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Delcath Systems Inc. (Nasdaq: DCTH) is a prominent interventional oncology company focusing on the treatment of primary and metastatic liver cancers. The company's flagship product, the HEPZATO KIT™ (comprising Hepzato (melphalan) for Injection and the Hepatic Delivery System), offers a revolutionary approach to liver-directed chemotherapy. This system enables high-dose chemotherapy delivery directly to the liver, minimizing systemic exposure and associated side effects.
HEPZATO KIT is FDA-approved in the United States for treating adult patients with metastatic uveal melanoma (mUM) presenting unresectable hepatic metastases, especially when the metastases affect less than 50% of the liver and there is no extrahepatic disease, or extrahepatic disease limited to specific regions like bone or lymph nodes that can be managed surgically or through radiation. The product's approval followed the pivotal Phase 3 FOCUS study, which demonstrated a significant improvement in overall response rates and progression-free survival compared to historical data.
In Europe and the United Kingdom, Delcath markets the product under the trade name CHEMOSAT® Hepatic Delivery System for Melphalan. This device-only configuration has been utilized in over 250 treatments across 20 leading European cancer centers, establishing itself as a reliable option for liver cancer therapy.
Delcath continues to make strides in enhancing treatment accessibility. Recently, the company launched a Healthcare Setting Locator on their website to help patients, caregivers, and healthcare providers find facilities offering HEPZATO KIT treatment. The company also secured a permanent J-code for HEPZATO, streamlining the reimbursement process and facilitating broader patient access.
Recent business highlights include the first commercial use of HEPZATO KIT at Moffitt Cancer Center and the successful closing of a $7 million private placement to support ongoing commercial endeavors. Delcath has also published significant data from the FOCUS study in the Annals of Surgical Oncology, reinforcing the clinical efficacy of their treatment.
As Delcath Systems Inc. forges ahead, they remain committed to expanding the clinical adoption of their innovative therapies in major markets, thus providing critical treatment options to liver cancer patients worldwide.
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.
Delcath Systems (DCTH) announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for treating metastatic uveal melanoma (mUM). The NCCN Guidelines now include HEPZATO KIT as a Category 2A treatment option for patients with hepatic-dominant uveal melanoma, expanding from its previous limitation to patients with metastases confined to the liver.
This update aligns with HEPZATO KIT's label and is particularly significant as over 90% of mUM patients develop liver metastases. A Phase 3 FOCUS trial subgroup analysis showed no significant differences in objective response rate, progression-free survival, or overall survival between patients with and without extrahepatic disease. HEPZATO KIT and CHEMOSAT are designed to administer high-dose chemotherapy to the liver.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced its participation in the BTIG Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference. The conference will take place from February 11-12, 2025, at The Cliff Lodge in Snowbird, Utah. The company's management team will be in attendance at this significant healthcare industry event.
Delcath Systems (NASDAQ: DCTH) has released preliminary financial results for Q4 and full-year 2024. The company reported Q4 revenue of approximately $15.1 million and full-year revenue of $37.2 million. Their primary product, HEPZATO KIT™, generated Q4 revenue of $13.7 million and full-year revenue of $32.3 million, while CHEMOSAT® contributed $1.4 million in Q4 and $4.9 million for the full year.
The company expects gross margins to range between 80%-85%. As of December 31, 2024, Delcath maintained a strong financial position with $53.2 million in cash, cash equivalents, and short-term investments, with no debt. Complete financial results and a detailed business update will be provided during their annual financial results release on March 6, 2025.
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.
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