Delcath Systems, Inc.

Good day and welcome to the DelCast Systems Report's first quarter fiscal 2023 financial results 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. Please note this event is being recorded. I would now like to turn the conference over to David Hoffman of General Counsel. Please go ahead. Thank you.

And once again, welcome to DelCast Systems' 2023 first quarter 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, General Manager of U.S. Interventional Oncology, 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 risk 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. Since filing the NDA resubmission on February 14th and receiving a notice on March 20th that FDA determined resubmissions constituted a complete Class II response, the company has been working with the agency on the review process as the August 14th BiducaDate approaches. This primarily entails a routine information request that would be expected during an NDA review. Since I know the question will be asked, At this time, we have received no indication about whether the agency will schedule an advisory committee meeting. Of course, until we hear otherwise, we will continue to assume one will be scheduled. Given the recent financing and the approach in Paducah today, we are accelerating our preparation for the commercial launch of Pepsado, if approved. Our commercial model will be comprised of referring oncologists and treating centers. Therefore, a core part of that sites, which are sites that are either trained in treating patients in the Expanded Access Protocol prior to launch, or committed to becoming trained within a few months after approval. As we have mentioned before, DELCAP currently has three sites enrolled in the Expanded Access Program, with four more sites undergoing startup activities. In addition, approximately five other sites have expressed their intention in becoming treating sites if the HPSADOC kit is approved. So in total, we believe there are over 10 sites with the potential to become treating sites in a relatively short timeframe post-launch. While we will continue to seek additional treating sites, we believe this number of identified sites will ensure that we do not have treatment bottlenecks as referrals build for medical oncologists post-launch. A second key component to a successful launch is outreach to medical oncologists. Recall that the majority of our U.S. investigators in the FOCUS trial for surgical oncologists. While we have a number of very supportive metastatic ocular melanoma KOLs, we need a broader set of medical oncologists familiar with our data. Thus, we have started to build a medical affairs team, and we will have MSLs out in the field by next month. Post-launch, the MSLs will continue to focus on medical education with oncologists. We have also begun recruiting for the sales course management team. The sales force will be bifurcated, with one team focused on supporting existing treatment centers and working on opening new treatment centers, with the second team focused on calling on medical oncologists to facilitate potential referral of appropriate treatment patients to treatment sites. Turning to ongoing clinical work, because we have spoken about the