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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 announced encouraging results from the phase 3 FOCUS study of its treatment HEPZATO for metastatic ocular melanoma.
The study showed a median duration of response of 14 months, with an overall response rate (ORR) of 31.4% and a 12-month survival hazard ratio (HR) of 0.37 (p=0.01) compared to the Best Alternative Care (BAC) arm.
HEPZATO also demonstrated a disease control rate of 65.7% and improved progression-free survival (PFS) compared to BAC. A new NDA submission is anticipated by mid-2022.
Delcath Systems, Inc. (Nasdaq: DCTH) announced an upcoming Investor Update Meeting on December 2, 2021, focusing on its investigational drug/device combination product, HEPZATO KIT. The meeting will feature discussions on the FOCUS trial results and the clinical experience with CHEMOSAT, detailing unmet needs in treating liver cancers. A panel of leading physicians will present key topics including PHP quality of life and future clinical development plans. This event underscores Delcath's commitment to innovative solutions for liver cancer treatment.
Delcath Systems (Nasdaq: DCTH) reported its Q3 2021 results, highlighting key developments including a $20 million debt facility and FDA approval for an expanded access protocol for HEPZATO™ Kit. Product revenue increased to $522,000, up from $466,000 year-over-year. However, the company faced a net loss of $7.1 million compared to $5.0 million in Q3 2020. Operating expenses rose to $7.0 million, influenced by stock option expenses. Cash reserves improved to $29 million from $11.1 million a year prior. Delcath plans to file its HEPZATO NDA mid-2022 and hosted an investor update on December 2.
Delcath Systems, a company specializing in interventional oncology, announced its participation in the Canaccord Virtual MedTech, Diagnostics, and Digital Health & Services Forum on November 18, 2021. The event will consist of one-on-one meetings only. Delcath focuses on treating rare liver cancers using its proprietary percutaneous hepatic perfusion (PHP) system, marketed in the U.S. as HEPZATO KIT and in Europe as CHEMOSAT. This innovative system administers high-dose chemotherapy directly to the liver while minimizing systemic side effects.
Delcath Systems (DCTH) will host an Investor Update on December 2, 2021, from 10 AM to 1 PM ET, focusing on its Hepzato Kit and its applications in treating liver cancers. Physicians will present updated data from the Focus trial and discuss the potential of Hepzato in treating hepatic-dominant metastatic ocular melanoma, colorectal cancer, and intrahepatic cholangiocarcinoma. The event will be accessible via a live webcast, with the archive available afterward on the company's website.
Delcath Systems (DCTH) announced a conference call on November 9, 2021, at 8:30 AM ET to discuss its Q3 2021 results ending September 30, 2021. The company specializes in interventional oncology, focusing on liver cancers through its proprietary percutaneous hepatic perfusion (PHP) system. In the U.S., it markets the system as HEPZATO KIT, while in Europe, it operates as CHEMOSAT Hepatic Delivery System. Interested parties can join the call via toll-free or international numbers, or stream it online.
Delcath Systems, Inc. (DCTH), a leader in interventional oncology, will present at three key healthcare conferences in September 2021. The H.C. Wainwright 23rd Annual Global Investment Conference runs from September 13-15, featuring on-demand presentations starting September 13 at 7:00 AM (ET). Next is the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 20-23, with a presentation on September 21 at 12:25 PM (ET). Lastly, the Cantor Fitzgerald Healthcare Conference will occur September 27-30, with a presentation on September 29 at 4:40 PM (ET).
Delcath Systems, Inc. (DCTH) reported its Q2 2021 financial results, showing product revenue of approximately $536K, up from $379K year-over-year. Despite this growth, the company incurred a net loss of $6.4M compared to a net income of $4.3M in Q2 2020. Key highlights include positive results from the FOCUS Phase III trial of HEPZATO™ KIT, with a 29.2% overall response rate in treated patients. Additionally, Delcath's CHEMOSAT® received updated guidance from the UK's National Institute for Health and Care Excellence, enhancing treatment funding prospects.
Delcath Systems (DCTH) has secured a debt facility of up to $20 million from Avenue Venture Fund, with an initial $15 million funded at closing. This financing aims to support the upcoming NDA filing for HEPZATO™, targeting the treatment of hepatic-dominant metastatic ocular melanoma, anticipated in early 2022. CEO Gerard Michel expressed optimism regarding the partnership, which will aid in advancing Delcath's innovative cancer treatment approaches.
Delcath Systems, Inc. (Nasdaq: DCTH) announced its participation in two key conferences. The BTIG Virtual Biotechnology Conference is set for August 9, 2021, from 10:00-10:25 AM ET, featuring management-led 1x1 investor meetings. The Canaccord Genuity 41st Annual Growth Conference will follow on August 11, 2021, at 10:00 AM ET, with a webcast available at this link. Delcath specializes in treating liver cancers through its proprietary PHP system.