0001628280-23-038618 | 10-Q | XBRL Viewer

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Stockholders' Equity - Equity Incentive Plan (Details) - shares	Jun. 12, 2023	Sep. 30, 2023
Stockholders' Equity Note [Abstract]
Increase in shares available under equity incentive plan (in shares)	2,650,000
Common stock, capital shares reserved (in shares)		5,125,000
Number of common shares remained available to be issued (in shares)		1,802,841

General (Policies)

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

Risks and Uncertainties

The Company is subject to risks common to companies in the biopharmaceutical industry including, but not limited to, the risks associated with developing product candidates and successfully launching and commercializing its drug/device combination products, the Company's ability to obtain regulatory approval of its such products in the United States and other geography markets, the uncertainty of the broad adoption of its approved products by physicians and consumers, and significant competition.

In addition, high rates of inflation have resulted in the U.S. Federal Reserve raising interest rates. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may further increase economic uncertainty and heighten these risks. Furthermore, if additional banks and financial institutions enter receivership or

become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our or our partners’ ability to access existing cash, cash equivalents and investments may be threatened and could have a material adverse effect on our business and financial condition, including our ability to access additional capital on favorable terms, or at all, which could in the future negatively affect our ability to pursue our business strategy.

Liquidity and Going Concern

On September 30, 2023, the Company had cash, cash equivalents and restricted cash totaling $40.5 million, as compared to cash, cash equivalents and restricted cash totaling $11.8 million at December 31, 2022. During the nine months ended September 30, 2023, the Company used $23.1 million of cash in its operating activities and $6.3 million for principal payments.

The Company’s future results are subject to substantial risks and uncertainties. The Company has operated at a loss for its entire history and there can be no assurance that it will ever achieve or maintain profitability. The Company has historically funded its operations primarily with proceeds from sales of common stock, warrants and prefunded warrants for the purchase of common stock, sales of preferred stock, proceeds from the issuance of convertible debt and borrowings under loan and security agreements.

The Company believes that current cash and cash equivalents will enable the Company to have sufficient cash through the launch of HEPZATO. If there is a substantial delay in the launch of HEPZATO, the Company expects to need to raise additional capital under structures available to the Company, including debt and/or equity offerings, which may not be on favorable terms. If commercialization were significantly delayed, the Company would not have sufficient funds to meet its obligations within twelve months from the issuance date of these condensed consolidated financial statements. As such, there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.

The Company’s capital commitments over the next twelve months include (a) $6.0 million to satisfy accounts payable, accrued expenses and lease liabilities and (b) $8.6 million of loan principal payments. Additional capital commitments beyond the next twelve months include (a) $0.1 million of lease liabilities; (b) $1.0 million for settlement of litigation with medac; and (c) $2.0 million of convertible note principal payments, if the holders do not elect to convert the notes into equity.

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 September 30, 2023 and 2022; however, certain information and footnote disclosures normally included in our audited consolidated financial statements included in our Annual Report 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.

Warrant Liabilities

The Company determined the warrant liability was not in accordance with the provisions of ASC 480, Distinguishing Liabilities from Equity, which classifies and measures certain financial instruments with characteristics of both liability and equity. Entities must consider whether to classify contracts that may be settled in its own stock, such as warrants, as equity of the entity or as an asset or liability. If an event that is not within the entity’s control could require net cash settlement,

then the contract should be classified as an asset or a liability at their fair value at issuance with subsequent changes in fair value recorded in earnings.

The Company has accounted for the Preferred Warrants as derivative instruments in accordance with ASC 815, Derivatives and Hedging. The Company classified the Preferred Warrants issued in conjunction with the Preferred Purchase Agreement (defined below) and the Common Warrants issued in conjunction with the Common Purchase Agreement (as defined below) as a liability due to the existence of a pre-specified volatility input to the Black-Scholes calculation which would be used to calculate the repurchase price of the Preferred Warrants and Common Warrants in the event of a Fundamental Transaction, as defined.

The valuations of the warrant liability and Series F-1 Preferred Stock (defined below) were determined using option pricing models. These models use inputs such as the underlying price of the shares issued at the measurement date, volatility, risk free interest rate and expected life of the instrument. In addition, the Company used probabilities of the FDA approval of the HEPZATO KIT (“FDA Approval”) and of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO as inputs to determine the fair value of warrants liability and Series F-1 Preferred Stock. The Company intends to adjust the fair value of the warranty liability at the end of each reporting period.

Recently Adopted and Issued Accounting Pronouncements

Recently Adopted and Issued Accounting Pronouncements We have not been required to adopt any accounting standards that had a significant impact on our consolidated financial statements in the two years ended December 31, 2022. We do not expect any recently issued accounting standards to have a significant impact on our consolidated financial statements.

Revision of Previously Issued Quarterly Financial Statements

In preparation of the Company's audited financial statements as of and for year ended December 31, 2022, the Company determined it needed to correct previously reported share-based compensation expense for each quarter during 2022. The correction for share-based compensation increased the net loss in amount of $0.8 million for the first quarter of 2022, $0.5 million for the second quarter of 2022 and $0.4 million for the third quarter of fiscal 2022. The share-based compensation adjustment is a non-cash adjustment and did not have any impact on the cash balances for the Company.

The following tables contain the financial information for the periods previously reported and have been updated to reflect the revisions of the Company’s financial statements. The revisions do not have an impact on the Company’s cash position. The Company has not amended its previously filed Quarterly Reports on Form 10-Q for the three quarterly periods ended September 30, 2022. The impact of the revision on the Company’s financial statements for the three and nine months ended September 30, 2022 is reflected in the following table:


(In thousands)	As previously reported		Adjustment		As revised
Balance Sheet for September 30, 2022 (unaudited)
Additional paid-in capital	$	442,066	$	1,671	$	443,737
Accumulated deficit	$	(447,341)	$	(1,671)	$	(449,012)

Consolidated Statement of Operations and Comprehensive Loss for the three months ended September 30, 2022 (unaudited)
Research and development expenses	$	3,953	$	112	$	4,065
Selling, general and administrative expenses	4,519		260		4,779
Total operating expenses	8,472		372		8,844
Operating loss	(7,801)		(372)		(8,173)
Net loss	(8,505)		(372)		(8,877)
Total other comprehensive loss	(8,551)		(372)		(8,923)
Basic and diluted loss per common share	$	(0.92)	$	(0.04)	$	(0.96)

Consolidated Statement of Operations and Comprehensive Loss for the nine months September 30, 2022 (unaudited)
Research and development expenses	$	13,649	$	503	$	14,152
Selling, general and administrative expenses	12,309		1,168		13,477
Total operating expenses	25,958		1,671		27,629
Operating loss	(24,327)		(1,671)		(25,998)
Net loss	(26,365)		(1,671)		(28,036)
Total other comprehensive loss	(26,447)		(1,671)		(28,118)
Basic and diluted loss per common share	$	(3.09)	$	(0.20)	$	(3.29)

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

Consolidated statement of Stockholders’ Equity (Deficit) for the nine months ended September 30, 2022 (unaudited)
Compensation expense for issuance of stock options	$	4,345	$	1,671	$	6,016
Net loss	$	(26,365)	$	(1,671)	$	(28,036)

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

Stockholders' Equity - At-the-Market Offering (Details) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2023	Dec. 31, 2022
Stockholders Equity Note [Line Items]
Sale of stock consideration received on the transaction	$ 197	$ 197	$ 100
Number of shares sold (in shares)	0	0
Controlled Equity Offering Sales Agreement \| Cantor Fitzgerald & Co
Stockholders Equity Note [Line Items]
Common stock, aggregate offering price	$ 17,000	$ 17,000
Sale of stock consideration received on the transaction	$ 4,000	$ 4,000

Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	$ 2,830	$ 1,627	$ 6,152	$ 6,016
Unrecognized compensation expense related to non-vested share-based compensation awards	7,700		$ 7,700
Cost expected to be recognized over weighted average period			2 years 4 months 24 days
Selling, general and administrative
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	1,674	1,117	$ 3,774	3,984
Research and development
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	1,027	458	2,095	1,872
Cost of goods sold
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	$ 129	$ 52	$ 283	$ 160

Leases

9 Months Ended

Sep. 30, 2023

Leases [Abstract]

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.

For the three and nine months ended September 30, 2023 and 2022, the Company recognized $0.1 million and $0.3 million, respectively, of operating lease expense in the U.S. and less than $0.1 million of operating lease expense in Ireland for the same periods.

As of September 30, 2023:


(In thousands)	U.S.			Ireland			Total
Operating cash flows for operating leases	$	238		$	24		$	262
Weighted average remaining lease term	0.0			2.8
Weighted average discount rate - operating leases	8		%	8		%

As of August 31, 2023, the lease of office space at 1633 Broadway, New York, NY was converted to a month-to-month lease. No ROU assets or lease liabilities are recognized on the balance sheet for this arrangement.

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


	U.S.		Ireland		Total
Year ended December 31, 2023	$	—	$	11	$	11
Year ended December 31, 2024	—		42		42
Year ended December 31, 2025	—		42		42
Year ended December 31, 2026	—		25		25
Total	—		120		120
Less present value discount	—		(13)		(13)
Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2023	$	—	$	107	$	107

Leases

As of September 30, 2023:


(In thousands)	U.S.			Ireland			Total
Operating cash flows for operating leases	$	238		$	24		$	262
Weighted average remaining lease term	0.0			2.8
Weighted average discount rate - operating leases	8		%	8		%

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


	U.S.		Ireland		Total
Year ended December 31, 2023	$	—	$	11	$	11
Year ended December 31, 2024	—		42		42
Year ended December 31, 2025	—		42		42
Year ended December 31, 2026	—		25		25
Total	—		120		120
Less present value discount	—		(13)		(13)
Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2023	$	—	$	107	$	107

Cash, Cash Equivalents and Restricted Cash - Narrative (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Mar. 15, 2023	Sep. 30, 2022
Cash and Cash Equivalents [Line Items]
Restricted cash	$ 50		$ 4,151
Avenue Loan
Cash and Cash Equivalents [Line Items]
Restricted cash		$ 4,000

Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2023 USD ($) $ / shares shares	Dec. 31, 2022 USD ($) $ / shares shares
Number of Options
Outstanding, beginning of period (in shares) \| shares	2,235,052
Granted (in shares) \| shares	2,122,757
Exercised (in shares) \| shares	(819)
Expired (in shares) \| shares	(115,772)
Cancelled/Forfeited (in shares) \| shares	(104,390)
Outstanding, end of period (in shares) \| shares	4,136,828	2,235,052
Exercisable (in shares) \| shares	2,020,026
Weighted Average Exercise Price Per Share
Outstanding, Weighted Average Exercise Price Per Share, beginning of period (in dollars per share) \| $ / shares	$ 10.30
Granted, Weighted Average Exercise Price Per Share (in dollars per share) \| $ / shares	6.08
Exercised, Weighted Average Exercise Price Per Share (in dollars per share) \| $ / shares	4.67
Expired, Weighted Average Exercise Price Per Share (in dollars per share) \| $ / shares	8.80
Cancelled-Forfeited, Weighted Average Exercise Price Per Share (in dollars per share) \| $ / shares	7.22
Outstanding, Weighted Average Exercise Price Per Share, end of period (in dollars per share) \| $ / shares	8.26	$ 10.30
Weighted Average Exercise Price, Exercisable (in dollars per share) \| $ / shares	$ 10.29
Weighted Average Remaining Contractual Term (in years) and Aggregate Intrinsic Value
Weighted Average Remaining Contractual Term (in years), Outstanding	8 years 6 months	7 years 9 months 18 days
Weighted Average Remaining Contractual Term (in years), Granted	9 years 1 month 6 days
Weighted Average Remaining Contractual Term (in years), Exercisable	7 years 8 months 12 days
Aggregate Intrinsic Value, Outstanding \| $	$ 72,850	$ 35,875
Aggregate Intrinsic Value, Exercisable \| $	$ 0

Net Loss per Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	19,819,735	8,334,956
Common stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	3,627,409	4,461,249
Assumed conversion of preferred stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	4,149,994	0
Assumed conversion of preferred stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	7,417,473	1,135,721
Assumed conversion of convertible notes
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	488,031	488,031
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	4,136,828	2,249,955

Accrued Expenses

9 Months Ended

Sep. 30, 2023

Payables and Accruals [Abstract]

Accrued Expenses

Accrued ExpensesAccrued expenses consist of the following:


(In thousands)	September 30, 2023		December 31, 2022
Clinical expenses	$	2,105	$	1,470
Compensation, excluding taxes	1,535		1,040
Professional fees	61		1,087
Interest on convertible note	673		553
Other	856		535
Total accrued expenses	$	5,230	$	4,685

Stockholders' Equity - Summary of Common Stock Warrant Activity (Details) - Common Warrants	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Class Of Warrant Or Right Outstanding [Roll Forward]
Outstanding, beginning of period (in shares) \| shares	5,153,291
Warrants issued (in shares) \| shares	81,848
Warrants exercised (in shares) \| shares	(569,938)
Outstanding, end of period (in shares) \| shares	4,665,201
Exercisable, end of period (in shares) \| shares	4,665,201
Weighted Average Exercise Price
Outstanding, beginning of period (in dollars per share) \| $ / shares	$ 7.01
Warrants issued (in dollars per share) \| $ / shares	2.94
Warrants exercised (in dollars per share) \| $ / shares	0.26
Outstanding, ending of period (in dollars per share) \| $ / shares	7.76
Exercisable, (in dollars per share) \| $ / shares	$ 7.76
Weighted Average Remaining Life (in years)
Weighted Average Remaining Life (in years), Outstanding	1 year 10 months 24 days
Weighted Average Remaining Life, Exercisable	1 year 10 months 24 days

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Cash flows from operating activities:
Net loss	$ (36,542)	$ (28,036)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock option compensation expense	6,152	6,016
Depreciation expense	87	98
Warrant liability fair value adjustment	8,224	0
Non-cash lease expense	262	339
Amortization of debt discount	582	574
Interest expense accrued related to convertible notes	120	120
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(743)	708
Accounts receivable	161	(493)
Inventory	(669)	(515)
Accounts payable and accrued expenses	(437)	2,907
Other liabilities, non-current	(270)	861
Deferred revenue	0	(170)
Net cash used in operating activities	(23,073)	(17,591)
Cash flows from investing activities:
Purchase of property, plant and equipment	(39)	(209)
Net cash used in investing activities	(39)	(209)
Cash flows from financing activities:
Net proceeds from private placement	22,960	4,896
Proceeds from the issuance of common stock relating to the employee stock purchase plan	123	0
Repayment of debt	(6,313)	0
Proceeds from exercise of warrants	35,004	0
Proceeds from exercise of stock options	3	0
Net cash provided by financing activities	51,777	4,896
Foreign currency effects on cash	25	(67)
Net increase (decrease) in total cash	28,690	(12,971)
Total Cash, Cash Equivalents and Restricted Cash:
Beginning of period	11,822	26,953
End of period	40,512	13,982
Cash, Cash Equivalents and Restricted Cash consisted of the following:
Cash	40,462	9,831
Restricted Cash	50	4,151
Total cash, cash equivalents and restricted cash shown in the statements of cash flows	40,512	13,982
Cash paid during the periods for:
Interest expense	1,122	1,337
Supplemental Disclosure of Non-Cash Investing and Financing Activities:
Right of use assets obtained in exchange for lease obligations	84	0
Conversion of mezzanine equity to common shares	11,269	0
Conversion of mezzanine equity to preferred shares	$ 7,099	$ 0

Stockholders' Equity

9 Months Ended

Sep. 30, 2023

Stockholders' Equity Note [Abstract]

Stockholders' Equity

Stockholders’ Equity

Public and Private Placements

Common Purchase Agreement

On March 27, 2023, the Company entered into a securities purchase agreement (the “Common Purchase Agreement”) with the Company’s Chief Executive Officer, Gerard Michel, pursuant to which the Company agreed to issue and sell, in a private placement (the “Common Offering”) shares of common stock, tranche A warrants (“Common Tranche A Warrants”) to acquire 31,110 shares of common stock, tranche B warrants (“Common Tranche B Warrants”, together with the Common Tranche A Warrants, the “Common Warrants”) to acquire 16,666 shares of common stock. On March 29, 2023, the Company closed the Common Offering.

The aggregate exercise price of the Common Tranche A Warrants issued pursuant to the Common Offering is approximately $0.1 million.

On August 14, 2023, the Company announced the receipt of the FDA Approval and all Common Tranche A Warrants were exercised and converted into 31,110 shares of common stock.

The aggregate exercise price of the Common Tranche B Warrants issued in the Common Offering is approximately $0.1 million. The Common Tranche B Warrants are exercisable for an aggregate of 16,666 shares of common stock until the earlier of 21 days following the Company’s announcement of receipt of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO and March 31, 2026.

The Company determined that the outstanding Common Warrants should be liability-classified. See “Note 1 – Warrant Liabilities” for a discussion of the accounting treatment of the Common Warrants and Preferred Warrants.

Registration Rights for Preferred and Common Offerings

Pursuant to the Preferred Purchase Agreement and the Common Purchase Agreement (collectively, the “Purchase Agreements”), the Company filed a registration statement on Form S-3 (the “Resale Registration Statement”) providing for

the resale by the investors party thereto of the common stock issuable upon conversion of the Registrable Shares (as defined in the Purchase Agreements). The Resale Registration Statement became effective on June 28, 2023.

There is no established public trading market for the Series F Preferred Stock, the Preferred Warrants, or the Common Warrants and the Company does not intend to list such securities on any national securities exchange or nationally recognized trading system.

At-the-Market Offering

The Company has entered into a Controlled Equity OfferingSM Sales Agreement (“ATM Sales Agreement”), with Cantor Fitzgerald & Co. (the “Sales Agent”), pursuant to which the Company may offer and sell, at its sole discretion through the Sales Agent, shares of common stock having an aggregate offering price of up to $17.0 million. To date, the Company has sold approximately $4.0 million of its common stock, prior to issuance costs, under the ATM Sales Agreement. No sales were made during the three and nine months ended September 30, 2023.

Authorized Shares

In June 2023, stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the total number of shares of its common stock authorized for issuance from 40 million shares to 80 million shares. The Company is authorized to issue 80 million shares of common stock, $0.01 par value, and 10 million shares of preferred stock, $0.01 par value. As of September 30, 2023, the Company has designated the following preferred stock:


Designated Preferred Shares						September 30, 2023
Series A						4,200
Series B						2,360
Series C						590
Series D						10,000
Series E						40,000
Series E-1						12,960
Series F-1						24,900
Series F-2						24,900
Series F-3						34,860
Series F-4						24,900
Total						179,670

Preferred Stock

As of September 30, 2023, there were an aggregate of 11,257 shares of Series E and Series E-1, 4,903 Series F-2 and 21,627 Series F-3 Convertible Preferred Stock outstanding, respectively.

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. On June 12, 2023, the stockholders approved the amendment to the Company’s 2020 Plan to increase the number of shares of common stock available under the plan by 2.65 million shares. 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 September 30, 2023, there are 5,125,000 shares of common stock reserved under the 2020 Plan, of which 1,802,841 remained available to be issued.

In addition to options granted from the 2020 Plan, the Company also grants employment inducement grants pursuant to Listing Rule 5635(c) of the corporate governance rules of the NASDAQ Stock Market. These inducement grants are intended to provide incentive to certain individuals to enter into employment with the Company. Inducement grants are

granted outside of the 2020 Plan, however they are governed in all respects as if they were issued under the 2020 Plan. These grants do not reduce the number of options available for issuance under the 2020 Plan.

Stock Options

The following tables include information for all options granted including inducement grants that are granted outside of the 2020 Plan.

The Company values stock options using the Black-Scholes option pricing model and used the following assumptions, on a weighted-average basis, during the reporting periods:


	Nine Months Ended September 30,
	2023	2022
Expected terms (years)	5.7	5.4
Expected volatility	160.4%	164.3%
Risk-free interest rate	3.99%	1.86%
Expected dividends	0.00%	0.00%

The following is a summary of stock option activity for the nine months ended September 30, 2023:


	Number of Options	Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)	Aggregate Intrinsic Value
Outstanding at January 1, 2023	2,235,052	$	10.30	7.8	$	35,875
Granted	2,122,757	6.08		9.1
Exercised	(819)	4.67
Expired	(115,772)	8.80
Cancelled/Forfeited	(104,390)	7.22
Outstanding at September 30, 2023	4,136,828	$	8.26	8.5	$	72,850
Exercisable at September 30, 2023	2,020,026	$	10.29	7.7	$	—

The following table summarizes information for stock option shares outstanding and exercisable at September 30, 2023:


		Options Outstanding
Range of Exercise Prices	Outstanding Number of Options	Weighted Average Remaining Option Term (in years)	Number of Options
$2.83 - $51.50	4,136,329	8.5	4,136,329
$51.50+	499	5.3	499
	4,136,828	8.5	4,136,828

The following is a summary of share-based compensation expense in the statement of operations for the three and nine months ended September 30, 2023:


	Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands)	2023		2022		2023		2022
Selling, general and administrative	$	1,674	$	1,117	$	3,774	$	3,984
Research and development	1,027		458		2,095		1,872
Cost of goods sold	129		52		283		160
Total	$	2,830	$	1,627	$	6,152	$	6,016

At September 30, 2023, there was $7.7 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 2.4 years.

Common Stock Warrants

The following is a summary of common stock warrant activity for the nine months ended September 30, 2023:


	Warrants	Weighted Average Exercise Price		Weighted Average Remaining Life (in years)
Outstanding at January 1, 2023	5,153,291	$	7.01
Warrants issued	81,848	2.94
Warrants exercised	(569,938)	0.26
Outstanding at September 30, 2023	4,665,201	$	7.76	1.9
Exercisable at September 30, 2023	4,665,201	$	7.76	1.9

The following table presents information related to common stock warrants outstanding at September 30, 2023:


		Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants	Weighted Average Remaining Warrant Term (in years)	Number of Warrants
$0.01	1,037,792	3.4	1,037,792
$6.00	16,666	2.5	16,666
$10.00	3,610,743	1.4	3,610,743
	4,665,201	1.9	4,665,201

As of September 30, 2023, there were 538,828 warrants priced at $0.01 and 31,110 warrants priced at $4.50 exercised for 569,938 common shares.

Preferred Stock Warrants

The following is a summary of preferred stock warrant activity for the nine months ended September 30, 2023:


	Warrants	Weighted Average Exercise Price		Weighted Average Remaining Life (in years)
Outstanding at January 1, 2023	—	$	—
Warrants issued	59,759	1,000
Warrants exercised	(34,859)	1,000
Outstanding at September 30, 2023	24,900	$	1,000	2.5
Exercisable at September 30, 2023	24,900	$	1,000	2.5

Employee Stock Purchase Plan

In August 2021, the Company’s Board of Directors, with shareholder approval in May 2022, adopted the Employee Stock Purchase Plan (the “ESPP”). The ESPP provides for a maximum of 260,295 shares of common stock to be purchased by participating employees. Employees who elect to participate in the ESPP will be able to purchase common stock at the lower of 85% of the fair market value of common stock on the first or last day of the applicable six-month offering period. In January 2023, an aggregate of 15,417 shares were purchased by participating employees for the offering period of July 1, 2022 to December 31, 2022. In July 2023, an aggregate of 26,018 shares were purchased by participating employees for the offering period of January 1, 2023 to June 30, 2023.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 13
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481004/946-505-50-6

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
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-URI https://asc.fasb.org//1943274/2147480008/505-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (g)
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

+ Details

Net Loss per Share (Tables)

9 Months Ended

Sep. 30, 2023

Earnings Per Share [Abstract]

Antidilutive 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 September 30, 2023 and 2022 because their effects would be anti-dilutive:


	September 30,
	2023	2022
Common stock warrants	3,627,409	4,461,249
Assumed conversion of preferred stock warrants	4,149,994	—
Assumed conversion of preferred stock	7,417,473	1,135,721
Assumed conversion of convertible notes	488,031	488,031
Stock options	4,136,828	2,249,955
Total	19,819,735	8,334,956

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 and nine months ended September 30, 2023 and 2022:


	Three months ended September 30,		Nine months ended September 30,
	2023	2022	2023	2022
Weighted average shares issued	16,825,286	8,470,006	12,745,035	8,096,551
Weighted average pre-funded warrants	1,037,792	745,780	1,240,213	439,455
Weighted average shares outstanding	17,863,078	9,215,786	13,985,248	8,536,006

Prepaid Expenses and Other Current Assets

9 Months Ended

Sep. 30, 2023

Prepaid Expense and Other Assets, Current [Abstract]

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following:


(In thousands)	September 30, 2023		December 31, 2022
Clinical trial expenses	$	1,630	$	1,630
Insurance premiums	71		123
Professional services	655		121
Other	356		95
Total prepaid expenses and other current assets	$	2,712	$	1,969

Stockholders' Equity - Preferred Stock Warrants (Details) - Preferred Warrants - $ / shares	9 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Class of Warrant or Right [Line Items]
Outstanding Number of Warrants (in shares)	24,900	0
Class Of Warrant Or Right Weighted Average Exercise Price	$ 1,000	$ 0
Warrants issued (in shares)	59,759
Warrants issued (in dollars per share)	$ 1,000
Warrants exercised (in shares)	34,859
Warrants exercised (in dollars per share)	$ 1,000
Warrants Exercisable, Weighted Average Remaining Warrant Term (in years)	2 years 6 months
Warrants Exercisable, Number of Warrants (in shares)	24,900
Warrants Exercisable, Weighted Average Exercise Price	$ 1,000
Weighted Average Remaining Life, Exercisable	2 years 6 months

Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Dec. 31, 2022	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2021
Statement of Stockholders' Equity [Abstract]
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01

Cash, Cash Equivalents and Restricted Cash (Tables)

9 Months Ended

Sep. 30, 2023

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)	September 30, 2023		December 31, 2022
Cash and cash equivalents	$	40,462	$	7,671
Restricted balance for loan agreement	—		4,000
Letters of credit	—		101
Security for credit cards	50		50
Total cash, cash equivalents and restricted cash shown in the statements of cash flows	$	40,512	$	11,822

Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Debt Instrument [Line Items]
Gross	$ 10,610	$ 16,923
Less Current Portion, Net	5,080	7,846
Total - Loans Payable, Non-Current, Net	$ 0	$ 3,070
Percentage of final payment included in gross amount	4.25%	4.25%
Final payment	$ 500	$ 500
Loans Payable
Debt Instrument [Line Items]
Gross	5,610	11,923
Discount	(530)	(1,008)
Net	5,080	10,916
Less Current Portion, Gross	5,610	8,570
Less Current Portion, Discount	(530)	(724)
Less Current Portion, Net	5,080	7,846
Total - Loans Payable, Non-Current, Gross	0	3,353
Total - Loans Payable, Non-Current, Discount	0	(284)
Total - Loans Payable, Non-Current, Net	0	3,070
Convertible Notes Payable
Debt Instrument [Line Items]
Gross	5,000	5,000
Discount	(124)	(228)
Net	4,876	4,772
Notes And Loans Payable, Net, Current	2,876	0
Less Current Portion, Gross	3,000	0
Less Current Portion, Discount	(124)	0
Notes And Loans Payable, Net, Noncurrent	2,000	4,772
Total - Loans Payable, Non-Current, Gross	2,000	5,000
Total - Loans Payable, Non-Current, Discount	$ 0	$ (228)

General

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

General

The unaudited interim condensed consolidated financial statements of Delcath Systems, Inc. (“Delcath” or the “Company”) as of and for the three and nine months ended September 30, 2023 and 2022 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, 2022 (the “Annual Report”), which was filed with the Securities and Exchange Commission (the “SEC”) on March 27, 2023 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, the HEPZATO KITTM (“HEPZATO” melphalan for Injection/Hepatic Delivery System), a drug/device combination product, was approved by the U.S. Food and Drug Administration (the “FDA”) on August 14, 2023 indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver with no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. 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.

In the United States, HEPZATO is considered a combination drug and device product and is regulated as a drug by the FDA. Primary jurisdiction for regulation of HEPZATO has been assigned to the FDA’s Center for Drug Evaluation and Research. The FDA has granted Delcath six orphan drug designations (five for melphalan in the treatment of patients with ocular (uveal) melanoma, cutaneous melanoma, intrahepatic cholangiocarcinoma, hepatocellular carcinoma, and neuroendocrine tumor indications and one for doxorubicin in the treatment of patients with hepatocellular carcinoma).

The Company’s clinical development program for HEPZATO was comprised of the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the “FOCUS Trial”), a global registration clinical trial that investigated objective response rate in metastatic ocular melanoma (“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 that will maximize the value of the HEPZATO platform. In addition to HEPZATO’s approved use to treat mOM, the Company believes that HEPZATO has the potential to treat other liver dominant cancers, such as Metastatic Colorectal Cancer and Cholangiocarcinoma, and plans to begin the study of HEPZATO to treat such conditions in the near future. The Company believes that the disease states it is investigating and intends to investigate are unmet medical needs that represent significant market opportunities.

As the Company prepares for commercial launch of HEPZATO, the Company continues its expanded access program (“EAP”) in the United States to make HEPZATO readily available to mOM patients. The Company is focused on continuing to treat these patients enrolled in the EAP sites.

On February 28, 2022, CHEMOSAT received Medical Device Regulation (“MDR”) 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

Liquidity and Going Concern

Basis of Presentation

Significant Accounting Policies

Other than the policies listed below, 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, 2022.

Warrant Liabilities

then the contract should be classified as an asset or a liability at their fair value at issuance with subsequent changes in fair value recorded in earnings.

Recently Adopted and Issued Accounting Pronouncements

We have not been required to adopt any accounting standards that had a significant impact on our consolidated financial statements in the two years ended December 31, 2022. We do not expect any recently issued accounting standards to have a significant impact on our consolidated financial statements.

Revision of Previously Issued Quarterly Financial Statements


(In thousands)	As previously reported		Adjustment		As revised
Balance Sheet for September 30, 2022 (unaudited)
Additional paid-in capital	$	442,066	$	1,671	$	443,737
Accumulated deficit	$	(447,341)	$	(1,671)	$	(449,012)

Consolidated Statement of Operations and Comprehensive Loss for the three months ended September 30, 2022 (unaudited)
Research and development expenses	$	3,953	$	112	$	4,065
Selling, general and administrative expenses	4,519		260		4,779
Total operating expenses	8,472		372		8,844
Operating loss	(7,801)		(372)		(8,173)
Net loss	(8,505)		(372)		(8,877)
Total other comprehensive loss	(8,551)		(372)		(8,923)
Basic and diluted loss per common share	$	(0.92)	$	(0.04)	$	(0.96)

Consolidated Statement of Operations and Comprehensive Loss for the nine months September 30, 2022 (unaudited)
Research and development expenses	$	13,649	$	503	$	14,152
Selling, general and administrative expenses	12,309		1,168		13,477
Total operating expenses	25,958		1,671		27,629
Operating loss	(24,327)		(1,671)		(25,998)
Net loss	(26,365)		(1,671)		(28,036)
Total other comprehensive loss	(26,447)		(1,671)		(28,118)
Basic and diluted loss per common share	$	(3.09)	$	(0.20)	$	(3.29)

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

Consolidated statement of Stockholders’ Equity (Deficit) for the nine months ended September 30, 2022 (unaudited)
Compensation expense for issuance of stock options	$	4,345	$	1,671	$	6,016
Net loss	$	(26,365)	$	(1,671)	$	(28,036)

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

Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Sep. 30, 2022	Dec. 31, 2021
Cash and Cash Equivalents [Abstract]
Cash and cash equivalents	$ 40,462	$ 7,671
Restricted balance for loan agreement	0	4,000
Letters of credit	0	101
Security for credit cards	50	50
Total cash, cash equivalents and restricted cash shown in the statements of cash flows	$ 40,512	$ 11,822	$ 13,982	$ 26,953

Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 6,391	$ 6,353
Accumulated depreciation	(5,017)	(4,931)
Property, plant and equipment, net	1,374	1,422
Buildings and land
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,301	1,301
Buildings
Property Plant And Equipment [Line Items]
Estimated Useful Life	30 years
Enterprise hardware and software
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,855	1,855
Estimated Useful Life	3 years
Leaseholds
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,772	1,774
Estimated Useful Life	Useful Life, Shorter of Lease Term or Asset Utility [Member]
Equipment
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,262	1,222
Estimated Useful Life	7 years
Furniture
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 201	$ 201
Estimated Useful Life	5 years

Preferred Purchase Agreement	9 Months Ended
Preferred Purchase Agreement	Sep. 30, 2023
Preferred Purchase Agreement [Abstract]
Preferred Purchase Agreement	Preferred Purchase Agreement On March 27, 2023, we entered into a securities purchase agreement with certain accredited investors (the “Preferred Purchase Agreement”), pursuant to which on March 29, 2023, the Company issued and sold, in a private placement (the “Series F Preferred Offering”), (i) 24,900 shares of Series F-1 Convertible Preferred Stock, par value $0.01 per share (the “Series F-1 Preferred Stock”), (ii) tranche A warrants (the “Preferred Tranche A Warrants”) to acquire 34,859 shares of Series F-3 Convertible Preferred Stock, par value $0.01 per share (the “Series F-3 Preferred Stock”) and (iii) tranche B warrants (the “Preferred Tranche B Warrants,” together with the Preferred Tranche A Warrant, the “Preferred Warrants”) to acquire 24,900 shares of Series F-4 Convertible Preferred Stock, par value $0.01 per share (the “Series F-4 Preferred Stock”) for an aggregate offering price of $24.9 million before deducting the fees paid to the placement agent and the financial advisors and other financing expenses payable by the Company. The gross proceeds of $24.9 million from the Series F Preferred Offering have been allocated first to the Preferred Warrant liabilities at their fair value of $4.9 million, with the residual of $20.0 million being allocated to the Series F-1 Preferred Stock. During the three months ended September 30, 2023, all of the Preferred Tranche A Warrants were exercised for an aggregate exercise price of $34.9 million into 34,859 shares of Series F-3 Preferred Stock and 13,232 shares of Series F-3 Preferred Stock were concurrently converted into 2,940,440 shares of common stock (in accordance with the beneficial ownership limitations then in effect). The Preferred Tranche B Warrants are exercisable for 24,900 shares of Series F-4 Preferred Stock, with an aggregate exercise price of $24.9 million until the earlier of (i) 21 days following the Company's announcement of receipt of at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO and (ii) March 31, 2026. Following stockholder approval, pursuant to the Certificate of Designation of Preferences, Rights and Limitations of the Series F Convertible Voting Preferred Stock (the “Certificate of Designation”), each share of Series F-1 Preferred Stock automatically converted into shares of common stock and/or, if applicable (in accordance with the beneficial ownership limitations then in effect), shares of Series F-2 Preferred Stock, par value $0.01 per share (the “Series F-2 Preferred Stock” and, together with the Series F-1 Preferred Stock, the Series F-3 Preferred Stock and the Series F-4 Preferred Stock, the “Series F Preferred Stock”) in lieu of common stock. Subject to limitations set forth in the Certificate of Designation, the shares of Series F-2, F-3 and F-4 Preferred Stock are convertible into common stock at the option of the holder at the conversion price of $3.30 per share, $4.50 per share and $6.00 per share, respectively, rounded down to the nearest whole share, and in each case subject to the terms and limitations contained in the Certificate of Designation. As of September 30, 2023, 33,229 shares of the Company's Series F-1, F-2 and F-3 Preferred Stock were converted into 9,000,582 shares of common stock. As of September 30, 2023, there were 4,903 shares of Series F-2 Preferred Stock, 21,627 shares of Series F-3 Preferred Stock and no shares of Series F-4 Preferred Stock outstanding. The Series F-2, F-3 and F-4 Preferred Stock are not mandatorily redeemable, redeemable at the holder’s election or contingently redeemable at the holder’s election (at this point, a Deemed Liquidation Event would potentially trigger pro rata liquidation payments to the preferred and common stockholders on a pro rata “as converted” basis). Accordingly, the Series F-2, F-3 and F-4 Preferred are now classified as permanent equity. The Company determined that the outstanding Preferred Warrants should be liability-classified. See “Note 1 – Warrant Liabilities” for a discussion of the accounting treatment of the Common Warrants and Preferred Warrants.

Stockholders' Equity - Designated Preferred Shares (Details)	Sep. 30, 2023 shares
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	179,670
Series A
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	4,200
Series B
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	2,360
Series C
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	590
Series D
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	10,000
Series E
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	40,000
Series E-1
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	12,960
Series F-1
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	24,900
Series F-2
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	24,900
Series F-3
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	34,860
Series F-4
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	24,900

Leases - Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands	Sep. 30, 2023 USD ($)
Lessee Lease Description [Line Items]
Year ended December 31, 2023	$ 11
Year ended December 31, 2024	42
Year ended December 31, 2025	42
Year ended December 31, 2026	25
Total	120
Less present value discount	(13)
Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2023	107
U.S.
Lessee Lease Description [Line Items]
Year ended December 31, 2023	0
Year ended December 31, 2024	0
Year ended December 31, 2025	0
Year ended December 31, 2026	0
Total	0
Less present value discount	0
Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2023	0
Ireland
Lessee Lease Description [Line Items]
Year ended December 31, 2023	11
Year ended December 31, 2024	42
Year ended December 31, 2025	42
Year ended December 31, 2026	25
Total	120
Less present value discount	(13)
Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2023	$ 107

Fair Value Measurements - Schedule of Fair Value of Outstanding Warrants (Details) - Valuation Technique, Option Pricing Model - Preferred And Common Warrants	Sep. 30, 2023	Mar. 29, 2023
Risk free interest rate \| Minimum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants measurement input		0.0380
Risk free interest rate \| Maximum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants measurement input	0.0480	0.0480
Expected term (years) \| Minimum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Expected term		6 months
Expected term (years) \| Maximum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Expected term	2 years 6 months	3 years
Expected volatility \| Minimum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants measurement input		0.70
Expected volatility \| Maximum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants measurement input	0.70	0.75
Expected dividends
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants measurement input	0.0000	0.0000

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2023

Payables and Accruals [Abstract]

Schedule of Accrued Expenses

Accrued expenses consist of the following:


(In thousands)	September 30, 2023		December 31, 2022
Clinical expenses	$	2,105	$	1,470
Compensation, excluding taxes	1,535		1,040
Professional fees	61		1,087
Interest on convertible note	673		553
Other	856		535
Total accrued expenses	$	5,230	$	4,685

Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands	Total	Preferred F-1 Stock	Preferred F-2 Stock	Preferred F-3 Stock	Common Stock	Common Stock Preferred F-1 Stock	Common Stock Preferred F-2 Stock	Common Stock Preferred F-3 Stock	Common Stock Preferred Series E Stock	Preferred Stock	Preferred Stock Preferred F-2 Stock	Preferred Stock Preferred F-3 Stock	Preferred Stock Preferred Series E Stock	Additional Paid in Capital	Additional Paid in Capital Preferred F-1 Stock	Additional Paid in Capital Preferred F-2 Stock	Additional Paid in Capital Preferred F-3 Stock	Accumulated Deficit	Accumulated Other Comprehensive Income (Loss)
Beginning Balance (in shares) at Dec. 31, 2021					7,906,728					11,357
Beginning Balance at Dec. 31, 2021	$ 11,952				$ 79					$ 0				$ 432,831				$ (420,976)	$ 18
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	2,271													2,271
Net loss	(9,000)																	(9,000)
Total comprehensive income	2																		2
Ending Balance (in shares) at Mar. 31, 2022					7,906,728					11,357
Ending Balance at Mar. 31, 2022	5,225				$ 79					$ 0				435,102				(429,976)	20
Beginning Balance (in shares) at Dec. 31, 2021					7,906,728					11,357
Beginning Balance at Dec. 31, 2021	11,952				$ 79					$ 0				432,831				(420,976)	18
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	(28,036)
Ending Balance (in shares) at Sep. 30, 2022					8,597,682					11,357
Ending Balance at Sep. 30, 2022	(5,246)				$ 86					$ 0				443,737				(449,012)	(57)
Beginning Balance (in shares) at Mar. 31, 2022					7,906,728					11,357
Beginning Balance at Mar. 31, 2022	5,225				$ 79					$ 0				435,102				(429,976)	20
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	2,119													2,119
Net loss	(10,159)																	(10,159)
Total comprehensive income	(31)																		(31)
Ending Balance (in shares) at Jun. 30, 2022					7,906,728					11,357
Ending Balance at Jun. 30, 2022	(2,846)				$ 79					$ 0				437,221				(440,135)	(11)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	1,627													1,627
Private placement - issuance of common stock and prefunded warrants, net of expense (in shares)					690,954
Private placement - issuance of common stock and prefunded warrants, net of expense	4,896				$ 7									4,889
Net loss	(8,877)																	(8,877)
Total comprehensive income	(46)																		(46)
Ending Balance (in shares) at Sep. 30, 2022					8,597,682					11,357
Ending Balance at Sep. 30, 2022	(5,246)				$ 86					$ 0				443,737				(449,012)	(57)
Beginning Balance (in shares) at Dec. 31, 2022					10,046,571					11,357
Beginning Balance at Dec. 31, 2022	(5,859)				$ 100					$ 0				451,608				(457,484)	(83)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	1,661													1,661
Private placement -issuance of common shares, net of expenses (in shares)					19,646
Private placement -issuance of common shares, net of expenses	56				$ 1									55
Issuance of common stock with the employee stock purchase plan (in shares)					15,417
Issuance of common stock with the employee stock purchase plan	47													47
Net loss	(9,000)																	(9,000)
Total comprehensive income	19																		19
Ending Balance (in shares) at Mar. 31, 2023					10,081,634					11,357
Ending Balance at Mar. 31, 2023	(13,076)				$ 101					$ 0				453,371				(466,484)	(64)
Beginning Balance (in shares) at Dec. 31, 2022					10,046,571					11,357
Beginning Balance at Dec. 31, 2022	$ (5,859)				$ 100					$ 0				451,608				(457,484)	(83)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock related to stock option exercises (in shares)	819
Net loss	$ (36,542)
Ending Balance (in shares) at Sep. 30, 2023					19,688,991					37,787
Ending Balance at Sep. 30, 2023	24,719				$ 197					$ 0				518,607				(494,026)	(59)
Beginning Balance (in shares) at Mar. 31, 2023					10,081,634					11,357
Beginning Balance at Mar. 31, 2023	(13,076)				$ 101					$ 0				453,371				(466,484)	(64)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	1,661													1,661
Stock issued during period (in shares)											9,624
Stock issued during the period			$ 7,099													$ 7,099
Conversion of shares (in shares)					538,828	4,629,539
Conversion of shares	5	$ 11,269			$ 5	$ 47									$ 11,222
Issuance of common stock related to stock option exercises (in shares)					468
Issuance of common stock related to stock option exercises	2													2
Net loss	(7,202)																	(7,202)
Total comprehensive income	0																		0
Ending Balance (in shares) at Jun. 30, 2023					15,250,469					20,981
Ending Balance at Jun. 30, 2023	(242)				$ 153					$ 0				473,355				(473,686)	(64)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options	2,783													2,783
Stock issued during period (in shares)												34,859
Stock issued during the period				$ 42,388													$ 42,388
Conversion of shares (in shares)					31,110		1,430,603	2,940,440	10,000		(4,721)	(13,232)	(100)
Conversion of shares			$ 0	$ 1			$ 14	$ 30								$ (14)	$ (29)
Issuance of common stock with the employee stock purchase plan (in shares)					26,018
Issuance of common stock with the employee stock purchase plan	76													76
Issuance of common stock related to stock option exercises (in shares)					351
Issuance of common stock related to stock option exercises	1													1
Compensation expense for issuance of employee stock purchase plan	47													47
Net loss	(20,340)																	(20,340)
Total comprehensive income	5																		5
Ending Balance (in shares) at Sep. 30, 2023					19,688,991					37,787
Ending Balance at Sep. 30, 2023	$ 24,719				$ 197					$ 0				$ 518,607				$ (494,026)	$ (59)

Loans and Convertible Notes Payable - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands						3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Aug. 14, 2023	Mar. 31, 2023	Mar. 15, 2023	Aug. 06, 2021	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Debt Instrument [Line Items]
Restricted Cash	$ 50					$ 50	$ 4,151	$ 50	$ 4,151
Principal payment								6,313	0
Final payment								500		$ 500
Proceeds from exercise of warrants								35,004	0
Interest expense incurred (less than)						$ 300	400	$ 1,100	1,300
Preferred Tranche A Warrant
Debt Instrument [Line Items]
Proceeds from exercise of warrants		$ 10,000
Series E
Debt Instrument [Line Items]
Debt instrument, conversion price (in dollars per share)	$ 1,500					$ 1,500		$ 1,500
Secured Convertible Notes Payable
Debt Instrument [Line Items]
Debt instrument, principal face amount	$ 2,000					$ 2,000		$ 2,000
Secured Convertible Notes Payable \| Series E
Debt Instrument [Line Items]
Debt instrument, conversion price (in dollars per share)					$ 1,198
Avenue Loan
Debt Instrument [Line Items]
Debt instrument, principal face amount					$ 3,000
Interest rate					7.70%
Debt instrument, interest rate	16.20%				10.95%
Initial tranche of loan					$ 15,000
Loan amount funded into restricted account					$ 4,000
Restricted Cash				$ 4,000
Principal payment				$ 2,100
Debt instrument, incremental final payment, percentage				4.25%
Final payment				$ 200
Debt instrument, conversion price (in dollars per share)					$ 11.98
Amortization of debt discount						$ 200	$ 200	600	600
Avenue Loan \| Warrant
Debt Instrument [Line Items]
Warrants issued to purchase of common stock (in shares)					127,755
Warrant exercise price (in dollars per share)					$ 0.01
Avenue Loan \| Condition for the Extension of Period of Interest Only Payments
Debt Instrument [Line Items]
Estimated minimum proceeds on issue of common stock for extension of due date of interest only interest payments			$ 10,000
Warrant exercise price (in dollars per share)			$ 0.01
Number of warrants outstanding (in shares)			34,072
Rosalind Notes \| Convertible Debt
Debt Instrument [Line Items]
Interest expense incurred (less than)								$ 100	$ 100
Rosalind Notes \| Convertible Notes Payable
Debt Instrument [Line Items]
Interest rate	8.00%					8.00%		8.00%
Maximum \| Avenue Loan
Debt Instrument [Line Items]
Debt instrument, principal face amount					$ 20,000

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Current assets
Cash and cash equivalents	$ 40,462	$ 7,671
Restricted cash	50	4,151
Accounts receivable, net	205	366
Inventory	2,667	1,998
Prepaid expenses and other current assets	2,712	1,969
Total current assets	46,096	16,155
Property, plant and equipment, net	1,374	1,422
Right-of-use assets	107	285
Total assets	47,577	17,862
Current liabilities
Accounts payable	753	2,018
Accrued expenses	5,230	4,685
Lease liabilities, current	35	186
Loan payable, current	5,080	7,846
Convertible notes payable, current	2,876	0
Total current liabilities	13,974	14,735
Warrant liability	5,773	0
Other liabilities, non-current	1,111	1,144
Loan payable, non-current	0	3,070
Convertible notes payable, non-current	2,000	4,772
Total liabilities	22,858	23,721
Commitments and contingencies (see note 13)
Stockholders’ equity (deficit)
Preferred stock, $0.01 par value; 10,000,000 shares authorized; 37,787 and 11,357 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively	0	0
Common stock, $0.01 par value; 80,000,000 shares authorized; 19,688,991 shares and 10,046,571 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively	197	100
Additional paid-in capital	518,607	451,608
Accumulated deficit	(494,026)	(457,484)
Accumulated other comprehensive loss	(59)	(83)
Total stockholders’ equity (deficit)	24,719	(5,859)
Total liabilities and stockholders’ equity	$ 47,577	$ 17,862

General - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended			9 Months Ended
General - Narrative (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022	Mar. 29, 2023	Dec. 31, 2022
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Cash cash equivalents and restricted cash				$ 40,500			$ 11,800
Net Cash Provided by (Used in) Operating Activities				(23,073)	$ (17,591)
Principal payments				6,300
Deferred revenue				10,000		$ 10,000
Impact of share-based compensation correction on net income (loss)	$ 400	$ 500	$ 800
Accounts Payable Accrued Expenses And Lease Liabilities
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Current capital commitments				6,000
Loan Principal Payments
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Current capital commitments				8,600
Lease Liabilities
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Noncurrent capital commitments				100
Third Party Settlement
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Noncurrent capital commitments				1,000
Convertible Note Principal Payments
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Noncurrent capital commitments				$ 2,000

Stockholders' Equity - Authorized Shares and Preferred Stock (Details) - $ / shares	Sep. 30, 2023	Jun. 30, 2023	May 31, 2023	Mar. 31, 2023	Dec. 31, 2022	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2021
Stockholders Equity Note [Line Items]
Common stock, shares authorized (in shares)	80,000,000	80,000,000	40,000,000		80,000,000
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01		$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Preferred stock, shares authorized (in shares)	10,000,000				10,000,000
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01		$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Preferred stock, shares outstanding (in shares)	37,787				11,357
Series E
Stockholders Equity Note [Line Items]
Preferred stock, shares outstanding (in shares)	11,257
Series E-1
Stockholders Equity Note [Line Items]
Preferred stock, shares outstanding (in shares)	11,257
Series F-2
Stockholders Equity Note [Line Items]
Preferred stock, par value (in dollars per share)	$ 3.30
Preferred stock, shares outstanding (in shares)	4,903
Series F-3
Stockholders Equity Note [Line Items]
Preferred stock, par value (in dollars per share)	$ 4.50
Preferred stock, shares outstanding (in shares)	21,627

Stockholders' Equity - Summary of Stock Option Shares Outstanding and Exercisable (Details) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options (in shares)	4,136,828	2,235,052
Weighted Average Remaining Option Term (in years), Options Outstanding	8 years 6 months	7 years 9 months 18 days
Number of Options Exercisable (in shares)	2,020,026
$2.83 - $51.50
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding Number of Options (in shares)	4,136,329
Weighted Average Remaining Option Term (in years), Options Outstanding	8 years 6 months
$2.83 - $51.50 \| Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Range of Exercise Prices (in dollars per share)	$ 51.50
$2.83 - $51.50 \| Minimum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Range of Exercise Prices (in dollars per share)	2.83
$51.50+
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Range of Exercise Prices (in dollars per share)	$ 51.50
Outstanding Number of Options (in shares)	499
Weighted Average Remaining Option Term (in years), Options Outstanding	5 years 3 months 18 days

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Name Accounting Standards Codification
-Section 35
-Paragraph 1D
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Net Loss per Share - Narrative (Details)	9 Months Ended
Net Loss per Share - Narrative (Details)	Sep. 30, 2023 shares
Earnings Per Share [Abstract]
Pre-funded penny warrants outstanding	1,037,792

Loans and Convertible Notes Payable - Summary of Remaining Maturities of Company's Loan and Convertible Note Payables (Details) $ in Thousands	Sep. 30, 2023 USD ($)
Debt Instrument [Line Items]
Loans	$ 5,610
Convertible Notes	5,000
Total	10,610
Year ended December 31, 2023
Debt Instrument [Line Items]
Loans	0
Convertible Notes	0
Total	0
Year ended December 31, 2024
Debt Instrument [Line Items]
Loans	5,610
Convertible Notes	5,000
Total	$ 10,610

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

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

Cash, Cash Equivalents and Restricted Cash

9 Months Ended

Sep. 30, 2023

Cash and Cash Equivalents [Abstract]

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.

Cash, cash equivalents, and restricted cash balances were as follows:


(In thousands)	September 30, 2023		December 31, 2022
Cash and cash equivalents	$	40,462	$	7,671
Restricted balance for loan agreement	—		4,000
Letters of credit	—		101
Security for credit cards	50		50
Total cash, cash equivalents and restricted cash shown in the statements of cash flows	$	40,512	$	11,822

On March 15, 2023, the Company returned to Avenue (as defined below) the $4.0 million held in restricted cash to pay down a portion of the outstanding Avenue Loan (defined below) balance. On March 31, 2023, the letter of credit for the sub-lease agreement for office space at 1633 Broadway, New York, NY expired.

Preferred Purchase Agreement (Details) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended	9 Months Ended
	Mar. 29, 2023	Sep. 30, 2023	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Dec. 31, 2022	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2021
Disclosure Of Preferred Purchase Agreement [Line Items]
Preferred stock, par value (in dollars per share)		$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Fair value of warrant liabilities		$ 7,044	$ 7,044			$ 1,280
Deferred revenue	$ 10,000	$ 10,000	$ 10,000
Preferred stock, shares outstanding (in shares)		37,787	37,787			11,357
Preferred Warrant Liabilities
Disclosure Of Preferred Purchase Agreement [Line Items]
Proceeds from issuance of warrants	24,900
Fair value of warrant liabilities	$ 4,900
Preferred Purchase Agreement \| Preferred Tranche A Warrant
Disclosure Of Preferred Purchase Agreement [Line Items]
Number of exercisable preferred warrants (in shares)		34,859
Aggregate exercise price of preferred warrants		$ 34,900
Preferred Purchase Agreement \| Preferred Tranche B Warrant
Disclosure Of Preferred Purchase Agreement [Line Items]
Number of exercisable preferred warrants (in shares)	24,900
Aggregate exercise price of preferred warrants		$ 24,900
Warrant exercise period		21 days
Preferred Purchase Agreement \| Series F-1
Disclosure Of Preferred Purchase Agreement [Line Items]
Number of exercisable preferred warrants (in shares)	24,900
Preferred Purchase Agreement \| Series F-4
Disclosure Of Preferred Purchase Agreement [Line Items]
Number of exercisable preferred warrants (in shares)		24,900
Series F-1 \| Preferred Warrant Liabilities
Disclosure Of Preferred Purchase Agreement [Line Items]
Proceeds from issuance of warrants	$ 20,000
Series F-1 \| Preferred Purchase Agreement
Disclosure Of Preferred Purchase Agreement [Line Items]
Preferred stock, par value (in dollars per share)	$ 0.01
Series F-3
Disclosure Of Preferred Purchase Agreement [Line Items]
Preferred stock, par value (in dollars per share)		$ 4.50	$ 4.50
Preferred stock, shares outstanding (in shares)		21,627	21,627
Series F-3 \| Preferred Tranche A Warrant
Disclosure Of Preferred Purchase Agreement [Line Items]
Number of exercisable preferred warrants (in shares)	34,859
Series F-3 \| Preferred Purchase Agreement
Disclosure Of Preferred Purchase Agreement [Line Items]
Preferred stock, par value (in dollars per share)	$ 0.01
Series F1, Series F2 and F3 Preferred Stock
Disclosure Of Preferred Purchase Agreement [Line Items]
Conversion of shares (in shares)			33,229
Common Stock
Disclosure Of Preferred Purchase Agreement [Line Items]
Number of shares converted (in shares)		9,000,582	9,000,582
Common Stock \| Preferred Purchase Agreement
Disclosure Of Preferred Purchase Agreement [Line Items]
Number of shares converted (in shares)		2,940,440	2,940,440
Common Stock \| Preferred Purchase Agreement \| Preferred Tranche A Warrant
Disclosure Of Preferred Purchase Agreement [Line Items]
Conversion of shares (in shares)		13,232
Series F-4
Disclosure Of Preferred Purchase Agreement [Line Items]
Preferred stock, par value (in dollars per share)		$ 6.00	$ 6.00
Preferred stock, shares outstanding (in shares)		0	0
Series F-4 \| Preferred Purchase Agreement
Disclosure Of Preferred Purchase Agreement [Line Items]
Preferred stock, par value (in dollars per share)	$ 0.01
Series F-2
Disclosure Of Preferred Purchase Agreement [Line Items]
Preferred stock, par value (in dollars per share)		$ 3.30	$ 3.30
Preferred stock, shares outstanding (in shares)		4,903	4,903
Series F-2 \| Preferred Purchase Agreement
Disclosure Of Preferred Purchase Agreement [Line Items]
Preferred stock, par value (in dollars per share)		$ 0.01	$ 0.01

Property, Plant, and Equipment

9 Months Ended

Sep. 30, 2023

Property, Plant and Equipment [Abstract]

Property, Plant, and Equipment

Property, plant, and equipment consist of the following:


(In thousands)	September 30, 2023		December 31, 2022		Estimated Useful Life
Buildings and land	$	1,301	$	1,301	30 years - Buildings
Enterprise hardware and software	1,855		1,855		3 years
Leaseholds	1,772		1,774		Lesser of lease term or estimated useful life
Equipment	1,262		1,222		7 years
Furniture	201		201		5 years
Property, plant and equipment, gross	6,391		6,353
Accumulated depreciation	(5,017)		(4,931)
Property, plant and equipment, net	$	1,374	$	1,422

Depreciation expense for the three and nine months ended September 30, 2023 and 2022 was less than $0.1 million for each period.

Loans and Convertible Notes Payable (Tables)

9 Months Ended

Sep. 30, 2023

Debt Disclosure [Abstract]

Summary of Loans and Convertible Notes Payable


	September 30, 2023						December 31, 2022
	Gross		Discount		Net		Gross		Discount		Net
Loans Payable, Current	5,610		(530)		5,080		8,570		(724)		7,846
Loans Payable, Non-Current	—		—		—		3,353		(284)		3,070
Total - Loans Payable1	$	5,610	$	(530)	$	5,080	$	11,923	$	(1,008)	$	10,916

Convertible Notes Payable - Current	$	3,000	$	(124)	$	2,876	$	—	$	—	$	—
Convertible Notes Payable - Non-Current	$	2,000	$	—	$	2,000	$	5,000	$	(228)	$	4,772
Total - Convertible Notes Payable	$	5,000	$	(124)	$	4,876	$	5,000	$	(228)	$	4,772

Total - Loans and Notes Payable	10,610						16,923

1 The gross amount includes the 4.25% final payment of $0.5 million.

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, 2023	$	—	$	—	$	—
Year ended December 31, 2024	5,610		5,000		10,610
Total	$	5,610	$	5,000	$	10,610

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

+ References

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

Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Payables and Accruals [Abstract]
Clinical expenses	$ 2,105	$ 1,470
Compensation, excluding taxes	1,535	1,040
Professional fees	61	1,087
Interest on convertible note	673	553
Other	856	535
Total accrued expenses	$ 5,230	$ 4,685

Net Loss per Share

9 Months Ended

Sep. 30, 2023

Earnings Per Share [Abstract]

Net Loss per 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, convertible preferred shares, and preferred and common 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 September 30, 2023 and 2022 because their effects would be anti-dilutive:


	September 30,
	2023	2022
Common stock warrants	3,627,409	4,461,249
Assumed conversion of preferred stock warrants	4,149,994	—
Assumed conversion of preferred stock	7,417,473	1,135,721
Assumed conversion of convertible notes	488,031	488,031
Stock options	4,136,828	2,249,955
Total	19,819,735	8,334,956

At September 30, 2023, the Company had 1,037,792 pre-funded warrants outstanding. The following table provides a reconciliation of the weighted average shares outstanding calculation for the three and nine months ended September 30, 2023 and 2022:


	Three months ended September 30,		Nine months ended September 30,
	2023	2022	2023	2022
Weighted average shares issued	16,825,286	8,470,006	12,745,035	8,096,551
Weighted average pre-funded warrants	1,037,792	745,780	1,240,213	439,455
Weighted average shares outstanding	17,863,078	9,215,786	13,985,248	8,536,006

Stockholders' Equity (Tables)

9 Months Ended

Sep. 30, 2023

Stockholders' Equity Note [Abstract]

Schedule of Designated Preferred Units

As of September 30, 2023, the Company has designated the following preferred stock:


Designated Preferred Shares						September 30, 2023
Series A						4,200
Series B						2,360
Series C						590
Series D						10,000
Series E						40,000
Series E-1						12,960
Series F-1						24,900
Series F-2						24,900
Series F-3						34,860
Series F-4						24,900
Total						179,670

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

The Company values stock options using the Black-Scholes option pricing model and used the following assumptions, on a weighted-average basis, during the reporting periods:


	Nine Months Ended September 30,
	2023	2022
Expected terms (years)	5.7	5.4
Expected volatility	160.4%	164.3%
Risk-free interest rate	3.99%	1.86%
Expected dividends	0.00%	0.00%

Summary of Stock Option Activity

The following is a summary of stock option activity for the nine months ended September 30, 2023:


	Number of Options	Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)	Aggregate Intrinsic Value
Outstanding at January 1, 2023	2,235,052	$	10.30	7.8	$	35,875
Granted	2,122,757	6.08		9.1
Exercised	(819)	4.67
Expired	(115,772)	8.80
Cancelled/Forfeited	(104,390)	7.22
Outstanding at September 30, 2023	4,136,828	$	8.26	8.5	$	72,850
Exercisable at September 30, 2023	2,020,026	$	10.29	7.7	$	—

Summary of Stock Option Shares Outstanding and Exercisable

The following table summarizes information for stock option shares outstanding and exercisable at September 30, 2023:


		Options Outstanding
Range of Exercise Prices	Outstanding Number of Options	Weighted Average Remaining Option Term (in years)	Number of Options
$2.83 - $51.50	4,136,329	8.5	4,136,329
$51.50+	499	5.3	499
	4,136,828	8.5	4,136,828

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 and nine months ended September 30, 2023:


	Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands)	2023		2022		2023		2022
Selling, general and administrative	$	1,674	$	1,117	$	3,774	$	3,984
Research and development	1,027		458		2,095		1,872
Cost of goods sold	129		52		283		160
Total	$	2,830	$	1,627	$	6,152	$	6,016

Summary of Warrant Activity

The following is a summary of common stock warrant activity for the nine months ended September 30, 2023:


	Warrants	Weighted Average Exercise Price		Weighted Average Remaining Life (in years)
Outstanding at January 1, 2023	5,153,291	$	7.01
Warrants issued	81,848	2.94
Warrants exercised	(569,938)	0.26
Outstanding at September 30, 2023	4,665,201	$	7.76	1.9
Exercisable at September 30, 2023	4,665,201	$	7.76	1.9

The following is a summary of preferred stock warrant activity for the nine months ended September 30, 2023:


	Warrants	Weighted Average Exercise Price		Weighted Average Remaining Life (in years)
Outstanding at January 1, 2023	—	$	—
Warrants issued	59,759	1,000
Warrants exercised	(34,859)	1,000
Outstanding at September 30, 2023	24,900	$	1,000	2.5
Exercisable at September 30, 2023	24,900	$	1,000	2.5

Schedule of Information Related to Stock Warrants Outstanding and Exercisable

The following table presents information related to common stock warrants outstanding at September 30, 2023:


		Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants	Weighted Average Remaining Warrant Term (in years)	Number of Warrants
$0.01	1,037,792	3.4	1,037,792
$6.00	16,666	2.5	16,666
$10.00	3,610,743	1.4	3,610,743
	4,665,201	1.9	4,665,201

- Definition

Tabular disclosure of an entity's stock, including par or stated value per share, number and dollar amount of share subscriptions, shares authorized, shares issued, shares outstanding, number and dollar amount of shares held in an employee trust, dividend per share, total dividends, share conversion features, par value plus additional paid in capital, the value of treasury stock and other information necessary to a fair presentation, and EPS information. Stock by class includes common, convertible, and preferred stocks which are not redeemable or redeemable solely at the option of the issuer. Includes preferred stock with redemption features that are solely within the control of the issuer and mandatorily redeemable stock if redemption is required to occur only upon liquidation or termination of the reporting entity. If more than one issue is outstanding, state the title of each issue and the corresponding dollar amount; dollar amount of any shares subscribed but unissued and the deduction of subscriptions receivable there from; number of shares authorized, issued, and outstanding.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Section S99
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Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef
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-Paragraph 1
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Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 8: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 9: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
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Reference 12: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 13: http://fasb.org/us-gaap/role/ref/legacyRef
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+ Details

Property, Plant, and Equipment (Tables)

9 Months Ended

Sep. 30, 2023

Property, Plant and Equipment [Abstract]

Components of Property, Plant and Equipment

Property, plant, and equipment consist of the following:


(In thousands)	September 30, 2023		December 31, 2022		Estimated Useful Life
Buildings and land	$	1,301	$	1,301	30 years - Buildings
Enterprise hardware and software	1,855		1,855		3 years
Leaseholds	1,772		1,774		Lesser of lease term or estimated useful life
Equipment	1,262		1,222		7 years
Furniture	201		201		5 years
Property, plant and equipment, gross	6,391		6,353
Accumulated depreciation	(5,017)		(4,931)
Property, plant and equipment, net	$	1,374	$	1,422

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2023

Fair Value Disclosures [Abstract]

Schedule of Level 3 Investments

The table below presents activity within Level 3 of the fair value hierarchy, our liabilities carried at fair value for the nine months ended September 30, 2023:


	Level 3
(In thousands)	Contingent liabilities		Warrants		Total
Balance at January 1, 2023	$	1,280	$	—	$	1,280
Total change in foreign exchange	(9)		—		(9)
Fair value of the warrant liability issued	—		4,940		4,940
Warrant liability fair value adjustment	—		8,224		8,224
Change due to warrant exercise	$	—	$	(7,391)	$	(7,391)
Balance at September 30, 2023	$	1,271	$	5,773	$	7,044

Schedule of Fair Value Warrants

The fair value of the preferred and common warrants at September 30, 2023 and March 29, 2023 was determined by using option pricing models assuming the following:


	March 29, 2023	September 30, 2023
Risk free interest rate	3.80% - 4.80%	4.80%
Expected term (years)	0.5 - 3.0	2.5
Expected volatility	70% - 75%	70%
Expected dividends	0.00%	0.00%

Schedule of Financial Assets Carried at Fair Value

The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value as of September 30, 2023 and December 31, 2022 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value. In general, the fair values were determined using Level 3:


(In thousands)	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		September 30, 2023
Liabilities:
Contingent liability	$	—	$	—	$	1,271	$	1,271
Warrant liability	—		—		5,773		5,773
Total liabilities	$	—	$	—	$	7,044	$	7,044

(In thousands)	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		December 31, 2022
Liabilities:
Contingent liability	$	—	$	—	$	1,280	$	1,280
Total liabilities	$	—	$	—	$	1,280	$	1,280

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
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)	37,787	11,357
Preferred stock, shares outstanding (in shares)	37,787	11,357
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	80,000,000	80,000,000
Common stock, shares issued (in shares)	19,688,991	10,046,571
Common stock, shares outstanding (in shares)	19,688,991	10,046,571

Inventory (Tables)

9 Months Ended

Sep. 30, 2023

Inventory Disclosure [Abstract]

Schedule of Inventory

Inventory consists of the following:


(In thousands)	September 30, 2023		December 31, 2022
Raw materials	$	924	$	763
Work-in-process	1,582		1,102
Finished goods	161		133
Total inventory	$	2,667	$	1,998

Income Taxes (Details) $ in Billions	9 Months Ended
Income Taxes (Details) $ in Billions	Sep. 30, 2023 USD ($)
Income Tax Disclosure [Abstract]
Corporate alternative minimum tax (as a percent)	15.00%
Minimum accounting profit required for preceding three financial year	$ 1
Percentage of excise tax on repurchases of stock	1.00%

General - Schedule of Error Corrections and Prior Period Adjustments (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Balance Sheet for September 30, 2022 (unaudited)
Additional paid-in capital	$ 518,607						$ 518,607		$ 451,608
Accumulated deficit	(494,026)						(494,026)		$ (457,484)
Consolidated Statement of Operations and Comprehensive Loss for the three months ended September 30, 2022 (unaudited)
Research and development expenses	4,662			$ 4,065			12,793	$ 14,152
Selling, general and administrative expenses	6,195			4,779			15,147	13,477
Total operating expenses	10,857			8,844			27,940	27,629
Operating loss	(10,556)			(8,173)			(26,878)	(25,998)
Net loss	(20,340)	$ (7,202)	$ (9,000)	(8,877)	$ (10,159)	$ (9,000)	(36,542)	(28,036)
Total other comprehensive loss	$ (20,335)			$ (8,923)			$ (36,518)	$ (28,118)
Basic loss per common share (in dollars per share)	$ (1.14)			$ (0.96)			$ (2.61)	$ (3.29)
Diluted loss per common share (in dollars per share)	$ (1.14)			$ (0.96)			$ (2.61)	$ (3.29)
Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended September 30, 2022 (unaudited)
Compensation expense for issuance of stock options	$ 2,783	1,661	1,661	$ 1,627	2,119	2,271
Net loss	(20,340)	(7,202)	(9,000)	(8,877)	(10,159)	(9,000)	$ (36,542)	$ (28,036)
Consolidated Statement of Cash Flows for the nine months ended September 30, 2022 (unaudited)
Net loss	$ (20,340)	$ (7,202)	$ (9,000)	(8,877)	$ (10,159)	$ (9,000)	(36,542)	(28,036)
Stock option compensation expense							$ 6,152	6,016
As previously reported
Balance Sheet for September 30, 2022 (unaudited)
Additional paid-in capital				442,066				442,066
Accumulated deficit				(447,341)				(447,341)
Consolidated Statement of Operations and Comprehensive Loss for the three months ended September 30, 2022 (unaudited)
Research and development expenses				3,953				13,649
Selling, general and administrative expenses				4,519				12,309
Total operating expenses				8,472				25,958
Operating loss				(7,801)				(24,327)
Net loss				(8,505)				(26,365)
Total other comprehensive loss				$ (8,551)				$ (26,447)
Basic loss per common share (in dollars per share)				$ (0.92)				$ (3.09)
Diluted loss per common share (in dollars per share)				$ (0.92)				$ (3.09)
Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended September 30, 2022 (unaudited)
Compensation expense for issuance of stock options				$ 1,255				$ 4,345
Net loss				(8,505)				(26,365)
Consolidated Statement of Cash Flows for the nine months ended September 30, 2022 (unaudited)
Net loss				(8,505)				(26,365)
Stock option compensation expense								4,345
Adjustment
Balance Sheet for September 30, 2022 (unaudited)
Additional paid-in capital				1,671				1,671
Accumulated deficit				(1,671)				(1,671)
Consolidated Statement of Operations and Comprehensive Loss for the three months ended September 30, 2022 (unaudited)
Research and development expenses				112				503
Selling, general and administrative expenses				260				1,168
Total operating expenses				372				1,671
Operating loss				(372)				(1,671)
Net loss				(372)				(1,671)
Total other comprehensive loss				$ (372)				$ (1,671)
Basic loss per common share (in dollars per share)				$ (0.04)				$ (0.20)
Diluted loss per common share (in dollars per share)				$ (0.04)				$ (0.20)
Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended September 30, 2022 (unaudited)
Compensation expense for issuance of stock options				$ 372				$ 1,671
Net loss				(372)				(1,671)
Consolidated Statement of Cash Flows for the nine months ended September 30, 2022 (unaudited)
Net loss				(372)				(1,671)
Stock option compensation expense								1,671
As revised
Balance Sheet for September 30, 2022 (unaudited)
Additional paid-in capital				443,737				443,737
Accumulated deficit				(449,012)				(449,012)
Consolidated Statement of Operations and Comprehensive Loss for the three months ended September 30, 2022 (unaudited)
Research and development expenses				4,065				14,152
Selling, general and administrative expenses				4,779				13,477
Total operating expenses				8,844				27,629
Operating loss				(8,173)				(25,998)
Net loss				(8,877)				(28,036)
Total other comprehensive loss				$ (8,923)				$ (28,118)
Basic loss per common share (in dollars per share)				$ (0.96)				$ (3.29)
Diluted loss per common share (in dollars per share)				$ (0.96)				$ (3.29)
Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended September 30, 2022 (unaudited)
Compensation expense for issuance of stock options				$ 1,627				$ 6,016
Net loss				(8,877)				(28,036)
Consolidated Statement of Cash Flows for the nine months ended September 30, 2022 (unaudited)
Net loss				$ (8,877)				(28,036)
Stock option compensation expense								$ 6,016

Fair Value Measurements

9 Months Ended

Sep. 30, 2023

Fair Value Disclosures [Abstract]

Fair Value Measurements

The table below presents activity within Level 3 of the fair value hierarchy, our liabilities carried at fair value for the nine months ended September 30, 2023:


	Level 3
(In thousands)	Contingent liabilities		Warrants		Total
Balance at January 1, 2023	$	1,280	$	—	$	1,280
Total change in foreign exchange	(9)		—		(9)
Fair value of the warrant liability issued	—		4,940		4,940
Warrant liability fair value adjustment	—		8,224		8,224
Change due to warrant exercise	$	—	$	(7,391)	$	(7,391)
Balance at September 30, 2023	$	1,271	$	5,773	$	7,044

Contingent liabilities are re-measured to fair value each reporting period using projected financial targets, discount rates, probabilities of payment, and projected payment dates. Projected contingent payment amounts are discounted back to the current period using a discounted cash flow model. Projected financial targets are based on our most recent internal operational budgets and may take into consideration alternate scenarios that could result in more or less profitability for the respective service line. Increases or decreases in projected financial targets and probabilities of payment may result in significant changes in the fair value measurements. Increases in discount rates and the time to payment may result in lower fair value measurements. Increases or decreases in any of those inputs in isolation may result in a significantly lower or higher fair value measurement.

As disclosed in Note 9 and Note 10 of the Company’s consolidated financial statements, the Company allocated part of the proceeds of the Series F Preferred Offering to warrant liability issued in connection with the transaction. The valuations of the warrants were determined using option pricing models. The Company concluded that the Preferred Warrants were not in the scope of Accounting Standards Codification (ASC 480), Distinguishing Liabilities from Equity (ASC 480,) since the

Preferred Warrants are not mandatorily redeemable; and do not have obligations to issue a variable number of shares of preferred stock. The Company determined the Preferred Warrants met the definition of a derivative in accordance with ASC 815 but were not considered indexed to the Company’s common stock since the warrants require early settlement by repurchasing the preferred warrants for cash in an amount equal to the Black-Scholes value in the event of a Fundamental Transaction at pre-specified volatility of 100% as an input to the Black-Scholes calculation. The Company determined to record the Preferred Warrants at fair value with subsequent changes in fair value recorded in earnings at the end of each reporting period. For the three and nine months ended September 30, 2023, the Company recorded other expense of $9.4 million and $8.2 million, respectively, related to the change in fair value of the warrant liability and Tranche A Warrant exercises. These models use inputs such as the underlying price of the shares issued at the measurement date, volatility, risk free interest rate and expected life of the instrument. The Company has classified the warrants as a long-term liability due to certain provisions relating to the holders’ ability to exercise the warrants beyond twelve months of the reporting date.

The fair value of the preferred and common warrants at September 30, 2023 and March 29, 2023 was determined by using option pricing models assuming the following:


	March 29, 2023	September 30, 2023
Risk free interest rate	3.80% - 4.80%	4.80%
Expected term (years)	0.5 - 3.0	2.5
Expected volatility	70% - 75%	70%
Expected dividends	0.00%	0.00%

Additionally, the Company has determined that the warrant liability should be classified within Level 3 of the fair-value hierarchy by evaluating each input for the option pricing models against the fair-value hierarchy criteria and using the lowest level of input as the basis for the fair-value classification as called for in ASC 820. There are six inputs: closing price of the Company’s stock on the day of evaluation; the exercise price of the warrants; the remaining term of the warrants; the volatility of the Company’s stock over that term; annual rate of dividends; and the risk-free rate of return. Of those inputs, the exercise price of the warrants and the remaining term are readily observable in the warrant agreements. The annual rate of dividends is based on the Company’s historical practice of not granting dividends. The closing price of the Company’s stock would fall under Level 1 of the fair-value hierarchy as it is a quoted price in an active market (ASC 820-10). The risk-free rate of return is a Level 2 input as defined in ASC 820-10, while the historical volatility is a Level 3 input as defined in ASC 820. Since the lowest level input is a Level 3, the Company determined the warrant liability is most appropriately classified within Level 3 of the fair value hierarchy.


(In thousands)	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		September 30, 2023
Liabilities:
Contingent liability	$	—	$	—	$	1,271	$	1,271
Warrant liability	—		—		5,773		5,773
Total liabilities	$	—	$	—	$	7,044	$	7,044

(In thousands)	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		December 31, 2022
Liabilities:
Contingent liability	$	—	$	—	$	1,280	$	1,280
Total liabilities	$	—	$	—	$	1,280	$	1,280

- Definition

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

+ References + Details

Leases - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Leases - Narrative (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Lessee Lease Description [Line Items]
Lease term	12 months		12 months
U.S.
Lessee Lease Description [Line Items]
Operating lease expense	$ 100	$ 300	$ 100	$ 300
Ireland
Lessee Lease Description [Line Items]
Operating lease expense	$ 100	$ 100	$ 100	$ 100

Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2023

Prepaid Expense and Other Assets, Current [Abstract]

Schedule of Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following:


(In thousands)	September 30, 2023		December 31, 2022
Clinical trial expenses	$	1,630	$	1,630
Insurance premiums	71		123
Professional services	655		121
Other	356		95
Total prepaid expenses and other current assets	$	2,712	$	1,969

Fair Value Measurements - Fair Value Measurements Using Significant Unobservable Inputs (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Beginning balance			$ 1,280
Total change in foreign exchange			(9)
Fair value of the warrant liability issued			4,940
Warrant liability fair value adjustment	$ 9,384	$ 0	8,224	$ 0
Change due to warrant exercise			(7,391)
Ending balance	7,044		7,044
Contingent liabilities
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Beginning balance			1,280
Total change in foreign exchange			(9)
Fair value of the warrant liability issued			0
Warrant liability fair value adjustment			0
Change due to warrant exercise			0
Ending balance	1,271		1,271
Warrants
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Beginning balance			0
Total change in foreign exchange			0
Fair value of the warrant liability issued			4,940
Ending balance	$ 5,773		$ 5,773

Loans and Convertible Notes Payable

9 Months Ended

Sep. 30, 2023

Debt Disclosure [Abstract]

Loans and Convertible Notes Payable


	September 30, 2023						December 31, 2022
	Gross		Discount		Net		Gross		Discount		Net
Loans Payable, Current	5,610		(530)		5,080		8,570		(724)		7,846
Loans Payable, Non-Current	—		—		—		3,353		(284)		3,070
Total - Loans Payable1	$	5,610	$	(530)	$	5,080	$	11,923	$	(1,008)	$	10,916

Convertible Notes Payable - Current	$	3,000	$	(124)	$	2,876	$	—	$	—	$	—
Convertible Notes Payable - Non-Current	$	2,000	$	—	$	2,000	$	5,000	$	(228)	$	4,772
Total - Convertible Notes Payable	$	5,000	$	(124)	$	4,876	$	5,000	$	(228)	$	4,772

Total - Loans and Notes Payable	10,610						16,923

1 The gross amount includes the 4.25% final payment of $0.5 million.

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


(In thousands)	Loans		Convertible Notes		Total
Year ended December 31, 2023	$	—	$	—	$	—
Year ended December 31, 2024	5,610		5,000		10,610
Total	$	5,610	$	5,000	$	10,610

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

On August 6, 2021, the Company entered into a Loan and Security Agreement (the “Avenue Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (the “Lender,” or “Avenue”) for a term loan in an aggregate principal amount of up to $20.0 million (the “Avenue Loan”). The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at September 30, 2023 was 16.20%. 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 was $15.0 million, including $4.0 million that was funded into a restricted account. On March 15, 2023, the Company returned to Avenue $4.0 million held in the restricted cash to pay down a portion of the

outstanding loan balance, principal payments of $2.1 million and an incremental 4.25% of the final payment of $0.2 million. On March 31, 2023, the Avenue Loan Agreement was amended (the “Avenue Amendment”) to defer the interest only period to September 30, 2023, with an additional extension option upon FDA Approval for the HEPZATO KIT and subsequent receipt of at least $10 million from the sale and issuance of equity securities. On August 14, 2023, the Company received FDA approval and has subsequently received over $10 million from the exercise of Tranche A Preferred Warrants. At the Company’s option, it has elected to extend the interest only period to December 31, 2023 and principal payments are deferred until January 2024.

Up to $3.0 million of the principal amount of the Avenue Loan outstanding may be converted, at Avenue's option, into shares of the Company’s common stock at a conversion price of $11.98 per share.

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 judgements.

In connection with the initial entry into the Avenue Loan Agreement, the Company issued warrants to Avenue (the “Initial Avenue Warrant”) to purchase 127,755 shares of common stock at an exercise price per share equal to $0.01. The Initial Avenue Warrant is exercisable until August 31, 2026. Additionally, in connection with the Avenue Amendment, the Company issued to Avenue a warrant to purchase 34,072 shares of common stock at an exercise price per share equal to $0.01.

The Company determined that the embedded conversion option associated with the Avenue Loan did not require bifurcation and met the criteria for equity classification. In addition, the amendment was recorded under debt modification guidance. Aggregate debt discount amortization of $0.2 million and $0.6 million was recorded during the three and nine months ended September 30, 2023 and 2022, respectively. Interest expense incurred was $0.3 million and $0.4 million for the three months ended September 30, 2023 and 2022, respectively and $1.1 million and $1.3 million for the nine months ended September 30, 2023 and 2022, respectively.

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 the original terms, the Rosalind Notes were convertible into Series E Preferred Stock at a price of $1,500 per share and were to mature on July 16, 2021. Interest expense was $0.1 million for the nine months ended September 30, 2023 and 2022, respectively.

On August 6, 2021, the Company executed an agreement to amend the Rosalind Notes to (i) reduce the conversion price to $1,198 per share of the Company’s Series E Preferred Stock; and (ii) extend the maturity date to October 30, 2024. In addition, the holders of the Rosalind Notes agreed to subordinate all of the Company’s indebtedness and obligations to Avenue and 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://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 470
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//470/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Publisher FASB
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Publisher FASB
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Paragraph 1I
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

+ Details

Commitments and Contingencies	9 Months Ended
Commitments and Contingencies	Sep. 30, 2023
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Commitments and Contingencies medac Matter In April 2021, the Company’s wholly owned subsidiary, Delcath Systems Ltd, issued to medac GmbH, a privately held, multi-national pharmaceutical company based in Germany (“medac”), an invoice for a €1 million milestone payment under a License, Supply and Marketing Agreement dated December 10, 2018 (the “medac Agreement”) between medac and the Company. The medac Agreement provided to medac the exclusive right to market and sell CHEMOSAT in certain designated countries for which the Company was entitled to a combination of upfront and success-based milestone payments as well as a fixed transfer price per unit of CHEMOSAT and specified royalties. In response to medac’s subsequent dispute and non-payment of the invoice, on October 12, 2021, the Company notified medac in writing that it was terminating the medac Agreement due to medac’s nonpayment of the €1 million milestone payment, with the effective date of termination of the medac Agreement being April 12, 2022. On December 16, 2021, the Company initiated an arbitration proceeding pursuant to the dispute resolution procedures of the medac Agreement for the non-payment of the invoice. On December 30, 2022, the parties reached a final settlement of the matter and the Company agreed to pay medac either (a) a royalty on sales of CHEMOSAT units over a defined minimum for a period of five years or until a maximum payment has been reached, or (b) a minimum annual payment of $0.2 million in the event the annual royalty payment does not reach the agreed minimum payment amount. The Company has estimated the fair value of the settlement to be $1.3 million as of September 30, 2023 and recorded $1.1 million as other liabilities, non-current and $0.2 million as accrued expenses on the Company’s condensed consolidated balance sheet as of September 30, 2023. Lachman Consulting Services, Inc. On January 24, 2023, Lachman Consultant Services, Inc (“Lachman”) served the Company with a complaint alleging that Delcath owed Lachman approximately $0.9 million in unpaid consulting fees plus interest, costs and attorneys’ fees. The dispute arose from a July 22, 2021 agreement between Lachman and Delcath under which Lachman provided assistance to the Company in regard to preparing for a FDA inspection and good manufacturing practices, training and support. A settlement was reached on July 5, 2023, under which the Company paid Lachman $0.9 million.

Stockholders' Equity - Summary of Common Stock Warrants Outstanding and Exercisable (Details) - $ / shares			9 Months Ended
	Aug. 14, 2023	Mar. 27, 2023	Sep. 30, 2023	Dec. 31, 2022
Common Warrants
Class of Warrant or Right [Line Items]
Outstanding Number of Warrants (in shares)			4,665,201	5,153,291
Warrants Exercisable, Weighted Average Remaining Warrant Term (in years)			1 year 10 months 24 days
Warrants Exercisable, Number of Warrants (in shares)			4,665,201
Warrants exercised (in shares)			569,938
Tranche A Warrants \| Common Purchase Agreement
Class of Warrant or Right [Line Items]
Number of exercisable common warrants (in shares)	31,110	31,110
$0.01
Class of Warrant or Right [Line Items]
Warrant exercise price (in dollars per share)			$ 0.01
Outstanding Number of Warrants (in shares)			538,828
$0.01 \| Common Warrants
Class of Warrant or Right [Line Items]
Outstanding Number of Warrants (in shares)			1,037,792
Warrants Exercisable, Weighted Average Remaining Warrant Term (in years)			3 years 4 months 24 days
Warrants Exercisable, Number of Warrants (in shares)			1,037,792
$6.00
Class of Warrant or Right [Line Items]
Warrant exercise price (in dollars per share)			$ 6.00
$6.00 \| Common Warrants
Class of Warrant or Right [Line Items]
Outstanding Number of Warrants (in shares)			16,666
Warrants Exercisable, Weighted Average Remaining Warrant Term (in years)			2 years 6 months
Warrants Exercisable, Number of Warrants (in shares)			16,666
$10.00
Class of Warrant or Right [Line Items]
Warrant exercise price (in dollars per share)			$ 10
$10.00 \| Common Warrants
Class of Warrant or Right [Line Items]
Outstanding Number of Warrants (in shares)			3,610,743
Warrants Exercisable, Weighted Average Remaining Warrant Term (in years)			1 year 4 months 24 days
Warrants Exercisable, Number of Warrants (in shares)			3,610,743
$4.50
Class of Warrant or Right [Line Items]
Warrant exercise price (in dollars per share)			$ 4.50
Outstanding Number of Warrants (in shares)			31,110

Leases - Summary of Lease Costs (Details) $ in Thousands	9 Months Ended
Leases - Summary of Lease Costs (Details) $ in Thousands	Sep. 30, 2023 USD ($)
Other information
Operating cash flows for operating leases	$ 262
U.S.
Other information
Operating cash flows for operating leases	$ 238
Weighted average remaining lease term	0 years
Weighted average discount rate - operating leases	8.00%
Ireland
Other information
Operating cash flows for operating leases	$ 24
Weighted average remaining lease term	2 years 9 months 18 days
Weighted average discount rate - operating leases	8.00%

Inventory

9 Months Ended

Sep. 30, 2023

Inventory Disclosure [Abstract]

Inventory

InventoryInventory consists of the following:


(In thousands)	September 30, 2023		December 31, 2022
Raw materials	$	924	$	763
Work-in-process	1,582		1,102
Finished goods	161		133
Total inventory	$	2,667	$	1,998

Inventory (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Inventory Disclosure [Abstract]
Raw materials	$ 924	$ 763
Work-in-process	1,582	1,102
Finished goods	161	133
Total inventory	$ 2,667	$ 1,998

Stockholders' Equity - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Stockholders' Equity Note [Abstract]
Expected volatility	160.40%	164.30%
Risk-free interest rate	3.99%	1.86%
Expected dividends	0.00%	0.00%
Expected terms (years)	5 years 8 months 12 days	5 years 4 months 24 days

Cover Page - shares	9 Months Ended
Cover Page - shares	Sep. 30, 2023	Nov. 08, 2023
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2023
Document Transition Report	false
Entity File Number	001-16133
Entity Registrant Name	DELCATH SYSTEMS, INC.
Entity Incorporation, State or Country Code	DE
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
Title of 12(b) Security	Common stock, $0.01 par value per share
Trading Symbol	DCTH
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		22,046,101
Entity Central Index Key	0000872912
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Amendment Flag	false

Commitments and contingencies - Additional Information (Details) € in Millions, $ in Millions	Jul. 05, 2023 USD ($)	Dec. 30, 2022 USD ($)	Sep. 30, 2023 USD ($)	Jan. 24, 2023 USD ($)	Oct. 12, 2021 EUR (€)	Apr. 30, 2021 EUR (€)
Loss Contingencies [Line Items]
Milestone payment unpaid \| €					€ 1
Medac
Loss Contingencies [Line Items]
Accounts receivable \| €						€ 1
Term over which the royalty is to be paid		5 years
Minimum annual payments		$ 0.2
Lachman
Loss Contingencies [Line Items]
Settlement amount	$ 0.9
Unpaid consulting fees				$ 0.9
Other Liabilities \| Medac
Loss Contingencies [Line Items]
Loss contingency accrual			$ 1.3
Other Noncurrent Liabilities \| Medac
Loss Contingencies [Line Items]
Loss contingency accrual			1.1
Accrued Expenses \| Medac
Loss Contingencies [Line Items]
Loss contingency accrual			$ 0.2

Leases (Tables)

9 Months Ended

Sep. 30, 2023

Leases [Abstract]

Summary of Lease Costs

As of September 30, 2023:


(In thousands)	U.S.			Ireland			Total
Operating cash flows for operating leases	$	238		$	24		$	262
Weighted average remaining lease term	0.0			2.8
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:


	U.S.		Ireland		Total
Year ended December 31, 2023	$	—	$	11	$	11
Year ended December 31, 2024	—		42		42
Year ended December 31, 2025	—		42		42
Year ended December 31, 2026	—		25		25
Total	—		120		120
Less present value discount	—		(13)		(13)
Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2023	$	—	$	107	$	107

Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Prepaid Expense and Other Assets, Current [Abstract]
Clinical trial expenses	$ 1,630	$ 1,630
Insurance premiums	71	123
Professional services	655	121
Other	356	95
Total prepaid expenses and other current assets	$ 2,712	$ 1,969

Income Taxes	9 Months Ended
Income Taxes	Sep. 30, 2023
Income Tax Disclosure [Abstract]
Income Taxes	Income Taxes As discussed in “Note 14—Income Taxes” to the notes to the consolidated financial statements contained in the 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. The Inflation Reduction Act of 2022 included tax legislation that became effective in the first quarter of 2023. Significant legislation for corporate taxpayers includes a corporate alternative minimum tax of 15% for companies with $1 billion or more in average net financial statement profits over the three previous years, as well as a 1% indirect excise tax on the repurchase of shares by a publicly traded company. The Company does not expect this legislation to have an effect on the tax provision as of September 30, 2023, however the Company will continue to evaluate the effect on the tax provision each reporting period.

- 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
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480990/946-20-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147482603/740-30-50-2

+ Details

Fair Value Measurements - Schedule of the Company's Financial Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Liabilities [Abstract]
Contingent liability	$ 1,271	$ 1,280
Warrant liability	5,773
Total liabilities	7,044	1,280
Quoted Prices in Active Markets (Level 1)
Liabilities [Abstract]
Contingent liability	0	0
Warrant liability	0
Total liabilities	0	0
Significant Other Observable Inputs (Level 2)
Liabilities [Abstract]
Contingent liability	0	0
Warrant liability	0
Total liabilities	0	0
Significant Unobservable Inputs (Level 3)
Liabilities [Abstract]
Contingent liability	1,271	1,280
Warrant liability	5,773
Total liabilities	$ 7,044	$ 1,280

- Definition

Fair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes liabilities not subject to a master netting arrangement and not elected to be offset.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147482907/825-10-50-10

+ Details

Fair Value Measurements - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Fair Value Disclosures [Abstract]
Other expense related to the change in fair value of the warrant liability	$ 9,384	$ 0	$ 8,224	$ 0

General (Tables)

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

Schedule of Error Corrections and Prior Period Adjustments

The impact of the revision on the Company’s financial statements for the three and nine months ended September 30, 2022 is reflected in the following table:


(In thousands)	As previously reported		Adjustment		As revised
Balance Sheet for September 30, 2022 (unaudited)
Additional paid-in capital	$	442,066	$	1,671	$	443,737
Accumulated deficit	$	(447,341)	$	(1,671)	$	(449,012)

Consolidated Statement of Operations and Comprehensive Loss for the three months ended September 30, 2022 (unaudited)
Research and development expenses	$	3,953	$	112	$	4,065
Selling, general and administrative expenses	4,519		260		4,779
Total operating expenses	8,472		372		8,844
Operating loss	(7,801)		(372)		(8,173)
Net loss	(8,505)		(372)		(8,877)
Total other comprehensive loss	(8,551)		(372)		(8,923)
Basic and diluted loss per common share	$	(0.92)	$	(0.04)	$	(0.96)

Consolidated Statement of Operations and Comprehensive Loss for the nine months September 30, 2022 (unaudited)
Research and development expenses	$	13,649	$	503	$	14,152
Selling, general and administrative expenses	12,309		1,168		13,477
Total operating expenses	25,958		1,671		27,629
Operating loss	(24,327)		(1,671)		(25,998)
Net loss	(26,365)		(1,671)		(28,036)
Total other comprehensive loss	(26,447)		(1,671)		(28,118)
Basic and diluted loss per common share	$	(3.09)	$	(0.20)	$	(3.29)

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

Consolidated statement of Stockholders’ Equity (Deficit) for the nine months ended September 30, 2022 (unaudited)
Compensation expense for issuance of stock options	$	4,345	$	1,671	$	6,016
Net loss	$	(26,365)	$	(1,671)	$	(28,036)

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

Property, Plant, and Equipment - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Property, Plant and Equipment [Abstract]
Depreciation expense (less than)	$ 100	$ 100	$ 87	$ 98

Stockholders' Equity - Equity Offerings and Placements (Details) - USD ($) $ in Millions	Aug. 14, 2023	Mar. 29, 2023	Mar. 27, 2023	Sep. 30, 2023
Stockholders Equity Note [Line Items]
Deferred revenue		$ 10.0		$ 10.0
Tranche A Warrants \| Common Purchase Agreement
Stockholders Equity Note [Line Items]
Number of exercisable common warrants (in shares)	31,110		31,110
Aggregate exercise price of preferred warrants		$ 0.1
Tranche B Warrants \| Common Purchase Agreement
Stockholders Equity Note [Line Items]
Number of exercisable common warrants (in shares)		16,666	16,666
Aggregate exercise price of preferred warrants		$ 0.1
Warrants exercisable, period				21 days

Stockholders' Equity - Summary of Employee Stock Purchase Plan (Details) - shares	1 Months Ended	9 Months Ended
	Aug. 31, 2021	Sep. 30, 2023	Jul. 31, 2023	Jan. 31, 2023
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items]
Employee stock purchase plan, offering period		6 months
May 2022 Employee Stock Purchase Plan
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items]
Share-based compensation arrangement by share-based payment award number of shares authorized (in shares)	260,295		26,018	15,417
Share-based compensation arrangement by share-based payment award purchase price of common stock (as a percent)	85.00%

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Total revenues	$ 434	$ 906	$ 1,526	$ 2,080
Cost of goods sold	(133)	(235)	(464)	(449)
Gross profit	301	671	1,062	1,631
Operating expenses:
Research and development expenses	4,662	4,065	12,793	14,152
Selling, general and administrative expenses	6,195	4,779	15,147	13,477
Total operating expenses	10,857	8,844	27,940	27,629
Operating loss	(10,556)	(8,173)	(26,878)	(25,998)
Change in fair value of warrant liability	(9,384)	0	(8,224)	0
Interest expense, net	(395)	(730)	(1,454)	(2,040)
Other income (expense)	(5)	26	14	2
Net loss	(20,340)	(8,877)	(36,542)	(28,036)
Other comprehensive income:
Foreign currency translation adjustments	5	(46)	24	(82)
Total other comprehensive loss	$ (20,335)	$ (8,923)	$ (36,518)	$ (28,118)
Common share data:
Basic loss per common share (in dollars per share)	$ (1.14)	$ (0.96)	$ (2.61)	$ (3.29)
Diluted loss per common share (in dollars per share)	$ (1.14)	$ (0.96)	$ (2.61)	$ (3.29)
Weighted average number of basic shares outstanding (in shares)	17,863,078	9,215,786	13,985,248	8,536,006
Weighted average number of diluted shares outstanding (in shares)	17,863,078	9,215,786	13,985,248	8,536,006
Product revenue
Total revenues	$ 434	$ 906	$ 1,526	$ 1,909
Other revenue
Total revenues	$ 0	$ 0	$ 0	$ 171

Net Loss per Share - Summary of Reconciliation of Weighted Average Shares Outstanding Calculation (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Earnings Per Share [Abstract]
Weighted average shares issued (in shares)	16,825,286	8,470,006	12,745,035	8,096,551
Weighted average pre-funded warrants (in shares)	1,037,792	745,780	1,240,213	439,455
Weighted average number of basic shares outstanding (in shares)	17,863,078	9,215,786	13,985,248	8,536,006
Weighted average number of diluted shares outstanding (in shares)	17,863,078	9,215,786	13,985,248	8,536,006