Delcath Systems

Delcath Systems, Inc. is an oncology company, which focuses on the treatment of primary and metastatic liver cancers. It develops and commercializes CHEMOSAT and Melphalan Hydrochloride for Injection, which is a proprietary product used with the Delcath Hepatic Delivery System. The company was founded in August 1988 and is headquartered in New York, NY.

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Delcath Systems secures $85M funding, advances FDA approval for HEPZATO

Delcath Systems showcased financial resilience with strategic financing, highlighted progress in regulatory milestones, and outlined plans for revenue generation and market expansion.

Delcath Systems reports revenue growth and secures financing for Hepzato

Delcath Systems' Q1 2023 performance reflects revenue growth, strategic financing, and increased cash reserves, positioning the company for future success.
While facing challenges in a competitive landscape and post-approval payment transitions, opportunities lie in market expansion, innovation, and strategic partnerships.
Overall, Delcath Systems shows strength in product development, financial stability, and market readiness, with potential for growth through strategic initiatives and market penetration.

Delcath Systems readies for HEPZATO KIT launch amid financial stability

Delcath Systems is financially stable with a strategic focus on commercial launch preparations
Challenges lie in transitioning patients and ensuring timely physician training for site readiness
Opportunities exist in expedited approvals, site expansions, and product adoption strategies

Delcath Systems reports progress in HEPZATO commercialization and funding

Delcath Systems made progress in commercializing HEPZATO for metastatic uveal melanoma in the U.S.
The company secured funding to support operations and reported a healthy cash position.
While facing challenges with low Q4 revenue and increased expenses, opportunities exist in expanding usage and revenue growth.
Overall, Delcath Systems is poised for growth with a focus on driving adoption of HEPZATO in key cancer centers.

Delcath Systems posts strong Q1 results, eyes market expansion

Delcath Systems demonstrated solid financial performance in Q1 2024, with revenue growth and efficient cost management, positioning the company for future success.
While facing challenges in cost control and operational scaling, Delcath's strategic focus on partnerships, revenue-driven R&D, and market expansion presents growth opportunities.
Overall, Delcath's strong financial position, positive study results, and growth projections indicate a promising outlook for the company in the oncology market.

Delcath Systems reports strong Q2 revenue growth and expansion plans

Delcath Systems demonstrated robust financial performance in Q2 2024, driven by strong revenue from HEPZATO and CHEMOSAT, with a focus on expanding treatment sites and revenue targets.
Despite facing challenges in scaling operations and achieving revenue goals, the company's strategic strengths in sales, margins, and cash position position it well for future growth.
Opportunities lie in clinical trials, product expansion, and market penetration, offering avenues for sustained revenue growth and market leadership in the long term.

Delcath Systems reports robust revenue growth and eyes oncology market

Delcath Systems demonstrated solid revenue growth driven by HEPZATO and CHEMOSAT sales, with a focus on expanding treatment centers and advancing clinical trials.
While facing financial challenges and operational complexities, the company is poised for growth through new indications and market adoption strategies.
Engagement with medical professionals and strategic trial planning offer avenues for revenue expansion and market leadership in targeted oncology treatments.
Balancing financial sustainability with growth ambitions will be crucial for Delcath's success in navigating the competitive healthcare landscape.

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Delcath Systems, Inc. is an oncology company, which engages in the treatment of primary and metastatic liver cancers. Its products include CHEMOSAT and HEPZATO. The company was founded in August 1988 and is headquartered in Queensbury, NY.

NEW YORK , Aug. 8, 2022 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and financial results for the second quarter ended June 30, 2022. Recent Business Highlights During and since the second quarter, Delcath: Held a pre-NDA meeting with FDA and locked the phase 3 FOCUS Trial database for the purpose of resubmitting the NDA for the Hepzato Kit® (melphalan hydrochloride for injection/hepatic delivery system) in the third quarter of 2022, Presented a poster updating the results from the FOCUS Trial at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, Opened two Expanded Access Program (NCT05022901) sites, and Raised $5 million in a private placement priced at market.

Delcath Systems Reports Second Quarter 2022 Results and Provides Business Update

Retrospective study in metastatic uveal melanoma patients with liver dominant disease shows an objective response rate of 59.4% and a disease control rate of 89.1%.  The study finds that achieving complete response, partial response, or stable disease is associated with improved survival.

Results of a Multicenter Study on Delcath's CHEMOSAT® Hepatic Delivery System Published in Cardiovascular and Interventional Radiology

NEW YORK , July 27, 2022 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on August 8, 2022, at 8:30 AM Eastern Time to discuss results for its second quarter ended June 30, 2022.   Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Delcath Systems to Host Second Quarter 2022 Results

NEW YORK , July 20, 2022 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced the closing of the previously announced private placement for the issuance and sale of 690,954 shares of common stock (the "Common Stock") and 566,751 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") to certain investors. Each share of Common Stock was sold at a price per share of $3.98 and the Pre-Funded Warrants were sold at a price of $3.97 per Pre-Funded Warrant.

Delcath Systems Closes Private Placement of $5.0 Million

NEW YORK , July 18, 2022 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that it has entered into a securities purchase agreement with certain accredited investors for a private placement transaction (the "Private Placement"). Delcath will issue and sell 690,954 shares of its common stock (the "Common Stock") at a price per share of $3.98, or, in lieu of shares of Common Stock, 566,761 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") at a price per Pre-Funded Warrant of $3.97.

Delcath Systems Announces Private Placement of $5.0 Million

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Initial results from the Phase 1b portion of the CHOPIN trial of PHP in combination with ipilimumab plus nivolumab in advanced uveal melanoma in seven patients resulted in 85.7% Best Overall Response and 100% Disease Control Rate. Median progression free survival currently is 22.4 months with all patients still alive as of last follow-up

Positive Initial Results from CHOPIN Phase 1b Trial, FOCUS Trial Update and QoL Study Presented at the 2022 ASCO Annual Meeting

Delcath Systems Ltd. (NASDAQ:DCTH ) Q1 2022 Earnings Conference Call May 10, 2022 8:30 AM ET Company Participants David Hoffman - General Counsel Gerard Michel - Chief Executive Officer Anthony Dias - Vice President of Finance Conference Call Participants Marie Thibault - BTIG Scott Henry - Roth Capital Partners Swayampakula Ramakanth - H.C.

Delcath Systems Ltd. (DCTH) CEO Gerard Michel on Q1 2022 Results - Earnings Call Transcript

Delcath Systems, Inc. (DCTH) delivered earnings and revenue surprises of -19.05% and 70%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?

Delcath Systems, Inc. (DCTH) Reports Q1 Loss, Misses Revenue Estimates

NEW YORK , May 10, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and financial results for the first quarter ended March 31, 2022.

Delcath Systems Reports First Quarter 2022 Results and Provides Business Update

NEW YORK, May 09, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced the acceptance of a poster presentation at the upcoming American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, to be held in-person on June 3-7, 2022, in Chicago, Illinois.

Delcath Announces Poster Presentation at the 2022 ASCO Annual Meeting

NEW YORK, April 28, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on May 10, 2022, at 8:30 AM Eastern Time to discuss results for its first quarter ended March 31, 2022.

Delcath Systems to Host First Quarter 2022 Results

NEW YORK, April 08, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, will participate in the Canaccord Genuity Horizons in Oncology Conference:

Delcath Systems to Participate in the Canaccord Genuity Horizons in Oncology Conference

NEW YORK, March 29, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today that it will be participating in the Lytham Partners Spring 2022 Investor Conference, via presentation and panel discussion:

Delcath Systems to Participate in the Lytham Partners Spring 2022 Investor Conference

Delcath Systems (DCTH) CEO, Gerard Michel on Q4 2021 Results - Earnings Call Transcript

NEW YORK, March 25, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and financial results for the fourth quarter and full-year ended December 31, 2021.

Delcath Systems Reports Fourth Quarter and Full-Year 2021 Results and Provides Business Update

NEW YORK, March 15, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on March 25, 2022, at 8:30 AM Eastern Time to discuss results for its fourth quarter and full year ended December 31, 2021.

Delcath Systems to Host Fourth Quarter and Full Year 2021 Results

NEW YORK, March 02, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, is pleased to announce that on February 28 its CHEMOSAT Hepatic Delivery System received Medical Device Regulation (MDR) certification under the new European Medical Devices Regulation [2017/745/EU]. Since April 2012, Chemosat had been certified under a previous regulation, the Medical Device Directive [2007/47/EC] (MDD), which is being replaced by MDR.

Delcath Systems Achieves Medical Device Regulation Certification for CHEMOSAT® in Europe

NEW YORK, Feb. 22, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today that effective March 1, 2022, it will resume direct responsibility for sales, marketing and distribution activities relating to the CHEMOSAT® Hepatic Delivery System in Europe (EU, United Kingdom, Norway, Liechtenstein, Switzerland). Since December 2018, medac GmbH, a privately held, multi-national pharmaceutical company based in Germany, has been the licensee for CHEMOSAT in Europe. Delcath and medac are working closely together on an orderly transition of activities.

Delcath Systems Announces Move to a Direct Sales & Marketing Model for CHEMOSAT®

NEW YORK, Feb. 10, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today that management will participate at these upcoming virtual investor conferences:

Delcath Systems to Present at Upcoming Virtual Investor Conferences

NEW YORK, Feb. 07, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today that the Company has appointed Anthony Dias as its new Vice President of Finance.

Delcath Appoints Anthony Dias as its new Vice President of Finance; Inducement Grant Reported

Delcath Systems Inc's  DCTH single-institution retrospective study data on CHEMOSAT Hepatic Delivery System for liver dominant metastatic uveal melanoma (mUM) were published in the journal Melanoma Research. Get the Inside Access Traders Are Using to Profit More and Win Bigger.

Delcath's Chemosat Hepatic Delivery System Shows Overall Response Rate Of 60.5% In Eye Cancer That Spreads To Liver

Retrospective Study by University Hospital Southampton in metastatic uveal melanoma (mUM) patients with liver dominant disease shows hepatic disease control rate of 88.9%, hepatic response rate of 66.7% and overall response rate of 60.5%

Results of Single Center Study on Delcath's CHEMOSAT® Hepatic Delivery System Published in Melanoma Research

NEW YORK, Jan. 25, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that David Hoffman has been appointed as General Counsel and Corporate Secretary. Mr. Hoffman will also serve as Delcath's Chief Compliance Officer.

David Hoffman Joins Delcath Systems, Inc. as General Counsel and Corporate Secretary

NEW YORK, Jan. 07, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will participate in an upcoming virtual investor conference:

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