Delcath Systems, Inc.

Delcath Systems, Inc. Earnings Recaps

DCTH Health Care 2 recaps
Q1 2026 May 8, 2026

Delcath Systems' stock rose modestly by 2.0% following its Q1 2026 earnings, reflecting a mixed reception to solid early patient start metrics and ongoing progress in clinical trial site activations, tempered by cautious pacing on site expansions and patient enrollments.

Key takeaways
  • Activated 4 new centers in Q1, progressing toward 37 active centers by year-end and 40 centers expected by early 2027, down from previous pacing projections.
  • New patient starts per site tracked slightly above Q1 2025 levels, at approximately 0.7 new patients per site per month, helping to sustain revenue growth.
  • Enrollment in metastatic colorectal cancer trial remains slow with only 7 patients enrolled out of 13 active sites, though site activation and training continue to advance.
  • Metastatic breast cancer trial progressing with 4 active screening sites and plans to reach 15 sites by late 2026, alongside physician education efforts to build familiarity with liver-directed therapies.
  • The company is exploring expanded indications beyond colorectal and breast cancer, driven by interest in combination regimens similar to CHOPIN results.
Q3 2025 Nov 5, 2025

Delcath Systems reported a mixed third quarter in 2025, with a notable impact from 340B pricing adjustments and seasonality affecting new patient starts, prompting a revised revenue guidance. However, positive clinical results from the CHOPIN trial highlight the potential for future growth.

Key takeaways
  • Revenue guidance for 2025 adjusted to $83M-$85M due to slower new patient starts and 340B pricing effects, resulting in a 13% decrease in average revenue per kit.
  • Four new treatment sites activated recently, increasing total to 25 REMS-certified centers, with a target of 26-28 centers by the end of 2025.
  • Strong clinical trial data from the CHOPIN trial reported at ESMO, showing significant improvements in progression-free survival and overall response rates, positioning HEPZATO as a key therapy for uveal melanoma.
  • Competition from various clinical trials noted as a factor in slower patient initiation, though the CHOPIN trial’s compelling results may mitigate this challenge.
  • Plans to expand the U.S. sales force further by 2026 to enhance site activation and referral networks to aid growth.