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, 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 (Stat ...

Delcath Systems, Inc. (NASDAQ:DCTH) Q2 2021 Earnings Conference Call August 10, 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 - Senior Vice President, Medical Affairs and Clinical Development Conference Call Participants Marie Thibault - BTIG Scott Henry - ROTH Capital Yale Jen - Laidlaw & Company Operator Good day ladies and gentlemen ...

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 ...

Financial Data and Key Metrics Changes - Product revenue for Q1 2021 was approximately $389,000, an increase from $293,000 in the prior year period [20] - Selling, general and administrative expenses rose to approximately $3.3 million from $2.3 million in the prior year quarter [20] - Research and development expenses increased to $3.7 million compared to $3 million in the prior year quarter [20] - Total operating expenses for the quarter were $7 million, up from $5.3 million in the prior year quarter [20] - The net loss for Q1 2021 was $6.8 million, compared to a net loss of $7.9 million in the same period in 2020 [21] - Cash, cash equivalents, and restricted cash totaled $26.7 million at March 31, 2021, compared to $4.7 million at the same time last year [21] Business Line Data and Key Metrics Changes - The FOCUS trial results indicated an overall response rate of 29.2%, significantly exceeding the pre-specified threshold of 8.3% for success [9] - In the per protocol population, the overall response rate was 32.9% for the HEPZATO arm versus 13.8% for the Best Alternative Care arm [10] - The disease control rate was 70.9% for HEPZATO compared to 37.9% for the Best Alternative Care arm [10] Market Data and Key Metrics Changes - The company anticipates a modest uptake in the UK market following changes to NICE guidelines, with a potential one-year lead time for revenue impact [25] - The company is preparing to expand into additional areas of high unmet need, including intrahepatic cholangiocarcinoma and metastatic colorectal cancers [12][14] Company Strategy and Development Direction - The company is focused on preparing for an NDA submission in early 2022 and expanding HEPZATO into additional indications [19] - A commercial launch strategy is being developed, assessing the size of the commercial organization and strategies for coding, pricing, and reimbursement [17] - The company is working with a consulting firm and KOL advisory boards to refine its commercial launch strategy [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the preliminary FOCUS trial data and its potential to establish HEPZATO as the standard of care for metastatic ocular melanoma [10] - The company is optimistic about the prospects for Delcath as it continues to analyze FOCUS trial data and prepare for NDA submission [54] - Management acknowledged the challenges posed by COVID-19 on data monitoring and site access but is actively working to mitigate these issues [13][49] Other Important Information - The FOCUS trial results will be presented at the American Society of Clinical Oncology annual meeting, with a Q&A webinar scheduled for June 7 [11] - The company is exploring the potential for additional chemotherapeutic agents to be used with the HEPZATO device in the future [52] Q&A Session Summary Question: Expectations for spending trends for the rest of the year - Management indicated that stock option expenses will continue at a similar level, with potential increases if new grants are issued [24] Question: Impact of NICE guidelines on revenue - Management expects a gradual revenue increase in the UK over the next three to six months as private insurance coverage begins [25] Question: Overall survival data trends - Management noted that overall survival data is still pending, with expectations to release it by the end of summer [26] Question: Pipeline development status - Management confirmed that planning is on track, with broader tumor-specific advisory boards being organized [29] Question: Expanded access program details - Management is in discussions with several major cancer centers to initiate the expanded access program [33] Question: Update on database and NDA filing - Management reported ongoing data entry and monitoring challenges due to COVID-19 but is implementing remote monitoring solutions [49] Question: Thoughts on partnering strategies - Management is cautious about regional partnerships, preferring to keep the asset clean for potential strategic partnerships in the future [52]

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. | --- | --- | |----------------------------------------------------------------|------------- ...

Financial Performance - Revenue for the three months ended September 30, 2020, was approximately $0.5 million, an increase from $0.4 million for the same period in 2019, representing a growth of 25%[130] - Revenue for the nine months ended September 30, 2020, remained stable at approximately $1.1 million, unchanged from the same period in 2019[137] - Net loss for the three months ended September 30, 2020, was $5.0 million, a decrease of $2.5 million compared to a net loss of $7.5 million for the same period in 2019[136] - Net loss for the nine months ended September 30, 2020, was $17.1 million, a decrease of $4.3 million compared to a net loss of $21.4 million for the same period in 2019[142] Expenses - Cost of goods sold for the three months ended September 30, 2020, remained stable at approximately $0.2 million, unchanged from the same period in 2019[131] - Research and development expenses increased to $3.3 million for the three months ended September 30, 2020, up from $1.8 million in the same period of 2019, reflecting resumed activities in clinical trials[132] - Selling, general and administrative expenses decreased to $2.0 million for the three months ended September 30, 2020, down from $4.0 million in the same period in 2019, primarily due to reduced personnel expenses[133] - Research and development expenses for the nine months ended September 30, 2020, rose to $8.5 million from $6.8 million in the same period of 2019[139] - Selling, general and administrative expenses for the nine months ended September 30, 2020, were $6.6 million, down from $9.2 million in the same period of 2019[140] Leadership Changes - The Company appointed Gerard Michel as CEO and John Purpura as COO, effective October 1, 2020, to strengthen its leadership team[115][116] Regulatory and Market Developments - The FDA granted conditional acceptance of the trade name HEPZATO™ KIT for the Company's melphalan hydrochloride for injection/hepatic delivery system on September 9, 2020[129] - The Company expects to submit a New Drug Application (NDA) to the FDA in the first quarter of 2022, following the conclusion of the FOCUS trial[117] - The COVID-19 pandemic has delayed clinical trial operations, affecting the timelines for the FOCUS trial and potentially impacting revenue from CHEMOSAT procedures[121] - The Company has paused work on the ALIGN trial to focus on the FOCUS trial conclusion and subsequent NDA filing[112] - The Company is evaluating the potential market opportunities for HEPZATO across various liver cancers, including ocular melanoma and intrahepatic cholangiocarcinoma[111] Financial Position - As of September 30, 2020, the company had cash, cash equivalents, and restricted cash totaling $11.1 million, compared to $15.5 million at September 30, 2019[145] - The company raised approximately $22.0 million from an underwritten public offering in May 2020 and launched an at-the-market offering of up to $10 million in August 2020[144] - The company expects that ongoing ATM Offering and existing cash resources will be sufficient to fund operations through the second quarter of 2021, but additional capital will be needed beyond that[144] Accounting Policies - The financial statements have been prepared in accordance with GAAP[149] - No material changes to critical accounting policies were reported for the nine months ended September 30, 2020[149] - Significant accounting policies impacting financial statement amounts are disclosed in Note 3 of the Annual Report[149]

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]

Financial Data and Key Metrics Changes - The product revenue for Q2 2020 was approximately $262,000, an increase from $221,000 in the prior year [27] - Selling, general, and administrative expenses were approximately $2.3 million, down from $2.7 million in the prior year [28] - Research and Development expenses increased to $2.2 million from $1.7 million in the prior year [28] - The net loss for Q2 2020 was $4.3 million, improved from a net loss of $6.0 million in the same period in 2019 [29] - Cash resources totaled $16.2 million as of June 30, 2020, compared to $10.2 million at December 31, 2019, and $1.4 million at June 30, 2019 [29] Business Line Data and Key Metrics Changes - The company completed a $22 million capital raise during the quarter, which supports the ongoing Phase 3 registration FOCUS trial for Melphalan/HDS [9] - Over 1,000 commercial procedures have been performed in the EU using the CHEMOSAT technology, although market penetration remains low due to reimbursement issues [23] Market Data and Key Metrics Changes - The U.S. market opportunity for metastatic ocular melanoma is estimated to be in the hundreds of millions of dollars, with approximately 1,500 new cases annually [13] - Initial surveys indicate a high unmet medical need and potential for Melphalan/HDS to be positioned as a frontline therapy if approved [12] Company Strategy and Development Direction - The company is focused on making Melphalan/HDS available as the only labeled therapy for metastatic ocular melanoma in the U.S. [8] - There is a strategic emphasis on expanding the U.S. opportunity beyond the initial indication of ocular melanoma [15] - A comprehensive review of clinical and commercial data is underway to guide future pipeline projects [17] Management's Comments on Operating Environment and Future Outlook - The management highlighted the transformational changes over the past year, including restructuring and recapitalization [7] - The ongoing COVID-19 pandemic has impacted clinical trials, but the company has managed to keep patients on protocol [21] - The goal is to report Phase 3 top-line data by the end of 2020 or early 2021, with an NDA resubmission expected by mid-2021 [22] Other Important Information - The company has received FDA feedback regarding potential protocol modifications for the Phase 3 study in intrahepatic cholangiocarcinoma [16] - The partnership with Medac is crucial for European commercialization, and the company is actively reviewing Medac's performance to ensure optimal execution [24] Q&A Session Summary Question: Expected cash milestones from Medac - The milestones are not substantial but sufficient to ensure cash runway through NDA filing [32] Question: Impact of COVID-19 on ongoing trials - The company managed to keep all ongoing patients on protocol despite the pandemic [34] Question: Spending trends during pre-commercialization - The company maintains a quarterly spend of about $4.5 to $5 million, with some fluctuations expected [36] Question: Parameters for product launch resources - The company is receiving commercialization guidance from a former Chief Commercialization Officer on how to proceed [37] Question: Timing for pursuing expanded indications - The company is assessing which indications to pursue without interfering with NDA submission timelines [38] Question: FDA feedback on intrahepatic cholangiocarcinoma - The company received guidance from the FDA, which is part of a broader strategic review [40] Question: Rolling submission pathway for NDA - The company plans a resubmission with a six-month review clock, with no current plans for a rolling submission [42]