0001193125-22-090104 | 10-K | XBRL Viewer

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2021

Loss before income taxes consists of:


	For the Years Ended December 31,
	2021			2020
Domestic	$	(25,881	)	$	(23,643	)
Foreign		232			(513	)

Loss before taxes	$	(25,649	)	$	(24,156	)

Income Tax Reconciliation

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


	For the Years Ended December 31,
	2021			2020
Income taxes using U.S federal statutory rate	$	(5,386	)	$	(5,073	)
Nondeductible interest		39			315
Loss of tax benefit of state net operating loss carryforwards		2,799			(11	)
Branch income		229			(238	)
State income taxes, net of federal benefit		311			(1,788	)
Foreign rate differential		27			(238	)
Valuation allowance		2,114			6,281
Derivative charge		—			595
Stock option expense, exercises and cancellations		446			308
Research and development costs		(375	)		(166	)
Other		(204	)		15

	$	—		$	—

Significant Components of Deferred Tax Assets

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


	For the Years Ended December 31,
	2021		2020
Deferred tax assets:
Employee compensation accruals	$	1,777	$	796
Accrued liabilities		29		361
Research tax credits		721		346
Lease obligation		107		265
Other		89		87
Net operating losses		20,520		19,742

Total deferred tax assets		23,243		21,597

Deferred tax liabilities:
Right of use asset		118		265

Total deferred tax liabilities		118		265

Valuation allowance		23,125		21,332

Net deferred tax assets	$	—	$	—

Summary of Change in Valuation

The change in valuation allowance is as follows:


	December 31,
	2021			2020
Beginning balance	$	21,332		$	14,793
Charged to costs and expenses		2,114			6,281
Charged to other comprehensive income		(321	)		258

Ending balance	$	23,125		$	21,332

Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

(3) Summary of Significant Accounting Policies

Use of Estimates

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

Cash Equivalents and Concentrations of Credit Risk

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

Restricted Cash

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

Accounts Receivable

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

Inventories

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

first-in,

first-out

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

work-in-process,

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

Property, Plant and Equipment

Property, plant, and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight-line basis over the estimated useful lives of the assets which range from

three

seven years

. Leasehold improvements will be amortized over the shorter of the lease term or the estimated useful life of the related assets when they are placed into service. The Company evaluates property, plant and equipment for impairment periodically to determine if changes in circumstances or the occurrence of events suggest the carrying value of the asset or asset group may not be recoverable. Maintenance and repairs are charged to operations as incurred. Expenditures which substantially increase the useful lives of the related assets are capitalized.

Fair Value Measurements

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

ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that

market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy).

•

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

can

access.

•

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

•

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

In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability.

Revenue Recognition

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

Delcath may enter into contracts with partners that contain multiple elements such as licensing, development, manufacturing, and commercialization components. These arrangements are often complex, and the Company may receive various types of consideration over the life of the arrangement, including up-front fees, reimbursements for research and development services, milestone payments, payments on product shipments, margin sharing arrangements, license fees and royalties.

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

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

•

Step 1: Identify the contract with the customer;

•

Step 2: Identify the performance obligations in the contract;

•

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

•

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

•

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

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

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

Deferred Revenue

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

Selling, General and Administrative

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

Research and Development

Research and development costs include the costs of materials used for clinical trials and R&D, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science

liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company’s proprietary drug delivery system. All such costs are charged to expense when incurred.

Stock Based Compensation

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

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

non-employee

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

Income Taxes

The Company accounts for income taxes following the asset and liability method in accordance with the ASC 740 “Income Taxes.” Under such method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company applies the accounting guidance issued to address the accounting for uncertain tax positions. This guidance clarifies the accounting for income taxes, by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements as well as provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company classifies interest and penalty expense related to uncertain tax positions as a component of income tax expense. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years that the asset is expected to be recovered or the liability settled. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in its assessment of a valuation allowance. See Note 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, 2021 and 2020 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive:


	December 31,
	2021		2020
Common stock warrants - equity		3,894,498		4,236,687
Assumed conversion of Series E and Series E-1 Preferred Stock		1,135,721		2,063,100
Assumed conversion of convertible notes		488,031		146,288
Stock options		1,732,460		1,078,499

Total		7,250,710		7,524,574

Segment Information

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

Foreign Currency and Currency Translation

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

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

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

Recently Adopted Accounting Pronouncements

In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)

2019-12,

“Simplifying the Accounting for Income Taxes.” The list of changes is comprehensive;

however, the changes did not significantly impact the Company due to the full valuation allowance that is recorded against the Company’s deferred tax assets. The Company adopted ASU

2019-12

on January 1, 2021, and there was no material impact on the Company’s financial statements or disclosures.

In March 2020, the FASB issued ASU

2020-03,

“Codification Improvements to Financial Instruments” (“ASU

2020-03”).

ASU

2020-03

improves and clarifies various financial instruments topics. ASU

2020-03

includes seven different issues that describe the areas of improvement and the related amendments to GAAP, intended to make the standards easier to understand and apply by eliminating inconsistencies and providing clarifications. The Company adopted ASU

2020-03

upon issuance, which did not have a material effect on the Company’s consolidated financial statements.

Recently Issued Accounting Pronouncements

In August 2020, the FASB issued ASU

2020-06, “Accounting

for Convertible Instruments and Contracts in an Entity’s Own Equity.” ASU

2020-06

simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity. ASU

2020-06

requires entities to provide expanded disclosures about the terms and features of convertible instruments and amends certain guidance in ASC 260, Earnings per Share, relating to the computation of earnings per share for convertible instruments and contracts in an entity’s own equity. The guidance becomes effective for the Company on January 1, 2024, with early adoption permitted. The Company early adopted ASU

2020-06

on January 1, 2022 and the adoption is not expected to have any immediate effect on the Company’s financial statements. Going forward, the Company will no longer be required to assess convertible instruments for beneficial conversion features.

In October 2020, the FASB issued ASU

2020-10

“Codification Improvements”, which improves consistency by amending the Codification to include all disclosure guidance in the appropriate disclosure sections and clarifies application of various provisions in the Codification by amending and adding new headings, cross referencing to other guidance, and refining or correcting terminology. The guidance is effective for the Company beginning in the first quarter of fiscal year 2022 with early adoption permitted. The Company adopted this guidance on January 1, 2022 and it did not have a material impact on its consolidated financial statements.

On May 3, 2021, the FASB issued ASU

2021-04,

“Earnings Per Share” (Topic 260), “Debt—Modifications and Extinguishments” (Subtopic

470-50),

“Compensation—Stock Compensation” (Topic 718), and “Derivatives and Hedging—Contracts in Entity’s Own Equity” (Subtopic

815-40):

“Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.” This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. Early adoption is permitted, including adoption in an interim period. If an issuer elects to early adopt the new standard in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The Company adopted this guidance on January 1, 2022 and it did not have a material impact on its consolidated financial statements.

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

12 Months Ended

Dec. 31, 2021

Dec. 31, 2020

Cash flows from operating activities:

Net loss

$ (25,649)

$ (24,156)

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

Stock option compensation expense

7,832

3,505

Restricted stock compensation expense

406

Depreciation expense

146

167

Amortization of right of use assets

322

Amortization of debt discount

323

Warrant liability fair value adjustment

2,832

Non-cash interest income

(1)

Interest expense accrued related to convertible notes

186

160

Changes in assets and liabilities:

Increase (decrease) in prepaid expenses and other assets

813

(910)

Increase (decrease) in accounts receivable

(36)

Increase in inventories

(557)

(201)

Decrease in accounts payable

(1,136)

(4,396)

Decrease in accrued expenses

(2,148)

Decrease in lease liabilities

(322)

Decrease in deferred revenue

(2,427)

(263)

Net cash used in operating activities

(22,604)

(22,868)

Cash flows from investing activities:

Purchase of property, plant and equipment

(143)

(782)

Net cash used in investing activities

(143)

(782)

Cash flows from financing activities:

Principal payments of financing leases

(26)

Payments related to registration costs

(106)

Net proceeds from Public Offerings

^[1]

39,764

(1)

Net proceeds from ATM Offering

^[2],[3]

3,923

866

Net proceeds from debt financing

^[4]

14,437

Proceeds from the exercise of stock options

Proceeds from the exercise of warrants

2,458

1,858

Net cash provided by financing activities

20,822

42,355

Foreign currency effects on cash

122

(132)

Net (decrease) increase in total cash

(1,803)

18,573

Total Cash, Cash Equivalents and Restricted Cash:

Beginning of period

28,756

10,183

End of period

26,953

28,756

Cash

22,802

28,575

Restricted Cash

4,151

181

Total

26,953

28,756

Supplemental Disclosure of Cash Flow Information:

Interest expense

681

Supplemental Disclosure of Non-Cash Investing and Financing Activities:

Conversions of preferred stock into common stock

Shares settled for services

Proceeds allocated to warrant

1,171

Reclassification of 2019 warrants from liability to equity

6,200

Right of use assets obtained in exchange for lease obligations

192

729

Financing of D&O insurance premium

$ 886

781

Issuance of restricted stock for 2019 bonuses due to executive officers

$ 230

[1]	Includes gross proceeds of $44,243, less total issuance costs of $4,479.
[2]	For 2020, includes gross proceeds of $910, less total issuance costs of $44.
[3]	For 2021, includes gross proceeds of $4,044, less total issuance costs of $121.
[4]	Includes gross proceeds of $15,000 less total costs of $563.

Prepaid Expenses and Other Current Assets (Tables)

12 Months Ended

Dec. 31, 2021

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,
	2021		2020
Clinical trial expenses	$	1,630	$	1,497
Insurance premiums		890		845
Other		223		328

Total prepaid expenses and other current assets	$	2,743	$	2,670

Summary of Significant Accounting Policies - Shares Excluded from the Computation of Diluted Earnings per Share (Details) - shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	7,250,710	7,524,574
Common stock warrants - equity [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	3,894,498	4,236,687
Assumed conversion of Series E and Series E-1 Preferred Stock [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	1,135,721	2,063,100
Assumed conversion of convertible Notes [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	488,031	146,288
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)	1,732,460	1,078,499

Commitments and contingencies - Additional Information (Details) $ in Thousands, € in Millions				12 Months Ended
	Mar. 31, 2021	Jul. 27, 2020 USD ($)	Apr. 01, 2020	Dec. 31, 2021 USD ($)	Apr. 01, 2021 USD ($)	Apr. 01, 2021 EUR (€)	Dec. 31, 2020 USD ($)
Loss Contingencies [Line Items]
Percentage of enrolled patients	87.00%
Increase in revenue recognition				$ 1,742
Medac [Member]
Loss Contingencies [Line Items]
Due from related parties					$ 1,160	€ 1,000
Agreement date			Dec. 10, 2018
Pending Litigation [Member]
Loss Contingencies [Line Items]
Unpaid compensation amounts claimed		$ 1,140
Accrued unpaid compensation amounts							$ 1,140

- Definition

For an unclassified balance sheet, amounts due from related parties including affiliates, employees, joint ventures, officers and stockholders, immediate families thereof, and pension funds.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(k)(1))
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 850
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-Section 50
-Paragraph 1
-Subparagraph (d)
-URI http://asc.fasb.org/extlink&oid=6457730&loc=d3e39549-107864

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
-Paragraph 1A
-Subparagraph (SX 210.13-01(a)(4)(iv))
-URI http://asc.fasb.org/extlink&oid=124359900&loc=SL124442526-122756

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
-Paragraph 1A
-Subparagraph (SX 210.13-01(a)(5))
-URI http://asc.fasb.org/extlink&oid=124359900&loc=SL124442526-122756

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(5))
-URI http://asc.fasb.org/extlink&oid=124359900&loc=SL124442552-122756

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 210
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-03.10(3))
-URI http://asc.fasb.org/extlink&oid=120398452&loc=d3e534808-122878

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iii)(C))
-URI http://asc.fasb.org/extlink&oid=124359900&loc=SL124442552-122756

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iv))
-URI http://asc.fasb.org/extlink&oid=124359900&loc=SL124442552-122756

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
-Paragraph 1A
-Subparagraph (SX 210.13-01(a)(4)(iii)(B))
-URI http://asc.fasb.org/extlink&oid=124359900&loc=SL124442526-122756

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 210
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-03.3)
-URI http://asc.fasb.org/extlink&oid=120400017&loc=d3e572229-122910

+ Details

Fair Value Measurements - Schedule of Fair Value of Outstanding Warrants (Details)	Dec. 31, 2020 d
Contractual life (in years) [Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Warrants expiration period	4 years 3 months 18 days
Expected Volatility [Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Warrants measurement input	208.2
Risk-free Interest Rates [Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Warrants measurement input	1.40

Description of Business

12 Months Ended

Dec. 31, 2021

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Description of Business

(1)	Description of Business

Delcath Systems, Inc. (“Delcath” or the “Company”) is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company’s lead product candidate, the HEPZATO

™

KIT (melphalan hydrochloride for injection/hepatic delivery system), or HEPZATO

™

, is a drug/device combination product. HEPZATO is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, Delcath’s commercial product is a stand-alone medical device having the same device components as the HEPZATO KIT, but without the melphalan hydrochloride, and is approved for sale under the trade name CHEMOSAT

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

Delcath’s 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. The Company is currently reviewing the incidence, unmet need, available efficacy data and development requirements for a broad set of liver cancers in order to select a portfolio of

follow-on

indications which will maximize the value of the HEPZATO platform.

In the United States, HEPZATO is considered a combination drug and device product regulated by the Food and Drug Administration (“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.

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 the Company can monitor data at its clinical trial sites. The resulting delay in completing enrollment and additional time required to monitor data has caused the Company’s planned announcement for the

top-line

data from its FOCUS Trial to shift to early 2021 and to be modified to a preliminary analysis. The Company now plans to submit a New Drug Application (NDA) to the FDA mid-2022 for the treatment of mOM. The ability to achieve this goal is contingent on the Company’s ability to monitor data at its clinical sites and therefore the timeline may shift as access to the clinical sites changes in response to the rapidly evolving situation. The Company also has experienced a decline in EU commercial product revenue and additional impacts to the business may arise that the Company is 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.

Although Delcath is not aware of any direct impacts of the war between the Ukraine and the Russian Federation on its supply chain, the war could adversely impact Delcath’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its third-party suppliers in a timely manner or at all.

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, 2021, the Company incurred net losses of $25,649 and used $22,554 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 the Company is not able to continue as a going concern, it is likely that holders of its common stock will lose all of their investment. The accompanying consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern.

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

Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) (Parenthetical)	12 Months Ended
	Dec. 31, 2021 USD ($)
Equity Method Investments And Cost Method Investments [Abstract]
Percentage of final payment included in gross amount	4.25%
Final payment	$ 637,500

Summary of Significant Accounting Policies - Additional Information (Details)	12 Months Ended
	Dec. 31, 2021
Summary Of Significant Accounting Policies [Line Items]
Maximum period of investments with original maturities from date of acquisition to be cash equivalents	3 months
Minimum [Member]
Summary Of Significant Accounting Policies [Line Items]
Property, plant and equipment, estimated useful life	3 years
Maximum [Member]
Summary Of Significant Accounting Policies [Line Items]
Property, plant and equipment, estimated useful life	7 years

Leases - Schedule of Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands	Dec. 31, 2021 USD ($)
Lessee Lease Description [Line Items]
Year ended December 31, 2022	$ 452
Year ended December 31, 2023	113
Year ended December 31, 2024	46
Year ended December 31, 2025	46
Year ended December 31, 2026	27
Total	684
Less present value discount	(61)
Operating lease liabilities included in the consolidated balance sheets at December 31, 2021	623
U.S. [Member]
Lessee Lease Description [Line Items]
Year ended December 31, 2022	406
Year ended December 31, 2023	67
Total	473
Less present value discount	(25)
Operating lease liabilities included in the consolidated balance sheets at December 31, 2021	448
Ireland [Member]
Lessee Lease Description [Line Items]
Year ended December 31, 2022	46
Year ended December 31, 2023	46
Year ended December 31, 2024	46
Year ended December 31, 2025	46
Year ended December 31, 2026	27
Total	211
Less present value discount	(36)
Operating lease liabilities included in the consolidated balance sheets at December 31, 2021	$ 175

Stockholders' Equity - Equity Incentive Plan - Additional Information (Details) - shares	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2021	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of common shares reserved for issuance		2,475,000
Number of common shares remained available to be issued			1,240,600
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%

Accrued Expenses

12 Months Ended

Dec. 31, 2021

Payables and Accruals [Abstract]

Accrued Expenses

(8)	Accrued Expenses

Current accrued expenses include the following:


	December 31,
	2021		2020
Clinical expenses	$	1,517	$	2,698
Compensation, excluding taxes		893		1,598
Short-term financing		551		382
Professional fees		603		225
Interest on Rosalind convertible note		393		234
Other		152		104

Total accrued expenses	$	4,109	$	5,241

Income Taxes - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Operating Loss Carryforwards [Line Items]
Income tax provision	$ 0	$ 0
Percentage of valuation allowance against deferred tax assets	100.00%
Decrease in deferred tax assets valuation allowance	$ 1,793	6,540
New York State [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income	191,914
New York City [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income	$ 176,137
Earliest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Open tax period	Dec. 31, 1998
Latest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Open tax period	Dec. 31, 2021
Federal [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 277,398	260,622
Operating loss carryforwards, annual limitation	28
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income	204,458
Operating loss carryforwards available for offset future taxable income	72,940
Operating loss carryforwards for unlimited period	71,203
Federal [Member] \| Expire Between 2019 and 2037 [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards available for offset future taxable income	$ 1,737
Federal [Member] \| Earliest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards, expiration dates	2022
Federal [Member] \| Latest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards, expiration dates	2037
Federal [Member] \| Research and Development Tax Credit Carryforwards [Member]
Operating Loss Carryforwards [Line Items]
Tax credit carryforwards	$ 5,833	5,458
Tax credit carryforwards, expiration dates	2041
Tax credit carryforwards expected to expire unutilized	$ 721
State and City [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 1,766	1,737
Operating loss carryforwards, expiration dates	2041
Foreign [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 27,951	30,880
Federal and State [Member] \| Earliest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Open tax period	Dec. 31, 2018
Federal and State [Member] \| Latest Tax Year [Member]
Operating Loss Carryforwards [Line Items]
Open tax period	Dec. 31, 2021
Minimum [Member] \| State and City [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 24,760	26,414
Maximum [Member] \| State and City [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 193,680	$ 192,466

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Current assets
Cash and cash equivalents	$ 22,802	$ 28,575
Restricted cash	4,151	181
Accounts receivable, net	44	57
Inventories	1,412	855
Prepaid expenses and other current assets	2,743	2,670
Total current assets	31,152	32,338
Property, plant and equipment, net	1,348	1,351
Right-of-use assets	624	946
Total assets	33,124	34,635
Current liabilities
Accounts payable	638	1,774
Accrued expenses	4,109	5,241
Deferred revenue, current	170	525
Lease liabilities, current	416	495
Loan payable, current	621
Convertible notes payable, current		2,000
Total current liabilities	5,954	10,035
Deferred revenue, non-current		2,072
Lease liabilities, non-current	207	450
Loan payable, non-current	10,372
Convertible notes payable, non-current	4,639
Total liabilities	21,172	12,557
Commitments and contingencies (Note 13)
Stockholders' equity
Preferred stock, $.01 par value; 10,000,000 shares authorized; 11,357 and 20,631 shares issued and outstanding at December 31, 2021 and 2020, respectively
Common stock, $.01 par value; 40,000,000 shares authorized; 7,906,728 and 5,996,101 shares issued and outstanding at December 31, 2021 and 2020, respectively	79	60
Additional paid-in capital	432,831	417,449
Accumulated deficit	(420,976)	(395,327)
Accumulated other comprehensive loss	18	(104)
Total stockholders' equity	11,952	22,078
Total liabilities and stockholders' equity	$ 33,124	$ 34,635

Cash, Cash Equivalents and Restricted Cash (Tables)

12 Months Ended

Dec. 31, 2021

Cash and Cash Equivalents [Abstract]

Schedule of Cash, Cash Equivalents, and Restricted Cash


	December 31,
	2021		2020
Cash and cash equivalents	$	22,802	$	28,575
Restricted balance for loan agreement		4,000		—
Letters of credit		101		131
Security for credit cards		50		50

Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$	26,953	$	28,756

Leases (Tables)

12 Months Ended

Dec. 31, 2021

Leases [Abstract]

Summary of Operating and Financing Leases

The following table summarizes the Company’s operating leases as of December 31, 2021:


	U.S .			Ireland			Total
Lease cost:
Operating lease cost	$	417		$	147		$	564
Sublease income		—			(132	)		(132	)

Total	$	417		$	15		$	432

Other information:
Operating cash flows out from operating leases	$	(417	)	$	(147	)	$	(564	)
Operating cash flows in from operating leases	$	—		$	132		$	132
Right-of-use assets exchanged for new operating lease liabilities	$	—		$	192		$	192
Weighted average remaining lease term		1.2			4.6
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:


	U.S .		Ireland		Total
Year ended December 31, 2022	$	406	$	46	$	452
Year ended December 31, 2023		67		46		113
Year ended December 31, 2024		—		46		46
Year ended December 31, 2025		—		46		46


	U.S .			Ireland			Total
Year ended December 31, 2026		—			27			27

Total		473			211			684
Less present value discount		(25	)		(36	)		(61	)

Operating lease liabilities included in the consolidated balance sheets at December 31, 2021	$	448		$	175		$	623

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2021	Dec. 31, 2020
Statement of Financial Position [Abstract]
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	11,357	20,631
Preferred stock, shares outstanding (in shares)	11,357	20,631
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	40,000,000	40,000,000
Common stock, shares issued (in shares)	7,906,728	5,996,101
Common stock, shares outstanding (in shares)	7,906,728	5,996,101

Loans and Convertible Notes Payable - Summary of Remaining Maturities of Company's Loan and Convertible Note Payables (Details) $ in Thousands	Dec. 31, 2021 USD ($)
Debt Instrument [Line Items]
Loans	$ 12,638
Convertible Notes	5,000
Total	17,638
Year ended December 31, 2022
Debt Instrument [Line Items]
Loans	714
Total	714
Year ended December 31, 2023
Debt Instrument [Line Items]
Loans	8,571
Total	8,571
Year ended December 31, 2024
Debt Instrument [Line Items]
Loans	3,353
Convertible Notes	5,000
Total	$ 8,353

Income Taxes - Income Tax Reconciliation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Provision for income taxes [Abstract]
Income taxes using U.S federal statutory rate	$ (5,386)	$ (5,073)
Nondeductible interest	39	315
Loss of tax benefit of state net operating loss carryforwards	2,799	(11)
Branch income	229	(238)
State income taxes, net of federal benefit	311	(1,788)
Foreign rate differential	27	(238)
Valuation allowance	2,114	6,281
Derivative charge		595
Stock option expense, exercises and cancellations	446	308
Research and development costs	(375)	(166)
Other	(204)	15
Total	$ 0	$ 0

Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Jan. 01, 2022	Dec. 31, 2021	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options granted		671,750
Weighted average estimated fair value of the stock options granted		$ 9.74	$ 11.41
Unrecognized compensation expense related to non-vested share-based compensation awards		$ 7,406
Cost expected to be recognized over weighted average period		2 years 3 days
Share-based compensation (Income) expense		$ 7,832	$ 3,505
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price		$ 10.07
Subsequent Event [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options granted	545,083
Stock options vesting period	3 years
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period	10 years
Subsequent Event [Member] \| Minimum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price	$ 6.61
Subsequent Event [Member] \| Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price	$ 7.25

Stockholders' Equity - Summary of Stock Option Shares Outstanding and Exercisable (Details) - shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	1,732,460	1,078,499
Weighted Average Remaining Contractual Term (Years), Exercisable	9 years
Number of Shares, Exercisable	600,113
$9.58 - $10.99 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	631,211
Weighted Average Remaining Contractual Term (Years), Exercisable	9 years 7 months 6 days
Number of Shares, Exercisable	153,733
$11.00 - $14.99 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	968,750
Weighted Average Remaining Contractual Term (Years), Exercisable	8 years 9 months 18 days
Number of Shares, Exercisable	393,481
$15.00 - $24.99 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	132,000
Weighted Average Remaining Contractual Term (Years), Exercisable	8 years 9 months 18 days
Number of Shares, Exercisable	52,400
$25 + [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	499
Weighted Average Remaining Contractual Term (Years), Exercisable	7 years 1 month 6 days
Number of Shares, Exercisable	499

Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Cost of goods sold	$ (671)	$ (640)
Gross profit	2,884	1,006
Operating expenses:
Research and development expenses	13,778	11,201
Selling, general and administrative expenses	13,637	11,108
Total operating expenses	27,415	22,309
Operating loss	(24,531)	(21,303)
Change in fair value of the warrant liability, net		(2,832)
Interest expense, net	(1,186)	(175)
Other income	68	154
Net loss	(25,649)	(24,156)
Deemed dividend for triggering of warrant down round feature		(55)
Net loss attributable to common stockholders	(25,649)	(24,211)
Net loss	(25,649)	(24,156)
Other comprehensive income (loss):
Foreign currency translation adjustments	122	(132)
Total other comprehensive loss	$ (25,527)	$ (24,288)
Common share data:
Basic and diluted loss per common share	$ (3.59)	$ (8.35)
Weighted average number of basic and diluted shares outstanding	7,145,754	2,897,827
Product Revenue [Member]
Revenue	$ 1,300	$ 1,156
Other Revenue [Member]
Revenue	$ 2,255	$ 490

Fair Value Measurements - Fair Value Measurements Using Significant Unobservable Inputs (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2020 USD ($)
Fair Value Disclosures [Abstract]
Beginning balance	$ 3,368
Total change in the liability included in earnings	2,832
Reclass from liability to equity	(6,200)
Ending balance	$ 0

Income Taxes

12 Months Ended

Dec. 31, 2021

Income Tax Disclosure [Abstract]

Income Taxes

(14)	Income Taxes

There is no income tax provision for the years ended December 31, 2021 and 2020, respectively.

Loss before income taxes consists of:


	For the Years Ended December 31,
	2021			2020
Domestic	$	(25,881	)	$	(23,643	)
Foreign		232			(513	)

Loss before taxes	$	(25,649	)	$	(24,156	)

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


	For the Years Ended December 31,
	2021			2020
Income taxes using U.S federal statutory rate	$	(5,386	)	$	(5,073	)
Nondeductible interest		39			315
Loss of tax benefit of state net operating loss carryforwards		2,799			(11	)
Branch income		229			(238	)
State income taxes, net of federal benefit		311			(1,788	)
Foreign rate differential		27			(238	)
Valuation allowance		2,114			6,281
Derivative charge		—			595
Stock option expense, exercises and cancellations		446			308
Research and development costs		(375	)		(166	)
Other		(204	)		15

	$	—		$	—

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


	For the Years Ended December 31,
	2021		2020
Deferred tax assets:
Employee compensation accruals	$	1,777	$	796
Accrued liabilities		29		361
Research tax credits		721		346
Lease obligation		107		265
Other		89		87
Net operating losses		20,520		19,742

Total deferred tax assets		23,243		21,597

Deferred tax liabilities:
Right of use asset		118		265

Total deferred tax liabilities		118		265

Valuation allowance		23,125		21,332

Net deferred tax assets	$	—	$	—

As of December 31, 2021, and 2020, the Company had net operating loss carryforwards for U.S. federal income tax purposes of approximately $277,398 and $260,622, respectively. A significant portion of the federal amount is subject to an annual limitation as low as $28 as a result of changes in the Company’s ownership in May 2003, November 2016, and multiple dates throughout 2017, 2018, 2019 and 2021, as defined by Section 382 of the United States Internal Revenue Code of 1986, as amended (the “IRC”), and

the related income tax regulations. As a result of the limitations caused by the multiple ownership changes, approximately $204,458 of the total net operating loss carryforwards is expected to expire unutilized and will be unavailable to offset future federal taxable income. Approximately $72,940 of net operating loss carryforwards remains available to offset future federal taxable income, of which $1,737 will expire between 2022 and 2037 and $71,203 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 the IRC Section 382 provisions (with the exception of Connecticut), adjusted for each state’s respective income apportionment percentages. As of December 31, 2021, and 2020, the Company had net operating loss carryforwards for state and city income tax purposes between approximately $24,760 and $193,680 and between approximately $26,414 and $192,466, respectively, which expire through 2041. As a result of the Section 382 limitations, approximately $191,914 and $176,137 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 $1,766 and $1,737 of net operating loss carryforwards, respectively, will be available to offset future state and city taxable income. As of December 31, 2021 and 2020 the Company had a net operating loss carryforward for foreign income tax purposes of $27,951 and $30,880, respectively, which have indefinite carryforward periods. As of December 31, 2021 and 2020, the Company had federal research and development tax credit carryforwards of approximately $5,833 and $5,458, respectively, which expire through 2041. As a result of the

ection 382 limitations, all but $721 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 $1,793 and $6,540 in 2021 and 2020, respectively. The change in valuation allowance is as follows:


	December 31,
	2021			2020
Beginning balance	$	21,332		$	14,793
Charged to costs and expenses		2,114			6,281
Charged to other comprehensive income		(321	)		258

Ending balance	$	23,125		$	21,332

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 the Company’s history of tax loss carryforwards and full valuation allowance, the CARES Act did not have a significant effect to 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 roll forward of unrecognized tax benefits. As there are no uncertain tax positions recognized, interest and penalties have not been accrued.

The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. The Company has not been audited by any state tax authorities in connection with income taxes. The Company has not been audited by international tax authorities or any states in connection with income taxes. The Company’s New York State tax returns have been subject to annual desk reviews which have resulted in insignificant adjustments to the related franchise tax liabilities and credits. The Company is no longer subject to federal and state examination for tax years ending prior to December 31, 2018; tax years ending December 31, 2018 through December 31, 2021 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, 2017 (as Ireland has not initiated an audit of 2016 as of December 31, 2021); tax years ending December 31, 2017 through December 31, 2021 remain open to examination. However, the Company’s tax years December 31, 1998 through December 31, 2021 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.

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

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI http://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI http://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
-Name Accounting Standards Codification
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
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-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

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

Dec. 31, 2021

Dec. 31, 2020

Gross

$ 5,000

$ 2,000

Discount

(361)

Net

4,639

2,000

Less Current Portion, Net

(621)

Total - Loans Payable, Non-Current, Gross

11,924

Total - Loans Payable, Non-Current, Discount

(1,552)

Total - Loans Payable, Non-Current, Net

10,372

Loan Avenue [Member]

Gross

^[1]

12,638

Discount

^[1]

(1,645)

Net

^[1]

10,993

Less Current Portion, Gross

^[1]

(714)

Less Current Portion, Discount

^[1]

Less Current Portion, Net

^[1]

(621)

Convertible Note Payable Rosalind [Member]

Gross

2,000

Net

2,000

$ 2,000

Convertible Loan Payable Avenue [Member]

Gross

3,000

Discount

(361)

Net

$ 2,639

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

Property, Plant, and Equipment - Additional Information (Details) - USD ($) $ in Thousands		12 Months Ended
	Jul. 31, 2020	Dec. 31, 2021	Dec. 31, 2020
Property, Plant and Equipment [Abstract]
Exercised option to purchase	$ 460
Depreciation expense		$ 146	$ 167

Cash, Cash Equivalents and Restricted Cash

12 Months Ended

Dec. 31, 2021

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,
	2021		2020
Cash and cash equivalents	$	22,802	$	28,575
Restricted balance for loan agreement		4,000		—
Letters of credit		101		131
Security for credit cards		50		50

Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$	26,953	$	28,756

Under the terms of a

sub-lease

agreement for office space at 1633 Broadway, New York, NY, as of December 31, 2021, the Company is required to maintain a letter of credit in the amount of $101, which will expire with the sublease in February 2023.

Stockholders' Equity - Equity Offerings and Placements - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Dec. 11, 2020	Dec. 31, 2021	Dec. 31, 2020	Dec. 09, 2020
Stockholders Equity Note [Line Items]
Common stock, shares issued (in shares)		7,906,728	5,996,101
Gross proceeds from issuance of common stock		$ 2,458
Canaccord Genuity L L C And Roth Capital Partner L L C
Stockholders Equity Note [Line Items]
Common stock, shares issued (in shares)	1,679,031
Shares issued, price per share				$ 13.25
Gross proceeds from issuance of common stock	$ 22,247
Underwriting discount, commission and estimated offering expenses	$ 1,860

Stockholders' Equity - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details)		12 Months Ended
	Aug. 06, 2021	Dec. 31, 2021	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected terms (years)	5 years 25 days		5 years 9 months 7 days
Expected volatility	187.00%		181.00%
Risk-free interest rate	0.77%
Expected dividends	0.00%	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected terms (years)		5 years 1 month 17 days
Expected volatility		177.52%
Risk-free interest rate		0.74%	0.27%
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected terms (years)		6 years 3 months 7 days
Expected volatility		181.33%
Risk-free interest rate		1.31%	0.40%

Loans and Convertible Notes Payable

12 Months Ended

Dec. 31, 2021

Debt Disclosure [Abstract]

Loans and Convertible Notes Payable

(10)	Loans and Convertible Notes Payable


	December 31,
	2021									2020
	Gross			Discount			Net			Gross		Discount		Net
Loan - Avenue [1]		12,638			(1,645	)		10,993			—		—		—
Loan - Avenue [1] - Less Current Portion		(714	)		93			(621	)		—		—		—

Total - Loans Payable, Non-Current	$	11,924		$	(1,552	)	$	10,372		$	—	$	—	$	—

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

Total - Convertible Notes Payable - Non-Current	$	5,000		$	(361	)	$	4,639		$	2,000	$	—	$	2,000


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

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


	Loans		Convertible Notes		Total
Year ended December 31, 2022	$	714	$	—	$	714
Year ended December 31, 2023		8,571		—		8,571
Year ended December 31, 2024		3,353		5,000		8,353

Total	$	12,638	$	5,000	$	17,638

Term Loan from Avenue Venture Opportunities Fund, L.P.

On August 6, 2021, the Company entered into a Loan and Security Agreement (the “Avenue Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (the “Lender,” or “Avenue”) for a term loan in an aggregate principal amount of up to $20,000 (the “Avenue Loan”). The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at December 31, 2021 was 10.95%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. The Avenue Loan matures on August 1, 2024.

The initial tranche of the Avenue Loan is $15,000, including $4,000 which has been funded into a restricted account and will be released upon achievement of (a)(x) positive FOCUS trial efficacy per the trial’s predefined Statistical Analysis Plan (SAP) (specifically the Overall Response Rate exceeds the prespecified threshold for success defined in the SAP by a statistically significant amount); and (y) based on data contained within the FOCUS trial database and appropriate for use with the U.S. Food and Drug Administration, safety and tolerability among FOCUS trial participants is within the range of currently approved and commonly used cytotoxic chemotherapeutic agents; and (b) raising subsequent net equity proceeds of at least $20,000. The Company may request an additional $5,000 of gross proceeds between October 1, 2022 and December 31, 2022, with funding, subject to the approval of Avenue’s Investment

Committee.

Up to $3,000 of the principal amount of the Avenue Loan outstanding may be converted, at the option of Avenue, into shares of the Company’s common stock at a conversion price of $11.98 per share.

In connection with the Avenue Loan, the Company issued to Avenue a warrant (the “Avenue Warrant”) to purchase 127,755 shares of common stock at an exercise price per share equal to $0.01. The Avenue Warrant is exercisable until August 31, 2026.

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

The Company paid an aggregate commitment fee of $150 at closing. Upon funding a second tranche of the Avenue Loan, the Lender will earn a 1.0% fee on the $5,000 of incremental committed capital, for a total commitment fee of $200.

The Avenue Loan Agreement requires the Company to make and maintain representations and warranties and other agreements that are customary in loan agreements of this type. The Avenue Loan Agreement also contains customary events of default, including

non-payment

of principal or interest, violations of covenants, bankruptcy and material judgments.

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

non-convertible

portion of the Avenue Loan, while $418 was allocated to the convertible portion of the Avenue Loan. Aggregate debt discount amortization of $323 was recorded during the year ended December 31, 2021, including $265 related to the

non-convertible

portion of the Avenue Loan and $58 related to the convertible portion of the Avenue Loan. The Company also determined that the convertible portion of the Avenue Loan did not include a beneficial conversion feature, because the effective conversion price exceeded the commitment

date market price of the Company’s common stock. Interest expense incurred was $675 for the year ended December 31, 2021

The

Avenue Warrant was valued at issuance at $1,309 using the Black-Scholes option pricing method using the following assumptions:


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

Convertible Notes Payable

The Company has $2,000

principal outstanding related to Senior Secured Promissory

Notes (the “Rosalind Notes”) which bear interest

at 8% per annum. Pursuant to

the

original terms, the Rosalind Notes

were

convertible into Series E Preferred Stock at a price of $1,500 per share and

were

to mature on July 16, 2021

Interest expense was $160 for both years ended December 31, 2021 and 2020.

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

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

Up to $3,000 of the principal amount of the Avenue Loan outstanding may be converted, at the option of the Lender, into shares of the Company’s common stock at a conversion price of $11.98 per share.

- Definition

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

+ References

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

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

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

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

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

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

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

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

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

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

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

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

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

+ Details

Leases - Summary of Operating and Financing Leases (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Lease Cost
Operating lease cost	$ 564
Sublease income	(132)
Total	432
Other information
Operating cash flows out from operating leases	(564)
Operating cash flows in from operating leases	132
Right-of-use assets exchanged for new operating lease liabilities	192	$ 729
U.S. [Member]
Lease Cost
Operating lease cost	417
Total	417
Other information
Operating cash flows out from operating leases	$ (417)
Weighted average remaining lease term	1 year 2 months 12 days
Weighted average discount rate - operating leases	8.00%
Ireland [Member]
Lease Cost
Operating lease cost	$ 147
Sublease income	(132)
Total	15
Other information
Operating cash flows out from operating leases	(147)
Operating cash flows in from operating leases	132
Right-of-use assets exchanged for new operating lease liabilities	$ 192
Weighted average remaining lease term	4 years 7 months 6 days
Weighted average discount rate - operating leases	8.00%

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2021

Fair Value Disclosures [Abstract]

Fair value measurements using significant unobservable inputs

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


	Warrant Liability
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 year ended December 31, 2020 were determined by using option pricing models assuming the following:


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

Inventories (Tables)

12 Months Ended

Dec. 31, 2021

Inventory Disclosure [Abstract]

Schedule of inventories

Inventories consist of:


	December 31,
	2021		2020
Raw materials	$	767	$	435
Work-in-process		645		420

Total Inventory	$	1,412	$	855

Leases - Additional Information (Details)			12 Months Ended
Leases - Additional Information (Details)	Jul. 01, 2020 USD ($) ft²	Jun. 25, 2020 USD ($)	Dec. 31, 2021 USD ($)	Sep. 22, 2020 ft²
Rent per month			$ 564,000
Lease term			12 months
Two Thousand Fifteen Sublease Agreement
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.
Additional area of space \| ft²	4,999
Extension of sublease	May 31, 2020 to August 2, 2021
Two Thousand Fifteen Sublease Agreement \| Minimum [Member]
Increase in sublease rent	$ 20,600
Two Thousand Fifteen Sublease Agreement \| Maximum [Member]
Increase in sublease rent	$ 14,600
2021 Sub-Lease [Member]
Rent per month		$ 3,700
Lease term		5 years
Additional area of space \| ft²				6,877
Sub lease rent			$ 406,000

Loans and Convertible Notes Payable - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Aug. 06, 2021	Dec. 31, 2021	Dec. 31, 2020	Jun. 30, 2021
Debt Instrument [Line Items]
Avenue warrant value		$ 1,309
Fair value of warrants reclassified from liability to equity			$ 6,199
Interest expense incurred		$ 675
Secured Convertible Notes Payable [Member]
Debt Instrument [Line Items]
Debt instrument, principal face amount	$ 2,000
Series E Preferred Stock [Member]
Debt Instrument [Line Items]
Debt instrument, conversion price				$ 1,500
Series E Preferred Stock [Member] \| Secured Convertible Notes Payable [Member]
Debt Instrument [Line Items]
Debt instrument maturity date	Oct. 30, 2024
Debt instrument, conversion price	$ 1,198
Term Loan from Avenue Venture Opportunities Fund L.P [Member]
Debt Instrument [Line Items]
Debt instrument maturity date	Aug. 01, 2024
Debt instrument, interest rate	7.70%
Debt instrument, interest rate	10.95%	10.95%
Debt instrument, interest rate term	The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at December 31, 2021 was 10.95%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property.
Initial tranche of loan	$ 15,000
Loan amount funded into restricted account	4,000
Gross proceeds from ATM Offering	20,000
Second tranche of loan	$ 5,000
Debt instrument, conversion price	$ 11.98
Frequency of periodic payment	monthly
Periodic interest payments, term	15 months
Debt instrument, incremental final payment	4.25%
Debt instrument, commitment fee	$ 150
Debt instrument, commitment fee, percentage	1.00%
Debt instrument, commitment fee upon funding of second tranche of loan	$ 200
Original issue discount	637
Cash issuance costs	563
Debit discount	519
Fair value of warrants reclassified from liability to equity	44
Aggregate debt discount	$ 2,327
Amortization of debt discount		$ 323
Current interest rate	7.70%
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Warrant [Member]
Debt Instrument [Line Items]
Warrants issued to purchase of common stock	127,755
Warrant exercise price	$ 0.01
Warrants, maturity date	Aug. 31, 2026
Fair value of the Avenue Warrant	$ 1,171
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Maximum [Member]
Debt Instrument [Line Items]
Debt instrument, principal face amount	20,000
Debt instrument, converted amount	$ 3,000
Periodic interest payments, term	24 months
Prepayment fee, percentage	3.00%
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Minimum [Member]
Debt Instrument [Line Items]
Prepayment fee, percentage	1.00%
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Non Convertible Debt [Member]
Debt Instrument [Line Items]
Aggregate debt discount	$ 1,909
Amortization of debt discount		265
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Convertible Debt [Member]
Debt Instrument [Line Items]
Aggregate debt discount	$ 418
Amortization of debt discount		$ 58
Eight Point Zero Percentage July Two Thousand And Nineteen Notes [Member] \| Convertible Notes Payable [Member]
Debt Instrument [Line Items]
Debt instrument, interest rate		8.00%
Current interest rate		8.00%
Interest expense incurred		$ 160	$ 160

Loans and Convertible Notes Payable - Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method (Details)		12 Months Ended
	Aug. 06, 2021	Dec. 31, 2021	Dec. 31, 2020
Contractual term (years)	5 years 25 days		5 years 9 months 7 days
Expected volatility	187.00%		181.00%
Risk-free interest rate	0.77%
Expected dividends	0.00%	0.00%	0.00%

Loans and Convertible Notes Payable (Tables)

12 Months Ended

Aug. 06, 2021

Dec. 31, 2021

Debt Disclosure [Abstract]

Summary of Loans and Convertible Notes Payable


	December 31,
	2021									2020
	Gross			Discount			Net			Gross		Discount		Net
Loan - Avenue [1]		12,638			(1,645	)		10,993			—		—		—
Loan - Avenue [1] - Less Current Portion		(714	)		93			(621	)		—		—		—

Total - Loans Payable, Non-Current	$	11,924		$	(1,552	)	$	10,372		$	—	$	—	$	—

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

Total - Convertible Notes Payable - Non-Current	$	5,000		$	(361	)	$	4,639		$	2,000	$	—	$	2,000


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

Summary of Remaining Maturities of Company's Loan and Convertible Note Payables

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


	Loans		Convertible Notes		Total
Year ended December 31, 2022	$	714	$	—	$	714
Year ended December 31, 2023		8,571		—		8,571
Year ended December 31, 2024		3,353		5,000		8,353

Total	$	12,638	$	5,000	$	17,638

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

date market price of the Company’s common stock. Interest expense incurred was $675 for the year ended December 31, 2021

The

Avenue Warrant was valued at issuance at $1,309 using the Black-Scholes option pricing method using the following assumptions:


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

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


	Years ended December 31,
	2021	2020
Expected terms (years)	5.13 - 6.27	5.77
Expected volatility	177.52% - 181.33%	181.00%
Risk-free interest rate	0.74% - 1.31%	0.27% - 0.40%
Expected dividends	0.00%	0.00%

Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Prepaid Expense and Other Assets, Current [Abstract]
Clinical trial expenses	$ 1,630	$ 1,497
Insurance premiums	890	845
Other	223	328
Total prepaid expenses and other current assets	$ 2,743	$ 2,670

Income Taxes - Schedule of Loss Before Income Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Income Loss From Continuing Operations Before Income Taxes Minority Interest And Income Loss From Equity Method Investments [Abstract]
Domestic	$ (25,881)	$ (23,643)
Foreign	232	(513)
Loss before taxes	$ (25,649)	$ (24,156)

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8933-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8906-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (f)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8933-108599

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 940
-SubTopic 20
-Section 25
-Paragraph 1
-URI http://asc.fasb.org/extlink&oid=123384075&loc=d3e41242-110953

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8736-108599

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(10))
-URI http://asc.fasb.org/extlink&oid=123367319&loc=SL114868664-224227

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(8))
-URI http://asc.fasb.org/extlink&oid=120400993&loc=SL114874131-224263

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

Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 31
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8924-108599

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

+ Details

Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Total	Common Stock [Member]	Preferred Stock [Member]	Additional Paid in Capital [Member]	Accumulated Deficit [Member]	Accumulated Other Comprehensive Income (Loss) [Member]
Balance at Dec. 31, 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
Shares settled for services	406	$ 1		405
Shares settled for services (in shares)		50,013
Conversion of preferred stock into common stock		$ 20		(20)
Conversion of Preferred stock into common stock (in shares)		2,084,507	(20,887)
Shares settled for accrued compensation	229			229
Shares settled for accrued compensation (in shares)		22,963
Exchange of warrants	1,858	$ 2		1,856
Exchange of warrants (in shares)		191,803
Common stock issued in connection with ATM Offering	867	$ 1		866
Common stock issued in connection with ATM Offering (Shares)		77,644
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	6,199			6,199
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
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)
Total comprehensive income (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
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	7,832			7,832
Shares settled for services	57			57
Shares settled for services (in shares)		2,636
Conversion of preferred stock into common stock	0	$ 9		(9)
Conversion of Preferred stock into common stock (in shares)		927,379	(9,274)
Exchange of warrants	2,458	$ 5		2,453
Exchange of warrants (in shares)		465,173
Proceeds allocated to warrant	1,171			1,171
Cash issuance costs of warrant	(44)			(44)
Exercise of options into common stock	$ 4			4
Exercise of options into common stock (shares)	439	439
Common stock issued in connection with ATM Offering	$ 3,923	$ 5		3,918
Common stock issued in connection with ATM Offering (Shares)		515,000
Net loss	(25,649)				(25,649)
Total comprehensive income (loss)	122					122
Balance at Dec. 31, 2021	$ 11,952	$ 79		$ 432,831	$ (420,976)	$ 18
Balance (in shares) at Dec. 31, 2021		7,906,728	11,357

Leases

12 Months Ended

Dec. 31, 2021

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 leases.

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

would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments.

Pursuant to a 2014 sublease agreement (the “2014 Sublease”) and a 2015 sublease agreement (the “2015 Sublease”) the Company subleased portions of its leased premises in Galway, Ireland to a sublessee. On May 15, 2020, the Company and its sublessee entered into amendments to the 2014 Sublease and the 2015 Sublease pursuant to which (i) the 2014 Sublease and 2015 Sublease were extended from May 31, 2020 to August 2, 2021, (ii) effective July 1, 2020, the leased premises under the 2015 Sublease would be expanded to include an additional 4,999 square feet of space, and (iii) effective July 1, 2020, the rent under the 2015 Sublease would increase from approximately $14.6 per month to $20.6 per month. The Company analyzed the terms of the amended 2014 Sublease and 2015 Sublease and determined that its ROU asset for the master operating lease was not impaired as a result of the amendments. On June 25, 2020, the Company entered into a

sub-lease

agreement (the “2021

Sub-Lease”)

with its previous sublessee under the 2014 Sublease and 2015 Sublease pursuant to which, effective August 2, 2021, the previous sublessee would become the lessee and the Company would then

sub-lease

its portion of the premises in Galway, Ireland from the previous sublessee. The Company’s rent expense under the 2021

Sub-Lease

is approximately $3.7 per month for a term of five years.

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

sub-lease

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

sub-lease

agreement began in April 2016 and, pursuant to the amendment, is extended through February 2023 for total annual base rent of $406.

The following table summarizes the Company’s operating leases as of December 31, 2021:


	U.S .			Ireland			Total
Lease cost:
Operating lease cost	$	417		$	147		$	564
Sublease income		—			(132	)		(132	)

Total	$	417		$	15		$	432

Other information:
Operating cash flows out from operating leases	$	(417	)	$	(147	)	$	(564	)
Operating cash flows in from operating leases	$	—		$	132		$	132
Right-of-use assets exchanged for new operating lease liabilities	$	—		$	192		$	192
Weighted average remaining lease term		1.2			4.6
Weighted average discount rate - operating leases		8	%		8	%

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


	U.S .		Ireland		Total
Year ended December 31, 2022	$	406	$	46	$	452
Year ended December 31, 2023		67		46		113
Year ended December 31, 2024		—		46		46
Year ended December 31, 2025		—		46		46


	U.S .			Ireland			Total
Year ended December 31, 2026		—			27			27

Total		473			211			684
Less present value discount		(25	)		(36	)		(61	)

Operating lease liabilities included in the consolidated balance sheets at December 31, 2021	$	448		$	175		$	623

Property, Plant, and Equipment (Tables)

12 Months Ended

Dec. 31, 2021

Property, Plant and Equipment [Abstract]

Components of property, plant and equipment

Property, plant, and equipment consists of:


	December 31,
	2021			2020			Estimated Useful Life
Buildings and land	$	1,222		$	1,109			30 years - Buildings
Enterprise hardware and software		1,858			1,862			3 years
Leaseholds		1,796			1,826			Lesser of lease term or estimated useful life
Equipment		1,094			1,063			7 years
Furniture		203			204			5 years

Property, plant, and equipment, gross		6,173			6,064
Accumulated depreciation		(4,825	)		(4,713	)

Property, plant, and equipment, net	$	1,348		$	1,351

Accrued Expenses - Schedule of Current Accrued Expenses (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Payables and Accruals [Abstract]
Clinical expenses	$ 1,517	$ 2,698
Compensation, excluding taxes	893	1,598
Short-term financing	551	382
Professional fees	603	225
Interest on Rosalind convertible note	393	234
Other	152	104
Total accrued expenses	$ 4,109	$ 5,241

Commitments and Contingencies

12 Months Ended

Dec. 31, 2021

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

(13)	Commitments and Contingencies

Litigation, Claims and Assessments

Former Officers Matter

Following the May 18, 2020 resignation (effective June 1, 2020) of Jennifer Simpson, the Company’s former President and Chief Executive Officer, and Barbra Keck, the Company’s former Chief Financial Officer (the “Claimants”), it became evident that there was a dispute regarding the Company’s compensation obligations to the Claimants. In a letter dated, June 29, 2020, an attorney representing the Claimants made certain claims and threatened litigation against the Company. On or about July 27, 2020, the Claimants filed a statement of claim with the American Arbitration Association against the Company. The Claimants sought payment of certain purported unpaid compensation amounts claimed to be due to them, in an approximate amount of $1,140 in the aggregate, as well as unspecified statutory damages under New York Labor Law, attorneys’ fees and costs, and statutory interest. The Claimants and the Company agreed to participate in

non-binding

mediation of their dispute before a neutral mediator, which resulted in the arbitration proceedings being placed in abeyance pending the outcome of the mediation process. With the assistance of the neutral mediator and after careful consideration by the Company’s board of directors following several weeks of negotiations, the Claimants and the Company agreed in

mid-May

of 2021 to a confidential settlement of their dispute to avoid the expenses and distractions of further arbitration proceedings, with no admission of liability or wrongdoing on the part of the Company. While the Company had accrued for the full purported unpaid compensation amount of $1,140 as of December 31, 2020, the Company ultimately paid less in full and final settlement of its dispute with both of the Claimants. As a result of the confidential settlement, the AAA Arbitration was dismissed with prejudice on June 1, 2021.

medac Matter

In April 2021, the Company issued an invoice for €1,000 (which currently converts to approximately $1,160) to medac GmbH, a privately held, multi-national pharmaceutical company based in Germany (“medac”), the Company’s EU product distribution partner, for a milestone payment due under the License, Supply and Marketing Agreement (the “License Agreement”) dated December 10, 2018, between the Company and medac. Pursuant to the License Agreement, a milestone is due upon achieving positive efficacy in the FOCUS trial as defined by the FOCUS trial protocol. Per the trial protocol and associated Statistical Analysis Plan, positive efficacy is based on whether the Objective Response Rate (ORR) exceeds a prespecified threshold. A preliminary analysis of the FOCUS trial data based on 87% of enrolled patients was released on March 31, 2021, and subsequently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held virtually from the 4th through the 8th of June 2021. Per that analysis, the ORR exceeded the prespecified threshold. While the final ORR is not yet known, given the magnitude by which the ORR exceeded the prespecified endpoint and the small number of patients yet to be assessed, the final ORR will be greater than the prespecified endpoint regardless of the responder status of the remaining patients. medac disagrees that the milestone is due and claims that a full clinical study report is required in addition to the existing ORR analysis. medac has not disputed the accuracy of the ORR analysis or underlying data, but simply asserts that a full clinical study report is required prior to payment.

While the Company disagrees with this interpretation, since medac has stated they do not intend to pay the invoice at this time, under revenue recognition criteria set out in ASC 606, the Company cannot recognize the revenue in the year ending December 31, 2021.

On October 12, 2021, the Company notified medac in writing that it was terminating the License Agreement

due to medac’s nonpayment of the milestone payment due under the License Agreement, with the effective date of termination of the License Agreement being April 12, 2022. medac disputed having an obligation to make a milestone payment under the Agreement and demanded withdrawal of the termination notice. The Company declined to withdraw the termination notice and, on December 16, 2021, the Company initiated an arbitration proceeding pursuant to the dispute resolution provisions of the Agreement. The arbitration proceeding is moving forward with the parties agreeing to stay the arbitration for a finite period to pursue settlement discussions.

On December 30, 2021, the Company received a letter from medac stating that, due to its failure to withdraw the termination notice, medac was terminating the License Agreement with immediate effect. In the letter, medac reserved its rights in full, including a purported claim for damages for wrongful termination. In a separate letter, medac agreed to orderly transition through February 28, 2022 in order to minimize the impact of any termination on patients and physicians. As a result of the early termination of the License Agreement, the Company revised its estimate of the contract life which resulted in an acceleration of

$1,742 of revenue recognition associated with deferred revenue.

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. 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.

Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Cash and Cash Equivalents [Abstract]
Cash and cash equivalents	$ 22,802	$ 28,575
Restricted balance for loan agreement	4,000
Letters of credit	101	131
Security for credit cards	50	50
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$ 26,953	$ 28,756	$ 10,183

Inventories

12 Months Ended

Dec. 31, 2021

Inventory Disclosure [Abstract]

Inventories

(5)	Inventories

Inventories consist of:


	December 31,
	2021		2020
Raw materials	$	767	$	435
Work-in-process		645		420

Total Inventory	$	1,412	$	855

Income Taxes - Summary of Change in Valuation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Abstract]
Beginning balance	$ 21,332	$ 14,793
Charged to costs and expenses	2,114	6,281
Charged to other comprehensive income	(321)	258
Ending balance	$ 23,125	$ 21,332

Stockholders' Equity - Summary of Warrants Outstanding and Exercisable (Details) - shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	3,894,498	4,236,687
Weighted average remaining life	3 years 2 months 12 days
Warrants Exercisable, Number Exercisable	3,894,498
$0.01 [Member]
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	283,755
Weighted average remaining life	3 years 10 months 24 days
Warrants Exercisable, Number Exercisable	283,755
$10.00 [Member]
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	3,610,743
Weighted average remaining life	3 years 2 months 12 days
Warrants Exercisable, Number Exercisable	3,610,743

Stockholders' Equity - At-the-Market Offering - Additional Information (Details) - USD ($)		12 Months Ended
	Aug. 18, 2020	Dec. 31, 2021	Dec. 31, 2020
Stockholders Equity Note [Line Items]
Gross proceeds from issuance of common stock		$ 2,458,000
Issuance costs			$ 1,000
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		$ 121,000
Roth Capital Partners L L C
Stockholders Equity Note [Line Items]
Percentage of fee on gross sale price per share	1.05%
Percentage of underwriting fee to be received on company offerings	35.00%
Common stock offering period	90 days
Maximum [Member] \| Cantor Fitzgerald & Co [Member]
Stockholders Equity Note [Line Items]
At-the-market offering, aggregate offering price	$ 10,000,000
Legal fees and disbursements	$ 50,000.0

Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Inventory Disclosure [Abstract]
Raw materials	$ 767	$ 435
Work-in-process	645	420
Total Inventory	$ 1,412	$ 855

Summary of Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

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


	December 31,
	2021		2020
Common stock warrants - equity		3,894,498		4,236,687
Assumed conversion of Series E and Series E-1 Preferred Stock		1,135,721		2,063,100
Assumed conversion of convertible notes		488,031		146,288
Stock options		1,732,460		1,078,499

Total		7,250,710		7,524,574

Fair Value Measurements

12 Months Ended

Dec. 31, 2021

Fair Value Disclosures [Abstract]

Fair Value Measurements

(12)	Fair Value Measurements

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


	Warrant Liability
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	$	—

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 year ended December 31, 2020 were determined by using option pricing models assuming the following:


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

- 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

Property, Plant, and Equipment

12 Months Ended

Dec. 31, 2021

Property, Plant and Equipment [Abstract]

Property, Plant, and Equipment

(7)	Property, Plant, and Equipment

Property, plant, and equipment consists of:


	December 31,
	2021			2020			Estimated Useful Life
Buildings and land	$	1,222		$	1,109			30 years - Buildings
Enterprise hardware and software		1,858			1,862			3 years
Leaseholds		1,796			1,826			Lesser of lease term or estimated useful life
Equipment		1,094			1,063			7 years
Furniture		203			204			5 years

Property, plant, and equipment, gross		6,173			6,064
Accumulated depreciation		(4,825	)		(4,713	)

Property, plant, and equipment, net	$	1,348		$	1,351

On July 31, 2020, the Company exercised its option to purchase its

95-97

Park Road office location in Queensbury, NY for $460, pursuant to the terms of the lease agreement dated September 17, 2018, as amended.

Depreciation expense for the years ended December 31, 2021 and 2020 was $146 and $167, respectively.

Prepaid Expenses and Other Current Assets

12 Months Ended

Dec. 31, 2021

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,
	2021		2020
Clinical trial expenses	$	1,630	$	1,497
Insurance premiums		890		845
Other		223		328

Total prepaid expenses and other current assets	$	2,743	$	2,670

Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Gross proceeds	$ 4,044	$ 910
Issuance costs		1
Proceeds from Issuance of Debt	15,000
Payments of Debt Issuance Costs	563
At-the-Market Offering [Member]
Issuance costs	121	$ 44
Public offering [Member]
Gross proceeds	44,243
Issuance costs	$ 4,479

Summary of Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

Risk and Uncertainties

Due to the global outbreak of

SARS-CoV-2,

a novel strain of coronavirus that causes Coronavirus disease

(COVID-19),

top-line

Liquidity and Going Concern

Use of Estimates

Cash Equivalents and Concentrations of Credit Risk

Restricted Cash

Accounts Receivable

Inventories

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

first-in,

first-out

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

work-in-process,

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

Property, Plant and Equipment

three

seven years

Fair Value Measurements

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

•

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

can

access.

•

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

Revenue Recognition

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

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

non-employee

Income Taxes

Net Loss per Common Share


	December 31,
	2021		2020
Common stock warrants - equity		3,894,498		4,236,687
Assumed conversion of Series E and Series E-1 Preferred Stock		1,135,721		2,063,100
Assumed conversion of convertible notes		488,031		146,288
Stock options		1,732,460		1,078,499

Total		7,250,710		7,524,574

Segment Information

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

Foreign Currency and Currency Translation

Recently Adopted and Issued Accounting Pronouncements

Recently Adopted Accounting Pronouncements

In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)

2019-12,

“Simplifying the Accounting for Income Taxes.” The list of changes is comprehensive;

however, the changes did not significantly impact the Company due to the full valuation allowance that is recorded against the Company’s deferred tax assets. The Company adopted ASU

2019-12

on January 1, 2021, and there was no material impact on the Company’s financial statements or disclosures.

In March 2020, the FASB issued ASU

2020-03,

“Codification Improvements to Financial Instruments” (“ASU

2020-03”).

ASU

2020-03

improves and clarifies various financial instruments topics. ASU

2020-03

upon issuance, which did not have a material effect on the Company’s consolidated financial statements.

Recently Issued Accounting Pronouncements

In August 2020, the FASB issued ASU

2020-06, “Accounting

for Convertible Instruments and Contracts in an Entity’s Own Equity.” ASU

2020-06

simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity. ASU

2020-06

In October 2020, the FASB issued ASU

2020-10

On May 3, 2021, the FASB issued ASU

2021-04,

“Earnings Per Share” (Topic 260), “Debt—Modifications and Extinguishments” (Subtopic

470-50),

“Compensation—Stock Compensation” (Topic 718), and “Derivatives and Hedging—Contracts in Entity’s Own Equity” (Subtopic

815-40):

Stockholders' Equity - Preferred Stock Issuances - Additional Information (Details) - $ / shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Nov. 23, 2020	Sep. 30, 2020
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	40,000,000	40,000,000	40,000,000	1,000,000,000
Number of preferred stock and warrants issued upon conversion	2,084,507
Preferred stock, shares outstanding (in shares)	11,357	20,631
Series A Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)	4,200
Series B Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)	2,360
Series C Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)	590
Series D Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)	10,000
Series E Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)	40,000
Conversion of stock preferred shares converted	9,274
Series E1 Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)	12,960
Series E-1 Convertible Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Conversion of stock preferred shares converted		20,887

Stockholders' Equity - Summary of Warrant Activity (Details)	12 Months Ended
	Dec. 31, 2021 $ / shares shares
Warrants outstanding [Roll Forward]
Outstanding, beginning of period (in shares) \| shares	4,236,687
Warrants issued (in shares) \| shares	127,755
Warrants exercised (in shares) \| shares	(469,933)
Warrants expired (in shares) \| shares	(11)
Outstanding, end of period (in shares) \| shares	3,894,498
Exercisable, end of period (in shares) \| shares	3,894,498
Warrants, Exercise Price per Share [Roll Forward]
Outstanding, beginning of period (in dollars per share) \| $ / shares	$ 9.13
Outstanding, ending of period (in dollars per share) \| $ / shares	9.27
Warrants issued (in dollars per share) \| $ / shares	0.01
Warrants exercised (in dollars per share) \| $ / shares	5.88
Warrants expired (in dollars per share) \| $ / shares	10.00
Exercisable, (in dollars per share) \| $ / shares	$ 9.27
Weighted average remaining life	3 years 2 months 12 days
Weighted average remaining life, Exercisable	3 years 2 months 12 days

Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($) $ / shares shares
Stockholders' Equity Note [Abstract]
Number of Shares, Outstanding \| shares	1,078,499
Number of Shares, Granted \| shares	671,750
Number of Shares, Exercised \| shares	(439)
Number of Shares, Expired \| shares	(392)
Number of Shares, Cancelled/Forfeited \| shares	(16,958)
Number of Shares, Outstanding \| shares	1,732,460
Number of Shares, Exercisable \| shares	600,113
Weighted Average Exercise Price, Outstanding \| $ / shares	$ 12.68
Weighted Average Exercise Price, Granted \| $ / shares	10.07
Weighted Average Exercise Price, Exercised \| $ / shares	9.85
Weighted Average Exercise Price, Expired \| $ / shares	11.67
Weighted Average Exercise Price, Cancelled/Forfeited \| $ / shares	10.59
Weighted Average Exercise Price, Outstanding \| $ / shares	11.69
Weighted Average Exercise Price, Exercisable \| $ / shares	$ 12.08
Weighted Average Remaining Contractual Term (Years), Outstanding	9 years 1 month 6 days
Weighted Average Remaining Contractual Term (Years), Exercisable	9 years
Aggregate Intrinsic Value, Outstanding \| $	$ 0
Aggregate Intrinsic Value, Exercisable \| $	$ 0

Stockholders' Equity

12 Months Ended

Dec. 31, 2021

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 par value. To date, the Company has designated the following preferred stock: Series A (4,200 shares), Series B (2,360 shares), Series C (590 shares), Series D (10,000 shares), Series E (40,000 shares) and Series

E-1

(12,960 shares).

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.

Preferred Stock

Series E and Series

E-1

Convertible Preferred Stock

During the years ended December 31, 2021 and 2020, 9,274 and 20,887 shares of Series E and Series

E-1

Convertible Preferred Stock were converted into 927,379 and 2,084,507 shares of the Company’s common stock, respectively.

As of December 31, 2021, there were an aggregate of 11,357 shares of Series E and Series

E-1

Convertible Preferred Stock outstanding.

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, 2021, there are 2,475,000 shares of common stock reserved under the 2020 Plan, of which 1,240,600 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 $1,860 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.

During the year ended December 31, 2021, the Company sold 515,000 shares of common stock pursuant to the ATM Offering for aggregate gross proceeds of $4,044, partially offset by $121 of issuance costs. During the year ended 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 $43 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.

The

Company

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 price of the Company’s Series E and Series

E-1

Convertible

Preferred Stock

was

adjusted to $10.00 per share and the exercise price of the 2019

common stock warrants issued in 2019 to the holders of the Company’s Series E and Series E-1 Convertible Preferred Stock

was adjusted to $10.00 per share and neither instrument is subject to further price resets. The repricing of the exercise price of the 2019

common stock warrants

resulted in the recognition of a $55 deemed dividend. Because the 2019

common stock warrants

are no longer subject to price resets, the $6,200 estimated fair value of the warrants was reclassified from derivative liability to equity.

Other Common Stock Issuances

During the year ended December 31, 2020, the Company issued 72,976 shares of common stock with an aggregate grant date value of $635 as compensation, including 22,963 shares valued at an aggregate of $229 which were issued to satisfy 2019 accrued compensation.

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

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

pre-funded

warrants at an exercise price of $0.01 per share, for aggregate cash proceeds of $2,458. 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.

Stock Options

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


	Years ended December 31,
	2021	2020
Expected terms (years)	5.13 - 6.27	5.77
Expected volatility	177.52% - 181.33%	181.00%
Risk-free interest rate	0.74% - 1.31%	0.27% - 0.40%
Expected dividends	0.00%	0.00%

The weighted average estimated fair value of the stock options granted during the years ended December 31, 2021 and 2020 was approximately $9.74 and $11.41 per share, respectively.

The following is a summary of stock option activity for the year ended December 31, 2021:


	Number of Options			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at January 1, 2021		1,078,499		$	12.68
Granted		671,750			10.07
Exercised		(439	)		9.85
Expired		(392	)		11.67
Cancelled/Forfeited		(16,958	)		10.59

Outstanding at December 31, 2021		1,732,460		$	11.69		9.1	$	—

Exercisable at December 31, 2021		600,113		$	12.08		9.0	$	—

The following table summarizes information for stock option shares outstanding and exercisable at December 31, 2021:


			Options Exercisable
Range of Exercise Prices	Outstanding Number of Options		Weighted Average Remaining Option Term (in years)		Number of Options
$9.58 - $10.99		631,211		9.6		153,733
$11.00 - $14.99		968,750		8.8		393,481
$15.00 - $24.99		132,000		8.8		52,400

$25 +		499		7.1		499

		1,732,460		9.0		600,113

At December 31, 2021, there was approximately $7,406 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 2.01 years. For the years ended December 31, 2021 and 2020, the Company recognized compensation expense $7,832 and $3,505, respectively, related to stock options granted to employees and board members, which were charged to the statement of operations as detailed below:


	Years ended December 31,
	2021		2020
Selling, general and administrative	$	5,334	$	2,304
Research and development		2,311		1,110
Cost of goods sold		187		91

Total	$	7,832	$	3,505

Subsequent to December 31, 2021, the Company made aggregate ten-year option grants to purchase 545,083 shares of common stock with exercise prices ranging from $6.61 to $7.25 per share. Vesting occurs over a three-year period.

Warrants

The following is a summary of warrant activity for the year ended December 31, 2021:


	Warrants			Weighted Average Exercise Price		Weighted Average Remaining Life (Years)
Outstanding at January 1, 2021		4,236,687		$	9.13
Warrants issued		127,755			0.01
Warrants exercised		(469,933	)		5.88
Warrants expired		(11	)		10.00

Outstanding at December 31, 2021		3,894,498		$	9.27		3.2

Exercisable at December 31, 2021		3,894,498		$	9.27		3.2

The following table presents information related to stock warrants at December 31, 2021:


			Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants		Weighted Average Remaining Warrants Term (in years)		Number of Warrants
$0.01		283,755		3.9		283,755
$10.00		3,610,743		3.2		3,610,743

		3,894,498		3.2		3,894,498

See Note 10 for additional information related to the warrant issued to Avenue during the year ended December 31, 2021 and 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.

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Stockholders' Equity - Common Stock Issuances - Additional Information (Details) - USD ($)
$ / shares in Units, $ in Thousands

1 Months Ended

12 Months Ended

May 05, 2020

Feb. 28, 2021

Dec. 31, 2021

Dec. 31, 2020

Dec. 31, 2019

Stockholders Equity Note [Line Items]

Proceeds on Public Offering (1)

^[1]

$ 39,764

Compensation expense for issuance of restricted stock (in shares)

72,976

22,963

Common stock grant date fair value

$ 635

$ 229

Gross proceeds from issuance of common stock

$ 2,458

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

6,000

Stock issued during period shares associated other warrants

185,803

Proceeds from exercise of warrants

$ 2,458

$ 1,858

Stock Issued During Period Shares Associated With Warrants

465,173

Issue Of Unregistered Common Stock For Advisory Services

2,636

Series F warrants [Member]

Stockholders Equity Note [Line Items]

Warrants issued to purchase of common stock

2,224,900

Warrant exercise price

$ 10.00

Pre-Funded Warrants [Member]

Stockholders Equity Note [Line Items]

Warrants issued to purchase of common stock

377,000

215,000

Warrant exercise price

$ 0.01

Common Stock [Member]

Stockholders Equity Note [Line Items]

Shares issued in public offering

515,000

77,644

Proceeds on Public Offering (1)

$ 21,996

Underwriting discounts and other offering expenses

$ 2,618

Common Stock [Member] | IPO [Member]

Stockholders Equity Note [Line Items]

Shares issued in public offering

1,823,000

2019 Warrants [Member]

Stockholders Equity Note [Line Items]

Warrant exercise price

$ 10.00

[1]	Includes gross proceeds of $44,243, less total issuance costs of $4,479.

Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	$ 7,832	$ 3,505
Selling, General and Administrative [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	5,334	2,304
Research and Development [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	2,311	1,110
Cost of Goods Sold [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	$ 187	$ 91

Income Taxes - Significant Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Deferred tax assets:
Employee compensation accruals	$ 1,777	$ 796
Accrued liabilities	29	361
Research tax credits	721	346
Lease obligation	107	265
Other	89	87
Net operating losses	20,520	19,742
Total deferred tax assets	23,243	21,597
Deferred tax liabilities:
Right of use asset	118	265
Total deferred tax liabilities	118	265
Valuation allowance	23,125	21,332	$ 14,793
Net deferred tax assets	$ 0	$ 0

Description of Business - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Net loss	$ 25,649	$ 24,156
Net cash used in operating activities	$ 22,554

- Definition

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

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+ Details

Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2021

Payables and Accruals [Abstract]

Schedule of current accrued expenses

Current accrued expenses include the following:


	December 31,
	2021		2020
Clinical expenses	$	1,517	$	2,698
Compensation, excluding taxes		893		1,598
Short-term financing		551		382
Professional fees		603		225
Interest on Rosalind convertible note		393		234
Other		152		104

Total accrued expenses	$	4,109	$	5,241

Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 6,173	$ 6,064
Accumulated depreciation	(4,825)	(4,713)
Property, plant, and equipment, net	1,348	1,351
Buildings and Land [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	1,222	1,109
Enterprise Hardware and Software [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,858	1,862
Property, plant and equipment, estimated useful life	3 years
Leaseholds [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,796	1,826
Property, plant and equipment, estimated useful life	Lesser of lease termor estimated usefullife
Equipment [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,094	1,063
Property, plant and equipment, estimated useful life	7 years
Furniture [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 203	$ 204
Property, plant and equipment, estimated useful life	5 years
Buildings [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, estimated useful life	30 years

Stockholders' Equity (Tables)

12 Months Ended

Aug. 06, 2021

Dec. 31, 2021

Stockholders' Equity Note [Abstract]

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

date market price of the Company’s common stock. Interest expense incurred was $675 for the year ended December 31, 2021

The

Avenue Warrant was valued at issuance at $1,309 using the Black-Scholes option pricing method using the following assumptions:


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

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


	Years ended December 31,
	2021	2020
Expected terms (years)	5.13 - 6.27	5.77
Expected volatility	177.52% - 181.33%	181.00%
Risk-free interest rate	0.74% - 1.31%	0.27% - 0.40%
Expected dividends	0.00%	0.00%

Summary of Stock Option Activity

The following is a summary of stock option activity for the year ended December 31, 2021:


	Number of Options			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at January 1, 2021		1,078,499		$	12.68
Granted		671,750			10.07
Exercised		(439	)		9.85
Expired		(392	)		11.67
Cancelled/Forfeited		(16,958	)		10.59

Outstanding at December 31, 2021		1,732,460		$	11.69		9.1	$	—

Exercisable at December 31, 2021		600,113		$	12.08		9.0	$	—

Summary of Stock Option Shares Outstanding and Exercisable

The following table summarizes information for stock option shares outstanding and exercisable at December 31, 2021:


			Options Exercisable
Range of Exercise Prices	Outstanding Number of Options		Weighted Average Remaining Option Term (in years)		Number of Options
$9.58 - $10.99		631,211		9.6		153,733
$11.00 - $14.99		968,750		8.8		393,481
$15.00 - $24.99		132,000		8.8		52,400

$25 +		499		7.1		499

		1,732,460		9.0		600,113

Summary of Recognized Share-based Compensation Cost


	Years ended December 31,
	2021		2020
Selling, general and administrative	$	5,334	$	2,304
Research and development		2,311		1,110
Cost of goods sold		187		91

Total	$	7,832	$	3,505

Summary of Warrant Activity

The following is a summary of warrant activity for the year ended December 31, 2021:


	Warrants			Weighted Average Exercise Price		Weighted Average Remaining Life (Years)
Outstanding at January 1, 2021		4,236,687		$	9.13
Warrants issued		127,755			0.01
Warrants exercised		(469,933	)		5.88
Warrants expired		(11	)		10.00

Outstanding at December 31, 2021		3,894,498		$	9.27		3.2

Exercisable at December 31, 2021		3,894,498		$	9.27		3.2

Schedule of Information Related to Stock Warrants Outstanding and Exercisable

The following table presents information related to stock warrants at December 31, 2021:


			Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants		Weighted Average Remaining Warrants Term (in years)		Number of Warrants
$0.01		283,755		3.9		283,755
$10.00		3,610,743		3.2		3,610,743

		3,894,498		3.2		3,894,498

Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Parenthetical) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Cash and Cash Equivalents [Abstract]
Letters of credit	$ 101	$ 131
Lessee, Operating Sublease, Expiry Term	2023-02

Basis of Consolidated Financial Statement Presentation

12 Months Ended

Dec. 31, 2021

Basis Of Condensed Consolidated Financial Statement Presentation [Abstract]

Basis of Consolidated Financial Statement Presentation

(2)	Basis of Consolidated Financial Statement Presentation

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