Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 14, 2020 | Jun. 30, 2019 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Entity Registrant Name | INVIVO THERAPEUTICS HOLDINGS CORP. | ||
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 | ||
Entity Common Stock, Shares Outstanding | 591,711 | ||
Entity Public Float | $ 6,882,577 | ||
Entity Central Index Key | 0001292519 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 6,602 | $ 16,660 |
Restricted cash | 4 | 4 |
Prepaid expenses and other current assets | 177 | 461 |
Total current assets | 6,783 | 17,125 |
Property, equipment and leasehold improvements, net | 73 | 100 |
Restricted cash - non current | 110 | 110 |
Operating lease right-of-use assets | 1,211 | |
Prepaid clinical trial expenses | 1,122 | 996 |
Other assets | 26 | 46 |
Total assets | 9,325 | 18,377 |
Current liabilities: | ||
Accounts payable | 942 | 815 |
Loan payable, current portion | 100 | |
Operating lease liabilities | 294 | |
Accrued expenses | 1,427 | 1,290 |
Total current liabilities | 2,663 | 2,205 |
Other liabilities | 59 | 61 |
Operating lease liabilities - non current | 1,020 | |
Total liabilities | 3,742 | 2,266 |
Commitments and contingencies (Note 15) | ||
Stockholders’ equity: | ||
Common stock, $0.00001 par value, authorized 16,666,667 shares; 550,736 shares issued and outstanding, including 6,886 shares of unvested restricted stock, at December 31, 2019; 310,330 shares issued and outstanding at December 31, 2018 | 2 | 1 |
Additional paid-in capital | 224,741 | 223,440 |
Accumulated deficit | (219,160) | (207,330) |
Total stockholders’ equity | 5,583 | 16,111 |
Total liabilities and stockholders’ equity | $ 9,325 | $ 18,377 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) | Feb. 11, 2020shares | Apr. 16, 2018 | Jan. 31, 2020shares | Jan. 21, 2020shares | Jan. 20, 2020shares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2018$ / sharesshares | May 31, 2018shares | Apr. 30, 2018shares |
Common stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 | |||||||
Common stock, authorized | 16,666,667 | 16,666,667 | 25,000,000 | 4,000,000 | |||||
Common stock, issued | 550,736 | 310,330 | |||||||
Common stock, outstanding | 550,736 | 310,330 | |||||||
Reverse stock split ratio | 0.04 | ||||||||
Restricted Stock [Member] | |||||||||
Common stock, issued | 6,886 | ||||||||
Subsequent event | |||||||||
Common stock, authorized | 16,666,667 | 500,000,000 | 500,000,000 | 25,000,000 | |||||
Reverse stock split ratio | 0.0333 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating expenses: | ||
Research and development | $ 5,602 | $ 4,931 |
General and administrative | 5,895 | 7,836 |
Total operating expenses | 11,497 | 12,767 |
Operating loss | (11,497) | (12,767) |
Other income / (expense): | ||
Interest income / (expense), net | 254 | 206 |
Warrant modification expense | (666) | (765) |
Derivatives loss | (11,400) | |
Other income | 79 | 1,303 |
Other income / (expense), net | (333) | (10,656) |
Net loss | $ (11,830) | $ (23,423) |
Net loss per share, basic and diluted (in dollars per share) | $ (35.28) | $ (140.81) |
Weighted average number of common shares outstanding, basic and diluted (In Shares) | 335,350 | 166,348 |
Consolidated Statements of Op_2
Consolidated Statements of Operations (Parenthetical) | Apr. 16, 2018 |
Consolidated Statements of Operations | |
Reverse stock split ratio | 0.04 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Stockholders' Equity Attributable to Parent, Beginning Balance at Dec. 31, 2017 | $ 1 | $ 194,016 | $ (183,907) | $ 10,110 |
Beginning Balance, (in shares) at Dec. 31, 2017 | 45,700 | |||
Share-based compensation expense | 618 | 618 | ||
Fair value of derivative warrant liability reclassified to additional paid-in capital | 25,327 | $ 25,327 | ||
Issuance of common stock upon vesting of restricted stock units (in shares) | 143 | 143 | ||
Issuance of common stock under ESPP | 4 | $ 4 | ||
Issuance of common stock under ESPP (in shares) | 48 | |||
Fractional shares issued due to reverse stock split | 92 | |||
Issuance of common stock upon exercise of warrants | 131 | 131 | ||
Issuance of common stock upon exercise of warrants (in shares) | 209,246 | |||
Issuance of common stock and warrants in public offerings | 3,338 | 3,338 | ||
Issuance of common stock and warrants in public offerings (in shares) | 55,084 | |||
Issuance of common stock to 401(k) plan | 6 | 6 | ||
Issuance of common stock to 401(k) plan (in shares) | 17 | |||
Net loss | (23,423) | (23,423) | ||
Stockholders' Equity Attributable to Parent, Ending Balance at Dec. 31, 2018 | $ 1 | 223,440 | (207,330) | $ 16,111 |
Ending Balance, (in shares) at Dec. 31, 2018 | 310,330 | 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 | |||
Issuance of common stock under ESPP | 1 | 1 | ||
Issuance of common stock under ESPP (in shares) | 36 | |||
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 | |||
Increase in fair value attributable to warrant modifications | 666 | 666 | ||
Net loss | (11,830) | (11,830) | ||
Stockholders' Equity Attributable to Parent, 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 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (11,830) | $ (23,423) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 57 | 91 |
Amortization of operating lease right-of-use assets | 265 | |
Loss on impairment of fixed assets | 48 | |
Warrant Modification | 666 | 765 |
Derivatives loss | 11,400 | |
Gain on lease assignment | (603) | |
Common stock issued to 401(k) plan | 6 | |
Share-based compensation expense | 268 | 618 |
Non-cash investment (income) expense, net | 1 | 3 |
Changes in operating assets and liabilities: | ||
Prepaid expenses | 267 | 77 |
Other assets | (123) | (985) |
Accounts payable | 127 | (173) |
Operating lease liability | (144) | |
Accrued expenses and other liabilities | 132 | (136) |
Net cash used in operating activities | (10,314) | (12,312) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (12) | (65) |
Net cash used in investing activities | (12) | (65) |
Cash flows from financing activities: | ||
Proceeds from issuance of stock under ESPP | 1 | 4 |
Proceeds from exercise of warrants | 131 | |
Repayment of loan payable | (100) | (752) |
Repurchase of warrants | (14) | |
Proceeds from issuance of common stock and warrants, net of commissions and issuance costs | 367 | 16,511 |
Net cash (used in) provided by financing activities | 268 | 15,880 |
Decrease in cash and cash equivalents and restricted cash | (10,058) | 3,503 |
Cash, cash equivalents and restricted cash at beginning of period | 16,774 | 13,271 |
Cash, cash equivalents and restricted cash at end of period | 6,716 | 16,774 |
Supplemental disclosure of cash flow information and non-cash investing and financing activities: | ||
Cash paid for interest | 1 | 44 |
Non-cash issuance of common stock for warrants | 287 | |
Fair value of derivative warrant liability reclassified to additional paid-in capital | $ 25,327 | |
Right-of-use assets and lease liability recorded upon adoption of ASC 842 | 1,475 | |
Fair value of warrants issued in connection with 2019 Offering | $ 59 |
NATURE OF OPERATIONS AND GOING
NATURE OF OPERATIONS AND GOING CONCERN | 12 Months Ended |
Dec. 31, 2019 | |
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 BCH and 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, 2019, the Company has consolidated cash and cash equivalents of $6.6 million. 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. Going Concern The Company’s financial statements as of December 31, 2019 were prepared under the assumption that the Company will continue as a going concern. At December 31, 2019, the Company had cash and cash equivalents of $6.6 million. The Company estimates that its existing cash resources will be sufficient to fund its operations into the second quarter of 2020. 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. If the Company seeks additional financing to fund its business activities in the future and there remains substantial doubt about its ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to the Company on commercially reasonable terms or at all. Based on these factors, management determined that there is substantial doubt regarding the Company’s ability to continue as a going concern. 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. On April 16, 2018, the Company effected a reverse stock split of its common stock, par value $0.00001 per share, at a ratio of 1-for-25 (the “2018 Reverse Stock Split”). As a result of the 2018 Reverse Stock Split, (i) every 25 shares of the issued and outstanding Common Stock were automatically converted into 1 newly issued and outstanding share of Common Stock, without any change in the par value per share; (ii) 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, and (iii) the number of authorized shares of Common Stock outstanding was proportionally decreased. 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 and 2018 Reverse Stock Split. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2019 | |
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. Reclassification Certain accounts in the 2018 consolidated financial statements have been reclassified for comparative purposes to conform to the presentation in the 2019 consolidated financial statements. These reclassifications have no effect on previously reported earnings. 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. At December 31, 2019 and 2018, cash equivalents were comprised of money market funds and other short-term investments. Cash and cash equivalents consist of the following: December 31, December 31, (In thousands) 2019 2018 Cash $ (15) $ (83) Money market funds 6,617 16,743 Total cash and cash equivalents $ 6,602 $ 16,660 Restricted cash Restricted cash as of both December 31, 2019 and 2018 was $114 thousand and 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 15). 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. The carrying value of the loan payable approximates fair value due to market terms. 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, 2019, the Company had $1.2 million in prepayments for CRO services of which $120 thousand is included in prepaid and other current asset balance on the balance sheet and the remaining $1.1 million is included within the other long term assets balance on the balance sheet. As of December 31, 2018, the Company had $1.3 million in prepayments for CRO services of which $290 thousand is included in prepaid and other current asset balance on the balance sheet and the remaining $996 thousand 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 1 operating segment, which is developing and commercializing biopolymer scaffolding devices for the treatment of spinal cord injuries. As of December 31, 2019, and 2018, all of the Company’s assets were located in 1 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 2019. There were no material uncertain tax positions that required accrual or disclosure to the financial statements as of December 31, 2019 or 2018. Tax years subsequent to 2015 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. On May 3, 2018, the Company assigned the Cambridge Lease (as defined in Note 15) to a third party who assumed all of the Company’s remaining rights and obligations under the Cambridge Lease and as a result recorded an impairment charge of $48 thousand. 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; however, certain warrants to purchase Common Stock that do not meet the requirements for classification as equity are classified as 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 charged (credited) 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 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. Diluted net income per share of Common Stock has been computed by dividing net income by the weighted average number of shares outstanding plus the dilutive effect, if any, of outstanding stock options, warrants and convertible securities. Diluted net loss per share of Common Stock has been computed by dividing the net loss for the period by the weighted average number of shares of Common Stock outstanding during such 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, 2019 and 2018, 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, 2019 2018 Warrants 270,940 255,781 Stock options 4,187 1,858 Unvested RSUs 200 343 Unvested RSAs 6,886 — Total potentially dilutive securities 282,213 257,982 Recent accounting pronouncements In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842). The guidance in this ASU supersedes the leasing guidance in Topic 840, Leases. Under the new guidance, lessees are required to recognize lease assets and lease liabilities on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance leases or operating leases, with classification affecting the pattern of expense recognition in the statement of operations. In January, July and December 2018, the FASB issued ASU No’s. 2018-01, 2018-10, 2018-11, 2018-20 and 2019-01, which were targeted improvements to ASU No. 2016-02 (collectively, with ASU No. 2016-02, “ASC 842”) and provided entities with an additional (and optional) transition method to adopt the new lease standard, and provided clarifications to address potential narrow-scope implementation issues. The Company adopted ASU No. 2016- 02 effective January 1, 2019 and elected the optional transition method for adoption. The Company also took advantage of the transition package of practical expedients permitted within ASU No. 2016-02, which among other things, allowed it to carryforward historical lease classifications. The Company also elected to keep leases with an initial term of 12 months or less off of the balance sheet as a policy election and will recognize those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. As of the adoption date, the Company identified one operating lease arrangement in which it is a lessee. The adoption of this standard resulted in the recognition of operating lease liabilities and right-of-use assets of $1.5 million and $1.5 million, respectively, on the Company’s balance sheet as of January 1, 2019. The adoption of the standard did not have a material effect on the Company’s consolidated statements of operations or statements of cash flows. In February 2018, the FASB issued ASU No. 2018-02, Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. This ASU relates to the impacts of the tax legislation commonly referred to as the Tax Reform Act. The guidance permits the reclassification of certain income tax effects of the Tax Reform Act from other comprehensive income to retained earnings (stranded tax effects). The guidance also requires certain new disclosures. The guidance was effective for annual periods beginning after December 15, 2018, and interim periods within those reporting periods. Early adoption was permitted. Entities may adopt the guidance using 1 of 2 transition methods: retrospective to each period (or periods) in which the income tax effects of the Tax Reform Act related to the items remaining in other comprehensive income are recognized or at the beginning of the period of adoption. The Company adopted ASU No. 2018-02 on January 1, 2019 and it did not have a material effect on the Company’s financial position, results of operations or disclosures. In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting which is intended to reduce cost and complexity and to improve financial reporting for nonemployee share-based payments. The amendment is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption was permitted, but no earlier than an entity’s adoption date of ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606). The Company adopted ASU No. 2018-07 on January 1, 2019 and it did not have a material effect on the Company’s financial position, results of operations or disclosures. In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements which clarifies, corrects errors in, and makes improvements to several Codification Topics, including to: · Clarify when excess tax benefits should be recognized for share-based compensation awards · Remove inconsistent guidance in income tax accounting for business combinations · Clarify the circumstances when derivatives may be offset · Clarify the measurement of liability or equity-classified financial instruments when an identical asset is held as an asset · Allow portfolios of financial instruments and nonfinancial instruments accounted for as derivatives to use the portfolio exception to valuation The transition and effective date guidance is based on the facts and circumstances of each amendment. Some of the amendments in this ASU do not require transition guidance and were effective upon issuance of this ASU. However, many of the amendments in this ASU do have transition guidance with effective dates for annual periods beginning after December 15, 2018. The Company adopted ASU No. 2018-09 on January 1, 2019, and it 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 does not expect the adoption of this ASU to have a material effect on its consolidated financial statements. In July 2019, the FASB issued ASU No. 2019-07, Codification Updates to SEC Sections. This ASU amends various SEC paragraphs pursuant to the issuance of SEC Final Rule Releases No. 33-10532, Disclosure Update and Simplification, and Nos. 33-10231 and 33-10442, Investment Company Reporting Modernization. One of the changes in the ASU requires a presentation of changes in stockholders’ equity in the form of a reconciliation, either as a separate financial statement or in the notes to the financial statements, for the current and comparative year-to-date interim periods. The Company presented changes in stockholders' equity as separate financial statements for the current and comparative year-to-date interim periods. The additional elements of the ASU did not have a material impact on the Company's consolidated financial statements. This guidance was effective immediately upon issuance. 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 was adopted by the Company 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. This guidance is applicable to the Company’s fiscal year beginning January 1, 2020. The Company is currently evaluating the effects of this pronouncement on its consolidated financial statements. In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which is intended to simplify various aspects related to accounting for income taxes. The pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. ASU No. 2019-12 is effective for the Company beginning in fiscal 2021. The Company is currently evaluating the effects of this pronouncement on its consolidated financial statements. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2019 | |
PROPERTY AND EQUIPMENT | |
PROPERTY AND EQUIPMENT | 3. PROPERTY AND EQUIPMENT Property and equipment, net consisted of the following: (In thousands) 2019 2018 Computer software and hardware $ 131 $ 131 Research and lab equipment 520 508 Leasehold improvements 66 66 Property and equipment 717 705 Less accumulated depreciation and amortization (644) (605) Property and equipment, net $ 73 $ 100 Depreciation expense for the years ended December 31, 2019 and 2018, was $39 thousand, and $74 thousand, respectively. Maintenance and repairs are charged to expense as incurred and any additions or improvements are capitalized. On May 3, 2018, the Company assigned the Cambridge Lease to a third party who assumed all of the Company’s remaining rights and obligations under the Cambridge Lease and as a result wrote off $1.3 million of fully depreciated assets and also recorded an impairment loss of $48 thousand related to certain fixed assets in connection with the reassignment. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2019 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | 4. INTANGIBLE ASSETS Intangible assets, included in “other assets,” consisted of patent licensing fees paid to license intellectual property (see Note 14). The Company is amortizing the license fee as a research and development expense over the 15– year term of the license. (In thousands) 2019 2018 Patent licensing fee $ 200 $ 200 Accumulated amortization (174) (156) Intangible assets, net $ 26 $ 44 For the years ended December 31, 2019 and 2018, the amortization expense was $18 thousand and $17 thousand respectively. Amortization expense is expected to be $18 thousand and $8 thousand in 2020 and 2021, respectively. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2019 | |
ACCRUED EXPENSES. | |
ACCRUED EXPENSES | 5. ACCRUED EXPENSES Accrued expenses consisted of the following: December 31, (In thousands) 2019 2018 Severance and restructuring $ — $ 517 Compensation 1,040 489 Clinical 143 73 Legal 37 35 Other accrued expenses 207 176 Total accrued expenses $ 1,427 $ 1,290 |
FAIR VALUES OF ASSETS AND LIABI
FAIR VALUES OF ASSETS AND LIABILITIES | 12 Months Ended |
Dec. 31, 2019 | |
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. The Company uses valuation methods and assumptions that consider, among other factors, the fair value of the underlying stock, risk‑free interest rate, volatility, expected life, and dividend rates in estimating the fair value for the warrants considered to be derivative instruments. Assets and liabilities measured at fair value on a recurring basis are summarized below: At December 31, 2019 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 6,617 $ — $ — $ 6,617 At December 31, 2018 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 16,743 $ — $ — $ 16,743 |
LOAN PAYABLE
LOAN PAYABLE | 12 Months Ended |
Dec. 31, 2019 | |
LOAN PAYABLE | |
LOAN PAYABLE | 7. LOAN PAYABLE In October 2012, the Company entered into a loan agreement with the Massachusetts Development Finance Agency (“MassDev”). The loan agreement provided the Company with a $2.0 million line of credit from the Commonwealth of Massachusetts’s Emerging Technology fund, with $200 thousand designated to be used for working capital purposes and the remainder to be used for the purchase of capital equipment. The annual interest rate on the loan was fixed at 6.5% with interest-only payments for the first 30 months, commencing on November 1, 2012, and then equal interest and principal payments over the next 54 months, until the final maturity of the loan in March 2019. Commencing on May 1, 2015, equal monthly payments of $41 thousand were due until loan maturity. In May 2018, in order to obtain the consent of MassDev for facility changes, including the assignment of the Cambridge Lease, and the sale of certain assets, the Company paid down $300 thousand of principal on the MassDev loan. During the year ended December 31, 2019 the Company made principal loan payments of $100 thousand. As of December 31, 2019, there was no outstanding loan payable balance. In October 2012, as part of the agreement, the Company issued MassDev a 7-year warrant for the purchase of 13 shares of the Company’s Common Stock with an exercise price of $4,980 per share. The fair value of the warrant was determined to be $32 thousand and was amortized through interest expense over the life of the note. For the years ended December 31, 2019 and 2018, the amortization expense was $1 thousand and $7 thousand respectively, and was included in interest expense in the Company’s consolidated statements of operations. The equipment line of credit was secured by substantially all the assets of the Company, excluding intellectual property. Interest expense related to this loan was $1 thousand and $43 thousand for the years ended December 31, 2019 and 2018, respectively. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2019 | |
INCOME TAXES | |
INCOME TAXES | 8. 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, 2019, the Company had U.S. federal and Massachusetts net operating loss carryforwards of $140.0 million and $131.9 million, respectively, of which $117.3 million of federal carryforwards will expire in varying amounts beginning in 2026 and $22.8 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 $1.3 million and $258 thousand respectively, at December 31, 2019, 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) 2019 2018 Net operating loss carryforward $ 37,744 $ 34,846 Research and development credit carryforward 1,544 1,390 Stock-based compensation 2,319 2,300 Depreciation and amortization 17 11 Accrued expenses 19 136 Lease liability 360 — ROU Asset (331) — Subtotal 41,672 38,683 Valuation allowance (41,672) (38,683) 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, 2019 and 2018, the valuation allowance increased by $3.0 million and $2.7 million, respectively. The Company has no uncertain tax positions at December 31, 2019 and 2018 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, 2019 2018 Statutory rate (21.0) % (21.0) % State taxes, net of benefit (5.7) % (2.9) % Permanent differences: Warrant modification expense 1.2 % — % Derivative losses — % 10.9 % Other 0.4 % 0.4 % Research and development tax credit (1.4) % (0.8) % Other 1.2 % 1.9 % Increase / (decrease) in valuation reserve 25.3 % 11.5 % Effective tax rate % % In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which is intended to simplify various aspects related to accounting for income taxes. The pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. ASU No. 2019-12 is effective for the Company beginning in fiscal 2021. We are currently in the process of evaluating the effects of this pronouncement on the Company’s financial statements. The Company is subject to U.S. Federal and Massachusetts state income taxes. The Company is currently not subject to examination under the statute of limitations by the Internal Revenue Service and Massachusetts for the tax years of 2015 and prior . |
COMMON STOCK
COMMON STOCK | 12 Months Ended |
Dec. 31, 2019 | |
COMMON STOCK. | |
COMMON STOCK | 9. COMMON STOCK In May 2018, 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 4,000,000 to 25,000,000 shares of Common Stock (giving effect to the 2018 Reverse Stock Split but not the 2020 Reverse Stock Split). 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. As of December 31, 2019 and 2018, 550,736 and 310,330 shares were issued and outstanding respectively. 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 H.C. Wainwright & Co., LLC (“Wainwright”), the placement agent for the Offering, warrants (the “Placement Agent Warrants”) to purchase an aggregate of 15,168 shares of the Company’s Common Stock. The Placement Agent Warrants have an exercise price of $4.50 per share, are immediately exercisable and expire in November 2024. In June 2018, the Company closed an underwritten public offering of an aggregate of 45,950 Common Units, at an offering price of $60.00 each, each comprised of 1 share of the Company’s Common Stock and 1 Series A warrant to purchase 1 share of Common Stock. The public offering also included 208,096 pre-funded units at an offering price of $59.70 each, each comprised of 1 pre-funded Series B Warrant and 1 Series A warrant to purchase 1 share of Common Stock. At the time the Company closed on the offering, each Series A warrant had an exercise price of $60.00 per share, was exercisable immediately and expired 5 years from the date of issuance. Each Series B warrant had an exercise price of $0.30 per share, was exercisable immediately and would have expired 20 years from the date of issuance. The net proceeds to the Company, after deducting the underwriting discounts and commissions and other offering expenses, were $13.5 million. In September 2018, the Company entered into an Amendment to the Warrant Agency Agreement and Warrants (the “Ladenburg Warrant Amendment”) with Continental Stock Transfer & Trust Company (“Continental”) that amended the Warrant Agency Agreement, by and between the Company and Continental, as Warrant Agent, dated June 25, 2018, and the Series A Common Stock Purchase Warrant, and the Series B Pre-Funded Common Stock Purchase Warrant both dated June 25, 2018 (the Series A and Series B Warrant, collectively the “2018 Warrants”). The Ladenburg Warrant Amendment added a provision to each of the warrants that allowed the Company or a successor entity whose stock is not listed on a trading market to, in connection with a Fundamental Transaction (as such term is defined in the 2018 Warrants) that is not within the Company’s control, purchase the warrant from the holder, at the holder’s option, by paying the same form of consideration in the same proportion that is offered to the holders of the Company’s Common Stock in connection with the Fundamental Transaction, including cash, stock, any combination thereof and any choice of consideration thereof, in an amount equal to the Black-Scholes Value of the remaining unexercised portion of the Warrant on the consummation date of the Fundamental Transaction. The 2018 Warrants were initially classified as liabilities, as a result of the amendment, the Company reassessed the warrant classification and concluded that the warrants qualified for equity classification. The fair value of the amended 2018 Warrants was re-measured immediately prior to the date of the Ladenburg Warrant Amendment with changes in fair value recorded as a loss of $764 thousand in the Company’s consolidated statement of operations and $14.7 million was reclassified to equity. 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 Series A warrants to reflect a reduced exercise price per share of $6.98 from $60.00. The fair value of the amended 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 expense of $666 thousand in the Company’s consolidated statement of operations. During the year ended December 31, 2018, the Company issued an aggregate of 208,096 and 1,150 shares of Common Stock upon the exercise of Series B and Series A warrants respectively, for aggregate proceeds of $131 thousand. The Company reclassified $10.6 million from derivative warrant liability to additional paid-in capital and recorded a derivative loss of $1.2 million in connection with the warrant exercises. During the year ended December 31, 2019, the Company did not issue any shares as a result of warrant exercise activity. There were no outstanding Series B warrants as of either December 31, 2019 or 2018. In January 2018, the Company entered into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the “RRA”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), under which it had the right to sell up to $15 million, in shares of its common stock, $0.00001 par value per share of Common Stock, to Lincoln Park over a 24 month period, subject to certain limitations and conditions set forth in the Purchase Agreement and RRA. On May 30, 2018, the Company’s stockholders approved to increase the issuance and sale by the Company to Lincoln Park, including the Company’s prior issuances and sales of shares of Common Stock to Lincoln Park since January 2018, of up to 40,000 shares of Common Stock. In accordance with the terms of the Purchase Agreement, at the time the Company signed the Purchase Agreement and the RRA, it issued 574 shares to Lincoln Park as consideration for its commitment to purchase shares of the Company’s Common Stock and recorded $627 thousand in deferred offering costs of which the full amount was capitalized into additional paid-in capital as of December 31, 2018. During the year ended December 31, 2018, the Company sold an aggregate of 8,561 shares to Lincoln Park, for aggregate proceeds of $3.1 million net of issuance costs. During the year ended December 31, 2019, the Company did not sell any shares to Lincoln Park. In May 2019, the Company terminated the Purchase Agreement with Lincoln Park. In May 2018, the Company’s Board of Directors approved to increase the number of shares of Common Stock reserved under the 401(k) Plan by 134 shares, bringing the aggregate number of shares of Common Stock eligible for distribution pursuant to the 401(k) Plan as of that date to 137 shares. 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, 2018, the Company issued an aggregate of 17 shares of Common Stock with a fair value of $6 thousand to the Company’s 401(k) plan as a matching contribution and also contributed $44 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. During the year ended December 31, 2018, the Company issued an aggregate of 48 shares of Common Stock under the Company’s Employee Stock Purchase Plan (the “ESPP”) and received cash proceeds of $4 thousand. In January 2019, 36 shares that were purchased in the offering period commencing on July 1, 2018 and ending on December 31, 2018 were issued under the ESPP. During the year ended December 31, 2018, as part of the adjustment to reflect the Company’s 2018 Reverse Stock Split, the Company issued 92 shares of Common Stock to account for the fractional roundup of shareholders. During the year ended December 31, 2018, the Company issued an aggregate of 143 shares of Common Stock upon vesting of restricted stock units. 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, 2019, the Company issued an aggregate 6,886 restricted stock awards (“RSAs”) to its employees under the 2015 Equity Incentive Plan. These awards are considered issued and outstanding based on the dividend payment rights and the conveyance of voting rights that was granted to the grant holders. Common Stock Reserves As of December 31, 2019, the Company had the following reserves established for the future issuance of Common Stock as follows: At December 31, 2019 Reserves for the exercise of warrants 270,940 Reserves for the exercise of stock options 4,187 Reserves for the vesting of RSUs 200 Reserves for the vesting of RSAs 6,886 Total Reserves 282,213 |
DERIVATIVE INSTRUMENTS
DERIVATIVE INSTRUMENTS | 12 Months Ended |
Dec. 31, 2019 | |
DERIVATIVE INSTRUMENTS | |
DERIVATIVE INSTRUMENTS | 10. DERIVATIVE INSTRUMENTS In November 2019, the Company agreed to issue the Placement Agent Warrants and in January 2020 the Company issued the Placement Agent Warrants. The Company evaluated the Placement Agent Warrants in accordance with ASC Topic 815, Derivatives and Hedging, and concluded that they are considered issued for accounting purposes in November 2019 and that they meet the scope exception for determining whether the instruments require accounting as derivatives (See Note 12). Accordingly, they are classified in stockholders’ equity. The fair value of the 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. The warrants issued in connection with the Company’s 2018 underwritten public offering had provisions that precluded the Company from classifying them as equity instruments (See Note 12). Accordingly, these warrants had been accounted for as derivative warrant liabilities. The Company used the Black-Scholes model and assumptions that considered, among other factors, the fair value of the underlying stock, risk-free interest rate, volatility, expected life, and dividend rates in estimating fair value for these warrants. At inception, the fair value of the Series B pre-funded warrants was estimated at $11.5 million using a Black-Scholes model with the following assumptions: expected volatility of 202.51%, risk free interest rate of 2.95%, expected life of 20 years and no dividends. At inception, the fair value of the Series A warrants was estimated at $13.7 million using a Black-Scholes model with the following assumptions: expected volatility of 202.51%, risk free interest rate of 2.75%, expected life of 5 years and no dividends. The Company allocated $13.2 million of the net proceeds to record the relative fair value of the warrant liability, with the remaining amount of $287 thousand recorded to permanent equity. The Company subsequently recorded the fair value of the warrant liability at $25.2 million with the loss of $12 million being recorded as a derivative loss on the Company’s consolidated statement of operations and comprehensive loss during the second quarter of 2018. In September 2018, the Company entered into the Ladenburg Warrant Amendment. As a result of the amendment, the Company reassessed the warrant classification and concluded that the warrants qualified for equity classification. The fair value of the amended 2018 Warrants was re-measured immediately prior to the date of the Ladenburg Warrant Amendment with changes in fair value recorded as a loss of $764 thousand in the Company’s consolidated statement of operations and $14.7 million was reclassified to equity. During the year ended December 31, 2018, the Company issued an aggregate of 208,096 shares of Common Stock upon the exercise of Series B warrants for aggregate proceeds of $62 thousand. During the year ended December 31, 2018, the Company issued an aggregate of 1,150 shares of Common Stock upon the exercise of Series A warrants for aggregate proceeds of $69 thousand. The Company reclassified $10.6 million from derivative warrant liability to additional paid-in capital and recorded a derivative loss of $1.2 million in connection with the warrant exercises. During the year ended December 31, 2019, the Company did not issue any shares as a result of warrant exercise activity. There were no outstanding Series B warrants as of either December 31, 2019 or December 31, 2018. The 2014 Warrants issued in connection with the Company’s May 2014 public offering had anti-dilution protection provisions and, under certain conditions, required the Company to automatically reprice the 2014 Warrants (See Note 12). Accordingly, the 2014 Warrants had been accounted for as derivative warrant liabilities. Through the date of the warrant exchange (see Note 12), the Company used the Binomial Lattice option pricing model and assumptions that considered, among other factors, the fair value of the underlying stock, risk-free interest rate, volatility, expected life, and dividend rates in estimating fair value for the 2014 Warrants considered to be derivative instruments. In May 2018, the Company entered into the Warrant Amendment (see Note 12), which removed provisions that had previously precluded equity classification treatment of the 2014 Warrants on the Company’s balance sheets. The fair value of the amended 2014 Warrants was re-measured immediately prior to the date of amendment with changes in fair value recorded as a loss of $1 thousand in the Company’s consolidated statement of operations and $1 thousand was reclassified to equity. As of both December 31, 2019 and 2018, the Company did not have any liability classified warrants. The table below presents the changes in derivative warrant liability during the year ended December 31, 2018: Year Ended December 31, (In thousands) 2018 Balance at beginning of year $ 4 Issuance of new warrants 13,172 Reduction in derivative liability due to exercise of warrants (10,620) Reclassification of fair value of derivative liabilities to equity on amendment of warrant agreements (14,707) Repurchase of warrants (14) Increase in the fair value of warrants 12,165 Balance at end of year $ — |
SHARE-BASED COMPENSATION, STOCK
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | 12 Months Ended |
Dec. 31, 2019 | |
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | |
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | 11. 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 provides 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. As of December 31, 2019, the total number of shares available to be issued under the 2015 Plan was 68 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. 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. As of December 31, 2019, there were 264 shares reserved for issuance under the ESPP. The 2015 ESPP is considered a compensatory plan with the related compensation cost recognized over each respective 6 month offering period. During the year ended December 31, 2019, none of the Company’s employees participated in the ESPP plan and consequently no compensation expense was recorded. The compensation expense related to the ESPP for the year ended December 31, 2018 was $2 thousand. Share‑based compensation For the years ended December 31, 2019 and 2018, the Company recorded stock‑based compensation expense of $268 thousand and $618 thousand, respectively, net of forfeitures, inclusive of the expense related to the ESPP. Stock-based compensation recognized was classified in the consolidated statements of operations as follows: (In thousands) Year Ended December 31, 2019 Year Ended December 31, 2018 Research and development $ 94 $ 183 General and administrative 174 435 Total $ 268 $ 618 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 assumptions used principally in determining the fair value of options granted were as follows: December 31, December 31, 2019 2018 Risk-free interest rate 2.55% 2.45 - 2.88% Expected dividend yield 0% 0% Expected term (employee grants) 6 Years 5.62 Years Expected volatility 105% 104% The Company grants restricted stock units, or RSUs, and RSAs, collectively referred to as restricted securities under its 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, 2019 and 2018 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, 2017 4,570 $ 4,845.94 $ 22 Granted 520 $ 148.08 Expired (180) $ 5,130.40 Cancelled/Forfeited (3,052) $ 5,166.77 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 8.17 $ — Vested and Exercisable at December 31, 2019 1,000 $ 3,874.14 5.63 $ — The weighted average grant‑date fair value of options granted during the years ended December 31, 2019 and 2018 was $37.46 and $114.60 per share, respectively. The total fair value of options that vested in years ended December 31, 2019 and 2018, was $135 thousand and $952 thousand respectively. For the years ended December 31, 2019 and 2018, the Company recorded stock-based compensation expense of $165 thousand and $528 thousand respectively. As of December 31, 2019, there was $180 thousand of total unrecognized compensation expense related to non‑vested share‑based option compensation arrangements. The unrecognized compensation expense is estimated to be recognized over a remaining weighted-average period of 1.63 years at December 31, 2019. Restricted Securities The following table summarizes the restricted securities activity under the 2015 Equity Incentive Plan for the years ended December 31, 2019 and 2018: Weighted-Average Restricted Securities Number of Grants Grant Date Fair Value Unvested balance at December 31, 2017 670 $ 767.16 Granted — — Vested/Released (143) $ 734.70 Forfeited (184) $ 934.10 Unvested balance at December 31, 2018 343 $ 693.17 Granted 6,886 $ 15.59 Vested (143) $ 734.70 Unvested balance at December 31, 2019 7,086 $ 33.78 For the year ended December 31, 2019 and 2018, the Company recorded stock-based compensation expense of $103 thousand and $88 thousand respectively, related to the time-based restricted securities. As of December 31, 2019, total unrecognized compensation expense related to non-vested restricted securities amounted to $227 thousand which the Company expects to recognize over a remaining weighted-average period of 2.29 years. All the restricted securities that remain unvested and outstanding at December 31, 2019 are subject to time-based vesting. |
WARRANTS
WARRANTS | 12 Months Ended |
Dec. 31, 2019 | |
WARRANTS | |
WARRANTS | 12. WARRANTS The following table presents information about warrants to purchase Common Stock issued and outstanding at December 31, 2019: Number of Exercise Year Issued Classification Warrants Price Date of Expiration 2014 Equity 11 $ 352.50 5/9/2021 2016 Equity 2,865 $ 7,500.00 3/18/2021 2018 Equity 252,896 $ 6.98 6/25/2023 2019 Equity 15,168 $ 4.50 11/21/2024 Total 270,940 Weighted average exercise price $ 86.09 Weighted average life in years 3.54 In November 2019, the Company agreed to issue the Placement Agent Warrants and in January 2020 the Company issued the Placement Agent Warrants. The Placement Agent Warrants are considered issued for accounting purposes as of November 2019 pursuant to the guidance in ASC Topic 815, Derivatives and Hedging. The Company assessed whether the warrants required accounting as derivatives and determined that the warrants 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 warrants meet the scope exception for determining whether the instruments require accounting as derivatives and accordingly are classified in stockholders’ equity. In May 2014, the Company issued warrants in a public offering (the “2014 Warrants”) and in June 2018, the Company closed an underwritten public offering in which warrants and Common Stock were issued. At inception, the warrants issued 2014 and 2018 had provisions that precluded equity classification. Upon amendment, the Company assessed whether the warrants required accounting as derivatives and determined that the warrants 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 warrants meet the scope exception for determining whether the instruments require accounting as derivatives and accordingly are classified in stockholders’ equity. See below for a further description of the warrant amendments. Warrant Cancellation During the year ended December 31, 2018, the Company entered into warrant cancellation agreements with certain holders of the 2014 Warrants to cancel and terminate such warrants for total cash consideration of $14 thousand. As of December 31, 2019, the remaining 2014 Warrants were exercisable for an aggregate of 11 shares of Common Stock. Warrant Amendments In May 2018, the Company entered into a warrant amendment agreement with the sole remaining holder of a 2014 Warrant (the “Warrant Amendment”). The warrant holder received cash compensation of $19 thousand and a 2 year extension of warrant term in exchange for the removal of all anti-dilution provisions except those for stock splits, reverse splits or stock dividends. As a result of the amendment, the Company reclassified the remaining 2014 warrants valued at $1 thousand to stockholders’ equity (see Note 10). In September 2018, the Company entered into the Ladenburg Warrant Amendment. As a result of the Ladenburg Warrant Amendment, the Company reclassified the 2018 Warrants valued at $14.7 million to stockholders’ equity (see Note 10). In November 2019, the Company entered into the Second Ladenburg Warrant Amendment to lower the exercise price of the Series A warrants from $60.00 to $6.98. As a result of the Second Ladenburg Warrant Amendment, the fair value of the amended 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 $666 thousand in the Company’s consolidated statement of operations. |
EMPLOYEE BENEFIT PLAN
EMPLOYEE BENEFIT PLAN | 12 Months Ended |
Dec. 31, 2019 | |
EMPLOYEE BENEFIT PLAN | |
EMPLOYEE BENEFIT PLAN | 13. 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 third 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, 2018, the Company issued an aggregate of 17 shares of Common Stock with a fair value of $6 thousand to the Company’s 401(k) plan as a matching contribution and also contributed $44 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, 2019 | |
INTELLECTUAL PROPERTY LICENSE | |
INTELLECTUAL PROPERTY LICENSE | 14. 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, 2019 and 2018 was $200 thousand (see Note 4). The Company accounts for milestone payments, maintenance fees and royalties when they become due and payable. The Company did not pay any milestone payments during the years ended December 31, 2019 or 2018. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2019 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 15. COMMITMENTS AND CONTINGENCIES Operating Leases On November 30, 2011, the Company entered into a commercial lease for 26,342 square feet of office, laboratory and manufacturing space in Cambridge, Massachusetts (as amended on September 17, 2012 and October 31, 2017, the “Cambridge Lease”). The term of the Cambridge Lease was 6 years and 3 months, with one 5‑year extension option. On August 21, 2017, the Company exercised its option for the 5-year extension on the Cambridge Lease. The 5- year renewal lease term was set to commence on November 1, 2018 and end on October 31, 2023. The terms of the Cambridge Lease required a standby letter of credit in the amount of $311 thousand. On June 13, 2017, the Company entered into a new short-term lease, to sub-lease 5,233 square feet of its facility (the “Moderna Sublease”). The lease term was from July 1, 2017 through October 26, 2018. On June 19, 2017, the Company received a $55 thousand security deposit under the terms of the Moderna Sublease. In connection with the Moderna Sublease, the Company received sublease income of $112 thousand for the year ended December 31, 2018, which was recorded as an offset to rent expense. In conjunction with the assignment of the Cambridge Lease on May 3, 2018 further described below, the $55 thousand security deposit received by the Company under the Moderna Sublease was transferred to the third party that assumed the lease. The Company did not record any sublease income associated with the Moderna Sublease during the year ended December 31, 2019. On May 3, 2018, the Company assigned the Cambridge Lease to a third party who assumed all of the Company’s remaining rights and obligations under the Cambridge Lease including the Moderna Sublease. On the same date as the lease assignment, the Company entered into a sublease for 5,104 square feet of space, originally part of the Cambridge Lease, from the third party to which the Company assigned the Cambridge Lease (the “Current Cambridge Lease”). The Current Cambridge Lease commenced on May 3, 2018 and expires October 31, 2023 and contains rent holiday and rent escalation clauses. The Current Cambridge Lease does not contain any renewal options. In connection with the Cambridge Lease Assignment and the Current Cambridge Lease, the $311 thousand standby letter of credit was terminated, and a new standby letter of credit was established for $40 thousand. On November 1, 2018, the standby letter of credit was increased to $60 thousand. The $55 thousand security deposit under the Moderna Sublease was transferred to the third party and $603 thousand of deferred rent was removed from the consolidated balance sheets. The resulting gain was recorded within the consolidated statement of operations during the second quarter of 2018. The Company also wrote off certain furniture, fixtures and equipment (including laboratory equipment) and recorded an impairment charge of $48 thousand for the year ended December 31, 2018. Under the Current 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 Current 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: Lease cost (In thousands) Year Ended December 31, 2019 Operating lease cost $ 364 Short-term lease cost 33 Variable lease cost 63 Total lease cost $ 460 Other information (In thousands) Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from short term leases $ 33 Operating cash flows from operating leases 243 Total cash paid for leases $ 276 Right-of-use assets obtained in exchange for operating lease liabilities - Weighted-average remaining lease term - operating leases 3.84 Years Weighted-average discount rate - operating leases Maturities of lease liabilities due under the Company’s Current Cambridge Lease as of December 31, 2019 is as follows: Leases (In thousands) As of December 31, 2019 2020 $ 375 2021 386 2022 398 2023 339 2024 — Total lease payments 1,498 Less: imputed interest (184) Present value of lease liabilities $ 1,314 Leases (In thousands) Classification As of December 31, 2019 Assets Lease asset Operating $ 1,211 Total lease assets $ 1,211 Liabilities Current Operating $ 294 Non-Current Operating 1,020 Total lease liabilities $ 1,314 Under ASC Topic 840, Leases (“ASC 840”) the Company recognized rent expense on a straight-line basis over the term of the lease and recorded the difference between the amount charged to expense and the rent paid as prepaid rent or deferred rent liability. As of December 31, 2018, the amount of prepaid rent was $17 thousand and this amount was subsequently reversed upon adoption of ASU No.2016-02 on January 1, 2019. Under ASC 840, rent expense related to the Company’s real estate lease charged to operations for the year ended December 31, 2018, including month ‑ to ‑ month leases, was $837 thousand. Compensation Commitment The Company entered into a compensation arrangement with an executive during September 2016 which provided for a future cash payment by the Company to the executive based on the February 13, 2017 stock price of the executive’s former employer. The award was earned over a period of 1 year. The expense related to the compensation arrangement was $174 thousand for the year ended December 31, 2018. As of both December 31, 2019 and 2018, there were no outstanding payments to the executive. Vendor Dispute In July 2018, the Company entered into a settlement agreement with a former vendor under which the vendor agreed to pay the Company $1.2 million, of which the full amount has been paid and was included in other income on the statement of operations. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2019 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | 16. SUBSEQUENT EVENTS Subsequent to December 31, 2019, and as of February 14, 2020, the Company issued an aggregate of 40,975 shares of common stock upon the exercise of the warrants, as amended, associated with the June 2018 underwritten public offering. Upon exercise, the Company received $286 thousand in cash. On January 21, 2020, the Company held its 2019 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 25,000,000 to 500,000,000 shares (without giving effect to the 2020 Reverse Stock Split). On February 11, 2020 the Company effected the 2020 Reverse Stock Split and as a result, 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. Any fractional shares resulting from the 2020 Reverse Stock Split have been rounded up to the nearest whole share. In connection with the 2020 Reverse Stock Split, the Company correspondingly reduced the number of authorized shares of Common Stock from 500,000,000 to 16,666,667. Throughout this report, the 2020 Reverse Stock Split was retroactively applied to all periods presented. In addition, at the Annual Meeting, the Company’s stockholders approved an amendment to the 2015 Plan to increase the number of shares available for issuance thereunder by 800,000 or 26,667 shares, as adjusted to reflect the 2020 Reverse Split, to a total of 960,000 or 32,000 shares, as adjusted to reflect the 2020 Reverse Split plus (i) the number of shares that remained available for issuance under the Company’s 2010 Equity Incentive Plan, as amended (the “Prior Plan”) as of the date that the Incentive Plan became effective and (ii) the number of shares that were subject to outstanding awards under the Prior Plan the date the Incentive Plan became effective that become available in the future due to cancellation, forfeiture or expiration of such outstanding awards and corresponding adjustments that will be reflected in various share limitations. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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. |
Reclassifications | Reclassification Certain accounts in the 2018 consolidated financial statements have been reclassified for comparative purposes to conform to the presentation in the 2019 consolidated financial statements. These reclassifications have no effect on previously reported earnings. |
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. At December 31, 2019 and 2018, cash equivalents were comprised of money market funds and other short-term investments. Cash and cash equivalents consist of the following: December 31, December 31, (In thousands) 2019 2018 Cash $ (15) $ (83) Money market funds 6,617 16,743 Total cash and cash equivalents $ 6,602 $ 16,660 |
Restricted cash | Restricted cash Restricted cash as of both December 31, 2019 and 2018 was $114 thousand and 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 15). |
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. The carrying value of the loan payable approximates fair value due to market terms. |
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, 2019, the Company had $1.2 million in prepayments for CRO services of which $120 thousand is included in prepaid and other current asset balance on the balance sheet and the remaining $1.1 million is included within the other long term assets balance on the balance sheet. As of December 31, 2018, the Company had $1.3 million in prepayments for CRO services of which $290 thousand is included in prepaid and other current asset balance on the balance sheet and the remaining $996 thousand 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 1 operating segment, which is developing and commercializing biopolymer scaffolding devices for the treatment of spinal cord injuries. As of December 31, 2019, and 2018, all of the Company’s assets were located in 1 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 2019. There were no material uncertain tax positions that required accrual or disclosure to the financial statements as of December 31, 2019 or 2018. Tax years subsequent to 2015 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. On May 3, 2018, the Company assigned the Cambridge Lease (as defined in Note 15) to a third party who assumed all of the Company’s remaining rights and obligations under the Cambridge Lease and as a result recorded an impairment charge of $48 thousand. |
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; however, certain warrants to purchase Common Stock that do not meet the requirements for classification as equity are classified as 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 charged (credited) 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 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. Diluted net income per share of Common Stock has been computed by dividing net income by the weighted average number of shares outstanding plus the dilutive effect, if any, of outstanding stock options, warrants and convertible securities. Diluted net loss per share of Common Stock has been computed by dividing the net loss for the period by the weighted average number of shares of Common Stock outstanding during such 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, 2019 and 2018, 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, 2019 2018 Warrants 270,940 255,781 Stock options 4,187 1,858 Unvested RSUs 200 343 Unvested RSAs 6,886 — Total potentially dilutive securities 282,213 257,982 |
Recently Adopted Accounting Standards | Recent accounting pronouncements In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842). The guidance in this ASU supersedes the leasing guidance in Topic 840, Leases. Under the new guidance, lessees are required to recognize lease assets and lease liabilities on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance leases or operating leases, with classification affecting the pattern of expense recognition in the statement of operations. In January, July and December 2018, the FASB issued ASU No’s. 2018-01, 2018-10, 2018-11, 2018-20 and 2019-01, which were targeted improvements to ASU No. 2016-02 (collectively, with ASU No. 2016-02, “ASC 842”) and provided entities with an additional (and optional) transition method to adopt the new lease standard, and provided clarifications to address potential narrow-scope implementation issues. The Company adopted ASU No. 2016- 02 effective January 1, 2019 and elected the optional transition method for adoption. The Company also took advantage of the transition package of practical expedients permitted within ASU No. 2016-02, which among other things, allowed it to carryforward historical lease classifications. The Company also elected to keep leases with an initial term of 12 months or less off of the balance sheet as a policy election and will recognize those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. As of the adoption date, the Company identified one operating lease arrangement in which it is a lessee. The adoption of this standard resulted in the recognition of operating lease liabilities and right-of-use assets of $1.5 million and $1.5 million, respectively, on the Company’s balance sheet as of January 1, 2019. The adoption of the standard did not have a material effect on the Company’s consolidated statements of operations or statements of cash flows. In February 2018, the FASB issued ASU No. 2018-02, Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. This ASU relates to the impacts of the tax legislation commonly referred to as the Tax Reform Act. The guidance permits the reclassification of certain income tax effects of the Tax Reform Act from other comprehensive income to retained earnings (stranded tax effects). The guidance also requires certain new disclosures. The guidance was effective for annual periods beginning after December 15, 2018, and interim periods within those reporting periods. Early adoption was permitted. Entities may adopt the guidance using 1 of 2 transition methods: retrospective to each period (or periods) in which the income tax effects of the Tax Reform Act related to the items remaining in other comprehensive income are recognized or at the beginning of the period of adoption. The Company adopted ASU No. 2018-02 on January 1, 2019 and it did not have a material effect on the Company’s financial position, results of operations or disclosures. In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting which is intended to reduce cost and complexity and to improve financial reporting for nonemployee share-based payments. The amendment is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption was permitted, but no earlier than an entity’s adoption date of ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606). The Company adopted ASU No. 2018-07 on January 1, 2019 and it did not have a material effect on the Company’s financial position, results of operations or disclosures. In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements which clarifies, corrects errors in, and makes improvements to several Codification Topics, including to: · Clarify when excess tax benefits should be recognized for share-based compensation awards · Remove inconsistent guidance in income tax accounting for business combinations · Clarify the circumstances when derivatives may be offset · Clarify the measurement of liability or equity-classified financial instruments when an identical asset is held as an asset · Allow portfolios of financial instruments and nonfinancial instruments accounted for as derivatives to use the portfolio exception to valuation The transition and effective date guidance is based on the facts and circumstances of each amendment. Some of the amendments in this ASU do not require transition guidance and were effective upon issuance of this ASU. However, many of the amendments in this ASU do have transition guidance with effective dates for annual periods beginning after December 15, 2018. The Company adopted ASU No. 2018-09 on January 1, 2019, and it 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 does not expect the adoption of this ASU to have a material effect on its consolidated financial statements. In July 2019, the FASB issued ASU No. 2019-07, Codification Updates to SEC Sections. This ASU amends various SEC paragraphs pursuant to the issuance of SEC Final Rule Releases No. 33-10532, Disclosure Update and Simplification, and Nos. 33-10231 and 33-10442, Investment Company Reporting Modernization. One of the changes in the ASU requires a presentation of changes in stockholders’ equity in the form of a reconciliation, either as a separate financial statement or in the notes to the financial statements, for the current and comparative year-to-date interim periods. The Company presented changes in stockholders' equity as separate financial statements for the current and comparative year-to-date interim periods. The additional elements of the ASU did not have a material impact on the Company's consolidated financial statements. This guidance was effective immediately upon issuance. 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 was adopted by the Company 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. This guidance is applicable to the Company’s fiscal year beginning January 1, 2020. The Company is currently evaluating the effects of this pronouncement on its consolidated financial statements. In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which is intended to simplify various aspects related to accounting for income taxes. The pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. ASU No. 2019-12 is effective for the Company beginning in fiscal 2021. The Company is currently evaluating the effects of this pronouncement on its consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of cash and cash equivalents | December 31, December 31, (In thousands) 2019 2018 Cash $ (15) $ (83) Money market funds 6,617 16,743 Total cash and cash equivalents $ 6,602 $ 16,660 |
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, 2019 2018 Warrants 270,940 255,781 Stock options 4,187 1,858 Unvested RSUs 200 343 Unvested RSAs 6,886 — Total potentially dilutive securities 282,213 257,982 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
PROPERTY AND EQUIPMENT | |
Schedule of property and equipment, net | (In thousands) 2019 2018 Computer software and hardware $ 131 $ 131 Research and lab equipment 520 508 Leasehold improvements 66 66 Property and equipment 717 705 Less accumulated depreciation and amortization (644) (605) Property and equipment, net $ 73 $ 100 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
INTANGIBLE ASSETS | |
Summary of intangible assets | (In thousands) 2019 2018 Patent licensing fee $ 200 $ 200 Accumulated amortization (174) (156) Intangible assets, net $ 26 $ 44 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
ACCRUED EXPENSES. | |
Summary of accrued expenses | December 31, (In thousands) 2019 2018 Severance and restructuring $ — $ 517 Compensation 1,040 489 Clinical 143 73 Legal 37 35 Other accrued expenses 207 176 Total accrued expenses $ 1,427 $ 1,290 |
FAIR VALUES OF ASSETS AND LIA_2
FAIR VALUES OF ASSETS AND LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
FAIR VALUES OF ASSETS AND LIABILITIES | |
Summary of assets and liabilities measured at fair value on a recurring basis | At December 31, 2019 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 6,617 $ — $ — $ 6,617 At December 31, 2018 (In thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 16,743 $ — $ — $ 16,743 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
INCOME TAXES | |
Schedule of significant components of net deferred tax assets | December 31, (In thousands) 2019 2018 Net operating loss carryforward $ 37,744 $ 34,846 Research and development credit carryforward 1,544 1,390 Stock-based compensation 2,319 2,300 Depreciation and amortization 17 11 Accrued expenses 19 136 Lease liability 360 — ROU Asset (331) — Subtotal 41,672 38,683 Valuation allowance (41,672) (38,683) Net deferred taxes $ — $ — |
Schedule of income tax benefits computed using the federal statutory income tax rate | December 31, 2019 2018 Statutory rate (21.0) % (21.0) % State taxes, net of benefit (5.7) % (2.9) % Permanent differences: Warrant modification expense 1.2 % — % Derivative losses — % 10.9 % Other 0.4 % 0.4 % Research and development tax credit (1.4) % (0.8) % Other 1.2 % 1.9 % Increase / (decrease) in valuation reserve 25.3 % 11.5 % Effective tax rate % % |
COMMON STOCK (Tables)
COMMON STOCK (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
COMMON STOCK. | |
Schedule of reserves established for future issuance of common stock | At December 31, 2019 Reserves for the exercise of warrants 270,940 Reserves for the exercise of stock options 4,187 Reserves for the vesting of RSUs 200 Reserves for the vesting of RSAs 6,886 Total Reserves 282,213 |
DERIVATIVE INSTRUMENTS (Tables)
DERIVATIVE INSTRUMENTS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
DERIVATIVE INSTRUMENTS | |
Changes in derivative warrant liability | Year Ended December 31, (In thousands) 2018 Balance at beginning of year $ 4 Issuance of new warrants 13,172 Reduction in derivative liability due to exercise of warrants (10,620) Reclassification of fair value of derivative liabilities to equity on amendment of warrant agreements (14,707) Repurchase of warrants (14) Increase in the fair value of warrants 12,165 Balance at end of year $ — |
SHARE-BASED COMPENSATION, STO_2
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES | |
Summary of stock based compensation classified in the consolidated statements of operations | (In thousands) Year Ended December 31, 2019 Year Ended December 31, 2018 Research and development $ 94 $ 183 General and administrative 174 435 Total $ 268 $ 618 |
Schedule of assumptions used principally in determining the fair value of options granted | December 31, December 31, 2019 2018 Risk-free interest rate 2.55% 2.45 - 2.88% Expected dividend yield 0% 0% Expected term (employee grants) 6 Years 5.62 Years Expected volatility 105% 104% |
Summary of option activity | Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Shares Price Term in Years Value Outstanding at December 31, 2017 4,570 $ 4,845.94 $ 22 Granted 520 $ 148.08 Expired (180) $ 5,130.40 Cancelled/Forfeited (3,052) $ 5,166.77 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 8.17 $ — Vested and Exercisable at December 31, 2019 1,000 $ 3,874.14 5.63 $ — |
Summary of restricted stock unit activity | Weighted-Average Restricted Securities Number of Grants Grant Date Fair Value Unvested balance at December 31, 2017 670 $ 767.16 Granted — — Vested/Released (143) $ 734.70 Forfeited (184) $ 934.10 Unvested balance at December 31, 2018 343 $ 693.17 Granted 6,886 $ 15.59 Vested (143) $ 734.70 Unvested balance at December 31, 2019 7,086 $ 33.78 |
WARRANTS (Tables)
WARRANTS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
WARRANTS | |
Schedule of information about warrants to purchase common stock issued and outstanding | Number of Exercise Year Issued Classification Warrants Price Date of Expiration 2014 Equity 11 $ 352.50 5/9/2021 2016 Equity 2,865 $ 7,500.00 3/18/2021 2018 Equity 252,896 $ 6.98 6/25/2023 2019 Equity 15,168 $ 4.50 11/21/2024 Total 270,940 Weighted average exercise price $ 86.09 Weighted average life in years 3.54 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
COMMITMENTS AND CONTINGENCIES | |
Schedule of other information | Lease cost (In thousands) Year Ended December 31, 2019 Operating lease cost $ 364 Short-term lease cost 33 Variable lease cost 63 Total lease cost $ 460 Other information (In thousands) Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from short term leases $ 33 Operating cash flows from operating leases 243 Total cash paid for leases $ 276 Right-of-use assets obtained in exchange for operating lease liabilities - Weighted-average remaining lease term - operating leases 3.84 Years Weighted-average discount rate - operating leases |
Schedule of maturities of lease liabilities | Leases (In thousands) As of December 31, 2019 2020 $ 375 2021 386 2022 398 2023 339 2024 — Total lease payments 1,498 Less: imputed interest (184) Present value of lease liabilities $ 1,314 |
Schedule of balance sheet information | Leases (In thousands) Classification As of December 31, 2019 Assets Lease asset Operating $ 1,211 Total lease assets $ 1,211 Liabilities Current Operating $ 294 Non-Current Operating 1,020 Total lease liabilities $ 1,314 |
NATURE OF OPERATIONS, BASIS OF
NATURE OF OPERATIONS, BASIS OF PRESENTATION AND RECENT ACCOUNTING PRONOUNCEMENTS - Reverse Stock Split (Details) $ / shares in Units, $ in Thousands | Feb. 11, 2020 | Apr. 16, 2018 | Dec. 31, 2019USD ($)$ / shares | Dec. 31, 2018USD ($)$ / shares |
Cash and cash equivalents | $ | $ 6,602 | $ 16,660 | ||
Common stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 | ||
Reverse stock split ratio | 0.04 | |||
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. On April 16, 2018, the Company effected a reverse stock split of its common stock, par value $0.00001 per share, at a ratio of 1-for-25 (the "2018 Reverse Stock Split"). As a result of the 2018 Reverse Stock Split, (i) every 25 shares of the issued and outstanding Common Stock were automatically converted into 1 newly issued and outstanding share of Common Stock, without any change in the par value per share; (ii) shares of Common Stock underlying outstanding stock options and other equity instruments convertible into Common Stock were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities, and (iii) the number of authorized shares of Common Stock outstanding was proportionally decreased. | |||
Going concern | false | |||
Subsequent event | ||||
Reverse stock split ratio | 0.0333 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES - CASH AND CASH EQUIVALENTS (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
CASH AND CASH EQUIVALENTS | ||
Cash | $ (15) | $ (83) |
Money market funds | 6,617 | 16,743 |
Total cash and cash equivalents | $ 6,602 | $ 16,660 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES - RESTRICTED CASH (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Restricted cash | $ 114 |
Security deposit related to credit card account | |
Restricted cash | 50 |
401K reserve account | |
Restricted cash | 4 |
Standby letter of credit in favor of a landlord | |
Restricted cash | $ 60 |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES, PROPERTY AND EQUIPMENT (Details) | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019USD ($)segmentitem | Dec. 31, 2018USD ($)item | |
Prepayments for CRO services | $ 1,200 | $ 1,300 |
Number of operating segments | segment | 1 | |
Number of locations in the United States | item | 1 | 1 |
Prepaid and other current assets | ||
Prepayments for CRO services | $ 120 | $ 290 |
Other long term assets | ||
Prepayments for CRO services | $ 1,100 | $ 996 |
SIGNIFICANT ACCOUNTING POLICI_8
SIGNIFICANT ACCOUNTING POLICIES, INCOME TAXES (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
SIGNIFICANT ACCOUNTING POLICIES | ||
Statutory tax rate (as a percent) | 21.00% | 21.00% |
SIGNIFICANT ACCOUNTING POLICI_9
SIGNIFICANT ACCOUNTING POLICIES, IMPAIRMENTS (Details) - USD ($) $ in Thousands | May 03, 2018 | Dec. 31, 2018 |
SIGNIFICANT ACCOUNTING POLICIES | ||
Impairment loss | $ 48 | $ 48 |
SIGNIFICANT ACCOUNTING POLIC_10
SIGNIFICANT ACCOUNTING POLICIES, NET LOSS PER COMMON SHARE (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 282,213 | 257,982 |
Warrant One | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 270,940 | 255,781 |
Stock Options | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 4,187 | 1,858 |
Unvested RSUs | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 200 | 343 |
Unvested RSAs | ||
Anti-dilutive | ||
Total potentially dilutive securities (in shares) | 6,886 |
SIGNIFICANT ACCOUNTING POLIC_11
SIGNIFICANT ACCOUNTING POLICIES, RECENT ACCOUNTING PRONOUNCEMENTS, ASU 2016-09 (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
New accounting pronouncements | ||
Operating lease liabilities | $ 1,314 | |
Operating lease right-of-use assets | $ 1,211 | |
ASU No. 2016-02 | Adjustment | ||
New accounting pronouncements | ||
Operating lease liabilities | $ 1,500 | |
Operating lease right-of-use assets | $ 1,500 |
PROPERTY AND EQUIPMENT, SCHEDUL
PROPERTY AND EQUIPMENT, SCHEDULE (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property and equipment | ||
Property and equipment | $ 717 | $ 705 |
Less accumulated depreciation and amortization | (644) | (605) |
Property and equipment, net | 73 | 100 |
Computer software and hardware | ||
Property and equipment | ||
Property and equipment | 131 | 131 |
Research and lab equipment | ||
Property and equipment | ||
Property and equipment | 520 | 508 |
Leasehold improvements | ||
Property and equipment | ||
Property and equipment | $ 66 | $ 66 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | May 03, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Depreciation | |||
Depreciation | $ 39 | $ 74 | |
Write off of fully depreciated assets | $ 1,300 | ||
Impairment loss | $ 48 | $ 48 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - Patent licensing fee - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Intangible assets | ||
Useful life | 15 years | |
Intangible assets - gross | $ 200 | $ 200 |
Accumulated amortization | (174) | (156) |
Intangible assets, net | $ 26 | $ 44 |
INTANGIBLE ASSETS, AMORTIZATION
INTANGIBLE ASSETS, AMORTIZATION (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Amortization | ||
Amortization expense | $ 18 | $ 17 |
Future amortization | ||
2020 | 18 | |
2021 | $ 8 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
ACCRUED EXPENSES. | ||
Severance and restructuring | $ 517 | |
Compensation | $ 1,040 | 489 |
Clinical | 143 | 73 |
Legal | 37 | 35 |
Other accrued expenses | 207 | 176 |
Total accrued expenses | $ 1,427 | $ 1,290 |
FAIR VALUES OF ASSETS AND LIA_3
FAIR VALUES OF ASSETS AND LIABILITIES (Details) - Recurring basis - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Assets and liabilities measured at fair value on a recurring basis | ||
Cash equivalents | $ 6,617 | $ 16,743 |
Level 1 | ||
Assets and liabilities measured at fair value on a recurring basis | ||
Cash equivalents | $ 6,617 | $ 16,743 |
LOAN PAYABLE (Details)
LOAN PAYABLE (Details) - USD ($) $ / shares in Units, $ in Thousands | May 01, 2015 | May 31, 2018 | Oct. 31, 2012 | Dec. 31, 2019 | Dec. 31, 2018 |
Loans Payable | |||||
Outstanding loan payable | $ 100 | ||||
Number of warrants outstanding | 270,940 | ||||
MassDev | |||||
Loans Payable | |||||
Line of credit, maximum | $ 2,000 | ||||
Line of credit for working capital purpose | $ 200 | ||||
Fixed interest rate (as a percent) | 6.50% | ||||
Period for interest-only payments | 30 months | ||||
Period for charging equal installments of interest and principal | 54 months | ||||
Maturity date | Mar. 1, 2019 | ||||
Commencement date of monthly installments | May 1, 2015 | ||||
Amount of monthly payment | $ 41 | ||||
Repayment of principal | $ 300 | ||||
Outstanding loan payable | $ 0 | ||||
Payments due in next twelve months | 100 | ||||
MassDev | 2012 Warrant Exercise price $166.00 | |||||
Loans Payable | |||||
Warrant expiration term (in years) | 7 years | ||||
Exercise price of warrant (in dollars per share) | $ 4,980 | ||||
Fair value of warrants | $ 32 | ||||
MassDev | 2012 Warrant Exercise price $166.00 | Interest Expense | |||||
Loans Payable | |||||
Amortization | 1 | 7 | |||
MassDev | 2012 Warrant Exercise price $166.00 | Common Stock | |||||
Loans Payable | |||||
Number of shares into which a warrant may be converted | 13 | ||||
MassDev | Equipment Line of Credit | |||||
Loans Payable | |||||
Interest expense | $ 1 | $ 43 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
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, 2019USD ($) |
U.S. federal | |
Net operating loss carryforwards | |
Net operating loss carryforwards | $ 140 |
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 | 22.8 |
Massachusetts | |
Net operating loss carryforwards | |
Net operating loss carryforwards | $ 131.9 |
INCOME TAXES, CREDITS (Details)
INCOME TAXES, CREDITS (Details) $ in Thousands | Dec. 31, 2018USD ($) |
U.S. federal | |
Tax credit carryforwards | |
Research and development tax credit carryforwards | $ 1,300 |
Massachusetts | |
Tax credit carryforwards | |
Research and development tax credit carryforwards | $ 258 |
INCOME TAXES, Tax Act (Details)
INCOME TAXES, Tax Act (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
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, 2019 | Dec. 31, 2018 | |
Significant components of net deferred tax asset | ||
Net operating loss carryforward | $ 37,744 | $ 34,846 |
Research and development credit carryforward | 1,544 | 1,390 |
Stock-based compensation | 2,319 | 2,300 |
Depreciation and amortization | 17 | 11 |
Accrued expenses | 19 | 136 |
Lease liability | 360 | |
ROU Asset | (331) | |
Subtotal | 41,672 | 38,683 |
Valuation allowance | (41,672) | (38,683) |
Net deferred taxes | 0 | 0 |
Retained earnings | (219,160) | (207,330) |
Increase (decrease) in valuation allowance | 3,000 | 2,700 |
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, 2019 | Dec. 31, 2018 | |
Income tax benefits computed using the federal statutory income tax rate | ||
Statutory rate | (21.00%) | (21.00%) |
State taxes, net of benefit | (5.70%) | (2.90%) |
Permanent differences: | ||
Warrant modification expense | 1.20% | |
Derivative losses | 10.90% | |
Other | 0.40% | 0.40% |
Research and development tax credit | (1.40%) | (0.80%) |
Other | 1.20% | 1.90% |
Increase / (decrease) in valuation reserve | 25.30% | 11.50% |
Effective tax rate | 0.00% | 0.00% |
COMMON STOCK, AUTHORIZED (Detai
COMMON STOCK, AUTHORIZED (Details) - shares | Feb. 11, 2020 | Jan. 31, 2020 | Jan. 21, 2020 | Jan. 20, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | May 31, 2018 | Apr. 30, 2018 |
Common stock, number of shares, par value and other disclosures | ||||||||
Common stock, authorized | 16,666,667 | 16,666,667 | 25,000,000 | 4,000,000 | ||||
Common stock, issued | 550,736 | 310,330 | ||||||
Common stock, outstanding | 550,736 | 310,330 | ||||||
Subsequent event | ||||||||
Common stock, number of shares, par value and other disclosures | ||||||||
Common stock, authorized | 16,666,667 | 500,000,000 | 500,000,000 | 25,000,000 |
COMMON STOCK, TRANSACTIONS (Det
COMMON STOCK, TRANSACTIONS (Details) - USD ($) $ / shares in Units, $ in Thousands | May 30, 2018 | Nov. 30, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | May 31, 2018 | Jan. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Oct. 31, 2019 |
Common stock disclosures | ||||||||||
Warrant Modification | $ 666 | $ 765 | ||||||||
Proceeds from issuance of common stock and warrants, net of issuance costs | $ 367 | 16,511 | ||||||||
Fair value adjustment of warrants | (12,165) | |||||||||
Warrant reclassified to equity | 14,707 | |||||||||
Proceeds from exercise of warrants | 131 | |||||||||
Number of Warrants | 270,940 | |||||||||
Aggregate number of shares reserved for issuance | 282,213 | |||||||||
Issuance of common stock to 401(k) plan | 6 | |||||||||
401(k) | ||||||||||
Common stock disclosures | ||||||||||
Company contributions to employee 401(k) accounts | $ 55 | $ 44 | ||||||||
2018 Series A Warrant Exercise price | ||||||||||
Common stock disclosures | ||||||||||
Exercise price (in dollars per unit) | $ 60 | |||||||||
Fair value adjustment of warrants | $ 666 | |||||||||
2018 Series B Warrant Exercise price | ||||||||||
Common stock disclosures | ||||||||||
Number of Warrants | 0 | 0 | ||||||||
2018 Warrants | ||||||||||
Common stock disclosures | ||||||||||
Fair value adjustment of warrants | $ 764 | |||||||||
Warrant reclassified to equity | $ 14,700 | |||||||||
2018 Warrant Exercise price $6.98 | ||||||||||
Common stock disclosures | ||||||||||
Exercise price (in dollars per unit) | $ 6.98 | $ 6.98 | ||||||||
Number of Warrants | 252,896 | |||||||||
Placement Agent Warrants | ||||||||||
Common stock disclosures | ||||||||||
Warrant expiration term (in years) | 5 years | |||||||||
Number of shares into which a warrant may be converted | 15,168 | |||||||||
Exercise price (in dollars per unit) | $ 4.50 | |||||||||
Common Stock | ||||||||||
Common stock disclosures | ||||||||||
Issuance of common stock and warrants in public offerings (in shares) | 233,341 | 55,084 | ||||||||
Issuance of common stock to 401(k) plan (in shares) | 17 | |||||||||
Restricted stock awards issued | 6,886 | |||||||||
Common Stock | 401(k) | ||||||||||
Common stock disclosures | ||||||||||
Issuance of common stock to 401(k) plan (in shares) | 17 | |||||||||
Aggregate number of shares reserved for issuance | 137 | |||||||||
Number of additional shares reserved | 134 | |||||||||
Issuance of common stock to 401(k) plan | $ 6 | |||||||||
Warrant One | ||||||||||
Common stock disclosures | ||||||||||
Aggregate number of shares reserved for issuance | 270,940 | |||||||||
Underwritten Public Offering, June 2018 | ||||||||||
Common stock disclosures | ||||||||||
Proceeds from issuance of common stock and warrants, net of issuance costs | $ 13,500 | |||||||||
Reclassification of derivative warrant liability to additional paid-in capital | $ 287 | |||||||||
Derivative loss | $ 12,000 | |||||||||
Underwritten Public Offering, June 2018 | 2018 Series A Warrant Exercise price | ||||||||||
Common stock disclosures | ||||||||||
Warrant expiration term (in years) | 5 years | 5 years | ||||||||
Exercise price (in dollars per unit) | $ 60 | |||||||||
Proceeds from exercise of warrants | $ 69 | |||||||||
Reclassification of derivative warrant liability to additional paid-in capital | 10,600 | |||||||||
Derivative loss | $ 1,200 | |||||||||
Underwritten Public Offering, June 2018 | 2018 Series B Warrant Exercise price | ||||||||||
Common stock disclosures | ||||||||||
Warrant expiration term (in years) | 20 years | 20 years | ||||||||
Exercise price (in dollars per unit) | $ 0.30 | |||||||||
Proceeds from exercise of warrants | $ 62 | |||||||||
Underwritten Public Offering, June 2018 | 2018 Warrants | ||||||||||
Common stock disclosures | ||||||||||
Proceeds from exercise of warrants | 131 | |||||||||
Reclassification of derivative warrant liability to additional paid-in capital | 10,600 | |||||||||
Derivative loss | $ 1,200 | |||||||||
Underwritten Public Offering, June 2018 | Common Stock And Warrants | ||||||||||
Common stock disclosures | ||||||||||
Issuance of common stock and warrants in public offerings (in shares) | 45,950 | |||||||||
Equity issuance (in price per unit) | $ 60 | $ 60 | ||||||||
Pre Funded Units | ||||||||||
Common stock disclosures | ||||||||||
Issuance of common stock and warrants in public offerings (in shares) | 208,096 | |||||||||
Equity issuance (in price per unit) | $ 59.70 | $ 59.70 | ||||||||
Pre Funded Units | 2018 Series A Warrant Exercise price | ||||||||||
Common stock disclosures | ||||||||||
Number of shares/warrants comprised in a unit (in shares) | 1 | |||||||||
Pre Funded Units | 2018 Series B Warrant Exercise price | ||||||||||
Common stock disclosures | ||||||||||
Number of shares/warrants comprised in a unit (in shares) | 1 | |||||||||
Pre Funded Units | Common Stock | ||||||||||
Common stock disclosures | ||||||||||
Number of shares of common stock to be purchased by each warrant | 1 | 1 | ||||||||
Underwritten public offering during November, 2019. | ||||||||||
Common stock disclosures | ||||||||||
Proceeds from issuance of common stock and warrants, net of issuance costs | $ 367 | |||||||||
Underwritten public offering during November, 2019. | Common Stock And Warrants | ||||||||||
Common stock disclosures | ||||||||||
Issuance of common stock and warrants in public offerings (in shares) | 233,341 | |||||||||
Equity issuance (in price per unit) | $ 3.60 | |||||||||
Purchase and registration rights agreement | Common Stock | ||||||||||
Common stock disclosures | ||||||||||
Issuance of common stock and warrants in public offerings (in shares) | 574 | 8,561 | ||||||||
Aggregate proceeds could be received | $ 15,000 | |||||||||
Term | 24 months | |||||||||
Deferred offering costs | $ 627 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 3,100 | |||||||||
Purchase and registration rights agreement | Common Stock | Maximum | ||||||||||
Common stock disclosures | ||||||||||
Aggregate number of shares reserved for issuance | 40,000 |
COMMON STOCK, TRANSACTIONS, OTH
COMMON STOCK, TRANSACTIONS, OTHER (Details) $ in Thousands | Apr. 16, 2018 | Apr. 16, 2018shares | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares |
Common stock disclosures | ||||
Proceeds from issuance of stock under ESPP | $ | $ 1 | $ 4 | ||
Reverse stock split ratio | 0.04 | |||
Issuance of common stock upon vesting of restricted stock units (in shares) | 143 | |||
Proceeds from exercise of warrants | $ | $ 131 | |||
Common Stock | ||||
Common stock disclosures | ||||
Stock issued under ESPP (in shares) | 36 | 48 | ||
Proceeds from issuance of stock under ESPP | $ | $ 4 | |||
Stock issued during period, shares, reverse stock splits | 92 | |||
Issuance of common stock upon vesting of restricted stock units (in shares) | 143 | 143 |
COMMON STOCK, RESERVES (Details
COMMON STOCK, RESERVES (Details) | Dec. 31, 2019shares |
Summary of common stock reserves | |
Total Reserves | 282,213 |
Warrant One | |
Summary of common stock reserves | |
Total Reserves | 270,940 |
Stock Options | |
Summary of common stock reserves | |
Total Reserves | 4,187 |
RSU | |
Summary of common stock reserves | |
Total Reserves | 200 |
RSA | |
Summary of common stock reserves | |
Total Reserves | 6,886 |
DERIVATIVE INSTRUMENTS, INCEPTI
DERIVATIVE INSTRUMENTS, INCEPTION FAIR VALUE OF WARRANTS (Details) $ in Thousands | Dec. 31, 2019USD ($) | Nov. 30, 2019USD ($)shares | Dec. 31, 2018USD ($) | Jun. 30, 2018USD ($)Y |
2018 Series B Warrant Exercise price | ||||
Fair value of warrants | ||||
Fair value of warrants | $ 0 | $ 0 | $ 11,500 | |
2018 Series B Warrant Exercise price | Underwritten Public Offering, June 2018 | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Warrant expiration term (in years) | 20 years | |||
2018 Series A Warrant Exercise price | ||||
Fair value of warrants | ||||
Fair value of warrants | $ 13,700 | |||
2018 Series A Warrant Exercise price | Underwritten Public Offering, June 2018 | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Warrant expiration term (in years) | 5 years | |||
Placement Agent Warrants | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Number of shares into which a warrant may be converted | shares | 15,168 | |||
Fair value of warrants | $ 59 | |||
Warrant expiration term (in years) | 5 years | |||
Risk-free interest rate | 2018 Series B Warrant Exercise price | ||||
Fair value of warrants | ||||
Derivative warrant liability measurement input | 2.95 | |||
Risk-free interest rate | 2018 Series A Warrant Exercise price | ||||
Fair value of warrants | ||||
Derivative warrant liability measurement input | 2.75 | |||
Risk-free interest rate | Placement Agent Warrants | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Fair value assumptions | 1.61 | |||
Expected dividend yield | 2018 Series B Warrant Exercise price | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Fair value assumptions | 0 | |||
Expected dividend yield | 2018 Series A Warrant Exercise price | ||||
Fair value of warrants | ||||
Derivative warrant liability measurement input | 0 | |||
Contractual term | 2018 Series B Warrant Exercise price | ||||
Fair value of warrants | ||||
Derivative warrant liability measurement input | Y | 20 | |||
Contractual term | 2018 Series A Warrant Exercise price | ||||
Fair value of warrants | ||||
Derivative warrant liability measurement input | Y | 5 | |||
Expected volatility | 2018 Series B Warrant Exercise price | ||||
Fair value of warrants | ||||
Derivative warrant liability measurement input | 202.51 | |||
Expected volatility | 2018 Series A Warrant Exercise price | ||||
Fair value of warrants | ||||
Derivative warrant liability measurement input | 202.51 | |||
Expected volatility | Placement Agent Warrants | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Fair value assumptions | 100.82 |
DERIVATIVE INSTRUMENTS (Details
DERIVATIVE INSTRUMENTS (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Nov. 30, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | May 31, 2018 | Jun. 30, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Oct. 31, 2019 | Dec. 31, 2017 | |
Derivative instruments | |||||||||
Derivative warrant liability | $ 0 | $ 4 | |||||||
Proceeds from exercise of warrants | 131 | ||||||||
Fair value adjustment of warrants | (12,165) | ||||||||
Warrant reclassified to equity | 14,707 | ||||||||
Warrant Modification | $ 666 | $ 765 | |||||||
Underwritten Public Offering, June 2018 | |||||||||
Derivative instruments | |||||||||
Proceeds allocated to warrant liability | $ 13,200 | ||||||||
Derivative warrant liability | 25,200 | $ 25,200 | |||||||
Derivative loss | $ 12,000 | ||||||||
Reclassification of derivative warrant liability to additional paid-in capital | $ 287 | ||||||||
Placement Agent Warrants | |||||||||
Derivative instruments | |||||||||
Warrant Exercise Price | $ 4.50 | ||||||||
2018 Series A Warrant Exercise price | |||||||||
Derivative instruments | |||||||||
Fair value adjustment of warrants | $ 666 | ||||||||
Warrant Exercise Price | $ 60 | ||||||||
2018 Series A Warrant Exercise price | Underwritten Public Offering, June 2018 | |||||||||
Derivative instruments | |||||||||
Derivative loss | 1,200 | ||||||||
Proceeds from exercise of warrants | 69 | ||||||||
Reclassification of derivative warrant liability to additional paid-in capital | $ 10,600 | ||||||||
Warrant Exercise Price | $ 60 | ||||||||
2018 Series B Warrant Exercise price | Underwritten Public Offering, June 2018 | |||||||||
Derivative instruments | |||||||||
Proceeds from exercise of warrants | $ 62 | ||||||||
Warrant Exercise Price | $ 0.30 | ||||||||
2014 Warrant Exercise price $352.50 | |||||||||
Derivative instruments | |||||||||
Fair value adjustment of warrants | $ 1 | ||||||||
Warrant reclassified to equity | $ 1 | ||||||||
Warrant Exercise Price | 352.50 | ||||||||
2018 Warrant Exercise price $6.98 | |||||||||
Derivative instruments | |||||||||
Warrant Exercise Price | $ 6.98 | $ 6.98 | |||||||
2018 Warrants | |||||||||
Derivative instruments | |||||||||
Fair value adjustment of warrants | $ 764 | ||||||||
Warrant reclassified to equity | $ 14,700 | ||||||||
2018 Warrants | Underwritten Public Offering, June 2018 | |||||||||
Derivative instruments | |||||||||
Derivative loss | $ 1,200 | ||||||||
Proceeds from exercise of warrants | 131 | ||||||||
Reclassification of derivative warrant liability to additional paid-in capital | $ 10,600 | ||||||||
Common Stock | 2018 Series A Warrant Exercise price | Underwritten Public Offering, June 2018 | |||||||||
Derivative instruments | |||||||||
Issuance of common stock upon exercise of warrants (in shares) | 1,150 | ||||||||
Common Stock | 2018 Series B Warrant Exercise price | Underwritten Public Offering, June 2018 | |||||||||
Derivative instruments | |||||||||
Issuance of common stock upon exercise of warrants (in shares) | 208,096 |
DERIVATIVE INSTRUMENTS, CHANGES
DERIVATIVE INSTRUMENTS, CHANGES IN DERIVATIVE WARRANT LIABILITY (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Changes in Derivative Warrant Liability | |
Balance at beginning of year | $ 4 |
Issuance of new warrants | 13,172 |
Reduction in derivative liability due to exercise of warrants | (10,620) |
Reclassification of fair value of derivative liabilities to equity on amendment of warrant agreements | 14,707 |
Reduction in derivative liability due to warrant exchange | (14) |
Repurchase of warrants | (14) |
Increase in the fair value of warrants | 12,165 |
Balance at end of period | $ 0 |
SHARE-BASED COMPENSATION, STO_3
SHARE-BASED COMPENSATION, STOCK OPTIONS, AND RESTRICTED SECURITIES (Details) - USD ($) $ in Thousands | Jan. 01, 2019 | Mar. 31, 2019 | Mar. 31, 2015 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2018 | Feb. 28, 2019 |
Stock options | |||||||
Aggregate number of shares reserved for issuance | 282,213 | ||||||
Stock-based compensation (in dollars) | $ 268 | $ 618 | |||||
Stock Options | |||||||
Stock options | |||||||
Granted (in shares) | 3,000 | 520 | |||||
Expected term | 10 years | ||||||
Aggregate number of shares reserved for issuance | 4,187 | ||||||
Stock-based compensation (in dollars) | $ 165 | $ 528 | |||||
2010 Plan | |||||||
Stock options | |||||||
Granted (in shares) | 0 | ||||||
Expected term | 10 years | ||||||
2015 Plan | |||||||
Stock options | |||||||
Shares available for future grants | 68 | ||||||
Shares authorized for issuance | 32,000 | 5,333 | |||||
Expected term | 10 years | ||||||
Increased share reserve | 26,667 | ||||||
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 | 264 | ||||||
Stock issued under ESPP (in shares) | 36 | ||||||
Offering Period | 6 months | ||||||
Stock-based compensation (in dollars) | $ 2 | ||||||
Employee Stock Purchase Plan | Maximum | |||||||
Stock options | |||||||
Aggregate number of shares reserved for issuance | 1,667 | ||||||
Common Stock | |||||||
Stock options | |||||||
Stock issued under ESPP (in shares) | 36 | 48 |
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, 2019 | Dec. 31, 2018 | |
Stock options | ||
Stock-based compensation (in dollars) | $ 268 | $ 618 |
Research and development | ||
Stock options | ||
Stock-based compensation (in dollars) | 94 | 183 |
General and administrative | ||
Stock options | ||
Stock-based compensation (in dollars) | 174 | 435 |
Stock Options | ||
Stock options | ||
Stock-based compensation (in dollars) | $ 165 | $ 528 |
Expected term | 10 years | |
Vesting period | 48 months |
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 | Dec. 31, 2018 | |
Assumptions used principally in determining the fair value of options granted | ||
Expected dividend yield (as a percent) | 0.00% | 0.00% |
Expected term (employee grants) | 6 years | 5 years 7 months 13 days |
Expected volatility (as a percent) | 105.00% | 104.00% |
Minimum | ||
Assumptions used principally in determining the fair value of options granted | ||
Risk-free interest rate (as a percent) | 2.55% | 2.45% |
Maximum | ||
Assumptions used principally in determining the fair value of options granted | ||
Risk-free interest rate (as a percent) | 2.88% |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock Option | |||
Stock-based compensation (in dollars) | $ 268 | $ 618 | |
Stock Options | |||
Summary of option activity - Shares | |||
Outstanding at the beginning of year (in shares) | 1,858 | 4,570 | |
Granted (in shares) | 3,000 | 520 | |
Expired (in shares) | (85) | (180) | |
Cancelled/Forfeited (in shares) | (586) | (3,052) | |
Outstanding at the end of period (in shares) | 4,187 | 1,858 | 4,570 |
Vested at the end of period (in shares) | 1,000 | ||
Summary of option activity - Weighted Average Exercise Price | |||
Outstanding at the beginning of year (in dollars per shares) | $ 2,976.58 | $ 4,845.94 | |
Granted (in dollars per shares) | 45.90 | 148.08 | |
Expired (in dollars per shares) | 6,794.12 | 5,130.40 | |
Cancelled/Forfeited (in dollars per shares) | 1,195.25 | 5,166.77 | |
Outstanding at the end of period (in dollars per shares) | 1,077.78 | $ 2,976.58 | $ 4,845.94 |
Vested at the end of period (in dollars per share) | $ 3,874.14 | ||
Option activity disclosures | |||
Weighted Average Remaining Contractual Term - Outstanding | 8 years 2 months 1 day | 7 years 3 months 26 days | 7 years 1 month 21 days |
Weighted Average Remaining Contractual Term - Vested | 5 years 7 months 17 days | ||
Aggregate Intrinsic Value - Outstanding (in dollars) | $ 22 | ||
Stock Option | |||
Weighted average grant-date fair value of options granted | $ 37.46 | $ 114.60 | |
Total fair value of options vested | $ 135 | $ 952 | |
Stock-based compensation (in dollars) | 165 | $ 528 | |
Total unrecognized compensation expense | $ 180 | ||
Period for unrecognized compensation expense is estimated to be recognized | 1 year 7 months 17 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, 2019 | Dec. 31, 2018 | |
Share-based compensation | ||
Stock-based compensation (in dollars) | $ 268 | $ 618 |
RSU | ||
Number of Grants | ||
Unvested balance at | 343 | 670 |
Granted (in shares) | 6,886 | |
Vested/Released (in shares) | (143) | (143) |
Forfeited (in shares) | (184) | |
Unvested balance at | 7,086 | 343 |
Weighted-Average Grant Date Fair Value | ||
Unvested balance at (in dollars per share) | $ 693.17 | $ 767.16 |
Granted (in dollars per share) | 15.59 | |
Vested/Released (in dollars per share) | 734.70 | 734.70 |
Forfeited (in dollars per share) | 934.10 | |
Unvested balance at (in dollars per share) | $ 33.78 | $ 693.17 |
Share-based compensation | ||
Stock-based compensation (in dollars) | $ 103 | $ 88 |
Unrecognized compensation | ||
Total unrecognized compensation expense | $ 227 | |
Period for unrecognized compensation expense is estimated to be recognized | 2 years 3 months 15 days |
WARRANTS (Details)
WARRANTS (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Nov. 30, 2019 | |
Warrants to purchase common stock issued and outstanding | ||
Number of Warrants | 270,940 | |
Weighted average exercise price | $ 86.09 | |
Weighted average life in years | 3 years 6 months 15 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 | 252,896 | |
Warrant Exercise Price | $ 6.98 | $ 6.98 |
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 |
WARRANTS, CANCELLATION AND AMEN
WARRANTS, CANCELLATION AND AMENDMENT (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Nov. 30, 2019 | Sep. 30, 2018 | May 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Oct. 31, 2019 | |
Warrants | ||||||
Repurchase of warrants | $ 14 | |||||
Warrant reclassified to equity | 14,707 | |||||
Fair value adjustment of warrants | $ (12,165) | |||||
2014 Warrant Exercise price $352.50 | ||||||
Warrants | ||||||
Repurchase of warrants | $ 14 | |||||
Cash compensation to warrant holder | $ 19 | |||||
Warranty extension period | 2 years | |||||
Warrant reclassified to equity | $ 1 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 352.50 | |||||
Fair value adjustment of warrants | $ 1 | |||||
2014 Warrant Exercise price $352.50 | Common Stock | ||||||
Warrants | ||||||
Number of shares into which a warrant may be converted | 11 | |||||
2018 Series A Warrant Exercise price | ||||||
Warrants | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 60 | |||||
Fair value adjustment of warrants | $ 666 | |||||
2018 Warrants | ||||||
Warrants | ||||||
Warrant reclassified to equity | $ 14,700 | |||||
Fair value adjustment of warrants | $ 764 | |||||
Placement Agent Warrants | ||||||
Warrants | ||||||
Number of shares into which a warrant may be converted | 15,168 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.50 |
EMPLOYEE BENEFIT PLAN (Details)
EMPLOYEE BENEFIT PLAN (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Employee benefit plan disclosures | ||
Eligibility criteria for participation in the Plan | 21 years | |
Stock Issued During Period, Value, Employee Benefit Plan | $ 6 | |
Employer Matching Contribution | 44 | |
Expense portion of fair value of stock | $ 6 | |
Common Stock | ||
Employee benefit plan disclosures | ||
Issuance of common stock to 401(k) plan (in shares) | 17 | |
401(k) | ||
Employee benefit plan disclosures | ||
Employer Matching Contribution | $ 55 | |
401(k) | Common Stock | ||
Employee benefit plan disclosures | ||
Issuance of common stock to 401(k) plan (in shares) | 17 | |
Stock Issued During Period, Value, Employee Benefit Plan | $ 6 |
INTELLECTUAL PROPERTY LICENSE (
INTELLECTUAL PROPERTY LICENSE (Details) - Boston Childrens Hospital Bch License - USD ($) $ in Thousands | Dec. 31, 2011 | Dec. 31, 2019 | Dec. 31, 2018 |
Intellectual Property License | |||
Useful life | 15 years | ||
Initial license fee paid | $ 75 | ||
Capitalized license fees, gross | $ 200 | $ 200 |
COMMITMENTS AND CONTINGENCIES,
COMMITMENTS AND CONTINGENCIES, LEASES (Details) $ in Thousands | May 03, 2018USD ($)ft² | Oct. 31, 2017USD ($)ft²item | Dec. 31, 2018USD ($) | Nov. 01, 2018USD ($) | Jun. 30, 2018USD ($) | Jun. 19, 2017USD ($) | Jun. 13, 2017ft² |
Lessee, Lease, Description [Line Items] | |||||||
Deferred rent removed and gain on lease assignment | $ 603 | ||||||
Loss on impairment of fixed assets | $ 48 | 48 | |||||
Prepaid rent | 17 | ||||||
Rent expense | 837 | ||||||
Operating Lease, Expense | 837 | ||||||
Moderna Sublease | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Lease space (in square feet) | ft² | 5,233 | ||||||
Sublease income recorded as offset to rent expense | 112 | ||||||
Tenant security deposit | $ 55 | ||||||
Third Party Lease | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Lease space (in square feet) | ft² | 5,104 | ||||||
Standby letter of credit | $ 40 | $ 60 | |||||
Tenant security deposit | $ 55 | ||||||
Cambridge Lease | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Lease space (in square feet) | ft² | 26,342 | ||||||
Term of commercial lease | 6 years 3 months | 5 years | |||||
Number of options to extend lease | item | 1 | ||||||
Term of lease extension option | 5 years | ||||||
Standby letter of credit | $ 311 | ||||||
Letter of credit terminated amount | $ 311 | ||||||
Loss on impairment of fixed assets | $ 48 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES, LEASE EXPENSE (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Lease expense | |
Operating lease cost | $ 364 |
Short-term lease cost | 33 |
Variable lease cost | 63 |
Total lease cost | $ 460 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES, LEASE OTHER INFORMATION (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
COMMITMENTS AND CONTINGENCIES | |
Operating cash flows from short term leases | $ 33 |
Operating cash flows from operating leases | 243 |
Total cash paid for leases | 276 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 1,475 |
Weighted-average remaining lease term - operating leases (years) | 3 years 10 months 2 days |
Weighted-average discount rate - operating leases | 7.00% |
COMMITMENTS AND CONTINGENCIES_4
COMMITMENTS AND CONTINGENCIES, MATURITIES OF LEASE LIABILITIES (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Maturities of lease liabilities | |
2020 | $ 375 |
2021 | 386 |
2022 | 398 |
2023 | 339 |
Total lease payments | 1,498 |
Less : Interest | (184) |
Present value of lease liabilities | $ 1,314 |
COMMITMENTS AND CONTINGENCIES_5
COMMITMENTS AND CONTINGENCIES, LEASE CLASSIFICATION (Details) $ in Thousands | Dec. 31, 2019USD ($) |
COMMITMENTS AND CONTINGENCIES | |
Operating Lease, Right-of-Use Asset | $ 1,211 |
Financial position | us-gaap:OperatingLeaseRightOfUseAsset |
Total lease assets | $ 1,211 |
Operating Liabilities - Current | $ 294 |
Financial position | Operating Liabilities - Current |
Operating Liabilities - Non Current | $ 1,020 |
Financial position | us-gaap:OperatingLeaseLiabilityNoncurrent |
Total Operating Liabilities | $ 1,314 |
Financial position | us-gaap:OperatingLeaseLiabilityCurrent us-gaap:OperatingLeaseLiabilityNoncurrent |
COMMITMENTS AND CONTINGENCIES_6
COMMITMENTS AND CONTINGENCIES, COMPENSATION (Details) - Executive - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Sep. 30, 2016 | Dec. 31, 2018 | Dec. 31, 2019 | |
Compensation Arrangement | |||
Term of award | 1 year | ||
Compensation expense | $ 174 | ||
Outstanding payments | $ 0 | $ 0 |
COMMITMENTS AND CONTINGENCIES_7
COMMITMENTS AND CONTINGENCIES, LITIGATION VENDOR DISPUTE (Details) - Former vendor $ in Millions | 1 Months Ended |
Jul. 31, 2018USD ($) | |
Litigation | |
Damages awarded | $ 1.2 |
Other income | |
Litigation | |
Proceeds received from settlement agreement | $ 1.2 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) $ / shares in Units, $ in Thousands | Feb. 14, 2020USD ($)shares | Feb. 11, 2020shares | Jan. 21, 2020shares | Apr. 16, 2018 | Dec. 31, 2019$ / sharesshares | Jan. 31, 2020shares | Jan. 20, 2020shares | Dec. 31, 2018$ / sharesshares | May 31, 2018shares | Apr. 30, 2018shares |
Subsequent events | ||||||||||
Common stock, authorized | 16,666,667 | 16,666,667 | 25,000,000 | 4,000,000 | ||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 | ||||||||
Stockholders' Equity, 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. On April 16, 2018, the Company effected a reverse stock split of its common stock, par value $0.00001 per share, at a ratio of 1-for-25 (the "2018 Reverse Stock Split"). As a result of the 2018 Reverse Stock Split, (i) every 25 shares of the issued and outstanding Common Stock were automatically converted into 1 newly issued and outstanding share of Common Stock, without any change in the par value per share; (ii) 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, and (iii) the number of authorized shares of Common Stock outstanding was proportionally decreased. | |||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 0.04 | |||||||||
Subsequent event | ||||||||||
Subsequent events | ||||||||||
Stock Issued During Period, Shares, New Issues | 40,975 | |||||||||
Proceeds from Issuance of Common Stock | $ | $ 286 | |||||||||
Common stock, authorized | 16,666,667 | 500,000,000 | 500,000,000 | 25,000,000 | ||||||
Increased share reserve | 26,667 | 800,000 | ||||||||
Shares authorized for issuance | 32,000 | 960,000 | ||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 0.0333 |