Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 25, 2016 | Jun. 30, 2015 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ITCI | ||
Entity Registrant Name | Intra-Cellular Therapies, Inc. | ||
Entity Central Index Key | 1,567,514 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 43,212,709 | ||
Entity Public Float | $ 750.7 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 47,159,303 | $ 61,325,044 |
Investment securities, available-for-sale | 428,041,021 | 68,320,672 |
Accounts receivable | 30,660 | 51,603 |
Prepaid expenses and other current assets | 8,025,147 | 1,288,953 |
Total current assets | 483,256,131 | 130,986,272 |
Property and equipment, net | 775,522 | 54,553 |
Other assets | 71,875 | 70,944 |
Total assets | 484,103,528 | 131,111,769 |
Current liabilities: | ||
Accounts payable | 1,632,905 | 2,052,765 |
Accrued and other current liabilities | 3,423,464 | 7,529,241 |
Accrued employee benefits | 1,207,143 | 975,058 |
Total current liabilities | 6,263,512 | 10,557,064 |
Long-term deferred rent | 1,597,105 | |
Total liabilities | 7,860,617 | 10,557,064 |
Stockholders' equity: | ||
Common stock, $.0001 par value: 100,000,000 shares authorized; 43,155,875 and 29,499,059 shares issued and outstanding at December 31, 2015 and 2014, respectively | 4,316 | 2,950 |
Additional paid-in capital | 669,878,103 | 208,912,345 |
Accumulated deficit | (193,049,098) | (88,255,957) |
Accumulated comprehensive loss | (590,410) | (104,633) |
Total stockholders' equity | 476,242,911 | 120,554,705 |
Total liabilities and stockholders' equity | $ 484,103,528 | $ 131,111,769 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
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 | 43,155,875 | 29,499,059 |
Common stock, shares outstanding | 43,155,875 | 29,499,059 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenues: | |||
License and collaboration revenue | $ 30,659 | $ 547,546 | $ 2,737,002 |
Grant Revenue | 60,705 | 29,755 | |
Total revenues | 91,364 | 577,301 | 2,737,002 |
Costs and expenses: | |||
Research and development | 87,718,074 | 21,226,345 | 23,027,578 |
General and administrative | 18,187,286 | 10,337,679 | 5,976,276 |
Total costs and expenses | 105,905,360 | 31,564,024 | 29,003,854 |
Loss from operations | (105,813,996) | (30,986,723) | (26,266,852) |
Interest income | 1,022,455 | 303,936 | 29,617 |
Interest expense | (7,073) | (612,963) | |
Income tax expense | (1,600) | (1,600) | (18,000) |
Net loss | $ (104,793,141) | $ (30,691,460) | $ (26,868,198) |
Net loss per common share: | |||
Basic & Diluted | $ (2.91) | $ (1.07) | $ (1.56) |
Weighted average number of common shares: | |||
Basic & Diluted | 36,069,237 | 28,650,067 | 17,260,768 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (104,793,141) | $ (30,691,460) | $ (26,868,198) |
Other comprehensive loss: | |||
Unrealized loss on investment securities | (485,777) | (104,633) | |
Comprehensive loss | $ (105,278,918) | $ (30,796,093) | $ (26,868,198) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | March 11, 2015 [Member] | September 28, 2015 [Member] | Common Stock [Member] | Common Stock [Member]March 11, 2015 [Member] | Common Stock [Member]September 28, 2015 [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]March 11, 2015 [Member] | Additional Paid-in Capital [Member]September 28, 2015 [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Loss [Member] |
Balance at Dec. 31, 2012 | $ 16,984,085 | $ 1,460 | $ 47,678,924 | $ (30,696,299) | |||||||
Balance, shares at Dec. 31, 2012 | 14,599,612 | ||||||||||
Conversion of convertible notes | 701,723 | $ 11 | 701,712 | ||||||||
Conversion of convertible notes, shares | 110,446 | ||||||||||
Private placement of common stock | 39,963,500 | $ 692 | 39,962,808 | ||||||||
Private placement of common stock, shares | 6,916,697 | ||||||||||
Exercise of stock options | 332,938 | $ 51 | 332,887 | ||||||||
Exercise of stock options, shares | 514,466 | ||||||||||
Stock subscription | 109,834 | $ 2 | 109,832 | ||||||||
Stock subscription, shares | 18,225 | ||||||||||
Share-based compensation | 391,393 | 391,393 | |||||||||
Net loss | (26,868,198) | (26,868,198) | |||||||||
Balance at Dec. 31, 2013 | 31,615,275 | $ 2,216 | 89,177,556 | (57,564,497) | |||||||
Balance, shares at Dec. 31, 2013 | 22,159,446 | ||||||||||
Common shares issued | 115,442,747 | $ 706 | 115,442,041 | ||||||||
Common shares issued, shares | 7,063,300 | ||||||||||
Exercise of stock options | 162,980 | $ 25 | 162,955 | ||||||||
Exercise of stock options, shares | 247,165 | ||||||||||
Stock issued for services | 176,085 | $ 1 | 176,084 | ||||||||
Stock issued for services, shares | 10,923 | ||||||||||
Stock subscription | 109,833 | $ 2 | 109,831 | ||||||||
Stock subscription, shares | 18,225 | ||||||||||
Share-based compensation | 3,843,878 | 3,843,878 | |||||||||
Net loss | (30,691,460) | (30,691,460) | |||||||||
Other comprehensive loss | (104,633) | $ (104,633) | |||||||||
Balance at Dec. 31, 2014 | 120,554,705 | $ 2,950 | 208,912,345 | (88,255,957) | (104,633) | ||||||
Balance, shares at Dec. 31, 2014 | 29,499,059 | ||||||||||
Common shares issued | $ 121,804,369 | $ 327,436,205 | $ 541 | $ 793 | $ 121,803,828 | $ 327,435,412 | |||||
Common shares issued, shares | 5,411,481 | 7,935,000 | |||||||||
Exercise of stock options | $ 653,046 | $ 31 | 653,015 | ||||||||
Exercise of stock options, shares | 305,005 | 305,005 | |||||||||
Stock issued for services | $ 182,599 | $ 1 | 182,598 | ||||||||
Stock issued for services, shares | 5,330 | ||||||||||
Share-based compensation | 10,890,905 | 10,890,905 | |||||||||
Net loss | (104,793,141) | (104,793,141) | |||||||||
Other comprehensive loss | (485,777) | (485,777) | |||||||||
Balance at Dec. 31, 2015 | $ 476,242,911 | $ 4,316 | $ 669,878,103 | $ (193,049,098) | $ (590,410) | ||||||
Balance, shares at Dec. 31, 2015 | 43,155,875 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating activities | |||
Net loss | $ (104,793,141) | $ (30,691,460) | $ (26,868,198) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation expense | 139,626 | 25,481 | 23,249 |
Share-based compensation expense | 10,890,905 | 3,843,878 | 391,393 |
Issuance of stock for services | 182,599 | 176,085 | |
Amortization of premiums on investment activities | 712,675 | 297,223 | |
Changes in operating assets and liabilities: | |||
Accounts receivable | 20,943 | 284,715 | (35,889) |
Prepaid expenses and other assets | (6,737,125) | (466,099) | (574,341) |
Accounts payable | (419,860) | (1,342,302) | 3,353,459 |
Accrued liabilities and employee benefits | (3,873,692) | 5,065,329 | 2,785,736 |
Deferred revenue | (1,666,674) | ||
Deferred rent | 1,597,105 | ||
Net cash used in operating activities | (102,279,965) | (22,807,150) | (22,591,265) |
Investing activities | |||
Purchases of investments | (514,308,249) | (103,601,836) | |
Maturities of investments | 153,389,448 | 36,879,308 | 1,500,000 |
Purchase of property and equipment | (860,595) | (11,762) | (33,255) |
Net cash (used in) provided by investing activities | (361,779,396) | (66,734,290) | 1,466,745 |
Financing activities | |||
Proceeds from issuance of convertible promissory notes, net | 100,000 | ||
Proceeds from stock option exercises | 653,046 | 162,980 | 332,938 |
Proceeds from stock subscription | 109,833 | 109,834 | |
Proceeds of public offerings | 449,996,887 | 116,191,285 | 43,841,850 |
Payment of costs of public offerings | (756,313) | (748,538) | (3,754,706) |
Net cash provided by financing activities | 449,893,620 | 115,715,560 | 40,629,916 |
Net (decrease) increase in cash and cash equivalents | (14,165,741) | 26,174,120 | 19,505,396 |
Cash and cash equivalents at beginning of period | 61,325,044 | 35,150,924 | 15,645,528 |
Cash and cash equivalents at end of period | $ 47,159,303 | 61,325,044 | 35,150,924 |
Cash paid for interest | $ 7,073 | $ 11,320 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Intra-Cellular Therapies, Inc. (the “Company”), through its wholly-owned operating subsidiary, ITI, Inc. (“ITI”), is a biopharmaceutical company focused on the discovery and clinical development of innovative, small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system (“CNS”). The Company’s lead product candidate, ITI-007, is in Phase 3 clinical development as a novel treatment for schizophrenia and bipolar depression. ITI was incorporated in the State of Delaware on May 22, 2001 under the name “Intra-Cellular Therapies, Inc.” and commenced operations in June 2002. ITI was founded to discover and develop drugs for the treatment of neurological and psychiatric disorders. On August 29, 2013, ITI completed a reverse merger (the “Merger”) with a public shell company named Oneida Resources Corp. (“Oneida”). Oneida was formed in August 2012 as a vehicle to investigate and, if such investigation warranted, acquire a target company or business seeking the perceived advantages of being a publicly held corporation. In the Merger, each outstanding share of capital stock of ITI was exchanged for 0.5 shares of common stock of Oneida, and each outstanding option to purchase one share of ITI common stock and each outstanding warrant to purchase one share of ITI common stock was assumed by Oneida and became exercisable for 0.5 shares of Oneida common stock. As a result of the Merger and related transactions, ITI survived as a wholly-owned subsidiary of Oneida, Oneida changed its fiscal year end from March 31 to December 31, and Oneida changed its name to Intra-Cellular Therapies, Inc. (the “Company”). In addition, the Company began operating ITI and its business, and therefore ceased being a shell company. Following the Merger and the redemption of all then outstanding shares of Oneida at the closing of the Merger, the former stockholders of ITI owned 100% of the shares of the Company’s outstanding capital stock. In accordance with Financial Accounting Standards Board (“FASB”), Accounting Standards Codification (“ASC”) Topic 805, Business Combinations Immediately prior to the Merger, on August 29, 2013, ITI sold to accredited investors approximately $60.0 million of its shares of common stock, or 18,889,307 shares at a price of $3.1764 per share (the “Private Placement”), which included $15.3 million in principal and $0.8 million in accrued interest from the conversion of ITI’s then outstanding convertible promissory notes (the “Notes”). On February 5, 2014, the Company completed a public offering of common stock in which the Company sold 7,063,300 shares of common stock, which included the exercise of the underwriters’ option to purchase an additional 921,300 shares, at an offering price of $17.50 per share. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $115.4 million. On October 31, 2014, the Company entered into a termination agreement with Takeda Pharmaceutical Company Limited (“Takeda”) terminating the worldwide license and collaboration agreement under which the Company and Takeda were jointly developing the Company’s proprietary compound ITI-214 and other selected compounds that selectively inhibit phosphodiesterase type 1 (“PDE1”) for use in the prevention and treatment of human diseases. Through December 31, 2015, the Company had received $29.0 million in total payments under the agreement and was eligible to receive milestone payments and royalties based on net sales. On September 15, 2015, Takeda completed the transfer of the Investigational New Drug application (“IND”) for ITI-214 to the Company. The Company intends to explore the development of its PDE program, including ITI-214 for the treatment of several CNS and non-CNS conditions. On March 11, 2015, the Company completed a public offering of common stock in which the Company sold 5,411,481 shares of common stock, which included the exercise of the underwriters’ option to purchase an additional 661,481 shares, at an offering price of $24.00 per share. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $121.8 million. On September 28, 2015, the Company completed a public offering of common stock in which the Company sold 7,935,000 shares of common stock, which included the exercise of the underwriters’ option to purchase an additional 1,035,000 shares, at an offering price of $43.50 per share. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $327.4 million. 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. 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements 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 as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). 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. Their carrying values 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 may consist of investments in U.S. Treasuries, various U.S. governmental agency debt securities, corporate bonds, certificates of deposit, and other fixed income securities with an average maturity of twelve months or less. Management classifies the Company’s investments as available-for-sale. Such securities are carried at estimated fair value, with any unrealized holding gains or losses reported, net of any tax effects reported, as accumulated other comprehensive income, which is a separate component of stockholders’ equity. Realized gains and losses, and declines in value judged to be other-than-temporary, if any, are included in consolidated results of operations. A decline in the market value of any available-for-sale security below cost that is deemed to be other-than-temporary results in a reduction in fair value, which is charged to earnings in that period, and a new cost basis for the security is established. Dividend and interest income is recognized as interest income when earned. The cost of securities sold is calculated using the specific identification method. Investment securities consisted of the following (in thousands): December 31, 2015 Amortized Unrealized Unrealized Estimated U.S. government agency securities $ 61,510 $ — $ (271 ) $ 61,239 FDIC certificates of deposit (1) 41,343 1 (11 ) 41,333 Certificates of deposit 219,500 — — 219,500 Commercial paper 30,122 — (48 ) 30,074 Corporate bonds/notes 76,157 — (262 ) 75,895 $ 428,632 $ 1 $ (592 ) $ 428,041 December 31, 2014 Amortized Unrealized Unrealized Estimated U.S. government agency securities $ 4,316 $ — $ (3 ) $ 4,313 FDIC certificates of deposit (1) 16,374 — (14 ) 16,360 Certificates of deposit 2,000 — — 2,000 Commercial paper 9,743 1 — 9,744 Corporate bonds/notes 35,992 — (89 ) 35,904 $ 68,425 $ 1 $ (106 ) $ 68,321 (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, including those with maturities beyond one year, as current assets on the consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. As of December 31, 2015 and December 31, 2014, the Company held $142.4 million and $31.8 million, respectively, of available-for-sale investment securities with contractual maturity dates more than one year and less than two years. 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 credit loss. In determining whether a decline in the value of an investment is other-than-temporary, As of December 31, 2015 the Company had approximately $9.2 million of investments that have been held for greater than one year which had a temporary impairment of approximately $19,000. As of December 31, 2014 the Company had no investments that had been held for greater than one year. The Company attributes the unrealized losses on the available-for-sale securities as of December 31, 2015 and 2014, to the variability in related market interest rates. The Company does not intend to sell these securities, nor is it more likely than not that the Company will be required to sell them prior to the end of their contractual terms. Furthermore, the Company does not believe that these securities expose us to undue market risk or counterparty credit risk. As such, the Company does not consider these securities to be other-than-temporarily impaired. 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 December 31, 2015 and December 31, 2014. The carrying value of cash held in money market funds of approximately $31.1 million as of December 31, 2015 and $8.5 million as of December 31, 2014, is included in cash and cash equivalents and approximates market value based on quoted market price or Level 1 inputs. The fair value measurements of the Company’s cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands): Fair Value Measurements at December 31, Quoted Prices Significant Significant Money market funds $ 31,114 $ 31,114 $ — $ — U.S. government agency securities 61,239 — 61,239 — FDIC certificates of deposit 41,333 — 41,333 — Certificates of deposit 219,500 — 219,500 — Commercial paper 30,074 — 30,074 — Corporate bonds/notes 75,895 — 75,895 — $ 459,155 $ 31,114 $ 428,041 $ — Fair Value Measurements at December 31, Quoted Prices Significant Significant Money market funds $ 8,495 $ 8,495 $ — $ — U.S. government agency securities 4,313 — 4,313 — FDIC certificates of deposit 16,360 — 16,360 — Certificates of deposit 41,000 — 41,000 — Commercial paper 9,744 — 9,744 — Corporate bonds/notes 35,903 — 35,903 — $ 115,815 $ 8,495 $ 107,320 $ — Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, accounts receivable, accounts payable and accrued liabilities, to approximate their fair value because of their relatively short maturities at December 31, 2015 and December 31, 2014. 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 remote. 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 December 31, 2015 and 2014, as the Company has a history of collecting on all its accounts including government agencies and collaborations funding its research. Property and Equipment Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three to five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the assets or the term of the related lease. Expenditures for maintenance and repairs are charged to operations as incurred. 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 360, Property, Plant and Equipment Revenue Recognition Revenue is recognized when all terms and conditions of the agreements have been met, including persuasive evidence of an arrangement, delivery has occurred or services have been rendered, price is fixed or determinable and collectability is reasonably assured. The Company is reimbursed for certain costs incurred on specified research projects under the terms and conditions of grants, collaboration agreements, and awards. The Company records the amount of reimbursement as revenues on a gross basis in accordance with ASC Topic 605-45, Revenue Recognition/Principal Agent Considerations The Company has entered into arrangements involving the delivery of more than one element. Each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting. For the Company, this determination is generally based on whether the deliverable has “stand-alone value” to the customer. The Company adopted this accounting standard on a prospective basis for all Multiple-Deliverable Revenue Arrangements (“MDRAs”) entered into on or after January 1, 2011, and for any MDRAs that were entered into prior to January 1, 2011, but materially modified on or after that date. The Company has adopted ASC Topic 605-28, Milestone Method • The milestone payments are non-refundable; • Achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; • Substantive effort on the Company’s part is involved in achieving the milestone; • The amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and • A reasonable amount of time passes between the up-front license payment and the first milestone payment, as well as between each subsequent milestone payment. Determination as to whether a payment meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, the resulting payment would not be considered a substantive milestone, and therefore, the resulting payment would be considered part of the consideration for the single unit of accounting and be recognized as revenue in accordance with the revenue models described above. In addition, the determination that one such payment was not a substantive milestone could prevent the Company from concluding that subsequent milestone payments were substantive milestones and, as a result, any additional milestone payments could also be considered part of the consideration for the single unit of accounting and would be recognized as revenue as such performance obligations are performed under either the proportional performance or straight-line methods, as applicable . 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, outside services, 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 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 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 discussion with applicable personnel and outside service providers as to the progress or state of consummation 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 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 years ended December 31, 2015 and 2014, 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 (previously included in FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes—an Interpretation of FASB Statement No. 109 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 sources. In accordance with accounting guidance, the Company presents the impact of any unrealized gains or (losses) on its investment securities in a separate statement of comprehensive income (loss) for each period. 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. For awards that contain a performance-based vesting condition, expense is amortized using the accelerated attribution method. Share-based compensation expense recognized in the statements of operations for the years ended December 31, 2015, 2014 and 2013 is based on share-based awards ultimately expected to vest, and this amount has therefore been reduced for estimated forfeitures. ASC Topic 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Pre-vesting forfeitures were estimated based on the Company’s historical experience and have not been material. 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. Restricted stock units are valued at the fair market value on the date of grant as determined by the closing stock price. Expected volatility rates are based on historical volatility of the common stock of comparable publicly traded entities and other factors due to the limited 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 is defined 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. Prior to January 1, 2014, given that there was no active market for the Company’s common stock, the exercise price of the stock options on the date of grant was determined and approved by the board of directors using several factors, including progress and milestones achieved in the Company’s business development and performance, the price per share of its convertible preferred stock offerings and general industry and economic trends. In establishing the estimated fair value of the common stock, the Company considered the guidance set forth in American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation 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 temporary difference in applying ASC Topic 740, Income Taxes Since the Company had net operating loss carryforwards as of December 31, 2015, 2014 and 2013, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations. Equity instruments issued to consultants are accounted for under the provisions of ASC Topic 718 and ASC Topic 505-50, Equity/Equity-Based Payments to Non-Employees 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. 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 years ended December 31, 2015, 2014 and 2013: Years Ended December 31, 2015 2014 2013 Stock Equivalents 1,322,311 958,712 898,982 Recently Issued Accounting Standards In November 2015, the FASB issued Accounting Standards Update No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. Current GAAP requires an entity to separate deferred income tax liabilities and assets into current and noncurrent amounts in a classified statement of financial position. To simplify the presentation of deferred income taxes, ASU 2015-17 requires that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The current requirement that deferred tax liabilities and assets of a tax-paying component of an entity be offset and presented as a single amount is not affected by the amendments in this Update. The amendments in this Update are effective for financial statements issued for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Earlier application is permitted for all entities as of the beginning of an interim or annual reporting period. The Company has elected to adopt this update as of the fourth quarter of 2015, retrospectively. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements and accompanying notes. In May 2014, the FASB issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction-specific and industry-specific revenue recognition guidance under current GAAP and replace it with a principle-based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In July 2015, the FASB decided to defer the effective date of the standard from January 1, 2017, to January 1, 2018, with an option that permits companies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. Presently, the Company is assessing what effect the adoption of this standard will have on our consolidated financial statements and accompanying notes. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 3. Property and Equipment Property and equipment consist of the following: December 31, 2015 2014 Computer equipment $ 42,064 $ 39,160 Furniture and fixtures 266,695 35,958 Scientific equipment 2,823,601 2,207,848 3,132,360 2,282,966 Less accumulated depreciation (2,356,838 ) (2,228,413 ) $ 775,522 $ 54,553 Depreciation expense for the years ended December 31, 2015, 2014 and 2013 was $139,626, $25,481 and $23,249, respectively. During 2015, the Company retired $11,201 of fully depreciated property and equipment. During 2014, in conjunction with its move in February 2015 to its new headquarters, the Company retired $319,553 of fully depreciated leasehold improvements and disposed of $709,518 of fully depreciated property and equipment. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 4. Share-Based Compensation The Company sponsors the Intra-Cellular Therapies, Inc. 2013 Equity Incentive Plan (the “2013 Plan”) to provide for the granting of stock-based awards, such as stock options, restricted common stock, restricted stock units and stock appreciation rights to employees, directors and consultants as determined by the Board of Directors. In August 2013, the Company assumed in the Merger the ITI 2003 Equity Incentive Plan, as amended (the “2003 Plan”), which expired by its terms in July 2013. As of December 31, 2015, there were options to purchase 2,737,657 shares of common stock outstanding under the 2013 Plan. Effective in November 2013, the Company adopted the 2013 Plan. The Company initially reserved 2,850,000 shares of common stock for issuance under the 2013 Plan. In both January 2015 and 2014, the number of shares of common stock reserved for issuance under the 2013 Plan automatically increased by 800,000 pursuant to the evergreen provisions of the 2013 Plan. On June 16, 2015, the stockholders of the Company approved, at the Company’s 2015 Annual Meeting of Stockholders, an amendment to the 2013 Plan to increase the number of shares of common stock available for issuance under the plan by 3,100,000 shares, to increase by 100,000 shares the maximum number of shares available for the issuance of options, stock appreciation rights and other similar awards to any one participant in any calendar year for purposes of meeting the requirements for qualified performance-based compensation under Section 162(m) of the Internal Revenue Code of 1986, as amended (the “Code”), and to eliminate the evergreen provisions of the 2013 Plan under which 800,000 shares were automatically added to the plan on each of January 1, 2014 and 2015. Stock options granted under the 2013 Plan may be either incentive stock options (“ISOs”) as defined by the Code, or non-qualified stock options. The Board of Directors determines who will receive options, the vesting periods (which are generally two to three years) and the exercise prices of such options. Options have a maximum term of 10 years. The exercise price of ISOs granted under the 2013 Plan must be at least equal to the fair market value of the common stock on the date of grant. Total stock-based compensation expense related to all of the Company’s share-based awards, including stock options and restricted stock units to employees, directors and consultants recognized during the years ended December 31, 2015, 2014 and 2013, was comprised of the following: Years Ended December 31, 2015 2014 2013 Research and development $ 4,768,131 $ 1,842,828 $ 132,543 General and administrative 6,122,774 2,001,050 258,850 Total share-based compensation expense $ 10,890,905 $ 3,843,878 $ 391,393 The following table describes the weighted-average assumptions used for calculating the value of options granted during the years ended December 31, 2015, 2014 and 2013: 2015 2014 2013 Dividend yield 0 % 0 % 0 % Expected volatility 80.0 % 80.0 % 80.0 % Weighted-average risk-free interest rate 1.8 % 2.0 % 2.2 % Expected term (in years) 5.9 6.3 6.2 Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of December 31, 2015, and changes during the period then ended, are summarized as follows: Number of Weighted- Aggregate Weighted- Outstanding at December 31, 2014 2,233,460 $ 9.20 $ — 7.3 years Options granted 884,703 $ 21.00 $ — 9.1 years Options exercised (305,005 ) $ 2.14 $ — 2.2 years Options canceled or expired (75,501 ) $ 12.33 $ — 8.0 years Outstanding at December 31, 2015 2,737,657 $ 13.72 $ 109,778,658 7.6 years Vested or expected to vest at December 31, 2015 2,737,657 $ 13.72 $ — Exercisable at December 31, 2015 1,485,918 $ 8.75 $ 66,920,372 6.7 years The weighted-average grant date fair value for awards granted during the years ended December 31, 2015, 2014, and 2013, was $21.00, $16.50, and $3.26 per share, respectively. Total intrinsic value of the options exercised during the years ended December 31, 2015, 2014, and 2013 was approximately $10,951,057, $3,696,775 and $580,623, respectively. The total fair value of shares vested in the years ended December 31, 2015, 2014 and 2013, was approximately $5,207,073, $3,703,000 and $278,000, respectively. During 2015, 2014 and 2013, the Company granted options to certain scientific advisory board members of the Company to purchase 45,571, 95,000 and 19,000 shares of common stock at an average exercise price per share of $17.57, $16.86, and $3.26, respectively. The options vest ratably over a period of 12 to 24 months. Stock compensation related to these grants will fluctuate with any changes in the underlying value of the Company’s common stock, as the performance period is not fixed. The unrecognized share-based compensation expense related to stock option awards at December 31, 2015, is $12,733,859 and will be recognized over a weighted-average period of 1.6 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 5. Income Taxes Total income tax expense for the years ended December 31 is allocated as follows: December 31, 2015 2014 2013 Current $ 1,600 $ 1,600 $ 18,000 Deferred (51,165,859 ) (14,655,320 ) (13,229,355 ) Valuation allowance 51,165,859 14,655,320 13,229,355 Provision for income taxes $ 1,600 $ 1,600 $ 18,000 A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31 is as follows: December 31, 2015 2014 2013 Income tax benefit at statutory federal rate 35.00 % 35.00 % 35.00 % Permanent differences (0.56 ) 0.12 (1.20 ) Return-to-provision—R&D Credit 0.00 (0.05 ) 2.61 R&D Credit—current year 4.19 2.32 3.72 Reserve for uncertain tax positions 0.00 (0.01 ) (6.53 ) Change in effective state tax rates (0.05 ) (0.14 ) 6.58 State income tax expense 10.24 10.50 10.12 Change in valuation allowance (48.82 ) (47.75 ) (50.37 ) Provision for income taxes (0.00 )% (0.01 )% (0.07 )% Deferred income taxes reflect the net tax effect of temporary differences that exist between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, using enacted tax rates in effect for the year in which the differences are expected to reverse. As of December 31, 2015, the Company had $174.8 million of federal net operating loss carryforwards, which expire at various dates through 2035. The gross amount of the state net operating loss carryforwards is equal to or less than the federal net operating loss carryforwards and expires over various periods based on individual state tax law. In general, businesses with U.S. net operating losses (“NOLs”) are considered loss corporations for U.S. federal income tax purposes. Pursuant to Section 382 of the Code, loss corporations that undergo an ownership change, as defined under the Code, may be subject to an annual limitation on the amount of NOLs (and certain other tax attributes) available to offset taxable income earned after such ownership change. For the year ended December 31, 2015, the Company performed a Section 382 ownership analysis and determined that an ownership change occurred (within the meaning of Section 382 of the Code) in 2015. Based on the analysis performed, however, the Company does not believe that the Section 382 annual limitation will impact the Company’s ability to utilize the tax attributes that existed as of the date of the ownership change in a material manner. If the Company experiences an ownership change in the future, the tax benefits related to the NOLs and tax credit carryforwards may be further limited or lost. At December 31, 2015, the Company had $5.7 million in excess tax benefits related to stock-based compensation deductions, the benefit of which will be recorded to additional paid-in-capital once the benefit is realized through a reduction of income taxes payable. The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2015 and 2014, respectively: December 31, 2015 2014 Deferred tax assets: Net operating loss carryforwards $ 76,741,198 $ 34,870,169 Accrued employee benefits 543,466 443,371 Research and development credit 6,962,731 2,570,540 Stock compensation 5,641,993 1,563,785 Deferred rent 725,195 — Deferred tax liabilities: Depreciation (6,062 ) (5,204 ) Net deferred tax asset 90,608,521 39,442,661 Valuation allowance (90,608,521 ) (39,442,661 ) Net deferred tax asset $ — $ — Based upon the Company’s historical operating performance and the reported cumulative net losses to date, the Company presently does not have sufficient objective evidence to support the recovery of its net deferred tax assets. Accordingly, the Company has established a valuation allowance against its net deferred tax assets for financial reporting purposes because it is not more likely than not that these deferred tax assets will be realized. The total amount of unrecognized tax benefits as of December 31, 2015 and December 31, 2014 were $1.72 million and $1.72 million respectively. If recognized none of these tax benefits would affect the effective tax rate due to valuation allowances. The following summarizes the significant components of gross unrecognized tax benefits as of December 31, 2015 and 2014, respectively: December 31, 2015 2014 Balance at January1, $ 1,717,635 $ 1,715,904 Current Year Uncertain Tax Positions: Gross Increases 3,277 1,731 Prior Year Uncertain Tax Positions: Balance at December 31, $ 1,720,912 $ 1,717,635 |
Collaborations and License Agre
Collaborations and License Agreements | 12 Months Ended |
Dec. 31, 2015 | |
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 of BMS relating to ITI-007 and other specified compounds. The agreement was amended on November 3, 2010. The licensed rights are exclusive, except BMS retains rights in specified compounds in the fields of obesity, diabetes, metabolic syndrome and cardiovascular disease. However, BMS has no right to use, develop or commercialize ITI-007 and other specified compounds in any field of use. The Company has the right to grant sublicenses of the rights conveyed by BMS. The Company is obliged under the license to use commercially reasonable efforts to develop and commercialize the licensed technology. The Company is also prohibited from engaging in the clinical development or commercialization of specified competitive compounds. 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 ITI-007 for patients with exacerbated schizophrenia. Possible milestone payments remaining total $12.0 million. 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 on sales of licensed products. The Company is obliged to pay to BMS a percentage of non-royalty payments made in consideration of any sublicense. The agreement extends, and royalties are payable, on a country-by-country and product-by-product basis, through the later of ten years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product, its method of manufacture or use, or the expiration of other government grants providing market exclusivity, subject to certain rights of the parties to terminate the agreement on the occurrence of certain events. On termination of the agreement, the Company may be obliged to convey to BMS rights in developments relating to a licensed compound or licensed product, including regulatory filings, research results and other intellectual property rights. The Takeda Pharmaceutical License and Collaboration Agreement and Termination Agreement On February 25, 2011, the Company entered into a license and collaboration agreement with Takeda Pharmaceutical Company Limited under which the Company agreed to collaborate to research, develop and commercialize its proprietary compound ITI-214 and other selected compounds that selectively inhibit PDE1 for use in the prevention and treatment of human diseases. As part of the agreement, the Company assigned to Takeda certain patents owned by the Company that claim ITI-214 and granted Takeda an exclusive license to develop and commercialize compounds identified in the conduct of the research program that satisfy specified criteria. However, the Company retained rights to all compounds that do not meet the specified criteria and the Company continues to develop PDE1 inhibitors outside the scope of the agreement. Under the terms of the agreement, the Company conducted a research program with an initial term of three years to identify and characterize compounds that meet certain specified criteria sufficient for further development by Takeda. This research program ended in February 2014. The Company was responsible for its expenses incurred in the conduct of certain research activities specified in the research plan. Takeda agreed to reimburse the Company for expenses the Company incurred in conducting additional research activities. Upon execution of the agreement, Takeda made a nonrefundable payment to the Company. The Company was eligible to receive payments of approximately $500 million in the aggregate upon achievement of certain development milestones and up to an additional $250 million in the aggregate upon achievement of certain sales-based milestones, along with tiered royalty payments ranging from the high single digits to the low teens in percent based on net sales by Takeda. On October 31, 2014, the Company entered into an agreement with Takeda terminating the Takeda License Agreement, pursuant to which all rights granted under the Takeda License Agreement were returned to the Company. On September 15, 2015, Takeda completed the transfer of the IND for ITI-214 to the Company. ITI-214 is the first compound in its class to successfully advance into Phase 1 clinical trials. The Company intends to explore the development of its PDE program, including ITI-214 for the treatment of several CNS and non-CNS conditions, which may include cognition in Parkinson’s disease, cognition in Alzheimer’s disease, cognition in schizophrenia and in other non-CNS indications. Other compounds in the PDE portfolio are also being advanced for the treatment of various indications. Other License Agreement In May 2002, ITI entered into a license agreement (the “License”) and research agreement with a university. Under the provisions of the License, ITI is entitled to use this organization’s patented technology and other intellectual property relating to diagnosis and treatment of central nervous system disorders. The License expires upon expiration of the patent rights or 15 years subsequent to the first sale of products developed through this License. ITI is required to make future milestone payments for initiation of clinical trials and approval of a New Drug Application (“NDA”). Should ITI commercialize the technology related to this License, ITI would be required to make royalty payments, and would also be required to pay fees under any sublicense agreements with third parties. In addition, ITI is required to use at least $1.0 million annually of its resources for the development and commercialization of the technology until ITI submits an NDA. ITI met its spending requirements in 2015. There were no other payments made or required under the License for the years ended December 31, 2015 and 2014. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies The Company currently has operating lease agreements with commitments for $16,255,927 for laboratory and office facilities through 2027. At December 31, 2015, future minimum lease payments under leases having an initial or remaining non-cancellable lease term in excess of one year are set forth in the table below: Year 2016 $ 0 2017 1,299,845 2018 1,457,008 2019 1,500,718 2020 1,545,740 Thereafter 10,452,616 $ 16,255,927 Rent expense for the years ended December 31, 2015, 2014 and 2013 was $1,385,207, $853,504 and $827,479, respectively. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2015 | |
Compensation and Retirement Disclosure [Abstract] | |
Employee Benefit Plan | 8. Employee Benefit Plan The Company sponsors a defined contribution 401(k) plan covering all full-time employees. Participants may elect to contribute their annual pre-tax earnings up to the federally allowed maximum limits. The Company makes a matching contribution of 50% on the first 6% of contributions made by participants. Participant and Company contributions vest immediately. During the years ended December 31, 2015, 2014 and 2013, the Company recorded matching contribution expense of $109,963, $84,757 and $77,138, respectively. |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions [Abstract] | |
Related Parties | 9. Related Parties In the first quarter of 2015, the Company moved its headquarters to 430 East 29th Street, New York, New York 10016. The Company has entered into a long-term lease for approximately 16,753 square feet of useable laboratory and office space . |
Unaudited Quarterly Financial I
Unaudited Quarterly Financial Information | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Financial Information | 10. Unaudited Quarterly Financial Information The tables herein set forth the Company’s unaudited condensed consolidated 2015 and 2014 quarterly statements of operations. The following table sets for the Company’s unaudited condensed consolidated statements of operations for the 2015 quarters ended: 2015 Quarter Ended December 31, September 30, June 30, March 31, Revenue $ 30,659 $ — $ 57,390 $ 3,315 Net loss (28,834,516 ) (32,160,483 ) (21,511,318 ) (22,286,824 ) Basic and diluted net loss per share $ (0.67 ) $ (0.91 ) $ (0.61 ) $ (0.72 ) The following table sets for the Company’s unaudited condensed consolidated statements of operations for the 2014 quarters ended: 2014 Quarter Ended December 31, September 30, June 30, March 31, Revenue $ 65,862 $ 124,414 $ 219,238 $ 167,787 Net loss (15,199,130 ) (6,415,507 ) (4,533,539 ) (4,543,284 ) Basic and diluted net loss per share $ (0.52 ) $ (0.22 ) $ (0.15 ) $ (0.17 ) |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying financial statements 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 as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
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. Their carrying values 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 may consist of investments in U.S. Treasuries, various U.S. governmental agency debt securities, corporate bonds, certificates of deposit, and other fixed income securities with an average maturity of twelve months or less. Management classifies the Company’s investments as available-for-sale. Such securities are carried at estimated fair value, with any unrealized holding gains or losses reported, net of any tax effects reported, as accumulated other comprehensive income, which is a separate component of stockholders’ equity. Realized gains and losses, and declines in value judged to be other-than-temporary, if any, are included in consolidated results of operations. A decline in the market value of any available-for-sale security below cost that is deemed to be other-than-temporary results in a reduction in fair value, which is charged to earnings in that period, and a new cost basis for the security is established. Dividend and interest income is recognized as interest income when earned. The cost of securities sold is calculated using the specific identification method. Investment securities consisted of the following (in thousands): December 31, 2015 Amortized Unrealized Unrealized Estimated U.S. government agency securities $ 61,510 $ — $ (271 ) $ 61,239 FDIC certificates of deposit (1) 41,343 1 (11 ) 41,333 Certificates of deposit 219,500 — — 219,500 Commercial paper 30,122 — (48 ) 30,074 Corporate bonds/notes 76,157 — (262 ) 75,895 $ 428,632 $ 1 $ (592 ) $ 428,041 December 31, 2014 Amortized Unrealized Unrealized Estimated U.S. government agency securities $ 4,316 $ — $ (3 ) $ 4,313 FDIC certificates of deposit (1) 16,374 — (14 ) 16,360 Certificates of deposit 2,000 — — 2,000 Commercial paper 9,743 1 — 9,744 Corporate bonds/notes 35,992 — (89 ) 35,904 $ 68,425 $ 1 $ (106 ) $ 68,321 (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, including those with maturities beyond one year, as current assets on the consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. As of December 31, 2015 and December 31, 2014, the Company held $142.4 million and $31.8 million, respectively, of available-for-sale investment securities with contractual maturity dates more than one year and less than two years. 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 credit loss. In determining whether a decline in the value of an investment is other-than-temporary, As of December 31, 2015 the Company had approximately $9.2 million of investments that have been held for greater than one year which had a temporary impairment of approximately $19,000. As of December 31, 2014 the Company had no investments that had been held for greater than one year. The Company attributes the unrealized losses on the available-for-sale securities as of December 31, 2015 and 2014, to the variability in related market interest rates. The Company does not intend to sell these securities, nor is it more likely than not that the Company will be required to sell them prior to the end of their contractual terms. Furthermore, the Company does not believe that these securities expose us to undue market risk or counterparty credit risk. As such, the Company does not consider these securities to be other-than-temporarily impaired. |
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 December 31, 2015 and December 31, 2014. The carrying value of cash held in money market funds of approximately $31.1 million as of December 31, 2015 and $8.5 million as of December 31, 2014, is included in cash and cash equivalents and approximates market value based on quoted market price or Level 1 inputs. The fair value measurements of the Company’s cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands): Fair Value Measurements at December 31, Quoted Prices Significant Significant Money market funds $ 31,114 $ 31,114 $ — $ — U.S. government agency securities 61,239 — 61,239 — FDIC certificates of deposit 41,333 — 41,333 — Certificates of deposit 219,500 — 219,500 — Commercial paper 30,074 — 30,074 — Corporate bonds/notes 75,895 — 75,895 — $ 459,155 $ 31,114 $ 428,041 $ — Fair Value Measurements at December 31, Quoted Prices Significant Significant Money market funds $ 8,495 $ 8,495 $ — $ — U.S. government agency securities 4,313 — 4,313 — FDIC certificates of deposit 16,360 — 16,360 — Certificates of deposit 41,000 — 41,000 — Commercial paper 9,744 — 9,744 — Corporate bonds/notes 35,903 — 35,903 — $ 115,815 $ 8,495 $ 107,320 $ — |
Financial Instruments | Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, accounts receivable, accounts payable and accrued liabilities, to approximate their fair value because of their relatively short maturities at December 31, 2015 and December 31, 2014. 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 remote. 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 December 31, 2015 and 2014, as the Company has a history of collecting on all its accounts including government agencies and collaborations funding its research. |
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 to five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the assets or the term of the related lease. Expenditures for maintenance and repairs are charged to operations as incurred. 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 360, Property, Plant and Equipment |
Revenue Recognition | Revenue Recognition Revenue is recognized when all terms and conditions of the agreements have been met, including persuasive evidence of an arrangement, delivery has occurred or services have been rendered, price is fixed or determinable and collectability is reasonably assured. The Company is reimbursed for certain costs incurred on specified research projects under the terms and conditions of grants, collaboration agreements, and awards. The Company records the amount of reimbursement as revenues on a gross basis in accordance with ASC Topic 605-45, Revenue Recognition/Principal Agent Considerations The Company has entered into arrangements involving the delivery of more than one element. Each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting. For the Company, this determination is generally based on whether the deliverable has “stand-alone value” to the customer. The Company adopted this accounting standard on a prospective basis for all Multiple-Deliverable Revenue Arrangements (“MDRAs”) entered into on or after January 1, 2011, and for any MDRAs that were entered into prior to January 1, 2011, but materially modified on or after that date. The Company has adopted ASC Topic 605-28, Milestone Method • The milestone payments are non-refundable; • Achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; • Substantive effort on the Company’s part is involved in achieving the milestone; • The amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and • A reasonable amount of time passes between the up-front license payment and the first milestone payment, as well as between each subsequent milestone payment. Determination as to whether a payment meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, the resulting payment would not be considered a substantive milestone, and therefore, the resulting payment would be considered part of the consideration for the single unit of accounting and be recognized as revenue in accordance with the revenue models described above. In addition, the determination that one such payment was not a substantive milestone could prevent the Company from concluding that subsequent milestone payments were substantive milestones and, as a result, any additional milestone payments could also be considered part of the consideration for the single unit of accounting and would be recognized as revenue as such performance obligations are performed under either the proportional performance or straight-line methods, as applicable . |
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, outside services, 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 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 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 discussion with applicable personnel and outside service providers as to the progress or state of consummation 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 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 years ended December 31, 2015 and 2014, 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 (previously included in FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes—an Interpretation of FASB Statement No. 109 |
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 sources. In accordance with accounting guidance, the Company presents the impact of any unrealized gains or (losses) on its investment securities in a separate statement of comprehensive income (loss) for each period. |
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. For awards that contain a performance-based vesting condition, expense is amortized using the accelerated attribution method. Share-based compensation expense recognized in the statements of operations for the years ended December 31, 2015, 2014 and 2013 is based on share-based awards ultimately expected to vest, and this amount has therefore been reduced for estimated forfeitures. ASC Topic 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Pre-vesting forfeitures were estimated based on the Company’s historical experience and have not been material. 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. Restricted stock units are valued at the fair market value on the date of grant as determined by the closing stock price. Expected volatility rates are based on historical volatility of the common stock of comparable publicly traded entities and other factors due to the limited 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 is defined 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. Prior to January 1, 2014, given that there was no active market for the Company’s common stock, the exercise price of the stock options on the date of grant was determined and approved by the board of directors using several factors, including progress and milestones achieved in the Company’s business development and performance, the price per share of its convertible preferred stock offerings and general industry and economic trends. In establishing the estimated fair value of the common stock, the Company considered the guidance set forth in American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation 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 temporary difference in applying ASC Topic 740, Income Taxes Since the Company had net operating loss carryforwards as of December 31, 2015, 2014 and 2013, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations. Equity instruments issued to consultants are accounted for under the provisions of ASC Topic 718 and ASC Topic 505-50, Equity/Equity-Based Payments to Non-Employees |
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. 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 years ended December 31, 2015, 2014 and 2013: Years Ended December 31, 2015 2014 2013 Stock Equivalents 1,322,311 958,712 898,982 |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In November 2015, the FASB issued Accounting Standards Update No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. Current GAAP requires an entity to separate deferred income tax liabilities and assets into current and noncurrent amounts in a classified statement of financial position. To simplify the presentation of deferred income taxes, ASU 2015-17 requires that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The current requirement that deferred tax liabilities and assets of a tax-paying component of an entity be offset and presented as a single amount is not affected by the amendments in this Update. The amendments in this Update are effective for financial statements issued for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Earlier application is permitted for all entities as of the beginning of an interim or annual reporting period. The Company has elected to adopt this update as of the fourth quarter of 2015, retrospectively. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements and accompanying notes. In May 2014, the FASB issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction-specific and industry-specific revenue recognition guidance under current GAAP and replace it with a principle-based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In July 2015, the FASB decided to defer the effective date of the standard from January 1, 2017, to January 1, 2018, with an option that permits companies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. Presently, the Company is assessing what effect the adoption of this standard will have on our consolidated financial statements and accompanying notes. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Schedule of Investment Securities | Investment Securities Investment securities consisted of the following (in thousands): December 31, 2015 Amortized Unrealized Unrealized Estimated U.S. government agency securities $ 61,510 $ — $ (271 ) $ 61,239 FDIC certificates of deposit (1) 41,343 1 (11 ) 41,333 Certificates of deposit 219,500 — — 219,500 Commercial paper 30,122 — (48 ) 30,074 Corporate bonds/notes 76,157 — (262 ) 75,895 $ 428,632 $ 1 $ (592 ) $ 428,041 December 31, 2014 Amortized Unrealized Unrealized Estimated U.S. government agency securities $ 4,316 $ — $ (3 ) $ 4,313 FDIC certificates of deposit (1) 16,374 — (14 ) 16,360 Certificates of deposit 2,000 — — 2,000 Commercial paper 9,743 1 — 9,744 Corporate bonds/notes 35,992 — (89 ) 35,904 $ 68,425 $ 1 $ (106 ) $ 68,321 (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 cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands): Fair Value Measurements at December 31, Quoted Prices Significant Significant Money market funds $ 31,114 $ 31,114 $ — $ — U.S. government agency securities 61,239 — 61,239 — FDIC certificates of deposit 41,333 — 41,333 — Certificates of deposit 219,500 — 219,500 — Commercial paper 30,074 — 30,074 — Corporate bonds/notes 75,895 — 75,895 — $ 459,155 $ 31,114 $ 428,041 $ — Fair Value Measurements at December 31, Quoted Prices Significant Significant Money market funds $ 8,495 $ 8,495 $ — $ — U.S. government agency securities 4,313 — 4,313 — FDIC certificates of deposit 16,360 — 16,360 — Certificates of deposit 41,000 — 41,000 — Commercial paper 9,744 — 9,744 — Corporate bonds/notes 35,903 — 35,903 — $ 115,815 $ 8,495 $ 107,320 $ — |
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 years ended December 31, 2015, 2014 and 2013: Years Ended December 31, 2015 2014 2013 Stock Equivalents 1,322,311 958,712 898,982 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consist of the following: December 31, 2015 2014 Computer equipment $ 42,064 $ 39,160 Furniture and fixtures 266,695 35,958 Scientific equipment 2,823,601 2,207,848 3,132,360 2,282,966 Less accumulated depreciation (2,356,838 ) (2,228,413 ) $ 775,522 $ 54,553 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Total Stock-Based Compensation Expense | Total stock-based compensation expense related to all of the Company’s share-based awards, including stock options and restricted stock units to employees, directors and consultants recognized during the years ended December 31, 2015, 2014 and 2013, was comprised of the following: Years Ended December 31, 2015 2014 2013 Research and development $ 4,768,131 $ 1,842,828 $ 132,543 General and administrative 6,122,774 2,001,050 258,850 Total share-based compensation expense $ 10,890,905 $ 3,843,878 $ 391,393 |
Weighted-Average 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 years ended December 31, 2015, 2014 and 2013: 2015 2014 2013 Dividend yield 0 % 0 % 0 % Expected volatility 80.0 % 80.0 % 80.0 % Weighted-average risk-free interest rate 1.8 % 2.0 % 2.2 % Expected term (in years) 5.9 6.3 6.2 |
Stock Option Activity | Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of December 31, 2015, and changes during the period then ended, are summarized as follows: Number of Weighted- Aggregate Weighted- Outstanding at December 31, 2014 2,233,460 $ 9.20 $ — 7.3 years Options granted 884,703 $ 21.00 $ — 9.1 years Options exercised (305,005 ) $ 2.14 $ — 2.2 years Options canceled or expired (75,501 ) $ 12.33 $ — 8.0 years Outstanding at December 31, 2015 2,737,657 $ 13.72 $ 109,778,658 7.6 years Vested or expected to vest at December 31, 2015 2,737,657 $ 13.72 $ — Exercisable at December 31, 2015 1,485,918 $ 8.75 $ 66,920,372 6.7 years |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Tax Expense | Total income tax expense for the years ended December 31 is allocated as follows: December 31, 2015 2014 2013 Current $ 1,600 $ 1,600 $ 18,000 Deferred (51,165,859 ) (14,655,320 ) (13,229,355 ) Valuation allowance 51,165,859 14,655,320 13,229,355 Provision for income taxes $ 1,600 $ 1,600 $ 18,000 |
Reconciliation of Statutory Federal Income Tax Rate and the Effective Income Tax Rate | A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31 is as follows: December 31, 2015 2014 2013 Income tax benefit at statutory federal rate 35.00 % 35.00 % 35.00 % Permanent differences (0.56 ) 0.12 (1.20 ) Return-to-provision—R&D Credit 0.00 (0.05 ) 2.61 R&D Credit—current year 4.19 2.32 3.72 Reserve for uncertain tax positions 0.00 (0.01 ) (6.53 ) Change in effective state tax rates (0.05 ) (0.14 ) 6.58 State income tax expense 10.24 10.50 10.12 Change in valuation allowance (48.82 ) (47.75 ) (50.37 ) Provision for income taxes (0.00 )% (0.01 )% (0.07 )% |
Deferred Tax Assets and Liabilities | The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2015 and 2014, respectively: December 31, 2015 2014 Deferred tax assets: Net operating loss carryforwards $ 76,741,198 $ 34,870,169 Accrued employee benefits 543,466 443,371 Research and development credit 6,962,731 2,570,540 Stock compensation 5,641,993 1,563,785 Deferred rent 725,195 — Deferred tax liabilities: Depreciation (6,062 ) (5,204 ) Net deferred tax asset 90,608,521 39,442,661 Valuation allowance (90,608,521 ) (39,442,661 ) Net deferred tax asset $ — $ — |
Summary of Gross Unrecognized Tax Benefits | The following summarizes the significant components of gross unrecognized tax benefits as of December 31, 2015 and 2014, respectively: December 31, 2015 2014 Balance at January1, $ 1,717,635 $ 1,715,904 Current Year Uncertain Tax Positions: Gross Increases 3,277 1,731 Prior Year Uncertain Tax Positions: Balance at December 31, $ 1,720,912 $ 1,717,635 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments having Initial or Remaining Non Cancellable Lease Term | At December 31, 2015, future minimum lease payments under leases having an initial or remaining non-cancellable lease term in excess of one year are set forth in the table below: Year 2016 $ 0 2017 1,299,845 2018 1,457,008 2019 1,500,718 2020 1,545,740 Thereafter 10,452,616 $ 16,255,927 |
Unaudited Quarterly Financial24
Unaudited Quarterly Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | The following table sets for the Company’s unaudited condensed consolidated statements of operations for the 2015 quarters ended: 2015 Quarter Ended December 31, September 30, June 30, March 31, Revenue $ 30,659 $ — $ 57,390 $ 3,315 Net loss (28,834,516 ) (32,160,483 ) (21,511,318 ) (22,286,824 ) Basic and diluted net loss per share $ (0.67 ) $ (0.91 ) $ (0.61 ) $ (0.72 ) The following table sets for the Company’s unaudited condensed consolidated statements of operations for the 2014 quarters ended: 2014 Quarter Ended December 31, September 30, June 30, March 31, Revenue $ 65,862 $ 124,414 $ 219,238 $ 167,787 Net loss (15,199,130 ) (6,415,507 ) (4,533,539 ) (4,543,284 ) Basic and diluted net loss per share $ (0.52 ) $ (0.22 ) $ (0.15 ) $ (0.17 ) |
Organization - Additional Infor
Organization - Additional Information (Detail) | Sep. 28, 2015USD ($)$ / sharesshares | Mar. 11, 2015USD ($)$ / sharesshares | Feb. 05, 2014USD ($)$ / sharesshares | Aug. 29, 2013USD ($)$ / sharesshares | Dec. 31, 2014USD ($) | Dec. 31, 2015USD ($) |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Voting rights percentage | 100.00% | |||||
Shares of common stock sold, value | $ 115,442,747 | |||||
Initial public offering of common stock | shares | 7,935,000 | 7,063,300 | ||||
Underwriters' option to purchase shares | shares | 1,035,000 | 661,481 | 921,300 | |||
Common stock price per share | $ / shares | $ 43.50 | $ 17.50 | ||||
Net proceeds of public offering | $ 327,400,000 | $ 121,800,000 | $ 115,400,000 | |||
Takeda Pharmaceutical Company Limited [Member] | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Total payments received | $ 29,000,000 | |||||
Date of termination agreement | Oct. 31, 2014 | |||||
Private Placement [Member] | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Shares of common stock sold, value | $ 60,000,000 | |||||
Initial public offering of common stock | shares | 18,889,307 | |||||
Shares of common stock sold, value per share | $ / shares | $ 3.1764 | |||||
Principal amount of convertible promissory notes converted in to common stock | $ 15,300,000 | |||||
Accrued interest | $ 800,000 | |||||
IPO [Member] | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Initial public offering of common stock | shares | 5,411,481 | |||||
Common stock price per share | $ / shares | $ 24 | |||||
Oneida Resources Corp. [Member] | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Outstanding share of capital stock exchanged | 0.5 | |||||
Company's outstanding capital stock, percentage | 100.00% | |||||
Outstanding option and outstanding warrant of capital stock exchanged | 0.5 |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Significant Accounting Policies [Line Items] | |||
Maturity of highly liquid investments | Three months or less | ||
Maturity of certificates of deposit, commercial paper, corporate notes and corporate bonds | More than three months | ||
Maturity period of marketable securities | 12 months | ||
Investment securities, available-for-sale | $ 428,041,021 | $ 68,320,672 | |
Investment securities, available for sale noncurrent | 9,200,000 | 0 | |
Investment securities, unrealized loss | 19,000 | ||
Carrying value of cash held in money market funds | 31,100,000 | 8,500,000 | |
Allowance recorded | $ 0 | $ 0 | |
Assumed expected dividend rate | 0.00% | 0.00% | 0.00% |
Excess tax benefits for tax deductions | $ 0 | $ 0 | |
Significant Unobservable Inputs (Level 3) [Member] | |||
Significant Accounting Policies [Line Items] | |||
Assets measured using quoted prices | 0 | 0 | |
Liabilities measured using quoted prices | 0 | 0 | |
Contractual Maturity Dates More Than One Year and Less Than Two Years [Member] | |||
Significant Accounting Policies [Line Items] | |||
Investment securities, available-for-sale | $ 142,400,000 | $ 31,800,000 | |
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 Accoun27
Summary of Significant Accounting Policies - Schedule of Investment Securities (Detail) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 428,632,000 | $ 68,425,000 |
Unrealized Gains | 1,000 | 1,000 |
Unrealized (Losses) | (592,000) | (106,000) |
Estimated Fair Value | 428,041,021 | 68,320,672 |
U.S. Government Agency Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 61,510,000 | 4,316,000 |
Unrealized (Losses) | (271,000) | (3,000) |
Estimated Fair Value | 61,239,000 | 4,313,000 |
FDIC Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 41,343,000 | 16,374,000 |
Unrealized Gains | 1,000 | |
Unrealized (Losses) | (11,000) | (14,000) |
Estimated Fair Value | 41,333,000 | 16,360,000 |
Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 219,500,000 | 2,000,000 |
Estimated Fair Value | 219,500,000 | 2,000,000 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 30,122,000 | 9,743,000 |
Unrealized Gains | 1,000 | |
Unrealized (Losses) | (48,000) | |
Estimated Fair Value | 30,074,000 | 9,744,000 |
Corporate Notes/Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 76,157,000 | 35,992,000 |
Unrealized (Losses) | (262,000) | (89,000) |
Estimated Fair Value | $ 75,895,000 | $ 35,904,000 |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Schedule of Fair Value Measurements of Cash Equivalents and Available-for-Sale Investment Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Jan. 31, 2014 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | $ 459,155 | $ 115,815 |
Money Market Funds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 31,114 | 8,495 |
U.S. Government Agency Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 61,239 | 4,313 |
FDIC Certificates of Deposit [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 41,333 | 16,360 |
Certificates of Deposit [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 219,500 | 41,000 |
Commercial Paper [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 30,074 | 9,744 |
Corporate Notes/Bonds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 75,895 | 35,903 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 31,114 | 8,495 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Funds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 31,114 | 8,495 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 428,041 | 107,320 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Government Agency Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 61,239 | 4,313 |
Significant Other Observable Inputs (Level 2) [Member] | FDIC Certificates of Deposit [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 41,333 | 16,360 |
Significant Other Observable Inputs (Level 2) [Member] | Certificates of Deposit [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 219,500 | 41,000 |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 30,074 | 9,744 |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Notes/Bonds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | $ 75,895 | $ 35,903 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
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 | 1,322,311 | 958,712 | 898,982 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 3,132,360 | $ 2,282,966 |
Less accumulated depreciation | (2,356,838) | (2,228,413) |
Property Plant and Equipment Net | 775,522 | 54,553 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 42,064 | 39,160 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 266,695 | 35,958 |
Scientific Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 2,823,601 | $ 2,207,848 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation expense | $ 139,626 | $ 25,481 | $ 23,249 |
Property, Plant and Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Depreciated lease hold improvements | $ 11,201 | 709,518 | |
Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Depreciated lease hold improvements | $ 319,553 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Jan. 31, 2015 | Jan. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Purchase of common stock | 2,737,657 | 2,233,460 | |||
Options, maximum term | 10 years | ||||
Weighted-average grant date fair value for awards granted | $ 21 | $ 16.50 | $ 3.26 | ||
Total intrinsic value of the options exercised | $ 10,951,057 | $ 3,696,775 | $ 580,623 | ||
Total fair value of shares vested | $ 5,207,073 | $ 3,703,000 | $ 278,000 | ||
Options granted, Number of Shares | 884,703 | ||||
Options granted, exercise price | $ 21 | ||||
Unrecognized share-based compensation expense related to employee stock option awards | $ 12,733,859 | ||||
Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 7 months 6 days | ||||
Scientific Advisory Board Members [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options granted, Number of Shares | 45,571 | 95,000 | 19,000 | ||
Options granted, exercise price | $ 17.57 | $ 16.86 | $ 3.26 | ||
2013 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Purchase of common stock | 2,737,657 | ||||
Shares of common stock reserved for issuance | 2,850,000 | 800,000 | 800,000 | ||
Number of shares of common stock available for issuance under the plan | 3,100,000 | ||||
Increase in maximum number of shares available for issuance of options, stock appreciation rights and other similar awards | 100,000 | ||||
Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Incentive stock options (ISOs), vesting period | 2 years | ||||
Minimum [Member] | Scientific Advisory Board Members [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Incentive stock options (ISOs), vesting period | 12 months | ||||
Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Incentive stock options (ISOs), vesting period | 3 years | ||||
Maximum [Member] | Scientific Advisory Board Members [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Incentive stock options (ISOs), vesting period | 24 months |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total share-based compensation expense | $ 10,890,905 | $ 3,843,878 | $ 391,393 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total share-based compensation expense | 4,768,131 | 1,842,828 | 132,543 |
General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total share-based compensation expense | $ 6,122,774 | $ 2,001,050 | $ 258,850 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted-Average Assumptions Used for Calculating Value of Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility | 80.00% | 80.00% | 80.00% |
Weighted-average risk-free interest rate | 1.80% | 2.00% | 2.20% |
Expected term (in years) | 5 years 10 months 24 days | 6 years 3 months 18 days | 6 years 2 months 12 days |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Outstanding at beginning of period, Number of Shares | 2,233,460 | |
Options granted, Number of Shares | 884,703 | |
Options exercised, Number of Shares | (305,005) | |
Options canceled or expired, Number of Shares | (75,501) | |
Outstanding at end of period, Number of Shares | 2,737,657 | 2,233,460 |
Vested or expected to vest at end of period, Number of Shares | 2,737,657 | |
Exercisable at end of period, Number of Shares | 1,485,918 | |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ 9.20 | |
Options granted, Weighted-Average Exercise Price | 21 | |
Options exercised, Weighted-Average Exercise Price | 2.14 | |
Options canceled or expired, Weighted-Average Exercise Price | 12.33 | |
Outstanding at end of period, Weighted-Average Exercise Price | 13.72 | $ 9.20 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | 13.72 | |
Exercisable at end of period, Weighted-Average Exercise Price | $ 8.75 | |
Outstanding at end of period, Aggregate Intrinsic Value | $ 109,778,658 | |
Exercisable at end of period, Aggregate Intrinsic Value | $ 66,920,372 | |
Options granted, Weighted-Average Contractual Life | 9 years 1 month 6 days | |
Options exercised, Weighted-Average Contractual Life | 2 years 2 months 12 days | |
Options canceled or expired, Weighted-Average Contractual Life | 8 years | |
Outstanding at end of period, Weighted-Average Contractual Life | 7 years 7 months 6 days | 7 years 3 months 18 days |
Exercisable at end of period, Weighted-Average Contractual Life | 6 years 8 months 12 days |
Income Taxes - Income Tax Expen
Income Taxes - Income Tax Expense (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Disclosure [Abstract] | |||
Current | $ 1,600 | $ 1,600 | $ 18,000 |
Deferred | (51,165,859) | (14,655,320) | (13,229,355) |
Valuation allowance | 51,165,859 | 14,655,320 | 13,229,355 |
Provision for income taxes | $ 1,600 | $ 1,600 | $ 18,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory Federal Income Tax Rate and the Effective Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Disclosure [Abstract] | |||
Income tax benefit at statutory federal rate | 35.00% | 35.00% | 35.00% |
Permanent differences | (0.56%) | 0.12% | (1.20%) |
Return-to-provision-R&D Credit | 0.00% | (0.05%) | 2.61% |
R&D Credit-current year | 4.19% | 2.32% | 3.72% |
Reserve for uncertain tax positions | (0.00%) | (0.01%) | (6.53%) |
Change in effective state tax rates | (0.05%) | (0.14%) | 6.58% |
State income tax expense | 10.24% | 10.50% | 10.12% |
Change in valuation allowance | (48.82%) | (47.75%) | (50.37%) |
Provision for income taxes | 0.00% | (0.01%) | (0.07%) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Disclosure [Abstract] | |||
Federal net operating loss carryforwards | $ 174,800,000 | ||
Federal net operating loss carryforwards expiration year | 2,035 | ||
Excess tax benefits related to stock-based compensation | $ 5,700,000 | ||
Unrecognized tax benefits | $ 1,720,912 | $ 1,717,635 | $ 1,715,904 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 76,741,198 | $ 34,870,169 |
Accrued employee benefits | 543,466 | 443,371 |
Research and development credit | 6,962,731 | 2,570,540 |
Stock compensation | 5,641,993 | 1,563,785 |
Deferred rent | 725,195 | |
Deferred tax liabilities: | ||
Depreciation | (6,062) | (5,204) |
Net deferred tax asset | 90,608,521 | 39,442,661 |
Valuation allowance | (90,608,521) | (39,442,661) |
Net deferred tax asset | $ 0 | $ 0 |
Income Taxes - Summary of Gross
Income Taxes - Summary of Gross Unrecognized Tax Benefits (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at January1, | $ 1,717,635 | $ 1,715,904 |
Current Year Uncertain Tax Positions: | ||
Gross Increases | 3,277 | 1,731 |
Prior Year Uncertain Tax Positions: | ||
Balance at December 31, | $ 1,720,912 | $ 1,717,635 |
Collaborations and License Ag41
Collaborations and License Agreements - Additional Information (Detail) - USD ($) | May. 31, 2005 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2015 |
Bristol-Myers Squibb Company [Member] | ||||||
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 | ||||
Company remaining milestone payment | $ 12,000,000 | |||||
Obliged to make milestone payments | $ 14,750,000 | $ 14,750,000 | ||||
License expiration period | Through the later of ten years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product. | |||||
Takeda Pharmaceutical Company Limited [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Initial term of research program | 3 years | |||||
Date of termination agreement | Oct. 31, 2014 | |||||
Takeda Pharmaceutical Company Limited [Member] | Maximum [Member] | Development Milestones [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Aggregate payment upon achievement of certain milestones | $ 500,000,000 | $ 500,000,000 | ||||
Takeda Pharmaceutical Company Limited [Member] | Maximum [Member] | Sales-based Milestones [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Aggregate payment upon achievement of certain milestones | $ 250,000,000 | $ 250,000,000 | ||||
University [Member] | Licensing Agreements [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
License expiration period | Upon expiration of the patent rights or 15 years subsequent to the first sale of products developed through this License. | |||||
Other payments | $ 0 | $ 0 | ||||
University [Member] | Licensing Agreements [Member] | Minimum [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Annual spending requirements for development and commercialization of technology expense | $ 1,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Other Commitments [Line Items] | |||
Operating lease agreements with commitments through 2027 | $ 16,255,927 | ||
Rent expense | 1,385,207 | $ 853,504 | $ 827,479 |
Laboratory and Office Facilities [Member] | |||
Other Commitments [Line Items] | |||
Operating lease agreements with commitments through 2027 | $ 16,255,927 |
Commitments and Contingencies43
Commitments and Contingencies - Schedule of Future Minimum Lease Payments having Initial or Remaining Non Cancellable Lease Term (Detail) | Dec. 31, 2015USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,016 | $ 0 |
2,017 | 1,299,845 |
2,018 | 1,457,008 |
2,019 | 1,500,718 |
2,020 | 1,545,740 |
Thereafter | 10,452,616 |
Total | $ 16,255,927 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Compensation and Retirement Disclosure [Abstract] | |||
Employer matching contribution | 50.00% | ||
Contributions made by participants for which the company makes matching contribution | 6.00% | ||
Contribution expense | $ 109,963 | $ 84,757 | $ 77,138 |
Related Party - Additional Info
Related Party - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2015ft² | Dec. 31, 2015USD ($) | |
Related Party Transactions [Abstract] | ||
Area of useable laboratory and office space | ft² | 16,753 | |
Term of long term lease | 12 years | |
Long-term deferred rent | $ | $ 1,597,105 |
Unaudited Quarterly Financial46
Unaudited Quarterly Financial Information - Schedule of Quarterly Financial Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 30,659 | $ 57,390 | $ 3,315 | $ 65,862 | $ 124,414 | $ 219,238 | $ 167,787 | $ 91,364 | $ 577,301 | $ 2,737,002 | |
Net loss | $ (28,834,516) | $ (32,160,483) | $ (21,511,318) | $ (22,286,824) | $ (15,199,130) | $ (6,415,507) | $ (4,533,539) | $ (4,543,284) | $ (104,793,141) | $ (30,691,460) | $ (26,868,198) |
Basic and diluted net loss per share | $ (0.67) | $ (0.91) | $ (0.61) | $ (0.72) | $ (0.52) | $ (0.22) | $ (0.15) | $ (0.17) | $ (2.91) | $ (1.07) | $ (1.56) |