Delcath Systems, Inc.

Good day and welcome to the Dell Curve Systems first quarter 2025 earnings call. All participants are in listen-only mode. There will be an opportunity to ask questions at the end of the formal presentation. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. Please note that this event is being recorded. I'd now like to turn the conference over to Mr. David Hoffman, DELCAS General Counsel. Go ahead, sir.

Thank you. And once again, welcome to DELCAS Systems' first quarter 2025 Earnings and Business Highlights Call. With me on the call are Gerard Michel, the Chief Executive Officer, Sandra Pinnell, Chief Financial Officer, Kevin Muir, General Manager, Interventional Oncology, Vojo Vukovic, Chief Medical Officer, and Martha Rook, 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 27 of the Securities Act of 1933 and Section 21 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 in a material manner 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 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. Our press release with our first quarter 2025 results is available on our website under the investor section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website. Now, I would like to turn the call over to Gerard Michel. Gerard, please proceed.

Thank you for joining us today to review our first quarter's financial results and business updates. I'm proud of our continued progress this quarter in terms of both revenue growth and incremental center openings. Both Hepsado and Chemostat have had an impressive first quarter of 2025, generating a combined revenue of $19.8 million. Hepsado sales in the U.S. contributed $18 million, while ChemoSat sales in Europe added $1.8 million. Thanks to the exceptional efforts of our commercial team, we ended the quarter with 17 treating sites and have since opened an additional two centers, bringing our total to 19 active centers in the U.S. In the first quarter, we continued to solidify the company's finances. With positive cash from operations of $2.2 million and an income of $1.1 million, positive adjusted EBITDA of $7.6 million. Additionally, we ended the quarter with no debt and approximately $59 million in cash and investments. With this strong financial footing, we will continue to leverage cash from operations to support Hepsado's research and development initiatives beyond metastatic uveal melanoma patients. Given our belief that Hepsado and the underlying hepatic delivery system platform has the potential to benefit a much broader set of patients, suffering from cancer in the liver. Turning back to center activations, in the first quarter, we activated the University of Kansas Health System, Cleveland Clinic, and Providence St. John's. So far in the second quarter, we activated Northwestern Memorial Hospital and the University of Miami. In addition to the 19 active treating centers, there are currently 10 centers now accepting referrals and pending activations. With our pace of opening between three to five centers per quarter, I am confident that we are well on track to achieve our previously stated goal of 30 active centers by year end. In the first quarter, we averaged approximately two treatments per month per center, and based on the expected pace of new center activations and mix of existing centers, we expect the average monthly treatment per site to be just under two for the remainder of the year. As we increase our footprint across the United States, we are expanding from four to six territories, with each territory having a liver-directed therapy manager, an oncology manager, and a clinical specialist. This transition to six territories is nearly complete, and we are successfully attracting top commercial talent across the United States to support our expansion. We continue to improve access for patients with metastatic uveal melanoma through our newly implemented Hepsado Kit Access 360 platform. This comprehensive program connects patients with authorized Hepsado Kit treatment centers and supports eligible patients in reducing their out-of-pocket costs. Hepsado Kit Access 360 also includes co-pay assistance for those with commercial insurance and also helps patients explore additional financial support available. The European market continues to experience growth, increasing 29% over the prior quarter to $1.8 million. As we have previously stated, given the reimbursement and pricing challenges in Europe, this market will not be a significant contributor to revenue, at least in the short to medium term. However, given Chemosat holds a comprehensive pan-solid tumor device label, and several of our European sites boast over a decade of experience with Chemosat, the region has and will continue to be a critical source of clinical data. Turning to company-sponsored trials, our clinical team is diligently working to establish sites for our liver-dominant metastatic colorectal and metastatic breast cancer trials, which represent a promising new indication for Hepsado. Our Phase II trial in metastatic colorectal patients received FDA clearance in December of 2024. As a reminder, the Phase II trial will evaluate the safety and efficacy of Hepsado in combination with standard of care versus standard of care alone in patients receiving third-line treatment. Standard of care will be trifluridine, tipterazole, and bevacuzumab. Our phase 2 trial of metastatic breast cancer received FDA clearance in April of this year. The phase 2 trial will evaluate the safety and efficacy of Hepzato in combination of standard of care versus standard of care alone in second- or third-line patients with liver-dominant HER2-negative metastatic breast cancer. Standard of care options will be erubuline, vinorelabine, or capcitabine. Each trial will enroll approximately 90 patients across over 20 sites in the United States and Europe. Both trials have a primary endpoint of hepatic progression-free survival. We anticipate both studies starting by the end of 2025 with enrollment for the metastatic colorectal trial to begin at third or early fourth quarter and enrollment for metastatic breast cancer to follow shortly thereafter. For metastatic colorectal, we anticipate the primary endpoint to read out by the end of 2027 or early 2028. with overall survival data expected to follow in 2028. For our metastatic breast cancer trial, we project hepatic progression-free survival data to be read out in late 2028 or early 2029, with overall survival data likely following in 2029. Our market research estimates an annual addressable market of approximately 7,000 patients with liver-dominant metastatic colorectal cancer advancing to third-line treatment in the U.S., alongside a comparable population of approximately 7,000 patients with liver-dominant metastatic breast cancer eligible for second- or third-line therapy. Each of these markets is approximately seven times larger than the metastatic uveal melanoma patient population, which affects approximately 1,000 patients annually in the U.S. These substantial patient populations face the significant unmet needs as neither systemic therapies nor permanent liver-directed therapies adequately address liver metastases. understoring the urgent demand for innovative treatment options. Our strong start to 2025 was marked by consistent revenue growth and the expansion of active treatment centers adopting Hepstado. In the first quarter, we achieved both positive net income and operating cash flow, driven by robust clinical demand and accelerating adoption among oncologists and interventional radiologists. Our ongoing engagement with these specialists underscores the critical role of whole liver treatment in addressing liver-dominant disease. informing our strategy to pursue additional invitations. These efforts position us to potentially transform care for a broader population of metastatic patients, including those with liver, dominant colorectal, and breast cancer. I'll now hand the call over to Sandra, who will provide a detailed overview of our financial performance.