UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-16133 DELCATH SYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 06-1245881 (State or ...

Delcath Systems, Inc. (NASDAQ:DCTH) Q1 2021 Earnings Conference Call May 11, 2021 8:30 AM ET Company Participants James Carbonara - Investor Relations Gerard Michel - Chief Executive Officer Christine Padula - Interim Principal Accounting Officer John Purpura - Chief Operating Officer Johnny John - Vice President, Clinical and Medical Affairs Kevin Muir - VP, Commercial Operations Conference Call Participants Scott Henry - ROTH Capital Yale Jen - Laidlaw & Company Marie Thibault - BTIG Arlinda Lee - Canacc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-16133 DELCATH SYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 06-1245881 (State or ...

Delcath Systems, Inc. (NASDAQ:DCTH) Q4 2020 Earnings Conference Call March 31, 2021 8:00 AM ET Company Participants James Carbonara - Investor Relations Gerard Michel - Chief Executive Officer John Purpura - Chief Operating Officer Johnny John - Senior Vice President, Clinical and Medical Affairs Jonathan Zager - Chief Academic Officer Conference Call Participants Marie Thibault - BTIG Scott Henry - ROTH Capital Arlinda Lee - Canaccord Yale Jen - Laidlaw & Company Swayampakula Ramakanth - H.C. Wainwright Op ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2020 ☐ Transition report pursuant to Section 13 or 15(d)of the Securities Exchange Act of 1934 for the transition period from ____________ to ____________ Commission file number: 001-16133 DELCATH SYSTEMS, INC. | --- | --- | |----------------------------------------------------------------|------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | |----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------- ...

Financial Data and Key Metrics Changes - Product revenue for Q3 2020 was approximately $340,000, an increase from $216,000 in the prior year period [42] - Selling, general and administrative expenses decreased to approximately $2 million from $4 million in the prior year quarter [43] - Research and development expenses increased to $3.3 million from $1.8 million in the prior year quarter [43] - Net loss for Q3 2020 was $5 million, compared to a net loss of $7.5 million for the same period in 2019 [44] - Cash, cash equivalents, and restricted cash totaled $11.1 million at September 30, 2020, compared to $10.2 million at December 31, 2019, and $15.5 million at the end of September 30, 2019 [44] Business Line Data and Key Metrics Changes - The company is focused on the Melphalan/HDS product, which is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure [9][10] - The lead indication is metastatic ocular melanoma, with an estimated 1,200 to 1,500 patients in the U.S. and no standard-of-care currently available [10] Market Data and Key Metrics Changes - The company believes Melphalan/HDS will eventually have a role in treating other solid tumors of the liver in the U.S., as it already does in the EU [15] - The liver is often the life-limiting organ for cancer patients, with overall survival usually under 12 months [16] Company Strategy and Development Direction - The company aims to complete the FOCUS trial and submit an approvable NDA, prepare for commercialization of Melphalan/HDS, raise awareness in the investor community, and prioritize additional indications for Melphalan/HDS [29] - The FDA conditionally accepted the trade name HEPZATO kit for use in the U.S. [36] - The company is focusing on expanding into larger markets over time, with plans to investigate the efficacy of Melphalan/HDS in a broader set of tumor types [17][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of the Melphalan/HDS device, noting improvements over the previous generation [18][22] - The company is navigating challenges related to COVID-19, which has impacted site access for data monitoring [31][34] - Management is optimistic about the upcoming top-line data release in early 2021 and NDA submission projected for Q1 2022 [30][31] Other Important Information - The company has not recorded any treatment-related deaths in over 1,000 treatments in Europe, and the FOCUS trial has not experienced any safety concerns requiring a pause [24][25][80] - The management team is committed to transparency and open communication with investors to raise awareness of the company's progress [37] Q&A Session Summary Question: Interpretation of treatment cycles per patient - Management noted that on average, patients are receiving about four treatments, which is an encouraging sign [46][47] Question: Gating factors for data release and NDA filing - The gating factor is monitoring, particularly at sites with a backlog due to COVID-19 [48][49] Question: Concerns about the 21% response rate bar - Management is not concerned that the bar has shifted significantly since the last meeting with the FDA [51][52] Question: Completion timeline for ongoing treatments - Management indicated that the completion of treatments for the nine patients depends on the number of cycles they receive [55][56] Question: Commercial viability based on response rates - Management believes that even a modest response rate above the bar would still be commercially viable due to the lack of available treatments [61][62] Question: Learnings from previous roles - Management emphasized the importance of transparency, trusting the team, and balancing specific goals with flexibility [64][66] Question: Novelty and learning curve of the technology - The technology's novelty lies in isolation, saturation, and filtration, and while there is a learning curve, training programs are in place to facilitate this [69][72] Question: Future indications for Melphalan/HDS - Management is considering multiple indications, including neuroendocrine tumors, breast cancer, and colorectal cancer, based on unmet needs and available data [76][79]

Delcath Systems, Inc. (NASDAQ:DCTH) Q2 2020 Results Earnings Conference Call August 13, 2020 4:30 PM ET Company Participants James Carbonara - Hayden IR John Purpura - Interim Chief Executive Officer Christine Padula - Principal Accounting Officer Johnny John - VP of Medical Affairs Gilad Aharon - Director Conference Call Participants Scott Henry - Roth Capital. Yale Jen - Laidlaw and Company Operator Ladies and gentlemen, thank you for standing by. And welcome to the Delcath Systems, Inc. Second Quarter Ea ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |---------------|-------|--------------------------------------|--------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ | --- | --- | |----------------------------------------------------------------------------------------------------------------------------- ...