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Delcath Systems, Inc. develops interventional oncology products for primary and metastatic liver cancers. Its core products include HEPZATO KIT, a melphalan and Hepatic Delivery System combination product approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma, and CHEMOSAT Hepatic Delivery System for Melphalan used in percutaneous hepatic perfusion.
Recurring news covers quarterly operating results, HEPZATO KIT and CHEMOSAT revenue, clinical publications from studies such as FOCUS and CHOPIN, presentations at oncology and interventional radiology meetings, guideline recognition, and studies of melphalan-based percutaneous hepatic perfusion in liver-dominant cancers. Company updates also address FDA-approved product status, European clinical practice references, and capital actions such as common-stock repurchases.
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.
Delcath Systems (Nasdaq: DCTH), a company specializing in interventional oncology for liver cancer treatment, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for Wednesday, September 11, 2024, at 11:00 a.m. Eastern Time. Delcath's management team will engage in a fireside chat during the conference, which will take place at the Lotte New York Palace Hotel in New York City.
This participation provides an opportunity for Delcath Systems to showcase its focus on treating primary and metastatic liver cancers to potential investors and industry professionals. The H.C. Wainwright conference is a significant platform for companies in the healthcare and life sciences sectors to present their latest developments and strategies.
Delcath Systems, Inc. (Nasdaq: DCTH) announced positive results from an independent study on liver-directed therapy for uveal melanoma patients. The study, published in Therapeutic Advances in Medical Oncology, showed that first-line liver-directed therapies, including Delcath's CHEMOSAT® Hepatic Delivery System, significantly improved melanoma-specific survival (MSS) in patients with liver metastases from uveal melanoma.
Key findings include:
- Patients receiving first-line liver-directed therapy (N=89) had a median MSS of 28 months, compared to 10 months for those receiving first-line systemic therapy (N=45)
- Patients diagnosed between 2016-2021 and treated with first-line liver-directed therapy, including CHEMOSAT, had a median MSS of 30 months, compared to 20 months for those diagnosed between 2005-2015
Delcath Systems, Inc. (Nasdaq: DCTH) announced positive outcomes from an independent study on hepatic perfusion for uveal melanoma patients. The study, conducted by researchers at Moffitt Cancer Center, compared Delcath's HEPZATO KIT™ to immunotherapy and other liver-directed therapies. Key findings include:
1. Overall Survival (OS): Median OS of 22.4 months for first-line therapy and 18.4 months for second-line therapy with HEPZATO KIT.
2. Hepatic Progression-Free Survival (hPFS): First-line HEPZATO KIT showed 17.6 months median hPFS, outperforming immunotherapy (8.8 months) and other therapies (9.2 months).
3. Progression-Free Survival (PFS): First-line HEPZATO KIT demonstrated 15.4 months median PFS, surpassing immunotherapy and other therapies.
The study suggests HEPZATO KIT provides better disease control and improved progression-free survival for patients with hepatic metastases from uveal melanoma.
Delcath Systems (Nasdaq: DCTH) announced promising results from an independent study on its CHEMOSAT® Hepatic Delivery System for liver tumors. The study, conducted at the University Hospital of Leipzig, Germany, evaluated 33 patients with various cancers, including uveal melanoma and cholangiocarcinoma. Key findings include:
- A 91% disease control rate
- 18.2% of patients achieved complete response in the liver
- Median hepatic progression-free survival of 52 weeks across all patients
- 69 weeks median hPFS in uveal melanoma patients
- 38 weeks median hPFS in cholangiocarcinoma patients
The study highlights the efficacy and safety of repeated CHEMOSAT treatments, showing potential as an essential tool for managing primary and secondary liver tumors.
Delcath Systems (Nasdaq: DCTH) announced a poster presentation at the 2024 ESMO Congress in Barcelona, Spain. The presentation, scheduled for September 14, 2024, will showcase data from the FOCUS Phase 3 study, focusing on the efficacy of the Melphalan/Hepatic Delivery System (Melphalan/HDS) in patients with unresectable metastatic uveal melanoma (mUM).
The poster, titled 'Subgroup Analysis of FOCUS Phase 3 Trial Efficacy Results,' will highlight the treatment's effectiveness across six patient subgroups. This presentation represents an important opportunity for Delcath to share its research findings with the international oncology community at one of the field's most prestigious conferences.
Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company, has announced the granting of an equity award as a material inducement to employment. The grant, approved by the Company's Compensation Committee, includes the right to purchase 23,000 shares of Delcath's common stock. The options were granted on July 31, 2024, with an exercise price of $8.62, matching the closing price of Delcath's common stock on that date.
The vesting schedule for the 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 following 24 months. The options have a ten-year term and are subject to the employee's continued employment with Delcath. This award was granted in accordance with Nasdaq Listing Rule 5635(c)(4) and the terms of the Company's 2023 Inducement Plan.