Delcath Sys Stock Price, News & Analysis

Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company granted stock options to purchase 30,000 shares of common stock to a new employee who joined on November 4, 2024.

The options, granted on December 31, 2024, have an exercise price of $12.04 per share, matching Delcath's closing stock price on that date. The vesting schedule includes one-third of the options vesting after one year, with the remaining two-thirds vesting in equal monthly installments over the following 24 months. The options have a ten-year term and require continued employment for vesting.

Delcath Systems (NASDAQ: DCTH) has secured an additional $16.3 million in funding through the exercise of 1.7 million Series E and E1 warrants. The warrants, originally issued in July and August 2019 during a private placement, had a $10.00 per share exercise price and were set to expire on December 24, 2024. Approximately 6.6% of the exercised warrants were subject to cashless exercise provisions.

CEO Gerard Michel stated that with this warrant exercise, existing cash reserves, and expected operational cash flow from revenue growth, the company is well-positioned to execute its commercialization efforts and clinical development plans for HEPZATO in treating uveal melanoma patients.

Delcath Systems (NASDAQ: DCTH) received FDA clearance for its IND application to begin a Phase 2 clinical trial of HEPZATO™ in liver-dominant metastatic colorectal cancer (mCRC). The trial will evaluate HEPZATO combined with standard care versus standard care alone in approximately 90 patients across 20+ US and European sites. Patient enrollment is expected to start in H2 2025, with hepatic progression-free survival results by end-2027 and overall survival data in 2028. The target market includes 6,000-10,000 US patients annually receiving third-line treatment for liver-dominant mCRC.

Delcath Systems (NASDAQ: DCTH) reported strong Q3 2024 results with total revenue of $11.2 million, up 44% from previous quarter. This includes $10.0 million from HEPZATO KIT™ and $1.2 million from CHEMOSAT®. The company activated four new HEPZATO treatment centers in Q3 and one in October, reaching twelve active centers total. Cash position stood at $14.0 million with quarterly burn of $3.6 million. Post-quarter, Delcath cleared all debt obligations and received approximately $25 million from warrant exercises. R&D expenses decreased to $3.9 million from $4.7 million year-over-year, while SG&A expenses increased to $7.0 million from $6.2 million due to commercial launch activities.

Delcath Systems (Nasdaq: DCTH), a company specializing in interventional oncology for liver cancer treatments, has announced its participation in two upcoming investor conferences. The company will participate in the Stephens Biotechnology Virtual Fireside Chats on November 13, 2024, at 9:30 am Eastern Time, which will be held virtually. Additionally, Delcath will attend the 15th Annual Craig-Hallum Alpha Select Conference on November 19, 2024, in New York, NY, where they will conduct one-on-one meetings.

Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced it will host a conference call on November 8, 2024, at 8:30 AM Eastern Time to discuss its third quarter 2024 financial results. The call will be accessible via toll-free and international dial-in numbers, with a webcast option available. A replay will be archived on the company's website after the event.

Delcath Systems (Nasdaq: DCTH) announced preliminary Q3 2024 revenue of $11.2 million, including $10.0 million in U.S. revenue from HEPZATO KIT commercialization. This $10 million U.S. revenue milestone triggers the exercise of Tranche B warrants from a previous PIPE, allowing holders to purchase common stock at $6.00 per share for up to $25 million. CEO Gerard Michel highlighted the strong demand for HEPZATO KIT in uveal melanoma patients with liver metastases. The additional $25 million financing will support the ongoing commercial launch and investment in new clinical trials for expanded indications planned for 2025. Delcath will provide final Q3 financial results and a detailed business update on November 8, 2024.

Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver cancer treatment, has announced the granting of equity awards to three new employees. These awards, approved by the Company's Compensation Committee, were granted as a material inducement to employment for individuals who joined in August 2024.

The grants include options to purchase a total of 46,000 shares of Delcath's common stock, subject to the terms of the Company's 2023 Inducement Plan. The options were granted on August 30, 2024, with an exercise price of $11.00 per share, matching the closing price of Delcath's stock on that date.

The vesting schedule for these options is as follows: one-third will vest on the first anniversary of the grant date, with the remaining two-thirds vesting in equal monthly installments over the subsequent 24 months. The options have a ten-year term, and vesting is contingent upon continued employment with Delcath. These awards were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

Delcath Systems (Nasdaq: DCTH) presented new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ at the ESMO Congress. The trial evaluated the efficacy and safety of HEPZATO KIT™ in patients with metastatic uveal melanoma (mUM). Key findings include:

1. No significant differences in overall survival (OS), objective response rate (ORR), or progression-free survival (PFS) between patients with and without extrahepatic lesions or based on prior therapy.
2. Consistent ORR and PFS regardless of liver tumor burden, but worse OS with more extensive liver involvement.
3. Objective tumor responses observed throughout the entire treatment period.
4. Consistent rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs), indicating no cumulative toxicity.

These results support the favorable benefit-risk profile of HEPZATO KIT™ for mUM patients with treatment options.