Delcath Systems, Inc.

Good day and welcome to the DELCAD Systems third quarter 2022 financial results conference call. 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, today's event is being recorded. I would now like to turn the conference over to David Hoffman, DELCAS General Counsel. Please go ahead.

Thank you. And once again, welcome to DELCAS Systems' third quarter 2022 earnings call. With me on the call are Gerard Michel, the Chief Executive Officer, Dr. Johnny John, Senior Vice President of Medical Affairs and Clinical Development, Kevin Muir, Vice President of Commercial Operations, 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. DELCAP has had a productive third quarter of 2022 for both Hepsodon Kit, the company's product development candidate from the United States, and ChemoSat, the company's marketed product in Europe. In the U.S., we have two centers enrolled in currently treating patients under the Expanded Access Program, or EAP, with a third center enrolled in pending training. In addition, the Four other sites are in various stages of the startup process, and these include sites that were not involved in the FOCUS trial. We are on track to file the Hopsado Class II resubmission of the NDA to FDA by the end of December. We expect that within 30 days after the submission, the FDA will confirm receipt of the submission and, if they agree the resubmission is sufficiently complete to warrant review, establish a PDUPA date six months from the submission date. As we previously reported, In the third quarter, a retrospective analysis of patients treated with chemo sat in three European centers, one in the Netherlands and two in Germany, between February 2014 and December 2019 was published. The analysis involved 212 PSP procedures on 101 patients. The publication reported an overall response rate of 59.4% and a disease control rate of 89.1%. The safety analysis showed mostly grade 1, 2 and self-limiting toxicities. consistent with previous reports on PHP. This continues to add to the growing body of published research documenting the efficacy and safety of our ChemoSense system in the European Commercial Center. Researchers from Leiden University Medical Center in the Netherlands are making rapid progress on the randomized Phase 2 portion of the CHAPAN trial, with approximately 50% of the planned 76 patients enrolled. Recall the goal of this combined Phase 1B randomized Phase 2 trials is to study the safety and potential synergistic effects of systemic immunotherapy, ipilimumab, and nivolumab, or ipinivo, when combined with Delcast proprietary liver-targeted treatment in metastatic uveal melanoma patients. We look forward to the completion of enrollment into this trial, possibly as early as late next year, given the pace of recruitment, and to provide updates on the progress of the seven patients who completed the Phase 1B course of the trial. At ASCO earlier this year, the investigators reported an ORR of 85.7% and a DCR of 100%. We expect updates on the previously reported median progression-free survival of 22.4 months as the data matures. If similar results are seen in the current larger randomized phase 2 portion of the trial and the combination continues to be well tolerated, it could represent a significant improvement over current standard of care, including THP alone. While the results will be important in terms of the treatment of metastatic bubeomelanol patients, they could have relevance across multiple tumor types where hepatic metastases are present and immunotherapy is an accepted treatment. Turning to the commercial progress of Kemosat in Europe, the third quarter was the second full quarter after we resumed direct responsibility for sales, marketing, and distribution activities, which occurred on March 1st, 2022. Excluding the Netherlands, where most patients are now being treated in the Chopin trial, our units increased 41% over the same quarter last year and increased 26% versus the second quarter. We will continue to operate the business on a cash flow break-even basis for the time being, but we'll make several key hires in Germany and engage with consultants to support submissions for national coverage. These submissions are reliant on the publication of the focus trial results, which will now occur early next year. The first submission for national coverage will be in the UK. In late October, we agreed with MEAC, the previous distributor of ChemoSat in the UK and EU, on terms to settle the parties' ongoing dispute over the termination of the distribution agreement. The parties will reach a definitive settlement agreement before the end of 2022, and with this dispute behind us and the planned upcoming publication of focus trial results, we are confident that Europe will become a meaningful revenue contributor to the business, with EU revenues likely growing along with U.S. commercial launch of Hipsado, if approved next year. Also in October, we successfully completed a notified body audit to recertify our Queensberry, New York, manufacturing facility for ChemoSET under the European Medical Device Regulation, or MDR. While recertification, even under the new MDR regulation, has become routine for the company, It is important to keep in mind that our team in Queensbury has been undergoing audits for years, and I'm confident that we are well prepared for a pre-approval inspection from the FDA. Finally, we continue to lay the foundation for the planned commercialization of Hepsado. During the third quarter, we held advisory boards in the United States with interventional radiologists and anesthesiologists to gain further insight into the way treating facilities will utilize Hepsado if approved within their continuum of care. We have solidified our market access plans and are confident that for Medicare patients, that data will primarily be reimbursed using pass-through status, initially with a miscellaneous C code before being assigned our unique C code. We are carefully watching the Uniforce progress and noticed that in their first full quarter, they obtained a unique C code and booked $20 million in revenue from U.S. contract sales, despite being restricted to less than 50% of the patient population given their mechanisms of action. Based on publicly available information, the U.S. contract is priced at a level which equates to approximately $925,000 per patient based on the average duration of therapy reported for their pivotal trial. An equivalent price for the Hepsadone kit would be somewhere between $150,000 to $225,000 per kit, depending upon whether the price is based on a nine-month duration of therapy or six kits or four Hepsadone treatments over six months. the mean number of treatments from the focus row. While it is premature to finalize the price, this dynamic is important for investors to understand as we approach commercialization next year. We believe that the ultra-orphan pricing dynamic, combined with the very focused set of treating centers we will support, and the growing number of EAP sites, will translate into rapid revenue growth, a short runway to becoming cash flow positive, and very strong operating margins. Obviously, there is much to get done between now and launch, but the commercial potential for this first indication and the value it represents is clear. I look forward to taking questions, but first we'll turn the call over to Tony to review the finances. Tony?