dcth-20250630

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, 2025


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 registrant as specified in its charter)

______________________


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

566 Queensbury Avenue

Queensbury, NY 12804

(Address of principal executive offices)

(518) 743-8892

(Registrant’s telephone number, including area code)

______________________

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, $0.01 par value per share

DCTH

The Nasdaq Capital Market

______________________

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Securities Act. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of July 31, 2025, 34,981,253 shares of the Company’s common stock, $0.01 par value, were outstanding.

Table o f Contents

DELCATH SYSTEMS, INC.

Table of Contents


		Page
PART I—FINANCIAL INFORMATION

Item 1.	Financial Statements

	Unaudited Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024	3

	Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income and Loss for the three and six months ended June 30, 2025 and 2024	4

	Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2025 and 2024	5

	Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024	7

	Notes to the Unaudited Condensed Consolidated Financial Statements	8

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26

Item 4.	Controls and Procedures	26

PART II—OTHER INFORMATION		28

Item 1.	Legal Proceedings	28

Item 1A.	Risk Factors	28

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	30

Item 3.	Defaults Upon Senior Securities	30

Item 4.	Mine Safety Disclosure	30

Item 5.	Other Information	31

Item 6.	Exhibits	32

SIGNATURES		34

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DELCATH SYSTEMS, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share data)


	June 30, 2025		December 31, 2024
Assets
Current assets
Cash and cash equivalents	$	34,421	$	32,412
Short-term investments	46,584		20,821
Accounts receivable	15,836		10,890
Inventories	10,523		6,933
Prepaid expenses and other current assets	6,118		2,704
Total current assets	113,482		73,760
Property, plant and equipment, net	2,401		1,790
Right-of-use assets	993		1,039
Total assets	$	116,876	$	76,589
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	4,716	$	961
Accrued expenses	5,603		5,078
Lease liabilities, current	116		105
Total current liabilities	10,435		6,144
Lease Liabilities, non-current	877		933
Other liabilities, non-current	578		766
Total liabilities	$	11,890	$	7,843
Commitments and contingencies (see Note 12)
Stockholders’ equity
Preferred stock, $0.01 par value; 10,000,000 shares authorized; 14,192 and 14,192 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively	—		—
Common stock, $0.01 par value; 80,000,000 shares authorized; 34,955,974 shares and 33,061,002 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively	350		331
Additional paid-in capital	631,826		599,881
Accumulated deficit	(527,782)		(531,548)
Accumulated other comprehensive income	592		82
Total stockholders’ equity	104,986		68,746
Total liabilities and stockholders’ equity	$	116,876	$	76,589

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

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DELCATH SYSTEMS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Income and Loss

(Unaudited)

(in thousands, except share and per share data)


	Three months ended June 30,				Six months ended June 30,
	2025		2024		2025		2024
Product revenue	$	24,156	$	7,766	$	43,940	$	10,905
Cost of goods sold	(3,318)		(1,519)		(6,163)		(2,422)
Gross profit	20,838		6,247		37,777		8,483
Operating expenses:
Research and development expenses	6,882		3,394		11,889		7,094
Selling, general and administrative expenses	11,366		6,765		22,656		15,579
Total operating expenses	18,248		10,159		34,545		22,673
Operating income (loss)	2,590		(3,912)		3,232		(14,190)
Change in fair value of warrant liability	—		(9,755)		—		(10,367)
Interest income (expense), net	649		(84)		1,267		(283)
Other income (expense)	(34)		10		(30)		$	(12)
Income (loss) before income taxes	3,205		(13,741)		4,469		(24,852)
Income tax expense	508		—		703		—
Net income (loss)	2,697		(13,741)		3,766		(24,852)
Other comprehensive income (loss):
Unrealized gain on investments adjustments	57		(141)		296		(133)
Foreign currency translation adjustments	154		(8)		214		6
Total comprehensive income (loss)	$	2,908	$	(13,890)	$	4,276	$	(24,979)
Common share data:
Basic income (loss) per common share	$	0.08	$	(0.48)	$	0.11	$	(0.93)
Weighted average number of basic shares outstanding	35,786,813		28,364,731		35,217,887		26,625,955
Diluted income (loss) per common share	$	0.07	$	(0.48)	$	0.09	$	(0.93)
Weighted average number of dilutive shares outstanding	40,262,764		28,364,731		39,890,102		26,625,955

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

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DELCATH SYSTEMS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share data)


	Preferred Stock $0.01 Par Value			Common Stock $0.01 Par Value			Additional Paid in Capital		Accumulated Deficit		Accumulated Other Comprehensive Income		Total
	No. of Shares	Amount		No. of Shares	Amount
Balance at January 1, 2025	14,192	$	—	33,061,002	$	331	$	599,881	$	(531,548)	$	82	$	68,746
Compensation expense for issuance of stock options	—	—		—	—		6,813		—		—		6,813
Compensation expense for Employee Stock Purchase Plan	—	—		—	—		50		—		—		50
Issuance of common stock with the Employee Stock Purchase Plan	—	—		35,513	—		238		—		—		238
Warrant Exercise - Series F	—	—		238,500	2		2,383		—		—		2,385
Stock Option Exercise	—	—		101,597	1		629		—		—		630
Net income	—	—		—	—		—		1,069		—		1,069
Unrealized gain on investment adjustments	—	—		—	—		—		—		239		239
Foreign currency translation adjustments	—	—		—	—		—		—		60		60
Balance at March 31, 2025	14,192	$	—	33,436,612	$	334	$	609,994	$	(530,479)	$	381	$	80,230
Compensation expense for issuance of stock options	—	—		—	—		7,159		—		—		7,159
Compensation expense for Employee Stock Purchase Plan	—	—		—	—		50		—		—		50
Warrant Exercise - Series F	—	—		1,377,275	14		13,759		—		—		13,773
Stock Option Exercise	—	—		142,087	2		864		—		—		866
Net income	—	—		—	—		—		2,697		—		2,697
Unrealized gain on investment adjustments	—	—		—	—		—		—		57		57
Foreign currency translation adjustments	—	—		—	—		—		—		154		154
Balance at June 30, 2025	14,192	—		34,955,974	350		631,826		(527,782)		592		104,986

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	Preferred Stock $0.01 Par Value			Common Stock $0.01 Par Value			Additional Paid in Capital		Accumulated Deficit		Accumulated Other Comprehensive Income (Loss)		Total
	No. of Shares	Amount		No. of Shares	Amount
Balance at January 1, 2024	24,819	$	—	22,761,554	$	228	$	520,576	$	(505,162)	$	135	$	15,777
Compensation expense for issuance of stock options	—	—		—	—		2,895		—		—		2,895
Compensation expense for Employee Stock Purchase Plan	—	—		—	—		50		—		—		50
Private placement -issuance of common shares, net of expenses	—	—		876,627	8		6,904		—		—		6,912
Issuance of common stock with the Employee Stock Purchase Plan	—	—		21,140	—		74		—		—		74
Conversion - F-3 Preferred to Common	(8,010)	—		1,779,998	18		(17)		—		—		1
Net loss	—	$	—	—	$	—	$	—	$	(11,111)	$	—	$	(11,111)
Unrealized gain on investments	—	—		—	—		—		—		8		8
Foreign currency translation adjustments	—	—		—	—		—		—		14		14
Balance at March 31, 2024	16,809	—		25,439,319	254		530,482		(516,273)		157		14,620
Compensation expense for issuance of stock options	—	—		—	—		3,021		—		—		3,021
Compensation expense for Employee Stock Purchase Plan	—	—		—	—		48		—		—		48
Prior quarter private placement - expenses	—	—		—	—		(141)		—		—		(141)
Warrant exercise and conversion - F-4 Preferred to Common	—	—		41,666	—		355		—		—		355
Conversion - F-3 Preferred to Common	(3,010)	—		668,888	7		(7)		—		—		—
Conversion - F-2 Preferred to Common	(1,457)	—		441,514	4		(4)		—		—		—
Pre-funded warrant exercise	—	—		1,307,706	13		(3)		—		—		10
Stock option exercise	—	—		32,300	1		168		—		—		169
Net loss	—	—		—	—		—		(13,741)		—		(13,741)
Unrealized loss on investments	—	—		—	—		—		—		(141)		(141)
Foreign currency translation adjustments	—	—		—	—		—		—		(8)		(8)
Balance at June 30, 2024	12,342	—		27,931,393	279		533,919		(530,014)		8		4,192

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

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DELCATH SYSTEMS, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)


	Six months ended June 30,
	2025		2024
Cash flows from operating activities:
Net income (loss)	$	3,766	$	(24,852)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock option compensation expense	14,072		6,014
Depreciation expense	94		62
Warrant liability fair value adjustment	—		10,367
Amortization of Right-of-Use Asset	54		37
Amortization of debt discount	—		447
Interest expense accrued related to convertible notes	—		80
Amortization of premiums and discounts on marketable securities	(765)		(379)
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(3,091)		(488)
Accounts receivable	(4,946)		(3,485)
Inventory	(3,590)		(2,994)
Accounts payable and accrued expenses	4,137		1,339
Other liabilities, non-current	(235)		(183)
Net cash provided by (used in) operating activities	9,496		(14,035)
Cash flows from investing activities:
Purchase of investment	(51,152)		(20,482)
Maturities of investments	26,127		35,540
Purchase of property, plant and equipment	(538)		(114)
Net cash (used in) provided by investing activities	(25,563)		14,944
Cash flows from financing activities:
Net proceeds from private placement	—		6,771
Proceeds from the issuance of common stock relating to the employee stock purchase plan	238		75
Repayment of debt	—		(6,107)
Proceeds from exercise of warrants	16,158		259
Proceeds from exercise of stock options	1,496		169
Net cash provided by financing activities	17,892		1,167
Foreign currency effects on cash	184		10
Net increase in total cash	2,009		2,086
Total Cash, Cash Equivalents and Restricted Cash:
Beginning of period	32,412		12,696
End of period	$	34,421	$	14,782
Cash and Cash Equivalents consisted of the following:
Cash and Cash Equivalents	$	34,409	$	14,782
Restricted Cash	12		—
Total	$	34,421	$	14,782


	Six months ended June 30,
	2025		2024
Supplemental Disclosure of Cash Flow Information:
Cash paid during the periods for:
Interest expense	$	—	$	375
Supplemental Disclosure of Non-Cash Investing and Financing Activities:
Right of use assets obtained in exchange for lease obligations	$	—	$	1,029

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

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DELCATH SYSTEMS, INC.

Notes to the Unaudited Condensed Consolidated Financial Statements

(amounts in thousands, except share and per share amounts)

(1) General

The unaudited interim condensed consolidated financial statements of Delcath Systems, Inc. (“Delcath” or the “Company”) as of and for the three and six months ended June 30, 2025 and 2024 should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Annual Report”), which was filed with the Securities and Exchange Commission (the “SEC”) on March 6, 2025 and may also be found on the Company’s website (www.delcath.com). In these notes to the interim condensed consolidated financial statements the terms “us”, “we” or “our” refer to Delcath and its consolidated subsidiaries.

Description of Business

The Company is an interventional oncology company focused on the treatment of primary and metastatic cancers to the liver. The Company’s lead product, the HEPZATOTM KIT (melphalan for Injection/Hepatic Delivery System) a drug/device combination product (“HEPZATO” or “HEPZATO KIT”), was approved by the US Food and Drug Administration (the “FDA”) on August 14, 2023, indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection, or radiation. The first commercial use of HEPZATO KIT for the treatment of metastatic uveal melanoma (“mUM”) occurred in January 2024.

In the United States, HEPZATO is considered a combination drug and device product and is regulated as a drug by the FDA. Primary jurisdiction for regulation of HEPZATO has been assigned to the FDA’s Center for Drug Evaluation and Research. The FDA has granted Delcath six orphan drug designations (five for melphalan in the treatment of patients with ocular (uveal) melanoma, cutaneous melanoma, intrahepatic cholangiocarcinoma, hepatocellular carcinoma, and neuroendocrine tumor indications and one for doxorubicin in the treatment of patients with hepatocellular carcinoma).

The Company has sufficient raw material and component constituent parts of the HEPZATO KIT to meet anticipated demand and it intends to manage supply chain risk through stockpiled inventory and, where commercially reasonable, contracting with multiple suppliers for critical components.

In Europe, the hepatic delivery system is a stand-alone medical device having the same device components as HEPZATO, but without the melphalan hydrochloride and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan (“CHEMOSAT”), where it has been used at major medical centers to treat a wide range of cancers in the liver. On February 28, 2022, CHEMOSAT received Medical Device Regulation (“MDR”) certification under the European Medical Devices Regulation (EU) 2017/745, which may be considered by jurisdictions when evaluating reimbursement. In June 2025, CHEMOSAT was approved for reimbursement for two years in the Vastra Gotaland Region in Sweden.

To support the New Drug Application for HEPZATO the Company conducted the FOCUS Clinical Trial for Patients with metastatic hepatic dominant Uveal Melanoma (the “FOCUS Trial”), a global registration clinical trial that investigated objective response rate in patients with mUM. On May 6, 2024, the Company announced the publication of results from the pivotal FOCUS Trial in the journal Annals of Surgical Oncology. In addition, on April 9, 2025, the Company announced the publication of a comparative analysis of the randomized portion of the FOCUS Trial in the Annals of Surgical Oncology. Currently, the Company’s clinical development program is seeking to generate clinical data for CHEMOSAT and HEPZATO either as monotherapy or in combination with immunotherapy. The Company expects that this will support increased clinical adoption of and reimbursement for CHEMOSAT in Europe, and to support reimbursement in various jurisdictions, including the United States.

In addition to HEPZATO’s use to treat mUM, the Company believes that HEPZATO has the potential to treat other cancers in the liver, such as metastatic colorectal cancer, metastatic breast cancer, metastatic neuroendocrine tumors, and intrahepatic cholangiocarcinoma. The Company believes that those and similar disease states are areas of unmet medical needs that represent significant market opportunities.

The Company’s investigational new drug application (“IND”) for a Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (“SOC”) for liver-dominant metastatic colorectal cancer was cleared by the FDA in December 2024. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study

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will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the second half of 2025. In July 2025, the Company received authorization from the European Union and United Kingdom regulatory authorities for the clinical study of Melphalan for Injection/Hepatic Delivery System in patients with refractory metastatic colorectal cancer with liver dominant disease.

On April 28, 2025, the Company announced the clearance by the FDA of its IND application for the Phase 2 clinical trial of HEPZATO in liver-dominant metastatic breast cancer. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be the physician’s choice of eribulin, vinorelbine or capecitabine. We expect approximately 90 patients will be enrolled in this randomized, controlled trial. The trial will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the fourth quarter of 2025.

Risks and Uncertainties

As detailed in the Company’s 2024 Annual Report filed on Form 10-K, the Company is subject to risks common to companies in the biopharmaceutical industry including, but not limited to, the risks associated with developing product candidates and successfully launching and commercializing its drug/device combination products, the Company’s ability to obtain regulatory approval of its such products in the United States and other geography markets, the uncertainty of the broad adoption of its approved products by physicians and consumers, and significant competition.

In addition, high rates of inflation have resulted in the United States Federal Reserve raising interest rates. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may further increase economic uncertainty and heighten these risks. Furthermore, if additional banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, the Company or its partners’ ability to access existing cash, cash equivalents and investments may be threatened and could have a material adverse effect on the Company’s business and financial condition, including the Company’s ability to access additional capital on favorable terms, or at all, which could in the future negatively affect the Company’s ability to pursue its business strategy.

SEC Form 10-Q filed by Delcath Systems Inc.