Delcath Systems Q1 2024 Results and Highlights

Delcath Systems, Inc., a company specializing in interventional oncology for liver cancer treatments, has announced its financial outcomes and significant business developments for the first quarter ending March 31, 2024.

Key Business Developments:
Throughout the initial quarter and extending beyond it, Delcath has achieved several milestones:

- The company recorded over $2.0 million in revenue from the sales of the HEPZATO KIT (melphalan/Hepatic Delivery System) and $1.1 million from CHEMOSAT sales up to March 31, 2024.
- Delcath updated its U.S. center activation forecast, aiming for 20 active centers by the end of 2024, an increase from the initial projection of 15.
- Four new treatment centers were activated in the first quarter, with an additional two in April. Moreover, five more centers are in the process of accepting patient referrals.
- The company successfully raised $7.0 million via a private placement with accredited investors, including existing investors, senior executives, and members of the Board of Directors.
- Dr. Martha S. Rook was appointed as Chief Operating Officer, bringing over 25 years of experience in academia and industry.
- Delcath received a permanent, product-specific J-code (J9248) and transitional pass-through payment status from the Centers for Medicare & Medicaid Services (CMS) for HEPZATO KIT, effective April 1, 2024.
- The company extended its agreement with Synerx Pharma, LLC and Mylan Teoranta for the supply of melphalan hydrochloride until December 31, 2028.
- Results from the pivotal Phase 3 FOCUS study of HEPZATO KIT were published on May 4, 2024, in the Annals of Surgical Oncology, showcasing its efficacy in treating patients with unresectable metastatic uveal melanoma.

Gerard Michel, Delcath’s Chief Executive Officer, highlighted the company's progress in training and activating new treatment centers. Michel emphasized the emerging importance of HEPZATO in treating metastatic uveal melanoma and expressed confidence in reaching the goal of 20 active centers by year-end.

First Quarter 2024 Financial Results:
As of March 31, 2024, Delcath reported cash, cash equivalents, and investments totaling $27.2 million, including the $7.0 million raised through private placement on March 19, 2024. The total revenue for the first quarter was $3.1 million, a significant increase from the $0.6 million reported for the same period the previous year, driven by sales of HEPZATO in the U.S. and CHEMOSAT in Europe.

Research and development expenses for the quarter were $3.7 million, down from $4.6 million in the prior year, primarily due to decreased clinical trial activities and FDA inspection-related costs, offset by an increase in personnel expenses. Selling, general, and administrative expenses rose to $8.8 million from $4.2 million in the same period last year, largely due to commercial launch activities, marketing expenses, and an expanded commercial team.

About Delcath Systems, Inc., HEPZATO KIT, and CHEMOSAT:
Delcath Systems, Inc. focuses on treating primary and metastatic liver cancers. The company’s proprietary products include the HEPZATO KIT™, a combination drug-device product regulated and approved by the FDA in the U.S., and the CHEMOSAT® Hepatic Delivery System, approved in Europe. The HEPZATO KIT is designed for liver-directed treatment of adult patients with metastatic uveal melanoma with unresectable hepatic metastases and specific conditions for extrahepatic disease. The system isolates the liver during melphalan infusion to deliver high-dose chemotherapy while minimizing systemic exposure and side effects.

In Europe, the CHEMOSAT system, a Class III medical device, is used in percutaneous hepatic perfusion procedures to treat various liver cancers at major medical centers.