0001564590-21-016962 | 10-K | XBRL Viewer

$ 0.01

Preferred stock, shares issued (in shares)

10,000,000

20,631

41,517

Preferred stock, shares outstanding (in shares)

20,631

41,517

Common stock, par value (in dollars per share)

^[1]

$ 0.01

Common stock, shares authorized (in shares)

^[1]

40,000,000

Common stock, shares outstanding (in shares)

^[1]

5,996,101

67,091

^[1]

5,996,101

67,091

[1]	reflects, a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019.

Consolidated Statements of Operations and Comprehensive Loss - USD ($)
$ in Thousands

12 Months Ended

Dec. 31, 2020

Dec. 31, 2019

Cost of goods sold

$ (640)

$ (719)

Gross profit

1,006

861

Operating expenses:

Research and development expenses

11,201

9,490

Selling, general and administrative expenses

11,108

11,279

Total operating expenses

22,309

20,769

Operating loss

(21,303)

(19,908)

Change in fair value of the warrant liability, net

(2,832)

17,493

Loss on issuance of financial instrument

(1,720)

Interest expense

(175)

(4,746)

Other income

154

Net loss

(24,156)

(8,879)

Deemed dividend for triggering of warrant down round feature

(55)

Net loss attributable to common stockholders

(24,211)

(8,879)

Net loss

(24,156)

(8,879)

Other comprehensive (loss) income:

Foreign currency translation adjustments

(132)

(22)

Total other comprehensive loss

$ (24,288)

$ (8,901)

Common share data:

Basic loss per common share*

^[1]

$ (8.35)

$ (342.83)

Diluted loss per common share*

^[1]

$ (8.35)

$ (342.83)

Weighted average number of basic shares outstanding*

^[1]

2,897,827

25,900

Weighted average number of diluted shares outstanding*

^[1]

2,897,827

25,900

Product Revenue [Member]

Revenue

$ 1,156

$ 1,101

Other Revenue [Member]

Revenue

$ 490

$ 479

[1]	* reflects, one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019.

Consolidated Statements of Operations and Comprehensive Loss (Parenthetical)	Dec. 24, 2019
Income Statement [Abstract]
Reverse stock split	1:700
Reverse stock split ratio	0.00142

Consolidated Statement of Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Total	Series D Preferred Stock [Member]	Series E Preferred Stock [Member]	Series E1 Preferred Stock [Member]	Common Stock [Member]	Common Stock [Member] Series D Warrants	Preferred Stock [Member]	Preferred Stock [Member] Series D Preferred Stock [Member]	Preferred Stock [Member] Series E Preferred Stock [Member]	Preferred Stock [Member] Series E1 Preferred Stock [Member]	Additional Paid in Capital [Member]	Additional Paid in Capital [Member] Series D Preferred Stock [Member]	Additional Paid in Capital [Member] Series E Preferred Stock [Member]	Additional Paid in Capital [Member] Series E1 Preferred Stock [Member]	Accumulated Deficit [Member]	Accumulated Deficit [Member] Series E Preferred Stock [Member]	Accumulated Deficit [Member] Series E1 Preferred Stock [Member]	Accumulated Other Comprehensive Income (Loss) [Member]
Balance at Dec. 31, 2018	$ (14,939)										$ 329,065				$ (344,054)			$ 50
Balance (in shares) at Dec. 31, 2018					14,715		101
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	273										273
Compensation expense for issuance of restricted stock	$ 4										4
Compensation expense for issuance of restricted stock (in shares)	20				20
Issuance of Preferred Stock		$ 150	$ 29,536	$ 9,510								$ 150	$ 42,876	$ 14,408		$ (13,340)	$ (4,898)
Issuance of Preferred Stock (in shares)								15	32,572	9,510
Retirement of Series D Preferred Stock		$ (1,160)										$ (1,160)
Retirement of Series D Preferred Stock (in Shares)								(116)
Exercise of pre-funded warrants (in shares)	11,285					11,285
Exchange of warrants	$ 13										13
Exchange of warrants (in shares)					92
Fair value of warrants issued	(20,844)										(20,844)
Conversion of preferred stock into common stock	1										1
Conversion of Preferred stock into common stock (in shares)					13,455		(565)
Fractional rounding related to reverse stock split					$ 1						(1)
Fractional rounding related to reverse stock split (in shares)					27,524
Net loss	(8,879)														(8,879)
Comprehensive loss	(22)																	(22)
Balance at Dec. 31, 2019	(6,357)				$ 1						364,785				(371,171)			28
Balance (in shares) at Dec. 31, 2019					67,091		41,517
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	$ 3,505										3,505
Compensation expense for issuance of restricted stock (in shares)	72,976
Shares settled for services	$ 406				$ 1						405
Shares settled for services (in shares)					50,013
Shares settled for accrued compensation	$ 230										230
Shares settled for accrued compensation (in shares)					22,963
Exercise of pre-funded warrants (in shares)	6,000
Conversion of preferred stock into common stock	$ (1)				$ 20						(21)
Conversion of Preferred stock into common stock (in shares)					2,084,507		(20,887)
Registration costs of Series E and Series E-1 Preferred Stock and related warrants	(106)										(106)
Fair value of warrants reclassified from liability to equity	6,200										6,200
Exercise of warrants into common stock	1,858				$ 2						1,856
Exercise of warrants into common stock (in shares)					191,803
Public Offering - issuance of common stock and warrants	19,378				$ 18						19,360
Public Offering - issuance of common stock and warrants (in shares)					1,823,000
ATM Offering	866				$ 1						865
ATM Offering, Shares					77,644
Confidentially Marketed Public Offering - issuance of common stock	20,387				$ 17						20,370
Confidentially Marketed Public Offering - issuance of common stock (in shares)					1,679,031
Fractional rounding related to reverse stock split (in shares)					49		1
Net loss	(24,156)														(24,156)
Comprehensive loss	(132)																	(132)
Balance at Dec. 31, 2020	$ 22,078				$ 60						$ 417,449				$ (395,327)			$ (104)
Balance (in shares) at Dec. 31, 2020					5,996,101		20,631

Consolidated Statement of Stockholders' Equity (Deficit) (Parenthetical)	Dec. 24, 2019
Statement Of Stockholders Equity [Abstract]
Reverse stock split	1:700
Reverse stock split ratio	0.00142

Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands	1 Months Ended		12 Months Ended
	Dec. 31, 2020	May 31, 2020	Dec. 31, 2020
Gross proceeds	$ 22,247	$ 21,996
Issuance costs	$ 1,861	$ 2,618	$ 1
At-the-Market Offering [Member]
Gross proceeds			910
Issuance costs			$ 44

Consolidated Statements of Cash Flows - USD ($)
$ in Thousands

12 Months Ended

Dec. 31, 2020

Dec. 31, 2019

Cash flows from operating activities:

Net loss

$ (24,156)

$ (8,879)

Adjustments to reconcile net loss to net cash used in operating activities:

Stock option compensation expense

3,505

273

Restricted stock compensation expense

406

Depreciation expense

167

212

Amortization of right of use assets

Warrant liability fair value adjustment

2,832

(17,493)

Non-cash interest income

(1)

(11)

Equitization of expenses

1,474

Loss on issuance of financial instruments

1,715

Interest expense accrued related to convertible notes

160

Debt discount amortization

4,467

Changes in assets and liabilities:

Increase in prepaid expenses and other assets

(910)

(807)

(Increase) decrease in accounts receivable

(36)

497

(Increase) decrease in inventories

(201)

204

Decrease in accounts payable and accrued expenses

(4,396)

(4,350)

Decrease in deferred revenue

(263)

(479)

Decrease in other liabilities

(627)

Net cash used in operating activities

(22,868)

(23,689)

Cash flows from investing activities:

Purchase of property, plant and equipment

(782)

(24)

Net cash used in investing activities

(782)

(24)

Net proceeds from the issuance of debt

3,719

Principal payments of financing leases

(26)

(39)

(106)

(1)

Proceeds from exercise of warrants

1,858

Net cash provided by financing activities

42,355

30,305

Foreign currency effects on cash, cash equivalents and restricted cash

(132)

Net increase in cash, cash equivalents and restricted cash

18,573

6,606

Cash, cash equivalents and restricted cash:

Beginning of year

10,183

3,577

End of year

28,756

10,183

Supplemental Disclosure of Cash Flow Information:

Interest expense

Supplemental Disclosure of Non-Cash Investing and Financing Activities:

Conversions of preferred stock into common stock

Reclassification of 2019 warrants from liability to equity

6,200

Equitization of debt, interest and expenses into July 2019 Private Placement

12,572

Fair value of warrants issued

20,844

Adoption of ASC 842 lease standard

1,652

Right of use assets obtained in exchange for lease obligations

729

874

Financing of D&O insurance premium

781

548

Issuance of restricted stock for 2019 bonuses due to executive officers

230

IPO [Member]

At-the-Market Offering [Member]

^[1]

19,378

Proceeds on ATM Offering Trades (2)

(44)

^[2]

866

IPO 2 [Member]

Series D Preferred Stock [Member]

^[3]

20,386

Net proceeds from the sale of Series E and E-1 Preferred Stock and warrants

150

Series E and E-1 Preferred Stock and Warrants [member]

Net proceeds from the sale of Series E and E-1 Preferred Stock and warrants

$ 0

$ 26,475

[1]	May 2020 Public Offering gross proceed were $21,996, with issuance costs of $2,618
[2]	ATM offering gross proceeds were $910, with issuances costs and fees of $44
[3]	December 2020 Public Offering gross proceeds were $22,247, with issuance costs of $1,861

Description of Business

12 Months Ended

Dec. 31, 2020

Organization Consolidation And Presentation Of Financial Statements [Abstract]

Description of Business

(1)	Description of Business

We are an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our lead product candidate, the HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system), or HEPZATO™, is a drug/device combination product. HEPZATO is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, our commercial product is a stand-alone medical device and is approved for sale under the trade name CHEMOSAT® Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used at major medical centers to treat a wide range of cancers of the liver.

Our clinical development program (“CDP”) for HEPZATO is comprised of the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the “FOCUS Trial”), a global registration clinical trial that is investigating objective response rate in metastatic ocular melanoma, or mOM, and the ALIGN Trial, a global Phase 3 clinical trial for intrahepatic cholangiocarcinoma, or ICC (the “ALIGN Trial”). The FOCUS Trial initiated treatment on the final enrolled patient on October 2, 2020. Presently, we have paused our work on the ALIGN Trial while we reevaluate the trial design and in order to be able to concentrate our efforts on the FOCUS Trial conclusion and subsequent new drug application, or NDA, filing with the United States Food and Drug Administration, or the FDA. We are currently reviewing the incidence, unmet need, available efficacy data and development requirements for a broad set of liver cancers in order to select a portfolio of follow-on indications which will maximize the value of the HEPZATO platform. Whether we continue the ALIGN Trial will be dependent on the relative value of the ICC indication versus other alternative indications. In addition, our CDP also includes a registry for CHEMOSAT commercial cases performed in Europe and sponsorship of select investigator-initiated trials or IITs.

In the United States, HEPZATO is considered a combination drug and device product regulated by 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 Europe, CHEMOSAT is regulated as a Class IIb medical device and received its CE Mark in 2012. We are commercializing CHEMOSAT in select markets in the United Kingdom and the European Union, or the EU, where we believe the prospect of securing reimbursement coverage for the use of CHEMOSAT is strongest.

Risks and Uncertainties

Due to the global outbreak of SARS-CoV-2, a novel strain of coronavirus that causes Coronavirus disease (COVID-19), the Company experienced an impact on certain areas of its business. These effects included a slowing of patient recruitment in the FOCUS trial and a reduction in the pace at which we can monitor data at our clinical trial sites. The resulting delay in completing enrollment and additional time required to monitor data has caused our planned announcement for the top-line data from our FOCUS Trial to shift to early 2021. We now plan to submit an NDA to the FDA in the first quarter of 2022 for the treatment of mOM. The ability to achieve this goal is contingent on our ability to monitor data at our clinical sites and therefore the timeline may shift as access to the clinical sites changes in response to the rapidly evolving situation. We have also experienced a decline in EU commercial product revenue and additional impacts to the business may arise that we are not aware of currently. The ultimate impact of the pandemic on the Company’s results of operations, financial position, liquidity, or capital resources cannot be reasonably estimated at this time.

Liquidity and Going Concern

The accompanying 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, 2020, the Company incurred net losses of $24,156 and used $22,868 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.

The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce or eliminate its research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If Delcath is not able to continue as a going concern, it is likely that holders of its common stock will lose all of their investment. The accompanying 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, 2020

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 Delcath. All significant inter-company accounts and transactions are eliminated.

Reverse Stock Splits

All share numbers presented in these financial statements, including these footnotes reflect a one-for seven hundred (1:700) reverse stock split effected on December 24, 2019.

Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 2020

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 derivative instrument liabilities, 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.

Derivative Instrument Liability

The Company accounts for derivative instruments in accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging, which establishes accounting and reporting standards for derivative instruments and hedging activities, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value, regardless of the hedging relationship designation. At December 31, 2020 and 2019, the Company did not have any derivative instruments that were designated as hedges.

Fair Value Measurements

The Company adheres to 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 has the ability to 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 we transfer control of the promised goods or services to our customers in an amount that reflects the consideration to which we expect 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.

We may enter into contracts with partners that contain multiple elements such as licensing, development, manufacturing, and commercialization components. These arrangements are often complex, and we 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 we believe 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. We believe this provides a reasonable basis for recognizing revenue; however, actual results could differ from estimates and significant changes in estimates could impact our 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.

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.

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 employee services and ASC 505-50, Equity-Based Payments to Non-Employees, which establishes accounting for equity-based payments to non-employees. 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 is required to record compensation cost for all share-based payments granted to employees based upon the grant date fair value, estimated in accordance with the provisions of ASC 718. Under the provisions of ASC 505-50, measurement of compensation cost related to common shares issued to non-employees for services is based on the value of the services provided or the fair value of the shares issued. The measurement of non-employee stock-based compensation is subject to periodic adjustment as the underlying equity instrument vests. 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 Delcath’s 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 Delcath’s stock over the option’s expected term, the risk-free interest rate over the option’s expected term, and Delcath’s 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 14 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 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, 2020 and 2019 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive:

	2020		2019
Common stock warrants - equity		4,236,687		-
Common stock warrants - liability		-		1,826,608
Assumed conversion of Series E and Series E-1 Preferred Stock		2,063,100		1,802,008
Assumed conversion of convertible notes		146,288		63,493
Stock options		1,078,499		1,640
Total		7,524,574		3,693,749

Segment Information

A single management team that reports to the CEO and President 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.

Reclassification of Prior Year Presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported consolidated statement of operations. The Company has reclassified categories related to lease obligations and right of use assets to properly reflect the changes in the cash flow statement.

Recently Issued Accounting Pronouncements

In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Simplifying the Accounting for Income Taxes. The list of changes is comprehensive; however, the changes will not significantly impact the Company due to the full valuation allowance that is recorded against the Company’s deferred tax assets. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption of ASU 2019-12 is permitted, including adoption in any interim period for public business entities for periods for which financial statements have not yet been issued. An entity that elects to early adopt the amendments in an interim period should reflect any adjustments as of the beginning of the annual period that includes that interim period. Additionally, an entity that elects early adoption must adopt all the amendments in the same period. The Company will adopt ASU 2019-12 in 2021.

Cash, Cash Equivalents and Restricted Cash

12 Months Ended

Dec. 31, 2020

Cash And Cash Equivalents [Abstract]

Cash, Cash Equivalents and Restricted Cash

(4)	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, 2020		December 31, 2019
Cash and cash equivalents	$	28,575	$	10,002
Letters of credit		131		131
Security for credit cards		50		50
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$	28,756	$	10,183

Inventories

12 Months Ended

Dec. 31, 2020

Inventory Disclosure [Abstract]

Inventories

(5)	Inventories

Inventories consist of:


	December 31, 2020		December 31, 2019
Raw materials	$	435	$	375
Work-in-process		420		279
Total Inventory	$	855	$	654

Prepaid Expenses and Other Current Assets

12 Months Ended

Dec. 31, 2020

Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract]

Prepaid Expenses And Other Current Assets

(6)	Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets include the following:

	December 31, 2020		December 31, 2019
Clinical trial expenses	$	1,497	$	725
Insurance premiums		845		589
Other¹		328		445
Total prepaid expenses and other current assets	$	2,670	$	1,759

¹Other consists of various prepaid expenses and other current assets, with no individual item accounting for more than 5% at December 31, 2020 and 2019.

Property, Plant, and Equipment

12 Months Ended

Dec. 31, 2020

Property Plant And Equipment [Abstract]

Property, Plant, and Equipment

(7)	Property, Plant, and Equipment

Property, plant, and equipment consists of:

	December 31, 2020			December 31, 2019			Estimated Useful Life
Buildings and land	$	1,109		$	589		30 years - Buildings
Enterprise hardware and software		1,862			1,739		3 years
Leaseholds		1,826			1,695		Lesser of lease term or estimated useful life
Equipment		1,063			1,025		7 years
Furniture		204			198		5 years
Property, plant, and equipment, gross		6,064			5,246
Accumulated depreciation		(4,713	)		(4,511	)
Property, plant, and equipment, net	$	1,351		$	735

On July 31, 2020, the Company exercised its option to purchase its 95-97 Park Road office location in Queensbury, NY for $460.3, pursuant to the terms of the lease agreement dated September 17, 2018, as amended.

Depreciation expense for the years ended December 31, 2020 and 2019 was $167 and $212, respectively.

Accrued Expenses

12 Months Ended

Dec. 31, 2020

Payables And Accruals [Abstract]

Accrued Expenses

(8)	Accrued Expenses

Current accrued expenses include the following:

	December 31, 2020		December 31, 2019
Clinical trial expenses	$	2,698	$	2,497
Compensation, excluding taxes		1,598		3,525
Other¹		945		925
Total accrued expenses	$	5,241	$	6,947

¹Other consists of various accrued expenses, with no individual item accounting for more than 5% of current liabilities at December 31, 2020 and 2019.

Leases

12 Months Ended

Dec. 31, 2020

Leases [Abstract]

Leases

(9)

Leases

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

The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the ROU asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments.

The following table summarizes the Company’s operating and financing leases as of December 31, 2020:

	US			Ireland			Total
Lease Cost
Operating lease cost	$	471		$	228		$	699
Financing lease cost	27				—			27
Sublease income		-			(206	)		(206	)
Total	$	498		$	22		$	520

Other information
Operating cash flows out from operating leases		(471	)		(228	)		(699	)
Operating cash flows in from operating leases		-			206			206
Operating cash flows out from financing leases		(26	)		—			(26	)
Right-of-use assets exchanged for new operating lease liabilities		729			—			729
Weighted average remaining lease term		2.2			0.6
Weighted average discount rate - operating leases		8	%		8	%

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

	US			Ireland			Total
Year ended December 31, 2021	$	416		$	133		$	549
Year ended December 31, 2022		406			—			406
Year ended December 31, 2023		67			—			67
Total		889			133			1,022
Less present value discount		(74	)		(3	)		(77	)
Operating lease liabilities included in the consolidated balance sheets at December 31, 2020	$	815		$	130		$	945

Convertible Notes Payable

12 Months Ended

Dec. 31, 2020

Debt Disclosure [Abstract]

Convertible Notes Payable

(10)	Convertible notes payable

On June 6, 2019, the Company entered into a note purchase agreement with two institutional investors, pursuant to which the investors agreed to transfer and surrender to the Company for cancellation, warrants to purchase 5,605 shares of the Company’s common stock (the “Series D Warrants”) and warrants to purchase 0.1 million shares of the Company’s common stock (the “Pre-Funded Series D Warrants”). Under the terms of the note purchase agreement, the Company agreed to sell and issue to the investors an 8% Senior Secured Promissory Notes in an aggregate principal amount of $2,000 and with a July 16, 2021 maturity date, in full payment and satisfaction of the purchase price for the Series D Warrants and Pre-Funded Series D Warrants. The transactions contemplated by the note purchase agreement were effective and the 8% Senior Secured Promissory Notes were issued on July 15, 2019, upon the closing of the Company’s July 2019 Private Placement discussed in Note 11 herein. Immediately following the closing of the July 2019 Private Placement, the 8% Senior Secured Promissory Notes were amended, pursuant to a note amending agreement dated as of July 15, 2019 between the Company and the investors, to provide that the outstanding principal amount of the 8% Senior Secured Promissory Notes and any accrued and unpaid interest thereon are convertible, at the option of the holder, into shares of Series E Preferred Stock at the price of $1,500. The principal amount of the 8% Senior Secured Promissory Notes is recognized in Convertible notes payable, on the consolidated balance sheets of the Company.

Maturity

date

Conversion

price

Current interest

rate

Principal

Convertible notes payable

8.0% July 2019 Notes

7/16/2021

1,500

2,000

Stockholders' Equity

12 Months Ended

Dec. 31, 2020

Stockholders Equity Note [Abstract]

Stockholders' Equity

(11)	Stockholders’ Equity

Authorized Shares

The Company is authorized to issue 10,000,000 shares of preferred stock, $0.01 per 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).

On November 23, 2020, the Company filed a Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company with the Secretary of State of the State of Delaware. The Certificate of Amendment, which became effective immediately upon its filing, decreased the total number of shares of common stock, $0.01 par value, that the Company is authorized to issue from 1,000,000,000 shares to 40,000,000 shares. The Board of Directors of the Company adopted a resolution approving the Certificate of Amendment on September 30, 2020.

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, 2020, there are 675,000 shares of common stock reserved under the 2020 Plan, of which 95,000 remained available to be issued.

Equity Offerings and Placements

Confidentially Marketed Public Offering

On December 11, 2020, the Company closed a confidentially marketed public offering with the issuance of 1,679,031 shares of the Company’s common stock at a price to the public of $13.25 per share. The Company received gross proceeds of $22,247, offset by $1,861 of underwriting discounts, commissions, and other estimated offering expenses.

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 $10,000 (the “ATM Offering”). 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 $50.0 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.

Through December 31, 2020, the Company sold 77,644 shares of common stock pursuant to the ATM Offering for aggregate gross proceeds of $910, partially offset by $44 of issuance costs.

May 2020 Public Offering

On May 5, 2020, the Company closed a public offering of 1,823,000 shares of common stock, 377,000 pre-funded warrants and Series F warrants to purchase 2,224,900 shares of the Company’s common stock at an exercise price of $10.00 per share. Delcath received gross proceeds of approximately $21,996 from the public offering, partially offset by $2,618 of underwriting discounts and other offering expenses. As a result of the public offering, the conversion prices of the Company’s Series E and Series E-1 Preferred Stock were adjusted to $10.00 per share and the exercise price of the 2019 Warrants was adjusted to $10.00 per share and neither instrument is subject to further price resets.

Series E and Series E-1 Preferred Stock Private Placements

On July 11, 2019, the Company issued 32,572 shares of our Series E convertible preferred stock, par value $0.01 per share (the “Series E Preferred Stock”). The Company entered into a securities purchase agreement with certain accredited investors pursuant to which Delcath sold an aggregate of 20,000 shares of Series E Preferred Stock, at a price of $1,000 per share and a warrant, or a “2019 E Warrant”, to purchase a number of shares of common stock equal to the number of shares of common stock issuable upon conversion of the Series E Preferred Stock purchased by the investor, or the “July 2019 Private Placement”. In connection with the July 2019 Private Placement, the Company exchanged $11,800 of debt, interest and Series D Warrants for 11,500 shares of Series E Preferred Stock and related 2019 E Warrants, $100 in accounts payables for 149 shares of Series E Preferred Stock and related 2019 E Warrants and issued 923 shares of Series E Preferred Stock and related 2019 E Warrants to certain investors in exchange for a waiver of rights under exchange agreements signed in December 2018 and March 2019, or the “Debt Exchange”.

On August 19, 2019, the Company entered into a securities purchase agreement with certain accredited investors pursuant to which Delcath sold to investors an aggregate of 9,510 shares of Series E-1 convertible preferred stock, par value $0.01 per share, or the Series E-1 Preferred Stock, at a price of $1,000 per share and a warrant, or a “2019 E-1 Warrant”, and together with the 2019 E Warrant, the “2019 Warrants”, to purchase a number of shares of common stock of the Company equal to the number of shares of common stock issuable upon conversion of the Series E-1 Preferred Stock purchased by the investor, or the “August 2019 Private Placement”, and, collectively with the July 2019 Private Placement, the “Private Placements”.

The Company received net cash proceeds after expenses of $26.5 million. Of the net proceeds and equitized value received, the Company allocated an estimated fair value of $20,844 to the 2019 Warrants, which was classified as a derivative liability due to the price reset features discussed below. As a result of the Series E Preferred Stock and Series E-1 Preferred Stock having an effective conversion price that was lower than the market price on the date of issuance, the Company has recognized a beneficial conversion feature of $18,238. Due to the Series E Preferred Stock and Series E-1 Preferred Stock being immediately convertible, the beneficial conversion feature was recognized in full as a deemed dividend.

Each share of Series E Preferred Stock and Series E-1 Preferred Stock, or, collectively, the “Preferred Stock”, is convertible at any time at the option of the holder into the number of shares of common stock determined by dividing the stated value by the conversion price of $42.00, subject to certain limitations and adjustments, or the Conversion Price. Except for certain adjustments, the holders of the Preferred Stock are entitled to receive dividends on shares of Preferred Stock equal (on an “as converted” basis) to and in the same form as dividends paid on shares of the common stock. Any such dividends that are not paid to the holders of the Preferred Stock will increase the stated value. No other dividends will be paid on shares of Preferred Stock. Each 2019 Warrant had an original exercise price equal to $42.00, subject to adjustment in accordance with the terms of the 2019 Warrants, or the Exercise Price, and became exercisable at any time upon the consummation of the Reverse Split and will be exercisable until 5:00 p.m. (NYC time) on the date that is five years following the date of the Reverse Split.

Pursuant to the terms of the Preferred Stock and the 2019 Warrants, the Conversion Price of the Preferred Stock and the Exercise Price of the 2019 Warrants were initially subject to adjustment in each of the following circumstances: (i) on the third trading day following the date that the Company effects a reverse stock split, or the Reverse Split Reset Date, (ii) the date that the initial registration statement covering the shares of common stock issuable upon the conversion of the Preferred Stock and the exercise of the 2019 Warrants is declared effective by the SEC, or the Registration Reset Date, and (iii) in the event that all of the shares of common stock which we were required to register with the SEC were not then registered on an effective registration statement, the date that all of the shares underlying the respective Preferred Stock and 2019 Warrants may be sold pursuant to Rule 144, or the Rule 144 Reset Date, each of such reset dates, a Reset Date and, collectively, the Reset Dates. On each Reset Date, the Conversion Price and the Exercise Price were to be reduced, and only reduced, to equal the lesser of (x) the then effective Conversion Price or Exercise Price, as applicable, and (y) 90% of the average of the five daily volume weighted average prices of the common stock immediately prior to each Reset Date, or the Reset Formula. In the event of a reduction in the Exercise Price, the aggregate number of Warrant Shares issuable upon the exercise of the 2019 Warrants were to be increased such that the aggregate Exercise Price of the Warrants on the day immediately following such Reset Date equaled the aggregate Exercise Price immediately prior to such adjustment. In addition, from the date of issuance of the Preferred Stock and Warrants until such time that the Company’s common stock is listed or quoted on a national exchange, the Conversion Price and the Exercise Price are subject to price-based anti-dilution protections.

The Registration Reset Date occurred on November 7, 2019. However, pursuant to the Reset Formula, no reduction in the Conversion Price or the Exercise Price occurred on the Registration Reset Date. The Reverse Split Reset Date occurred on December 30, 2019. Pursuant to the Reset Formula, the Conversion Price and the Exercise Price were reduced to $23.04 per share as of the Reverse Split Reset Date. The Rule 144 Reset Date with respect to the Series E Preferred Stock and the Series E Warrants occurred on January 15, 2020, but no reset in the Conversion Price or the Exercise Price of the Series E Preferred Stock or the Series E Warrants occurred as of such date because all of the shares of common stock issuable in respect of such securities had been registered for resale. The Rule 144 Reset Date with respect to the Series E-1 Preferred Stock and the Series E-1 Warrants occurred on February 19, 2020, but no reset in the Conversion Price or the Exercise Price of the Series E-1 Preferred Stock or the Series E-1 Warrants occurred as of such date because all of the shares of common stock issuable in respect of such securities had been registered for resale.

As a consequence of the reduction of the Conversion Price on the Reverse Split Reset Date, an additional 813,473 shares of common stock became issuable upon the conversion of the Preferred Stock and, as a consequence of the reduction of the Exercise Price on the Reverse Split Reset Date, an additional 824,587 shares of common stock became issuable upon the exercise of the 2019 Warrants, or collectively the Reset Shares. Pursuant to the terms of the registration rights agreements entered into in connection with the Private Placements and the Debt Exchange we were required to register a number of shares of our common stock that would be issuable assuming that the Conversion Price and the Exercise Price were $16.10 per share, regardless of the actual Conversion Price or the Exercise Price. Pursuant to that requirement, even though we were obligated to issue only the Reset Shares as a result of the Reverse Split, we registered a total of 3,429,680 shares of common stock for sale or other disposition by the selling stockholders on our registration statement on Form S-1 (File No. 333-235751), which included the Reset Shares.

During the year ended December 31, 2020, the Company incurred $106 of costs to register the shares of common stock underlying the Preferred Stock and the 2019 Warrants.

The conversion price of the Preferred Stock and the exercise price of the 2019 Warrant were subsequently adjusted to $10.00 per share (and they are no longer subject to price resets) upon the pricing of the Company’s May 2020 public offering. As a result of the price adjustment, the excess of the fair value of the common stock that will be received on conversion of the Preferred Stock, measured on the price reset date, exceeded the original proceeds allocated to the Preferred Stock by $12,000. The repricing of the exercise price of the 2019 Warrants resulted in the recognition of a $55 deemed dividend. Because the 2019 Warrants are no longer subject to price resets, the $6,200 estimated fair value of the warrants was reclassified from derivative liability to equity.

During the years ended December 31, 2020 and 2019, 20,887 and 565 shares of Series E and Series E-1 Convertible Preferred Stock were converted into 2,084,507 and 13,455 shares of common stock, respectively.

As of December 31, 2020, there were 20,631 shares of Preferred Stock outstanding.

Other Common Stock Issuances

During the years ended December 31, 2020 and 2019, the Company issued 72,976 and 20 shares of common stock with a grant date value of $636 and $4, respectively, as compensation. The 2020 issuances include shares valued at $230 which were issued to satisfy 2019 accrued compensation.

During the year ended December 31, 2020, the Company issued 6,000 shares of common stock associated with the exercise of pre-funded warrants and 185,803 shares of common stock associated with other warrants for combined proceeds of $1,858. During the year ended December 31, 2019, the Company issued 11,285 shares of common stock associated with the exercise of pre-funded warrants for de minimis proceeds

In April 2019, the Company entered into an exchange agreement with an institutional investor with respect to warrants held by such investor. Pursuant to the exchange agreement, the Company issued 92 shares of the Company’s common stock in exchange for warrants to purchase 82,521 shares of common stock at a weighted average exercise price of $170 per share. The exchange resulted in a loss of approximately $6 which is recognized within loss on issuance of financial instrument in the statement of operations.

Series D Preferred Stock Issuance and Exchange

On November 5, 2018, the Company’s Board authorized the establishment of a new series of preferred stock designated as Series D Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock. During 2019, the Company issued an additional 15 shares of Series D Preferred Stock (in addition to the 101 shares issued previously) for gross proceeds of $150. On March 29, 2019, the Company exchanged all 116 issued and outstanding shares of its Series D Preferred Stock (having an aggregate stated value of $1,160) and received $400 in cash proceeds in exchange for the issuance of a senior secured promissory note (the “March 2019 Note”) in the principal amount of $1,560. The March 2019 Note bore interest at the rate of 8% per annum, was scheduled to mature on April 1, 2020, and was not convertible. The March 2019 Note was exchanged as part of the July 2019 preferred stock private placement discussed above and is no longer outstanding.

Stock Options

Pursuant to his Employment Agreement, on October 1, 2020, the Company granted a ten-year nonqualified and non-plan stock option to purchase 498,000 shares of the Company’s common stock to the Company’s new Chief Executive Officer, Gerard Michel. The exercise price of the option is equal to (i) $11.67 per share , the closing trading price per share of the Company’s common stock on October 1, 2020 as to the first 396,000 option shares to vest, (ii) 1.5 times the closing trading price per share of the Company’s common stock on October 1, 2020 as to the next 51,000 option shares to vest and (iii) 2.0 times the closing trading price per share of the Company’s common stock on October 1, 2020 as to the remaining 51,000 option shares to vest. The options vest ratably on a monthly basis over 36 months. The grant date value of the awards was $5,629, which will be recognized based on a graded approach over the vesting period.

On October 1, 2020, the Company granted ten-year options to directors and employees to purchase an aggregate of 550,000 shares of common stock at an exercise price of $11.67 per share. The options vest ratably on a monthly basis over 36 months. The grant date value of the awards was $6,230, which will be recognized using a graded approach over the vesting period.

On December 7, 2020, the Company granted ten-year options to a new employee to purchase an aggregate of 30,000 shares of common stock at an exercise price of $15.32 per share. The options vest ratably on a monthly basis over 36 months. The grant date value of the award was $446, which will be recognized using a graded approach over the vesting period.

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

	For the year ended December 31, 2020	For the year ended December 31, 2019
Expected terms (years)	5.77		5.50
Expected volatility	181.00%	147.63%
Risk-free interest rate	0.27% - 0.40%	2.51% - 2.59%
Expected dividends	0.00%	0.00%

The weighted average estimated fair value of the stock options granted during the years ended December 31, 2020 and 2019 was approximately $11.41 and $181.41 per share, respectively.

The following is a summary of stock option activity under the 2019 Plan and the 2020 Plan For the year ended December 31, 2020:

	Number of Options			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at January 1, 2020		1,640		$	196.70
Granted		1,078,000		$	12.60
Exercised		—			—
Cancelled/Forfeited		(1,141	)	$	196.70
Outstanding at December 31, 2020		1,078,499		$	12.68		9.8	$	6,012
Exercisable at December 31, 2020		87,834		$	13.57		9.8	$	494

The following table summarizes information for stock option shares outstanding and exercisable at December 31, 2020:

			Options Exercisable
Range of Exercise Prices	Outstanding Number of Options		Weighted Average Remaining Option Term (in years)		Number of Options
$10 - $15		946,000		9.8		78,835
$15 - $20		81,000		9.8		4,250
$20 - $25		51,000		9.8		4,250
$25+		499		8.1		499
		1,078,499		9.8		87,834

At December 31, 2020, there was approximately $8,824 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 9.8 year. For the years ended December 31, 2020 and 2019, the Company recognized compensation expense $3,505 and $273, respectively, related to stock options granted to employees and board members, which were charged to the statement of operations as detailed below:

	For the year ended December 31, 2020		For the year ended December 31, 2019
Selling, general and administrative	$	2,304	$	214
Research and development		1,110		59
Cost of goods sold		91		—
Total	$	3,505	$	273

Warrants

The following is a summary of warrant activity for the year ended December 31, 2020 :

	Warrants			Weighted Average Exercise Price		Weighted Average Remaining Life (Years)		Aggregate Intrinsic Value
Outstanding at January 1, 2020		1,826,608		$	23.04
Warrants issued		2,601,900		$	8.55
Warrants exercised		(191,803	)	$	9.69
Warrants expired		(18	)	$	10.00
Outstanding at December 31, 2020		4,236,687		$	9.13		4.2		37,261
Exercisable at December 31, 2020		4,236,687		$	9.13		4.2		37,261

The following table presents information related to stock warrants at December 31, 2020:

				Warrants Exercisable
Range of Exercise Prices		Outstanding Number of Warrants		Weighted Average Remaining Warrants Term (in years)		Number of Warrants
$	0.01		371,000		4.3		371,000
$	10.00		3,865,687		4.2		3,865,687
			4,236,687		4.2		4,236,687

As of December 31, 2020, warrants to purchase 371,000 shares of common stock were pre-funded, and the exercise price was $0.01 per share. The remaining warrants were exercisable at $10.00 per share. See Series E and Series E-1 Preferred Stock Private Placement above for additional information related to the price reset of the 2019 Warrants.

See the May 2020 Public Offering section above for additional information related to the warrants issued during the year ended December 31, 2020.

See the Other Common Stock Issuances section above for additional information related to warrant exercises.

Fair Value Measurements

12 Months Ended

Dec. 31, 2020

Fair Value Disclosures [Abstract]

Fair Value Measurements

(12)	Fair Value Measurements

The table below presents the activity within Level 3 of the fair value hierarchy for the twelve months ended December 31, 2020:

Fair Value Measurements Using Significant Unobservable

Inputs (Level 3)

	Warrant Liability
Balance at January 1, 2019	$	33
Total change in the liability included in earnings		(17,498	)
Reclass from liability to equity		(11	)
Fair value of warrants issued		20,844
Balance at December 31, 2019		3,368
Total change in the liability included in earnings		2,832
Reclass from liability to equity		(6,200	)
Balance at December 31, 2020		-

At December 31, 2018, the Company had a total of 179 warrants outstanding that were surrendered pursuant to a settlement agreement entered into between the Company and the holders of such warrants on April 18, 2019. The final payment under the settlement was made on July 16, 2019.

See Note 11 for information related to the warrants issued in the year ended December 31, 2019 that were classified as derivative liabilities but were reclassified as equity during the year ended December 31, 2020.

The fair value of the warrants measured during the years ended December 31, 2020 and 2019 were determined by using option pricing models assuming the following:

	For the Year Ended December 31,
	2020		2019
Contractual life (in years)		4.30		4.60
Expected volatility	208.2%		207.50%
Risk-free interest rates	1.40%		1.70%

The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2020 and 2019, aggregated by the level in the fair value hierarchy within which those measurements fall.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

	Assets and Liabilities Measured at Fair Value on a Recurring Basis
	Level 1				Level 2				Level 3				Balance at December 31,
	2020		2019		2020		2019		2020		2019		2020		2019
Liabilities
Derivative instrument liabilities	$	—	$	—	$	—	$	—	$	—	$	3,368	$	—	$	3,368

For the twelve months ended December 31, 2020 and 2019 there were no transfers in or out of Level 1, 2 or 3 inputs.

- 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

Commitments

12 Months Ended

Dec. 31, 2020

Commitments And Contingencies Disclosure [Abstract]

Commitments

(13)	Commitments

Litigation, Claims and Assessments

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 seek payment of certain purported unpaid compensation amounts claimed to be due to them, in an approximate amount of $1,140 in the aggregate, as well as unspecified statutory damages under New York Labor Law, attorneys’ fees and costs, and statutory interest. The Company intends to defend the claims vigorously. The arbitrator had scheduled hearings to take place during the week of May 17, 2021. However, the Claimants and the Company recently 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. At this time, the mediation process between the Claimants and the Company is ongoing. As of December 31, 2020, the Company has accrued for the full purported unpaid compensation amounts.

Officer Appointment – Chief Executive Officer

On October 1, 2020, Gerard Michel was appointed as the Company’s new Chief Executive Officer and a Class I Director. Pursuant to an employment agreement dated as of August 31, 2020 between the Company and Mr. Michel (the “Employment Agreement”), the term of Mr. Michel’s employment began on October 1, 2020. Under the Employment Agreement, Mr. Michel will receive an annual base salary of $450 subject to annual review by the Board’s Compensation and Stock Option Committee and will be eligible to participate in the Company’s annual incentive plan with a target annual cash bonus equal to 50% of his then-current base salary. In addition, the Company will reimburse Mr. Michel up to $6.5 per month to cover his temporary expenses incurred in connection with traveling to and living in the New York City tristate area to work onsite at the Company’s principal corporate office for the initial eighteen (18) months of his employment.

Pursuant to the Employment Agreement, on October 1, 2020, the Company granted stock options to Mr. Michel. See Note 11 for additional details.

If Mr. Michel resigns his at-will employment for Good Reason, (as defined in the Employment Agreement), or the Company terminates Mr. Michel’s employment other than for Cause, (as defined in the Employment Agreement) , then Mr. Michel shall be entitled to his accrued and unpaid compensation and, subject to him entering into and not revoking a general release of claims in favor of the Company and fully complying with the terms of an Employee Confidentiality, Invention Assignment and Restrictive Covenants Agreement (the “Restrictive Covenants Agreement”), Mr. Michel shall also be entitled to: (a) a severance payment equal in the aggregate to twelve (12) months of his annual base salary at the time of termination, payable in twelve (12) equal monthly installments; and (b) specified continuing health plan benefits until the earlier of (i) the twelve (12) month anniversary of his termination date, (ii) the last day he’s eligible for coverage pursuant to COBRA or (iii) the date on which he becomes eligible for similar coverage from another employer.

Operating Leases

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 Dublin, 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 sub-lease agreement (the “2021 Sub-Lease”) with its current sublessee under the 2014 Sublease and 2015 Sublease pursuant to which, effective August 2, 2021, the current sublessee will become the lessee and the Company will sub-lease its portion of the premises from the current sublessee. The Company’s rent under the 2021 Sub-Lease will be approximately $3.7 per month for a term of five years. Aside from the 2021 Sub-Lease, the Company has no operating or financing leases that have not yet commenced.

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, is extended through February 2023 for total annual base rent of $405.7.

Future minimum lease payments, net of receipts due under the terms of subleases, under all operating leases at December 31, 2020 are as follows:

	Future Lease Payments
2021		419
2022		406
2023		68

For the years ended December 31, 2020 and 2019 rent expense, net of receipts under the terms of subleases, totaled approximately $423 and $529, respectively.

Letters of Credit

Under the terms of a sub-lease agreement for office space at 1633 Broadway, New York, NY, the Company is required to maintain a letter of credit in the amount of $131, which will expire with the sublease in February 2023.

Income Taxes

12 Months Ended

Dec. 31, 2020

Income Tax Disclosure [Abstract]

Income Taxes

(14)	Income Taxes

There is no income tax expense recognized for the years ended December 31, 2020 and 2019, respectively.

Loss before taxes consists of:

	December 31, 2020			December 31, 2019
Domestic	$	(23,643	)	$	(4,882	)
Foreign		(513	)		(3,997	)
Income (loss) before taxes	$	(24,156	)	$	(8,879	)

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


	December 31, 2020			December 31, 2019
Income taxes using U.S federal statutory rate	$	(5,073	)	$	(1,865	)
Nondeductible interest		315			994
Loss on extinguishment of debt		—			361
Loss of tax benefit of state net operating loss carryforwards		(11	)		1,477
Loss of tax benefit of federal tax credit carryforwards		—			324
Branch income		(238	)		—
State income taxes, net of federal benefit		(1,788	)		(1,461	)
Foreign rate differential		(238	)		664
Valuation allowance		6,281			3,512
Derivative charge		595			(3,674	)
Stock option exercises and cancellations		308			—
Research and development costs		(166	)		(316	)
Other		15			(16	)
Total	$	—		$	—

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


	December 31, 2020		December 31, 2019
Deferred tax assets:
Employee compensation accruals	$	796	$	84
Accrued liabilities		361		—
Research tax credits		346		135
Lease obligation		265		206
Other		87		72
Net operating losses		19,742		14,502
Total deferred tax assets		21,597		14,999
Deferred tax liabilities:
Right of use asset		265		206
Total deferred tax liabilities		265		206
Valuation allowance		21,332		14,793
Net deferred tax assets	$	—	$	—

As of December 31, 2020, and 2019, the Company had net operating loss carryforwards for U.S. federal income tax purposes of approximately $260,622 and $246,347, respectively. A significant portion of the federal amount is subject to an annual limitation as low as $27,500 as a result of changes in the Company’s ownership in May 2003, November 2016, and multiple dates throughout 2017, 2018 and 2019, 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 May 2003, November 2016 and multiple 2017, 2018 and 2019 ownership changes, approximately $206,112 of the total net operating loss carryforwards is expected to expire unutilized and will be unavailable to offset future federal taxable income. Approximately $54,510 of net operating loss carryforwards remains available to offset future federal taxable income, of which $1,737 will expire between 2020 and 2037 and $52,773 will have an unlimited carryforward period as a result of the Tax Cuts and Jobs Act.

In addition, the Company’s state net operating losses are also subject to annual limitations that generally follow IRC Section 382 provisions (with the exception of Connecticut), adjusted for each state’s respective income apportionment percentages. As of December 31, 2020, and 2019, the Company had net operating loss carryforwards for state and city income tax purposes between approximately $26,414 and $192,466 and between approximately $27,311 and $180,611, respectively, which expire through 2040. As a result of the IRC Section 382 limitations, approximately $168,826 and $153,056 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 $23,641 and $23,623 of net operating loss carryforwards, respectively, will be available to offset future state and city taxable income. As of December 31, 2020, and 2019 the Company had a net operating loss carryforward for foreign income tax purposes of $30,880 and $26,141, respectively, which have indefinite carryforward periods. As of December 31, 2020, and 2019, the Company had federal research and development tax credit carryforwards of approximately $5,458 and $5,292, respectively, which expire through 2040. As a result of the IRC Section 382 limitations, all but $346 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 $6,540 and $3,428 in 2020 and 2019, respectively. The change in valuation is as follows:

	December 31, 2020		December 31, 2019
Beginning balance	$	14,793	$	11,364
Charged to costs and expenses		6,281		3,512
Charged to additional paid-in capital		—		—
Charged to retained earnings		—		—
Charged to other comprehensive income		258		(83	)
Ending balance	$	21,332	$	14,793

On March 27, 2020, President Trump signed into law the $2 trillion bipartisan Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748). The CARES Act includes a variety of economic and tax relief measures intended to stimulate the economy, including loans for small businesses, payroll tax credits/deferrals, and corporate income tax relief. Due to the Company’s history of tax loss carryforwards and full valuation allowance, the CARES Act did not have a significant effect on the income tax provision, as the corporate income tax relief was directed towards cash taxpayers.

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 rollforward 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, 2017; tax years ending December 31, 2017 through December 31, 2020 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, 2016 (as Ireland has not initiated an audit of 2015 as of December 31, 2020); tax years ending December 31, 2016 through December 31, 2020 remain open to examination. However, the Company’s tax years December 31, 1998 through December 31, 2020 generally remain open to adjustment for all federal, state and foreign tax matters until its net operating loss and tax credit carryforwards are utilized 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.

Delcath 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.

+ References + Details

Subsequent Events

12 Months Ended

Dec. 31, 2020

Subsequent Events [Abstract]

Subsequent Events

(15)	Subsequent Events

Series E and E-1 Preferred Stock Conversions

Subsequent to December 31, 2020, the Company has issued 15,000 shares of common stock pursuant to conversions of Series E and Series E-1 Convertible Preferred Stock.

Stock Warrant Exercises

Subsequent to December 31, 2020, warrants to purchase 232,945 shares of the Company’s common stock with an exercise price of $10.00 per share were exercised for proceeds of $2,329,450.

Subsequent to December 31, 2020, the Company has issued 4,575 shares of common stock pursuant to the option of a cashless exercise of Series E warrants.

Sales of Unregistered Securities

On February 18, 2021, the Company issued 2,636 shares of unregistered Common Stock in lieu of cash payment of deferred accrued director fees to former director, William Rueckert.

Summary of Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2020

Accounting Policies [Abstract]

Risk and Uncertainties

Risks and Uncertainties

Liquidity and Going Concern

Use of Estimates

Cash Equivalents and Concentrations of Credit Risk

Restricted Cash

Accounts Receivable

Inventories

Property, Plant and Equipment

Derivative Instrument Liability

Fair Value Measurements

•

Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to 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

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.

Deferred Revenue

Selling, General and Administrative

Research and Development

Stock Based Compensation

Income Taxes

Net Loss per Common Share

	2020		2019
Common stock warrants - equity		4,236,687		-
Common stock warrants - liability		-		1,826,608
Assumed conversion of Series E and Series E-1 Preferred Stock		2,063,100		1,802,008
Assumed conversion of convertible notes		146,288		63,493
Stock options		1,078,499		1,640
Total		7,524,574		3,693,749

Segment Information

A single management team that reports to the CEO and President comprehensively manages the business. Accordingly, the Company does not have separately reportable segments.

Foreign Currency and Currency Translation

Reclassification of Prior Year Presentation

Recently issued Accounting Pronouncements and Accounting Standards to be Adopted

Recently Issued Accounting Pronouncements

Summary of Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2020

Accounting Policies [Abstract]

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

	2020		2019
Common stock warrants - equity		4,236,687		-
Common stock warrants - liability		-		1,826,608
Assumed conversion of Series E and Series E-1 Preferred Stock		2,063,100		1,802,008
Assumed conversion of convertible notes		146,288		63,493
Stock options		1,078,499		1,640
Total		7,524,574		3,693,749

Cash, Cash Equivalents and Restricted Cash (Tables)

12 Months Ended

Dec. 31, 2020

Cash And Cash Equivalents [Abstract]

Schedule of Cash, Cash Equivalents, and Restricted Cash

	December 31, 2020		December 31, 2019
Cash and cash equivalents	$	28,575	$	10,002
Letters of credit		131		131
Security for credit cards		50		50
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$	28,756	$	10,183

Inventories (Tables)

12 Months Ended

Dec. 31, 2020

Inventory Disclosure [Abstract]

Schedule of inventories

Inventories consist of:


	December 31, 2020		December 31, 2019
Raw materials	$	435	$	375
Work-in-process		420		279
Total Inventory	$	855	$	654

Prepaid Expenses and Other Current Assets (Tables)

12 Months Ended

Dec. 31, 2020

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, 2020		December 31, 2019
Clinical trial expenses	$	1,497	$	725
Insurance premiums		845		589
Other¹		328		445
Total prepaid expenses and other current assets	$	2,670	$	1,759

¹Other consists of various prepaid expenses and other current assets, with no individual item accounting for more than 5% at December 31, 2020 and 2019.

Property, Plant, and Equipment (Tables)

12 Months Ended

Dec. 31, 2020

Property Plant And Equipment [Abstract]

Components of property, plant and equipment

Property, plant, and equipment consists of:

	December 31, 2020			December 31, 2019			Estimated Useful Life
Buildings and land	$	1,109		$	589		30 years - Buildings
Enterprise hardware and software		1,862			1,739		3 years
Leaseholds		1,826			1,695		Lesser of lease term or estimated useful life
Equipment		1,063			1,025		7 years
Furniture		204			198		5 years
Property, plant, and equipment, gross		6,064			5,246
Accumulated depreciation		(4,713	)		(4,511	)
Property, plant, and equipment, net	$	1,351		$	735

Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2020

Payables And Accruals [Abstract]

Schedule of current accrued expenses

Current accrued expenses include the following:

	December 31, 2020		December 31, 2019
Clinical trial expenses	$	2,698	$	2,497
Compensation, excluding taxes		1,598		3,525
Other¹		945		925
Total accrued expenses	$	5,241	$	6,947

¹Other consists of various accrued expenses, with no individual item accounting for more than 5% of current liabilities at December 31, 2020 and 2019.

Leases (Tables)

12 Months Ended

Dec. 31, 2020

Leases [Abstract]

Summary of Operating and Financing Leases

The following table summarizes the Company’s operating and financing leases as of December 31, 2020:

	US			Ireland			Total
Lease Cost
Operating lease cost	$	471		$	228		$	699
Financing lease cost	27				—			27
Sublease income		-			(206	)		(206	)
Total	$	498		$	22		$	520

Other information
Operating cash flows out from operating leases		(471	)		(228	)		(699	)
Operating cash flows in from operating leases		-			206			206
Operating cash flows out from financing leases		(26	)		—			(26	)
Right-of-use assets exchanged for new operating lease liabilities		729			—			729
Weighted average remaining lease term		2.2			0.6
Weighted average discount rate - operating leases		8	%		8	%

Schedule of Maturity of Operating Leases Excluding Short-Term Leases

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

	US			Ireland			Total
Year ended December 31, 2021	$	416		$	133		$	549
Year ended December 31, 2022		406			—			406
Year ended December 31, 2023		67			—			67
Total		889			133			1,022
Less present value discount		(74	)		(3	)		(77	)
Operating lease liabilities included in the consolidated balance sheets at December 31, 2020	$	815		$	130		$	945

Convertible Notes Payable (Tables)

12 Months Ended

Dec. 31, 2020

Debt Disclosure [Abstract]

Summary of Various Notes Issued

Maturity

date

Conversion

price

Current interest

rate

Principal

Convertible notes payable

8.0% July 2019 Notes

7/16/2021

1,500

2,000

Stockholders' Equity (Tables)

12 Months Ended

Dec. 31, 2020

Stockholders Equity Note [Abstract]

Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model

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

	For the year ended December 31, 2020	For the year ended December 31, 2019
Expected terms (years)	5.77		5.50
Expected volatility	181.00%	147.63%
Risk-free interest rate	0.27% - 0.40%	2.51% - 2.59%
Expected dividends	0.00%	0.00%

Summary of Stock Option Activity

The following is a summary of stock option activity under the 2019 Plan and the 2020 Plan For the year ended December 31, 2020:

	Number of Options			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at January 1, 2020		1,640		$	196.70
Granted		1,078,000		$	12.60
Exercised		—			—
Cancelled/Forfeited		(1,141	)	$	196.70
Outstanding at December 31, 2020		1,078,499		$	12.68		9.8	$	6,012
Exercisable at December 31, 2020		87,834		$	13.57		9.8	$	494

Summary of Stock Option Shares Outstanding and Exercisable

The following table summarizes information for stock option shares outstanding and exercisable at December 31, 2020:

			Options Exercisable
Range of Exercise Prices	Outstanding Number of Options		Weighted Average Remaining Option Term (in years)		Number of Options
$10 - $15		946,000		9.8		78,835
$15 - $20		81,000		9.8		4,250
$20 - $25		51,000		9.8		4,250
$25+		499		8.1		499
		1,078,499		9.8		87,834

Summary of Recognized Share-based Compensation Cost

	For the year ended December 31, 2020		For the year ended December 31, 2019
Selling, general and administrative	$	2,304	$	214
Research and development		1,110		59
Cost of goods sold		91		—
Total	$	3,505	$	273

Summary of Warrant Activity

The following is a summary of warrant activity for the year ended December 31, 2020 :

	Warrants			Weighted Average Exercise Price		Weighted Average Remaining Life (Years)		Aggregate Intrinsic Value
Outstanding at January 1, 2020		1,826,608		$	23.04
Warrants issued		2,601,900		$	8.55
Warrants exercised		(191,803	)	$	9.69
Warrants expired		(18	)	$	10.00
Outstanding at December 31, 2020		4,236,687		$	9.13		4.2		37,261
Exercisable at December 31, 2020		4,236,687		$	9.13		4.2		37,261

Schedule of Information Related to Stock Warrants Outstanding and Exercisable

The following table presents information related to stock warrants at December 31, 2020:

				Warrants Exercisable
Range of Exercise Prices		Outstanding Number of Warrants		Weighted Average Remaining Warrants Term (in years)		Number of Warrants
$	0.01		371,000		4.3		371,000
$	10.00		3,865,687		4.2		3,865,687
			4,236,687		4.2		4,236,687

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2020

Fair Value Disclosures [Abstract]

Fair value measurements using significant unobservable inputs

The table below presents the activity within Level 3 of the fair value hierarchy for the twelve months ended December 31, 2020:

Fair Value Measurements Using Significant Unobservable

Inputs (Level 3)

	Warrant Liability
Balance at January 1, 2019	$	33
Total change in the liability included in earnings		(17,498	)
Reclass from liability to equity		(11	)
Fair value of warrants issued		20,844
Balance at December 31, 2019		3,368
Total change in the liability included in earnings		2,832
Reclass from liability to equity		(6,200	)
Balance at December 31, 2020		-

Schedule of fair value of the outstanding warrants

The fair value of the warrants measured during the years ended December 31, 2020 and 2019 were determined by using option pricing models assuming the following:

	For the Year Ended December 31,
	2020		2019
Contractual life (in years)		4.30		4.60
Expected volatility	208.2%		207.50%
Risk-free interest rates	1.40%		1.70%

Assets and liabilities measured at fair value on a recurring basis

Assets and Liabilities Measured at Fair Value on a Recurring Basis

	Assets and Liabilities Measured at Fair Value on a Recurring Basis
	Level 1				Level 2				Level 3				Balance at December 31,
	2020		2019		2020		2019		2020		2019		2020		2019
Liabilities
Derivative instrument liabilities	$	—	$	—	$	—	$	—	$	—	$	3,368	$	—	$	3,368

Commitments (Tables)

12 Months Ended

Dec. 31, 2020

Commitments And Contingencies Disclosure [Abstract]

Schedule of future minimum lease payments, net of receipts due under terms of subleases under all operating leases

Future minimum lease payments, net of receipts due under the terms of subleases, under all operating leases at December 31, 2020 are as follows:

	Future Lease Payments
2021		419
2022		406
2023		68

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2020

Income Tax Disclosure [Abstract]

Schedule of Loss Before Income Taxes

Loss before taxes consists of:

	December 31, 2020			December 31, 2019
Domestic	$	(23,643	)	$	(4,882	)
Foreign		(513	)		(3,997	)
Income (loss) before taxes	$	(24,156	)	$	(8,879	)

Income Tax Reconciliation

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


	December 31, 2020			December 31, 2019
Income taxes using U.S federal statutory rate	$	(5,073	)	$	(1,865	)
Nondeductible interest		315			994
Loss on extinguishment of debt		—			361
Loss of tax benefit of state net operating loss carryforwards		(11	)		1,477
Loss of tax benefit of federal tax credit carryforwards		—			324
Branch income		(238	)		—
State income taxes, net of federal benefit		(1,788	)		(1,461	)
Foreign rate differential		(238	)		664
Valuation allowance		6,281			3,512
Derivative charge		595			(3,674	)
Stock option exercises and cancellations		308			—
Research and development costs		(166	)		(316	)
Other		15			(16	)
Total	$	—		$	—

Significant Components of Deferred Tax Assets

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


	December 31, 2020		December 31, 2019
Deferred tax assets:
Employee compensation accruals	$	796	$	84
Accrued liabilities		361		—
Research tax credits		346		135
Lease obligation		265		206
Other		87		72
Net operating losses		19,742		14,502
Total deferred tax assets		21,597		14,999
Deferred tax liabilities:
Right of use asset		265		206
Total deferred tax liabilities		265		206
Valuation allowance		21,332		14,793
Net deferred tax assets	$	—	$	—

Summary of Change in Valuation

The change in valuation is as follows:

	December 31, 2020		December 31, 2019
Beginning balance	$	14,793	$	11,364
Charged to costs and expenses		6,281		3,512
Charged to additional paid-in capital		—		—
Charged to retained earnings		—		—
Charged to other comprehensive income		258		(83	)
Ending balance	$	21,332	$	14,793

Description of Business - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Organization Consolidation And Presentation Of Financial Statements [Abstract]
Net loss	$ 24,156	$ 8,879
Net cash used in operating activities	$ 22,868	$ 23,689

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 2: http://www.xbrl.org/2003/role/exampleRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 12: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
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-Subparagraph (SX 210.5-03(20))
-URI http://asc.fasb.org/extlink&oid=120395209&loc=SL114868664-224227

Reference 13: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=121586364&loc=d3e3602-108585

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Basis of Consolidated Financial Statement Presentation - Additional Information (Details)	Dec. 24, 2019
Basis Of Condensed Consolidated Financial Statement Presentation [Abstract]
Reverse stock split ratio	0.00142
Reverse stock split	1:700

Summary of Significant Accounting Policies - Additional Information (Details) - Derivative	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Summary Of Significant Accounting Policies [Line Items]
Maximum period of investments with original maturities from date of acquisition to be cash equivalents	3 months
Designated as Hedges [Member]
Summary Of Significant Accounting Policies [Line Items]
Number of derivative instruments	0	0
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, 2020	Dec. 31, 2019
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	7,524,574	3,693,749
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)	4,236,687
Common Stock Warrants - Liability [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)		1,826,608
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)	2,063,100	1,802,008
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)	146,288	63,493
Stock Options [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	1,078,499	1,640

Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Cash And Cash Equivalents [Abstract]
Cash and cash equivalents	$ 28,575	$ 10,002
Letters of credit	131	131
Security for credit cards	50	50
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$ 28,756	$ 10,183	$ 3,577

Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands	Dec. 31, 2020	Dec. 31, 2019
Inventory Disclosure [Abstract]
Raw materials	$ 435	$ 375
Work-in-process	420	279
Total Inventory	$ 855	$ 654

Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($)
$ in Thousands

Dec. 31, 2020

Dec. 31, 2019

Prepaid Expense And Other Assets Current [Abstract]

Clinical trial expenses

$ 1,497

$ 725

Insurance premiums

845

589

Other

^[1]

328

445

Total prepaid expenses and other current assets

$ 2,670

$ 1,759

[1]	1Other consists of various prepaid expenses and other current assets, with no individual item accounting for more than 5% at December 31, 2020 and 2019.

Prepaid Expenses and Other Current Assets - Additional Information (Details)	Dec. 31, 2020	Dec. 31, 2019
Prepaid Expense And Other Assets Current [Abstract]
Maximum percentage of prepaid expenses and other current assets (in hundredths)	5.00%	5.00%

Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 6,064	$ 5,246
Accumulated depreciation	(4,713)	(4,511)
Property, plant, and equipment, net	1,351	735
Buildings and Land [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	1,109	589
Enterprise Hardware and Software [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,862	1,739
Property, plant and equipment, estimated useful life	3 years
Leaseholds [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,826	1,695
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	$ 1,063	1,025
Property, plant and equipment, estimated useful life	7 years
Furniture [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 204	$ 198
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 ($)		12 Months Ended
	Jul. 31, 2020	Dec. 31, 2020	Dec. 31, 2019
Property Plant And Equipment [Abstract]
Exercised option to purchase	$ 460,300
Depreciation expense		$ 167,000	$ 212,000

Accrued Expenses - Schedule of Current Accrued Expenses (Details) - USD ($)
$ in Thousands

Dec. 31, 2020

Dec. 31, 2019

Payables And Accruals [Abstract]

Clinical trial expenses

$ 2,698

$ 2,497

Compensation, excluding taxes

1,598

3,525

Other

^[1]

945

925

Total accrued expenses

$ 5,241

$ 6,947

[1]	1Other consists of various accrued expenses, with no individual item accounting for more than 5% of current liabilities at December 31, 2020 and 2019.

Accrued Expenses - Schedule of Current Accrued Expenses (Parenthetical) (Details)	Dec. 31, 2020	Dec. 31, 2019
Payables And Accruals [Abstract]
Maximum percentage of current liabilities accrued (in hundredths)	5.00%	5.00%

Leases - Additional Information (Details)	Dec. 31, 2020
Leases [Abstract]
Lease term	12 months

Leases - Summary of Operating and Financing Leases (Details) - USD ($)		12 Months Ended
	Jun. 25, 2020	Dec. 31, 2020	Dec. 31, 2019
Lease Cost
Operating lease cost		$ 699,000
Financing lease cost		27,000
Sublease income		(206,000)
Total	$ 0	520,000
Other information
Operating cash flows out from operating leases		(699,000)
Operating cash flows in from operating leases		206,000
Operating cash flows out from financing leases		(26,000)
Right-of-use assets exchanged for new operating lease liabilities		729,000	$ 874,000
U.S. [Member]
Lease Cost
Operating lease cost		471,000
Financing lease cost		27,000
Total		498,000
Other information
Operating cash flows out from operating leases		(471,000)
Operating cash flows out from financing leases		(26,000)
Right-of-use assets exchanged for new operating lease liabilities		$ 729,000
Weighted average remaining lease term		2 years 2 months 12 days
Weighted average discount rate - operating leases		8.00%
Ireland [Member]
Lease Cost
Operating lease cost		$ 228,000
Sublease income		(206,000)
Total		22,000
Other information
Operating cash flows out from operating leases		(228,000)
Operating cash flows in from operating leases		$ 206,000
Weighted average remaining lease term		7 months 6 days
Weighted average discount rate - operating leases		8.00%

Leases - Schedule of Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands	Dec. 31, 2020 USD ($)
Lessee Lease Description [Line Items]
Year ended December 31, 2021	$ 549
Year ended December 31, 2022	406
Year ended December 31, 2023	67
Total	1,022
Less present value discount	(77)
Operating lease liabilities included in the consolidated balance sheets at December 31, 2020	945
U.S. [Member]
Lessee Lease Description [Line Items]
Year ended December 31, 2021	416
Year ended December 31, 2022	406
Year ended December 31, 2023	67
Total	889
Less present value discount	(74)
Operating lease liabilities included in the consolidated balance sheets at December 31, 2020	815
Ireland [Member]
Lessee Lease Description [Line Items]
Year ended December 31, 2021	133
Total	133
Less present value discount	(3)
Operating lease liabilities included in the consolidated balance sheets at December 31, 2020	$ 130

Convertible Notes Payable - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	Jun. 06, 2019	May 05, 2020
Debt Instrument [Line Items]
Debt instrument, conversion price		$ 10.00
Senior Secured Promissory Notes [Member]
Debt Instrument [Line Items]
Debt instrument, principal face amount	$ 2,000
Debt instrument maturity date	Jul. 16, 2021
Interest rate	8.00%
Debt Instrument, issuance date	Jul. 15, 2019
Series D Warrants
Debt Instrument [Line Items]
Number of common shares issuable on cancellation of warrants	5,605
Pre Funded Series D Warrant [Member]
Debt Instrument [Line Items]
Number of common shares issuable on cancellation of warrants	100,000
Series E Preferred Stock [Member]
Debt Instrument [Line Items]
Debt instrument, conversion price	$ 1,500

Convertible Notes Payable - Summary of Various Notes Issued (Details) - USD ($)	12 Months Ended
	Dec. 31, 2020	May 05, 2020
Debt Instrument [Line Items]
Debt instrument, conversion price		$ 10.00
Convertible Notes Payable [Member] \| 8.0% July 2019 Notes [Member]
Debt Instrument [Line Items]
Debt instrument maturity date	Jul. 16, 2021
Debt instrument, conversion price	$ 1,500
Current interest rate	8.00%
Principal	$ 2,000

Stockholders' Equity - Preferred Stock Issuances - Additional Information (Details) - USD ($)

12 Months Ended

Nov. 07, 2019

Aug. 19, 2019

Jul. 11, 2019

Mar. 29, 2019

Nov. 06, 2018

Dec. 31, 2020

Dec. 31, 2019

Nov. 23, 2020

Sep. 30, 2020

May 05, 2020

Jun. 06, 2019

Nov. 05, 2018

10,000,000

Common stock, par value (in dollars per share)

$ 0.01

$ 0.01

^[1]

$ 0.01

^[1]

$ 0.01

Common stock, shares authorized (in shares)

40,000,000

^[1]

40,000,000

^[1]

40,000,000

1,000,000,000

Number of preferred stock and warrants issued upon conversion

2,084,507

13,455

Fair value of warrants issued

$ 0

$ 20,844,000

$ 10.00

Preferred stock, shares outstanding (in shares)

$ 10.00

20,631

41,517

Preferred stock, aggregate stated value

$ 0

2019 Warrants [Member]

Number of shares called upon exercise of warrant

$ 10.00

824,587

Deemed dividend for triggering of warrant down round feature

$ 55,000

Estimated fair value of warrant reclassified from Derivative liability to equity

$ 6,200,000

Common Stock [Member]

Conversion of stock, shares issued

813,473

August 2019 Private Placement [Member] | 2019 Warrants [Member]

Fair value of warrants issued

$ 20,844,000

Series A Preferred Stock [Member]

Series C Preferred Stock [Member]

4,200

Series C Preferred Stock [Member]

2,360

Series E Preferred Stock [Member]

590

40,000

Series E1 Preferred Stock [Member]

$ 1,500

Series E Convertible Preferred Stock [Member]

12,960

Conversion of stock preferred shares converted

20,887

565

Series E Convertible Preferred Stock [Member] | July Two Thousand Nineteen Private Placement

$ 0.01

Series E Convertible Preferred Stock [Member] | July Two Thousand Nineteen Private Placement | Securities Purchase Agreement

32,572

Shares issued, price per share

20,000

$ 1,000

Series E Preferred Stock and Related Warrants [Member] | July Two Thousand Nineteen Private Placement

Debt and warrants exchanged for preferred stock

$ 11,800,000

Number of preferred stock and warrants issued upon conversion

11,500

Value of accounts payable exchanged

$ 100,000

Number of shares issued upon exchange of accounts payable

149

Number of shares issued upon exchange of investor waiver rights

923

Series E-1 Convertible Preferred Stock [Member]

Conversion of stock preferred shares converted

20,887

565

Series E-1 Convertible Preferred Stock [Member] | August 2019 Private Placement [Member] | Securities Purchase Agreement

$ 0.01

Shares issued, price per share

9,510

$ 1,000

Convertible Preferred Stock

$ 23.04

$ 42.00

Registration cost of shares of common stock

23.04

$ 42.00

Warrant exercisable term

5 years

$ 106,000

Excess of the fair value of the common stock

$ 12,000,000

Convertible Preferred Stock | 2019 Warrants [Member]

Convertible Preferred Stock | August 2019 Private Placement [Member]

$ 10.00

Net proceeds from issuance of preferred stock

$ 26,500,000

Beneficial conversion feature

$ 18,238,000

Preferred Stock and 2019 Warrants [Member]

Conversion of stock, description

the Conversion Price of the Preferred Stock and the Exercise Price of the 2019 Warrants were initially subject to adjustment in each of the following circumstances: (i) on the third trading day following the date that the Company effects a reverse stock split, or the Reverse Split Reset Date, (ii) the date that the initial registration statement covering the shares of common stock issuable upon the conversion of the Preferred Stock and the exercise of the 2019 Warrants is declared effective by the SEC, or the Registration Reset Date, and (iii) in the event that all of the shares of common stock which we were required to register with the SEC were not then registered on an effective registration statement, the date that all of the shares underlying the respective Preferred Stock and 2019 Warrants may be sold pursuant to Rule 144, or the Rule 144 Reset Date, each of such reset dates, a Reset Date and, collectively, the Reset Dates. On each Reset Date, the Conversion Price and the Exercise Price were to be reduced, and only reduced, to equal the lesser of (x) the then effective Conversion Price or Exercise Price, as applicable, and (y) 90% of the average of the five daily volume weighted average prices of the common stock immediately prior to each Reset Date, or the Reset Formula.

Private Placements and Debt Exchange [Member]

Conversion price and exercise price per share

$ 16.10

Private Placements and Debt Exchange [Member] | Common Stock [Member]

Shares issued in public offering

3,429,680

Series D Preferred Shares [Member]

10,000

$ 0.01

Net proceeds from the sale of Series E and E-1 Preferred Stock and warrants

101

$ 150,000

$ 0

$ 150,000

Preferred stock shares exchanged

116

Preferred stock, aggregate stated value

$ 1,160,000

Proceeds from exchange of senior secured promissory note

400,000

Issuance of senior secured promissory note in exchange of preferred stock

$ 1,560,000

Interest rate

8.00%

Debt instrument maturity date

Apr. 01, 2020

[1]	reflects, a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019.

Stockholders' Equity - Equity Incentive Plan - Additional Information (Details)	12 Months Ended
	Dec. 31, 2020 shares
2019 Equity Incentive Plan [Member] \| Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of common shares reserved for issuance	2,142
2019 Equity Incentive Plan [Member] \| Minimum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options, exercise price of common stock granted as percentage of fair value on the date of grant	100.00%
2020 Omnibus Equity Incentive Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of common shares reserved for issuance	675,000
Number of common shares remained available to be issued	95,000

Stockholders' Equity - Equity Offerings and Placements - Additional Information (Details) - USD ($)
$ / shares in Units, $ in Thousands

12 Months Ended

Dec. 11, 2020

Dec. 31, 2020

Dec. 09, 2020

Nov. 23, 2020

Dec. 31, 2019

^[1]

Apr. 30, 2019

Common stock, par value (in dollars per share)

5,996,101

^[1]

67,091

$ 0.01

^[1]

$ 0.01

Gross proceeds from issuance of common stock

$ 230

Canaccord Genuity L L C And Roth Capital Partner L L C

Shares issued, price per share

1,679,031

$ 13.25

Gross proceeds from issuance of common stock

$ 22,247

Underwriting discount, commission and estimated offering expenses

$ 1,861

[1]	reflects, a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019.

Stockholders' Equity - At-the-Market Offering - Additional Information (Details) - USD ($)		1 Months Ended		12 Months Ended
	Aug. 18, 2020	Dec. 31, 2020	May 31, 2020	Dec. 31, 2020	Dec. 31, 2019
Stockholders Equity Note [Line Items]
Gross proceeds from issuance of common stock				$ 230,000
Issuance costs		$ 1,861,000	$ 2,618,000	$ 1,000	$ 0
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]
Shares issued in public offering				77,644
Gross proceeds from issuance of common stock				$ 910,000
Issuance costs				$ 44,000
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 ($)

1 Months Ended

12 Months Ended

May 05, 2020

Apr. 30, 2019

Dec. 31, 2020

Dec. 31, 2019

$ 10.00

Compensation expense for issuance of restricted stock (in shares)

$ 10.00

72,976

Common stock grant date fair value

$ 636,000

$ 4,000

Gross proceeds from issuance of common stock

$ 230,000

Exercise of pre-funded Series D Warrants (in shares)

6,000

11,285

Stock issued during period shares associated other warrants

185,803

Proceeds from exercise of warrants

$ 1,858,000

$ 0

Weighted average exercise price

5,996,101

^[1]

67,091

^[1]

Purchase of warrants

82,521

$ 170

Loss in exchange of common stock with warrants

$ 6,000

Series F warrants [Member]

Warrants issued to purchase of common stock

2,224,900

Pre-Funded Warrants [Member]

$ 10.00

Warrants issued to purchase of common stock

377,000

IPO [Member]

^[2]

$ 19,378,000

$ 0

Common Stock [Member]

Underwriting discounts and other offering expenses

$ 21,996,000

$ 2,618,000

Compensation expense for issuance of restricted stock (in shares)

Common Stock [Member] | IPO [Member]

Shares issued in public offering

1,823,000

2019 Warrants [Member]

$ 10.00

[1]	reflects, a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019.
[2]	May 2020 Public Offering gross proceed were $21,996, with issuance costs of $2,618

Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands			12 Months Ended
	Dec. 07, 2020	Oct. 01, 2020	Dec. 31, 2020	Dec. 31, 2019
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options granted			1,078,000
Weighted Average Remaining Contractual Term (Years), Exercisable			9 years 9 months 18 days
Weighted average estimated fair value of the stock options granted			$ 11.41	$ 181.41
Unrecognized compensation expense related to non-vested share-based compensation awards			$ 8,824
Cost expected to be recognized over weighted average period			9 years 9 months 18 days
Share-based compensation (Income) expense			$ 3,505	$ 273
Stock Options [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Share-based compensation (Income) expense			$ 3,505	$ (273)
Chief Executive Officer [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options granted		550,000	498,000
Stock options vesting period		36 months	36 months
Stock options exercise price per share		$ 11.67	$ 11.67
Stock options outstanding to vest			51,000
Grant date fair value of award		$ 6,230	$ 5,629
Weighted Average Remaining Contractual Term (Years), Exercisable		10 years	10 years
New Employee [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options granted	30,000
Stock options vesting period	36 months
Stock options exercise price per share	$ 15.32
Grant date fair value of award	$ 446
Weighted Average Remaining Contractual Term (Years), Exercisable	10 years
1.5 times closing trading price per share [Member] \| Chief Executive Officer [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options vested			396,000
2.0 times closing trading price per share [Member] \| Chief Executive Officer [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options vested			51,000

Stockholders' Equity - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Stockholders Equity Note [Abstract]
Expected terms (years)	5 years 9 months 7 days	5 years 6 months
Expected volatility	181.00%	147.63%
Risk-free interest rate, minimum	0.27%	2.51%
Risk-free interest rate, maximum	0.40%	2.59%
Expected dividends	0.00%	0.00%

Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2020 USD ($) $ / shares shares
Stockholders Equity Note [Abstract]
Number of Shares, Outstanding \| shares	1,640
Number of Shares, Granted \| shares	1,078,000
Number of Shares, Cancelled/Forfeited \| shares	(1,141)
Number of Shares, Outstanding \| shares	1,078,499
Number of Shares, Exercisable \| shares	87,834
Weighted Average Exercise Price, Outstanding \| $ / shares	$ 196.70
Weighted Average Exercise Price, Granted \| $ / shares	12.60
Weighted Average Exercise Price, Cancelled/Forfeited \| $ / shares	196.70
Weighted Average Exercise Price, Outstanding \| $ / shares	12.68
Weighted Average Exercise Price, Exercisable \| $ / shares	$ 13.57
Weighted Average Remaining Contractual Term (Years), Outstanding	9 years 9 months 18 days
Weighted Average Remaining Contractual Term (Years), Exercisable	9 years 9 months 18 days
Aggregate Intrinsic Value, Outstanding \| $	$ 6,012
Aggregate Intrinsic Value, Exercisable \| $	$ 494

Stockholders' Equity - Summary of Stock Option Shares Outstanding and Exercisable (Details) - shares	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	1,078,499	1,640
Weighted Average Remaining Contractual Term (Years), Outstanding	9 years 9 months 18 days
Number of Shares, Exercisable	87,834
$10 - $15 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	946,000
Weighted Average Remaining Contractual Term (Years), Outstanding	9 years 9 months 18 days
Number of Shares, Exercisable	78,835
$15 - $20 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	81,000
Weighted Average Remaining Contractual Term (Years), Outstanding	9 years 9 months 18 days
Number of Shares, Exercisable	4,250
$20 - $25 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	51,000
Weighted Average Remaining Contractual Term (Years), Outstanding	9 years 9 months 18 days
Number of Shares, Exercisable	4,250
+ $25 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	499
Weighted Average Remaining Contractual Term (Years), Outstanding	8 years 1 month 6 days
Number of Shares, Exercisable	499

Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	$ 3,505	$ 273
Selling, General and Administrative [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	2,304	214
Research and Development [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	1,110	$ 59
Cost of Goods Sold [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	$ 91

Stockholders' Equity - Summary of Warrant Activity (Details) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2020 USD ($) $ / shares shares
Warrants outstanding [Roll Forward]
Outstanding, beginning of period (in shares) \| shares	1,826,608
Warrants issued (in shares) \| shares	2,601,900
Warrants exercised (in shares) \| shares	(191,803)
Warrants expired (in shares) \| shares	(18)
Outstanding, end of period (in shares) \| shares	4,236,687
Exercisable, end of period (in shares) \| shares	4,236,687
Warrants, Exercise Price per Share [Roll Forward]
Outstanding, beginning of period (in dollars per share) \| $ / shares	$ 23.04
Outstanding, ending of period (in dollars per share) \| $ / shares	9.13
Warrants issued (in dollars per share) \| $ / shares	8.55
Warrants exercised (in dollars per share) \| $ / shares	9.69
Warrants expired (in dollars per share) \| $ / shares	10.00
Exercisable, (in dollars per share) \| $ / shares	$ 9.13
Weighted average remaining life	4 years 2 months 12 days
Weighted average remaining life, Exercisable	4 years 2 months 12 days
Aggregate Intrinsic Value, Outstanding \| $	$ 37,261
Aggregate Intrinsic Value, Exercisable \| $	$ 37,261

Stockholders' Equity - Summary of Warrants Outstanding and Exercisable (Details) - shares	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	4,236,687	1,826,608
Weighted average remaining life	4 years 2 months 12 days
Warrants Exercisable, Number Exercisable	4,236,687
$0.01 [Member]
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	371,000
Weighted average remaining life	4 years 3 months 18 days
Warrants Exercisable, Number Exercisable	371,000
$10.00 [Member]
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	3,865,687
Weighted average remaining life	4 years 2 months 12 days
Warrants Exercisable, Number Exercisable	3,865,687

Stockholders' Equity - Warrants - Additional Information (Details) - $ / shares	Dec. 31, 2020	Dec. 31, 2019
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	4,236,687	1,826,608
Warrant exercise price	$ 10.00
Prefunded Warrant [Member]
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	371,000
Warrant exercise price	$ 0.01

Fair Value Measurements - Fair Value Measurements Using Significant Unobservable Inputs (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Fair Value Disclosures [Abstract]
Beginning balance	$ 3,368	$ 33
Total change in the liability included in earnings	2,832	(17,498)
Reclass from liability to equity	$ (6,200)	(11)
Fair value of warrants issued		20,844
Ending balance		$ 3,368

Fair Value Measurements - Additional Information (Details) - shares	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Class Of Warrant Or Right [Line Items]
Number of warrants outstanding (in shares)	4,236,687	1,826,608
Febuary 2018 Warrants [Member]
Class Of Warrant Or Right [Line Items]
Number of warrants outstanding (in shares)			179

Fair Value Measurements - Schedule of Fair Value of Outstanding Warrants (Details)	Dec. 31, 2020	Dec. 31, 2019
Contractual Term [Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Warrants expiration period	4 years 3 months 18 days	4 years 7 months 6 days
Expected Volatility [Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Warrants measurement input	2.082	2.0750
Risk-free Interest Rates [Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Warrants measurement input	0.0140	0.0170

Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Derivative Instruments Liabilities [Member] - Recurring [Member] $ in Thousands	Dec. 31, 2019 USD ($)
Liabilities [Abstract]
Total Liabilities	$ 3,368
Level 3 [Member]
Liabilities [Abstract]
Total Liabilities	$ 3,368

Commitments - Additional Information (Details)							12 Months Ended
Commitments - Additional Information (Details)	Oct. 01, 2020 USD ($)	Sep. 22, 2020 ft²	Jul. 27, 2020 USD ($)	Jul. 02, 2020 USD ($)	Jul. 01, 2020 USD ($) ft²	Jun. 25, 2020 USD ($)	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)
Loss Contingencies [Line Items]
Employment agreement, description	Mr. Michel shall also be entitled to: (a) a severance payment equal in the aggregate to twelve (12) months of his annual base salary at the time of termination, payable in twelve (12) equal monthly installments; and (b) specified continuing health plan benefits until the earlier of (i) the twelve (12) month anniversary of his termination date, (ii) the last day he’s eligible for coverage pursuant to COBRA or (iii) the date on which he becomes eligible for similar coverage from another employer.
Lease, description							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.
Extension of sublease					May 31, 2020 to August 2, 2021
Lease term							12 months
Operating or finance lease						$ 0	$ 520,000
Sub lease expiration date		Feb. 28, 2023
Rent expense, net of receipts under the terms of subleases							423,000	$ 529,000
Sublease 2015 [Member]
Loss Contingencies [Line Items]
Additional area of space \| ft²					4,999
Increase in sublease rent				$ 20,600,000	$ 14,600,000
2021 Sub-Lease Agreement [Member]
Loss Contingencies [Line Items]
Additional area of space \| ft²		6,877
Sublease rent						$ 3,700	405,700
Lease term						5 years
Office Space at 1301 Avenue of the Americas, New York, NY [Member]
Letter of credit
Minimum letter of credit amount required to be maintained under lease agreement							$ 131,000
Expiration date of letter of credit							Feb. 28, 2023
Chief Executive Officer [Member]
Loss Contingencies [Line Items]
Salary and wage, Officer	$ 450,000
Annual target cash bonus, (in percent)	50.00%
Chief Executive Officer [Member] \| Maximum [Member]
Loss Contingencies [Line Items]
Reimbursement for travel and stay, per month	$ 6,500
Pending Litigation [Member]
Loss Contingencies [Line Items]
Unpaid compensation amounts claimed			$ 1,140,000
Accrued unpaid compensation amounts							$ 1,140,000

Commitments - Schedule Future Minimum Lease Payments, Net of Receipts Due Under Terms of Subleases Under All Operating Leases (Details) $ in Thousands	Dec. 31, 2020 USD ($)
Future minimum lease payments under all operating leases [Abstract]
2021	$ 419
2022	406
2023	$ 68

Income Taxes - Additional Information (Details) - USD ($)

12 Months Ended

Dec. 31, 2020

Dec. 31, 2019

Percentage of valuation allowance against deferred tax assets

Income tax expense

$ 0

^[1]

100.00%

Decrease in deferred tax assets valuation allowance

$ 6,540,000

^[1]

3,428,000

New York State [Member]

Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income

168,826,000

New York City [Member]

Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income

$ 153,056,000

Earliest Tax Year [Member]

Dec. 31, 1998

Latest Tax Year [Member]

Dec. 31, 2020

Federal [Member]

Operating loss carryforwards, annual limitation

$ 260,622,000

246,347,000

27,500

Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income

206,112,000

Operating loss carryforwards available for offset future taxable income

54,510,000

Operating loss carryforwards for unlimited period

52,773,000

Federal [Member] | Expire Between 2019 and 2037 [Member]

Operating loss carryforwards available for offset future taxable income

$ 1,737,000

Federal [Member] | Earliest Tax Year [Member]

Operating loss carryforwards, expiration dates

2020

Federal [Member] | Latest Tax Year [Member]

Operating loss carryforwards, expiration dates

2037

Federal [Member] | Research and Development Tax Credit Carryforwards [Member]

Tax credit carryforwards, expiration dates

Tax credit carryforwards

$ 5,458,000

5,292,000

2040

Tax credit carryforwards expected to expire unutilized

$ 346,000

State and City [Member]

Operating loss carryforwards, expiration dates

$ 23,641,000

23,623,000

2040

Foreign [Member]

Federal and State [Member] | Earliest Tax Year [Member]

$ 30,880,000

26,141,000

Federal and State [Member] | Latest Tax Year [Member]

Dec. 31, 2017

Minimum [Member] | State and City [Member]

Dec. 31, 2020

Maximum [Member] | State and City [Member]

$ 26,414,000

27,311,000