Delcath Sys Stock Price, News & Analysis

Delcath Systems (DCTH) has granted equity awards to eleven new employees who joined the company in March and April 2025. The inducement grants include options to purchase 111,000 shares of common stock at an exercise price of $12.04 per share, which was the closing price on April 30, 2025. The options have a 10-year term with a vesting schedule where one-third vests after the first year, and the remaining two-thirds vest in equal monthly installments over the following 24 months. These grants were made under Delcath's 2023 Inducement Plan and comply with Nasdaq Listing Rule 5635(c)(4).

Delcath Systems (NASDAQ: DCTH) reported strong Q1 2025 financial results, marking its first quarter of profitability. The company achieved total revenue of $19.8 million, a significant increase from $3.1 million in Q1 2024. HEPZATO KIT™ sales reached $18.0 million, while CHEMOSAT® revenue was $1.8 million. The company reported net income of $1.1 million, compared to a net loss of $11.1 million in Q1 2024, with gross margins improving to 86%. Delcath expanded its treatment network to 19 active centers, with 10 additional centers accepting referrals. The company maintained a strong financial position with $58.9 million in cash and no debt, supported by $16.2 million from warrant exercises. Additionally, Delcath received FDA clearance for a phase 2 clinical trial of HEPZATO™ in liver-dominant metastatic breast cancer.

Delcath Systems (NASDAQ: DCTH) has received FDA clearance for its Investigational New Drug (IND) application to begin a Phase 2 clinical trial of HEPZATO™. The trial will evaluate HEPZATO in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC).

The randomized, controlled trial will involve approximately 90 patients across 20+ sites in the United States and Europe. Patient enrollment is expected to begin in Q4 2025. The study will compare HEPZATO plus SOC versus SOC alone (eribulin, vinorelbine or capecitabine) in patients with liver-dominant HER2-negative mBC who failed previous treatments.

Primary endpoint results (hepatic progression-free survival) are expected by end of 2028, with overall survival results in 2029. The company estimates 7,000 patients annually in the US are candidates for third-line treatment of HER2-negative metastatic breast cancer with liver metastases.

Delcath Systems (NASDAQ: DCTH), an interventional oncology company specializing in liver cancer treatments, has scheduled its first quarter 2025 earnings conference call for May 8, 2025, at 8:30 AM Eastern Time. The call will discuss financial results for the quarter ending March 31, 2025.

Participants can join via toll-free number (1-877-407-3982) or international line (1-201-493-6780). A webcast will be available, and a replay will be archived on the company's website following the call.

Delcath Systems (NASDAQ: DCTH) has published a comparative analysis from the randomized portion of their Phase 3 FOCUS study in the Annals of Surgical Oncology. The study evaluated Melphalan/Hepatic Delivery System (Melphalan/HDS) against best alternative care (BAC) in patients with unresectable metastatic uveal melanoma.

Key findings from the 72 treated patients (40 Melphalan/HDS; 32 BAC) showed significant improvements with Melphalan/HDS:

• Median progression-free survival: 9.1 months vs 3.3 months for BAC
• Median overall survival: 18.5 months vs 14.5 months for BAC
• Objective response rate: 27.5% vs 9.4% for BAC
• Disease control rate: 80.0% vs 46.9% for BAC
• Median hepatic progression-free survival: 11.4 months vs 3.3 months for BAC

The safety profile was consistent with prior reports, primarily showing hematologic effects, with no treatment-related deaths reported.

Delcath Systems (Nasdaq: DCTH), a company specializing in interventional oncology with a focus on treating primary and metastatic liver cancers, has announced its upcoming participation in the CG Horizons in Oncology Virtual Conference. The presentation is scheduled for April 7, 2025, at 10:00 a.m. ET. Interested investors are advised to contact their Canaccord representative to participate in the event.

Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced equity inducement grants to six new employees who joined in January and February 2025. The grants include options to purchase 264,000 shares of common stock under the company's 2023 Inducement Plan.

The stock options were granted on February 28, 2025, with an exercise price of $14.17 per share, matching the closing price of Delcath's common stock on that date. The vesting schedule includes one-third of options vesting after the first year, with the remaining two-thirds vesting in equal monthly installments over 24 months. The options have a ten-year term and require continued employment for vesting.

Delcath Systems (NASDAQ: DCTH) reported strong financial results for Q4 and full year 2024. The company achieved total revenue of $15.1M in Q4 and $37.2M for the full year, with HEPZATO KIT generating $13.7M and $32.3M respectively. CHEMOSAT contributed $1.4M in Q4 and $4.9M for the year.

The company demonstrated solid financial metrics with 86% gross margins in Q4 and 83% for the year. Q4 showed positive adjusted EBITDA of $4.6M, while reporting a net loss of $3.4M. The full-year net loss was $26.4M with an adjusted EBITDA loss of $2.5M.

Operationally, Delcath expanded to 16 active centers and received FDA clearance for a Phase 2 trial of HEPZATO in liver-dominant metastatic colorectal cancer. The company ended 2024 with a strong cash position of $53.2M, bolstered by $41.3M from warrant exercises, and operates debt-free.

Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced it will host a conference call to discuss its fourth quarter and full year 2024 financial results. The call is scheduled for March 6, 2025, at 8:30 AM Eastern Time.

Participants can join the call using toll-free number 1-877-407-3982 for domestic callers or 1-201-493-6780 for international callers. A webcast will be available, and a replay will be archived on the company's website following the call.