Delcath Sys Stock Price, News & Analysis

Delcath Systems (Nasdaq: DCTH) granted equity inducements under Nasdaq Listing Rule 5635(c)(4) to four new employees who began work in November or December 2025. The company issued 36,250 Restricted Stock Units (RSUs) under its 2023 Inducement Plan, with grants dated January 2, 2026. Vesting: one-third on the first anniversary of the grant and the remaining two-thirds in equal annual installments over the next two years, subject to continued employment on each vesting date. The awards were approved by the Compensation Committee and issued pursuant to the Plan and Nasdaq rules.

Delcath (Nasdaq: DCTH) reported preliminary, unaudited results for Q4 and full-year 2025. Total revenue is expected to be approximately $20.7M in Q4 and $85.2M for FY2025. HEPZATO KIT revenue is expected at $19.0M (Q4) and $78.8M (FY), while CHEMOSAT revenue is expected at $1.7M (Q4) and $6.4M (FY). The company repurchased 628,572 shares for $6.0M under a $25.0M buyback program. Cash and short-term investments were approximately $91.0M with no debt as of December 31, 2025. Procedure volume for HEPZATO grew ~140% in 2025 versus 2024. Final audited results and a detailed update will be released on the company’s annual call.

Delcath Systems (Nasdaq: DCTH) announced publication of subgroup analyses from the Phase 3 FOCUS study of HEPZATO KIT (melphalan/Hepatic Delivery System) in unresectable metastatic uveal melanoma, published December 31, 2025.

Key findings in 91 treated patients: higher ORR when tumor burden was below the median (51.1% vs 22.2%, p=0.008); longer median PFS for lower tumor burden (11.3 vs 5.8 months, p=0.007); longer OS with smaller liver involvement, lower tumor burden, and low/normal LDH (p=0.032, p=0.008, p=0.019 respectively). Safety was consistent across subgroups with no treatment-related deaths.

Delcath Systems (Nasdaq: DCTH) announced publication of a 10-year, single-center retrospective study reporting outcomes for 38 patients with liver-dominant metastatic uveal melanoma treated with 99 percutaneous hepatic perfusion (PHP) procedures using the CHEMOSAT Hepatic Delivery System for melphalan.

Key outcomes: median overall survival 29.1 months from first PHP (95% CI: 18.4–38.9), 1-/2-/3-year OS of 79.5%/53.2%/28.5%, no treatment-related deaths, procedure-related adverse events ≥2 in 10.5%, and a numerical OS improvement with ≥3 cycles (29.8 vs 21.4 months; p=0.058) with each additional cycle associated with HR=0.414 (~40% lower risk of death).

Delcath Systems (Nasdaq: DCTH) announced publication of an expert narrative review in JVIR titled "Treatment of Liver Metastases from Uveal Melanoma with Percutaneous Hepatic Perfusion." The review summarizes use of percutaneous hepatic perfusion (PHP) with melphalan delivered via Delcath's HEPZATO KIT, covering rationale, technique, patient selection, outcomes, and future research.

Reported pooled outcomes include objective response rates 36%–72%, median overall survival 15–20 months, and disease control rates up to 89%. The article highlights short hospital stays, limited systemic toxicity via extracorporeal filtration, quality-of-life recovery by Day 28, and ongoing studies combining PHP with immunotherapy and expanding indications.

Delcath Systems (Nasdaq: DCTH) granted equity inducements to six new employees who started in September or October 2025 under its 2023 Inducement Plan.

The awards grant the right to purchase 62,500 shares via stock options granted on October 31, 2025 with an exercise price of $9.83 (the closing price that day). One‑third vests on the first anniversary; the remaining two‑thirds vest monthly over the next 24 months. Options have a 10‑year term and vest only with continued employment. Grants were made per Nasdaq Rule 5635(c)(4).

Delcath Systems (Nasdaq: DCTH) highlighted a University of Tubingen retrospective analysis (2005–2021) of 167 metastatic uveal melanoma patients with liver metastases that links early liver-directed therapy, including chemosaturation/percutaneous hepatic perfusion (PHP), to improved long-term outcomes.

Key metrics: 33 long-term survivors (20%); 82% of long-term survivors had liver-directed therapy as first-line metastatic treatment; 93% disease control rate with first-line liver-specific therapy vs 63% with first-line systemic therapy; 52% received PHP with median overall survival 37.35 months and median progression-free survival 10.28 months; PHP as first liver-directed therapy showed 100% disease control and 69% partial response. The analysis used Delcath CHEMOSAT technology (same as FDA-approved HEPZATO KIT).

Delcath Systems (Nasdaq: DCTH) said management will attend two investor conferences in New York in November 2025: the Craig-Hallum Alpha Select Conference on November 18, 2025 and the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum on November 20, 2025. The company focuses on interventional oncology and therapies for primary and metastatic liver cancers.

Delcath Systems (Nasdaq: DCTH) reported third quarter 2025 results: $20.6M total revenue, including $19.3M HEPZATO kit sales and $1.3M CHEMOSAT sales. Gross margin was 87%, net income was $0.8M, and non-GAAP adjusted EBITDA was $5.3M. Cash and investments totaled $88.9M with no debt as of September 30, 2025.

Operational highlights include 25 active U.S. centers, first patient dosed in the global Phase 2 HEPZATO trial for liver-dominant metastatic colorectal cancer, and presentation of positive Phase 2 CHOPIN investigator-initiated results showing improved one-year PFS for CHEMOSAT plus ipilimumab/nivolumab. Full-year 2025 revenue guidance: $83–$85M (about 150% volume increase vs 2024) with continued positive adjusted EBITDA and cashflow each quarter.