Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 31, 2018 | |
Document Entity Information [Abstract] | ||
Entity Registrant Name | Minerva Neurosciences, Inc. | |
Entity Central Index Key | 1,598,646 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | NERV | |
Entity Common Stock, Shares Outstanding | 38,871,467 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 87,296,544 | $ 26,051,821 |
Marketable securities | 10,308,684 | 102,109,419 |
Restricted cash | 100,000 | 80,000 |
Prepaid expenses and other current assets | 3,699,556 | 1,299,184 |
Total current assets | 101,404,784 | 129,540,424 |
Marketable securities - noncurrent | 5,022,982 | |
Equipment, net | 37,845 | 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 | 150,526,836 | 183,698,558 |
Current liabilities | ||
Notes payable | 3,962,664 | |
Accounts payable | 874,749 | 1,435,636 |
Accrued expenses and other current liabilities | 2,995,515 | 1,439,848 |
Total current liabilities | 3,870,264 | 6,838,148 |
Deferred taxes | 4,057,488 | 4,057,488 |
Deferred revenue | 41,175,600 | 41,175,600 |
Other noncurrent liabilities | 30,076 | 29,878 |
Total liabilities | 49,133,428 | 52,101,114 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity | ||
Preferred stock; $0.0001 par value; 100,000,000 shares authorized; none issued or outstanding as of September 30, 2018 and December 31, 2017 | ||
Common stock; $0.0001 par value; 125,000,000 shares authorized; 38,846,467 and 38,749,343 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively | 3,885 | 3,875 |
Additional paid-in capital | 302,739,419 | 295,975,010 |
Accumulated deficit | (201,349,896) | (164,381,441) |
Total stockholders’ equity | 101,393,408 | 131,597,444 |
Total liabilities and stockholders’ equity | $ 150,526,836 | $ 183,698,558 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Sep. 30, 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 | 38,846,467 | 38,749,343 |
Common stock, shares outstanding | 38,846,467 | 38,749,343 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Expenses | ||||
Research and development | $ 8,369,451 | $ 8,956,468 | $ 25,880,952 | $ 23,714,932 |
General and administrative | 4,054,575 | 2,450,588 | 12,221,429 | 7,922,738 |
Total expenses | 12,424,026 | 11,407,056 | 38,102,381 | 31,637,670 |
Loss from operations | (12,424,026) | (11,407,056) | (38,102,381) | (31,637,670) |
Foreign exchange gains (losses) | (10,987) | (9,417) | 178 | (46,215) |
Investment income | 418,347 | 293,797 | 1,244,196 | 508,116 |
Interest expense | (4,018) | (137,899) | (110,448) | (509,526) |
Net loss | $ (12,020,684) | $ (11,260,575) | $ (36,968,455) | $ (31,685,295) |
Net loss per share, basic and diluted | $ (0.31) | $ (0.28) | $ (0.95) | $ (0.84) |
Weighted average shares outstanding, basic and diluted | 38,781,839 | 40,880,359 | 38,760,294 | 37,676,686 |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Changes in Stockholders' Equity (Unaudited) - 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-Private | (389) | $ (389) | ||
Repurchase of common stock-Private (in shares) | (3,892,256) | |||
Issuance of common stock-Public | 44,562,500 | $ 575 | 44,561,925 | |
Issuance of common stock-Public (in shares) | 5,750,000 | |||
Costs related to issuance of commons stock | (2,944,168) | (2,944,168) | ||
Warrant exercises | 9,356,833 | $ 162 | 9,356,671 | |
Warrant exercises (in shares) | 1,621,073 | |||
Stock option exercise | 1,130,544 | $ 20 | 1,130,524 | |
Stock option exercise (in shares) | 197,874 | |||
Stock based compensation | 3,775,469 | 3,775,469 | ||
Net Income (Loss) | (31,685,295) | (31,685,295) | ||
Balance at Sep. 30, 2017 | 130,177,702 | $ 3,870 | 294,717,361 | (164,543,529) |
Balance (in shares) at Sep. 30, 2017 | 38,700,693 | |||
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 | ||
Stock option exercise | $ 490,829 | $ 10 | 490,819 | |
Stock option exercise (in shares) | 97,124 | |||
Stock based compensation | 6,273,590 | 6,273,590 | ||
Net Income (Loss) | (36,968,455) | (36,968,455) | ||
Balance at Sep. 30, 2018 | $ 101,393,408 | $ 3,885 | $ 302,739,419 | $ (201,349,896) |
Balance (in shares) at Sep. 30, 2018 | 38,846,467 | 38,846,467 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (36,968,455) | $ (31,685,295) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 13,100 | 9,310 |
Amortization of debt discount recorded as interest expense | 38,040 | 170,822 |
Accretion of marketable securities | (92,801) | (83,268) |
Stock-based compensation expense | 6,273,590 | 3,775,469 |
Changes in operating assets and liabilities | ||
Prepaid expenses and other current assets | (2,400,372) | (51,840) |
Accounts payable | (560,887) | 35,071 |
Accrued expenses and other current liabilities | 1,555,667 | 1,206,592 |
Accrued collaborative expenses | (2,547,952) | |
Deferred revenue | 41,175,600 | |
Other noncurrent liabilities | 198 | |
Net cash (used in) provided by operating activities | (32,141,920) | 12,004,509 |
Cash flows from investing activities: | ||
Proceeds from the maturity and redemption of marketable securities | 104,851,000 | 27,390,000 |
Purchase of marketable securities | (7,934,482) | (134,554,390) |
Net cash provided by (used in) investing activities | 96,916,518 | (107,164,390) |
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 | 490,829 | 1,130,544 |
Repayments of notes payable | (4,000,704) | (3,671,300) |
Net cash (used in) provided by financing activities | (3,509,875) | 48,434,020 |
Net increase (decrease) in cash and cash equivalents | 61,264,723 | (46,725,861) |
Cash, cash equivalents and restricted cash | ||
Beginning of period | 26,131,821 | 82,980,609 |
End of period | 87,396,544 | 36,254,748 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 92,916 | 360,272 |
Reconciliation of the Condensed Consolidated Statements of Cash Flows to the Condensed Consolidated Balance Sheets | ||
Cash and cash equivalents | 87,296,544 | 36,254,748 |
Restricted cash | 100,000 | 80,000 |
Total cash, cash equivalents and restricted cash | $ 87,396,544 | $ 36,334,748 |
Nature of Operations and Liquid
Nature of Operations and Liquidity | 9 Months Ended |
Sep. 30, 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 September 30, 2018, the Company has an accumulated deficit of approximately $201.3 million As of September 30, 2018, the Company had cash, cash equivalents, restricted cash and marketable securities of $97.7 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 interim condensed 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 | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | NOTE 2 — SIGNIFICANT ACCOUNTING POLICIES Basis of presentation The interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim reporting and the requirements of the Securities and Exchange Commission (“SEC”) in accordance with Regulation S-X, Rule 10-01. Under those rules, certain notes and financial information that are normally required for annual financial statements can be condensed or omitted. In the opinion of the Company’s management, the accompanying financial statements contain all adjustments (consisting of items of a normal and recurring nature) necessary to present fairly the financial position as of September 30, 2018, the results of operations for the three and nine months ended September 30, 2018 and 2017 and cash flows for the nine months ended September 30, 2018 and 2017. The results of operations for the three and nine months ended September 30, 2018, are not necessarily indicative of the results to be expected for the full year. When preparing financial statements in conformity with GAAP, management must make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure 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. The consolidated balance sheet as of December 31, 2017 was derived from the audited annual financial statements. The accompanying unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 12, 2018. 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 September 30, 2018 and December 31, 2017, respectively. Marketable securities Marketable securities consists of corporate and U.S. government debt securities maturing in eleven 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 September 30, 2018, remaining final maturities of marketable securities ranged from November 2018 to February 2019, with a weighted average remaining maturity of approximately 2.9 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 September 30, 2018: September 30, 2018 Amortized Aggregate Unrealized Unrealized Net Carrying Cost Fair Value Gains Losses Value Marketable securities: Corporate bonds/notes $ 10,308,684 $ 10,286,354 $ (22,330 ) $ — $ 10,308,684 Marketable securities total $ 10,308,684 $ 10,286,354 $ (22,330 ) $ — $ 10,308,684 Research and development costs Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company’s research and development projects as well as fees paid to consultants and various entities that perform certain research and testing on behalf of the Company and costs related to salaries, benefits, bonuses and stock-based compensation granted to employees in research and development functions. The Company determines expenses related to clinical studies based on estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations that conduct and manage clinical studies on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the accrual is adjusted accordingly. The expenses for some trials may be recognized on a straight-line basis if the anticipated costs are expected to be incurred ratably during the period. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued expenses. 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 three and nine months ended September 30, 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 US dollar. The Company pays certain vendor invoices in the respective foreign currency. The Company records an expense in US 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. Concentration of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and marketable securities (current and non-current). 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 September 30, 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 tests its goodwill for impairment as of November 30. There was no impairment of goodwill for the nine months ended September 30, 2018 and 2017. 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 When the Company enters into an arrangement that meets the definition of a collaboration under ASC 808, Collaboration Arrangements, the Company recognizes revenue as research and development is performed and its respective share of the expenses are incurred. The Company assesses whether the arrangement contains multiple elements or deliverables, which may include (1) licenses to the Company's technology, (2) research and development activities performed for the collaboration partner, and (3) participation on Joint Steering Committees. Payments may include non-refundable, upfront payments, milestone payments upon achieving significant development events, and royalties on future sales. Each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting based on whether the deliverable has “stand-alone value” to the customer. The arrangement’s consideration is then allocated to each separate unit of accounting based on the relative selling price of each deliverable. The estimated selling price of each deliverable is determined using the following hierarchy of values: (i) vendor-specific objective evidence of fair value; (ii) third-party evidence of selling price; and (iii) best estimate of selling price. The best estimate of selling price reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis. The consideration allocated to each unit of accounting is then recognized as the related goods or services are delivered, limited to the consideration that is not contingent upon future deliverables. Supply or service transactions may involve the charge of a nonrefundable initial fee with subsequent periodic payments for future products or services. The up-front fees, even if nonrefundable, are recognized as revenue as the products and/or services are delivered and performed over the term of the arrangement. Deferred revenue The Company applies the revenue recognition guidance in accordance with FASB ASC 606, Revenue from Contracts with Customers. Using FASB 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 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 In January 2017, the FASB issued ASU No. 2017-4, Intangibles — Goodwill and Other (Topic 350). In March 2017, the FASB issued ASU No. 2017-8, 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 | 9 Months Ended |
Sep. 30, 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: September 30, 2018 December 31, 2017 Research and development costs and other accrued expenses $ 1,335,743 $ 1,162,441 Accrued bonus 1,251,621 5,899 Professional fees 332,437 251,000 Interest payable — 20,508 Vacation pay 75,714 — $ 2,995,515 $ 1,439,848 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 9 Months Ended |
Sep. 30, 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: Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Net loss $ (12,020,684 ) $ (11,260,575 ) $ (36,968,455 ) $ (31,685,295 ) Weighted average shares of common stock outstanding 38,781,839 40,880,359 38,760,294 37,676,686 Net loss per share of common stock – basic and diluted $ (0.31 ) $ (0.28 ) $ (0.95 ) $ (0.84 ) The following securities outstanding at September 30, 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: September 30, 2018 2017 Common stock options 6,793,026 3,997,650 Restricted stock units 185,950 194,600 Common stock warrants 40,790 40,790 |
Debt
Debt | 9 Months Ended |
Sep. 30, 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. As of September 30, 2018, the Company had no borrowings outstanding under the Term Loans. For the three months ended September 30, 2018 and 2017, the Company recognized interest expense of $9 thousand and $0.1 million, respectively, including $1 thousand and $0.1 million respectively, including $38 thousand and $0.2 million, respectively, The Term Loans matured on August 1, 2018 and the Company made a final repayment in the amount of $510 thousand on such date. |
Co-Development and License Agre
Co-Development and License Agreement | 9 Months Ended |
Sep. 30, 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 original Agreement contains certain provisions, which include the Company’s ability to opt-out of the Agreement upon completion of certain milestones. If the Company elects to participate in the development program through to the potential commercial approval of seltorexant, the Company will pay a quarterly royalty percentage to the licensor in the high single digits on aggregate net sales for seltorexant products sold by the Company, its affiliates and sublicensees in the Minerva Territory. The licensor will pay a quarterly royalty percentage to the Company in the high single digits on aggregate net sales for seltorexant products sold by the licensor outside the Minerva Territory. In accordance with the development agreement, the Company will pay 40% of seltorexant development costs related to the joint development of any seltorexant products. The Company’s share of aggregate development costs shall not exceed (i) $5.0 million for the period beginning from the effective date of the license and ending following the completion of certain Phase 1b clinical trials and animal toxicology studies, and (ii) $24.0 million for the period beginning from the effective date of the license and ending following the completion of certain Phase 2 clinical trials. Janssen has a right to opt out at the end of certain development milestones, after which Janssen will not have to fund further development of seltorexant and the Minerva Territory will be expanded to also include all of North America. The Company would then owe Janssen a reduced royalty in the mid-single digits for all sales in the Minerva Territory. Janssen may also terminate the Agreement for the Company’s material breach or certain insolvency events, including if the Company is unable to fund its portion of the development costs. The Company accounts for the Agreement as a joint risk-sharing collaboration in accordance with ASC 808, Collaboration 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. The Company has included zero in accrued collaborative expenses as of September 30, 2018 and December 31, 2017, related to the Agreement. In the nine months ended September 30, 2018 and 2017, the Company paid zero and $2.5 million, respectively, related to development activities under the Agreement. 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 three months ended September 30, 2018 and 2017, the Company recorded an expense of zero and $4.5 million, respectively, for certain development activities in accordance with the terms of the Agreement. During the nine months ended September 30, 2018 and 2017, the Company recorded an expense 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 to the Agreement (“the Amendment”). 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 the amended Agreement, 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 as adjunctive therapy for MDD, which include an exclusive license in the Minerva Territory, with royalties payable by the Company to Janssen on seltorexant MDD sales. 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 the remaining payments due from the Company until completion of the Phase 2 development of seltorexant. The $30 million payment and $11.2 million in previously accrued collaborative expenses, which were forgiven upon the effective date of the Amendment, will be 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 September 30, 2018 and December 31, 2017, respectively. 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 the clinical development of seltorexant for insomnia and has no further financial obligations until the Phase 2b development milestone has been completed, which is expected to occur in the second half of 2019. Upon completion of this development milestone, referred to as “Decision Point 4”, Minerva has the right to opt-out of the Agreement and collect a royalty on worldwide sales of seltorexant in the single digits with no further obligations to Janssen. If the Company elects to continue past “Decision Point 4” into Phase 3, the Company would be obligated to fund the clinical trials related to insomnia, and receive $40 million in milestone payments from Janssen, and would also 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 solely dependent on future developments and therefore are considered non-substantive and will recognize such revenue in the periods in which the milestones are achieved. Similarly, the Company will recognize royalty revenues in the periods of the sale of the related products, provided that the reported sales are reliably measurable, collectability is reasonably assured and the Company has no further performance obligations. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 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. Warrant 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 September 30, 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 September 30, 2018. |
Stock Award Plan and Stock-Base
Stock Award Plan and Stock-Based Compensation | 9 Months Ended |
Sep. 30, 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 , 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. Shares Issuable Pursuant to Stock Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Total Intrinsic Value (in thousands) Outstanding January 1, 2018 6,132,650 $ 6.54 8.4 — Granted 790,000 $ 7.06 — — Exercised (97,124 ) $ 5.05 — $ 521 Forfeited (32,500 ) $ 10.62 — — Outstanding September 30, 2018 6,793,026 $ 6.60 7.8 $ 40,725 Exercisable September 30, 2018 3,152,470 $ 5.74 6.5 $ 17,984 Available for future grant 2,507,654 The weighted average grant-date fair value of stock options outstanding on September 30, 2018 was $4.99 per share. Total unrecognized compensation costs related to non-vested stock options at September 30, 2018 was approximately $17.6 million and is expected to be recognized within future operating results over a weighted-average period of 2.8 years. The total intrinsic value of the options exercised during the nine months ended September 30, 2017 was approximately $0.7 million. 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 volatility assumption was determined by examining the historical volatilities for industry peer companies, as the Company did not have sufficient trading history for its common stock. The risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the options. The dividend assumption is based on the Company’s history and expectation of dividend payouts. The Company has never paid dividends on its common stock and does not anticipate paying dividends on its common stock in the foreseeable future. Accordingly, the Company has assumed no dividend yield for purposes of estimating the fair value of the options. The Company uses the Black Scholes model to estimate the fair value of stock options granted. For stock options granted during the nine months ended September 30, 2018 and 2017, the Company utilized the following assumptions: September 30, 2018 2017 Expected term (years) 5.5-6.25 5.5-6.25 Risk free interest rate 2.33-2.93% 1.83-2.02% Volatility 76-83% 79-84% Dividend yield 0% 0% Weighted average grant date fair value per share of common stock $ 4.97 $ 5.08 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 40,000 stock options to non-employees during the nine months ended September 30, 2018. The Company recorded stock-based compensation expense for stock options granted to non-employees of $ million and $0.2 million during the nine months ended September 30, 2018 and 2017, respectively. For stock options granted to non-employees, the Company utilized the following assumptions: September 30, 2018 2017 Expected term (years) 7.9-9.3 8.9-9.5 Risk free interest rate 2.46-3.04% 2.27-2.31% Volatility 83-88% 111-112% Dividend yield 0% 0% Weighted average reporting date fair value per share of common stock $ 10.94 $ 6.85 RSU activity under the Plan for the nine months ended September 30, 2018 is as follows: Weighted- Average Grant Date RSUs Fair Value Unvested January 1, 2018 185,950 $ 11.86 Granted — $ — Vested — $ — Forfeited — $ — Unvested September 30, 2018 185,950 $ 11.86 RSUs awarded to employees generally vest one-fourth per year over four years from the anniversary of the date of grant, provided the employee remains continuously employed with the Company. Shares of the Company’s stock are delivered to the employee upon vesting, subject to payment of applicable withholding taxes. The fair value of RSUs is equal to the closing price of the Company’s common stock on the date of grant. Total unrecognized compensation costs related to non-vested RSUs at September 30, 2018 was approximately $1.6 million and is expected to be recognized within future operating results over a period of 2.3 years. The following table presents stock-based compensation expense included in the Company’s consolidated statements of operations: Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Research and development $ 718,507 $ 461,210 $ 1,827,372 $ 1,471,161 General and administrative 1,543,274 772,675 4,446,218 2,304,308 Total $ 2,261,781 $ 1,233,885 $ 6,273,590 $ 3,775,469 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 9 — 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 | 9 Months Ended |
Sep. 30, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | NOTE 10 — 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. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of presentation The interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim reporting and the requirements of the Securities and Exchange Commission (“SEC”) in accordance with Regulation S-X, Rule 10-01. Under those rules, certain notes and financial information that are normally required for annual financial statements can be condensed or omitted. In the opinion of the Company’s management, the accompanying financial statements contain all adjustments (consisting of items of a normal and recurring nature) necessary to present fairly the financial position as of September 30, 2018, the results of operations for the three and nine months ended September 30, 2018 and 2017 and cash flows for the nine months ended September 30, 2018 and 2017. The results of operations for the three and nine months ended September 30, 2018, are not necessarily indicative of the results to be expected for the full year. When preparing financial statements in conformity with GAAP, management must make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure 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. The consolidated balance sheet as of December 31, 2017 was derived from the audited annual financial statements. The accompanying unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 12, 2018. |
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 September 30, 2018 and December 31, 2017, respectively. |
Marketable Securities | Marketable securities Marketable securities consists of corporate and U.S. government debt securities maturing in eleven 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 September 30, 2018, remaining final maturities of marketable securities ranged from November 2018 to February 2019, with a weighted average remaining maturity of approximately 2.9 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 September 30, 2018: September 30, 2018 Amortized Aggregate Unrealized Unrealized Net Carrying Cost Fair Value Gains Losses Value Marketable securities: Corporate bonds/notes $ 10,308,684 $ 10,286,354 $ (22,330 ) $ — $ 10,308,684 Marketable securities total $ 10,308,684 $ 10,286,354 $ (22,330 ) $ — $ 10,308,684 |
Research and Development Costs | Research and development costs Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company’s research and development projects as well as fees paid to consultants and various entities that perform certain research and testing on behalf of the Company and costs related to salaries, benefits, bonuses and stock-based compensation granted to employees in research and development functions. The Company determines expenses related to clinical studies based on estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations that conduct and manage clinical studies on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the accrual is adjusted accordingly. The expenses for some trials may be recognized on a straight-line basis if the anticipated costs are expected to be incurred ratably during the period. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued expenses. |
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 three and nine months ended September 30, 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 US dollar. The Company pays certain vendor invoices in the respective foreign currency. The Company records an expense in US 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. |
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 (current and non-current). 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 September 30, 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 tests its goodwill for impairment as of November 30. There was no impairment of goodwill for the nine months ended September 30, 2018 and 2017. |
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 When the Company enters into an arrangement that meets the definition of a collaboration under ASC 808, Collaboration Arrangements, the Company recognizes revenue as research and development is performed and its respective share of the expenses are incurred. The Company assesses whether the arrangement contains multiple elements or deliverables, which may include (1) licenses to the Company's technology, (2) research and development activities performed for the collaboration partner, and (3) participation on Joint Steering Committees. Payments may include non-refundable, upfront payments, milestone payments upon achieving significant development events, and royalties on future sales. Each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting based on whether the deliverable has “stand-alone value” to the customer. The arrangement’s consideration is then allocated to each separate unit of accounting based on the relative selling price of each deliverable. The estimated selling price of each deliverable is determined using the following hierarchy of values: (i) vendor-specific objective evidence of fair value; (ii) third-party evidence of selling price; and (iii) best estimate of selling price. The best estimate of selling price reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis. The consideration allocated to each unit of accounting is then recognized as the related goods or services are delivered, limited to the consideration that is not contingent upon future deliverables. Supply or service transactions may involve the charge of a nonrefundable initial fee with subsequent periodic payments for future products or services. The up-front fees, even if nonrefundable, are recognized as revenue as the products and/or services are delivered and performed over the term of the arrangement. |
Deferred Revenue | Deferred revenue The Company applies the revenue recognition guidance in accordance with FASB ASC 606, Revenue from Contracts with Customers. Using FASB 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 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 In January 2017, the FASB issued ASU No. 2017-4, Intangibles — Goodwill and Other (Topic 350). In March 2017, the FASB issued ASU No. 2017-8, 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) | 9 Months Ended |
Sep. 30, 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 September 30, 2018: September 30, 2018 Amortized Aggregate Unrealized Unrealized Net Carrying Cost Fair Value Gains Losses Value Marketable securities: Corporate bonds/notes $ 10,308,684 $ 10,286,354 $ (22,330 ) $ — $ 10,308,684 Marketable securities total $ 10,308,684 $ 10,286,354 $ (22,330 ) $ — $ 10,308,684 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: September 30, 2018 December 31, 2017 Research and development costs and other accrued expenses $ 1,335,743 $ 1,162,441 Accrued bonus 1,251,621 5,899 Professional fees 332,437 251,000 Interest payable — 20,508 Vacation pay 75,714 — $ 2,995,515 $ 1,439,848 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 9 Months Ended |
Sep. 30, 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: Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Net loss $ (12,020,684 ) $ (11,260,575 ) $ (36,968,455 ) $ (31,685,295 ) Weighted average shares of common stock outstanding 38,781,839 40,880,359 38,760,294 37,676,686 Net loss per share of common stock – basic and diluted $ (0.31 ) $ (0.28 ) $ (0.95 ) $ (0.84 ) |
Securities Excluded from Calculation of Weighted Average Shares Outstanding as their Effect is Antidilutive | The following securities outstanding at September 30, 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: September 30, 2018 2017 Common stock options 6,793,026 3,997,650 Restricted stock units 185,950 194,600 Common stock warrants 40,790 40,790 |
Stock Award Plan and Stock-Ba_2
Stock Award Plan and Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 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 under the Plan for the nine months ended September 30, 2018 is as follows: Shares Issuable Pursuant to Stock Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Total Intrinsic Value (in thousands) Outstanding January 1, 2018 6,132,650 $ 6.54 8.4 — Granted 790,000 $ 7.06 — — Exercised (97,124 ) $ 5.05 — $ 521 Forfeited (32,500 ) $ 10.62 — — Outstanding September 30, 2018 6,793,026 $ 6.60 7.8 $ 40,725 Exercisable September 30, 2018 3,152,470 $ 5.74 6.5 $ 17,984 Available for future grant 2,507,654 |
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 during the nine months ended September 30, 2018 and 2017, the Company utilized the following assumptions: September 30, 2018 2017 Expected term (years) 5.5-6.25 5.5-6.25 Risk free interest rate 2.33-2.93% 1.83-2.02% Volatility 76-83% 79-84% Dividend yield 0% 0% Weighted average grant date fair value per share of common stock $ 4.97 $ 5.08 |
Schedule of RSU Activity | RSU activity under the Plan for the nine months ended September 30, 2018 is as follows: Weighted- Average Grant Date RSUs Fair Value Unvested January 1, 2018 185,950 $ 11.86 Granted — $ — Vested — $ — Forfeited — $ — Unvested September 30, 2018 185,950 $ 11.86 |
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: Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Research and development $ 718,507 $ 461,210 $ 1,827,372 $ 1,471,161 General and administrative 1,543,274 772,675 4,446,218 2,304,308 Total $ 2,261,781 $ 1,233,885 $ 6,273,590 $ 3,775,469 |
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: September 30, 2018 2017 Expected term (years) 7.9-9.3 8.9-9.5 Risk free interest rate 2.46-3.04% 2.27-2.31% Volatility 83-88% 111-112% Dividend yield 0% 0% Weighted average reporting date fair value per share of common stock $ 10.94 $ 6.85 |
NATURE OF OPERATIONS AND LIQU_2
NATURE OF OPERATIONS AND LIQUIDITY - Additional Information (Details) | 9 Months Ended | ||
Sep. 30, 2018USD ($)License | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($) | |
Nature Of Operations And Liquidity [Line Items] | |||
Accumulated deficit | $ 201,349,896 | $ 164,381,441 | |
Net cash used in operating activities | 32,141,920 | $ (12,004,509) | |
Cash, cash equivalents, restricted cash and marketable securities | $ 97,700,000 | ||
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) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($)Segment | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($) | |
Significant Accounting Policies [Line Items] | |||||
Restricted cash balances as collateral for corporate credit cards | $ 100,000 | $ 80,000 | $ 100,000 | $ 80,000 | $ 80,000 |
Marketable securities, weighted average remaining maturity | 2 months 27 days | ||||
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 | $ 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) | Sep. 30, 2018USD ($) |
Schedule Of Held To Maturity Securities [Line Items] | |
Marketable securities, Amortized Cost | $ 10,308,684 |
Marketable securities, Aggregate Fair Value | 10,286,354 |
Marketable securities, Unrealized Gains | (22,330) |
Marketable securities, Net Carrying Value | 10,308,684 |
Corporate Bonds/Notes | |
Schedule Of Held To Maturity Securities [Line Items] | |
Marketable securities, Amortized Cost | 10,308,684 |
Marketable securities, Aggregate Fair Value | 10,286,354 |
Marketable securities, Unrealized Gains | (22,330) |
Marketable securities, Net Carrying Value | $ 10,308,684 |
ACCRUED EXPENSES AND OTHER LI_3
ACCRUED EXPENSES AND OTHER LIABILITIES - Accrued Expenses and Other Liabilities (Details) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Research and development costs and other accrued expenses | $ 1,335,743 | $ 1,162,441 |
Accrued bonus | 1,251,621 | 5,899 |
Professional fees | 332,437 | 251,000 |
Interest payable | 20,508 | |
Vacation pay | 75,714 | |
Accrued expenses and other liabilities | $ 2,995,515 | $ 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 | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (12,020,684) | $ (11,260,575) | $ (36,968,455) | $ (31,685,295) |
Weighted average shares of common stock outstanding | 38,781,839 | 40,880,359 | 38,760,294 | 37,676,686 |
Net loss per share of common stock – basic and diluted | $ (0.31) | $ (0.28) | $ (0.95) | $ (0.84) |
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 | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 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 | 6,793,026 | 3,997,650 |
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 | 185,950 | 194,600 |
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 ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) |
Debt Instrument [Line Items] | |||||||
Amortization of debt discount recorded as interest expense | $ 38,040 | $ 170,822 | |||||
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 | |||||
Borrowings outstanding | $ 0 | 0 | |||||
Amortization of debt discount recorded as interest expense | 1,000 | $ 100,000 | $ 38,000 | 200,000 | |||
Term loans maturity date | Aug. 1, 2018 | ||||||
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 | $ 9,000 | $ 100,000 | $ 100,000 | $ 500,000 |
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 | Feb. 13, 2014 | Aug. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 |
Co-development and license agreement | ||||||||||
Research and development expense | $ 8,369,451 | $ 8,956,468 | $ 25,880,952 | $ 23,714,932 | ||||||
Aggregate purchase price | 389 | |||||||||
Phase 3 Insomnia Trail | ||||||||||
Co-development and license agreement | ||||||||||
Percentage of milestone payment on aggregate product development cost | 40.00% | |||||||||
Seltorexant | Co-Development and License Agreement | Phase 1b Clinical Trials | Maximum | ||||||||||
Co-development and license agreement | ||||||||||
Share of aggregate development cost following completion of Phase 1b clinical trials and animal toxicology studies | $ 5,000,000 | |||||||||
Seltorexant | Co-Development and License Agreement | Phase 2 Clinical Trials | Maximum | ||||||||||
Co-development and license agreement | ||||||||||
Share of aggregate development cost following completion of Phase 1b clinical trials and animal toxicology studies | $ 24,000,000 | |||||||||
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 | |||||||||
Percentage of development costs related to joint development of products | 40.00% | |||||||||
Accrued collaborative expenses | 0 | 0 | $ 0 | |||||||
Payment of development costs | $ 3,500,000 | 0 | 2,500,000 | |||||||
Direct expenses incurred | $ 300,000 | |||||||||
Research and development expense | $ 0 | $ 4,500,000 | $ 0 | $ 11,200,000 | ||||||
Janssen | Seltorexant | Amendment to Co-Development and License Agreement | ||||||||||
Co-development and license agreement | ||||||||||
Accrued collaborative expenses | $ 11,200,000 | |||||||||
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, will be 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. | |||||||||
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 | Sep. 30, 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 | Sep. 30, 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 | 9 Months Ended | |
Mar. 31, 2017 | Sep. 30, 2017 | Sep. 30, 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 | Dec. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 |
Stock Award Plan and Stock-Based Compensation | |||||||
Fair value of common stock on grant date (in dollars per share) | $ 4.99 | ||||||
Total intrinsic value of the stock options exercised | $ 700,000 | ||||||
Dividend yield (as a percent) | 0.00% | ||||||
Stock-based compensation expense | $ 2,261,781 | $ 1,233,885 | $ 6,273,590 | $ 3,775,469 | |||
Employee Stock Option | |||||||
Stock Award Plan and Stock-Based Compensation | |||||||
Total unrecognized compensation costs | 17,600,000 | $ 17,600,000 | |||||
Weighted-average period over which unrecognized compensation costs is expected to be recognized | 2 years 9 months 18 days | ||||||
RSUs | |||||||
Stock Award Plan and Stock-Based Compensation | |||||||
Total unrecognized compensation costs | $ 1,600,000 | $ 1,600,000 | |||||
Weighted-average period over which unrecognized compensation costs is expected to be recognized | 2 years 3 months 18 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 | ||||||
Non-Employees Stock Options | |||||||
Stock Award Plan and Stock-Based Compensation | |||||||
Shares issued | 40,000 | ||||||
Stock-based compensation expense | $ 1,000,000 | $ 200,000 | |||||
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% | 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 | |||||||
Stock Award Plan and Stock-Based Compensation | |||||||
Shares issued | 775,000 | ||||||
2013 Equity Incentive Plan | RSUs | Common Stock | |||||||
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 | Employee Stock Option | |||||||
Stock Award Plan and Stock-Based Compensation | |||||||
Fair value of common stock on grant date (in dollars per share) | $ 4.97 | $ 5.08 | |||||
Dividend yield (as a percent) | 0.00% | 0.00% | |||||
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) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Weighted-Average Exercise Price | ||
Total Intrinsic Value Exercised | $ 700 | |
Employees and Non-Employees Stock Option | ||
Shares Issuable Pursuant to Stock Options | ||
Outstanding at the beginning of period (in shares) | 6,132,650 | |
Granted (in shares) | 790,000 | |
Exercised (in shares) | (97,124) | |
Forfeited (in shares) | (32,500) | |
Outstanding at the end of the period (in shares) | 6,793,026 | 6,132,650 |
Exercisable at the end of the period (in shares) | 3,152,470 | |
Available for future grant (in shares) | 2,507,654 | |
Weighted-Average Exercise Price | ||
Outstanding at the beginning of period (in dollars per share) | $ 6.54 | |
Granted (in dollars per share) | 7.06 | |
Exercised (in dollars per share) | 5.05 | |
Forfeited (in dollars per share) | 10.62 | |
Outstanding at the end of the period (in dollars per share) | 6.60 | $ 6.54 |
Exercisable at the end of the period (in dollars per share) | $ 5.74 | |
Weighted-Average Remaining Contractual Term Outstanding (years) | 7 years 9 months 18 days | 8 years 4 months 24 days |
Weighted-Average Remaining Contractual Term Exercisable (years) | 6 years 6 months | |
Total Intrinsic Value Exercised | $ 521 | |
Total Intrinsic Value Outstanding | 40,725 | |
Total Intrinsic Value Exercisable | $ 17,984 |
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 | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Stock Award Plan and Stock-Based Compensation | ||
Dividend yield | 0.00% | |
Weighted average grant date fair value per share of common stock | $ 4.99 | |
Employee Stock Option | Minimum | ||
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% |
Dividend yield | 0.00% | 0.00% |
Weighted average grant date fair value per share of common stock | $ 4.97 | $ 5.08 |
Employee Stock Option | Maximum | ||
Stock Award Plan and Stock-Based Compensation | ||
Expected term (years) | 6 years 3 months | 6 years 3 months |
Risk free interest rate | 2.93% | 2.02% |
Volatility | 83.00% | 84.00% |
Non-Employees Stock Options | Minimum | ||
Stock Award Plan and Stock-Based Compensation | ||
Expected term (years) | 7 years 10 months 24 days | 8 years 10 months 24 days |
Risk free interest rate | 2.46% | 2.27% |
Volatility | 83.00% | 111.00% |
Dividend yield | 0.00% | 0.00% |
Weighted average reporting date fair value per share of common stock | $ 10.94 | $ 6.85 |
Non-Employees Stock Options | Maximum | ||
Stock Award Plan and Stock-Based Compensation | ||
Expected term (years) | 9 years 3 months 18 days | 9 years 6 months |
Risk free interest rate | 3.04% | 2.31% |
Volatility | 88.00% | 112.00% |
STOCK OPTION PLAN AND STOCK-BAS
STOCK OPTION PLAN AND STOCK-BASED COMPENSATION - Schedule of RSU Activity (Details) - RSUs | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Stock Options | |
Unvested at the beginning of the period (in shares) | shares | 185,950 |
Granted (in shares) | shares | |
Vested (in shares) | shares | |
Forfeited (in shares) | shares | |
Unvested at the end of the period (in shares) | shares | 185,950 |
Weighted-Average Grant Date Fair Value | |
Unvested, Weighted-Average Grant Date Fair Value | $ / shares | $ 11.86 |
Granted (in dollars per share) | $ / shares | |
Vested (in dollars per share) | $ / shares | |
Forfeited (in dollars per share) | $ / shares | |
Unvested, Weighted-Average Grant Date Fair Value | $ / shares | $ 11.86 |
STOCK AWARD PLAN AND STOCK-BA_6
STOCK AWARD PLAN AND STOCK-BASED COMPENSATION - Schedule of Stock-Based Compensation Expense Included in the Company's Consolidated Statements of Operations (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock based compensation expense | $ 2,261,781 | $ 1,233,885 | $ 6,273,590 | $ 3,775,469 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock based compensation expense | 718,507 | 461,210 | 1,827,372 | 1,471,161 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock based compensation expense | $ 1,543,274 | $ 772,675 | $ 4,446,218 | $ 2,304,308 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Details) - Office Sublease Agreement - Profitect, Inc | Oct. 02, 2017USD ($)ft² | Sep. 30, 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% |