Financial Data and Key Metrics Changes - The company ended Q3 2023 with $40.5 million in cash, with cash used in operations approximately $9.2 million for the third quarter and $23.1 million for the first nine months of the year [24] - R&D expenses increased to $4.7 million in Q3 2023 from $4.1 million in Q3 2022, attributed to FDA inspection activities [25] - Selling, general and administrative expenses rose from $4.8 million to $6.2 million due to preparations for the commercial launch [25] Business Line Data and Key Metrics Changes - The company is focused on the commercialization of HEPZATO KIT, which received FDA approval on August 14, 2023, for treating metastatic uveal melanoma [13][23] - The company anticipates starting commercial sales in January 2024, with plans to have at least 10 treatment sites operational by the end of Q2 2024 [23][38] Market Data and Key Metrics Changes - The company is working with over 20 sites to build referral networks and has initiated the formulary approval process in 13 hospitals [15][36] - The company expects to have five active treatment sites by the end of Q1 2024, increasing to 10 by the end of Q2 and 15 by the end of 2024 [38] Company Strategy and Development Direction - The company is focused on building a robust supply chain to avoid stockouts and ensure a smooth launch of HEPZATO KIT [2] - The strategy includes training treatment teams and working with medical oncologists to integrate HEPZATO KIT into their practices [15][36] - The company aims to establish HEPZATO KIT as the standard of care for liver-directed therapy in metastatic uveal melanoma patients [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for HEPZATO KIT, citing positive feedback from medical professionals and the need for the product in treating metastatic uveal melanoma [36] - The company is optimistic about the approval process with Value Analysis Committees, expecting quicker approvals due to the lack of standard care for the targeted patient population [93] Other Important Information - The company is working on obtaining necessary reimbursement codes from CMS, which are crucial for the commercial launch [20][77] - The company has faced delays in product availability due to complexities in working with contract manufacturers for melphalan [84][91] Q&A Session Summary Question: How active is Delcath in the Value Analysis Committee approval process? - Management indicated that while Delcath supports the process, it is primarily an internal hospital procedure, and they have received positive feedback so far [68][49] Question: How do you see HEPZATO being used post KIMMTRAK? - Management noted that some patients may be too far progressed for HEPZATO, but there is potential for liver-directed therapy to be used first in certain cases [29][121] Question: What is the expected inventory level for the launch? - The company aims to maintain at least a year's worth of inventory, ensuring adequate supply for anticipated demand [96] Question: How long do Value Analysis Committee approvals typically take? - Management expects these approvals to take closer to three months rather than the typical nine months due to the urgency and need for the product [93] Question: What is the expected patient volume for the first year? - Management anticipates that by the end of the first quarter, five sites will be operational, with a gradual increase in patient treatments as more sites come online [108]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _____________________ FORM 10-Q ______________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Or o 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 regi ...

Financial Performance - Total revenues for the three months ended June 30, 2023, were $495,000, a decrease of 38% compared to $797,000 for the same period in 2022[112]. - Gross profit for the three months ended June 30, 2023, was $345,000, down from $617,000 in the same period of 2022, reflecting lower demand for CHEMOSAT[112][113]. - The net loss for the three months ended June 30, 2023, was $7.2 million, compared to a net loss of $10.2 million for the same period in 2022[112]. - Total revenues for the three months ended June 30, 2023, were $495,000, a decrease of 37.9% compared to $797,000 for the same period in 2022[112]. - Gross profit for the three months ended June 30, 2023, was $345,000, down 44.1% from $617,000 in the prior year[112]. - The net loss for the three months ended June 30, 2023, was $7.202 million, compared to a net loss of $10.159 million for the same period in 2022, reflecting a 29.2% improvement[112]. Expenses - Research and development expenses for the three months ended June 30, 2023, were $3.6 million, a decrease of 37% compared to $5.6 million in the same period of 2022[112][115]. - Selling, general and administrative expenses increased to $4.8 million for the three months ended June 30, 2023, compared to $4.5 million in the same period of 2022, due to preparations for commercial launch[112][116]. - Research and development expenses for the three months ended June 30, 2023, were $3.555 million, a decrease of 36.4% from $5.606 million in 2022, attributed to the completion of clinical trial activities[115]. - Selling, general and administrative expenses increased to $4.787 million for the three months ended June 30, 2023, up 6.5% from $4.497 million in 2022, due to preparations for commercial launch[116]. Cash and Capital - As of June 30, 2023, the company had cash, cash equivalents, and restricted cash totaling $14.6 million, an increase from $11.8 million at December 31, 2022[118]. - The company used $13.9 million of cash for operating activities during the six months ended June 30, 2023[118]. - Capital commitments for the next twelve months include $6.6 million for accounts payable and lease liabilities, and $5.1 million for loan principal payments[124]. - The company has entered into an ATM Sales Agreement allowing for the sale of up to $17.0 million in common stock, with approximately $4.0 million sold to date[125]. - The Avenue Loan Agreement has a principal amount of up to $20 million, with an interest rate of 15.95% as of June 30, 2023, maturing on August 1, 2024[126]. Regulatory and Supply Chain - The PDUFA target action date for the HEPZATO KIT is set for August 14, 2023, following the NDA resubmission to the FDA[109]. - The company is focused on securing a long-term supply of critical components necessary for the HEPZATO KIT, including melphalan, to mitigate supply chain risks[110]. - The company expects to utilize cash and cash equivalents for activities related to the HEPZATO NDA resubmission and commercialization efforts, as well as ongoing support for CHEMOSAT and future clinical trials[123]. - The company is focused on securing a long-term supply of melphalan, with sufficient quantities to meet forecasted demand during a planned shutdown of the current manufacturer[110]. - CHEMOSAT received Medical Device Regulation (MDR) certification in Europe, and the company has taken direct responsibility for its sales and marketing in the region[111]. Stock and Financing - The company has issued 24,900 shares of Series F-1 Convertible Preferred Stock in a private placement, raising approximately $24.9 million before expenses[128]. - As of June 30, 2023, 15,276 shares of Series F-1 Preferred Stock were converted into 4,629,539 shares of common stock[131]. - The company anticipates needing to raise additional capital if there is a substantial delay in the approval of HEPZATO, which could affect its ability to meet obligations within twelve months[122].

Table of Contents 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, 2023 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 other j ...

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 ...

Table of Contents 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, 2022 ☐ 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 definitions of "large accelerated filer," "accelerated filer", "smaller reportin ...

Financial Data and Key Metrics Changes - Product revenues for Q3 2022 were approximately $906,000, a 129% increase compared to $395,000 in the prior quarter, primarily due to the termination of the medac distribution agreement [23][24] - The net loss for Q3 2022 was $8.5 million, or $0.92 per share, compared to a net loss of $7.1 million, or $0.94 per share for the same period in 2021 [26] - Cash, cash equivalents, and restricted cash totaled $14 million as of September 30, 2022, down from $27 million on December 31, 2021 [27] Business Line Data and Key Metrics Changes - In Europe, CHEMOSAT units increased by 41% year-over-year and 26% sequentially from Q2 to Q3 2022 [15] - The company is on track to file the HEPZATO KIT NDA with the FDA by the end of December 2022 [8] Market Data and Key Metrics Changes - The company has two centers treating patients under the Expanded Access Program (EAP) in the U.S., with a third center pending training [7] - The CHOPIN trial is progressing with approximately 50% of the planned 76 patients enrolled [11] Company Strategy and Development Direction - The company aims to operate on a cash flow breakeven basis while making key hires in Germany to support national coverage submissions [16] - The focus is on the commercialization of HEPZATO, with plans for market access and reimbursement strategies for Medicare patients [20][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming NDA submission and the potential for rapid revenue growth post-approval [22] - The company is monitoring referral patterns and believes that HEPZATO and KIMMTRAK can be used in a complementary manner for patient treatment [36] Other Important Information - A settlement agreement with medac regarding the termination of the distribution agreement is expected by the end of 2022 [17] - The company successfully completed a Notified Body audit for its manufacturing facility under the European Medical Device Regulation [18] Q&A Session Summary Question: Updates on CROs and NDA resubmission - Management indicated that medical writing is the primary gating item for the NDA resubmission, expected by the end of December [31] Question: EAP site treatments and learnings - A total of seven treatments have been conducted, with an eighth scheduled, and early learnings are being applied to inform referral pathways [33] Question: FDA review timeline and panel meetings - Management is focused on ensuring a complete submission package to facilitate a smooth review process, with no meetings scheduled with the FDA at this time [40] Question: European revenue trends - Management noted that revenue growth may be lumpy due to small numbers, but hiring a representative in Germany is expected to improve referral patterns [41] Question: Volume expectations post-approval - An average of one treatment per week per site is anticipated post-launch, with potential for growth to 20 sites over two years [43] Question: FOCUS study final survival data - The primary endpoint is objective response rate, and there is no need to update the data for FDA submission, but the agency will be kept informed [45] Question: Operating expenses outlook - Management expects operating expenses to remain steady for the next two quarters [46] Question: FDA facility inspection timeline - A preapproval inspection is expected to be scheduled four to six weeks prior to the PDUFA date [47] Question: FDA expectations for pivotal data - Management highlighted the importance of demonstrating clinically meaningful objective response and duration of response, with favorable comparisons to existing treatments [50]

Table of Contents Title of each classTrading Symbol(s)Name of each exchange on which registered Common stock, $0.01 par value per share DCTH The NASDAQ Capital Market 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, 2022 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period fro ...

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 Ya ...

Revenue Performance - Delcath Systems recorded approximately $0.8 million in revenue for Q2 2022, up from $0.4 million in Q2 2021, primarily due to the transition to direct sales in Europe[74]. - For the six months ended June 30, 2022, revenue was approximately $1.2 million, compared to $0.9 million for the same period in 2021, again due to the direct sales transition in Europe[80]. Research and Development Expenses - Research and development expenses increased to $5.5 million in Q2 2022 from $3.5 million in Q2 2021, driven by costs related to the pre-NDA meeting and NDA submission preparations[76]. - Research and development expenses for the six months ended June 30, 2022, increased to $9.7 million from $7.2 million in the prior year, attributed to NDA submission preparations[82]. Selling, General and Administrative Expenses - Selling, general and administrative expenses rose to $4.1 million in Q2 2022 from $3.3 million in Q2 2021, reflecting higher costs for HEPZATO commercialization preparations[78]. - Selling, general and administrative expenses for the six months ended June 30, 2022, were $7.8 million, up from $6.6 million in the prior year, due to commercialization efforts and increased headcount[83]. Cash and Capital Commitments - As of June 30, 2022, Delcath had cash, cash equivalents, and restricted cash totaling $14.4 million, with $12.4 million used in operating activities during the first half of 2022[85]. - The company has capital commitments of $7.8 million for accounts payable and $5.0 million for loan principal payments over the next twelve months[88]. Going Concern and Capital Raising - Delcath's ability to continue as a going concern is dependent on raising additional capital through equity or debt securities[87]. Drug Application and Financing Activities - The company plans to submit a new drug application for HEPZATO to the FDA by the end of Q3 2022, following a successful pre-NDA meeting[72]. - The Company entered into a Loan and Security Agreement for a term loan of up to $20.0 million, with an interest rate that increased from 11.7% to 13.2% between June and August 2022[91]. - On July 20, 2022, Delcath closed a private placement, issuing 690,954 shares of common stock at $3.98 each and 566,751 pre-funded warrants at $3.97 each, raising approximately $5.0 million in gross proceeds[92]. Accounting and Internal Controls - There were no material changes to critical accounting estimates during the six months ended June 30, 2022, as reported in the Annual Report[93]. - The financial statements were prepared in accordance with generally accepted accounting principles, with no material changes to critical accounting policies during the six months ended June 30, 2022[94]. - The Company's management evaluated the effectiveness of disclosure controls and procedures, concluding they are functioning effectively as of June 30, 2022[96]. - There were no changes in internal control over financial reporting during the quarter ended June 30, 2022, that materially affected the internal control[97].