Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 07, 2019 | Jun. 29, 2018 | |
Document Entity Information [Abstract] | |||
Entity Registrant Name | Minerva Neurosciences, Inc. | ||
Entity Central Index Key | 0001598646 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Accelerated Filer | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 271.1 | ||
Entity Common Stock, Shares Outstanding | 39,025,471 | ||
Trading Symbol | NERV | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Small Business | true |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 50,234,871 | $ 26,051,821 |
Marketable securities | 37,762,439 | 102,109,419 |
Restricted cash | 100,000 | 80,000 |
Prepaid expenses and other current assets | 1,921,050 | 1,299,184 |
Total current assets | 90,018,360 | 129,540,424 |
Marketable securities - noncurrent | 5,022,982 | |
Equipment, net | 33,478 | 50,945 |
Other noncurrent assets | 14,808 | 14,808 |
In-process research and development | 34,200,000 | 34,200,000 |
Goodwill | 14,869,399 | 14,869,399 |
Total assets | 139,136,045 | 183,698,558 |
Current liabilities | ||
Notes payable - current portion | 3,962,664 | |
Accounts payable | 1,799,666 | 1,435,636 |
Accrued expenses and other current liabilities | 1,809,532 | 1,439,848 |
Total current liabilities | 3,609,198 | 6,838,148 |
Deferred taxes | 4,057,488 | 4,057,488 |
Deferred revenue | 41,175,600 | 41,175,600 |
Other noncurrent liabilities | 28,990 | 29,878 |
Total liabilities | 48,871,276 | 52,101,114 |
Commitments and contingencies | ||
Stockholders’ equity | ||
Preferred stock; $.0001 par value; 100,000,000 shares authorized; none issued or outstanding as of December 31, 2018 and 2017, respectively | ||
Common stock; $.0001 par value; 125,000,000 shares authorized; 38,937,971 and 38,749,343 shares issued and outstanding as of December 31, 2018 and 2017, respectively | 3,894 | 3,875 |
Additional paid-in capital | 304,813,603 | 295,975,010 |
Accumulated deficit | (214,552,728) | (164,381,441) |
Total stockholders’ equity | 90,264,769 | 131,597,444 |
Total liabilities and stockholders’ equity | $ 139,136,045 | $ 183,698,558 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 100,000,000 | 100,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 38,937,971 | 38,749,343 |
Common stock, shares outstanding | 38,937,971 | 38,749,343 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Expenses | ||
Research and development | $ 34,888,574 | $ 30,255,892 |
General and administrative | 16,841,308 | 10,914,269 |
Total expenses | 51,729,882 | 41,170,161 |
Loss from operations | (51,729,882) | (41,170,161) |
Foreign exchange losses | (4,847) | (56,887) |
Investment income | 1,673,890 | 941,833 |
Interest expense | (110,448) | (614,264) |
Loss before income taxes | (50,171,287) | (40,899,479) |
Benefit for income taxes | 0 | (9,376,272) |
Net loss | $ (50,171,287) | $ (31,523,207) |
Net loss per share, basic and diluted | $ (1.29) | $ (0.83) |
Weighted average shares outstanding, basic and diluted | 38,792,581 | 37,937,191 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2016 | $ 105,982,208 | $ 3,502 | $ 238,836,940 | $ (132,858,234) |
Balance (in shares) at Dec. 31, 2016 | 35,024,002 | |||
Repurchase of common stock | (389) | $ (389) | ||
Repurchase of common stock (in shares) | (3,892,256) | |||
Issuance of common stock in a public offering, net of issuance costs of $2,944,168 | 41,618,332 | $ 575 | 41,617,757 | |
Issuance of common stock in a public offering, net of issuance costs of $2,944,168 (in shares) | 5,750,000 | |||
Exercise of common stock warrants | 9,356,833 | $ 162 | 9,356,671 | |
Exercise of common stock warrants (in shares) | 1,621,073 | |||
Exercise of stock options | 1,130,544 | $ 20 | 1,130,524 | |
Exercise of stock options (in shares) | 197,874 | |||
Vesting of restricted stock units | $ 5 | (5) | ||
Vesting of restricted stock units (in shares) | 48,650 | |||
Stock-based compensation | 5,033,123 | 5,033,123 | ||
Net loss | (31,523,207) | (31,523,207) | ||
Balance at Dec. 31, 2017 | $ 131,597,444 | $ 3,875 | 295,975,010 | (164,381,441) |
Balance (in shares) at Dec. 31, 2017 | 38,749,343 | 38,749,343 | ||
Exercise of stock options | $ 655,934 | $ 13 | 655,921 | |
Exercise of stock options (in shares) | 129,978 | |||
Vesting of restricted stock units | $ 6 | (6) | ||
Vesting of restricted stock units (in shares) | 58,650 | |||
Stock-based compensation | 8,182,678 | 8,182,678 | ||
Net loss | (50,171,287) | (50,171,287) | ||
Balance at Dec. 31, 2018 | $ 90,264,769 | $ 3,894 | $ 304,813,603 | $ (214,552,728) |
Balance (in shares) at Dec. 31, 2018 | 38,937,971 | 38,937,971 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Public Offering | |
Issuance cost | $ 2,944,168 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (50,171,287) | $ (31,523,207) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 17,467 | 11,094 |
Amortization of debt discount recorded as interest expense | 38,040 | 206,562 |
(Accretion) of marketable securities premium | (119,614) | (185,488) |
Stock-based compensation expense | 8,182,678 | 5,033,123 |
Deferred taxes | (9,376,272) | |
Changes in operating assets and liabilities | ||
Prepaid expenses and other current assets | (621,866) | (306,996) |
Accounts payable | 364,030 | (32,705) |
Accrued expenses and other current liabilities | 369,684 | 624,035 |
Accrued collaborative expenses | (2,547,952) | |
Deferred revenue | 41,175,600 | |
Other noncurrent assets | (14,808) | |
Other noncurrent liabilities | (888) | 29,878 |
Net cash (used in) provided by operating activities | (41,941,756) | 3,092,864 |
Cash flows from investing activities: | ||
Purchases of marketable securities | (40,661,424) | (134,525,859) |
Proceeds from the maturity and redemption of marketable securities | 110,151,000 | 27,390,000 |
Purchases of equipment | (52,400) | |
Net cash provided by (used in) investing activities | 69,489,576 | (107,188,259) |
Cash flows from financing activities: | ||
Proceeds from sale of common stock in public offering | 44,562,500 | |
Costs paid in connection with public offering | (2,944,168) | |
Repurchase of common stock | (389) | |
Proceeds from exercise of common stock warrants | 9,356,833 | |
Proceeds from exercise of stock options | 655,934 | 1,130,544 |
Repayments of notes payable | (4,000,704) | (4,938,713) |
Net cash (used in) provided by financing activities | (3,344,770) | 47,166,607 |
Net increase (decrease) in cash and cash equivalents | 24,203,050 | (56,928,788) |
Cash, cash equivalents, and restricted cash | ||
Beginning of period | 26,131,821 | 83,060,609 |
End of period | 50,334,871 | 26,131,821 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 92,916 | 436,717 |
Reconciliation of the Condensed Consolidated Statements of Cash Flows to the Condensed Consolidated Balance Sheets | ||
Cash and cash equivalents | 50,234,871 | 26,051,821 |
Restricted cash | 100,000 | 80,000 |
Total cash, cash equivalents, and restricted cash | $ 50,334,871 | $ 26,131,821 |
Nature of Operations and Liquid
Nature of Operations and Liquidity | 12 Months Ended |
Dec. 31, 2018 | |
Nature Of Operations And Liquidity Disclosure [Abstract] | |
Nature of Operations and Liquidity | NOTE 1 — NATURE OF OPERATIONS AND LIQUIDITY Nature of Operations Minerva Neurosciences, Inc. (“Minerva” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat patients suffering from central nervous system diseases. The Company has acquired or in-licensed four development-stage proprietary compounds that it believes have innovative mechanisms of action and therapeutic profiles that may potentially address the unmet needs of patients with these diseases. The Company’s lead product candidate is roluperidone (also known as MIN-101), a compound the Company is developing for the treatment of schizophrenia. In addition, the Company’s portfolio includes seltorexant (also known as MIN-202 or JNJ-42847922), a compound the Company is co-developing with Janssen Pharmaceutica NV (“Janssen”) for the treatment of insomnia disorder and major depressive disorder (“MDD”); MIN-117, a compound the Company is developing for the treatment of MDD; and MIN-301, a compound the Company is developing for the treatment of Parkinson’s disease. In November 2013, the Company merged with Sonkei Pharmaceuticals Inc. (“Sonkei”), a clinical-stage biopharmaceutical company and, in February 2014, the Company acquired Mind-NRG, a pre-clinical-stage biopharmaceutical company. The Company refers to these transactions as the Sonkei Merger and Mind-NRG Acquisition, respectively. The Company holds licenses to roluperidone and MIN-117 from Mitsubishi Tanabe Pharma Corporation (“MTPC”) with the rights to develop, sell and import roluperidone and MIN-117 globally, excluding most of Asia. With the acquisition of Mind-NRG, the Company obtained exclusive rights to develop and commercialize MIN-301. The Company has also entered into a co-development and license agreement with Janssen, for the exclusive right to commercialize, and the co-exclusive right (with Janssen and its affiliates) to use and develop, seltorexant in the European Union, Switzerland, Liechtenstein, Iceland and Norway (the “Minerva Territory”), subject to certain royalty payments to Janssen, and royalty rights for any sales outside the Minerva Territory. Liquidity The accompanying financial statements have been prepared as though the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has limited capital resources and has incurred recurring operating losses and negative cash flows from operations since inception. As of December 31, 2018, the Company has an accumulated deficit of approximately $214.6 million and net cash used in operating activities was approximately $41.9 million during the year ended December 31, 2018. As of December 31, 2018, the Company had cash, cash equivalents, restricted cash, and marketable securities of $88.1 million. The Company believes that its existing cash, cash equivalents, restricted cash, and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months after the date that the financial statements are issued. The process of drug development can be costly and the timing and outcomes of clinical trials is uncertain. The assumptions upon which the Company has based its estimates are routinely evaluated and may be subject to change. The actual amount of the Company’s expenditures will vary depending upon a number of factors including but not limited to the design, timing and duration of future clinical trials, the progress of the Company’s research and development programs, the infrastructure to support a commercial enterprise, the cost of a commercial product launch, and the level of financial resources available. The Company has the ability to adjust its operating plan spending levels based on the timing of future clinical trials which will be predicated upon adequate funding to complete the trials. The Company will need to raise additional capital in order to continue to fund operations and fully fund later stage clinical development programs. The Company believes that it will be able to obtain additional working capital through equity financings or other arrangements to fund future operations; however, there can be no assurance that such additional financing, if available, can be obtained on terms acceptable to the Company. If the Company is unable to obtain such additional financing, future operations would need to be scaled back or discontinued. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | NOTE 2 — SIGNIFICANT ACCOUNTING POLICIES Basis of presentation The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”), and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. From its inception, the Company has devoted substantially all of its efforts to business planning, engaging regulatory, manufacturing and other technical consultants, planning and executing clinical trials and raising capital. Consolidation The accompanying consolidated financial statements include the results of the Company and its wholly-owned subsidiaries, Mind-NRG Sarl and Minerva Neurosciences Securities Corporation. Intercompany transactions have been eliminated. Significant risks and uncertainties The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. The Company currently has no commercially approved products and there can be no assurance that the Company’s research and development will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property. Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Cash and cash equivalents Cash equivalents include short-term, highly-liquid instruments, consisting of money market accounts and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk. Restricted cash Cash accounts with any type of restriction are classified as restricted. The Company maintained restricted cash balances as collateral for corporate credit cards in the amount of $100 thousand and $80 thousand at December 31, 2018 and 2017, respectively. Marketable securities Marketable securities consists of corporate and U.S. government debt securities maturing in nine months or less. Based on the Company’s intentions regarding its marketable securities, all marketable securities are classified as held-to-maturity and are carried under the amortized cost approach. The Company’s investments in marketable securities are classified as Level 2 within the fair value hierarchy. As of December 31, 2018, remaining final maturities of marketable securities ranged from January 2019 to September 2019, with a weighted average remaining maturity of approximately 4.91 months. The following table provides the amortized cost basis, aggregate fair value, net unrealized (gains)/losses and the net carrying value of investments in held-to-maturity securities as of December 31, 2018 and 2017: December 31, 2018 Amortized Aggregate Unrealized Unrealized Net Carrying Cost Fair Value Gains Losses Value Marketable securities: Corporate bonds/notes $ 16,054,071 $ 16,050,462 $ 3,609 $ — $ 16,054,071 Commercial paper 17,756,394 17,756,394 — — 17,756,394 U.S. government agency securities 3,951,974 3,951,040 934 — 3,951,974 Marketable securities total $ 37,762,439 $ 37,757,896 $ 4,543 $ — $ 37,762,439 December 31, 2017 Amortized Aggregate Unrealized Unrealized Net Carrying Cost Fair Value Gains Losses Value Marketable securities current: Corporate bonds/notes $ 43,528,246 $ 43,438,463 $ 89,783 $ — $ 43,528,246 Commercial paper 43,385,762 43,385,762 — — 43,385,762 U.S. government agency securities 15,195,411 15,178,278 17,133 — 15,195,411 Marketable securities current total 102,109,419 102,002,503 106,916 — 102,109,419 Marketable securities non-current: Corporate bonds/notes 5,022,982 4,998,870 24,112 — 5,022,982 Commercial paper — — — — — U.S. government agency securities — — — — — Marketable securities non-current total 5,022,982 4,998,870 24,112 — 5,022,982 Marketable securities total $ 107,132,401 $ 107,001,373 $ 131,028 $ — $ 107,132,401 Research and development costs In-process research and development In-process research and development (“IPR&D”) assets represent capitalized incomplete research projects that the Company acquired through business combinations. Such assets are initially measured at their acquisition date fair values. The initial fair value of the research projects are recorded as intangible assets on the balance sheet, rather than expensed, regardless of whether these assets have an alternative future use. The amounts capitalized are being accounted for as indefinite-lived intangible assets, subject to impairment testing, until completion or abandonment of research and development efforts associated with the project. An IPR&D asset is considered abandoned when it ceases to be used (that is, research and development efforts associated with the asset have ceased, and there are no plans to sell or license the asset or derive defensive value from the asset). At that point, the asset is considered to be disposed of and is written off. Upon successful completion of each project, the Company will make a determination about the then remaining useful life of the intangible asset and begin amortization. The Company tests its indefinite-lived intangibles, IPR&D assets, for impairment annually on November 30 and more frequently if events or changes in circumstances indicate that it is more likely than not that the asset is impaired. When testing indefinite-lived intangibles for impairment, the Company may assess qualitative factors for its indefinite-lived intangibles to determine whether it is more likely than not (that is, a likelihood of more than 50 percent) that the asset is impaired. Alternatively, the Company may bypass this qualitative assessment for some or all of its indefinite-lived intangibles and perform the quantitative impairment test that compares the fair value of the indefinite-lived intangible asset with the asset’s carrying amount. There was no impairment of IPR&D for the years ended December 31, 2018 or 2017. Stock-based compensation The Company recognizes compensation cost relating to stock-based payment transactions using a fair-value measurement method, which requires all stock-based payments to employees, including grants of employee stock options, to be recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. The Company determines the fair value of stock-based awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield, expected forfeiture rate and expected life of the options. The fair value of restricted stock units (“RSUs”) is equal to the closing price of the Company’s common stock on the date of grant. The date of expense recognition for grants to non-employees is the earlier of the date at which a commitment for performance by the counterparty to earn the equity instrument is reached or the date at which the counterparty’s performance is complete. The Company determines the fair value of stock-based awards granted to non-employees similar to the way fair value of awards are determined for employees except that certain assumptions used in the Black-Scholes option-pricing model, such as expected life of the option, may be different and the fair value of each unvested award is adjusted at the end of each period for any change in fair value from the previous valuation until the award vests. Foreign currency transactions The Company’s functional currency is the U.S. dollar. The Company pays certain vendor invoices in the respective foreign currency. The Company records an expense in United States Dollars at the time the liability is incurred. Changes in the applicable foreign currency rate between the date an expense is recorded and the payment date is recorded as a foreign currency gain or loss. Loss per share Basic loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding for the period. Diluted loss per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. The treasury stock method is used to determine the dilutive effect of the Company’s stock options and warrants. The Company had a net loss in all periods presented thus the inclusion of stock options and warrants would be anti-dilutive to net loss per share. Income taxes Deferred tax assets and liabilities are determined based on differences between financial reporting and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Uncertain tax positions are evaluated and if appropriate, the amount of unrecognized tax benefits are recorded within deferred tax assets. Deferred tax assets are evaluated for realization based on a more-likely-than-not criterion in determining if a valuation allowance should be provided. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company uses a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. The Company has elected to treat interest and penalties, to the extent they arise, as a component of income tax expense. There was no interest or penalties related to income taxes for the years ended December 31, 2018 or 2017. Income tax years beginning in 2012 for federal and state purposes are generally subject to examination by taxing authorities, although net operating losses from all prior years are subject to examinations and adjustments for at least three years following the year in which the tax attributes are utilized. On December 22, 2017, the United States enacted tax reform legislation commonly known as the Tax Cuts and Jobs Act (the “Act”), resulting in significant modifications to existing law. The Company completed the accounting for the effects of the Act during 2017. The Company’s financial statements for the year ended December 31, 2017, reflected the effects of the Act which included a reduction in the corporate tax rate from 34% to 21%. Accordingly, the Company’s deferred tax assets and liabilities were revalued at the enacted rates effective in 2018 and in future years; the reduction in federal rate from 34% to 21% resulted in no impact to total income tax expense. In addition to the federal rate change impact, the Company accounted for the impact of legislation on the timing of deferred tax positions and overall financial statement presentation, resulting in a total income tax benefit of $9.4 million related to future implications of indefinite lived deferred tax positions in 2017. As the accounting for the effects was complete during 2017, no further changes impacted tax positions during the period ending December 31, 2018. Concentration of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and marketable securities. The Company maintains its cash and cash equivalent balances in the form of business checking accounts and money market accounts, the balances of which, at times, may exceed federally insured limits. Exposure to cash and cash equivalents credit risk is reduced by placing such deposits with major financial institutions and monitoring their credit ratings. Marketable securities consist primarily of corporate bonds, with fixed interest rates. Exposure to credit risk of marketable securities is reduced by maintaining a diverse portfolio and monitoring their credit ratings. Equipment Equipment is stated at cost less accumulated depreciation. Equipment is depreciated on the straight-line basis over their estimated useful lives of three years. Expenditures for maintenance and repairs are charged to expense as incurred. Long-lived assets The Company reviews the recoverability of all long-lived assets, including the related useful lives, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. If required, the Company compares the estimated undiscounted future net cash flows to the related asset’s carrying value to determine whether there has been an impairment. If an asset is considered impaired, the asset is written down to fair value, which is based either on discounted cash flows or appraised values in the period the impairment becomes known. The Company believes that all long-lived assets are recoverable, and no impairment was deemed necessary at December 31, 2018 and 2017. Goodwill The Company tests its goodwill for impairment annually, or whenever events or changes in circumstances indicate an impairment may have occurred, by comparing its reporting unit’s carrying value to its fair value. Impairment may result from, among other things, deterioration in the performance of the acquired business, adverse market conditions, adverse changes in applicable laws or regulations and a variety of other circumstances. If the Company determines that an impairment has occurred, it is required to record a write-down of the carrying value and charge the impairment as an operating expense in the period the determination is made. In evaluating the recoverability of the carrying value of goodwill, the Company must make assumptions regarding estimated future cash flows and other factors to determine the fair value of the acquired assets. Changes in strategy or market conditions could significantly impact those judgments in the future and require an adjustment to the recorded balances. The Company tested its goodwill for impairment as of November 30. There was no impairment of goodwill for the years ended December 31, 2018 or 2017. Fair value of financial instruments The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels: Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 — Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). Level 3 — Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data. The following tables present information about the Company’s cash equivalents and marketable securities (current and non-current) as of December 31, 2018 and 2017, measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: December 31, 2018 Total Level 1 Level 2 Level 3 Cash equivalents $ 42,575,645 $ 36,600,836 $ 5,974,809 $ — Marketable securities 37,757,896 — 37,757,896 — Total fair value $ 80,333,541 $ 36,600,836 $ 43,732,705 $ — December 31, 2017 Total Level 1 Level 2 Level 3 Cash equivalents $ 22,782,626 $ 22,782,626 $ — $ — Marketable securities 107,132,401 — 107,132,401 — Total fair value $ 129,915,027 $ 22,782,626 $ 107,132,401 $ — Cash equivalents include short-term, highly-liquid instruments, consisting of money market accounts and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk. Marketable securities consists of corporate and U.S. government debt securities maturing in nine months or less. Based on the Company’s intentions regarding its marketable securities, all marketable securities are classified as held-to-maturity and are carried under the amortized cost approach. Marketable securities are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. The carrying amounts of cash, restricted cash, accounts payable, and accrued liabilities approximate fair value because of their short-term nature. The Company believes that the Company’s debt obligations accrue interest at rates which approximate prevailing market rates for instruments with similar characteristics and, accordingly, the carrying values for these instruments approximate fair value. Revenue recognition The Company applies the revenue recognition guidance in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customer’s When the Company enters into an arrangement that meets the definition of a collaboration under ASC 808, Collaborative Arrangements Deferred revenue The Company applies the revenue recognition guidance in accordance with ASC 606, Revenue from Contracts with Customer’s. Using ASC 606, revenue that is unearned is deferred. Deferred revenue expected to be recognized as revenue more than one year subsequent to the balance sheet date is classified as long-term deferred revenue. Segment information Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) about which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief decision maker, who is the Chief Executive Officer, reviews operating results to make decisions about allocating resources and assessing performance for the entire Company. The Company views its operations and manages its business as one operating segment. Comprehensive loss The Company had no items of comprehensive loss other than its net loss for each period presented. Recent accounting pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as of the specified effective date. Recently Adopted Accounting Pronouncements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net) Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients The Revenue ASUs provide an accounting standard for a single comprehensive model for use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. The accounting standard is effective for interim and annual periods beginning after December 15, 2017. The guidance permits two methods of adoption: retrospectively to each prior reporting period presented (the full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). The Company performed a detailed review of its collaboration agreements and assessed the differences in accounting for such contracts under this guidance compared with current revenue accounting standards. The Company adopted the new standard on January 1, 2018 using the modified retrospective method. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows – Classification of Certain Cash Receipts and Cash Payments (Topic 230) In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows- Restricted Cash (Topic 230) Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued ASU No. 2016-02, Leases Commitments and Contingencies In January 2017, the FASB issued ASU No. 2017-04, Intangibles — Goodwill and Other (Topic 350). In March 2017, the FASB issued ASU No. 2017-08, Receivables—Nonrefundable Fees and Other Costs (Subtopic 310-20) Premium Amortization on Purchased Callable Debt Securities. In June 2018, the FASB issued ASU No. 2018-07, Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting Topic 718, Compensation-Stock Compensation Subtopic 505-50, Equity-Equity-Based payments to Non-Employees Topic 606, Revenue from Contracts with Customers |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | NOTE 3 — ACCRUED EXPENSES AND OTHER LIABILITIES Accrued expenses and other liabilities consist of the following: December 31, 2018 December 31, 2017 Research and development costs and other accrued expenses $ 1,353,987 $ 1,162,441 Professional fees 455,545 251,000 Interest payable — 20,508 Accrued bonus — 5,899 $ 1,809,532 $ 1,439,848 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share of Common Stock | NOTE 4 — NET LOSS PER SHARE OF COMMON STOCK Diluted loss per share is the same as basic loss per share for all periods presented as the effects of potentially dilutive items were anti-dilutive given the Company’s net loss. Basic loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding. The following table sets forth the computation of basic and diluted loss per share for common stockholders: Year Ended December 31, 2018 2017 Net loss $ (50,171,287 ) $ (31,523,207 ) Weighted average shares of common stock outstanding 38,792,581 37,937,191 Net loss per share of common stock – basic and diluted $ (1.29 ) $ (0.83 ) The following securities outstanding at December 31, 2018 and 2017 have been excluded from the calculation of weighted average shares outstanding as their effect on the calculation of loss per share is antidilutive: December 31, 2018 December 31, 2017 Common stock options 8,498,047 6,132,650 Restricted stock units 127,300 185,950 Common stock warrants 40,790 40,790 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt | NOTE 5 — DEBT Loan and security agreement On January 16, 2015, the Company entered into a Loan and Security Agreement (as amended, the “Loan Agreement”) with Oxford Finance LLC (“Oxford”) and Silicon Valley Bank (“SVB” and, together with Oxford, the “Lenders”), providing for term loans to the Company in an aggregate principal amount of up to $15 million, in two tranches (the “Term Loans”) The Company drew down the initial Term Loans in the aggregate principal amount of $10 million (the “Term A Loans”), on January 16, 2015. The Term A Loans bore interest at a fixed rate of 7.05% per annum. The Company believes that the Company's debt obligations accrued interest at rates which approximated prevailing market rates for instruments with similar characteristics and, accordingly, the carrying values for these instruments approximated fair value. The Company paid a facility fee at the time of borrowing of $75 thousand for access to the Term Loans and paid a final payment of $510 thousand in August 2018, representing 5.1% of the total amount borrowed, which has been included as a component of the debt discount and was amortized to interest expense over the term of the loans. The Term Loans matured on August 1, 2018 and the Company made a final repayment in the amount of $510 thousand on such date. As of December 31, 2018, the Company had no borrowings outstanding under the Term Loans. For the year ended December 31, 2018, and 2017, the Company recognized interest expense of $0.1 million and $0.6 million, respectively, including $38 thousand and $0.2 million, respectively, |
Co-Development and License Agre
Co-Development and License Agreement | 12 Months Ended |
Dec. 31, 2018 | |
Co Development And License Agreement Disclosure [Abstract] | |
Co-Development and License Agreement | NOTE 6 — CO-DEVELOPMENT AND LICENSE AGREEMENT On February 13, 2014, the Company signed a co-development and license agreement (the “Agreement”) with Janssen, which became effective upon completion of the Company’s initial public offering and provided for the payment of a $22.0 million license fee by the Company. Under the Agreement, Janssen, the licensor, granted the Company an exclusive license, with the right to sublicense, in the Minerva Territory, under (i) certain patent and patent applications to sell products containing any orexin 2 compound, controlled by the licensor and claimed in a licensor patent right as an active ingredient, and (ii) seltorexant for any use in humans. In addition, upon regulatory approval in the Minerva Territory (and earlier if certain default events occur), the Company will have rights to manufacture seltorexant, also known as JNJ-42847922. The Company has granted to the licensor an exclusive license, with the right to sublicense, under all patent rights and know-how controlled by the Company related to seltorexant to sell seltorexant outside the Minerva Territory. In consideration of the licenses granted on July 7, 2014, the Company made a license fee payment of $22.0 million, which was included as a component of research and development expense in 2014. The Company accounts for the Agreement as a joint risk-sharing collaboration in accordance with ASC 808, “Collaborative Arrangements”. Payments between the Company and the licensor with respect to each party’s share of seltorexant development costs that have been incurred pursuant to the joint development plan are recorded within research and development expenses or general and administrative expenses, as applicable, in the accompanying consolidated statements of operations due to the joint risk-sharing nature of the activities. On July 6, 2016, the Company and Janssen agreed that “Decision Point 2” had been reached as defined under the Agreement. As neither party exercised their right to withdraw from the Agreement, the Company paid Janssen $3.5 million and has incurred direct expenses of $0.3 million related to development activities under the current phase of development. During the 12 months ended December 31, 2018 and 2017, the Company recorded expenses of zero and $11.2 million, respectively, for certain development activities in accordance with the terms of the Agreement. In June 2017, the Company entered into an amendment (“the Amendment”) to the co-development and license agreement with Janssen dated February 13, 2014 (the “Agreement”). The effectiveness of the Amendment was contingent upon approval of its terms by the European Commission and the closing of the acquisition of Actelion Ltd. by affiliates of Janssen. These conditions were subsequently met, and the Amendment became effective on August 29, 2017. Under Amendment, Janssen has waived its right to royalties on seltorexant insomnia sales in the Minerva Territory. The Company retains all of its rights to seltorexant, including commercialization of the molecule for the treatment of insomnia and as an adjunctive therapy for MDD, which include an exclusive license in the Minerva Territory, with royalties payable by the Company to Janssen on seltorexant sales outside of the insomnia indication. Royalties on sales outside of the Minerva Territory are payable by Janssen to the Company. Janssen made an upfront payment to the Company of $30 million upon the effectiveness of the Amendment and agreed to make a $20 million payment at the start of a Phase 3 insomnia trial for seltorexant and a $20 million payment when 50% of the patients are enrolled in this trial. Janssen further agreed to waive development payments from the Company until completion of the Phase 2b development milestone. This milestone is referred to as “Decision Point 4” and is expected to occur in the second half of 2019. The $30 million payment and $11.2 million in previously accrued collaborative expenses, which were forgiven upon the effective date of the Amendment, are earned and recognized as revenue as the services are performed from the commencement of Phase 3 development to the completion of the development activities using the proportional performance method. The $30 million payment along with the $11.2 million in previously accrued collaborative expenses have been included under deferred revenue on the Company’s balance sheet at December 31, 2018 and December 31, 2017. In connection with the Amendment, the Company repurchased all of the approximately 3.9 million shares of its common stock previously owned by Johnson & Johnson Innovation-JJDC Inc. at a per share price of $0.0001, for an aggregate purchase price of approximately $389. As a result of the Amendment, the Company assumed strategic control of matters relating to the clinical development of seltorexant for insomnia and has no further financial obligations until after Decision Point 4. After Decision Point 4, both the Company and Janssen have the right to opt-out of the Agreement. If the Company opts-out, it collects a royalty on worldwide sales of seltorexant in the single digits with no further obligations to Janssen. If Janssen opts-out, the Minerva Territory would be expanded to include North America and the Company would pay Janssen royalties on sales of seltorexant outside of the insomnia indication in the single digits. If both parties elect to continue past Decision Point 4 into Phase 3, the Company would be obligated to fund the clinical trials related to insomnia, receive up to $40 million in milestone payments from Janssen, and be responsible for 40% of all costs incurred in the Phase 3 MDD program. The Company determined that the license under the Amendment is not considered to be a separate deliverable as it contains no value without the development activities performed under the Agreement. The participation in the joint steering committee under the Amendment is considered to be not separable from the development activities and therefore the two deliverables are combined into a single unit of account. The Company concluded that the milestone payments are related to future performance obligations and will be recognized as those performance obligations are performed by the Company. Similarly, the Company will recognize royalty revenues in the periods of the sale of the related products, provided that no future performance obligations exists and revenue recognition is limited to amounts for which it is probable that a significant reversal will not occur. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | NOTE 7 — STOCKHOLDERS’ EQUITY Public Offering of Common Stock On July 5, 2017, the Company closed a public offering of its common stock, in which the Company issued and sold 5,750,000 shares of its common stock, including 750,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares, at a public offering price of $7.75, for aggregate gross proceeds to the Company of $44.6 million. All of the shares issued and sold in this public offering were registered under the Securities Act pursuant to a registration statement on Form S-3 (File No. 333-205764) and a related prospectus and prospectus supplement, in each case filed with the Securities and Exchange Commission Share Repurchase In August 2017, in connection with the Amendment (see Note 6), the Company repurchased all of the approximately 3.9 million shares of its common stock previously owned by Johnson & Johnson Innovation-JJDC Inc. at a per share price of $0.0001, for an aggregate purchase price of approximately $389. Warrants Exercises In March 2017, certain investors in the Company’s March 2015 private placement exercised their warrants at an exercise price of $5.772 per share and received an aggregate of 1,621,073 shares of the Company’s common stock. The Company received gross proceeds of approximately $9.4 million from the exercise of these warrants. As of December 31, 2018, there are no remaining warrants outstanding under the Company’s March 2015 private placement. Term Loan Warrants In connection with the Loan Agreement, the Company issued the Lenders warrants to purchase shares of its common stock upon its draw of each tranche of the Term Loans (see Note 5). The aggregate number of shares of common stock issuable upon exercise of the warrants is equal to 2.25% of the amount drawn of such tranche, divided by the average closing price per share of the Company’s common stock reported on the Nasdaq Global Market for the 10 consecutive trading days prior to the applicable draw. Upon the draw of the Term A Loans, the Company issued the Lenders warrants to purchase 40,790 shares of common stock at a per share exercise price of $5.516. The warrants are immediately exercisable upon issuance, and other than in connection with certain mergers or acquisitions, will expire on the ten-year anniversary of the date of issuance. The fair value of the warrants was estimated at $0.2 million using a Black-Scholes model and assuming: (i) expected volatility of 100.8%, (ii) risk free interest rate of 1.83%, (iii) an expected life of 10 years and (iv) no dividend payments. The fair value of the warrants was included as a discount to the Term A Loans and also as a component of additional paid-in capital and will be amortized to interest expense over the term of the loan. All such warrants were outstanding as of December 31, 2018. |
Stock Award Plan and Stock-Base
Stock Award Plan and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Award Plan and Stock-Based Compensation | NOTE 8 — STOCK AWARD PLAN AND STOCK-BASED COMPENSATION In December 2013, the Company adopted the 2013 Equity Incentive Plan (as subsequently amended and restated, the “Plan”), which provides for the issuance of options, stock appreciation rights, stock awards and stock units. On January 1, 2018, in accordance with the terms of the Plan, the total shares authorized for issuance under the plan increased by 750,000 to 6,531,333. This increase represents the lesser of 750,000 shares or 4% of the total shares outstanding calculated as of the end of the most recent fiscal year. In December 2017, the Company, issued inducement awards in the form of an option to purchase 775,000 shares of the Company’s common stock with an exercise price of $6.05 per share and restricted stock unit award to acquire 40,000 shares of the Company’s common stock, to Rick Russell in connection with his appointment as the Company’s President. These inducement awards are outside of, but subject to the terms generally consistent with, the Company’s 2013 Equity Incentive Plan, as amended, or the 2013 Plan, as a material inducement to Mr. Russell’s acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The exercise price per share shall not be less than the fair value of the Company’s underlying common stock on the grant date and no option may have a term in excess of ten years. In June 2018, the Company increased the aggregate number of shares of common stock authorized for issuance under the 2013 Plan by 2,500,000 shares. Stock option activity for employees and non-employees for the year ended December 31, 2018 is as follows: Shares Issuable Pursuant to Stock Options Weighted-Average Exercise Price Weighted-Average Remaining Contractual Terms (years) Total Intrinsic Value (in thousands) Outstanding January 1, 2018 6,132,650 $ 6.54 8.4 — Granted 2,658,500 $ 7.92 Exercised (129,978 ) $ 5.05 Forfeited (163,125 ) $ 6.97 Outstanding December 31, 2018 8,498,047 $ 6.99 8.1 $ 5,214 Exercisable December 31, 2018 3,745,660 $ 6.44 6.7 $ 3,344 Available for future grant 769,779 The weighted average grant-date fair value of stock options outstanding on December 31, 2018 was $5.18 per share. Total unrecognized compensation costs related to non-vested stock options at December 31, 2018 was approximately $23.7 million and is expected to be recognized within future operating results over a weighted-average period of 3.2 years. The total intrinsic value of the options exercised during the years ended December 31, 2018 and 2017 was approximately $0.8 million and $0.7 million, respectively. The expected term of the employee-related options was estimated using the “simplified” method as defined by the Securities and Exchange Commission’s Staff Accounting Bulletin No. 107, Share-Based Payment The Company uses the Black-Scholes model to estimate the fair value of stock options granted. For stock options granted to employees during the years ended December 31, 2018 and 2017, the Company utilized the following assumptions: Year ended December 31, 2018 2017 Expected term (years) 5.5-6.25 5.5-6.25 Risk free interest rate 2.33-3.01% 1.83-2.25% Volatility 76-83% 79-84% Dividend yield 0% 0% Weighted average grant date fair value per share of common stock $ 5.57 $ 4.50 Stock-Based Awards Granted to Non-employees- The Company from time to time grants options to purchase common stock to non-employees for services rendered and records expense ratably over the vesting period of each award. The Company estimates the fair value of the stock options using the Black-Scholes valuation model at each reporting date. The Company granted 215,000 stock options to non-employees and recorded stock-based compensation expense of $1,033,000 during the year ended December 31, 2018. The Company granted 480,000 stock options to non-employees and recorded stock-based compensation expense of $287,000 during the year ended December 31, 2017. For stock options granted to non-employees, the Company utilized the following assumptions: Year ended December 31, 2018 2017 Expected term (years) 0.3-9.9 8.7-9.9 Risk free interest rate 2.39-2.89% 2.37-2.40% Volatility 75-109% 111-113% Dividend yield 0% 0% Weighted average reporting date fair value per share of common stock $ 5.91 $ 5.54 RSU activity under the Plan for the year ended December 31, 2018 is as follows: RSUs Weighted-Average Grant Date Fair Value Unvested January 1, 2018 185,950 $ 11.86 Granted — $ — Vested (58,650 ) $ 12.19 Forfeited — $ — Unvested December 31, 2018 127,300 $ 11.71 RSUs awarded to employees generally vest one ‑ Total unrecognized compensation costs related to non-vested RSUs at December 31, 2018 was approximately $1.5 million and is expected to be recognized within future operating results over a period of 2.07 years. The total fair value of shares vested during the years ended December 31, 2018 and 2017 was approximately $0.5 million and $0.3 million, respectively. The following table presents stock-based compensation expense included in the Company’s consolidated statements of operations: Year ended December 31, 2018 2017 Research and development $ 2,257,102 $ 1,966,126 General and administrative 5,925,576 3,066,997 Total $ 8,182,678 $ 5,033,123 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 9 — INCOME TAXES The provision for federal, foreign and state income taxes for the years ended December 31, 2018 and 2017 are as follows: Year ended December 31, 2018 (1) 2017 Current income tax provision (benefit) Federal $ — $ — Foreign — — State — — Deferred income tax provision (benefit) Federal — (9,376,272 ) Foreign — — State — — Total income tax provision (benefit) $ — $ (9,376,272 ) (1) There was no tax provision for income taxes for the year ended December 31, 2018 due to losses. Net deferred tax assets (liabilities) as of December 31, 2018 and 2017 consist of the following: December 31, December 31, 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 15,049,549 $ 18,265,530 Research and development tax credits 145,115 145,115 Capitalized research and development costs 22,072,598 14,858,509 Stock-based compensation 5,532,341 4,180,651 Deferred start-up and license costs 5,929,901 6,532,419 Deferred Revenue 11,249,174 3,053,174 Other — 129,082 Net deferred tax assets 59,978,678 47,164,480 Valuation allowance (54,687,950 ) (41,878,528 ) Net deferred tax assets $ 5,290,728 $ 5,285,952 Deferred tax liabilities: In-process research and development (9,343,440 ) (9,343,440 ) Other (4,776 ) — Net deferred tax liabilities $ (4,057,488 ) $ (4,057,488 ) A reconciliation between the Company’s effective tax rate and the federal statutory rate for the years ended December 31, 2018 and 2017 are as follows: Year ended December 31, 2018 2017 Federal statutory rate (21.00 %) (34.00 %) Permanent differences 0.38 % 0.66 % State income taxes 0.00 % 0.00 % Valuation allowance 20.62 % 56.33 % Effective tax rate 0.00 % 22.99 % In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based upon the level of historical losses and the uncertainty of future taxable income over the periods which the Company will realize the benefits of its net deferred tax assets, management believes it is more likely than not that the Company will not realize the benefits on the balance of its net deferred tax asset and, accordingly, the Company has established a full valuation allowance on its net deferred tax assets. The valuation allowance increased by approximately $12.8 million and decreased by $9.9 million during the years ended December 31, 2018 and 2017. As of December 31, 2018, the Company had approximately $53.9 million of Federal net operating losses that will begin to expire in 2027. As of December 31, 2018, the Company's wholly owned subsidiary had approximately $2.6 million of operating losses in Switzerland which have begun to expire. As of December 31, 2018, the Company had approximately $7.7 million of New Jersey and approximately $40.6 million of Massachusetts operating losses that will begin to expire in 2029 and 2033, respectively. As of December 31, 2018, the Company had approximately $0.2 million of federal research and development credits that will begin to expire in 2027. The Internal Revenue Code ("IRC") limits the amounts of net operating loss carryforwards that a company may use in any one year in the event of certain cumulative changes in ownership over a three-year period as described in Section 382 of the IRS. The Company has not performed a detailed analysis to determine whether an ownership change has occurred as of December 31, 2018. On December 22, 2017, the United States enacted tax reform legislation commonly known as the Tax Cuts and Jobs Act (the “Act”), resulting in significant modifications to existing law. The Company completed the accounting for the effects of the Act during 2017. The Company’s financial statements for the year ended December 31, 2017, reflected the effects of the Act which included a reduction in the corporate tax rate from 34% to 21%. Accordingly, the Company’s deferred tax assets and liabilities were revalued at the enacted rates effective in 2018 and in future years; the reduction in federal rate from 34% to 21% resulted in no impact to total income tax expense. In addition to the federal rate change impact, the Company accounted for the impact of legislation on the timing of deferred tax positions and overall financial statement presentation, resulting in a total income tax benefit of $9.4 million related to future implications of indefinite lived deferred tax positions in 2017. As the accounting for the effects was complete during 2017, no further changes impacted tax positions during the period ending December 31, 2018. This legislative change regarding the carryforward period of net operating losses impacts the Company’s indefinite lived deferred tax liabilities related to its IPR&D intangibles. Prior to the change in tax law, the Company’s net operating losses could not be used to offset deferred tax liabilities resulting from taxable temporary differences with an indefinite life. After the legislative change, federal net operating loss incurred after December 31, 2017 will have an indefinite life. As a result, the Company’s deductible temporary differences will reverse and create unlimited lived deferred tax assets which may be available to offset indefinite lived deferred tax liabilities. Accordingly, the Company has recognized a tax benefit for the period ending December 31, 2017 to reflect this reversal pattern. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending income tax examinations. The Company’s tax years are still open under statute from 2012 to the present. As of December 31, 2018 and 2017, the Company had no liability recorded for unrecognized tax benefits. The Company classifies penalties and interest expense related to income tax liabilities as an income tax expense. There were no interest and penalties recognized in the statements of operations for the years ended December 31, 2018 and 2017, or accrued on the balance sheets as of December 31, 2018 and 2017. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 10 — COMMITMENTS AND CONTINGENCIES On October 2, 2017, the Company entered into an office sublease agreement (the “Sublease”) with Profitect, Inc. (the “Sublandlord”) to sublease approximately 5,923 rentable square feet of office space located at 1601 Trapelo Road, Waltham, MA 02451 (the “Premises”). The term of the Sublease began on November 1, 2017 and will expire on July 30, 2021, with a monthly rental rate starting at $14,808 and escalating to a maximum monthly rental rate of $16,288 in the final 12 months of the term. The Sublandlord has agreed to provide the Premises to the Company free of charge for the first two months of the term. The Company will recognize the remaining expense on a straight-line basis over the remaining lease term which will expire on July 30, 2021. From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of the Company’s business activities. At this time, the Company is not aware of any such legal proceedings or claims. The Company is not aware of any claim or litigation, the outcome of which, if determined adversely to the Company, would have a material effect on the Company’s financial position or results of operations. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | NOTE 11 — RELATED PARTY TRANSACTIONS In January 2016, the Company entered into a services agreement with V-Watch SA (“V-Watch”), for approximately $105 thousand for the use of V-Watch’s SomnoArt device for monitoring sleep in the roluperidone Phase 2b and MIN-117 Phase 2a trials. The Company’s Chief Executive Officer is the chairman of the board of directors of V-Watch. Funds affiliated with Index Ventures, a stockholder of the Company, hold greater than 10% of the outstanding capital stock of V-Watch. Also refer to Note 6 – Co-Development and License Agreement and Note 7 – Stockholder’s Equity for additional related party transactions. |
Quarterly Results (Unaudited)
Quarterly Results (Unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Results | NOTE 12 — QUARTERLY RESULTS (Unaudited) Three Months Ended March 31, 2018 June 30, 2018 September 30, 2018 December 31, 2018 (in thousands, except per share data) Total revenues $ — $ — $ — $ — Operating loss (12,744 ) (12,935 ) (12,424 ) (13,627 ) Net loss (12,418 ) (12,529 ) (12,021 ) (13,203 ) Loss per share, basic and diluted $ (0.32 ) $ (0.32 ) $ (0.31 ) $ (0.34 ) Three Months Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 (in thousands, except per share data) Total revenues $ — $ — $ — $ — Operating loss (10,485 ) (9,746 ) (11,407 ) (9,532 ) Net (loss) income (10,645 ) (9,780 ) (11,260 ) 162 Loss per share, basic and diluted $ (0.30 ) $ (0.27 ) $ (0.28 ) $ 0.00 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 13 — SUBSEQUENT EVENTS None. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of presentation The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”), and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. From its inception, the Company has devoted substantially all of its efforts to business planning, engaging regulatory, manufacturing and other technical consultants, planning and executing clinical trials and raising capital. |
Consolidation | Consolidation The accompanying consolidated financial statements include the results of the Company and its wholly-owned subsidiaries, Mind-NRG Sarl and Minerva Neurosciences Securities Corporation. Intercompany transactions have been eliminated. |
Significant Risks and Uncertainties | Significant risks and uncertainties The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. The Company currently has no commercially approved products and there can be no assurance that the Company’s research and development will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property. |
Use of Estimates | Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and cash equivalents Cash equivalents include short-term, highly-liquid instruments, consisting of money market accounts and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk. |
Restricted Cash | Restricted cash Cash accounts with any type of restriction are classified as restricted. The Company maintained restricted cash balances as collateral for corporate credit cards in the amount of $100 thousand and $80 thousand at December 31, 2018 and 2017, respectively. |
Marketable Securities | Marketable securities Marketable securities consists of corporate and U.S. government debt securities maturing in nine months or less. Based on the Company’s intentions regarding its marketable securities, all marketable securities are classified as held-to-maturity and are carried under the amortized cost approach. The Company’s investments in marketable securities are classified as Level 2 within the fair value hierarchy. As of December 31, 2018, remaining final maturities of marketable securities ranged from January 2019 to September 2019, with a weighted average remaining maturity of approximately 4.91 months. The following table provides the amortized cost basis, aggregate fair value, net unrealized (gains)/losses and the net carrying value of investments in held-to-maturity securities as of December 31, 2018 and 2017: December 31, 2018 Amortized Aggregate Unrealized Unrealized Net Carrying Cost Fair Value Gains Losses Value Marketable securities: Corporate bonds/notes $ 16,054,071 $ 16,050,462 $ 3,609 $ — $ 16,054,071 Commercial paper 17,756,394 17,756,394 — — 17,756,394 U.S. government agency securities 3,951,974 3,951,040 934 — 3,951,974 Marketable securities total $ 37,762,439 $ 37,757,896 $ 4,543 $ — $ 37,762,439 December 31, 2017 Amortized Aggregate Unrealized Unrealized Net Carrying Cost Fair Value Gains Losses Value Marketable securities current: Corporate bonds/notes $ 43,528,246 $ 43,438,463 $ 89,783 $ — $ 43,528,246 Commercial paper 43,385,762 43,385,762 — — 43,385,762 U.S. government agency securities 15,195,411 15,178,278 17,133 — 15,195,411 Marketable securities current total 102,109,419 102,002,503 106,916 — 102,109,419 Marketable securities non-current: Corporate bonds/notes 5,022,982 4,998,870 24,112 — 5,022,982 Commercial paper — — — — — U.S. government agency securities — — — — — Marketable securities non-current total 5,022,982 4,998,870 24,112 — 5,022,982 Marketable securities total $ 107,132,401 $ 107,001,373 $ 131,028 $ — $ 107,132,401 |
Research and Development Costs | Research and development costs |
In-Process Research and Development | In-process research and development In-process research and development (“IPR&D”) assets represent capitalized incomplete research projects that the Company acquired through business combinations. Such assets are initially measured at their acquisition date fair values. The initial fair value of the research projects are recorded as intangible assets on the balance sheet, rather than expensed, regardless of whether these assets have an alternative future use. The amounts capitalized are being accounted for as indefinite-lived intangible assets, subject to impairment testing, until completion or abandonment of research and development efforts associated with the project. An IPR&D asset is considered abandoned when it ceases to be used (that is, research and development efforts associated with the asset have ceased, and there are no plans to sell or license the asset or derive defensive value from the asset). At that point, the asset is considered to be disposed of and is written off. Upon successful completion of each project, the Company will make a determination about the then remaining useful life of the intangible asset and begin amortization. The Company tests its indefinite-lived intangibles, IPR&D assets, for impairment annually on November 30 and more frequently if events or changes in circumstances indicate that it is more likely than not that the asset is impaired. When testing indefinite-lived intangibles for impairment, the Company may assess qualitative factors for its indefinite-lived intangibles to determine whether it is more likely than not (that is, a likelihood of more than 50 percent) that the asset is impaired. Alternatively, the Company may bypass this qualitative assessment for some or all of its indefinite-lived intangibles and perform the quantitative impairment test that compares the fair value of the indefinite-lived intangible asset with the asset’s carrying amount. There was no impairment of IPR&D for the years ended December 31, 2018 or 2017. |
Stock-Based Compensation | Stock-based compensation The Company recognizes compensation cost relating to stock-based payment transactions using a fair-value measurement method, which requires all stock-based payments to employees, including grants of employee stock options, to be recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. The Company determines the fair value of stock-based awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield, expected forfeiture rate and expected life of the options. The fair value of restricted stock units (“RSUs”) is equal to the closing price of the Company’s common stock on the date of grant. The date of expense recognition for grants to non-employees is the earlier of the date at which a commitment for performance by the counterparty to earn the equity instrument is reached or the date at which the counterparty’s performance is complete. The Company determines the fair value of stock-based awards granted to non-employees similar to the way fair value of awards are determined for employees except that certain assumptions used in the Black-Scholes option-pricing model, such as expected life of the option, may be different and the fair value of each unvested award is adjusted at the end of each period for any change in fair value from the previous valuation until the award vests. |
Foreign Currency Transactions | Foreign currency transactions The Company’s functional currency is the U.S. dollar. The Company pays certain vendor invoices in the respective foreign currency. The Company records an expense in United States Dollars at the time the liability is incurred. Changes in the applicable foreign currency rate between the date an expense is recorded and the payment date is recorded as a foreign currency gain or loss. |
Loss Per Share | Loss per share Basic loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding for the period. Diluted loss per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. The treasury stock method is used to determine the dilutive effect of the Company’s stock options and warrants. The Company had a net loss in all periods presented thus the inclusion of stock options and warrants would be anti-dilutive to net loss per share. |
Income Taxes | Income taxes Deferred tax assets and liabilities are determined based on differences between financial reporting and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Uncertain tax positions are evaluated and if appropriate, the amount of unrecognized tax benefits are recorded within deferred tax assets. Deferred tax assets are evaluated for realization based on a more-likely-than-not criterion in determining if a valuation allowance should be provided. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company uses a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. The Company has elected to treat interest and penalties, to the extent they arise, as a component of income tax expense. There was no interest or penalties related to income taxes for the years ended December 31, 2018 or 2017. Income tax years beginning in 2012 for federal and state purposes are generally subject to examination by taxing authorities, although net operating losses from all prior years are subject to examinations and adjustments for at least three years following the year in which the tax attributes are utilized. On December 22, 2017, the United States enacted tax reform legislation commonly known as the Tax Cuts and Jobs Act (the “Act”), resulting in significant modifications to existing law. The Company completed the accounting for the effects of the Act during 2017. The Company’s financial statements for the year ended December 31, 2017, reflected the effects of the Act which included a reduction in the corporate tax rate from 34% to 21%. Accordingly, the Company’s deferred tax assets and liabilities were revalued at the enacted rates effective in 2018 and in future years; the reduction in federal rate from 34% to 21% resulted in no impact to total income tax expense. In addition to the federal rate change impact, the Company accounted for the impact of legislation on the timing of deferred tax positions and overall financial statement presentation, resulting in a total income tax benefit of $9.4 million related to future implications of indefinite lived deferred tax positions in 2017. As the accounting for the effects was complete during 2017, no further changes impacted tax positions during the period ending December 31, 2018. |
Concentration of Credit Risk | Concentration of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and marketable securities. The Company maintains its cash and cash equivalent balances in the form of business checking accounts and money market accounts, the balances of which, at times, may exceed federally insured limits. Exposure to cash and cash equivalents credit risk is reduced by placing such deposits with major financial institutions and monitoring their credit ratings. Marketable securities consist primarily of corporate bonds, with fixed interest rates. Exposure to credit risk of marketable securities is reduced by maintaining a diverse portfolio and monitoring their credit ratings. |
Equipment | Equipment Equipment is stated at cost less accumulated depreciation. Equipment is depreciated on the straight-line basis over their estimated useful lives of three years. Expenditures for maintenance and repairs are charged to expense as incurred. |
Long-Lived Assets | Long-lived assets The Company reviews the recoverability of all long-lived assets, including the related useful lives, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. If required, the Company compares the estimated undiscounted future net cash flows to the related asset’s carrying value to determine whether there has been an impairment. If an asset is considered impaired, the asset is written down to fair value, which is based either on discounted cash flows or appraised values in the period the impairment becomes known. The Company believes that all long-lived assets are recoverable, and no impairment was deemed necessary at December 31, 2018 and 2017. |
Goodwill | Goodwill The Company tests its goodwill for impairment annually, or whenever events or changes in circumstances indicate an impairment may have occurred, by comparing its reporting unit’s carrying value to its fair value. Impairment may result from, among other things, deterioration in the performance of the acquired business, adverse market conditions, adverse changes in applicable laws or regulations and a variety of other circumstances. If the Company determines that an impairment has occurred, it is required to record a write-down of the carrying value and charge the impairment as an operating expense in the period the determination is made. In evaluating the recoverability of the carrying value of goodwill, the Company must make assumptions regarding estimated future cash flows and other factors to determine the fair value of the acquired assets. Changes in strategy or market conditions could significantly impact those judgments in the future and require an adjustment to the recorded balances. The Company tested its goodwill for impairment as of November 30. There was no impairment of goodwill for the years ended December 31, 2018 or 2017. |
Fair Value of Financial Instruments | Fair value of financial instruments The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels: Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 — Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). Level 3 — Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data. The following tables present information about the Company’s cash equivalents and marketable securities (current and non-current) as of December 31, 2018 and 2017, measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: December 31, 2018 Total Level 1 Level 2 Level 3 Cash equivalents $ 42,575,645 $ 36,600,836 $ 5,974,809 $ — Marketable securities 37,757,896 — 37,757,896 — Total fair value $ 80,333,541 $ 36,600,836 $ 43,732,705 $ — December 31, 2017 Total Level 1 Level 2 Level 3 Cash equivalents $ 22,782,626 $ 22,782,626 $ — $ — Marketable securities 107,132,401 — 107,132,401 — Total fair value $ 129,915,027 $ 22,782,626 $ 107,132,401 $ — Cash equivalents include short-term, highly-liquid instruments, consisting of money market accounts and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk. Marketable securities consists of corporate and U.S. government debt securities maturing in nine months or less. Based on the Company’s intentions regarding its marketable securities, all marketable securities are classified as held-to-maturity and are carried under the amortized cost approach. Marketable securities are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. The carrying amounts of cash, restricted cash, accounts payable, and accrued liabilities approximate fair value because of their short-term nature. The Company believes that the Company’s debt obligations accrue interest at rates which approximate prevailing market rates for instruments with similar characteristics and, accordingly, the carrying values for these instruments approximate fair value. |
Revenue Recognition | Revenue recognition The Company applies the revenue recognition guidance in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customer’s When the Company enters into an arrangement that meets the definition of a collaboration under ASC 808, Collaborative Arrangements |
Deferred Revenue | Deferred revenue The Company applies the revenue recognition guidance in accordance with ASC 606, Revenue from Contracts with Customer’s. Using ASC 606, revenue that is unearned is deferred. Deferred revenue expected to be recognized as revenue more than one year subsequent to the balance sheet date is classified as long-term deferred revenue. |
Segment Information | Segment information Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) about which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief decision maker, who is the Chief Executive Officer, reviews operating results to make decisions about allocating resources and assessing performance for the entire Company. The Company views its operations and manages its business as one operating segment. |
Comprehensive Loss | Comprehensive loss The Company had no items of comprehensive loss other than its net loss for each period presented. |
Recent Accounting Pronouncements | Recent accounting pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as of the specified effective date. Recently Adopted Accounting Pronouncements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net) Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients The Revenue ASUs provide an accounting standard for a single comprehensive model for use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. The accounting standard is effective for interim and annual periods beginning after December 15, 2017. The guidance permits two methods of adoption: retrospectively to each prior reporting period presented (the full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). The Company performed a detailed review of its collaboration agreements and assessed the differences in accounting for such contracts under this guidance compared with current revenue accounting standards. The Company adopted the new standard on January 1, 2018 using the modified retrospective method. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows – Classification of Certain Cash Receipts and Cash Payments (Topic 230) In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows- Restricted Cash (Topic 230) Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued ASU No. 2016-02, Leases Commitments and Contingencies In January 2017, the FASB issued ASU No. 2017-04, Intangibles — Goodwill and Other (Topic 350). In March 2017, the FASB issued ASU No. 2017-08, Receivables—Nonrefundable Fees and Other Costs (Subtopic 310-20) Premium Amortization on Purchased Callable Debt Securities. In June 2018, the FASB issued ASU No. 2018-07, Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting Topic 718, Compensation-Stock Compensation Subtopic 505-50, Equity-Equity-Based payments to Non-Employees Topic 606, Revenue from Contracts with Customers |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Amortized Cost Basis, Aggregate Fair Value, Net Unrealized (Gains)/Losses and Net Carrying Value of Investments in Held-to-maturity Securities | The following table provides the amortized cost basis, aggregate fair value, net unrealized (gains)/losses and the net carrying value of investments in held-to-maturity securities as of December 31, 2018 and 2017: December 31, 2018 Amortized Aggregate Unrealized Unrealized Net Carrying Cost Fair Value Gains Losses Value Marketable securities: Corporate bonds/notes $ 16,054,071 $ 16,050,462 $ 3,609 $ — $ 16,054,071 Commercial paper 17,756,394 17,756,394 — — 17,756,394 U.S. government agency securities 3,951,974 3,951,040 934 — 3,951,974 Marketable securities total $ 37,762,439 $ 37,757,896 $ 4,543 $ — $ 37,762,439 December 31, 2017 Amortized Aggregate Unrealized Unrealized Net Carrying Cost Fair Value Gains Losses Value Marketable securities current: Corporate bonds/notes $ 43,528,246 $ 43,438,463 $ 89,783 $ — $ 43,528,246 Commercial paper 43,385,762 43,385,762 — — 43,385,762 U.S. government agency securities 15,195,411 15,178,278 17,133 — 15,195,411 Marketable securities current total 102,109,419 102,002,503 106,916 — 102,109,419 Marketable securities non-current: Corporate bonds/notes 5,022,982 4,998,870 24,112 — 5,022,982 Commercial paper — — — — — U.S. government agency securities — — — — — Marketable securities non-current total 5,022,982 4,998,870 24,112 — 5,022,982 Marketable securities total $ 107,132,401 $ 107,001,373 $ 131,028 $ — $ 107,132,401 |
Fair Value of Cash Equivalents and Marketable Securities Measured on Recurring Basis and Determined by Valuation Techniques | The following tables present information about the Company’s cash equivalents and marketable securities (current and non-current) as of December 31, 2018 and 2017, measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: December 31, 2018 Total Level 1 Level 2 Level 3 Cash equivalents $ 42,575,645 $ 36,600,836 $ 5,974,809 $ — Marketable securities 37,757,896 — 37,757,896 — Total fair value $ 80,333,541 $ 36,600,836 $ 43,732,705 $ — December 31, 2017 Total Level 1 Level 2 Level 3 Cash equivalents $ 22,782,626 $ 22,782,626 $ — $ — Marketable securities 107,132,401 — 107,132,401 — Total fair value $ 129,915,027 $ 22,782,626 $ 107,132,401 $ — |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: December 31, 2018 December 31, 2017 Research and development costs and other accrued expenses $ 1,353,987 $ 1,162,441 Professional fees 455,545 251,000 Interest payable — 20,508 Accrued bonus — 5,899 $ 1,809,532 $ 1,439,848 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Loss Per Share | The following table sets forth the computation of basic and diluted loss per share for common stockholders: Year Ended December 31, 2018 2017 Net loss $ (50,171,287 ) $ (31,523,207 ) Weighted average shares of common stock outstanding 38,792,581 37,937,191 Net loss per share of common stock – basic and diluted $ (1.29 ) $ (0.83 ) |
Securities Excluded from Calculation of Weighted Average Shares Outstanding as their Effect is Antidilutive | The following securities outstanding at December 31, 2018 and 2017 have been excluded from the calculation of weighted average shares outstanding as their effect on the calculation of loss per share is antidilutive: December 31, 2018 December 31, 2017 Common stock options 8,498,047 6,132,650 Restricted stock units 127,300 185,950 Common stock warrants 40,790 40,790 |
Stock Award Plan and Stock-Ba_2
Stock Award Plan and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Stock Option Activity for Employees and Non-Employees | Stock option activity for employees and non-employees for the year ended December 31, 2018 is as follows: Shares Issuable Pursuant to Stock Options Weighted-Average Exercise Price Weighted-Average Remaining Contractual Terms (years) Total Intrinsic Value (in thousands) Outstanding January 1, 2018 6,132,650 $ 6.54 8.4 — Granted 2,658,500 $ 7.92 Exercised (129,978 ) $ 5.05 Forfeited (163,125 ) $ 6.97 Outstanding December 31, 2018 8,498,047 $ 6.99 8.1 $ 5,214 Exercisable December 31, 2018 3,745,660 $ 6.44 6.7 $ 3,344 Available for future grant 769,779 |
Schedule of RSU Activity | RSU activity under the Plan for the year ended December 31, 2018 is as follows: RSUs Weighted-Average Grant Date Fair Value Unvested January 1, 2018 185,950 $ 11.86 Granted — $ — Vested (58,650 ) $ 12.19 Forfeited — $ — Unvested December 31, 2018 127,300 $ 11.71 |
Schedule of Stock-Based Compensation Expense Included in the Company's Consolidated Statements of Operations | The following table presents stock-based compensation expense included in the Company’s consolidated statements of operations: Year ended December 31, 2018 2017 Research and development $ 2,257,102 $ 1,966,126 General and administrative 5,925,576 3,066,997 Total $ 8,182,678 $ 5,033,123 |
Employee Stock Option | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Assumptions Used in Black Scholes Model to Estimate Fair Value of Stock Options | The Company uses the Black-Scholes model to estimate the fair value of stock options granted. For stock options granted to employees during the years ended December 31, 2018 and 2017, the Company utilized the following assumptions: Year ended December 31, 2018 2017 Expected term (years) 5.5-6.25 5.5-6.25 Risk free interest rate 2.33-3.01% 1.83-2.25% Volatility 76-83% 79-84% Dividend yield 0% 0% Weighted average grant date fair value per share of common stock $ 5.57 $ 4.50 |
Non-Employees Stock Options | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Assumptions Used in Black Scholes Model to Estimate Fair Value of Stock Options | For stock options granted to non-employees, the Company utilized the following assumptions: Year ended December 31, 2018 2017 Expected term (years) 0.3-9.9 8.7-9.9 Risk free interest rate 2.39-2.89% 2.37-2.40% Volatility 75-109% 111-113% Dividend yield 0% 0% Weighted average reporting date fair value per share of common stock $ 5.91 $ 5.54 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Federal, Foreign and State Income Taxes | The provision for federal, foreign and state income taxes for the years ended December 31, 2018 and 2017 are as follows: Year ended December 31, 2018 (1) 2017 Current income tax provision (benefit) Federal $ — $ — Foreign — — State — — Deferred income tax provision (benefit) Federal — (9,376,272 ) Foreign — — State — — Total income tax provision (benefit) $ — $ (9,376,272 ) (1) There was no tax provision for income taxes for the year ended December 31, 2018 due to losses. |
Schedule of Deferred Tax Assets and Liabilities | Net deferred tax assets (liabilities) as of December 31, 2018 and 2017 consist of the following: December 31, December 31, 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 15,049,549 $ 18,265,530 Research and development tax credits 145,115 145,115 Capitalized research and development costs 22,072,598 14,858,509 Stock-based compensation 5,532,341 4,180,651 Deferred start-up and license costs 5,929,901 6,532,419 Deferred Revenue 11,249,174 3,053,174 Other — 129,082 Net deferred tax assets 59,978,678 47,164,480 Valuation allowance (54,687,950 ) (41,878,528 ) Net deferred tax assets $ 5,290,728 $ 5,285,952 Deferred tax liabilities: In-process research and development (9,343,440 ) (9,343,440 ) Other (4,776 ) — Net deferred tax liabilities $ (4,057,488 ) $ (4,057,488 ) |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation between the Company’s effective tax rate and the federal statutory rate for the years ended December 31, 2018 and 2017 are as follows: Year ended December 31, 2018 2017 Federal statutory rate (21.00 %) (34.00 %) Permanent differences 0.38 % 0.66 % State income taxes 0.00 % 0.00 % Valuation allowance 20.62 % 56.33 % Effective tax rate 0.00 % 22.99 % |
Quarterly Results (Unaudited) (
Quarterly Results (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | Three Months Ended March 31, 2018 June 30, 2018 September 30, 2018 December 31, 2018 (in thousands, except per share data) Total revenues $ — $ — $ — $ — Operating loss (12,744 ) (12,935 ) (12,424 ) (13,627 ) Net loss (12,418 ) (12,529 ) (12,021 ) (13,203 ) Loss per share, basic and diluted $ (0.32 ) $ (0.32 ) $ (0.31 ) $ (0.34 ) Three Months Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 (in thousands, except per share data) Total revenues $ — $ — $ — $ — Operating loss (10,485 ) (9,746 ) (11,407 ) (9,532 ) Net (loss) income (10,645 ) (9,780 ) (11,260 ) 162 Loss per share, basic and diluted $ (0.30 ) $ (0.27 ) $ (0.28 ) $ 0.00 |
NATURE OF OPERATIONS AND LIQU_2
NATURE OF OPERATIONS AND LIQUIDITY - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2018USD ($)License | Dec. 31, 2017USD ($) | |
Nature Of Operations And Liquidity [Line Items] | ||
Accumulated deficit | $ 214,552,728 | $ 164,381,441 |
Net cash used in operating activities | 41,941,756 | $ (3,092,864) |
Cash, cash equivalents, restricted cash and marketable securities | $ 88,100,000 | |
Development-stage Proprietary Compounds | ||
Nature Of Operations And Liquidity [Line Items] | ||
Number of licenses acquired | License | 4 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2018USD ($)Segment | Dec. 31, 2017USD ($) | |
Significant Accounting Policies [Line Items] | ||
Restricted cash balances as collateral for corporate credit cards | $ 100,000 | $ 80,000 |
Marketable securities, weighted average remaining maturity | 4 months 27 days | |
Interest or penalties related to income taxes | $ 0 | $ 0 |
Corporate tax rate | 21.00% | 34.00% |
Income tax benefit due to federal rate change impact | $ 9,400,000 | |
Equipment estimated useful life | 3 years | |
Impairment of Long-Lived Assets | $ 0 | $ 0 |
Impairment of goodwill | 0 | 0 |
Revenues from product sales to date | $ 0 | |
Number of operating segments | Segment | 1 | |
In-Process Research and Development | ||
Significant Accounting Policies [Line Items] | ||
Asset impairment charges | $ 0 | $ 0 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES - Amortized Cost Basis, Aggregate Fair Value, Net Unrealized (Gains)/Losses and Net Carrying Value of Investments in Held-to-maturity Securities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Schedule Of Held To Maturity Securities [Line Items] | ||
Marketable securities, Amortized Cost | $ 37,762,439 | $ 107,132,401 |
Marketable securities, Aggregate Fair Value | 37,757,896 | 107,001,373 |
Marketable securities, Unrealized Gains | 4,543 | 131,028 |
Marketable securities, Net Carrying Value | 37,762,439 | 107,132,401 |
Marketable Securities Current | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Marketable securities, Amortized Cost | 102,109,419 | |
Marketable securities, Aggregate Fair Value | 102,002,503 | |
Marketable securities, Unrealized Gains | 106,916 | |
Marketable securities, Net Carrying Value | 102,109,419 | |
Marketable Securities Non-Current | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Marketable securities, Amortized Cost | 5,022,982 | |
Marketable securities, Aggregate Fair Value | 4,998,870 | |
Marketable securities, Unrealized Gains | 24,112 | |
Marketable securities, Net Carrying Value | 5,022,982 | |
Corporate Bonds/Notes | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Marketable securities, Amortized Cost | 16,054,071 | |
Marketable securities, Aggregate Fair Value | 16,050,462 | |
Marketable securities, Unrealized Gains | 3,609 | |
Marketable securities, Net Carrying Value | 16,054,071 | |
Corporate Bonds/Notes | Marketable Securities Current | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Marketable securities, Amortized Cost | 43,528,246 | |
Marketable securities, Aggregate Fair Value | 43,438,463 | |
Marketable securities, Unrealized Gains | 89,783 | |
Marketable securities, Net Carrying Value | 43,528,246 | |
Corporate Bonds/Notes | Marketable Securities Non-Current | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Marketable securities, Amortized Cost | 5,022,982 | |
Marketable securities, Aggregate Fair Value | 4,998,870 | |
Marketable securities, Unrealized Gains | 24,112 | |
Marketable securities, Net Carrying Value | 5,022,982 | |
Commercial Paper | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Marketable securities, Amortized Cost | 17,756,394 | |
Marketable securities, Aggregate Fair Value | 17,756,394 | |
Marketable securities, Net Carrying Value | 17,756,394 | |
Commercial Paper | Marketable Securities Current | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Marketable securities, Amortized Cost | 43,385,762 | |
Marketable securities, Aggregate Fair Value | 43,385,762 | |
Marketable securities, Net Carrying Value | 43,385,762 | |
U.S. government Agency Securities | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Marketable securities, Amortized Cost | 3,951,974 | |
Marketable securities, Aggregate Fair Value | 3,951,040 | |
Marketable securities, Unrealized Gains | 934 | |
Marketable securities, Net Carrying Value | $ 3,951,974 | |
U.S. government Agency Securities | Marketable Securities Current | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Marketable securities, Amortized Cost | 15,195,411 | |
Marketable securities, Aggregate Fair Value | 15,178,278 | |
Marketable securities, Unrealized Gains | 17,133 | |
Marketable securities, Net Carrying Value | $ 15,195,411 |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES - Fair Value of Cash Equivalents and Marketable Securities Measured on Recurring Basis and Determined by Valuation Techniques (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair value | $ 80,333,541 | $ 129,915,027 |
Cash Equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair value | 42,575,645 | 22,782,626 |
Marketable Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair value | 37,757,896 | 107,132,401 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair value | 36,600,836 | 22,782,626 |
Level 1 | Cash Equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair value | 36,600,836 | 22,782,626 |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair value | 43,732,705 | 107,132,401 |
Level 2 | Cash Equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair value | 5,974,809 | |
Level 2 | Marketable Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair value | $ 37,757,896 | $ 107,132,401 |
ACCRUED EXPENSES AND OTHER LI_3
ACCRUED EXPENSES AND OTHER LIABILITIES - Accrued Expenses and Other Liabilities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Research and development costs and other accrued expenses | $ 1,353,987 | $ 1,162,441 |
Professional fees | 455,545 | 251,000 |
Interest payable | 20,508 | |
Accrued bonus | 5,899 | |
Accrued expenses and other liabilities | $ 1,809,532 | $ 1,439,848 |
NET LOSS PER SHARE OF COMMON _3
NET LOSS PER SHARE OF COMMON STOCK - Computation of Basic and Diluted Loss Per Share (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Earnings Per Share [Abstract] | ||||||||||
Net loss | $ (13,203,000) | $ (12,021,000) | $ (12,529,000) | $ (12,418,000) | $ 162,000 | $ (11,260,000) | $ (9,780,000) | $ (10,645,000) | $ (50,171,287) | $ (31,523,207) |
Weighted average shares of common stock outstanding | 38,792,581 | 37,937,191 | ||||||||
Net loss per share of common stock – basic and diluted | $ (1.29) | $ (0.83) |
NET LOSS PER SHARE OF COMMON _4
NET LOSS PER SHARE OF COMMON STOCK - Securities Excluded from Calculation of Weighted Average Shares Outstanding as their Effect is Antidilutive (Details) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Common Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities outstanding excluded from the calculation of weighted average shares outstanding | 8,498,047 | 6,132,650 |
Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities outstanding excluded from the calculation of weighted average shares outstanding | 127,300 | 185,950 |
Common Stock Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities outstanding excluded from the calculation of weighted average shares outstanding | 40,790 | 40,790 |
DEBT - Additional Information (
DEBT - Additional Information (Details) | Aug. 01, 2018USD ($) | Jan. 16, 2015USD ($)Tranche | Aug. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Debt Instrument [Line Items] | |||||
Amortization of debt discount recorded as interest expense | $ 38,040 | $ 206,562 | |||
Loan and Security Agreement | Term Loan | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | $ 15,000,000 | ||||
Number of tranches | Tranche | 2 | ||||
Facility fee payment | $ 75,000 | ||||
Final payment of term loan | 5.10% | ||||
Term loan final payment amount | $ 510,000 | $ 510,000 | |||
Term loans maturity date | Aug. 1, 2018 | ||||
Borrowings outstanding | $ 0 | ||||
Amortization of debt discount recorded as interest expense | 38,000 | 200,000 | |||
Loan and Security Agreement | Term Loan | Term A Loans | |||||
Debt Instrument [Line Items] | |||||
Amount drew dawn during period | $ 10,000,000 | ||||
Interest rate (as a percent) | 7.05% | ||||
Interest expense | $ 100,000 | $ 600,000 |
CO-DEVELOPMENT AND LICENSE AG_2
CO-DEVELOPMENT AND LICENSE AGREEMENT - Additional Information (Details) - USD ($) $ / shares in Units, shares in Millions | Aug. 29, 2017 | Jul. 06, 2016 | Jul. 07, 2014 | Aug. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Co-development and license agreement | ||||||
Research and development expense | $ 34,888,574 | $ 30,255,892 | ||||
Aggregate purchase price | 389 | |||||
Phase 3 Insomnia Trail | ||||||
Co-development and license agreement | ||||||
Percentage of milestone payment on aggregate product development cost | 40.00% | |||||
Janssen | Phase 3 Insomnia Trail | ||||||
Co-development and license agreement | ||||||
Milestone method payments | $ 40,000,000 | |||||
Janssen | Seltorexant | Co-Development and License Agreement | ||||||
Co-development and license agreement | ||||||
Payment of license fee | $ 22,000,000 | |||||
Payment of development costs | $ 3,500,000 | |||||
Direct expenses incurred | $ 300,000 | |||||
Research and development expense | $ 0 | 11,200,000 | ||||
Janssen | Seltorexant | Amendment to Co-Development and License Agreement | ||||||
Co-development and license agreement | ||||||
Upfront payment | $ 30,000,000 | |||||
Revenue recognition, milestone method, factors | The $30 million payment and $11.2 million in previously accrued collaborative expenses, which were forgiven upon the effective date of the Amendment, are earned and recognized as revenue as the services are performed from the commencement of Phase 3 development to the completion of the development activities using the proportional performance method. | |||||
Accrued collaborative expenses | 11,200,000 | |||||
Upfront payment received | $ 30,000,000 | 30,000,000 | ||||
Previously accrued collaborative expenses recognized as revenue | $ 11,200,000 | $ 11,200,000 | ||||
Janssen | Seltorexant | Amendment to Co-Development and License Agreement | Phase 3 Insomnia Trail | ||||||
Co-development and license agreement | ||||||
Payment start of Phase | 20,000,000 | |||||
Payment upon enrollment of patients | $ 20,000,000 | |||||
Percentage of patients to be enrolled | 50.00% | |||||
Johnson & Johnson Innovation-JJDC Inc | ||||||
Co-development and license agreement | ||||||
Stock repurchased | 3.9 | 3.9 | ||||
Stock repurchased price per share | $ 0.0001 | $ 0.0001 | ||||
Aggregate purchase price | $ 389 | $ 389 |
STOCKHOLDERS' EQUITY - Public O
STOCKHOLDERS' EQUITY - Public Offering of Common Stock - Additional Information (Details) - USD ($) | Jul. 05, 2017 | Dec. 31, 2017 |
Class Of Stock [Line Items] | ||
Proceeds from sale of common stock in public offering | $ 44,562,500 | |
Underwriting discounts and commissions and transaction costs | $ 2,944,168 | |
Public Offering | ||
Class Of Stock [Line Items] | ||
Shares of common stock issued | 5,750,000 | |
Share price (in dollars per share) | $ 7.75 | |
Proceeds from sale of common stock in public offering | $ 44,600,000 | |
Underwriting discounts and commissions and transaction costs | 3,000,000 | |
Net proceeds from issuance of common stock | $ 41,600,000 | |
Exercise of Underwriters | ||
Class Of Stock [Line Items] | ||
Shares of common stock issued | 750,000 |
STOCKHOLDERS' EQUITY - Share Re
STOCKHOLDERS' EQUITY - Share Repurchase - Additional Information (Details) - USD ($) $ / shares in Units, shares in Millions | Aug. 29, 2017 | Aug. 31, 2017 | Dec. 31, 2017 |
Class Of Stock [Line Items] | |||
Aggregate purchase price | $ 389 | ||
Johnson & Johnson Innovation-JJDC Inc | |||
Class Of Stock [Line Items] | |||
Stock repurchased | 3.9 | 3.9 | |
Stock repurchased price per share | $ 0.0001 | $ 0.0001 | |
Aggregate purchase price | $ 389 | $ 389 |
STOCKHOLDERS' EQUITY - Warrants
STOCKHOLDERS' EQUITY - Warrants Exercises - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2018 | |
Class Of Warrant Or Right [Line Items] | |||
Proceeds from exercise of warrants | $ 9,356,833 | ||
Private Placement | Warrants | |||
Class Of Warrant Or Right [Line Items] | |||
Common stock exercise price per share | $ 5.772 | ||
Shares of common stock to purchase by warrant | 1,621,073 | ||
Proceeds from exercise of warrants | $ 9,400,000 | ||
Warrants outstanding | 0 |
STOCKHOLDERS' EQUITY - Term Loa
STOCKHOLDERS' EQUITY - Term Loan Warrants - Additional Information (Details) $ / shares in Units, $ in Millions | Jan. 16, 2015USD ($)TradingDay$ / sharesshares |
Class Of Warrant Or Right [Line Items] | |
Fair value of warrants estimated | $ | $ 0.2 |
Warrant | |
Class Of Warrant Or Right [Line Items] | |
Expiration anniversary date of issuance | 10 years |
Warrant | Valuation Technique, Option Pricing Model | Measurement Input, Price Volatility | |
Class Of Warrant Or Right [Line Items] | |
Alternative investment, measurement input | 100.8 |
Warrant | Valuation Technique, Option Pricing Model | Measurement Input, Risk Free Interest Rate | |
Class Of Warrant Or Right [Line Items] | |
Alternative investment, measurement input | 1.83 |
Warrant | Valuation Technique, Option Pricing Model | Measurement Input, Expected Term | |
Class Of Warrant Or Right [Line Items] | |
Expected life | 10 years |
Warrant | Valuation Technique, Option Pricing Model | Measurement Input, Expected Dividend Payment | |
Class Of Warrant Or Right [Line Items] | |
Expected dividend | $ 0 |
Term Loan | |
Class Of Warrant Or Right [Line Items] | |
Aggregate number of shares of Common Stock issuable | 2.25% |
Consecutive trading days | TradingDay | 10 |
Term Loan | Term A Loans | |
Class Of Warrant Or Right [Line Items] | |
Shares of common stock to purchase by warrant | shares | 40,790 |
Common stock exercise price per share | $ 5.516 |
STOCK AWARD PLAN AND STOCK-BA_3
STOCK AWARD PLAN AND STOCK-BASED COMPENSATION - Additional Information (Details) - USD ($) | Jan. 01, 2018 | Jun. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Stock Award Plan and Stock-Based Compensation | |||||
Fair value of common stock on grant date (in dollars per share) | $ 5.18 | ||||
Total intrinsic value of the stock options exercised | $ 800,000 | $ 700,000 | |||
Dividend yield (as a percent) | 0.00% | ||||
Stock-based compensation expense | $ 8,182,678 | $ 5,033,123 | |||
Employee Stock Option | |||||
Stock Award Plan and Stock-Based Compensation | |||||
Fair value of common stock on grant date (in dollars per share) | $ 5.57 | $ 4.50 | |||
Total unrecognized compensation costs | $ 23,700,000 | ||||
Weighted-average period over which unrecognized compensation costs is expected to be recognized | 3 years 2 months 12 days | ||||
Dividend yield (as a percent) | 0.00% | 0.00% | |||
Non-Employees Stock Options | |||||
Stock Award Plan and Stock-Based Compensation | |||||
Shares issued | 215,000 | 480,000 | |||
Stock-based compensation expense | $ 1,033,000 | $ 287,000 | |||
Restricted Stock Units | |||||
Stock Award Plan and Stock-Based Compensation | |||||
Total unrecognized compensation costs | $ 1,500,000 | ||||
Weighted-average period over which unrecognized compensation costs is expected to be recognized | 2 years 25 days | ||||
Vesting rights percentage | 25.00% | ||||
Vesting period | 4 years | ||||
Description of vesting rights | RSUs awarded to employees generally vest one‑fourth per year over four years from the anniversary of the date of grant | ||||
Total fair value of shares vested | $ 500,000 | $ 300,000 | |||
2013 Equity Incentive Plan | |||||
Stock Award Plan and Stock-Based Compensation | |||||
Increase in number of shares authorized for issuance | 750,000 | ||||
Shares authorized for issuance under the plan | 6,531,333 | ||||
Additional shares authorized for issuance under the plan as percentage of total shares outstanding | 4.00% | ||||
2013 Equity Incentive Plan | Common Stock | |||||
Stock Award Plan and Stock-Based Compensation | |||||
Increase in number of shares authorized for issuance | 2,500,000 | ||||
2013 Equity Incentive Plan | Employee Stock Option | Common Stock | Rick Russell | |||||
Stock Award Plan and Stock-Based Compensation | |||||
Shares issued | 775,000 | ||||
Shares issued, price per share | $ 6.05 | $ 6.05 | |||
2013 Equity Incentive Plan | Restricted Stock Units | Common Stock | Rick Russell | |||||
Stock Award Plan and Stock-Based Compensation | |||||
Shares issued | 40,000 | ||||
Maximum | 2013 Equity Incentive Plan | Employee Stock Option | |||||
Stock Award Plan and Stock-Based Compensation | |||||
Term of share-based award | 10 years | ||||
Minimum | Non-Employees Stock Options | |||||
Stock Award Plan and Stock-Based Compensation | |||||
Dividend yield (as a percent) | 0.00% | 0.00% |
STOCK AWARD PLAN AND STOCK-BA_4
STOCK AWARD PLAN AND STOCK-BASED COMPENSATION - Stock Option Activity for Employees and Non-Employees (Details) - Employees and Non-Employees Stock Option - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Shares Issuable Pursuant to Stock Options | ||
Outstanding at the beginning of period (in shares) | 6,132,650 | |
Granted (in shares) | 2,658,500 | |
Exercised (in shares) | (129,978) | |
Forfeited (in shares) | (163,125) | |
Outstanding at the end of the period (in shares) | 8,498,047 | 6,132,650 |
Exercisable at the end of the period (in shares) | 3,745,660 | |
Available for future grant (in shares) | 769,779 | |
Weighted-Average Exercise Price | ||
Outstanding at the beginning of period (in dollars per share) | $ 6.54 | |
Granted (in dollars per share) | 7.92 | |
Exercised (in dollars per share) | 5.05 | |
Forfeited (in dollars per share) | 6.97 | |
Outstanding at the end of the period (in dollars per share) | 6.99 | $ 6.54 |
Exercisable at the end of the period (in dollars per share) | $ 6.44 | |
Weighted-Average Remaining Contractual Term Outstanding (years) | 8 years 1 month 6 days | 8 years 4 months 24 days |
Weighted-Average Remaining Contractual Term Exercisable (years) | 6 years 8 months 12 days | |
Total Intrinsic Value Outstanding | $ 5,214 | |
Total Intrinsic Value Exercisable | $ 3,344 |
STOCK AWARD PLAN AND STOCK-BA_5
STOCK AWARD PLAN AND STOCK-BASED COMPENSATION - Summary of Assumptions Used in Black Scholes Model to Estimate Fair Value of Stock Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock Award Plan and Stock-Based Compensation | ||
Dividend yield | 0.00% | |
Weighted average grant date fair value per share of common stock | $ 5.18 | |
Employee Stock Option | ||
Stock Award Plan and Stock-Based Compensation | ||
Dividend yield | 0.00% | 0.00% |
Weighted average grant date fair value per share of common stock | $ 5.57 | $ 4.50 |
Minimum | Employee Stock Option | ||
Stock Award Plan and Stock-Based Compensation | ||
Expected term (years) | 5 years 6 months | 5 years 6 months |
Risk free interest rate | 2.33% | 1.83% |
Volatility | 76.00% | 79.00% |
Minimum | Non-Employees Stock Options | ||
Stock Award Plan and Stock-Based Compensation | ||
Expected term (years) | 3 months 18 days | 8 years 8 months 12 days |
Risk free interest rate | 2.39% | 2.37% |
Volatility | 75.00% | 111.00% |
Dividend yield | 0.00% | 0.00% |
Weighted average reporting date fair value per share of common stock | $ 5.91 | $ 5.54 |
Maximum | Employee Stock Option | ||
Stock Award Plan and Stock-Based Compensation | ||
Expected term (years) | 6 years 3 months | 6 years 3 months |
Risk free interest rate | 3.01% | 2.25% |
Volatility | 83.00% | 84.00% |
Maximum | Non-Employees Stock Options | ||
Stock Award Plan and Stock-Based Compensation | ||
Expected term (years) | 9 years 10 months 24 days | 9 years 10 months 24 days |
Risk free interest rate | 2.89% | 2.40% |
Volatility | 109.00% | 113.00% |
STOCK AWARD PLAN AND STOCK-BA_6
STOCK AWARD PLAN AND STOCK-BASED COMPENSATION - Schedule of RSU Activity (Details) - Restricted Stock Units | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Stock Options | |
Unvested at the beginning of the period (in shares) | shares | 185,950 |
Vested (in shares) | shares | (58,650) |
Unvested at the end of the period (in shares) | shares | 127,300 |
Weighted-Average Grant Date Fair Value | |
Unvested at the beginning of the period (in dollars per share) | $ / shares | $ 11.86 |
Vested (in dollars per share) | $ / shares | 12.19 |
Unvested at the end of the period (in dollars per share) | $ / shares | $ 11.71 |
STOCK AWARD PLAN AND STOCK-BA_7
STOCK AWARD PLAN AND STOCK-BASED COMPENSATION - Schedule of Stock-Based Compensation Expense Included in the Company's Consolidated Statements of Operations (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock based compensation expense | $ 8,182,678 | $ 5,033,123 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock based compensation expense | 2,257,102 | 1,966,126 |
General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock based compensation expense | $ 5,925,576 | $ 3,066,997 |
INCOME TAXES - Schedule of Prov
INCOME TAXES - Schedule of Provision for Federal, Foreign and State Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Deferred income tax provision (benefit) | ||
Federal | $ (9,376,272) | |
Total income tax provision (benefit) | $ 0 | $ (9,376,272) |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | ||
Incom tax provision (benefit) | $ 0 | $ (9,376,272) |
Increase (decrease) in valuation allowance on net deferred tax assets | $ 12,800,000 | $ (9,900,000) |
Corporate tax rate | 21.00% | 34.00% |
Unrecognized tax benefits, liability | $ 0 | $ 0 |
Interest and penalties recognized | 0 | 0 |
Interest and penalties accrued | 0 | $ 0 |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | $ 53,900,000 | |
Operating losses, year begin to expire | 2027 | |
Federal | Federal research and development | ||
Operating Loss Carryforwards [Line Items] | ||
Federal research and development credits | $ 200,000 | |
Federal research and development credits expiration year | 2027 | |
Switzerland | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | $ 2,600,000 | |
New jersey | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | $ 7,700,000 | |
Operating losses, year begin to expire | 2029 | |
Massachusetts | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | $ 40,600,000 | |
Operating losses, year begin to expire | 2033 |
INCOME TAXES - Net Deferred Tax
INCOME TAXES - Net Deferred Tax Assets (Liabilities) (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 15,049,549 | $ 18,265,530 |
Research and development tax credits | 145,115 | 145,115 |
Capitalized research and development costs | 22,072,598 | 14,858,509 |
Stock-based compensation | 5,532,341 | 4,180,651 |
Deferred start-up and license costs | 5,929,901 | 6,532,419 |
Deferred Revenue | 11,249,174 | 3,053,174 |
Other | 129,082 | |
Net deferred tax assets | 59,978,678 | 47,164,480 |
Valuation allowance | (54,687,950) | (41,878,528) |
Net deferred tax assets | 5,290,728 | 5,285,952 |
Deferred tax liabilities: | ||
In-process research and development | (9,343,440) | (9,343,440) |
Other | (4,776) | |
Net deferred tax liabilities | $ (4,057,488) | $ (4,057,488) |
INCOME TAXES - Schedule of Effe
INCOME TAXES - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | (21.00%) | (34.00%) |
Permanent differences | 0.38% | 0.66% |
State income taxes | (0.00%) | (0.00%) |
Valuation allowance | 20.62% | 56.33% |
Effective tax rate | (0.00%) | 22.99% |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Details) - Office Sublease Agreement - Profitect, Inc | Oct. 02, 2017USD ($)ft² | Dec. 31, 2018 |
Loss Contingencies [Line Items] | ||
Sublease rentable square feet | ft² | 5,923 | |
Lease description | The term of the Sublease began on November 1, 2017 and will expire on July 30, 2021, with a monthly rental rate starting at $14,808 and escalating to a maximum monthly rental rate of $16,288 in the final 12 months of the term. The Sublandlord has agreed to provide the Premises to the Company free of charge for the first two months of the term. The Company will recognize the remaining expense on a straight-line basis over the remaining lease term which will expire on July 30, 2021. | |
Lease commencement date | Nov. 1, 2017 | |
Sublease expire date | Jul. 30, 2021 | |
Minimum | ||
Loss Contingencies [Line Items] | ||
Monthly rental rate | $ 14,808 | |
Maximum | ||
Loss Contingencies [Line Items] | ||
Monthly rental rate | $ 16,288 |
RELATED PARTY TRANSACTIONS - Ad
RELATED PARTY TRANSACTIONS - Additional Information (Details) - V - Watch SA $ in Thousands | 1 Months Ended |
Jan. 31, 2016USD ($) | |
Related Party Transaction [Line Items] | |
Services agreement | $ 105 |
Minimum | |
Related Party Transaction [Line Items] | |
Percentage of outstanding capital stock | 10.00% |
QUARTERLY RESULTS (Unaudited) -
QUARTERLY RESULTS (Unaudited) - Schedule of Quarterly Financial Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | ||||||||||
Total revenues | $ 0 | |||||||||
Operating loss | $ (13,627,000) | $ (12,424,000) | $ (12,935,000) | $ (12,744,000) | $ (9,532,000) | $ (11,407,000) | $ (9,746,000) | $ (10,485,000) | (51,729,882) | $ (41,170,161) |
Net (loss) income | $ (13,203,000) | $ (12,021,000) | $ (12,529,000) | $ (12,418,000) | $ 162,000 | $ (11,260,000) | $ (9,780,000) | $ (10,645,000) | $ (50,171,287) | $ (31,523,207) |
Loss per share, basic and diluted | $ (0.34) | $ (0.31) | $ (0.32) | $ (0.32) | $ 0 | $ (0.28) | $ (0.27) | $ (0.30) |