0001193125-23-079836 | 10-K | XBRL Viewer

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Cover Page - USD ($) $ in Thousands	12 Months Ended
Cover Page - USD ($) $ in Thousands	Dec. 31, 2022	Mar. 24, 2023	Jun. 30, 2022
Cover [Abstract]
Entity Registrant Name	DELCATH SYSTEMS, INC.
Entity Central Index Key	0000872912
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Document Annual Report	true
Document Transition Report	false
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Incorporation, State or Country Code	DE
Entity Interactive Data Current	Yes
Entity File Number	001-16133
Entity Tax Identification Number	06-1245881
Entity Address, Address Line One	1633 Broadway
Entity Address, Address 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
Entity Shell Company	false
Entity Public Float			$ 31,947,845
Entity Common Stock, Shares Outstanding		10,061,988
Document Period End Date	Dec. 31, 2022
Document Fiscal Year Focus	2022
Trading Symbol	DCTH
Title of 12(b) Security	Common stock, $0.01 par value per share
Document Fiscal Period Focus	FY
Document Type	10-K
Amendment Flag	false
ICFR Auditor Attestation Flag	false
Security Exchange Name	NASDAQ
Auditor Name	Marcum LLP
Auditor Firm ID	688
Auditor Location	New York, NY
Documents Incorporated by Reference	DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s Proxy Statement for the 2023 Annual Meeting of Stockholders are incorporated by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. Such proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year ended December 31, 2022.

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Current assets
Cash and cash equivalents	$ 7,671	$ 22,802
Restricted cash	4,151	4,151
Accounts receivable, net	366	44
Inventories	1,998	1,412
Prepaid expenses and other current assets	1,969	2,743
Total current assets	16,155	31,152
Property, plant and equipment, net	1,422	1,348
Right-of-use assets	285	624
Total assets	17,862	33,124
Current liabilities
Accounts payable	2,018	638
Accrued expenses	4,685	4,109
Deferred revenue	0	170
Lease liabilities, current	186	416
Loan payable, current	7,846	621
Total current liabilities	14,735	5,954
Other liabilities, non-current	1,144	207
Loan payable, non-current	3,070	10,372
Convertible notes payable, non-current	4,772	4,639
Total liabilities	23,721	21,172
Commitments and contingencies	0	0
Stockholders' equity (deficit)
Preferred stock, $.01 par value; 10,000,000 shares authorized; 11,357 shares issued and outstanding at December 31, 2022 and 2021
Common stock, $.01 par value; 40,000,000 shares authorized; 10,046,571 shares and 7,906,728 shares issued and outstanding at December 31, 2022 and 2021, respectively	100	79
Additional paid-in capital	451,608	432,831
Accumulated deficit	(457,484)	(420,976)
Accumulated other comprehensive (loss) income	(83)	18
Total stockholders' equity (deficit)	(5,859)	11,952
Total liabilities and stockholders' equity (deficit)	$ 17,862	$ 33,124

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	11,357	11,357
Preferred stock, shares outstanding (in shares)	11,357	11,357
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	40,000,000	40,000,000
Common stock, shares issued (in shares)	10,046,571	10,046,571
Common stock, shares outstanding (in shares)	7,906,728	7,906,728

Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Revenue	$ 2,719	$ 3,555
Cost of goods sold	(686)	(671)
Gross profit	2,033	2,884
Operating expenses:
Research and development expenses	18,583	13,778
Selling, general and administrative expenses	17,303	13,637
Total operating expenses	35,886	27,415
Operating loss	(33,853)	(24,531)
Interest expense, net	(2,685)	(1,186)
Other income	30	68
Net loss	(36,508)	(25,649)
Other comprehensive (loss) income:
Foreign currency translation adjustments	101	122
Total other comprehensive loss	$ (36,407)	$ (25,527)
Common share data:
Basic loss per common share*	$ (4.12)	$ (3.59)
Diluted loss per common share*	$ (4.12)	$ (3.59)
Weighted average number of basic shares outstanding*	8,864,615	7,145,754
Weighted average number of diluted shares outstanding*	8,864,615	7,145,754
Product Revenue [Member]
Revenue	$ 2,548	$ 1,300
Other Revenue [Member]
Revenue	$ 171	$ 2,255

Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Total	Common Stock [Member]	Preferred Stock [Member]	Additional Paid in Capital [Member]	Accumulated Deficit [Member]	Accumulated Other Comprehensive Income (Loss) [Member]
Balance at Dec. 31, 2020	$ 22,078	$ 60	$ 0	$ 417,449	$ (395,327)	$ (104)
Balance (in shares) at Dec. 31, 2020		5,996,101	20,631
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	7,832			7,832
Shares settled for services	57			57
Shares settled for services (in shares)		2,636
Conversion of preferred stock into common stock		$ 9		(9)
Conversion of Preferred stock into common stock (in shares)		927,379	(9,274)
Exercise of warrants into common stock	2,458	$ 5		2,453
Exercise of warrants into common stock (in shares)		465,173
Proceeds allocated to warrant	1,171			1,171
Cash issuance costs of warrant	(44)			(44)
Exercise of options into common stock	4			4
Exercise of options into common stock (shares)		439
Common stock issued in connection with ATM Offering	3,923	$ 5		3,918
Common stock issued in connection with ATM Offering (Shares)		515,000
Net loss	(25,649)				(25,649)
Total comprehensive income (loss)	122					122
Balance at Dec. 31, 2021	11,952	$ 79	$ 0	432,831	(420,976)	18
Balance (in shares) at Dec. 31, 2021		7,906,728	11,357
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	7,941			7,941
Private placement -issuance of common shares and prefunded warrants, net of expenses, Shares (in shares)		2,139,843
Private placement -issuance of common shares and prefunded warrants, net of expenses	10,857	$ 21		10,836
Net loss	(36,508)				(36,508)
Total comprehensive income (loss)	(101)					(101)
Balance at Dec. 31, 2022	$ (5,859)	$ 100	$ 0	$ 451,608	$ (457,484)	$ (83)
Balance (in shares) at Dec. 31, 2022		10,046,571	11,357

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Cash flows from operating activities:
Net loss	$ (36,508)	$ (25,649)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock option compensation expense	7,941	7,832
Depreciation expense	132	146
Non-cash lease expense	443	322
Amortization of debt discount	768	323
Interest expense accrued related to convertible notes	160	186
Changes in assets and liabilities:
Decrease in prepaid expenses and other assets	774	813
(Increase) decrease in accounts receivable	(322)	13
Increase in inventories	(587)	(557)
Increase (decrease) in accounts payable and accrued expenses	1,798	(3,284)
Increase (decrease) in other liabilities, non-current	621	(322)
Decrease in deferred revenue	(170)	(2,427)
Net cash used in operating activities	(24,950)	(22,604)
Cash flows from investing activities:
Purchase of property, plant and equipment	(209)	(143)
Net cash used in investing activities	(209)	(143)
Cash flows from financing activities:
Net proceeds from private placement	10,857	0
Net proceeds from ATM Offering		3,923
Net proceeds from debt financing	0	14,437
Proceeds from the exercise of stock options		4
Proceeds from the exercise of warrants	0	2,458
Payment of loan payable	(714)
Net cash provided by financing activities	10,143	20,822
Foreign currency effects on cash	(115)	122
Net decrease in total cash	(15,131)	(1,803)
Total Cash, Cash Equivalents and Restricted Cash:
Beginning of period	26,953	28,756
End of period	11,822	26,953
Cash	7,671	22,802
Restricted Cash	4,151	4,151
Total	11,822	26,953
Supplemental Disclosure of Cash Flow Information:
Interest expense	1,873	681
Supplemental Disclosure of Non-Cash Investing and Financing Activities:
Issuance of restricted stock for accrued fees due to a former board member	0	57
Proceeds allocated to warrant	0	1,171
Financing of D&O insurance premium		886
Right of use assets obtained in exchange for lease obligations	$ 86	$ 0

Description of Business

12 Months Ended

Dec. 31, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Description of Business

(1)	Description of Business

Delcath Systems, Inc. (“Delcath” or 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. HEPZATO is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, our commercial product is a stand-alone medical device having the same device components as the HEPZATO KIT, but without the melphalan hydrochloride, and is approved for sale under the trade name CHEMOSAT

Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used at major medical centers to treat a wide range of cancers of the liver.

The Company’s clinical development program for HEPZATO was comprised of the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the “FOCUS Trial”), a global registration clinical trial investigating objective response rate in metastatic ocular melanoma, or mOM, a type of primary liver cancer. 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 which will maximize the value of the HEPZATO platform.

In the United States, HEPZATO is considered a combination drug and device product regulated by the 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 ocular melanoma, cutaneous melanoma, cholangiocarcinoma, hepatocellular carcinoma, and neuroendocrine tumor indications and one for doxorubicin in the hepatocellular carcinoma indication). HEPZATO has not been approved for sale in the United States.

In December 2021, the Company announced that the FOCUS Trial of HEPZATO met its

pre-specified

endpoint. On February 14, 2023 filed a New Drug Application resubmission to the FDA for the HEPZATO Kit (melphalan hydrochloride for Injection/Hepatic Delivery System) seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM). On March 20, 2023, the FDA determined the resubmission constituted a complete response and set a Prescription Drug User Fee Act target action date of August 14, 2023.

The resubmission is in response to a September 12, 2013 Complete Response Letter (CRL) from the FDA. The NDA resubmission contains comprehensive data and information relating to the matters identified in the CRL. We continue to promote our early access programs in the United States to make HEPZATO readily available to mOM patients. We are focused on continuing to treat these patients with mOM as regulatory approval is sought in the United States. There are currently patients enrolled in our early access program sites.

On February 28, 2022, CHEMOSAT received Medical Device Regulation 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

Although the Company is not aware of any direct impacts of the war between the Ukraine and the Russian Federation on its supply chain, the war could adversely impact the Company’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its

third-party suppliers in a timely manner or at all. In addition, at this time, although the Company is not aware of any direct impacts, any increase in COVID cases and associated restrictions, could adversely impact the Company’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its third-party suppliers in a timely manner or at all. Any rise in COVID cases and the associated absences from work of internal and external resources may also impact the Company’s ability to meet anticipated timelines.

Liquidity and Going Concern

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements, during the year ended December 31, 2022, the Company incurred net losses of $36.5 million and used $25.0 million of cash for its operating activities. These factors among others raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time.

On July 20, 2022, the Company closed a private placement for the issuance and sale of 690,954 shares of common stock and 566,751

pre-funded

warrants to purchase common stock to certain investors. Each share of common stock was sold at a price per share of $3.98 and the

pre-funded

warrants were sold at a price of $3.97 per

pre-funded

warrant. The

pre-funded

warrants have an exercise price of $0.01 per share of common stock and are immediately exercisable. The Company received gross proceeds from the private placement of approximately $5.0 million before deducting offering expenses.

On December 13, 2022, the Company closed a private placement for the issuance and sale of 1,448,889 shares of common stock and 692,042

pre-funded

warrants to purchase common stock to certain investors. Each share of common stock was sold at a price per share of $2.90 and the

pre-funded

warrants were sold at a price of $2.89

per pre-funded warrant. The pre-funded warrants have an exercise price of

$0.01 per share of Common Stock and are immediately exercisable. The Company received gross proceeds from the private placement of approximately $6.2 million before deducting offering expenses.

The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce or eliminate its research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If the Company is not able to continue as a going concern, it is likely that holders of its common stock will lose all of their investment. The accompanying consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern.

The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. Additional working capital will be required to continue operations. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of product development and clinical trial results; uncertainty regarding regulatory approval; technological uncertainty; uncertainty regarding patents and

proprietary rights; comprehensive government regulations; limited commercial manufacturing, marketing or sales experience; and dependence on key personnel.

Basis of Consolidated Financial Statement Presentation

12 Months Ended

Dec. 31, 2022

Basis Of Condensed Consolidated Financial Statement Presentation [Abstract]

Basis of Consolidated Financial Statement Presentation

(2)

Basis of Consolidated Financial Statement Presentation

The accounting and financial reporting policies of the Company conform to generally accepted accounting principles in the United States of America (“GAAP”). The preparation of consolidated financial statements in conformity with GAAP requires management to make assumptions and estimates that impact the amounts reported in the Company’s consolidated financial statements. The consolidated financial statements include the accounts of all entities controlled by the Company. All significant inter-company accounts and transactions are eliminated.

Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

(3)

Summary of Significant Accounting Policies

Use of Estimates

The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s consolidated balance sheets and the amount of revenues and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for valuation of warrants, stock-based compensation, valuation of inventory, impairment of long-lived assets, income taxes and operating expense accruals. Such assumptions and estimates are subject to change in the future as additional information becomes available or as circumstances are modified. Actual results could differ from these estimates.

Cash Equivalents and Concentrations of Credit Risk

The Company considers investments with original maturities of three months or less at date of acquisition to be cash equivalents. The Company has deposits that exceed amounts insured by the Federal Deposit Insurance Corporation; however, the Company does not consider this a significant concentration of credit risk based on the strength of the financial institution.

Restricted Cash

Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded as restricted cash on the accompanying consolidated balance sheets.

Accounts Receivable

Accounts receivable, principally trade, are generally due within 30 days and are stated at amounts due from customers. Collections and payments from customers are monitored and a provision for estimated credit losses may be created based upon historical experience and specific customer collection issues that may be identified.

Inventories

Inventories are valued at the lower of cost or net realizable value (“NRV”) using the

first-in,

first-out

method. The reported “NRV” of inventory includes finished saleable products,

work-in-process,

and raw materials that will be sold or used in future periods. The Company reserves for expired, obsolete, and slow-moving inventory.

Property, Plant and Equipment

Property, plant, and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight-line basis over the estimated useful lives of the assets which range from three to seven years. Leasehold improvements will be amortized over the shorter of the lease term or the estimated useful life of the related assets when they are placed into service. The Company evaluates property, plant and equipment for impairment periodically to determine if changes in circumstances or the occurrence of events suggest the carrying value of the asset or asset group may not be recoverable. Maintenance and repairs are charged to operations as incurred. Expenditures which substantially increase the useful lives of the related assets are capitalized.

Fair Value Measurements

The Company adheres to Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 applies to reported balances that are required or permitted to be measured at fair value under existing accounting pronouncements; accordingly, the standard does not require any new fair value measurements of reported balances.

ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy).

•

Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company can access.

•

Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals.

•

Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity’s own assumptions, as there is little, if any, related market activity.

In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value

measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability.

Revenue Recognition

Revenue is generated from proprietary and partnered product sales and license and royalty arrangements. Revenue is recognized when or as the Company transfers control of the promised goods or services to its customers in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for those goods or services. When obligations or contingencies remain after the products are shipped, such as training and certifying the treatment centers, revenue is deferred until the obligations or contingencies are satisfied.

Delcath may enter into contracts with partners that contain multiple elements such as licensing, development, manufacturing, and commercialization components. These arrangements are often complex, and the Company may receive various types of consideration over the life of the arrangement, including

up-front

fees, reimbursements for research and development services, milestone payments, payments on product shipments, margin sharing arrangements, license fees and royalties.

The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASC 606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation.

The following five steps are applied to achieve that core principle:

•

Step 1: Identify the contract with the customer;

•

Step 2: Identify the performance obligations in the contract;

•

Step 3: Determine the transaction price, including an estimation of any variable consideration expected to be received in connection with the contract;

•

Step 4: Allocate the transaction price to the performance obligations in the contract; and

•

Step 5: Recognize revenue when the company satisfies a performance obligation.

Each of these steps in the revenue recognition process requires management to make judgments and/or estimates. The most significant judgements and estimates involve the determination of variable consideration to be included in the transaction price. Variable consideration is recognized at an amount management believes is not subject to significant reversal and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. Management believes this provides a reasonable basis for recognizing revenue; however, actual results could differ from estimates and

significant changes in estimates could impact the Company’s results of operations in future periods.

As required by ASC 606, the Company disaggregates its revenue into the categories of product revenue and other revenue. The Company recognizes product revenue and milestone payments at a point in time, whereas other revenues (primarily license fees) are recognized over time. Milestone payments that are contingent upon the occurrence of future events, are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved. See Note 13 – Commitments and Contingencies – Litigations, Claims and Assessments – medac Matter.

Deferred Revenue

The timing of the Company’s revenue recognition may differ from the timing of payment by its customers. A receivable is recorded when revenue is recognized prior to payment and the Company has an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. See Note 13 – Commitments and Contingencies – Litigations, Claims and Assessments – medac Matter.

Selling, General and Administrative

Selling, general and administrative costs include personnel costs and related expenses for the Company’s sales, marketing, general management and administrative staff, recruitment, costs related to the Company’s commercialization efforts in Europe, professional service fees, professional license fees, business development and certain general legal activities. All such costs are charged to expense when incurred.

Research and Development

Research and development costs include the costs of materials used for clinical trials and R&D, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company’s proprietary drug delivery system. All such costs are charged to expense when incurred.

Stock Based Compensation

The Company accounts for its share-based compensation in accordance with the provisions of ASC 718, Stock-Based Compensation, which establishes accounting for equity instruments exchanged for services. Under the provisions of ASC 718, share-based compensation is measured at the grant date, based upon the fair value of the award, and is recognized as an expense over the option holders’ requisite service period (generally the vesting period of the equity grant). The Company expenses its share-based compensation granted under the accelerated method, which treats each vesting tranche as if it were an individual grant.

The Company periodically grants stock options for a fixed number of shares of common stock to its employees, directors, and

non-employee

contractors, with an exercise price greater than or equal to the fair

market value of the common stock at the date of the grant. The Company estimates the fair value of stock options using an option pricing model. Key inputs used to estimate the fair value of stock options include the exercise price of the option, the expected term, the expected volatility of the stock over the option’s expected term, the risk-free interest rate over the option’s expected term, and the expected annual dividend yield. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons who receive equity awards.

Income Taxes

The Company accounts for income taxes following the asset and liability method in accordance with the ASC 740 “Income Taxes.” Under such method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company applies the accounting guidance issued to address the accounting for uncertain tax positions. This guidance clarifies the accounting for income taxes, by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements as well as provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company classifies interest and penalty expense related to uncertain tax positions as a component of income tax expense. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years that the asset is expected to be recovered or the liability settled. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in its assessment of a valuation allowance. See Note 1

for additional information.

Net Loss per Common Share

Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities, except for those shares that are issuable for little or no cash consideration. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options, stock purchased pursuant to the Company’s employee stock purchase plan, convertible notes and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options and warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal.

For the years ended December 31, 2022 and 2021 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive:


	December 31,
	2022		2021
Common stock warrants - equity		3,610,743		3,610,743
Assumed conversion of Series E and Series E-1 Preferred Stock		1,135,721		1,135,721
Assumed conversion of convertible notes		488,031		488,031
Stock options		2,235,052		1,732,460

Total		7,469,547		6,966,955

Segment Information

A single management team that reports to the Chief Executive Officer comprehensively manages the business. Accordingly, the Company does not have separately reportable segments.

Foreign Currency and Currency Translation

Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses)/gains in the statements of operations.

The assets and liabilities of the Company’s international subsidiaries are translated from their functional currencies into United States dollars at exchange rates prevailing at the balance sheet date. The majority of the foreign subsidiaries revenues and operating expenses are denominated in Euros. The reporting currency for the Company is the United States dollar. Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions.

Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive income.

Subsequent Events

Management has evaluated events occurring subsequent to the consolidated balance sheet date, through Marc

h 27, 2

023, which is the date the consolidated financial statements were issued, determining all subsequent events have been disclosed.

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

12 Months Ended

Dec. 31, 2022

Prior Period Adjustment [Abstract]

Revision of Previously Issued Quarterly Financial Statements

(4)	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 $797 for the first quarter of 2022, $502 for the second quarter of 2022 and $372 for the third quarter of fiscal 2022. The share-based compensation adjustment is a non-cash adjustment did not have any impact on the cash balances for the Company.

The following tables contains 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 financial information that has been previously filed or otherwise reported for the three quarterly periods ended September 30, 2022 is superseded by the information in this Quarterly Report on Form 10-Q, and the financial statements and related financial information for the quarterly periods ended September 30, 2022 contained in such previously filed report should no longer be relied upon. The impact of the revision on the Company’s financial statements is reflected in the following table:


	As previously report			Adjustment			As revised
Balance Sheet for March 31, 2022 (unaudited)
Additional paid-in capital	$	434,305		$	797		$	435,102
Accumulated deficit		(429,179	)		(797	)		(429,976	)

Consolidated Statement of Operations and Comprehensive Loss for the three months March 31, 2022 (unaudited)
Research and development expenses		4,240			241			4,481
Selling, general and administrative expenses		3,648			556			4,204

Total operating expenses		7,888			797			8,685
Operating loss		(7,543	)		(797	)		(8,340	)
Net loss		(8,203	)		(797	)		(9,000	)
Total other comprehensive loss		(8,201	)		(797	)		(8,998	)
Basic and diluted loss per common share		(1.00	)		(0.10	)		(1.10	)

Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended March 31, 2022 (unaudited)
Compensation expense for issuance of stock options		1,474			797			2,271
Net loss		(8,203	)		(797	)		(9,000	)

Consolidated Statement of Cash Flows for the three months ended March 31, 2022 (unaudited)
Net loss		(8,203	)		(797	)		(9,000	)
Stock option compensation expense		1,474			797			2,271

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	)


	As previously report			Adjustment			As revised

Consolidated Statement of Operations and Comprehensive Loss for the three months 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 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	)

Balance Sheet for September 30, 2022 (unaudited)
Additional paid-in capital		442,066			1,671			443,737
Accumulated deficit		(447,341	)		(1,671	)		(449,012	)

Consolidated Statement of Operations and Comprehensive Loss for the three months September 30, 2022 (unaudited)
Research and development expenses		3,953			112			4,065
Selling, general and administrative expenses		4,519			260			4,779

Total operating expenses		8,472			372			8,844
Operating loss		(7,801	)		(372	)		(8,173	)
Net loss		(8,505	)		(372	)		(8,877	)
Total other comprehensive loss		(8,551	)		(372	)		(8,923	)
Basic and diluted loss per common share		(0.92	)		(0.04	)		-0.96

Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended September 30, 2022 (unaudited)
Compensation expense for issuance of stock options		1,255			372			1,627
Net loss		(8,505	)		(372	)		(8,877	)

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	)


	As previously report			Adjustment			As revised

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

Consolidated Statement of Operations and Comprehensive Loss for the nine months September 30, 2022 (unaudited)
Research and development expenses		13,649			503			14,152
Selling, general and administrative expenses		12,309			1,168			13,477

Total operating expenses		25,958			1,671			27,629
Operating loss		(24,327	)		(1,671	)		(25,998	)
Net loss		(26,365	)		(1,671	)		(28,036	)
Total other comprehensive loss		(26,447	)		(1,671	)		(28,118	)
Basic and diluted loss per common share		(3.09	)		(0.20	)		(3.29	)

Consolidated Statement of Cash Flows for the nine months ended September 30, 2022 (unaudited)
Net loss		(26,365	)		(1,671	)		(28,036	)
Stock option compensation expense		4,345			1,671			6,016

Cash, Cash Equivalents and Restricted Cash

12 Months Ended

Dec. 31, 2022

Cash and Cash Equivalents [Abstract]

Cash, Cash Equivalents and Restricted Cash

(5)	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 sheet. Restricted cash does not include required minimum balances.


	December 31,		December 31,
	2022		2021
Cash and cash equivalents	$	7,671	$	22,802
Restricted balance for loan agreement		4,000		4,000
Letters of credit		101		101
Security for credit cards		50		50

Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$	11,822	$	26,953

Under the terms of a

sub-lease

agreement for office space at 1633 Broadway, New York, NY, as of December 31, 2022, the Company is required to maintain a letter of credit in the amount of $101, which will expire with the sublease in May 2023

. On March 15, 2023, the Company returned to Avenue the $4.0 million held in the restricted cash to paydown a portion of the outstanding loan balance.

Inventories

12 Months Ended

Dec. 31, 2022

Inventory Disclosure [Abstract]

Inventories

(6)	Inventories

Inventories consist of:


	December 31,		December 31,
	2022		2021
Raw materials	$	763	$	767
Work-in-process		1,102		645
Finished goods		133		—

Total inventories	$	1,998	$	1,412

Prepaid Expenses and Other Current Assets

12 Months Ended

Dec. 31, 2022

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

Prepaid Expenses And Other Current Assets

(

)

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets include the following:


	December 31,		December 31,
	2022		2021
Clinical trial expenses	$	1,630	$	1,630
Insurance premiums		123		890
Professional services		121		15
Other		95		208

Total prepaid expenses and other current assets	$	1,969	$	2,743

Property, Plant, and Equipment

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Abstract]

Property, Plant, and Equipment

(8)	Property, Plant, and Equipment

Property, plant, and equipment consists of:


	December 31, 2022			December 31, 2021			Estimated Useful Life
Buildings and land	$	1,301		$	1,222		30 years - Buildings
Enterprise hardware and software		1,855			1,858		3 years
Leaseholds		1,774			1,796		Lesser of lease term or estimated useful life
Equipment		1,222			1,094		7 years
Furniture		201			203		5 years

Property, plant and equipment, gross		6,353			6,173
Accumulated depreciation		(4,931	)		(4,825	)

Property, plant and equipment, net	$	1,422		$	1,348

Depreciation expense for the years ended December 31, 2022 and 2021 was $

132

and $

146

, respectively.

Accrued Expenses

12 Months Ended

Dec. 31, 2022

Payables and Accruals [Abstract]

Accrued Expenses

(

)

Accrued Expenses

Current accrued expenses include the following:


	December 31, 2022		December 31, 2021
Clinical expenses	$	1,470	$	1,517
Compensation, excluding taxes		1,040		893
Short-term financing		—		551
Professional fees		1,087		603
Interest on convertible note		553		393
Other		535		152

Total accrued expenses	$	4,685	$	4,109

Leases

12 Months Ended

Dec. 31, 2022

Leases [Abstract]

Leases

(

)

Leases

The Company recognizes

right-of-use

(“ROU”) assets and lease liabilities when it obtains the right to control an asset under a leasing arrangement with an initial term greater than twelve months. The Company leases its facilities under

non-cancellable

operating 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.

Pursuant to a 2014 sublease agreement (the “2014 Sublease”) and a 2015 sublease agreement (the “2015 Sublease”) the Company subleased portions of its leased premises in Galway, Ireland to a sublessee. On May 15, 2020, the Company and its sublessee entered into amendments to the 2014 Sublease and the 2015 Sublease pursuant to which (i) the 2014 Sublease and 2015 Sublease were extended from May 31, 2020 to August 2, 2021, (ii) effective July 1, 2020, the leased premises under the 2015 Sublease would be expanded to include an additional

4,999 square feet of space, and (iii) effective July 1, 2020, the rent under the 2015 Sublease would increase from approximately $14.6 per month to $20.6 per month.

The Company analyzed the terms of the amended 2014 Sublease and 2015 Sublease and determined that its ROU asset for the master operating lease was not impaired as a result of the amendments. On June 25, 2020, the Company entered into a sublease agreement (the “2021

Sub-Lease”)

with its previous sublessee under the 2014 Sublease and 2015 Sublease pursuant to which, effective August 2, 2021, the previous sublessee would become the lessee and the Company would then sublease its portion of the premises in Galway, Ireland from the previous sublessee. The Company’s rent expense under the 2021

Sub-Lease

is approximately $

3.7

per month for a term of

five years

On September 22, 2020, the Company entered into an amendment to a

sub-lease

agreement executed in March 2016 for approximately 6,877 square feet of office space at 1633 Broadway, New York, NY. The term of the

sub-lease

agreement began in April 2016 and, pursuant to the amendment on November 2022, is extended through May 2023.

The following table summarizes the Company’s operating leases as of December 31, 2022:


	U.S.			Ireland			Total
Lease cost
Operating lease cost	$	406		$	37		$	443
Other information
Operating cash flows out from operating leases		(406	)		(37	)		(443	)
Weighted average remaining lease term		0.5			3.6
Weighted average discount rate - operating leases		8	%		8	%

Maturities of the Company’s operating leases, excluding short-term leases, are as follows:


	U.S.			Ireland			Total
Year ended December 31, 2023		155			37			192
Year ended December 31, 2024		—			37			37
Year ended December 31, 2025		—			37			37
Year ended December 31, 2026		—			22			22

Total		155			133			288
Less present value discount		(3	)		(17	)		(20	)

Operating lease liabilities included in the condensed consolidated balance sheets at December 31, 2022	$	152		$	116		$	268

Loans and Convertible Notes Payable

12 Months Ended

Dec. 31, 2022

Debt Disclosure [Abstract]

Loans and Convertible Notes Payable

)

Loans and Convertible Notes Payable


	December 31, 2022									December 31, 2021
	Gross			Discount			Net			Gross			Discount			Net
Loan - Avenue [1]	$	11,923		$	(1,008	)	$	10,916		$	12,638		$	(1,645	)	$	10,993
Loan - Avenue [1] - Less Current Portion		(8,570	)		724			(7,846	)		(714	)		93			(621	)

Total - Loans Payable, Non-Current	$	3,353		$	(284	)	$	3,070		$	11,924		$	(1,552	)	$	10,372

Convertible Note Payable - Rosalind		2,000			—			2,000			2,000			—			2,000
Convertible Portion of Loan Payable - Avenue		3,000			(228	)		2,772			3,000			(361	)		2,639

Total - Convertible Notes Payable - Non-Current	$	5,000		$	(228	)	$	4,772		$	5,000		$	(361	)	$	4,639

[1]	The gross amount includes the 4.25% final payment of $637.5.

Remaining maturities of the Company’s loan and convertible note payables are as follows:


			Convertible
	Loans		Notes		Total
Year ended December 31, 2023	$	8,570	$	—	$	8,570
Year ended December 31, 2024		3,353		5,000		8,353

Total	$	11,923	$	5,000	$	16,923

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 December 31, 2022 was 15.2%. 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

which has been funded into a restricted account and will be released upon achievement of (a)(x) positive FOCUS trial efficacy per the trial’s predefined Statistical Analysis Plan (SAP) (specifically the Overall Response Rate exceeds the prespecified threshold for success defined in the SAP by a statistically significant amount); and (y) based on data contained within the FOCUS trial database and appropriate for use with the U.S. Food and Drug Administration, safety and tolerability among FOCUS trial participants is within the range of currently approved and commonly used cytotoxic chemotherapeutic agents; and (b) raising subsequent net equity proceeds of at least $20.0

million

. The Company may request an additional $5.0

million

of gross proceeds between October 1, 2022 and December 31, 2022, with funding, subject to the approval of Avenue’s Investment Committee. Since the Company did not achieve a net equity raise of $20.0

million of gross proceeds, the Company did not request an additional $5.0 million of funding during the period from October 1, 2022 through December 31, 2022.

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

The Company will make monthly interest-only payments during the first fifteen months of the term of the Avenue Loan, which could be increased to up to twenty-four months upon the achievement of specified performance milestones. Following the interest-only period, the Company will make equal monthly payments of principal plus interest until the maturity date, when all remaining principal outstanding and accrued interest must be paid. The interest only period ended in November 2022, and the Company began making principal payments on December 1, 2022. If the Company prepays the Avenue Loan, it will be required to pay (a) a prepayment fee of 3% if the Avenue Loan is prepaid during the interest-only period; and (b) a prepayment fee of 1% if the Avenue Loan is prepaid after the interest-only period. The Company must make an incremental final payment equal to 4.25% of the aggregate fund

ing.

On March 15, 2023, the Company returned to Avenue the $4.0 million held in the restricted cash to paydown a portion of the outstanding loan balance

and reduce the monthly principal payments.

The Company paid an aggregate commitment fee of $150 at closing. Upon funding a second tranche of the Avenue Loan, the Lender will earn a 1.0% fee on the $5.0

million

of incremental committed capital, for a total commitment fee of $200.

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 was not required to be bifurcated. The Company determined that the Avenue Warrant met the criteria to be equity-classified. The $637 value of the final payment was treated as original issue discount. The $1,171 relative fair value of the Avenue Warrant was credited to Additional Paid in Capital while it was debited as debt discount. Of the $563 of cash issuance costs, $519 was allocated to the Avenue Loan and was recorded as debit discount, while $44 was allocated to the Avenue Warrant and was debited to Additional Paid in Capital. Of the $2,327 of aggregate debt discount, $1,909 was allocated to the

non-convertible

portion of the Avenue Loan, while $418 was allocated to the convertible portion of the Avenue Loan. Aggregate debt discount amortization of $0.8 million was recorded during the year ended December 31, 2022. The Company also determined that the convertible portion of the Avenue Loan did not include a beneficial conversion feature, because the effective conversion price exceeded the commitment date market price of the Company’s common stock. Interest expense was $1.9 million for the year ended December 31, 2022.

The Avenue Warrant was valued at issuance at $1.3 million using the Black-Scholes option pricing method using the following assumptions:


	August 6, 2021
Contractual term (years)		5.07
Expected volatility		187.0	%
Risk-free interest rate		0.77	%
Expected dividends		0.00	%

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 their 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

On August 6, 2021, the Company executed an agreement to amend the Rosalind Notes to (a) reduce the conversion price to $1,198 per share of the Company’s Series E Convertible Preferred Stock; and (b) extend the maturity date to October 30, 2024.

In addition, in order to induce the Avenue Venture Opportunities Fund, L.P. to provide the Avenue Loan described above, the holders of the Rosalind Notes agreed to subordinate (a) all of the Company’s indebtedness and obligations to the holders; and (b) all of the holders’ security interest, to the Avenue Loan and Avenue’s security interest in the Company’s property.

Up to $3.0

million

of the principal amount of the Avenue Loan outstanding may be converted, at the option of the Lender, into shares of the Company’s common stock at a conversion price of $11.98 per share.

Interest expense with respect to the Rosalind Notes was $160 for both years ended December 31, 2022 and 2021

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-URI https://asc.fasb.org/topic&trid=2208564

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (g)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1E
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495348-112611

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (i)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

+ Details

Stockholders' Equity

12 Months Ended

Dec. 31, 2022

Stockholders' Equity Note [Abstract]

Stockholders' Equity

(12)	Stockholders’ Equity

Authorized Shares

The Company is authorized to issue 40,000,000 shares of common stock, $0.01 par value, and 10,000,000 shares of preferred stock, $0.01 par value. To date, the Company has designated the following preferred stock: Series A (4,200 shares), Series B (2,360 shares), Series C (590 shares), Series D (10,000 shares), Series E (40,000 shares) and Series

E-1

(12,960 shares).

Preferred Stock

Series E and Series

E-1

Convertible Preferred Stock

During the years ended December 31, 2021, 9,274 shares of Series E and Series

E-1

Convertible Preferred Stock were converted into 927,379 shares of the Company’s common stock.

As of December 31, 2022, there were an aggregate of 11,357 shares of Series E and Series

E-1

Convertible Preferred Stock outstanding.

Equity Offerings and Placements

At-the-Market

Offering

On August 18, 2020, the Company entered into a sales agreement with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), pursuant to which the Company may offer and sell, from time to time, through Cantor Fitzgerald, as sales agent or principal, shares of the Company’s common stock, (the “Placement Shares”), having an aggregate offering price of up to $10 million (the “ATM Offering”). On November 9, 2021 the Company filed a supplement to increase the aggregate amount to

$25

million. On February 27, 2023, filed an amendment to change the aggregate offering price to the limit of

$17

million.

The Company has no obligation to sell any Placement Shares under the sales agreement. Subject to the terms and conditions of the sales agreement, Cantor Fitzgerald is required to use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of the Nasdaq Stock Market, to sell Placement Shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. The Company will pay Cantor Fitzgerald a commission of 3.0% of the aggregate gross proceeds from each sale of Placement Shares, reimburse Cantor Fitzgerald’s legal fees and disbursements up to $50 and provide Cantor Fitzgerald with customary indemnification and contribution rights. The sales agreement may be terminated by Cantor Fitzgerald or the Company upon notice to the other party as provided in the sales agreement, or by Cantor Fitzgerald at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisable to market the Placement Shares or to enforce contracts for the sale of the Placement Shares.

In connection with the ATM Offering, in consideration for a fee equal to 1.05% of the gross sales price per share sold in the ATM Offering, ROTH Capital Advisors, LLC (“Roth”) waived, solely with respect to the ATM Offering, (i) Roth’s right, pursuant to certain engagement letters dated August 14, 2019 and January 13, 2020 between Roth and the Company, to act as placement agent or underwriter with respect to offerings of the Company’s securities and to receive a minimum of 35% of the fees paid to the agents or underwriters for such offerings and (ii) the

lock-up

provision included in a certain underwriting agreement dated May 1, 2020 between Roth and the Company requiring the prior written consent of Roth for any offer or sale of the Company’s common stock by the Company during the

90-day

period following the date of such underwriting agreement.

During the year ended December 31, 2021, the Company sold

515,000

shares of common stock pursuant to the ATM Offering for aggregate gross proceeds of $4

million

, partially offset by $121 of issuance costs. There were no shares sold year ended December 31, 2022.

Private Placement

On July 20, 2022, the Company closed a private placement for the issuance and sale of 690,954 shares of common stock and 566,751

pre-funded

warrants to purchase common stock to certain investors. Each share of common stock was sold at a price per share of $3.98 and the

pre-funded

warrants were sold at a price of $3.97 per

pre-funded

warrant. The

pre-funded

On December 13, 2022, the Company closed a private placement for the issuance and sale of 1,448,889 shares of common stock and 692,042

pre-funded

warrants to purchase common stock to certain investors. Each share of common stock was sold at a price per share of $2.90 and the

pre-funded

warrants were sold at a price of $2.89 per

pre-funded

warrant. The

pre-funded

Other Common Stock Issuances

In February 2021, the Company issued 2,636 shares of unregistered common stock in lieu of a cash payment of deferred accrued director fees to a former director.

During the year ended December 31, 2021, the Company issued 465,173 shares of common stock associated with the exercise of warrants, including 215,000

pre-funded

warrants at an exercise price of $0.01 per share, for aggregate cash proceeds of $2.5

million

Stock Incentive Plans

The Company’s 2019 Equity Incentive Plan (the “2019 Plan”) allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. All of the Company’s officers, directors, employees, consultants, and advisors are eligible to receive grants under the 2019 Plan. The 2019 Plan provides for the grant of options to purchase shares of common stock at exercise prices not less than 100% of fair value on the dates of grant. The maximum number of shares reserved for issuance under the 2019 Plan was 2,142. The 2019 Plan has been superseded by the 2020 Plan discussed below and no further awards will be made under the 2019 Plan; however, outstanding awards granted under the 2019 Plan will remain outstanding and continue to be administered in accordance with the terms of the 2019 Plan and the applicable award agreements.

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. 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 December 31, 2022, there are 2,475,000 shares of common stock reserved under the 2020 Plan, of which 870,508 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:


	Years Ended December 31
	2022	2021
Expected terms (years)	0.7 - 8.4	5.1 - 6.3
Expected volatility	166.4% -180.3%	177.% - 181.3%
Risk-free interest rate	1.2% - 4.4%	0.7% - 1.3%
Expected dividends	0.00%	0.00%

The weighted average estimated fair value of the stock options granted during the years ended December 31, 2022 and 2021 was approximately $6.05 and $9.74 per share, respectively.

The following is a summary of stock option activity for the year ended December

2022


	Number of Options			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at January 1, 2022		1,732,460		$	11.69
Granted		702,583			6.74
Expired		(65,690	)		10.43
Cancelled/Forfeited		(134,301	)		9.59

Outstanding at December 31, 2022		2,235,052		$	10.30		8.0	$	36

Exercisable at December 31, 2022		1,316,515		$	11.13		7.6	$	—

The following table summarizes information for stock option shares outstanding and exercisable at December 31, 2022:


			Options Exercisable
			Weighted Average
	Outstanding Number of		Remaining Option Term
Range of Exercise Prices	Options		(in years)		Number of Options
$6.24 - $53.85		2,234,553		8.0		1,316,016
$53.85+		499		6.1		499

		2,235,052		7.6		1,316,515

At December 31, 2022, there was approximately $2.8 million of aggregate unrecognized compensation expense related to employee and board stock option grants. The cost is expected to be recognized over a weighted average period of 1.6 years. For the years ended December 31, 2022 and 2021, the Company recognized compensation expense $7.9 million and $7.8 million, respectively, related to stock options granted to employees and board members, which were charged to the statement of operations as detailed below:


	Years Ended December 31,
	2022		2021
Selling, general and administrative	$	5,282	$	5,334
Research and development		2,449		2,311
Cost of goods sold		210		187

Total	$	7,941	$	7,832

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

% 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

15,417

shares were purchased by participating employees for the offering period of July

2022

to December

2022

. The fair value of each ESPP award of $

2.23

was estimated on the first day of the offering period using the Black-Scholes option-pricing model. The Company recognized share-based compensation expense of $

, which is equal to the fair value of the ESPP awards on a straight-line basis over the offering period.

Warrants

The following is a summary of warrant activity for the year ended December 31, 2022:


					Weighted Average
			Weighted Average		Remaining Life
	Warrants		Exercise Price		(in years)
Outstanding at January 1, 2022		3,894,498	$	9.27
Warrants issued		1,258,793		.01

Outstanding at December 31, 2022		5,153,291	$	7.01		2.8

Exercisable at December 31, 2022		5,153,291	$	7.01		2.8

The following table presents information related to stock warrants at December 31, 2022:


			Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants		Weighted Average Remaining Warrant Term (in years)		Number of Warrants
$0.01		1,542,548		4.4		1,542,548
$10.00		3,610,743		2.2		3,610,743

		5,153,291		2.8		5,153,291

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

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+ Details

Commitments and Contingencies

12 Months Ended

Dec. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

)

Commitments and Contingencies

Litigation, Claims and Assessments

Former Officers Matter

Following the May 18, 2020 resignation (effective June 1, 2020) of Jennifer Simpson, the Company’s former President and Chief Executive Officer, and Barbra Keck, the Company’s former Chief Financial Officer (the “Claimants”), it became evident that there was a dispute regarding the Company’s compensation obligations to the Claimants. In a letter dated, June 29, 2020, an attorney representing the Claimants made certain claims and threatened litigation against the Company. On or about July 27, 2020, the Claimants filed a statement of claim with the American Arbitration Association against the Company. The Claimants sought payment of certain purported unpaid compensation amounts claimed to be due to them, in an approximate amount of $1.1 million in the aggregate, as well as unspecified statutory damages under New York Labor Law, attorneys’ fees and costs, and statutory interest. The Claimants and the Company agreed to participate in non-binding mediation of their dispute before a neutral mediator, which resulted in the arbitration proceedings being placed in abeyance pending the outcome of the mediation process. With the assistance of the neutral mediator and after careful consideration by the Company’s board of directors following several weeks of negotiations, the Claimants and the Company agreed in mid-May of 2021 to a confidential settlement of their dispute to avoid the expenses and distractions of further arbitration proceedings, with no admission of liability or wrongdoing on the part of the Company. While the Company had accrued for the full purported unpaid compensation amount of

$1.1

million as of December 31, 2020, the Company ultimately paid less in full and final settlement of its dispute with both of the Claimants. As a result of the confidential settlement, the AAA Arbitration was dismissed with prejudice on June 1, 2021.

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 all member states of the European Union, Norway, Liechtenstein, Switzerland and the United Kingdom 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. medac disputed having an obligation to make the milestone payment and demanded withdrawal of the termination notice. In response to medac’s continued failure to make the milestone payment and its demand for the Company to withdraw its termination notice, on December 16, 2021, we initiated an arbitration proceeding pursuant to the dispute resolution procedures of the medac Agreement. Thereafter, on December 30, 2021, we received a letter from medac stating that, due to our failure to withdraw the termination notice, medac was terminating the medac Agreement with immediate effect. In a separate letter, medac agreed to orderly transition through February 28, 2022 in order to minimize the impact of any termination on patients and physicians. The Company agreed to purchase inventory held at medac in March 2022 for approximately $0.2 million. As a result of the early termination of the medac Agreement, the Company revised its estimate of the contract life which resulted in an acceleration of $1.7 million of revenue recognition associated with deferred revenue.

On December 30, 2022, the parties reached a final settlement of the matter and Delcath has agreed pay medac 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. The settlement terms also contain a minimum annual payment of $0.2 million in the event the annual royalty payment does not reach the agreed on minimum payment amount. The Company has estimated the settlement to be $1.2

million and recorded $1.0

million as other liabilities,

non-current and

$0.2

million as accrued expenses on the Company’s condensed consolidated

balance sheet and a $1.2 million charge in selling, general and administrative expenses in the Company’s condensed consolidated statement of operations and comprehensive loss for the year ended December 31, 2022.

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 $900

in unpaid consulting fees plus interest, costs and attorneys’ fees. The lawsuit is

Lachman Consultant Services, Inc. v. Delcath Systems, Inc., Index No.

650103-2023 (New York Supreme Court, New York County

. The Company filed an answer to Lachman’s Complaint on February 22, 2023. On March 17, 2023, Delcath responded to Lachman’s March 3, 2023 Motion for Partial Summary Judgment. On March 20, 2023, the Court denied Lachman’s request that the case be moved into the Commercial Division. The current return date of Lachman’s motion for partial summary judgment is March 31, 2023. The dispute arises from a July 22, 2021 agreement between Lachman and Delcath under which Lachman was to provide assistance to the Company in regard to preparing for a FDA inspection and good manufacturing practices, training and support. In August 2022, the Company disputed

$300 of charges from Lachman As of December 31, 2022, the Company has accrued $0.9 million as accrued liability on the Company’s condensed consolidated balance sheet. The Company plans to vigorously defend this lawsuit and has reserved its rights to dispute all of Lachman charges as the litigation proceeds.

Income Taxes

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Income Taxes

(14)	Income Taxes

There is no income tax provision for the years ended December 31, 2022 and 2021, respectively.

Loss before income taxes consists of:


	For the Year Ended December 31,
	2022			2021
Domestic	$	(34,547	)	$	(25,881	)
Foreign		(1,960	)		232

Income before taxes	$	(36,507	)	$	(25,649	)

The provision for income taxes differs from the amount computed by applying the statutory rate as follows:


	For the Year Ended December 31,
	2022			2021
Income taxes using U.S federal statutory rate	$	(7,666	)	$	(5,386	)
Nondeductible interest		139			39
Loss of tax benefit of state net operating loss carryforwards		—			2,799
Branch income		(385	)		229
State income taxes, net of federal benefit		(531	)		311
Foreign rate differential		165			27
Valuation allowance		9,221			2,114
Stock option expense, exercises and cancellations		752			446
Research and development costs		(708	)		(375	)
Other		(987	)		(204	)

	$	—		$	—

Significant components of the Company’s deferred tax assets are as follows:


	For the Year Ended December 31,
	2022		2021
Deferred tax assets:
Employee compensation accruals	$	2,772	$	1,777
Accrued liabilities		197		29
Research tax credits		1,429		721
Lease obligation		38		107
Other		160		89
Research expense capitalization		3,203		—
Net operating losses		24,595		20,520

Total deferred tax assets		32,394		23,243


	For the Year Ended December 31,
	2022		2021
Deferred tax liabilities:
Right of use asset		50		118

Total deferred tax liabilities		50		118

Valuation allowance		32,344		23,125

Net deferred tax assets	$	—	$	—

As of

December 31, 2022, and 2021, the Company had net operating loss carryforwards for U.S. federal income tax purposes of approximately $

290.4

million and $

277.4

million, respectively. A significant portion of the federal amount is subject to an annual limitation as low as $

as a result of changes in the Company’s ownership in May 2003, November 2016, and multiple dates throughout 2017, 2018, 2019 and 2021, as defined by Section 382 of the United States Internal Revenue Code of 1986, as amended (the “IRC”), and the related income tax regulations. As a result of the limitations caused by the multiple ownership changes, approximately $

202.6

million of the total net operating loss carryforwards is expected

to expire unutilized and will be unavailable to offset future federal taxable income. Approximately $

87.7

million of net operating loss carryforwards remains available to offset future federal taxable income, of which $

1.7

million will expire between

2023

and

2037

and $

86.0

million will have an unlimited carryforward period.

In addition, the Company’s state net operating losses are also subject to annual limitations that generally follow the IRC Section 382 provisions (with the exception of Connecticut and Florida), adjusted for each state’s respective income apportionment percentages. As of December 31, 2022, and 2021, the Company had net operating loss carryforwards for states and city income tax purposes between approximately $0.3 million and $195.3

million and between approximately $24.8 million and $193.7

million, respectively, which expire through 2042. As a result of the Section 382 limitations, approximately $190.3 million and $174.5 million of New York State and New York City net operating losses are expected to expire unutilized and will be unavailable to offset future taxable income. Approximately $5.1 million and $5.0 million of net operating loss carryforwards, respectively, will be available to offset future state and city taxable income. As of December 31, 2022 and 2021, the Company had a net operating loss carryforward for foreign income tax purposes of $33.4 million and $28.0 million, respectively, which have indefinite carryforward periods. As of December 31, 2022 and 2021, the Company had federal research and development tax credit carryforwards of approximately $6.5

million

and $5.8

million, respectively, which expire through 2042. As a result of the Section 382 limitations, all but $1.4 million of the tax credit carryforwards is expected to expire unutilized.

Management has established a 100% valuation allowance against the deferred tax assets as management does not believe it is more likely than not that these assets will be realized. The Company’s valuation allowance increased by approximately $9.2 million and $1.8 million in 2022 and 2021, respectively. The change in valuation allowance is as follows:


	December 31,
	2022			2021
Beginning Balance	$	23,125		$	21,332
Charged to costs and expenses		9,221			2,114
Charged to other comprehensive income		(2	)		(321	)

Ending balance	$	32,344		$	23,125

The Company complies with the provisions of ASC

740-10

in accounting for its uncertain tax positions. ASC

740-10

addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC

740-10,

the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The Company has determined that the Company has no significant uncertain tax positions requiring recognition under ASC

740-10

and therefore has not included a tabular roll forward of unrecognized tax benefits. As there are no uncertain tax positions recognized, interest and penalties have not been accrued.

The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. The Company has not been audited by any state tax authorities in connection with income taxes. The Company has not been audited by international tax authorities or any states in connection with income taxes. The Company’s New York State tax returns have been subject to annual desk reviews which have resulted in insignificant adjustments to the related franchise tax liabilities and credits. The Company is no longer subject to federal and state examination for tax years ending prior to December 31, 2019; tax years ending

December 31, 2019 through December 31, 2022 remain open to examination. The Republic of Ireland is the Company’s only significant foreign jurisdiction. The Company is no longer subject to Ireland tax examination for tax years ending prior to December 31, 2018 (as Ireland has not initiated an audit of 2017 as of December 31, 2022); tax years ending December 31, 2018 through December 31, 2022 remain open to examination. However, the Company’s tax years

December 31, 1998

through

December 31, 2022

generally remain open to adjustment for all federal, state and foreign tax matters until its net operating loss and tax credit carryforwards a reutilized or expire prior to utilization, and the applicable statutes of limitation have expired in the utilization year. 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.

The Company recognizes interest accrued related to unrecognized tax benefits and penalties, if incurred, as a component of income tax expense.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI https://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Fair Value Measurements

12 Months Ended

Dec. 31, 2022

Fair Value Disclosures [Abstract]

Fair Value Measurements

(15)	Fair Value Measurements

The table below presents activity within Level 3 of the fair value hierarchy, our liabilities carried at fair value for the year ended December 31, 2022:


	Level 3
Balance at January 1, 2022	$	—
Add: contingent liability recorded on medac settlement		1,168
Change in exchange rate		112

Balance at December 31, 2022	$	1,280

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.

The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value as of December 31, 2022 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value. There were no financial assets and liabilities that have been measured at fair value as of December 31, 2021. In general, the fair values were determined using Level 3:


Description	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		December 31, 2021
Liabilities:
Contingent Liability					$	1,280	$	1,280

Total Liabilities	$	—	$	—	$	1,280	$	1,280

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Summary of Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Use of Estimates

Cash Equivalents and Concentrations of Credit Risk

Restricted Cash

Accounts Receivable

Inventories

Inventories are valued at the lower of cost or net realizable value (“NRV”) using the

first-in,

first-out

method. The reported “NRV” of inventory includes finished saleable products,

work-in-process,

and raw materials that will be sold or used in future periods. The Company reserves for expired, obsolete, and slow-moving inventory.

Property, Plant and Equipment

Fair Value Measurements

•

Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company can access.

•

Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity’s own assumptions, as there is little, if any, related market activity.

Revenue Recognition

up-front

fees, reimbursements for research and development services, milestone payments, payments on product shipments, margin sharing arrangements, license fees and royalties.

The following five steps are applied to achieve that core principle:

•

Step 1: Identify the contract with the customer;

•

Step 2: Identify the performance obligations in the contract;

•

Step 3: Determine the transaction price, including an estimation of any variable consideration expected to be received in connection with the contract;

•

Step 4: Allocate the transaction price to the performance obligations in the contract; and

•

Step 5: Recognize revenue when the company satisfies a performance obligation.

significant changes in estimates could impact the Company’s results of operations in future periods.

Deferred Revenue

Selling, General and Administrative

Research and Development

Stock Based Compensation

The Company periodically grants stock options for a fixed number of shares of common stock to its employees, directors, and

non-employee

contractors, with an exercise price greater than or equal to the fair

Income Taxes

for additional information.

Net Loss per Common Share


	December 31,
	2022		2021
Common stock warrants - equity		3,610,743		3,610,743
Assumed conversion of Series E and Series E-1 Preferred Stock		1,135,721		1,135,721
Assumed conversion of convertible notes		488,031		488,031
Stock options		2,235,052		1,732,460

Total		7,469,547		6,966,955

Segment Information

A single management team that reports to the Chief Executive Officer comprehensively manages the business. Accordingly, the Company does not have separately reportable segments.

Foreign Currency and Currency Translation

Subsequent Events

Management has evaluated events occurring subsequent to the consolidated balance sheet date, through Marc

h 27, 2

023, which is the date the consolidated financial statements were issued, determining all subsequent events have been disclosed.

Recently Adopted and Issued Accounting Pronouncements

Summary of Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Anti-dilutive securities excluded from the computation of earnings per share


	December 31,
	2022		2021
Common stock warrants - equity		3,610,743		3,610,743
Assumed conversion of Series E and Series E-1 Preferred Stock		1,135,721		1,135,721
Assumed conversion of convertible notes		488,031		488,031
Stock options		2,235,052		1,732,460

Total		7,469,547		6,966,955

Revision of Previously Issued Quarterly Financial Statements (Tables)

12 Months Ended

Dec. 31, 2022

Prior Period Adjustment [Abstract]

Schedule of error corrections and prior period adjustments

The impact of the revision on the Company’s financial statements is reflected in the following table:


	As previously report			Adjustment			As revised
Balance Sheet for March 31, 2022 (unaudited)
Additional paid-in capital	$	434,305		$	797		$	435,102
Accumulated deficit		(429,179	)		(797	)		(429,976	)

Consolidated Statement of Operations and Comprehensive Loss for the three months March 31, 2022 (unaudited)
Research and development expenses		4,240			241			4,481
Selling, general and administrative expenses		3,648			556			4,204

Total operating expenses		7,888			797			8,685
Operating loss		(7,543	)		(797	)		(8,340	)
Net loss		(8,203	)		(797	)		(9,000	)
Total other comprehensive loss		(8,201	)		(797	)		(8,998	)
Basic and diluted loss per common share		(1.00	)		(0.10	)		(1.10	)

Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended March 31, 2022 (unaudited)
Compensation expense for issuance of stock options		1,474			797			2,271
Net loss		(8,203	)		(797	)		(9,000	)

Consolidated Statement of Cash Flows for the three months ended March 31, 2022 (unaudited)
Net loss		(8,203	)		(797	)		(9,000	)
Stock option compensation expense		1,474			797			2,271

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	)


	As previously report			Adjustment			As revised

Consolidated Statement of Operations and Comprehensive Loss for the three months 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 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	)

Balance Sheet for September 30, 2022 (unaudited)
Additional paid-in capital		442,066			1,671			443,737
Accumulated deficit		(447,341	)		(1,671	)		(449,012	)

Consolidated Statement of Operations and Comprehensive Loss for the three months September 30, 2022 (unaudited)
Research and development expenses		3,953			112			4,065
Selling, general and administrative expenses		4,519			260			4,779

Total operating expenses		8,472			372			8,844
Operating loss		(7,801	)		(372	)		(8,173	)
Net loss		(8,505	)		(372	)		(8,877	)
Total other comprehensive loss		(8,551	)		(372	)		(8,923	)
Basic and diluted loss per common share		(0.92	)		(0.04	)		-0.96

Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended September 30, 2022 (unaudited)
Compensation expense for issuance of stock options		1,255			372			1,627
Net loss		(8,505	)		(372	)		(8,877	)

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	)


	As previously report			Adjustment			As revised

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

Consolidated Statement of Operations and Comprehensive Loss for the nine months September 30, 2022 (unaudited)
Research and development expenses		13,649			503			14,152
Selling, general and administrative expenses		12,309			1,168			13,477

Total operating expenses		25,958			1,671			27,629
Operating loss		(24,327	)		(1,671	)		(25,998	)
Net loss		(26,365	)		(1,671	)		(28,036	)
Total other comprehensive loss		(26,447	)		(1,671	)		(28,118	)
Basic and diluted loss per common share		(3.09	)		(0.20	)		(3.29	)

Consolidated Statement of Cash Flows for the nine months ended September 30, 2022 (unaudited)
Net loss		(26,365	)		(1,671	)		(28,036	)
Stock option compensation expense		4,345			1,671			6,016

Cash, Cash Equivalents and Restricted Cash (Tables)

12 Months Ended

Dec. 31, 2022

Cash and Cash Equivalents [Abstract]

Schedule of Cash, Cash Equivalents, and Restricted Cash


	December 31,		December 31,
	2022		2021
Cash and cash equivalents	$	7,671	$	22,802
Restricted balance for loan agreement		4,000		4,000
Letters of credit		101		101
Security for credit cards		50		50

Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$	11,822	$	26,953

Inventories (Tables)

12 Months Ended

Dec. 31, 2022

Inventory Disclosure [Abstract]

Schedule of inventories

Inventories consist of:


	December 31,		December 31,
	2022		2021
Raw materials	$	763	$	767
Work-in-process		1,102		645
Finished goods		133		—

Total inventories	$	1,998	$	1,412

Prepaid Expenses and Other Current Assets (Tables)

12 Months Ended

Dec. 31, 2022

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets include the following:


	December 31,		December 31,
	2022		2021
Clinical trial expenses	$	1,630	$	1,630
Insurance premiums		123		890
Professional services		121		15
Other		95		208

Total prepaid expenses and other current assets	$	1,969	$	2,743

Property, Plant, and Equipment (Tables)

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Abstract]

Components of property, plant and equipment

Property, plant, and equipment consists of:


	December 31, 2022			December 31, 2021			Estimated Useful Life
Buildings and land	$	1,301		$	1,222		30 years - Buildings
Enterprise hardware and software		1,855			1,858		3 years
Leaseholds		1,774			1,796		Lesser of lease term or estimated useful life
Equipment		1,222			1,094		7 years
Furniture		201			203		5 years

Property, plant and equipment, gross		6,353			6,173
Accumulated depreciation		(4,931	)		(4,825	)

Property, plant and equipment, net	$	1,422		$	1,348

Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2022

Payables and Accruals [Abstract]

Schedule of accrued expenses

Current accrued expenses include the following:


	December 31, 2022		December 31, 2021
Clinical expenses	$	1,470	$	1,517
Compensation, excluding taxes		1,040		893
Short-term financing		—		551
Professional fees		1,087		603
Interest on convertible note		553		393
Other		535		152

Total accrued expenses	$	4,685	$	4,109

Leases (Tables)

12 Months Ended

Dec. 31, 2022

Leases [Abstract]

Summary of Operating and Financing Leases

The following table summarizes the Company’s operating leases as of December 31, 2022:


	U.S.			Ireland			Total
Lease cost
Operating lease cost	$	406		$	37		$	443
Other information
Operating cash flows out from operating leases		(406	)		(37	)		(443	)
Weighted average remaining lease term		0.5			3.6
Weighted average discount rate - operating leases		8	%		8	%

Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases

Maturities of the Company’s operating leases, excluding short-term leases, are as follows:


	U.S.			Ireland			Total
Year ended December 31, 2023		155			37			192
Year ended December 31, 2024		—			37			37
Year ended December 31, 2025		—			37			37
Year ended December 31, 2026		—			22			22

Total		155			133			288
Less present value discount		(3	)		(17	)		(20	)

Operating lease liabilities included in the condensed consolidated balance sheets at December 31, 2022	$	152		$	116		$	268

Loans and Convertible Notes Payable (Tables)

12 Months Ended

Aug. 06, 2021

Dec. 31, 2022

Debt Disclosure [Abstract]

Summary of Loans and Convertible Notes Payable


	December 31, 2022									December 31, 2021
	Gross			Discount			Net			Gross			Discount			Net
Loan - Avenue [1]	$	11,923		$	(1,008	)	$	10,916		$	12,638		$	(1,645	)	$	10,993
Loan - Avenue [1] - Less Current Portion		(8,570	)		724			(7,846	)		(714	)		93			(621	)

Total - Loans Payable, Non-Current	$	3,353		$	(284	)	$	3,070		$	11,924		$	(1,552	)	$	10,372

Convertible Note Payable - Rosalind		2,000			—			2,000			2,000			—			2,000
Convertible Portion of Loan Payable - Avenue		3,000			(228	)		2,772			3,000			(361	)		2,639

Total - Convertible Notes Payable - Non-Current	$	5,000		$	(228	)	$	4,772		$	5,000		$	(361	)	$	4,639

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:


			Convertible
	Loans		Notes		Total
Year ended December 31, 2023	$	8,570	$	—	$	8,570
Year ended December 31, 2024		3,353		5,000		8,353

Total	$	11,923	$	5,000	$	16,923

Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method

The Avenue Warrant was valued at issuance at $1.3 million using the Black-Scholes option pricing method using the following assumptions:


	August 6, 2021
Contractual term (years)		5.07
Expected volatility		187.0	%
Risk-free interest rate		0.77	%
Expected dividends		0.00	%

The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods:


	Years Ended December 31
	2022	2021
Expected terms (years)	0.7 - 8.4	5.1 - 6.3
Expected volatility	166.4% -180.3%	177.% - 181.3%
Risk-free interest rate	1.2% - 4.4%	0.7% - 1.3%
Expected dividends	0.00%	0.00%

Stockholders' Equity (Tables)

12 Months Ended

Aug. 06, 2021

Dec. 31, 2022

Stockholders' Equity Note [Abstract]

Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method

The Avenue Warrant was valued at issuance at $1.3 million using the Black-Scholes option pricing method using the following assumptions:


	August 6, 2021
Contractual term (years)		5.07
Expected volatility		187.0	%
Risk-free interest rate		0.77	%
Expected dividends		0.00	%

The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods:


	Years Ended December 31
	2022	2021
Expected terms (years)	0.7 - 8.4	5.1 - 6.3
Expected volatility	166.4% -180.3%	177.% - 181.3%
Risk-free interest rate	1.2% - 4.4%	0.7% - 1.3%
Expected dividends	0.00%	0.00%

Summary of Stock Option Activity

The following is a summary of stock option activity for the year ended December

2022


	Number of Options			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at January 1, 2022		1,732,460		$	11.69
Granted		702,583			6.74
Expired		(65,690	)		10.43
Cancelled/Forfeited		(134,301	)		9.59

Outstanding at December 31, 2022		2,235,052		$	10.30		8.0	$	36

Exercisable at December 31, 2022		1,316,515		$	11.13		7.6	$	—

Summary of Stock Option Shares Outstanding and Exercisable

The following table summarizes information for stock option shares outstanding and exercisable at December 31, 2022:


			Options Exercisable
			Weighted Average
	Outstanding Number of		Remaining Option Term
Range of Exercise Prices	Options		(in years)		Number of Options
$6.24 - $53.85		2,234,553		8.0		1,316,016
$53.85+		499		6.1		499

		2,235,052		7.6		1,316,515

Summary of Recognized Share-based Compensation Cost


	Years Ended December 31,
	2022		2021
Selling, general and administrative	$	5,282	$	5,334
Research and development		2,449		2,311
Cost of goods sold		210		187

Total	$	7,941	$	7,832

Summary of Warrant Activity

The following is a summary of warrant activity for the year ended December 31, 2022:


					Weighted Average
			Weighted Average		Remaining Life
	Warrants		Exercise Price		(in years)
Outstanding at January 1, 2022		3,894,498	$	9.27
Warrants issued		1,258,793		.01

Outstanding at December 31, 2022		5,153,291	$	7.01		2.8

Exercisable at December 31, 2022		5,153,291	$	7.01		2.8

Schedule of Information Related to Stock Warrants Outstanding and Exercisable

The following table presents information related to stock warrants at December 31, 2022:


			Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants		Weighted Average Remaining Warrant Term (in years)		Number of Warrants
$0.01		1,542,548		4.4		1,542,548
$10.00		3,610,743		2.2		3,610,743

		5,153,291		2.8		5,153,291

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Schedule of Loss Before Income Taxes

Loss before income taxes consists of:


	For the Year Ended December 31,
	2022			2021
Domestic	$	(34,547	)	$	(25,881	)
Foreign		(1,960	)		232

Income before taxes	$	(36,507	)	$	(25,649	)

Income Tax Reconciliation

The provision for income taxes differs from the amount computed by applying the statutory rate as follows:


	For the Year Ended December 31,
	2022			2021
Income taxes using U.S federal statutory rate	$	(7,666	)	$	(5,386	)
Nondeductible interest		139			39
Loss of tax benefit of state net operating loss carryforwards		—			2,799
Branch income		(385	)		229
State income taxes, net of federal benefit		(531	)		311
Foreign rate differential		165			27
Valuation allowance		9,221			2,114
Stock option expense, exercises and cancellations		752			446
Research and development costs		(708	)		(375	)
Other		(987	)		(204	)

	$	—		$	—

Significant Components of Deferred Tax Assets

Significant components of the Company’s deferred tax assets are as follows:


	For the Year Ended December 31,
	2022		2021
Deferred tax assets:
Employee compensation accruals	$	2,772	$	1,777
Accrued liabilities		197		29
Research tax credits		1,429		721
Lease obligation		38		107
Other		160		89
Research expense capitalization		3,203		—
Net operating losses		24,595		20,520

Total deferred tax assets		32,394		23,243


	For the Year Ended December 31,
	2022		2021
Deferred tax liabilities:
Right of use asset		50		118

Total deferred tax liabilities		50		118

Valuation allowance		32,344		23,125

Net deferred tax assets	$	—	$	—

Summary of Change in Valuation

The change in valuation allowance is as follows:


	December 31,
	2022			2021
Beginning Balance	$	23,125		$	21,332
Charged to costs and expenses		9,221			2,114
Charged to other comprehensive income		(2	)		(321	)

Ending balance	$	32,344		$	23,125

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2022

Fair Value Disclosures [Abstract]

Fair value measurements using significant unobservable inputs

The table below presents activity within Level 3 of the fair value hierarchy, our liabilities carried at fair value for the year ended December 31, 2022:


	Level 3
Balance at January 1, 2022	$	—
Add: contingent liability recorded on medac settlement		1,168
Change in exchange rate		112

Balance at December 31, 2022	$	1,280

Schedule of the Company's financial assets and liabilities that have been measured at fair value


Description	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		December 31, 2021
Liabilities:
Contingent Liability					$	1,280	$	1,280

Total Liabilities	$	—	$	—	$	1,280	$	1,280

Description of Business - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands				12 Months Ended
	Dec. 13, 2022	Jul. 20, 2022	Jul. 07, 2022	Dec. 31, 2022	Dec. 31, 2021
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Net loss				$ (36,508)	$ (25,649)
Net cash used in operating activities				25,000
Proceeds from issuance of private placement				$ 10,857	$ 0
Common Stock [Member]
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Stock issued during period shares					515,000
Pre Funded Warrants [Member]
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Exercise price of warrant					$ 0.01
Private Placement [Member]
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Sale Of stock price per share	$ 2.9	$ 3.98
Proceeds from issuance of private placement	$ 6,200	$ 5,000	$ 5,000
Private Placement [Member] \| Common Stock [Member]
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Stock issued during period shares	1,448,889	690,954
Private Placement [Member] \| Pre Funded Warrants [Member]
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Class of warrants and rights issued during the period	692,042	566,751
Class of warrants and rights issued, price per warrant	$ 2.89	$ 3.97
Exercise price of warrant	$ 0.01	$ 0.01

Summary of Significant Accounting Policies - Additional Information (Details)	12 Months Ended
	Dec. 31, 2022
Summary Of Significant Accounting Policies [Line Items]
Maximum period of investments with original maturities from date of acquisition to be cash equivalents	3 months
Minimum [Member]
Summary Of Significant Accounting Policies [Line Items]
Property, plant and equipment, estimated useful life	3 years
Maximum [Member]
Summary Of Significant Accounting Policies [Line Items]
Property, plant and equipment, estimated useful life	7 years

Summary of Significant Accounting Policies - Shares Excluded from the Computation of Diluted Earnings per Share (Details) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	7,469,547	6,966,955
Common stock warrants - equity [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	3,610,743	3,610,743
Assumed conversion of Series E and Series E-1 Preferred Stock [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	1,135,721	1,135,721
Assumed conversion of convertible Notes [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	488,031	488,031
Stock Options [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	2,235,052	1,732,460

Revision of Previously Issued Quarterly Financial Statements - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended
	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022
Prior Period Adjustment [Abstract]
Impact of Correction of Share Based Compensation on Net Income Loss	$ 372	$ 502	$ 797

Revision of Previously Issued Quarterly Financial Statements - Schedule of Error Corrections and Prior Period Adjustments (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended			6 Months Ended	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2022	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Additional paid-in capital						$ 451,608	$ 432,831
Accumulated deficit						(457,484)	(420,976)
Statement of Operations and Comprehensive Loss [Abstract]
Research and development expenses						18,583	13,778
Selling, general and administrative expenses						17,303	13,637
Total operating expenses						35,886	27,415
Operating loss						(33,853)	(24,531)
Net loss						(36,508)	(25,649)
Total other comprehensive loss						$ (36,407)	$ (25,527)
Basic loss per common share*						$ (4.12)	$ (3.59)
Diluted loss per common share*						$ (4.12)	$ (3.59)
Statement of Stockholders' Equity [Abstract]
Compensation expense for issuance of stock options						$ 7,941	$ 7,832
Net loss						(36,508)	(25,649)
Statement of Cash Flows [Abstract]
Net loss						(36,508)	(25,649)
Stock option compensation expense						$ 7,941	$ 7,832
Previously Reported [Member]
Statement of Financial Position [Abstract]
Additional paid-in capital	$ 442,066	$ 435,922	$ 434,305	$ 435,922	$ 442,066
Accumulated deficit	(447,341)	(438,836)	(429,179)	(438,836)	(447,341)
Statement of Operations and Comprehensive Loss [Abstract]
Research and development expenses	3,953	5,456	4,240	9,696	13,649
Selling, general and administrative expenses	4,519	4,145	3,648	7,791	12,309
Total operating expenses	8,472	9,601	7,888	17,487	25,958
Operating loss	(7,801)	(8,984)	(7,543)	(16,527)	(24,327)
Net loss	(8,505)	(9,657)	(8,203)	(17,860)	(26,365)
Total other comprehensive loss	$ (8,551)	$ (9,688)	$ (8,201)	$ (17,889)	$ (26,447)
Basic loss per common share*	$ (0.92)	$ (1.18)	$ (1)	$ (2.18)	$ (3.09)
Diluted loss per common share*	$ (0.92)	$ (1.18)	$ (1)	$ (2.18)	$ (3.09)
Statement of Stockholders' Equity [Abstract]
Compensation expense for issuance of stock options	$ 1,255	$ 1,617	$ 1,474
Net loss	(8,505)	(9,657)	(8,203)	$ (17,860)	$ (26,365)
Statement of Cash Flows [Abstract]
Net loss	(8,505)	(9,657)	(8,203)	(17,860)	(26,365)
Stock option compensation expense			1,474	3,091	4,345
Revision of Prior Period, Adjustment [Member]
Statement of Financial Position [Abstract]
Additional paid-in capital	1,671	1,299	797	1,299	1,671
Accumulated deficit	(1,671)	(1,299)	(797)	(1,299)	(1,671)
Statement of Operations and Comprehensive Loss [Abstract]
Research and development expenses	112	150	241	391	503
Selling, general and administrative expenses	260	352	556	908	1,168
Total operating expenses	372	502	797	1,299	1,671
Operating loss	(372)	(502)	(797)	(1,299)	(1,671)
Net loss	(372)	(502)	(797)	(1,299)	(1,671)
Total other comprehensive loss	$ (372)	$ (502)	$ (797)	$ (1,299)	$ (1,671)
Basic loss per common share*	$ (0.04)	$ (0.06)	$ (0.1)	$ (0.16)	$ (0.2)
Diluted loss per common share*	$ (0.04)	$ (0.06)	$ (0.1)	$ (0.16)	$ (0.2)
Statement of Stockholders' Equity [Abstract]
Compensation expense for issuance of stock options	$ 372	$ 502	$ 797
Net loss	(372)	(502)	(797)	$ (1,299)	$ (1,671)
Statement of Cash Flows [Abstract]
Net loss	(372)	(502)	(797)	(1,299)	(1,671)
Stock option compensation expense			797	1,299	1,671
As Revised [Member]
Statement of Financial Position [Abstract]
Additional paid-in capital	443,737	437,221	435,102	437,221	443,737
Accumulated deficit	(449,012)	(440,135)	(429,976)	(440,135)	(449,012)
Statement of Operations and Comprehensive Loss [Abstract]
Research and development expenses	4,065	5,606	4,481	10,087	14,152
Selling, general and administrative expenses	4,779	4,497	4,204	8,699	13,477
Total operating expenses	8,844	10,103	8,685	18,786	27,629
Operating loss	(8,173)	(9,486)	(8,340)	(17,826)	(25,998)
Net loss	(8,877)	(10,159)	(9,000)	(19,159)	(28,036)
Total other comprehensive loss	$ (8,923)	$ (10,190)	$ (8,998)	$ (19,188)	$ (28,118)
Basic loss per common share*	$ 0.96	$ (1.24)	$ (1.1)	$ (2.34)	$ (3.29)
Diluted loss per common share*	$ 0.96	$ (1.24)	$ (1.1)	$ (2.34)	$ (3.29)
Statement of Stockholders' Equity [Abstract]
Compensation expense for issuance of stock options	$ 1,627	$ 2,119	$ 2,271
Net loss	(8,877)	(10,159)	(9,000)	$ (19,159)	$ (28,036)
Statement of Cash Flows [Abstract]
Net loss	$ (8,877)	$ (10,159)	(9,000)	(19,159)	(28,036)
Stock option compensation expense			$ 2,271	$ 4,390	$ 6,016

Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Cash and Cash Equivalents [Abstract]
Cash and cash equivalents	$ 7,671	$ 22,802
Restricted balance for loan agreement	4,000	4,000
Letters of credit	101	101
Security for credit cards	50	50
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$ 11,822	$ 26,953	$ 28,756

Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Parenthetical) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Mar. 15, 2023	Dec. 31, 2021
Cash and Cash Equivalents [Line Items]
Letters of credit	$ 101		$ 101
Lessee, Operating Sublease, Expiry Term	2023-05
Restricted Cash	$ 4,151		$ 4,151
Term Loan From Avenue Venture Opportunities Fund LP [Member] \| Subsequent Event [Member]
Cash and Cash Equivalents [Line Items]
Restricted Cash		$ 4,000

Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Inventory Disclosure [Abstract]
Raw materials	$ 763	$ 767
Work-in-process	1,102	645
Finished goods	133	0
Total Inventory	$ 1,998	$ 1,412

Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Prepaid Expense and Other Assets, Current [Abstract]
Clinical trial expenses	$ 1,630	$ 1,630
Insurance premiums	123	890
Professional services	121	15
Other	95	208
Total prepaid expenses and other current assets	$ 1,969	$ 2,743

Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 6,353	$ 6,173
Accumulated depreciation	(4,931)	(4,825)
Property, plant, and equipment, net	1,422	1,348
Buildings and Land [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	1,301	1,222
Enterprise Hardware and Software [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,855	1,858
Property, plant and equipment, estimated useful life	3 years
Leaseholds [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,774	1,796
Property, plant and equipment, estimated useful life	Lesser of lease term or estimated useful life
Equipment [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,222	1,094
Property, plant and equipment, estimated useful life	7 years
Furniture [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 201	$ 203
Property, plant and equipment, estimated useful life	5 years
Buildings [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, estimated useful life	30 years

Property, Plant, and Equipment - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 132	$ 146

Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
Clinical expenses	$ 1,470	$ 1,517
Compensation, excluding taxes	1,040	893
Short-term financing	0	551
Professional fees	1,087	603
Interest on Rosalind convertible note	553	393
Other	535	152
Total accrued expenses	$ 4,685	$ 4,109

Leases - Additional Information (Details)			12 Months Ended
Leases - Additional Information (Details)	Jul. 01, 2020 USD ($) ft²	Jun. 25, 2020 USD ($)	Dec. 31, 2022 USD ($)	Sep. 22, 2020 ft²
Rent per month			$ 443,000
Lease term			12 months
Two Thousand Fifteen Sublease Agreement
Lease, description	Pursuant to a 2014 sublease agreement (the “2014 Sublease”) and a 2015 sublease agreement (the “2015 Sublease”) the Company subleased portions of its leased premises in Galway, Ireland to a sublessee. On May 15, 2020, the Company and its sublessee entered into amendments to the 2014 Sublease and the 2015 Sublease pursuant to which (i) the 2014 Sublease and 2015 Sublease were extended from May 31, 2020 to August 2, 2021, (ii) effective July 1, 2020, the leased premises under the 2015 Sublease would be expanded to include an additional 4,999 square feet of space, and (iii) effective July 1, 2020, the rent under the 2015 Sublease would increase from approximately $14.6 per month to $20.6 per month.
Additional area of space \| ft²	4,999
Two Thousand Fifteen Sublease Agreement \| Minimum [Member]
Increase in sublease rent	$ 20,600
Two Thousand Fifteen Sublease Agreement \| Maximum [Member]
Increase in sublease rent	$ 14,600
2021 Sub-Lease [Member]
Rent per month		$ 3,700
Lease term		5 years
Additional area of space \| ft²				6,877

Leases - Summary of Operating and Financing Leases (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2022 USD ($)
Lease Cost
Operating lease cost	$ 443
Other information
Operating cash flows out from operating leases	(443)
U.S. [Member]
Lease Cost
Operating lease cost	406
Other information
Operating cash flows out from operating leases	$ (406)
Weighted average remaining lease term	6 months
Weighted average discount rate - operating leases	8.00%
Ireland [Member]
Lease Cost
Operating lease cost	$ 37
Other information
Operating cash flows out from operating leases	$ (37)
Weighted average remaining lease term	3 years 7 months 6 days
Weighted average discount rate - operating leases	8.00%

Leases - Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands	Dec. 31, 2022 USD ($)
Lessee Lease Description [Line Items]
Year ended December 31, 2023	$ 192
Year ended December 31, 2024	37
Year ended December 31, 2025	37
Year ended December 31, 2026	22
Total	288
Less present value discount	(20)
Operating lease liabilities included in the condensed consolidated balance sheets at December 31, 2022	268
U.S. [Member]
Lessee Lease Description [Line Items]
Year ended December 31, 2023	155
Year ended December 31, 2024	0
Total	155
Less present value discount	(3)
Operating lease liabilities included in the condensed consolidated balance sheets at December 31, 2022	152
Ireland [Member]
Lessee Lease Description [Line Items]
Year ended December 31, 2023	37
Year ended December 31, 2024	37
Year ended December 31, 2025	37
Year ended December 31, 2026	22
Total	133
Less present value discount	(17)
Operating lease liabilities included in the condensed consolidated balance sheets at December 31, 2022	$ 116

Loans and Convertible Notes Payable - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended	12 Months Ended
	Aug. 06, 2021	Dec. 31, 2022	Dec. 31, 2022	Dec. 31, 2021	Mar. 15, 2023
Debt Instrument [Line Items]
Avenue warrant value			$ 1,300
Interest expense incurred			1,900
Restricted Cash		$ 4,151	$ 4,151	$ 4,151
Secured Convertible Notes Payable [Member]
Debt Instrument [Line Items]
Debt instrument, principal face amount	$ 2,000
Series E Preferred Stock [Member]
Debt Instrument [Line Items]
Debt instrument, conversion price		$ 1,500	$ 1,500
Series E Preferred Stock [Member] \| Secured Convertible Notes Payable [Member]
Debt Instrument [Line Items]
Debt instrument maturity date	Oct. 30, 2024
Debt instrument, conversion price	$ 1,198
Term Loan from Avenue Venture Opportunities Fund L.P [Member]
Debt Instrument [Line Items]
Debt instrument, principal face amount	$ 3,000
Debt instrument maturity date	Aug. 01, 2024
Debt instrument, interest rate	7.70%
Debt instrument, interest rate	10.95%		15.20%
Debt instrument, interest rate term	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 December 31, 2022 was 15.2%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property.
Initial tranche of loan	$ 15,000
Loan amount funded into restricted account	4,000
Gross proceeds from ATM Offering	20,000
Second tranche of loan	$ 5,000
Debt instrument, conversion price	$ 11.98
Frequency of periodic payment	monthly
Periodic interest payments, term	15 months
Debt instrument, incremental final payment	4.25%
Debt instrument, commitment fee	$ 150
Debt instrument, commitment fee, percentage	1.00%
Debt instrument, commitment fee upon funding of second tranche of loan	$ 200
Original issue discount	637
Cash issuance costs	563
Debit discount	519
Fair value of warrants reclassified from liability to equity	44
Aggregate debt discount	$ 2,327
Amortization of debt discount			$ 800
Current interest rate	7.70%
Minimum equity proceeds not raised		$ 20,000
Additional funding not eligible		$ 5,000
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Subsequent Event [Member]
Debt Instrument [Line Items]
Restricted Cash					$ 4,000
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Warrant [Member]
Debt Instrument [Line Items]
Warrants Issued ToPurchase Of Common Stock	127,755
Warrant exercise price	$ 0.01
Warrants, maturity date	Aug. 31, 2026
Fair value of the Avenue Warrant	$ 1,171
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Maximum [Member]
Debt Instrument [Line Items]
Debt instrument, principal face amount	20,000
Debt instrument, converted amount	$ 3,000
Periodic interest payments, term	24 months
Prepayment fee, percentage	3.00%
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Minimum [Member]
Debt Instrument [Line Items]
Prepayment fee, percentage	1.00%
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Non Convertible Debt [Member]
Debt Instrument [Line Items]
Aggregate debt discount	$ 1,909
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Convertible Debt [Member]
Debt Instrument [Line Items]
Aggregate debt discount	$ 418
Eight Point Zero Percentage July Two Thousand And Nineteen Notes [Member] \| Convertible Notes Payable [Member]
Debt Instrument [Line Items]
Debt instrument, interest rate		8.00%	8.00%
Current interest rate		8.00%	8.00%
Eight Point Zero Percentage July Two Thousand And Nineteen Notes [Member] \| Convertible Debt [Member]
Debt Instrument [Line Items]
Interest expense incurred			$ 160	$ 160

Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) - USD ($)
$ in Thousands

Dec. 31, 2022

Dec. 31, 2021

Gross

$ 5,000

Discount

(228)

(361)

Net

4,772

4,639

Less Current Portion, Net

(7,846)

(621)

Total - Loans Payable, Non-Current, Gross

3,353

11,924

Total - Loans Payable, Non-Current, Discount

(284)

(1,552)

Total - Loans Payable, Non-Current, Net

3,070

10,372

Loan Avenue [Member]

Gross

^[1]

11,923

12,638

Discount

^[1]

(1,008)

(1,645)

Net

^[1]

10,916

10,993

Less Current Portion, Gross

^[1]

(8,570)

(714)

Less Current Portion, Discount

^[1]

724

Less Current Portion, Net

^[1]

(7,846)

(621)

Convertible Note Payable Rosalind [Member]

Gross

2,000

Net

2,000

Convertible Loan Payable Avenue [Member]

Gross

3,000

Discount

(228)

(361)

Net

$ 2,772

$ 2,639

[1]	The gross amount includes the 4.25% final payment of $637.5.

Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) (Parenthetical)	12 Months Ended
	Dec. 31, 2022 USD ($)
Equity Method Investments And Cost Method Investments [Abstract]
Percentage of final payment included in gross amount	4.25%
Final payment	$ 637,500

Loans and Convertible Notes Payable - Summary of Remaining Maturities of Company's Loan and Convertible Note Payables (Details) $ in Thousands	Dec. 31, 2022 USD ($)
Debt Instrument [Line Items]
Loans	$ 11,923
Convertible Notes	5,000
Total	16,923
Year ended December 31, 2023
Debt Instrument [Line Items]
Loans	8,570
Total	8,570
Year ended December 31, 2024
Debt Instrument [Line Items]
Loans	3,353
Convertible Notes	5,000
Total	$ 8,353

Loans and Convertible Notes Payable - Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method (Details)		12 Months Ended
	Aug. 06, 2021	Dec. 31, 2022	Dec. 31, 2021
Contractual term (years)	5 years 25 days
Expected volatility	187.00%
Risk-free interest rate	0.77%
Expected dividends	0.00%	0.00%	0.00%

Stockholders' Equity - Preferred Stock Issuances - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions	12 Months Ended
	Dec. 31, 2021	Feb. 27, 2023	Dec. 31, 2022	Nov. 09, 2021
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)	10,000,000		10,000,000
Preferred stock, par value (in dollars per share)	$ 0.01		$ 0.01
Common stock, par value (in dollars per share)	$ 0.01		$ 0.01
Common stock, shares authorized (in shares)	40,000,000		40,000,000
Number of preferred stock and warrants issued upon conversion	927,379
Preferred stock, shares outstanding (in shares)	11,357		11,357
Cantor Fitzgerald And Co [Member]
Stockholders Equity Note [Line Items]
Increase in aggregate amount				$ 25
Cantor Fitzgerald And Co [Member] \| Subsequent Event [Member]
Stockholders Equity Note [Line Items]
Increase decrease in aggregate offering price limit		$ 17
Series A Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)			4,200
Series B Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)			2,360
Series C Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)			590
Series D Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)			10,000
Series E Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)			40,000
Conversion of stock preferred shares converted	9,274
Series E1 Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)			12,960
Series E-1 Convertible Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares outstanding (in shares)			11,357

Stockholders' Equity - Equity Incentive Plan - Additional Information (Details) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Common Stock Capital Shares Reserved	2,475,000
Number of common shares remained available to be issued		870,508
2019 Equity Incentive Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Common Stock Capital Shares Reserved	2,142
Share based Payment Award Purchase Price Of Common Stock Percent	100.00%

Stockholders' Equity - At-the-Market Offering - Additional Information (Details) - USD ($)					12 Months Ended
	Dec. 13, 2022	Jul. 20, 2022	Jul. 07, 2022	Aug. 18, 2020	Dec. 31, 2022	Dec. 31, 2021
Stockholders Equity Note [Line Items]
Proceeds from issuance of private placement					$ 10,857,000	$ 0
Number of Shares Sold					0
Pre Funded Warrants [Member]
Stockholders Equity Note [Line Items]
Warrants issued to purchase of common stock						215,000
Exercise price of warrant						$ 0.01
Common Stock [Member]
Stockholders Equity Note [Line Items]
Shares issued in public offering						515,000
Private Placement [Member]
Stockholders Equity Note [Line Items]
Proceeds from issuance of private placement	$ 6,200,000	$ 5,000,000	$ 5,000,000
Private Placement [Member] \| Pre Funded Warrants [Member]
Stockholders Equity Note [Line Items]
Warrants issued to purchase of common stock	692,042	566,751
Warrants issued to purchase of common stock, Price per warrant	$ 2.89	$ 3.97
Exercise price of warrant	$ 0.01	$ 0.01
Private Placement [Member] \| Common Stock [Member]
Stockholders Equity Note [Line Items]
Shares issued in public offering	1,448,889	690,954
Shares issued, price per share	$ 2.9	$ 3.98
Cantor Fitzgerald & Co [Member]
Stockholders Equity Note [Line Items]
Percentage of commission on aggregate gross proceeds				3.00%
Cantor Fitzgerald & Co [Member] \| At-the-Market Offering [Member]
Stockholders Equity Note [Line Items]
Issuance costs					$ 121,000
Roth Capital Partners L L C
Stockholders Equity Note [Line Items]
Percentage of fee on gross sale price per share				1.05%
Percentage of underwriting fee to be received on company offerings				35.00%
Common stock offering period				90 days
Maximum [Member] \| Cantor Fitzgerald & Co [Member]
Stockholders Equity Note [Line Items]
At-the-market offering, aggregate offering price				$ 10,000,000
Legal fees and disbursements				$ 50,000

Stockholders' Equity - Common Stock Issuances - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended	12 Months Ended
	Feb. 28, 2021	Dec. 31, 2021
Stockholders Equity Note [Line Items]
Gross proceeds from issuance of common stock		$ 2.5
Stock issued during period shares associated other warrants		465,173
Issue Of Unregistered Common Stock For Advisory Services	2,636
Pre-Funded Warrants [Member]
Stockholders Equity Note [Line Items]
Warrants issued to purchase of common stock		215,000
Warrant exercise price		$ 0.01

Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted average estimated fair value of the stock options granted	$ 6.05	$ 9.74
Unrecognized compensation expense related to non-vested share-based compensation awards	$ 2,800
Cost expected to be recognized over weighted average period	1 year 7 months 6 days
Share-based compensation (Income) expense	$ 7,941	$ 7,832

Stockholders' Equity - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details)		12 Months Ended
	Aug. 06, 2021	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected terms (years)	5 years 25 days
Expected volatility	187.00%
Risk-free interest rate	0.77%
Expected dividends	0.00%	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected terms (years)		8 months 12 days	5 years 1 month 6 days
Expected volatility		166.40%	177.00%
Risk-free interest rate		1.20%	0.70%
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected terms (years)		8 years 4 months 24 days	6 years 3 months 18 days
Expected volatility		180.30%	181.30%
Risk-free interest rate		4.40%	1.30%

Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022 USD ($) $ / shares shares
Stockholders' Equity Note [Abstract]
Number of Shares, Outstanding \| shares	1,732,460
Number of Shares, Granted \| shares	702,583
Number of Shares, Expired \| shares	(65,690)
Number of Shares, Cancelled/Forfeited \| shares	(134,301)
Number of Shares, Outstanding \| shares	2,235,052
Number of Shares, Exercisable \| shares	1,316,515
Weighted Average Exercise Price, Outstanding \| $ / shares	$ 11.69
Weighted Average Exercise Price, Granted \| $ / shares	6.74
Weighted Average Exercise Price, Expired \| $ / shares	10.43
Weighted Average Exercise Price, Cancelled/Forfeited \| $ / shares	9.59
Weighted Average Exercise Price, Outstanding \| $ / shares	10.3
Weighted Average Exercise Price, Exercisable \| $ / shares	$ 11.13
Weighted Average Remaining Contractual Term (Years), Outstanding	8 years
Weighted Average Remaining Contractual Term (Years), Exercisable	7 years 7 months 6 days
Aggregate Intrinsic Value, Outstanding \| $	$ 36
Aggregate Intrinsic Value, Exercisable \| $	$ 0

Stockholders' Equity - Summary of Stock Option Shares Outstanding and Exercisable (Details) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	2,235,052	1,732,460
Weighted Average Remaining Contractual Term (Years), Exercisable	7 years 7 months 6 days
Number of Shares, Exercisable	1,316,515
$15.00 - $24.99 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	2,234,553
Weighted Average Remaining Contractual Term (Years), Exercisable	8 years
Number of Shares, Exercisable	1,316,016
$25 + [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	499
Weighted Average Remaining Contractual Term (Years), Exercisable	6 years 1 month 6 days
Number of Shares, Exercisable	499

Stockholders' Equity (Deficit) - Summary of Employee Stock Purchase Plan (Details) - May Two Thousand And Twenty Two Employee Stock Purchase Plan [Member] - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended
	Jan. 31, 2023	Aug. 31, 2021
Stockholders Equity Note [Line Items]
Share-based compensation arrangement by share-based payment award number of shares authorized		260,295
Share-based compensation arrangement by share-based payment award purchase price of common stock, percent		85.00%
Subsequent Event [Member]
Stockholders Equity Note [Line Items]
Share-based compensation arrangement by share-based payment award number of shares authorized	15,417
Share Price	$ 2.23
Share Based Compensation Expense	$ 34

Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	$ 7,941	$ 7,832
Selling, General and Administrative [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	5,282	5,334
Research and Development [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	2,449	2,311
Cost of Goods Sold [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	$ 210	$ 187

Stockholders' Equity - Summary of Warrant Activity (Details)	12 Months Ended
	Dec. 31, 2022 $ / shares shares
Warrants outstanding [Roll Forward]
Outstanding, beginning of period (in shares) \| shares	3,894,498
Warrants issued (in shares) \| shares	1,258,793
Outstanding, end of period (in shares) \| shares	5,153,291
Exercisable, end of period (in shares) \| shares	5,153,291
Warrants, Exercise Price per Share [Roll Forward]
Outstanding, beginning of period (in dollars per share) \| $ / shares	$ 9.27
Outstanding, ending of period (in dollars per share) \| $ / shares	7.01
Warrants issued (in dollars per share) \| $ / shares	0.01
Exercisable, (in dollars per share) \| $ / shares	$ 7.01
Weighted average remaining life	2 years 9 months 18 days
Weighted average remaining life, Exercisable	2 years 9 months 18 days

Stockholders' Equity - Summary of Warrants Outstanding and Exercisable (Details) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	5,153,291	3,894,498
Weighted average remaining life	2 years 9 months 18 days
Warrants Exercisable, Number Exercisable	5,153,291
$0.01 [Member]
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	1,542,548
Weighted average remaining life	4 years 4 months 24 days
Warrants Exercisable, Number Exercisable	1,542,548
$10.00 [Member]
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	3,610,743
Weighted average remaining life	2 years 2 months 12 days
Warrants Exercisable, Number Exercisable	3,610,743

Commitments and contingencies - Additional Information (Details) $ in Thousands, € in Millions				12 Months Ended
	Dec. 30, 2022 USD ($)	Apr. 01, 2021 EUR (€)	Jul. 27, 2020 USD ($)	Dec. 31, 2022 USD ($)	Jan. 24, 2023 USD ($)	Mar. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Oct. 12, 2021 EUR (€)	Dec. 31, 2020 USD ($)
Loss Contingencies [Line Items]
Increase in revenue recognition				$ 1,700
Inventories				$ 1,998			$ 1,412
Milestone payment unpaid \| €								€ 1
Medac [Member]
Loss Contingencies [Line Items]
Due from related parties \| €		€ 1
Agreement date		Dec. 10, 2018
Inventories						$ 200
Term over which the royalty is to be paid	5 years
Minimum annual payments	$ 200
Medac [Member] \| Other Liabilities
Loss Contingencies [Line Items]
Loss Contingency Accrual	1,200
Medac [Member] \| Other Noncurrent Liabilities
Loss Contingencies [Line Items]
Loss Contingency Accrual	1,000
Medac [Member] \| Accrued Expenses
Loss Contingencies [Line Items]
Loss Contingency Accrual	200
Medac [Member] \| Selling, General and Administrative [Member]
Loss Contingencies [Line Items]
Loss Contingency Accrual	$ 1,200
Lachman [Member] \| Subsequent Event [Member]
Loss Contingencies [Line Items]
Loss Contingency Accrual					$ 900
Unpaid consulting fees					900
Loss contingency disputes charges					$ 300
Pending Litigation [Member]
Loss Contingencies [Line Items]
Unpaid compensation amounts claimed			$ 1,100
Loss Contingency Accrual									$ 1,100

Income Taxes - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Operating Loss Carryforwards [Line Items]
Income tax provision	$ 0	$ 0
Percentage of valuation allowance against deferred tax assets	100.00%
Decrease in deferred tax assets valuation allowance	$ 9,200	1,800
New York State [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income	190,300
New York City [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income	$ 174,500
Earliest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Open tax period	Dec. 31, 1998
Latest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Open tax period	Dec. 31, 2022
Federal [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 290,400	277,400
Operating loss carryforwards, annual limitation	28
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income	202,600
Operating loss carryforwards available for offset future taxable income	87,700
Operating loss carryforwards for unlimited period	86,000
Federal [Member] \| Expire Between 2019 and 2037 [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards available for offset future taxable income	$ 1,700
Federal [Member] \| Earliest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards, expiration dates	2023
Federal [Member] \| Latest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards, expiration dates	2037
Federal [Member] \| Research and Development Tax Credit Carryforwards [Member]
Operating Loss Carryforwards [Line Items]
Tax credit carryforwards	$ 6,500	5,800
Tax credit carryforwards, expiration dates	2042
Tax credit carryforwards expected to expire unutilized	$ 1,400
State and City [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 5,100	5,000
Operating loss carryforwards, expiration dates	2042
Foreign [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 33,400	28,000
Federal and State [Member] \| Earliest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Open tax period	Dec. 31, 2019
Federal and State [Member] \| Latest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Open tax period	Dec. 31, 2022
Minimum [Member] \| State and City [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 300	24,800
Maximum [Member] \| State and City [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 195,300	$ 193,700

Income Taxes - Schedule of Loss Before Income Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Loss From Continuing Operations Before Income Taxes Minority Interest And Income Loss From Equity Method Investments [Abstract]
Domestic	$ (34,547)	$ (25,881)
Foreign	(1,960)	232
Income before taxes	$ (36,507)	$ (25,649)

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-SubTopic 10
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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-Section 50
-Paragraph 32
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Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
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-Topic 940
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-Section 25
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-URI https://asc.fasb.org/extlink&oid=126941158&loc=d3e41242-110953

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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-Section 50
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-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(10))
-URI https://asc.fasb.org/extlink&oid=126953954&loc=SL114868664-224227

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
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-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(8))
-URI https://asc.fasb.org/extlink&oid=120400993&loc=SL114874131-224263

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 235
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
-URI https://asc.fasb.org/extlink&oid=120399901&loc=d3e537907-122884

Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 31
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8924-108599

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(15))
-URI https://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

+ Details

Income Taxes - Income Tax Reconciliation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Provision for income taxes [Abstract]
Income taxes using U.S federal statutory rate	$ (7,666)	$ (5,386)
Nondeductible interest	139	39
Loss of tax benefit of state net operating loss carryforwards	0	2,799
Branch income	(385)	229
State income taxes, net of federal benefit	(531)	311
Foreign rate differential	165	27
Valuation allowance	9,221	2,114
Stock option expense, exercises and cancellations	752	446
Research and development costs	(708)	(375)
Other	(987)	(204)
Total	$ 0	$ 0

Income Taxes - Significant Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Deferred tax assets:
Employee compensation accruals	$ 2,772	$ 1,777
Accrued liabilities	197	29
Research tax credits	1,429	721
Lease obligation	38	107
Other	160	89
Research expense capitalization	3,203	0
Net operating losses	24,595	20,520
Total deferred tax assets	32,394	23,243
Deferred tax liabilities:
Right of use asset	50	118
Total deferred tax liabilities	50	118
Valuation allowance	32,344	23,125	$ 21,332
Net deferred tax assets	$ 0	$ 0

Income Taxes - Summary of Change in Valuation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Beginning balance	$ 23,125	$ 21,332
Charged to costs and expenses	9,221	2,114
Charged to other comprehensive income	(2)	(321)
Ending balance	$ 32,344	$ 23,125

Fair Value Measurements - Fair Value Measurements Using Significant Unobservable Inputs (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2022 USD ($)
Fair Value Disclosures [Abstract]
Beginning balance	$ 0
Add: contingent liability recorded on medac settlement	1,168
Change in exchange rate	112
Ending balance	$ 1,280

Fair Value Measurements - Schedule of the Company's financial assets and liabilities that have been measured at fair value (Details) $ in Thousands	Dec. 31, 2022 USD ($)
Liabilities [Abstract]
Contingent Liability	$ 1,280
Total Liabilities	1,280
Level 3 [Member]
Liabilities [Abstract]
Contingent Liability	1,280
Total Liabilities	$ 1,280