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.

Earnings data Q1 2021

Earnings data Q2 2021

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Earnings data Q1 2022

Earnings data Q2 2022

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Earnings data Q4 2022

Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

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.

Delcath Systems Inc. (NASDAQ:DCTH ) Q1 2023 Earnings Conference Call May 12, 2023 8:30 AM ET Company Participants Gerard Michel - Chief Executive Officer Anthony Dias - Vice President, Finance Kevin Muir - General Manager, U.S. Interventional Oncology David Hoffman - General Counsel, Chief Compliance Officer Conference Call Participants Yale Jen - Laidlaw & Co. Swayampakula Ramakanth - HC Wainwright Bill Maughan - Canaccord Genuity Operator Good day and welcome to the Delcath Systems Reports First Quarter Fiscal 2023 Financial Results Call. All participants will be in listen-only mode, and should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Delcath Systems (DCTH) Q1 2023 Earnings Call Transcript

NEW YORK , May 12, 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 certain preliminary financial results for the first quarter ended March 31, 2023. Recent Business Highlights During and since the first quarter, Delcath: Received an acknowledgement of Class 2 NDA resubmission from the U.S. Food and Drug Administration (FDA) for Hepzato Kit® (melphalan hydrochloride for Injection/Hepatic Delivery System) with a Prescription Drug User Fee Act (PDUFA) goal date of August 14, 2023, Completed a private placement of up to $85 million in gross proceeds, including the closing of initial upfront funding of $25 million.

Delcath Systems Provides Business Update and Reports Preliminary First Quarter 2023 Financial Results

NEW YORK , May 9, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, will be participating in the Lytham Partners Spring 2023 Investor Conference taking place virtually on Thursday, May 18, 2023. Industry Panel Delcath CEO Gerard Michel will be participating on a panel titled Advancements in the Fight Against Cancer.

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

NEW YORK , May 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 today it will host a conference call on May 12, 2023, at 8:30 AM Eastern Time to discuss results for its first quarter ended March 31, 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 First Quarter 2023 Results

Amendment with Avenue Venture Opportunities Fund, L.P. provides for an interest-only period from March 31, 2023 to September 30, 2023 and defers $4.3 million in principal payments NEW YORK , April 3, 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 it reached an agreement to amend its existing loan agreement with Avenue Venture Opportunities Fund, L.P.

Delcath Systems Announces Resumption of Interest-Only Period for Company's Debt Facility

Led by Vivo Capital with participation from Logos Capital, BVF Partners LP, Stonepine Capital Management, LLC, Serrado Capital LLC and supported by existing investor, Rosalind Advisors $25 million financing upfront with up to an additional $60 million tied to satisfaction of milestones Aggregate financing expected to be sufficient to fund Company through potential approval of HEPZATO and commercialization NEW YORK , March 29, 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, today announces that it has closed its previously announced private placement (the "Private Placement"), for gross proceeds of approximately $25.0 million from the issuance and sale of shares of the Company's common stock and shares of its Series F Convertible Preferred Stock and warrants, before deducting the fees paid to the placement agent and the financial advisors of the Private Placement and other financing expenses payable by the Company. The Company intends to use the net proceeds from the Private Placement for working capital purposes and other general corporate purposes.

Delcath Systems Announces Closing of Private Placement of up to $85 Million

NEW YORK , March 27, 2023 /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 fourth quarter and full year ended December 31, 2022. Recent Business Highlights During and since the fourth quarter, Delcath Systems, Inc. (Delcath or the Company): Received an acceptance of the NDA resubmission from the U.S. Food and Drug Administration (FDA) for Hepzato Kit® (melphalan hydrochloride for injection/Hepatic Delivery System) with a Prescription Drug User Fee Act (PDUFA) target action date of August 14, 2023, Priced a financing that is expected to provide an initial upfront funding of $25 million, with up to an additional $60 million tied to satisfaction of milestones, in gross proceeds to Delcath through a private placement.

Delcath Systems Reports Fourth Quarter and Full Year 2022 Results and Provides Business Update

Led by Vivo Capital with participation from Logos Capital, BVF Partners LP, Stonepine Capital Management, LLC, Serrado Capital LLC and supported by existing investor, Rosalind Advisors $25 million financing upfront with up to an additional $60 million tied to satisfaction of milestones Aggregate financing expected to be sufficient to fund Company through potential approval of HEPZATO and commercialization NEW YORK , March 27, 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, today announced that the Company has signed securities purchase agreements with certain healthcare-focused institutional investors that will provide up to $85 million in gross proceeds to Delcath through a private placement that includes initial upfront funding of $25 million. The financing is being led by Vivo Capital with participation from Logos Capital, BVF Partners LP, Stonepine Capital Management, LLC, Serrado Capital LLC and supported by existing investor, Rosalind Advisors.

Delcath Systems Announces up to $85 Million Financing

NEW YORK , March 27, 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 the US Food and Drug Administration (FDA) has accepted Delcath Systems, Inc.'s (Delcath) new drug application resubmission for HEPZATO™ Kit (melphalan hydrochloride for Injection/Hepatic Delivery System) seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM). The FDA also communicated to Delcath that they consider the submission a complete class 2 response and the PDUFA date for the resubmission is August 14, 2023.

Delcath Systems, Inc. Announces FDA Acceptance of New Drug Application Resubmission of Hepzato Kit with a PDUFA Date of August 14, 2023

NEW YORK , Feb. 16, 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 its Board of Directors has voted to appoint John R. Sylvester as Delcath's new Chairman.

Delcath Announces Rotation of the Board of Directors Chairmanship; John R. Sylvester Appointed New Chairman as Company Prepares for US Commercial Launch

NEW YORK , Feb. 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 it submitted a new drug application (NDA) resubmission to the US Food and Drug Administration (FDA) for the HEPZATO™ Kit (melphalan hydrochloride for Injection/Hepatic Delivery System or Melphalan/HDS) seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM). The resubmission is in response to a September 12, 2013 Complete Response Letter (CRL) from the FDA.

Delcath Systems Announces New Drug Application Resubmission for HEPZATO Kit

NEW YORK , Jan. 30, 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 BTIG MedTech, Digital Health, Life Sciences, & Diagnostics Tools Conference in Snowbird, Utah on February 14 to 16. Delcath CEO, Gerard Michel will be conducting one-on-one meetings.

Delcath Systems to Participate at the BTIG MedTech, Digital Health, Life Sciences & Diagnostic Tools Conference on February 14 to 16

Updated results in seven patients with advanced uveal melanoma treated with CHEMOSAT and ipilimumab plus nivolumab show a Median PFS of 29.1 months All seven patients treated still alive as of last follow-up at a median follow-up of 29.1 months NEW YORK , Jan. 17, 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 updated results from the Phase 1b CHOPIN Trial, conducted at Leiden University Medical Center on the use of the Delcath CHEMOSAT® Hepatic Delivery System with Melphalan (CHEMOSAT) in combination with the immune checkpoint inhibitors (ICI) ipilimumab and nivolumab to treat patients with metastatic uveal melanoma with liver metastases. The publication is entitled "Combining Melphalan Percutaneous Hepatic Perfusion with Ipilimumab Plus Nivolumab in Advanced Uveal Melanoma: First Safety and Efficacy Data from the Phase 1b Part of the CHOPIN Trial" and was published in Cardiovascular and Interventional Radiology.

Delcath Systems Announces Updated Results from CHOPIN Phase 1b Trial Published in Cardiovascular and Interventional Radiology

NEW YORK , Dec. 16, 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 the Company granted an equity award, previously approved by the Company's Compensation Committee, as a material inducement to employment for one individual. The employee received a total of 12,500 shares of the Company's common stock, outside of the Company's Amended and Restated 2020 Stock Incentive Plan ("Plan").

Delcath Systems Announces Inducement of Grant Under NASDAQ Listing Rule 5635(C)(4)

NEW YORK , Dec. 13, 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 with certain accredited investors (the "Private Placement"). Delcath issued and sold 1,448,889 shares of its common stock (the "Common Stock") at a price per share of $2.90, or, in lieu of shares of Common Stock, 692,042 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") at a price per Pre-Funded Warrant of $2.89.

Delcath Systems Closes Private Placement of $6.2 Million

NEW YORK , Dec. 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 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 1,448,889 shares of its common stock (the "Common Stock") at a price per share of $2.90, or, in lieu of shares of Common Stock, 692,042 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") at a price per Pre-Funded Warrant of $2.89.

Delcath Systems Announces Private Placement of $6.2 Million

Results show that percutaneous hepatic perfusion with CHEMOSAT® is an effective and safe treatment option for patients with advanced cholangiocarcinoma and has the potential to prolong life in patients with inoperable, treatment-refractory liver metastases. NEW YORK , Dec. 5, 2022 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced the publication of a retrospective analysis of patients who underwent a percutaneous hepatic perfusion procedure (PHP) with CHEMOSAT for the treatment of either inoperable intrahepatic cholangiocarinomas (iCCA) or extrahepatic cholangiocarinoma (eCCA) with liver metastases.

Results of a Single Center Study on Delcath's CHEMOSAT® Hepatic Delivery System In the Treatment of Cholangiocarcinoma Published in the Journal Clinical & Experimental Metastasis

Start Time: 08:30 January 1, 0000 9:00 AM ET Delcath Systems, Inc. (NASDAQ:DCTH ) Q3 2022 Earnings Conference Call November 08, 2022, 08:30 AM ET Company Participants Gerard Michel - CEO Anthony Dias - VP of Finance Johnny John - VP, Clinical Development & Medical Affairs Kevin Muir - VP, Commercial Operations David Hoffman - General Counsel, Corporate Secretary and Chief Compliance Officer Conference Call Participants Sam Eiber - BTIG Scott Henry - ROTH Capital Yale Jen - Laidlaw & Company Bill Maughan - Canaccord Genuity Operator Good day, and welcome to the Delcath Systems Third Quarter 2022 Financial Results Conference Call. All participants will be in listen-only mode.

Delcath Systems, Inc. (DCTH) Q3 2022 Earnings Call Transcript

Delcath Systems, Inc. (DCTH) delivered earnings and revenue surprises of 12.38% and 10.49%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

Delcath Systems, Inc. (DCTH) Reports Q3 Loss, Tops Revenue Estimates

NEW YORK , Nov. 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 third quarter ended September 30, 2022. Recent Business Highlights During and since the third quarter, Delcath: Confirmed the pending resubmission of the NDA for the Hepzato Kit® (melphalan hydrochloride for injection/Hepatic Delivery System) to the FDA by the end of the year, Attracted a growing number of sites to our Expanded Access Program (EAP), Strengthened its balance sheet by raising $5 million in a private placement priced at market, Reached terms of settlement to end its dispute with medac, its former distributor in Europe, and Announced that independent investigators published Predictive Parameters in Patients Undergoing Percutaneous Hepatic Perfusion with Melphalan for Unresectable Liver Metastases from Uveal Melanoma: A Retrospective Pooled Analysis in the journal Cardiovascular and Interventional Radiology "We are excited by the level of clinician interest in Hepzato and have enrolled three EAP sites with an additional four sites in process" said Gerard Michel, Chief Executive Officer of Delcath.

Delcath Systems Reports Third Quarter 2022 Results and Provides Business Update

NEW YORK , Oct. 24, 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 November 8, 2022, at 8:30 AM Eastern Time to discuss results for its third quarter ended September 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 Third Quarter 2022 Results

NEW YORK , Sept. 1, 2022 /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.

Delcath Systems to Participate at the H.C. Wainwright 24th Annual Global Investor Conference on September 12 and 13, 2022

Delcath Systems, Inc. (NASDAQ:DCTH ) Q2 2022 Earnings Conference Call August 8, 2022 8:30 AM ET Company Participants David Hoffman - General Counsel Gerard Michel - Chief Executive Officer Anthony Dias - Vice President of Finance Johnny John - Senior Vice President of Medical Affairs and Clinical Development Kevin Muir - Vice President of Commercial Operations John Purpura - Chief Operating Officer Conference Call Participants Scott Henry - Roth Capital Marie Sebalt - BTIG Bill Maughan - Canaccord Genuity Yale Jen - Laidlaw & Co Swayampakula Ramakanth - HC Wainright Operator Good morning, and welcome to the Delcath Systems Second Quarter Fiscal 2022 Financial Results Conference Call. All participants' will be in listen-only mode.

Delcath Systems, Inc. (DCTH) CEO Gerard Michel on Q2 2022 Results - Earnings Call Transcript

Delcath Systems, Inc. (DCTH) delivered earnings and revenue surprises of -34.09% and 36.49%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?

Delcath Systems, Inc. (DCTH) Reports Q2 Loss, Lags Revenue Estimates

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.

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