NEW YORK, March 15, 2024 /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 comprised of existing investors, Delcath Executives and members of its Board of Directors, for a private placement transaction (the "Private Placement"). Delcath will issue and sell 876,627 shares of its common stock ( ...

NEW YORK, March 8, 2024 /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 Company management will be attending the following upcoming investor conferences: Leerink Partners Global Biopharma Conference Date: March 13, 2024Location: Miami Beach, FL 36th Annual ROTH ConferenceDate: March 18 - 19, 2024Location: Dana Point, CA Management is scheduled to host one-on-one meetings thr ...

NEW YORK, Feb. 22, 2024 /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 has launched a Healthcare Setting Locator (Locator) on the hepzatokit.com website. Potential patients, caregivers, and healthcare providers may use the Locator to identify healthcare settings, offering treatment with the HEPZATO KIT. Sites included on the Locator are accepting inquiries from ...

NEW YORK, Feb. 16, 2024 /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, announces that the Company granted equity awards, previously approved by the Company's Compensation Committee, as a material inducement to the employment of three individuals whose employment commenced in January 2024.   The grant totaled the right to purchase an aggregate of 50,000 shares of the ...

NEW YORK, Jan. 31, 2024 /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 Centers for Medicare & Medicaid Services ("CMS") has established a permanent and product-specific J-code (J9248) for HEPZATO. The J-code will become effective on April 1, 2024. J-codes are a form of Healthcare Common Procedure Coding System Level II identifiers used by payors to streamline the billin ...

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 ...