Delcath Systems, Inc.

Greetings, and welcome to the Delcath Systems' fourth quarter 2024 earnings conference call. At this time, all participants will be in listen-only mode. The question and answer session will follow the formal presentation. If anyone today should require operator assistance, please press star zero from your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce David Hoffman, Delcath's General Counsel. Mr. Hoffman, you may begin.

Thank you, and once again, welcome to Delcat Systems' fourth quarter and full year 2024 Earnings and Business Highlights Call. With me on the call are Gerard Michel, Chief Executive Officer, Sandra Pinnell, Chief Financial Officer, Kevin Muir, General Manager, Interventional Oncology, Oya 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 27A of the Securities Act of 1933 and Section 21E of the Security 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 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 fourth quarter and full year 2024 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, and thank you all for joining us today. 2024 was truly a transformative year for DELCAF, given the U.S. launch of Hepsado in January of that year. We generated $32.3 million of Hepsado revenue in the U.S. for the year, including $13.7 million in the fourth quarter from 14 active U.S. treatment centers. Importantly, in 2024, we secured both a permanent J-code and a new technology add-on payment, commonly called NTAP. While incremental revenue from Europe remains modest due to pricing and reimbursement structures, European growth in 2024 over 2023 was 137%, and this growth remains an important strategic component of the business. These achievements reflect the strength of our world-class commercial team, which has successfully navigated the complexities of launching Hepsado and expanding chemosat usage. Their ability to train multidisciplinary healthcare providers, secure hospital formulary approvals, and drive procedural adoption at major academic centers has been exceptional. In the fourth quarter, our cash burn was only at $1 million, and we achieved $4.6 million in positive adjusted EBITDA, a first for the company. and ended the year with $53.2 million in cash and investments with no debt. During the year, we received over $41 million in proceeds from the exercise of warrants. This financial stability enables us to expand R&D and new initiatives to maximize the hepatic delivery system's potential to treat other liver-dominant cancers. Shifting focus to the specifics of Q4 results and 2025 plans, during the fourth quarter, we activated three new U.S. treatment centers, Duke University of Utah and Mayo Jacksonville. So far in 2025, we have activated another two centers, bringing the total to 16 with an additional center scheduled for its first treatment in March and eight more centers accepting referrals. Our goal remains 30 active centers by year end. It is important to note that the centers we have activated or are in the process of being activated are leading academic centers, such as Mayo Clinic, MGH, Cleveland Clinic, and Thomas Jefferson, all of which are active, as well as Northwestern and D. Anderson, which are not yet active but accepting referrals. In Q4, the average treatment rate per site was slightly under two per month, a rate expected to continue in 2025 as we bring on new centers, which typically start at lower utilization rates before ramping up. To support this expansion, we are increasing our commercial team and expanding from four to six regions, each structure with a liver-directed therapy manager, an oncology manager, and a clinical specialist. The liver-directed therapy manager drives the hospital approval process and ensures the Habsado kit procedure team is appropriately trained and, once the site is active, supports the site as they manage the patient flow. The oncology managers engage community-based medical oncologists outside of our treatment centers with the goal of building peer-to-peer referral networks between the community oncologists and the treating centers. The clinical specialists support the treatment teams in preparation for and during the treatment with the goal of ensuring patient safety and improving patient outcomes. Additionally, we are enhancing the field support to assist centers with administrative processes, ensure accurate coding, and efficient claim submissions, which will facilitate broader adoption. Since the field force will be expanded by mid-year, we expect more than half of the incremental centers to be added this year to come on board in the second half of the year. Chemosat volumes in Europe grew 137% in 2024, with Germany up 75%, and other markets, including the UK and Turkey, doubling year over year. There were two new centers activated and one existing center reactivated in Germany. We expect modest study growth moving forward, maintaining a break-even strategy in the region. The strategic value of our European presence lies in supporting clinical trials and generating publications. In 2024, over 10 studies from European centers were published, including research on chemo sets used in intrahepatic cholangiocarcinoma. In 2025, we plan to expand into France, Italy, and Spain, complementing our strong presence in the UK, Germany, and the Netherlands. We continue to engage oncologists in both the U.S. and Europe to integrate Hepsado into treatment algorithms. In 2024, the Scandium-3 trial in Sweden began to screen patients. This 40-patient study compares two cycles of chemosat followed by ipilimumab and nivolumab versus ipilimumab and nivolumab alone. Meanwhile, the Chopin trial in the Netherlands, which sequences two chemosat treatments after initial ipilimumab and nivolumab therapy, completed enrollment with 76 patients in the third quarter of 2024. We expect the primary employee analysis of progression-free survival at one year to be reported in the second half of the year. In 2024, expert consensus identified liver-dominant metastatic colorectal cancer and metastatic breast cancer as promising new indications for HEP-SATO. Our phase two trial in metastatic CRC received FDA clearance in December, and we'll compare HEP-SATO plus trifluridine, tipuracil, babesumab versus standard of care alone in 90 patients. Enrollment is expected to begin in the second half of 2025 across 20-plus U.S. and European sites. The primary endpoint, hepatic PFS, is expected to read out by the end of 2027, with overall survival data following in 2028. Our market research estimates a total addressable market of 6,000 to 10,000 patients annually in the third-line liver-dominant metastatic CRC. The phase two metastatic breast cancer trial in a third-line setting of liver-dominant patients is expected to begin in the fourth quarter of 2025, pending FDA IMD clearance. Additional details of the trial design will be shared upon clearance. To drive further innovation, we are expanding our internal R&D capabilities. As an example, we recently appointed Dr. Michael Bruner, a former president of the Society of Interventional Radiology, with over 25 years of experience in academia and biotech leadership, a senior vice president of interventional oncology, to advance procedural improvements and explore new indications. In summary, the first year of U.S. launch of EPSADO has been a success. In 2024, we have been able to provide a novel treatment to patients suffering from metastatic uveal melanoma. This success has brought us very close to cash flow break-even and has directly led to a stronger balance sheet. We now have over $50 million in cash and investments and no debt. We are well-positioned to continue to grow revenue while investing in high-impact R&D initiatives. The future for Delcath has never been brighter. I will now hand the call over to Sandra to share further details on our financial position.