dcth-20250930

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, 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 October 27, 2025, 35,313,718 shares of the Company’s common stock, $0.01 par value, were outstanding.

Table of Contents

DELCATH SYSTEMS, INC.

Table of Contents


		Page
PART I—FINANCIAL INFORMATION

Item 1.	Financial Statements

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

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

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

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

	Notes to the Unaudited Condensed Consolidated Financial Statements	9

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	29

Item 4.	Controls and Procedures	29

PART II—OTHER INFORMATION		30

Item 1.	Legal Proceedings	30

Item 1A.	Risk Factors	30

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	32

Item 3.	Defaults Upon Senior Securities	32

Item 4.	Mine Safety Disclosure	32

Item 5.	Other Information	33

Item 6.	Exhibits	34

SIGNATURES		35

Table of Contents

DELCATH SYSTEMS, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share data)


	September 30, 2025		December 31, 2024
Assets
Current assets
Cash and cash equivalents	$	41,813	$	32,412
Short-term investments	47,099		20,821
Accounts receivable	13,751		10,890
Inventories	10,745		6,933
Prepaid expenses and other current assets	7,207		2,704
Total current assets	120,615		73,760
Property, plant and equipment, net	2,715		1,790
Right-of-use assets	965		1,039
Total assets	$	124,295	$	76,589
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	2,133	$	961
Accrued expenses	5,768		5,078
Lease liabilities, current	110		105
Total current liabilities	8,011		6,144
Lease liabilities, non-current	855		933
Other liabilities, non-current	582		766
Total liabilities	$	9,448	$	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 September 30, 2025 and December 31, 2024, respectively	—		—
Common stock, $0.01 par value; 80,000,000 shares authorized; 35,308,939 shares and 33,061,002 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively	353		331
Additional paid-in capital	640,571		599,881
Accumulated deficit	(526,952)		(531,548)
Accumulated other comprehensive income	875		82
Total stockholders’ equity	114,847		68,746
Total liabilities and stockholders’ equity	$	124,295	$	76,589

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

Table of Contents

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 September 30,				Nine months ended September 30,
	2025		2024		2025		2024
Product revenue	$	20,563	$	11,200	$	64,503	$	22,105
Cost of goods sold	(2,624)		(1,640)		(8,787)		(4,062)
Gross profit	17,939		9,560		55,716		18,043
Operating expenses:
Research and development expenses	7,986		3,866		19,875		10,960
Selling, general and administrative expenses	10,341		6,953		32,997		22,532
Total operating expenses	18,327		10,819		52,872		33,492
Operating income (loss)	(388)		(1,259)		2,844		(15,449)
Change in fair value of warrant liability	—		2,975		—		(7,392)
Interest income (expense), net	796		113		2,063		(170)
Other income (expense)	(33)		35		(63)		$	23
Income (loss) before income taxes	375		1,864		4,844		(22,988)
Income tax (benefit) expense	(455)		—		248		—
Net income (loss)	830		1,864		4,596		(22,988)
Other comprehensive income (loss):
Unrealized gain on investments adjustments	296		(14)		592		(147)
Foreign currency translation adjustments	(13)		17		201		23
Total comprehensive income (loss)	$	1,113	$	1,867	$	5,389	$	(23,112)
Common share data:
Basic income (loss) per common share	$	0.02	$	0.06	$	0.13	$	(0.84)
Weighted average number of basic shares outstanding	36,383,277		28,738,307		35,610,619		27,335,212
Diluted income (loss) per common share	$	0.02	$	0.06	$	0.12	$	(0.84)
Weighted average number of dilutive shares outstanding	40,056,814		32,345,672		39,949,941		27,335,212

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

Table of Contents

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
Compensation expense for issuance of stock options	—	—		—	—		5,567		—		—		5,567
Compensation expense for Employee Stock Purchase Plan	—	—		—	—		81		—		—		81
Issuance of common stock with the Employee Stock Purchase Plan	—	—		22,858	—		243		—		—		243
Stock Option Exercise	—	—		330,107	3		2,854		—		—		2,857
Net income	—	—		—	—		—		830		—		830
Unrealized gain on investment adjustments	—	—		—	—		—		—		296		296
Foreign currency translation adjustments	—	—		—	—		—		—		(13)		(13)
Balance at September 30, 2025	14,192	$	—	35,308,939	$	353	$	640,571	$	(526,952)	$	875	$	114,847

Table of Contents


	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	$

SEC Form 10-Q filed by Delcath Systems Inc.