0001193125-22-147433 | 10-Q | XBRL Viewer

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Cover Page - shares	3 Months Ended
Cover Page - shares	Mar. 31, 2022	May 11, 2022
Cover [Abstract]
Entity Registrant Name	DELCATH SYSTEMS, INC.
Entity Central Index Key	0000872912
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Document Quarterly Report	true
Document Transition Report	false
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Incorporation, State or Country Code	DE
Entity Interactive Data Current	Yes
Entity File Number	001-16133
Entity Tax Identification Number	06-1245881
Entity Address, Address Line One	1633 Broadway
Entity Address, Address Line Two	Suite 22C
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10019
City Area Code	212
Local Phone Number	489-2100
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		7,906,728
Document Period End Date	Mar. 31, 2022
Document Fiscal Year Focus	2022
Trading Symbol	DCTH
Title of 12(b) Security	Common stock, $0.01 par value per share
Document Fiscal Period Focus	Q1
Document Type	10-Q
Amendment Flag	false
Security Exchange Name	NASDAQ

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Current assets
Cash and cash equivalents	$ 16,340	$ 22,802
Restricted cash	4,151	4,151
Accounts receivable, net	178	44
Inventories	2,011	1,412
Prepaid expenses and other current assets	2,704	2,743
Total current assets	25,384	31,152
Property, plant and equipment, net	1,406	1,348
Right-of-use assets	527	624
Total assets	27,317	33,124
Current liabilities
Accounts payable	1,243	638
Accrued expenses	4,495	4,109
Deferred revenue, current	0	170
Lease liabilities, current	404	416
Loan payable, current	2,520	621
Total current liabilities	8,662	5,954
Lease liabilities, non-current	122	207
Loan payable, non-current	8,633	10,372
Convertible notes payable, non-current	4,675	4,639
Total liabilities	22,092	21,172
Commitments and contingencies (Note 13)
Stockholders' equity
Preferred stock, $.01 par value; 10,000,000 shares authorized; 11,357 shares issued and outstanding at March 31, 2022 and December 31, 2021
Common stock, $.01 par value; 40,000,000 shares authorized; 7,906,728 shares issued and outstanding at March 31, 2022 and December 31, 2021	79	79
Additional paid-in capital	434,305	432,831
Accumulated deficit	(429,179)	(420,976)
Accumulated other comprehensive income	20	18
Total stockholders' equity	5,225	11,952
Total liabilities and stockholders' equity	$ 27,317	$ 33,124

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

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Cost of goods sold	$ (33)	$ (112)
Gross profit	345	276
Operating expenses:
Research and development expenses	4,240	3,707
Selling, general and administrative expenses	3,648	3,296
Total operating expenses	7,888	7,003
Operating loss	(7,543)	(6,727)
Interest expense, net	(645)	(41)
Other income (expense), net	(15)	21
Net loss	(8,203)	(6,747)
Other comprehensive income:
Foreign currency translation adjustments	2	94
Total other comprehensive loss	$ (8,201)	$ (6,653)
Common share data:
Basic and diluted loss per common share	$ (1.00)	$ (1.04)
Weighted average number of basic and diluted shares outstanding	8,190,483	6,496,922
Product Revenue [Member]
Revenue	$ 207	$ 261
Other Revenue [Member]
Revenue	$ 171	$ 127

Condensed Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Total	Common Stock [Member]	Preferred Stock [Member]	Additional Paid in Capital [Member]	Accumulated Deficit [Member]	Accumulated Other Comprehensive Income (Loss) [Member]
Balance at Dec. 31, 2020	$ 22,078	$ 60		$ 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	2,148			2,148
Shares settled for services	57			57
Shares settled for services (in shares)		2,636
Conversion of Preferred stock into common stock (in shares)		15,000	(150)
Exercise of warrants into common stock	2,376	$ 3		2,373
Exercise of warrants into common stock (in shares)		237,520
Net loss	(6,747)				(6,747)
Total comprehensive income	94					94
Balance at Mar. 31, 2021	20,006	$ 63		422,027	(402,074)	(10)
Balance (in shares) at Mar. 31, 2021		6,251,257	20,481
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
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	1,474			1,474
Net loss	(8,203)				(8,203)
Total comprehensive income	2					2
Balance at Mar. 31, 2022	$ 5,225	$ 79		$ 434,305	$ (429,179)	$ 20
Balance (in shares) at Mar. 31, 2022		7,906,728	11,357

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Cash flows from operating activities:
Net loss	$ (8,203)	$ (6,747)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock option compensation expense	1,474	2,148
Depreciation expense	31	39
Non-cash lease expense	97	155
Amortization of debt discount	194
Interest expense accrued related to convertible notes	40	39
Changes in assets and liabilities:
Decrease in prepaid expenses and other assets	39	301
Increase in accounts receivable	(134)	(18)
Increase in inventories	(599)	(254)
Increase in accounts payable and accrued expenses	953	164
Decrease in lease liabilities	(97)	(155)
Decrease in deferred revenue	(170)	(239)
Net cash used in operating activities	(6,375)	(4,567)
Cash flows from investing activities:
Purchase of property, plant and equipment	(89)	(9)
Net cash used in investing activities	(89)	(9)
Cash flows from financing activities:
Net proceeds from the exercise of warrants		2,376
Net cash provided by financing activities		2,376
Foreign currency effects on cash	2	94
Net decrease in total cash	(6,462)	(2,106)
Total Cash:
Beginning of period	26,953	28,756
End of period	20,491	26,650
Cash	16,340	26,600
Restricted Cash	4,151	50
Total	20,491	26,650
Supplemental Disclosure of Cash Flow Information:
Interest expense	$ 411	3
Supplemental Disclosure of Non-Cash Investing and Financing Activities:
Issuance of restricted stock for accrued fees due to a former board member		$ 57

General

3 Months Ended

Mar. 31, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

General

(1)

General

The unaudited interim condensed consolidated financial statements of Delcath Systems, Inc. (“Delcath” or the “Company”) as of and for the three months ended March 31, 2022 and 2021 should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form

10-K

for the fiscal year ended December 31, 2021 (the “Annual Report”), which was filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2022 and may also be found on the Company’s website (www.delcath.com). In these notes to the interim condensed consolidated financial statements the terms “us”, “we” or “our” refer to Delcath and its consolidated subsidiaries.

Description of Business

The Company is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company’s lead product candidate, the HEPZATO

™

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

™

, is a drug/device combination product designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. HEPZATO has not been approved for sale in the United States. In Europe, the hepatic delivery system is a stand-alone medical device having the same device components as HEPZATO, but without the melphalan hydrochloride, and is approved for sale under the trade name CHEMOSAT

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

The Company’s clinical development program for HEPZATO is comprised of the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the “FOCUS Trial”), a global registration clinical trial that is investigating objective response rate in metastatic ocular melanoma, 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 the Company 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).

In December 2021, the Company announced that the FOCUS Trial of HEPZATO met its pre-specific endpoint. Based on the FOCUS Trial results, the Company is preparing to submit a new drug application, or NDA, to the FDA for HEPZATO. The Company held a

pre-NDA

meeting with the FDA in April 2022 and is awaiting the official minutes from the meeting. Based on the feedback from the FDA, the Company does not believe any additional

pre-clinical

or clinical studies are required to

re-file

the NDA. Due to vendor delays in delivering certain reports, the Company plans to submit an NDA to the FDA by the end of the third quarter of 2022.

On February 28, 2022, CHEMOSAT received Medical Device Regulation certification under the European Medical Devices Regulation [2017/745/EU], which may be considered by jurisdictions when evaluating reimbursement. As of March 1, 2022, the Company has assumed direct responsibility for sales, marketing and distribution of CHEMOSAT in Europe.

Risks and Uncertainties

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

Liquidity and Going Concern

The accompanying interim condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred significant losses and has an accumulated deficit of $429.2 million as of March 31, 2022. These losses, among other factors, raise substantial doubt about the Company’s ability to continue as a going concern.

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

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

Basis of Presentation

These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the SEC’s instructions to Form

10-Q

and Article 10 of Regulation

S-X.

They include the accounts of all wholly owned subsidiaries and all significant inter-company accounts and transactions have been eliminated in consolidation.

The preparation of interim condensed consolidated financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended March 31, 2022 and 2021; however, certain information and footnote disclosures normally included in our audited consolidated financial statements included in our Annual Report on Form

10-K

have been condensed or omitted as permitted by GAAP. It is important to note that the Company’s results of operations and cash flows for interim periods are not necessarily indicative of the results of operations and cash flows to be expected for a full fiscal year or any interim period.

Significant Accounting Policies

There have been no material changes to our significant accounting policies as set forth in Note 3 Summary of Significant Accounting Policies to the consolidated financial statements included in the Company’s Annual Report on Form

10-K

for the fiscal year ended December 31, 2021.

Recently Adopted Accounting Pronouncements

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 Accounting Standards Codification 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 did not have any immediate effect on the Company’s condensed consolidated 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 was 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 condensed 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 condensed consolidated financial statements.

Cash, Cash Equivalents and Restricted Cash

3 Months Ended

Mar. 31, 2022

Cash and Cash Equivalents [Abstract]

Cash, Cash Equivalents and Restricted Cash

(2)	Cash, Cash Equivalents and Restricted Cash

Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded in

Restricted Cash

on the balance sheets. Restricted cash does not include required minimum balances.

Cash, cash equivalents, and restricted cash balances were as follows (in thousands):


	March 31, 2022		December 31, 2021
Cash and cash equivalents	$	16,340	$	22,802
Restricted balance for loan agreement		4,000	$	4,000
Letters of credit		101		101
Security for credit cards		50		50

Total cash, cash equivalents and restricted cash shown in the statements of cash flows	$	20,491	$	26,953

Under the terms of a

sub-lease

agreement for office space at 1633 Broadway, New York, NY, as of March 31, 2022, the Company is required to maintain a letter of credit which will expire with the sublease in February 2023.

Inventories

3 Months Ended

Mar. 31, 2022

Inventory Disclosure [Abstract]

Inventories

(3)	Inventories

Inventories consist of the following (in thousands):


	March 31, 2022		December 31, 2021
Raw materials	$	841	$	767
Work-in-process		881		645
Finished goods		289		—

Total inventories	$	2,011	$	1,412

Prepaid Expenses and Other Current Assets

3 Months Ended

Mar. 31, 2022

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

Prepaid Expenses And Other Current Assets

(4)	Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):


	March 31, 2022		December 31, 2021
Clinical trial expenses	$	1,630	$	1,630
Insurance premiums		645		890
Other		429		223

Total prepaid expenses and other current assets	$	2,704	$	2,743

Property, Plant, and Equipment

3 Months Ended

Mar. 31, 2022

Property, Plant and Equipment [Abstract]

Property, Plant, and Equipment

(5)	Property, Plant, and Equipment

Property, plant, and equipment consist of the following (in thousands):


	March 31, 2022			December 31, 2021			Estimated Useful Life
Buildings and land	$	1,222		$	1,222			30 years- Buildings
Enterprise hardware and software		1,858			1,858			3 years
Leaseholds		1,788			1,796			Lesser of lease term or estimated useful life
Equipment		1,184			1,094			7 years
Furniture		202			203			5 years

Property, plant and equipment, gross		6,254			6,173
Accumulated depreciation		(4,848	)		(4,825	)

Property, plant and equipment, net	$	1,406		$	1,348

Depreciation expense for the three months ended March 31, 2022 was approximately $31,000 as compared to approximately $39,000 for the same period in 2021.

Accrued Expenses

3 Months Ended

Mar. 31, 2022

Payables and Accruals [Abstract]

Accrued Expenses

(6)	Accrued Expenses

Accrued expenses consist of the following (in thousands):


	March 31, 2022		December 31, 2021
Clinical expenses	$	1,578	$	1,517
Compensation, excluding taxes		796		893
Short term financing		315		551
Professional fees		1,298		603
Interest on convertible note		433		393
Other		75		152

Total accrued expenses	$	4,495	$	4,109

Leases

3 Months Ended

Mar. 31, 2022

Leases [Abstract]

Leases

(7)

Leases

The Company recognizes

right-of-use

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

non-cancellable

operating and financing leases.

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

The following table summarizes the Company’s operating leases as of and for the three months ended March 31, 2022 (in thousands):


	U.S.			Ireland			Total
Lease cost:
Operating lease cost	$	101		$	8		$	109

Other information:
Operating cash flows out from operating leases	$	(101	)	$	(8	)	$	(109	)
Weighted average remaining lease term		0.9			4.4
Weighted average discount rate - operating leases		8	%		8	%

Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows (in thousands):


	U.S.			Ireland			Total
Year ended December 31, 2022	$	304		$	35		$	339
Year ended December 31, 2023		67			46			113
Year ended December 31, 2024		—			46			46
Year ended December 31, 2025		—			46			46
Year ended December 31, 2026		—			26			26

Total		371			199			570
Less present value discount		(14	)		(30	)		(44	)

Operating lease liabilities included in the consolidated balance sheets at March 31, 2022	$	357		$	169		$	526

Loans and Convertible Notes Payable

3 Months Ended

Mar. 31, 2022

Debt Disclosure [Abstract]

Loans and Convertible Notes Payable

(8)	Loans and Convertible Notes Payable

(in thousands):

	March 31, 2022									December 31, 2021
	Gross			Discount			Net			Gross			Discount			Net
Loan - Avenue [1]		12,638			(1,485	)		11,153			12,638			(1,645	)		10,993
Loan - Avenue [1] - Less Current Portion		(2,856	)		336			(2,520	)		(714	)		93			(621	)

Total - Loans Payable, Non-Current	$	9,782		$	(1,149	)	$	8,633		$	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			(325	)		2,675			3,000			(361	)		2,639

Total - Convertible Notes Payable - Non-Current	$	5,000		$	(325	)	$	4,675		$	5,000		$	(361	)	$	4,639

[1]	The gross amount includes the 4.25% final payment of $638,000.

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


	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

million

(the “Avenue Loan”). The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at March 31, 2022 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 $15.0

million,

including $4.0

million

which has been funded into a restricted account and will be released upon achievement of (a)(x) positive FOCUS trial efficacy per the trial’s predefined Statistical Analysis Plan (SAP) (specifically the Overall Response Rate exceeds the

pre-specified

threshold for success defined in the SAP by a statistically significant amount); and (y) based on data contained within the FOCUS trial database and appropriate for use with the 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

million

. The Company may request an additional $5.0

million

of gross proceeds between October 1, 2022 and December 31, 2022, with funding, subject to the approval of Avenue’s Investment Committee.

Up to $3

million

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

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

The Company will make monthly interest-only payments during the first fifteen months of the term of the Avenue Loan, which could be increased to up to twenty-four months upon the achievement of specified performance milestones. Following the interest-only period, the Company will make equal monthly payments of principal plus interest until the maturity date, when all remaining principal outstanding and accrued interest must be paid. 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 $150,000 at closing. Upon funding a second tranche of the Avenue Loan, the Lender will earn a 1.0% fee on the $5.0 million of incremental committed capital, for a total commitment fee of $0.2 million.

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 $0.6 million value of the final payment was treated as original issue discount. The $1.2 million relative fair value of the Avenue Warrant was credited to Additional Paid in Capital while it was debited as debt discount. Of the $563,000 of cash issuance costs, $519,000 was allocated to the Avenue Loan and was recorded as debit discount, while $44,000 was allocated to the Avenue Warrant and was debited to Additional Paid in Capital. Of the $2.3 million of aggregate debt discount, $1.9 million was allocated to the

non-convertible

portion of the Avenue Loan, while $418,000 was allocated to the convertible portion of the Avenue Loan. Aggregate debt discount amortization of $0.2 million was recorded during the three months ended March 31, 2022, including $159,000 related to the

non-convertible

portion of the Avenue Loan and $35,000 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 $0.4 million for the three months ended March 31, 2022.

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


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

Convertible Notes Payable

The Company has $2.0 million of principal outstanding related to Senior Secured Promissory Notes (the “Rosalind Notes”) which bear interest at 8% per annum. Pursuant to their original terms, the Rosalind Notes were convertible into Series E Preferred Stock at a price of $1,500 per share and were to mature on July 16, 2021

Interest expense was $40 for the three months ended March 31, 2022 and 2021, respectively.

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 Avenue. 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.

- 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

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-Name Accounting Standards Codification
-Topic 470
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-Publisher FASB
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+ Details

Stockholders' Equity

3 Months Ended

Mar. 31, 2022

Stockholders' Equity Note [Abstract]

Stockholders' Equity

(9)	Stockholders’ Equity

Authorized Shares

The Company is authorized to issue 40,000,000 shares of common stock, $0.01 par value, and

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

E-1

(12,960 shares).

Preferred Stock

As of March 30, 2022, there were an aggregate of 11,707 shares of Series E and Series E-1 Convertible Preferred Stock outstanding.

Omnibus Equity Incentive Plan

On September 30, 2020, the Company’s 2020 Omnibus Equity Incentive Plan (the “2020 Plan”) was adopted by the Company’s Board of Directors. On November 23, 2020, the Company’s stockholders approved the 2020 Plan. The 2020 Plan will continue in effect until the tenth anniversary of the date of its adoption by the Board or until earlier terminated by the Board. The 2020 Plan is administered by the Board of Directors or a committee designated by the Board of Directors. 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 March 31, 2022, there are 2,475,000 shares of common stock reserved under the 2020 Plan, of which 737,957 remained available to be issued.

Employee Stock Purchase Plan

In August 2021, the Company’s Board of Directors, with shareholder approval in May 2022, adopted the Employee Stock Purchase Plan (ESPP). The Company ESPP’s plan provides for a maximum of 260,295 shares of common stock to

be purchased by

participating employees. Employees who elect to participate in the Company’s ESPP will be able to purchase common stock at the lower of 85% of the fair market value of common stock on the first or last day of the applicable six-month offering period.

Equity Offerings and Placements

At-the-Market

Offering

On August 18, 2020, the Company entered into a sales agreement with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), pursuant to which the Company may offer and sell, from time to time, through Cantor Fitzgerald, as sales agent or principal, shares of the Company’s common stock, (the “Placement Shares”), having an aggregate offering price of up to $10.0 million (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 $50,000 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.

There were no shares sold during the three months ended March 31, 2022.

Stock Options

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


	Three months ended March 31,
	2022			2021
Expected terms (years)		5.46 - 6.46		N/A
Expected volatility		174.81% - 177.09	%	N/A
Risk-free interest rate		1.75% - 1.90	%	N/A
Expected dividends		0.00	%	N/A

The weighted average estimated fair value of the stock options granted during the three months ended March 31, 2022 was approximately $6.86 per share.

The following is a summary of stock option activity for the three months ended March 31, 2022:


	Number of Option			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at January 1, 2022		1,732,460		$	11.69
Granted		549,333			7.10
Expired		(6,650	)		10.88
Cancelled/Forfeited		(37,040	)		10.42

Outstanding at March 31, 2022		2,238,103		$	10.60		9.2	$	—

Exercisable at March 31, 2022		766,619		$	11.83		8.7	$	—

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


			Options Exercisable
Range of Exercise Prices	Outstanding Number of Options		Weighted Average Remaining Option Term (in years)		Number of Options
$6.61 - $9.99		825,256		9.2		110,389
$10.00 - $14.99		1,280,348		8.7		592,317
$15.00 - $24.99		132,000		8.5		63,414
$25 +		499		6.8		499

		2,238,103		8.7		766,619

The following is a summary of share-based compensation expense in the statement of operations for the three months ended March 31, 2022 (in thousands):


	Three months ended March 31,
	2022		2021
Selling, general and administrative	$	919	$	1,466
Research and development		503		630
Cost of goods sold		52		52

Total	$	1,474	$	2,148

At March 31, 2022, there was $9.2

million of aggregate unrecognized compensation expense related employee and board stock option grants. The cost is expected to be recognized over a weighted average period of 3 years.

Warrants

The following is a summary of warrant activity for the three months ended March 31, 2022:


	Warrants		Weighted Average Exercise Price		Weighted Average Remaining Life (in years)
Outstanding at January 1, 2022		3,894,498	$	9.27
Warrants issued		—		—
Warrants exercised		—		—
Warrants expired		—		—

Outstanding at March 31, 2022		3,894,498	$	9.27		3.0

Exercisable at March 31, 2022		3,894,498	$	9.27		3.0

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


			Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants		Weighted Average Remaining Warrant Term (in years)		Number of Warrants
$0.01		283,755		3.7		283,755
$10.00		3,610,743		2.9		3,610,743

		3,894,498		3.0		3,894,498

- 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.

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-Publisher FASB
-Name Accounting Standards Codification
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+ Details

Net Loss per Common Share

3 Months Ended

Mar. 31, 2022

Earnings Per Share [Abstract]

Net Loss per Common Share

(10)	Net Loss per Common Share

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

The following potentially dilutive securities were excluded from the computation of earnings per share as of March 31, 2022 and 2021 because their effects would be anti-dilutive:


	March 31,
	2022		2021
Stock options		2,238,103		1,078,499
Common stock warrants - equity		3,894,498		3,994,107
Assumed conversion of Series E and Series E-1 Preferred Stock		1,135,721		2,048,101
Assumed conversion of convertible notes		488,031		146,288

Total		7,756,353		7,266,995

At March 31, 2022, the Company had 283,755

pre-funded

warrants outstanding. The following table provides a reconciliation of the weighted average shares outstanding calculation for the three months ended March 31, 2022 and 2021:


	Three months ended March 31,
	2022		2021
Weighted average shares issued		7,906,728		6,125,922
Weighted average pre-funded warrants		283,755		371,000

Weighted average shares outstanding		8,190,483		6,496,922

Income Taxes

3 Months Ended

Mar. 31, 2022

Income Tax Disclosure [Abstract]

Income Taxes

(11)	Income Taxes

As discussed in Note 14 Income Taxes of the Company’s Annual Report, the Company has a valuation allowance against the full amount of its net deferred tax assets. The Company currently provides a valuation allowance against deferred tax assets when it is more likely than not that some portion or all of its deferred tax assets will not be realized. The Company has not recognized any unrecognized tax benefits in its balance sheet.

The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. The federal and state tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a period within the statute of limitations. Additional information regarding the statutes of limitations can be found in Note 14 Income Taxes of the Company’s Annual Report.

- 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
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+ Details

Commitments and Contingencies

3 Months Ended

Mar. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

(

)

Commitments and Contingencies

Litigation, Claims and Assessments

medac Matter

In April 2021, the Company issued an invoice for €1

million

(which currently converts to approximately $1.2

million)

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

rial as defined by the FOCUS

rial

protocol. Per the

rial

protocol and associated Statistical Analysis Plan, positive efficacy is based on whether the Objective Response Rate (ORR) exceeds a pre

specified threshold. A preliminary analysis of the FOCUS

rial 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 pre

specified threshold. While the final ORR is not yet known, given the magnitude by which the ORR exceeded the pre

specified endpoint and the small number of patients yet to be assessed, the final ORR will be greater than the pre

specified 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

it doe

not intend to pay the invoice at this time, under revenue recognition criteria set out in ASC 606, the Company cannot recognize the revenue.

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 License Agreement.

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 an orderly transition through February 28, 2022 in order to minimize the impact of any termination on patients and physicians. The Company agreed to purchase inventory held at medac in

March 2022 for approximately

$0.2 million.

The arbitration proceeding is moving forward with the parties agreeing to stay the arbitration for a finite period to pursue settlement

discussions.

General (Policies)	3 Months Ended
General (Policies)	Mar. 31, 2022
Accounting Policies [Abstract]
Risk and Uncertainties	Risks and Uncertainties Although the Company is not aware of any direct impacts of the war between the Ukraine and the Russian Federation on its supply chain, the war could adversely impact the Company’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its third-party suppliers in a timely manner or at all. In addition, at this time, the Company is not aware of any direct impacts, the increase in COVID cases and associated restrictions, which could adversely impact the Company’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its third-party suppliers in a timely manner or at all.
Liquidity and Going Concern	Liquidity and Going Concern The accompanying interim condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred significant losses and has an accumulated deficit of $429.2 million as of March 31, 2022. These losses, among other factors, raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce, or eliminate its research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If 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 interim condensed consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. Additional working capital will be required to continue operations. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of product development and clinical trial results; uncertainty regarding regulatory approval; technological uncertainty; uncertainty regarding patents and proprietary rights; comprehensive government regulations; limited commercial manufacturing, marketing, or sales experience; and dependence on key personnel.
Basis of Presentation	Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the SEC’s instructions to Form 10-Q and Article 10 of Regulation S-X. They include the accounts of all wholly owned subsidiaries and all significant inter-company accounts and transactions have been eliminated in consolidation. The preparation of interim condensed consolidated financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended March 31, 2022 and 2021; however, certain information and footnote disclosures normally included in our audited consolidated financial statements included in our Annual Report on Form 10-K have been condensed or omitted as permitted by GAAP. It is important to note that the Company’s results of operations and cash flows for interim periods are not necessarily indicative of the results of operations and cash flows to be expected for a full fiscal year or any interim period.
Recently Adopted and Issued Accounting Pronouncements	Recently Adopted Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 Accounting Standards Codification 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 did not have any immediate effect on the Company’s condensed consolidated 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 was 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 condensed 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 condensed consolidated financial statements.

Cash, Cash Equivalents and Restricted Cash (Tables)

3 Months Ended

Mar. 31, 2022

Cash and Cash Equivalents [Abstract]

Schedule of Cash, Cash Equivalents, and Restricted Cash

Cash, cash equivalents, and restricted cash balances were as follows (in thousands):


	March 31, 2022		December 31, 2021
Cash and cash equivalents	$	16,340	$	22,802
Restricted balance for loan agreement		4,000	$	4,000
Letters of credit		101		101
Security for credit cards		50		50

Total cash, cash equivalents and restricted cash shown in the statements of cash flows	$	20,491	$	26,953

Inventories (Tables)

3 Months Ended

Mar. 31, 2022

Inventory Disclosure [Abstract]

Schedule of inventories

Inventories consist of the following (in thousands):


	March 31, 2022		December 31, 2021
Raw materials	$	841	$	767
Work-in-process		881		645
Finished goods		289		—

Total inventories	$	2,011	$	1,412

Prepaid Expenses and Other Current Assets (Tables)

3 Months Ended

Mar. 31, 2022

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

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):


	March 31, 2022		December 31, 2021
Clinical trial expenses	$	1,630	$	1,630
Insurance premiums		645		890
Other		429		223

Total prepaid expenses and other current assets	$	2,704	$	2,743

Property, Plant, and Equipment (Tables)

3 Months Ended

Mar. 31, 2022

Property, Plant and Equipment [Abstract]

Components of property, plant and equipment

(5)	Property, Plant, and Equipment

Property, plant, and equipment consist of the following (in thousands):


	March 31, 2022			December 31, 2021			Estimated Useful Life
Buildings and land	$	1,222		$	1,222			30 years- Buildings
Enterprise hardware and software		1,858			1,858			3 years
Leaseholds		1,788			1,796			Lesser of lease term or estimated useful life
Equipment		1,184			1,094			7 years
Furniture		202			203			5 years

Property, plant and equipment, gross		6,254			6,173
Accumulated depreciation		(4,848	)		(4,825	)

Property, plant and equipment, net	$	1,406		$	1,348

Accrued Expenses (Tables)

3 Months Ended

Mar. 31, 2022

Payables and Accruals [Abstract]

Schedule of accrued expenses

Accrued expenses consist of the following (in thousands):


	March 31, 2022		December 31, 2021
Clinical expenses	$	1,578	$	1,517
Compensation, excluding taxes		796		893
Short term financing		315		551
Professional fees		1,298		603
Interest on convertible note		433		393
Other		75		152

Total accrued expenses	$	4,495	$	4,109

Leases (Tables)

3 Months Ended

Mar. 31, 2022

Leases [Abstract]

Summary of Operating and Financing Leases

The following table summarizes the Company’s operating leases as of and for the three months ended March 31, 2022 (in thousands):


	U.S.			Ireland			Total
Lease cost:
Operating lease cost	$	101		$	8		$	109

Other information:
Operating cash flows out from operating leases	$	(101	)	$	(8	)	$	(109	)
Weighted average remaining lease term		0.9			4.4
Weighted average discount rate - operating leases		8	%		8	%

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

Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows (in thousands):


	U.S.			Ireland			Total
Year ended December 31, 2022	$	304		$	35		$	339
Year ended December 31, 2023		67			46			113
Year ended December 31, 2024		—			46			46
Year ended December 31, 2025		—			46			46
Year ended December 31, 2026		—			26			26

Total		371			199			570
Less present value discount		(14	)		(30	)		(44	)

Operating lease liabilities included in the consolidated balance sheets at March 31, 2022	$	357		$	169		$	526

Loans and Convertible Notes Payable (Tables)

3 Months Ended

Aug. 06, 2021

Mar. 31, 2022

Debt Disclosure [Abstract]

Summary of Loans and Convertible Notes Payable

	March 31, 2022									December 31, 2021
	Gross			Discount			Net			Gross			Discount			Net
Loan - Avenue [1]		12,638			(1,485	)		11,153			12,638			(1,645	)		10,993
Loan - Avenue [1] - Less Current Portion		(2,856	)		336			(2,520	)		(714	)		93			(621	)

Total - Loans Payable, Non-Current	$	9,782		$	(1,149	)	$	8,633		$	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			(325	)		2,675			3,000			(361	)		2,639

Total - Convertible Notes Payable - Non-Current	$	5,000		$	(325	)	$	4,675		$	5,000		$	(361	)	$	4,639

[1]	The gross amount includes the 4.25% final payment of $638,000.

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

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


	Loans		Convertible 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

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


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

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


	Three months ended March 31,
	2022			2021
Expected terms (years)		5.46 - 6.46		N/A
Expected volatility		174.81% - 177.09	%	N/A
Risk-free interest rate		1.75% - 1.90	%	N/A
Expected dividends		0.00	%	N/A

Stockholders' Equity (Tables)

3 Months Ended

Aug. 06, 2021

Mar. 31, 2022

Stockholders' Equity Note [Abstract]

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

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


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

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


	Three months ended March 31,
	2022			2021
Expected terms (years)		5.46 - 6.46		N/A
Expected volatility		174.81% - 177.09	%	N/A
Risk-free interest rate		1.75% - 1.90	%	N/A
Expected dividends		0.00	%	N/A

Summary of Stock Option Activity

The following is a summary of stock option activity for the three months ended March 31, 2022:


	Number of Option			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at January 1, 2022		1,732,460		$	11.69
Granted		549,333			7.10
Expired		(6,650	)		10.88
Cancelled/Forfeited		(37,040	)		10.42

Outstanding at March 31, 2022		2,238,103		$	10.60		9.2	$	—

Exercisable at March 31, 2022		766,619		$	11.83		8.7	$	—

Summary of Stock Option Shares Outstanding and Exercisable

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


			Options Exercisable
Range of Exercise Prices	Outstanding Number of Options		Weighted Average Remaining Option Term (in years)		Number of Options
$6.61 - $9.99		825,256		9.2		110,389
$10.00 - $14.99		1,280,348		8.7		592,317
$15.00 - $24.99		132,000		8.5		63,414
$25 +		499		6.8		499

		2,238,103		8.7		766,619

Summary of Recognized Share-based Compensation Cost

The following is a summary of share-based compensation expense in the statement of operations for the three months ended March 31, 2022 (in thousands):


	Three months ended March 31,
	2022		2021
Selling, general and administrative	$	919	$	1,466
Research and development		503		630
Cost of goods sold		52		52

Total	$	1,474	$	2,148

Summary of Warrant Activity

The following is a summary of warrant activity for the three months ended March 31, 2022:


	Warrants		Weighted Average Exercise Price		Weighted Average Remaining Life (in years)
Outstanding at January 1, 2022		3,894,498	$	9.27
Warrants issued		—		—
Warrants exercised		—		—
Warrants expired		—		—

Outstanding at March 31, 2022		3,894,498	$	9.27		3.0

Exercisable at March 31, 2022		3,894,498	$	9.27		3.0

Schedule of Information Related to Stock Warrants Outstanding and Exercisable

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


			Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants		Weighted Average Remaining Warrant Term (in years)		Number of Warrants
$0.01		283,755		3.7		283,755
$10.00		3,610,743		2.9		3,610,743

		3,894,498		3.0		3,894,498

Net Loss per Common Share (Tables)

3 Months Ended

Mar. 31, 2022

Earnings Per Share [Abstract]

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

The following potentially dilutive securities were excluded from the computation of earnings per share as of March 31, 2022 and 2021 because their effects would be anti-dilutive:


	March 31,
	2022		2021
Stock options		2,238,103		1,078,499
Common stock warrants - equity		3,894,498		3,994,107
Assumed conversion of Series E and Series E-1 Preferred Stock		1,135,721		2,048,101
Assumed conversion of convertible notes		488,031		146,288

Total		7,756,353		7,266,995

Summary of reconciliation of weighted average shares outstanding calculation

The following table provides a reconciliation of the weighted average shares outstanding calculation for the three months ended March 31, 2022 and 2021:


	Three months ended March 31,
	2022		2021
Weighted average shares issued		7,906,728		6,125,922
Weighted average pre-funded warrants		283,755		371,000

Weighted average shares outstanding		8,190,483		6,496,922

General - Additional Information (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Basis Of Condensed Consolidated Financial Statement Presentation [Abstract]
Retained Earnings Accumulated Deficit	$ (429,179)	$ (420,976)

- Definition

The cumulative amount of the reporting entity's undistributed earnings or deficit.

+ References + Details

Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021	Mar. 31, 2021	Dec. 31, 2020
Cash and Cash Equivalents [Abstract]
Cash and cash equivalents	$ 16,340	$ 22,802
Restricted balance for loan agreement	4,000	4,000
Letters of credit	101	101
Security for credit cards	50	50
Total cash, cash equivalents and restricted cash shown in the statements of cash flows	$ 20,491	$ 26,953	$ 26,650	$ 28,756

Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Inventory Disclosure [Abstract]
Raw materials	$ 841	$ 767
Work-in-process	881	645
Finished goods	289	0
Total inventories	$ 2,011	$ 1,412

Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Prepaid Expense and Other Assets, Current [Abstract]
Clinical trial expenses	$ 1,630	$ 1,630
Insurance premiums	645	890
Other	429	223
Total prepaid expenses and other current assets	$ 2,704	$ 2,743

Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 6,254	$ 6,173
Accumulated depreciation	(4,848)	(4,825)
Property, plant, and equipment, net	1,406	1,348
Buildings and Land [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	1,222	1,222
Enterprise Hardware and Software [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,858	1,858
Property, plant and equipment, estimated useful life	3 years
Leaseholds [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,788	1,796
Property, plant and equipment, estimated useful life	Lesser ofleaseterm orestimatedusefullife
Equipment [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,184	1,094
Property, plant and equipment, estimated useful life	7 years
Furniture [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 202	$ 203
Property, plant and equipment, estimated useful life	5 years
Buildings [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, estimated useful life	30 years

Property, Plant, and Equipment - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 31	$ 39

Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
Clinical expenses	$ 1,578	$ 1,517
Compensation, excluding taxes	796	893
Short-term financing	315	551
Professional fees	1,298	603
Interest on convertible note	433	393
Other	75	152
Total accrued expenses	$ 4,495	$ 4,109

Leases - Additional Information (Details)	Mar. 31, 2022
Lease term	12 months

Leases - Summary of Operating and Financing Leases (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2022 USD ($)
Lease Cost
Operating lease cost	$ 109
Other information
Operating cash flows out from operating leases	(109)
U.S. [Member]
Lease Cost
Operating lease cost	101
Other information
Operating cash flows out from operating leases	$ (101)
Weighted average remaining lease term	10 months 24 days
Weighted average discount rate - operating leases	8.00%
Ireland [Member]
Lease Cost
Operating lease cost	$ 8
Other information
Operating cash flows out from operating leases	$ (8)
Weighted average remaining lease term	4 years 4 months 24 days
Weighted average discount rate - operating leases	8.00%

Leases - Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands	Mar. 31, 2022 USD ($)
Lessee Lease Description [Line Items]
Year ended December 31, 2022	$ 339
Year ended December 31, 2023	113
Year ended December 31, 2024	46
Year ended December 31, 2025	46
Year ended December 31, 2026	26
Total	570
Less present value discount	(44)
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2022	526
U.S. [Member]
Lessee Lease Description [Line Items]
Year ended December 31, 2022	304
Year ended December 31, 2023	67
Total	371
Less present value discount	(14)
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2022	357
Ireland [Member]
Lessee Lease Description [Line Items]
Year ended December 31, 2022	35
Year ended December 31, 2023	46
Year ended December 31, 2024	46
Year ended December 31, 2025	46
Year ended December 31, 2026	26
Total	199
Less present value discount	(30)
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2022	$ 169

Loans and Convertible Notes Payable - Additional Information (Details) - USD ($)		3 Months Ended
	Aug. 06, 2021	Mar. 31, 2022	Jun. 30, 2021
Debt Instrument [Line Items]
Avenue warrant value		$ 1,300,000
Debt instrument, commitment fee	$ 150,000
Interest expense incurred		$ 400,000
Secured Convertible Notes Payable [Member]
Debt Instrument [Line Items]
Debt instrument, principal face amount	$ 2,000,000.0
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 March 31, 2022 was 10.95%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property.
Initial tranche of loan	$ 15,000,000.0
Loan amount funded into restricted account	4,000,000.0
Gross proceeds from ATM Offering	20,000,000
Second tranche of loan	$ 5,000,000.0
Frequency of periodic payment	monthly
Periodic interest payments, term	15 months
Debt instrument, incremental final payment	4.25%
Debt instrument, commitment fee, percentage	1.00%
Debt instrument, commitment fee upon funding of second tranche of loan	$ 200,000
Original issue discount	600,000
Cash issuance costs	563,000
Debit discount	519,000
Fair value of warrants reclassified from liability to equity	44,000
Aggregate debt discount	$ 2,300,000
Amortization of debt discount		$ 200,000
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	$ 1,200,000
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Maximum [Member]
Debt Instrument [Line Items]
Debt instrument, principal face amount	$ 20,000,000
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	$ 1,900,000
Amortization of debt discount		159,000
Term Loan from Avenue Venture Opportunities Fund L.P [Member] \| Convertible Debt [Member]
Debt Instrument [Line Items]
Aggregate debt discount	$ 418,000
Amortization of debt discount		$ 35,000
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		$ 40,000

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

Mar. 31, 2022

Dec. 31, 2021

Gross

$ 5,000

Discount

(325)

(361)

Net

4,675

4,639

Less Current Portion, Net

(2,520)

(621)

Total - Loans Payable, Non-Current, Gross

9,782

11,924

Total - Loans Payable, Non-Current, Discount

(1,149)

(1,552)

Total - Loans Payable, Non-Current, Net

8,633

10,372

Loan Avenue [Member]

Gross

^[1]

12,638

Discount

^[1]

(1,485)

(1,645)

Net

^[1]

11,153

10,993

Less Current Portion, Gross

^[1]

(2,856)

(714)

Less Current Portion, Discount

^[1]

336

Less Current Portion, Net

^[1]

(2,520)

(621)

Convertible Note Payable Rosalind [Member]

Gross

2,000

Net

2,000

Convertible Loan Payable Avenue [Member]

Gross

3,000

Discount

(325)

(361)

Net

$ 2,675

$ 2,639

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

Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) (Parenthetical)	3 Months Ended
	Mar. 31, 2022 USD ($)
Equity Method Investments And Cost Method Investments [Abstract]
Percentage of final payment included in gross amount	4.25%
Final payment	$ 638,000

Loans and Convertible Notes Payable - Summary of Remaining Maturities of Company's Loan and Convertible Note Payables (Details) $ in Thousands	Mar. 31, 2022 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

Loans and Convertible Notes Payable - Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method (Details)		3 Months Ended
	Aug. 06, 2021	Mar. 31, 2022
Contractual term (years)	5 years 25 days
Expected volatility	187.00%
Risk-free interest rate	0.77%
Expected dividends	0.00%	0.00%

Stockholders' Equity - Preferred Stock Issuances - Additional Information (Details) - $ / shares	Mar. 31, 2022	Mar. 30, 2022	Dec. 31, 2021
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)	10,000,000		10,000,000
Preferred stock, par value (in dollars per share)	$ 0.01		$ 0.01
Common stock, par value (in dollars per share)	$ 0.01		$ 0.01
Common stock, shares authorized (in shares)	40,000,000		40,000,000
Preferred stock, shares outstanding (in shares)	11,357		11,357
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
Series E1 Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares authorized (in shares)	12,960
Series E Convertible Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares outstanding (in shares)		11,707
Series E-1 Convertible Preferred Stock [Member]
Stockholders Equity Note [Line Items]
Preferred stock, shares outstanding (in shares)		11,707

Stockholders' Equity - Equity Incentive Plan - Additional Information (Details) - shares	Mar. 31, 2022	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		737,957

Stockholders' Equity - Summary of Employee Stock Purchase Plan (Details) - May 2022 Employee Stock Purchase Plan (ESPP) [Member]	1 Months Ended
	Aug. 31, 2021 shares
Stockholders Equity Note [Line Items]
Share-based compensation arrangement by share-based payment award number of shares authorized	260,295
Share-based compensation arrangement by share-based payment award purchase price of common stock, percent	85.00%

Stockholders' Equity - At-the-Market Offering - Additional Information (Details) - USD ($)		3 Months Ended
	Aug. 18, 2020	Mar. 31, 2022
Stockholders Equity Note [Line Items]
Number of Shares Sold		0
Cantor Fitzgerald & Co [Member]
Stockholders Equity Note [Line Items]
Percentage of commission on aggregate gross proceeds	3.00%
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	$ 10,000,000.0
Legal fees and disbursements	$ 50,000

Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) $ / shares in Units, $ in Millions	3 Months Ended
	Mar. 31, 2022 USD ($) $ / shares
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted average estimated fair value of the stock options granted \| $ / shares	$ 6.86
Unrecognized compensation expense related to non-vested share-based compensation awards \| $	$ 9.2
Cost expected to be recognized over weighted average period	3 years

Stockholders' Equity - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details)		3 Months Ended
	Aug. 06, 2021	Mar. 31, 2022
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility	187.00%
Expected terms (years)	5 years 25 days
Risk-free interest rate	0.77%
Expected dividends	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility		174.81%
Expected terms (years)		5 years 5 months 15 days
Risk-free interest rate		1.75%
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility		177.09%
Expected terms (years)		6 years 5 months 15 days
Risk-free interest rate		1.90%

Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2022 USD ($) $ / shares shares
Stockholders' Equity Note [Abstract]
Number of Shares, Outstanding \| shares	1,732,460
Number of Shares, Granted \| shares	549,333
Number of Shares, Expired \| shares	(6,650)
Number of Shares, Cancelled/Forfeited \| shares	(37,040)
Number of Shares, Outstanding \| shares	2,238,103
Number of Shares, Exercisable \| shares	766,619
Weighted Average Exercise Price, Outstanding \| $ / shares	$ 11.69
Weighted Average Exercise Price, Granted \| $ / shares	7.10
Weighted Average Exercise Price, Expired \| $ / shares	10.88
Weighted Average Exercise Price, Cancelled/Forfeited \| $ / shares	10.42
Weighted Average Exercise Price, Outstanding \| $ / shares	10.60
Weighted Average Exercise Price, Exercisable \| $ / shares	$ 11.83
Weighted Average Remaining Contractual Term (Years), Outstanding	9 years 2 months 12 days
Weighted Average Remaining Contractual Term (Years), Exercisable	8 years 8 months 12 days
Aggregate Intrinsic Value, Outstanding \| $	$ 0
Aggregate Intrinsic Value, Exercisable \| $	$ 0

Stockholders' Equity - Summary of Stock Option Shares Outstanding and Exercisable (Details) - shares	3 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	2,238,103	1,732,460
Weighted Average Remaining Contractual Term (Years), Exercisable	8 years 8 months 12 days
Number of Shares, Exercisable	766,619
$6.61 - $9.99 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	825,256
Weighted Average Remaining Contractual Term (Years), Exercisable	9 years 2 months 12 days
Number of Shares, Exercisable	110,389
$10.00 - $14.99 [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	1,280,348
Weighted Average Remaining Contractual Term (Years), Exercisable	8 years 8 months 12 days
Number of Shares, Exercisable	592,317
$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 6 months
Number of Shares, Exercisable	63,414
$25 + [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options	499
Weighted Average Remaining Contractual Term (Years), Exercisable	6 years 9 months 18 days
Number of Shares, Exercisable	499

Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	$ 1,474	$ 2,148
Selling, General and Administrative [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	919	1,466
Research and Development [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	503	630
Cost of Goods Sold [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Share-based compensation (Income) expense	$ 52	$ 52

Stockholders' Equity - Summary of Warrant Activity (Details)	3 Months Ended
	Mar. 31, 2022 $ / shares shares
Warrants outstanding [Roll Forward]
Outstanding, beginning of period (in shares) \| shares	3,894,498
Warrants issued (in shares) \| shares	0
Warrants exercised (in shares) \| shares	0
Warrants expired (in shares) \| shares	0
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	$ 9.27
Warrants issued (in dollars per share) \| $ / shares	0
Warrants exercised (in dollars per share) \| $ / shares	0
Warrants expired (in dollars per share) \| $ / shares	0
Outstanding, ending of period (in dollars per share) \| $ / shares	9.27
Exercisable, (in dollars per share) \| $ / shares	$ 9.27
Weighted average remaining life	3 years
Weighted average remaining life, Exercisable	3 years

Stockholders' Equity - Summary of Warrants Outstanding and Exercisable (Details) - shares	3 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Class Of Warrant Or Right [Line Items]
Warrants Outstanding, Number Outstanding	3,894,498	3,894,498
Weighted average remaining life	3 years
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 8 months 12 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	2 years 10 months 24 days
Warrants Exercisable, Number Exercisable	3,610,743

Net Loss per Common Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	7,756,353	7,266,995
Stock Options [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	2,238,103	1,078,499
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	3,994,107
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	2,048,101
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

Net Loss per Common Share - Additional Information (Details)	3 Months Ended
	Mar. 31, 2022 shares
Earnings Per Share [Abstract]
Pre-funded penny warrants outstanding	283,755

Net Loss per Common Share - Summary of Reconciliation of Weighted Average Shares Outstanding Calculation (Details) - shares	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Earnings Per Share [Abstract]
Weighted average shares issued	7,906,728	6,125,922
Weighted average pre-funded warrants	283,755	371,000
Weighted average shares outstanding	8,190,483	6,496,922

Commitments and contingencies - Additional Information (Details) € in Millions	Mar. 31, 2021	Apr. 01, 2020	Mar. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Apr. 01, 2021 USD ($)	Apr. 01, 2021 EUR (€)
Loss Contingencies [Line Items]
Percentage of enrolled patients	87.00%
Inventory			$ 2,011,000	$ 1,412,000
Medac [Member]
Loss Contingencies [Line Items]
Due from related parties					$ 1,200	€ 1
Agreement date		Dec. 10, 2018
Inventory			$ 200,000

- 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))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 850
-SubTopic 10
-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