Delcath Systems (DCTH) 10-Q 11 May 22 2022 Q1 Quarterly report Financial data

Cover Page

Cover Page - shares	3 Months Ended
	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

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 Balanc_2

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 Statemen

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)	$ (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 Statem_2

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 Statem_3

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

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 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 ™ ™ ® 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 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 pre-clinical re-file 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 S-X. 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 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 Recently Adopted Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, “Accounting 2020-06 2020-06 2020-06 In October 2020, the FASB issued ASU 2020-10 On May 3, 2021, the FASB issued ASU 2021-04, 470-50), 815-40):

Cash, Cash Equivalents and Rest

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 Cash, cash equivalents, and restricted cash balances were as follows (in thousands): March 31, December 31, 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

Inventories

Inventories	3 Months Ended
	Mar. 31, 2022
Inventory Disclosure [Abstract]
Inventories	(3) Inventories Inventories consist of the following (in thousands): March 31, December 31, Raw materials $ 841 $ 767 Work-in-process 881 645 Finished goods 289 — Total inventories $ 2,011 $ 1,412

Prepaid Expenses and Other Curr

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, December 31, 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

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, December 31, Estimated Useful Life Buildings and land $ 1,222 $ 1,222 30 years- Enterprise hardware and software 1,858 1,858 3 years Leaseholds 1,788 1,796 Lesser of 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

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, December 31, 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

Leases	3 Months Ended
	Mar. 31, 2022
Leases [Abstract]
Leases	(7) Leases The Company recognizes right-of-use non-cancellable 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 $ 357 $ 169 $ 526

Loans and Convertible Notes Pay

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] (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 initial tranche of the Avenue Loan is $15.0 million, million pre-specified million million Up to $3 million 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 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 non-convertible The Avenue Warrant was valued at issuance at $1.3 million using the Black-Scholes option pricing method using the following assumptions: August 6, 2021 Contractual term (years) 5.07 Expected volatility 187.0 % Risk-free interest rate 0.77 % Expected dividends 0.00 % Convertible Notes Payable The Company has $2.0 million of principal outstanding related to Senior Secured Promissory Notes (the “Rosalind Notes”) which bear interest at 8% per annum. Pursuant to their original terms, the Rosalind Notes were convertible into Series E Preferred Stock at a price of $1,500 per share and were to mature on July 16, 2021 . On August 6, 2021, the Company executed an agreement to amend the Rosalind Notes to (a) reduce the conversion price to $1,198 per share of the Company’s Series E Convertible Preferred Stock; and (b) extend the maturity date to October 30, 2024. In addition, in order to induce 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.

Stockholders' Equity

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 E-1 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 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 Equity Offerings and Placements At-the-Market 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 90-day 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 - N/A Expected volatility 174.81% - % N/A Risk-free interest rate 1.75% - % 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 Weighted Average 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 Weighted Average 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

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 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 Three months ended March 31, 2022 2021 Weighted average shares issued 7,906,728 6,125,922 Weighted average pre-funded 283,755 371,000 Weighted average shares outstanding 8,190,483 6,496,922

Income Taxes

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.

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	( 1 2 Commitments and Contingencies Litigation, Claims and Assessments medac Matter In April 2021, the Company issued an invoice for €1 million million) T T rial t rial - T presented - - - it doe s 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 The arbitration proceeding is moving forward with the parties agreeing to stay the arbitration for a finite period to pursue settlement discussions.

General (Policies)

General (Policies)	3 Months Ended
	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 S-X. 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
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 2020-06 2020-06 2020-06 In October 2020, the FASB issued ASU 2020-10 On May 3, 2021, the FASB issued ASU 2021-04, 470-50), 815-40):

Cash, Cash Equivalents and Re_2

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, December 31, 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)

Inventories (Tables)	3 Months Ended
	Mar. 31, 2022
Inventory Disclosure [Abstract]
Schedule of inventories	Inventories consist of the following (in thousands): March 31, December 31, Raw materials $ 841 $ 767 Work-in-process 881 645 Finished goods 289 — Total inventories $ 2,011 $ 1,412

Prepaid Expenses and Other Cu_2

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, December 31, 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

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, December 31, Estimated Useful Life Buildings and land $ 1,222 $ 1,222 30 years- Enterprise hardware and software 1,858 1,858 3 years Leaseholds 1,788 1,796 Lesser of 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)

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, December 31, 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)

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 $ 357 $ 169 $ 526

Loans and Convertible Notes P_2

Loans and Convertible Notes Payable (Tables)	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] (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 - N/A Expected volatility 174.81% - % N/A Risk-free interest rate 1.75% - % N/A Expected dividends 0.00 % N/A

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	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 - N/A Expected volatility 174.81% - % N/A Risk-free interest rate 1.75% - % 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 Weighted Average 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 Weighted Average 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 (Tabl

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 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 283,755 371,000 Weighted average shares outstanding 8,190,483 6,496,922

General - Additional Informatio

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)

Cash, Cash Equivalents and Re_3

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 Inven

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 Cu_3

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 Equipmen_2

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 Equipmen_3

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 - 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

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

Leases - Summary of Operating a

Leases - Summary of Operating and Financing Leases (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2022USD ($)
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

Leases - Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands	Mar. 31, 2022USD ($)
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 P_3

Loans and Convertible Notes Payable - Additional Information (Details) - USD ($)	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
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. 1, 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
Loan amount funded into restricted account	4,000,000
Gross proceeds from ATM Offering	20,000,000
Second tranche of loan	$ 5,000,000
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 P_4

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	$ 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	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	93
Less Current Portion, Net	[1]	(2,520)	(621)
Convertible Note Payable Rosalind [Member]
Gross		2,000	2,000
Net		2,000	2,000
Convertible Loan Payable Avenue [Member]
Gross		3,000	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 P_5

Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) (Parenthetical)	3 Months Ended
	Mar. 31, 2022USD ($)
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 P_6

Loans and Convertible Notes Payable - Summary of Remaining Maturities of Company's Loan and Convertible Note Payables (Details) $ in Thousands	Mar. 31, 2022USD ($)
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 P_7

Loans and Convertible Notes Payable - Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method (Details)	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 - Preferre

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 I

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

Stockholders' Equity - Summary of Employee Stock Purchase Plan (Details) - May 2022 Employee Stock Purchase Plan (ESPP) [Member]	1 Months Ended
	Aug. 31, 2021shares
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-M

Stockholders' Equity - At-the-Market Offering - Additional Information (Details) - USD ($)	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
Legal fees and disbursements	$ 50,000

Stockholders' Equity - Stock In

Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) $ / shares in Units, $ in Millions	3 Months Ended
	Mar. 31, 2022USD ($)$ / 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

Stockholders' Equity - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details)	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 - Summar_2

Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2022USD ($)$ / sharesshares
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 - Summar_3

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 - Summar_4

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 - Summar_5

Stockholders' Equity - Summary of Warrant Activity (Details)	3 Months Ended
	Mar. 31, 2022$ / sharesshares
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 - Summar_6

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 - Ant

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 - Add

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

Net Loss per Common Share - Sum

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 -

Commitments and contingencies - Additional Information (Details) € in Millions	Mar. 31, 2021	Apr. 01, 2020	Mar. 31, 2022USD ($)	Dec. 31, 2021USD ($)	Apr. 01, 2021USD ($)	Apr. 01, 2021EUR (€)
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