Delcath Systems (DCTH) 10-Q 10 Aug 21 2021 Q2 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	6 Months Ended
	Jun. 30, 2021	Aug. 10, 2021
Cover [Abstract]
Entity Registrant Name	DELCATH SYSTEMS, INC.
Entity Central Index Key	0000872912
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Document Quarterly Report	true
Document Transition Report	false
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Incorporation, State or Country Code	DE
Entity Interactive Data Current	Yes
Entity File Number	001-16133
Entity Tax Identification Number	06-1245881
Entity Address, Address Line One	1633 Broadway
Entity Address Address Line2	Suite 22C
Entity Address City Or Town	New York
Entity Address State Or Province	NY
Entity Address Postal Zip Code	10019
City Area Code	212
Local Phone Number	489-2100
Entity Shell Company	false
Entity Current Reporting Status	Yes
Entity Common Stock, Shares Outstanding		7,356,289
Document Period End Date	Jun. 30, 2021
Document Fiscal Year Focus	2021
Trading Symbol	DCTH
Title of 12(b) Security	Common stock, $0.01 par value per share
Document Fiscal Period Focus	Q2
Document Type	10-Q
Amendment Flag	false
Security Exchange Name	NASDAQ

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Jun. 30, 2021	Dec. 31, 2020
Current assets
Cash and cash equivalents	$ 19,274	$ 28,575
Restricted cash	151	181
Accounts receivable, net	75	57
Inventories	1,221	855
Prepaid expenses and other current assets	2,185	2,670
Total current assets	22,906	32,338
Property, plant and equipment, net	1,361	1,351
Right-of-use assets	650	946
Total assets	24,917	34,635
Current liabilities
Accounts payable	1,224	1,774
Accrued expenses	3,621	5,241
Deferred revenue, current	509	525
Lease liabilities, current	387	495
Convertible notes payable, current		2,000
Total current liabilities	5,741	10,035
Deferred revenue, non-current	1,754	2,072
Lease liabilities, non-current	263	450
Total liabilities	9,758	12,557
Commitments and contingencies (Note 11)
Stockholders' equity
Preferred stock, $.01 par value; 10,000,000 shares authorized; 11,707 and 20,631 shares issued and outstanding at June 30, 2021, and December 31, 2020, respectively
Common stock, $.01 par value; 40,000,000 shares authorized; 7,349,777 and 5,996,101 shares issued and outstanding at June 30, 2021, and December 31, 2020, respectively	74	60
Additional paid-in capital	423,660	417,449
Accumulated deficit	(408,504)	(395,327)
Accumulated other comprehensive loss	(71)	(104)
Total stockholders' equity	15,159	22,078
Total liabilities and stockholders' equity	24,917	$ 34,635
Convertible notes payable, non-current	$ 2,000

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Jun. 30, 2021	Dec. 31, 2020
Statement Of Financial Position [Abstract]
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	11,707	20,631
Preferred stock, shares outstanding (in shares)	11,707	20,631
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	40,000,000	40,000,000
Common stock, shares issued (in shares)	7,349,777	5,996,101
Common stock, shares outstanding (in shares)	7,349,777	5,996,101

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Cost of goods sold	$ (202)	$ (168)	$ (314)	$ (246)
Gross profit	334	211	610	426
Operating expenses:
Research and development expenses	3,497	2,223	7,204	5,197
Selling, general and administrative expenses	3,288	2,257	6,584	4,573
Total operating expenses	6,785	4,480	13,788	9,770
Operating loss	(6,451)	(4,269)	(13,178)	(9,344)
Change in fair value of the warrant liability, net				(2,832)
Interest expense, net	(40)	(52)	(81)	(88)
Other income	61	46	82	128
Net loss	(6,430)	(4,275)	(13,177)	(12,136)
Deemed dividend for triggering of warrant down round feature		(55)		(55)
Net loss attributable to common stockholders	(6,430)	(4,330)	(13,177)	(12,191)
Net loss	(6,430)	(4,275)	(13,177)	(12,136)
Other comprehensive (loss) income:
Foreign currency translation adjustments	(61)	(1)	33	65
Total other comprehensive loss	$ (6,491)	$ (4,276)	$ (13,144)	$ (12,071)
Common share data:
Basic loss per common share	$ (0.96)	$ (1.90)	$ (2)	$ (10.40)
Diluted loss per common share	$ (0.96)	$ (1.90)	$ (2)	$ (10.40)
Weighted average number of basic shares outstanding	6,681,369	2,273,187	6,589,655	1,171,994
Weighted average number of diluted shares outstanding	6,681,369	2,273,187	6,589,655	1,171,994
Product Revenue [Member]
Revenue	$ 398	$ 262	$ 659	$ 437
Other Revenue [Member]
Revenue	$ 138	$ 117	$ 265	$ 235

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands	Total	Preferred Stock [Member]	Common Stock [Member]	Additional Paid In Capital [Member]	Accumulated Deficit [Member]	Accumulated Other Comprehensive Income [Member]
Balance at Dec. 31, 2019	$ (6,357)		$ 1	$ 364,785	$ (371,171)	$ 28
Balance (in shares) at Dec. 31, 2019		41,517	67,091
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	25			25
Shares settled for services	30			30
Shares settled for services (in shares)			2,717
Conversion of Preferred stock into common stock (in shares)		(70)	2,915
Fractional rounding related to Reverse stock split			$ 50
Registration costs	(106)			(106)
Fair value of warrants reclassified from liability to equity	6,199			6,199
Net loss	(7,861)				(7,861)
Total comprehensive income (loss)	65					65
Balance at Mar. 31, 2020	(8,005)		$ 1	370,933	(379,032)	93
Balance (in shares) at Mar. 31, 2020		41,447	72,773
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	25			25
Shares settled for services	30			30
Shares settled for services (in shares)			2,717
Conversion of Preferred stock into common stock (in shares)		(70)	2,915
Net loss	(7,861)				(7,861)
Total comprehensive income (loss)	65					65
Balance at Mar. 31, 2020	(8,005)		$ 1	370,933	(379,032)	93
Balance (in shares) at Mar. 31, 2020		41,447	72,773
Balance at Dec. 31, 2019	(6,357)		$ 1	364,785	(371,171)	28
Balance (in shares) at Dec. 31, 2019		41,517	67,091
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	(12,136)
Balance at Jun. 30, 2020	7,702		$ 35	390,882	(383,307)	92
Balance (in shares) at Jun. 30, 2020		25,950	3,521,641
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	(12,136)
Balance at Jun. 30, 2020	7,702		$ 35	390,882	(383,307)	92
Balance (in shares) at Jun. 30, 2020		25,950	3,521,641
Balance at Mar. 31, 2020	(8,005)		$ 1	370,933	(379,032)	93
Balance (in shares) at Mar. 31, 2020		41,447	72,773
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Shares settled for services	606		$ 1	605
Shares settled for services (in shares)			70,259
Conversion of Preferred stock into common stock	(1)		$ 15	(16)
Conversion of Preferred stock into common stock (in shares)		(15,497)	1,549,609
Conversion of Pre-funded Series F Warrants			6,000
Public Offering - issuance of common stock and warrants	19,378		$ 18	19,360
Public Offering - issuance of common stock and warrants (in shares)			1,823,000
Net loss	(4,275)				(4,275)
Total comprehensive income (loss)	(1)					(1)
Balance at Jun. 30, 2020	7,702		$ 35	390,882	(383,307)	92
Balance (in shares) at Jun. 30, 2020		25,950	3,521,641
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Shares settled for services	606		$ 1	605
Shares settled for services (in shares)			70,259
Conversion of Preferred stock into common stock	(1)		$ 15	(16)
Conversion of Preferred stock into common stock (in shares)		(15,497)	1,549,609
Public Offering - issuance of common stock and warrants	19,378		$ 18	19,360
Public Offering - issuance of common stock and warrants (in shares)			1,823,000
Net loss	(4,275)				(4,275)
Total comprehensive income (loss)	(1)					(1)
Balance at Jun. 30, 2020	7,702		$ 35	390,882	(383,307)	92
Balance (in shares) at Jun. 30, 2020		25,950	3,521,641
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Conversion of Pre-funded Series F Warrants			6,000
Balance at Dec. 31, 2020	22,078		$ 60	417,449	(395,327)	(104)
Balance (in shares) at Dec. 31, 2020		20,631	5,996,101
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	2,148			2,148
Shares settled for services	57			$ 57
Shares settled for services (in shares)			2,636
Conversion of Preferred stock into common stock (in shares)		(150)	15,000
Exercise of warrants into common stock	2,376		$ 3
Exchange of warrants (in shares)			237,520	2,373
Net loss	(6,747)				(6,747)
Total comprehensive income (loss)	94					94
Balance at Mar. 31, 2021	20,006		$ 63	$ 422,027	(402,074)	(10)
Balance (in shares) at Mar. 31, 2021		20,481	6,251,257
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	2,148			2,148
Shares settled for services	57			$ 57
Shares settled for services (in shares)			2,636
Conversion of Preferred stock into common stock (in shares)		(150)	15,000
Exercise of warrants into common stock	2,376		$ 3
Exchange of warrants (in shares)			237,520	2,373
Net loss	(6,747)				(6,747)
Total comprehensive income (loss)	94					94
Balance at Mar. 31, 2021	20,006		$ 63	$ 422,027	(402,074)	(10)
Balance (in shares) at Mar. 31, 2021		20,481	6,251,257
Balance at Dec. 31, 2020	22,078		$ 60	417,449	(395,327)	(104)
Balance (in shares) at Dec. 31, 2020		20,631	5,996,101
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	(13,177)
Balance at Jun. 30, 2021	15,159		$ 74	423,660	(408,504)	(71)
Balance (in shares) at Jun. 30, 2021		11,707	7,349,777
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	(13,177)
Balance at Jun. 30, 2021	15,159		$ 74	423,660	(408,504)	(71)
Balance (in shares) at Jun. 30, 2021		11,707	7,349,777
Balance at Mar. 31, 2021	20,006		$ 63	422,027	(402,074)	(10)
Balance (in shares) at Mar. 31, 2021		20,481	6,251,257
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	1,626			1,626
Conversion of Preferred stock into common stock	1		$ 9	(8)
Conversion of Preferred stock into common stock (in shares)		(8,774)	877,379
Exercise of warrants into common stock	17		$ 2	15
Exchange of warrants (in shares)			221,141
Net loss	(6,430)				(6,430)
Total comprehensive income (loss)	(61)					(61)
Balance at Jun. 30, 2021	15,159		$ 74	423,660	(408,504)	(71)
Balance (in shares) at Jun. 30, 2021		11,707	7,349,777
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	1,626			1,626
Conversion of Preferred stock into common stock	1		$ 9	(8)
Conversion of Preferred stock into common stock (in shares)		(8,774)	877,379
Exercise of warrants into common stock	17		$ 2	15
Exchange of warrants (in shares)			221,141
Net loss	(6,430)				(6,430)
Total comprehensive income (loss)	(61)					(61)
Balance at Jun. 30, 2021	$ 15,159		$ 74	$ 423,660	$ (408,504)	$ (71)
Balance (in shares) at Jun. 30, 2021		11,707	7,349,777

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
Cash flows from operating activities:
Net loss	$ (13,177)	$ (12,136)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock option compensation expense	3,774	25
Restricted stock compensation expense		635
Depreciation expense	78	92
Amortization of right of use assets		22
Warrant liability fair value adjustment		2,832
Interest expense accrued related to convertible notes	79	80
Changes in assets and liabilities:
Decrease (increase) in prepaid expenses and other assets	485	(232)
Increase in accounts receivable	(17)	(125)
Increase in inventories	(366)	(70)
Decrease in accounts payable	(550)	(2,359)
Decrease in accrued expenses	(1,641)	(1,598)
Decrease in deferred revenue	(334)	(248)
Net cash used in operating activities	(11,669)	(13,082)
Cash flows from investing activities:
Purchase of property, plant and equipment	(88)	(221)
Net cash used in investing activities	(88)	(221)
Cash flows from financing activities:
Principal payments on financing leases		(23)
Net payments related to registration costs		(106)
Net proceeds from Public Offering		19,378
Net proceeds from the exercise of warrants	2,393
Net cash provided by financing activities	2,393	19,249
Foreign currency effects on cash	33	63
Net (decrease) / increase in total cash	(9,331)	6,009
Total Cash:
Beginning of period	28,756	10,183
End of period	19,425	16,192
Supplemental Disclosure of Cash Flow Information:
Interest expense	4	7
Supplemental Disclosure of Non-Cash Investing and Financing Activities:
Reclassification of 2019 warrants from liability to equity		6,199
Conversions of preferred stock into common stock	9	$ 15
Board of Directors Chairman
Supplemental Disclosure of Non-Cash Investing and Financing Activities:
Issuance of restricted stock for accrued fees due to a former board member	$ 57

General

General	6 Months Ended
	Jun. 30, 2021
Organization Consolidation And Presentation Of Financial Statements [Abstract]
General	(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, 2021 and 2020 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, 2020 (the “Annual Report”), which was filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2021 and may also be found on the Company’s website (www.delcath.com). In these notes to the condensed consolidated financial statements the terms “us”, “we” or “our” refer to Delcath and its consolidated subsidiaries. Description of Business We are an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our lead product candidate, the HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system), or HEPZATO™, is a drug/device combination product. HEPZATO is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, our commercial product is a stand-alone medical device having the same device components as the HEPZATO KIT but without the melphalan hydrochloride and is approved for sale under the trade name CHEMOSAT® Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used at major medical centers to treat a wide range of cancers of the liver. Our clinical development program for HEPZATO is primarily comprised of the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (FOCUS Trial), a global registration clinical trial that is investigating objective response rate in metastatic ocular melanoma, or mOM. We are currently reviewing the incidence, unmet need, available efficacy data and development requirements for a broad set of liver cancers in order to select a portfolio of follow-on indications which will maximize the value of the HEPZATO platform. Risks and Uncertainties Due to the global outbreak of SARS-CoV-2, a novel strain of coronavirus that causes Coronavirus disease (COVID-19), the Company experienced an impact on certain areas of its business. These effects included a slowing of patient recruitment in the FOCUS trial and a reduction in the pace at which we can monitor data at our clinical trial sites. The resulting delay in completing enrollment and additional time required to monitor data caused our announcement for the top-line data from our FOCUS Trial to shift to early 2021 and to be modified to a preliminary analysis. We now plan to submit a New Drug Application (NDA) to the FDA in the first quarter of 2022 for the treatment of mOM. The ability to achieve this goal is contingent on our ability to monitor data at our clinical sites and therefore the timeline may shift as access to the clinical sites changes in response to the rapidly evolving situation. We have also experienced an increased volatility in EU commercial product revenue and additional impacts to the business may arise that we are not aware of currently. The ultimate impact of the pandemic on the Company’s results of operations, financial position, liquidity, or capital resources cannot be reasonably estimated at this time. Liquidity and Going Concern The accompanying interim condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred losses since inception and expects to continue incurring losses for the next several years. These losses, among other factors, raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce, or eliminate its research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If Delcath is not able to continue as a going concern, it is likely that holders of its common stock will lose all of their investment. The accompanying interim condensed consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern . The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. These circumstances raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued . Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the SEC’s instructions to Form 10-Q and Article 10 of Regulation S-X. They include the accounts of all entities controlled by Delcath and all significant inter-company accounts and transactions have been eliminated in consolidation. The preparation of interim condensed consolidated financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended June 30, 2021 and 2020; however, certain information and footnote disclosures normally included in our audited consolidated financial statements included in our Annual Report on Form 10-K have been condensed or omitted as permitted by GAAP. It is important to note that the Company’s results of operations and cash flows for interim periods are not necessarily indicative of the results of operations and cash flows to be expected for a full fiscal year or any interim period. Significant Accounting Policies There have been no material changes to our significant accounting policies as set forth in Note 3 Summary of Significant Accounting Policies to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, except for the following: Reclassifications . Certain prior period balances have been reclassified in order to conform to current period presentation. These reclassifications have no effect on previously reported results of operations or loss per share. Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Simplifying the Accounting for Income Taxes. The list of changes is comprehensive; however, the changes will not significantly impact the Company due to the full valuation allowance that is recorded against the Company’s deferred tax assets. Early adoption of ASU 2019-12 is permitted, including adoption in any interim period for public business entities for periods for which financial statements have not yet been issued. An entity that elects to early adopt the amendments in an interim period should reflect any adjustments as of the beginning of the annual period that includes that interim period. Additionally, an entity that elects early adoption must adopt all the amendments in the same period. The Company adopted ASU 2019-12 on January 1, 2021, and there was no material impact on the Company’s financial statements or disclosures. On May 3, 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. Early adoption is permitted, including adoption in an interim period. If an issuer elects to early adopt the new standard in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The Company is evaluating this new standard.

Cash, Cash Equivalents and Rest

Cash, Cash Equivalents and Restricted Cash	6 Months Ended
	Jun. 30, 2021
Cash And Cash Equivalents [Abstract]
Cash, Cash Equivalents and Restricted Cash	(2) Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded in Restricted Cash Cash, cash equivalents, and r estricted cash balances were as follows: June 30, December 31, 2021 2020 Cash and cash equivalents $ 19,274 $ 28,575 Letters of credit 101 131 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 19,425 $ 28,756

Inventories

Inventories	6 Months Ended
	Jun. 30, 2021
Inventory Disclosure [Abstract]
Inventories	(3) Inventories Inventories consist of the following: June 30, December 31, 2021 2020 Raw materials $ 517 $ 435 Work-in-process 704 420 Total inventories $ 1,221 $ 855

Prepaid Expenses and Other Curr

Prepaid Expenses and Other Current Assets	6 Months Ended
	Jun. 30, 2021
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract]
Prepaid Expenses And Other Current Assets	(4) Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: June 30, December 31, 2021 2020 Clinical trial expenses $ 1,497 $ 1,497 Insurance premiums 290 845 Other 398 328 Total prepaid expenses and other current assets $ 2,185 $ 2,670

Property, Plant, and Equipment

Property, Plant, and Equipment	6 Months Ended
	Jun. 30, 2021
Property Plant And Equipment [Abstract]
Property, Plant, and Equipment	(5) Property, Plant, and Equipment Property, plant, and equipment consist of the following: June 30, December 31, Estimated 2021 2020 Useful Life Buildings and land $ 1,191 $ 1,109 30 years - Buildings Enterprise hardware and software 1,862 1,862 3 years Leaseholds 1,814 1,826 Lesser of lease term or estimated useful life Equipment 1,068 1,063 7 years Furniture 204 204 5 years Property, plant and equipment, gross 6,139 6,064 Accumulated depreciation (4,778 ) (4,713 ) Property, plant and equipment, net $ 1,361 $ 1,351 Depreciation expense for the three and six months ended June 30, 2021 was approximately $39.6 and $78.4 as compared to approximately $44.4 and $92.0 for the same period in 2020.

Accrued Expenses

Accrued Expenses	6 Months Ended
	Jun. 30, 2021
Payables And Accruals [Abstract]
Accrued Expenses	(6) Accrued Expenses Accrued expenses consist of the following: June 30, December 31, 2021 2020 Clinical expenses $ 2,216 $ 2,698 Compensation, excluding taxes 747 1,598 Professional fees 188 225 Interest on convertible note 313 234 Other 157 486 Total accrued expenses $ 3,621 $ 5,241

Leases

Leases	6 Months Ended
	Jun. 30, 2021
Leases [Abstract]
Leases	(7) Leases The Company recognizes right-of-use (“ROU”) assets and lease liabilities when it obtains the right to control an asset under a leasing arrangement with an initial term greater than twelve months. The Company leases its facilities under non-cancellable operating and financing leases. The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the ROU asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The following table summarizes the Company’s operating leases as of and for the six months ended June 30, 2021: US Ireland Total Lease cost Operating lease cost $ 214 $ 110 $ 324 Sublease income — (109 ) (109 ) Total $ 214 $ 1 $ 215 Other information Operating cash flows out from operating leases (214 ) (110 ) (324 ) Operating cash flows in from operating leases - 109 109 Weighted average remaining lease term 1.7 - Weighted average discount rate - operating leases 8 % 8 % Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows: US Ireland Total Year ended December 31, 2021 $ 203 $ 18 $ 221 Year ended December 31, 2022 406 - 406 Year ended December 31, 2023 67 - 67 Total 676 18 694 Less present value discount (44 ) - (44 ) Operating lease liabilities included in the condensed consolidated balance sheet at June 30, 2021 $ 632 $ 18 $ 650

Convertible Notes Payable

Convertible Notes Payable	6 Months Ended
	Jun. 30, 2021
Debt Disclosure [Abstract]
Convertible Notes Payable	(8) Convertible Notes Payable Conversion price Current interest rate Principal Convertible notes payable 8.0% July 2019 Notes (maturity date - July 16, 2021) $ 1,500 8 % $ 2,000 The note payable is convertible into Preferred Stock. See Note 12 Subsequent Events for information related to an amendment which reduced the conversion price and extended the maturity of the convertible notes payable.

Stockholders' Equity

Stockholders' Equity	6 Months Ended
	Jun. 30, 2021
Stockholders Equity Note [Abstract]
Stockholders' Equity	(9) Stockholders’ Equity Preferred Stock Series E and Series E-1 Preferred Stock During the six months ended June 30, 2021, 8,924 shares of Preferred Stock were converted into 892,379 shares of the Company’s common stock. As of June 30, 2021, there were an aggregate of 11,707 shares of Series E and Series E-1 Preferred Stock outstanding. Other Common Stock Issuances During the six months ended June 30, 2021, the Company issued 458,661 shares of common stock associated with the exercise of warrants, including 215,000 prefunded warrants at an exercise price of $0.01 per share. Stock Incentive Plan 2020 Omnibus Equity Incentive Plan As of June 30, 2021, there were 2,475,000 shares of the Company’s common stock reserved under the Delcath Systems, Inc. Omnibus Equity Incentive Plan (the “2020 Plan”), of which 1,881,608 remained available to be issued. On March 30, 2021, the Company’s Board of Directors approved an amendment of the 2020 Plan to increase the number of shares of the Company’s common stock available for issuance under the 2020 Plan by 1,800,000, subject to stockholder approval of the amendment. The amendment of the 2020 Plan was approved by the stockholders at the Company’s annual meeting of stockholders held on May 6, 2021, and, effective as of such date, the number of shares of the Company’s common stock available for issuance under the 2020 Plan increased by 1,800,000 resulting in a total share reserve of 2,475,000 shares of common stock. Share-Based Compensation The following is a summary of stock option activity for the six months ended June 30, 2021: Number of Option Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding at January 1, 2021 1,078,499 $ 12.68 Granted 15,000 9.87 Exercised — — Cancelled/Forfeited (1,611 ) 11.67 Outstanding at June 30, 2021 1,091,888 $ 12.65 9.3 $ 929 Exercisable at June 30, 2021 262,388 $ 12.87 9.2 $ 246 The following table summarizes information for stock option shares outstanding and exercisable at June 30, 2021 Options Exercisable Range of Exercise Prices Outstanding Number of Options Weighted Average Remaining Option Term (in years) Number of Options $9 - $15 959,389 9.2 236,389 $15 - $20 81,000 9.3 12,750 $20 - $25 51,000 9.3 12,750 $25+ 499 7.6 499 1,091,888 9.2 262,388 The following is a summary of share-based compensation expense in the statement of operations for the three and six months ended June 30, 2021 Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Cost of goods sold 39 — 91 — Research and development 463 117 1,093 122 Selling, general and administrative $ 1,124 $ 488 $ 2,590 $ 537 Total $ 1,626 $ 605 $ 3,774 $ 660 At June 30, 2021, there was $5,176 of aggregate unrecognized compensation expense related employee and board stock option grants. This will be recognized over the next 2.9 years. Warrants The following is a summary of warrant activity for the six months ended June 30, 2021: Warrants Weighted Average Exercise Price Weighted Average Remaining Life (in years) Outstanding at January 1, 2021 4,236,687 $ 9.13 Warrants issued — — Warrants exercised (463,421 ) 5.37 Warrants expired — — Outstanding at June 30, 2021 3,773,266 $ 9.59 3.7 Exercisable at June 30, 2021 3,773,266 $ 9.59 3.7 The following table presents information related to stock warrants at June 30, 2021 Warrants Exercisable Range of Exercise Prices Outstanding Number of Warrants Weighted Average Remaining Warrant Term (in years) Number of Warrants $ 0.01 156,000 3.8 156,000 $ 10.00 3,617,266 3.7 3,617,266 3,773,266 3.7 3,773,266 As of June 30, 2021, warrants to purchase 156,000 shares of the Company’s common stock were pre-funded, and the exercise price was $0.01 per share. The remaining warrants were exercisable at $10.00 per share.

Net Loss per Common Share

Net Loss per Common Share	6 Months Ended
	Jun. 30, 2021
Earnings Per Share [Abstract]
Net Loss per Common Share	( 10 ) Net Loss per Common Share Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities, except for those shares that are issuable for little or no cash consideration. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options and warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. The following potentially dilutive securities were excluded from the computation of earnings per share as of June 30, 2021 and 2020 because their effects would be anti-dilutive: June 30, 2021 2020 Stock options 1,091,888 1,640 Common stock warrants - equity 3,773,266 4,051,499 Common stock reserved for conversion of preferred shares 1,170,700 2,595,087 Assumed conversion of convertible notes 154,222 146,288 Total 6,190,076 6,794,514 At June 30, 2021, the Company had 156,000 pre-funded warrants outstanding. The following table provides a reconciliation of the weighted average shares outstanding calculation for the three and six months ended June 30, 2021 and 2020: Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Weighted average shares issued 6,511,194 2,038,297 6,319,622 1,054,549 Weighted average pre-funded warrants 170,175 234,890 270,033 117,445 Weighted average shares outstanding 6,681,369 2,273,187 6,589,655 1,171,994

Commitments and Contingencies

Commitments and Contingencies	6 Months Ended
	Jun. 30, 2021
Commitments And Contingencies Disclosure [Abstract]
Commitments and Contingencies	(1 1 ) Commitments and Contingencies Litigation, Claims and Assessments Following the May 18, 2020 resignation (effective June 1, 2020) of Jennifer Simpson, the Company’s former President and CEO, and Barbra Keck, the Company’s former CFO (the “Claimants”), it became evident that there was a dispute regarding the Company’s compensation obligations. In a letter dated, June 29, 2020, an attorney representing the Claimants made certain claims and threatened litigation against the Company. On or about July 27, 2020, the Claimants filed a statement of claim with the American Arbitration Association against the Company. The Claimants sought payment of certain purported unpaid compensation amounts claimed to be due to them, in an approximate amount of $1,140 in the aggregate, as well as unspecified statutory damages under the New York Labor Law, attorneys’ fees and costs, and statutory interest. The Company denied any liability or wrongdoing and was vigorously defending against the claims, with contested arbitration hearings initially scheduled to commence in the week of May 17, 2021. However, the Claimants and the Company agreed to participate in non-binding mediation of their dispute before a neutral mediator, which resulted in the arbitration proceedings being placed in abeyance pending the outcome of the mediation process. With the assistance of the neutral mediator and after careful consideration by the Company’s board of directors following several weeks of negotiations, the Claimants and the Company agreed in mid-May of 2021 to a confidential settlement of their dispute to avoid the expenses and distractions of further arbitration proceedings, with no admission of liability or wrongdoing on the part of the Company. While the Company had accrued for the full purported unpaid compensation amount of $1,140 as of December 31, 2020, the Company ultimately paid less in full and final settlement of its dispute with both of the Claimants. As a result of the confidential settlement, the AAA Arbitration was dismissed with prejudice on June 1, 2021. Other Transactions In April 2021, the Company issued an invoice for $1,178 to medac, the Company’s EU product distribution partner, for a milestone payment due under the License, Supply and Marketing Agreement (the “Agreement”) dated December 10, 2018, between the Company and medac, Per the Agreement, a milestone is due upon achieving positive efficacy in the FOCUS trial as defined by the FOCUS trial protocol. Per the trial protocol and associated Statistical Analysis Plan, positive efficacy is based on whether the Objective Response Rate (ORR) exceeds a prespecified threshold. A preliminary analysis of the FOCUS trial data based on 87 % of enrolled patients was released on March 31, 2021, and subsequently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held virtually from the 4 th through the 8 th of June 2021. Per that analysis, the ORR exceeded the prespecified threshold. While the final ORR is not yet known, given the magnitude by which the ORR exceeded the prespecified endpoint and the small number of patients yet to be assessed, the final ORR will be greater than the prespecified endpoint regardless of the responder status of the remaining patients. medac disagrees that the milestone is due and claims that a full clinical study report is required in addition to the existing ORR analysis. medac has not disputed the accuracy of the ORR analysis or underlying data but simply asserts that a full clinical study report is required prior to payment. While the C ompany disagrees with this interpretation, since medac has stated they do not intend to pay the invoice at this time, under revenue recognition criteria set out in ASC 606 we cannot recognize the revenue in the quarter ending June 30, 2021.

Subsequent Events

Subsequent Events	6 Months Ended
	Jun. 30, 2021
Subsequent Events [Abstract]
Subsequent Events	(1 2 ) Subsequent Events Warrant Exercises Subsequent to June 30, 2021, warrants to purchase 6,512 shares of the Company’s common stock with an exercise price of $10.00 per share were exercised for proceeds of $65,120. Other Transactions Growth Capital Term Loan On August 6, 2021, the Company entered into a Loan and Security Agreement (the “Loan”) with Avenue Venture Opportunities Fund, L.P. (the “Lender,” or “Avenue”) for an aggregate principal amount of up to $20,000. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The Loan is secured by all of the Company’s assets globally, including intellectual property. The Loan maturity date is August 1, 2024. The initial tranche of the Loan is $15,000, including $4,000 which has been funded into a restricted account and will be released upon achievement of (a)(x) positive FOCUS trial efficacy per the trial’s predefined Statistical Analysis Plan (SAP) (specifically the Overall Response Rate exceeds the prespecified threshold for success defined in the SAP by a statistically significant amount); and (y) based on data contained within the FOCUS trial database and appropriate for use with the U.S. Food and Drug Administration, safety and tolerability among FOCUS trial participants is within the range of currently approved and commonly used cytotoxic chemotherapeutic agents; and (b) raising subsequent net equity proceeds of at least $20,000. The Company may request an additional $5,000 of gross proceeds between October 1, 2022 and December 31, 2022, with funding, subject to the approval of Avenue’s Investment Committee. In connection with the Loan, the Company issued to the Lender warrants to purchase 127,755 shares of common stock at an exercise price per share equal to $0.01. The warrants are exercisable until August 31, 2026. Up to $3,000 of the principal amount outstanding may be converted at the option of the Lender into shares of the Company’s common stock at a conversion price of $11.98 per share. The Company will make monthly interest-only payments during the first fifteen months of the Loan, which could be increased to up to twenty-four months upon the achievement of specified performance milestones. Following the interest-only period, the Company will make equal monthly payments of principal until the maturity date, plus interest. If the Company prepays the Loan, it will be required to pay (a) a prepayment fee of 3% if the Loan is prepaid during the interest-only period; and (b) a prepayment fee of 1% if the Loan is prepaid after the interest-only period. The Company must make an incremental final payment equal to 4.25% of the aggregate funding. The Company paid an aggregate commitment fee of $150 at closing. Upon a second tranche, the Lender will earn a 1.0% fee on the $5,000 of incremental committed capital, for a total commitment fee of $200. The Loan requires the Company to make and maintain representations and warranties and other agreements that are customary in loan agreements of this type. The Loan also contains customary events of default, including non-payment of principal or interest, violations of covenants, bankruptcy and material judgments. The Company intends to use any proceeds from the Loan for general corporate purposes. Extension and Amendment of Convertible Note Payable On August 6, 2021, the Company executed an agreement to amend an aggregate of $2,000 outstanding secured convertible notes payable to Rosalind Opportunities Fund I L.P. and Rosalind Master Fund L.P., respectively, which (a) reduces the conversion price to $1,198 per share of the Company’s Series E Convertible Preferred Stock; and (b) extends the maturity date to October 30, 2024. In addition, in order to induce Avenue to provide the Loan described above, the holders of the convertible notes payable agreed to subordinate (a) all of the Company’s indebtedness and obligations to the holders; and (b) all of the holders’ security interest, to the Loan and Avenue’s security interest in the Company’s property.

General (Policies)

General (Policies)	6 Months Ended
	Jun. 30, 2021
Organization Consolidation And Presentation Of Financial Statements [Abstract]
Risk and Uncertainties	Risks and Uncertainties Due to the global outbreak of SARS-CoV-2, a novel strain of coronavirus that causes Coronavirus disease (COVID-19), the Company experienced an impact on certain areas of its business. These effects included a slowing of patient recruitment in the FOCUS trial and a reduction in the pace at which we can monitor data at our clinical trial sites. The resulting delay in completing enrollment and additional time required to monitor data caused our announcement for the top-line data from our FOCUS Trial to shift to early 2021 and to be modified to a preliminary analysis. We now plan to submit a New Drug Application (NDA) to the FDA in the first quarter of 2022 for the treatment of mOM. The ability to achieve this goal is contingent on our ability to monitor data at our clinical sites and therefore the timeline may shift as access to the clinical sites changes in response to the rapidly evolving situation. We have also experienced an increased volatility in EU commercial product revenue and additional impacts to the business may arise that we are not aware of currently. The ultimate impact of the pandemic on the Company’s results of operations, financial position, liquidity, or capital resources cannot be reasonably estimated at this time.
Liquidity and Going Concern	Liquidity and Going Concern The accompanying interim condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred losses since inception and expects to continue incurring losses for the next several years. These losses, among other factors, raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce, or eliminate its research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If Delcath is not able to continue as a going concern, it is likely that holders of its common stock will lose all of their investment. The accompanying interim condensed consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern . The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. These circumstances raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued .
Basis of Presentation	Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the SEC’s instructions to Form 10-Q and Article 10 of Regulation S-X. They include the accounts of all entities controlled by Delcath and all significant inter-company accounts and transactions have been eliminated in consolidation. The preparation of interim condensed consolidated financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended June 30, 2021 and 2020; however, certain information and footnote disclosures normally included in our audited consolidated financial statements included in our Annual Report on Form 10-K have been condensed or omitted as permitted by GAAP. It is important to note that the Company’s results of operations and cash flows for interim periods are not necessarily indicative of the results of operations and cash flows to be expected for a full fiscal year or any interim period.
Reclassifications	Reclassifications . Certain prior period balances have been reclassified in order to conform to current period presentation. These reclassifications have no effect on previously reported results of operations or loss per share.
Recently Adopted and Issued Accounting Pronouncements	Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Simplifying the Accounting for Income Taxes. The list of changes is comprehensive; however, the changes will not significantly impact the Company due to the full valuation allowance that is recorded against the Company’s deferred tax assets. Early adoption of ASU 2019-12 is permitted, including adoption in any interim period for public business entities for periods for which financial statements have not yet been issued. An entity that elects to early adopt the amendments in an interim period should reflect any adjustments as of the beginning of the annual period that includes that interim period. Additionally, an entity that elects early adoption must adopt all the amendments in the same period. The Company adopted ASU 2019-12 on January 1, 2021, and there was no material impact on the Company’s financial statements or disclosures. On May 3, 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. Early adoption is permitted, including adoption in an interim period. If an issuer elects to early adopt the new standard in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The Company is evaluating this new standard.

Cash, Cash Equivalents and Re_2

Cash, Cash Equivalents and Restricted Cash (Tables)	6 Months Ended
	Jun. 30, 2021
Cash And Cash Equivalents [Abstract]
Schedule of Cash, Cash Equivalents, and Restricted Cash	Cash, cash equivalents, and r estricted cash balances were as follows: June 30, December 31, 2021 2020 Cash and cash equivalents $ 19,274 $ 28,575 Letters of credit 101 131 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 19,425 $ 28,756

Inventories (Tables)

Inventories (Tables)	6 Months Ended
	Jun. 30, 2021
Inventory Disclosure [Abstract]
Schedule of inventories	Inventories consist of the following: June 30, December 31, 2021 2020 Raw materials $ 517 $ 435 Work-in-process 704 420 Total inventories $ 1,221 $ 855

Prepaid Expenses and Other Cu_2

Prepaid Expenses and Other Current Assets (Tables)	6 Months Ended
	Jun. 30, 2021
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract]
Prepaid Expenses and Other Current Assets	Prepaid expenses and other current assets consist of the following: June 30, December 31, 2021 2020 Clinical trial expenses $ 1,497 $ 1,497 Insurance premiums 290 845 Other 398 328 Total prepaid expenses and other current assets $ 2,185 $ 2,670

Property, Plant, and Equipment

Property, Plant, and Equipment (Tables)	6 Months Ended
	Jun. 30, 2021
Property Plant And Equipment [Abstract]
Components of property, plant and equipment	Property, plant, and equipment consist of the following: June 30, December 31, Estimated 2021 2020 Useful Life Buildings and land $ 1,191 $ 1,109 30 years - Buildings Enterprise hardware and software 1,862 1,862 3 years Leaseholds 1,814 1,826 Lesser of lease term or estimated useful life Equipment 1,068 1,063 7 years Furniture 204 204 5 years Property, plant and equipment, gross 6,139 6,064 Accumulated depreciation (4,778 ) (4,713 ) Property, plant and equipment, net $ 1,361 $ 1,351

Accrued Expenses (Tables)

Accrued Expenses (Tables)	6 Months Ended
	Jun. 30, 2021
Payables And Accruals [Abstract]
Schedule of accrued expenses	Accrued expenses consist of the following: June 30, December 31, 2021 2020 Clinical expenses $ 2,216 $ 2,698 Compensation, excluding taxes 747 1,598 Professional fees 188 225 Interest on convertible note 313 234 Other 157 486 Total accrued expenses $ 3,621 $ 5,241

Leases (Tables)

Leases (Tables)	6 Months Ended
	Jun. 30, 2021
Leases [Abstract]
Summary of Operating and Financing Leases	The following table summarizes the Company’s operating leases as of and for the six months ended June 30, 2021: US Ireland Total Lease cost Operating lease cost $ 214 $ 110 $ 324 Sublease income — (109 ) (109 ) Total $ 214 $ 1 $ 215 Other information Operating cash flows out from operating leases (214 ) (110 ) (324 ) Operating cash flows in from operating leases - 109 109 Weighted average remaining lease term 1.7 - Weighted average discount rate - operating leases 8 % 8 %
Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases	Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows: US Ireland Total Year ended December 31, 2021 $ 203 $ 18 $ 221 Year ended December 31, 2022 406 - 406 Year ended December 31, 2023 67 - 67 Total 676 18 694 Less present value discount (44 ) - (44 ) Operating lease liabilities included in the condensed consolidated balance sheet at June 30, 2021 $ 632 $ 18 $ 650

Convertible Notes Payable (Tabl

Convertible Notes Payable (Tables)	6 Months Ended
	Jun. 30, 2021
Debt Disclosure [Abstract]
Summary of Various Notes Issued	Conversion price Current interest rate Principal Convertible notes payable 8.0% July 2019 Notes (maturity date - July 16, 2021) $ 1,500 8 % $ 2,000

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	6 Months Ended
	Jun. 30, 2021
Stockholders Equity Note [Abstract]
Summary of Stock Option Activity	The following is a summary of stock option activity for the six months ended June 30, 2021: Number of Option Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding at January 1, 2021 1,078,499 $ 12.68 Granted 15,000 9.87 Exercised — — Cancelled/Forfeited (1,611 ) 11.67 Outstanding at June 30, 2021 1,091,888 $ 12.65 9.3 $ 929 Exercisable at June 30, 2021 262,388 $ 12.87 9.2 $ 246
Summary of Stock Option Shares Outstanding and Exercisable	The following table summarizes information for stock option shares outstanding and exercisable at June 30, 2021 Options Exercisable Range of Exercise Prices Outstanding Number of Options Weighted Average Remaining Option Term (in years) Number of Options $9 - $15 959,389 9.2 236,389 $15 - $20 81,000 9.3 12,750 $20 - $25 51,000 9.3 12,750 $25+ 499 7.6 499 1,091,888 9.2 262,388
Summary of Recognized Share-based Compensation Cost	The following is a summary of share-based compensation expense in the statement of operations for the three and six months ended June 30, 2021 Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Cost of goods sold 39 — 91 — Research and development 463 117 1,093 122 Selling, general and administrative $ 1,124 $ 488 $ 2,590 $ 537 Total $ 1,626 $ 605 $ 3,774 $ 660
Summary of Warrant Activity	The following is a summary of warrant activity for the six months ended June 30, 2021: Warrants Weighted Average Exercise Price Weighted Average Remaining Life (in years) Outstanding at January 1, 2021 4,236,687 $ 9.13 Warrants issued — — Warrants exercised (463,421 ) 5.37 Warrants expired — — Outstanding at June 30, 2021 3,773,266 $ 9.59 3.7 Exercisable at June 30, 2021 3,773,266 $ 9.59 3.7
Schedule of Information Related to Stock Warrants Outstanding and Exercisable	The following table presents information related to stock warrants at June 30, 2021 Warrants Exercisable Range of Exercise Prices Outstanding Number of Warrants Weighted Average Remaining Warrant Term (in years) Number of Warrants $ 0.01 156,000 3.8 156,000 $ 10.00 3,617,266 3.7 3,617,266 3,773,266 3.7 3,773,266

Net Loss per Common Share (Tabl

Net Loss per Common Share (Tables)	6 Months Ended
	Jun. 30, 2021
Earnings Per Share [Abstract]
Anti-dilutive securities excluded from the computation of earnings per share	The following potentially dilutive securities were excluded from the computation of earnings per share as of June 30, 2021 and 2020 because their effects would be anti-dilutive: June 30, 2021 2020 Stock options 1,091,888 1,640 Common stock warrants - equity 3,773,266 4,051,499 Common stock reserved for conversion of preferred shares 1,170,700 2,595,087 Assumed conversion of convertible notes 154,222 146,288 Total 6,190,076 6,794,514
Summary of reconciliation of weighted average shares outstanding calculation	The following table provides a reconciliation of the weighted average shares outstanding calculation for the three and six months ended June 30, 2021 and 2020: Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Weighted average shares issued 6,511,194 2,038,297 6,319,622 1,054,549 Weighted average pre-funded warrants 170,175 234,890 270,033 117,445 Weighted average shares outstanding 6,681,369 2,273,187 6,589,655 1,171,994

Cash, Cash Equivalents and Re_3

Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands	Jun. 30, 2021	Dec. 31, 2020	Jun. 30, 2020	Dec. 31, 2019
Cash And Cash Equivalents [Abstract]
Cash and cash equivalents	$ 19,274	$ 28,575
Letters of credit	101	131
Security for credit cards	50	50
Total cash, cash equivalents and restricted cash shown in the statements of cash flows	$ 19,425	$ 28,756	$ 16,192	$ 10,183

Inventories - Schedule of Inven

Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands	Jun. 30, 2021	Dec. 31, 2020
Inventory Disclosure [Abstract]
Raw materials	$ 517	$ 435
Work-in-process	704	420
Total inventories	$ 1,221	$ 855

Prepaid Expenses and Other Cu_3

Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Jun. 30, 2021	Dec. 31, 2020
Prepaid Expense And Other Assets Current [Abstract]
Clinical trial expenses	$ 1,497	$ 1,497
Insurance premiums	290	845
Other	398	328
Total prepaid expenses and other current assets	$ 2,185	$ 2,670

Property, Plant, and Equipmen_2

Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2021	Dec. 31, 2020
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 6,139	$ 6,064
Accumulated depreciation	(4,778)	(4,713)
Property, plant and equipment, net	1,361	1,351
Buildings and Land [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	1,191	1,109
Enterprise Hardware and Software [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,862	1,862
Property, plant and equipment, estimated useful life	3 years
Leaseholds [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,814	1,826
Property, plant and equipment, estimated useful life	Lesser of lease term or estimated useful life
Equipment [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,068	1,063
Property, plant and equipment, estimated useful life	7 years
Furniture [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 204	$ 204
Property, plant and equipment, estimated useful life	5 years
Buildings [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, estimated useful life	30 years

Property, Plant, and Equipmen_3

Property, Plant, and Equipment - Additional Information (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Property Plant And Equipment [Abstract]
Depreciation expense	$ 39,600	$ 44,400	$ 78,400	$ 92,000

Accrued Expenses - Schedule of

Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands	Jun. 30, 2021	Dec. 31, 2020
Payables And Accruals [Abstract]
Clinical expenses	$ 2,216	$ 2,698
Compensation, excluding taxes	747	1,598
Professional fees	188	225
Interest on convertible note	313	234
Other	157	486
Total accrued expenses	$ 3,621	$ 5,241

Leases - Additional Information

Leases - Additional Information (Details)	Jun. 30, 2021
Leases [Abstract]
Lease term	12 months

Leases - Summary of Operating a

Leases - Summary of Operating and Financing Leases (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2021USD ($)
Lease cost
Operating lease cost	$ 324
Sublease income	(109)
Total	215
Other information
Operating cash flows out from operating leases	(324)
Operating cash flows in from operating leases	109
U.S. [Member]
Lease cost
Operating lease cost	214
Total	214
Other information
Operating cash flows out from operating leases	$ (214)
Weighted average remaining lease term	1 year 8 months 12 days
Weighted average discount rate - operating leases	8.00%
Ireland [Member]
Lease cost
Operating lease cost	$ 110
Sublease income	(109)
Total	1
Other information
Operating cash flows out from operating leases	(110)
Operating cash flows in from operating leases	$ 109
Weighted average discount rate - operating leases	8.00%

Leases - Schedule of Remaining

Leases - Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands	Jun. 30, 2021USD ($)
Lessee Lease Description [Line Items]
Year ended December 31, 2021	$ 221
Year ended December 31, 2022	406
Year ended December 31, 2023	67
Total	694
Less present value discount	(44)
Operating lease liabilities included in the condensed consolidated balance sheet at June 30, 2021	650
U.S. [Member]
Lessee Lease Description [Line Items]
Year ended December 31, 2021	203
Year ended December 31, 2022	406
Year ended December 31, 2023	67
Total	676
Less present value discount	(44)
Operating lease liabilities included in the condensed consolidated balance sheet at June 30, 2021	632
Ireland [Member]
Lessee Lease Description [Line Items]
Year ended December 31, 2021	18
Total	18
Operating lease liabilities included in the condensed consolidated balance sheet at June 30, 2021	$ 18

Convertible Notes Payable - Sum

Convertible Notes Payable - Summary of Various Notes Issued (Details) - Convertible Notes Payable [Member] - 8.0% July 2019 Notes [Member]	Jun. 30, 2021USD ($)$ / shares
Debt Instrument [Line Items]
Conversion price | $ / shares	$ 1,500
Current interest rate	8.00%
Principal | $	$ 2,000

Convertible Notes Payable - S_2

Convertible Notes Payable - Summary of Various Notes Issued (Details) (Parenthetical)	6 Months Ended
	Jun. 30, 2021
Equity Method Investments And Cost Method Investments [Abstract]
Maturity date	Jul. 16, 2021

Stockholders' Equity - Preferre

Stockholders' Equity - Preferred Stock Issuances - Additional Information (Details) - shares	6 Months Ended
	Jun. 30, 2021	Dec. 31, 2020
Stockholders Equity Note [Line Items]
Conversion of stock shares issued	892,379
Preferred stock, shares outstanding (in shares)	11,707	20,631
Series E Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Conversion of stock preferred shares converted	8,924
Preferred stock, shares outstanding (in shares)	11,707
Series E1 Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Conversion of stock preferred shares converted	8,924
Preferred stock, shares outstanding (in shares)	11,707

Stockholders' Equity - Common S

Stockholders' Equity - Common Stock Issuances - Additional Information (Details)	6 Months Ended
	Jun. 30, 2021$ / sharesshares
Stockholders Equity Note [Line Items]
Common stock associated with the exercise of warrants | shares	458,661
Warrants Exercise Price | $ / shares	$ 10
Pre Funded Warrants
Stockholders Equity Note [Line Items]
Prefunded Warrants | shares	215,000
Warrants Exercise Price | $ / shares	$ 0.01

Stockholders' Equity - Stock In

Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) - 2020 Omnibus Equity Incentive Plan [Member]	Jun. 30, 2021shares
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of common shares reserved for issuance	2,475,000
Number of common shares remained available to be issued	1,881,608
Number of increased common shares for future issuance	1,800,000
Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of common shares reserved for issuance	2,475,000

Stockholders' Equity - Summary

Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands	6 Months Ended
	Jun. 30, 2021USD ($)$ / sharesshares
Stockholders Equity Note [Abstract]
Number of Shares, Outstanding | shares	1,078,499
Number of Shares, Granted | shares	15,000
Number of Shares, Cancelled/Forfeited | shares	(1,611)
Number of Shares, Outstanding | shares	1,091,888
Number of Shares, Exercisable | shares	262,388
Weighted Average Exercise Price, Outstanding | $ / shares	$ 12.68
Weighted Average Exercise Price, Granted | $ / shares	9.87
Weighted Average Exercise Price, Cancelled/Forfeited | $ / shares	11.67
Weighted Average Exercise Price, Outstanding | $ / shares	12.65
Weighted Average Exercise Price, Exercisable | $ / shares	$ 12.87
Weighted Average Remaining Contractual Term (Years), Outstanding	9 years 3 months 18 days
Weighted Average Remaining Contractual Term (Years), Exercisable	9 years 2 months 12 days
Aggregate Intrinsic Value, Outstanding | $	$ 929
Aggregate Intrinsic Value, Exercisable | $	$ 246

Stockholders' Equity - Summar_2

Stockholders' Equity - Summary of Stock Option Shares Outstanding and Exercisable (Details) - shares	6 Months Ended
	Jun. 30, 2021	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	1,091,888	1,078,499
Weighted Average Remaining Contractual Term (Years), Exercisable	9 years 2 months 12 days
Number of Shares, Exercisable	262,388
$9 - $15 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	959,389
Weighted Average Remaining Contractual Term (Years), Exercisable	9 years 2 months 12 days
Number of Shares, Exercisable	236,389
$15 - $20 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	81,000
Weighted Average Remaining Contractual Term (Years), Exercisable	9 years 3 months 18 days
Number of Shares, Exercisable	12,750
$20 - $25 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	51,000
Weighted Average Remaining Contractual Term (Years), Exercisable	9 years 3 months 18 days
Number of Shares, Exercisable	12,750
+ $25 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	499
Weighted Average Remaining Contractual Term (Years), Exercisable	7 years 7 months 6 days
Number of Shares, Exercisable	499

Stockholders' Equity - Summar_3

Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	$ 1,626	$ 605	$ 3,774	$ 660
Selling, General and Administrative [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	1,124	488	2,590	537
Research and Development [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	463	$ 117	1,093	$ 122
Cost of Goods Sold [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	$ 39		$ 91

Stockholders' Equity - Share-Ba

Stockholders' Equity - Share-Based Compensation - Additional Information (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2021USD ($)
Stockholders Equity Note [Abstract]
Unrecognized compensation expense related to non-vested share-based compensation awards	$ 5,176
Unrecognized compensation period related to non-vested share-based compensation awards	2 years 10 months 24 days

Stockholders' Equity - Summar_4

Stockholders' Equity - Summary of Warrant Activity (Details)	6 Months Ended
	Jun. 30, 2021$ / sharesshares
Warrants outstanding [Roll Forward]
Outstanding, beginning of period (in shares) | shares	4,236,687
Warrants exercised (in shares) | shares	(463,421)
Outstanding, end of period (in shares) | shares	3,773,266
Exercisable, end of period (in shares) | shares	3,773,266
Warrants, Exercise Price per Share [Roll Forward]
Outstanding, beginning of period (in dollars per share) | $ / shares	$ 9.13
Outstanding, ending of period (in dollars per share) | $ / shares	9.59
Warrants exercised (in dollars per share) | $ / shares	5.37
Exercisable, (in dollars per share) | $ / shares	$ 9.59
Weighted average remaining life	3 years 10 months 24 days
Weighted average remaining life, Exercisable	3 years 10 months 24 days

Stockholders' Equity - Summar_5

Stockholders' Equity - Summary of Warrants Outstanding and Exercisable (Details) - shares	6 Months Ended
	Jun. 30, 2021	Dec. 31, 2020
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	3,773,266	4,236,687
Weighted average remaining life	3 years 10 months 24 days
Warrants Exercisable, Number Exercisable	3,773,266
$0.01 [Member]
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	156,000
Weighted average remaining life	4 years 1 month 6 days
Warrants Exercisable, Number Exercisable	156,000
$10.00 [Member]
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	3,617,266
Weighted average remaining life	3 years 10 months 24 days
Warrants Exercisable, Number Exercisable	3,617,266

Stockholders' Equity - Warrants

Stockholders' Equity - Warrants - Additional Information (Details) - $ / shares	Jun. 30, 2021	Dec. 31, 2020
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	3,773,266	4,236,687
Warrants Exercise Price	$ 10
Prefunded Warrant [Member]
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	156,000
Warrants Exercise Price	$ 0.01

Net Loss per Common Share - Ant

Net Loss per Common Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares	6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	6,190,076	6,794,514
Stock Options [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	1,091,888	1,640
Common Stock Warrants - Equity [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	3,773,266	4,051,499
Common Stock Reserved For Conversion of Preferred Shares [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	1,170,700	2,595,087
Assumed Conversion of Convertible Notes [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	154,222	146,288

Net Loss per Common Share - Add

Net Loss per Common Share - Additional Information (Details)	6 Months Ended
	Jun. 30, 2021shares
Earnings Per Share [Abstract]
Pre-funded penny warrants outstanding	156,000

Net Loss per Common Share - Sum

Net Loss per Common Share - Summary of Reconciliation of Weighted Average Shares Outstanding Calculation (Details) - shares	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Earnings Per Share [Abstract]
Weighted average shares issued	6,511,194	2,038,297	6,319,622	1,054,549
Weighted average pre-funded warrants	170,175	234,890	270,033	117,445
Weighted average shares outstanding	6,681,369	2,273,187	6,589,655	1,171,994

Commitments and Contingencies -

Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands	Apr. 01, 2021	Mar. 31, 2021	Jul. 27, 2020	Dec. 31, 2020
Loss Contingencies [Line Items]
Percentage of enrolled patients		87.00%
Pending Litigation [Member]
Loss Contingencies [Line Items]
Unpaid compensation amounts claimed			$ 1,140
Accrued unpaid compensation amounts				$ 1,140
Medac [Member]
Loss Contingencies [Line Items]
Due from related parties	$ 1,178
Agreement date	Dec. 10, 2018

Subsequent Events - Additional

Subsequent Events - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	Aug. 06, 2021	Jul. 01, 2021	Jun. 30, 2021
Subsequent Event [Line Items]
Warrant exercise price			$ 10
Proceeds from warrant exercise			$ 2,393
Debt instrument, maturity date			Jul. 16, 2021
Subsequent Event [Member]
Subsequent Event [Line Items]
Debt instrument, interest rate term	The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The Loan is secured by all of the Company’s assets globally, including intellectual property.
Subsequent Event [Member] | Secured Convertible Notes Payable [Member]
Subsequent Event [Line Items]
Debt instrument, principal face amount	$ 2,000
Subsequent Event [Member] | Secured Convertible Notes Payable [Member] | Series E Convertible Preferred Stock [Member]
Subsequent Event [Line Items]
Debt instrument, maturity date	Oct. 30, 2024
Debt instrument, conversion price	$ 1,198
Subsequent Event [Member] | Growth Capital Term Loan [Member]
Subsequent Event [Line Items]
Debt instrument, interest rate	7.70%
Debt instrument, interest rate	10.95%
Debt instrument, maturity date	Aug. 1, 2024
Initial tranche of loan	$ 15,000
Loan amount funded into restricted account	4,000
Proceeds from issuance or sale of equity	20,000
Second tranche of loan	$ 5,000
Debt instrument, conversion price	$ 11.98
Frequency of periodic payment	monthly
Periodic interest payments, term	15 months
Debt instrument, incremental final payment	4.25%
Debt instrument, commitment fee	$ 150
Debt instrument, commitment fee, percentage	1.00%
Debt instrument, commitment fee upon funding of second tranche of loan	$ 200
Subsequent Event [Member] | Growth Capital Term Loan [Member] | Maximum [Member]
Subsequent Event [Line Items]
Debt instrument, principal face amount	20,000
Debt instrument, converted amount	$ 3,000
Periodic interest payments, term	24 months
Prepayment fee, percentage	3.00%
Subsequent Event [Member] | Growth Capital Term Loan [Member] | Minimum [Member]
Subsequent Event [Line Items]
Prepayment fee, percentage	1.00%
Stock Warrant Exercises [Member] | Subsequent Event [Member]
Subsequent Event [Line Items]
Warrants issued to purchase of common stock		6,512
Warrant exercise price		$ 10
Proceeds from warrant exercise		$ 65,120
Stock Warrant Exercises [Member] | Subsequent Event [Member] | Growth Capital Term Loan [Member]
Subsequent Event [Line Items]
Warrants issued to purchase of common stock	127,755
Warrant exercise price	$ 0.01
Warrants, maturity date	Aug. 31, 2026