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Delcath Systems, Inc. develops interventional oncology products for primary and metastatic liver cancers. Its core products include HEPZATO KIT, a melphalan and Hepatic Delivery System combination product approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma, and CHEMOSAT Hepatic Delivery System for Melphalan used in percutaneous hepatic perfusion.
Recurring news covers quarterly operating results, HEPZATO KIT and CHEMOSAT revenue, clinical publications from studies such as FOCUS and CHOPIN, presentations at oncology and interventional radiology meetings, guideline recognition, and studies of melphalan-based percutaneous hepatic perfusion in liver-dominant cancers. Company updates also address FDA-approved product status, European clinical practice references, and capital actions such as common-stock repurchases.
Delcath Systems (Nasdaq:DCTH) reported second quarter 2026 revenue of $29.1M, up from $24.2M in 2025, driven by HEPZATO KIT $27.1M and CHEMOSAT $2.0M. Gross margin rose to 90%. Net income was $2.7M, flat year over year, while non-GAAP adjusted EBITDA declined to $7.6M from $9.8M. Operating cash flow was $5.7M, and cash and investments totaled $95.9M with no debt at June 30, 2026.
The company now guides 2026 revenue to $104M–$108M, implying at least 28% HEPZATO KIT volume growth, full-year gross margin of 86%–89%, and positive adjusted EBITDA. Delcath highlighted 31 active treatment centers, ~30% HEPZATO volume growth, new investigator-initiated combination trials in melanoma, and first dosing in a global Phase 2 study in liver-dominant HER2-negative metastatic breast cancer.
Delcath Systems (Nasdaq: DCTH) announced that its management will attend the Canaccord Genuity 46th Annual Growth Conference on Tuesday, August 11, 2026, in Boston, MA. Delcath is an interventional oncology company focused on treating primary and metastatic cancers of the liver.
Delcath Systems (Nasdaq: DCTH) will host a conference call on Thursday, August 6, 2026, at 8:30 AM Eastern Time to discuss its financial results for the second quarter ended June 30, 2026. Investors can join via toll-free and international dial-in numbers or through a webcast link. A replay will be available and archived on the company’s website shortly after the call.
Delcath Systems (Nasdaq: DCTH) granted equity awards as material inducements to four new employees who started in May or June 2026. The awards comprise 17,000 RSUs under the 2023 Inducement Plan, granted on July 1, 2026, with vesting over three years, subject to continued employment and in accordance with Nasdaq Listing Rule 5635(c)(4).
Delcath Systems (Nasdaq:DCTH) reported dosing the first patient in its global Phase 2 DELUMA trial of HEPZATO plus standard of care for liver-dominant HER2-negative metastatic breast cancer.
The randomized trial will enroll about 90 patients at >20 US and European sites, assessing hepatic progression-free survival and multiple secondary endpoints.
Delcath Systems (Nasdaq:DCTH) announced two investigator-initiated trials-in-progress abstracts accepted for poster presentation at the ASCO 2026 Annual Meeting. Both studies evaluate the HEPZATO KIT percutaneous hepatic perfusion (PHP) system in metastatic melanoma with liver involvement, in combination or sequence with modern systemic therapies.
One Phase 2 trial in metastatic uveal melanoma pairs sequential HEPZATO PHP and tebentafusp, while a Phase 1b/2 trial studies HEPZATO with nivolumab/relatlimab in metastatic non-uveal melanoma. Enrollment began in November 2025 and January 2026, respectively.
Delcath Systems (Nasdaq:DCTH) granted equity awards as material inducements to four new employees who began in March or April 2026. The awards total 24,500 RSUs of common stock under the 2023 Inducement Plan and were granted on May 1, 2026.
One-third vests after one year, with the remaining two-thirds vesting in equal annual installments over two additional years, subject to continued employment. The grants were made in accordance with Nasdaq Listing Rule 5635(c)(4).
Delcath Systems (Nasdaq:DCTH), an interventional oncology company targeting primary and metastatic liver cancers, announced that its management will attend the H.C. Wainwright 4th Annual BioConnect Investor Conference on Tuesday, May 19, 2026 at Nasdaq in New York, NY.
Delcath Systems (Nasdaq: DCTH) reported Q1 2026 results and provided 2026 guidance. Total revenue was $25.0M (HEPZATO $23.3M; CHEMOSAT $1.7M). Gross margin was 85%. Net loss was $1.1M and adjusted EBITDA was $3.4M. Cash and investments totaled $89.3M as of March 31, 2026.
The company reaffirmed 2026 revenue guidance of at least $100M, projected gross margins of 84–87%, and positive adjusted EBITDA. Business highlights include ~36% HEPZATO volume growth YoY and 29 active centers.
Delcath Systems (Nasdaq: DCTH) announced presentation of new retrospective data on percutaneous hepatic perfusion with melphalan (M-PHP) for liver-dominant metastatic breast cancer at ESMO Breast Cancer Congress 2026 on May 7, 2026.
Presentation: e-poster at 13:15 local time, Abstract #574eP, presenter Cornelia Lieselotte Angelika Dewald, MD (Hannover Medical School). The analysis evaluates safety and feasibility of M-PHP using the CHEMOSAT Hepatic Delivery System.