Delcath Systems (DCTH) 10-Q 9 Aug 23 2023 Q2 Quarterly report Financial data

Cover Page

Cover Page - shares	6 Months Ended
	Jun. 30, 2023	Aug. 03, 2023
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2023
Document Transition Report	false
Entity File Number	001-16133
Entity Registrant Name	DELCATH SYSTEMS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	06-1245881
Entity Address, Address Line One	1633 Broadway
Entity Address, Address Line Two	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
Title of 12(b) Security	Common stock, $0.01 par value per share
Trading Symbol	DCTH
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		15,276,487
Entity Central Index Key	0000872912
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q2
Amendment Flag	false

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Current assets
Cash and cash equivalents	$ 14,540	$ 7,671
Restricted cash	50	4,151
Accounts receivable, net	127	366
Inventory	2,480	1,998
Prepaid expenses and other current assets	2,275	1,969
Total current assets	19,472	16,155
Property, plant and equipment, net	1,403	1,422
Right-of-use assets	175	285
Total assets	21,050	17,862
Current liabilities
Accounts payable	966	2,018
Accrued expenses	5,546	4,685
Lease liabilities, current	92	186
Loan payable, current	4,510	7,846
Total current liabilities	11,114	14,735
Warrant liability	3,780	0
Other liabilities, non-current	1,146	1,144
Loan payable, non-current	411	3,070
Convertible notes payable, non-current	4,841	4,772
Total liabilities	21,292	23,721
Commitments and contingencies (see note 13)
Stockholders’ equity (deficit)
Preferred stock, $0.01 par value; 10,000,000 shares authorized; 20,981 and 11,357 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively	0	0
Common stock, $0.01 par value; 80,000,000 shares authorized; 15,250,469 shares and 10,046,571 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively	153	100
Additional paid-in capital	473,355	451,608
Accumulated deficit	(473,686)	(457,484)
Accumulated other comprehensive loss	(64)	(83)
Total stockholders’ equity (deficit)	(242)	(5,859)
Total liabilities and stockholders’ equity	$ 21,050	$ 17,862

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Jun. 30, 2023	Dec. 31, 2022
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)	20,981	11,357
Preferred stock, shares outstanding (in shares)	20,981	11,357
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	80,000,000	80,000,000
Common stock, shares issued (in shares)	15,250,469	10,046,571
Common stock, shares outstanding (in shares)	15,250,469	10,046,571

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Total revenues	$ 495	$ 797	$ 1,092	$ 1,174
Cost of goods sold	(150)	(180)	(331)	(214)
Gross profit	345	617	761	960
Operating expenses:
Research and development expenses	3,555	5,606	8,131	10,087
Selling, general and administrative expenses	4,787	4,497	8,952	8,699
Total operating expenses	8,342	10,103	17,083	18,786
Operating loss	(7,997)	(9,486)	(16,322)	(17,826)
Change in fair value of warrant liability	1,160	0	1,160	0
Interest expense, net	(371)	(665)	(1,059)	(1,309)
Other income (expense)	6	(8)	19	(24)
Net loss	(7,202)	(10,159)	(16,202)	(19,159)
Other comprehensive income:
Foreign currency translation adjustments	0	(31)	19	(29)
Total other comprehensive loss	$ (7,202)	$ (10,190)	$ (16,183)	$ (19,188)
Common share data:
Basic loss per common share (in dollars per share)	$ (0.58)	$ (1.24)	$ (1.35)	$ (2.34)
Diluted loss per common share (in dollars per share)	$ (0.58)	$ (1.24)	$ (1.35)	$ (2.34)
Weighted average number of basic shares outstanding (in shares)	12,463,665	8,190,483	12,035,738	8,190,483
Weighted average number of diluted shares outstanding (in shares)	12,463,665	8,190,483	12,035,738	8,190,483
Product revenue
Total revenues	$ 495	$ 797	$ 1,092	$ 1,003
Other revenue
Total revenues	$ 0	$ 0	$ 0	$ 171

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands	Total	Preferred F-1 Stock	Series F-2	Common Stock	Common Stock Preferred F-1 Stock	Preferred Stock	Preferred Stock Series F-2	Additional Paid in Capital	Additional Paid in Capital Preferred F-1 Stock	Additional Paid in Capital Series F-2	Accumulated Deficit	Accumulated Other Comprehensive Income (Loss)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Preferred stock, par value (in dollars per share)	$ 0.01
Common stock, par value (in dollars per share)	$ 0.01
Beginning Balance (in shares) at Dec. 31, 2021				7,906,728		11,357
Beginning Balance at Dec. 31, 2021	$ 11,952			$ 79		$ 0		$ 432,831			$ (420,976)	$ 18
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	2,271							2,271
Net loss	(9,000)										(9,000)
Total comprehensive income	2											2
Ending Balance (in shares) at Mar. 31, 2022				7,906,728		11,357
Ending Balance at Mar. 31, 2022	5,225			$ 79		$ 0		435,102			(429,976)	20
Beginning Balance (in shares) at Dec. 31, 2021				7,906,728		11,357
Beginning Balance at Dec. 31, 2021	11,952			$ 79		$ 0		432,831			(420,976)	18
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	(19,159)
Ending Balance (in shares) at Jun. 30, 2022				7,906,728		11,357
Ending Balance at Jun. 30, 2022	$ (2,846)			$ 79		$ 0		437,221			(440,135)	(11)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Preferred stock, par value (in dollars per share)	$ 0.01
Common stock, par value (in dollars per share)	$ 0.01
Beginning Balance (in shares) at Mar. 31, 2022				7,906,728		11,357
Beginning Balance at Mar. 31, 2022	$ 5,225			$ 79		$ 0		435,102			(429,976)	20
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	2,119							2,119
Net loss	(10,159)										(10,159)
Total comprehensive income	(31)											(31)
Ending Balance (in shares) at Jun. 30, 2022				7,906,728		11,357
Ending Balance at Jun. 30, 2022	$ (2,846)			$ 79		$ 0		437,221			(440,135)	(11)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Preferred stock, par value (in dollars per share)	$ 0.01
Common stock, par value (in dollars per share)	0.01
Preferred stock, par value (in dollars per share)	0.01
Common stock, par value (in dollars per share)	$ 0.01
Beginning Balance (in shares) at Dec. 31, 2022				10,046,571		11,357
Beginning Balance at Dec. 31, 2022	$ (5,859)			$ 100		$ 0		451,608			(457,484)	(83)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	1,661							1,661
Private placement -issuance of common shares, net of expenses (in shares)				19,646
Private placement -issuance of common shares, net of expenses	56			$ 1				55
Issuance of common stock with the employee stock purchase plan (in shares)				15,417
Issuance of common stock with the employee stock purchase plan	47							47
Net loss	(9,000)										(9,000)
Total comprehensive income	19											19
Ending Balance (in shares) at Mar. 31, 2023				10,081,634		11,357
Ending Balance at Mar. 31, 2023	(13,076)			$ 101		$ 0		453,371			(466,484)	(64)
Beginning Balance (in shares) at Dec. 31, 2022				10,046,571		11,357
Beginning Balance at Dec. 31, 2022	$ (5,859)			$ 100		$ 0		451,608			(457,484)	(83)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
[Series E] Warrant Exercise (in shares)			9,624
Issuance of common stock related to stock option exercises (in shares)	468
Net loss	$ (16,202)
Ending Balance (in shares) at Jun. 30, 2023				15,250,469		20,981
Ending Balance at Jun. 30, 2023	$ (242)			$ 153		$ 0		473,355			(473,686)	(64)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Preferred stock, par value (in dollars per share)	$ 0.01
Common stock, par value (in dollars per share)	$ 0.01
Beginning Balance (in shares) at Mar. 31, 2023				10,081,634		11,357
Beginning Balance at Mar. 31, 2023	$ (13,076)			$ 101		$ 0		453,371			(466,484)	(64)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	1,661							1,661
Stock issued during period (in shares)							9,624
Stock issued during the period			$ 7,099							$ 7,099
[Series E] Warrant Exercise (in shares)				538,828	4,629,539
Prefunded warrant exercise	$ 5	$ 11,269		$ 5	$ 47				$ 11,222
Issuance of common stock related to stock option exercises (in shares)	468
Issuance of common stock related to stock option exercises	$ 2							2
Net loss	(7,202)										(7,202)
Ending Balance (in shares) at Jun. 30, 2023				15,250,469		20,981
Ending Balance at Jun. 30, 2023	$ (242)			$ 153		$ 0		$ 473,355			$ (473,686)	$ (64)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Preferred stock, par value (in dollars per share)	$ 0.01
Common stock, par value (in dollars per share)	$ 0.01

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Cash flows from operating activities:
Net loss	$ (16,202)	$ (19,159)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock option compensation expense	3,322	4,390
Depreciation expense	59	31
Warrant liability fair value adjustment	(1,160)	0
Non-cash lease expense	195	234
Amortization of debt discount	388	380
Interest expense accrued related to convertible notes	80	80
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(306)	374
Accounts receivable	239	(394)
Inventory	(482)	(628)
Accounts payable and accrued expenses	132	2,667
Other liabilities, non-current	(177)	(217)
Deferred revenue	0	(170)
Net cash used in operating activities	(13,912)	(12,412)
Cash flows from investing activities:
Purchase of property, plant and equipment	(40)	(141)
Net cash used in investing activities	(40)	(141)
Cash flows from financing activities:
Net proceeds from private placement	22,960	0
Proceeds from the issuance of common stock relating to the employee stock purchase plan	47	0
Repayment of debt	(6,313)	0
Proceeds from exercise of warrants	5	0
Proceeds from exercise of stock options	2	0
Net cash provided by financing activities	16,701	0
Foreign currency effects on cash	19	(46)
Net increase (decrease) in total cash	2,768	(12,599)
Total Cash, Cash Equivalents and Restricted Cash:
Beginning of period	11,822	26,953
End of period	14,590	14,354
Cash, Cash Equivalents and Restricted Cash consisted of the following:
Cash	14,540	10,203
Restricted Cash	50	4,151
Total cash, cash equivalents and restricted cash shown in the statements of cash flows	14,590	14,354
Cash paid during the periods for:
Interest expense	787	842
Supplemental Disclosure of Non-Cash Investing and Financing Activities:
Right of use assets obtained in exchange for lease obligations	84	0
Conversion of mezzanine equity to common shares	11,269	0
Conversion of mezzanine equity to preferred shares	$ 7,099	$ 0

General

General	6 Months Ended
	Jun. 30, 2023
Accounting Policies [Abstract]
General	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, 2023 and 2022 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, 2022 (the “Annual Report”), which was filed with the Securities and Exchange Commission (the “SEC”) on March 27, 2023 and may also be found on the Company’s website (www.delcath.com). In these notes to the interim condensed consolidated financial statements the terms “us”, “we” or “our” refer to Delcath and its consolidated subsidiaries. Description of Business The Company is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company’s lead product candidate, the HEPZATO ® KIT (melphalan hydrochloride for injection/hepatic delivery system), or HEPZATO, is a drug/device combination product designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, the hepatic delivery system is a stand-alone medical device having the same device components as HEPZATO but without the melphalan hydrochloride and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used at major medical centers to treat a wide range of cancers of the liver. In the United States, HEPZATO is considered a combination drug and device product and is regulated as a drug by the United States Food and Drug Administration (the “FDA”). Primary jurisdiction for regulation of HEPZATO has been assigned to the FDA’s Center for Drug Evaluation and Research. The FDA has granted Delcath six orphan drug designations (five for melphalan in the treatment of patients with ocular (uveal) melanoma, cutaneous melanoma, intrahepatic cholangiocarcinoma, hepatocellular carcinoma, and neuroendocrine tumor indications and one for doxorubicin in the treatment of patients with hepatocellular carcinoma). HEPZATO has not been approved for sale in the United States. The Company’s clinical development program for HEPZATO is comprised of the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the “FOCUS Trial”), a global registration clinical trial that is investigating objective response rate in metastatic ocular melanoma (“mOM”), a type of primary liver cancer. The Company’s most advanced development program is the treatment of mOM. The Company is 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 that will maximize the value of the HEPZATO platform. In addition to HEPZATO’s use to treat mOM, the Company believes that HEPZATO has the potential to treat other liver dominant cancers, such as Metastatic Colorectal Cancer and Cholangiocarcinoma, and plans to begin the study of HEPZATO to treat such conditions in the near future. The Company believes that the disease states we are investigating and intend to investigate are unmet medical needs that represent significant market opportunities. In December 2021, the Company announced that the FOCUS Trial for HEPZATO met its pre-specified endpoint. For information on the FOCUS Trial, see “Part I, Item 1. Business—Clinical Development Program—The FOCUS Trial” in our Annual Report. On February 14, 2023, the Company filed a New Drug Application (“NDA”) resubmission (the “NDA resubmission”) with the FDA for the HEPZATO KIT (melphalan hydrochloride for Injection/Hepatic Delivery System) seeking approval of the HEPZATO KIT in the treatment of patients with unresectable hepatic-dominant mOM. The NDA resubmission was in response to a September 12, 2013 Complete Response Letter (“CRL”) from the FDA for the NDA the Company submitted in December 2010 seeking approval of its first generation melphalan hydrochloride for injection/hepatic delivery system. The NDA resubmission contains comprehensive data and information on Generation Two HEPZATO KIT relating to the matters identified in the CRL. On March 20, 2023, the FDA determined the NDA resubmission constituted a complete response and set a Prescription Drug User Fee Act (“PDUFA”) target action date of August 14, 2023. The Company continues its expanded access programs (“EAP”) in the United States to make HEPZATO readily available to mOM patients. The Company is focused on continuing to treat these patients with mOM as regulatory approval is sought in the United States. There are currently patients enrolled in the Company’s EAP sites. On February 28, 2022, CHEMOSAT received Medical Device Regulation (“MDR”) certification under the European Medical Devices Regulation [2017/745/EU], which may be considered by jurisdictions when evaluating reimbursement. As of March 1, 2022, the Company has assumed direct responsibility for sales, marketing and distribution of CHEMOSAT in Europe. Risks and Uncertainties The Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and commercial success of its drug/device combination products, its ability to obtain regulatory approval of its such produ cts in the United States and other geography markets, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition. In addition, inflation rates have increased recently to levels not seen in decades. As a result, the U.S. Federal Reserve has raised interest rates in response to concerns about inflation. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may further increase economic uncertainty and heighten these risks. Furthermore, if, in addition to the recent bank failures of Silicon Valley Bank, Signature Bank and First Republic Bank, other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our or our partners’ ability to access existing cash, cash equivalents and investments may be threatened and could have a material adverse effect on our business and financial condition. If the disruptions and slowdown deepen or persist, we may not be able to access additional capital on favorable terms, or at all, which could in the future negatively affect our ability to pursue our business strategy. Liquidity and Going Concern On June 30, 2023, the Company had cash, cash equivalents and restricted cash totaling $14.6 million, as compared to cash, cash equivalents and restricted cash totaling $11.8 million at December 31, 2022. During the six months ended June 30, 2023, the Company used $13.9 million of cash in its operating activities and $6.3 million for principal payments. The Company’s future results are subject to substantial risks and uncertainties. The Company has operated at a loss for its entire history and there can be no assurance that it will ever achieve or maintain profitability. The Company has historically funded its operations primarily with proceeds from sales of common stock, warrants and prefunded warrants for the purchase of common stock, sales of preferred stock, proceeds from the issuance of convertible debt and borrowings under loan and security agreements. The Company believes that current cash and cash equivalents will enable the Company to have sufficient cash past our anticipated PDUFA date of August 14, 2023. If there is a substantial delay in the approval of HEPZATO, the Company expects to need to raise additional capital under structures available to the Company, including debt and/or equity offerings, which may not be on favorable terms. In a delayed approval scenario, the Company will not have sufficient funds to meet its obligations within twelve months from the issuance date of these condensed consolidated financial statements. The Company’s capital commitments over the next twelve months include (a) $6.6 million to satisfy accounts payable, accrued expenses and lease liabilities and (b) $5.1 million of loan principal payments. Additional capital commitments beyond the next twelve months include (a) $0.1 million of lease liabilities; (b) $1.0 million for settlement of litigation with medac; (c) $0.5 million of loan principal payments; and (d) $5.0 million of convertible note principal payments, if the holders do not elect to convert the notes into equity. 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 wholly owned subsidiaries 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, 2023 and 2022; however, certain information and footnote disclosures normally included in our audited consolidated financial statements included in our Annual Report 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 Other than the policies listed below, 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, 2022. Warrant Liabilities The Company determined the warrant liability was not in accordance with the provisions of ASC 480, Distinguishing Liabilities from Equity, which classifies and measures certain financial instruments with characteristics of both liability and equity. Entities must consider whether to classify contracts that may be settled in its own stock, such as warrants, as equity of the entity or as an asset or liability. If an event that is not within the entity’s control could require net cash settlement, then the contract should be classified as an asset or a liability at their fair value at issuance with subsequent changes in fair value recorded in earnings. The Company has accounted for the Preferred Warrants as derivative instruments in accordance with ASC 815, Derivatives and Hedging. The Company classified the Preferred Warrants issued in conjunction with the Preferred Purchase Agreement (defined below) and the Common Warrants issued in conjunction with the Common Purchase Agreement as a liability due to the existence of a pre-specified volatility input to the Black-Scholes calculation which would be used to calculate the repurchase price of the Preferred Warrants and Common Warrants in the event of a Fundamental Transaction, as defined. The valuations of the warrant liability and Series F-1 Preferred Stock (defined below) were determined using option pricing models. These models use inputs such as the underlying price of the shares issued at the measurement date, volatility, risk free interest rate and expected life of the instrument. In addition, the Company used probabilities of the FDA approval of the HEPZATO KIT (“FDA Approval”) and of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO as inputs to determine the fair value of warrants liability and Series F-1 Preferred Stock. The Company intends to adjust the fair value of the warranty liability at the end of each reporting period. Recently Adopted and Issued Accounting Pronouncements We have not been required to adopt any accounting standards that had a significant impact on our consolidated financial statements in the two years ended December 31, 2022. We do not expect any recently issued accounting standards to have a significant impact on our consolidated financial statements. Revision of Previously Issued Quarterly Financial Statements In preparation of the Company’s audited financial statements as of and for year ended December 31, 2022, the Company determined it needed to correct previously reported share-based compensation expense for each quarter during 2022. The correction for share-based compensation increased the net loss in amount of $0.8 million for the first quarter of 2022, $0.5 million for the second quarter of 2022 and $0.4 million for the third quarter of fiscal 2022. The share-based compensation adjustment is a non-cash adjustment and did not have any impact on the cash balances for the Company. The following tables contain the financial information for the periods previously reported and have been updated to reflect the revisions of the Company’s financial statements. The revisions do not have an impact on the Company’s cash position. The Company has not amended its previously filed Quarterly Reports on Form 10-Q for the three quarterly periods ended September 30, 2022. The impact of the revision on the Company’s financial statements for the three and six months ended June 30, 2022 is reflected in the following table: (In thousands) As previously reported Adjustment As revised Balance Sheet for June 30, 2022 (unaudited) Additional paid-in capital $ 435,922 $ 1,299 $ 437,221 Accumulated deficit $ (438,836) $ (1,299) $ (440,135) Consolidated Statement of Operations and Comprehensive Loss for the three months ended June 30, 2022 (unaudited) Research and development expenses $ 5,456 $ 150 $ 5,606 Selling, general and administrative expenses 4,145 352 4,497 Total operating expenses 9,601 502 10,103 Operating loss (8,984) (502) (9,486) Net loss (9,657) (502) (10,159) Total other comprehensive loss (9,688) (502) (10,190) Basic and diluted loss per common share $ (1.18) $ (0.06) $ (1.24) Consolidated Statement of Operations and Comprehensive Loss for the six months June 30, 2022 (unaudited) Research and development expenses $ 9,696 $ 391 $ 10,087 Selling, general and administrative expenses 7,791 908 8,699 Total operating expenses 17,487 1,299 18,786 Operating loss (16,527) (1,299) (17,826) Net loss (17,860) (1,299) (19,159) Total other comprehensive loss (17,889) (1,299) (19,188) Basic and diluted loss per common share $ (2.18) $ (0.16) $ (2.34) Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended June 30, 2022 (unaudited) Compensation expense for issuance of stock options $ 1,617 $ 502 $ 2,119 Net loss $ (9,657) $ (502) $ (10,159) Consolidated statement of Stockholders’ Equity (Deficit) for the six months ended June 30, 2022 (unaudited) Compensation expense for issuance of stock options $ 3,091 $ 1,299 $ 4,390 Net loss $ (17,860) $ (1,299) $ (19,159) Consolidated Statement of Cash Flows for the six months ended June 30, 2022 (unaudited) Net loss $ (17,860) $ (1,299) $ (19,159) Stock option compensation expense $ 3,091 $ 1,299 $ 4,390

Cash, Cash Equivalents and Rest

Cash, Cash Equivalents and Restricted Cash	6 Months Ended
	Jun. 30, 2023
Cash and Cash Equivalents [Abstract]
Cash, Cash Equivalents and Restricted Cash	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 on the balance sheets. Cash, cash equivalents, and restricted cash balances were as follows: (In thousands) June 30, December 31, Cash and cash equivalents $ 14,540 $ 7,671 Restricted balance for loan agreement — 4,000 Letters of credit — 101 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 14,590 $ 11,822

Inventory

Inventory	6 Months Ended
	Jun. 30, 2023
Inventory Disclosure [Abstract]
Inventory	Inventory Inventory consists of the following: (In thousands) June 30, December 31, Raw materials $ 796 $ 763 Work-in-process 1,571 1,102 Finished goods 113 133 Total inventory $ 2,480 $ 1,998

Prepaid Expenses and Other Curr

Prepaid Expenses and Other Current Assets	6 Months Ended
	Jun. 30, 2023
Prepaid Expense and Other Assets, Current [Abstract]
Prepaid Expenses and Other Current Assets	Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: (In thousands) June 30, December 31, Clinical trial expenses $ 1,630 $ 1,630 Insurance premiums 94 123 Professional services 389 121 Other 162 95 Total prepaid expenses and other current assets $ 2,275 $ 1,969

Property, Plant, and Equipment

Property, Plant, and Equipment	6 Months Ended
	Jun. 30, 2023
Property, Plant and Equipment [Abstract]
Property, Plant, and Equipment	Property, Plant, and Equipment Property, plant, and equipment consist of the following: (In thousands) June 30, 2023 December 31, 2022 Estimated Useful Life Buildings and land $ 1,301 $ 1,301 30 years - Buildings Enterprise hardware and software 1,856 1,855 3 years Leaseholds 1,781 1,774 Lesser of lease term or estimated useful life Equipment 1,263 1,222 7 years Furniture 201 201 5 years Property, plant and equipment, gross 6,402 6,353 Accumulated depreciation (4,999) (4,931) Property, plant and equipment, net $ 1,403 $ 1,422 Depreciation expense for the three and six months ended June 30, 2023 and 2022 was less than $0.1 million for each period.

Accrued Expenses

Accrued Expenses	6 Months Ended
	Jun. 30, 2023
Payables and Accruals [Abstract]
Accrued Expenses	Accrued Expenses Accrued expenses consist of the following: (In thousands) June 30, December 31, Clinical expenses $ 1,769 $ 1,470 Compensation, excluding taxes 1,328 1,040 Professional fees 1,219 1,087 Interest on convertible note 633 553 Other 597 535 Total accrued expenses $ 5,546 $ 4,685

Leases

Leases	6 Months Ended
	Jun. 30, 2023
Leases [Abstract]
Leases	LeasesThe 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. For the three and six months ended June 30, 2023 and 2022, the Company recognized $0.1 million and $0.2 million, respectively, of operating lease expense in the U.S. and less than $0.1 million of operating lease expense in Ireland for the same periods. As of June 30, 2023: (In thousands) U.S. Ireland Total Operating cash flows for operating leases $ 181 $ 14 $ 195 Weighted average remaining lease term 0.3 3.1 Weighted average discount rate - operating leases 8 % 8 % Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows: U.S. Ireland Total Year ended December 31, 2023 $ 56 $ 18 $ 74 Year ended December 31, 2024 — 36 36 Year ended December 31, 2025 — 36 36 Year ended December 31, 2026 — 21 21 Total 56 111 167 Less present value discount (1) (12) (13) Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2023 $ 55 $ 99 $ 154
Leases	LeasesThe 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. For the three and six months ended June 30, 2023 and 2022, the Company recognized $0.1 million and $0.2 million, respectively, of operating lease expense in the U.S. and less than $0.1 million of operating lease expense in Ireland for the same periods. As of June 30, 2023: (In thousands) U.S. Ireland Total Operating cash flows for operating leases $ 181 $ 14 $ 195 Weighted average remaining lease term 0.3 3.1 Weighted average discount rate - operating leases 8 % 8 % Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows: U.S. Ireland Total Year ended December 31, 2023 $ 56 $ 18 $ 74 Year ended December 31, 2024 — 36 36 Year ended December 31, 2025 — 36 36 Year ended December 31, 2026 — 21 21 Total 56 111 167 Less present value discount (1) (12) (13) Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2023 $ 55 $ 99 $ 154

Loans and Convertible Notes Pay

Loans and Convertible Notes Payable	6 Months Ended
	Jun. 30, 2023
Debt Disclosure [Abstract]
Loans and Convertible Notes Payable	Loans and Convertible Notes Payable June 30, 2023 December 31, 2022 (In thousands) Gross Discount Net Gross Discount Net Loan - Avenue [1] $ 5,610 $ (689) $ 4,921 $ 11,923 $ (1,008) $ 10,916 Loan - Avenue [1] - Less Current Portion (5,142) 632 (4,510) (8,570) 724 (7,846) Total - Loans Payable, Non-Current $ 468 $ (57) $ 411 $ 3,353 $ (284) $ 3,070 Convertible Note Payable - Rosalind 2,000 2,000 2,000 — 2,000 Convertible Portion of Loan Payable - Avenue 3,000 (159) 2,841 3,000 (228) 2,772 Total - Convertible Notes Payable - Non-Current $ 5,000 $ (159) $ 4,841 $ 5,000 $ (228) $ 4,772 [1] The gross amount includes the 4.25% final payment of $0.5 million. Remaining maturities of the Company’s loan and convertible note payables are as follows: (In thousands) Loans Convertible Total Year ended December 31, 2023 $ 2,221 $ — $ 2,221 Year ended December 31, 2024 3,389 5,000 8,389 Total $ 5,610 $ 5,000 $ 10,610 Term Loan from Avenue Venture Opportunities Fund, L.P. On August 6, 2021, the Company entered into a Loan and Security Agreement (the “Avenue Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (the “Lender,” or “Avenue”) for a term loan in an aggregate principal amount of up to $20.0 million (the “Avenue Loan”). The Avenue 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 interest rate at June 30, 2023 was 15.95%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. The Avenue Loan matures on August 1, 2024. The initial tranche of the Avenue Loan is $15.0 million, including $4.0 million that was funded into a restricted account and was 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 pre-specified 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 FDA, 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 million. Up to $3.0 million of the principal amount of the Avenue Loan outstanding may be converted, at the option of Avenue, into shares of the Company’s common stock at a conversion price of $11.98 per share. In connection with the Avenue Loan, the Company issued to Avenue a warrant (the “Avenue Warrant”) to purchase 127,755 shares of common stock at an exercise price per share equal to $0.01. The Avenue Warrant is exercisable until August 31, 2026. On March 15, 2023, the Company returned to Avenue $4.0 million held in the restricted cash to pay down a portion of the outstanding loan balance, principal payments of $2.1 million and an incremental 4.25% of the final payment of $0.2 million. On March 31, 2023, the Company reached an agreement to amend the Avenue Loan Agreement to defer the interest only to September 30, 2023. The interest only period may be extended at the Company’s option to December 31, 2023 if, by September 30, 2023, the Company has (a) received FDA approval for the HEPZATO KIT and (b) received net proceeds of at least $10 million from the sale and issuance of equity securities or exercise of existing warrants. In exchange for this extension, the Company has agreed to provide Avenue with 34,072 warrants to purchase shares of common stock. The exercise price of the warrants is $0.01. The Avenue Loan Agreement requires the Company to make and maintain representations and warranties and other agreements that are customary in loan agreements of this type. The Avenue Loan Agreement also contains customary events of default, including non-payment of principal or interest, violations of covenants, bankruptcy and material judgments. The Company determined that the embedded conversion option associated with the Avenue Loan did not require bifurcation and met the criteria for equity classification. In addition, the amendment was recorded under debt modification guidance. Aggregate debt discount amortization of $0.2 million and $0.4 million was recorded during the three and six months ended June 30, 2023 and 2022, respectively. Interest expense incurred was $0.3 million and $0.4 million for the three months ended June 30, 2023 and 2022, respectively and $0.8 million for both the six months ended June 30, 2023 and 2022. Convertible Notes Payable The Company has $2.0 million of principal outstanding related to Senior Secured Promissory Notes (the “Rosalind Notes”) which bear interest at 8% per annum. Pursuant to the original terms, the Rosalind Notes were convertible into Series E Preferred Stock at a price of $1,500 per share and were to mature on July 16, 2021. Interest expense was less than $0.1 million for the three and six months ended June 30, 2023 and 2022, respectively.

Preferred Purchase Agreement

Preferred Purchase Agreement	6 Months Ended
	Jun. 30, 2023
Preferred Purchase Agreement [Abstract]
Preferred Purchase Agreement	Preferred Purchase Agreement Preferred Purchase Agreement On March 29, 2023, the Company closed the Series F Preferred Offering (defined below). Pursuant to the Certificate of Designation of Preferences, Rights and Limitations of the Series F Convertible Voting Preferred Stock (the “Certificate of Designation”), upon the Stockholder Approval (defined below), each share of Series F-1 Preferred Stock was automatically converted into shares of common stock and/or, if applicable (in accordance with the beneficial ownership limitations then in effect), shares of Series F-2 Preferred Stock, par value $0.01 per share (the “Series F-2 Preferred Stock” and, together with the Series F-1 Preferred Stock, the Series F-3 Preferred Stock and the Series F-4 Preferred Stock, the “Series F Preferred Stock”) in lieu of common stock. The aggregate exercise price of the Preferred Tranche A Warrants (defined below) is approximately $34.9 million, exercisable for an aggregate of 34,860 shares of Series F-3 Preferred Stock until the earlier of 21 days following the Company’s announcement of receipt of approval from the U.S. Food and Drug Administration for HEPZATO and March 31, 2026. The aggregate exercise price of the Preferred Tranche B Warrants (defined below) is approximately $24.9 million, exercisable for an aggregate of 24,900 shares of Series F-4 Preferred Stock until the earlier of 21 days following the Company’s announcement of receipt of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO and March 31, 2026; provided, however, that if the FDA Approval occurs on or before February 15, 2024 and the holder of the Preferred Tranche B Warrant has not exercised its Preferred Tranche A Warrant by or before March 7, 2024, then any Series F-4 Preferred Stock not yet exercised pursuant to the Preferred Tranche B Warrant at such time shall expire. The gross proceeds of $24.9 million were allocated first to the Preferred Warrant liabilities at their fair value of $4.9 million, with the residual of $20.0 million being allocated to the Series F-1 Preferred Stock. The Company also expensed $0.4 million of issuance costs that were allocated to the warranty liability during the three and six months ended June 30, 2023. The Series F-2, F-3 and F-4 Preferred Stock are not mandatorily redeemable, redeemable at the holder’s election or contingently redeemable at the holder’s election (at this point, a Deemed Liquidation Event would potentially trigger pro rata liquidation payments to the preferred and common stockholders on a pro rata “as converted” basis). Accordingly, the Series F-2, F-3 and F-4 Preferred are now classified as permanent equity following the Stockholder Approval. As of June 30, 2023, 15,276 shares of the Company’s Series F-1 Preferred Stock were converted into 4,629,539 shares of common stock and 9,624 shares of the Company’s Series F-1 Preferred Stock were converted into an equal number of shares of Series F-2 Preferred Stock.

Stockholders' Equity

Stockholders' Equity	6 Months Ended
	Jun. 30, 2023
Stockholders' Equity Note [Abstract]
Stockholders' Equity	Stockholders’ Equity Public and Private Placements Common Purchase Agreement On March 29, 2023, the Company closed the Common Offering. The aggregate exercise price of the Common Tranche A Warrants issued under the Common Offering is approximately $0.1 million, exercisable for an aggregate of 31,110 shares of common stock until the earlier of 21 days following the Company’s announcement of receipt of FDA Approval and March 31, 2026. The aggregate exercise price of the Common Tranche B Warrants issued under the Common Offering is approximately $0.1 million, exercisable for an aggregate of 16,666 shares of common stock until the earlier of 21 days following the Company’s announcement of receipt of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO and March 31, 2026; provided, however, that if the FDA Approval occurs on or before February 15, 2024 and the holder of the Common Tranche B Warrant has not exercised its Common Tranche A Warrant by or before March 7, 2024, then any warrants not yet exercised pursuant to the Common Tranche B Warrant at such time shall expire. The Company determined that the Common Warrants should be liability-classified. See “Note 1 – Warrant Liabilities” for a discussion of the accounting treatment of the Common Warrants and Preferred Warrants. Registration Rights for Preferred and Common Offerings Pursuant to the Preferred Purchase Agreement and the Common Purchase Agreement (collectively, the “Purchase Agreements”), and the Stockholder Approval, the Company filed a registration statement on Form S-3 providing for the resale by the investors party thereto of the common stock issuable upon conversion of the Registrable Shares (as defined in the Purchase Agreements). The Form S-3 became effective on June 28, 2023. The securities issued in the Series F Preferred Offering and the Common Offering have not been registered under the Securities Act of 1933, as amended (the “Securities Act”). There is no established public trading market for the Series F Preferred Stock, the Preferred Warrants, or the Common Warrants and the Company does not intend to list such securities on any national securities exchange or nationally recognized trading system. At-the-Market Offering The Company has entered into a Controlled Equity Offering SM Sales Agreement (“ATM Sales Agreement”), with Cantor Fitzgerald & Co. (the “Sales Agent”), pursuant to which the Company may offer and sell, at its sole discretion through the Sales Agent, shares of common stock having an aggregate offering price of up to $17.0 million. To date, the Company has sold approximately $4.0 million of its common stock, prior to issuance costs, under the ATM Sales Agreement. No sales were made during the three and six months ended June 30, 2023. Authorized Shares Stockholders approved the amendment of the Company’s Amended and Restated Certificate of Incorporation to increase the total number of shares of its common stock authorized for issuance from 40 million shares to 80 million shares. The Company is authorized to issue 80 million shares of common stock, $0.01 par value, and 10 million shares of preferred stock, $0.01 par value. As of June 30, 2023, the Company has designated the following preferred stock: Designated Preferred Shares June 30, 2023 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 Preferred Stock As of June 30, 2023, there were an aggregate of 11,357 shares of Series E and Series E-1 and 9,624 Series F-2 Convertible Preferred Stock outstanding, respectively. Omnibus Equity Incentive Plan On September 30, 2020, the Company’s 2020 Omnibus Equity Incentive Plan (the “2020 Plan”) was adopted by the Company’s Board of Directors. On November 23, 2020, the Company’s stockholders approved the 2020 Plan. The 2020 Plan will continue in effect until the tenth anniversary of the date of its adoption by the Board or until earlier terminated by the Board. The 2020 Plan is administered by the Board of Directors or a committee designated by the Board of Directors. On June 12, 2023, the stockholders approved the amendment to the Company’s 2020 Plan to increase the number of shares of common stock available under the plan by 2.65 million shares. The 2020 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards, as well as other stock-based awards or cash awards that are deemed to be consistent with the purposes of the plan to Company employees, directors and consultants. As of June 30, 2023, there are 5,125,000 shares of common stock reserved under the 2020 Plan, of which 1,861,160 remained available to be issued. Stock Options The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods: Six Months Ended June 30, 2023 2022 Expected terms (years) 5.2-5.8 5.2-6.5 Expected volatility 129.8%-172.8% 174.8% -180.3% Risk-free interest rate 3.88% -4.08% 1.75% - 2.90% Expected dividends 0.00% 0.00% The following is a summary of stock option activity for the six months ended June 30, 2023: Number of Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding at January 1, 2023 2,235,052 $ 10.30 Granted 1,991,757 6.19 Exercised (468) 4.67 Expired (75,772) 9.49 Cancelled/Forfeited (22,637) 10.36 Outstanding at June 30, 2023 4,127,932 $ 8.33 8.7 $ 994 Exercisable at June 30, 2023 1,741,313 $ 10.56 7.7 $ 116 The following table summarizes information for stock option shares outstanding and exercisable at June 30, 2023: Options Outstanding Range of Exercise Prices Outstanding Number of Weighted Average Number of Options $2.83 - $51.50 4,127,433 8.7 1,740,814 $51.50+ 499 5.6 499 4,127,932 8.7 1,741,313 The following is a summary of share-based compensation expense in the statement of operations for the three and six months ended June 30, 2023: Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2023 2022 2023 2022 Selling, general and administrative $ 911 $ 1,467 $ 2,099 $ 2,866 Research and development 651 613 1,068 1,416 Cost of goods sold 99 39 155 108 Total $ 1,661 $ 2,119 $ 3,322 $ 4,390 At June 30, 2023, there was $10.0 million of aggregate unrecognized compensation expense related employee and board stock option grants. The cost is expected to be recognized over a weighted average period of 2.6 years. Common Stock Warrants The following is a summary of common stock warrant activity for the six months ended June 30, 2023: Warrants Weighted Average Exercise Price Weighted Average Outstanding at January 1, 2023 5,153,291 $ 7.01 Warrants issued 81,849 2.94 Warrants exercised (538,828) 0.01 Outstanding at June 30, 2023 4,696,312 $ 7.74 2.1 Exercisable at June 30, 2023 4,696,312 $ 7.74 2.1 The following table presents information related to common stock warrants at June 30, 2023: Warrants Exercisable Range of Exercise Prices Outstanding Weighted Average Number of Warrants $0.01 1,037,792 3.7 1,037,792 $4.50-$6.00 47,777 2.8 47,777 $10.00 3,610,743 1.7 3,610,743 4,696,312 2.1 4,696,312 On April 18, 2023, there were 538,828 of $0.01 warrants exercised for 538,828 common shares. Employee Stock Purchase Plan In August 2021, the Company’s Board of Directors, with shareholder approval in May 2022, adopted the Employee Stock Purchase Plan (the “ESPP”). The ESPP provides for a maximum of 260,295 shares of common stock to be purchased by participating employees. Employees who elect to participate in the ESPP will be able to purchase common stock at the lower of 85% of the fair market value of common stock on the first or last day of the applicable six-month offering period. In January 2023, an aggregate of 15,417 shares were purchased by participating employees for the offering period of July 1, 2022 to December 31, 2022. In July 2023, an aggregate of 26,018 shares were purchased by participating employees for the offering period of January 1, 2023 to June 30, 2023.

Net Loss per Share

Net Loss per Share	6 Months Ended
	Jun. 30, 2023
Earnings Per Share [Abstract]
Net Loss per Share	Net Loss per ShareBasic 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 convertible preferred shares and preferred and common 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, 2023 and 2022 because their effects would be anti-dilutive: June 30, 2023 2022 Common stock warrants 3,658,520 3,894,498 Assumed conversation of preferred stock warrants 11,896,667 — Assumed conversion of preferred stock 4,051,637 1,135,721 Assumed conversion of convertible notes 488,031 488,031 Stock options 4,127,932 2,311,393 Total 24,222,787 7,829,643 At June 30, 2023, the Company had 1,037,792 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, 2023 and 2022: Three months ended June 30, Six months ended June 30, 2023 2022 2023 2022 Weighted average shares issued 11,320,450 7,906,728 10,693,762 7,906,728 Weighted average pre-funded warrants 1,143,215 283,755 1,341,976 283,755 Weighted average shares outstanding 12,463,665 8,190,483 12,035,738 8,190,483

Income Taxes

Income Taxes	6 Months Ended
	Jun. 30, 2023
Income Tax Disclosure [Abstract]
Income Taxes	Income Taxes As discussed in “Note 14—Income Taxes” to the notes to the consolidated financial statements contained in the Annual Report, the Company has a valuation allowance against the full amount of its net deferred tax assets. The Company currently provides a valuation allowance against deferred tax assets when it is more likely than not that some portion or all of its deferred tax assets will not be realized. The Company has not recognized any unrecognized tax benefits in its balance sheet. The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. The federal and state tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a period within the statute of limitations. Additional information regarding the statutes of limitations can be found in Note 14 Income Taxes of the Company’s Annual Report.

Commitments and Contingencies

Commitments and Contingencies	6 Months Ended
	Jun. 30, 2023
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Commitments and Contingencies medac Matter In April 2021, the Company’s wholly owned subsidiary, Delcath Systems Ltd, issued to medac GmbH, a privately held, multi-national pharmaceutical company based in Germany (“medac”), an invoice for a €1 million milestone payment under a License, Supply and Marketing Agreement dated December 10, 2018 (the “medac Agreement”) between medac and the Company. The medac Agreement provided to medac the exclusive right to market and sell CHEMOSAT in certain designated countries for which the Company was entitled to a combination of upfront and success-based milestone payments as well as a fixed transfer price per unit of CHEMOSAT and specified royalties. In response to medac’s subsequent dispute and non-payment of the invoice, on October 12, 2021, the Company notified medac in writing that it was terminating the medac Agreement due to medac’s nonpayment of the €1 million milestone payment, with the effective date of termination of the medac Agreement being April 12, 2022. On December 16, 2021, the Company initiated an arbitration proceeding pursuant to the dispute resolution procedures of the medac Agreement for the non-payment of the invoice. On December 30, 2022, the parties reached a final settlement of the matter and the Company agreed to pay medac either (a) a royalty on sales of CHEMOSAT units over a defined minimum for a period of five years or until a maximum payment has been reached, or (b) a minimum annual payment of $0.2 million in the event the annual royalty payment does not reach the agreed minimum payment amount. The Company has estimated the fair value of the settlement to be $1.3 million as of June 30, 2023 and recorded $1.1 million as other liabilities, non-current and $0.2 million as accrued expenses on the Company’s condensed consolidated balance sheet as of June 30, 2023. Lachman Consulting Services, Inc On January 24, 2023, Lachman Consultant Services, Inc (“Lachman”) served the Company with a Complaint alleging that Delcath owes Lachman approximately $0.9 million in unpaid consulting fees plus interest, costs and attorneys’ fees. The dispute arose from a July 22, 2021 agreement between Lachman and Delcath under which Lachman provided assistance to the Company in regard to preparing for a FDA inspection and good manufacturing practices, training and support. As of June 30, 2023, the Company recorded $0.9 million as an accrued liability on the Company’s condensed consolidated balance sheet. A settlement was reached on July 5, 2023, under which the Company paid Lachman $0.9 million.

Fair Value Measurements

Fair Value Measurements	6 Months Ended
	Jun. 30, 2023
Fair Value Disclosures [Abstract]
Fair Value Measurements	Fair Value Measurements The table below presents activity within Level 3 of the fair value hierarchy, our liabilities carried at fair value for the six months ended June 30, 2023: Level 3 (In thousands) Contingent Warrants Total Balance at January 1, 2023 $ 1,280 $ — $ 1,280 Total change in foreign exchange 24 24 Fair value of the warrant liability issued — 4,940 4,940 Warrant liability fair value adjustment — (1,160) (1,160) Balance at June 30, 2023 $ 1,304 $ 3,780 $ 5,084 Contingent liabilities are re-measured to fair value each reporting period using projected financial targets, discount rates, probabilities of payment, and projected payment dates. Projected contingent payment amounts are discounted back to the current period using a discounted cash flow model. Projected financial targets are based on our most recent internal operational budgets and may take into consideration alternate scenarios that could result in more or less profitability for the respective service line. Increases or decreases in projected financial targets and probabilities of payment may result in significant changes in the fair value measurements. Increases in discount rates and the time to payment may result in lower fair value measurements. Increases or decreases in any of those inputs in isolation may result in a significantly lower or higher fair value measurement. As disclosed in Note 9 and Note 10 of the Company’s consolidated financial statements, the Company allocated part of the proceeds of the Series F Preferred Offering to warrant liability issued in connection with the transaction. The valuations of the warrants were determined using option pricing models. The Company concluded that the Preferred Warrants were not in the scope of Accounting Standards Codification (ASC 480), Distinguishing Liabilities from Equity (ASC 480,) since the Preferred Warrants are not mandatorily redeemable; and do not have obligations to issue a variable number of shares of preferred stock. The Company determined the Preferred Warrants met the definition of a derivative in accordance with ASC 815 but were not considered indexed to the Company’s common stock since the warrants require early settlement by repurchasing the preferred warrants for cash in an amount equal to the Black-Scholes value in the event of a Fundamental Transaction at pre-specified volatility of 100% as an input to the Black-Scholes calculation. The Company determined to record the Preferred Warrants at fair value with subsequent changes in fair value recorded in earnings at the end of each reporting period. For the three and six months ended June 30, 2023, the Company recorded other income of $1.2 million related to the change in fair value of the warrant liability. These models use inputs such as the underlying price of the shares issued at the measurement date, volatility, risk free interest rate and expected life of the instrument. The Company has classified the warrants as a long-term liability due to certain provisions relating to the holders’ ability to exercise the warrants beyond twelve months of the reporting date. The fair value of the preferred and common warrants at June 30, 2023 and March 29, 2023 was determined by using option pricing models assuming the following: March 29, 2023 June 30, 2023 Risk free interest rate 3.80% - 4.80% 4.39% - 5.29% Expected term (years) 0.5 - 3.0 0.3 - 2.8 Expected volatility 70% - 75% 65% - 70% Expected dividends 0.00 % 0.00 % Additionally, the Company has determined that the warrant liability should be classified within Level 3 of the fair-value hierarchy by evaluating each input for the option pricing models against the fair-value hierarchy criteria and using the lowest level of input as the basis for the fair-value classification as called for in ASC 820. There are six inputs: closing price of the Company’s stock on the day of evaluation; the exercise price of the warrants; the remaining term of the warrants; the volatility of the Company’s stock over that term; annual rate of dividends; and the risk-free rate of return. Of those inputs, the exercise price of the warrants and the remaining term are readily observable in the warrant agreements. The annual rate of dividends is based on the Company’s historical practice of not granting dividends. The closing price of the Company’s stock would fall under Level 1 of the fair-value hierarchy as it is a quoted price in an active market (ASC 820-10). The risk-free rate of return is a Level 2 input as defined in ASC 820-10, while the historical volatility is a Level 3 input as defined in ASC 820. Since the lowest level input is a Level 3, the Company determined the warrant liability is most appropriately classified within Level 3 of the fair value hierarchy. The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value as of June 30, 2023 and December 31, 2022 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value. In general, the fair values were determined using Level 3: (In thousands) Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant June 30, Liabilities: Contingent liability $ — $ — $ 1,304 $ 1,304 Warrant liability — — 3,780 3,780 Total liabilities $ — $ — $ 5,084 $ 5,084 (In thousands) Quoted Prices in Significant Other Observable Inputs (Level 2) Significant December 31, Liabilities: Contingent liability $ — $ — $ 1,280 $ 1,280 Total liabilities $ — $ — $ 1,280 $ 1,280

General (Policies)

General (Policies)	6 Months Ended
	Jun. 30, 2023
Accounting Policies [Abstract]
Risks and Uncertainties	Risks and Uncertainties The Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and commercial success of its drug/device combination products, its ability to obtain regulatory approval of its such produ cts in the United States and other geography markets, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition. In addition, inflation rates have increased recently to levels not seen in decades. As a result, the U.S. Federal Reserve has raised interest rates in response to concerns about inflation. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may further increase economic uncertainty and heighten these risks. Furthermore, if, in addition to the recent bank failures of Silicon Valley Bank, Signature Bank and First Republic Bank, other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our or our partners’ ability to access existing cash, cash equivalents and investments may be threatened and could have a material adverse effect on our business and financial condition. If the disruptions and slowdown deepen or persist, we may not be able to access additional capital on favorable terms, or at all, which could in the future negatively affect our ability to pursue our business strategy.
Liquidity and Going Concern	Liquidity and Going Concern On June 30, 2023, the Company had cash, cash equivalents and restricted cash totaling $14.6 million, as compared to cash, cash equivalents and restricted cash totaling $11.8 million at December 31, 2022. During the six months ended June 30, 2023, the Company used $13.9 million of cash in its operating activities and $6.3 million for principal payments. The Company’s future results are subject to substantial risks and uncertainties. The Company has operated at a loss for its entire history and there can be no assurance that it will ever achieve or maintain profitability. The Company has historically funded its operations primarily with proceeds from sales of common stock, warrants and prefunded warrants for the purchase of common stock, sales of preferred stock, proceeds from the issuance of convertible debt and borrowings under loan and security agreements. The Company believes that current cash and cash equivalents will enable the Company to have sufficient cash past our anticipated PDUFA date of August 14, 2023. If there is a substantial delay in the approval of HEPZATO, the Company expects to need to raise additional capital under structures available to the Company, including debt and/or equity offerings, which may not be on favorable terms. In a delayed approval scenario, the Company will not have sufficient funds to meet its obligations within twelve months from the issuance date of these condensed consolidated financial statements.
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 wholly owned subsidiaries and all significant inter-company accounts and transactions have been eliminated in consolidation.
Warrant Liabilities	Warrant Liabilities The Company determined the warrant liability was not in accordance with the provisions of ASC 480, Distinguishing Liabilities from Equity, which classifies and measures certain financial instruments with characteristics of both liability and equity. Entities must consider whether to classify contracts that may be settled in its own stock, such as warrants, as equity of the entity or as an asset or liability. If an event that is not within the entity’s control could require net cash settlement, then the contract should be classified as an asset or a liability at their fair value at issuance with subsequent changes in fair value recorded in earnings. The Company has accounted for the Preferred Warrants as derivative instruments in accordance with ASC 815, Derivatives and Hedging. The Company classified the Preferred Warrants issued in conjunction with the Preferred Purchase Agreement (defined below) and the Common Warrants issued in conjunction with the Common Purchase Agreement as a liability due to the existence of a pre-specified volatility input to the Black-Scholes calculation which would be used to calculate the repurchase price of the Preferred Warrants and Common Warrants in the event of a Fundamental Transaction, as defined.
Recently Adopted and Issued Accounting Pronouncements	Recently Adopted and Issued Accounting Pronouncements We have not been required to adopt any accounting standards that had a significant impact on our consolidated financial statements in the two years ended December 31, 2022. We do not expect any recently issued accounting standards to have a significant impact on our consolidated financial statements.
Revision of Previously Issued Quarterly Financial Statements	Revision of Previously Issued Quarterly Financial Statements In preparation of the Company’s audited financial statements as of and for year ended December 31, 2022, the Company determined it needed to correct previously reported share-based compensation expense for each quarter during 2022. The correction for share-based compensation increased the net loss in amount of $0.8 million for the first quarter of 2022, $0.5 million for the second quarter of 2022 and $0.4 million for the third quarter of fiscal 2022. The share-based compensation adjustment is a non-cash adjustment and did not have any impact on the cash balances for the Company. The following tables contain the financial information for the periods previously reported and have been updated to reflect the revisions of the Company’s financial statements. The revisions do not have an impact on the Company’s cash position. The Company has not amended its previously filed Quarterly Reports on Form 10-Q for the three quarterly periods ended September 30, 2022. The impact of the revision on the Company’s financial statements for the three and six months ended June 30, 2022 is reflected in the following table: (In thousands) As previously reported Adjustment As revised Balance Sheet for June 30, 2022 (unaudited) Additional paid-in capital $ 435,922 $ 1,299 $ 437,221 Accumulated deficit $ (438,836) $ (1,299) $ (440,135) Consolidated Statement of Operations and Comprehensive Loss for the three months ended June 30, 2022 (unaudited) Research and development expenses $ 5,456 $ 150 $ 5,606 Selling, general and administrative expenses 4,145 352 4,497 Total operating expenses 9,601 502 10,103 Operating loss (8,984) (502) (9,486) Net loss (9,657) (502) (10,159) Total other comprehensive loss (9,688) (502) (10,190) Basic and diluted loss per common share $ (1.18) $ (0.06) $ (1.24) Consolidated Statement of Operations and Comprehensive Loss for the six months June 30, 2022 (unaudited) Research and development expenses $ 9,696 $ 391 $ 10,087 Selling, general and administrative expenses 7,791 908 8,699 Total operating expenses 17,487 1,299 18,786 Operating loss (16,527) (1,299) (17,826) Net loss (17,860) (1,299) (19,159) Total other comprehensive loss (17,889) (1,299) (19,188) Basic and diluted loss per common share $ (2.18) $ (0.16) $ (2.34) Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended June 30, 2022 (unaudited) Compensation expense for issuance of stock options $ 1,617 $ 502 $ 2,119 Net loss $ (9,657) $ (502) $ (10,159) Consolidated statement of Stockholders’ Equity (Deficit) for the six months ended June 30, 2022 (unaudited) Compensation expense for issuance of stock options $ 3,091 $ 1,299 $ 4,390 Net loss $ (17,860) $ (1,299) $ (19,159) Consolidated Statement of Cash Flows for the six months ended June 30, 2022 (unaudited) Net loss $ (17,860) $ (1,299) $ (19,159) Stock option compensation expense $ 3,091 $ 1,299 $ 4,390

General (Tables)

General (Tables)	6 Months Ended
	Jun. 30, 2023
Accounting Policies [Abstract]
Schedule of Error Corrections and Prior Period Adjustments	The impact of the revision on the Company’s financial statements for the three and six months ended June 30, 2022 is reflected in the following table: (In thousands) As previously reported Adjustment As revised Balance Sheet for June 30, 2022 (unaudited) Additional paid-in capital $ 435,922 $ 1,299 $ 437,221 Accumulated deficit $ (438,836) $ (1,299) $ (440,135) Consolidated Statement of Operations and Comprehensive Loss for the three months ended June 30, 2022 (unaudited) Research and development expenses $ 5,456 $ 150 $ 5,606 Selling, general and administrative expenses 4,145 352 4,497 Total operating expenses 9,601 502 10,103 Operating loss (8,984) (502) (9,486) Net loss (9,657) (502) (10,159) Total other comprehensive loss (9,688) (502) (10,190) Basic and diluted loss per common share $ (1.18) $ (0.06) $ (1.24) Consolidated Statement of Operations and Comprehensive Loss for the six months June 30, 2022 (unaudited) Research and development expenses $ 9,696 $ 391 $ 10,087 Selling, general and administrative expenses 7,791 908 8,699 Total operating expenses 17,487 1,299 18,786 Operating loss (16,527) (1,299) (17,826) Net loss (17,860) (1,299) (19,159) Total other comprehensive loss (17,889) (1,299) (19,188) Basic and diluted loss per common share $ (2.18) $ (0.16) $ (2.34) Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended June 30, 2022 (unaudited) Compensation expense for issuance of stock options $ 1,617 $ 502 $ 2,119 Net loss $ (9,657) $ (502) $ (10,159) Consolidated statement of Stockholders’ Equity (Deficit) for the six months ended June 30, 2022 (unaudited) Compensation expense for issuance of stock options $ 3,091 $ 1,299 $ 4,390 Net loss $ (17,860) $ (1,299) $ (19,159) Consolidated Statement of Cash Flows for the six months ended June 30, 2022 (unaudited) Net loss $ (17,860) $ (1,299) $ (19,159) Stock option compensation expense $ 3,091 $ 1,299 $ 4,390

Cash, Cash Equivalents and Re_2

Cash, Cash Equivalents and Restricted Cash (Tables)	6 Months Ended
	Jun. 30, 2023
Cash and Cash Equivalents [Abstract]
Schedule of Cash, Cash Equivalents, and Restricted Cash	Cash, cash equivalents, and restricted cash balances were as follows: (In thousands) June 30, December 31, Cash and cash equivalents $ 14,540 $ 7,671 Restricted balance for loan agreement — 4,000 Letters of credit — 101 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 14,590 $ 11,822

Inventory (Tables)

Inventory (Tables)	6 Months Ended
	Jun. 30, 2023
Inventory Disclosure [Abstract]
Schedule of Inventory	Inventory consists of the following: (In thousands) June 30, December 31, Raw materials $ 796 $ 763 Work-in-process 1,571 1,102 Finished goods 113 133 Total inventory $ 2,480 $ 1,998

Prepaid Expenses and Other Cu_2

Prepaid Expenses and Other Current Assets (Tables)	6 Months Ended
	Jun. 30, 2023
Prepaid Expense and Other Assets, Current [Abstract]
Schedule of Prepaid Expenses and Other Current Assets	Prepaid expenses and other current assets consist of the following: (In thousands) June 30, December 31, Clinical trial expenses $ 1,630 $ 1,630 Insurance premiums 94 123 Professional services 389 121 Other 162 95 Total prepaid expenses and other current assets $ 2,275 $ 1,969

Property, Plant, and Equipment

Property, Plant, and Equipment (Tables)	6 Months Ended
	Jun. 30, 2023
Property, Plant and Equipment [Abstract]
Components of Property, Plant and Equipment	Property, plant, and equipment consist of the following: (In thousands) June 30, 2023 December 31, 2022 Estimated Useful Life Buildings and land $ 1,301 $ 1,301 30 years - Buildings Enterprise hardware and software 1,856 1,855 3 years Leaseholds 1,781 1,774 Lesser of lease term or estimated useful life Equipment 1,263 1,222 7 years Furniture 201 201 5 years Property, plant and equipment, gross 6,402 6,353 Accumulated depreciation (4,999) (4,931) Property, plant and equipment, net $ 1,403 $ 1,422

Accrued Expenses (Tables)

Accrued Expenses (Tables)	6 Months Ended
	Jun. 30, 2023
Payables and Accruals [Abstract]
Schedule of Accrued Expenses	Accrued expenses consist of the following: (In thousands) June 30, December 31, Clinical expenses $ 1,769 $ 1,470 Compensation, excluding taxes 1,328 1,040 Professional fees 1,219 1,087 Interest on convertible note 633 553 Other 597 535 Total accrued expenses $ 5,546 $ 4,685

Leases (Tables)

Leases (Tables)	6 Months Ended
	Jun. 30, 2023
Leases [Abstract]
Summary of Lease Costs	As of June 30, 2023: (In thousands) U.S. Ireland Total Operating cash flows for operating leases $ 181 $ 14 $ 195 Weighted average remaining lease term 0.3 3.1 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: U.S. Ireland Total Year ended December 31, 2023 $ 56 $ 18 $ 74 Year ended December 31, 2024 — 36 36 Year ended December 31, 2025 — 36 36 Year ended December 31, 2026 — 21 21 Total 56 111 167 Less present value discount (1) (12) (13) Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2023 $ 55 $ 99 $ 154

Loans and Convertible Notes P_2

Loans and Convertible Notes Payable (Tables)	6 Months Ended
	Jun. 30, 2023
Debt Disclosure [Abstract]
Summary of Loans and Convertible Notes Payable	June 30, 2023 December 31, 2022 (In thousands) Gross Discount Net Gross Discount Net Loan - Avenue [1] $ 5,610 $ (689) $ 4,921 $ 11,923 $ (1,008) $ 10,916 Loan - Avenue [1] - Less Current Portion (5,142) 632 (4,510) (8,570) 724 (7,846) Total - Loans Payable, Non-Current $ 468 $ (57) $ 411 $ 3,353 $ (284) $ 3,070 Convertible Note Payable - Rosalind 2,000 2,000 2,000 — 2,000 Convertible Portion of Loan Payable - Avenue 3,000 (159) 2,841 3,000 (228) 2,772 Total - Convertible Notes Payable - Non-Current $ 5,000 $ (159) $ 4,841 $ 5,000 $ (228) $ 4,772 [1] The gross amount includes the 4.25% final payment of $0.5 million.
Summary of Remaining Maturities of Company's Loan and Convertible Note Payables	Remaining maturities of the Company’s loan and convertible note payables are as follows: (In thousands) Loans Convertible Total Year ended December 31, 2023 $ 2,221 $ — $ 2,221 Year ended December 31, 2024 3,389 5,000 8,389 Total $ 5,610 $ 5,000 $ 10,610

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	6 Months Ended
	Jun. 30, 2023
Stockholders' Equity Note [Abstract]
Schedule of Designated Preferred Units	As of June 30, 2023, the Company has designated the following preferred stock: Designated Preferred Shares June 30, 2023 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
Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method	The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods: Six Months Ended June 30, 2023 2022 Expected terms (years) 5.2-5.8 5.2-6.5 Expected volatility 129.8%-172.8% 174.8% -180.3% Risk-free interest rate 3.88% -4.08% 1.75% - 2.90% Expected dividends 0.00% 0.00%
Summary of Stock Option Activity	The following is a summary of stock option activity for the six months ended June 30, 2023: Number of Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding at January 1, 2023 2,235,052 $ 10.30 Granted 1,991,757 6.19 Exercised (468) 4.67 Expired (75,772) 9.49 Cancelled/Forfeited (22,637) 10.36 Outstanding at June 30, 2023 4,127,932 $ 8.33 8.7 $ 994 Exercisable at June 30, 2023 1,741,313 $ 10.56 7.7 $ 116
Summary of Stock Option Shares Outstanding and Exercisable	The following table summarizes information for stock option shares outstanding and exercisable at June 30, 2023: Options Outstanding Range of Exercise Prices Outstanding Number of Weighted Average Number of Options $2.83 - $51.50 4,127,433 8.7 1,740,814 $51.50+ 499 5.6 499 4,127,932 8.7 1,741,313
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, 2023: Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2023 2022 2023 2022 Selling, general and administrative $ 911 $ 1,467 $ 2,099 $ 2,866 Research and development 651 613 1,068 1,416 Cost of goods sold 99 39 155 108 Total $ 1,661 $ 2,119 $ 3,322 $ 4,390
Summary of Warrant Activity	The following is a summary of common stock warrant activity for the six months ended June 30, 2023: Warrants Weighted Average Exercise Price Weighted Average Outstanding at January 1, 2023 5,153,291 $ 7.01 Warrants issued 81,849 2.94 Warrants exercised (538,828) 0.01 Outstanding at June 30, 2023 4,696,312 $ 7.74 2.1 Exercisable at June 30, 2023 4,696,312 $ 7.74 2.1
Schedule of Information Related to Stock Warrants Outstanding and Exercisable	The following table presents information related to common stock warrants at June 30, 2023: Warrants Exercisable Range of Exercise Prices Outstanding Weighted Average Number of Warrants $0.01 1,037,792 3.7 1,037,792 $4.50-$6.00 47,777 2.8 47,777 $10.00 3,610,743 1.7 3,610,743 4,696,312 2.1 4,696,312

Net Loss per Share (Tables)

Net Loss per Share (Tables)	6 Months Ended
	Jun. 30, 2023
Earnings Per Share [Abstract]
Antidilutive 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, 2023 and 2022 because their effects would be anti-dilutive: June 30, 2023 2022 Common stock warrants 3,658,520 3,894,498 Assumed conversation of preferred stock warrants 11,896,667 — Assumed conversion of preferred stock 4,051,637 1,135,721 Assumed conversion of convertible notes 488,031 488,031 Stock options 4,127,932 2,311,393 Total 24,222,787 7,829,643
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, 2023 and 2022: Three months ended June 30, Six months ended June 30, 2023 2022 2023 2022 Weighted average shares issued 11,320,450 7,906,728 10,693,762 7,906,728 Weighted average pre-funded warrants 1,143,215 283,755 1,341,976 283,755 Weighted average shares outstanding 12,463,665 8,190,483 12,035,738 8,190,483

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	6 Months Ended
	Jun. 30, 2023
Fair Value Disclosures [Abstract]
Schedule of Level 3 Investments	The table below presents activity within Level 3 of the fair value hierarchy, our liabilities carried at fair value for the six months ended June 30, 2023: Level 3 (In thousands) Contingent Warrants Total Balance at January 1, 2023 $ 1,280 $ — $ 1,280 Total change in foreign exchange 24 24 Fair value of the warrant liability issued — 4,940 4,940 Warrant liability fair value adjustment — (1,160) (1,160) Balance at June 30, 2023 $ 1,304 $ 3,780 $ 5,084
Schedule of Fair Value Warrants	The fair value of the preferred and common warrants at June 30, 2023 and March 29, 2023 was determined by using option pricing models assuming the following: March 29, 2023 June 30, 2023 Risk free interest rate 3.80% - 4.80% 4.39% - 5.29% Expected term (years) 0.5 - 3.0 0.3 - 2.8 Expected volatility 70% - 75% 65% - 70% Expected dividends 0.00 % 0.00 %
Schedule of Financial Assets Carried at Fair Value	The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value as of June 30, 2023 and December 31, 2022 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value. In general, the fair values were determined using Level 3: (In thousands) Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant June 30, Liabilities: Contingent liability $ — $ — $ 1,304 $ 1,304 Warrant liability — — 3,780 3,780 Total liabilities $ — $ — $ 5,084 $ 5,084 (In thousands) Quoted Prices in Significant Other Observable Inputs (Level 2) Significant December 31, Liabilities: Contingent liability $ — $ — $ 1,280 $ 1,280 Total liabilities $ — $ — $ 1,280 $ 1,280

General - Narrative (Details)

General - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended			6 Months Ended
	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2023	Jun. 30, 2022	Mar. 29, 2023	Dec. 31, 2022
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Cash cash equivalents and restricted cash				$ 14,600			$ 11,800
Net cash used in operating activities				13,912	$ 12,412
Principal payments				6,300
Deferred revenue						$ 10,000
Impact of share-based compensation correction on net income (loss)	$ 400	$ 500	$ 800
Accounts Payable Accrued Expenses And Lease Liabilities
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Current capital commitments				6,600
Loan Principal Payments
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Current capital commitments				5,100
Noncurrent capital commitments				500
Lease Liabilities
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Noncurrent capital commitments				100
Third Party Settlement
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Noncurrent capital commitments				1,000
Convertible Note Principal Payments
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Noncurrent capital commitments				$ 5,000

General - Schedule of Error Cor

General - Schedule of Error Corrections and Prior Period Adjustments (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended				6 Months Ended
	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Balance Sheet for June 30, 2022 (unaudited)
Additional paid-in capital	$ 473,355				$ 473,355		$ 451,608
Accumulated deficit	(473,686)				(473,686)		$ (457,484)
Consolidated Statement of Operations and Comprehensive Loss for the three months ended June 30, 2022 (unaudited)
Research and development expenses	3,555		$ 5,606		8,131	$ 10,087
Selling, general and administrative expenses	4,787		4,497		8,952	8,699
Total operating expenses	8,342		10,103		17,083	18,786
Operating loss	(7,997)		(9,486)		(16,322)	(17,826)
Net loss	(7,202)	$ (9,000)	(10,159)	$ (9,000)	(16,202)	(19,159)
Total other comprehensive loss	$ (7,202)		$ (10,190)		$ (16,183)	$ (19,188)
Basic loss per common share (in dollars per share)	$ (0.58)		$ (1.24)		$ (1.35)	$ (2.34)
Diluted loss per common share (in dollars per share)	$ (0.58)		$ (1.24)		$ (1.35)	$ (2.34)
Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended June 30, 2022 (unaudited)
Compensation expense for issuance of stock options	$ 1,661	1,661	$ 2,119	2,271
Net loss	(7,202)	(9,000)	(10,159)	(9,000)	$ (16,202)	$ (19,159)
Consolidated Statement of Cash Flows for the six months ended June 30, 2022 (unaudited)
Net loss	$ (7,202)	$ (9,000)	(10,159)	$ (9,000)	(16,202)	(19,159)
Stock option compensation expense					$ 3,322	4,390
As previously reported
Balance Sheet for June 30, 2022 (unaudited)
Additional paid-in capital			435,922			435,922
Accumulated deficit			(438,836)			(438,836)
Consolidated Statement of Operations and Comprehensive Loss for the three months ended June 30, 2022 (unaudited)
Research and development expenses			5,456			9,696
Selling, general and administrative expenses			4,145			7,791
Total operating expenses			9,601			17,487
Operating loss			(8,984)			(16,527)
Net loss			(9,657)			(17,860)
Total other comprehensive loss			$ (9,688)			$ (17,889)
Basic loss per common share (in dollars per share)			$ (1.18)			$ (2.18)
Diluted loss per common share (in dollars per share)			$ (1.18)			$ (2.18)
Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended June 30, 2022 (unaudited)
Compensation expense for issuance of stock options			$ 1,617			$ 3,091
Net loss			(9,657)			(17,860)
Consolidated Statement of Cash Flows for the six months ended June 30, 2022 (unaudited)
Net loss			(9,657)			(17,860)
Stock option compensation expense						3,091
Adjustment
Balance Sheet for June 30, 2022 (unaudited)
Additional paid-in capital			1,299			1,299
Accumulated deficit			(1,299)			(1,299)
Consolidated Statement of Operations and Comprehensive Loss for the three months ended June 30, 2022 (unaudited)
Research and development expenses			150			391
Selling, general and administrative expenses			352			908
Total operating expenses			502			1,299
Operating loss			(502)			(1,299)
Net loss			(502)			(1,299)
Total other comprehensive loss			$ (502)			$ (1,299)
Basic loss per common share (in dollars per share)			$ (0.06)			$ (0.16)
Diluted loss per common share (in dollars per share)			$ (0.06)			$ (0.16)
Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended June 30, 2022 (unaudited)
Compensation expense for issuance of stock options			$ 502			$ 1,299
Net loss			(502)			(1,299)
Consolidated Statement of Cash Flows for the six months ended June 30, 2022 (unaudited)
Net loss			(502)			(1,299)
Stock option compensation expense						1,299
As revised
Balance Sheet for June 30, 2022 (unaudited)
Additional paid-in capital			437,221			437,221
Accumulated deficit			(440,135)			(440,135)
Consolidated Statement of Operations and Comprehensive Loss for the three months ended June 30, 2022 (unaudited)
Research and development expenses			5,606			10,087
Selling, general and administrative expenses			4,497			8,699
Total operating expenses			10,103			18,786
Operating loss			(9,486)			(17,826)
Net loss			(10,159)			(19,159)
Total other comprehensive loss			$ (10,190)			$ (19,188)
Basic loss per common share (in dollars per share)			$ (1.24)			$ (2.34)
Diluted loss per common share (in dollars per share)			$ (1.24)			$ (2.34)
Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended June 30, 2022 (unaudited)
Compensation expense for issuance of stock options			$ 2,119			$ 4,390
Net loss			(10,159)			(19,159)
Consolidated Statement of Cash Flows for the six months ended June 30, 2022 (unaudited)
Net loss			$ (10,159)			(19,159)
Stock option compensation expense						$ 4,390

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, 2023	Dec. 31, 2022	Jun. 30, 2022	Dec. 31, 2021
Cash and Cash Equivalents [Abstract]
Cash and cash equivalents	$ 14,540	$ 7,671
Restricted balance for loan agreement	0	4,000
Letters of credit	0	101
Security for credit cards	50	50
Total cash, cash equivalents and restricted cash shown in the statements of cash flows	$ 14,590	$ 11,822	$ 14,354	$ 26,953

Cash, Cash Equivalents and Re_4

Cash, Cash Equivalents and Restricted Cash - Narrative (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Mar. 15, 2023	Jun. 30, 2022
Cash and Cash Equivalents [Line Items]
Restricted cash	$ 50		$ 4,151
Avenue Loan
Cash and Cash Equivalents [Line Items]
Restricted cash		$ 4,000

Inventory (Details)

Inventory (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Inventory Disclosure [Abstract]
Raw materials	$ 796	$ 763
Work-in-process	1,571	1,102
Finished goods	113	133
Total inventory	$ 2,480	$ 1,998

Prepaid Expenses and Other Cu_3

Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Prepaid Expense and Other Assets, Current [Abstract]
Clinical trial expenses	$ 1,630	$ 1,630
Insurance premiums	94	123
Professional services	389	121
Other	162	95
Total prepaid expenses and other current assets	$ 2,275	$ 1,969

Property, Plant, and Equipmen_2

Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 6,402	$ 6,353
Accumulated depreciation	(4,999)	(4,931)
Property, plant and equipment, net	1,403	1,422
Buildings and land
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,301	1,301
Buildings
Property Plant And Equipment [Line Items]
Estimated Useful Life	30 years
Enterprise hardware and software
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,856	1,855
Estimated Useful Life	3 years
Leaseholds
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,781	1,774
Estimated Useful Life	Useful Life, Shorter of Lease Term or Asset Utility [Member]
Equipment
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,263	1,222
Estimated Useful Life	7 years
Furniture
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 201	$ 201
Estimated Useful Life	5 years

Property, Plant, and Equipmen_3

Property, Plant, and Equipment - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Property, Plant and Equipment [Abstract]
Depreciation expense (less than for the three months ended)	$ 100	$ 100	$ 59	$ 31

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Payables and Accruals [Abstract]
Clinical expenses	$ 1,769	$ 1,470
Compensation, excluding taxes	1,328	1,040
Professional fees	1,219	1,087
Interest on convertible note	633	553
Other	597	535
Total accrued expenses	$ 5,546	$ 4,685

Leases - Narrative (Details)

Leases - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Lessee Lease Description [Line Items]
Lease term	12 months		12 months
U.S.
Lessee Lease Description [Line Items]
Operating lease expense	$ 100	$ 200	$ 100	$ 200
Ireland
Lessee Lease Description [Line Items]
Operating lease expense	$ 100	$ 100	$ 100	$ 100

Leases - Summary of Lease Costs

Leases - Summary of Lease Costs (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2023 USD ($)
Other information
Operating cash flows for operating leases	$ 195
U.S.
Other information
Operating cash flows for operating leases	$ 181
Weighted average remaining lease term	3 months 18 days
Weighted average discount rate - operating leases	8%
Ireland
Other information
Operating cash flows for operating leases	$ 14
Weighted average remaining lease term	3 years 1 month 6 days
Weighted average discount rate - operating leases	8%

Leases - Schedule of Remaining

Leases - Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands	Jun. 30, 2023 USD ($)
Lessee Lease Description [Line Items]
Year ended December 31, 2023	$ 74
Year ended December 31, 2024	36
Year ended December 31, 2025	36
Year ended December 31, 2026	21
Total	167
Less present value discount	(13)
Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2023	154
U.S.
Lessee Lease Description [Line Items]
Year ended December 31, 2023	56
Year ended December 31, 2024	0
Year ended December 31, 2025	0
Year ended December 31, 2026	0
Total	56
Less present value discount	(1)
Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2023	55
Ireland
Lessee Lease Description [Line Items]
Year ended December 31, 2023	18
Year ended December 31, 2024	36
Year ended December 31, 2025	36
Year ended December 31, 2026	21
Total	111
Less present value discount	(12)
Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2023	$ 99

Loans and Convertible Notes P_3

Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) - USD ($) $ in Thousands	6 Months Ended	12 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
Debt Instrument [Line Items]
Gross	$ 5,000	$ 5,000
Discount	(159)	(228)
Net	4,841	4,772
Less Current Portion, Net	(4,510)	(7,846)
Total - Loans Payable, Non-Current, Gross	468	3,353
Total - Loans Payable, Non-Current, Discount	(57)	(284)
Total - Loans Payable, Non-Current, Net	$ 411	$ 3,070
Percentage of final payment included in gross amount	4.25%	4.25%
Final payment	$ 500	$ 500
Loan Avenue
Debt Instrument [Line Items]
Gross	5,610	11,923
Discount	(689)	(1,008)
Net	4,921	10,916
Less Current Portion, Gross	(5,142)	(8,570)
Less Current Portion, Discount	632	724
Less Current Portion, Net	(4,510)	(7,846)
Convertible Note Payable Rosalind
Debt Instrument [Line Items]
Gross	2,000	2,000
Discount		0
Net	2,000	2,000
Convertible Loan Payable Avenue
Debt Instrument [Line Items]
Gross	3,000	3,000
Discount	(159)	(228)
Net	$ 2,841	$ 2,772

Loans and Convertible Notes P_4

Loans and Convertible Notes Payable - Summary of Remaining Maturities of Company's Loan and Convertible Note Payables (Details) $ in Thousands	Jun. 30, 2023 USD ($)
Debt Instrument [Line Items]
Loans	$ 5,610
Convertible Notes	5,000
Total	10,610
Year ended December 31, 2023
Debt Instrument [Line Items]
Loans	2,221
Convertible Notes	0
Total	2,221
Year ended December 31, 2024
Debt Instrument [Line Items]
Loans	3,389
Convertible Notes	5,000
Total	$ 8,389

Loans and Convertible Notes P_5

Loans and Convertible Notes Payable - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands				3 Months Ended		6 Months Ended		12 Months Ended
	Mar. 31, 2023	Mar. 15, 2023	Aug. 06, 2021	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022	Apr. 18, 2023
Debt Instrument [Line Items]
Warrant exercise price (in dollars per share)									$ 0.01
Restricted cash				$ 50	$ 4,151	$ 50	$ 4,151
Principal payment						6,313	0
Final payment						500		$ 500
Interest expense incurred (less than)				300	400	800	800
Secured Convertible Notes Payable
Debt Instrument [Line Items]
Debt instrument, principal face amount				$ 2,000		$ 2,000
Series E
Debt Instrument [Line Items]
Debt instrument, conversion price (in dollars per share)				$ 1,500		$ 1,500
Series E | Secured Convertible Notes Payable
Debt Instrument [Line Items]
Debt instrument, conversion price (in dollars per share)			$ 1,198
Avenue Loan
Debt Instrument [Line Items]
Debt instrument, principal face amount			$ 3,000
Interest rate			7.70%
Debt instrument, interest rate			10.95%	15.95%
Initial tranche of loan			$ 15,000
Loan amount funded into restricted account			4,000
Net equity proceeds			$ 20,000
Debt instrument, conversion price (in dollars per share)			$ 11.98
Restricted cash		$ 4,000
Principal payment		$ 2,100
Debt instrument, incremental final payment, percentage		4.25%
Final payment		$ 200
Amortization of debt discount				$ 200		$ 400
Avenue Loan | Condition for the Extension of Period of Interest Only Payments
Debt Instrument [Line Items]
Warrant exercise price (in dollars per share)	$ 0.01
Estimated minimum proceeds on issue of common stock for extension of due date of interest only interest payments	$ 10,000
Number of warrants outstanding (in shares)	34,072
Avenue Loan | Warrant
Debt Instrument [Line Items]
Warrants issued to purchase of common stock (in shares)			127,755
Warrant exercise price (in dollars per share)			$ 0.01
Avenue Loan | Maximum
Debt Instrument [Line Items]
Debt instrument, principal face amount			$ 20,000
Rosalind Notes | Convertible Notes Payable
Debt Instrument [Line Items]
Interest rate				8%		8%
Rosalind Notes | Convertible Debt
Debt Instrument [Line Items]
Interest expense incurred (less than)				$ 100	$ 100	$ 100	$ 100

Preferred Purchase Agreement (D

Preferred Purchase Agreement (Details) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended	6 Months Ended
	Mar. 29, 2023	Jun. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Dec. 31, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2021
Disclosure Of Preferred Purchase Agreement [Line Items]
Preferred stock, par value (in dollars per share)		$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Deferred revenue	$ 10,000
Fair value of warrant liabilities		$ 5,084	$ 5,084		$ 1,280
Warrant
Disclosure Of Preferred Purchase Agreement [Line Items]
Stock issuance costs paid		400	400
Preferred Warrant Liabilities
Disclosure Of Preferred Purchase Agreement [Line Items]
Proceeds from issuance of warrants		24,900
Fair value of warrant liabilities		4,900	$ 4,900
Series F-1
Disclosure Of Preferred Purchase Agreement [Line Items]
[Series E] Warrant Exercise (in shares)			15,276
Series F-1 | Preferred Warrant Liabilities
Disclosure Of Preferred Purchase Agreement [Line Items]
Proceeds from issuance of warrants		$ 20,000
Series F-3 | Preferred Tranche A Warrant
Disclosure Of Preferred Purchase Agreement [Line Items]
Number of exercisable preferred warrants (in shares)	34,860
Common Stock
Disclosure Of Preferred Purchase Agreement [Line Items]
[Series E] Warrant Exercise (in shares)			4,629,539
Series F-2
Disclosure Of Preferred Purchase Agreement [Line Items]
[Series E] Warrant Exercise (in shares)			9,624
Preferred Purchase Agreement | Preferred Tranche A Warrant
Disclosure Of Preferred Purchase Agreement [Line Items]
Aggregate exercise price of preferred warrants	$ 34,900
Warrant exercise period	21 days
Preferred Purchase Agreement | Preferred Tranche B Warrant
Disclosure Of Preferred Purchase Agreement [Line Items]
Aggregate exercise price of preferred warrants	$ 24,900
Number of exercisable preferred warrants (in shares)	24,900
Warrant exercise period	21 days
Preferred Purchase Agreement | Series F-1
Disclosure Of Preferred Purchase Agreement [Line Items]
Preferred stock, par value (in dollars per share)	$ 0.01

Stockholders' Equity - Equity O

Stockholders' Equity - Equity Offerings and Placements (Details) - USD ($) $ in Millions	Mar. 29, 2023	Jun. 30, 2023
Stockholders Equity Note [Line Items]
Deferred revenue	$ 10
Tranche A Warrants | Common Purchase Agreement
Stockholders Equity Note [Line Items]
Aggregate exercise price of preferred warrants	$ 0.1
Number of exercisable common warrants (in shares)	31,110
Warrants exercisable, period		21 days
Tranche B Warrants | Common Purchase Agreement
Stockholders Equity Note [Line Items]
Aggregate exercise price of preferred warrants	$ 0.1
Number of exercisable common warrants (in shares)	16,666
Warrants exercisable, period		21 days

Stockholders' Equity - At-the-M

Stockholders' Equity - At-the-Market Offering (Details) - USD ($) $ in Thousands	3 Months Ended	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2023	Dec. 31, 2022
Stockholders Equity Note [Line Items]
Sale of stock consideration received on the transaction	$ 153	$ 153	$ 100
Number of shares sold (in shares)	0	0
Controlled Equity Offering Sales Agreement | Cantor Fitzgerald & Co
Stockholders Equity Note [Line Items]
Common stock, aggregate offering price	$ 17,000	$ 17,000
Sale of stock consideration received on the transaction	$ 4,000	$ 4,000

Stockholders' Equity - Designat

Stockholders' Equity - Designated Preferred Shares (Details)	Jun. 30, 2023 shares
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	179,670
Series A
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	4,200
Series B
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	2,360
Series C
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	590
Series D
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	10,000
Series E
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	40,000
Series E-1
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	12,960
Series F-1
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	24,900
Series F-2
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	24,900
Series F-3
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	34,860
Series F-4
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	24,900

Stockholders' Equity - Authoriz

Stockholders' Equity - Authorized Shares and Preferred Stock (Details) - $ / shares	Jun. 30, 2023	May 31, 2023	Mar. 31, 2023	Dec. 31, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2021
Stockholders Equity Note [Line Items]
Common stock, shares authorized (in shares)	80,000,000	40,000,000		80,000,000
Common stock, par value (in dollars per share)	$ 0.01		$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Preferred stock, shares authorized (in shares)	10,000,000			10,000,000
Preferred stock, par value (in dollars per share)	$ 0.01		$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Preferred stock, shares outstanding (in shares)	20,981			11,357
Series E
Stockholders Equity Note [Line Items]
Preferred stock, shares outstanding (in shares)	11,357
Series E-1
Stockholders Equity Note [Line Items]
Preferred stock, shares outstanding (in shares)	11,357
Series F-2
Stockholders Equity Note [Line Items]
Preferred stock, shares outstanding (in shares)	9,624

Stockholders' Equity - Equity I

Stockholders' Equity - Equity Incentive Plan (Details) - shares	Jun. 12, 2023	Jun. 30, 2023
Stockholders' Equity Note [Abstract]
Increase in shares available under equity incentive plan (in shares)	2,650,000
Common stock, capital shares reserved (in shares)		5,125,000
Number of common shares remained available to be issued (in shares)		1,861,160

Stockholders' Equity - Schedule

Stockholders' Equity - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected dividends	0%	0%
Minimum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected volatility	129.80%	174.80%
Risk-free interest rate	3.88%	1.75%
Expected terms (years)	5 years 2 months 12 days	5 years 2 months 12 days
Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected volatility	172.80%	180.30%
Risk-free interest rate	4.08%	2.90%
Expected terms (years)	5 years 9 months 18 days	6 years 6 months

Stockholders' Equity - Summary

Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands	3 Months Ended	6 Months Ended
	Jun. 30, 2023 USD ($) $ / shares shares	Jun. 30, 2023 USD ($) $ / shares shares
Number of Options
Outstanding, beginning of period (in shares) | shares		2,235,052
Granted (in shares) | shares		1,991,757
Exercised (in shares) | shares	(468)	(468)
Expired (in shares) | shares		(75,772)
Cancelled/Forfeited (in shares) | shares		(22,637)
Outstanding, end of period (in shares) | shares	4,127,932	4,127,932
Exercisable (in shares) | shares	1,741,313	1,741,313
Weighted Average Exercise Price Per Share
Outstanding, Weighted Average Exercise Price Per Share, beginning of period (in dollars per share) | $ / shares		$ 10.30
Granted, Weighted Average Exercise Price Per Share (in dollars per share) | $ / shares		6.19
Exercised, Weighted Average Exercise Price Per Share (in dollars per share) | $ / shares		4.67
Expired, Weighted Average Exercise Price Per Share (in dollars per share) | $ / shares		9.49
Cancelled-Forfeited, Weighted Average Exercise Price Per Share (in dollars per share) | $ / shares		10.36
Outstanding, Weighted Average Exercise Price Per Share, end of period (in dollars per share) | $ / shares	$ 8.33	8.33
Weighted Average Exercise Price, Exercisable (in dollars per share) | $ / shares	$ 10.56	$ 10.56
Weighted Average Remaining Contractual Term (in years) and Aggregate Intrinsic Value
Weighted Average Remaining Contractual Term (in years), Outstanding		8 years 8 months 12 days
Weighted Average Remaining Contractual Term (in years), Exercisable		7 years 8 months 12 days
Aggregate Intrinsic Value, Outstanding | $	$ 994	$ 994
Aggregate Intrinsic Value, Exercisable | $	$ 116	$ 116

Stockholders' Equity - Summar_2

Stockholders' Equity - Summary of Stock Option Shares Outstanding and Exercisable (Details) - $ / shares	6 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options (in shares)	4,127,932	2,235,052
Weighted Average Remaining Option Term (in years), Options Outstanding	8 years 8 months 12 days
Number of Options Exercisable (in shares)	1,741,313
$2.83 - $51.50
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options (in shares)	4,127,433
Weighted Average Remaining Option Term (in years), Options Outstanding	8 years 8 months 12 days
Number of Options Exercisable (in shares)	1,740,814
$2.83 - $51.50 | Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Range of Exercise Prices (in dollars per share)	$ 51.50
$2.83 - $51.50 | Minimum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Range of Exercise Prices (in dollars per share)	2.83
$51.50+
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Range of Exercise Prices (in dollars per share)	$ 51.50
Outstanding Number of Options (in shares)	499
Weighted Average Remaining Option Term (in years), Options Outstanding	5 years 7 months 6 days
Number of Options Exercisable (in shares)	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, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	$ 1,661	$ 2,119	$ 3,322	$ 4,390
Unrecognized compensation expense related to non-vested share-based compensation awards	10,000		$ 10,000
Cost expected to be recognized over weighted average period			2 years 7 months 6 days
Selling, general and administrative
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	911	1,467	$ 2,099	2,866
Research and development
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	651	613	1,068	1,416
Cost of goods sold
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	$ 99	$ 39	$ 155	$ 108

Stockholders' Equity - Summar_4

Stockholders' Equity - Summary of Warrant Activity (Details) - $ / shares		6 Months Ended
	Apr. 18, 2023	Jun. 30, 2023
Warrants
Outstanding, beginning of period (in shares)		5,153,291
Warrants issued (in shares)		81,849
Warrants exercised (in shares)	(538,828)	(538,828)
Outstanding, end of period (in shares)	538,828	4,696,312
Exercisable, end of period (in shares)		4,696,312
Weighted Average Exercise Price
Outstanding, beginning of period (in dollars per share)		$ 7.01
Warrants issued (in dollars per share)		2.94
Warrants exercised (in dollars per share)		0.01
Outstanding, ending of period (in dollars per share)		7.74
Exercisable, (in dollars per share)		$ 7.74
Weighted Average Remaining Life (in years)
Weighted Average Remaining Life (in years), Outstanding		2 years 1 month 6 days
Weighted Average Remaining Life, Exercisable		2 years 1 month 6 days

Stockholders' Equity - Summar_5

Stockholders' Equity - Summary of Warrants Outstanding and Exercisable (Details) - $ / shares	6 Months Ended
	Jun. 30, 2023	Apr. 18, 2023	Dec. 31, 2022
Class of Warrant or Right [Line Items]
Warrant exercise price (in dollars per share)		$ 0.01
Outstanding Number of Warrants (in shares)	4,696,312	538,828	5,153,291
Warrants Exercisable, Weighted Average Remaining Warrant Term (in years)	2 years 1 month 6 days
Warrants Exercisable, Number of Warrants (in shares)	4,696,312
$0.01
Class of Warrant or Right [Line Items]
Warrant exercise price (in dollars per share)	$ 0.01
Outstanding Number of Warrants (in shares)	1,037,792
Warrants Exercisable, Weighted Average Remaining Warrant Term (in years)	3 years 8 months 12 days
Warrants Exercisable, Number of Warrants (in shares)	1,037,792
$4.50-$6.00
Class of Warrant or Right [Line Items]
Outstanding Number of Warrants (in shares)	47,777
Warrants Exercisable, Weighted Average Remaining Warrant Term (in years)	2 years 9 months 18 days
Warrants Exercisable, Number of Warrants (in shares)	47,777
$4.50-$6.00 | Minimum
Class of Warrant or Right [Line Items]
Warrant exercise price (in dollars per share)	$ 4.50
$4.50-$6.00 | Maximum
Class of Warrant or Right [Line Items]
Warrant exercise price (in dollars per share)	6
$10.00
Class of Warrant or Right [Line Items]
Warrant exercise price (in dollars per share)	$ 10
Outstanding Number of Warrants (in shares)	3,610,743
Warrants Exercisable, Weighted Average Remaining Warrant Term (in years)	1 year 8 months 12 days
Warrants Exercisable, Number of Warrants (in shares)	3,610,743

Stockholders' Equity - Common S

Stockholders' Equity - Common Stock Warrants (Details) - $ / shares		6 Months Ended
	Apr. 18, 2023	Jun. 30, 2023	Dec. 31, 2022
Stockholders' Equity Note [Abstract]
Warrants outstanding (in shares)	538,828	4,696,312	5,153,291
Warrant exercise price (in dollars per share)	$ 0.01
Class of warrant or right exercised	538,828	538,828

Stockholders' Equity - Summar_6

Stockholders' Equity - Summary of Employee Stock Purchase Plan (Details) - shares	1 Months Ended	6 Months Ended
	Aug. 31, 2021	Jun. 30, 2023	Jul. 31, 2023	Jan. 31, 2023
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items]
Employee stock purchase plan, offering period		6 months
May 2022 Employee Stock Purchase Plan
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items]
Share-based compensation arrangement by share-based payment award number of shares authorized (in shares)	260,295			15,417
Share-based compensation arrangement by share-based payment award purchase price of common stock (as a percent)	85%
May 2022 Employee Stock Purchase Plan | Subsequent Event [Member]
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items]
Share-based compensation arrangement by share-based payment award number of shares authorized (in shares)			26,018

Net Loss per Share - Anti-Dilut

Net Loss per Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	24,222,787	7,829,643
Common stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	3,658,520	3,894,498
Assumed conversation of preferred stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	11,896,667	0
Assumed conversion of preferred stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	4,051,637	1,135,721
Assumed conversion of convertible notes
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	488,031	488,031
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	4,127,932	2,311,393

Net Loss per Share - Narrative

Net Loss per Share - Narrative (Details)	6 Months Ended
	Jun. 30, 2023 shares
Earnings Per Share [Abstract]
Pre-funded penny warrants outstanding	1,037,792

Net Loss per Share - Summary of

Net Loss per Share - Summary of Reconciliation of Weighted Average Shares Outstanding Calculation (Details) - shares	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Earnings Per Share [Abstract]
Weighted average shares issued (in shares)	11,320,450	7,906,728	10,693,762	7,906,728
Weighted average pre-funded warrants (in shares)	1,143,215	283,755	1,341,976	283,755
Weighted average number of basic shares outstanding (in shares)	12,463,665	8,190,483	12,035,738	8,190,483
Weighted average number of diluted shares outstanding (in shares)	12,463,665	8,190,483	12,035,738	8,190,483

Income Taxes (Details)

Income Taxes (Details) $ in Billions	3 Months Ended
	Jun. 30, 2023 USD ($)
Income Tax Disclosure [Abstract]
Corporate alternative minimum tax (as a percent)	15%
Minimum accounting profit required for preceding three financial year	$ 1
Percentage of excise tax on repurchases of stock	1%

Commitments and contingencies -

Commitments and contingencies - Additional Information (Details) € in Millions, $ in Millions	Jul. 05, 2023 USD ($)	Dec. 30, 2022 USD ($)	Jun. 30, 2023 USD ($)	Jan. 24, 2023 USD ($)	Oct. 12, 2021 EUR (€)	Apr. 01, 2021 EUR (€)
Loss Contingencies [Line Items]
Milestone payment unpaid | €					€ 1
Medac
Loss Contingencies [Line Items]
Accounts receivable | €						€ 1
Term over which the royalty is to be paid		5 years
Minimum annual payments		$ 0.2
Lachman
Loss Contingencies [Line Items]
Loss contingency accrual			$ 0.9
Unpaid consulting fees				$ 0.9
Lachman | Subsequent Event [Member]
Loss Contingencies [Line Items]
Settlement amount	$ 0.9
Other Liabilities | Medac
Loss Contingencies [Line Items]
Loss contingency accrual			1.3
Other Noncurrent Liabilities | Medac
Loss Contingencies [Line Items]
Loss contingency accrual			1.1
Accrued Expenses | Medac
Loss Contingencies [Line Items]
Loss contingency accrual			$ 0.2

Fair Value Measurements - Fair

Fair Value Measurements - Fair Value Measurements Using Significant Unobservable Inputs (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Beginning balance			$ 1,280
Total change in foreign exchange			24
Fair value of the warrant liability issued			4,940
Warrant liability fair value adjustment	$ (1,160)	$ 0	(1,160)	$ 0
Ending balance	5,084		5,084
Other income related to the change in fair value of the warrant liability	1,160	$ 0	1,160	$ 0
Contingent liabilities
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Beginning balance			1,280
Total change in foreign exchange			24
Fair value of the warrant liability issued			0
Warrant liability fair value adjustment			0
Ending balance	1,304		1,304
Other income related to the change in fair value of the warrant liability			0
Warrants
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Beginning balance			0
Total change in foreign exchange
Fair value of the warrant liability issued			4,940
Ending balance	$ 3,780		$ 3,780

Fair Value Measurements - Sched

Fair Value Measurements - Schedule of Fair Value of Outstanding Warrants (Details) - Valuation Technique, Option Pricing Model - Preferred And Common Warrants	Jun. 30, 2023	Mar. 29, 2023
Risk free interest rate | Minimum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants measurement input	0.0439	0.0380
Risk free interest rate | Maximum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants measurement input	0.0529	0.0480
Expected term (years) | Minimum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Expected term	3 months 18 days	6 months
Expected term (years) | Maximum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Expected term	2 years 9 months 18 days	3 years
Expected volatility | Minimum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants measurement input	0.65	0.70
Expected volatility | Maximum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants measurement input	0.70	0.75
Expected dividends
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants measurement input	0	0

Fair Value Measurements - Sch_2

Fair Value Measurements - Schedule of the Company's Financial Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Liabilities [Abstract]
Contingent liability	$ 1,304	$ 1,280
Warrant liability	3,780
Total liabilities	5,084	1,280
Quoted Prices in Active Markets (Level 1)
Liabilities [Abstract]
Contingent liability	0	0
Warrant liability	0
Total liabilities	0	0
Significant Other Observable Inputs (Level 2)
Liabilities [Abstract]
Contingent liability	0	0
Warrant liability	0
Total liabilities	0	0
Significant Unobservable Inputs (Level 3)
Liabilities [Abstract]
Contingent liability	1,304	1,280
Warrant liability	3,780
Total liabilities	$ 5,084	$ 1,280