Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2023 | May 22, 2023 | |
Cover [Abstract] | ||
Entity Registrant Name | DELCATH SYSTEMS, INC. | |
Entity Central Index Key | 0000872912 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Incorporation, State or Country Code | DE | |
Entity Interactive Data Current | Yes | |
Entity File Number | 001-16133 | |
Entity Tax Identification Number | 06-1245881 | |
Entity Address, Address Line One | 1633 Broadway | |
Entity Address, Address Line Two | Suite 22C | |
Entity Address, City or Town | New York | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10019 | |
City Area Code | 212 | |
Local Phone Number | 489-2100 | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 10,620,813 | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Trading Symbol | DCTH | |
Title of 12(b) Security | Common stock, $0.01 par value per share | |
Document Fiscal Period Focus | Q1 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 24,222 | $ 7,671 |
Restricted cash | 50 | 4,151 |
Accounts receivable, net | 458 | 366 |
Inventories | 2,337 | 1,998 |
Prepaid expenses and other current assets | 1,955 | 1,969 |
Total current assets | 29,022 | 16,155 |
Property, plant and equipment, net | 1,392 | 1,422 |
Right-of-use assets | 185 | 285 |
Total assets | 30,599 | 17,862 |
Current liabilities | ||
Accounts payable | 2,428 | 2,018 |
Accrued expenses | 7,120 | 4,685 |
Lease liabilities, current | 93 | 186 |
Loan payable, current | 3,770 | 7,846 |
Total current liabilities | 13,411 | 14,735 |
Warrant liability | 4,940 | |
Other liabilities, non-current | 1,158 | 1,144 |
Loan payable, non-current | 992 | 3,070 |
Convertible notes payable, non-current | 4,806 | 4,772 |
Total liabilities | 25,307 | 23,721 |
Commitments and contingencies | ||
Mezzanine equity | ||
Preferred F-1 stock, $.01 par value; 24,900 shares designated; 24,900 shares and 0 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 18,368 | 0 |
Stockholders' equity (deficit) | ||
Preferred stock, $.01 par value; 10,000,000 shares authorized; 11,357 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | ||
Common stock, $.01 par value; 40,000,000 shares authorized; 10,081,634 shares and 10,046,571 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 101 | 100 |
Additional paid-in capital | 453,370 | 451,608 |
Accumulated deficit | (466,483) | (457,484) |
Accumulated other comprehensive loss | (64) | (83) |
Total stockholders' equity (deficit) | (13,076) | (5,859) |
Total liabilities and stockholders' equity | $ 30,599 | $ 17,862 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 11,357 | 11,357 |
Preferred stock, shares outstanding (in shares) | 11,357 | 11,357 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 40,000,000 | 40,000,000 |
Common stock, shares issued (in shares) | 10,081,634 | 10,081,634 |
Common stock, shares outstanding (in shares) | 10,046,571 | 10,046,571 |
Preferred F-1 Stock [Member] | ||
Temporary equity, par or stated value per share | $ 0.01 | $ 0.01 |
Temporary equity, shares authorized | 24,900 | 24,900 |
Temporary equity, shares issued | 24,900 | 24,900 |
Temporary equity, shares outstanding | 0 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue | $ 597 | $ 378 |
Cost of goods sold | (181) | (33) |
Gross profit | 416 | 345 |
Operating expenses: | ||
Research and development expenses | 4,576 | 4,481 |
Selling, general and administrative expenses | 4,165 | 4,204 |
Total operating expenses | 8,741 | 8,685 |
Operating loss | (8,325) | (8,340) |
Interest expense, net | (688) | (645) |
Other income (loss) | 13 | (15) |
Net loss | (9,000) | (9,000) |
Other comprehensive income: | ||
Foreign currency translation adjustments | 19 | 2 |
Total other comprehensive loss | $ (8,981) | $ (8,998) |
Common share data: | ||
Basic loss per common share | $ (0.77) | $ (1.1) |
Diluted loss per common share | $ (0.77) | $ (1.1) |
Weighted average number of basic shares outstanding | 11,622,384 | 8,190,483 |
Weighted average number of diluted shares outstanding | 11,622,384 | 8,190,483 |
Product Revenue [Member] | ||
Revenue | $ 597 | $ 207 |
Other Revenue [Member] | ||
Revenue | $ 0 | $ 171 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Preferred Stock [Member] | Additional Paid in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] |
Balance at Dec. 31, 2021 | $ 11,952 | $ 79 | $ 0 | $ 432,831 | $ (420,976) | $ 18 |
Balance (in shares) at Dec. 31, 2021 | 7,906,728 | 11,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Compensation expense for issuance of stock options | 2,271 | 2,271 | ||||
Net loss | (9,000) | (9,000) | ||||
Total comprehensive income | 2 | 2 | ||||
Balance at Mar. 31, 2022 | 5,225 | $ 79 | $ 0 | 435,102 | (429,976) | 20 |
Balance (in shares) at Mar. 31, 2022 | 7,906,728 | 11,357 | ||||
Balance at Dec. 31, 2022 | (5,859) | $ 100 | $ 0 | 451,607 | (457,483) | (83) |
Balance (in shares) at Dec. 31, 2022 | 10,046,571 | 11,357 | ||||
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 | ||||
Balance at Mar. 31, 2023 | $ (13,076) | $ 101 | $ 0 | $ 453,370 | $ (466,483) | $ (64) |
Balance (in shares) at Mar. 31, 2023 | 10,081,634 | 11,357 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (9,000) | $ (9,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock option compensation expense | 1,661 | 2,271 |
Depreciation expense | 30 | 31 |
Non-cash lease expense | 100 | 97 |
Amortization of debt discount | 194 | 194 |
Interest expense accrued related to convertible notes | 27 | 40 |
Changes in assets and liabilities: | ||
Decrease in prepaid expenses and other assets | 14 | 39 |
Increase in accounts receivable | (92) | (134) |
Increase in inventories | (339) | (599) |
Increase in accounts payable and accrued expenses | 3,221 | 953 |
Decrease in other liabilities, non current | (80) | (97) |
Decrease in deferred revenue | 0 | (170) |
Net cash used in operating activities | (4,264) | (6,375) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | 0 | (89) |
Net cash used in investing activities | 0 | (89) |
Cash flows from financing activities: | ||
Net proceeds from private placement | 22,960 | 0 |
Proceeds from the issuance of common stock relating to the employee stock purchase plan | 47 | 0 |
Repayment of debt | (6,313) | 0 |
Net cash provided by financing activities | 16,694 | 0 |
Foreign currency effects on cash | 20 | 2 |
Net increase (decrease) in total cash | 12,450 | (6,462) |
Total Cash, Cash Equivalents and Restricted Cash: | ||
Beginning of period | 11,822 | 26,953 |
End of period | 24,272 | 20,491 |
Cash, Cash Equivalents and Restricted Cash consisted of the following: | ||
Cash | 24,222 | 16,340 |
Restricted Cash | 50 | 4,151 |
Total | 24,272 | 20,491 |
Supplemental Disclosure of Cash Flow Information: | ||
Interest expense | $ 491 | $ 411 |
General
General | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
General | (1) General The unaudited interim condensed consolidated financial statements of Delcath Systems, Inc. (“Delcath” or the “Company”) as of and for the three months ended March 31, 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 Description of Business The Company is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company’s lead product candidate, the HEPZATO ® In the United States, HEPZATO is considered a combination drug and device product and is regulated as a drug by the United States Food and Drug Administration (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). HEPZATO has not been approved for sale in the United States. The Company’s clinical development program for HEPZATO is comprised of the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the “FOCUS Trial”), a global registration clinical trial that is investigating objective response rate in metastatic ocular melanoma (“mOM”), a type of primary liver cancer. The Company’s most advanced development program is the treatment of mOM. The Company is currently reviewing the incidence, unmet need, available efficacy data and development requirements for a broad set of liver cancers in order to select a portfolio of follow-on In December 2021, the Company announced that the FOCUS Trial for HEPZATO met its pre-specified On February 14, 2023, the Company filed a New Drug Application (“NDA”) resubmission (the “NDA resubmission”) with the FDA for the HEPZATO Kit (melphalan hydrochloride for Injection/Hepatic Delivery System) seeking approval of the HEPZATO Kit in the treatment of patients with unresectable hepatic-dominant mOM. The resubmission was in response to a September 12, 2013 Complete Response Letter (“CRL”) from the FDA for the Company’s NDA in December 2010 seeking approval of its first generation melphalan hydrochloride for injection/hepatic delivery system. The NDA resubmission contains comprehensive data and information on Generation Two HEPZATO Kit relating to the matters identified in the CRL. On March 20, 2023, the FDA determined the NDA resubmission constituted a complete response and set a Prescription Drug User Fee Act target action date of August 14, 2023. The Company continues to promote its early access programs in the United States to make HEPZATO readily available to mOM patients. The Company is focused on continuing to treat these patients with mOM as regulatory approval is sought in the United States. There are currently patients enrolled in our early access program 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 While the long-term economic impact of either the COVID-19 disruptions and slowdown deepen or persist, we may not be able to access additional capital on favorable terms, or at all, which could in the future negatively affect our ability to pursue our business strategy. See “Risk Factors” in “Par t I – Liquidity and Going Concern At March 31, 2023, the Company had cash, cash equivalents and restricted cash totaling $24.3 million, as compared to cash, cash equivalents and restricted cash totaling $11.8 million at December 31, 2022. During the three months ended March 31, 2023, the Company used $4.3 million of cash in our operating activities. On March 10, 2023, the Company had a banking relationship with SVB. As of the closure of SVB on March 10, 2023, it held approximately $1.1 million of unrestricted cash in deposits held in SVB, $4.0 million held in a restricted SVB account as required per the Avenue Loan Agreement (as defined in “Note 8 – Loans and Convertible Notes Payable”) and approximately $0.2 million of restricted cash held in SVB collateral accounts as required per the Company’s line of credit for the property in New York City and its credit card program with SVB. SVB was closed on March 10, 2023 by the California Department of Financial Protection and Innovation, which appointed the FDIC as receiver. On March 12, 2023, the U.S. Treasury, Federal Reserve, and FDIC announced that SVB depositors would have access to all of their money starting March 13,2023. On March 13, 2023, the Company was able to access all of its cash, cash equivalents and investments held at or through SVB. While the Company has not experienced any losses in such accounts, the recent failure of SVB exposed it to significant credit risk prior to the completion by the FDIC of the resolution of SVB in a manner that fully protected all depositors. The Company is evaluating alternative solutions which management believes does not expose us to significant credit risk or jeopardizes our liquidity. 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 has entered into a Controlled Equity Offering SM We currently believe that our current cash and cash equivalents will enable us to have sufficient cash past our anticipated PDUFA date of August 14, 2023. Subject to the approval by our stockholders of the private placement that we closed on March 29, 2023 at our upcoming annual general meeting of stockholders, the Tranche A and B warrants issued in such private placement will become exercisable. The exercise of all such warrants would generate approximately $60.0 million in proceeds. We believe that this amount will be adequate to fund the commercialization of HEPZATO, if approved. If there is a substantial delay in the approval of HEPZATO we expect to need to raise additional capital under structures available to us, including debt and/or equity offerings, which may not be on terms favorable to us. In a delayed approval scenario, our ability to continue as a going concern depends on our ability to raise additional capital through the sale of equity or debt securities, or through partnering or licensing transactions in which we receive cash to support our future operations. If we are unable to secure additional capital or if additional capital is not available on favorable terms for us, we may be required to curtail our research and development initiatives and take additional measures to reduce costs in order to conserve our cash. The Company’s capital commitments over the next twelve months include (a) $9.6 million to satisfy accounts payable, accrued expenses and lease liabilities and (b) $4.4 million of loan principal payments. Additional capital commitments beyond the next twelve months include (a) $0.2 million of lease liabilities; (b) $1.0 million for settlement of litigation with medac; (c) $1.2 million of loan principal payments; and (d) $5.0 million of convertible note principal payments, if the holders do not elect to convert the notes into equity. The Company also expects to use cash and cash equivalents to fund its On August 6, 2021, the Company entered into the Avenue Loan Agreement with Avenue Venture Opportunities Fund, L.P. (the “Lender,” or “Avenue”) for a term loan in an aggregate principal amount of up to $20 million (the “Avenue Loan”). The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.7% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at March 31, 2023 was 15.45%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. with On March 27, 2023, the Company entered into to a securities purchase agreement with certain accredited investors (the “Preferred Purchase Agreement”). Pursuant to the Preferred Purchase Agreement, on March 29, 2023, the Company issued to purchasers an aggregate $24.9 million in shares, consisting of 24,900 shares of the Company’s Series F-1 “Series F-1 Preferred • Tranche A warrants (the “Preferred Tranche A Warrant s F-3 “Series F-3 Preferred • Tranche B warrants (the “Preferred Tranche B Warrant s F-4 F-4 F-3 The shares of Series F-1 F-1 from the private placement by the Company. See Note 9 – Preferred Purchase Agreement for additional details related to the Series F Preferred Offering. Also on March 27, 2023, the Company entered into a securities purchase agreement with the Company’s Chief Executive Officer, Gerard Michel (the “Common Purchase Agreement”). Pursuant to the Common Purchase Agreement, on March 29, 2023, the Company issued to Mr. Michel 19,646 shares of common stock and two tranches of warrants that are exercisable as follows: • A m • A Preferred Tranche B Warrant (the “Common Tranche B Warrant” and, together with the Common Tranche A Warrant, the “Common Warrants”) for an aggregate exercise price of $0.1 million 16,666 See Note 10 – Stockholders’ Equity – Equity Offerings and Placements – Common Purchase Agreement for additional details related to the Common Offering. Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the SEC’s instructions to Form 10-Q S-X. The preparation of interim condensed consolidated financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended March 31, 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. Significant Accounting Policies Other than the new 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 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. Management has determined that the Preferred Warrants issued in conjunction with the Preferred Purchase Agreement and the Common Warrants issued in conjunction with the Common Purchase Agreement should be liability classified 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 preferred F-1 shares 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 and of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO as inputs in the model to determine the fair value of warrants liability and preferred F-1 shares. The Company will adjust the fair value of the warranty liability at the end of each reporting period. Mezzanine Equity The Company accounts for its warrant liability 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. When ordinary or preferred shares are determined to be conditionally redeemable upon the occurrence of certain events that are not solely within the control of the issuer, and upon such event, the shares would become redeemable at the option of the holders, they are classified as ‘mezzanine equity’ (temporary equity). The purpose of this classification is to convey that such a security may not be permanently part of equity and could result in a demand for cash, securities or other assets of the entity in the future. 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 million for million for compensation adjustment is a non-cash The following tables contain the financial . 10-Q As previously Adjustment As revised Balance Sheet for March 31, 2022 (unaudited) Additional paid-in $ 434,305 $ 797 $ 435,102 Accumulated deficit (429,179 ) (797 ) (429,976 ) Consolidated Statement of Operations and Comprehensive Loss for the three months March 31, 2022 (unaudited) Research and development expenses 4,240 241 4,481 Selling, general and administrative expenses 3,648 556 4,204 Total operating expenses 7,888 797 8,685 Operating loss (7,543 ) (797 ) (8,340 ) Net loss (8,203 ) (797 ) (9,000 ) Total other comprehensive loss (8,201 ) (797 ) (8,998 ) Basic and diluted loss per common share (1.00 ) (0.10 ) (1.10 ) Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended March 31, 2022 (unaudited) Compensation expense for issuance of stock options 1,474 797 2,271 Net loss (8,203 ) (797 ) (9,000 ) Consolidated Statement of Cash Flows for the three months ended March 31, 2022 (unaudited) Net loss (8,203 ) (797 ) (9,000 ) Stock option compensation expense 1,474 797 2,271 Balance Sheet for June 30, 2022 (unaudited) Additional paid-in 435,922 1,299 437,221 Accumulated deficit (438,836 ) (1,299 ) (440,135 ) |
Cash, Cash Equivalents and Rest
Cash, Cash Equivalents and Restricted Cash | 3 Months Ended |
Mar. 31, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Restricted Cash | (2) Cash, Cash Equivalents and Restricted Cas h Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded in Restricted Cash Cash, cash equivalents, and restricted cash balances were as follows: March 31, December 31, Cash and cash equivalents $ 24,222 $ 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 $ 24,272 $ 11,822 On March 15, 2023, the Company returned to Avenue the $4.0 million held in the restricted cash to paydown a portion of the outstanding Avenue Loan balance. On March 31, 2023, letter of credit for the sub-lease |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | (3) Inventories Inventories consist of the following: March 31, December 31, Raw materials $ 811 $ 763 Work-in-process 1,410 1,102 Finished goods 116 133 Total inventories $ 2,337 $ 1,998 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses And Other Current Assets | (4) Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: March 31, December 31, 2023 2022 Clinical trial expenses $ 1,630 $ 1,630 Insurance premiums 109 123 Professional services 91 121 Other 125 95 Total prepaid expenses and other current assets $ 1,955 $ 1,969 |
Property, Plant, and Equipment
Property, Plant, and Equipment | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant, and Equipment | (5) Property, Plant, and Equipment Property, plant, and equipment consist of the following: March 31, 2023 December 31, 2022 Estimated Useful Life Buildings and land $ 1,301 $ 1,301 30 years - Buildings Enterprise hardware and software 1,856 1,855 3 years Leaseholds 1,781 1,774 Lesser of lease term or estimated useful life Equipment 1,223 1,222 7 years Furniture 201 201 5 years Property, plant and equipment, gross 6,362 6,353 Accumulated depreciation (4,970 ) (4,931 ) Property, plant and equipment, net $ 1,392 $ 1,422 Depreciation expenses for the three months ended March 31, 2023 and 2022 was $30 and $31 respectively. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | (6) Accrued Expenses Accrued expenses consist of the following: March 31, December 31, 2023 2022 Clinical expenses $ 2,398 $ 1,470 Compensation, excluding taxes 1,559 1,040 Professional fees 2,189 1,087 Interest on convertible note 593 553 Other 381 535 Total accrued expenses $ 7,120 $ 4,685 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Leases | (7) Leases The Company recognizes right-of-use non-cancellable The following table summarizes the Company’s operating leases as of and for the three months ended March 31, 2023: U.S. Ireland Total Lease cost Operating lease cost $ 97 $ 9 $ 106 Other information Operating cash flows out from operating leases (97 ) (9 ) (106 ) Weighted average remaining lease term 0.5 3.6 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 58 28 86 Year ended December 31, 2024 — 37 37 Year ended December 31, 2025 — 37 37 Year ended December 31, 2026 — 22 22 Total 58 124 182 Less present value discount (1 ) (15 ) (16 ) Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2023 $ 57 $ 109 $ 166 |
Loans and Convertible Notes Pay
Loans and Convertible Notes Payable | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Loans and Convertible Notes Payable | (8) Loans and Convertible Notes Payable March 31, 2023 December 31, 2022 Gross Discount Net Gross Discount Net Loan - Avenue [1] 5,610 (849 ) 4,762 11,923 (1,008 ) 10,916 Loan - Avenue [1] (4,442 ) 672 (3,770 ) (8,570 ) 724 (7,846 ) Total - Loans Payable, Non-Current $ 1,168 $ (177 ) $ 992 $ 3,353 $ (284 ) $ 3,070 Convertible Note Payable - Rosalind 2,000 — 2,000 2,000 — 2,000 Convertible Portion of Loan Payable - Avenue 3,000 (201 ) 2,799 3,000 (228 ) 2,772 Total - Convertible Notes Payable - Non-Current $ 5,000 $ (201 ) $ 4,799 $ 5,000 $ (228 ) $ 4,772 [1] The gross amount includes the 4.25% final payment of $467.5. Remaining maturities of the Company’s loan and convertible note payables are as follows: Loans Convertible Total Year ended December 31, 2023 $ 4,442 $ — $ 4,442 Year ended December 31, 2024 1,168 5,000 6,168 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 for a term loan in an aggregate principal amount of up to $20.0 million. The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at March 31, 2023 was 15.45%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. The Avenue Loan matures on August 1, 2024. The initial tranche of the Avenue Loan is $15.0 million, including $4.0 million that was funded into a restricted account and would be released upon achievement of (a)(x) positive FOCUS trial efficacy per the trial’s predefined Statistical Analysis Plan (SAP) (specifically the Overall Response Rate exceeds the pre-specified Up to $3.0 million of the principal amount of the Avenue Loan outstanding may be converted, at the option of Avenue, into shares of the Company’s common stock at a conversion price of $11.98 per share. In connection with the Avenue Loan, the Company issued to Avenue a warrant (the “Avenue Warrant”) to purchase 127,755 shares of common stock at an exercise price per share equal to $0.01. The Avenue Warrant is exercisable until August 31, 2026. The Company will make monthly interest-only payments during the first fifteen months of the term of the Avenue Loan, which could be increased to up to twenty-four months upon the achievement of specified performance milestones. Following the interest-only period, the Company will make equal monthly payments of principal plus interest until the maturity date, when all remaining principal outstanding and accrued interest must be paid. If the Company prepays the Avenue Loan, it will be required to pay (a) a prepayment fee of 3% if the Avenue Loan is prepaid during the interest-only period; and (b) a prepayment fee of 1% if the Avenue Loan is prepaid after the interest-only period. The Company must make an incremental final payment equal to 4.25% of the aggregate funding. On March 15, 2023, the Company returned to Avenue $4.0 million held in the restricted cash to paydown a portion of the outstanding loan balance and reduce the monthly principal payments and an incremental 4.25% of the final payment totaling $0.2 million with The Avenue Loan Agreement requires the Company to make and maintain representations and warranties and other agreements that are customary in loan agreements of this type. The Avenue Loan Agreement also contains customary events of default, including non-payment The Company determined that the embedded conversion option associated with the Avenue Loan was not required to be bifurcated. The Company determined that the Avenue Warrant met the criteria to be equity-classified. The $0.6 million value of the final payment was treated as original issue discount. The $1.2 million relative fair value of the Avenue Warrant was credited to Additional Paid in Capital while it was debited as debt discount. Of the $0.6 million million million non-convertible million March 31, 2023, including million non-convertible nominal amount Convertible Notes Payable The Company has $2.0 million of principal outstanding related to Senior Secured Promissory Notes (the “Rosalind Notes”) which bear interest at 8% per annum. Pursuant to their original terms, the Rosalind Notes were convertible into Series E Preferred Stock at a price of $1,500 per share and were to mature on July 16, 2021. Interest expense was $40 for the three months ended March 31, 2023 and 2022, respectively. On August 6, 2021, the Company executed an agreement to amend the Rosalind Notes to (a) reduce the conversion price to $1,198 per share of the Company’s Series E Convertible Preferred Stock; and (b) extend the maturity date to October 30, 2024. In addition, in order to induce Avenue to provide the Avenue Loan described above, the holders of the Rosalind Notes agreed to subordinate all of the Company’s indebtedness and obligations to the holders; and (b) all of the holders’ security interest, to the Avenue Loan and Avenue’s security interest in the Company’s property. |
Preferred Purchase Agreement
Preferred Purchase Agreement | 3 Months Ended |
Mar. 31, 2023 | |
Preferred Purchase Agreement [Abstract] | |
Preferred Purchase Agreement | (9) Preferred Purchase Agreement Preferred Purchase Agreement On March 29, 2023, the Company closed the Series F Preferred Offering. 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 Series F-2 Preferred F-2 F-1 F-3 F-4 The aggregate exercise price of the Preferred Tranche A Warrants is approximately $34.9 million, exercisable for an aggregate of 34,860 shares of Series F-3 Preferred The aggregate exercise price of the Preferred Tranche B Warrants is approximately $24.9 million, exercisable for an aggregate of 24,900 shares of Series F-4 Preferred Series F-4 Preferred Subject to the terms and limitations contained in the Certificate of Designation, the Series F-1 Preferred Series F-1 Preferred Certificate of Designation, at the option of the holder, each share of Series F-2 Preferred Series F-3 Preferred Series F-4 Preferred If Stockholder Approval isn’t received by the one-year F-1 E-1 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 but were not considered indexed to the Company’s stock common 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 The gross proceeds of million, with the residual of being allocated to the Series F-1 Preferred Stock. Since the Series F-1 F-1 20.0 1.6 0.4 The Series F-2, F-3 F-4 F-2, F-3 F-4 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | (10) Stockholders’ Equity Equity Offerings and Placements Common Purchase Agreement On March 29, 2023, the Company closed the Common Offering. The aggregate exercise price of the Common Tranche A Warrants is approximately $0.1 million The aggregate exercise price of the Common Tranche B Warrants is approximately $0.1 mi llion expire. The Company determined that the common warrants should be liability-classified because they had the same features that resulted in the preferred warrants being liability-classified. Registration Rights for Preferred and Common Offerings Pursuant Form S-3 providing within twenty-one (21) days The securities issued in the Series F Preferred Offering and the Common Offering have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and until so registered the securities may not be offered or sold absent registration or availability of an applicable exemption from registration. There is no established public trading market for the Series F Preferred Stock, the Preferred Warrants, the Preferred Warrant Shares or the Common Warrants and the Company does not intend to list such securities on any national securities exchange or nationally recognized trading system. The Company concluded that the common warrants were in the scope of Accounting Standards Codification (ASC) 480, Distinguishing Liabilities from Equity ASC 480,) since the common warrants are not mandatorily redeemable; and do not have obligations to issue a variable number of shares of common stock, The Company determined the common warrants met the definition of a derivativ e and w ere not considered indexed to the Company’s stock common since the warrants require early settle by repurchasing the warrants for cash in an amount equal to the Black-Scholes Value in the event of a Fundamental Transaction at pre-specified volatility at 100% as an input to the Black-Scholes calculation. Since the common warrants uses a pre-specific volatility and needing stockholders’ approval, the Company determined to record the common warrants at fair value and will be marked-to-market at subsequent reporting dates. Other Private Placements On July 20, 2022, the Company closed a private placement for the issuance and sale of 690,954 shares of common stock and 566,751 pre-funded pre-funded pre-funded pre-funded On December 13, 2022, the Company closed a private placement for the issuance and sale of 1,448,889 shares of common stock and 692,042 pre-funded pre-funded pre-funded pre-funded At-the-Market The Company has entered into the ATM Sales Agreement, 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 months ended March 31, 2023. The Company has no obligation to sell any shares of common stock under the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, the Sales Agent is required to use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of the Nasdaq Stock Market, to sell shares of common stock from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. The Company will pay the Sales Agent a commission of 3.0% of the aggregate gross proceeds from each such sale, reimburse the Sales Agent’s legal fees and disbursements up to $50 and provide the Sales GENT with customary indemnification and contribution rights. The Sales Agreement may be terminated by the Sales Agent or the Company upon notice to the other party as provided in the sales agreement, or the Sales Agent at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisable to market common stock or to enforce contracts for the sale of common stock. Authorized Shares The Company is authorized to issue 40 million shares of common stock, $0.01 par value, and 10 million shares of preferred stock, $0.01 par value. To date, the Company has designated the following preferred stock: Series A (4,200 shares), Series B (2,360 shares), Series C (590 shares), Series D (10,000 shares), Series E (40,000 shares), Series E-1 F-1 24,900 F-2 F-3 F-4 Preferred Stock As of March 31, 2023, there were an aggregate of 11,357 shares of Series E and Series E-1 Omnibus Equity Incentive Plan On September 30, 2020, the Company’s 2020 Omnibus Equity Incentive Plan (the “2020 Plan”) was adopted by the Company’s Board of Directors. On November 23, 2020, the Company’s stockholders approved the 2020 Plan. The 2020 Plan will continue in effect until the tenth anniversary of the date of its adoption by the Board or until earlier terminated by the Board. The 2020 Plan is administered by the Board of Directors or a committee designated by the Board of Directors. The 2020 Plan provides for the grant of incentive stock options, non-qualified Stock Options The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods: Three Months Ended March 31, 2023 2022 Expected terms (years) 5.8 % 5.5%-6.5% Expected volatility 172.8 % 174.8.% -177.1% Risk-free interest rate 4.08 % 1.75% - 1.90% Expected dividends — 0.00% The following is a summary of stock option activity for the three months ended March 31, 2023: Number of Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding at January 1, 2,235,052 $ 10.30 Granted 728,000 4.67 Expired (51,073 ) 10.54 Cancelled/Forfeited (17,586 ) 11.42 Outstanding at March 31, 2023 2,894,393 $ 8.87 8.4 $ 935 Exercisable at March 31, 2023 1,505,927 $ 10.81 7.7 $ 44 The following table summarizes information for stock option shares outstanding and exercisable at March 31, 2023: Options Exercisable Range of Exercise Prices Outstanding Number of Weighted Average Number of Options $2.83 - $51.50 2,893,894 8.4 1,505,428 $51.50+ 499 5.8 499 2,894,393 7.7 1,505,927 The following is a summary of share-based compensation expense in the statement of operations for the three months ended March 31, 2023 (in thousands): Three Months Ended March 31, 2023 2022 Selling, general and administrative $ 1,118 $ 1,475 Research and development 417 744 Cost of goods sold 126 52 Total $ 1,661 $ 2,271 At March 31, 2023, there was $1.9 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 1.4 years. Common Stock Warrants The following is a summary of common stock warrant activity for the three months ended March 31, 2023: Warrants Weighted Average Exercise Price Weighted Average Outstanding at January 1, 2023 5,153,291 $ 7.01 Warrants issued 81,849 2.94 Outstanding at March 31, 2023 5,235,140 $ 6.95 2.6 Exercisable at March 31, 2023 5,187,363 $ 6.96 2.6 The following table presents information related to common stock warrants at March 31, 2023: Warrants Exercisable Range of Exercise Prices Outstanding Weighted Average Remaining Warrant Term (in years) Number of Warrants $0.01 1,576,620 4.2 1,576,620 $4.50-$6.00 47,777 $10.00 3,610,743 1.9 3,610,743 5,235,140 2.6 5,187,363 On April 18, 2023, there were 538,828 $0.01 warrants exercised for 538,828 common shares. Employee Stock Purchase Plan In August 2021, the Company’s Board of Directors, with shareholder approval in May 2022, adopted the Employee six-month of |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | (11) 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 March 31, 2023 and 2022 because their effects would be anti-dilutive: March 31, 2023 2022 Common stock warrants 3,658,520 3,610,743 Assumed conversation of preferred stock warrants 11,896,667 — Assumed conversion of preferred stock 8,681,176 1,135,721 Assumed conversion of convertible notes 488,031 488,031 Stock options 2,894,393 2,238,103 Total 27,618,787 7,472,598 At March 31, 2023, the Company had 1,576,620 pre-funded Three months ended March 31, 2023 2022 Weighted average shares issued 10,081,634 7,906,728 Weighted average pre-funded 1,540,750 283,755 Weighted average shares outstanding 11,622,384 8,190,483 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (12) 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 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (13) 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 all member states of the European Union, Norway, Liechtenstein, Switzerland and the United Kingdom 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 , On December 30, 2022, the parties reached a final settlement of the matter and the Company agreed non-current Lachman Consulting Services, Inc On January 24, 2023, Lachman Consultant Services, Inc (“Lachman”) served the Company with a Complaint alleging that Delcath owes Lachman approximately $0.9 million in unpaid consulting fees plus interest, costs and attorneys’ fees. The lawsuit is Lachman Consultant Services, Inc. v. Delcath Systems, Inc., Index No. 650103-2023 (New York Supreme Court, New York County. The Company filed an answer to Lachman’s Complaint on February 22, 2023. On March 17, 2023, Delcath responded to Lachman’s March 3, 2023 Motion for Partial Summary Judgment. On March 20, 2023, the Court denied Lachman’s request that the case be moved into the Commercial Division. The current return date of Lachman’s motion for partial summary judgment is March 31, 2023. The dispute arises from a July 22, 2021 agreement between Lachman and Delcath under which Lachman was to provide assistance to the Company in regard to preparing for a FDA inspection and good manufacturing practices, training and support. In August 2022, the Company disputed $0.3 million of charges from Lachman As of March 31, 2023, the Company has accrued $0.9 million as accrued liability on the Company’s condensed consolidated balance sheet. The Company plans to vigorously defend this lawsuit and has reserved its rights to dispute all of Lachman charges as the litigation proceeds. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | (14) Fair Value Measurements The table below presents activity within Level 3 of the fair value hierarchy, our liabilities carried at fair value for the year ended March 31, 2023: Level 3 Contigent Warrants Total Balance at January 1, 2023 $ 1,280 $ — $ 1,280 Total change in foreign exchange 25 25 Fair value of the warrant liability issued 4,940 4,940 Balance at March 31, 2023 $ 1,305 $ 4,940 $ 6,245 Contingent liabilities are re-measured As disclosed in Note 9 and Note 10 of the Company’s consolidated financial statements, the Company allocated part of the proceeds of private placement of the Company’s preferred F-1 The fair value of the preferred and common warrants at March 29, 2023 was determined by using option pricing models assuming the following: March 29, 2023 Risk free interest rate 3.80% - 4.80 % Expected term (years) 0.5 - 3.0 Expected volatility 70% - 75 % Expected dividends 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 Delcath 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 Delcath stock would fall under Level 1 of the fair-value hierarchy as it is a quoted price in an active market (ASC 820-10). 820-10, The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value as of March 31, 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: Quoted Prices in Significant Inputs Significant Inputs March 31, Description Liabilities: Contingent liability — — $ 1,305 $ 1,305 Warrant liability 4,940 4,940 Total liabilities $ — $ — $ 6,245 $ 6,245 Quoted Prices in Significant Significant Inputs December 31, Description Liabilities: Contingent liability — — $ 1,280 $ 1,280 Total liabilities $ — $ — $ 1,280 $ 1,280 |
General (Policies)
General (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Risk and Uncertainties | Risks and Uncertainties While the long-term economic impact of either the COVID-19 disruptions and slowdown deepen or persist, we may not be able to access additional capital on favorable terms, or at all, which could in the future negatively affect our ability to pursue our business strategy. See “Risk Factors” in “Par t I – |
Liquidity and Going Concern | Liquidity and Going Concern At March 31, 2023, the Company had cash, cash equivalents and restricted cash totaling $24.3 million, as compared to cash, cash equivalents and restricted cash totaling $11.8 million at December 31, 2022. During the three months ended March 31, 2023, the Company used $4.3 million of cash in our operating activities. On March 10, 2023, the Company had a banking relationship with SVB. As of the closure of SVB on March 10, 2023, it held approximately $1.1 million of unrestricted cash in deposits held in SVB, $4.0 million held in a restricted SVB account as required per the Avenue Loan Agreement (as defined in “Note 8 – Loans and Convertible Notes Payable”) and approximately $0.2 million of restricted cash held in SVB collateral accounts as required per the Company’s line of credit for the property in New York City and its credit card program with SVB. SVB was closed on March 10, 2023 by the California Department of Financial Protection and Innovation, which appointed the FDIC as receiver. On March 12, 2023, the U.S. Treasury, Federal Reserve, and FDIC announced that SVB depositors would have access to all of their money starting March 13,2023. On March 13, 2023, the Company was able to access all of its cash, cash equivalents and investments held at or through SVB. While the Company has not experienced any losses in such accounts, the recent failure of SVB exposed it to significant credit risk prior to the completion by the FDIC of the resolution of SVB in a manner that fully protected all depositors. The Company is evaluating alternative solutions which management believes does not expose us to significant credit risk or jeopardizes our liquidity. 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 has entered into a Controlled Equity Offering SM We currently believe that our current cash and cash equivalents will enable us to have sufficient cash past our anticipated PDUFA date of August 14, 2023. Subject to the approval by our stockholders of the private placement that we closed on March 29, 2023 at our upcoming annual general meeting of stockholders, the Tranche A and B warrants issued in such private placement will become exercisable. The exercise of all such warrants would generate approximately $60.0 million in proceeds. We believe that this amount will be adequate to fund the commercialization of HEPZATO, if approved. If there is a substantial delay in the approval of HEPZATO we expect to need to raise additional capital under structures available to us, including debt and/or equity offerings, which may not be on terms favorable to us. In a delayed approval scenario, our ability to continue as a going concern depends on our ability to raise additional capital through the sale of equity or debt securities, or through partnering or licensing transactions in which we receive cash to support our future operations. If we are unable to secure additional capital or if additional capital is not available on favorable terms for us, we may be required to curtail our research and development initiatives and take additional measures to reduce costs in order to conserve our cash. The Company’s capital commitments over the next twelve months include (a) $9.6 million to satisfy accounts payable, accrued expenses and lease liabilities and (b) $4.4 million of loan principal payments. Additional capital commitments beyond the next twelve months include (a) $0.2 million of lease liabilities; (b) $1.0 million for settlement of litigation with medac; (c) $1.2 million of loan principal payments; and (d) $5.0 million of convertible note principal payments, if the holders do not elect to convert the notes into equity. The Company also expects to use cash and cash equivalents to fund its On August 6, 2021, the Company entered into the Avenue Loan Agreement with Avenue Venture Opportunities Fund, L.P. (the “Lender,” or “Avenue”) for a term loan in an aggregate principal amount of up to $20 million (the “Avenue Loan”). The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.7% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at March 31, 2023 was 15.45%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. with On March 27, 2023, the Company entered into to a securities purchase agreement with certain accredited investors (the “Preferred Purchase Agreement”). Pursuant to the Preferred Purchase Agreement, on March 29, 2023, the Company issued to purchasers an aggregate $24.9 million in shares, consisting of 24,900 shares of the Company’s Series F-1 “Series F-1 Preferred • Tranche A warrants (the “Preferred Tranche A Warrant s F-3 “Series F-3 Preferred • Tranche B warrants (the “Preferred Tranche B Warrant s F-4 F-4 F-3 The shares of Series F-1 F-1 from the private placement by the Company. See Note 9 – Preferred Purchase Agreement for additional details related to the Series F Preferred Offering. Also on March 27, 2023, the Company entered into a securities purchase agreement with the Company’s Chief Executive Officer, Gerard Michel (the “Common Purchase Agreement”). Pursuant to the Common Purchase Agreement, on March 29, 2023, the Company issued to Mr. Michel 19,646 shares of common stock and two tranches of warrants that are exercisable as follows: • A m • A Preferred Tranche B Warrant (the “Common Tranche B Warrant” and, together with the Common Tranche A Warrant, the “Common Warrants”) for an aggregate exercise price of $0.1 million 16,666 See Note 10 – Stockholders’ Equity – Equity Offerings and Placements – Common Purchase Agreement for additional details related to the Common Offering. |
Basis of Presentation | Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the SEC’s instructions to Form 10-Q S-X. The preparation of interim condensed consolidated financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended March 31, 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 | 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. Management has determined that the Preferred Warrants issued in conjunction with the Preferred Purchase Agreement and the Common Warrants issued in conjunction with the Common Purchase Agreement should be liability classified 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 preferred F-1 shares 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 and of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO as inputs in the model to determine the fair value of warrants liability and preferred F-1 shares. The Company will adjust the fair value of the warranty liability at the end of each reporting period. |
Mezzanine Equity | Mezzanine Equity The Company accounts for its warrant liability 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. When ordinary or preferred shares are determined to be conditionally redeemable upon the occurrence of certain events that are not solely within the control of the issuer, and upon such event, the shares would become redeemable at the option of the holders, they are classified as ‘mezzanine equity’ (temporary equity). The purpose of this classification is to convey that such a security may not be permanently part of equity and could result in a demand for cash, securities or other assets of the entity in the future. |
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 | 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 million for million for compensation adjustment is a non-cash The following tables contain the financial . 10-Q As previously Adjustment As revised Balance Sheet for March 31, 2022 (unaudited) Additional paid-in $ 434,305 $ 797 $ 435,102 Accumulated deficit (429,179 ) (797 ) (429,976 ) Consolidated Statement of Operations and Comprehensive Loss for the three months March 31, 2022 (unaudited) Research and development expenses 4,240 241 4,481 Selling, general and administrative expenses 3,648 556 4,204 Total operating expenses 7,888 797 8,685 Operating loss (7,543 ) (797 ) (8,340 ) Net loss (8,203 ) (797 ) (9,000 ) Total other comprehensive loss (8,201 ) (797 ) (8,998 ) Basic and diluted loss per common share (1.00 ) (0.10 ) (1.10 ) Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended March 31, 2022 (unaudited) Compensation expense for issuance of stock options 1,474 797 2,271 Net loss (8,203 ) (797 ) (9,000 ) Consolidated Statement of Cash Flows for the three months ended March 31, 2022 (unaudited) Net loss (8,203 ) (797 ) (9,000 ) Stock option compensation expense 1,474 797 2,271 Balance Sheet for June 30, 2022 (unaudited) Additional paid-in 435,922 1,299 437,221 Accumulated deficit (438,836 ) (1,299 ) (440,135 ) |
General (Tables)
General (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Prior Period Adjustment [Abstract] | |
Schedule of error corrections and prior period adjustments | The impact of the revision on the Company’s financial statements for the first quarter of 2022 is reflected in the following table: As previously Adjustment As revised Balance Sheet for March 31, 2022 (unaudited) Additional paid-in $ 434,305 $ 797 $ 435,102 Accumulated deficit (429,179 ) (797 ) (429,976 ) Consolidated Statement of Operations and Comprehensive Loss for the three months March 31, 2022 (unaudited) Research and development expenses 4,240 241 4,481 Selling, general and administrative expenses 3,648 556 4,204 Total operating expenses 7,888 797 8,685 Operating loss (7,543 ) (797 ) (8,340 ) Net loss (8,203 ) (797 ) (9,000 ) Total other comprehensive loss (8,201 ) (797 ) (8,998 ) Basic and diluted loss per common share (1.00 ) (0.10 ) (1.10 ) Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended March 31, 2022 (unaudited) Compensation expense for issuance of stock options 1,474 797 2,271 Net loss (8,203 ) (797 ) (9,000 ) Consolidated Statement of Cash Flows for the three months ended March 31, 2022 (unaudited) Net loss (8,203 ) (797 ) (9,000 ) Stock option compensation expense 1,474 797 2,271 Balance Sheet for June 30, 2022 (unaudited) Additional paid-in 435,922 1,299 437,221 Accumulated deficit (438,836 ) (1,299 ) (440,135 ) |
Cash, Cash Equivalents and Re_2
Cash, Cash Equivalents and Restricted Cash (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash, Cash Equivalents, and Restricted Cash | Cash, cash equivalents, and restricted cash balances were as follows: March 31, December 31, Cash and cash equivalents $ 24,222 $ 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 $ 24,272 $ 11,822 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of inventories | Inventories consist of the following: March 31, December 31, Raw materials $ 811 $ 763 Work-in-process 1,410 1,102 Finished goods 116 133 Total inventories $ 2,337 $ 1,998 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following: March 31, December 31, 2023 2022 Clinical trial expenses $ 1,630 $ 1,630 Insurance premiums 109 123 Professional services 91 121 Other 125 95 Total prepaid expenses and other current assets $ 1,955 $ 1,969 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Components of property, plant and equipment | Property, plant, and equipment consist of the following: March 31, 2023 December 31, 2022 Estimated Useful Life Buildings and land $ 1,301 $ 1,301 30 years - Buildings Enterprise hardware and software 1,856 1,855 3 years Leaseholds 1,781 1,774 Lesser of lease term or estimated useful life Equipment 1,223 1,222 7 years Furniture 201 201 5 years Property, plant and equipment, gross 6,362 6,353 Accumulated depreciation (4,970 ) (4,931 ) Property, plant and equipment, net $ 1,392 $ 1,422 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Accrued expenses consist of the following: March 31, December 31, 2023 2022 Clinical expenses $ 2,398 $ 1,470 Compensation, excluding taxes 1,559 1,040 Professional fees 2,189 1,087 Interest on convertible note 593 553 Other 381 535 Total accrued expenses $ 7,120 $ 4,685 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Summary of Operating and Financing Leases | The following table summarizes the Company’s operating leases as of and for the three months ended March 31, 2023: U.S. Ireland Total Lease cost Operating lease cost $ 97 $ 9 $ 106 Other information Operating cash flows out from operating leases (97 ) (9 ) (106 ) Weighted average remaining lease term 0.5 3.6 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 58 28 86 Year ended December 31, 2024 — 37 37 Year ended December 31, 2025 — 37 37 Year ended December 31, 2026 — 22 22 Total 58 124 182 Less present value discount (1 ) (15 ) (16 ) Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2023 $ 57 $ 109 $ 166 |
Loans and Convertible Notes P_2
Loans and Convertible Notes Payable (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Summary of Loans and Convertible Notes Payable | March 31, 2023 December 31, 2022 Gross Discount Net Gross Discount Net Loan - Avenue [1] 5,610 (849 ) 4,762 11,923 (1,008 ) 10,916 Loan - Avenue [1] (4,442 ) 672 (3,770 ) (8,570 ) 724 (7,846 ) Total - Loans Payable, Non-Current $ 1,168 $ (177 ) $ 992 $ 3,353 $ (284 ) $ 3,070 Convertible Note Payable - Rosalind 2,000 — 2,000 2,000 — 2,000 Convertible Portion of Loan Payable - Avenue 3,000 (201 ) 2,799 3,000 (228 ) 2,772 Total - Convertible Notes Payable - Non-Current $ 5,000 $ (201 ) $ 4,799 $ 5,000 $ (228 ) $ 4,772 [1] The gross amount includes the 4.25% final payment of $467.5. |
Summary of Remaining Maturities of Company's Loan and Convertible Note Payables | Remaining maturities of the Company’s loan and convertible note payables are as follows: Loans Convertible Total Year ended December 31, 2023 $ 4,442 $ — $ 4,442 Year ended December 31, 2024 1,168 5,000 6,168 Total $ 5,610 $ 5,000 $ 10,610 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
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 during the reporting periods: Three Months Ended March 31, 2023 2022 Expected terms (years) 5.8 % 5.5%-6.5% Expected volatility 172.8 % 174.8.% -177.1% Risk-free interest rate 4.08 % 1.75% - 1.90% Expected dividends — 0.00% |
Summary of Stock Option Activity | The following is a summary of stock option activity for the three months ended March 31, 2023: Number of Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding at January 1, 2,235,052 $ 10.30 Granted 728,000 4.67 Expired (51,073 ) 10.54 Cancelled/Forfeited (17,586 ) 11.42 Outstanding at March 31, 2023 2,894,393 $ 8.87 8.4 $ 935 Exercisable at March 31, 2023 1,505,927 $ 10.81 7.7 $ 44 |
Summary of Stock Option Shares Outstanding and Exercisable | The following table summarizes information for stock option shares outstanding and exercisable at March 31, 2023: Options Exercisable Range of Exercise Prices Outstanding Number of Weighted Average Number of Options $2.83 - $51.50 2,893,894 8.4 1,505,428 $51.50+ 499 5.8 499 2,894,393 7.7 1,505,927 |
Summary of Recognized Share-based Compensation Cost | The following is a summary of share-based compensation expense in the statement of operations for the three months ended March 31, 2023 (in thousands): Three Months Ended March 31, 2023 2022 Selling, general and administrative $ 1,118 $ 1,475 Research and development 417 744 Cost of goods sold 126 52 Total $ 1,661 $ 2,271 |
Summary of Warrant Activity | The following is a summary of common stock warrant activity for the three months ended March 31, 2023: Warrants Weighted Average Exercise Price Weighted Average Outstanding at January 1, 2023 5,153,291 $ 7.01 Warrants issued 81,849 2.94 Outstanding at March 31, 2023 5,235,140 $ 6.95 2.6 Exercisable at March 31, 2023 5,187,363 $ 6.96 2.6 |
Schedule of Information Related to Stock Warrants Outstanding and Exercisable | The following table presents information related to common stock warrants at March 31, 2023: Warrants Exercisable Range of Exercise Prices Outstanding Weighted Average Remaining Warrant Term (in years) Number of Warrants $0.01 1,576,620 4.2 1,576,620 $4.50-$6.00 47,777 $10.00 3,610,743 1.9 3,610,743 5,235,140 2.6 5,187,363 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Anti-dilutive securities excluded from the computation of earnings per share | The following potentially dilutive securities were excluded from the computation of earnings per share as of March 31, 2023 and 2022 because their effects would be anti-dilutive: March 31, 2023 2022 Common stock warrants 3,658,520 3,610,743 Assumed conversation of preferred stock warrants 11,896,667 — Assumed conversion of preferred stock 8,681,176 1,135,721 Assumed conversion of convertible notes 488,031 488,031 Stock options 2,894,393 2,238,103 Total 27,618,787 7,472,598 |
Summary of reconciliation of weighted average shares outstanding calculation | The following table provides a reconciliation of the weighted average shares outstanding calculation for the three months ended March 31, 2023 and 2022: Three months ended March 31, 2023 2022 Weighted average shares issued 10,081,634 7,906,728 Weighted average pre-funded 1,540,750 283,755 Weighted average shares outstanding 11,622,384 8,190,483 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements using significant unobservable inputs | The table below presents activity within Level 3 of the fair value hierarchy, our liabilities carried at fair value for the year ended March 31, 2023: Level 3 Contigent Warrants Total Balance at January 1, 2023 $ 1,280 $ — $ 1,280 Total change in foreign exchange 25 25 Fair value of the warrant liability issued 4,940 4,940 Balance at March 31, 2023 $ 1,305 $ 4,940 $ 6,245 |
Schedule of fair value of the outstanding warrants | The fair value of the preferred and common warrants at March 29, 2023 was determined by using option pricing models assuming the following: March 29, 2023 Risk free interest rate 3.80% - 4.80 % Expected term (years) 0.5 - 3.0 Expected volatility 70% - 75 % Expected dividends 0.00 % |
Schedule of the Company's financial assets and liabilities that have been measured 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 March 31, 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: Quoted Prices in Significant Inputs Significant Inputs March 31, Description Liabilities: Contingent liability — — $ 1,305 $ 1,305 Warrant liability 4,940 4,940 Total liabilities $ — $ — $ 6,245 $ 6,245 Quoted Prices in Significant Significant Inputs December 31, Description Liabilities: Contingent liability — — $ 1,280 $ 1,280 Total liabilities $ — $ — $ 1,280 $ 1,280 |
General - Additional Informatio
General - Additional Information (Details) - USD ($) | 3 Months Ended | ||||||||
Mar. 29, 2023 | Mar. 15, 2023 | Aug. 06, 2021 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Mar. 10, 2023 | Dec. 31, 2022 | |
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Net cash used in operating activities | $ 4,300,000 | ||||||||
Proceeds from issuance of private placement | 22,960,000 | $ 0 | |||||||
Impact of Correction of Share Based Compensation on Net Income Loss | $ 400,000 | $ 500,000 | $ 800,000 | ||||||
Cash cash equivalents and restricted cash | 24,300,000 | $ 11,800,000 | |||||||
Sale of stock consideration received on the transaction | $ 101,000 | $ 100,000 | |||||||
Deferred revenue | $ 10,000,000 | ||||||||
Common stock, shares issued (in shares) | 10,081,634 | 10,081,634 | |||||||
Proceeds from exercise of warrants | $ 60,000,000 | ||||||||
Preferred Purchase Agreement [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Stock issued during period shares | 24,900 | ||||||||
Stock issued during the period value new issues | $ 24,900,000 | ||||||||
Share price | $ 0.01 | ||||||||
Conversion of stock preferred shares converted | 7,600,000 | ||||||||
Conversion of stock shares converted per share price | $ 3.3 | ||||||||
Preferred Purchase Agreement [Member] | Series F-1 Convertible Preferred Stock [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Proceeds from issuance of private placement | $ 24,900,000 | ||||||||
Shares issued, price per share | $ 1,000 | ||||||||
Common Purchase Agreement [Member] | Chief Executive Officer [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Common stock, shares issued (in shares) | 19,646 | ||||||||
Accounts Payable Accrued Expenses And Lease Liabilities [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Capital commitments current | $ 9,600,000 | ||||||||
Loan Principal Payments [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Capital commitments current | 4,400,000 | ||||||||
Capital commitement non current | 1,200,000 | ||||||||
Lease Liabilities [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Capital commitement non current | 200,000 | ||||||||
Third Party Settlement [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Capital commitement non current | 1,000,000 | ||||||||
Convertibe Note Principal Payments [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Capital commitement non current | 5,000,000 | ||||||||
Controlled Equity Offering Sales Agreement [Member] | Cantor Fitzgerald And Co [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Common stock subscribed but not issued value | 17,000,000 | ||||||||
Sale of stock consideration received on the transaction | 4,000,000 | ||||||||
Stock issued during the period value new issues | $ 0 | ||||||||
Term Loan From Avenue Venture Opportunities Fund LP [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Debt instrument, principal face amount | $ 3,000,000 | ||||||||
Interest rate | 7.70% | ||||||||
Debt instrument, interest rate | 10.95% | 15.45% | |||||||
Debt instrument maturity date | Aug. 01, 2024 | ||||||||
Debt instrument, interest rate term | The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at March 31, 2023 was 15.45%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. | The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at March 31, 2023 was 15.45%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. | |||||||
Long term debt variable interest rate percentage | 15.45% | ||||||||
Restricted cash used to repay loans proceeds | $ 4,000,000 | ||||||||
Term Loan From Avenue Venture Opportunities Fund LP [Member] | Condition For The Extension Of Period OF Interest Only Payments [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Class of warrants or rights exercise price per share | $ 0.01 | ||||||||
Estimated minimum proceeds on issue of common stock for extension of due date of interest only interest payments | $ 10,000,000 | ||||||||
Class of warrants or rights number of securities covered by the warrants or rights | 34,072 | ||||||||
Term Loan From Avenue Venture Opportunities Fund LP [Member] | Maximum [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Debt instrument, principal face amount | $ 20,000,000 | ||||||||
Term Loan From Avenue Venture Opportunities Fund LP [Member] | Unrestricted Cash With Silicon Valley Bank [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Unrestricted investments current | $ 1,100,000 | ||||||||
Term Loan From Avenue Venture Opportunities Fund LP [Member] | Restricted Investment As Per Loan Agreement [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Restricted investments current | 4,000,000 | ||||||||
Term Loan From Avenue Venture Opportunities Fund LP [Member] | Collateral Held With Silicon Valley Bank [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Restricted investments current | $ 200,000 | ||||||||
PreferredTranche A Warrant [Member] | Preferred Purchase Agreement [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Class of warrants or rights exercise price per share | $ 1,000 | ||||||||
Share price | $ 0.01 | ||||||||
Conversion of stock preferred shares converted | 7,800,000 | ||||||||
Conversion of stock shares converted per share price | $ 4.5 | ||||||||
Aggregate exercise price of preferred warrants | $ 34,900,000 | ||||||||
Number of exercisable preferred warrants | 34,860 | ||||||||
Preferred Tranche B Warrant [Member] | Preferred Purchase Agreement [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Class of warrants or rights exercise price per share | $ 1,000 | ||||||||
Share price | $ 0.01 | ||||||||
Conversion of stock preferred shares converted | 4,200,000 | ||||||||
Conversion of stock shares converted per share price | $ 6 | ||||||||
Aggregate exercise price of preferred warrants | $ 24,900,000 | ||||||||
Number of exercisable preferred warrants | 24,900 | ||||||||
Deferred revenue | $ 10,000,000 | ||||||||
Common Tranche A Warrant [Member] | Preferred Purchase Agreement [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Aggregate exercise price of preferred warrants | $ 100,000 | ||||||||
Number of exercisable preferred warrants | 31,110 | ||||||||
Common Tranche B Warrant [Member] | Preferred Purchase Agreement [Member] | |||||||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||||||
Aggregate exercise price of preferred warrants | $ 100,000 | ||||||||
Number of exercisable preferred warrants | 16,666 | ||||||||
Deferred revenue | $ 10,000,000 |
General - Schedule of Error Cor
General - Schedule of Error Corrections and Prior Period Adjustments (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Jun. 30, 2022 | |
Statement of Financial Position [Abstract] | ||||
Additional paid-in capital | $ 453,370 | $ 451,608 | ||
Accumulated deficit | (466,483) | $ (457,484) | ||
Statement of Operations and Comprehensive Loss [Abstract] | ||||
Research and development expenses | 4,576 | $ 4,481 | ||
Selling, general and administrative expenses | 4,165 | 4,204 | ||
Total operating expenses | 8,741 | 8,685 | ||
Operating loss | (8,325) | (8,340) | ||
Net loss | 9,000 | 9,000 | ||
Total other comprehensive loss | $ (8,981) | $ (8,998) | ||
Basic loss per common share | $ (0.77) | $ (1.1) | ||
Diluted loss per common share | $ (0.77) | $ (1.1) | ||
Statement of Stockholders' Equity [Abstract] | ||||
Compensation expense for issuance of stock options | $ 1,661 | $ 2,271 | ||
Net loss | 9,000 | 9,000 | ||
Statement of Cash Flows [Abstract] | ||||
Net loss | 9,000 | 9,000 | ||
Stock option compensation expense | $ 1,661 | 2,271 | ||
Previously Reported [Member] | ||||
Statement of Financial Position [Abstract] | ||||
Additional paid-in capital | 434,305 | $ 435,922 | ||
Accumulated deficit | (429,179) | (438,836) | ||
Statement of Operations and Comprehensive Loss [Abstract] | ||||
Research and development expenses | 4,240 | |||
Selling, general and administrative expenses | 3,648 | |||
Total operating expenses | 7,888 | |||
Operating loss | (7,543) | |||
Net loss | (8,203) | |||
Total other comprehensive loss | $ (8,201) | |||
Basic loss per common share | $ (1) | |||
Diluted loss per common share | $ (1) | |||
Statement of Stockholders' Equity [Abstract] | ||||
Compensation expense for issuance of stock options | $ 1,474 | |||
Net loss | (8,203) | |||
Statement of Cash Flows [Abstract] | ||||
Net loss | (8,203) | |||
Stock option compensation expense | 1,474 | |||
Revision of Prior Period, Adjustment [Member] | ||||
Statement of Financial Position [Abstract] | ||||
Additional paid-in capital | 797 | 1,299 | ||
Accumulated deficit | (797) | (1,299) | ||
Statement of Operations and Comprehensive Loss [Abstract] | ||||
Research and development expenses | 241 | |||
Selling, general and administrative expenses | 556 | |||
Total operating expenses | 797 | |||
Operating loss | (797) | |||
Net loss | (797) | |||
Total other comprehensive loss | $ (797) | |||
Basic loss per common share | $ (0.1) | |||
Diluted loss per common share | $ (0.1) | |||
Statement of Stockholders' Equity [Abstract] | ||||
Compensation expense for issuance of stock options | $ 797 | |||
Net loss | (797) | |||
Statement of Cash Flows [Abstract] | ||||
Net loss | (797) | |||
Stock option compensation expense | 797 | |||
As Revised [Member] | ||||
Statement of Financial Position [Abstract] | ||||
Additional paid-in capital | 435,102 | 437,221 | ||
Accumulated deficit | (429,976) | $ (440,135) | ||
Statement of Operations and Comprehensive Loss [Abstract] | ||||
Research and development expenses | 4,481 | |||
Selling, general and administrative expenses | 4,204 | |||
Total operating expenses | 8,685 | |||
Operating loss | (8,340) | |||
Net loss | (9,000) | |||
Total other comprehensive loss | $ (8,998) | |||
Basic loss per common share | $ (1.1) | |||
Diluted loss per common share | $ (1.1) | |||
Statement of Stockholders' Equity [Abstract] | ||||
Compensation expense for issuance of stock options | $ 2,271 | |||
Net loss | (9,000) | |||
Statement of Cash Flows [Abstract] | ||||
Net loss | (9,000) | |||
Stock option compensation expense | $ 2,271 |
Cash, Cash Equivalents and Re_3
Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 24,222 | $ 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 | $ 24,272 | $ 11,822 | $ 20,491 | $ 26,953 |
Cash, Cash Equivalents and Re_4
Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Parenthetical) (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Mar. 15, 2023 | Mar. 31, 2022 |
Cash and Cash Equivalents [Line Items] | |||
Restricted Cash | $ 50 | $ 4,151 | |
Term Loan From Avenue Venture Opportunities Fund LP [Member] | |||
Cash and Cash Equivalents [Line Items] | |||
Restricted Cash | $ 4,000 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 811 | $ 763 |
Work-in-process | 1,410 | 1,102 |
Finished goods | 116 | 133 |
Total inventories | $ 2,337 | $ 1,998 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Clinical trial expenses | $ 1,630 | $ 1,630 |
Insurance premiums | 109 | 123 |
Professional services | 91 | 121 |
Other | 125 | 95 |
Total prepaid expenses and other current assets | $ 1,955 | $ 1,969 |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 6,362 | $ 6,353 |
Accumulated depreciation | (4,970) | (4,931) |
Property, plant, and equipment, net | 1,392 | 1,422 |
Buildings and Land [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,301 | 1,301 |
Enterprise Hardware and Software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,856 | 1,855 |
Property, plant and equipment, estimated useful life | 3 years | |
Leaseholds [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,781 | 1,774 |
Property, plant and equipment, estimated useful life | Lesser of lease term or estimated useful life | |
Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,223 | 1,222 |
Property, plant and equipment, estimated useful life | 7 years | |
Furniture [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 201 | $ 201 |
Property, plant and equipment, estimated useful life | 5 years | |
Buildings [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, estimated useful life | 30 years |
Property, Plant, and Equipmen_3
Property, Plant, and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 30 | $ 31 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Clinical expenses | $ 2,398 | $ 1,470 |
Compensation, excluding taxes | 1,559 | 1,040 |
Professional fees | 2,189 | 1,087 |
Interest on convertible note | 593 | 553 |
Other | 381 | 535 |
Total accrued expenses | $ 7,120 | $ 4,685 |
Leases - Additional Information
Leases - Additional Information (Details) | Mar. 31, 2023 |
Lease term | 12 months |
Leases - Summary of Operating a
Leases - Summary of Operating and Financing Leases (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Lease Cost | |
Operating lease cost | $ 106 |
Other information | |
Operating cash flows out from operating leases | (106) |
U.S. [Member] | |
Lease Cost | |
Operating lease cost | 97 |
Other information | |
Operating cash flows out from operating leases | $ (97) |
Weighted average remaining lease term | 6 months |
Weighted average discount rate - operating leases | 8% |
Ireland [Member] | |
Lease Cost | |
Operating lease cost | $ 9 |
Other information | |
Operating cash flows out from operating leases | $ (9) |
Weighted average remaining lease term | 3 years 7 months 6 days |
Weighted average discount rate - operating leases | 8% |
Leases - Schedule of Remaining
Leases - Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2023 | $ 86 |
Year ended December 31, 2024 | 37 |
Year ended December 31, 2025 | 37 |
Year ended December 31, 2026 | 22 |
Total | 182 |
Less present value discount | (16) |
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2023 | 166 |
U.S. [Member] | |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2023 | 58 |
Year ended December 31, 2024 | 0 |
Total | 58 |
Less present value discount | (1) |
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2023 | 57 |
Ireland [Member] | |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2023 | 28 |
Year ended December 31, 2024 | 37 |
Year ended December 31, 2025 | 37 |
Year ended December 31, 2026 | 22 |
Total | 124 |
Less present value discount | (15) |
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2023 | $ 109 |
Loans and Convertible Notes P_3
Loans and Convertible Notes Payable - Additional Information (Details) - USD ($) | 3 Months Ended | |||
Mar. 15, 2023 | Aug. 06, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | |
Debt Instrument [Line Items] | ||||
Interest expense incurred | $ 500,000 | $ 400,000 | ||
Restricted Cash | 50,000 | 4,151,000 | ||
Final payment | $ 467,500 | |||
Secured Convertible Notes Payable [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, principal face amount | $ 2,000,000 | |||
Series E Preferred Stock [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, conversion price | $ 1,500 | |||
Series E Preferred Stock [Member] | Secured Convertible Notes Payable [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument maturity date | Oct. 30, 2024 | |||
Debt instrument, conversion price | $ 1,198 | |||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, principal face amount | $ 3,000,000 | |||
Debt instrument maturity date | Aug. 01, 2024 | |||
Debt instrument, interest rate | 7.70% | |||
Debt instrument, interest rate | 10.95% | 15.45% | ||
Debt instrument, interest rate term | The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at March 31, 2023 was 15.45%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. | The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at March 31, 2023 was 15.45%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. | ||
Initial tranche of loan | $ 15,000,000 | |||
Loan amount funded into restricted account | 4,000,000 | |||
Gross proceeds from ATM Offering | $ 20,000,000 | |||
Debt instrument, conversion price | $ 11.98 | |||
Frequency of periodic payment | monthly | |||
Periodic interest payments, term | 15 months | |||
Debt instrument, incremental final payment | 4.25% | 4.25% | ||
Original issue discount | $ 600,000 | |||
Cash issuance costs | 600,000 | |||
Debit discount | 500,000 | |||
Fair value of warrants reclassified from liability to equity | 100,000 | |||
Aggregate debt discount | $ 2,300,000 | |||
Amortization of debt discount | $ 200,000 | |||
Current interest rate | 7.70% | |||
Restricted Cash | $ 4,000,000 | |||
Final payment | $ 200,000 | |||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Condition For The Extension Of Period OF Interest Only Payments [Member] | ||||
Debt Instrument [Line Items] | ||||
Class of warrants or rights number of securities covered by the warrants or rights | 34,072 | |||
Warrant exercise price | $ 0.01 | |||
Estimated minimum proceeds on issue of common stock for extension of due date of interest only interest payments | $ 10,000,000 | |||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Warrant [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants Issued ToPurchase Of Common Stock | 127,755 | |||
Warrant exercise price | $ 0.01 | |||
Warrants, maturity date | Aug. 31, 2026 | |||
Fair value of the Avenue Warrant | $ 1,200,000 | |||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Maximum [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, principal face amount | $ 20,000,000 | |||
Periodic interest payments, term | 24 months | |||
Prepayment fee, percentage | 3% | |||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Minimum [Member] | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee, percentage | 1% | |||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Non Convertible Debt [Member] | ||||
Debt Instrument [Line Items] | ||||
Aggregate debt discount | $ 1,900,000 | |||
Amortization of debt discount | $ 200,000 | |||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Convertible Debt [Member] | ||||
Debt Instrument [Line Items] | ||||
Aggregate debt discount | $ 400,000 | |||
Eight Point Zero Percentage July Two Thousand And Nineteen Notes [Member] | Convertible Notes Payable [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, interest rate | 8% | |||
Current interest rate | 8% | |||
Eight Point Zero Percentage July Two Thousand And Nineteen Notes [Member] | Convertible Debt [Member] | ||||
Debt Instrument [Line Items] | ||||
Interest expense incurred | $ 40,000 | $ 40,000 |
Loans and Convertible Notes P_4
Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | |
Gross | $ 5,000 | $ 5,000 | |
Discount | (201) | (228) | |
Net | 4,799 | 4,772 | |
Less Current Portion, Net | (3,770) | (7,846) | |
Total - Loans Payable, Non-Current, Gross | 1,168 | 3,353 | |
Total - Loans Payable, Non-Current, Discount | (177) | (284) | |
Total - Loans Payable, Non-Current, Net | 992 | 3,070 | |
Loan Avenue [Member] | |||
Gross | [1] | 5,610 | 11,923 |
Discount | [1] | (849) | (1,008) |
Net | [1] | 4,762 | 10,916 |
Less Current Portion, Gross | [1] | (4,442) | (8,570) |
Less Current Portion, Discount | [1] | 672 | 724 |
Less Current Portion, Net | [1] | (3,770) | (7,846) |
Convertible Note Payable Rosalind [Member] | |||
Gross | 2,000 | 2,000 | |
Net | 2,000 | 2,000 | |
Convertible Loan Payable Avenue [Member] | |||
Gross | 3,000 | 3,000 | |
Discount | (201) | (228) | |
Net | $ 2,799 | $ 2,772 | |
[1]The gross amount includes the 4.25% final payment of $467.5. |
Loans and Convertible Notes P_5
Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) (Parenthetical) | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Equity Method Investments And Cost Method Investments [Abstract] | |
Percentage of final payment included in gross amount | 4.25% |
Final payment | $ 467,500 |
Loans and Convertible Notes P_6
Loans and Convertible Notes Payable - Summary of Remaining Maturities of Company's Loan and Convertible Note Payables (Details) $ in Thousands | Mar. 31, 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 | 4,442 |
Total | 4,442 |
Year ended December 31, 2024 | |
Debt Instrument [Line Items] | |
Loans | 1,168 |
Convertible Notes | 5,000 |
Total | $ 6,168 |
Preferred Purchase Agreement -
Preferred Purchase Agreement - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||
Mar. 29, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | |
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | |
Deferred revenue | $ 10,000 | ||
Financial and nonfinancial liabilities | $ 6,245 | $ 1,280 | |
Warrant [Member] | |||
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Stock issuance cost paid | 400 | ||
Preferred Warrant Liabilities [Member] | |||
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Proceeds from issuance of warrants | 24,900 | ||
Financial and nonfinancial liabilities | 4,900 | ||
Series F-1 Preferred Stock [Member] | Preferred Warrant Liabilities [Member] | |||
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Proceeds from issuance of warrants | 20,000 | ||
Series F-3 Preferred Stock [Member] | Preferred Tranche A Warrant [Member] | |||
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Number of exercisable preferred warrants | 34,860 | ||
Preferred Purchase Agreement [Member] | Preferred Tranche A Warrant [Member] | |||
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Aggregate exercise price of preferred warrants | $ 34,900 | ||
Number of exercisable preferred warrants | 34,860 | ||
Preferred Purchase Agreement [Member] | Preferred Tranche B Warrant [Member] | |||
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Aggregate exercise price of preferred warrants | $ 24,900 | ||
Number of exercisable preferred warrants | 24,900 | ||
Deferred revenue | $ 10,000 | ||
Preferred Purchase Agreement [Member] | Series F-1 Preferred Stock [Member] | |||
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Preferred stock, par value (in dollars per share) | $ 0.01 | ||
Preferred stock convertible conversion price | 3.3 | ||
Stock issuance costs | 1,600 | ||
Proceeds from issuance of preferred stock | $ 20,000 | ||
Preferred Purchase Agreement [Member] | Series F-2 Preferred Stock [Member] | |||
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Preferred stock convertible conversion price | 3.3 | ||
Preferred Purchase Agreement [Member] | Series F-3 Preferred Stock [Member] | |||
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Preferred stock convertible conversion price | 4.5 | ||
Preferred Purchase Agreement [Member] | Series F-4 Preferred Stock [Member] | |||
Disclosure Of Preferred Purchase Agreement [Line Items] | |||
Preferred stock convertible conversion price | $ 6 |
Stockholders' Equity - Preferre
Stockholders' Equity - Preferred Stock Issuances - Additional Information (Details) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 40,000,000 | 40,000,000 |
Preferred stock, shares outstanding (in shares) | 11,357 | 11,357 |
Series A Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 4,200 | |
Series B Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 2,360 | |
Series C Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 590 | |
Series D Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 10,000 | |
Series E Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 40,000 | |
Preferred stock, shares outstanding (in shares) | 11,357 | |
Series E1 Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 12,960 | |
Series F-1 Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 24,900 | |
Series F-2 Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 24,900 | |
Series F-3 Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 34,860 | |
Series F-4 Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 24,900 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Incentive Plan - Additional Information (Details) - shares | Mar. 31, 2023 | Dec. 31, 2020 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Common Stock Capital Shares Reserved | 2,475,000 | |
Number of common shares remained available to be issued | 195,167 |
Stockholders' Equity - Equity O
Stockholders' Equity - Equity Offerings and Placements - Additional Information (Details) $ in Millions | Mar. 29, 2023 USD ($) shares | Mar. 31, 2023 |
Stockholders Equity Note [Line Items] | ||
Deferred revenue | $ 10 | |
Black Scholes Valuation Technique [Member] | Measurement Input, Price Volatility [Member] | ||
Stockholders Equity Note [Line Items] | ||
Volatility | 100 | |
Tranche A Warrants [Member] | Common Purchase Agreement [Member] | ||
Stockholders Equity Note [Line Items] | ||
Aggregate exercise price of preferred warrants | $ 0.1 | |
Number of exercisable common warrants | shares | 31,110 | |
Tranche B Warrants [Member] | Common Purchase Agreement [Member] | ||
Stockholders Equity Note [Line Items] | ||
Aggregate exercise price of preferred warrants | $ 0.1 | |
Number of exercisable common warrants | shares | 16,666 |
Stockholders' Equity - At-the-M
Stockholders' Equity - At-the-Market Offering - Additional Information (Details) - USD ($) | 3 Months Ended | ||||
Dec. 31, 2022 | Jul. 20, 2022 | Aug. 18, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | |
Stockholders Equity Note [Line Items] | |||||
Proceeds from issuance of private placement | $ 22,960,000 | $ 0 | |||
Number of Shares Sold | 0 | ||||
Private Placement [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Proceeds from issuance of private placement | $ 6,200,000 | $ 5,000,000 | |||
Private Placement [Member] | Pre Funded Warrants [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Warrants issued to purchase of common stock | 692,042 | 566,751 | |||
Warrants issued to purchase of common stock, Price per warrant | $ 2.89 | $ 3.97 | |||
Exercise price of warrant | $ 0.01 | $ 0.01 | |||
Private Placement [Member] | Common Stock [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Shares issued in public offering | 1,448,889 | 690,954 | |||
Shares issued, price per share | $ 2.9 | $ 3.98 | |||
Cantor Fitzgerald & Co [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Percentage of commission on aggregate gross proceeds | 3% | ||||
Maximum [Member] | Cantor Fitzgerald & Co [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
At-the-market offering, aggregate offering price | $ 17,000,000 | ||||
Legal fees and disbursements | $ 50,000 |
Stockholders' Equity - Stock In
Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized compensation expense related to non-vested share-based compensation awards | $ 1.9 |
Cost expected to be recognized over weighted average period | 1 year 4 months 24 days |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected terms (years) | 5 years 9 months 18 days | |
Expected volatility | 172.80% | |
Risk-free interest rate | 4.08% | |
Expected dividends | 0% | 0% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected terms (years) | 5 years 6 months | |
Expected volatility | 174.80% | |
Risk-free interest rate | 1.75% | |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected terms (years) | minus 6 years 6 months | |
Expected volatility | 177.10% | |
Risk-free interest rate | 1.90% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) $ / shares shares | |
Stockholders' Equity Note [Abstract] | |
Number of Shares, Outstanding | shares | 2,235,052 |
Number of Shares, Granted | shares | 728,000 |
Number of Shares, Expired | shares | (51,073) |
Number of Shares, Cancelled/Forfeited | shares | (17,586) |
Number of Shares, Outstanding | shares | 2,894,393 |
Number of Shares, Exercisable | shares | 1,505,927 |
Weighted Average Exercise Price, Outstanding | $ / shares | $ 10.3 |
Weighted Average Exercise Price, Granted | $ / shares | 4.67 |
Weighted Average Exercise Price, Expired | $ / shares | 10.54 |
Weighted Average Exercise Price, Cancelled/Forfeited | $ / shares | 11.42 |
Weighted Average Exercise Price, Outstanding | $ / shares | 8.87 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 10.81 |
Weighted Average Remaining Contractual Term (Years), Outstanding | 8 years 4 months 24 days |
Weighted Average Remaining Contractual Term (Years), Exercisable | 7 years 8 months 12 days |
Aggregate Intrinsic Value, Outstanding | $ | $ 935 |
Aggregate Intrinsic Value, Exercisable | $ | $ 44 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock Option Shares Outstanding and Exercisable (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 2,894,393 | 2,235,052 |
Weighted Average Remaining Contractual Term (Years), Exercisable | 7 years 8 months 12 days | |
Number of Shares, Exercisable | 1,505,927 | |
$2.83 - $51.50 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 2,893,894 | |
Weighted Average Remaining Contractual Term (Years), Exercisable | 8 years 4 months 24 days | |
Number of Shares, Exercisable | 1,505,428 | |
$51.50+ | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 499 | |
Weighted Average Remaining Contractual Term (Years), Exercisable | 5 years 9 months 18 days | |
Number of Shares, Exercisable | 499 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Employee Stock Purchase Plan (Details) - May Two Thousand And Twenty Two Employee Stock Purchase Plan [Member] - shares | 1 Months Ended | |
Aug. 31, 2021 | Jan. 31, 2023 | |
Stockholders Equity Note [Line Items] | ||
Share-based compensation arrangement by share-based payment award number of shares authorized | 260,295 | 15,417 |
Share-based compensation arrangement by share-based payment award purchase price of common stock, percent | 85% |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | $ 1,661 | $ 2,271 |
Selling, General and Administrative [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | 1,118 | 1,475 |
Research and Development [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | 417 | 744 |
Cost of Goods Sold [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | $ 126 | $ 52 |
Stockholders' Equity - Summar_5
Stockholders' Equity - Summary of Warrant Activity (Details) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Warrants outstanding [Roll Forward] | |
Outstanding, beginning of period (in shares) | shares | 5,153,291 |
Warrants issued (in shares) | shares | 81,849 |
Outstanding, end of period (in shares) | shares | 5,235,140 |
Exercisable, end of period (in shares) | shares | 5,187,363 |
Warrants, Exercise Price per Share [Roll Forward] | |
Outstanding, beginning of period (in dollars per share) | $ / shares | $ 7.01 |
Outstanding, ending of period (in dollars per share) | $ / shares | 6.95 |
Warrants issued (in dollars per share) | $ / shares | 2.94 |
Exercisable, (in dollars per share) | $ / shares | $ 6.96 |
Weighted average remaining life | 2 years 7 months 6 days |
Weighted average remaining life, Exercisable | 2 years 7 months 6 days |
Stockholders' Equity - Summar_6
Stockholders' Equity - Summary of Warrants Outstanding and Exercisable (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 5,235,140 | 5,153,291 |
Weighted average remaining life | 2 years 7 months 6 days | |
Warrants Exercisable, Number Exercisable | 5,187,363 | |
$0.01 [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 1,576,620 | |
Weighted average remaining life | 4 years 2 months 12 days | |
Warrants Exercisable, Number Exercisable | 1,576,620 | |
$4.50-$6.00 [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 47,777 | |
$10.00 [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 3,610,743 | |
Weighted average remaining life | 1 year 10 months 24 days | |
Warrants Exercisable, Number Exercisable | 3,610,743 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock Warrants - Additional Information (Details) - $ / shares | Apr. 18, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Stockholders Equity Note [Line Items] | |||
Class Of Warrant Or Right Outstanding | 5,235,140 | 5,153,291 | |
Subsequent Event [Member] | |||
Stockholders Equity Note [Line Items] | |||
Class Of Warrant Or Right Outstanding | 538,828 | ||
Class of warrants or rights exercise price per share | $ 0.01 | ||
Class of warrant or right exercised | 538,828 |
Net Loss per Share - Anti-Dilut
Net Loss per Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 27,618,787 | 7,472,598 |
Common stock warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 3,658,520 | 3,610,743 |
Assumed Conversation Of Preferred Stock Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 11,896,667 | 0 |
Assumed Conversion Of Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 8,681,176 | 1,135,721 |
Assumed Conversion Of Convertible Notes [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 488,031 | 488,031 |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 2,894,393 | 2,238,103 |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2023 shares | |
Earnings Per Share [Abstract] | |
Pre-funded penny warrants outstanding | 1,576,620 |
Net Loss per Share - Summary of
Net Loss per Share - Summary of Reconciliation of Weighted Average Shares Outstanding Calculation (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Weighted average shares issued | 10,081,634 | 7,906,728 |
Weighted average pre-funded warrants | 1,540,750 | 283,755 |
Weighted average number of basic shares outstanding | 11,622,384 | 8,190,483 |
Weighted average number of diluted shares outstanding | 11,622,384 | 8,190,483 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) $ in Billions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Corporate alternative minimum tax | 15% |
Minimum accounting profit required for preceding three financial year | $ 1 |
Percentage of excise tax on repurchases of stock | 1% |
Commitments and contingencies -
Commitments and contingencies - Additional Information (Details) $ in Thousands, € in Millions | Dec. 30, 2022 USD ($) | Apr. 01, 2021 EUR (€) | Mar. 31, 2023 USD ($) | Jan. 24, 2023 USD ($) | Dec. 31, 2022 USD ($) | Mar. 31, 2022 USD ($) | Oct. 12, 2021 EUR (€) |
Loss Contingencies [Line Items] | |||||||
Inventories | $ 2,337 | $ 1,998 | |||||
Milestone payment unpaid | € | € 1 | ||||||
Medac [Member] | |||||||
Loss Contingencies [Line Items] | |||||||
Due from related parties | € | € 1 | ||||||
Agreement date | Dec. 10, 2018 | ||||||
Inventories | $ 200 | ||||||
Term over which the royalty is to be paid | 5 years | ||||||
Minimum annual payments | $ 200 | ||||||
Medac [Member] | Other Liabilities | |||||||
Loss Contingencies [Line Items] | |||||||
Loss Contingency Accrual | 1,300 | ||||||
Medac [Member] | Other Noncurrent Liabilities | |||||||
Loss Contingencies [Line Items] | |||||||
Loss Contingency Accrual | 1,100 | ||||||
Medac [Member] | Accrued Expenses | |||||||
Loss Contingencies [Line Items] | |||||||
Loss Contingency Accrual | $ 200 | ||||||
Lachman [Member] | |||||||
Loss Contingencies [Line Items] | |||||||
Loss Contingency Accrual | $ 900 | ||||||
Unpaid consulting fees | 900 | ||||||
Loss contingency disputes charges | $ 300 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value of Outstanding Warrants (Details) - Preferred And Common Warrants [Member] - Valuation Technique, Option Pricing Model [Member] | Mar. 29, 2023 |
Risk-free Interest Rates [Member] | Minimum [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Warrants measurement input | 3.8 |
Risk-free Interest Rates [Member] | Maximum [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Warrants measurement input | 4.8 |
Contractual life (in years) [Member] | Minimum [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Expected term | 6 months |
Contractual life (in years) [Member] | Maximum [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Expected term | 3 years |
Expected Volatility [Member] | Minimum [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Warrants measurement input | 70 |
Expected Volatility [Member] | Maximum [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Warrants measurement input | 75 |
Measurement Input, Expected Dividend Rate [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Warrants measurement input | 0 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Measurements Using Significant Unobservable Inputs (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Beginning balance | $ 1,280 |
Total change in foreign exchange | 25 |
Fair value of the warrant liability issued | 4,940 |
Ending balance | 6,245 |
Contigent liabilities | |
Beginning balance | 1,280 |
Total change in foreign exchange | 25 |
Ending balance | 1,305 |
Warrants | |
Beginning balance | 0 |
Fair value of the warrant liability issued | 4,940 |
Ending balance | $ 4,940 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of the Company's financial assets and liabilities that have been measured at fair value (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Liabilities [Abstract] | ||
Contigent liability | $ 1,305 | $ 1,280 |
Warrant liability | 4,940 | |
Total liabilites | 6,245 | 1,280 |
Level 3 [Member] | ||
Liabilities [Abstract] | ||
Contigent liability | 1,305 | 1,280 |
Warrant liability | 4,940 | |
Total liabilites | $ 6,245 | $ 1,280 |