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 , Jan. 31, 2024 /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 the Centers for Medicare & Medicaid Services ("CMS") has established a permanent and product-specific J-code (J9248) for HEPZATO. The J-code will become effective on April 1, 2024.

Delcath Systems Receives Permanent J-Code (J9248) for HEPZATO™ (melphalan/Hepatic Delivery System) Effective April 1, 2024

NEW YORK , Jan. 23, 2024 /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 Gerard Michel, CEO, will participate in a fireside chat moderated by Bill Maughan Ph.D., Senior Analyst at Canaccord Genuity, at the Lytham Partners 2024 Investor Select Conference.

Delcath Systems to Participate in a Fireside Chat at the Lytham Partners 2024 Investor Select Conference

NEW YORK , Jan. 16, 2024 /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 first commercial use of HEPZATO KIT for the treatment of metastatic uveal melanoma (mUM). The procedure took place at Moffitt Cancer Center in Tampa, Florida by Dr. Jonathan S.

Delcath Systems Announces U.S. Launch and First Commercial Treatment Utilizing HEPZATO KIT™

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Retrospective Analysis of Changes in Patients with Metastatic Uveal Melanoma treated with Chemosat Hepatic Delivery System Results Support that Utilizing Delcath's HDS to Administer High-Dose Melphalan to the Liver Is Well Tolerated by Patients NEW YORK , Dec. 7, 2023 /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 publication of a clinical study in the journal Melanoma Research. The publication, entitled "Quality of Life After Melphalan Hepatic Perfusion for Uveal Melanoma", was based on an independent clinical study conducted by investigators from University Hospital Southampton, UK and focused on the impact of melphalan percutaneous hepatic perfusion treatment on the quality of life (QoL) of patients with metastatic uveal melanoma.

Delcath Systems Announces Publication by Independent Investigators of a Retrospective Analysis of Quality of Life in the Journal Melanoma Research

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Delcath's Hepzato Kit is the only liver directed FDA approved treatment for mUM, a rare form of cancer. It will launch in the US in January. The treatment had a 36.3% objective response rate, outperforming the best available alternative treatment by nearly triple. Delcath aims to expand the use of Hepzato Kit beyond uveal melanoma by targeting other indications such as intrahepatic cholangiocarcinoma and metastatic colorectal cancer.

Adoption Of Delcath's Hepzato Kit Will Snowball Quicker Than The Market Expects

NEW YORK , Nov. 15, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announces that the Company granted equity awards, previously approved by the Company's Compensation Committee, as a material inducement to the employment of five individuals. The grant totaled the right to purchase an aggregate of 69,000 shares of the Company's common stock, outside of the Company's Omnibus 2020 Equity Incentive Plan, as amended ("Plan").

Delcath Systems Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Delcath Systems Inc. (NASDAQ:DCTH ) Q3 2023 Earnings Conference Call November 13, 2023 4:30 PM ET Company Participants David Hoffman - General Counsel, Chief Compliance Officer Gerard Michel - CEO Sandra Pennell - SVP, Finance Kevin Muir - General Manager, U.S. Interventional Oncology Conference Call Participants William Maughan - Canaccord Genuity Scott Henry - ROTH Capital Yale Jen - Laidlaw & Co. Operator Good day, and welcome to the Delcath Systems Reports Third Quarter Fiscal Year 2023 Financial Results. All participants will be in listen-only mode.

Delcath Systems Inc. (DCTH) Q3 2023 Earnings Call Transcript

NEW YORK , Nov. 13, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), 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 third quarter ended September 30, 2023. Recent Business Highlights Received approval from the US Food and Drug Administration (FDA) for HEPZATO KIT™ (melphalan)/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation; Raised approximately $35 million through the exercise of all the Tranche A warrants issued as part the previously announced March 29, 2023, financing with up to an additional $25 million available upon the achievement of $10 million in quarterly revenue; Announced publication by independent investigators of a retrospective comparative study of CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP) and Selective Internal Radiation Therapy (SIRT) citing a statistically significant difference in median overall survival with 301 days for SIRT and 516 days for PHP; Announced that independent investigators at Leiden University recruited 55 of 76 planned patients in the CHOPIN trial studying the impact of CHEMOSAT and immune checkpoint inhibitor combination therapy in the treatment of metastatic uveal melanoma and expect the trial to be fully enrolled mid-2024.

Delcath Systems Reports Third Quarter 2023 Results and Provides Business Update

NEW YORK , Nov. 6, 2023 /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 November 13, 2023, at 4:30 PM Eastern Time to discuss results for its third quarter ended September 30, 2023.   Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Delcath Systems to Host Third Quarter 2023 Results Call

Retrospective Comparison of Two Liver Directed Therapies in Patients with Metastatic Uveal Melanoma Significantly Longer Overall Survival for Patients Treated with Chemosat vs. SIRT (17 and 9.9 months, respectively; p=0.006) NEW YORK , Oct. 16, 2023 /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 publication of an article entitled "Selective Internal Radiotherapy (SIRT) and Chemosaturation Percutaneous Hepatic Perfusion (CS-PHP) for Metastasized Uveal Melanoma: A Retrospective Comparative Study" in the peer reviewed oncology journal Cancers.

Delcath Systems Announces a Comparative Study of Chemosat and SIRT Published in the Journal Cancers

NEW YORK , Oct. 10, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that it will be participating in the Lytham Partners Fall 2023 Investor Conference taking place virtually on Tuesday, October 17, 2023. Company Webcast Gerard Michel, CEO, will be participating in a fireside chat.

Delcath Systems to Participate in the Lytham Partners Fall 2023 Investor Conference

NEW YORK , Oct. 3, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, will participate at the Roth MKM Healthcare Opportunities Conference in New York. Delcath CEO, Gerard Michel will present on October 12 at 11:45 AM ET.

Delcath Systems to Participate at the Roth MKM 2023 Healthcare Opportunities Conference on October 12, 2023

Independent Investigator Study Compared Two Liver Directed Therapies in Patients with Metastatic Uveal Melanoma  Significantly Longer Overall Survival for Patients Treated with Chemosat vs. SIRT (516 and 301 days, respectively; p=0.006) NEW YORK , Sept.

A Retrospective Comparative Study of Chemosat and SIRT Presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting

NEW YORK , Sept. 5, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, will participate at the H.C Wainwright 25th Annual Global Investor Conference.

Delcath Systems to Participate at the H.C. Wainwright 25th Annual Investor Conference on September 12 and 13, 2023

NEW YORK , Sept. 1, 2023 /PRNewswire/ -- 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 raised approximately $35 million through the exercise of all the Tranche A warrants issued as part the previously announced March 29, 2023 Private Investment in Public Equity (PIPE) financing.

Delcath Systems, Inc. Announces Additional $35 Million in Funding Tied to the FDA Approval of HEPZATO KIT™

A Retrospective Comparative Study of SIRT and CS-PHP for Liver Targeted Therapy of Patients with Metastatic Uveal Melanoma NEW YORK , Aug. 29, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced an oral presentation by independent investigators at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting to be held in Copenhagen, Denmark from September 9-13, 2023. CIRSE Presentation Details: Title: Selective internal radiotherapy (SIRT) and chemosaturation-percutaneous hepatic perfusion (CS-PHP) for metastasized uveal melanoma: a retrospective comparative study Type: Scientific Paper Session Session: Advanced IO techniques: pushing the bar in IO Presenters: Professor Dr. med.

Delcath Systems Announces an Independent Investigator Presentation at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting

Delcath Systems (NASDAQ: DCTH ) stock is rocketing higher on Tuesday after getting an update from the FDA. This has the FDA approving HEPZATO KIT.

Why Is Delcath Systems (DCTH) Stock Up 72% Today?

HEPZATO KIT is the only FDA approved liver-directed therapy to treat metastatic uveal melanoma Approval includes treatment naïve and previously treated patients and is not limited by HLA genotype Delcath to hold Business Update Call on August 15, 2023 at 8:00 a.m. Eastern Time NEW YORK , Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

Delcath Systems recently passed FDA inspection without any manufacturing-related observations. The medical review for HEPZATO KIT has likely concluded successfully; FDA seems to have proposed a Black Box Warning, instead of asking for more clinical data. Recent sell-off due to API supplier concerns likely misplaced.

Delcath Systems: HEPZATO KIT Should Receive Approval On Aug 14 PDUFA

NEW YORK , Aug. 9, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), 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, 2023. Recent Business Highlights During and since the second quarter, Delcath: Has continued to communicate with the United States Food and Drug Administration (FDA) as the agency continues its review of the HEPZATO KIT™ New Drug Application (NDA) resubmission with an anticipated PDUFA date of August 14, 2023; Received stockholders approval for the potential issuance in excess of 19.99% of Delcath's outstanding common stock upon the conversion of the preferred stock issued pursuant to a private placement that closed on March 29, 2023 and generated $25 million on closing with up to an additional $35 million expected upon the exercise of warrants into additional series of preferred stock upon the approval of the HEPZATO KIT NDA and up to an additional $25 million upon the achievement of $10 million in quarterly revenue; Hired Vojislav Vukovic, MD, PhD as Chief Medical Officer; Sandra Pennell as Senior Vice President of Finance; and Zac MacLean as Director of Sales and Strategy; and Continued to treat patients at 3 Expanded Access Program sites.

Delcath Systems Reports Second Quarter 2023 Results and Provides Business Update

NEW YORK , Aug. 3, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that it plans to report the Company's 2Q23 earnings and issue its Form 10-Q the week of August 7, 2023. Subsequently, shortly after the FDA's decision on its HEPZATO™ KIT's new drug application ("NDA") resubmission, Delcath expects to hold a conference call to review the quarter and the details of the FDA action.

Delcath Systems to File Its Second Quarter 2023 10-Q the Week of August 7 and Expects to Host a Conference Call the Following Week

NEW YORK , June 20, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, is pleased to announce the appointment of Dr.  Vojislav "Vojo" Vukovic as its new Chief Medical Officer (CMO). Dr. Vukovic is an experienced drug development executive with a distinguished career in cancer research and global clinical development.

Delcath Systems Appoints Vojislav Vukovic as Chief Medical Officer

NEW YORK , June 7, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, is pleased to announce that the Company has appointed Sandra Pennell as its new Senior Vice President of Finance. Ms. Pennell will also serve as an Executive Officer of the Company and its Principal Accounting Officer and Principal Financial Officer.

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