Delcath Sys Stock Price, News & Analysis

Delcath Systems (NASDAQ:DCTH) has initiated dosing in a global Phase 2 clinical trial evaluating HEPZATO™ for liver-dominant metastatic colorectal cancer (mCRC). The study will assess HEPZATO in combination with standard care versus standard care alone in third-line treatment, enrolling approximately 90 patients across 20+ sites in the US and Europe.

The trial's primary endpoint results for hepatic progression-free survival are expected by mid-2028, with overall survival data in late 2028. The addressable market comprises 6,000-10,000 patients annually in the United States with significant liver disease burden.

Delcath Systems (Nasdaq: DCTH) reported strong Q2 2025 financial results, with total revenue reaching $24.2 million, a significant increase from $7.8 million in Q2 2024. The company's HEPZATO KIT™ generated $22.5 million in revenue, while CHEMOSAT® contributed $1.7 million. Notable achievements include net income of $2.7 million, compared to a previous year's loss of $13.7 million, and positive adjusted EBITDA of $9.8 million.

The company activated three new U.S. centers, bringing the total to 20 active centers, with 10 additional centers accepting referrals. For fiscal year 2025, Delcath projects total revenue between $93-96 million, representing over 150% growth from 2024, with gross margins of 83-85%. The company maintains a strong financial position with $81.0 million in cash and no debt.

Delcath Systems (Nasdaq: DCTH), a company specializing in interventional oncology treatments for liver cancers, has announced its participation in the Canaccord Genuity 45th Annual Growth Conference. The event will take place on Tuesday, August 12, 2025 at The InterContinental Boston in Boston, MA.

Delcath Systems (Nasdaq: DCTH), an interventional oncology company focused on liver cancer treatments, has granted equity inducement awards to three new employees who joined in June 2025. The awards consist of options to purchase 52,500 shares of common stock at an exercise price of $13.60 per share.

The options, granted under Delcath's 2023 Inducement Plan, will vest over three years with one-third vesting after the first year and the remainder vesting monthly over the following 24 months. The options have a ten-year term and require continued employment for vesting.

Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, will host its second quarter 2025 earnings conference call on August 6, 2025, at 8:30 AM Eastern Time. The call will discuss financial results for the quarter ended June 30, 2025.

Investors can participate by dialing 1-877-407-3982 (toll-free) or 1-201-493-6780 (international). A webcast will be available, and a replay will be archived on the company's website following the call.

Delcath Systems (NASDAQ: DCTH), a company specializing in interventional oncology treatments for liver cancers, has announced its participation in the upcoming Craig-Hallum 22nd Annual Investor Conference. The event is scheduled for Wednesday, May 28, 2025, and will take place at The Depot Renaissance Hotel in Minneapolis, MN. The company's management team will be present at the conference.

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.