Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 25, 2021 | Jun. 30, 2020 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2020 | ||
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 | 34,184,071 | ||
Entity Public Float | $ 7,671,905 | ||
Entity Central Index Key | 0001292519 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 19,493 | $ 6,602 |
Restricted cash | 4 | |
Prepaid expenses and other current assets | 163 | 177 |
Total current assets | 19,656 | 6,783 |
Property, equipment and leasehold improvements, net | 85 | 73 |
Restricted cash - non current | 110 | 110 |
Operating lease right-of-use assets | 928 | 1,211 |
Prepaid clinical trial expenses | 1,122 | 1,122 |
Other assets | 9 | 26 |
Total assets | 21,910 | 9,325 |
Current liabilities: | ||
Accounts payable | 481 | 942 |
Operating lease liabilities | 327 | 294 |
Accrued expenses | 1,164 | 1,427 |
Total current liabilities | 1,972 | 2,663 |
Other liabilities | 59 | 59 |
Operating lease liabilities - non current | 693 | 1,020 |
Total liabilities | 2,724 | 3,742 |
Commitments and contingencies (Note 13) | ||
Stockholders’ equity: | ||
Common stock, $0.00001 par value, authorized 50,000,000 shares; 23,631,886 shares issued and outstanding, including 6,302 shares of unvested restricted stock, at December 31, 2020; authorized 16,666,667 shares; 550,736 shares issued and outstanding, including 6,886 shares of unvested restricted stock, at December 31, 2019 | 3 | 2 |
Additional paid-in capital | 247,417 | 224,741 |
Accumulated deficit | (228,234) | (219,160) |
Total stockholders’ equity | 19,186 | 5,583 |
Total liabilities and stockholders’ equity | $ 21,910 | $ 9,325 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) | Feb. 11, 2020$ / sharesshares | Dec. 31, 2020$ / sharesshares | Aug. 04, 2020shares | Aug. 03, 2020shares | Jan. 31, 2020shares | Dec. 31, 2019$ / sharesshares | May 31, 2018shares |
Common stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 | $ 0.00001 | ||||
Common stock, authorized | 16,666,667 | 50,000,000 | 50,000,000 | 16,666,667 | 500,000,000 | 16,666,667 | 25,000,000 |
Common stock, issued | 23,631,886 | 550,736 | |||||
Common stock, outstanding | 23,631,886 | 550,736 | |||||
Reverse stock split ratio | 0.0333 | ||||||
Restricted Stock [Member] | |||||||
Common stock, issued | 6,302 | 6,886 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating expenses: | ||
Research and development | $ 3,939 | $ 5,602 |
General and administrative | 5,158 | 5,895 |
Total operating expenses | 9,097 | 11,497 |
Operating loss | (9,097) | (11,497) |
Other income / (expense): | ||
Interest income / (expense), net | 19 | 254 |
Warrant modification expense | (666) | |
Other income | 4 | 79 |
Other income / (expense), net | 23 | (333) |
Net loss | $ (9,074) | $ (11,830) |
Net loss per share, basic and diluted | $ (1.31) | $ (35.28) |
Weighted average number of common shares outstanding, basic and diluted (In Shares) | 6,902,693 | 335,350 |
Consolidated Statements of Op_2
Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) | Feb. 11, 2020 |
Consolidated Statements of Operations and Comprehensive Loss | |
Reverse stock split ratio | 0.0333 |
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, 2018 | $ 1 | $ 223,440 | $ (207,330) | $ 16,111 |
Beginning Balance, (in shares) at Dec. 31, 2018 | 310,330 | |||
Share-based compensation expense | 268 | $ 268 | ||
Issuance of common stock upon vesting of restricted stock units (in shares) | 143 | |||
Issuance of restricted common stock (in shares) | 6,886 | 6,886 | ||
Issuance of common stock under ESPP | 1 | $ 1 | ||
Issuance of common stock under ESPP (in shares) | 36 | |||
Increase in fair value attributable to warrant modifications | 666 | 666 | ||
Issuance of common stock and warrants in public offerings | $ 1 | 366 | 367 | |
Issuance of common stock and warrants in public offerings (in shares) | 233,341 | |||
Net loss | (11,830) | (11,830) | ||
Ending Balance at Dec. 31, 2019 | $ 2 | 224,741 | (219,160) | $ 5,583 |
Ending Balance, (in shares) at Dec. 31, 2019 | 550,736 | 550,736 | ||
Share-based compensation expense | 215 | $ 215 | ||
Issuance of common stock upon vesting of restricted stock units (in shares) | 100 | 584 | ||
Fractional shares issued due to reverse stock split | 7,692 | |||
Forfeiture of restricted stock | (584) | |||
Issuance of common stock upon exercise of warrants | 343 | $ 343 | ||
Issuance of common stock upon exercise of warrants (in shares) | 8,618,089 | |||
Issuance of common stock and warrants in public offerings | $ 1 | 22,118 | 22,119 | |
Issuance of common stock and warrants in public offerings (in shares) | 14,455,853 | |||
Net loss | (9,074) | (9,074) | ||
Ending Balance at Dec. 31, 2020 | $ 3 | $ 247,417 | $ (228,234) | $ 19,186 |
Ending Balance, (in shares) at Dec. 31, 2020 | 23,631,886 | 23,631,886 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) | Feb. 11, 2020 |
Consolidated Statements of Changes in Stockholders' Equity (Deficit) | |
Reverse stock split ratio | 0.0333 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (9,074) | $ (11,830) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 46 | 57 |
Amortization of operating lease right-of-use assets | 283 | 265 |
Warrant modification expense | 666 | |
Share-based compensation expense | 215 | 268 |
Non-cash investment (income) expense, net | 1 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses | 14 | 267 |
Other assets | (123) | |
Accounts payable | (461) | 127 |
Operating lease liability | (294) | (144) |
Accrued expenses and other liabilities | (263) | 132 |
Net cash used in operating activities | (9,534) | (10,314) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (41) | (12) |
Net cash used in investing activities | (41) | (12) |
Cash flows from financing activities: | ||
Proceeds from issuance of stock under ESPP | 1 | |
Proceeds from exercise of warrants | 343 | |
Repayment of loan payable | (100) | |
Proceeds from issuance of common stock and warrants, net of commissions and issuance costs | 22,119 | 367 |
Net cash provided by financing activities | 22,462 | 268 |
Increase / (decrease) in cash and cash equivalents and restricted cash | 12,887 | (10,058) |
Cash, cash equivalents and restricted cash at beginning of period | 6,716 | 16,774 |
Cash, cash equivalents and restricted cash at end of period | 19,603 | 6,716 |
Supplemental disclosure of cash flow information and non-cash investing and financing activities: | ||
Fair value of warrants issued in connection with financing activities | $ 15,194 | 59 |
Cash paid for interest | 1 | |
Right-of-use assets and lease liability recorded upon adoption of ASC 842 | $ 1,475 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) | Feb. 11, 2020 |
Consolidated Statements of Cash Flows | |
Reverse stock split ratio | 0.0333 |
NATURE OF OPERATIONS AND GOING
NATURE OF OPERATIONS AND GOING CONCERN | 12 Months Ended |
Dec. 31, 2020 | |
NATURE OF OPERATIONS AND GOING CONCERN | |
NATURE OF OPERATIONS AND GOING CONCERN | 1. NATURE OF OPERATIONS AND GOING CONCERN Business InVivo Therapeutics Holdings Corp. (the “Company”) is a pioneering 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. At December 31, 2020, the Company has unrestricted consolidated cash and cash equivalents of $19.5 million. Subsequent to December 31, 2020, and as of February 25, 2021, the Company received $8.4 million upon the exercise of certain October 2020 Series A Warrants and October 2020 Placement Agent Warrants . Given the Company’s development plans, the Company estimates cash resources will be sufficient to fund its operations through the second quarter of 2023. 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. The Company expects that it will need additional capital to fund its operations, which it may raise through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements, and other collaborations, strategic alliances, and licensing arrangements. 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. On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 pandemic”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 pandemic as a pandemic, based on the rapid increase in exposure globally. The Company is aware that a significant number of its clinical sites had previously temporarily suspended enrollment into the INSPIRE 2.0 Study at their institution due to the COVID-19 pandemic, and as such, the COVID-19 pandemic has affected and may continue to affect the potential for enrollment in the Company’s INSPIRE 2.0 Study as clinical sites suspend studies in order to manage the pandemic. Aside from the impact on enrollment in the Company’s INSPIRE 2.0 Study, the Company did not experience any significant impact from the COVID-19 pandemic on its financial condition, liquidity, other operations, suppliers, industry, and workforce during the year ended December 31, 2020. As of February 25, 2021, we have 17 clinical sites open for enrollment and one clinical site that is currently not open for enrollment due to reasons unrelated to the COVID-19 pandemic. The full impact of the COVID-19 pandemic continues to evolve as of the date of filing this Annual Report on Form 10-K, and we cannot be certain what future impact the COVID-19 pandemic may have on our clinical sites and their respective abilities to enroll patients. As the pandemic continues to evolve, there may be additional government actions or disruptions that could cause our clinical sites to suspend or alter operations in a manner that would impact enrollment of the INSPIRE 2.0 Study. The Company is actively monitoring the impact of the global situation on its financial condition, liquidity, operations, suppliers, industry, and workforce, although there remains significant uncertainty related to the public health situation globally. Given the daily evolution of the COVID-19 pandemic and the global responses to curb its spread, the Company is not able to estimate the ultimate effects of the COVID-19 pandemic on its future results of operations, financial condition, or liquidity in the future. However, as the COVID-19 pandemic continues, it will likely continue to have an adverse effect on enrollment in the Company’s INSPIRE 2.0 Study, and may also have an adverse effect on the Company’s results of future operations, financial position, and liquidity, and even after the COVID-19 pandemic has subsided, the Company may continue to experience adverse impacts to its business as a result of any economic recession or depression that has occurred or may occur in the future. Going Concern The Company’s financial statements as of December 31, 2020 were prepared under the assumption that the Company will continue as a going concern. At December 31, 2020, the Company had cash and cash equivalents of $19.5 million. Subsequent to December 31, 2020, and as of February 25, 2021, the Company received $8.4 million upon the exercise of certain October 2020 Series A Warrants and October 2020 Placement Agent Warrants . Given the Company’s development plans, the Company estimates cash resources will be sufficient to fund its operations through the second quarter of 2023. The Company’s ability to continue as a going concern depends on its ability to obtain additional equity or debt financing, attain further operating efficiencies, reduce expenditures, and, ultimately, to generate revenue. If the Company is 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 audited financial statements, and it is likely that investors will lose all or part of their investment. Reverse Stock Split On February 11, 2020, the Company effected a reverse stock split of its common stock, par value $0.00001 per share, at a ratio of 1-for-30 (the “2020 Reverse Stock Split”). As a result of the 2020 Reverse Stock Split, (i) every 30 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. 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 were adjusted, on a retroactive basis to reflect the 2020 Reverse Stock Split. 2020 Increase in Authorized Shares In January 2020, 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 25,000,000 to 500,000,000 (without giving effect to the 2020 Reverse Stock Split). On February 11, 2020, the Company effected the 2020 Reverse Stock Split and the number of shares of authorized Common Stock was reduced to 16,666,667. On August 4, 2020, the Company held its 2020 Annual Meeting of Stockholders (the “Annual Meeting”). At the 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 16,666,667 to 50,000,000 shares. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2020 | |
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. 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. From time to time, the Company may have cash balances in financial institutions in excess of insurance 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, 2020 and 2019, cash equivalents were comprised primarily of money market funds. Cash and cash equivalents consist of the following: December 31, December 31, (In thousands) 2020 2019 Cash $ (13) $ (15) Money market funds 19,506 6,617 Total cash and cash equivalents $ 19,493 $ 6,602 Restricted cash Restricted cash as of December 31, 2020 and 2019 was $110 thousand and $114 thousand, respectively. Restricted cash as of December 31, 2020 included a $50 thousand security deposit related to the Company’s credit card account and a $60 thousand standby letter of credit in favor of a landlord (see Note 13). Restricted cash as of December 31, 2019 included a $50 thousand security deposit related to the Company’s credit card account, $4 thousand related to 401(k) reserve account and a $60 thousand standby letter of credit in favor of a landlord (see Note 13). 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. Property and equipment Property and equipment are carried at cost. Depreciation and amortization expense are recorded over the estimated useful lives of the assets using the straight‑line method. A summary of the estimated useful lives is as follows: Classification Estimated Useful Life Computer hardware 3 - 5 years Software 3 years Office furniture and equipment 5 years Research and lab equipment 5 years Leasehold improvements Remaining life of lease Warrant modifications The Company treats a modification of the terms or conditions of an equity award in accordance with Accounting Standards Codification (“ASC”) Topic 718-20-35-3 by treating the modification as an exchange of the original award for a new award. In substance, the entity repurchases the original instrument by issuing a new instrument of equal or greater value, incurring additional cost for any incremental value. Incremental cost shall be measured as the excess, if any, of the fair value of the modified award determined in accordance with the provisions of this Topic over the fair value of the original award immediately before its terms are modified, measured based on the share price and other pertinent factors at that date. Research and development expenses Costs incurred for research and development are expensed as incurred. Certain agreements require the Company to make pre-payments for clinical research organizations (“CROs”) services. As of December 31, 2020, the Company had $1.2 million in prepayments for CRO services of which $110 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 section of the balance sheet. As of December 31, 2019, the Company had $1.2 million in prepayments for CRO services of which $120 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, 2020 and 2019, 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 2020. There were no material uncertain tax positions that required accrual or disclosure to the financial statements as of December 31, 2020 or 2019. Tax years subsequent to 2017 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 a 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. In a net loss period, options, warrants, unvested restricted stock units and convertible securities are anti‑dilutive and therefore excluded from diluted loss per share calculations. For the year ended December 31, 2020 and 2019, 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, 2020 2019 Warrants 24,714,084 270,940 Stock options 4,169 4,187 Unvested RSUs 100 200 Unvested RSAs 6,302 6,886 Total potentially dilutive securities 24,724,655 282,213 Recently adopted accounting pronouncements In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, “Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” and subsequent amendments to the initial guidance: ASU No. 2018-19 “Codification Improvements to Topic 326, Financial Instruments-Credit Losses”, ASU No. 2019-04 “Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments”, ASU No. 2019-05 “Financial Instruments-Credit Losses”, ASU No. 2019-11 “Codification Improvements to Topic 326, Financial Instruments - Credit Losses”, ASU No. 2020-02 “Financial Instruments—Credit Losses (Topic 326) and Leases (Topic 842)” and ASU No. 2020-03 “Codification Improvements to Financial Instruments, (collectively, “Topic 326”)”. Topic 326 requires measurement and recognition of expected credit losses for financial assets held. Topic 326 is effective for all public business entities, excluding smaller reporting companies, for periods beginning after December 15, 2019 and all other entities beginning after December 15, 2022. The Company early adopted ASU No. 2016-13 and the related amending ASU’s on January 1, 2020, and the adoption did not have a material effect on the Company’s financial position, results of operations or disclosures. In August 2018, the FASB issued ASU No. 2018-13 “Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement” which improves the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement. The amendments in this ASU are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of this ASU. The Company adopted ASU No. 2018-13 on January 1, 2020, and the adoption did not have a material effect on the Company’s financial position, results of operations or disclosures. In November 2019, the FASB issued ASU No. 2019-08 “Compensation - Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606): Codification Improvements - Share-Based Consideration Payable to a Customer.” ASU No. 2019-08 amends and clarifies ASU No. 2018-07, which we adopted on January 1, 2019, to require that an entity measure and classify share-based payment awards granted to a customer by applying the guidance in Topic 718. For entities that have already adopted the amendments in ASU No. 2018-07, the amendments in this ASU are effective for fiscal years beginning after December 15, 2019, and for interim periods within those fiscal years, with early adoption permitted. The Company adopted ASU No. 2019-08 on January 1, 2020, and the adoption did not have any impact on the Company’s financial position, results of operations or disclosures. In December 2019, the FASB issued ASU No. 2019-12, Simplifications to Accounting for Income Taxes (Topic 740). The amendments in this ASU removes certain exceptions for recognizing deferred taxes for investments, performing intra-period allocation, and calculating income taxes in interim periods. This ASU also adds guidance to reduce complexity in certain areas, including deferred taxes for goodwill and allocating taxes for members of a consolidated group. This ASU is effective for all entities for fiscal years beginning after December 15, 2020, and early adoption is permitted. The Company adopted ASU No. 2019-12 on January 1, 2020, and the adoption did not have any impact on the Company’s financial position, results of operations or disclosures. New Accounting Pronouncements Not Yet Adopted In January 2020, the FASB issued ASU No. 2020-01 “Investments—Equity Securities (Topic 321), Investments—Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815) —clarifying the interactions between Topic 321, Topic 323 and Topic 815 (a consensus of the emerging issues task force)”. The amendments in this ASU clarify the interaction between the accounting for investments in equity securities, investment in equity method and certain derivatives instruments. The ASU is expected to reduce diversity in practice and increase comparability of the accounting for these interactions. The pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2021. ASU No. 2020- 01 is effective for the Company beginning in fiscal 2022. The Company is currently in the process of evaluating the effects of this pronouncement on its financial statements. In August 2020, the FASB issued ASU No. 2020-06 “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity”, related to the measurement and disclosure requirements for convertible instruments and contracts in an entity's own equity. The pronouncement simplifies and adds disclosure requirements for the accounting and measurement of convertible instruments and the settlement assessment for contracts in an entity's own equity. This pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning in fiscal 2022. The Company is currently in the process of evaluating the effects of this pronouncement on its financial statements. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2020 | |
PROPERTY AND EQUIPMENT | |
PROPERTY AND EQUIPMENT | 3. PROPERTY AND EQUIPMENT Property and equipment, net consisted of the following: December 31, December 31, (In thousands) 2020 2019 Computer software and hardware $ 40 $ 131 Research and lab equipment 520 520 Leasehold improvements 66 66 Property and equipment 626 717 Less accumulated depreciation (541) (644) Property and equipment, net $ 85 $ 73 Depreciation expense for the years ended December 31, 2020 and 2019, was $29 thousand, and $39 thousand, respectively. Maintenance and repairs are charged to expense as incurred and any additions or improvements are capitalized. During the year ended December 31, 2020, the Company wrote off $132 thousand of fully depreciated computer software and hardware assets that were no longer in use. The Company did not write off any assets during the year ended December 31, 2019. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2020 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | 4. INTANGIBLE ASSETS Intangible assets included in “other assets” on the balance sheet consisted of patent licensing fees paid to license intellectual property (see Note 12). The Company is amortizing the license fee as a research and development expense over the 15– year term of the license. December 31, December 31, (In thousands) 2020 2019 Patent licensing fee $ 200 $ 200 Accumulated amortization (191) (174) Other assets $ 9 $ 26 For the years ended December 31, 2020 and 2019, amortization expense was $17 thousand a nd $18 thousand respectively. The remaining intangible assets balance of $9 thousand as of December 31, 2020 will be fully amortized in the year ended December 31, 2021. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2020 | |
ACCRUED EXPENSES. | |
ACCRUED EXPENSES | 5. ACCRUED EXPENSES Accrued expenses consisted of the following: December 31, December 31, (In thousands) 2020 2019 Compensation $ 996 $ 1,040 Clinical 5 143 Legal 17 37 Other accrued expenses 146 207 Total accrued expenses $ 1,164 $ 1,427 |
FAIR VALUES OF ASSETS AND LIABI
FAIR VALUES OF ASSETS AND LIABILITIES | 12 Months Ended |
Dec. 31, 2020 | |
FAIR VALUES OF ASSETS AND LIABILITIES | |
FAIR VALUES OF ASSETS AND LIABILITIES | 6. 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. 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. Assets and liabilities measured at fair value on a recurring basis are summarized below: At December 31, 2020 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 19,506 $ — $ — $ 19,506 At December 31, 2019 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 6,617 $ — $ — $ 6,617 During the years ended December 31, 2020 and 2019, there were no transfers between levels. The fair value of the Company’s cash equivalents, consisting of a money market fund, is based on quoted market prices in active markets with no valuation adjustment. The Company believes the carrying amounts of its prepaid expenses and other current assets, restricted cash, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these amounts. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2020 | |
INCOME TAXES | |
INCOME TAXES | 7. 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, 2020, the Company had U.S. federal and Massachusetts net operating loss carryforwards of $148.9 million and $140.8 million, respectively, of which $117.3 million of federal carryforwards will expire in varying amounts beginning in 2026 and $31.6 million carry forward indefinitely . State net operating losses begin to expire in 2029. Utili zation 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 $1.4 million and $0.2 million respectively, at December 31, 2020, which will begin to expire in 2026 and 2029, respectively, unless previously utilized. Significant components of the Company’s net deferred tax assets are as follows: December 31, (In thousands) 2020 2019 Net operating loss carryforward $ 40,175 $ 37,744 Research and development credit carryforward 1,608 1,544 Stock-based compensation 421 2,319 Depreciation and amortization 16 17 Accrued expenses 7 19 Lease liability 279 360 Right of use asset (253) (331) Subtotal 42,253 41,672 Valuation allowance (42,253) (41,672) 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, 2020 and 2019, the valuation allowance increased by $0.6 million and $3.0 million, respectively. The Company has no uncertain tax positions at December 31, 2020 and 2019 that would affect its effective tax rate. The Company does not anticipate a significant change in the amount of uncertain tax positions over the next 12 months. Since the Company is in a loss carryforward position, the Company is generally subject to U.S. federal and state income tax examinations by tax authorities for all years for which a loss carryforward is available. 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, 2020 2019 Statutory rate (21.0) % (21.0) % State taxes, net of benefit (5.8) % (5.7) % Permanent differences: Warrant modification expense — % 1.2 % Other 0.3 % 0.4 % Research and development tax credit (1.1) % (1.4) % Stock-based compensation 21.2 % — % Other — % 1.2 % Increase / (decrease) in valuation reserve 6.4 % 25.3 % 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, 2017 through December 31, 2020, however federal and state tax attributes that were generated prior to the tax year ending December 31, 2017 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 . On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law making several changes to the Internal Revenue Code. The changes include, but are not limited to: increasing the limitation on the amount of deductible interest expense, allowing companies to carryback certain net operating losses, and increasing the amount of net operating loss carryforwards that corporations can use to offset taxable income. The tax law changes in the Act did not have a material impact on the Company’s income tax provision . |
COMMON STOCK
COMMON STOCK | 12 Months Ended |
Dec. 31, 2020 | |
COMMON STOCK. | |
COMMON STOCK | 8. COMMON STOCK In January 2020, 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 25,000,000 to 500,000,000 (without giving effect to the 2020 Reverse Stock Split). On February 11, 2020, the Company effected the 2020 Reverse Stock Split and the number of shares of authorized common stock was reduced to 16,666,667. On August 4, 2020, the Company held the Annual Meeting. At the 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 16,666,667 to 50,000,000 shares. As of December 31, 2020 and 2019, 23,631,886 and 550,736 shares were issued and outstanding respectively. In October 2020, the Company completed a registered public offering (the “October 2020 Offering”) in which it sold an aggregate of (i) 11,785,000 shares of common stock, (the “October 2020 Shares”) and Series A Warrants exercisable for an aggregate of 11,785,000 shares of our common stock (the “October 2020 Series A Warrants”) at a combined public offering price of $0.80 per share and associated warrant and (ii) pre-funded Series B warrants exercisable for an aggregate of 6,965,000 shares of common stock (the “October 2020 Series B Pre-funded Warrants”) and Series A Warrants exercisable for an aggregate of 6,965,000 shares of our common stock (also the “October 2020 Series A Warrants”) at a combined public offering price of $0.80 per pre-funded warrant and associated warrant. Each October 2020 Series A Warrant has an exercise price of $0.80 per share, is exercisable immediately and expires in October 2025. Each October 2020 Series B Pre-funded Warrant has an exercise price of $0.00001 per share, is exercisable immediately, and expires when exercised in full, subject to certain conditions. In connection with the October 2020 Offering, the Company issued, to designees of H.C. Wainwright & Co., LLC (“Wainwright”) the placement agent for the October 2020 Offering, warrants (the “October 2020 Placement Agent Warrants”) to purchase an aggregate of 1,218,750 shares of the Company’s common stock, which represents a number of shares of common stock equal to 6.5% of the aggregate number of shares of common stock and October 2020 Series B Pre-funded Warrants sold in the October 2020 Offering. The October 2020 Placement Agent Warrants have an exercise price of $1.00 per share, are immediately exercisable and expire in October 2025. The net proceeds to the Company, after deducting Wainwright's placement agent fees and other offering expenses payable by the Company, were approximately $13.5 million. The Company assessed whether the October 2020 Series A Warrants, October 2020 Series B Pre-funded Warrants and the October 2020 Placement Agent Warrants 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 Accounting Standards Codification (“ASC”) Topic 815, Derivatives and Hedging. As such, the Company concluded that the October 2020 Series A Warrants, October 2020 Series B Pre-funded Warrants and the October 2020 Placement Agent Warrants 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 2020 Series A Warrants and October 2020 Placement Agent Warrants was estimated at $8.7 million and $551.3 thousand, respectively, using a Black-Scholes model with the following assumptions: expected volatility of 119.13%, risk free interest rate of 0.35%, expected life of 5 years and no dividends. The October 2020 Series B Pre-funded Warrants had an intrinsic value of approximately $5.6 million. During the year ended December 31, 2020, the Company issued an aggregate of 6,965,000 shares of common stock upon the exercise of all of the October 2020 Series B Pre-funded Warrants for an immaterial amount, as they were substantially pre-funded. The Company did not issue any shares as a result of October 2020 Series A Warrants or October 2020 Placement Agent Warrants exercise activity during the year ended December 31, 2020. In April 2020, the Company entered into a securities purchase agreement (the "April 2020 Purchase Agreement") with certain institutional investors (the "April 2020 Purchasers"), pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of 1,715,240 of common stock, at a purchase price per share of $1.75 (the "April 2020 Shares" "; the offering, the “April 2020 Registered Offering). The April 2020 Shares were offered by the Company pursuant to a shelf registration statement on Form S-3, which was declared effective by the SEC on November 14, 2019 (File No. 333-234353) and a prospectus supplement thereunder. Pursuant to the April 2020 Purchase Agreement, in a concurrent private placement, the Company also issued to the April 2020 Purchasers warrants (the "April 2020 Series C Warrants") to purchase up to 1,715,240 shares of common stock (the "Private Placement" and together with the April 2020 Registered Offering, the "April 2020 Offerings"). The April 2020 Series C Warrants are exercisable immediately at an exercise price of $1.62 per share of common stock, subject to adjustment in certain circumstances, and expire on October 17, 2025. In connection with the April 2020 Offerings, the Company also issued to Wainwright warrants to purchase an aggregate of 111,491 shares of the Company’s common stock (“April 2020 Placement Agent Warrants”) which represents a number of shares of common stock equal to 6.5% of the aggregate number of April 2020 Shares sold in the April 2020 Registered Offering, at an exercise price of $2.1875 per share with a term expiring on April 15, 2025. The net proceeds to the Company, after deducting Wainwright's placement agent fees and other offering expenses payable by the Company, were approximately $2.6 million. The Company assessed whether the April 2020 Series C Warrants, and the April 2020 Placement Agent Warrants 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 Accounting Standards Codification (“ASC”) Topic 815, Derivatives and Hedging. As such, the Company concluded that the April 2020 Series C Warrants and the April 2020 Placement Agent Warrants 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 April 2020 Series C Warrants was estimated at $2.1 million, using a Black-Scholes model with the following assumptions: expected volatility of 115.84%, risk free interest rate of 0.40%, expected life of 5.5 years and no dividends. The fair value of the April 2020 Placement Agent Warrants was estimated at $128 thousand, using a Black-Scholes model with the following assumptions: expected volatility of 116.14%, risk free interest rate of 0.36%, expected life of 5 years and no dividends. In March 2020, the Company completed a registered public offering (the “March 2020 Offering”) in which it sold an aggregate of (i) 955,613 shares of common stock (the “March 2020 Shares”) and Series A Warrants exercisable for an aggregate of 955,613 shares of our common stock (the “March 2020 Series A Warrants”) at a combined public offering price of $2.75 per share and associated warrant and (ii) pre-funded Series B warrants exercisable for an aggregate of 1,589,842 shares of common stock (the “March 2020 Series B Warrants”) and Series A Warrants exercisable for an aggregate of 1,589,842 shares of our common stock (also the “March 2020 Series A Warrants”) at a combined public offering price of $2.75 per pre-funded warrant and associated warrant. Each March 2020 Series A Warrant has an exercise price of $2.75 per share, is exercisable immediately and expires in March 2025. Each March 2020 Series B Warrant has an exercise price of $0.00001 per share, is exercisable immediately, and expires when exercised in full, subject to certain conditions. In connection with the March 2020 Offering, the Company issued, to Wainwright the placement agent for the March 2020 Offering, warrants to purchase an aggregate of 165,455 shares of the Company’s common stock (the “March 2020 Placement Agent Warrants”), which represents a number of shares of common stock equal to 6.5% of the aggregate number of shares of common stock and March 2020 Series B Warrants sold in the March 2020 Offering. The March 2020 Placement Agent Warrants have an exercise price of $3.4375 per share, are immediately exercisable and expire in March 2025. The net proceeds to the Company, after deducting Wainwright's placement agent fees and other offering expenses payable by the Company, were approximately $6.0 million. The Company assessed whether the March 2020 Series A Warrants, March 2020 Series B Warrants and the March 2020 Placement Agent Warrants 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 Accounting Standards Codification (“ASC”) Topic 815, Derivatives and Hedging. As such, the Company concluded that the March 2020 Series A Warrants, March 2020 Series B Warrants and the March 2020 Placement Agent Warrants 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 March 2020 Series A warrants and March 2020 Placement Agent Warrants was estimated at $3.5 million and $218 thousand, respectively, using a Black-Scholes model with the following assumptions: expected volatility of 115.22%, risk free interest rate of 0.63%, expected life of 5 years and no dividends. The March 2020 Series B Warrants had an intrinsic value of approximately $4.4 million. During the year ended December 31, 2020, the Company issued an aggregate of 1,577,114 shares of common stock upon the exercise of certain of the pre-funded March 2020 Series B Warrants for an immaterial amount, as they were substantially pre-funded. During the year ended December 31, 2020, the Company did not issue any shares as a result of the March 2020 Placement Agent Warrants or March 2020 Series A Warrants exercise activity. In November 2019, the Company closed a public offering of an aggregate of 233,341 shares of its common stock, at an offering price of $3.60 per share (the offering, the “2019 Offering”). The net proceeds to the Company after deducting placement agent fees and other offering expenses, were $367 thousand. In connection with the 2019 Offering, the Company agreed to issue, and in January 2020 issued, to designees of Wainwright, the placement agent for the 2019 Offering, warrants to purchase an aggregate of 15,168 shares of the Company’s common stock (the “2019 Placement Agent Warrants”). The 2019 Placement Agent Warrants have an exercise price of $4.50 per share, are immediately exercisable and expire in November 2024. The Company assessed whether the 2019 Placement Agent Warrants 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 2019 Placement Agent Warrants 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 2019 Placement Agent Warrants was estimated at $59 thousand using a Black-Scholes model with the following assumptions: expected volatility of 100.82%, risk free interest rate of 1.61%, expected life of 5 years and no dividends. During the year ended December 31, 2020, there was no exercise activity related to the 2019 Placement Agent Warrants. During the year ended December 31, 2020 the Company issued an aggregate of 40,975 shares of common stock upon the exercise of certain warrants issued in 2018 for aggregate proceeds of $286 thousand. During the year ended December 31, 2019, there was no exercise activity related to any of the warrants that were issued in 2018. In January 2019, 36 shares that were purchased pursuant to the Company’s ESPP in the offering period commencing on July 1, 2018 and ending on December 31, 2018 were issued. During the year ended December 31, 2020, the Company did not issue any shares under the Company’s ESPP. During the year ended December 31, 2019, the Company issued an aggregate of 143 shares of common stock upon vesting of restricted stock units. During the year ended December 31, 2020, the Company issued an aggregate of 100 shares of common stock upon vesting of restricted stock units. During the year ended December 31, 2019, the Company issued an aggregate 6,886 During the year ended December 31, 2020, as part of the adjustment to reflect the 2020 Reverse Stock Split, the Company issued 7,692 shares of common stock to account for the fractional roundup of shareholders. Common Stock Reserves As of December 31, 2020, the Company had the following reserves established for the future issuance of common stock as follows: At December 31, 2020 Reserves for the exercise of warrants 24,714,084 Reserves for the exercise of stock options 4,169 Reserves for the vesting of RSUs 100 Total Reserves 24,718,353 |
SHARE-BASED COMPENSATION, STOCK
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | 12 Months Ended |
Dec. 31, 2020 | |
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | |
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | 9. SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES In 2007, the Company’s Board of Directors adopted, and the Company’s shareholders subsequently approved, the 2007 Employee, Director and Consultant Stock Plan (the “2007 Plan”). The 2007 Plan provided that the Company’s Board of Directors (or committees and/or executive officers delegated by the Board of Directors) could grant incentive and nonqualified stock options to the Company’s employees, officers, directors, consultants and advisors. 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. Upon approval of the 2015 Plan by the Company’s shareholders on June 16, 2015, the 2010 Plan was terminated and no additional shares or share awards have been subsequently granted under the 2010 Plan. In March 2019, the Company’s Board approved, and recommended to the Company’s shareholders for approval, an amendment to the 2015 Plan (the “2015 Plan Amendment”), and on January 21, 2020, the Company’ shareholders subsequently approved the 2015 Plan Amendment. The 2015 Plan Amendment increased the maximum number of shares reserved for issuance under the 2015 Plan by 26,667 shares to a total of 32,000 shares. In June 2020, the Company’s Board approved, and recommended to the Company’s shareholders for approval, another amendment to the 2015 Plan to increase the number of shares available for issuance by 400,000 shares, and on August 4, 2020, the Company’ shareholders subsequently approved that amendment. As of December 31, 2020, the total number of shares available to be issued under the 2015 Plan was 427,272 shares, consisting of, (i) 5,333 shares initially authorized under the 2015 Plan shares plus (ii) the shares that remained available for grant under the 2010 Plan at the time of its termination adjusted for cumulative cancellations, forfeitures and issuances from the 2010 Plan and 2015 Plan, (iii) the 26,667 shares approved for increase during the January 2020 shareholders meeting and (iv) the 400,000 shares approved for increase during the August 2020 shareholders meeting. Options issued under the 2007 Plan, 2010 Plan, and 2015 Plan (collectively, the “Plans”) are exercisable for up to 10 years from the date of issuance. In March 2015, the Company’s Board of Directors adopted, and the Company’s shareholders subsequently approved the ESPP. The ESPP allows employees to buy company stock twice a year through after-tax payroll deductions at a discount from market. The Company’s Board of Directors initially authorized 250 shares for issuance under the ESPP. Commencing on the first day of the year ended December 31, 2016 and on the first day of each year thereafter during the term of the ESPP, the number of shares of common stock reserved for issuance shall be increased by the lesser of (i) 1% of the Company’s outstanding shares of common stock on such date, (ii) 67 shares or (iii) a lesser amount determined by the Board of Directors. Under the terms of the ESPP, in no event shall the aggregate number of shares reserved for issuance during the term of the ESPP exceed 1,667 shares. In December 2020, pursuant to the authority granted to it under the ESPP, the Company’s Board of Directors terminated the ESPP. As a result of such termination, as of December 31, 2020, there were no shares reserved for issuance under the ESPP. The 2015 ESPP was considered a compensatory plan with the related compensation cost recognized over each respective 6 month offering period. During years ended December 31, 2020 and 2019, none of the Company’s employees participated in the ESPP plan and consequently no compensation expense was recorded. Share‑based compensation For the years ended December 31, 2020 and 2019, the Company recorded stock‑based compensation expense of $215 thousand and $268 thousand, respectively, net of forfeitures. Stock-based compensation recognized was classified in the consolidated statements of operations as follows: Year Ended December 31, (In thousands) 2020 2019 Research and development $ 40 $ 94 General and administrative 175 174 Total $ 215 $ 268 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). For non‑employee options, the expected term is the contractual term. The risk‑free rate is based on the yield of a U.S. Treasury security with a term consistent with the option. The impact of forfeitures on compensation expense is recorded as they occur. The Company did not grant any awards during the year ended December 31, 2020. The assumptions used principally in determining the fair value of options granted during the year ended year ended December 31, 2019, were as follows: December 31, 2019 Risk-free interest rate 2.55% Expected dividend yield 0% Expected term (employee grants) 6 Years Expected volatility 105% The Company grants restricted stock units, or RSUs, and 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, 2020 and 2019 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 at December 31, 2018 1,858 $ 2,976.58 $ — Granted 3,000 $ 45.90 Expired (85) $ 6,794.12 Cancelled/Forfeited (586) $ 1,195.25 Outstanding at December 31, 2019 4,187 $ 1,077.78 $ — Expired (17) $ 6,780.00 Cancelled/Forfeited (1) $ 3,262.50 Outstanding at December 31, 2020 4,169 $ 1,054.01 7.18 $ — Vested and Exercisable at December 31, 2020 2,104 $ 1,984.48 6.38 $ — Vested and expected to vest at December 31, 2020 4,169 $ 1,054.01 7.18 $ — The Company did not grant any awards during the year ended December 31, 2020. The weighted average grant‑date fair value of options granted during the year ended December 31, 2019 was $37.46 per share. The total fair value of options that vested in years ended December 31, 2020 and 2019, was $117 thousand and $135 thousand respectively. For the years ended December 31, 2020 and 2019, the Company recorded stock-based compensation expense of $117 thousand and $165 thousand respectively related to stock options. As of December 31, 2020, there was $61 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 0.84 years at December 31, 2020. Restricted Securities The following table summarizes the restricted securities activity under the 2015 Equity Incentive Plan for the years ended December 31, 2020 and 2019: Weighted-Average Restricted Securities Number of Grants Grant Date Fair Value Unvested balance at December 31, 2018 343 $ 693.17 Granted 6,886 15.59 Vested/Released (143) $ 734.70 Unvested balance at December 31, 2019 7,086 $ 33.78 Vested (100) $ 660.00 Forfeited (584) $ 15.60 Unvested balance at December 31, 2020 6,402 $ 25.67 For years ended December 31, 2020 and 2019, the Company recorded stock-based compensation expense of $98 thousand and $103 thousand respectively, related to the time-based restricted securities. As of December 31, 2020, total unrecognized compensation expense related to non-vested restricted securities amounted to $120 thousand which the Company expects to recognize over a remaining weighted-average period of 1.32 years. All the restricted securities that remain unvested and outstanding at December 31, 2020 are subject to time-based vesting. |
WARRANTS
WARRANTS | 12 Months Ended |
Dec. 31, 2020 | |
WARRANTS | |
WARRANTS | 10. WARRANTS The following table presents information about warrants to purchase common stock issued and outstanding at December 31, 2020: Number of Exercise Price as of Year Issued Defined Name Classification Warrants December 31, 2020 Date of Expiration 2014 2014 Warrants Equity 11 $ 352.50 5/9/2021 2016 2016 Warrants Equity 2,865 $ 7,500.00 3/18/2021 2018 2018 Series A Warrants Equity 211,921 $ 6.98 6/25/2023 2019 2019 Placement Agent Warrants Equity 15,168 $ 4.50 11/21/2024 2020 March 2020 Series A Warrants Equity 2,545,455 $ 2.75 3/10/2025 2020 March 2020 Placement Agent Warrants Equity 165,455 $ 3.4375 3/5/2025 2020 March 2020 Series B Warrants Equity 12,728 $ 0.00001 Until Fully Exercised 2020 April 2020 Series C Warrants Equity 1,680,240 $ 1.62 10/17/2025 2020 April 2020 Placement Agent Warrants Equity 111,491 $ 2.1875 4/15/2025 2020 October 2020 Placement Agent Warrants Equity 1,218,750 $ 1.00 10/22/2025 2020 October 2020 Series A Warrants Equity 18,750,000 $ 0.80 10/27/2025 Total 24,714,084 Weighted average exercise price $ 2.01 Weighted average life in years 4.73 2019 Warrant Amendments In November 2019, the Company entered into a Second Amendment to Warrant Agency Agreement and Warrants, (“the Second Ladenburg Warrant Amendment”), by and between the Company and Continental, as Warrant Agent, that amended the 2018 Series A warrants issued by the Company in the June 2018 underwritten public offering to reflect a reduced exercise price per share of $6.98 from $60.00. As a result of the Second Ladenburg Warrant Amendment, the fair value of the amended 2018 Series A warrants was re-measured immediately prior to the date of the Second Ladenburg Warrant Amendment with changes in fair value recorded as incremental warrant modification expense of $0.7 million in the Company’s consolidated statement of operations for the year ended December 31, 2019. |
EMPLOYEE BENEFIT PLAN
EMPLOYEE BENEFIT PLAN | 12 Months Ended |
Dec. 31, 2020 | |
EMPLOYEE BENEFIT PLAN | |
EMPLOYEE BENEFIT PLAN | 11. 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. In the second quarter of 2018, the Company revised its 401(k) matching policy to move from share matching to cash-based matching. During the year ended December 31, 2020, the Company contributed $60 thousand in matching cash contributions to employee 401(k) accounts. During the year ended December 31, 2019, the Company contributed $55 thousand in matching cash contributions to employee 401(k) accounts. |
INTELLECTUAL PROPERTY LICENSE
INTELLECTUAL PROPERTY LICENSE | 12 Months Ended |
Dec. 31, 2020 | |
INTELLECTUAL PROPERTY LICENSE | |
INTELLECTUAL PROPERTY LICENSE | 12. INTELLECTUAL PROPERTY LICENSE In July 2007, the Company entered into a worldwide exclusive license (the “BCH License”) for patents co-owned by BCH and MIT initially covering the use of biopolymers to treat spinal cord injuries, and to promote the survival and proliferation of human stem cells in the spinal cord. During 2011, the BCH License was amended, and the Company obtained additional rights for use in the field of peripheral nerve injuries. The BCH License, as amended, has a 15‑year term, or as long as the life of the last expiring patent right thereunder, whichever is longer, unless terminated earlier by the licensor, under certain conditions as defined in the related license agreement. In connection with the BCH License, the Company paid an initial $75 thousand licensing fee and is required to pay certain annual maintenance fees, milestone payments and royalties. License fees are capitalized and the gross total at December 31, 2020 and 2019 was $200 thousand (see Note 4). The Company accounts for milestone payments, maintenance fees and royalties when they become due and payable. The Company paid $10 thousand in maintenance fees during each of the years ended December 31, 2020 and 2019. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2020 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 13. 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 Lease”). The Cambridge Lease commenced on May 3, 2018 and expires October 31, 2023 with no renewal options. The Cambridge Lease contains rent holiday and rent escalation clauses. In connection with the Cambridge Lease, a standby letter of credit was established for $40 thousand. On November 1, 2018, the standby letter of credit was increased to $60 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 Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities: · As the Company’s Cambridge Lease does not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. The Company has estimated its incremental borrowing rate based on electing the remaining lease term as of the adoption date. · 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) 2020 2019 Operating lease cost $ 364 $ 364 Short-term lease cost 21 33 Variable lease cost 139 63 Total lease cost $ 524 $ 460 Other information (In thousands) Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from short term leases $ 21 $ 33 Operating cash flows from operating leases 375 243 Total cash paid for leases $ 396 $ 276 Weighted-average remaining lease term - operating leases 2.83 Years 3.84 Years Weighted-average discount rate - operating leases Maturities of lease liabilities due under the Company’s Cambridge Lease as of December 31, 2020 is as follows: Leases (In thousands) As of December 31, 2020 2021 $ 386 2022 398 2023 339 Total lease payments 1,123 Less: imputed interest (103) Present value of lease liabilities $ 1,020 Leases (In thousands) Classification December 31, 2020 December 31, 2019 Assets Lease asset, net Operating $ 928 $ 1,211 Total lease assets $ 928 $ 1,211 Liabilities Current Operating $ 327 $ 294 Non-current Operating 693 1,020 Total lease liabilities $ 1,020 $ 1,314 Clinical Trial Commitments The Company has engaged and executed contracts with clinical research organizations (“CROs”) to assist with the administration of its ongoing INSPIRE 1.0 and INSPIRE 2.0 clinical trials. As of December 31, 2020, approximately $4.5 million remains to be paid on these contracts. The timelines and related costs necessary to complete these trials may vary depending on a number of factors including the rate of patient enrollment into our INSPIRE 2.0 trial. In the event the Company were to terminate the INSPIRE 2.0 trial, certain financial penalties would become payable to the CROs for costs to wind down the terminated trial. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2020 | |
RELATED PARTY TRANSACTIONS. | |
RELATED PARTY TRANSACTIONS | 14. RELATED PARTY TRANSACTIONS In our October 2020 Offering, the Company sold shares of our common stock and warrants to three investors that, based on Schedule 13-G filings with the SEC, owned more than 5% of our outstanding shares at the time of our October 2020 Offering: Sabby Volatility Warrant Master Fund, Ltd., which acquired 535,000 shares of the Company’s common stock and warrants to purchase 3,215,000 shares of the Company’s common stock; Intracoastal Capital, LLC, which acquired 500,000 shares of the Company’s common stock and warrants to purchase 2,000,000 shares of the Company’s common stock; and CVI Investments, Inc., which acquired 500,000 shares of the Company’s common stock and warrants to purchase 500,000 shares of the Company’s common stock. In addition, in the March 2020 Offering, Dr. Toselli, Mr. Christopher, and Ms. Merrifield participated as purchasers of the Company’s common stock and warrants to purchase the Company’s common stock. Each of Dr. Toselli, Mr. Christopher and Ms. Merrifield acquired 3,636 shares of the Company’s common stock and warrants to purchase 3,636 shares of the Company’s common stock. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2020 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | 15. SUBSEQUENT EVENTS Subsequent to December 31, 2020, and as of February 25, 2021, the Company issued an aggregate of 10,539,997 and 12,188 shares of common stock upon the exercise of certain of the As previously disclosed by the Company on a Current Report on Form 8-K filed on December 8, 2020 with the SEC, on December 4, 2020, the Company received a written notice (the “Initial Notice”) from the Listing Qualifications department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum closing bid price of $1.00 per share of the Company’s common stock (the “Minimum Bid Price Requirement”). The Initial Notice provided the Company 180 calendar days, or until June 2, 2021, to regain compliance with the Minimum Bid Price Requirement. On February 1, 2021, the Company received a letter (the “Compliance Letter”) from the Listing Qualifications department of Nasdaq notifying the Company that it has regained compliance with the Minimum Bid Price Requirement. The Compliance Letter noted that (i) the Company’s common stock had a closing bid price of at least $1.00 for a minimum of ten consecutive trading days from January 15, 2021 through January 29, 2021, and (ii) the Company has regained compliance with the Minimum Bid Price Requirement. Accordingly, Nasdaq considers the matter closed. |
NATURE OF OPERATIONS AND GOIN_2
NATURE OF OPERATIONS AND GOING CONCERN (Policy) | 12 Months Ended |
Dec. 31, 2020 | |
NATURE OF OPERATIONS AND GOING CONCERN | |
Going Concern | Going Concern The Company’s financial statements as of December 31, 2020 were prepared under the assumption that the Company will continue as a going concern. At December 31, 2020, the Company had cash and cash equivalents of $19.5 million. Subsequent to December 31, 2020, and as of February 25, 2021, the Company received $8.4 million upon the exercise of certain October 2020 Series A Warrants and October 2020 Placement Agent Warrants . Given the Company’s development plans, the Company estimates cash resources will be sufficient to fund its operations through the second quarter of 2023. The Company’s ability to continue as a going concern depends on its ability to obtain additional equity or debt financing, attain further operating efficiencies, reduce expenditures, and, ultimately, to generate revenue. If the Company is 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 audited financial statements, and it is likely that investors will lose all or part of their investment. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
NATURE OF OPERATIONS AND GOING CONCERN | |
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. |
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. From time to time, the Company may have cash balances in financial institutions in excess of insurance 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, 2020 and 2019, cash equivalents were comprised primarily of money market funds. Cash and cash equivalents consist of the following: December 31, December 31, (In thousands) 2020 2019 Cash $ (13) $ (15) Money market funds 19,506 6,617 Total cash and cash equivalents $ 19,493 $ 6,602 |
Restricted cash | Restricted cash Restricted cash as of December 31, 2020 and 2019 was $110 thousand and $114 thousand, respectively. Restricted cash as of December 31, 2020 included a $50 thousand security deposit related to the Company’s credit card account and a $60 thousand standby letter of credit in favor of a landlord (see Note 13). Restricted cash as of December 31, 2019 included a $50 thousand security deposit related to the Company’s credit card account, $4 thousand related to 401(k) reserve account and a $60 thousand standby letter of credit in favor of a landlord (see Note 13). |
Financial instruments | 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. |
Warrant modifications | Warrant modifications The Company treats a modification of the terms or conditions of an equity award in accordance with Accounting Standards Codification (“ASC”) Topic 718-20-35-3 by treating the modification as an exchange of the original award for a new award. In substance, the entity repurchases the original instrument by issuing a new instrument of equal or greater value, incurring additional cost for any incremental value. Incremental cost shall be measured as the excess, if any, of the fair value of the modified award determined in accordance with the provisions of this Topic over the fair value of the original award immediately before its terms are modified, measured based on the share price and other pertinent factors at that date. |
Property and equipment | Property and equipment Property and equipment are carried at cost. Depreciation and amortization expense are recorded over the estimated useful lives of the assets using the straight‑line method. A summary of the estimated useful lives is as follows: Classification Estimated Useful Life Computer hardware 3 - 5 years Software 3 years Office furniture and equipment 5 years Research and lab equipment 5 years Leasehold improvements Remaining life of lease |
Research and development expenses | Research and development expenses Costs incurred for research and development are expensed as incurred. Certain agreements require the Company to make pre-payments for clinical research organizations (“CROs”) services. As of December 31, 2020, the Company had $1.2 million in prepayments for CRO services of which $110 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 section of the balance sheet. As of December 31, 2019, the Company had $1.2 million in prepayments for CRO services of which $120 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, 2020 and 2019, 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 2020. There were no material uncertain tax positions that required accrual or disclosure to the financial statements as of December 31, 2020 or 2019. Tax years subsequent to 2017 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 a 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. In a net loss period, options, warrants, unvested restricted stock units and convertible securities are anti‑dilutive and therefore excluded from diluted loss per share calculations. For the year ended December 31, 2020 and 2019, 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, 2020 2019 Warrants 24,714,084 270,940 Stock options 4,169 4,187 Unvested RSUs 100 200 Unvested RSAs 6,302 6,886 Total potentially dilutive securities 24,724,655 282,213 |
Recently Adopted Accounting Standards | Recently adopted accounting pronouncements In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, “Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” and subsequent amendments to the initial guidance: ASU No. 2018-19 “Codification Improvements to Topic 326, Financial Instruments-Credit Losses”, ASU No. 2019-04 “Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments”, ASU No. 2019-05 “Financial Instruments-Credit Losses”, ASU No. 2019-11 “Codification Improvements to Topic 326, Financial Instruments - Credit Losses”, ASU No. 2020-02 “Financial Instruments—Credit Losses (Topic 326) and Leases (Topic 842)” and ASU No. 2020-03 “Codification Improvements to Financial Instruments, (collectively, “Topic 326”)”. Topic 326 requires measurement and recognition of expected credit losses for financial assets held. Topic 326 is effective for all public business entities, excluding smaller reporting companies, for periods beginning after December 15, 2019 and all other entities beginning after December 15, 2022. The Company early adopted ASU No. 2016-13 and the related amending ASU’s on January 1, 2020, and the adoption did not have a material effect on the Company’s financial position, results of operations or disclosures. In August 2018, the FASB issued ASU No. 2018-13 “Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement” which improves the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement. The amendments in this ASU are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of this ASU. The Company adopted ASU No. 2018-13 on January 1, 2020, and the adoption did not have a material effect on the Company’s financial position, results of operations or disclosures. In November 2019, the FASB issued ASU No. 2019-08 “Compensation - Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606): Codification Improvements - Share-Based Consideration Payable to a Customer.” ASU No. 2019-08 amends and clarifies ASU No. 2018-07, which we adopted on January 1, 2019, to require that an entity measure and classify share-based payment awards granted to a customer by applying the guidance in Topic 718. For entities that have already adopted the amendments in ASU No. 2018-07, the amendments in this ASU are effective for fiscal years beginning after December 15, 2019, and for interim periods within those fiscal years, with early adoption permitted. The Company adopted ASU No. 2019-08 on January 1, 2020, and the adoption did not have any impact on the Company’s financial position, results of operations or disclosures. In December 2019, the FASB issued ASU No. 2019-12, Simplifications to Accounting for Income Taxes (Topic 740). The amendments in this ASU removes certain exceptions for recognizing deferred taxes for investments, performing intra-period allocation, and calculating income taxes in interim periods. This ASU also adds guidance to reduce complexity in certain areas, including deferred taxes for goodwill and allocating taxes for members of a consolidated group. This ASU is effective for all entities for fiscal years beginning after December 15, 2020, and early adoption is permitted. The Company adopted ASU No. 2019-12 on January 1, 2020, and the adoption did not have any impact on the Company’s financial position, results of operations or disclosures. New Accounting Pronouncements Not Yet Adopted In January 2020, the FASB issued ASU No. 2020-01 “Investments—Equity Securities (Topic 321), Investments—Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815) —clarifying the interactions between Topic 321, Topic 323 and Topic 815 (a consensus of the emerging issues task force)”. The amendments in this ASU clarify the interaction between the accounting for investments in equity securities, investment in equity method and certain derivatives instruments. The ASU is expected to reduce diversity in practice and increase comparability of the accounting for these interactions. The pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2021. ASU No. 2020- 01 is effective for the Company beginning in fiscal 2022. The Company is currently in the process of evaluating the effects of this pronouncement on its financial statements. In August 2020, the FASB issued ASU No. 2020-06 “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity”, related to the measurement and disclosure requirements for convertible instruments and contracts in an entity's own equity. The pronouncement simplifies and adds disclosure requirements for the accounting and measurement of convertible instruments and the settlement assessment for contracts in an entity's own equity. This pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning in fiscal 2022. The Company is currently in the process of evaluating the effects of this pronouncement on its financial statements. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of cash and cash equivalents | December 31, December 31, (In thousands) 2020 2019 Cash $ (13) $ (15) Money market funds 19,506 6,617 Total cash and cash equivalents $ 19,493 $ 6,602 |
Summary of estimated useful lives | Classification Estimated Useful Life Computer hardware 3 - 5 years Software 3 years Office furniture and equipment 5 years Research and lab equipment 5 years Leasehold improvements Remaining life of lease |
Schedule of potentially dilutive securities not included in the computation of net loss per share because effect would be anti-dilutive | December 31, 2020 2019 Warrants 24,714,084 270,940 Stock options 4,169 4,187 Unvested RSUs 100 200 Unvested RSAs 6,302 6,886 Total potentially dilutive securities 24,724,655 282,213 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
PROPERTY AND EQUIPMENT | |
Schedule of property and equipment, net | December 31, December 31, (In thousands) 2020 2019 Computer software and hardware $ 40 $ 131 Research and lab equipment 520 520 Leasehold improvements 66 66 Property and equipment 626 717 Less accumulated depreciation (541) (644) Property and equipment, net $ 85 $ 73 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
INTANGIBLE ASSETS | |
Summary of intangible assets | December 31, December 31, (In thousands) 2020 2019 Patent licensing fee $ 200 $ 200 Accumulated amortization (191) (174) Other assets $ 9 $ 26 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
ACCRUED EXPENSES. | |
Summary of accrued expenses | December 31, December 31, (In thousands) 2020 2019 Compensation $ 996 $ 1,040 Clinical 5 143 Legal 17 37 Other accrued expenses 146 207 Total accrued expenses $ 1,164 $ 1,427 |
FAIR VALUES OF ASSETS AND LIA_2
FAIR VALUES OF ASSETS AND LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
FAIR VALUES OF ASSETS AND LIABILITIES | |
Summary of assets and liabilities measured at fair value on a recurring basis | At December 31, 2020 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 19,506 $ — $ — $ 19,506 At December 31, 2019 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 6,617 $ — $ — $ 6,617 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
INCOME TAXES | |
Schedule of significant components of net deferred tax assets | December 31, (In thousands) 2020 2019 Net operating loss carryforward $ 40,175 $ 37,744 Research and development credit carryforward 1,608 1,544 Stock-based compensation 421 2,319 Depreciation and amortization 16 17 Accrued expenses 7 19 Lease liability 279 360 Right of use asset (253) (331) Subtotal 42,253 41,672 Valuation allowance (42,253) (41,672) Net deferred taxes $ — $ — |
Schedule of income tax benefits computed using the federal statutory income tax rate | December 31, 2020 2019 Statutory rate (21.0) % (21.0) % State taxes, net of benefit (5.8) % (5.7) % Permanent differences: Warrant modification expense — % 1.2 % Other 0.3 % 0.4 % Research and development tax credit (1.1) % (1.4) % Stock-based compensation 21.2 % — % Other — % 1.2 % Increase / (decrease) in valuation reserve 6.4 % 25.3 % Effective tax rate 0.0 % 0.0 % |
COMMON STOCK (Tables)
COMMON STOCK (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
COMMON STOCK. | |
Schedule of reserves established for future issuance of common stock | At December 31, 2020 Reserves for the exercise of warrants 24,714,084 Reserves for the exercise of stock options 4,169 Reserves for the vesting of RSUs 100 Total Reserves 24,718,353 |
SHARE-BASED COMPENSATION, STO_2
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | |
Summary of stock based compensation classified in the consolidated statements of operations | Year Ended December 31, (In thousands) 2020 2019 Research and development $ 40 $ 94 General and administrative 175 174 Total $ 215 $ 268 |
Schedule of assumptions used principally in determining the fair value of options granted | December 31, 2019 Risk-free interest rate 2.55% Expected dividend yield 0% Expected term (employee grants) 6 Years Expected volatility 105% |
Summary of option activity | Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Shares Price Term in Years Value Outstanding at December 31, 2018 1,858 $ 2,976.58 $ — Granted 3,000 $ 45.90 Expired (85) $ 6,794.12 Cancelled/Forfeited (586) $ 1,195.25 Outstanding at December 31, 2019 4,187 $ 1,077.78 $ — Expired (17) $ 6,780.00 Cancelled/Forfeited (1) $ 3,262.50 Outstanding at December 31, 2020 4,169 $ 1,054.01 7.18 $ — Vested and Exercisable at December 31, 2020 2,104 $ 1,984.48 6.38 $ — Vested and expected to vest at December 31, 2020 4,169 $ 1,054.01 7.18 $ — |
Summary of restricted stock unit activity | Weighted-Average Restricted Securities Number of Grants Grant Date Fair Value Unvested balance at December 31, 2018 343 $ 693.17 Granted 6,886 15.59 Vested/Released (143) $ 734.70 Unvested balance at December 31, 2019 7,086 $ 33.78 Vested (100) $ 660.00 Forfeited (584) $ 15.60 Unvested balance at December 31, 2020 6,402 $ 25.67 |
WARRANTS (Tables)
WARRANTS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 Date of Expiration 2014 2014 Warrants Equity 11 $ 352.50 5/9/2021 2016 2016 Warrants Equity 2,865 $ 7,500.00 3/18/2021 2018 2018 Series A Warrants Equity 211,921 $ 6.98 6/25/2023 2019 2019 Placement Agent Warrants Equity 15,168 $ 4.50 11/21/2024 2020 March 2020 Series A Warrants Equity 2,545,455 $ 2.75 3/10/2025 2020 March 2020 Placement Agent Warrants Equity 165,455 $ 3.4375 3/5/2025 2020 March 2020 Series B Warrants Equity 12,728 $ 0.00001 Until Fully Exercised 2020 April 2020 Series C Warrants Equity 1,680,240 $ 1.62 10/17/2025 2020 April 2020 Placement Agent Warrants Equity 111,491 $ 2.1875 4/15/2025 2020 October 2020 Placement Agent Warrants Equity 1,218,750 $ 1.00 10/22/2025 2020 October 2020 Series A Warrants Equity 18,750,000 $ 0.80 10/27/2025 Total 24,714,084 Weighted average exercise price $ 2.01 Weighted average life in years 4.73 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
COMMITMENTS AND CONTINGENCIES | |
Schedule of other information | Year Ended December 31, Lease cost (In thousands) 2020 2019 Operating lease cost $ 364 $ 364 Short-term lease cost 21 33 Variable lease cost 139 63 Total lease cost $ 524 $ 460 Other information (In thousands) Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from short term leases $ 21 $ 33 Operating cash flows from operating leases 375 243 Total cash paid for leases $ 396 $ 276 Weighted-average remaining lease term - operating leases 2.83 Years 3.84 Years Weighted-average discount rate - operating leases |
Schedule of maturities of lease liabilities | Leases (In thousands) As of December 31, 2020 2021 $ 386 2022 398 2023 339 Total lease payments 1,123 Less: imputed interest (103) Present value of lease liabilities $ 1,020 |
Schedule of balance sheet information | Leases (In thousands) Classification December 31, 2020 December 31, 2019 Assets Lease asset, net Operating $ 928 $ 1,211 Total lease assets $ 928 $ 1,211 Liabilities Current Operating $ 327 $ 294 Non-current Operating 693 1,020 Total lease liabilities $ 1,020 $ 1,314 |
NATURE OF OPERATIONS AND GOIN_3
NATURE OF OPERATIONS AND GOING CONCERN - Reverse Stock Split (Details) $ / shares in Units, $ in Thousands | Feb. 11, 2020$ / sharesshares | Feb. 25, 2021USD ($) | Dec. 31, 2020USD ($)$ / sharesshares | Aug. 04, 2020shares | Aug. 03, 2020shares | Jan. 31, 2020shares | Dec. 31, 2019USD ($)$ / sharesshares | May 31, 2018shares |
Cash and cash equivalents | $ 19,493 | $ 6,602 | ||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 | $ 0.00001 | |||||
Reverse stock split ratio | 0.0333 | |||||||
Proceeds from Warrant Exercises | $ 343 | |||||||
Common Stock, Shares Authorized | shares | 16,666,667 | 50,000,000 | 50,000,000 | 16,666,667 | 500,000,000 | 16,666,667 | 25,000,000 | |
Stock issued during period, shares, reverse stock splits | shares | 7,692 | |||||||
Going concern | false | |||||||
Reverse stock split | On February 11, 2020, the Company effected a reverse stock split of its common stock, par value $0.00001 per share, at a ratio of 1-for-30 (the "2020 Reverse Stock Split"). As a result of the 2020 Reverse Stock Split, (i) every 30 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. | |||||||
Subsequent event | ||||||||
Proceeds from Warrant Exercises | $ 8,400 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES - CASH AND CASH EQUIVALENTS (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
CASH AND CASH EQUIVALENTS | ||
Cash | $ (13) | $ (15) |
Money market funds | 19,506 | 6,617 |
Total cash and cash equivalents | $ 19,493 | $ 6,602 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES - RESTRICTED CASH (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Restricted cash | $ 110 | $ 114 |
Security deposit related to credit card account | ||
Restricted cash | 50 | 50 |
401K reserve account | ||
Restricted cash | 4 | |
Standby letter of credit in favor of a landlord | ||
Restricted cash | $ 60 | $ 60 |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES, PROPERTY AND EQUIPMENT (Details) | 12 Months Ended |
Dec. 31, 2020 | |
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 |
Office furniture and equipment | |
Property and equipment | |
Estimated Useful Life | 5 years |
Research and lab equipment | |
Property and equipment | |
Estimated Useful Life | 5 years |
SIGNIFICANT ACCOUNTING POLICI_7
SIGNIFICANT ACCOUNTING POLICIES, RESEARCH AND DEVELOPMENT AND SEGMENT (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020USD ($)segmentlocation | Dec. 31, 2019USD ($)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 | $ 110 | $ 120 |
Other long term assets | ||
Prepayments for CRO services | $ 1,100 | $ 1,100 |
SIGNIFICANT ACCOUNTING POLICI_8
SIGNIFICANT ACCOUNTING POLICIES, NET LOSS PER COMMON SHARE (Details) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 24,724,655 | 282,213 |
Warrant One | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 24,714,084 | 270,940 |
Stock Options | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 4,169 | 4,187 |
Unvested RSUs | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 100 | 200 |
Unvested RSAs | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 6,302 | 6,886 |
PROPERTY AND EQUIPMENT, SCHEDUL
PROPERTY AND EQUIPMENT, SCHEDULE (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property and equipment | ||
Property and equipment | $ 626 | $ 717 |
Less accumulated depreciation and amortization | (541) | (644) |
Property and equipment, net | 85 | 73 |
Computer software and hardware | ||
Property and equipment | ||
Property and equipment | 40 | 131 |
Research and lab equipment | ||
Property and equipment | ||
Property and equipment | 520 | 520 |
Leasehold improvements | ||
Property and equipment | ||
Property and equipment | $ 66 | $ 66 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Depreciation | ||
Depreciation | $ 29 | $ 39 |
Write off of fully depreciated assets | $ 132 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - Patent licensing fee - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Intangible assets | ||
Useful life | 15 years | |
Intangible assets - gross | $ 200 | $ 200 |
Accumulated amortization | (191) | (174) |
Intangible assets, net | $ 9 | $ 26 |
INTANGIBLE ASSETS, AMORTIZATION
INTANGIBLE ASSETS, AMORTIZATION (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Amortization | ||
Amortization expense | $ 17 | $ 18 |
Future amortization | ||
2021 | $ 9 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
ACCRUED EXPENSES. | ||
Compensation | $ 996 | $ 1,040 |
Clinical | 5 | 143 |
Legal | 17 | 37 |
Other accrued expenses | 146 | 207 |
Total accrued expenses | $ 1,164 | $ 1,427 |
FAIR VALUES OF ASSETS AND LIA_3
FAIR VALUES OF ASSETS AND LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Assets and liabilities measured at fair value on a recurring basis | ||
Transfers from Level 1 to Level 2 | $ 0 | $ 0 |
Transfers from Level 2 to Level 1 | 0 | 0 |
Recurring basis | ||
Assets and liabilities measured at fair value on a recurring basis | ||
Cash equivalents | 19,506 | 6,617 |
Recurring basis | Level 1 | ||
Assets and liabilities measured at fair value on a recurring basis | ||
Cash equivalents | $ 19,506 | $ 6,617 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
INCOME TAXES | ||
Provision or benefit for federal or state income taxes | $ 0 | $ 0 |
INCOME TAXES, CARRYFORWARDS (De
INCOME TAXES, CARRYFORWARDS (Details) $ in Millions | Dec. 31, 2020USD ($) |
U.S. federal | |
Net operating loss carryforwards | |
Net operating loss carryforwards | $ 148.9 |
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 | 31.6 |
Massachusetts | |
Net operating loss carryforwards | |
Net operating loss carryforwards | $ 140.8 |
INCOME TAXES, CREDITS (Details)
INCOME TAXES, CREDITS (Details) $ in Millions | Dec. 31, 2020USD ($) |
U.S. federal | |
Tax credit carryforwards | |
Research and development tax credit carryforwards | $ 1.4 |
Massachusetts | |
Tax credit carryforwards | |
Research and development tax credit carryforwards | $ 0.2 |
INCOME TAXES, Tax Act (Details)
INCOME TAXES, Tax Act (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
INCOME TAXES | ||
Statutory tax rate (as a percent) | 21.00% | 21.00% |
INCOME TAXES, NET DEFERRED TAX
INCOME TAXES, NET DEFERRED TAX ASSET (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Significant components of net deferred tax asset | ||
Net operating loss carryforward | $ 40,175 | $ 37,744 |
Research and development credit carryforward | 1,608 | 1,544 |
Stock-based compensation | 421 | 2,319 |
Depreciation and amortization | 16 | 17 |
Accrued expenses | 7 | 19 |
Lease liability | 279 | 360 |
Right of use asset | (253) | (331) |
Subtotal | 42,253 | 41,672 |
Valuation allowance | (42,253) | (41,672) |
Net deferred taxes | 0 | 0 |
Retained earnings | (228,234) | (219,160) |
Increase (decrease) in valuation allowance | 600 | 3,000 |
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 RATES (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income tax benefits computed using the federal statutory income tax rate | ||
Statutory rate | (21.00%) | (21.00%) |
State taxes, net of benefit | (5.80%) | (5.70%) |
Permanent differences: | ||
Warrant modification expense | 1.20% | |
Other | 0.30% | 0.40% |
Research and development tax credit | (1.10%) | (1.40%) |
Stock-based compensation | 21.20% | |
Other | 1.20% | |
Increase / (decrease) in valuation reserve | 6.40% | 25.30% |
Effective tax rate | 0.00% | 0.00% |
COMMON STOCK, AUTHORIZED (Detai
COMMON STOCK, AUTHORIZED (Details) - shares | Dec. 31, 2020 | Aug. 04, 2020 | Aug. 03, 2020 | Feb. 11, 2020 | Jan. 31, 2020 | Dec. 31, 2019 | May 31, 2018 |
Common stock, number of shares, par value and other disclosures | |||||||
Common stock, authorized | 50,000,000 | 50,000,000 | 16,666,667 | 16,666,667 | 500,000,000 | 16,666,667 | 25,000,000 |
Common stock, issued | 23,631,886 | 550,736 | |||||
Common stock, outstanding | 23,631,886 | 550,736 |
COMMON STOCK, TRANSACTIONS (Det
COMMON STOCK, TRANSACTIONS (Details) | 1 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2020USD ($)$ / sharesshares | Oct. 31, 2020USD ($)$ / sharesshares | Apr. 30, 2020USD ($)$ / sharesshares | Mar. 31, 2020USD ($)$ / sharesshares | Nov. 30, 2019USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)shares | Oct. 31, 2019$ / shares | |
Common stock disclosures | ||||||||
Warrant modification expense | $ | $ 666,000 | |||||||
Proceeds from issuance of common stock and warrants, net of issuance costs | $ | $ 22,119,000 | 367,000 | ||||||
Proceeds from exercise of warrants | $ | $ 343,000 | |||||||
Number of Warrants | 24,714,084 | 24,714,084 | ||||||
Aggregate number of shares reserved for issuance | 24,718,353 | 24,718,353 | ||||||
Series A Warrants | ||||||||
Common stock disclosures | ||||||||
Exercise price (in dollars per unit) | $ / shares | $ 2.75 | |||||||
Number of Warrants | 1,589,842 | |||||||
Series B Warrants 2020 | ||||||||
Common stock disclosures | ||||||||
Exercise price (in dollars per unit) | $ / shares | $ 0.00001 | |||||||
Intrinsic value | $ | $ 4,400,000 | $ 4,400,000 | ||||||
Shares issued on exercise of warrants | 1,577,114 | |||||||
Number of Warrants | 1,589,842 | |||||||
April 2020 Warrants | ||||||||
Common stock disclosures | ||||||||
Fair value of warrants | $ | $ 2,100,000 | |||||||
Number of shares into which a warrant may be converted | 1,715,240 | |||||||
Exercise price (in dollars per unit) | $ / shares | $ 1.62 | |||||||
Proceeds from exercise of warrants | $ | $ 57,000 | |||||||
Shares issued on exercise of warrants | 35,000 | |||||||
April 2020 Warrants | Expected volatility | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | 1.1584 | |||||||
April 2020 Warrants | Risk-free interest rate | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | 0.0040 | |||||||
April 2020 Warrants | Contractual term | ||||||||
Common stock disclosures | ||||||||
Warrant expiration term (in years) | 5 years 6 months | |||||||
April 2020 Warrants | Expected dividend yield | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | $ | 0 | |||||||
Wainwright 2020 Placement Agent Warrants | ||||||||
Common stock disclosures | ||||||||
Fair value of warrants | $ | $ 128,000 | |||||||
Number of shares into which a warrant may be converted | 111,491 | |||||||
Exercise price (in dollars per unit) | $ / shares | $ 2.1875 | |||||||
Proceeds from issuance of common stock and warrants, net of issuance costs | $ | $ 13,500,000 | $ 6,000,000 | ||||||
Percentage of warrants issued as a percentage of the warrants issued to the investors | 6.50% | |||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 2,600,000 | |||||||
Wainwright 2020 Placement Agent Warrants | Expected volatility | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | 1.1614 | |||||||
Wainwright 2020 Placement Agent Warrants | Risk-free interest rate | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | 0.0036 | |||||||
Wainwright 2020 Placement Agent Warrants | Contractual term | ||||||||
Common stock disclosures | ||||||||
Warrant expiration term (in years) | 5 years | |||||||
Wainwright 2020 Placement Agent Warrants | Expected dividend yield | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | $ | 0 | |||||||
March 2020 Series A Warrants | ||||||||
Common stock disclosures | ||||||||
Issuance of common stock and warrants in public offerings (in shares) | 955,613 | |||||||
2018 Series A Warrant Exercise price | ||||||||
Common stock disclosures | ||||||||
Exercise price (in dollars per unit) | $ / shares | $ 6.98 | |||||||
Fair value adjustment of warrants | $ | $ 700,000 | |||||||
2018 Warrants | ||||||||
Common stock disclosures | ||||||||
Proceeds from exercise of warrants | $ | $ 286,000 | |||||||
Shares issued on exercise of warrants | 0 | |||||||
2018 Warrant Exercise price $6.98 | ||||||||
Common stock disclosures | ||||||||
Exercise price (in dollars per unit) | $ / shares | $ 6.98 | $ 6.98 | $ 60 | |||||
Number of Warrants | 211,921 | 211,921 | ||||||
Placement Agent Warrants | ||||||||
Common stock disclosures | ||||||||
Fair value of warrants | $ | $ 59,000 | |||||||
Number of shares into which a warrant may be converted | 15,168 | |||||||
Exercise price (in dollars per unit) | $ / shares | $ 1 | $ 3.4375 | $ 4.50 | $ 1 | ||||
Percentage of aggregate number of shares available | $ | $ 6.50 | |||||||
Shares issued on exercise of warrants | 0 | |||||||
Number of Warrants | 1,218,750 | 165,455 | 1,218,750 | |||||
Placement Agent Warrants | Expected volatility | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | 1.0082 | |||||||
Placement Agent Warrants | Risk-free interest rate | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | 0.0161 | |||||||
Placement Agent Warrants | Contractual term | ||||||||
Common stock disclosures | ||||||||
Warrant expiration term (in years) | 5 years | |||||||
Placement Agent Warrants | Expected dividend yield | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | $ | 0 | |||||||
Common Stock | ||||||||
Common stock disclosures | ||||||||
Issuance of common stock and warrants in public offerings (in shares) | 14,455,853 | 233,341 | ||||||
Warrant One | ||||||||
Common stock disclosures | ||||||||
Aggregate number of shares reserved for issuance | 24,714,084 | 24,714,084 | ||||||
October 2020 Offering | ||||||||
Common stock disclosures | ||||||||
Issuance of common stock and warrants in public offerings (in shares) | 11,785,000 | |||||||
Equity issuance (in price per unit) | $ / shares | $ 0.80 | |||||||
October 2020 Offering | Expected volatility | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | 1.1913 | |||||||
October 2020 Offering | Risk-free interest rate | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | 0.0035 | |||||||
October 2020 Offering | Contractual term | ||||||||
Common stock disclosures | ||||||||
Warrant expiration term (in years) | 5 years | |||||||
October 2020 Offering | Expected dividend yield | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | $ / shares | 0 | |||||||
October 2020 Offering | Series A Prefunded Warrants October 2020 | ||||||||
Common stock disclosures | ||||||||
Issuance of common stock and warrants in public offerings (in shares) | 6,965,000 | |||||||
Equity issuance (in price per unit) | $ / shares | $ 0.80 | |||||||
Fair value of warrants | $ | $ 8,700,000 | |||||||
October 2020 Offering | Series B Prefunded Warrants October 2020 | ||||||||
Common stock disclosures | ||||||||
Fair value of warrants | $ | $ 5,600,000 | |||||||
Number of shares into which a warrant may be converted | 6,965,000 | |||||||
Exercise price (in dollars per unit) | $ / shares | $ 0.00001 | |||||||
October 2020 Offering | Series A Warrants | ||||||||
Common stock disclosures | ||||||||
Number of shares into which a warrant may be converted | 11,785,000 | |||||||
Exercise price (in dollars per unit) | $ / shares | $ 0.80 | |||||||
October 2020 Offering | Wainwright 2020 Placement Agent Warrants | ||||||||
Common stock disclosures | ||||||||
Number of shares into which a warrant may be converted | 1,218,750 | |||||||
Exercise price (in dollars per unit) | $ / shares | $ 1 | |||||||
Percentage of aggregate number of shares available | $ | $ 6.50 | |||||||
October 2020 Offering | Placement Agent Warrants | ||||||||
Common stock disclosures | ||||||||
Fair value of warrants | $ | $ 551,300 | |||||||
October 2020 Offering | Common Stock And Warrants | ||||||||
Common stock disclosures | ||||||||
Issuance of common stock and warrants in public offerings (in shares) | 6,965,000 | |||||||
April 2020 Shares | ||||||||
Common stock disclosures | ||||||||
Issuance of common stock and warrants in public offerings (in shares) | 1,715,240 | |||||||
Equity issuance (in price per unit) | $ / shares | $ 1.75 | |||||||
Underwritten Public Offering March 2020 [Member] | ||||||||
Common stock disclosures | ||||||||
Issuance of common stock and warrants in public offerings (in shares) | 955,613 | |||||||
Equity issuance (in price per unit) | $ / shares | $ 2.75 | |||||||
Underwritten Public Offering March 2020 [Member] | Expected volatility | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | 1.1522 | |||||||
Underwritten Public Offering March 2020 [Member] | Risk-free interest rate | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | 0.0063 | |||||||
Underwritten Public Offering March 2020 [Member] | Contractual term | ||||||||
Common stock disclosures | ||||||||
Warrant expiration term (in years) | 5 years | |||||||
Underwritten Public Offering March 2020 [Member] | Expected dividend yield | ||||||||
Common stock disclosures | ||||||||
Fair value assumptions | $ / shares | 0 | |||||||
Underwritten Public Offering March 2020 [Member] | Series A Warrants | ||||||||
Common stock disclosures | ||||||||
Fair value of warrants | $ | $ 3,500,000 | |||||||
Underwritten Public Offering March 2020 [Member] | Placement Agent Warrants | ||||||||
Common stock disclosures | ||||||||
Fair value of warrants | $ | $ 218,000 | |||||||
Underwritten public offering during November, 2019. | ||||||||
Common stock disclosures | ||||||||
Issuance of common stock and warrants in public offerings (in shares) | 233,341 | |||||||
Equity issuance (in price per unit) | $ / shares | $ 3.60 | |||||||
Proceeds from issuance of common stock and warrants, net of issuance costs | $ | $ 367,000 |
COMMON STOCK, TRANSACTIONS, OTH
COMMON STOCK, TRANSACTIONS, OTHER (Details) $ in Thousands | Feb. 11, 2020 | Jan. 31, 2019shares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($)shares |
Common stock disclosures | ||||
Proceeds from issuance of stock under ESPP | $ | $ 1 | |||
Reverse stock split ratio | 0.0333 | |||
Stock issued during period, shares, reverse stock splits | 7,692 | |||
Issuance of common stock upon vesting of restricted stock units (in shares) | 584 | |||
Issuance of restricted common stock (in shares) | 6,886 | |||
Proceeds from exercise of warrants | $ | $ 343 | |||
2018 Warrants | ||||
Common stock disclosures | ||||
Shares issued on exercise of warrants | 0 | |||
Proceeds from exercise of warrants | $ | $ 286 | |||
Issuance of stock in exchange for warrants (in shares) | 40,975 | |||
Common Stock | ||||
Common stock disclosures | ||||
Stock issued under ESPP (in shares) | 36 | 36 | ||
Issuance of common stock upon vesting of restricted stock units (in shares) | 100 | 143 | ||
Issuance of restricted common stock (in shares) | 6,886 |
COMMON STOCK, RESERVES (Details
COMMON STOCK, RESERVES (Details) | Dec. 31, 2020shares |
Summary of common stock reserves | |
Total Reserves | 24,718,353 |
Warrant One | |
Summary of common stock reserves | |
Total Reserves | 24,714,084 |
Stock Options | |
Summary of common stock reserves | |
Total Reserves | 4,169 |
RSU | |
Summary of common stock reserves | |
Total Reserves | 100 |
SHARE-BASED COMPENSATION, STO_3
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES (Details) - USD ($) $ in Thousands | Jan. 21, 2021 | Aug. 04, 2020 | Jan. 31, 2019 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 31, 2020 | Apr. 30, 2015 |
Stock options | |||||||||
Expected term | 10 years | ||||||||
Aggregate number of shares reserved for issuance | 24,718,353 | ||||||||
Vesting period | 48 months | ||||||||
Stock-based compensation (in dollars) | $ 215 | $ 268 | |||||||
Stock Options | |||||||||
Stock options | |||||||||
Granted (in shares) | 0 | 3,000 | |||||||
Aggregate number of shares reserved for issuance | 4,169 | ||||||||
Stock-based compensation (in dollars) | $ 117 | $ 165 | |||||||
RSU | |||||||||
Stock options | |||||||||
Aggregate number of shares reserved for issuance | 100 | ||||||||
Vesting period | 3 years | ||||||||
Stock-based compensation (in dollars) | $ 98 | $ 103 | |||||||
Common Stock | |||||||||
Stock options | |||||||||
Stock issued under ESPP (in shares) | 36 | 36 | |||||||
2010 Plan | |||||||||
Stock options | |||||||||
Granted (in shares) | 0 | ||||||||
Expected term | 10 years | ||||||||
2015 Plan | |||||||||
Stock options | |||||||||
Shares available for future grants | 427,272 | ||||||||
Shares authorized for issuance | 400,000 | 26,667 | 5,333 | ||||||
Expected term | 10 years | ||||||||
2015 Plan Amendment | |||||||||
Stock options | |||||||||
Shares authorized for issuance | 32,000 | ||||||||
Increase in shares of common stock reserved for issuance (in shares) | 26,667 | 400,000 | |||||||
2007 Plan | |||||||||
Stock options | |||||||||
Expected term | 10 years | ||||||||
Employee Stock Purchase Plan | |||||||||
Stock options | |||||||||
Shares authorized for issuance | 250 | ||||||||
Percentage of outstanding shares reserved for future issuance | 1.00% | ||||||||
Increase in shares of common stock reserved for issuance (in shares) | 67 | ||||||||
Aggregate number of shares reserved for issuance | 0 | ||||||||
Offering Period | 6 months | ||||||||
Stock-based compensation (in dollars) | $ 0 | $ 0 | |||||||
Employee Stock Purchase Plan | Maximum | |||||||||
Stock options | |||||||||
Aggregate number of shares reserved for issuance | 1,667 |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stock options | |||
Stock-based compensation (in dollars) | $ 215 | $ 268 | |
Expected term | 10 years | ||
Vesting period | 48 months | ||
Cumulative Adjustment on adoption of ASU 2016-09. | $ 19,186 | 5,583 | $ 16,111 |
Research and development | |||
Stock options | |||
Stock-based compensation (in dollars) | 40 | 94 | |
General and administrative | |||
Stock options | |||
Stock-based compensation (in dollars) | 175 | 174 | |
Stock Options | |||
Stock options | |||
Stock-based compensation (in dollars) | $ 117 | $ 165 |
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, 2019 | |
Assumptions used principally in determining the fair value of options granted | |
Risk-free interest rate (as a percent) | 2.55% |
Expected dividend yield (as a percent) | 0.00% |
Expected term (employee grants) | 6 years |
Expected volatility (as a percent) | 105.00% |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stock Option | |||
Stock-based compensation (in dollars) | $ 215 | $ 268 | |
Stock Options | |||
Summary of option activity - Shares | |||
Outstanding at the beginning of year (in shares) | 4,187 | 1,858 | |
Granted (in shares) | 0 | 3,000 | |
Expired (in shares) | (17) | (85) | |
Cancelled/Forfeited (in shares) | (1) | (586) | |
Outstanding at the end of period (in shares) | 4,169 | 4,187 | 1,858 |
Vested at the end of period (in shares) | 2,104 | ||
Vested and expected to vest at the end of period (in shares) | 4,169 | ||
Summary of option activity - Weighted Average Exercise Price | |||
Outstanding at the beginning of year (in dollars per shares) | $ 1,077.78 | $ 2,976.58 | |
Granted (in dollars per shares) | 45.90 | ||
Expired (in dollars per shares) | 6,780 | 6,794.12 | |
Cancelled/Forfeited (in dollars per shares) | 3,262.50 | 1,195.25 | |
Outstanding at the end of period (in dollars per shares) | 1,054.01 | $ 1,077.78 | $ 2,976.58 |
Vested at the end of period (in dollars per share) | 1,984.48 | ||
Vested and expected to vest at the end of period (in dollars per share) | $ 1,054.01 | ||
Option activity disclosures | |||
Weighted Average Remaining Contractual Term - Outstanding | 7 years 2 months 5 days | 8 years 2 months 1 day | 7 years 3 months 26 days |
Weighted Average Remaining Contractual Term - Vested | 6 years 4 months 17 days | ||
Weighted Average Remaining Contractual Term - Vested and expected to vest | 7 years 2 months 5 days | ||
Stock Option | |||
Weighted average grant-date fair value of options granted | $ 37.46 | ||
Total fair value of options vested | $ 117 | $ 135 | |
Stock-based compensation (in dollars) | 117 | $ 165 | |
Total unrecognized compensation expense | $ 61 | ||
Period for unrecognized compensation expense is estimated to be recognized | 10 months 2 days |
SHARE-BASED COMPENSATION, STO_7
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES, RESTRICTED STOCK (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based compensation | ||
Stock-based compensation (in dollars) | $ 215 | $ 268 |
RSU | ||
Number of Grants | ||
Unvested balance at | 7,086 | 343 |
Granted (in shares) | 6,886 | |
Vested/Released (in shares) | (100) | (143) |
Forfeiture of restricted stock | (584) | |
Unvested balance at | 6,402 | 7,086 |
Weighted-Average Grant Date Fair Value | ||
Unvested balance at (in dollars per share) | $ 33.78 | $ 693.17 |
Granted (in dollars per share) | 15.59 | |
Vested/Released (in dollars per share) | 660 | 734.70 |
Forfeited (in dollars per share) | 15.60 | |
Unvested balance at (in dollars per share) | $ 25.67 | $ 33.78 |
Share-based compensation | ||
Stock-based compensation (in dollars) | $ 98 | $ 103 |
Unrecognized compensation | ||
Total unrecognized compensation expense | $ 120 | |
Period for unrecognized compensation expense is estimated to be recognized | 1 year 3 months 26 days |
WARRANTS (Details)
WARRANTS (Details) - $ / shares | 12 Months Ended | |||
Dec. 31, 2020 | Mar. 31, 2020 | Nov. 30, 2019 | Oct. 31, 2019 | |
Warrants to purchase common stock issued and outstanding | ||||
Number of Warrants | 24,714,084 | |||
Weighted average exercise price | $ 2.01 | |||
Weighted average life in years | 4 years 8 months 23 days | |||
2014 Warrant Exercise price $352.50 | ||||
Warrants to purchase common stock issued and outstanding | ||||
Warrants Issued Year | 2014 | |||
Number of Warrants | 11 | |||
Warrant Exercise Price | $ 352.50 | |||
Expiration date | May 9, 2021 | |||
2016 Warrant Exercise price $7500.00 | ||||
Warrants to purchase common stock issued and outstanding | ||||
Warrants Issued Year | 2016 | |||
Number of Warrants | 2,865 | |||
Warrant Exercise Price | $ 7,500 | |||
Expiration date | Mar. 18, 2021 | |||
2018 Warrant Exercise price $6.98 | ||||
Warrants to purchase common stock issued and outstanding | ||||
Warrants Issued Year | 2018 | |||
Number of Warrants | 211,921 | |||
Warrant Exercise Price | $ 6.98 | $ 60 | ||
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 | 15,168 | |||
Warrant Exercise Price | $ 4.50 | |||
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 | 2,545,455 | |||
Warrant Exercise Price | $ 2.75 | |||
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 | 165,455 | |||
Warrant Exercise Price | $ 3.4375 | |||
Expiration date | Mar. 5, 2025 | |||
2020 Series B Warrants Exercise price $ 0.00001 | ||||
Warrants to purchase common stock issued and outstanding | ||||
Warrants Issued Year | 2020 | |||
Number of Warrants | 12,728 | |||
Warrant Exercise Price | $ 0.00001 | |||
2020 Series C Warrants Exercise price $1.62 | ||||
Warrants to purchase common stock issued and outstanding | ||||
Warrants Issued Year | 2020 | |||
Number of Warrants | 1,680,240 | |||
Warrant Exercise Price | $ 1.62 | |||
Expiration date | Oct. 17, 2025 | |||
2020 Placement Agent Warrants Exercise price $2.1875 | ||||
Warrants to purchase common stock issued and outstanding | ||||
Warrants Issued Year | 2020 | |||
Number of Warrants | 111,491 | |||
Warrant Exercise Price | $ 2.1875 | |||
Expiration date | Apr. 15, 2025 | |||
Placement Agent Warrants | ||||
Warrants to purchase common stock issued and outstanding | ||||
Warrants Issued Year | 2020 | |||
Number of Warrants | 1,218,750 | 165,455 | ||
Warrant Exercise Price | $ 1 | $ 3.4375 | $ 4.50 | |
Expiration date | Oct. 22, 2025 | |||
October 2020 Offering | ||||
Warrants to purchase common stock issued and outstanding | ||||
Warrants Issued Year | 2020 | |||
Number of Warrants | 18,750,000 | |||
Warrant Exercise Price | $ 0.80 | |||
Expiration date | Oct. 27, 2025 |
WARRANTS, CANCELLATION AND AMEN
WARRANTS, CANCELLATION AND AMENDMENT (Details) - 2018 Series A Warrant Exercise price - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Nov. 30, 2019 | |
Warrants | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6.98 | |
Fair value adjustment of warrants | $ 0.7 |
EMPLOYEE BENEFIT PLAN (Details)
EMPLOYEE BENEFIT PLAN (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Employee benefit plan disclosures | ||
Eligibility criteria for participation in the Plan | 21 years | |
401(k) | ||
Employee benefit plan disclosures | ||
Employer Matching Contribution | $ 60 | $ 55 |
INTELLECTUAL PROPERTY LICENSE (
INTELLECTUAL PROPERTY LICENSE (Details) - Boston Childrens Hospital Bch License - USD ($) $ in Thousands | Dec. 31, 2011 | Dec. 31, 2020 | Dec. 31, 2019 |
Intellectual Property License | |||
Useful life | 15 years | ||
Initial license fee paid | $ 75 | ||
Capitalized license fees, gross | $ 200 | $ 200 | |
Maintenance fees | $ 10 | $ 10 |
COMMITMENTS AND CONTINGENCIES,
COMMITMENTS AND CONTINGENCIES, LEASES (Details) - Cambridge Lease $ in Thousands | Nov. 01, 2018USD ($) | May 03, 2018USD ($)ft² |
Lessee, Lease, Description [Line Items] | ||
Standby letter of credit | $ | $ 60 | $ 40 |
Sublease | ||
Lessee, Lease, Description [Line Items] | ||
Lease space (in square feet) | ft² | 5,104 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES, LEASE EXPENSE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Lease expense | ||
Operating lease cost | $ 364 | $ 364 |
Short-term lease cost | 21 | 33 |
Variable lease cost | 139 | 63 |
Total lease cost | $ 524 | $ 460 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES, LEASE OTHER INFORMATION (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
COMMITMENTS AND CONTINGENCIES | ||
Operating cash flows from short term leases | $ 21 | $ 33 |
Operating cash flows from operating leases | 375 | 243 |
Total cash paid for leases | $ 396 | 276 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 1,475 | |
Weighted-average remaining lease term - operating leases (years) | 2 years 9 months 29 days | 3 years 10 months 2 days |
Weighted-average discount rate - operating leases | 7.00% | 7.00% |
COMMITMENTS AND CONTINGENCIES_4
COMMITMENTS AND CONTINGENCIES, MATURITIES OF LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Maturities of lease liabilities | ||
2021 | $ 386 | |
2022 | 398 | |
2023 | 339 | |
Total lease payments | 1,123 | |
Less: imputed interest | (103) | |
Present value of lease liabilities | $ 1,020 | $ 1,314 |
COMMITMENTS AND CONTINGENCIES_5
COMMITMENTS AND CONTINGENCIES, LEASE CLASSIFICATION (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
COMMITMENTS AND CONTINGENCIES | ||
Operating Lease, Right-of-Use Asset | $ 928 | $ 1,211 |
Financial position | us-gaap:OperatingLeaseRightOfUseAsset | |
Total lease assets | $ 928 | 1,211 |
Operating Liabilities - Current | $ 327 | 294 |
Financial position | Operating Liabilities - Current | |
Operating Liabilities - Non Current | $ 693 | 1,020 |
Financial position | us-gaap:OperatingLeaseLiabilityNoncurrent | |
Total Operating Liabilities | $ 1,020 | $ 1,314 |
Financial position | us-gaap:OperatingLeaseLiabilityCurrent us-gaap:OperatingLeaseLiabilityNoncurrent |
COMMITMENTS AND CONTINGENCIES_6
COMMITMENTS AND CONTINGENCIES, COMPENSATION (Details) $ in Millions | Dec. 31, 2020USD ($) |
Research and Development Arrangement [Member] | |
Compensation Arrangement | |
Commitments | $ 4.5 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) | 1 Months Ended | |
Oct. 31, 2020entityshares | Mar. 31, 2020shares | |
Related Party Transactions | ||
Number of investors who owned more then five percent of outstanding shares at time of offering | entity | 3 | |
Maximum percent ownership threshold | 5.00% | |
October 2020 Offering | ||
Related Party Transactions | ||
Issuance of common stock and warrants in public offerings (in shares) | 11,785,000 | |
Dr. Toselli [Member] | ||
Related Party Transactions | ||
Issuance of common stock and warrants in public offerings (in shares) | 3,636 | |
Warrants for purchase of common stock (in shares) | 3,636 | |
Mr. Christopher [Member] | ||
Related Party Transactions | ||
Issuance of common stock and warrants in public offerings (in shares) | 3,636 | |
Warrants for purchase of common stock (in shares) | 3,636 | |
Ms. Merrifield [Member] | ||
Related Party Transactions | ||
Issuance of common stock and warrants in public offerings (in shares) | 3,636 | |
Warrants for purchase of common stock (in shares) | 3,636 | |
Sabby Volatility Warrant Master Fund, Limited [Member] | ||
Related Party Transactions | ||
Issuance of common stock and warrants in public offerings (in shares) | 535,000 | |
Warrants for purchase of common stock (in shares) | 3,215,000 | |
Intracoastal Capital, LLC [Member] | ||
Related Party Transactions | ||
Issuance of common stock and warrants in public offerings (in shares) | 500,000 | |
Warrants for purchase of common stock (in shares) | 2,000,000 | |
CVI Investments [Member] | ||
Related Party Transactions | ||
Issuance of common stock and warrants in public offerings (in shares) | 500,000 | |
Warrants for purchase of common stock (in shares) | 500,000 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - Subsequent event - USD ($) $ in Millions | Feb. 25, 2021 | Feb. 25, 2021 |
Subsequent events | ||
Proceeds from Issuance of Common Stock | $ 8.4 | |
Series A [Member] | ||
Subsequent events | ||
Stock Issued During Period, Shares, New Issues | 10,539,997 | |
Placement Agent Warrants | ||
Subsequent events | ||
Stock Issued During Period, Shares, New Issues | 12,188 |