dcth-20260331

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 March 31, 2026


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 April 30, 2026, 34,521,647 shares of the Company’s common stock, $0.01 par value, were outstanding.


		Page
PART I—FINANCIAL INFORMATION

Item 1.	Financial Statements

	Unaudited Condensed Consolidated Balance Sheets	3

	Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income and Loss	4

	Unaudited Condensed Consolidated Statements of Stockholders’ Equity	5

	Unaudited Condensed Consolidated Statements of Cash Flows	6

	Notes to the Unaudited Condensed Consolidated Financial Statements	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	23

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	28

Item 4.	Controls and Procedures	28

PART II—OTHER INFORMATION		29

Item 1.	Legal Proceedings	29

Item 1A.	Risk Factors	29

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	29

Item 3.	Defaults Upon Senior Securities	29

Item 4.	Mine Safety Disclosure	30

Item 5.	Other Information	30

Item 6.	Exhibits	31

SIGNATURES		32


	March 31, 2026		December 31, 2025
	(Unaudited)
Assets
Current assets
Cash and cash equivalents	$	41,313	$	43,454
Short-term investments	47,986		47,582
Accounts receivable	14,159		11,744
Inventories	9,808		10,252
Prepaid expenses and other current assets	7,003		6,498
Total current assets	120,269		119,530
Property, plant and equipment, net	3,662		3,166
Right-of-use assets	907		936
Total assets	$	124,838	$	123,632
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	3,463	$	2,658
Accrued expenses	7,143		8,191
Lease liabilities, current	92		101
Total current liabilities	10,698		10,950
Lease liabilities, non-current	815		835
Other liabilities, non-current	615		628
Total liabilities	$	12,128	$	12,413
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 March 31, 2026 and December 31, 2025, respectively	—		—
Common stock, $0.01 par value; 80,000,000 shares authorized; 34,465,087 shares and 34,691,671 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively	344		347
Additional paid-in capital	641,713		639,145
Accumulated deficit	(529,918)		(528,848)
Accumulated other comprehensive income	571		575
Total stockholders’ equity	112,710		111,219
Total liabilities and stockholders’ equity	$	124,838	$	123,632


	Three months ended March 31,
	2026		2025
Product revenue	$	24,994	$	19,784
Cost of goods sold	(3,736)		(2,845)
Gross profit	21,258		16,939
Operating expenses:
Research and development expenses	9,824		5,007
Selling, general and administrative expenses	13,071		11,290
Total operating expenses	22,895		16,297
Operating (loss) income	(1,637)		642
Interest income	787		618
Other (expense) income	(58)		4
(Loss) income before income taxes	(908)		1,264
Income tax expense	162		195
Net (loss) income	(1,070)		1,069
Other comprehensive income (loss):
Unrealized gain on investments adjustments	45		239
Foreign currency translation adjustments	(49)		60
Total comprehensive (loss) income	$	(1,074)	$	1,368
Common share data:
Basic (loss) income per common share	$	(0.03)	$	0.03
Weighted average number of basic shares outstanding	36,021,210		34,642,641
Diluted (loss) income per common share	$	(0.03)	$	0.03
Weighted average number of dilutive shares outstanding	36,021,210		39,511,120


	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, 2026	14,192	$	—	34,691,671	$	347	$	639,145	$	(528,848)	$	575	$	111,219
Compensation expense for issuance of stock options	—	—		—	—		4,876		—		—		4,876
Compensation expense for Employee Stock Purchase Plan	—	—		—	—		70		—		—		70
Issuance of common stock with the Employee Stock Purchase Plan	—	—		46,008	—		389		—		—		389
Stock Option Exercise	—	—		43,431	—		230		—		—		230
Repurchase and retirement of common stock	—	—		(316,023)	(3)		(2,997)		—		—		(3,000)
Net loss	—	—		—	—		—		(1,070)		—		(1,070)
Unrealized gain on investment adjustments	—	—		—	—		—		—		45		45
Foreign currency translation adjustments	—	—		—	—		—		—		(49)		(49)
Balance at March 31, 2026	14,192	$	—	34,465,087	$	344	$	641,713	$	(529,918)	$	571	$	112,710


	Three Months Ended March 31,
(In thousands)	2026		2025
CHEMOSAT	$	1,747	$	1,761
HEPZATO KIT	23,247		18,023
Total revenue	$	24,994	$	19,784


For the three months ended and as of March 31, 2026	% of Revenue		% of Accounts Receivable
Customer 1	15.9	%	10.7	%
Customer 2	10.6	%	9.3	%


	March 31, 2026
(In thousands)	Amortized Cost		Gross Unrealized Gains		Estimated Fair Value
U.S. government agency bonds	$	47,411	$	575	$	47,986
Total short-term investments					$	47,986


	December 31, 2025
(In thousands)	Amortized Cost		Gross Unrealized Gains		Estimated Fair Value
U.S. government agency bonds	$	47,053	$	529	$	47,582
Total short-term investments					$	47,582


(In thousands)	U.S.			Ireland			Total
Operating cash flows for operating leases	$	(36)		$	(11)		$	(47)
Weighted average remaining lease term	7.8			0.3
Weighted average discount rate - operating leases	8		%	8		%


Designated Preferred Shares						March 31, 2026
Series A						4,200
Series B						2,360
Series C						590
Series D						10,000
Series E						40,000
Series E-1						12,960
Series F-1						24,900
Series F-2						24,900
Series F-3						34,860
Series F-4						24,900
Total						179,670


(In thousands)	March 31, 2026		December 31, 2025
Clinical trial expenses	$	2,445	$	2,405
Insurance premiums	557		547
Professional services	941		804
Interest receivable	581		499
Licenses	538		613
Software	1,072		706
Taxes	523		696
Other	346		228
Total prepaid expenses and other current assets	$	7,003	$	6,498


(In thousands)	March 31, 2026		December 31, 2025		Estimated Useful Life
Buildings and land	$	1,567	$	1,557	30 years - Buildings 15 years - Land Improvements
Enterprise hardware and software	1,818		1,819		3 years
Leaseholds	1,659		1,648		Lesser of lease term or estimated useful life
Equipment	3,511		2,894		7 years
Furniture	258		251		5 years
Equipment in process	189		245
Property, plant and equipment, gross	9,002		8,414
Accumulated depreciation	(5,340)		(5,248)
Property, plant and equipment, net	$	3,662	$	3,166


(In thousands)	March 31, 2026		December 31, 2025
Clinical expenses	$	2,100	$	2,065
Compensation, excluding taxes	2,810		4,248
ESPP withholding	198		396
Professional fees	1,355		736
Inventory	28		74
medac(1)	—		235
Other	652		437
Total accrued expenses	$	7,143	$	8,191


	Three Months Ended March 31,
	2026	2025
Expected terms (years)	5.7	5.7
Expected volatility	70.5%	90.0%
Risk-free interest rate	3.73%	4.35%
Expected dividends	0.00%	0.00%


	Number of Options	Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)	Aggregate Intrinsic Value (in thousands)
Outstanding at January 1, 2026	7,785,149	$	10.05	7.8	$	17,391
Granted	922,369	9.40		9.8
Exercised	(43,431)	5.30
Expired	(2,583)	16.25
Cancelled/Forfeited	(40,874)	10.82
Outstanding at March 31, 2026	8,620,630	$	10.00	7.7	$	13,933

Exercisable at March 31, 2026	5,416,653	$	9.00	7.0	$	11,392
Unvested at March 31, 2026	3,203,977	$	11.69	9.0	$	2,541


	Number of Restricted Stock Units	Weighted Average Grant Date Fair Value
Outstanding at January 1, 2026	—	$	—
Granted	914,477	9.41
Vested	—	—
Forfeited	(7,311)	9.40
Outstanding at March 31, 2026	907,166	$	9.41


	Warrants	Weighted Average Exercise Price
Outstanding at January 1, 2026	1,341,375	$	0.01
Warrants issued	—	—
Warrants exercised	—	—
Warrants canceled	—	—
Outstanding and exercisable at March 31, 2026	1,341,375	$	0.01


	Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants	Weighted Average Remaining Warrant Term (in years)
$0.01 (1)	1,341,375	n/a


Weighted average number of diluted shares outstanding
	Three months ended March 31,
	2026	2025
Weighted average shares outstanding (Basic)	36,021,210	34,642,641
Additional dilutive shares	—	4,868,479
Weighted average shares outstanding (Diluted)	36,021,210	39,511,120


	Level 3
(In thousands)	Contingent liabilities
Balance at January 1, 2026	$	864
Change due to liability payment	—
Liability fair value adjustment	—
Total change in foreign exchange	(19)
Balance at March 31, 2026	$	845


	March 31, 2026
(In thousands)	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Assets:
Money market funds	$	1	$	—	$	—	$	1
U.S. government agency bonds	—		47,986		—		47,986
Total Assets	$	1	$	47,986	$	—	$	47,987

Liabilities:
Contingent Liability	$	—	$	—	$	845	$	845
Total Liabilities	$	—	$	—	$

SEC Form 10-Q filed by Delcath Systems Inc.