation to support reimbursement, such as a value dossier and an NTAP submission. as well as holding advisory boards and treating physicians to better understand the patient journey. Finally, we continue to plan on expanding the PHP platform into other indications. An important part of that is garnering further input from both medical oncologists and interventional oncologists to ensure that there is broad interest in sites and any trial can recruit patients. As hopefully was evident from the virtual investor update presentation, there is real interest in investigating the U.S. the use of PSV platform in a variety of other cancers, specifically both intrahepatic cholangiocarcinoma and colorectal carcinoma. We have scheduled a series of further advisory boards to review proposed protocols for each indication, after which we will start formal discussions with sites and prepare any required regulatory submissions. Given our first priority remains submitting the NDA and launching in the U.S., DELCAP is primarily focused on those regulatory and commercial bills. However, these expanded indications are still a core part of our strategy and our efforts will continue in parallel. In summary, fiscal year 2021 and nearly a quarter into 2022, we've taken important steps towards commercialization of our PHP system in our initial indication and expansion into new areas. We have brought in key personnel and continue to be supported by a growing body of data as demonstrated by our positive phase two results and the study at Southampton. Ahead of refiling our NDA plan for mid-2022, we're excited to conduct a pre-NDA meeting in coming weeks. I look forward to taking questions, but first we'll turn the call over to Tony to review the financials. Tony?