dcth-20250331

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, 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 May 6, 2025, 34,826,183 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 as of March 31, 2025 and December 31, 2024	3

	Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income and Loss for the three months ended March 31, 2025 and 2024	4

	Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2025 and 2024	5

	Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024	6

	Notes to the Unaudited Condensed Consolidated Financial Statements	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	21

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	25

Item 4.	Controls and Procedures	25

PART II—OTHER INFORMATION		27

Item 1.	Legal Proceedings	27

Item 1A.	Risk Factors	27

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	27

Item 3.	Defaults Upon Senior Securities	27

Item 4.	Mine Safety Disclosure	27

Item 5.	Other Information	27

Item 6.	Exhibits	27

SIGNATURES		29


	March 31, 2025		December 31, 2024
Assets
Current assets
Cash and cash equivalents	$	12,776	$	32,412
Short-term investments	46,120		20,821
Accounts receivable	13,942		10,890
Inventories	7,132		6,933
Prepaid expenses and other current assets	4,379		2,704
Total current assets	84,349		73,760
Property, plant and equipment, net	1,954		1,790
Right-of-use assets	1,016		1,039
Total assets	$	87,319	$	76,589
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	1,619	$	961
Accrued expenses	3,558		5,078
Lease liabilities, current	110		105
Total current liabilities	5,287		6,144
Lease Liabilities, non-current	906		933
Other liabilities, non-current	896		766
Total liabilities	$	7,089	$	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 March 31, 2025 and December 31, 2024, respectively	—		—
Common stock, $0.01 par value; 80,000,000 shares authorized; 33,436,612 shares and 33,061,002 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively	334		331
Additional paid-in capital	609,994		599,881
Accumulated deficit	(530,479)		(531,548)
Accumulated other comprehensive income	381		82
Total stockholders’ equity	80,230		68,746
Total liabilities and stockholders’ equity	$	87,319	$	76,589


	Three months ended March 31,
	2025		2024
Product revenue	$	19,784	$	3,139
Cost of goods sold	(2,845)		(903)
Gross profit	16,939		2,236
Operating expenses:
Research and development expenses	5,007		3,700
Selling, general and administrative expenses	11,290		8,814
Total operating expenses	16,297		12,514
Operating gain (loss)	642		(10,278)
Change in fair value of warrant liability	—		(612)
Interest income (expense), net	618		(199)
Other income (expense)	4		(22)
Income (loss) before income taxes	1,264		(11,111)
Income tax expense	195		—
Net income (loss)	1,069		(11,111)
Other comprehensive income (loss):
Unrealized gain on investments adjustments	239		8
Foreign currency translation adjustments	60		14
Total comprehensive income (loss)	$	1,368	$	(11,089)
Common share data:
Basic income (loss) per common share	$	0.03	$	(0.45)
Weighted average number of basic shares outstanding	34,642,641		24,887,180
Diluted income (loss) per common share	$	0.03	$	(0.45)
Weighted average number of dilutive shares outstanding	39,511,120		24,887,180


	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


	Three Months Ended March 31,
(In thousands)	2025		2024
CHEMOSAT	$	1,761	$	1,131
HEPZATO KIT	18,023		2,008
Total revenue	$	19,784	$	3,139


For the three months ended and as of March 31, 2025	% of Revenue		% of Accounts Receivable
Customer 1	15.0	%	21.3	%
Customer 2	13.1	%	8.1	%
Customer 3	10.3	%	6.7	%
Customer 4	9.4	%	10.8	%


	March 31, 2025
			Gross Unrealized
(In thousands)	Amortized Cost		Gains		Estimated Fair Value
U.S. government agency bonds	$	45,746	$	374	$	46,120
Short-term investments					$	46,120


	December 31, 2024
			Gross Unrealized
(in thousands)	Amortized Cost		Gains		Estimated Fair Value
U.S. government agency bonds	$	20,686	$	135	$	20,821
Short-term investments					$	20,821


(In thousands)	U.S.			Ireland			Total
Operating cash flows for operating leases	$	(36)		$	(11)		$	(47)
Weighted average remaining lease term	8.8			1.3
Weighted average discount rate - operating leases	8		%	8		%


Designated Preferred Shares						March 31, 2025
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, 2025		December 31, 2024
Clinical trial expenses	$	1,207	$	222
Insurance premiums	277		161
Professional services	821		762
Interest receivable	379		125
Licenses	996		990
Software	160		164
Taxes	60		45
Prepayments on project initiatives	269		—
Other	210		235
Total prepaid expenses and other current assets	$	4,379	$	2,704


(In thousands)	March 31, 2025		December 31, 2024		Estimated Useful Life
Buildings and land	$	1,318	$	1,318	30 years - Buildings
Enterprise hardware and software	1,813		1,811		3 years
Leaseholds	1,619		1,585		Lesser of lease term or estimated useful life
Equipment	1,792		1,671		7 years
Furniture	250		232		5 years
Equipment in process	177		127
Property, plant and equipment, gross	6,969		6,744
Accumulated depreciation	(5,015)		(4,954)
Property, plant and equipment, net	$	1,954	$	1,790


(In thousands)	March 31, 2025		December 31, 2024
Clinical expenses	$	697	$	615
Compensation, excluding taxes	1,861		3,471
ESPP withholding	125		240
Professional fees	321		57
Inventory	9		44
medac	217		208
Other	328		443
Total accrued expenses	$	3,558	$	5,078


	Three Months Ended March 31,
	2025	2024
Expected terms (years)	5.7	5.6
Expected volatility	90.0%	115.0%
Risk-free interest rate	4.35%	4.19%
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, 2025	5,766,927	$	7.23	7.5	$	28,796
Granted	2,356,163	15.97		9.8
Exercised	(101,597)	6.20
Expired	—	—
Cancelled/Forfeited	(53,432)	9.80
Outstanding at March 31, 2025	7,968,061	$	9.81	8.0	$	31,861

Exercisable at March 31, 2025	3,873,579	$	8.37	6.6	$	18,258
Unvested at March 31, 2025	4,094,482	$	11.17	9.3	$	13,603


	Warrants	Weighted Average Exercise Price
Outstanding at January 1, 2025	3,193,275	$	5.80
Warrants issued	—	—
Warrants exercised	(238,500)	10.00
Outstanding and exercisable at March 31, 2025	2,954,775	$	5.46


	Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants	Weighted Average Remaining Warrant Term (in years)
$0.01 (1)	1,341,375
$10.00 (2)	1,613,400	0.1
	2,954,775


Weighted average number of diluted shares outstanding
	Three months ended March 31,
	2025	2024
Weighted average shares outstanding (Basic)	34,642,641	24,887,180
Additional dilutive shares	4,868,479	—
Weighted average shares outstanding (Diluted)	39,511,120	24,887,180


	Level 3
(In thousands)	Contingent liabilities
Balance at January 1, 2025	$	974
Liability fair value adjustment	99
Total change in foreign exchange	40
Balance at March 31, 2025	$	1,113


	March 31, 2025
(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	$	11	$	—	$	—	$	11
U.S. government agency bonds	—		46,120		—		46,120
Total Assets	$	11	$	46,120	$	—	$	46,131

Liabilities:
Contingent Liability	$	—	$	—	$	1,113	$	1,113
Total Liabilities	$	—

SEC Form 10-Q filed by Delcath Systems Inc.