Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 04, 2019 | |
Cover [Abstract] | ||
Amendment Flag | false | |
Document Type | 10-Q | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Document Quarterly Report | true | |
Entity Central Index Key | 0001567514 | |
Document Transition Report | false | |
Current Fiscal Year End Date | --12-31 | |
Document Period End Date | Sep. 30, 2019 | |
Entity Registrant Name | Intra-Cellular Therapies, Inc. | |
Trading Symbol | ITCI | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Interactive Data Current | Yes | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-36274 | |
Entity Tax Identification Number | 36-4742850 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 430 East 29th Street | |
Entity Address, City or Town | New York | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10016 | |
City Area Code | 646 | |
Local Phone Number | 440-9333 | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 55,261,027 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 102,162,982 | $ 54,947,502 |
Investment securities, available-for-sale | 153,270,596 | 292,583,046 |
Prepaid expenses and other current assets | 4,023,348 | 7,908,133 |
Total current assets | 259,456,926 | 355,438,681 |
Property and equipment, net | 2,174,993 | 1,159,766 |
Right of use assets, net | 18,540,418 | |
Deferred tax asset, net | 264,609 | 529,218 |
Other assets | 86,084 | 78,833 |
Total assets | 280,523,030 | 357,206,498 |
Current liabilities: | ||
Accounts payable | 6,230,923 | 13,961,060 |
Accrued and other current liabilities | 17,323,632 | 20,044,866 |
Lease liabilities, short-term | 2,286,885 | |
Accrued employee benefits | 7,531,659 | 2,293,259 |
Total current liabilities | 33,373,099 | 36,299,185 |
Deferred rent | 3,192,432 | |
Lease liabilities | 20,269,646 | |
Total liabilities | 53,642,745 | 39,491,617 |
Stockholders' equity: | ||
Common stock, $0.0001 par value: 100,000,000 shares authorized; 55,247,579 and 54,895,295 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 5,525 | 5,490 |
Additional paid-in capital | 896,191,230 | 880,753,339 |
Accumulated deficit | (669,515,518) | (562,376,191) |
Accumulated comprehensive gain/(loss) | 199,048 | (667,757) |
Total stockholders' equity | 226,880,285 | 317,714,881 |
Total liabilities and stockholders' equity | $ 280,523,030 | $ 357,206,498 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 55,247,579 | 54,895,295 |
Common stock, shares outstanding | 55,247,579 | 54,895,295 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Statement [Abstract] | ||||
Revenues | ||||
Costs and expenses: | ||||
Research and development | 21,339,792 | $ 35,419,016 | $ 70,059,113 | $ 98,561,284 |
General and administrative | 15,036,444 | 7,972,329 | 42,184,078 | 21,082,544 |
Total costs and expenses | 36,376,236 | 43,391,345 | 112,243,191 | 119,643,828 |
Loss from operations | (36,376,236) | (43,391,345) | (112,243,191) | (119,643,828) |
Interest income | 1,513,837 | 1,868,431 | 5,105,464 | 5,266,053 |
Loss before provision for income taxes | (34,862,399) | (41,522,914) | (107,137,727) | (114,377,775) |
Income tax expense | 1,600 | 1,600 | ||
Net loss | $ (34,862,399) | $ (41,522,914) | $ (107,139,327) | $ (114,379,375) |
Net loss per common share: | ||||
Basic & Diluted | $ (0.63) | $ (0.76) | $ (1.94) | $ (2.09) |
Weighted average number of common shares: | ||||
Basic & Diluted | 55,207,400 | 54,708,065 | 55,155,854 | 54,693,827 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (34,862,399) | $ (41,522,914) | $ (107,139,327) | $ (114,379,375) |
Other comprehensive income/(loss): | ||||
Unrealized (loss)/gain on investment securities | (33,396) | 183,239 | 866,805 | (46,961) |
Comprehensive loss | $ (34,895,795) | $ (41,339,675) | $ (106,272,522) | $ (114,426,336) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Comprehensive Gain (Loss) [Member] |
Balance at Dec. 31, 2017 | $ 454,436,961 | $ 5,460 | $ 862,479,505 | $ (407,248,780) | $ (799,224) |
Balance, shares at Dec. 31, 2017 | 54,597,679 | ||||
Exercise of stock options and issuances of restricted stock | 488,342 | $ 10 | 488,332 | ||
Exercise of stock options and issuances of restricted stock, shares | 107,127 | ||||
Stock issued for services | 143,951 | $ 1 | 143,950 | ||
Stock issued for services, shares | 7,203 | ||||
Share-based compensation | 12,971,496 | 12,971,496 | |||
Exercise of stock warrant | 10,982 | 10,982 | |||
Exercise of stock warrant, shares | 1,822 | ||||
Net loss | (114,379,375) | (114,379,375) | |||
Other comprehensive income (loss) | (46,961) | (46,961) | |||
Balance at Sep. 30, 2018 | 353,625,396 | $ 5,471 | 876,094,265 | (521,628,155) | (846,185) |
Balance, shares at Sep. 30, 2018 | 54,713,831 | ||||
Balance at Jun. 30, 2018 | 390,387,442 | $ 5,470 | 871,516,637 | (480,105,241) | (1,029,424) |
Balance, shares at Jun. 30, 2018 | 54,700,580 | ||||
Exercise of stock options and issuances of restricted stock | 144,416 | 144,416 | |||
Exercise of stock options and issuances of restricted stock, shares | 9,192 | ||||
Stock issued for services | 48,543 | $ 1 | 48,542 | ||
Stock issued for services, shares | 2,237 | ||||
Share-based compensation | 4,373,688 | 4,373,688 | |||
Exercise of stock warrant | 10,982 | 10,982 | |||
Exercise of stock warrant, shares | 1,822 | ||||
Net loss | (41,522,914) | (41,522,914) | |||
Other comprehensive income (loss) | 183,239 | 183,239 | |||
Balance at Sep. 30, 2018 | 353,625,396 | $ 5,471 | 876,094,265 | (521,628,155) | (846,185) |
Balance, shares at Sep. 30, 2018 | 54,713,831 | ||||
Balance at Dec. 31, 2018 | 317,714,881 | $ 5,490 | 880,753,339 | (562,376,191) | (667,757) |
Balance, shares at Dec. 31, 2018 | 54,895,295 | ||||
Exercise of stock options and issuances of restricted stock | 442,826 | $ 34 | 442,792 | ||
Exercise of stock options and issuances of restricted stock, shares | 338,054 | ||||
Stock issued for services | 145,691 | $ 1 | 145,690 | ||
Stock issued for services, shares | 14,230 | ||||
Share-based compensation | 14,849,409 | 14,849,409 | |||
Net loss | (107,139,327) | (107,139,327) | |||
Other comprehensive income (loss) | 866,805 | 866,805 | |||
Balance at Sep. 30, 2019 | 226,880,285 | $ 5,525 | 896,191,230 | (669,515,518) | 199,048 |
Balance, shares at Sep. 30, 2019 | 55,247,579 | ||||
Balance at Jun. 30, 2019 | 256,768,362 | $ 5,519 | 891,183,518 | (634,653,119) | 232,444 |
Balance, shares at Jun. 30, 2019 | 55,186,745 | ||||
Exercise of stock options and issuances of restricted stock | 152,379 | $ 6 | 152,373 | ||
Exercise of stock options and issuances of restricted stock, shares | 54,332 | ||||
Stock issued for services | 48,571 | 48,571 | |||
Stock issued for services, shares | 6,502 | ||||
Share-based compensation | 4,806,768 | 4,806,768 | |||
Net loss | (34,862,399) | (34,862,399) | |||
Other comprehensive income (loss) | (33,396) | (33,396) | |||
Balance at Sep. 30, 2019 | $ 226,880,285 | $ 5,525 | $ 896,191,230 | $ (669,515,518) | $ 199,048 |
Balance, shares at Sep. 30, 2019 | 55,247,579 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows used in operating activities | ||
Net loss | $ (107,139,327) | $ (114,379,375) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 335,461 | 273,206 |
Share-based compensation | 14,849,409 | 12,971,496 |
Stock issued for services | 145,691 | 143,951 |
Amortization of premiums and discounts on investment securities, net | (871,412) | (544,716) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 4,020,430 | (2,384,203) |
Accounts payable | (7,730,137) | 4,279,647 |
Accrued liabilities and other | 3,462,560 | 10,688,036 |
Deferred rent | (55,619) | |
Net cash used in operating activities | (92,927,325) | (89,007,577) |
Cash flows provided by investing activities | ||
Purchases of investments | (58,332,886) | (241,114,631) |
Maturities of investments | 199,383,553 | 361,942,241 |
Purchases of property and equipment | (1,350,688) | (332,515) |
Net cash provided by investing activities | 139,699,979 | 120,495,095 |
Cash flows provided by financing activities | ||
Proceeds from exercise of stock options | 442,826 | 488,342 |
Proceeds from exercise of warrants | 10,982 | |
Net cash provided by financing activities | 442,826 | 499,324 |
Net increase in cash and cash equivalents | 47,215,480 | 31,986,842 |
Cash and cash equivalents at beginning of period | 54,947,502 | 37,790,114 |
Cash and cash equivalents at end of period | 102,162,982 | $ 69,776,956 |
Non-cash investing and financing activities | ||
Right of use assets under operating leases | $ 219,703 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Intra-Cellular Therapies, Inc. (the “Company”), through its wholly-owned operating subsidiaries, ITI, Inc. (“ITI”) and ITI Limited, is a biopharmaceutical company focused on the discovery and clinical development of innovative, small molecule drugs that address underserved medical needs primarily in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system (“CNS”). The Company’s lead product candidate, lumateperone, is under review by the U.S. Food and Drug Administration (“FDA”) for the treatment of schizophrenia and in Phase 3 clinical development as a novel treatment for bipolar depression. The Company was incorporated in the State of Delaware in August 2012 under the name “Oneida Resources Corp.” Prior to a reverse merger that occurred on August 29, 2013 (the “Merger”), Oneida Resources Corp. was a “shell” company registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with no specific business plan or purpose until it began operating the business of ITI, through the Merger transaction on August 29, 2013. The Company was incorporated in Delaware and focuses primarily on the development of novel drugs for the treatment of neuropsychiatric and neurologic diseases and other disorders of the CNS. In September 2016, the Company licensed certain intellectual property rights to its wholly-owned subsidiary, ITI Limited, which was formed in the third quarter of 2016. Although the license of intellectual property rights did not result in any gain or loss in the consolidated statements of operations, the $125 million of gain related to the transaction helped generate net taxable income for tax purposes in the U.S. and the Company utilized a significant portion of its available federal and state net operating loss carryforwards to offset the majority of this gain. Any taxes incurred related to intercompany transactions were treated as tax expense in the Company’s consolidated statement of operations. In addition to the license, the Company also entered into a research and development agreement with ITI Limited pursuant to which the Company will conduct research and development services related to the license agreement and charge ITI Limited for these services. In order to further its research projects and support its collaborations, the Company will require additional financing until such time, if ever, that revenue streams are sufficient to generate consistent positive cash flow from operations. The Company currently projects that its cash, cash equivalents and investments will be sufficient to fund operating expenses and capital expenditures for a minimum of twelve months from the date that this Quarterly Report was filed. Possible sources of funds include public or private sales of the Company’s equity securities, sales of debt securities, the incurrence of debt from commercial lenders, strategic collaborations, licensing a portion or all of the Company’s product candidates and technology and, to a lesser extent, grant funding. On August 30 9 S-3, 2 9 , which includes million of common stock that the Company may issue and sell from time to time, through SVB Leerink LLC acting as its sales agent, pursuant to the sale agreement that the Company entered into with SVB Leerink on August 29, 2019 for the Company’s “at-the-market” . In the third quarter of 2018, the Company completed the rolling submission of its New Drug Application (“NDA”) to the FDA for lumateperone, a once-daily, oral investigational medicine with a novel mechanism of action for the treatment of schizophrenia. In the fourth quarter of 2018, the FDA accepted for review the Company’s NDA and assigned a Prescription Drug User Fee Act, or PDUFA, goal date of September 27, 2019, which has been extended to December 27, 2019. The NDA submission is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone. Lumateperone received Fast Track designation from the FDA in November 2017 for the treatment of schizophrenia. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly own subsidiaries have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles set forth in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). All intercompany accounts and transactions have been eliminated in consolidation. The Company currently operates in one operating segment. Operating segments are defined as components of an enterprise about which separate discrete information is available for the chief operating decision maker, or decision making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business in one segment, which is discovering and developing drugs for the treatment of neurological and psychiatric disorders. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Although actual results could differ from those estimates, management does not believe that such differences would be material. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents consist of checking accounts, money market accounts, money market mutual funds, and certificates of deposit with a maturity date of three months or less. The carrying values of cash and cash equivalents approximate the fair market value. Certificates of deposit, commercial paper, corporate notes and corporate bonds with a maturity date of more than three months are classified separately on the balance sheet. Investment Securities Investment securities consisted of the following (in thousands): September 30, 2019 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value (Unaudited) U.S. Government Agency Securities $ 55,402 $ 70 $ (13 ) $ 55,459 Certificates of Deposit 3,000 — — 3,000 Commercial Paper 33,705 16 (6 ) 33,715 Corporate Notes/Bonds 60,965 135 (3 ) 61,097 $ 153,072 $ 221 $ (22 ) $ 153,271 December 31, 2018 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 124,691 $ 24 $ (289 ) $ 124,426 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 41,317 — (45 ) 41,272 Corporate Notes/Bonds 125,998 7 (365 ) 125,640 $ 293,251 $ 31 $ (699 ) $ 292,583 (1) “FDIC Certificates of Deposit” consist of deposits that are less than $250,000. The Company has classified all of its investment securities available-for-sale, available-for-sale The Company monitors its investment portfolio for impairment quarterly or more frequently if circumstances warrant. In the event that the carrying value of an investment exceeds its fair value and the decline in value is determined to be other-than-temporary, the Company records an impairment charge within earnings attributable to the estimated loss. In determining whether a decline in the value of an investment is other-than-temporary, the Company evaluates currently available factors that may include, among others: (1) general market conditions; (2) the duration and extent to which fair value has been less than the carrying value; (3) the investment issuer’s financial condition and business outlook; and (4) the Company’s assessment as to whether it is more likely than not that the Company will be required to sell a security prior to recovery of its amortized cost basis. As of September 30, 2019, the aggregate related fair value of investments with unrealized losses was $36 million and the aggregate amount of unrealized losses was approximately $22,000. Of the $36 million, $10 million has been held in a continuous unrealized loss position for less than 12 months and $26 million has been held in a continuous loss position for 12 months or longer. The total continuous unrealized loss for investments held for 12 months or longer is approximately $16,000 as of September 30, 2019. As of December 31, 2018, the Company had approximately $92.1 million of investments with a continuous unrealized loss for 12 months or longer of approximately $345,000. The Company attributes the unrealized gains and losses on the available-for-sale Fair Value Measurements The Company applies the fair value method under ASC Topic 820, Fair Value Measurements and Disclosures • Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. • Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. • Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity—e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security. The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the ASC Topic 820 hierarchy. The Company has no assets or liabilities that were measured using quoted prices for significant unobservable inputs (Level 3 assets and liabilities) as of September 30, 2019 and December 31, 2018. The carrying value of cash held in money market funds of approximately $55.4 million as of September 30, 2019 and $39.6 million as of December 31, 2018 is included in cash and cash equivalents and approximates market value based on quoted market prices (Level 1 inputs). The carrying value of cash held in certificates of deposit of approximately $39.0 million and $7.5 million as of September 30, 2019 and December 31, 2018, respectively, is included in cash and cash equivalents and approximates market value based due to their short term maturities. The fair value measurements of the Company’s c u available-for-sale : Fair Value Measurements at Reporting Date Using September 30, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 55,355 $ 55,355 $ — $ — U.S. Government Agency Securities 55,459 — 55,459 — Certificates of Deposit 42,000 — 42,000 — Commercial Paper 33,715 — 33,715 — Corporate Notes/Bonds 61,097 — 61,097 — $ 247,626 $ 55,355 $ 192,271 $ — Fair Value Measurements at Reporting Date Using December 31, 2018 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 39,591 $ 39,591 $ — $ — U.S. Government Agency Securities 124,426 — 124,426 — FDIC Certificates of Deposit 245 — 245 — Certificates of Deposit 8,500 — 8,500 — Commercial Paper 41,272 — 41,272 — Corporate Notes/Bonds 125,640 — 125,640 — $ 339,674 $ 39,591 $ 300,083 $ — Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of certain cash equivalents, prepaid expenses, accounts payable right of use asset, net, accrued liabilities and lease liabilities, to approximate their fair value because of their relatively short maturities at September 30, 2019 and December 31, 2018. Management believes that the risks associated with its financial instruments are minimal as the counterparties are various corporations, financial institutions and government agencies of high credit standing. Concentration of Credit Risk Cash equivalents are held with major financial institutions in the United States. Certificates of deposit, cash and cash equivalents held with banks may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. Accounts Receivable Accounts receivable that management has the intent and ability to collect are reported in the balance sheets at outstanding amounts, less an allowance for doubtful accounts. The Company writes off uncollectible receivables when the likelihood of collection is not probable. The Company evaluates the collectability of accounts receivable on a regular basis. The allowance, if any, is based upon various factors including the financial condition and payment history of customers, an overall review of collections experience on other accounts and economic factors or events expected to affect future collections experience. No allowance was recorded as of September 30, 2019 and December 31, 2018, as the Company has a history of collecting on all its accounts including from government agencies and collaborations funding its research. As of September 30, 2019 and December 31, 2018, the Company did not have accounts receivable. Property and Equipment Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteria established in ASC Topic 360, Property, Plant and Equipment Research and Development Except for payments made in advance of services, the Company expenses its research and development costs as incurred. For payments made in advance, the Company recognizes research and development expense as the services are rendered. Research and development costs primarily consist of salaries and related expenses for personnel and resources and the costs of clinical trials. Other research and development expenses include preclinical analytical testing, manufacturing of drug product, outside service providers, materials and consulting fees. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. 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 financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account various clinical information provided by vendors and discussion with applicable personnel and external service providers as to the progress toward or state of completion of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations, clinical sites and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the three and nine months ended September 30, 2019 and 2018, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Income Taxes Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce net deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable for the period and the change during the period in deferred tax assets and liabilities. The Company accounts for uncertain tax positions pursuant to ASC Topic 740. Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more-likely-than-not On December 22, 2017, President Trump signed into law the “Tax Cuts and Jobs Act” (“TCJA”) that significantly reforms the Internal Revenue Code of 1986, as amended (the “Code”). The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest and net operating loss carryforwards, allows for the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system. In addition, the TCJA repealed the alternative minimum tax (“AMT”) and provides for a refund of taxes paid between 2018 and 2021. With the passing of the TCJA, the Company will receive refunds in future periods for AMT paid in prior years. The Company therefore recognized a benefit of approximately $1.1 million for these taxes for the year ended December 31, 2017. We received approximately $529,000 in the third quarter of 2019. As of September 30, 2019 , The Company’s effective tax rate for the nine months ended September 30, 2019 and 2018 was approximately 0% for both periods, respectively. The Company’s annual effective tax rate of approximately 0% is substantially lower than the U.S. statutory rate of 21% due to valuation allowances recorded on current year losses where the Company is not at more-likely than not to recognize a future tax benefit. Comprehensive Income (Loss) All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are incurred. Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner Share-Based Compensation Share-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation For all awards granted with time based vesting conditions, expense is amortized using the straight-line attribution method. Share-based compensation expense recognized in the statements of operations for the three and nine months ended September 30, 2019 and 2018 is based on share-based awards ultimately expected to vest. The Company utilizes the Black-Scholes model for estimating fair value of its stock options granted. Option valuation models, including the Black-Scholes model, require the input of subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. Expected volatility rates are based on a combination of the historical volatility of the common stock of comparable publicly traded entities and the historical information about the Company’s common stock. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the limited historical exercise data, the expected life is determined using the “simplified method,” which defines expected life as the midpoint between the vesting date and the end of the contractual term. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. For stock options granted, the exercise price was determined by using the closing market price of the Company’s common stock on the date of grant. The Company recognizes the effect of forfeitures when they occur. A restricted stock unit (“RSU”) is a stock-based award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the fair market value of the Company’s common stock on the date of grant. The Company has granted RSUs that vest in three equal annual installments provided that the grantee in the service of In the first quarter of each fiscal year beginning in 2016, the Company granted time based RSUs that vest in three the Company granted performance-based RSUs, which vest based on the achievement of certain milestones that include (i) the submission of a new drug application (“NDA”) with the U.S. Food and Drug Administration (the “FDA”), (ii) the approval of the NDA by the FDA (together, the “Milestone RSUs”) and (iii) the achievement of certain comparative shareholder returns against the Company’s peers (the “TSR RSUs”). The Milestone RSUs were valued at the closing price on March 8, 2017. The Milestone RSUs related to the NDA submission have been fully amortized through December 31, 2018. The NDA submission milestone was achieved in the third quarter of 2018, so the Milestone RSUs related to the NDA submission vested on December 31, 2018. The amortization of the expenses for RSUs related to the approval of the NDA will commence if and when the NDA submission has been approved through the last day of the calendar year in which the milestone is achieved and expires on December 31, 2019 if not achieved. The TSR RSUs were valued using the Monte Carlo Simulation method and will be amortized over the life of the RSU agreements which ends December 31, 2019. The Milestone RSUs and TSR RSUs are target based and the ultimate awards, if attained, could be the target amount or higher or lower than the target amount, depending on the timing or achievement of the goal. Under ASC Topic 718, the cumulative amount of compensation cost recognized for instruments classified as equity that ordinarily would result in a future tax deduction under existing tax law shall be considered to be a deductible difference in applying ASC Topic 740, Income Taxes Since the Company had net operating loss carryforwards as of September 30, 2019 and 2018, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations. Loss Per Share Basic net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants and RSUs. The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect would be anti-dilutive as applied to the loss from operations for the three and nine months ended September 30, 2019 and 2018: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Stock options 283,129 872,246 305,810 871,844 RSUs 459,946 387,953 512,749 372,744 TSR RSUs 79,182 75,143 89,139 75,143 Recently Issued Accounting Standards In May 2014, the FASB issued ASC Update No. 2014-09, The Company adopted this standard using the “modified retrospective method,” which did not result in an impact to its financial statements as the Company has not had product sales to date. Upon commercializing a product or executing any revenue generating contracts, the Company will provide additional disclosures in the notes to the consolidated financial statements related to the relevant aspects of any revenue generating contracts that the Company has entered In February 2016, the FASB issued ASU No. 2016-02, 2016-02”). 2016-02 2016-02 , The adoption of the standard resulted in recognition of additional net lease assets and lease liabilities of approximately $20.2 million and $23.4 million, respectively, as of January 1, 2019. The difference between these amounts represents the net deferred rent as of January 1, 2019 with no impact on the accumulated deficit. The adoption of the new lease standard was a non-cash In February 2018, the FASB issued ASU 2018-02, 2018-02 In August 2018, the SEC issued a final rule Release No. 33-10532, 10-Q In June 2016, the FASB issued ASU No. 2016-13, 2016-13”). available-for-sale held-to-maturity |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 3. Property and Equipment Property and equipment consist of the following: September 30, 2019 December 31, 2018 Computer equipment $ 60,377 $ 44,427 Furniture and fixtures 423,097 341,582 Scientific equipment 3,849,747 3,658,209 Leasehold improvements 1,208,543 149,470 5,541,764 4,193,688 Less accumulated depreciation (3,366,771 ) (3,033,922 ) $ 2,174,993 $ 1,159,766 Depreciation expense for the nine months ended September 30, 2019 and 2018 was $335,461 and $273,206, respectively. |
Right Of Use Assets and Lease L
Right Of Use Assets and Lease Liabilities | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Right Of Use Assets and Lease Liabilities | 4. Right Of Use Assets and Lease Liabilities In 2014, the Company entered into a long-term lease with a related party which, as amended, provided for a lease of 16,753 square feet of useable laboratory and office space located at 430 East 29th Street, New York, New York 10016. A member of the Company’s board of directors is the Executive Chairman of the parent company to the landlord under this lease. Concurrent with this lease, the Company entered into a license agreement to occupy certain vivarium related space in the same facility for the same term and rent escalation provisions as the lease. This license has the primary characteristics of a lease and is characterized as a lease in accordance with ASU 2016-02 further amended the lease to obtain an additional non-lease In adopting ASU 2016-02 non-lease 2016-02, Right of use assets and lease liabilities for operating leases were $18.5 million and $22.6 million as of September 30, 2019, respectively. Maturity analysis under the lease agreements are as follows: Three ending $ (56,130 ) Year end ing 3,346,376 Year end ing 3,448,323 Year end ing 3,491,166 Year end ing 3,566,466 Thereafter 21,302,235 Total 35,098,436 Less: Present value discount (12,541,905 ) Total Lease liability $ 22,556,531 Less: current portion (2,286,885 ) Long-term lease liabilities $ 20,269,646 In the three months ending December 31, 2019 the Company expects to receive approximately $ 880,000 When collected, incre ase Lease expense for the three and nine months ended September 30, 2019 was approximately $818,000 and $2.5 million, respectively, as compared to approximately $361,000 and $1.1 million , respectively. |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 5. Share-Based Compensation On June 18, 2018, the Company’s stockholders approved the 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan provides for the granting of stock-based awards, such as stock options, restricted common stock, RSUs and stock appreciation rights to employees, directors and consultants as determined by the Board of Directors. The 2018 Plan replaced the Company’s Amended and Restated 2013 Equity Incentive Plan (the “2013 Plan”). The Company will grant no further stock options or other awards under the 2013 Plan. Any options or other awards outstanding under the 2013 Plan remain outstanding in accordance with their terms and the terms of the 2013 Plan. As of December 31, 2018, the total number of shares reserved under all equity plans was 10,287,390 and the Company had 4,807,323 shares available for future issuance under the 2018 Plan. Stock options granted under the 2018 Plan may be either incentive stock options (“ISOs”) as defined by the Code, or non-qualified one . Total stock-based compensation expense related to all of the Company’s share-based awards, including stock options and RSUs to employees, directors and consultants, recognized during the three and nine months ended September 30, 2019 and 2018, was comprised of the following: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Research and development $ 2,023,700 $ 1,819,375 $ 6,785,280 $ 5,614,641 General and administrative 2,783,068 2,554,313 8,064,129 7,356,855 Total share-based compensation expense $ 4,806,768 $ 4,373,688 $ 14,849,409 $ 12,971,496 The following table describes the weighted-average assumptions used for calculating the value of options granted during the nine months ended September 30, 2019 and 2018: 2019 2018 Dividend yield 0% 0% Expected volatility 83.7%-85.7 85.2%-85.8 Weighted-average risk-free interest rate 2.32% 2.4% Expected term (in years) 6.0 6.0 Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of September 30, 2019, and changes during the nine-month period then ended, are summarized as follows: Number of Shares Weighted- Exercise Price Weighted- Contractual Life Outstanding at December 31, 2018 4,748,391 $ 18.75 7.0 years Options granted 1,821,258 $ 12.84 9.4 years Options exercised (85,650 ) $ 5.17 3.7 years Options canceled or expired (153,085 ) $ 19.55 7.7 years Outstanding at September 30, 2019 6,330,914 $ 16.85 7.2 years Vested or expected to vest at September 30, 2019 6,330,914 $ 16.85 Exercisable at September 30, 2019 3,403,319 $ 19.66 5.6 years The fair value of the time based RSUs and the Milestone RSUs is based on the closing price of the Company’s common stock on the date of grant. The fair value of the TSR RSUs was determined using the Monte Carlo simulation method. Information regarding the time based RSU activity and changes during the nine-month period ended September 30, 2019 are summarized as follows: Number of Shares Weighted-Average Grant Date Fair Value Per Share Outstanding at December 31, 2018 647,411 $ 18.16 Time based RSUs granted 950,449 $ 12.79 Time based RSUs vested in 2019 (253,695 ) $ 21.80 Time based RSUs cancelled in 2019 (48,934 ) $ 14.31 Outstanding at September 30, 2019 1,295,231 $ 13.65 Information related to the Company’s Milestone RSUs and TSR RSUs during the nine-month period ended September 30, 2019 are summarized as follows: Number of Shares Weighted-Average Grant Date Fair Value Per Share Outstanding at December 31, 2018 278,592 $ 15.64 Milestone RSUs and TSR RSUs granted in 2019 — $ — Milestone RSUs and TSR RSUs cancelled in 2019 (14,194 ) $ 15.64 Outstanding at September 30, 2019 264,398 $ 15.64 The weighted average estimated fair value per share of the TSR RSUs granted in 2017 was $17.08, which was derived from a Monte Carlo simulation. Significant assumptions utilized in estimating the value of the awards granted include an expected dividend yield of 0%, a risk free rate of 1.6%, and expected volatility of 95.4%. The TSR RSUs granted in 2017 will entitle the grantee to receive a number of shares of the Company’s common stock determined over a three-year d The Company recognized non-cash |
Collaborations and License Agre
Collaborations and License Agreements | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborations and License Agreements | 6. Collaborations and License Agreements The Bristol-Myers Squibb License Agreement On May 31, 2005, the Company entered into a worldwide, exclusive License Agreement with Bristol-Myers Squibb Company (“BMS”), pursuant to which the Company holds a license to certain patents and know-how Under the agreement, the Company made an upfront payment of $1.0 million to BMS, a milestone payment of $1.25 million in December 2013, and a milestone payment of $1.5 million in December 2014 following the initiation of the Company’s first Phase 3 clinical trial for lumateperone for patients with exacerbated schizophrenia. Upon FDA acceptance for review of an NDA submission for lumateperone, the Company was obligated to pay BMS a $2.0 million milestone payment. This milestone was achieved in the third quarter of 2018. The Company accrued the $2.0 million milestone payment obligation in 2018 and paid it in January 2019. Possible milestone payments remaining total $10.0 million, including a $5.0 million milestone payment payable upon an NDA approval. Under the agreement, the Company may be obliged to make other milestone payments to BMS for each licensed product of up to an aggregate of approximately $14.75 million. The Company is also obliged to make tiered single digit percentage royalty payments ranging between 5 – 9% on sales of licensed products. The Company is obliged to pay to BMS a percentage of non-royalty The agreement extends, and royalties are payable, on a country-by-country product-by-product In September 2016, the Company transferred certain of its rights under the BMS agreement to its wholly owned subsidiary, ITI Limited. In connection with the transfer, the Company guaranteed ITI Limited’s performance of its obligations under the BMS agreement. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly own subsidiaries have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles set forth in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). All intercompany accounts and transactions have been eliminated in consolidation. The Company currently operates in one operating segment. Operating segments are defined as components of an enterprise about which separate discrete information is available for the chief operating decision maker, or decision making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business in one segment, which is discovering and developing drugs for the treatment of neurological and psychiatric disorders. |
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 amounts reported in the financial statements and accompanying notes. Although actual results could differ from those estimates, management does not believe that such differences would be material. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents consist of checking accounts, money market accounts, money market mutual funds, and certificates of deposit with a maturity date of three months or less. The carrying values of cash and cash equivalents approximate the fair market value. Certificates of deposit, commercial paper, corporate notes and corporate bonds with a maturity date of more than three months are classified separately on the balance sheet. |
Investment Securities | Investment Securities Investment securities consisted of the following (in thousands): September 30, 2019 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value (Unaudited) U.S. Government Agency Securities $ 55,402 $ 70 $ (13 ) $ 55,459 Certificates of Deposit 3,000 — — 3,000 Commercial Paper 33,705 16 (6 ) 33,715 Corporate Notes/Bonds 60,965 135 (3 ) 61,097 $ 153,072 $ 221 $ (22 ) $ 153,271 December 31, 2018 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 124,691 $ 24 $ (289 ) $ 124,426 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 41,317 — (45 ) 41,272 Corporate Notes/Bonds 125,998 7 (365 ) 125,640 $ 293,251 $ 31 $ (699 ) $ 292,583 (1) “FDIC Certificates of Deposit” consist of deposits that are less than $250,000. The Company has classified all of its investment securities available-for-sale, available-for-sale The Company monitors its investment portfolio for impairment quarterly or more frequently if circumstances warrant. In the event that the carrying value of an investment exceeds its fair value and the decline in value is determined to be other-than-temporary, the Company records an impairment charge within earnings attributable to the estimated loss. In determining whether a decline in the value of an investment is other-than-temporary, the Company evaluates currently available factors that may include, among others: (1) general market conditions; (2) the duration and extent to which fair value has been less than the carrying value; (3) the investment issuer’s financial condition and business outlook; and (4) the Company’s assessment as to whether it is more likely than not that the Company will be required to sell a security prior to recovery of its amortized cost basis. As of September 30, 2019, the aggregate related fair value of investments with unrealized losses was $36 million and the aggregate amount of unrealized losses was approximately $22,000. Of the $36 million, $10 million has been held in a continuous unrealized loss position for less than 12 months and $26 million has been held in a continuous loss position for 12 months or longer. The total continuous unrealized loss for investments held for 12 months or longer is approximately $16,000 as of September 30, 2019. As of December 31, 2018, the Company had approximately $92.1 million of investments with a continuous unrealized loss for 12 months or longer of approximately $345,000. The Company attributes the unrealized gains and losses on the available-for-sale |
Fair Value Measurements | Fair Value Measurements The Company applies the fair value method under ASC Topic 820, Fair Value Measurements and Disclosures • Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. • Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. • Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity—e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security. The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the ASC Topic 820 hierarchy. The Company has no assets or liabilities that were measured using quoted prices for significant unobservable inputs (Level 3 assets and liabilities) as of September 30, 2019 and December 31, 2018. The carrying value of cash held in money market funds of approximately $55.4 million as of September 30, 2019 and $39.6 million as of December 31, 2018 is included in cash and cash equivalents and approximates market value based on quoted market prices (Level 1 inputs). The carrying value of cash held in certificates of deposit of approximately $39.0 million and $7.5 million as of September 30, 2019 and December 31, 2018, respectively, is included in cash and cash equivalents and approximates market value based due to their short term maturities. The fair value measurements of the Company’s c u available-for-sale : Fair Value Measurements at Reporting Date Using September 30, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 55,355 $ 55,355 $ — $ — U.S. Government Agency Securities 55,459 — 55,459 — Certificates of Deposit 42,000 — 42,000 — Commercial Paper 33,715 — 33,715 — Corporate Notes/Bonds 61,097 — 61,097 — $ 247,626 $ 55,355 $ 192,271 $ — Fair Value Measurements at Reporting Date Using December 31, 2018 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 39,591 $ 39,591 $ — $ — U.S. Government Agency Securities 124,426 — 124,426 — FDIC Certificates of Deposit 245 — 245 — Certificates of Deposit 8,500 — 8,500 — Commercial Paper 41,272 — 41,272 — Corporate Notes/Bonds 125,640 — 125,640 — $ 339,674 $ 39,591 $ 300,083 $ — |
Financial Instruments | Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of certain cash equivalents, prepaid expenses, accounts payable right of use asset, net, accrued liabilities and lease liabilities, to approximate their fair value because of their relatively short maturities at September 30, 2019 and December 31, 2018. Management believes that the risks associated with its financial instruments are minimal as the counterparties are various corporations, financial institutions and government agencies of high credit standing. |
Concentration of Credit Risk | Concentration of Credit Risk Cash equivalents are held with major financial institutions in the United States. Certificates of deposit, cash and cash equivalents held with banks may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. |
Accounts Receivable | Accounts Receivable Accounts receivable that management has the intent and ability to collect are reported in the balance sheets at outstanding amounts, less an allowance for doubtful accounts. The Company writes off uncollectible receivables when the likelihood of collection is not probable. The Company evaluates the collectability of accounts receivable on a regular basis. The allowance, if any, is based upon various factors including the financial condition and payment history of customers, an overall review of collections experience on other accounts and economic factors or events expected to affect future collections experience. No allowance was recorded as of September 30, 2019 and December 31, 2018, as the Company has a history of collecting on all its accounts including from government agencies and collaborations funding its research. As of September 30, 2019 and December 31, 2018, the Company did not have accounts receivable. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteria established in ASC Topic 360, Property, Plant and Equipment |
Research and Development | Research and Development Except for payments made in advance of services, the Company expenses its research and development costs as incurred. For payments made in advance, the Company recognizes research and development expense as the services are rendered. Research and development costs primarily consist of salaries and related expenses for personnel and resources and the costs of clinical trials. Other research and development expenses include preclinical analytical testing, manufacturing of drug product, outside service providers, materials and consulting fees. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. 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 financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account various clinical information provided by vendors and discussion with applicable personnel and external service providers as to the progress toward or state of completion of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations, clinical sites and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the three and nine months ended September 30, 2019 and 2018, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Income Taxes | Income Taxes Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce net deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable for the period and the change during the period in deferred tax assets and liabilities. The Company accounts for uncertain tax positions pursuant to ASC Topic 740. Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more-likely-than-not On December 22, 2017, President Trump signed into law the “Tax Cuts and Jobs Act” (“TCJA”) that significantly reforms the Internal Revenue Code of 1986, as amended (the “Code”). The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest and net operating loss carryforwards, allows for the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system. In addition, the TCJA repealed the alternative minimum tax (“AMT”) and provides for a refund of taxes paid between 2018 and 2021. With the passing of the TCJA, the Company will receive refunds in future periods for AMT paid in prior years. The Company therefore recognized a benefit of approximately $1.1 million for these taxes for the year ended December 31, 2017. We received approximately $529,000 in the third quarter of 2019. As of September 30, 2019 , The Company’s effective tax rate for the nine months ended September 30, 2019 and 2018 was approximately 0% for both periods, respectively. The Company’s annual effective tax rate of approximately 0% is substantially lower than the U.S. statutory rate of 21% due to valuation allowances recorded on current year losses where the Company is not at more-likely than not to recognize a future tax benefit. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are incurred. Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner |
Share-Based Compensation | Share-Based Compensation Share-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation For all awards granted with time based vesting conditions, expense is amortized using the straight-line attribution method. Share-based compensation expense recognized in the statements of operations for the three and nine months ended September 30, 2019 and 2018 is based on share-based awards ultimately expected to vest. The Company utilizes the Black-Scholes model for estimating fair value of its stock options granted. Option valuation models, including the Black-Scholes model, require the input of subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. Expected volatility rates are based on a combination of the historical volatility of the common stock of comparable publicly traded entities and the historical information about the Company’s common stock. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the limited historical exercise data, the expected life is determined using the “simplified method,” which defines expected life as the midpoint between the vesting date and the end of the contractual term. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. For stock options granted, the exercise price was determined by using the closing market price of the Company’s common stock on the date of grant. The Company recognizes the effect of forfeitures when they occur. A restricted stock unit (“RSU”) is a stock-based award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the fair market value of the Company’s common stock on the date of grant. The Company has granted RSUs that vest in three equal annual installments provided that the grantee in the service of In the first quarter of each fiscal year beginning in 2016, the Company granted time based RSUs that vest in three the Company granted performance-based RSUs, which vest based on the achievement of certain milestones that include (i) the submission of a new drug application (“NDA”) with the U.S. Food and Drug Administration (the “FDA”), (ii) the approval of the NDA by the FDA (together, the “Milestone RSUs”) and (iii) the achievement of certain comparative shareholder returns against the Company’s peers (the “TSR RSUs”). The Milestone RSUs were valued at the closing price on March 8, 2017. The Milestone RSUs related to the NDA submission have been fully amortized through December 31, 2018. The NDA submission milestone was achieved in the third quarter of 2018, so the Milestone RSUs related to the NDA submission vested on December 31, 2018. The amortization of the expenses for RSUs related to the approval of the NDA will commence if and when the NDA submission has been approved through the last day of the calendar year in which the milestone is achieved and expires on December 31, 2019 if not achieved. The TSR RSUs were valued using the Monte Carlo Simulation method and will be amortized over the life of the RSU agreements which ends December 31, 2019. The Milestone RSUs and TSR RSUs are target based and the ultimate awards, if attained, could be the target amount or higher or lower than the target amount, depending on the timing or achievement of the goal. Under ASC Topic 718, the cumulative amount of compensation cost recognized for instruments classified as equity that ordinarily would result in a future tax deduction under existing tax law shall be considered to be a deductible difference in applying ASC Topic 740, Income Taxes Since the Company had net operating loss carryforwards as of September 30, 2019 and 2018, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations. |
Loss Per Share | Loss Per Share Basic net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants and RSUs. The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect would be anti-dilutive as applied to the loss from operations for the three and nine months ended September 30, 2019 and 2018: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Stock options 283,129 872,246 305,810 871,844 RSUs 459,946 387,953 512,749 372,744 TSR RSUs 79,182 75,143 89,139 75,143 |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In May 2014, the FASB issued ASC Update No. 2014-09, The Company adopted this standard using the “modified retrospective method,” which did not result in an impact to its financial statements as the Company has not had product sales to date. Upon commercializing a product or executing any revenue generating contracts, the Company will provide additional disclosures in the notes to the consolidated financial statements related to the relevant aspects of any revenue generating contracts that the Company has entered In February 2016, the FASB issued ASU No. 2016-02, 2016-02”). 2016-02 2016-02 , The adoption of the standard resulted in recognition of additional net lease assets and lease liabilities of approximately $20.2 million and $23.4 million, respectively, as of January 1, 2019. The difference between these amounts represents the net deferred rent as of January 1, 2019 with no impact on the accumulated deficit. The adoption of the new lease standard was a non-cash In February 2018, the FASB issued ASU 2018-02, 2018-02 In August 2018, the SEC issued a final rule Release No. 33-10532, 10-Q In June 2016, the FASB issued ASU No. 2016-13, 2016-13”). available-for-sale held-to-maturity |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Investment Securities | Investment securities consisted of the following (in thousands): September 30, 2019 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value (Unaudited) U.S. Government Agency Securities $ 55,402 $ 70 $ (13 ) $ 55,459 Certificates of Deposit 3,000 — — 3,000 Commercial Paper 33,705 16 (6 ) 33,715 Corporate Notes/Bonds 60,965 135 (3 ) 61,097 $ 153,072 $ 221 $ (22 ) $ 153,271 December 31, 2018 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 124,691 $ 24 $ (289 ) $ 124,426 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 41,317 — (45 ) 41,272 Corporate Notes/Bonds 125,998 7 (365 ) 125,640 $ 293,251 $ 31 $ (699 ) $ 292,583 (1) “FDIC Certificates of Deposit” consist of deposits that are less than $250,000. |
Schedule of Fair Value Measurements of Cash Equivalents and Available-for-Sale Investment Securities | The fair value measurements of the Company’s c u available-for-sale : Fair Value Measurements at Reporting Date Using September 30, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 55,355 $ 55,355 $ — $ — U.S. Government Agency Securities 55,459 — 55,459 — Certificates of Deposit 42,000 — 42,000 — Commercial Paper 33,715 — 33,715 — Corporate Notes/Bonds 61,097 — 61,097 — $ 247,626 $ 55,355 $ 192,271 $ — Fair Value Measurements at Reporting Date Using December 31, 2018 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 39,591 $ 39,591 $ — $ — U.S. Government Agency Securities 124,426 — 124,426 — FDIC Certificates of Deposit 245 — 245 — Certificates of Deposit 8,500 — 8,500 — Commercial Paper 41,272 — 41,272 — Corporate Notes/Bonds 125,640 — 125,640 — $ 339,674 $ 39,591 $ 300,083 $ — |
Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share | The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect would be anti-dilutive as applied to the loss from operations for the three and nine months ended September 30, 2019 and 2018: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Stock options 283,129 872,246 305,810 871,844 RSUs 459,946 387,953 512,749 372,744 TSR RSUs 79,182 75,143 89,139 75,143 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consist of the following: September 30, 2019 December 31, 2018 Computer equipment $ 60,377 $ 44,427 Furniture and fixtures 423,097 341,582 Scientific equipment 3,849,747 3,658,209 Leasehold improvements 1,208,543 149,470 5,541,764 4,193,688 Less accumulated depreciation (3,366,771 ) (3,033,922 ) $ 2,174,993 $ 1,159,766 |
Right Of Use Assets and Lease_2
Right Of Use Assets and Lease Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Schedule Of Maturity Analysis Under Lease Agreements | Maturity analysis under the lease agreements are as follows: Three ending $ (56,130 ) Year end ing 3,346,376 Year end ing 3,448,323 Year end ing 3,491,166 Year end ing 3,566,466 Thereafter 21,302,235 Total 35,098,436 Less: Present value discount (12,541,905 ) Total Lease liability $ 22,556,531 Less: current portion (2,286,885 ) Long-term lease liabilities $ 20,269,646 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Total Stock-Based Compensation Expense | Total stock-based compensation expense related to all of the Company’s share-based awards, including stock options and RSUs to employees, directors and consultants, recognized during the three and nine months ended September 30, 2019 and 2018, was comprised of the following: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Research and development $ 2,023,700 $ 1,819,375 $ 6,785,280 $ 5,614,641 General and administrative 2,783,068 2,554,313 8,064,129 7,356,855 Total share-based compensation expense $ 4,806,768 $ 4,373,688 $ 14,849,409 $ 12,971,496 |
Assumptions Used for Calculating Value of Options Granted | The following table describes the weighted-average assumptions used for calculating the value of options granted during the nine months ended September 30, 2019 and 2018: 2019 2018 Dividend yield 0% 0% Expected volatility 83.7%-85.7 85.2%-85.8 Weighted-average risk-free interest rate 2.32% 2.4% Expected term (in years) 6.0 6.0 |
Stock Option Activity | Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of September 30, 2019, and changes during the nine-month period then ended, are summarized as follows: Number of Shares Weighted- Exercise Price Weighted- Contractual Life Outstanding at December 31, 2018 4,748,391 $ 18.75 7.0 years Options granted 1,821,258 $ 12.84 9.4 years Options exercised (85,650 ) $ 5.17 3.7 years Options canceled or expired (153,085 ) $ 19.55 7.7 years Outstanding at September 30, 2019 6,330,914 $ 16.85 7.2 years Vested or expected to vest at September 30, 2019 6,330,914 $ 16.85 Exercisable at September 30, 2019 3,403,319 $ 19.66 5.6 years |
Time Based Restricted Stock Units [Member] | |
Summary of Information Regarding RSU Activity | Information regarding the time based RSU activity and changes during the nine-month period ended September 30, 2019 are summarized as follows: Number of Shares Weighted-Average Grant Date Fair Value Per Share Outstanding at December 31, 2018 647,411 $ 18.16 Time based RSUs granted 950,449 $ 12.79 Time based RSUs vested in 2019 (253,695 ) $ 21.80 Time based RSUs cancelled in 2019 (48,934 ) $ 14.31 Outstanding at September 30, 2019 1,295,231 $ 13.65 |
Milestone and Total Shareholder Return Restricted Stock Units [Member] | |
Summary of Information Regarding RSU Activity | Information related to the Company’s Milestone RSUs and TSR RSUs during the nine-month period ended September 30, 2019 are summarized as follows: Number of Shares Weighted-Average Grant Date Fair Value Per Share Outstanding at December 31, 2018 278,592 $ 15.64 Milestone RSUs and TSR RSUs granted in 2019 — $ — Milestone RSUs and TSR RSUs cancelled in 2019 (14,194 ) $ 15.64 Outstanding at September 30, 2019 264,398 $ 15.64 |
Organization - Additional Infor
Organization - Additional Information (Detail) | Aug. 08, 2019 | Sep. 30, 2019USD ($) | Sep. 12, 2019USD ($) |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Duration Of Time Essential For The Cash,Cash Equivalents And Other Investments Thereof For Funding The Operating Expenses And Capital Expenditure | 12 months | ||
Lumateperone [member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Number of clinical trials | 20 | ||
ITI Limited [Member] | Intellectual Property [Member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Finite lived intangible assets transactional gain | $ 125,000,000 | ||
Maximum [Member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Universal shelf registration statement, effective date value | $ 350,000,000 | ||
Maximum [Member] | Common Stock [Member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Universal shelf registration statement, effective date value | $ 75,000,000 | ||
Minimum [Member] | Lumateperone [member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Number of subjects exposed medicine | 1,900 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($)Segment | Sep. 30, 2018USD ($) | Dec. 31, 2017USD ($) | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | |
Significant Accounting Policies [Line Items] | ||||||
Number of operating segments | Segment | 1 | |||||
Maturity of highly liquid investments | 3 months | |||||
Maturity of certificates of deposit, commercial paper, corporate notes and corporate bonds | more than three months | |||||
Investment securities, available-for-sale | $ 153,270,596 | $ 153,270,596 | $ 292,583,046 | |||
Aggregate related fair value of investments with unrealized losses | 36,000,000 | 36,000,000 | ||||
Investment securities aggregate amount of unrealized loss | 22,000 | 22,000 | ||||
Investment securities, held in continuous unrealized loss position for less than 12 months | 10,000,000 | 10,000,000 | 92,100,000 | |||
Investment securities, held in continuous unrealized loss position for 12 months or longer | 26,000,000 | 26,000,000 | 345,000 | |||
Total continuous unrealized loss for investments held for 12 months or longer | 16,000 | 16,000 | ||||
Carrying value of cash held in money market funds | 55,400,000 | 55,400,000 | ||||
Impairment losses recognized | $ 0 | |||||
Recognized tax benefit | $ 1,100,000 | |||||
Effective tax rate | 0.00% | 0.00% | ||||
Annual effective tax rate | 0.00% | |||||
US statutory rate | 21.00% | |||||
Assumed expected dividend rate | 0.00% | 0.00% | ||||
Excess tax benefits for tax deductions | $ 0 | $ 0 | ||||
Net lease assets | 18,540,418 | 18,540,418 | ||||
Net lease liabilities | $ 22,556,531 | 22,556,531 | ||||
Date Of Expiry Of Result Based Restricted Stock Units If Targets Are Not Achieved | Dec. 31, 2019 | |||||
Deferred Tax Assets, Net, Noncurrent | $ 264,609 | 264,609 | 529,218 | |||
Income tax refund received | 529,000 | |||||
Cash and Cash Equivalents [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Carrying value of cash held in money market funds | 39,600,000 | |||||
Carrying value of cash held in certificates of deposit | 39,000,000 | 39,000,000 | 7,500,000 | |||
Prepaid Expenses and Other Current Assets [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Deferred Tax Assets, Net, Current | 264,600 | 264,600 | 529,000 | |||
Deferred Tax Assets, Net, Noncurrent | 264,600 | 264,600 | 529,000 | |||
Significant Unobservable Inputs (Level 3) [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Assets measured using quoted prices | 0 | 0 | 0 | |||
Liabilities measured using quoted prices | 0 | 0 | 0 | |||
Accounting Standards Update 2016-02 [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Net lease assets | $ 20,200,000 | |||||
Net lease liabilities | $ 23,400,000 | |||||
Contractual Maturity Dates More Than One Year and Less Than Two Years [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Investment securities, available-for-sale | $ 10,000,000 | $ 10,000,000 | $ 64,600,000 | |||
RSUs [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Service period for granted RSUs, vest in annual installment | 3 years | |||||
Minimum [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Property and equipment, estimated useful life | 3 years | |||||
Maximum [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Property and equipment, estimated useful life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Investment Securities (Detail) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 | |
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 153,072,000 | $ 293,251,000 | |
Unrealized Gains | 221,000 | 31,000 | |
Unrealized (Losses) | (22,000) | (699,000) | |
Estimated Fair Value | 153,270,596 | 292,583,046 | |
U.S. Government Agency Securities [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 55,402,000 | 124,691,000 | |
Unrealized Gains | 70,000 | 24,000 | |
Unrealized (Losses) | (13,000) | (289,000) | |
Estimated Fair Value | 55,459,000 | 124,426,000 | |
FDIC Certificates of Deposit [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | [1] | 245,000 | |
Estimated Fair Value | [1] | 245,000 | |
Certificates of Deposit [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 3,000,000 | 1,000,000 | |
Estimated Fair Value | 3,000,000 | 1,000,000 | |
Commercial Paper [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 33,705,000 | 41,317,000 | |
Unrealized Gains | 16,000 | ||
Unrealized (Losses) | (6,000) | (45,000) | |
Estimated Fair Value | 33,715,000 | 41,272,000 | |
Corporate Notes/Bonds [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 60,965,000 | 125,998,000 | |
Unrealized Gains | 135,000 | 7,000 | |
Unrealized (Losses) | (3,000) | (365,000) | |
Estimated Fair Value | $ 61,097,000 | $ 125,640,000 | |
[1] | “FDIC Certificates of Deposit” consist of deposits that are less than $250,000. |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Investment Securities (Parenthetical) (Detail) | Dec. 31, 2018USD ($) |
FDIC Certificates of Deposit [Member] | Maximum [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Deposits under FDIC Certificates of Deposit | $ 250,000 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Fair Value Measurements of Cash Equivalents and Available-for-Sale Investment Securities (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 247,626 | $ 339,674 |
Money Market Funds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 55,355 | 39,591 |
U.S. Government Agency Securities [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 55,459 | 124,426 |
FDIC Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 245 | |
Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 42,000 | 8,500 |
Commercial Paper [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 33,715 | 41,272 |
Corporate Notes/Bonds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 61,097 | 125,640 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 55,355 | 39,591 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Funds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 55,355 | 39,591 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 192,271 | 300,083 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Government Agency Securities [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 55,459 | 124,426 |
Significant Other Observable Inputs (Level 2) [Member] | FDIC Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 245 | |
Significant Other Observable Inputs (Level 2) [Member] | Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 42,000 | 8,500 |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 33,715 | 41,272 |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Notes/Bonds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 61,097 | $ 125,640 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Stock options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Number of anti-dilutive securities excluded from computation of earnings per share | 283,129 | 872,246 | 305,810 | 871,844 |
RSUs [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Number of anti-dilutive securities excluded from computation of earnings per share | 459,946 | 387,953 | 512,749 | 372,744 |
Total Shareholder Return Restricted Stock Units [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Number of anti-dilutive securities excluded from computation of earnings per share | 79,182 | 75,143 | 89,139 | 75,143 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 5,541,764 | $ 4,193,688 |
Less accumulated depreciation | (3,366,771) | (3,033,922) |
Property Plant and Equipment Net | 2,174,993 | 1,159,766 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 60,377 | 44,427 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 423,097 | 341,582 |
Scientific Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 3,849,747 | 3,658,209 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 1,208,543 | $ 149,470 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 335,461 | $ 273,206 |
Right Of Use Assets and Lease_3
Right Of Use Assets and Lease Liabilities - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | ||||||
Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($)ft² | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($)ft² | Feb. 28, 2019ft² | Jan. 01, 2019USD ($) | Jan. 01, 2014ft² | |
Right of use assets, net | $ 18,540,418 | $ 18,540,418 | ||||||
Net lease liabilities | 22,556,531 | 22,556,531 | ||||||
Operating lease expense | $ 818,000 | $ 361,000 | $ 2,500,000 | $ 1.1 | ||||
Accounting Standards Update 2016-02 [Member] | ||||||||
Right of use assets, net | $ 20,200,000 | |||||||
Net lease liabilities | 23,400,000 | |||||||
Eliminated deferred rent | $ 3,200,000 | |||||||
Forecast [Member] | Leasehold Improvements [Member] | ||||||||
Reimbursements from leasehold improvements | $ 880,000 | |||||||
NEW YORK | ||||||||
Area of usable laboratory and office space | ft² | 15,534 | 15,534 | 16,753 | |||||
Term of long term lease | 14 years 3 months 18 days | 14 years 3 months 18 days | ||||||
NEW YORK | Accounting Standards Update 2016-02 [Member] | ||||||||
Operating lease discount rate | 7.21% | |||||||
Operating Lease, Weighted Average Remaining Lease Term | 3 years 2 months 12 days | |||||||
MARYLAND | ||||||||
Area of usable laboratory and office space | ft² | 3,164 | |||||||
Term of long term lease | 3 years 2 months 12 days | |||||||
MARYLAND | Accounting Standards Update 2016-02 [Member] | ||||||||
Operating lease discount rate | 9.10% | |||||||
Operating Lease, Weighted Average Remaining Lease Term | 14 years 3 months 18 days |
Right Of Use Assets and Lease_4
Right Of Use Assets and Lease Liabilities - Maturity analysis under the lease agreements (Detail) | Sep. 30, 2019USD ($) |
Operating Lease Liabilities, Payments Due [Abstract] | |
Three months ending December 31, 2019 | $ (56,130) |
Year ending December 31, 2020 | 3,346,376 |
Year ending December 31, 2021 | 3,448,323 |
Year ending December 31, 2022 | 3,491,166 |
Year ending December 31, 2023 | 3,566,466 |
Thereafter | 21,302,235 |
Total | 35,098,436 |
Less: Present value discount | (12,541,905) |
Total Lease liability | 22,556,531 |
Less: current portion | (2,286,885) |
Long-term lease liabilities | $ 20,269,646 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Mar. 31, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares of common stock reserved for issuance | 10,287,390 | |||||
Expected dividend yield | 0.00% | 0.00% | ||||
Risk free interest rate | 2.32% | 2.40% | ||||
2018 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares of common stock reserved for issuance | 4,807,323 | |||||
Total Shareholder Return Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options, vesting term | 3 years | |||||
Weighted average grant date fair value of stock options granted | $ 17.08 | |||||
Unrecognized compensation costs related to unvested RSUs | $ 1.8 | $ 1.8 | ||||
Expected dividend yield | 0.00% | |||||
Risk free interest rate | 1.60% | |||||
Expected volatility | 95.40% | |||||
Vesting date | Dec. 31, 2019 | |||||
Terms of award | Total shareholder return is determined by dividing the average share value of the Company’s common stock over the 30 trading days preceding January 1, 2020 by the average share value of the Company’s common stock over the 30 trading days beginning on January 1, 2017, with a deemed reinvestment of any dividends declared during the performance period. | |||||
Time Based Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation costs related to unvested RSUs | 12.5 | $ 12.5 | ||||
Non-cash stock-based compensation expense recognized | 1.7 | $ 1.2 | 5.6 | $ 3.5 | ||
RSUs [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation costs related to unvested RSUs | 0.2 | 0.2 | ||||
Non-cash stock-based compensation expense recognized | $ 1.9 | $ 1.6 | $ 6.1 | $ 4.6 | ||
Stock Options [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options, maximum term | 10 years | |||||
Stock Options [Member] | Minimum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options, vesting term | 1 year | |||||
Stock Options [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options, vesting term | 3 years |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | $ 4,806,768 | $ 4,373,688 | $ 14,849,409 | $ 12,971,496 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | 2,023,700 | 1,819,375 | 6,785,280 | 5,614,641 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | $ 2,783,068 | $ 2,554,313 | $ 8,064,129 | $ 7,356,855 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions Used for Calculating Value of Options Granted (Detail) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility, minimum | 83.70% | 85.20% |
Expected volatility, maximum | 85.70% | 85.80% |
Weighted-average risk-free interest rate | 2.32% | 2.40% |
Expected term (in years) | 6 years | 6 years |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity (Detail) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Outstanding at beginning of period, Number of Shares | 4,748,391 | |
Options granted, Number of Shares | 1,821,258 | |
Options exercised, Number of Shares | (85,650) | |
Options canceled or expired, Number of Shares | (153,085) | |
Outstanding at end of period, Number of Shares | 6,330,914 | 4,748,391 |
Vested or expected to vest at end of period, Number of Shares | 6,330,914 | |
Exercisable at end of period, Number of Shares | 3,403,319 | |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ 18.75 | |
Options granted, Weighted-Average Exercise Price | 12.84 | |
Options exercised, Weighted-Average Exercise Price | 5.17 | |
Options canceled or expired, Weighted-Average Exercise Price | 19.55 | |
Outstanding at end of period, Weighted-Average Exercise Price | 16.85 | $ 18.75 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | 16.85 | |
Exercisable at end of period, Weighted-Average Exercise Price | $ 19.66 | |
Options granted, Weighted-Average Contractual Life | 9 years 4 months 24 days | |
Options exercised, Weighted-Average Contractual Life | 3 years 8 months 12 days | |
Options canceled or expired, Weighted-Average Contractual Life | 7 years 8 months 12 days | |
Outstanding at end of period, Weighted-Average Contractual Life | 7 years 2 months 12 days | 7 years |
Exercisable at end of period, Weighted-Average Contractual Life | 5 years 7 months 6 days |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Information Regarding the Time Based RSU Activity and Changes (Detail) - RSUs [Member] | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period, Number of Shares | shares | 647,411 |
Time based RSU's granted, Number of Shares | shares | 950,449 |
Time based RSU's vested, Number of Shares | shares | (253,695) |
Time based RSU's cancelled, Number of Shares | shares | (48,934) |
Outstanding at end of period, Number of Shares | shares | 1,295,231 |
Outstanding at beginning of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 18.16 |
Time based RSU's granted, Weighted-Average Grant Date Fair Value | $ / shares | 12.79 |
Time based RSU's vested, Weighted-Average Grant Date Fair Value | $ / shares | 21.80 |
Time based RSU's cancelled, Weighted-Average Grant Date Fair Value | $ / shares | 14.31 |
Outstanding at end of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 13.65 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Information Regarding Milestone RSU grants and TSR RSU grants (Detail) - Milestone and Total Shareholder Return Restricted Stock Units [Member] | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period, Number of Shares | shares | 278,592 |
Milestone RSUs and TSR RSU's cancelled, Number of Shares | shares | (14,194) |
Outstanding at end of period, Number of Shares | shares | 264,398 |
Outstanding at beginning of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 15.64 |
Milestone RSUs and TSR RSU's cancelled, Weighted-Average Grant Date Fair Value | $ / shares | 15.64 |
Outstanding at end of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 15.64 |
Collaborations and License Ag_2
Collaborations and License Agreements - Additional Information (Detail) - Collaborative Arrangement, Product [Member] - Bristol-Myers Squibb Company [Member] - USD ($) | May 31, 2005 | Dec. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2019 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Company made an upfront payment | $ 1,000,000 | |||
Company made milestone payment | $ 1,500,000 | $ 1,250,000 | ||
Obliged to make milestone payments | $ 14,750,000 | |||
Company remaining milestone payment | $ 10,000,000 | |||
License expiration period | through the later of 10 years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product | |||
Minimum [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Royalty payment, percentage | 5.00% | |||
Maximum [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Royalty payment, percentage | 9.00% | |||
Food and Drug Administration [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Obliged to make milestone payments | $ 2,000,000 | |||
National Democratic Alliance [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Obliged to make milestone payments | $ 5,000,000 |