Cover Page
Cover Page - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 24, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Entity Registrant Name | DELCATH SYSTEMS, INC. | ||
Entity Central Index Key | 0000872912 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Document Annual 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 Public Float | $ 31,947,845 | ||
Entity Common Stock, Shares Outstanding | 10,061,988 | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Trading Symbol | DCTH | ||
Title of 12(b) Security | Common stock, $0.01 par value per share | ||
Document Fiscal Period Focus | FY | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
ICFR Auditor Attestation Flag | false | ||
Security Exchange Name | NASDAQ | ||
Auditor Name | Marcum LLP | ||
Auditor Firm ID | 688 | ||
Auditor Location | New York, NY | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s Proxy Statement for the 2023 Annual Meeting of Stockholders are incorporated by reference in Part III of this Annual Report on Form 10-K |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 7,671 | $ 22,802 |
Restricted cash | 4,151 | 4,151 |
Accounts receivable, net | 366 | 44 |
Inventories | 1,998 | 1,412 |
Prepaid expenses and other current assets | 1,969 | 2,743 |
Total current assets | 16,155 | 31,152 |
Property, plant and equipment, net | 1,422 | 1,348 |
Right-of-use assets | 285 | 624 |
Total assets | 17,862 | 33,124 |
Current liabilities | ||
Accounts payable | 2,018 | 638 |
Accrued expenses | 4,685 | 4,109 |
Deferred revenue | 0 | 170 |
Lease liabilities, current | 186 | 416 |
Loan payable, current | 7,846 | 621 |
Total current liabilities | 14,735 | 5,954 |
Other liabilities, non-current | 1,144 | 207 |
Loan payable, non-current | 3,070 | 10,372 |
Convertible notes payable, non-current | 4,772 | 4,639 |
Total liabilities | 23,721 | 21,172 |
Commitments and contingencies | 0 | 0 |
Stockholders' equity (deficit) | ||
Preferred stock, $.01 par value; 10,000,000 shares authorized; 11,357 shares issued and outstanding at December 31, 2022 and 2021 | ||
Common stock, $.01 par value; 40,000,000 shares authorized; 10,046,571 shares and 7,906,728 shares issued and outstanding at December 31, 2022 and 2021, respectively | 100 | 79 |
Additional paid-in capital | 451,608 | 432,831 |
Accumulated deficit | (457,484) | (420,976) |
Accumulated other comprehensive (loss) income | (83) | 18 |
Total stockholders' equity (deficit) | (5,859) | 11,952 |
Total liabilities and stockholders' equity (deficit) | $ 17,862 | $ 33,124 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 11,357 | 11,357 |
Preferred stock, shares outstanding (in shares) | 11,357 | 11,357 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 40,000,000 | 40,000,000 |
Common stock, shares issued (in shares) | 10,046,571 | 10,046,571 |
Common stock, shares outstanding (in shares) | 7,906,728 | 7,906,728 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue | $ 2,719 | $ 3,555 |
Cost of goods sold | (686) | (671) |
Gross profit | 2,033 | 2,884 |
Operating expenses: | ||
Research and development expenses | 18,583 | 13,778 |
Selling, general and administrative expenses | 17,303 | 13,637 |
Total operating expenses | 35,886 | 27,415 |
Operating loss | (33,853) | (24,531) |
Interest expense, net | (2,685) | (1,186) |
Other income | 30 | 68 |
Net loss | (36,508) | (25,649) |
Other comprehensive (loss) income: | ||
Foreign currency translation adjustments | 101 | 122 |
Total other comprehensive loss | $ (36,407) | $ (25,527) |
Common share data: | ||
Basic loss per common share* | $ (4.12) | $ (3.59) |
Diluted loss per common share* | $ (4.12) | $ (3.59) |
Weighted average number of basic shares outstanding* | 8,864,615 | 7,145,754 |
Weighted average number of diluted shares outstanding* | 8,864,615 | 7,145,754 |
Product Revenue [Member] | ||
Revenue | $ 2,548 | $ 1,300 |
Other Revenue [Member] | ||
Revenue | $ 171 | $ 2,255 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock [Member] | Preferred Stock [Member] | Additional Paid in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] |
Balance at Dec. 31, 2020 | $ 22,078 | $ 60 | $ 0 | $ 417,449 | $ (395,327) | $ (104) |
Balance (in shares) at Dec. 31, 2020 | 5,996,101 | 20,631 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Compensation expense for issuance of stock options | 7,832 | 7,832 | ||||
Shares settled for services | 57 | 57 | ||||
Shares settled for services (in shares) | 2,636 | |||||
Conversion of preferred stock into common stock | $ 9 | (9) | ||||
Conversion of Preferred stock into common stock (in shares) | 927,379 | (9,274) | ||||
Exercise of warrants into common stock | 2,458 | $ 5 | 2,453 | |||
Exercise of warrants into common stock (in shares) | 465,173 | |||||
Proceeds allocated to warrant | 1,171 | 1,171 | ||||
Cash issuance costs of warrant | (44) | (44) | ||||
Exercise of options into common stock | 4 | 4 | ||||
Exercise of options into common stock (shares) | 439 | |||||
Common stock issued in connection with ATM Offering | 3,923 | $ 5 | 3,918 | |||
Common stock issued in connection with ATM Offering (Shares) | 515,000 | |||||
Net loss | (25,649) | (25,649) | ||||
Total comprehensive income (loss) | 122 | 122 | ||||
Balance at Dec. 31, 2021 | 11,952 | $ 79 | $ 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 | 7,941 | 7,941 | ||||
Private placement -issuance of common shares and prefunded warrants, net of expenses, Shares (in shares) | 2,139,843 | |||||
Private placement -issuance of common shares and prefunded warrants, net of expenses | 10,857 | $ 21 | 10,836 | |||
Net loss | (36,508) | (36,508) | ||||
Total comprehensive income (loss) | (101) | (101) | ||||
Balance at Dec. 31, 2022 | $ (5,859) | $ 100 | $ 0 | $ 451,608 | $ (457,484) | $ (83) |
Balance (in shares) at Dec. 31, 2022 | 10,046,571 | 11,357 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (36,508) | $ (25,649) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock option compensation expense | 7,941 | 7,832 |
Depreciation expense | 132 | 146 |
Non-cash lease expense | 443 | 322 |
Amortization of debt discount | 768 | 323 |
Interest expense accrued related to convertible notes | 160 | 186 |
Changes in assets and liabilities: | ||
Decrease in prepaid expenses and other assets | 774 | 813 |
(Increase) decrease in accounts receivable | (322) | 13 |
Increase in inventories | (587) | (557) |
Increase (decrease) in accounts payable and accrued expenses | 1,798 | (3,284) |
Increase (decrease) in other liabilities, non-current | 621 | (322) |
Decrease in deferred revenue | (170) | (2,427) |
Net cash used in operating activities | (24,950) | (22,604) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (209) | (143) |
Net cash used in investing activities | (209) | (143) |
Cash flows from financing activities: | ||
Net proceeds from private placement | 10,857 | 0 |
Net proceeds from ATM Offering | 3,923 | |
Net proceeds from debt financing | 0 | 14,437 |
Proceeds from the exercise of stock options | 4 | |
Proceeds from the exercise of warrants | 0 | 2,458 |
Payment of loan payable | (714) | |
Net cash provided by financing activities | 10,143 | 20,822 |
Foreign currency effects on cash | (115) | 122 |
Net decrease in total cash | (15,131) | (1,803) |
Total Cash, Cash Equivalents and Restricted Cash: | ||
Beginning of period | 26,953 | 28,756 |
End of period | 11,822 | 26,953 |
Cash | 7,671 | 22,802 |
Restricted Cash | 4,151 | 4,151 |
Total | 11,822 | 26,953 |
Supplemental Disclosure of Cash Flow Information: | ||
Interest expense | 1,873 | 681 |
Supplemental Disclosure of Non-Cash Investing and Financing Activities: | ||
Issuance of restricted stock for accrued fees due to a former board member | 0 | 57 |
Proceeds allocated to warrant | 0 | 1,171 |
Financing of D&O insurance premium | 886 | |
Right of use assets obtained in exchange for lease obligations | $ 86 | $ 0 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | (1) Description of Business Delcath Systems, Inc. (“Delcath” or the “Company”) is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company’s lead product candidate, the HEPZATO ™ ™ ® The Company’s clinical development program for HEPZATO was comprised of the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the “FOCUS Trial”), a global registration clinical trial investigating objective response rate in metastatic ocular melanoma, or mOM, a type of primary liver cancer. The Company is currently reviewing the incidence, unmet need, available efficacy data and development requirements for a broad set of liver cancers in order to select a portfolio of follow-on In the United States, HEPZATO is considered a combination drug and device product regulated by the Food and Drug Administration (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 ocular melanoma, cutaneous melanoma, cholangiocarcinoma, hepatocellular carcinoma, and neuroendocrine tumor indications and one for doxorubicin in the hepatocellular carcinoma indication). HEPZATO has not been approved for sale in the United States. In December 2021, the Company announced that the FOCUS Trial of HEPZATO met its pre-specified The resubmission is in response to a September 12, 2013 Complete Response Letter (CRL) from the FDA. The NDA resubmission contains comprehensive data and information relating to the matters identified in the CRL. We continue to promote our early access programs in the United States to make HEPZATO readily available to mOM patients. We are 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 certification under the European Medical Devices Regulation [2017/745/EU], which may be considered by jurisdictions when evaluating reimbursement. As of March 1, 2022, the Company has assumed direct responsibility for sales, marketing and distribution of CHEMOSAT in Europe. Risks and Uncertainties Although the Company is not aware of any direct impacts of the war between the Ukraine and the Russian Federation on its supply chain, the war could adversely impact the Company’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its third-party suppliers in a timely manner or at all. In addition, at this time, although the Company is not aware of any direct impacts, any increase in COVID cases and associated restrictions, could adversely impact the Company’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its third-party suppliers in a timely manner or at all. Any rise in COVID cases and the associated absences from work of internal and external resources may also impact the Company’s ability to meet anticipated timelines. Liquidity and Going Concern The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements, during the year ended December 31, 2022, the Company incurred net losses of $36.5 million and used $25.0 million of cash for its operating activities. These factors among others raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. 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 per pre-funded warrant. The pre-funded warrants have an exercise price of The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce or eliminate its research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If the Company is not able to continue as a going concern, it is likely that holders of its common stock will lose all of their investment. The accompanying consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. Additional working capital will be required to continue operations. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of product development and clinical trial results; uncertainty regarding regulatory approval; technological uncertainty; uncertainty regarding patents and proprietary rights; comprehensive government regulations; limited commercial manufacturing, marketing or sales experience; and dependence on key personnel. |
Basis of Consolidated Financial
Basis of Consolidated Financial Statement Presentation | 12 Months Ended |
Dec. 31, 2022 | |
Basis Of Condensed Consolidated Financial Statement Presentation [Abstract] | |
Basis of Consolidated Financial Statement Presentation | (2) Basis of Consolidated Financial Statement Presentation The accounting and financial reporting policies of the Company conform to generally accepted accounting principles in the United States of America (“GAAP”). The preparation of consolidated financial statements in conformity with GAAP requires management to make assumptions and estimates that impact the amounts reported in the Company’s consolidated financial statements. The consolidated financial statements include the accounts of all entities controlled by the Company. All significant inter-company accounts and transactions are eliminated. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | (3) Summary of Significant Accounting Policies Use of Estimates The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s consolidated balance sheets and the amount of revenues and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for valuation of warrants, stock-based compensation, valuation of inventory, impairment of long-lived assets, income taxes and operating expense accruals. Such assumptions and estimates are subject to change in the future as additional information becomes available or as circumstances are modified. Actual results could differ from these estimates. Cash Equivalents and Concentrations of Credit Risk The Company considers investments with original maturities of three months or less at date of acquisition to be cash equivalents. The Company has deposits that exceed amounts insured by the Federal Deposit Insurance Corporation; however, the Company does not consider this a significant concentration of credit risk based on the strength of the financial institution. Restricted Cash Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded as restricted cash on the accompanying consolidated balance sheets. Accounts Receivable Accounts receivable, principally trade, are generally due within 30 days and are stated at amounts due from customers. Collections and payments from customers are monitored and a provision for estimated credit losses may be created based upon historical experience and specific customer collection issues that may be identified. Inventories Inventories are valued at the lower of cost or net realizable value (“NRV”) using the first-in, first-out work-in-process, Property, Plant and Equipment Property, plant, and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight-line basis over the estimated useful lives of the assets which range from three Fair Value Measurements The Company adheres to Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 applies to reported balances that are required or permitted to be measured at fair value under existing accounting pronouncements; accordingly, the standard does not require any new fair value measurements of reported balances. ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy). • Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company can access. • Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. • Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. Revenue Recognition Revenue is generated from proprietary and partnered product sales and license and royalty arrangements. Revenue is recognized when or as the Company transfers control of the promised goods or services to its customers in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for those goods or services. When obligations or contingencies remain after the products are shipped, such as training and certifying the treatment centers, revenue is deferred until the obligations or contingencies are satisfied. Delcath may enter into contracts with partners that contain multiple elements such as licensing, development, manufacturing, and commercialization components. These arrangements are often complex, and the Company may receive various types of consideration over the life of the arrangement, including up-front The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASC 606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. The following five steps are applied to achieve that core principle: • Step 1: Identify the contract with the customer; • Step 2: Identify the performance obligations in the contract; • Step 3: Determine the transaction price, including an estimation of any variable consideration expected to be received in connection with the contract; • Step 4: Allocate the transaction price to the performance obligations in the contract; and • Step 5: Recognize revenue when the company satisfies a performance obligation. Each of these steps in the revenue recognition process requires management to make judgments and/or estimates. The most significant judgements and estimates involve the determination of variable consideration to be included in the transaction price. Variable consideration is recognized at an amount management believes is not subject to significant reversal and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. Management believes this provides a reasonable basis for recognizing revenue; however, actual results could differ from estimates and significant changes in estimates could impact the Company’s results of operations in future periods. As required by ASC 606, the Company disaggregates its revenue into the categories of product revenue and other revenue. The Company recognizes product revenue and milestone payments at a point in time, whereas other revenues (primarily license fees) are recognized over time. Milestone payments that are contingent upon the occurrence of future events, are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved. See Note 13 – Commitments and Contingencies – Litigations, Claims and Assessments – medac Matter. Deferred Revenue The timing of the Company’s revenue recognition may differ from the timing of payment by its customers. A receivable is recorded when revenue is recognized prior to payment and the Company has an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. See Note 13 – Commitments and Contingencies – Litigations, Claims and Assessments – medac Matter. Selling, General and Administrative Selling, general and administrative costs include personnel costs and related expenses for the Company’s sales, marketing, general management and administrative staff, recruitment, costs related to the Company’s commercialization efforts in Europe, professional service fees, professional license fees, business development and certain general legal activities. All such costs are charged to expense when incurred. Research and Development Research and development costs include the costs of materials used for clinical trials and R&D, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company’s proprietary drug delivery system. All such costs are charged to expense when incurred. Stock Based Compensation The Company accounts for its share-based compensation in accordance with the provisions of ASC 718, Stock-Based Compensation, which establishes accounting for equity instruments exchanged for services. Under the provisions of ASC 718, share-based compensation is measured at the grant date, based upon the fair value of the award, and is recognized as an expense over the option holders’ requisite service period (generally the vesting period of the equity grant). The Company expenses its share-based compensation granted under the accelerated method, which treats each vesting tranche as if it were an individual grant. The Company periodically grants stock options for a fixed number of shares of common stock to its employees, directors, and non-employee market value of the common stock at the date of the grant. The Company estimates the fair value of stock options using an option pricing model. Key inputs used to estimate the fair value of stock options include the exercise price of the option, the expected term, the expected volatility of the stock over the option’s expected term, the risk-free interest rate over the option’s expected term, and the expected annual dividend yield. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons who receive equity awards. Income Taxes The Company accounts for income taxes following the asset and liability method in accordance with the ASC 740 “Income Taxes.” Under such method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company applies the accounting guidance issued to address the accounting for uncertain tax positions. This guidance clarifies the accounting for income taxes, by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements as well as provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company classifies interest and penalty expense related to uncertain tax positions as a component of income tax expense. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years that the asset is expected to be recovered or the liability settled. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in its assessment of a valuation allowance. See Note 1 4 Net Loss per Common Share Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities, except for those shares that are issuable for little or no cash consideration. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options, stock purchased pursuant to the Company’s employee stock purchase plan, convertible notes and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options and warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. For the years ended December 31, 2022 and 2021 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive: December 31, 2022 2021 Common stock warrants - equity 3,610,743 3,610,743 Assumed conversion of Series E and Series E-1 1,135,721 1,135,721 Assumed conversion of convertible notes 488,031 488,031 Stock options 2,235,052 1,732,460 Total 7,469,547 6,966,955 Segment Information A single management team that reports to the Chief Executive Officer comprehensively manages the business. Accordingly, the Company does not have separately reportable segments. Foreign Currency and Currency Translation Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses)/gains in the statements of operations. The assets and liabilities of the Company’s international subsidiaries are translated from their functional currencies into United States dollars at exchange rates prevailing at the balance sheet date. The majority of the foreign subsidiaries revenues and operating expenses are denominated in Euros. The reporting currency for the Company is the United States dollar. Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions. Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive income. Subsequent Events Management has evaluated events occurring subsequent to the consolidated balance sheet date, through Marc h 27, 2 023, which is the date the consolidated financial statements were issued, determining all subsequent events have been disclosed. 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 Q
Revision of Previously Issued Quarterly Financial Statements | 12 Months Ended |
Dec. 31, 2022 | |
Prior Period Adjustment [Abstract] | |
Revision of Previously Issued Quarterly Financial Statements | (4) 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 $797 for the first quarter of 2022, $502 for the second quarter of 2022 and $372 for the third quarter of fiscal 2022. The share-based compensation adjustment is a non-cash adjustment did not have any impact on the cash balances for the Company. The following tables contains the financial information for the periods previously reported and have been updated to reflect the revisions of the Company’s financial statements. The revisions do not have an impact on the Company’s cash position The Company has not amended its previously filed Quarterly Reports on Form 10-Q for the three quarterly periods ended September 30, 2022. The financial information that has been previously filed or otherwise reported for the three quarterly periods ended September 30, 2022 is superseded by the information in this Quarterly Report on Form 10-Q, and the financial statements and related financial information for the quarterly periods ended September 30, 2022 contained in such previously filed report should no longer be relied upon. The impact of the revision on the Company’s financial statements is reflected in the following table: As previously report 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 ) As previously report Adjustment As revised Consolidated Statement of Operations and Comprehensive Loss for the three months June 30, 2022 (unaudited) Research and development expenses 5,456 150 5,606 Selling, general and administrative expenses 4,145 352 4,497 Total operating expenses 9,601 502 10,103 Operating loss (8,984 ) (502 ) (9,486 ) Net loss (9,657 ) (502 ) (10,159 ) Total other comprehensive loss (9,688 ) (502 ) (10,190 ) Basic and diluted loss per common share (1.18 ) (0.06 ) (1.24 ) Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended June 30, 2022 (unaudited) Compensation expense for issuance of stock options 1,617 502 2,119 Net loss (9,657 ) (502 ) (10,159 ) Balance Sheet for September 30, 2022 (unaudited) Additional paid-in 442,066 1,671 443,737 Accumulated deficit (447,341 ) (1,671 ) (449,012 ) Consolidated Statement of Operations and Comprehensive Loss for the three months September 30, 2022 (unaudited) Research and development expenses 3,953 112 4,065 Selling, general and administrative expenses 4,519 260 4,779 Total operating expenses 8,472 372 8,844 Operating loss (7,801 ) (372 ) (8,173 ) Net loss (8,505 ) (372 ) (8,877 ) Total other comprehensive loss (8,551 ) (372 ) (8,923 ) Basic and diluted loss per common share (0.92 ) (0.04 ) -0.96 Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended September 30, 2022 (unaudited) Compensation expense for issuance of stock options 1,255 372 1,627 Net loss (8,505 ) (372 ) (8,877 ) Consolidated Statement of Operations and Comprehensive Loss for the six months June 30, 2022 (unaudited) Research and development expenses 9,696 391 10,087 Selling, general and administrative expenses 7,791 908 8,699 Total operating expenses 17,487 1,299 18,786 Operating loss (16,527 ) (1,299 ) (17,826 ) Net loss (17,860 ) (1,299 ) (19,159 ) Total other comprehensive loss (17,889 ) (1,299 ) (19,188 ) Basic and diluted loss per common share (2.18 ) (0.16 ) (2.34 ) As previously report Adjustment As revised Consolidated Statement of Cash Flows for the six months ended June 30, 2022 (unaudited) Net loss (17,860 ) (1,299 ) (19,159 ) Stock option compensation expense 3,091 1,299 4,390 Consolidated Statement of Operations and Comprehensive Loss for the nine months September 30, 2022 (unaudited) Research and development expenses 13,649 503 14,152 Selling, general and administrative expenses 12,309 1,168 13,477 Total operating expenses 25,958 1,671 27,629 Operating loss (24,327 ) (1,671 ) (25,998 ) Net loss (26,365 ) (1,671 ) (28,036 ) Total other comprehensive loss (26,447 ) (1,671 ) (28,118 ) Basic and diluted loss per common share (3.09 ) (0.20 ) (3.29 ) Consolidated Statement of Cash Flows for the nine months ended September 30, 2022 (unaudited) Net loss (26,365 ) (1,671 ) (28,036 ) Stock option compensation expense 4,345 1,671 6,016 |
Cash, Cash Equivalents and Rest
Cash, Cash Equivalents and Restricted Cash | 12 Months Ended |
Dec. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Restricted Cash | (5) Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded in Restricted Cash December 31, December 31, 2022 2021 Cash and cash equivalents $ 7,671 $ 22,802 Restricted balance for loan agreement 4,000 4,000 Letters of credit 101 101 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 11,822 $ 26,953 Under the terms of a sub-lease . 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 loan balance. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | (6) Inventories Inventories consist of: December 31, December 31, 2022 2021 Raw materials $ 763 $ 767 Work-in-process 1,102 645 Finished goods 133 — Total inventories $ 1,998 $ 1,412 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses And Other Current Assets | ( 7 Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets include the following: December 31, December 31, 2022 2021 Clinical trial expenses $ 1,630 $ 1,630 Insurance premiums 123 890 Professional services 121 15 Other 95 208 Total prepaid expenses and other current assets $ 1,969 $ 2,743 |
Property, Plant, and Equipment
Property, Plant, and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant, and Equipment | (8) Property, Plant, and Equipment Property, plant, and equipment consists of: December 31, 2022 December 31, 2021 Estimated Useful Life Buildings and land $ 1,301 $ 1,222 30 years - Buildings Enterprise hardware and software 1,855 1,858 3 years Leaseholds 1,774 1,796 Lesser of lease term or estimated useful life Equipment 1,222 1,094 7 years Furniture 201 203 5 years Property, plant and equipment, gross 6,353 6,173 Accumulated depreciation (4,931 ) (4,825 ) Property, plant and equipment, net $ 1,422 $ 1,348 Depreciation expense for the years ended December 31, 2022 and 2021 was $ and $ , respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | ( 9 Accrued Expenses Current accrued expenses include the following: December 31, December 31, Clinical expenses $ 1,470 $ 1,517 Compensation, excluding taxes 1,040 893 Short-term financing — 551 Professional fees 1,087 603 Interest on convertible note 553 393 Other 535 152 Total accrued expenses $ 4,685 $ 4,109 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | ( 10 Leases The Company recognizes right-of-use non-cancellable The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the ROU asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. Pursuant to a 2014 sublease agreement (the “2014 Sublease”) and a 2015 sublease agreement (the “2015 Sublease”) the Company subleased portions of its leased premises in Galway, Ireland to a sublessee. On May 15, 2020, the Company and its sublessee entered into amendments to the 2014 Sublease and the 2015 Sublease pursuant to which (i) the 2014 Sublease and 2015 Sublease were extended from May 31, 2020 to August 2, 2021, (ii) effective July 1, 2020, the leased premises under the 2015 Sublease would be expanded to include an additional The Company analyzed the terms of the amended 2014 Sublease and 2015 Sublease and determined that its ROU asset for the master operating lease was not impaired as a result of the amendments. On June 25, 2020, the Company entered into a sublease agreement (the “2021 Sub-Lease”) with its previous sublessee under the 2014 Sublease and 2015 Sublease pursuant to which, effective August 2, 2021, the previous sublessee would become the lessee and the Company would then sublease its portion of the premises in Galway, Ireland from the previous sublessee. The Company’s rent expense under the 2021 Sub-Lease is approximately $ per month for a term of . On September 22, 2020, the Company entered into an amendment to a sub-lease sub-lease The following table summarizes the Company’s operating leases as of December 31, 2022: U.S. Ireland Total Lease cost Operating lease cost $ 406 $ 37 $ 443 Other information Operating cash flows out from operating leases (406 ) (37 ) (443 ) Weighted average remaining lease term 0.5 3.6 Weighted average discount rate - operating leases 8 % 8 % Maturities of the Company’s operating leases, excluding short-term leases, are as follows: U.S. Ireland Total Year ended December 31, 2023 155 37 192 Year ended December 31, 2024 — 37 37 Year ended December 31, 2025 — 37 37 Year ended December 31, 2026 — 22 22 Total 155 133 288 Less present value discount (3 ) (17 ) (20 ) Operating lease liabilities included in the condensed consolidated balance sheets at December 31, 2022 $ 152 $ 116 $ 268 |
Loans and Convertible Notes Pay
Loans and Convertible Notes Payable | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Loans and Convertible Notes Payable | (1 1 Loans and Convertible Notes Payable December 31, 2022 December 31, 2021 Gross Discount Net Gross Discount Net Loan - Avenue [1] $ 11,923 $ (1,008 ) $ 10,916 $ 12,638 $ (1,645 ) $ 10,993 Loan - Avenue [1] (8,570 ) 724 (7,846 ) (714 ) 93 (621 ) Total - Loans Payable, Non-Current $ 3,353 $ (284 ) $ 3,070 $ 11,924 $ (1,552 ) $ 10,372 Convertible Note Payable - Rosalind 2,000 — 2,000 2,000 — 2,000 Convertible Portion of Loan Payable - Avenue 3,000 (228 ) 2,772 3,000 (361 ) 2,639 Total - Convertible Notes Payable - Non-Current $ 5,000 $ (228 ) $ 4,772 $ 5,000 $ (361 ) $ 4,639 [1] The gross amount includes the 4.25% final payment of $637.5. Remaining maturities of the Company’s loan and convertible note payables are as follows: Convertible Loans Notes Total Year ended December 31, 2023 $ 8,570 $ — $ 8,570 Year ended December 31, 2024 3,353 5,000 8,353 Total $ 11,923 $ 5,000 $ 16,923 Term Loan from Avenue Venture Opportunities Fund, L.P. On August 6, 2021, the Company entered into a Loan and Security Agreement (the “Avenue Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (the “Lender,” or “Avenue”) for a term loan in an aggregate principal amount of up to $20.0 million The initial tranche of the Avenue Loan is $15.0 million million million million 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 shares of common stock at an exercise price per share equal to $ . The Avenue Warrant is exercisable until . 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. The interest only period ended in November 2022, and the Company began making principal payments on December 1, 2022. 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 fund ing. 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 loan balance and reduce the monthly principal payments. The Company paid an aggregate commitment fee of $150 at closing. Upon funding a second tranche of the Avenue Loan, the Lender will earn a 1.0% fee on the $5.0 million The Avenue Loan Agreement requires the Company to make and maintain representations and warranties and other agreements that are customary in loan agreements of this type. The Avenue Loan Agreement also contains customary events of default, including non-payment The Company determined that the embedded conversion option associated with the Avenue Loan was not required to be bifurcated. The Company determined that the Avenue Warrant met the criteria to be equity-classified. The $637 value of the final payment was treated as original issue discount. The $1,171 relative fair value of the Avenue Warrant was credited to Additional Paid in Capital while it was debited as debt discount. Of the $563 of cash issuance costs, $519 was allocated to the Avenue Loan and was recorded as debit discount, while $44 was allocated to the Avenue Warrant and was debited to Additional Paid in Capital. Of the $2,327 of aggregate debt discount, $1,909 was allocated to the non-convertible The Avenue Warrant was valued at issuance at $1.3 million using the Black-Scholes option pricing method using the following assumptions: August 6, Contractual term (years) 5.07 Expected volatility 187.0 % Risk-free interest rate 0.77 % Expected dividends 0.00 % Convertible Notes Payable The Company has $2.0 million . On August 6, 2021, the Company executed an agreement to amend the Rosalind Notes to (a) reduce the conversion price to $1,198 per share of the Company’s Series E Convertible Preferred Stock; and (b) extend the maturity date to October 30, 2024. In addition, in order to induce the Avenue Venture Opportunities Fund, L.P. to provide the Avenue Loan described above, the holders of the Rosalind Notes agreed to subordinate (a) all of the Company’s indebtedness and obligations to the holders; and (b) all of the holders’ security interest, to the Avenue Loan and Avenue’s security interest in the Company’s property. Up to $3.0 million Interest expense with respect to the Rosalind Notes was $160 for both years ended December 31, 2022 and 2021 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | (12) Stockholders’ Equity Authorized Shares The Company is authorized to issue 40,000,000 shares of common stock, $0.01 par value, and 10,000,000 shares of preferred stock, $0.01 par value. To date, the Company has designated the following preferred stock: Series A (4,200 shares), Series B (2,360 shares), Series C (590 shares), Series D (10,000 shares), Series E (40,000 shares) and Series E-1 Preferred Stock Series E and Series E-1 During the years ended December 31, 2021, 9,274 shares of Series E and Series E-1 As of December 31, 2022, there were an aggregate of 11,357 shares of Series E and Series E-1 Equity Offerings and Placements At-the-Market On August 18, 2020, the Company entered into a sales agreement with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), pursuant to which the Company may offer and sell, from time to time, through Cantor Fitzgerald, as sales agent or principal, shares of the Company’s common stock, (the “Placement Shares”), having an aggregate offering price of up to $10 million (the “ATM Offering”). On November 9, 2021 the Company filed a supplement to increase the aggregate amount to million. On February 27, 2023, filed an amendment to change the aggregate offering price to the limit of The Company has no obligation to sell any Placement Shares under the sales agreement. Subject to the terms and conditions of the sales agreement, Cantor Fitzgerald is required to use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of the Nasdaq Stock Market, to sell Placement Shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. The Company will pay Cantor Fitzgerald a commission of 3.0% of the aggregate gross proceeds from each sale of Placement Shares, reimburse Cantor Fitzgerald’s legal fees and disbursements up to $50 and provide Cantor Fitzgerald with customary indemnification and contribution rights. The sales agreement may be terminated by Cantor Fitzgerald or the Company upon notice to the other party as provided in the sales agreement, or by Cantor Fitzgerald at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisable to market the Placement Shares or to enforce contracts for the sale of the Placement Shares. In connection with the ATM Offering, in consideration for a fee equal to 1.05% of the gross sales price per share sold in the ATM Offering, ROTH Capital Advisors, LLC (“Roth”) waived, solely with respect to the ATM Offering, (i) Roth’s right, pursuant to certain engagement letters dated August 14, 2019 and January 13, 2020 between Roth and the Company, to act as placement agent or underwriter with respect to offerings of the Company’s securities and to receive a minimum of 35% of the fees paid to the agents or underwriters for such offerings and (ii) the lock-up 90-day During the year ended December 31, 2021, the Company sold 515,000 .0 million Private Placement 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 Other Common Stock Issuances In February 2021, the Company issued 2,636 shares of unregistered common stock in lieu of a cash payment of deferred accrued director fees to a former director. During the year ended December 31, 2021, the Company issued 465,173 shares of common stock associated with the exercise of warrants, including 215,000 pre-funded million Stock Incentive Plans The Company’s 2019 Equity Incentive Plan (the “2019 Plan”) allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. All of the Company’s officers, directors, employees, consultants, and advisors are eligible to receive grants under the 2019 Plan. The 2019 Plan provides for the grant of options to purchase shares of common stock at exercise prices not less than 100% of fair value on the dates of grant. The maximum number of shares reserved for issuance under the 2019 Plan was 2,142. The 2019 Plan has been superseded by the 2020 Plan discussed below and no further awards will be made under the 2019 Plan; however, outstanding awards granted under the 2019 Plan will remain outstanding and continue to be administered in accordance with the terms of the 2019 Plan and the applicable award agreements. On September 30, 2020, the Company’s 2020 Omnibus Equity Incentive Plan (the “2020 Plan”) was adopted by the Company’s Board of Directors. On November 23, 2020, the Company’s stockholders approved the 2020 Plan. The 2020 Plan will continue in effect until the tenth anniversary of the date of its adoption by the Board or until earlier terminated by the Board. The 2020 Plan is administered by the Board of Directors or a committee designated by the Board of Directors. The 2020 Plan provides for the grant of incentive stock options, non-qualified Stock Options The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods: Years Ended December 31 2022 2021 Expected terms (years) 0.7 - 8.4 5.1 - 6.3 Expected volatility 166.4% -180.3% 177.% - 181.3% Risk-free interest rate 1.2% - 4.4% 0.7% - 1.3% Expected dividends 0.00% 0.00% The weighted average estimated fair value of the stock options granted during the years ended December 31, 2022 and 2021 was approximately $6.05 and $9.74 per share, respectively. The following is a summary of stock option activity for the year ended December , : Number of Options Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding at January 1, 2022 1,732,460 $ 11.69 Granted 702,583 6.74 Expired (65,690 ) 10.43 Cancelled/Forfeited (134,301 ) 9.59 Outstanding at December 31, 2022 2,235,052 $ 10.30 8.0 $ 36 Exercisable at December 31, 2022 1,316,515 $ 11.13 7.6 $ — The following table summarizes information for stock option shares outstanding and exercisable at December 31, 2022: Options Exercisable Weighted Average Outstanding Number of Remaining Option Term Range of Exercise Prices Options (in years) Number of Options $6.24 - $53.85 2,234,553 8.0 1,316,016 $53.85+ 499 6.1 499 2,235,052 7.6 1,316,515 At December 31, 2022, there was approximately $2.8 million of aggregate unrecognized compensation expense related to employee and board stock option grants. The cost is expected to be recognized over a weighted average period of 1.6 years. For the years ended December 31, 2022 and 2021, the Company recognized compensation expense $7.9 million and $7.8 million, respectively, related to stock options granted to employees and board members, which were charged to the statement of operations as detailed below: Years Ended December 31, 2022 2021 Selling, general and administrative $ 5,282 $ 5,334 Research and development 2,449 2,311 Cost of goods sold 210 187 Total $ 7,941 $ 7,832 Employee Stock Purchase Plan In August 2021, the Company’s Board of Directors, with shareholder approval in May 2022, adopted the Employee Stock Purchase Plan ( the “ESPP”). The ESPP provides for a maximum of 260,295 shares of common stock to be purchased by participating employees. Employees who elect to participate in the ESPP will be able to purchase common stock at the lower of % of the fair market value of common stock on the first or last day of the applicable six-month offering period. In , an aggregate shares were purchased by participating employees for the offering period of July , to December , . The fair value of each ESPP award of $ was estimated on the first day of the offering period using the Black-Scholes option-pricing model. The Company recognized share-based compensation expense of $ , which is equal to the fair value of the ESPP awards on a straight-line basis over the offering period. Warrants The following is a summary of warrant activity for the year ended December 31, 2022: Weighted Average Weighted Average Remaining Life Warrants Exercise Price (in years) Outstanding at January 1, 2022 3,894,498 $ 9.27 Warrants issued 1,258,793 .01 Outstanding at December 31, 2022 5,153,291 $ 7.01 2.8 Exercisable at December 31, 2022 5,153,291 $ 7.01 2.8 The following table presents information related to stock warrants at December 31, 2022: Warrants Exercisable Range of Exercise Prices Outstanding Number of Warrants Weighted Average Term (in years) Number of $0.01 1,542,548 4.4 1,542,548 $10.00 3,610,743 2.2 3,610,743 5,153,291 2.8 5,153,291 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (1 3 Commitments and Contingencies Litigation, Claims and Assessments Former Officers Matter Following the May 18, 2020 resignation (effective June 1, 2020) of Jennifer Simpson, the Company’s former President and Chief Executive Officer, and Barbra Keck, the Company’s former Chief Financial Officer (the “Claimants”), it became evident that there was a dispute regarding the Company’s compensation obligations to the Claimants. In a letter dated, June 29, 2020, an attorney representing the Claimants made certain claims and threatened litigation against the Company. On or about July 27, 2020, the Claimants filed a statement of claim with the American Arbitration Association against the Company. The Claimants sought payment of certain purported unpaid compensation amounts claimed to be due to them, in an approximate amount of $1.1 million in the aggregate, as well as unspecified statutory damages under New York Labor Law, attorneys’ fees and costs, and statutory interest. The Claimants and the Company agreed to participate in non-binding mediation of their dispute before a neutral mediator, which resulted in the arbitration proceedings being placed in abeyance pending the outcome of the mediation process. With the assistance of the neutral mediator and after careful consideration by the Company’s board of directors following several weeks of negotiations, the Claimants and the Company agreed in mid-May of 2021 to a confidential settlement of their dispute to avoid the expenses and distractions of further arbitration proceedings, with no admission of liability or wrongdoing on the part of the Company. While the Company had accrued for the full purported unpaid compensation amount of million as of December 31, 2020, the Company ultimately paid less in full and final settlement of its dispute with both of the Claimants. As a result of the confidential settlement, the AAA Arbitration was dismissed with prejudice on June 1, 2021. medac Matter In April 2021, the Company’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 Delcath has agreed pay medac a royalty on sales of CHEMOSAT units over a defined minimum for a period of five years or until a maximum payment has been reached. The settlement terms also contain a minimum annual payment of $0.2 million in the event the annual royalty payment does not reach the agreed on minimum payment amount. The Company has estimated the settlement to be $1.2 non-current and 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 $900 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 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (14) Income Taxes There is no income tax provision for the years ended December 31, 2022 and 2021, respectively. Loss before income taxes consists of: For the Year Ended 2022 2021 Domestic $ (34,547 ) $ (25,881 ) Foreign (1,960 ) 232 Income before taxes $ (36,507 ) $ (25,649 ) The provision for income taxes differs from the amount computed by applying the statutory rate as follows: For the Year Ended 2022 2021 Income taxes using U.S federal statutory rate $ (7,666 ) $ (5,386 ) Nondeductible interest 139 39 Loss of tax benefit of state net operating loss carryforwards — 2,799 Branch income (385 ) 229 State income taxes, net of federal benefit (531 ) 311 Foreign rate differential 165 27 Valuation allowance 9,221 2,114 Stock option expense, exercises and cancellations 752 446 Research and development costs (708 ) (375 ) Other (987 ) (204 ) $ — $ — Significant components of the Company’s deferred tax assets are as follows: For the Year Ended December 31, 2022 2021 Deferred tax assets: Employee compensation accruals $ 2,772 $ 1,777 Accrued liabilities 197 29 Research tax credits 1,429 721 Lease obligation 38 107 Other 160 89 Research expense capitalization 3,203 — Net operating losses 24,595 20,520 Total deferred tax assets 32,394 23,243 For the Year Ended December 31, 2022 2021 Deferred tax liabilities: Right of use asset 50 118 Total deferred tax liabilities 50 118 Valuation allowance 32,344 23,125 Net deferred tax assets $ — $ — As of December 31, 2022, and 2021, the Company had net operating loss carryforwards for U.S. federal income tax purposes of approximately $ million and $ million, respectively. A significant portion of the federal amount is subject to an annual limitation as low as $ as a result of changes in the Company’s ownership in May 2003, November 2016, and multiple dates throughout 2017, 2018, 2019 and 2021, as defined by Section 382 of the United States Internal Revenue Code of 1986, as amended (the “IRC”), and the related income tax regulations. As a result of the limitations caused by the multiple ownership changes, approximately $ million of the total net operating loss carryforwards is expected to expire unutilized and will be unavailable to offset future federal taxable income. Approximately $ million of net operating loss carryforwards remains available to offset future federal taxable income, of which $ million will expire between and and $ million will have an unlimited carryforward period. In addition, the Company’s state net operating losses are also subject to annual limitations that generally follow the IRC Section 382 provisions (with the exception of Connecticut and Florida), adjusted for each state’s respective income apportionment percentages. As of December 31, 2022, and 2021, the Company had net operating loss carryforwards for states and city income tax purposes between approximately $0.3 million and $195.3 Management has established a 100% valuation allowance against the deferred tax assets as management does not believe it is more likely than not that these assets will be realized. The Company’s valuation allowance increased by approximately $9.2 million and $1.8 million in 2022 and 2021, respectively. The change in valuation allowance is as follows: December 31, 2022 2021 Beginning Balance $ 23,125 $ 21,332 Charged to costs and expenses 9,221 2,114 Charged to other comprehensive income (2 ) (321 ) Ending balance $ 32,344 $ 23,125 The Company complies with the provisions of ASC 740-10 740-10 740-10, 740-10 The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. The Company has not been audited by any state tax authorities in connection with income taxes. The Company has not been audited by international tax authorities or any states in connection with income taxes. The Company’s New York State tax returns have been subject to annual desk reviews which have resulted in insignificant adjustments to the related franchise tax liabilities and credits. The Company is no longer subject to federal and state examination for tax years ending prior to December 31, 2019; tax years ending December 31, 2019 through December 31, 2022 remain open to examination. The Republic of Ireland is the Company’s only significant foreign jurisdiction. The Company is no longer subject to Ireland tax examination for tax years ending prior to December 31, 2018 (as Ireland has not initiated an audit of 2017 as of December 31, 2022); tax years ending December 31, 2018 through December 31, 2022 remain open to examination. However, the Company’s tax years through generally remain open to adjustment for all federal, state and foreign tax matters until its net operating loss and tax credit carryforwards a reutilized or expire prior to utilization, and the applicable statutes of limitation have expired in the utilization year. The federal and state tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a period within the statute of limitations. The Company recognizes interest accrued related to unrecognized tax benefits and penalties, if incurred, as a component of income tax expense. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | (15) 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 December 31, 2022: Level 3 Balance at January 1, 2022 $ — Add: contingent liability recorded on medac settlement 1,168 Change exchange rate 112 Balance at December 31, 2022 $ 1,280 Contingent liabilities are re-measured targets and probabilities of payment may result in significant changes in the fair value measurements. Increases in discount rates and the time to payment may result in lower fair value measurements. Increases or decreases in any of those inputs in isolation may result in a significantly lower or higher fair value measurement. The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value as of December 31, 2022 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value. There were no financial assets and liabilities that have been measured at fair value as of December 31, 2021. In general, the fair values were determined using Level 3: Description Quoted Significant Significant December 31, Liabilities: Contingent Liability $ 1,280 $ 1,280 Total Liabilities $ — $ — $ 1,280 $ 1,280 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s consolidated balance sheets and the amount of revenues and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for valuation of warrants, stock-based compensation, valuation of inventory, impairment of long-lived assets, income taxes and operating expense accruals. Such assumptions and estimates are subject to change in the future as additional information becomes available or as circumstances are modified. Actual results could differ from these estimates. |
Cash Equivalents and Concentrations of Credit Risk | Cash Equivalents and Concentrations of Credit Risk The Company considers investments with original maturities of three months or less at date of acquisition to be cash equivalents. The Company has deposits that exceed amounts insured by the Federal Deposit Insurance Corporation; however, the Company does not consider this a significant concentration of credit risk based on the strength of the financial institution. |
Restricted Cash | Restricted Cash Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded as restricted cash on the accompanying consolidated balance sheets. |
Accounts Receivable | Accounts Receivable Accounts receivable, principally trade, are generally due within 30 days and are stated at amounts due from customers. Collections and payments from customers are monitored and a provision for estimated credit losses may be created based upon historical experience and specific customer collection issues that may be identified. |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value (“NRV”) using the first-in, first-out work-in-process, |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant, and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight-line basis over the estimated useful lives of the assets which range from three |
Fair Value Measurements | Fair Value Measurements The Company adheres to Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 applies to reported balances that are required or permitted to be measured at fair value under existing accounting pronouncements; accordingly, the standard does not require any new fair value measurements of reported balances. ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy). • Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company can access. • Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. • Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. |
Revenue Recognition | Revenue Recognition Revenue is generated from proprietary and partnered product sales and license and royalty arrangements. Revenue is recognized when or as the Company transfers control of the promised goods or services to its customers in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for those goods or services. When obligations or contingencies remain after the products are shipped, such as training and certifying the treatment centers, revenue is deferred until the obligations or contingencies are satisfied. Delcath may enter into contracts with partners that contain multiple elements such as licensing, development, manufacturing, and commercialization components. These arrangements are often complex, and the Company may receive various types of consideration over the life of the arrangement, including up-front The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASC 606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. The following five steps are applied to achieve that core principle: • Step 1: Identify the contract with the customer; • Step 2: Identify the performance obligations in the contract; • Step 3: Determine the transaction price, including an estimation of any variable consideration expected to be received in connection with the contract; • Step 4: Allocate the transaction price to the performance obligations in the contract; and • Step 5: Recognize revenue when the company satisfies a performance obligation. Each of these steps in the revenue recognition process requires management to make judgments and/or estimates. The most significant judgements and estimates involve the determination of variable consideration to be included in the transaction price. Variable consideration is recognized at an amount management believes is not subject to significant reversal and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. Management believes this provides a reasonable basis for recognizing revenue; however, actual results could differ from estimates and significant changes in estimates could impact the Company’s results of operations in future periods. As required by ASC 606, the Company disaggregates its revenue into the categories of product revenue and other revenue. The Company recognizes product revenue and milestone payments at a point in time, whereas other revenues (primarily license fees) are recognized over time. Milestone payments that are contingent upon the occurrence of future events, are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved. See Note 13 – Commitments and Contingencies – Litigations, Claims and Assessments – medac Matter. |
Deferred Revenue | Deferred Revenue The timing of the Company’s revenue recognition may differ from the timing of payment by its customers. A receivable is recorded when revenue is recognized prior to payment and the Company has an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. See Note 13 – Commitments and Contingencies – Litigations, Claims and Assessments – medac Matter. |
Selling, General and Administrative | Selling, General and Administrative Selling, general and administrative costs include personnel costs and related expenses for the Company’s sales, marketing, general management and administrative staff, recruitment, costs related to the Company’s commercialization efforts in Europe, professional service fees, professional license fees, business development and certain general legal activities. All such costs are charged to expense when incurred. |
Research and Development | Research and Development Research and development costs include the costs of materials used for clinical trials and R&D, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company’s proprietary drug delivery system. All such costs are charged to expense when incurred. |
Stock Based Compensation | Stock Based Compensation The Company accounts for its share-based compensation in accordance with the provisions of ASC 718, Stock-Based Compensation, which establishes accounting for equity instruments exchanged for services. Under the provisions of ASC 718, share-based compensation is measured at the grant date, based upon the fair value of the award, and is recognized as an expense over the option holders’ requisite service period (generally the vesting period of the equity grant). The Company expenses its share-based compensation granted under the accelerated method, which treats each vesting tranche as if it were an individual grant. The Company periodically grants stock options for a fixed number of shares of common stock to its employees, directors, and non-employee market value of the common stock at the date of the grant. The Company estimates the fair value of stock options using an option pricing model. Key inputs used to estimate the fair value of stock options include the exercise price of the option, the expected term, the expected volatility of the stock over the option’s expected term, the risk-free interest rate over the option’s expected term, and the expected annual dividend yield. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons who receive equity awards. |
Income Taxes | Income Taxes The Company accounts for income taxes following the asset and liability method in accordance with the ASC 740 “Income Taxes.” Under such method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company applies the accounting guidance issued to address the accounting for uncertain tax positions. This guidance clarifies the accounting for income taxes, by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements as well as provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company classifies interest and penalty expense related to uncertain tax positions as a component of income tax expense. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years that the asset is expected to be recovered or the liability settled. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in its assessment of a valuation allowance. See Note 1 4 |
Net Loss per Common Share | Net Loss per Common Share Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities, except for those shares that are issuable for little or no cash consideration. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options, stock purchased pursuant to the Company’s employee stock purchase plan, convertible notes and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options and warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. For the years ended December 31, 2022 and 2021 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive: December 31, 2022 2021 Common stock warrants - equity 3,610,743 3,610,743 Assumed conversion of Series E and Series E-1 1,135,721 1,135,721 Assumed conversion of convertible notes 488,031 488,031 Stock options 2,235,052 1,732,460 Total 7,469,547 6,966,955 |
Segment Information | Segment Information A single management team that reports to the Chief Executive Officer comprehensively manages the business. Accordingly, the Company does not have separately reportable segments. |
Foreign Currency and Currency Translation | Foreign Currency and Currency Translation Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses)/gains in the statements of operations. The assets and liabilities of the Company’s international subsidiaries are translated from their functional currencies into United States dollars at exchange rates prevailing at the balance sheet date. The majority of the foreign subsidiaries revenues and operating expenses are denominated in Euros. The reporting currency for the Company is the United States dollar. Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions. Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive income. |
Subsequent Events | Subsequent Events Management has evaluated events occurring subsequent to the consolidated balance sheet date, through Marc h 27, 2 023, which is the date the consolidated financial statements were issued, determining all subsequent events have been disclosed. |
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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Anti-dilutive securities excluded from the computation of earnings per share | For the years ended December 31, 2022 and 2021 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive: December 31, 2022 2021 Common stock warrants - equity 3,610,743 3,610,743 Assumed conversion of Series E and Series E-1 1,135,721 1,135,721 Assumed conversion of convertible notes 488,031 488,031 Stock options 2,235,052 1,732,460 Total 7,469,547 6,966,955 |
Revision of Previously Issued_2
Revision of Previously Issued Quarterly Financial Statements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Prior Period Adjustment [Abstract] | |
Schedule of error corrections and prior period adjustments | The impact of the revision on the Company’s financial statements is reflected in the following table: As previously report 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 ) As previously report Adjustment As revised Consolidated Statement of Operations and Comprehensive Loss for the three months June 30, 2022 (unaudited) Research and development expenses 5,456 150 5,606 Selling, general and administrative expenses 4,145 352 4,497 Total operating expenses 9,601 502 10,103 Operating loss (8,984 ) (502 ) (9,486 ) Net loss (9,657 ) (502 ) (10,159 ) Total other comprehensive loss (9,688 ) (502 ) (10,190 ) Basic and diluted loss per common share (1.18 ) (0.06 ) (1.24 ) Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended June 30, 2022 (unaudited) Compensation expense for issuance of stock options 1,617 502 2,119 Net loss (9,657 ) (502 ) (10,159 ) Balance Sheet for September 30, 2022 (unaudited) Additional paid-in 442,066 1,671 443,737 Accumulated deficit (447,341 ) (1,671 ) (449,012 ) Consolidated Statement of Operations and Comprehensive Loss for the three months September 30, 2022 (unaudited) Research and development expenses 3,953 112 4,065 Selling, general and administrative expenses 4,519 260 4,779 Total operating expenses 8,472 372 8,844 Operating loss (7,801 ) (372 ) (8,173 ) Net loss (8,505 ) (372 ) (8,877 ) Total other comprehensive loss (8,551 ) (372 ) (8,923 ) Basic and diluted loss per common share (0.92 ) (0.04 ) -0.96 Consolidated statement of Stockholders’ Equity (Deficit) for the three months ended September 30, 2022 (unaudited) Compensation expense for issuance of stock options 1,255 372 1,627 Net loss (8,505 ) (372 ) (8,877 ) Consolidated Statement of Operations and Comprehensive Loss for the six months June 30, 2022 (unaudited) Research and development expenses 9,696 391 10,087 Selling, general and administrative expenses 7,791 908 8,699 Total operating expenses 17,487 1,299 18,786 Operating loss (16,527 ) (1,299 ) (17,826 ) Net loss (17,860 ) (1,299 ) (19,159 ) Total other comprehensive loss (17,889 ) (1,299 ) (19,188 ) Basic and diluted loss per common share (2.18 ) (0.16 ) (2.34 ) As previously report Adjustment As revised Consolidated Statement of Cash Flows for the six months ended June 30, 2022 (unaudited) Net loss (17,860 ) (1,299 ) (19,159 ) Stock option compensation expense 3,091 1,299 4,390 Consolidated Statement of Operations and Comprehensive Loss for the nine months September 30, 2022 (unaudited) Research and development expenses 13,649 503 14,152 Selling, general and administrative expenses 12,309 1,168 13,477 Total operating expenses 25,958 1,671 27,629 Operating loss (24,327 ) (1,671 ) (25,998 ) Net loss (26,365 ) (1,671 ) (28,036 ) Total other comprehensive loss (26,447 ) (1,671 ) (28,118 ) Basic and diluted loss per common share (3.09 ) (0.20 ) (3.29 ) Consolidated Statement of Cash Flows for the nine months ended September 30, 2022 (unaudited) Net loss (26,365 ) (1,671 ) (28,036 ) Stock option compensation expense 4,345 1,671 6,016 |
Cash, Cash Equivalents and Re_2
Cash, Cash Equivalents and Restricted Cash (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash, Cash Equivalents, and Restricted Cash | December 31, December 31, 2022 2021 Cash and cash equivalents $ 7,671 $ 22,802 Restricted balance for loan agreement 4,000 4,000 Letters of credit 101 101 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 11,822 $ 26,953 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of inventories | Inventories consist of: December 31, December 31, 2022 2021 Raw materials $ 763 $ 767 Work-in-process 1,102 645 Finished goods 133 — Total inventories $ 1,998 $ 1,412 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets include the following: December 31, December 31, 2022 2021 Clinical trial expenses $ 1,630 $ 1,630 Insurance premiums 123 890 Professional services 121 15 Other 95 208 Total prepaid expenses and other current assets $ 1,969 $ 2,743 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Components of property, plant and equipment | Property, plant, and equipment consists of: December 31, 2022 December 31, 2021 Estimated Useful Life Buildings and land $ 1,301 $ 1,222 30 years - Buildings Enterprise hardware and software 1,855 1,858 3 years Leaseholds 1,774 1,796 Lesser of lease term or estimated useful life Equipment 1,222 1,094 7 years Furniture 201 203 5 years Property, plant and equipment, gross 6,353 6,173 Accumulated depreciation (4,931 ) (4,825 ) Property, plant and equipment, net $ 1,422 $ 1,348 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Current accrued expenses include the following: December 31, December 31, Clinical expenses $ 1,470 $ 1,517 Compensation, excluding taxes 1,040 893 Short-term financing — 551 Professional fees 1,087 603 Interest on convertible note 553 393 Other 535 152 Total accrued expenses $ 4,685 $ 4,109 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Summary of Operating and Financing Leases | The following table summarizes the Company’s operating leases as of December 31, 2022: U.S. Ireland Total Lease cost Operating lease cost $ 406 $ 37 $ 443 Other information Operating cash flows out from operating leases (406 ) (37 ) (443 ) 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 | Maturities of the Company’s operating leases, excluding short-term leases, are as follows: U.S. Ireland Total Year ended December 31, 2023 155 37 192 Year ended December 31, 2024 — 37 37 Year ended December 31, 2025 — 37 37 Year ended December 31, 2026 — 22 22 Total 155 133 288 Less present value discount (3 ) (17 ) (20 ) Operating lease liabilities included in the condensed consolidated balance sheets at December 31, 2022 $ 152 $ 116 $ 268 |
Loans and Convertible Notes P_2
Loans and Convertible Notes Payable (Tables) | 12 Months Ended | |
Aug. 06, 2021 | Dec. 31, 2022 | |
Debt Disclosure [Abstract] | ||
Summary of Loans and Convertible Notes Payable | December 31, 2022 December 31, 2021 Gross Discount Net Gross Discount Net Loan - Avenue [1] $ 11,923 $ (1,008 ) $ 10,916 $ 12,638 $ (1,645 ) $ 10,993 Loan - Avenue [1] (8,570 ) 724 (7,846 ) (714 ) 93 (621 ) Total - Loans Payable, Non-Current $ 3,353 $ (284 ) $ 3,070 $ 11,924 $ (1,552 ) $ 10,372 Convertible Note Payable - Rosalind 2,000 — 2,000 2,000 — 2,000 Convertible Portion of Loan Payable - Avenue 3,000 (228 ) 2,772 3,000 (361 ) 2,639 Total - Convertible Notes Payable - Non-Current $ 5,000 $ (228 ) $ 4,772 $ 5,000 $ (361 ) $ 4,639 | |
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: Convertible Loans Notes Total Year ended December 31, 2023 $ 8,570 $ — $ 8,570 Year ended December 31, 2024 3,353 5,000 8,353 Total $ 11,923 $ 5,000 $ 16,923 | |
Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method | The Avenue Warrant was valued at issuance at $1.3 million using the Black-Scholes option pricing method using the following assumptions: August 6, Contractual term (years) 5.07 Expected volatility 187.0 % Risk-free interest rate 0.77 % Expected dividends 0.00 % | The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods: Years Ended December 31 2022 2021 Expected terms (years) 0.7 - 8.4 5.1 - 6.3 Expected volatility 166.4% -180.3% 177.% - 181.3% Risk-free interest rate 1.2% - 4.4% 0.7% - 1.3% Expected dividends 0.00% 0.00% |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended | |
Aug. 06, 2021 | Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | ||
Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method | The Avenue Warrant was valued at issuance at $1.3 million using the Black-Scholes option pricing method using the following assumptions: August 6, Contractual term (years) 5.07 Expected volatility 187.0 % Risk-free interest rate 0.77 % Expected dividends 0.00 % | The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods: Years Ended December 31 2022 2021 Expected terms (years) 0.7 - 8.4 5.1 - 6.3 Expected volatility 166.4% -180.3% 177.% - 181.3% Risk-free interest rate 1.2% - 4.4% 0.7% - 1.3% Expected dividends 0.00% 0.00% |
Summary of Stock Option Activity | The following is a summary of stock option activity for the year ended December , : Number of Options Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding at January 1, 2022 1,732,460 $ 11.69 Granted 702,583 6.74 Expired (65,690 ) 10.43 Cancelled/Forfeited (134,301 ) 9.59 Outstanding at December 31, 2022 2,235,052 $ 10.30 8.0 $ 36 Exercisable at December 31, 2022 1,316,515 $ 11.13 7.6 $ — | |
Summary of Stock Option Shares Outstanding and Exercisable | The following table summarizes information for stock option shares outstanding and exercisable at December 31, 2022: Options Exercisable Weighted Average Outstanding Number of Remaining Option Term Range of Exercise Prices Options (in years) Number of Options $6.24 - $53.85 2,234,553 8.0 1,316,016 $53.85+ 499 6.1 499 2,235,052 7.6 1,316,515 | |
Summary of Recognized Share-based Compensation Cost | At December 31, 2022, there was approximately $2.8 million of aggregate unrecognized compensation expense related to employee and board stock option grants. The cost is expected to be recognized over a weighted average period of 1.6 years. For the years ended December 31, 2022 and 2021, the Company recognized compensation expense $7.9 million and $7.8 million, respectively, related to stock options granted to employees and board members, which were charged to the statement of operations as detailed below: Years Ended December 31, 2022 2021 Selling, general and administrative $ 5,282 $ 5,334 Research and development 2,449 2,311 Cost of goods sold 210 187 Total $ 7,941 $ 7,832 | |
Summary of Warrant Activity | The following is a summary of warrant activity for the year ended December 31, 2022: Weighted Average Weighted Average Remaining Life Warrants Exercise Price (in years) Outstanding at January 1, 2022 3,894,498 $ 9.27 Warrants issued 1,258,793 .01 Outstanding at December 31, 2022 5,153,291 $ 7.01 2.8 Exercisable at December 31, 2022 5,153,291 $ 7.01 2.8 | |
Schedule of Information Related to Stock Warrants Outstanding and Exercisable | The following table presents information related to stock warrants at December 31, 2022: Warrants Exercisable Range of Exercise Prices Outstanding Number of Warrants Weighted Average Term (in years) Number of $0.01 1,542,548 4.4 1,542,548 $10.00 3,610,743 2.2 3,610,743 5,153,291 2.8 5,153,291 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Taxes | Loss before income taxes consists of: For the Year Ended 2022 2021 Domestic $ (34,547 ) $ (25,881 ) Foreign (1,960 ) 232 Income before taxes $ (36,507 ) $ (25,649 ) |
Income Tax Reconciliation | The provision for income taxes differs from the amount computed by applying the statutory rate as follows: For the Year Ended 2022 2021 Income taxes using U.S federal statutory rate $ (7,666 ) $ (5,386 ) Nondeductible interest 139 39 Loss of tax benefit of state net operating loss carryforwards — 2,799 Branch income (385 ) 229 State income taxes, net of federal benefit (531 ) 311 Foreign rate differential 165 27 Valuation allowance 9,221 2,114 Stock option expense, exercises and cancellations 752 446 Research and development costs (708 ) (375 ) Other (987 ) (204 ) $ — $ — |
Significant Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets are as follows: For the Year Ended December 31, 2022 2021 Deferred tax assets: Employee compensation accruals $ 2,772 $ 1,777 Accrued liabilities 197 29 Research tax credits 1,429 721 Lease obligation 38 107 Other 160 89 Research expense capitalization 3,203 — Net operating losses 24,595 20,520 Total deferred tax assets 32,394 23,243 For the Year Ended December 31, 2022 2021 Deferred tax liabilities: Right of use asset 50 118 Total deferred tax liabilities 50 118 Valuation allowance 32,344 23,125 Net deferred tax assets $ — $ — |
Summary of Change in Valuation | The change in valuation allowance is as follows: December 31, 2022 2021 Beginning Balance $ 23,125 $ 21,332 Charged to costs and expenses 9,221 2,114 Charged to other comprehensive income (2 ) (321 ) Ending balance $ 32,344 $ 23,125 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 December 31, 2022: Level 3 Balance at January 1, 2022 $ — Add: contingent liability recorded on medac settlement 1,168 Change exchange rate 112 Balance at December 31, 2022 $ 1,280 |
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 December 31, 2022 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value. There were no financial assets and liabilities that have been measured at fair value as of December 31, 2021. In general, the fair values were determined using Level 3: Description Quoted Significant Significant December 31, Liabilities: Contingent Liability $ 1,280 $ 1,280 Total Liabilities $ — $ — $ 1,280 $ 1,280 |
Description of Business - Addit
Description of Business - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||
Dec. 13, 2022 | Jul. 20, 2022 | Jul. 07, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||
Net loss | $ (36,508) | $ (25,649) | |||
Net cash used in operating activities | 25,000 | ||||
Proceeds from issuance of private placement | $ 10,857 | $ 0 | |||
Common Stock [Member] | |||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||
Stock issued during period shares | 515,000 | ||||
Pre Funded Warrants [Member] | |||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||
Exercise price of warrant | $ 0.01 | ||||
Private Placement [Member] | |||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||
Sale Of stock price per share | $ 2.9 | $ 3.98 | |||
Proceeds from issuance of private placement | $ 6,200 | $ 5,000 | $ 5,000 | ||
Private Placement [Member] | Common Stock [Member] | |||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||
Stock issued during period shares | 1,448,889 | 690,954 | |||
Private Placement [Member] | Pre Funded Warrants [Member] | |||||
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items] | |||||
Class of warrants and rights issued during the period | 692,042 | 566,751 | |||
Class of warrants and rights issued, price per warrant | $ 2.89 | $ 3.97 | |||
Exercise price of warrant | $ 0.01 | $ 0.01 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Summary Of Significant Accounting Policies [Line Items] | |
Maximum period of investments with original maturities from date of acquisition to be cash equivalents | 3 months |
Minimum [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Property, plant and equipment, estimated useful life | 3 years |
Maximum [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Property, plant and equipment, estimated useful life | 7 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Shares Excluded from the Computation of Diluted Earnings per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 7,469,547 | 6,966,955 |
Common stock warrants - equity [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 3,610,743 | 3,610,743 |
Assumed conversion of Series E and Series E-1 Preferred Stock [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,135,721 | 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) | 2,235,052 | 1,732,460 |
Revision of Previously Issued_3
Revision of Previously Issued Quarterly Financial Statements - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | |
Prior Period Adjustment [Abstract] | |||
Impact of Correction of Share Based Compensation on Net Income Loss | $ 372 | $ 502 | $ 797 |
Revision of Previously Issued_4
Revision of Previously Issued Quarterly Financial Statements - Schedule of Error Corrections and Prior Period Adjustments (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Financial Position [Abstract] | |||||||
Additional paid-in capital | $ 451,608 | $ 432,831 | |||||
Accumulated deficit | (457,484) | (420,976) | |||||
Statement of Operations and Comprehensive Loss [Abstract] | |||||||
Research and development expenses | 18,583 | 13,778 | |||||
Selling, general and administrative expenses | 17,303 | 13,637 | |||||
Total operating expenses | 35,886 | 27,415 | |||||
Operating loss | (33,853) | (24,531) | |||||
Net loss | (36,508) | (25,649) | |||||
Total other comprehensive loss | $ (36,407) | $ (25,527) | |||||
Basic loss per common share* | $ (4.12) | $ (3.59) | |||||
Diluted loss per common share* | $ (4.12) | $ (3.59) | |||||
Statement of Stockholders' Equity [Abstract] | |||||||
Compensation expense for issuance of stock options | $ 7,941 | $ 7,832 | |||||
Net loss | (36,508) | (25,649) | |||||
Statement of Cash Flows [Abstract] | |||||||
Net loss | (36,508) | (25,649) | |||||
Stock option compensation expense | $ 7,941 | $ 7,832 | |||||
Previously Reported [Member] | |||||||
Statement of Financial Position [Abstract] | |||||||
Additional paid-in capital | $ 442,066 | $ 435,922 | $ 434,305 | $ 435,922 | $ 442,066 | ||
Accumulated deficit | (447,341) | (438,836) | (429,179) | (438,836) | (447,341) | ||
Statement of Operations and Comprehensive Loss [Abstract] | |||||||
Research and development expenses | 3,953 | 5,456 | 4,240 | 9,696 | 13,649 | ||
Selling, general and administrative expenses | 4,519 | 4,145 | 3,648 | 7,791 | 12,309 | ||
Total operating expenses | 8,472 | 9,601 | 7,888 | 17,487 | 25,958 | ||
Operating loss | (7,801) | (8,984) | (7,543) | (16,527) | (24,327) | ||
Net loss | (8,505) | (9,657) | (8,203) | (17,860) | (26,365) | ||
Total other comprehensive loss | $ (8,551) | $ (9,688) | $ (8,201) | $ (17,889) | $ (26,447) | ||
Basic loss per common share* | $ (0.92) | $ (1.18) | $ (1) | $ (2.18) | $ (3.09) | ||
Diluted loss per common share* | $ (0.92) | $ (1.18) | $ (1) | $ (2.18) | $ (3.09) | ||
Statement of Stockholders' Equity [Abstract] | |||||||
Compensation expense for issuance of stock options | $ 1,255 | $ 1,617 | $ 1,474 | ||||
Net loss | (8,505) | (9,657) | (8,203) | $ (17,860) | $ (26,365) | ||
Statement of Cash Flows [Abstract] | |||||||
Net loss | (8,505) | (9,657) | (8,203) | (17,860) | (26,365) | ||
Stock option compensation expense | 1,474 | 3,091 | 4,345 | ||||
Revision of Prior Period, Adjustment [Member] | |||||||
Statement of Financial Position [Abstract] | |||||||
Additional paid-in capital | 1,671 | 1,299 | 797 | 1,299 | 1,671 | ||
Accumulated deficit | (1,671) | (1,299) | (797) | (1,299) | (1,671) | ||
Statement of Operations and Comprehensive Loss [Abstract] | |||||||
Research and development expenses | 112 | 150 | 241 | 391 | 503 | ||
Selling, general and administrative expenses | 260 | 352 | 556 | 908 | 1,168 | ||
Total operating expenses | 372 | 502 | 797 | 1,299 | 1,671 | ||
Operating loss | (372) | (502) | (797) | (1,299) | (1,671) | ||
Net loss | (372) | (502) | (797) | (1,299) | (1,671) | ||
Total other comprehensive loss | $ (372) | $ (502) | $ (797) | $ (1,299) | $ (1,671) | ||
Basic loss per common share* | $ (0.04) | $ (0.06) | $ (0.1) | $ (0.16) | $ (0.2) | ||
Diluted loss per common share* | $ (0.04) | $ (0.06) | $ (0.1) | $ (0.16) | $ (0.2) | ||
Statement of Stockholders' Equity [Abstract] | |||||||
Compensation expense for issuance of stock options | $ 372 | $ 502 | $ 797 | ||||
Net loss | (372) | (502) | (797) | $ (1,299) | $ (1,671) | ||
Statement of Cash Flows [Abstract] | |||||||
Net loss | (372) | (502) | (797) | (1,299) | (1,671) | ||
Stock option compensation expense | 797 | 1,299 | 1,671 | ||||
As Revised [Member] | |||||||
Statement of Financial Position [Abstract] | |||||||
Additional paid-in capital | 443,737 | 437,221 | 435,102 | 437,221 | 443,737 | ||
Accumulated deficit | (449,012) | (440,135) | (429,976) | (440,135) | (449,012) | ||
Statement of Operations and Comprehensive Loss [Abstract] | |||||||
Research and development expenses | 4,065 | 5,606 | 4,481 | 10,087 | 14,152 | ||
Selling, general and administrative expenses | 4,779 | 4,497 | 4,204 | 8,699 | 13,477 | ||
Total operating expenses | 8,844 | 10,103 | 8,685 | 18,786 | 27,629 | ||
Operating loss | (8,173) | (9,486) | (8,340) | (17,826) | (25,998) | ||
Net loss | (8,877) | (10,159) | (9,000) | (19,159) | (28,036) | ||
Total other comprehensive loss | $ (8,923) | $ (10,190) | $ (8,998) | $ (19,188) | $ (28,118) | ||
Basic loss per common share* | $ 0.96 | $ (1.24) | $ (1.1) | $ (2.34) | $ (3.29) | ||
Diluted loss per common share* | $ 0.96 | $ (1.24) | $ (1.1) | $ (2.34) | $ (3.29) | ||
Statement of Stockholders' Equity [Abstract] | |||||||
Compensation expense for issuance of stock options | $ 1,627 | $ 2,119 | $ 2,271 | ||||
Net loss | (8,877) | (10,159) | (9,000) | $ (19,159) | $ (28,036) | ||
Statement of Cash Flows [Abstract] | |||||||
Net loss | $ (8,877) | $ (10,159) | (9,000) | (19,159) | (28,036) | ||
Stock option compensation expense | $ 2,271 | $ 4,390 | $ 6,016 |
Cash, Cash Equivalents and Re_3
Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Cash and Cash Equivalents [Abstract] | |||
Cash and cash equivalents | $ 7,671 | $ 22,802 | |
Restricted balance for loan agreement | 4,000 | 4,000 | |
Letters of credit | 101 | 101 | |
Security for credit cards | 50 | 50 | |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 11,822 | $ 26,953 | $ 28,756 |
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 | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 15, 2023 | Dec. 31, 2021 | |
Cash and Cash Equivalents [Line Items] | |||
Letters of credit | $ 101 | $ 101 | |
Lessee, Operating Sublease, Expiry Term | 2023-05 | ||
Restricted Cash | $ 4,151 | $ 4,151 | |
Term Loan From Avenue Venture Opportunities Fund LP [Member] | Subsequent Event [Member] | |||
Cash and Cash Equivalents [Line Items] | |||
Restricted Cash | $ 4,000 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 763 | $ 767 |
Work-in-process | 1,102 | 645 |
Finished goods | 133 | 0 |
Total Inventory | $ 1,998 | $ 1,412 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Clinical trial expenses | $ 1,630 | $ 1,630 |
Insurance premiums | 123 | 890 |
Professional services | 121 | 15 |
Other | 95 | 208 |
Total prepaid expenses and other current assets | $ 1,969 | $ 2,743 |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 6,353 | $ 6,173 |
Accumulated depreciation | (4,931) | (4,825) |
Property, plant, and equipment, net | 1,422 | 1,348 |
Buildings and Land [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,301 | 1,222 |
Enterprise Hardware and Software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,855 | 1,858 |
Property, plant and equipment, estimated useful life | 3 years | |
Leaseholds [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,774 | 1,796 |
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 | $ 1,222 | 1,094 |
Property, plant and equipment, estimated useful life | 7 years | |
Furniture [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 201 | $ 203 |
Property, plant and equipment, estimated useful life | 5 years | |
Buildings [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, estimated useful life | 30 years |
Property, Plant, and Equipmen_3
Property, Plant, and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 132 | $ 146 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Clinical expenses | $ 1,470 | $ 1,517 |
Compensation, excluding taxes | 1,040 | 893 |
Short-term financing | 0 | 551 |
Professional fees | 1,087 | 603 |
Interest on Rosalind convertible note | 553 | 393 |
Other | 535 | 152 |
Total accrued expenses | $ 4,685 | $ 4,109 |
Leases - Additional Information
Leases - Additional Information (Details) | 12 Months Ended | |||
Jul. 01, 2020 USD ($) ft² | Jun. 25, 2020 USD ($) | Dec. 31, 2022 USD ($) | Sep. 22, 2020 ft² | |
Rent per month | $ 443,000 | |||
Lease term | 12 months | |||
Two Thousand Fifteen Sublease Agreement | ||||
Lease, description | Pursuant to a 2014 sublease agreement (the “2014 Sublease”) and a 2015 sublease agreement (the “2015 Sublease”) the Company subleased portions of its leased premises in Galway, Ireland to a sublessee. On May 15, 2020, the Company and its sublessee entered into amendments to the 2014 Sublease and the 2015 Sublease pursuant to which (i) the 2014 Sublease and 2015 Sublease were extended from May 31, 2020 to August 2, 2021, (ii) effective July 1, 2020, the leased premises under the 2015 Sublease would be expanded to include an additional 4,999 square feet of space, and (iii) effective July 1, 2020, the rent under the 2015 Sublease would increase from approximately $14.6 per month to $20.6 per month. | |||
Additional area of space | ft² | 4,999 | |||
Two Thousand Fifteen Sublease Agreement | Minimum [Member] | ||||
Increase in sublease rent | $ 20,600 | |||
Two Thousand Fifteen Sublease Agreement | Maximum [Member] | ||||
Increase in sublease rent | $ 14,600 | |||
2021 Sub-Lease [Member] | ||||
Rent per month | $ 3,700 | |||
Lease term | 5 years | |||
Additional area of space | ft² | 6,877 |
Leases - Summary of Operating a
Leases - Summary of Operating and Financing Leases (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Lease Cost | |
Operating lease cost | $ 443 |
Other information | |
Operating cash flows out from operating leases | (443) |
U.S. [Member] | |
Lease Cost | |
Operating lease cost | 406 |
Other information | |
Operating cash flows out from operating leases | $ (406) |
Weighted average remaining lease term | 6 months |
Weighted average discount rate - operating leases | 8% |
Ireland [Member] | |
Lease Cost | |
Operating lease cost | $ 37 |
Other information | |
Operating cash flows out from operating leases | $ (37) |
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 | Dec. 31, 2022 USD ($) |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2023 | $ 192 |
Year ended December 31, 2024 | 37 |
Year ended December 31, 2025 | 37 |
Year ended December 31, 2026 | 22 |
Total | 288 |
Less present value discount | (20) |
Operating lease liabilities included in the condensed consolidated balance sheets at December 31, 2022 | 268 |
U.S. [Member] | |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2023 | 155 |
Year ended December 31, 2024 | 0 |
Total | 155 |
Less present value discount | (3) |
Operating lease liabilities included in the condensed consolidated balance sheets at December 31, 2022 | 152 |
Ireland [Member] | |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2023 | 37 |
Year ended December 31, 2024 | 37 |
Year ended December 31, 2025 | 37 |
Year ended December 31, 2026 | 22 |
Total | 133 |
Less present value discount | (17) |
Operating lease liabilities included in the condensed consolidated balance sheets at December 31, 2022 | $ 116 |
Loans and Convertible Notes P_3
Loans and Convertible Notes Payable - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Aug. 06, 2021 | Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 15, 2023 | |
Debt Instrument [Line Items] | |||||
Avenue warrant value | $ 1,300 | ||||
Interest expense incurred | 1,900 | ||||
Restricted Cash | $ 4,151 | $ 4,151 | $ 4,151 | ||
Secured Convertible Notes Payable [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, principal face amount | $ 2,000 | ||||
Series E Preferred Stock [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, conversion price | $ 1,500 | $ 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 | ||||
Debt instrument maturity date | Aug. 01, 2024 | ||||
Debt instrument, interest rate | 7.70% | ||||
Debt instrument, interest rate | 10.95% | 15.20% | |||
Debt instrument, interest rate term | The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at December 31, 2022 was 15.2%. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. | ||||
Initial tranche of loan | $ 15,000 | ||||
Loan amount funded into restricted account | 4,000 | ||||
Gross proceeds from ATM Offering | 20,000 | ||||
Second tranche of loan | $ 5,000 | ||||
Debt instrument, conversion price | $ 11.98 | ||||
Frequency of periodic payment | monthly | ||||
Periodic interest payments, term | 15 months | ||||
Debt instrument, incremental final payment | 4.25% | ||||
Debt instrument, commitment fee | $ 150 | ||||
Debt instrument, commitment fee, percentage | 1% | ||||
Debt instrument, commitment fee upon funding of second tranche of loan | $ 200 | ||||
Original issue discount | 637 | ||||
Cash issuance costs | 563 | ||||
Debit discount | 519 | ||||
Fair value of warrants reclassified from liability to equity | 44 | ||||
Aggregate debt discount | $ 2,327 | ||||
Amortization of debt discount | $ 800 | ||||
Current interest rate | 7.70% | ||||
Minimum equity proceeds not raised | $ 20,000 | ||||
Additional funding not eligible | $ 5,000 | ||||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Subsequent Event [Member] | |||||
Debt Instrument [Line Items] | |||||
Restricted Cash | $ 4,000 | ||||
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 | $ 1,171 | ||||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Maximum [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, principal face amount | 20,000 | ||||
Debt instrument, converted amount | $ 3,000 | ||||
Periodic interest payments, term | 24 months | ||||
Prepayment fee, percentage | 3% | ||||
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 | $ 1,909 | ||||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Convertible Debt [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate debt discount | $ 418 | ||||
Eight Point Zero Percentage July Two Thousand And Nineteen Notes [Member] | Convertible Notes Payable [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, interest rate | 8% | 8% | |||
Current interest rate | 8% | 8% | |||
Eight Point Zero Percentage July Two Thousand And Nineteen Notes [Member] | Convertible Debt [Member] | |||||
Debt Instrument [Line Items] | |||||
Interest expense incurred | $ 160 | $ 160 |
Loans and Convertible Notes P_4
Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Gross | $ 5,000 | $ 5,000 | |
Discount | (228) | (361) | |
Net | 4,772 | 4,639 | |
Less Current Portion, Net | (7,846) | (621) | |
Total - Loans Payable, Non-Current, Gross | 3,353 | 11,924 | |
Total - Loans Payable, Non-Current, Discount | (284) | (1,552) | |
Total - Loans Payable, Non-Current, Net | 3,070 | 10,372 | |
Loan Avenue [Member] | |||
Gross | [1] | 11,923 | 12,638 |
Discount | [1] | (1,008) | (1,645) |
Net | [1] | 10,916 | 10,993 |
Less Current Portion, Gross | [1] | (8,570) | (714) |
Less Current Portion, Discount | [1] | 724 | 93 |
Less Current Portion, Net | [1] | (7,846) | (621) |
Convertible Note Payable Rosalind [Member] | |||
Gross | 2,000 | 2,000 | |
Net | 2,000 | 2,000 | |
Convertible Loan Payable Avenue [Member] | |||
Gross | 3,000 | 3,000 | |
Discount | (228) | (361) | |
Net | $ 2,772 | $ 2,639 | |
[1]The gross amount includes the 4.25% final payment of $637.5. |
Loans and Convertible Notes P_5
Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) (Parenthetical) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Equity Method Investments And Cost Method Investments [Abstract] | |
Percentage of final payment included in gross amount | 4.25% |
Final payment | $ 637,500 |
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 | Dec. 31, 2022 USD ($) |
Debt Instrument [Line Items] | |
Loans | $ 11,923 |
Convertible Notes | 5,000 |
Total | 16,923 |
Year ended December 31, 2023 | |
Debt Instrument [Line Items] | |
Loans | 8,570 |
Total | 8,570 |
Year ended December 31, 2024 | |
Debt Instrument [Line Items] | |
Loans | 3,353 |
Convertible Notes | 5,000 |
Total | $ 8,353 |
Loans and Convertible Notes P_7
Loans and Convertible Notes Payable - Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method (Details) | 12 Months Ended | ||
Aug. 06, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Contractual term (years) | 5 years 25 days | ||
Expected volatility | 187% | ||
Risk-free interest rate | 0.77% | ||
Expected dividends | 0% | 0% | 0% |
Stockholders' Equity - Preferre
Stockholders' Equity - Preferred Stock Issuances - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |||
Dec. 31, 2021 | Feb. 27, 2023 | Dec. 31, 2022 | Nov. 09, 2021 | |
Stockholders Equity Note [Line Items] | ||||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||
Common stock, shares authorized (in shares) | 40,000,000 | 40,000,000 | ||
Number of preferred stock and warrants issued upon conversion | 927,379 | |||
Preferred stock, shares outstanding (in shares) | 11,357 | 11,357 | ||
Cantor Fitzgerald And Co [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Increase in aggregate amount | $ 25 | |||
Cantor Fitzgerald And Co [Member] | Subsequent Event [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Increase decrease in aggregate offering price limit | $ 17 | |||
Series A Preferred Stock [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Preferred stock, shares authorized (in shares) | 4,200 | |||
Series B Preferred Stock [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Preferred stock, shares authorized (in shares) | 2,360 | |||
Series C Preferred Stock [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Preferred stock, shares authorized (in shares) | 590 | |||
Series D Preferred Stock [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Preferred stock, shares authorized (in shares) | 10,000 | |||
Series E Preferred Stock [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Preferred stock, shares authorized (in shares) | 40,000 | |||
Conversion of stock preferred shares converted | 9,274 | |||
Series E1 Preferred Stock [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Preferred stock, shares authorized (in shares) | 12,960 | |||
Series E-1 Convertible Preferred Stock [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Preferred stock, shares outstanding (in shares) | 11,357 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Incentive Plan - Additional Information (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | 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 | 870,508 | |
2019 Equity Incentive Plan [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Common Stock Capital Shares Reserved | 2,142 | |
Share based Payment Award Purchase Price Of Common Stock Percent | 100% |
Stockholders' Equity - At-the-M
Stockholders' Equity - At-the-Market Offering - Additional Information (Details) - USD ($) | 12 Months Ended | |||||
Dec. 13, 2022 | Jul. 20, 2022 | Jul. 07, 2022 | Aug. 18, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stockholders Equity Note [Line Items] | ||||||
Proceeds from issuance of private placement | $ 10,857,000 | $ 0 | ||||
Number of Shares Sold | 0 | |||||
Pre Funded Warrants [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants issued to purchase of common stock | 215,000 | |||||
Exercise price of warrant | $ 0.01 | |||||
Common Stock [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Shares issued in public offering | 515,000 | |||||
Private Placement [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Proceeds from issuance of private placement | $ 6,200,000 | $ 5,000,000 | $ 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% | |||||
Cantor Fitzgerald & Co [Member] | At-the-Market Offering [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Issuance costs | $ 121,000 | |||||
Roth Capital Partners L L C | ||||||
Stockholders Equity Note [Line Items] | ||||||
Percentage of fee on gross sale price per share | 1.05% | |||||
Percentage of underwriting fee to be received on company offerings | 35% | |||||
Common stock offering period | 90 days | |||||
Maximum [Member] | Cantor Fitzgerald & Co [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
At-the-market offering, aggregate offering price | $ 10,000,000 | |||||
Legal fees and disbursements | $ 50,000 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock Issuances - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended |
Feb. 28, 2021 | Dec. 31, 2021 | |
Stockholders Equity Note [Line Items] | ||
Gross proceeds from issuance of common stock | $ 2.5 | |
Stock issued during period shares associated other warrants | 465,173 | |
Issue Of Unregistered Common Stock For Advisory Services | 2,636 | |
Pre-Funded Warrants [Member] | ||
Stockholders Equity Note [Line Items] | ||
Warrants issued to purchase of common stock | 215,000 | |
Warrant exercise price | $ 0.01 |
Stockholders' Equity - Stock In
Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted average estimated fair value of the stock options granted | $ 6.05 | $ 9.74 |
Unrecognized compensation expense related to non-vested share-based compensation awards | $ 2,800 | |
Cost expected to be recognized over weighted average period | 1 year 7 months 6 days | |
Share-based compensation (Income) expense | $ 7,941 | $ 7,832 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details) | 12 Months Ended | ||
Aug. 06, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected terms (years) | 5 years 25 days | ||
Expected volatility | 187% | ||
Risk-free interest rate | 0.77% | ||
Expected dividends | 0% | 0% | 0% |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected terms (years) | 8 months 12 days | 5 years 1 month 6 days | |
Expected volatility | 166.40% | 177% | |
Risk-free interest rate | 1.20% | 0.70% | |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected terms (years) | 8 years 4 months 24 days | 6 years 3 months 18 days | |
Expected volatility | 180.30% | 181.30% | |
Risk-free interest rate | 4.40% | 1.30% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Stockholders' Equity Note [Abstract] | |
Number of Shares, Outstanding | shares | 1,732,460 |
Number of Shares, Granted | shares | 702,583 |
Number of Shares, Expired | shares | (65,690) |
Number of Shares, Cancelled/Forfeited | shares | (134,301) |
Number of Shares, Outstanding | shares | 2,235,052 |
Number of Shares, Exercisable | shares | 1,316,515 |
Weighted Average Exercise Price, Outstanding | $ / shares | $ 11.69 |
Weighted Average Exercise Price, Granted | $ / shares | 6.74 |
Weighted Average Exercise Price, Expired | $ / shares | 10.43 |
Weighted Average Exercise Price, Cancelled/Forfeited | $ / shares | 9.59 |
Weighted Average Exercise Price, Outstanding | $ / shares | 10.3 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 11.13 |
Weighted Average Remaining Contractual Term (Years), Outstanding | 8 years |
Weighted Average Remaining Contractual Term (Years), Exercisable | 7 years 7 months 6 days |
Aggregate Intrinsic Value, Outstanding | $ | $ 36 |
Aggregate Intrinsic Value, Exercisable | $ | $ 0 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock Option Shares Outstanding and Exercisable (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 2,235,052 | 1,732,460 |
Weighted Average Remaining Contractual Term (Years), Exercisable | 7 years 7 months 6 days | |
Number of Shares, Exercisable | 1,316,515 | |
$15.00 - $24.99 [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 2,234,553 | |
Weighted Average Remaining Contractual Term (Years), Exercisable | 8 years | |
Number of Shares, Exercisable | 1,316,016 | |
$25 + [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 499 | |
Weighted Average Remaining Contractual Term (Years), Exercisable | 6 years 1 month 6 days | |
Number of Shares, Exercisable | 499 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) - Summary of Employee Stock Purchase Plan (Details) - May Two Thousand And Twenty Two Employee Stock Purchase Plan [Member] - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | |
Jan. 31, 2023 | Aug. 31, 2021 | |
Stockholders Equity Note [Line Items] | ||
Share-based compensation arrangement by share-based payment award number of shares authorized | 260,295 | |
Share-based compensation arrangement by share-based payment award purchase price of common stock, percent | 85% | |
Subsequent Event [Member] | ||
Stockholders Equity Note [Line Items] | ||
Share-based compensation arrangement by share-based payment award number of shares authorized | 15,417 | |
Share Price | $ 2.23 | |
Share Based Compensation Expense | $ 34 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | $ 7,941 | $ 7,832 |
Selling, General and Administrative [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | 5,282 | 5,334 |
Research and Development [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | 2,449 | 2,311 |
Cost of Goods Sold [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | $ 210 | $ 187 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Warrant Activity (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Warrants outstanding [Roll Forward] | |
Outstanding, beginning of period (in shares) | shares | 3,894,498 |
Warrants issued (in shares) | shares | 1,258,793 |
Outstanding, end of period (in shares) | shares | 5,153,291 |
Exercisable, end of period (in shares) | shares | 5,153,291 |
Warrants, Exercise Price per Share [Roll Forward] | |
Outstanding, beginning of period (in dollars per share) | $ / shares | $ 9.27 |
Outstanding, ending of period (in dollars per share) | $ / shares | 7.01 |
Warrants issued (in dollars per share) | $ / shares | 0.01 |
Exercisable, (in dollars per share) | $ / shares | $ 7.01 |
Weighted average remaining life | 2 years 9 months 18 days |
Weighted average remaining life, Exercisable | 2 years 9 months 18 days |
Stockholders' Equity - Summar_5
Stockholders' Equity - Summary of Warrants Outstanding and Exercisable (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 5,153,291 | 3,894,498 |
Weighted average remaining life | 2 years 9 months 18 days | |
Warrants Exercisable, Number Exercisable | 5,153,291 | |
$0.01 [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 1,542,548 | |
Weighted average remaining life | 4 years 4 months 24 days | |
Warrants Exercisable, Number Exercisable | 1,542,548 | |
$10.00 [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 3,610,743 | |
Weighted average remaining life | 2 years 2 months 12 days | |
Warrants Exercisable, Number Exercisable | 3,610,743 |
Commitments and contingencies -
Commitments and contingencies - Additional Information (Details) $ in Thousands, € in Millions | 12 Months Ended | ||||||||
Dec. 30, 2022 USD ($) | Apr. 01, 2021 EUR (€) | Jul. 27, 2020 USD ($) | Dec. 31, 2022 USD ($) | Jan. 24, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Oct. 12, 2021 EUR (€) | Dec. 31, 2020 USD ($) | |
Loss Contingencies [Line Items] | |||||||||
Increase in revenue recognition | $ 1,700 | ||||||||
Inventories | $ 1,998 | $ 1,412 | |||||||
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 | 1,200 | ||||||||
Medac [Member] | Other Noncurrent Liabilities | |||||||||
Loss Contingencies [Line Items] | |||||||||
Loss Contingency Accrual | 1,000 | ||||||||
Medac [Member] | Accrued Expenses | |||||||||
Loss Contingencies [Line Items] | |||||||||
Loss Contingency Accrual | 200 | ||||||||
Medac [Member] | Selling, General and Administrative [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Loss Contingency Accrual | $ 1,200 | ||||||||
Lachman [Member] | Subsequent Event [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Loss Contingency Accrual | $ 900 | ||||||||
Unpaid consulting fees | 900 | ||||||||
Loss contingency disputes charges | $ 300 | ||||||||
Pending Litigation [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Unpaid compensation amounts claimed | $ 1,100 | ||||||||
Loss Contingency Accrual | $ 1,100 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||
Income tax provision | $ 0 | $ 0 |
Percentage of valuation allowance against deferred tax assets | 100% | |
Decrease in deferred tax assets valuation allowance | $ 9,200 | 1,800 |
New York State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income | 190,300 | |
New York City [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income | $ 174,500 | |
Earliest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax period | Dec. 31, 1998 | |
Latest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax period | Dec. 31, 2022 | |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 290,400 | 277,400 |
Operating loss carryforwards, annual limitation | 28 | |
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income | 202,600 | |
Operating loss carryforwards available for offset future taxable income | 87,700 | |
Operating loss carryforwards for unlimited period | 86,000 | |
Federal [Member] | Expire Between 2019 and 2037 [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards available for offset future taxable income | $ 1,700 | |
Federal [Member] | Earliest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards, expiration dates | 2023 | |
Federal [Member] | Latest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards, expiration dates | 2037 | |
Federal [Member] | Research and Development Tax Credit Carryforwards [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | $ 6,500 | 5,800 |
Tax credit carryforwards, expiration dates | 2042 | |
Tax credit carryforwards expected to expire unutilized | $ 1,400 | |
State and City [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 5,100 | 5,000 |
Operating loss carryforwards, expiration dates | 2042 | |
Foreign [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 33,400 | 28,000 |
Federal and State [Member] | Earliest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax period | Dec. 31, 2019 | |
Federal and State [Member] | Latest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax period | Dec. 31, 2022 | |
Minimum [Member] | State and City [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 300 | 24,800 |
Maximum [Member] | State and City [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 195,300 | $ 193,700 |
Income Taxes - Schedule of Loss
Income Taxes - Schedule of Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Loss From Continuing Operations Before Income Taxes Minority Interest And Income Loss From Equity Method Investments [Abstract] | ||
Domestic | $ (34,547) | $ (25,881) |
Foreign | (1,960) | 232 |
Income before taxes | $ (36,507) | $ (25,649) |
Income Taxes - Income Tax Recon
Income Taxes - Income Tax Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Provision for income taxes [Abstract] | ||
Income taxes using U.S federal statutory rate | $ (7,666) | $ (5,386) |
Nondeductible interest | 139 | 39 |
Loss of tax benefit of state net operating loss carryforwards | 0 | 2,799 |
Branch income | (385) | 229 |
State income taxes, net of federal benefit | (531) | 311 |
Foreign rate differential | 165 | 27 |
Valuation allowance | 9,221 | 2,114 |
Stock option expense, exercises and cancellations | 752 | 446 |
Research and development costs | (708) | (375) |
Other | (987) | (204) |
Total | $ 0 | $ 0 |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | |||
Employee compensation accruals | $ 2,772 | $ 1,777 | |
Accrued liabilities | 197 | 29 | |
Research tax credits | 1,429 | 721 | |
Lease obligation | 38 | 107 | |
Other | 160 | 89 | |
Research expense capitalization | 3,203 | 0 | |
Net operating losses | 24,595 | 20,520 | |
Total deferred tax assets | 32,394 | 23,243 | |
Deferred tax liabilities: | |||
Right of use asset | 50 | 118 | |
Total deferred tax liabilities | 50 | 118 | |
Valuation allowance | 32,344 | 23,125 | $ 21,332 |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Summary of Chang
Income Taxes - Summary of Change in Valuation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Beginning balance | $ 23,125 | $ 21,332 |
Charged to costs and expenses | 9,221 | 2,114 |
Charged to other comprehensive income | (2) | (321) |
Ending balance | $ 32,344 | $ 23,125 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Measurements Using Significant Unobservable Inputs (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Fair Value Disclosures [Abstract] | |
Beginning balance | $ 0 |
Add: contingent liability recorded on medac settlement | 1,168 |
Change in exchange rate | 112 |
Ending balance | $ 1,280 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of the Company's financial assets and liabilities that have been measured at fair value (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Liabilities [Abstract] | |
Contingent Liability | $ 1,280 |
Total Liabilities | 1,280 |
Level 3 [Member] | |
Liabilities [Abstract] | |
Contingent Liability | 1,280 |
Total Liabilities | $ 1,280 |