Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 24, 2023 | Jun. 30, 2022 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Incorporation, State or Country Code | NV | ||
Entity Address, Address Line One | One Kendall Square | ||
Entity Address, Address Line Two | Suite B14402 | ||
Entity Address, City or Town | Cambridge | ||
Entity Address, State or Province | MA | ||
Document Period End Date | Dec. 31, 2022 | ||
Entity Registrant Name | INVIVO THERAPEUTICS HOLDINGS CORP. | ||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | NVIV | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Common Stock, Shares Outstanding | 2,860,446 | ||
Entity File Number | 001-37350 | ||
Entity Tax Identification Number | 36-4528166 | ||
Entity Address, Postal Zip Code | 02139 | ||
Local Phone Number | 863-5500 | ||
City Area Code | 617 | ||
Entity Public Float | $ 5,632,327 | ||
Auditor Name | RSM US LLP | ||
Auditor Firm ID | 49 | ||
Auditor Location | Massachusetts | ||
Entity Central Index Key | 0001292519 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 16,351 | $ 19,031 |
Prepaid expenses | 97 | 83 |
Other current assets | 1,153 | 28 |
Total current assets | 17,601 | 19,142 |
Property, equipment and leasehold improvements, net | 227 | 127 |
Restricted cash - non-current | 150 | 150 |
Operating lease right-of-use assets | 844 | 1,229 |
Prepaid clinical trial expenses | 1,122 | |
Total assets | 18,822 | 21,770 |
Current liabilities: | ||
Accounts payable | 617 | 605 |
Operating lease liabilities | 396 | 361 |
Accrued expenses | 1,455 | 1,646 |
Total current liabilities | 2,468 | 2,612 |
Other liabilities | 55 | 94 |
Operating lease liabilities - non-current | 553 | 949 |
Total liabilities | 3,076 | 3,655 |
Commitments and contingencies (Note 11) | ||
Stockholders' equity: | ||
Preferred stock, $0.00001 par value, authorized 1,000,000 and None at December 31, 2022 and December 31, 2021. No Preferred Stock issued and outstanding at December 31, 2022 and December 31, 2021 respectively. | ||
Common stock, $0.00001 par value, authorized 250,000,000 and 2,000,000 at December 31, 2022 and December 31, 2021, respectively. 2,429,446 and 1,370,595 shares issued and outstanding including 0 and 254 shares of unvested restricted stock awards, at December 31, 2022 and December 31, 2021, respectively. | 3 | 3 |
Additional paid-in capital | 264,362 | 256,241 |
Accumulated deficit | (248,619) | (238,129) |
Total stockholders' equity | 15,746 | 18,115 |
Total liabilities and stockholders' equity | $ 18,822 | $ 21,770 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Sep. 09, 2022 | Sep. 08, 2022 | Apr. 26, 2022 | Dec. 31, 2021 |
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | |||
Preferred stock, authorized | 1,000,000 | 0 | |||
Preferred stock, issued | 0 | 0 | |||
Preferred stock, outstanding | 0 | 0 | |||
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | $ 0.00001 | ||
Common stock, authorized | 250,000,000 | 250,000,000 | 2,000,000 | 2,000,000 | |
Common stock, issued | 2,429,446 | 1,370,595 | |||
Common stock, outstanding | 2,429,446 | 1,370,595 | |||
Restricted Stock [Member] | |||||
Common stock, outstanding | 0 | 254 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 5,226 | $ 4,381 |
General and administrative | 5,424 | 5,519 |
Total operating expenses | 10,650 | 9,900 |
Operating loss | (10,650) | (9,900) |
Other income: | ||
Interest income (expense), net | 151 | 3 |
Other income | 9 | 2 |
Interest and other income, net | 160 | 5 |
Net loss | $ (10,490) | $ (9,895) |
Net loss per share, basic | $ (6.83) | $ (7.48) |
Net loss per share, diluted | $ (6.83) | $ (7.48) |
Weighted average number of common shares outstanding, basic (In Shares) | 1,536,474 | 1,323,659 |
Weighted average number of common shares outstanding, diluted (In Shares) | 1,536,474 | 1,323,659 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2020 | $ 3 | $ 247,417 | $ (228,234) | $ 19,186 |
Beginning Balance, (in shares) at Dec. 31, 2020 | 945,276 | |||
Share-based compensation expense | 315 | $ 315 | ||
Issuance of common stock upon vesting of restricted stock units (in shares) | 2 | 2 | ||
Issuance of common stock upon exercise of warrants | 8,509 | $ 8,509 | ||
Issuance of common stock upon exercise of warrants (in shares) | 425,317 | |||
Net loss | (9,895) | (9,895) | ||
Ending Balance at Dec. 31, 2021 | $ 3 | 256,241 | (238,129) | $ 18,115 |
Ending Balance, (in shares) at Dec. 31, 2021 | 1,370,595 | 1,370,595 | ||
Share-based compensation expense | 159 | $ 159 | ||
Forfeiture of restricted stock | (54) | (54) | ||
Fractional shares issued due to 1 for 25 reverse stock split (in shares) | 20,619 | |||
Issuance of common stock and warrants in public offerings | 7,962 | $ 7,962 | ||
Issuance of common stock and warrants in public offerings (in shares) | 154,000 | |||
Issuance of common stock upon exercise of warrants (in shares) | 884,286 | |||
Net loss | (10,490) | (10,490) | ||
Ending Balance at Dec. 31, 2022 | $ 3 | $ 264,362 | $ (248,619) | $ 15,746 |
Ending Balance, (in shares) at Dec. 31, 2022 | 2,429,446 | 2,429,446 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) | 12 Months Ended | |
Apr. 26, 2022 | Dec. 31, 2022 | |
Consolidated Statements of Changes in Stockholders' Equity (Deficit) | ||
Reverse stock split ratio | 0.04 | 0.04 |
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 | $ (10,490) | $ (9,895) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 60 | 44 |
Amortization of operating lease right-of-use assets | 385 | 328 |
Share-based compensation expense | 159 | 315 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (17) | 52 |
Accounts payable | 12 | 124 |
Operating lease liability | (360) | (339) |
Accrued expenses and other liabilities | (231) | 517 |
Net cash used in operating activities | (10,482) | (8,854) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (160) | (77) |
Net cash used in investing activities | (160) | (77) |
Cash flows from financing activities: | ||
Proceeds from exercise of warrants | 8,509 | |
Proceeds from issuance of common stock and warrants, net of commissions and issuance costs | 7,962 | |
Net cash provided by financing activities | 7,962 | 8,509 |
(Decrease) Increase in cash and cash equivalents and restricted cash | (2,680) | (422) |
Cash, cash equivalents and restricted cash at beginning of period | 19,181 | 19,603 |
Cash, cash equivalents and restricted cash at end of period | 16,501 | 19,181 |
Supplemental disclosure of cash flow information and non-cash investing and financing activities: | ||
Fair value of warrants issued in connection with financing activities | 5,225 | |
Increase in operating right-of-use assets and liabilities related to lease modifications | 629 | |
Cash and cash equivalents | 16,351 | 19,031 |
Restricted cash included in other non-current assets | 150 | 150 |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 16,501 | $ 19,181 |
NATURE OF OPERATIONS AND GOING
NATURE OF OPERATIONS AND GOING CONCERN | 12 Months Ended |
Dec. 31, 2022 | |
NATURE OF OPERATIONS AND GOING CONCERN | |
NATURE OF OPERATIONS AND GOING CONCERN | 1. NATURE OF OPERATIONS AND GOING CONCERN Business InVivo Therapeutics Holdings Corp., including its subsidiary, (the “Company”) is a biomaterials and biotechnology company with a focus on the treatment of spinal cord injuries (“SCIs”). The Company’s proprietary technologies incorporate intellectual property that is licensed under an exclusive, worldwide license from Boston Children’s Hospital (“BCH”) and the Massachusetts Institute of Technology (“MIT”), as well as intellectual property that has been developed internally in collaboration with its advisors and partners. Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets, and raising capital. The Company has historically financed its operations primarily through the sale of equity-related securities. The Company has not achieved profitability and may not be able to realize sufficient revenue to achieve or sustain profitability in the future. The Company does not expect to be profitable in the next several years, but rather expects to incur additional operating losses. The Company has limited liquidity and capital resources and must obtain significant additional capital resources in order to sustain its product development efforts, for acquisition of technologies and intellectual property rights, for preclinical and clinical testing of its anticipated products, pursuit of regulatory approvals, acquisition of capital equipment, laboratory and office facilities, establishment of production capabilities, for selling, general and administrative expenses, and other working capital requirements. Going Concern The Company’s consolidated financial statements as of December 31, 2022 were prepared under the assumption that the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, as of December 31, 2022, substantial doubt exists about the Company’s ability to continue as a going concern. Since the Company’s inception, the Company has suffered recurring losses and negative cash flows from operations and will need additional funding to complete planned development efforts. As of December 31, 2022, the Company had unrestricted cash and cash equivalents of $16.4 million and during the year ended December 31, 2022, the Company recorded a net loss of $10.5 million. At December 31, 2022, the Company had. Given the Company’s current plans, the Company estimates cash resources will be sufficient to fund its operations into the first quarter of 2024. The Company will require additional liquidity to continue operations beyond the next 12 months. The Company is evaluating strategies to obtain the required additional funding for future operations. These strategies may include but are not limited to equity offerings, debt financings, other third-party funding, marketing and distribution arrangements, and other collaborations, strategic alliances, and licensing arrangements. However, given a variety of external factors including the impact of the recent economic downturn in the U.S. and global financial markets, the Company may be unable to access further equity or debt financing when needed. Lack of necessary funds may require the Company to, among other things, delay, scale back or eliminate some or all of its research and product development programs, planned clinical trials, and capital expenditures or to license its potential products or technologies to third parties. The Company may alternatively engage in cost-cutting measures in an attempt to extend its cash resources as long as possible. As such, there can be no assurance that the Company will be able to obtain additional liquidity when needed or under acceptable terms, if at all. The Company believes that it can be successful in obtaining additional capital; however, no assurance can be provided that it will be able to do so. There is no assurance, moreover, that any funds raised will be sufficient to enable the Company to attain profitable operations or continue as a going concern. The Company’s consolidated financial statements as of December 31, 2022, do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern. If the Company is unable to raise additional capital and is therefore unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on its consolidated financial statements, and it is likely that investors will lose all or part of their investment. Reverse Stock Split On April 26, 2022, the Company effected a reverse stock split of its common stock, par value $0.00001 per share, at a ratio of 1-for- 25 The 2022 Reverse Stock Split became effective at 5:00 pm New York time on April 26, 2022, with the common stock trading on a post-split basis under the Company's existing trading symbol, “NVIV,” at the market open on April 27, 2022. Fractional shares resulting from the 2022 Reverse Stock Split were rounded up to the nearest whole share, and all shares of common stock (including fractions thereof) issuable upon the 2022 Reverse Stock Split to a given stockholder were aggregated for the purpose of determining whether the 2022 Reverse Stock Split would result in the issuance of a fractional share. Pursuant to Section 78.209 of the Nevada Revised Statutes, the Company’s Board of Directors was able take action to effect the 2022 Reverse Stock Split by filing a Certificate of Change with the Secretary of State of the State of Nevada without the consent of the Company’s stockholders. All of the Company’s historical share and per share information related to issued and outstanding common stock and outstanding options and warrants exercisable for common stock in these consolidated financial statements have been adjusted, on a retroactive basis, to reflect the 2022 Reverse Stock Split. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
SIGNIFICANT ACCOUNTING POLICIES | |
SIGNIFICANT ACCOUNTING POLICIES | 2. SIGNIFICANT ACCOUNTING POLICIES A summary of the significant accounting policies followed by the Company in the preparation of the financial statements is as follows: Use of estimates The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements and the reported amounts expensed during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. Basis of presentation and principles of consolidation The consolidated financial statements include the accounts of InVivo Therapeutics Holdings Corp. and its wholly-owned subsidiary, InVivo Therapeutics Corporation. All significant intercompany balances and transactions have been eliminated in consolidation. The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. Certain reclassifications have been made to the prior year financial statements to conform to the presentation used in the current year. In the current year the Company reclassified other current assets from Prepaid expenses and other current assets and presented them under other current assets on the Consolidated Balance Sheets. These reclassifications did not have an impact on total assets or total liabilities of the Consolidated Balance Sheets or cash flows as previously reported. Cash and cash equivalents The Company considers only those investments that are highly liquid, readily convertible to cash, and that mature within 3 months from date of purchase to be cash equivalents. As of each of December 31, 2022 and 2021, the Company has cash balances in a financial institution in excess of insured limits. The Company has not experienced any losses related to these balances. Management believes it is not exposed to significant credit risk. At December 31, 2022 and 2021, cash equivalents were comprised primarily of money market funds. Cash and cash equivalents consist of the following: December 31, (In thousands) 2022 2021 Cash $ 55 $ 5 Money market funds 16,296 19,026 Total cash and cash equivalents $ 16,351 $ 19,031 Restricted cash Restricted cash as each of December 31, 2022 and 2021 was $150 thousand. Restricted cash as of December 31, 2022 and 2021 included a $50 thousand security deposit related to the Company’s credit card account and a $100 thousand standby letter of credit in favor of a landlord. Fair Value of Financial instruments The carrying amounts reported in the Company’s consolidated balance sheets for cash, cash equivalents and accounts payable approximate fair value based on the short-term nature of these instruments. Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820 Fair Value Measurements and Disclosures (“ASC 820”) defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy are described below: Level 1—Valuation is based on quoted prices in active markets for identical assets or liabilities. Level 1 assets and liabilities generally include debt and equity securities that are traded in an active exchange market. Valuations are obtained from readily available pricing sources for market transactions involving identical assets or liabilities. Level 2—Valuation is based on observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Valuation is based on unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation. Fair value estimates discussed herein are based upon certain market assumptions and pertinent information available to management as of December 31, 2022. The respective carrying value of certain on-balance-sheet financial instruments approximated their fair values due to the short-term nature of these instruments. These financial instruments include accounts payable and accrued expenses. Property and equipment Property and equipment of the Company is stated at cost. In accordance with ASC Topic 360 Property, Plant and Equipment, expenditure for fixed assets that substantially increase the useful lives of existing assets are capitalized at cost and depreciated. Routine expenditures for repairs and maintenance are expensed as incurred. Depreciation is provided principally on the straight-line method over the estimated useful lives of the asset. A summary of the estimated useful lives is as follows: Classification Estimated Useful Life Computer hardware 3 - 5 years Software 3 years Research and lab equipment 5 years Leasehold improvements Remaining life of lease Research and development expenses The Company expenses R&D costs as incurred. As part of the process of preparing the Company's financial statements, the Company to estimate certain research and development expenses. This process involves reviewing clinical agreements and open contracts and purchase orders, communicating with its CRO to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the services when the Company has not yet been invoiced or otherwise notified of the actual costs. The majority of the Company's service providers invoice the Company in arrears for services performed, on a predetermined schedule or when contractual milestones are met; however, a few require advanced payments. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known to it at that time. Examples of estimated accrued research and development expenses include fees paid to: ● clinical research organizations, or CROs, in connection with performing research services on its behalf and clinical trials; ● investigative sites or other providers in connection with clinical trials; and ● vendors in connection with clinical development activities The Company bases its expenses related to clinical trials on its estimates of the services received and efforts expended pursuant to quotes and contracts with CROs that conduct and manage clinical trials on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company's vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed, enrollment of patients, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjusts the accrual or amount of prepaid expense accordingly. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low in any particular period. To date, the Company has not made any material adjustments to its prior estimates of accrued research and development expenses. As of December 31, 2022, the Company had $1.2 million in prepayments for CRO services all of which are included in the other current assets balance on the balance sheet. As of December 31, 2021, the Company had $1.2 million in prepayments for CRO services of which $28 thousand is included in prepaid expense and other current assets balance on the balance sheet and the remaining $1.1 million is included within the other long term assets balance on the balance sheet. Concentrations of credit risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash in commercial banks, which may at times exceed Federally Insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant credit risk on cash and cash equivalents. Segment information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing biopolymer scaffolding devices for the treatment of spinal cord injuries. As of December 31, 2022 and 2021, all of the Company’s assets were located in one location in the United States. Income taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, the Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more likely than not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold would be recorded as a tax expense in 2022. There were no material uncertain tax positions that required accrual or disclosure to the financial statements as of December 31, 2022 or 2021. Tax years subsequent to 2019 remain open to examination by U.S. federal and state tax authorities. Impairment of long-lived assets The Company continually monitors events and changes in circumstances that could indicate that carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected cash flows are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and future undiscounted cash flows of the underlying assets. The Company’s policy is to record an impairment loss when it is determined that the carrying value of the asset may not be recoverable. Share-based payments The Company accounts for all stock-based payment awards granted to employees and nonemployees using the fair value method. The Company’s stock-based payments include stock options and grants of common stock, including common stock subject to vesting. The measurement date for both employee and nonemployee awards is the date of grant, and stock-based compensation costs are recognized as expense over the employees’ requisite service period, which is the vesting period, on a straight-line basis. Stock-based compensation costs for nonemployees are recognized as expense over the vesting period on a straight-line basis. Stock-based compensation is classified in the accompanying consolidated statements of operations and comprehensive loss based on the department to which the related services are provided. Derivative instruments The Company generally does not use derivative instruments to hedge exposures to cash-flow or market risks. In the past certain of the Company’s issued and outstanding warrants to purchase common stock previously contained anti-dilution provisions. These warrants did not meet the requirements for classification as equity and were thus recorded as derivative warrant liabilities. In such instances, net-cash settlement is assumed for financial reporting purposes, even when the terms of the underlying contracts do not provide for a net-cash settlement. Such financial instruments are initially recorded at fair value, with subsequent changes in fair value recorded to operations in each reporting period. If these instruments subsequently meet the requirements for classification as equity, the Company reclassifies the fair value to equity. Net loss per common share Basic and diluted net loss per share of common stock has been computed by dividing net loss by the weighted average number of shares outstanding during the period as follows: Year Ended December 31, 2022 2021 Numerator: Net loss (in thousands) $ (10,490) $ (9,895) Denominator: Weighted average shares used in calculating net loss per share — basic and diluted 1,536,474 1,323,659 Net loss per share — basic and diluted $ (6.83) $ (7.48) In a net loss period, options, warrants, unvested restricted stock units and convertible securities are anti-dilutive and are therefore excluded from diluted loss per share calculations. For the year ended December 31, 2022 and 2021, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive: December 31, 2022 2021 Warrants 3,064,877 563,162 Stock options 136,568 14,582 Unvested RSAs — 254 Total potentially dilutive securities 3,201,445 577,998 New Accounting Pronouncements In May 2021 FASB) issued Accounting Standards Update (“ASU”) No. 2021-04, “Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options, a consensus of the Emerging Issues Task Force”. This ASU amends the ASC to provide explicit guidance, and, thus, reduce diversity in practice, on accounting by issuers for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after the modification or exchange. This amendment provides that for an entity that presents earnings per share (“EPS’) in accordance with Topic 260, the effects of a modification or an exchange of a freestanding equity-classified written call option that is recognized as a dividend should be an adjustment to net income (or net loss) in the basic EPS calculation. The Company adopted ASU 2021-04 effective January 1, 2022, and it did not have a material impact on the Company's consolidated financial statements. No other accounting standards known by the Company to be applicable to it that have been issued by the FASB or other standard-setting bodies and that do not require adoption until a future date are expected to have a material impact on the Company’s consolidated financial statements upon adoption. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2022 | |
PROPERTY AND EQUIPMENT | |
PROPERTY AND EQUIPMENT | 3. PROPERTY AND EQUIPMENT Property and equipment, net consisted of the following: December 31, December 31, (In thousands) 2022 2021 Computer hardware $ 67 $ 52 Computer Software 7 5 Research and lab equipment 723 580 Leasehold improvements 66 66 Property and equipment 863 703 Less accumulated depreciation (636) (576) Property and equipment, net $ 227 $ 127 Depreciation expense for the years ended December 31, 2022 and 2021, was $60 thousand, and $35 thousand, respectively. Maintenance and repairs are charged to expense as incurred and any additions or improvements are capitalized. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2022 | |
ACCRUED EXPENSES. | |
ACCRUED EXPENSES | 4. ACCRUED EXPENSES Accrued expenses consisted of the following: December 31, (In thousands) 2022 2021 Compensation $ 852 $ 1,287 Clinical 433 218 Other accrued expenses 170 141 Total accrued expenses $ 1,455 $ 1,646 |
FAIR VALUES OF ASSETS AND LIABI
FAIR VALUES OF ASSETS AND LIABILITIES | 12 Months Ended |
Dec. 31, 2022 | |
FAIR VALUES OF ASSETS AND LIABILITIES | |
FAIR VALUES OF ASSETS AND LIABILITIES | 5. FAIR VALUES OF ASSETS AND LIABILITIES The Company groups its assets and liabilities generally measured at fair value in 3 levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. Refer to Note 2, "Significant Accounting Policies," for additional information on the accounting policies related to fair value. Assets and liabilities measured at fair value on a recurring basis are summarized below: As of December 31, 2022 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 16,296 $ — $ — $ 16,296 As of December 31, 2021 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 19,026 $ — $ — $ 19,026 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2022 | |
INCOME TAXES | |
INCOME TAXES | 6. INCOME TAXES No provision or benefit for federal or state income taxes has been recorded as the Company has incurred a net loss for all of the periods presented and the Company has provided a full valuation allowance against its deferred tax assets. At December 31, 2022, the Company had U.S. federal and Massachusetts net operating loss carryforwards of $164.4 million and $153.9 million, respectively, of which $117.3 million of federal carryforwards will expire in varying amounts beginning in 2026 and $47.0 million carry forward indefinitely. State net operating losses begin to expire in 2029. Utilization of net operating losses and tax credit carryforwards may be subject to substantial annual limitations due to the “change in ownership” provisions of the Internal Revenue Code, and similar state provisions. The annual limitations may result in the expiration of net operating losses before utilization. The Company has completed several financings since its inception, which may have resulted in a change in ownership, or could result in a change in ownership in the future but has not yet completed a Section 382 analysis of whether an ownership change limitation exists. The Company will complete an appropriate analysis before its tax attributes are utilized. The Company also had federal and state research and development tax credits of $1.6 million and $0.2 million respectively, at December 31, 2022, which will begin to expire in 2026 and 2031, respectively, unless previously utilized. Significant components of the Company’s net deferred tax assets are as follows: December 31, (In thousands) 2022 2021 Net operating loss carryforward $ 44,249 $ 42,696 Research and development credit carryforward 1,718 1,663 Stock-based compensation 359 431 Depreciation and amortization 4 17 Capitalized research expenses 1,226 — Lease liability 252 344 Right of use asset (224) (323) Other deferred tax liabilities (225) — Accruals and other temporary differences 189 — Subtotal 47,548 44,828 Valuation allowance (47,548) (44,828) Net deferred taxes $ — $ — The Company has maintained a full valuation allowance against its deferred tax assets in all periods presented. A valuation allowance is required to be recorded when it is more likely than not that some portion or all of the net deferred tax assets will not be realized. Since the Company cannot be assured of generating taxable income and thereby realizing the net deferred tax assets, a full valuation allowance has been provided. In the years ended December 31, 2022 and 2021, the valuation allowance increased by $2.7 million and $2.6 million, respectively. The Company has no uncertain tax positions at December 31, 2022 and 2021 that would affect its effective tax rate. The Company does not Income tax benefits computed using the federal statutory income tax rate differ from the same benefits computed using the Company’s effective tax rate primarily due to the following: December 31, 2022 2021 Statutory rate (21.0) % (21.0) % State taxes, net of benefit (5.1) % (4.7) % Permanent differences 0.1 % 0.4 % Research and development tax credit (0.7) % (0.9) % Stock-based compensation 0.9 % 0.2 % Increase in valuation reserve 25.9 % 26.0 % Other (0.1) — % Effective tax rate (0.0) % 0.0 % The Company is subject to U.S. Federal and Massachusetts state income taxes. The statute of limitations for assessment by the Internal Revenue Service or state tax authority is generally open for the tax years ending December 31, 2019 through December 31, 2022, however federal and state tax attributes that were generated prior to the tax year ending December 31, 2018 may still be adjusted upon examination by the Internal Revenue Service or stat tax authority if the attributes either have been, or will be, used in a future period . Beginning in 2022, the Tax Cuts and Jobs Act of 2017 (“Tax Act”) eliminates the option to deduct research and development expenditures currently and requires taxpayers to amortize them, over five years for domestically incurred expenditures and over fifteen years for foreign incurred expenditures, pursuant to Internal Revenue Code (“IRC”) Section 174. As of December 31, 2022, the Company has recorded a deferred tax asset of $1.2 million related to the Capitalized IRC Section 174 expenditures. |
STOCKHOLDERS EQUITY
STOCKHOLDERS EQUITY | 12 Months Ended |
Dec. 31, 2022 | |
STOCKHOLDERS EQUITY | |
STOCKHOLDERS EQUITY | 7. STOCKHOLDERS EQUITY Preferred Stock On September 9, 2022, the Company held its 2022 Annual Meeting of Stockholders (the “2022 Annual Meeting”). At the 2022 Annual Meeting, the Company’s stockholders approved an amendment to the Company’s Articles of Incorporation to approve the issuance of preferred stock. As of December 31, 2022, the Company had 1,000,000 authorized shares of undesignated preferred stock, $0.00001 par value per share, the rights, preferences and privileges of which may be designated from time to time by our board of directors. No shares of preferred stock have been issued or are outstanding Common Stock At the 2022 Annual Meeting, the Company’s stockholders approved an amendment to the Company’s Articles of Incorporation to increase the number of shares of authorized common stock from 2,000,000 to 250,000,000. As of December 31, 2022 and 2021, 2,429,446 and 1,370,595 shares were issued outstanding On October 9, 2022, the Company closed a registered offering of shares of its common stock and pre-funded warrants to purchase common stock (the “October 2022 Registered Direct Offering”) and a concurrent private placement of pre-funded warrants and preferred investment options (the “October 2022 Private Placement”), with an institutional investor (together, the “October 2022 Financing”). In the October 2022 Registered Direct Offering, the Company issued (i) an aggregate of 154,000 common shares (“Shares”); and (ii) 369,810 pre-funded warrants (the “October 2022 Pre-Funded Warrants”). In the concurrent October 2022 Private Placement, the Company issued additional October 2022 Pre-Funded Warrants to purchase an aggregate of 1,190,476 shares of its common stock, and (ii) Preferred Investment Options to purchase an aggregate of 1,714,286 shares of its common stock (the “October 2022 Preferred Investment Options”). The purchase price of each Share and associated October 2022 Preferred Investment Option sold in the October 2022 Registered Direct Offering was $5.25 and the purchase price of each October 2022 Pre-Funded Warrant and associated October 2022 Preferred Investment Option sold in each of the October 2022 Registered Direct Offering and October 2022 Private Placement was $5.2499. In connection with the October 2022 Financing, the Company issued to designees of H.C. Wainwright & Co., LLC (“Wainwright”), the placement agent for the October 2022 Financing, Preferred Investment Options to purchase an aggregate of 111,429 shares of its common stock (the “October 2022 Placement Agent Warrants”). The net proceeds to the Company after deducting Wainwright's placement agent fees and other offering expenses payable by the Company, were approximately $8.0 million. The Company assessed whether the October 2022 Pre-Funded Warrants, October 2022 Placement Agent Warrants and the October 2022 Preferred Investment Options required accounting as derivatives and determined that they were (1) indexed to the Company’s own stock and (2) classified in stockholders’ equity in accordance with ASC Topic 815, Derivatives and Hedging. As such, the Company concluded that the October 2022 Pre-Funded Warrants, October 2022 Placement Agent Warrants and the October 2022 Preferred Investment Options meet the scope exception for determining whether the instruments require accounting as derivatives and accordingly are classified in stockholders’ equity. The fair value of the October 2022 Placement Agent Warrants was estimated at $0.3 million using a Black-Scholes model with the following assumptions: expected volatility of 129.96%, risk free interest rate of 4.14%, expected life of five years and no dividends. The fair value of the October 2022 Preferred Investment Options was estimated at $4.9 million using a Black-Scholes model with the following assumptions: expected volatility of 128.87%, risk free interest rate of 4.12%, expected life of five the Company issued an aggregate of Concurrent with the October 2022 Financing, the Company modified certain outstanding warrants, consisting of 29,091 Series A Warrants issued in March 2020, 19,048 Series C Warrants issued in April 2020 and 32,000 Series A Warrants issued in October 2020 (collectively the “Existing Warrants”) held by the institutional investor that participated in the October 2022 Financing to lower the exercise price of these warrants to $5.05 and extend the term through April 2028. The change in the term and exercise price of the Existing Warrants was accounted for as modification of an equity instrument. The Company remeasured the Existing Warrants Fair Value both immediately before and after the modification and the remeasurement resulted in an incremental fair value of $0.1 million. As the modification was executed in an effort to induce the investor to participate in the October 2022 Registered Direct Offering and concurrent October 2022 Private Placement, the incremental fair value was accounted for as an issuance cost. During the year ended December 31, 2022, as part of the adjustment to reflect the 2022 Reverse Stock Split, the Company issued an aggregate of 20,619 shares of common stock to account for the fractional roundup of shareholders. During the year ended December 31, 2022, 54 restricted stock shares that were considered issued and outstanding as of December 31, 2021 were forfeited. During the year ended December 31, 2022, there was no exercise activity related to any warrants that were issued in 2018, 2019 and 2020. During the year ended December 31, 2021, the Company issued an aggregate of 424,829 and 488 shares of common stock upon the exercise of certain Series A Warrants and placement agent warrants issued in October 2020, respectively, for aggregate proceeds of $8.5 million. During the year ended December 31, 2021, the Company issued an aggregate of 2 shares of common stock upon vesting of restricted stock units. Common Stock Reserves As of December 31, 2022, the Company had the following reserves established for the future issuance of common stock as follows: As of December 31, 2022 Reserves for the exercise of warrants 3,064,877 Reserves for the exercise of stock options 136,568 Total reserves 3,201,445 |
SHARE-BASED COMPENSATION, STOCK
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | 12 Months Ended |
Dec. 31, 2022 | |
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | |
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | 8. SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES On October 26, 2010, the Company’s Board of Directors adopted, and the Company’s shareholders subsequently approved, the 2010 Equity Incentive Plan (as subsequently amended, the “2010 Plan”). The 2010 Plan provided for grants of incentive stock options to employees, and nonqualified stock options and restricted common stock to employees, consultants, and non-employee directors of the Company. In April 2015, the Company’s Board of Directors adopted, and the Company’ shareholders subsequently approved, the 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for grants of incentive stock options to employees, and nonqualified stock, restricted common stock, restricted stock units and stock appreciation rights to employees, consultants, and directors of the Company. As of December 31, 2022, the total number of shares available to be issued under the 2015 Plan was 788,697. Options issued under the 2010 Plan Share-based compensation For the years ended December 31, 2022 and 2021, Stock-based compensation recognized was classified in the consolidated statements of operations as follows: Year Ended December 31, (In thousands) 2022 2021 Research and development $ (8) $ 22 General and administrative 167 293 Total $ 159 $ 315 The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model, which uses the assumptions noted in the following table. The Company uses historical data, as well as subsequent events occurring prior to the issuance of the financial statements, to estimate option exercises within the valuation model. The expected term of options granted under the Plans, all of which qualify as “plain vanilla,” is based on the average of the contractual term (10 years) and the vesting period (generally, 48 months The assumptions used principally in determining the fair value of options granted during the years ended December 31, 2022 and 2021, were as follows: December 31, December 31, 2022 2021 Risk-free interest rate 3.87% 1.03% Expected dividend yield 0% 0% Expected term (employee grants) 5.71 5.70 Expected volatility 126.66% 117.34% The Company grants restricted stock units (“RSUs”), and restricted stock awards (“RSAs”), collectively referred to as restricted securities under the 2015 Equity Incentive Plan. These restricted securities generally vest over a three-year period, contingent on the recipient’s continued employment. Prior to vesting, all RSAs have the right to vote and receive dividends under the 2015 Equity Incentive Plan; however, the Company’s form of Restricted Stock Agreement provides that the payment of dividends on unvested RSAs shall be deferred until such time as the shares vest. The grant date fair value of these awards is based on the fair market value of our common stock on the date of grant. Stock Options A summary of option activity as of December 31, 2022 and changes for the year then ended are presented below: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Shares Price Term in Years Value Outstanding as of December 31, 2021 14,582 $ 437.78 9.18 $ — Granted 126,600 $ 2.50 Cancelled/Forfeited (4,613) $ 345.06 Expired (1) $ 129,750.00 Outstanding as of December 31, 2022 136,568 $ 36.46 9.72 $ — Vested and Exercisable as of December 31, 2022 8,268 $ 547.95 8.15 $ — Vested and expected to vest as of December 31, 2022 136,568 $ 36.46 9.72 $ — During the years ended December 31, 2022 and 2021, the Company granted 126,000 and 14,400 stock options respectively. The weighted average grant-date fair value of options granted during the years ended December 31, 2022 and 2021 was $2.21 per share and $23.19 per share, respectively. The total fair value of options that vested in years ended December 31, 2022 and 2021, was $239 thousand and $67 thousand, respectively. For the years ended December 31, 2022 and 2021, the Company recorded stock-based compensation expense of $157 thousand and $219 thousand, respectively, related to stock options. As of December 31, 2022, there was $277 thousand of total unrecognized compensation expense related to non-vested share-based option compensation arrangements. The unrecognized compensation expense is estimated to be recognized over a remaining weighted-average period of 1.42 years at December 31, 2022. Restricted Securities A summary of restricted securities activity as of December 31, 2022 and changes for the year then ended are presented below: Weighted-Average Restricted Securities Number of Grants Grant Date Fair Value Unvested balance as of December 31, 2021 254 $ 387.05 Vested (200) $ 387.50 Cancelled/Forfeited (54) $ 385.38 Unvested balance as of December 31, 2022 — $ — For years ended December 31, 2022 and 2021, the Company recorded stock-based compensation expense of $3 thousand and $96 thousand, respectively, related to the time-based restricted securities. |
WARRANTS
WARRANTS | 12 Months Ended |
Dec. 31, 2022 | |
WARRANTS | |
WARRANTS | 9. WARRANTS The following table presents information about warrants to purchase common stock issued and outstanding at December 31, 2022: Number of Exercise Price as of Year Issued Defined Name Classification Warrants December 31, 2022 Date of Expiration 2018 2018 Series A Warrants Equity 8,483 $ 174.53 6/25/2023 2019 2019 Placement Agent Warrants Equity 610 $ 112.50 11/21/2024 2020 March 2020 Series A Warrants Equity 72,738 $ 68.75 3/10/2025 2020 Amended March 2020 Series A Warrants Equity 29,091 5.05 4/11/2028 2020 March 2020 Placement Agent Warrants Equity 6,620 $ 85.9400 3/5/2025 2020 March 2020 Series B Warrants Equity 510 $ 0.00025 Until Fully Exercised 2020 April 2020 Series C Warrants Equity 48,163 $ 40.50 10/17/2025 2020 Amended April 2020 Series C Warrants Equity 19,048 5.05 4/11/2028 2020 April 2020 Placement Agent Warrants Equity 4,461 $ 54.6900 4/15/2025 2020 October 2020 Placement Agent Warrants Equity 48,264 $ 25.00 10/22/2025 2020 October 2020 Series A Warrants Equity 293,174 $ 20.00 10/27/2025 2020 Amended October 2020 Series A Warrants Equity 32,000 5.05 4/11/2028 2022 October 2022 Pre-funded Warrants Equity 676,000 0.00001 Until Fully Exercised 2022 October 2022 Preferred Investment Options Equity 1,714,286 5.05 4/11/2028 2022 October 2022 Placement Agent Warrants Equity 111,429 6.56 10/7/2027 Total 3,064,877 Weighted average exercise price $ 8.54 Weighted average life in years 3.69 |
EMPLOYEE BENEFIT PLAN
EMPLOYEE BENEFIT PLAN | 12 Months Ended |
Dec. 31, 2022 | |
EMPLOYEE BENEFIT PLAN | |
EMPLOYEE BENEFIT PLAN | 10. EMPLOYEE BENEFIT PLAN In November 2006, the Company adopted a 401(k) plan (the “Plan”) covering all employees. Employees must be 21 years of age in order to participate in the Plan. Under the Plan, the Company has the option to make matching contributions. During the years ended December 31, 2022 and 2021, the Company contributed $71 thousand and $69 thousand, respectively, in cash matching contributions to employee 401(k) accounts. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 11. COMMITMENTS AND CONTINGENCIES Operating Leases On May 3, 2018, the Company entered into a sublease for 5,104 square feet of space for its corporate offices and laboratory space in Cambridge Massachusetts (the “Cambridge Sublease”). The Cambridge Lease commenced on May 3, 2018 and was scheduled to expire on October 31, 2023. In May 2021, the Company entered into an agreement to terminate the Cambridge Sublease (the “Sublease Termination”). In connection with the Sublease Termination, the $60 thousand standby letter of credit was cancelled and returned to the Company. Concurrent with the Sublease Termination, the Company entered into a new lease for the same space with ARE-MA (the “Cambridge Lease”). The Cambridge Lease commenced on June 1, 2021 and was originally scheduled to expire on December 31, 2023. The Cambridge Lease contained rent escalation clauses. In connection with the Cambridge Lease, a new standby letter of credit was established for $100 thousand. Under the Cambridge Lease, the Company will be required to pay its proportionate share of certain operating costs and property taxes applicable to the leased premises in excess of new base year amounts. These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability. The Sublease Termination and concurrent execution of the Cambridge Lease was determined to be a lease modification that qualified as a change of accounting on the existing lease and not a separate contract. As such, the right-of-use assets and operating lease liabilities were remeasured using an incremental borrowing rate at the date of modification of 5.74%, which resulted in an increase of $143 thousand in both the right-of-use asset and operating lease liabilities. On November 23, 2021, the Company amended the Cambridge Lease to extend the term through December 31, 2024. No other terms within the Cambridge Lease were amended. The amendment of the Cambridge Lease was determined to be a lease modification that qualified as a change of accounting on the existing lease and not a separate contract. As such, the right-of-use assets and operating lease liabilities were remeasured using an incremental borrowing rate at the date of modification of 5.97%, which resulted in an increase of $486 thousand in both the right-of-use asset and operating lease liabilities. The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities: ● As the Cambridge Lease does not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. ● Since the Company elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the combined lease component. ● The expected lease terms include noncancelable lease periods. The elements of lease expense are as follows: Year Ended December 31, Lease cost (In thousands) 2022 2021 Operating lease cost $ 452 $ 392 Short-term lease cost 8 3 Variable lease cost 182 95 Total lease cost $ 642 $ 490 Other information (In thousands) Increase in operating right-of-use assets and liabilities related to lease modifications $ — $ 629 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from short term leases $ 8 $ 3 Operating cash flows from operating leases 427 403 Total cash paid for leases $ 435 $ 406 Weighted-average remaining lease term - operating leases 2 Years 3 Years Weighted-average discount rate - operating leases 6.0% 6.0% Maturities of lease liabilities due under the Cambridge Lease as of December 31, 2022 is as follows: Leases (In thousands) As of December 31, 2022 2023 $ 440 2024 568 Total lease payments 1,008 Less: imputed interest (59) Present value of lease liabilities $ 949 Leases (In thousands) Classification December 31, 2022 December 31, 2021 Assets Lease asset, net Operating $ 844 $ 1,229 Total lease assets $ 844 $ 1,229 Liabilities Current Operating $ 396 $ 361 Non-current Operating 553 949 Total lease liabilities $ 949 $ 1,310 Clinical Trial Commitments The Company has engaged and executed contracts with CROs to assist with the administration of its ongoing INSPIRE 1.0 and INSPIRE 2.0 clinical trials. As of December 31, 2022, approximately $3.9 million remains to be paid on these contracts. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2022 | |
RELATED PARTY TRANSACTIONS. | |
RELATED PARTY TRANSACTIONS | 12. RELATED PARTY TRANSACTIONS During the years ended December 31, 2022 and 2021, the Company did not identify any related party transactions requiring disclosure. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
SIGNIFICANT ACCOUNTING POLICIES | |
Use of estimates | Use of estimates The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements and the reported amounts expensed during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. |
Basis of presentation and principles of consolidation | Basis of presentation and principles of consolidation The consolidated financial statements include the accounts of InVivo Therapeutics Holdings Corp. and its wholly-owned subsidiary, InVivo Therapeutics Corporation. All significant intercompany balances and transactions have been eliminated in consolidation. The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. Certain reclassifications have been made to the prior year financial statements to conform to the presentation used in the current year. In the current year the Company reclassified other current assets from Prepaid expenses and other current assets and presented them under other current assets on the Consolidated Balance Sheets. These reclassifications did not have an impact on total assets or total liabilities of the Consolidated Balance Sheets or cash flows as previously reported. |
Cash and cash equivalents | Cash and cash equivalents The Company considers only those investments that are highly liquid, readily convertible to cash, and that mature within 3 months from date of purchase to be cash equivalents. As of each of December 31, 2022 and 2021, the Company has cash balances in a financial institution in excess of insured limits. The Company has not experienced any losses related to these balances. Management believes it is not exposed to significant credit risk. At December 31, 2022 and 2021, cash equivalents were comprised primarily of money market funds. Cash and cash equivalents consist of the following: December 31, (In thousands) 2022 2021 Cash $ 55 $ 5 Money market funds 16,296 19,026 Total cash and cash equivalents $ 16,351 $ 19,031 |
Restricted cash | Restricted cash Restricted cash as each of December 31, 2022 and 2021 was $150 thousand. Restricted cash as of December 31, 2022 and 2021 included a $50 thousand security deposit related to the Company’s credit card account and a $100 thousand standby letter of credit in favor of a landlord. |
Fair Value of Financial instruments | Fair Value of Financial instruments The carrying amounts reported in the Company’s consolidated balance sheets for cash, cash equivalents and accounts payable approximate fair value based on the short-term nature of these instruments. Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820 Fair Value Measurements and Disclosures (“ASC 820”) defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy are described below: Level 1—Valuation is based on quoted prices in active markets for identical assets or liabilities. Level 1 assets and liabilities generally include debt and equity securities that are traded in an active exchange market. Valuations are obtained from readily available pricing sources for market transactions involving identical assets or liabilities. Level 2—Valuation is based on observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Valuation is based on unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation. Fair value estimates discussed herein are based upon certain market assumptions and pertinent information available to management as of December 31, 2022. The respective carrying value of certain on-balance-sheet financial instruments approximated their fair values due to the short-term nature of these instruments. These financial instruments include accounts payable and accrued expenses. |
Property and equipment | Property and equipment Property and equipment of the Company is stated at cost. In accordance with ASC Topic 360 Property, Plant and Equipment, expenditure for fixed assets that substantially increase the useful lives of existing assets are capitalized at cost and depreciated. Routine expenditures for repairs and maintenance are expensed as incurred. Depreciation is provided principally on the straight-line method over the estimated useful lives of the asset. A summary of the estimated useful lives is as follows: Classification Estimated Useful Life Computer hardware 3 - 5 years Software 3 years Research and lab equipment 5 years Leasehold improvements Remaining life of lease |
Research and development expenses | Research and development expenses The Company expenses R&D costs as incurred. As part of the process of preparing the Company's financial statements, the Company to estimate certain research and development expenses. This process involves reviewing clinical agreements and open contracts and purchase orders, communicating with its CRO to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the services when the Company has not yet been invoiced or otherwise notified of the actual costs. The majority of the Company's service providers invoice the Company in arrears for services performed, on a predetermined schedule or when contractual milestones are met; however, a few require advanced payments. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known to it at that time. Examples of estimated accrued research and development expenses include fees paid to: ● clinical research organizations, or CROs, in connection with performing research services on its behalf and clinical trials; ● investigative sites or other providers in connection with clinical trials; and ● vendors in connection with clinical development activities The Company bases its expenses related to clinical trials on its estimates of the services received and efforts expended pursuant to quotes and contracts with CROs that conduct and manage clinical trials on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company's vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed, enrollment of patients, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjusts the accrual or amount of prepaid expense accordingly. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low in any particular period. To date, the Company has not made any material adjustments to its prior estimates of accrued research and development expenses. As of December 31, 2022, the Company had $1.2 million in prepayments for CRO services all of which are included in the other current assets balance on the balance sheet. As of December 31, 2021, the Company had $1.2 million in prepayments for CRO services of which $28 thousand is included in prepaid expense and other current assets balance on the balance sheet and the remaining $1.1 million is included within the other long term assets balance on the balance sheet. |
Concentrations of credit risk | Concentrations of credit risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash in commercial banks, which may at times exceed Federally Insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant credit risk on cash and cash equivalents. |
Segment information | Segment information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing biopolymer scaffolding devices for the treatment of spinal cord injuries. As of December 31, 2022 and 2021, all of the Company’s assets were located in one location in the United States. |
Income taxes | Income taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, the Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more likely than not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold would be recorded as a tax expense in 2022. There were no material uncertain tax positions that required accrual or disclosure to the financial statements as of December 31, 2022 or 2021. Tax years subsequent to 2019 remain open to examination by U.S. federal and state tax authorities. |
Impairment of long-lived assets | Impairment of long-lived assets The Company continually monitors events and changes in circumstances that could indicate that carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected cash flows are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and future undiscounted cash flows of the underlying assets. The Company’s policy is to record an impairment loss when it is determined that the carrying value of the asset may not be recoverable. |
Share-based payments | Share-based payments The Company accounts for all stock-based payment awards granted to employees and nonemployees using the fair value method. The Company’s stock-based payments include stock options and grants of common stock, including common stock subject to vesting. The measurement date for both employee and nonemployee awards is the date of grant, and stock-based compensation costs are recognized as expense over the employees’ requisite service period, which is the vesting period, on a straight-line basis. Stock-based compensation costs for nonemployees are recognized as expense over the vesting period on a straight-line basis. Stock-based compensation is classified in the accompanying consolidated statements of operations and comprehensive loss based on the department to which the related services are provided. |
Derivative instruments | Derivative instruments The Company generally does not use derivative instruments to hedge exposures to cash-flow or market risks. In the past certain of the Company’s issued and outstanding warrants to purchase common stock previously contained anti-dilution provisions. These warrants did not meet the requirements for classification as equity and were thus recorded as derivative warrant liabilities. In such instances, net-cash settlement is assumed for financial reporting purposes, even when the terms of the underlying contracts do not provide for a net-cash settlement. Such financial instruments are initially recorded at fair value, with subsequent changes in fair value recorded to operations in each reporting period. If these instruments subsequently meet the requirements for classification as equity, the Company reclassifies the fair value to equity. |
Net loss per common share | Net loss per common share Basic and diluted net loss per share of common stock has been computed by dividing net loss by the weighted average number of shares outstanding during the period as follows: Year Ended December 31, 2022 2021 Numerator: Net loss (in thousands) $ (10,490) $ (9,895) Denominator: Weighted average shares used in calculating net loss per share — basic and diluted 1,536,474 1,323,659 Net loss per share — basic and diluted $ (6.83) $ (7.48) In a net loss period, options, warrants, unvested restricted stock units and convertible securities are anti-dilutive and are therefore excluded from diluted loss per share calculations. For the year ended December 31, 2022 and 2021, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive: December 31, 2022 2021 Warrants 3,064,877 563,162 Stock options 136,568 14,582 Unvested RSAs — 254 Total potentially dilutive securities 3,201,445 577,998 |
New Accounting Pronouncements | New Accounting Pronouncements In May 2021 FASB) issued Accounting Standards Update (“ASU”) No. 2021-04, “Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options, a consensus of the Emerging Issues Task Force”. This ASU amends the ASC to provide explicit guidance, and, thus, reduce diversity in practice, on accounting by issuers for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after the modification or exchange. This amendment provides that for an entity that presents earnings per share (“EPS’) in accordance with Topic 260, the effects of a modification or an exchange of a freestanding equity-classified written call option that is recognized as a dividend should be an adjustment to net income (or net loss) in the basic EPS calculation. The Company adopted ASU 2021-04 effective January 1, 2022, and it did not have a material impact on the Company's consolidated financial statements. No other accounting standards known by the Company to be applicable to it that have been issued by the FASB or other standard-setting bodies and that do not require adoption until a future date are expected to have a material impact on the Company’s consolidated financial statements upon adoption. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of cash and cash equivalents | December 31, (In thousands) 2022 2021 Cash $ 55 $ 5 Money market funds 16,296 19,026 Total cash and cash equivalents $ 16,351 $ 19,031 |
Summary of estimated useful lives | Classification Estimated Useful Life Computer hardware 3 - 5 years Software 3 years Research and lab equipment 5 years Leasehold improvements Remaining life of lease |
Schedule of earnings per share, basic and diluted | Basic and diluted net loss per share of common stock has been computed by dividing net loss by the weighted average number of shares outstanding during the period as follows: Year Ended December 31, 2022 2021 Numerator: Net loss (in thousands) $ (10,490) $ (9,895) Denominator: Weighted average shares used in calculating net loss per share — basic and diluted 1,536,474 1,323,659 Net loss per share — basic and diluted $ (6.83) $ (7.48) |
Schedule of potentially dilutive securities not included in the computation of net loss per share because effect would be anti-dilutive | December 31, 2022 2021 Warrants 3,064,877 563,162 Stock options 136,568 14,582 Unvested RSAs — 254 Total potentially dilutive securities 3,201,445 577,998 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
PROPERTY AND EQUIPMENT | |
Schedule of property and equipment, net | December 31, December 31, (In thousands) 2022 2021 Computer hardware $ 67 $ 52 Computer Software 7 5 Research and lab equipment 723 580 Leasehold improvements 66 66 Property and equipment 863 703 Less accumulated depreciation (636) (576) Property and equipment, net $ 227 $ 127 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
ACCRUED EXPENSES. | |
Summary of accrued expenses | December 31, (In thousands) 2022 2021 Compensation $ 852 $ 1,287 Clinical 433 218 Other accrued expenses 170 141 Total accrued expenses $ 1,455 $ 1,646 |
FAIR VALUES OF ASSETS AND LIA_2
FAIR VALUES OF ASSETS AND LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
FAIR VALUES OF ASSETS AND LIABILITIES | |
Summary of assets and liabilities measured at fair value on a recurring basis | As of December 31, 2022 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 16,296 $ — $ — $ 16,296 As of December 31, 2021 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 19,026 $ — $ — $ 19,026 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
INCOME TAXES | |
Schedule of significant components of net deferred tax assets | December 31, (In thousands) 2022 2021 Net operating loss carryforward $ 44,249 $ 42,696 Research and development credit carryforward 1,718 1,663 Stock-based compensation 359 431 Depreciation and amortization 4 17 Capitalized research expenses 1,226 — Lease liability 252 344 Right of use asset (224) (323) Other deferred tax liabilities (225) — Accruals and other temporary differences 189 — Subtotal 47,548 44,828 Valuation allowance (47,548) (44,828) Net deferred taxes $ — $ — |
Schedule of income tax benefits computed using the federal statutory income tax rate | December 31, 2022 2021 Statutory rate (21.0) % (21.0) % State taxes, net of benefit (5.1) % (4.7) % Permanent differences 0.1 % 0.4 % Research and development tax credit (0.7) % (0.9) % Stock-based compensation 0.9 % 0.2 % Increase in valuation reserve 25.9 % 26.0 % Other (0.1) — % Effective tax rate (0.0) % 0.0 % |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
STOCKHOLDERS EQUITY | |
Schedule of reserves established for future issuance of common stock | As of December 31, 2022 Reserves for the exercise of warrants 3,064,877 Reserves for the exercise of stock options 136,568 Total reserves 3,201,445 |
SHARE-BASED COMPENSATION, STO_2
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | |
Summary of stock based compensation classified in the consolidated statements of operations | For the years ended December 31, 2022 and 2021, Stock-based compensation recognized was classified in the consolidated statements of operations as follows: Year Ended December 31, (In thousands) 2022 2021 Research and development $ (8) $ 22 General and administrative 167 293 Total $ 159 $ 315 |
Schedule of assumptions used principally in determining the fair value of options granted | December 31, December 31, 2022 2021 Risk-free interest rate 3.87% 1.03% Expected dividend yield 0% 0% Expected term (employee grants) 5.71 5.70 Expected volatility 126.66% 117.34% |
Summary of option activity | Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Shares Price Term in Years Value Outstanding as of December 31, 2021 14,582 $ 437.78 9.18 $ — Granted 126,600 $ 2.50 Cancelled/Forfeited (4,613) $ 345.06 Expired (1) $ 129,750.00 Outstanding as of December 31, 2022 136,568 $ 36.46 9.72 $ — Vested and Exercisable as of December 31, 2022 8,268 $ 547.95 8.15 $ — Vested and expected to vest as of December 31, 2022 136,568 $ 36.46 9.72 $ — |
Summary of restricted stock unit activity | Weighted-Average Restricted Securities Number of Grants Grant Date Fair Value Unvested balance as of December 31, 2021 254 $ 387.05 Vested (200) $ 387.50 Cancelled/Forfeited (54) $ 385.38 Unvested balance as of December 31, 2022 — $ — |
WARRANTS (Tables)
WARRANTS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
WARRANTS | |
Schedule of information about warrants to purchase common stock issued and outstanding | Number of Exercise Price as of Year Issued Defined Name Classification Warrants December 31, 2022 Date of Expiration 2018 2018 Series A Warrants Equity 8,483 $ 174.53 6/25/2023 2019 2019 Placement Agent Warrants Equity 610 $ 112.50 11/21/2024 2020 March 2020 Series A Warrants Equity 72,738 $ 68.75 3/10/2025 2020 Amended March 2020 Series A Warrants Equity 29,091 5.05 4/11/2028 2020 March 2020 Placement Agent Warrants Equity 6,620 $ 85.9400 3/5/2025 2020 March 2020 Series B Warrants Equity 510 $ 0.00025 Until Fully Exercised 2020 April 2020 Series C Warrants Equity 48,163 $ 40.50 10/17/2025 2020 Amended April 2020 Series C Warrants Equity 19,048 5.05 4/11/2028 2020 April 2020 Placement Agent Warrants Equity 4,461 $ 54.6900 4/15/2025 2020 October 2020 Placement Agent Warrants Equity 48,264 $ 25.00 10/22/2025 2020 October 2020 Series A Warrants Equity 293,174 $ 20.00 10/27/2025 2020 Amended October 2020 Series A Warrants Equity 32,000 5.05 4/11/2028 2022 October 2022 Pre-funded Warrants Equity 676,000 0.00001 Until Fully Exercised 2022 October 2022 Preferred Investment Options Equity 1,714,286 5.05 4/11/2028 2022 October 2022 Placement Agent Warrants Equity 111,429 6.56 10/7/2027 Total 3,064,877 Weighted average exercise price $ 8.54 Weighted average life in years 3.69 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES | |
Schedule of other information | Year Ended December 31, Lease cost (In thousands) 2022 2021 Operating lease cost $ 452 $ 392 Short-term lease cost 8 3 Variable lease cost 182 95 Total lease cost $ 642 $ 490 Other information (In thousands) Increase in operating right-of-use assets and liabilities related to lease modifications $ — $ 629 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from short term leases $ 8 $ 3 Operating cash flows from operating leases 427 403 Total cash paid for leases $ 435 $ 406 Weighted-average remaining lease term - operating leases 2 Years 3 Years Weighted-average discount rate - operating leases 6.0% 6.0% |
Schedule of maturities of lease liabilities | Leases (In thousands) As of December 31, 2022 2023 $ 440 2024 568 Total lease payments 1,008 Less: imputed interest (59) Present value of lease liabilities $ 949 |
Schedule of balance sheet information | Leases (In thousands) As of December 31, 2022 2023 $ 440 2024 568 Total lease payments 1,008 Less: imputed interest (59) Present value of lease liabilities $ 949 Leases (In thousands) Classification December 31, 2022 December 31, 2021 Assets Lease asset, net Operating $ 844 $ 1,229 Total lease assets $ 844 $ 1,229 Liabilities Current Operating $ 396 $ 361 Non-current Operating 553 949 Total lease liabilities $ 949 $ 1,310 |
NATURE OF OPERATIONS AND GOIN_2
NATURE OF OPERATIONS AND GOING CONCERN - Reverse Stock Split (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Apr. 26, 2022 $ / shares | Dec. 31, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) $ / shares | |
NATURE OF OPERATIONS AND GOING CONCERN | |||
Cash and cash equivalents | $ 16,351 | $ 19,031 | |
Net loss | $ (10,490) | $ (9,895) | |
Common stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 | $ 0.00001 |
Reverse stock split ratio | 0.04 | 0.04 | |
Going concern | false | ||
Reverse stock split | On April 26, 2022, the Company effected a reverse stock split of its common stock, par value $0.00001 per share, at a ratio of 1-for-25 (the “2022 Reverse Stock Split”). As a result of the 2022 Reverse Stock Split, (i) every 25 shares of the issued and outstanding common stock were automatically converted into one newly issued and outstanding share of common stock, without any change in the par value per share; (ii) the number of shares of common stock into which each outstanding warrant or option to purchase common stock is exercisable was proportionally decreased, and (iii) the number of authorized shares of common stock outstanding was proportionally decreased. Shares of common stock underlying outstanding stock options and other equity instruments convertible into common stock were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities. |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES - Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
SIGNIFICANT ACCOUNTING POLICIES | ||
Cash | $ 55 | $ 5 |
Money market funds | 16,296 | 19,026 |
Total cash and cash equivalents | $ 16,351 | $ 19,031 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES - Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Restricted cash | $ 150 | $ 150 |
Security deposit related to credit card account | ||
Restricted cash | 50 | 50 |
Standby letter of credit in favor of a landlord | ||
Restricted cash | $ 100 | $ 100 |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Computer hardware | Minimum | |
Property and equipment | |
Estimated Useful Life | 3 years |
Computer hardware | Maximum | |
Property and equipment | |
Estimated Useful Life | 5 years |
Software | |
Property and equipment | |
Estimated Useful Life | 3 years |
Research and lab equipment | |
Property and equipment | |
Estimated Useful Life | 5 years |
SIGNIFICANT ACCOUNTING POLICI_7
SIGNIFICANT ACCOUNTING POLICIES - Research and Development Expenses and Segment (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 USD ($) segment location | Dec. 31, 2021 USD ($) location | |
Prepayments for CRO services | $ 1,200 | $ 1,200 |
Number of operating segments | segment | 1 | |
Number of locations in the United States | location | 1 | 1 |
Prepaid and other current assets | ||
Prepayments for CRO services | $ 28 | |
Other long term assets | ||
Prepayments for CRO services | $ 1,100 |
SIGNIFICANT ACCOUNTING POLICI_8
SIGNIFICANT ACCOUNTING POLICIES - Net loss per common share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
SIGNIFICANT ACCOUNTING POLICIES | ||
Net Loss (Basic) | $ (10,490) | $ (9,895) |
Net Loss (Diluted) | $ (10,490) | $ (9,895) |
Weighted average shares used in calculating net loss per share, Basic | 1,536,474 | 1,323,659 |
Weighted average shares used in calculating net loss per share, Diluted | 1,536,474 | 1,323,659 |
Net loss per share - Basic | $ (6.83) | $ (7.48) |
Net loss per share, Diluted | $ (6.83) | $ (7.48) |
SIGNIFICANT ACCOUNTING POLICI_9
SIGNIFICANT ACCOUNTING POLICIES - Potentially Dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 3,201,445 | 577,998 |
Warrant One | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 3,064,877 | 563,162 |
Stock Options | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 136,568 | 14,582 |
Unvested RSAs | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 254 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property and equipment | ||
Property and equipment | $ 863 | $ 703 |
Less accumulated depreciation and amortization | (636) | (576) |
Property and equipment, net | 227 | 127 |
Computer hardware | ||
Property and equipment | ||
Property and equipment | 67 | 52 |
Computer software | ||
Property and equipment | ||
Property and equipment | 7 | 5 |
Research and lab equipment | ||
Property and equipment | ||
Property and equipment | 723 | 580 |
Leasehold improvements | ||
Property and equipment | ||
Property and equipment | $ 66 | $ 66 |
PROPERTY AND EQUIPMENT - Deprec
PROPERTY AND EQUIPMENT - Depreciation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Depreciation | ||
Depreciation | $ 60 | $ 35 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
ACCRUED EXPENSES. | ||
Compensation | $ 852 | $ 1,287 |
Clinical | 433 | 218 |
Other accrued expenses | 170 | 141 |
Total accrued expenses | $ 1,455 | $ 1,646 |
FAIR VALUES OF ASSETS AND LIA_3
FAIR VALUES OF ASSETS AND LIABILITIES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Assets and liabilities measured at fair value on a recurring basis | ||
Fair value assets, transfers between levels, amount | $ 0 | $ 0 |
Recurring basis | ||
Assets and liabilities measured at fair value on a recurring basis | ||
Cash equivalents | 16,296 | 19,026 |
Recurring basis | Level 1 | ||
Assets and liabilities measured at fair value on a recurring basis | ||
Cash equivalents | $ 16,296 | $ 19,026 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
INCOME TAXES | ||
Provision or benefit for federal or state income taxes | $ 0 | $ 0 |
Capitalized research expenses | $ 1,226 |
INCOME TAXES - Carryforward (De
INCOME TAXES - Carryforward (Details) $ in Millions | Dec. 31, 2022 USD ($) |
U.S. federal | |
Net operating loss carryforwards | |
Net operating loss carryforwards | $ 164.4 |
U.S. federal | Expiring beginning in 2026 | |
Net operating loss carryforwards | |
Net operating loss carryforwards | 117.3 |
U.S. federal | Never expiring | |
Net operating loss carryforwards | |
Net operating loss carryforwards | 47 |
Massachusetts | |
Net operating loss carryforwards | |
Net operating loss carryforwards | $ 153.9 |
INCOME TAXES - Credits (Details
INCOME TAXES - Credits (Details) $ in Millions | Dec. 31, 2022 USD ($) |
U.S. federal | |
Tax credit carryforwards | |
Research and development tax credit carryforwards | $ 1.6 |
Massachusetts | |
Tax credit carryforwards | |
Research and development tax credit carryforwards | $ 0.2 |
INCOME TAXES - Net deferred tax
INCOME TAXES - Net deferred tax assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Significant components of net deferred tax asset | ||
Net operating loss carryforward | $ 44,249 | $ 42,696 |
Research and development credit carryforward | 1,718 | 1,663 |
Stock-based compensation | 359 | 431 |
Depreciation and amortization | 4 | 17 |
Capitalized research expenses | 1,226 | |
Accrued expenses | 189 | |
Lease liability | 252 | 344 |
Right of use asset | (224) | (323) |
Other deferred tax liabilities | (225) | |
Accruals and other temporary differences | 189 | |
Subtotal | 47,548 | 44,828 |
Valuation allowance | (47,548) | (44,828) |
Net deferred taxes | 0 | 0 |
Retained earnings | (248,619) | (238,129) |
Increase (decrease) in valuation allowance | 2,700 | 2,600 |
Uncertain tax positions that would affect its effective tax rate | 0 | $ 0 |
Amount of significant change in uncertain tax positions over the next 12 months | $ 0 |
INCOME TAXES - Statutory income
INCOME TAXES - Statutory income tax rate (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income tax benefits computed using the federal statutory income tax rate | ||
Statutory rate | (21.00%) | (21.00%) |
State taxes, net of benefit | (5.10%) | (4.70%) |
Permanent differences: | ||
Permanent differences | 0.10% | 0.40% |
Research and development tax credit | (0.70%) | (0.90%) |
Stock-based compensation | 0.90% | 0.20% |
Other | (0.10%) | |
Increase in valuation reserve | 25.90% | 26% |
Effective tax rate | 0% | 0% |
Capitalized research expenses | $ 1,226 |
STOCKHOLDERS EQUITY - Authorize
STOCKHOLDERS EQUITY - Authorized (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
Dec. 31, 2021 | Dec. 31, 2022 | Sep. 09, 2022 | Sep. 08, 2022 | Apr. 26, 2022 | Dec. 31, 2020 | |
Common stock, number of shares, par value and other disclosures | ||||||
Preferred stock, authorized | 0 | 1,000,000 | ||||
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | ||||
Preferred stock, issued | 0 | 0 | ||||
Preferred stock, outstanding | 0 | 0 | ||||
Common stock, authorized | 2,000,000 | 250,000,000 | 250,000,000 | 2,000,000 | ||
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | $ 0.00001 | |||
Common stock, issued | 1,370,595 | 2,429,446 | ||||
Common stock, outstanding | 1,370,595 | 2,429,446 | ||||
Proceeds from exercise of warrants | $ 8,509 | |||||
Common Stock | ||||||
Common stock, number of shares, par value and other disclosures | ||||||
Common stock, issued | 1,370,595 | 2,429,446 | 945,276 |
STOCKHOLDERS EQUITY - Common St
STOCKHOLDERS EQUITY - Common Stock Transaction (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Oct. 09, 2022 USD ($) $ / shares shares | Oct. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) shares | |
Common stock disclosures | |||||
Issuance of common stock and warrants in public offerings (in shares) | 154,000 | ||||
Proceeds from issuance of common stock and warrants, net of issuance costs | $ | $ 7,962,000 | ||||
Proceeds from exercise of warrants | $ | $ 8,509,000 | ||||
Number of Warrants | 3,064,877 | 3,064,877 | |||
Aggregate number of shares reserved for issuance | 3,201,445 | 3,201,445 | |||
Issuance of common stock upon vesting of restricted stock units (in shares) | 2 | ||||
Series A Prefunded Warrants October 2020 | |||||
Common stock disclosures | |||||
Warrants modified | 32,000 | ||||
March 2020 Series A Warrants | |||||
Common stock disclosures | |||||
Warrants modified | 29,091 | ||||
2018 Warrants | |||||
Common stock disclosures | |||||
Shares issued on exercise of warrants | 0 | ||||
2018 Warrant Exercise price $6.98 | |||||
Common stock disclosures | |||||
Exercise price (in dollars per unit) | $ / shares | $ 174.53 | $ 174.53 | |||
Number of Warrants | 8,483 | 8,483 | |||
October 2022 Pre-Funded Warrants [Member] | |||||
Common stock disclosures | |||||
Number of shares into which a warrant may be converted | 369,810 | ||||
Exercise price (in dollars per unit) | $ / shares | $ 5.2499 | ||||
October 2022 Private Placement Pre-Funded Warrants [Member] | |||||
Common stock disclosures | |||||
Number of shares into which a warrant may be converted | 1,190,476 | ||||
Preferred Investment Options [Member] | |||||
Common stock disclosures | |||||
Number of shares into which a warrant may be converted | 1,714,286 | ||||
Exercise price (in dollars per unit) | $ / shares | $ 5.25 | ||||
Wainwright Preferred Investment Options [Member] | |||||
Common stock disclosures | |||||
Number of shares into which a warrant may be converted | 111,429 | ||||
Proceeds from issuance of common stock and warrants, net of issuance costs | $ | $ 8,000,000 | ||||
2020 Series C Warrants Exercise price $1.62 | |||||
Common stock disclosures | |||||
Exercise price (in dollars per unit) | $ / shares | $ 0.00025 | $ 0.00025 | |||
Number of Warrants | 510 | 510 | |||
Warrants modified | 19,048 | ||||
October 2022 Financing [Member] | |||||
Common stock disclosures | |||||
Exercise price (in dollars per unit) | $ / shares | $ 5.05 | ||||
Common Stock | |||||
Common stock disclosures | |||||
Issuance of common stock and warrants in public offerings (in shares) | 154,000 | ||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 2 | ||||
Fractional shares issued due to 1 for 25 reverse stock split | 20,619 | ||||
Warrant One | |||||
Common stock disclosures | |||||
Aggregate number of shares reserved for issuance | 3,064,877 | 3,064,877 | |||
October 2020 Offering | Common Stock | |||||
Common stock disclosures | |||||
Proceeds from issuance of common stock and warrants, net of issuance costs | $ | $ 8,500,000 | ||||
October 2020 Offering | Common Stock | Series A Prefunded Warrants October 2020 | |||||
Common stock disclosures | |||||
Issuance of common stock and warrants in public offerings (in shares) | 424,829 | ||||
October 2020 Offering | Common Stock | Placement Agent Warrants | |||||
Common stock disclosures | |||||
Issuance of common stock and warrants in public offerings (in shares) | 488 | ||||
October 2022 Offering [Member] | |||||
Common stock disclosures | |||||
Fair value adjustment of warrants | $ | $ 100,000 | ||||
October 2022 Offering [Member] | Contractual term | |||||
Common stock disclosures | |||||
Warrant expiration term (in years) | 5 years | ||||
October 2022 Offering [Member] | Expected dividend yield | |||||
Common stock disclosures | |||||
Fair value assumptions | $ / shares | 0 | ||||
October 2022 Offering [Member] | October 2022 Pre-Funded Warrants [Member] | |||||
Common stock disclosures | |||||
Fair value of warrants | $ | $ 8,200,000 | ||||
October 2022 Offering [Member] | October 2022 - Preferred Investment Options | |||||
Common stock disclosures | |||||
Fair value of warrants | $ | $ 4,900,000 | ||||
October 2022 Offering [Member] | October 2022 - Preferred Investment Options | Expected volatility | |||||
Common stock disclosures | |||||
Fair value assumptions | 1.2887 | ||||
October 2022 Offering [Member] | October 2022 - Preferred Investment Options | Risk-free interest rate | |||||
Common stock disclosures | |||||
Fair value assumptions | 0.0412 | ||||
October 2022 Offering [Member] | October 2022 - Preferred Investment Options | Contractual term | |||||
Common stock disclosures | |||||
Warrant expiration term (in years) | 5 years 6 months | ||||
October 2022 Offering [Member] | October 2022 - Preferred Investment Options | Expected dividend yield | |||||
Common stock disclosures | |||||
Fair value assumptions | $ / shares | 0 | ||||
October 2022 Offering [Member] | October 2022 Placement Agent Warrants | |||||
Common stock disclosures | |||||
Fair value of warrants | $ | $ 300,000 | ||||
October 2022 Offering [Member] | October 2022 Placement Agent Warrants | Expected volatility | |||||
Common stock disclosures | |||||
Fair value assumptions | 1.2996 | ||||
October 2022 Offering [Member] | October 2022 Placement Agent Warrants | Risk-free interest rate | |||||
Common stock disclosures | |||||
Fair value assumptions | 0.0414 | ||||
October 2022 Offering [Member] | Common Stock | October 2022 Pre-Funded Warrants [Member] | |||||
Common stock disclosures | |||||
Issuance of common stock and warrants in public offerings (in shares) | 884,286 |
STOCKHOLDERS EQUITY - Common _2
STOCKHOLDERS EQUITY - Common Stock Reserves (Details) | Dec. 31, 2022 shares |
Summary of common stock reserves | |
Total Reserves | 3,201,445 |
Warrant One | |
Summary of common stock reserves | |
Total Reserves | 3,064,877 |
Stock Options | |
Summary of common stock reserves | |
Total Reserves | 136,568 |
SHARE-BASED COMPENSATION, STO_3
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock options | ||
Granted (in shares) | 126,000 | 14,400 |
Expected term | 10 years | |
Aggregate number of shares reserved for issuance | 3,201,445 | |
Vesting period | 48 months | |
Stock-based compensation (in dollars) | $ 159 | $ 315 |
Stock Options | ||
Stock options | ||
Granted (in shares) | 126,600 | |
Aggregate number of shares reserved for issuance | 136,568 | |
Stock-based compensation (in dollars) | $ 157 | 219 |
RSU | ||
Stock options | ||
Vesting period | 3 years | |
Stock-based compensation (in dollars) | $ 3 | $ 96 |
2010 Plan | ||
Stock options | ||
Expected term | 10 years | |
2015 Plan | ||
Stock options | ||
Shares available for future grants | 788,697 | |
Expected term | 10 years |
SHARE-BASED COMPENSATION, STO_4
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES - Share-based compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stock options | |||
Stock-based compensation (in dollars) | $ 159 | $ 315 | |
Expected term | 10 years | ||
Vesting period | 48 months | ||
Cumulative Adjustment on adoption of ASU 2016-09. | $ 15,746 | 18,115 | $ 19,186 |
Research and development | |||
Stock options | |||
Stock-based compensation (in dollars) | (8) | 22 | |
General and administrative | |||
Stock options | |||
Stock-based compensation (in dollars) | 167 | 293 | |
Stock Options | |||
Stock options | |||
Stock-based compensation (in dollars) | $ 157 | $ 219 |
SHARE-BASED COMPENSATION, STO_5
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES - Assumptions Used in Determining the Fair Value (Details) - Stock Options | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Assumptions used principally in determining the fair value of options granted | ||
Risk-free interest rate (as a percent) | 3.87% | 1.03% |
Expected dividend yield (as a percent) | 0% | 0% |
Expected term (employee grants) | 5 years 8 months 15 days | 5 years 8 months 12 days |
Expected volatility (as a percent) | 126.66% | 117.34% |
SHARE-BASED COMPENSATION, STO_6
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES - Summary of Option Activity - (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Summary of option activity - Shares | ||
Granted (in shares) | 126,000 | 14,400 |
Stock Option | ||
Stock-based compensation (in dollars) | $ 159 | $ 315 |
Stock Options | ||
Summary of option activity - Shares | ||
Outstanding at the beginning of year (in shares) | 14,582 | |
Granted (in shares) | 126,600 | |
Expired (in shares) | (1) | |
Cancelled/Forfeited (in shares) | (4,613) | |
Outstanding at the end of period (in shares) | 136,568 | 14,582 |
Vested at the end of period (in shares) | 8,268 | |
Vested and expected to vest at the end of period (in shares) | 136,568 | |
Summary of option activity - Weighted Average Exercise Price | ||
Outstanding at the beginning of year (in dollars per shares) | $ 437.78 | |
Granted (in dollars per shares) | 2.50 | |
Expired (in dollars per shares) | 129,750 | |
Cancelled/Forfeited (in dollars per shares) | 345.06 | |
Outstanding at the end of period (in dollars per shares) | 36.46 | $ 437.78 |
Vested at the end of period (in dollars per share) | 547.95 | |
Vested and expected to vest at the end of period (in dollars per share) | $ 36.46 | |
Option activity disclosures | ||
Weighted Average Remaining Contractual Term - Outstanding | 9 years 8 months 19 days | 9 years 2 months 4 days |
Weighted Average Remaining Contractual Term - Vested | 8 years 1 month 24 days | |
Weighted Average Remaining Contractual Term - Vested and expected to vest | 9 years 8 months 19 days | |
Stock Option | ||
Weighted average grant-date fair value of options granted | $ 2.21 | $ 23.19 |
Total fair value of options vested | $ 239 | $ 67 |
Stock-based compensation (in dollars) | 157 | $ 219 |
Total unrecognized compensation expense | $ 277 | |
Period for unrecognized compensation expense is estimated to be recognized | 1 year 5 months 1 day |
SHARE-BASED COMPENSATION, STO_7
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES - Restricted Securities (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based compensation | ||
Stock-based compensation (in dollars) | $ 159 | $ 315 |
RSU | ||
Number of Grants | ||
Unvested balance at | 254 | |
Vested/Released (in shares) | (200) | |
Cancelled/Forfeiture (in shares) | (54) | |
Unvested balance at | 254 | |
Weighted-Average Grant Date Fair Value | ||
Unvested balance at (in dollars per share) | $ 387.05 | |
Vested/Released (in dollars per share) | 387.50 | |
Forfeited (in dollars per share) | $ 385.38 | |
Unvested balance at (in dollars per share) | $ 387.05 | |
Share-based compensation | ||
Stock-based compensation (in dollars) | $ 3 | $ 96 |
WARRANTS (Details)
WARRANTS (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Warrants to purchase common stock issued and outstanding | |
Number of Warrants | shares | 3,064,877 |
Weighted average exercise price | $ / shares | $ 8.54 |
Weighted average life in years | 3 years 8 months 8 days |
2018 Warrant Exercise price $6.98 | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2018 |
Number of Warrants | shares | 8,483 |
Warrant Exercise Price | $ / shares | $ 174.53 |
Expiration date | Jun. 25, 2023 |
2019 Warrant Exercise price $4.50 | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2019 |
Number of Warrants | shares | 610 |
Warrant Exercise Price | $ / shares | $ 112.50 |
Expiration date | Nov. 21, 2024 |
2020 Series A Warrants Exercise price $2.75 | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2020 |
Number of Warrants | shares | 72,738 |
Warrant Exercise Price | $ / shares | $ 68.75 |
Expiration date | Mar. 10, 2025 |
2020 Placement Agent Warrants Exercise price $3.475 | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2020 |
Number of Warrants | shares | 29,091 |
Warrant Exercise Price | $ / shares | $ 5.05 |
Expiration date | Apr. 11, 2028 |
2020 Series B Warrants Exercise price $ 0.00001 | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2020 |
Number of Warrants | shares | 6,620 |
Warrant Exercise Price | $ / shares | $ 85.9400 |
Expiration date | Mar. 05, 2025 |
2020 Series C Warrants Exercise price $1.62 | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2020 |
Number of Warrants | shares | 510 |
Warrant Exercise Price | $ / shares | $ 0.00025 |
2020 Placement Agent Warrants Exercise price $2.1875 | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2020 |
Number of Warrants | shares | 48,163 |
Warrant Exercise Price | $ / shares | $ 40.50 |
Expiration date | Oct. 17, 2025 |
Warrants Outstanding 2020 Sixth [Member] | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2020 |
Number of Warrants | shares | 19,048 |
Warrant Exercise Price | $ / shares | $ 5.05 |
Expiration date | Apr. 11, 2028 |
Warrants Outstanding 2020 Seventh [Member] | |
Warrants to purchase common stock issued and outstanding | |
Number of Warrants | shares | 4,461 |
Warrant Exercise Price | $ / shares | $ 54.6900 |
Expiration date | Apr. 15, 2025 |
Warrants Outstanding 2020 Eight [Member] | |
Warrants to purchase common stock issued and outstanding | |
Number of Warrants | shares | 48,264 |
Warrant Exercise Price | $ / shares | $ 25 |
Expiration date | Oct. 22, 2025 |
Warrants Outstanding 2020 Ninth [Member] | |
Warrants to purchase common stock issued and outstanding | |
Number of Warrants | shares | 293,174 |
Warrant Exercise Price | $ / shares | $ 20 |
Expiration date | Oct. 27, 2025 |
Warrants Outstanding 2020 Tenth [Member] | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2020 |
Number of Warrants | shares | 32,000 |
Warrant Exercise Price | $ / shares | $ 5.05 |
Expiration date | Apr. 11, 2028 |
Warrants Outstanding 2022 One [Member] | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2022 |
Number of Warrants | shares | 676,000 |
Warrant Exercise Price | $ / shares | $ 0.00001 |
Warrants Outstanding 2022 Two [[Member] | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2022 |
Number of Warrants | shares | 1,714,286 |
Warrant Exercise Price | $ / shares | $ 5.05 |
Expiration date | Apr. 11, 2028 |
Warrants Outstanding 2022 Three [[Member] | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2022 |
Number of Warrants | shares | 111,429 |
Warrant Exercise Price | $ / shares | $ 6.56 |
Expiration date | Oct. 07, 2024 |
Placement Agent Warrants | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2020 |
October 2020 Offering | |
Warrants to purchase common stock issued and outstanding | |
Warrants Issued Year | 2020 |
EMPLOYEE BENEFIT PLAN (Details)
EMPLOYEE BENEFIT PLAN (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
EMPLOYEE BENEFIT PLAN | ||
Eligibility criteria for participation in the Plan | 21 years | |
Employer Matching Contribution | $ 71 | $ 69 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Leases (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Nov. 23, 2021 USD ($) | Jun. 01, 2021 USD ($) | May 31, 2021 USD ($) | Dec. 31, 2021 USD ($) | May 03, 2018 ft² | |
Lessee, Lease, Description [Line Items] | |||||
Letter of credit terminated amount | $ 60 | ||||
Borrowing rate used in modification | 5.97% | 5.74% | |||
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 486 | $ 143 | $ 629 | ||
Cambridge Lease | |||||
Lessee, Lease, Description [Line Items] | |||||
Standby letter of credit | $ 100 | ||||
Cambridge Lease | Sublease | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease space (in square feet) | ft² | 5,104 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Lease Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Lease expense | ||
Operating lease cost | $ 452 | $ 392 |
Short-term lease cost | 8 | 3 |
Variable lease cost | 182 | 95 |
Total lease cost | $ 642 | $ 490 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES - Lease Other Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Nov. 23, 2021 | Jun. 01, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
COMMITMENTS AND CONTINGENCIES | ||||
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 486 | $ 143 | $ 629 | |
Operating cash flows from short term leases | $ 8 | 3 | ||
Operating cash flows from operating leases | 427 | 403 | ||
Total cash paid for leases | $ 435 | $ 406 | ||
Weighted-average remaining lease term - operating leases (years) | 2 years | 3 years | ||
Weighted-average discount rate - operating leases | 6% | 6% |
COMMITMENTS AND CONTINGENCIES_4
COMMITMENTS AND CONTINGENCIES - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Maturities of lease liabilities | ||
2023 | $ 440 | |
2024 | 568 | |
Total lease payments | 1,008 | |
Less: imputed interest | (59) | |
Present value of lease liabilities | $ 949 | $ 1,310 |
COMMITMENTS AND CONTINGENCIES_5
COMMITMENTS AND CONTINGENCIES - Lease Classification (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
COMMITMENTS AND CONTINGENCIES | ||
Operating Lease, Right-of-Use Asset | $ 844 | $ 1,229 |
Financial position | Total lease assets | Total lease assets |
Total lease assets | $ 844 | $ 1,229 |
Operating Liabilities - Current | $ 396 | $ 361 |
Financial position | Operating Liabilities - Current | Operating Liabilities - Current |
Operating Liabilities - Non Current | $ 553 | $ 949 |
Financial position | Operating Liabilities - Non Current | Operating Liabilities - Non Current |
Total Operating Liabilities | $ 949 | $ 1,310 |
Financial position | Operating Liabilities - Current, Operating Liabilities - Non Current |
COMMITMENTS AND CONTINGENCIES_6
COMMITMENTS AND CONTINGENCIES - Compensation (Details) $ in Millions | Dec. 31, 2022 USD ($) |
Research and Development Arrangement [Member] | |
Compensation Arrangement | |
Commitments | $ 3.9 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) | Oct. 09, 2022 shares |
Related Party Transactions | |
Issuance of common stock and warrants in public offerings (in shares) | 154,000 |