Delcath Systems, Inc.

Greetings and welcome to DelCast Systems' fourth quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. It is now my pleasure to turn the conference over to Mr. David Hoffman, DelCast's General Counsel. Thank you. You may begin.

Thank you, and welcome to DelCast Systems' fourth quarter and year-end 2025 earnings call. With me on the call are Gerard Michel, Chief Executive Officer, Sandra Pinnell, Chief Financial Officer, Kevin Muir, General Manager, Interventional Oncology, Boyo 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 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 with our 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.

Thanks, David. 2025 was a pivotal year, delivering over 40% volume growth and record revenue of $85.2 million, including $20.7 million in the fourth quarter alone. Today, we operate 28 active treatment centers, and the highly anticipated Chopin data demonstrating clear clinical benefit when PHP is sequenced with checkpoint inhibitors is slated for publication. Entering our third year of launch with strong momentum, we are confident that continued site activations, commercial expansion, and the Chopin results will drive meaningful revenue acceleration and create substantial shareholder value. 2025 was a pivotal year. in which we achieved over 40% volume growth and achieved record annual revenue of $85.2 million. We currently have a little bit of a glitch on the screen here. We have organized our commercial strategy around three priorities, expanding site capacity, changing prescribing patterns, and building referral networks. We track our progress against these priorities through three internal KPIs, the number of site activations, the rate of new patient starts per day, per site per month, and the average number of treatments per patient. We use these KPIs internally to model our projections and set guidance. The latter KPI, treatment number per patient, has remained consistent at approximately four cycles per patient since launch. The first two KPIs have shown significant variability as expected in the launch phase of any product, especially when treating an ultra-orphan patient population where small changes in patient numbers can have a large impact. Despite this variability, we are very encouraged by the trends we are seeing. The first strategic priority, expanding site capacity, is a function of the number of active sites and the volume of patients our sites can treat. We had a strong surge in activations earlier this year, bringing three new sites online, specifically MD Anderson, UT Southwestern, and Mayo Clinic Scottsdale. We now have 28 Risk Evaluation and Mitigation Strategy certified treatment sites. Leading cancer centers continue to engage, and we are targeting 40 active treatment centers by the end of 2026. The pace of vaccinations will likely be variable. Given the planned timing of the Salesforce expansion, as well as the anticipated increase in interest and support following a dependent publication of SHPAN results, We expect more activations to occur in the second half to 2026 compared to the first half. The expansion of U.S. commercial team divides the country into nine regions. Consistent with our current structure, each region will be staffed with a liver-directed therapy manager, an oncology manager, and a clinical specialist. This structure allows us to maintain a steady pace of site onboarding while also servicing our existing accounts. In addition to the expanded commercial team, we have revamped our medical affairs team with both new leadership and a new team of MSLs. Total site capacity is a function of open sites and the total number of patients a center can treat. Our 2026 projections regarding total site capacity, which can vary by month, assumes a similar summer seasonality pattern that we experienced last year. Seasonality is partially driven by the small number of REM certified team members at a treating site. For instance, when key personnel take vacation, sites cannot easily add new patients. While we are working to minimize the seasonality by increasing bench strength, we anticipate some seasonal loss of capacity in the late summer. Our second strategic priority is changing prescribing patterns by expanding the set of patients our treating oncologists consider appropriate for PHP. We are off to a strong start in 2026, having treated new patients per site per month at a rate of approximately 0.75 for the first two months of 2026, similar to the pace we saw in the first quarter of 2025. For context, for the full year in 2025, the average rate was 0.5 new patients per site per month with significant seasonality. For those modeling projections, keep in mind new patient starts impact revenue for the next three quarters. The expansion of both the commercial and medical field forces previously mentioned will also support our efforts to ensure all treating professionals are properly educated about HepsadoKit and thus can appropriately consider its usage. Our college's feedback remains positive. with PHP clearly addressing a significant unmet need in liver metastases from uveal melanoma. Recent 2025 publications and real-world evidence have reinforced the value of early and effective liver-directed therapy. In a recent uveal melanoma webinar hosted by Acure Insight, several of our strongest Hubsado advocates highlighted that initiating PHP treatment earlier in the disease course can meaningfully improve outcomes by reducing tumor burdens. and that combining Hepsado with systemic therapies can further enhance effectiveness. We expect increasing impact from the Chopin Phase II data. As a reminder, this investigator-initiated trial showed that sequencing PHP with ipilimumab and nivolumab delivers statistically significant and clinically meaningful improvements in one-year progression-free survival, overall survival, and objective response rates versus PHP alone. all within a very short 10-week treatment window. The ability to quickly initiate this combination therapy addresses concerns about delaying systemic therapy, and the combination itself addresses concerns regarding treating patients with extrahepatic disease. Leading centers such as UCLA, Massachusetts General Hospital, are already adopting Chopin-inspired protocols, including flexible sequencing and combination use with agents like Dibentadust in eligible patients. These data are helping both to establish Hepsado as a preferred first-line liver-directed option and to expand the patient populations our treating oncologists are comfortable referring for PHP treatment. We are also actively engaging key opinionators to support potential updates to the NCCN guidelines for metastatic uveal melanoma following publication of the SHOTAN data, with the goal of further highlighting the established role of Hepsado kit in this disease. Our third strategic priority, developing referral patterns, is critical to ensure eligible patients are identified and officially referred to one of our treating centers. The majority of patients with uveal melanoma are initially diagnosed with metastatic disease and managed at community or non-PHP institutions, making early referral a critical lever for both patient capture and better outcomes. To address this systematically, we are currently leveraging a variety of data sources to identify oncologists who have a patient who has very recently been diagnosed with metastatic disease before treatment decisions are locked in. Our oncology managers then engage those physicians to provide education on treatment options and the locations of our treating centers. Again, the expansion of both the commercial and medical field forces will also support this third strategic priority. the development of referral networks to our treating centers. We believe this upstream approach is already producing results, and strengthening these referral networks across the country is a top priority and will be a meaningful driver of new patients per site going forward. Collectively, these three priorities and the underlying KPIs support the 2026 guidance Sandra will share shortly. We are confident that consistent execution and expanding site capacity higher utilization at existing centers, and the active referral development will deliver continued long-term growth. I will now turn to an update in our clinical development programs. In our ongoing metastatic colorectal cancer trial, we continue activation of new trial sites and now have a total of eight centers actively screening patients. While opening and training sites for medical device clinical trials is more complex than a clinical trial with conventional drugs, we are on track to activate nearly all of the currently targeted 26 trial sites by mid-2026 and to present interim data results in late 2027. Our second program in metastatic breast cancer has one active clinical trial site, and additional sites are opening soon. Compared to physicians who treat metastatic colorectal cancer patients, breast cancer doctors have much less experience with liver-directed therapies. This lower level of awareness requires extensive communication and education on the potential benefits of PHP for patients with metastatic breast cancer. We are now targeting 15 trial sites and expect to activate them by late 2026. We will provide guidance related to the readouts for the metastatic breast cancer trial later this year, once progress of operational activities allows for more precise forecasting. Based on the results of the Chopin trial and the resulting interest in the medical community, we are evaluating combination PHP immune checkpoint inhibitor trials in various tumor types where there are clear areas of unmet need in the subset of these patients with liver metastases. We have had numerous well-attended advisory boards, and it will take another three to six months to finalize development plans for future combination trials and other indications. I look forward to sharing future updates on this topic. I will now ask Sandra to review our financial results.