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 ...

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 June 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 registran ...

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]