Financial Data and Key Metrics Changes - Product revenues for Q1 2022 were approximately $207,000, a decrease from $261,000 in the prior year quarter due to the resumption of direct sales of CHEMOSAT in Europe [21] - Other income for the quarter increased to $171,000 compared to $127,000 in the prior year quarter [21] - Research and development expenses rose to $4.2 million from $3.7 million in the prior year quarter, primarily due to higher professional service costs related to the pre-NDA meeting with the FDA [22] - Selling, general and administrative expenses increased to approximately $3.6 million from $3.3 million in the prior year quarter, attributed to pre-launch costs for HEPZATO [23] - Cash, cash equivalents, and restricted cash totaled $20.5 million as of March 31, 2022, down from $27 million on December 31, 2021 [24] Business Line Data and Key Metrics Changes - HEPZATO's NDA resubmission is planned for the third quarter of 2022, with no significant new issues arising from the pre-NDA meeting with the FDA [6][9] - CHEMOSAT's safety and efficacy data from various studies in Europe continue to support its market presence, with a focus on increasing sales and distribution activities [7][13] Market Data and Key Metrics Changes - The company resumed direct responsibility for sales, marketing, and distribution of CHEMOSAT in Europe, with plans to expand into additional markets [16][48] - The company anticipates that Europe will become a meaningful revenue contributor, especially with the upcoming US commercial launch [17] Company Strategy and Development Direction - The company aims to open 10 expanded access sites for HEPZATO by the expected launch, focusing on a niche market with significant unmet needs [11] - Plans to expand the PHP platform into other indications, with a focus on ICC and CRC trials, are underway [18][19] - The management team is being strengthened to support both development and commercialization efforts in the US and Europe [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the pre-NDA meeting with the FDA, indicating a positive outlook for HEPZATO's NDA resubmission [28][29] - The company is facing challenges related to nursing shortages impacting clinical trial resources, which is a broader industry issue [33] - Management is adjusting spending on new indications due to the current market environment, focusing on low-cost initiatives [41] Other Important Information - The company received Medical Device Regulation certification for CHEMOSAT in Europe, changing its designation from Class IIb to Class III [15][16] - The company is actively working on reimbursement strategies in the UK and other European markets [45][46] Q&A Session Summary Question: Insights from the pre-NDA meeting with the FDA and vendor delays - Management noted that the pre-NDA meeting provided positive signals regarding efficacy analysis and clarified FDA expectations, with no significant downsides [27][28] - Delays from a vendor were attributed to the need for quality tests on off-the-shelf components, but management is confident in resolving these issues soon [30][31] Question: EAP site readiness and enrollment - Management highlighted that nursing shortages are impacting the ability to enroll patients in the EAP, but they are optimistic about meeting their goal of 10 sites [32][33] Question: Maturity of survival data and R&D expenses - Management confirmed that survival data will continue to mature over the next year, with updates expected at ASCO [35] - R&D expenses are expected to remain high for another quarter before potentially declining [36] Question: Impact of market conditions on future indications and restricted cash - Management is slowing down spending on new indications due to market conditions but is still focused on low-cost initiatives [41] - Restricted cash can be released through additional equity financing, with discussions possible if needed [42]

Financial Performance - For the three months ended March 31, 2022, Delcath recorded approximately $378,000 in revenue, a slight decrease from $388,000 in the same period of 2021, primarily due to the transition to direct sales in Europe [70]. - Cost of goods sold for the same period was approximately $33,000, down from $112,000 in the prior year, attributed to the direct sales transition in Europe [71]. - Revenue for the three months ended March 31, 2022, was approximately $378,000, a slight decrease from $388,000 in the same period of 2021 [70]. - Cost of goods sold decreased to approximately $33,000 for the three months ended March 31, 2022, compared to $112,000 in the prior year period [71]. Expenses - Research and development expenses increased to $4.2 million from $3.7 million year-over-year, mainly due to costs associated with the pre-NDA meeting and NDA submission preparations [72]. - Selling, general and administrative expenses rose to $3.6 million from $3.3 million, reflecting higher costs in preparation for the commercialization of HEPZATO in the U.S. [73]. - Other expenses increased significantly to $0.6 million from $20,000, primarily due to interest and amortization expenses related to debt financing [74]. - Research and development expenses increased to $4.2 million for the three months ended March 31, 2022, up from $3.7 million in the prior year, primarily due to pre-NDA meeting preparations [72]. - Selling, general and administrative expenses rose to $3.6 million for the three months ended March 31, 2022, compared to $3.3 million in the same period of 2021, driven by commercialization preparations for HEPZATO [73]. - Other expenses increased to $0.6 million for the three months ended March 31, 2022, from $20,000 in the prior year, mainly due to interest and amortization expenses [74]. Cash and Commitments - As of March 31, 2022, Delcath had cash, cash equivalents, and restricted cash totaling $20.5 million, with $6.4 million used in operating activities during the quarter [75]. - The company has capital commitments of $6.1 million for accounts payable and $2.9 million for loan principal payments over the next twelve months [78]. - The Avenue Loan Agreement provides Delcath with a term loan of up to $20 million, with an interest rate of 10.95% as of March 31, 2022, maturing on August 1, 2024 [81]. - The Avenue Loan Agreement provides a term loan of up to $20.0 million, with an interest rate of 10.95% as of March 31, 2022, maturing on August 1, 2024 [81]. Regulatory and Product Development - Delcath plans to submit a new drug application for HEPZATO to the FDA by the end of Q3 2022, following a successful FOCUS Trial [68]. - The company is preparing to submit a new drug application (NDA) for HEPZATO to the FDA by the end of Q3 2022, following positive results from the FOCUS Trial [68]. - CHEMOSAT received Medical Device Regulation certification in Europe on February 28, 2022, and the company has taken direct responsibility for its sales and marketing in Europe [69]. - The company has received six orphan drug designations from the FDA for melphalan and one for doxorubicin, targeting various types of cancer [68].

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, 2021 ☐ 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. Delaware 06-1245881 (State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.) ...

Delcath Systems Ltd. (NASDAQ:DCTH) Q4 2021 Earnings Conference Call March 25, 2022 8:30 AM ET Company Participants Gerard Michel - Chief Executive Officer Dr. Johnny John - Senior Vice President, Medical Affairs and Clinical Development Kevin Muir - Vice President, Commercial Operations Anthony Dias - Vice President, Finance David Hoffman - General Counsel Conference Call Participants Marie Thibault - BTIG Yale Jen - Laidlaw & Company Scott Henry - Roth Capital Swayampakula Ramakanth - HC Wainwright Ben Sh ...

Financial Data and Key Metrics Changes - Product revenue for Q3 2021 was approximately $522,000, an increase from $466,000 in the prior year period [33] - Selling, general and administrative expenses rose to approximately $4 million from $2 million in the prior year quarter [33] - Research and development expenses decreased slightly to $3 million from $3.3 million in the prior year quarter [33] - The net loss for Q3 2021 was $7.1 million, compared to a net loss of $5 million for the same period in 2020 [34] - Total cash as of September 30, 2021, was $29 million, up from $11.1 million at the end of the previous year [34] Business Line Data and Key Metrics Changes - The company is focused on the Hepzato product, with significant progress in the Phase III FOCUS trial, achieving a 29.2% objective response rate [7] - The company plans to submit a New Drug Application (NDA) for Hepzato, with a delay in resubmission guidance pushed from late Q1 to mid-year 2022 due to COVID-related issues [9][10] Market Data and Key Metrics Changes - The company has received FDA approval for its expanded access protocol (EAP), with five sites intending to participate, including notable cancer centers [12] - The company is preparing for commercialization, leveraging its inclusion in NCCN guidelines for treating metastatic ocular melanoma [24] Company Strategy and Development Direction - The company aims to expand its clinical trials into new tumor types, including intrahepatic cholangiocarcinoma and colorectal cancer [23] - The company is enhancing its commercial preparation by developing a global value dossier and mapping territories for future sales efforts [25] Management's Comments on Operating Environment and Future Outlook - Management acknowledged delays in timelines due to COVID-19 but expressed confidence in the data and the potential for a rolling submission to the FDA [9][10] - The company is optimistic about the efficacy of Hepzato based on recent trial data and aims to present this at an upcoming investor day [29] Other Important Information - The company has strengthened its balance sheet through a $20 million venture debt financing transaction [35] - The company has increased its headcount by 40% over the past year to support its development and commercialization goals [27][28] Q&A Session Summary Question: Will the FOCUS update on December 2 include all final data for FDA submission? - Management confirmed that the data presented will be final, with some minor data still being monitored but not affecting efficacy parameters [38] Question: What is the status of the expanded access program? - Management confirmed that the EAP has received FDA clearance and is at various stages of site readiness [43] Question: What are the next steps for the CHOPIN trial? - The trial has moved into Phase II, and ongoing patient treatments are being conducted [51] Question: What is the expected timeline for FDA approval? - Management indicated that if the FDA meets its PDUFA requirements, approval could be targeted for the end of 2022 [49] Question: What is the status of the CMC module for the rolling submission? - The CMC module is ongoing and expected to be ready for submission along with non-clinical data [58]

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 ...

Revenue Performance - Revenue for the three months ended June 30, 2021, was approximately $536,000, an increase of $157,000 compared to $379,000 for the same period in 2020, driven by increased CHEMOSAT unit sales[91]. - Revenue for the six months ended June 30, 2021, was approximately $924, an increase of $252 from $672 for the same period in 2020, driven by increased CHEMOSAT unit sales[98]. - Total revenue for the six months ended June 30, 2021, was approximately $924,000, an increase of 37.4% compared to $672,000 for the same period in 2020[98]. Cost of Goods Sold - Cost of goods sold for the three months ended June 30, 2021, was approximately $202,000, up from $168,000 in the prior year, primarily due to increased sales volume[92]. - Cost of goods sold for the three months ended June 30, 2021, was approximately $202,000, up from $168,000 in the prior year, reflecting increased sales volume[92]. Research and Development Expenses - Research and development expenses rose to $3,497,000 for the three months ended June 30, 2021, compared to $2,223,000 in the prior year, influenced by stock option expenses and hiring of additional employees[94]. - Research and development expenses increased to $7,204 for the six months ended June 30, 2021, from $5,197 in the prior year, partly due to stock option expenses of $1,093 and hiring five additional employees[99]. - Research and development expenses for the six months ended June 30, 2021, rose to $7,204,000 from $5,197,000 in the prior year, influenced by stock option expenses and ongoing trial costs[99]. Selling, General and Administrative Expenses - Selling, general and administrative expenses increased to $3,288,000 for the three months ended June 30, 2021, from $2,257,000 in the prior year, largely due to stock option expenses of $1,163,000[95]. - Selling, general and administrative expenses rose to $6,584 for the six months ended June 30, 2021, from $4,573 in the prior year, primarily due to stock option expenses of $2,681[100]. - Selling, general and administrative expenses for the six months ended June 30, 2021, were $6,584,000, up from $4,573,000 in the prior year, largely due to stock option expenses[100]. Net Loss - Net loss for the six months ended June 30, 2021, was $13,177, an increase of $1,041 compared to a net loss of $12,136 for the same period in 2020[102]. - Net loss for the three months ended June 30, 2021, was $6,430,000, an increase of 50.5% compared to a net loss of $4,275,000 for the same period in 2020[97]. Clinical Trials - The FOCUS Trial for HEPZATO reported an objective response rate (ORR) of 29.2% in the intent-to-treat population, significantly exceeding the predefined success criterion of 8.3%[83]. - The median progression-free survival (PFS) in the HEPZATO arm was 9.0 months, compared to 3.1 months in the Best Alternative Care (BAC) arm, indicating a statistically significant improvement[83]. - The company has paused the ALIGN Trial due to enrollment difficulties but is reviewing the potential to restart it based on market opportunities[85]. - The company experienced delays in patient recruitment and data monitoring for the FOCUS Trial due to the COVID-19 pandemic, impacting timelines for data announcements[87]. - The company intends to submit a New Drug Application (NDA) to the FDA in Q1 2022 for the treatment of metastatic ocular melanoma, contingent on the completion of the FOCUS Trial[87]. Cash Position - Cash, cash equivalents, and restricted cash totaled $19,425 at June 30, 2021, down from $28,756 at December 31, 2020, and $16,192 at June 30, 2020[103]. - Cash, cash equivalents, and restricted cash totaled $19,425,000 as of June 30, 2021, down from $28,756,000 at December 31, 2020[103]. Regulatory Status - The current CE Mark under the Medical Device Directive remains effective until April 2024, allowing the company to operate in Europe while working towards MDR certification[90]. - The company has not yet achieved MDR certification as of June 30, 2021, but the current CE Mark remains effective until April 2024[90]. Future Outlook - The company anticipates continued operating losses and emphasizes the need for additional capital to support future operations[104][105]. - The company is focused on maximizing the value of the HEPZATO platform by investigating a broad set of liver cancers to address unmet medical needs[86].

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 ...