Delcath Systems, Inc.

Good morning, ladies and gentlemen, and welcome to the DELCA Systems First Quarter 2026 Earnings Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, May 7, 2026. I would now like to turn the conference over to David Hoffman. Please go ahead.

Thank you, and welcome to DelCast Systems' first quarter 2026 earnings call. With me on the call are Gerard Michel, Chief Executive Officer, Sandra Pinnell, Chief Financial Officer, Kevin Muir, Chief Commercial Officer, Voyo Vukovic, Chief Medical Officer, and Martha Rook, Chief Operating Officer. 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 in a material manner 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 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 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 of our first quarter 2026 results is available on our website under the Investors 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. Gerard, please proceed.

Thank you, David, and welcome, everyone. We've had a very successful first quarter marked by four center activations and record new patient starts in the first quarter, both of which are core growth drivers for the businesses. In addition, we continue to advance numerous commercial and medical initiatives to ensure the long-term growth of Hepsado, with a strong focus on a third critical growth driver, building referral networks to quickly connect eligible patients with treating centers. To support center activations, increased utilization at existing centers, and expanded referral patterns, we have nearly completed our U.S. commercial expansion into nine regions. In addition, the expanded MSL team is fully trained and in the field, educating physicians about metastatic uveal melanoma with a focus on the Chopin results. As of today, we have 29 REN-certified sites, and we are in active discussions with over 50 potential new centers. And 38 of these centers have had one or more members of a potential treatment team take the time to travel and be preceptive. While not all of these centers will become activated, And the process can take over a year in some cases. There is clearly broad-based interest in this therapy, which bodes well for the long-term growth of the business. As we note on every call, it is very difficult to predict pacing. And given where we are at this point in the year, we are modifying our year-end activated center goal to 37 active centers, with 40 active treatment centers sometime in the first quarter of 2027. In addition to center activation, we are focused on changing prescribing patterns by expanding the set of appropriate patients that treating teams consider for PHP through education, fostering peer-to-peer conversations, and evidence generation. First quarter 2026 new patients starts per site have tracked at or slightly higher than the first quarter of 2025 at approximately 0.7 new patients per site per month. New patient starts contribute to revenue over subsequent quarters as patients receive a series of treatments. We expect the strong first quarter new patient starts to offset the reduced site activation pace. Based on conversations with some treating physicians, we know that the publication of the SHPAN results in Lancet Oncology is already changing treatment patterns at certain centers. One piece of publicly available anecdotal evidence is the recent webinar hosted by the patient advocacy group, A Cure Insight, during which Dr. Sid Patia, an interventional radiologist from UCLA, shared his experience treating metastatic uveal melanoma patients with Epsado. Some of the patients Dr. Patia is treating with PHP are also being treated with immunotherapy. and he noted on the webinar that his results with these patients are consistent with or perhaps superior than the positive results reported from the Chopin trial. As a reminder, Chopin response rates improved from approximately 40% with Hubsado alone to about 76% when Hubsado was combined with immunotherapy, including some cases of complete response. The combination armed the demographic survival benefit with a clear separation between survival curves at both one and two years. Dr. Padia characterized these study results as extremely encouraging and consistent with his clinical experience. Many metastatic uvea melanoma patients are managed outside REN-certified centers, so earlier identification and streamlined referral processes are essential. One important approach to enhancing referral patterns is to use multiple data sources to identify physicians treating newly diagnosed metastatic patients, and promptly connect these patients to the suitable Hepsado treatment center. As these networks mature, we expect referrals to be an important driver of new patient starts across our footprint. I now would like to turn to our clinical development programs. In our ongoing metastatic colorectal cancer trial, we continue to activate new trial sites and now have a total of 13 centers who can actively screen CRC patients. We have implemented specialized training modules and streamlined onboarding processes to continue to accelerate site readiness and ensure protocol adherence. We are on track to activate nearly all of the currently targeted 26 trial sites by the end of this year and anticipate presenting interim results in late 2027. To date, we have enrolled seven patients. While this pace has been slower than initially anticipated, we believe the program is picking up momentum. Our second program, in metastatic breast cancer, now has four clinical trial sites that are prepared to screen patients, with additional sites opening soon. Since breast cancer physicians typically have less experience with liver-directed therapies compared to those treating metastatic colorectal cancer, we are conducting targeted education and outreach initiatives to increase awareness of hepatocytosis potential benefits in patients with metastatic breast cancer. We are targeting 15 trial sites and expect to activate them by late 2026. We will provide guidance related to the readouts from this trial later this year as operational progress supports more precise forecasting. We are seeing growing interest in Hepsado beyond colorectal and breast cancer and are exploring clinical trial design into additional indications, data by physician input and advisory board feedback. Based on the results of the Chopin trial, there is strong enthusiasm from the medical community to investigate a Chopin-like combination regimen to treat liver involvement in patients with a variety of cell or tumor types. I look forward to sharing updates on these plans later in the year. I will now ask Sandra to review our financial results.