NEW YORK, April 4, 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 an equity award, previously approved by the Company's Compensation Committee, as a material inducement to the employment of one individual whose employment commenced in March 2024. The grant totaled the right to purchase an aggregate of 30,000 shares of the Comp ...

Investors might want to bet on Delcath Systems, Inc. (DCTH) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a c ...

Financial Data and Key Metrics Changes - The company ended Q4 with $32.5 million in cash and investments, with cash used in operations approximately $8.1 million for the fourth quarter [31] - Revenue from sales of CHEMOSAT was $0.5 million for the three months ended December 31, 2023, compared to $0.6 million for the same period in 2022 [32] - Selling, general and administrative expenses increased to $7 million from $3.8 million due to activities preparing for the commercial launch [51] Business Line Data and Key Metrics Changes - The company expects to have 4 active sites treating commercial patients by the end of Q1 2024, including Moffitt Cancer Center, Stanford University Cancer Center, and Thomas Jefferson University [6] - Average treatments per site are expected to increase from approximately 1 per month early in Q2 to a run rate of 2 treatments per month by late Q4 [7] Market Data and Key Metrics Changes - The company is working with over 20 leading cancer centers across the U.S. that have expressed interest in incorporating HEPZATO KIT into their practices [41] - The establishment of a permanent J-code for HEPZATO is expected to simplify the reimbursement process and increase the pace of facilities conducting their first commercial treatment [8][20] Company Strategy and Development Direction - The company is increasing its site activation guidance from 15 to 20 active sites by the end of 2024, with a pacing of 10 active sites by the end of Q2 and 15 by the end of Q3 [18] - The company plans to pursue additional indications for HEPZATO, targeting unmet medical needs in liver cancers [30][48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving $10 million in quarterly revenue no later than Q4 2024, driven by the ramp-up of active treatment sites [31][32] - The company believes that the future has never been brighter, with significant growth opportunities in treating metastatic uveal melanoma and other liver cancers [30][49] Other Important Information - The company closed a $7 million private placement to ensure sufficient cash for operations until achieving $10 million in quarterly revenue [50] - The company has trained over 90 healthcare professionals across approximately 20 institutions in the U.S. [21] Q&A Session Summary Question: What therapies are patients being treated with and what is the interest in combination therapies? - Management indicated that patients have varied treatment histories, with some having prior systemic or liver-directed treatments, and there is interest in combination therapies with ongoing trials [54][57] Question: What is the base case outlook for the company's finances going forward? - The base case is to achieve cash flow positivity and fund new development from cash flows without additional financing, assuming the stock performs well [58] Question: How many patients have been treated commercially so far and what are the trends? - Approximately 80% of the first quarter's revenue is expected to come from Moffitt, with patients returning for repeat treatments [61][74] Question: What percentage of the overall market do you expect to cover by the end of this year? - It is estimated that over 75% of patients who have one or more referrals at the first 20 sites will be covered [67][80] Question: What reimbursement processes have been encountered so far? - The company faced challenges in obtaining reimbursement codes initially but managed to activate four sites using a miscellaneous code before the J-code became effective [68]

[Part I](index=4&type=section&id=PART%20I) [Business](index=7&type=section&id=Item%201.%20Business) Delcath Systems is an interventional oncology company focused on treating liver cancers with its primary product, the FDA-approved HEPZATO KIT, and expanding its European CHEMOSAT sales and clinical development for other liver-dominant cancers - The company's lead product, **HEPZATO KIT**, was approved by the US FDA on August 14, 2023, for treating adult patients with uveal melanoma with unresectable hepatic metastases[24](index=24&type=chunk) - The first commercial use of **HEPZATO** in the United States took place in January 2024, marking the beginning of the product's commercial launch[24](index=24&type=chunk)[53](index=53&type=chunk) - In Europe, the device-only version, **CHEMOSAT**, received Medical Device Regulation (MDR) certification in February 2022, and Delcath assumed direct responsibility for its sales, marketing, and distribution as of March 1, 2022[26](index=26&type=chunk)[65](index=65&type=chunk)[105](index=105&type=chunk) - The company plans to initiate studies in 2024 to explore **HEPZATO's** potential in treating other liver cancers, including metastatic colorectal cancer, neuroendocrine tumors, breast cancer, and intrahepatic cholangiocarcinoma[28](index=28&type=chunk) Estimated Annual Addressable Patient Populations and Market | Cancer Type | U.S. & Europe Patient Candidates | Estimated Annual Market (mUM only) | | :--- | :--- | :--- | | Uveal Melanoma (mUM) | 2,000 | ~$600 million | | Colorectal Cancer (CRC) | 98,000 | N/A | | Breast Cancer (BC) | 6,000 - 16,000 | N/A | | Neuroendocrine Tumors (NETs) | 12,000 | N/A | | Intrahepatic Cholangiocarcinoma (ICC) | 2,000 | N/A | - As of March 1, 2024, the company had approximately **76 full-time employees**, with **66 in the United States** and **10 in Europe**[126](index=126&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including going concern doubts, commercialization challenges for HEPZATO, supply chain reliance, reimbursement uncertainties, intense competition, and stock price volatility - The company's independent registered public accounting firm has expressed substantial doubt about its ability to continue as a **going concern** due to a significant working capital deficiency, recurring losses, and the need to raise additional funds[136](index=136&type=chunk) - Delcath requires additional capital to fund the commercialization of **HEPZATO** and **CHEMOSAT** and for future product development; failure to raise capital could significantly limit operations[139](index=139&type=chunk)[140](index=140&type=chunk) Net Loss History | Year | Net Loss (in millions) | | :--- | :--- | | 2023 | $47.7 | | 2022 | $36.5 | - The company has limited experience as a commercial entity, and the success of the **HEPZATO** launch is critical; failure to generate significant revenue could prevent the company from ever becoming profitable[156](index=156&type=chunk) - There is a significant risk related to the supply of **melphalan** and other critical components, as the company relies on single contracted suppliers and must maintain compliance with manufacturing regulations (cGMPs)[158](index=158&type=chunk)[161](index=161&type=chunk) - Market success is heavily dependent on obtaining adequate coverage and reimbursement from third-party payors like **CMS** and private insurers in both the U.S. and Europe, which is uncertain[205](index=205&type=chunk)[207](index=207&type=chunk) - The market price of the company's common stock (**DCTH**) has been highly volatile, with a **52-week range between $2.25 and $7.96**, posing a risk to investors[251](index=251&type=chunk) [Unresolved Staff Comments](index=48&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - Not applicable[279](index=279&type=chunk) [Cybersecurity](index=49&type=section&id=Item%201C.%20Cybersecurity) Delcath manages cybersecurity risks through a program led by finance and IT, with technical safeguards, employee training, third-party management, and Board oversight - The company's cybersecurity risk management is led by the **Senior Vice President of Finance** and the **Director of Information Technology**[281](index=281&type=chunk)[284](index=284&type=chunk) - Cybersecurity measures include technical controls (e.g., encryption, access controls), disaster recovery planning, and mandatory annual cybersecurity training for all employees[282](index=282&type=chunk) - The **Board of Directors** provides oversight for cybersecurity, reviewing risks, policies, and emerging threats on an annual basis with senior management[286](index=286&type=chunk) [Properties](index=50&type=section&id=Item%202.%20Properties) The company owns corporate and manufacturing facilities in Queensbury, New York, and subleases a facility in Galway, Ireland, for European operations, with recent expansion in Queensbury - The company owns its corporate office (**10,320 sq ft**) and another building (**6,000 sq ft**) in Queensbury, New York, which house manufacturing, R&D, and office functions[289](index=289&type=chunk) - In January 2024, the company entered into a new **five-year lease** for approximately **18,000 square feet** of space in Queensbury, New York[289](index=289&type=chunk) - The company sub-leases a **2,409 square foot** facility in Galway, Ireland, for office and manufacturing, with the lease expiring in August 2026[289](index=289&type=chunk) [Legal Proceedings](index=50&type=section&id=Item%203.%20Legal%20Proceedings) The company is subject to ordinary course claims, with a specific dispute with former European distributor medac GmbH settled in December 2022 involving royalty or minimum annual payments - A dispute with former European distributor **medac GmbH** regarding a **€1 million milestone payment** was settled on December 30, 2022[465](index=465&type=chunk)[467](index=467&type=chunk) - The settlement terms require Delcath to pay medac either a royalty on **CHEMOSAT** sales or a minimum annual payment of **$0.2 million** for five years, or until a maximum payment is reached[467](index=467&type=chunk) [Mine Safety Disclosures](index=50&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[292](index=292&type=chunk) [Part II](index=47&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=51&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Delcath's common stock trades on Nasdaq, has approximately 57 record holders, has never paid dividends, and made no share repurchases in 2023 - The company's common stock trades on **The Nasdaq Capital Market** under the symbol "**DCTH**"[295](index=295&type=chunk) - As of February 29, 2024, there were approximately **57 holders of record** of the common stock[295](index=295&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future; its loan agreement with Avenue also prohibits cash dividends[296](index=296&type=chunk) - No shares of common stock were repurchased during the fiscal year ended December 31, 2023[299](index=299&type=chunk) [Reserved.](index=51&type=section&id=Item%206.%20%5BReserved.%5D) This item is reserved and contains no information [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=51&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Delcath, an interventional oncology company with FDA-approved HEPZATO, faces going concern doubts due to losses and capital needs, reporting a $47.7 million net loss in 2023 on $2.1 million revenue [Overview](index=51&type=section&id=Overview) Delcath is an interventional oncology company with FDA-approved HEPZATO KIT, planning to expand its use to other liver cancers and directly managing CHEMOSAT sales in Europe - Delcath is an interventional oncology company whose lead product, **HEPZATO KIT**, was approved by the FDA on August 14, 2023, for treating uveal melanoma with unresectable hepatic metastases[301](index=301&type=chunk) - The company plans to study **HEPZATO** for other liver dominant cancers, such as metastatic colorectal cancer and neuroendocrine tumors, viewing them as significant market opportunities[303](index=303&type=chunk)[304](index=304&type=chunk) - As of March 1, 2022, Delcath assumed direct responsibility for sales, marketing, and distribution of its device-only product, **CHEMOSAT**, in Europe[305](index=305&type=chunk) [Liquidity and Capital Resources](index=52&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $12.7 million in cash and $19.8 million in short-term investments, but faces substantial doubt about its going concern ability due to capital needs and a maturing term loan - As of December 31, 2023, the company had **$12.7 million** in cash, cash equivalents, and restricted cash, and **$19.8 million** in short-term investments[306](index=306&type=chunk) - The company's ability to continue as a **going concern** is in substantial doubt, as it may not have sufficient funds to meet obligations within the next twelve months if there are significant delays in the commercial ramp-up of **HEPZATO**[308](index=308&type=chunk) - In 2023, the company raised capital through a private placement of preferred stock and warrants, generating approximately **$25 million** in initial proceeds and an additional **$35 million** from the exercise of Tranche A warrants[314](index=314&type=chunk)[316](index=316&type=chunk) - The company has a term loan with Avenue, which matures on **August 1, 2024**; principal payments of approximately **$1.0 million per month** began in January 2024[313](index=313&type=chunk) [Results of Operations](index=54&type=section&id=Results%20of%20Operations) In 2023, revenue decreased to $2.1 million, while SG&A expenses increased by $4.8 million for HEPZATO's U.S. launch, and R&D expenses decreased by $1.1 million Comparison of Operations for Years Ended December 31 | (In thousands) | 2023 | 2022 | | :--- | :--- | :--- | | Total revenues | $2,065 | $2,719 | | Gross profit | $1,430 | $2,033 | | R&D expenses | $17,502 | $18,583 | | SG&A expenses | $22,110 | $17,303 | | Operating loss | $(38,182) | $(33,853) | | Net loss | $(47,678) | $(36,508) | - Revenue decreased by **$0.6 million** in 2023 compared to 2022, primarily due to the transition to direct selling of **CHEMOSAT** in Europe starting in March 2022[319](index=319&type=chunk) - Selling, general and administrative (**SG&A**) expenses increased by **$4.8 million (28%)** in 2023, mainly due to increased headcount and costs to prepare for the commercialization of **HEPZATO** in the U.S[322](index=322&type=chunk) - Research and development (**R&D**) expenses decreased by **$1.1 million (6%)** in 2023, as 2022 included higher costs related to the preparation and resubmission of the New Drug Application (NDA) for **HEPZATO**[321](index=321&type=chunk) [Critical Accounting Estimates](index=55&type=section&id=Critical%20Accounting%20Estimates) Key accounting estimates involve fair value measurements for contingent liabilities, warrant liabilities, and stock-based compensation, requiring significant judgment and model inputs - Key accounting estimates involve fair value measurements for contingent liabilities, warrant liabilities, and stock-based compensation[326](index=326&type=chunk) - The valuation of warrant liability is determined using option pricing models with significant inputs such as stock price, volatility, and probabilities of achieving revenue milestones[328](index=328&type=chunk) - Stock-based compensation is valued using the **Black-Scholes model**, which requires assumptions about expected term, volatility, and risk-free interest rates[329](index=329&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=55&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) This item is not required for smaller reporting companies - Not required[331](index=331&type=chunk) [Financial Statements and Supplementary Data](index=56&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for 2023 and 2022, including an auditor's going concern doubt, balance sheets, income statements, equity statements, cash flows, and notes - The independent auditor's report includes an explanatory paragraph highlighting conditions that raise substantial doubt about the company's ability to continue as a **going concern**, citing its significant working capital deficiency and recurring losses[336](index=336&type=chunk) Consolidated Balance Sheet Highlights (as of Dec 31, 2023) | (In thousands) | Amount | | :--- | :--- | | Cash, cash equivalents, and restricted cash | $12,696 | | Short-term investments | $19,808 | | Total Assets | $38,613 | | Total Current Liabilities | $16,448 | | Total Liabilities | $22,836 | | Total Stockholders' Equity | $15,777 | Consolidated Statement of Operations Highlights (Year ended Dec 31, 2023) | (In thousands) | Amount | | :--- | :--- | | Total Revenues | $2,065 | | Operating Loss | $(38,182) | | Net Loss | $(47,678) | | Basic and Diluted Loss Per Share | $(2.94) | - Net cash used in operating activities was **$31.3 million** for the year ended December 31, 2023, compared to **$25.0 million** in 2022[306](index=306&type=chunk)[356](index=356&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=91&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reported no changes in or disagreements with its accountants on any accounting or financial disclosure matters - None[489](index=489&type=chunk) [Controls and Procedures](index=91&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, having remediated a prior material weakness in share-based compensation - Management concluded that disclosure controls and procedures were **effective** as of December 31, 2023[490](index=490&type=chunk) - Management concluded that internal control over financial reporting was **effective** as of December 31, 2023[492](index=492&type=chunk) - A previously disclosed material weakness in internal control over financial reporting related to share-based compensation was **remediated** as of December 31, 2023[493](index=493&type=chunk)[494](index=494&type=chunk) [Other Information](index=91&type=section&id=Item%209B.%20Other%20Information) No Director or Officer adopted, modified, or terminated a Rule 10b5-1 trading plan during the fiscal year ended December 31, 2023 - No Director or Officer of the Company adopted, modified, or terminated a **Rule 10b5-1 trading plan** during the year ended December 31, 2023[496](index=496&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=91&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[497](index=497&type=chunk) [Part III](index=56&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=92&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance will be provided in the company's 2024 proxy statement and is incorporated by reference - Information is incorporated by reference from the registrant's **Proxy Statement for the 2024 Annual Meeting of Stockholders**[499](index=499&type=chunk) [Executive Compensation](index=92&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation details will be included in the company's 2024 proxy statement, which is incorporated by reference into this report - Information is incorporated by reference from the registrant's **Proxy Statement for the 2024 Annual Meeting of Stockholders**[501](index=501&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=92&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership by beneficial owners and management, along with related stockholder matters, will be provided in the company's 2024 proxy statement - Information is incorporated by reference from the registrant's **Proxy Statement for the 2024 Annual Meeting of Stockholders**[502](index=502&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=92&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Details on certain relationships, related party transactions, and director independence will be presented in the company's 2024 proxy statement, incorporated by reference - Information is incorporated by reference from the registrant's **Proxy Statement for the 2024 Annual Meeting of Stockholders**[503](index=503&type=chunk) [Principal Accountant Fees and Services](index=92&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Disclosure of fees paid to the principal accountant and services rendered will be included in the company's 2024 proxy statement and is incorporated by reference - Information is incorporated by reference from the registrant's **Proxy Statement for the 2024 Annual Meeting of Stockholders**[504](index=504&type=chunk) [Part IV](index=56&type=section&id=PART%20IV) [Exhibits and Financial Statement Schedules](index=92&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists documents filed as part of the Form 10-K, including consolidated financial statements and an index of all exhibits - This item lists the consolidated financial statements and provides an index of all exhibits filed with the report, such as the Certificate of Incorporation, material contracts, and certifications[506](index=506&type=chunk)[508](index=508&type=chunk) [Form 10-K Summary](index=92&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for this item - None[506](index=506&type=chunk)

Part I [Business Highlights and Updates](index=1&type=section&id=Business%20Highlights%20and%20Updates) Delcath Systems achieved key milestones: first HEPZATO KIT commercial use, increased site activations, secured J-code, and strengthened its balance sheet - Announced the first commercial use of HEPZATO KIT™ for treating metastatic uveal melanoma (mUM) at Moffitt Cancer Center[3](index=3&type=chunk) - Increased the 2024 treatment site activation guidance from 15 to **20 sites** by year-end, with several sites already active or expected to be active shortly[3](index=3&type=chunk)[4](index=4&type=chunk) - Secured a permanent, product-specific J-code (J9248) and transitional pass-through payment status from CMS for HEPZATO, effective April 1, 2024, simplifying reimbursement[3](index=3&type=chunk) - Raised **$7.0 million** in a private placement from existing investors, senior executives, and board members to strengthen the balance sheet[3](index=3&type=chunk)[5](index=5&type=chunk) - Appointed Martha S. Rook, Ph.D., as Chief Operating Officer, bringing over 25 years of industry experience in biologics and combination products manufacturing[3](index=3&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Delcath's 2023 financial performance showed decreased revenue, widened operating loss, and a strengthened cash position post-year-end financing [Key Financial Metrics](index=2&type=section&id=Key%20Financial%20Metrics) 2023 metrics show slight revenue decrease, reduced R&D, increased SG&A for HEPZATO KIT launch, and a **$32.5 million** year-end cash balance - As of December 31, 2023, cash, cash equivalents, and investments totaled **$32.5 million**. A subsequent private placement in March 2024 added **$7.0 million**[5](index=5&type=chunk) Revenue Performance (in millions) | Period | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | **Q4 Revenue** | $0.5 | $0.6 | -16.7% | | **Full Year Revenue** | $2.1 | $2.7 | -22.2% | Operating Expenses (in millions) | Expense Category | Full Year 2023 | Full Year 2022 | Change | | :--- | :--- | :--- | :--- | | **Research & Development** | $17.5 | $18.6 | -5.9% | | **Selling, General & Admin** | $22.1 | $17.3 | +27.7% | [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Delcath's 2023 balance sheet shows total assets increased to **$38.6 million** and a shift to **$15.8 million** stockholders' equity Selected Balance Sheet Data (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Cash, cash equivalents & short-term investments** | $32,454 | $7,671 | | **Total Current Assets** | $37,158 | $16,155 | | **Total Assets** | $38,613 | $17,862 | | **Total Liabilities** | $22,836 | $23,721 | | **Total Stockholders' Equity (Deficit)** | $15,777 | $(5,859) | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Delcath's 2023 operations show **$2.1 million** total revenues, **$38.2 million** operating loss, and **$47.7 million** net loss or **($2.94)** per share Full Year Statement of Operations Highlights (in thousands, except per share data) | Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | **Total Revenues** | $2,065 | $2,719 | | **Gross Profit** | $1,430 | $2,033 | | **Operating Loss** | $(38,182) | $(33,853) | | **Net Loss** | $(47,678) | $(36,508) | | **Basic and Diluted Loss Per Share** | $(2.94) | $(4.12) | [Company and Product Overview](index=2&type=section&id=Company%20and%20Product%20Overview) Delcath Systems is an interventional oncology company focused on liver cancer treatment with HEPZATO KIT™ (U.S.) and CHEMOSAT® (Europe) - Delcath's core technology, percutaneous hepatic perfusion (PHP), administers high-dose chemotherapy (melphalan) to the liver while controlling systemic exposure[8](index=8&type=chunk) - In the U.S., HEPZATO KIT™ is an FDA-approved drug/device combination for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases under specific conditions[8](index=8&type=chunk) - In Europe, the product is regulated as a Class III medical device under the name CHEMOSAT® and is used to treat a wide range of liver cancers[9](index=9&type=chunk) [Safe Harbor / Forward-Looking Statements](index=3&type=section&id=Safe%20Harbor%20%2F%20Forward-Looking%20Statements) This section provides a standard safe harbor statement, noting forward-looking statements are subject to risks, especially for HEPZATO KIT commercialization and supply chain - The press release contains forward-looking statements regarding the company's plans and expectations[10](index=10&type=chunk) - Identified risks include uncertainties related to commercialization plans, supply chain management, FDA inspections, and reimbursement for the HEPZATO KIT[10](index=10&type=chunk)

NEW YORK, March 20, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, confirmed the closing of the previously announced private placement 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 issued and sold 876,627 shares of its common stock (the "Comm ...

NEW YORK, March 19, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on March 26, 2024, at 8:30 AM Eastern Time to discuss results for its fourth quarter and year ended December 31, 2023 and provide a business update.  Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call ...

NEW YORK, March 18, 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, is pleased to announce the appointment of Martha S. Rook as its new Chief Operating Officer (COO). Martha S. Rook, Ph.D., is an experienced industry leader who brings more than 25 years of academic and industry experience in molecular biology, diagnostics development, biologics process developme ...

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 ...