Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 06, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | SNDX | ||
Entity Registrant Name | SYNDAX PHARMACEUTICALS INC | ||
Entity Central Index Key | 1,395,937 | ||
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 | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 25,000,740 | ||
Entity Public Float | $ 118 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 33,769 | $ 35,168 |
Restricted cash | 101 | 106 |
Short-term investments | 47,142 | 94,806 |
Prepaid expenses and other current assets | 2,334 | 3,362 |
Total current assets | 83,346 | 133,442 |
Long-term investments | 3,246 | |
Property and equipment, net | 373 | 267 |
Other assets | 219 | 231 |
Total assets | 83,938 | 137,186 |
Current liabilities: | ||
Accounts payable | 1,439 | 2,232 |
Accrued expenses and other current liabilities | 13,149 | 11,993 |
Current portion of deferred revenue | 1,517 | 1,573 |
Total current liabilities | 16,105 | 15,798 |
Long-term liabilities: | ||
Deferred revenue, less current portion | 14,650 | 16,759 |
Other long-term liabilities | 136 | 310 |
Total long-term liabilities | 14,786 | 17,069 |
Total liabilities | 30,891 | 32,867 |
Commitments (Note 14) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; 0 shares outstanding at December 31, 2018 and December 31, 2017, respectively | ||
Common stock, $0.0001 par value, 100,000,000 shares authorized; 24,835,951 and 24,390,033 shares outstanding at December 31, 2018 and December 31, 2017, respectively | 2 | 2 |
Additional paid-in capital | 492,493 | 470,571 |
Accumulated other comprehensive loss | (25) | (143) |
Accumulated deficit | (439,423) | (366,111) |
Total stockholders' equity | 53,047 | 104,319 |
Total liabilities and stockholders' equity | $ 83,938 | $ 137,186 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares outstanding | 24,835,951 | 24,390,033 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | |||
Total revenues | $ 1,517 | $ 2,108 | $ 1,220 |
Type of revenue [extensible list] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | |||
Research and development | $ 60,106 | $ 48,201 | $ 31,665 |
General and administrative | 17,287 | 15,861 | 13,321 |
Total operating expenses | 77,393 | 64,062 | 44,986 |
Loss from operations | (75,876) | (61,954) | (43,766) |
Other income (expense): | |||
Interest income (expense), net | 1,942 | 1,421 | 956 |
Change in fair value of common stock warrant liability | (1,703) | ||
Other (expense) income, net | (27) | (269) | 41 |
Total other income (expense) | 1,915 | 1,152 | (706) |
Net loss | (73,961) | (60,802) | (44,472) |
Net loss attributable to common stockholders | $ (73,961) | $ (60,802) | $ (47,070) |
Net loss per share attributable to common stockholders—basic and diluted | $ (2.92) | $ (2.90) | $ (3.22) |
Weighted-average common shares outstanding—basic and diluted | 25,371,511 | 20,997,211 | 14,619,716 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Of Income And Comprehensive Income [Abstract] | |||||||||||
Net loss | $ (18,837) | $ (17,338) | $ (18,388) | $ (19,398) | $ (19,104) | $ (15,088) | $ (13,639) | $ (12,971) | $ (73,961) | $ (60,802) | $ (44,472) |
Other comprehensive loss: | |||||||||||
Unrealized (losses) gains on marketable securities, net of tax | 118 | (199) | 28 | ||||||||
Comprehensive loss | $ (73,843) | $ (61,001) | $ (44,444) |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Convertible Preferred Stock [Member] | Series A Convertible Preferred Stock [Member] |
Beginning balance at Dec. 31, 2015 | $ 319,113 | ||||||
Beginning balance, Shares at Dec. 31, 2015 | 12,732,466 | ||||||
Beginning balance at Dec. 31, 2015 | $ (252,415) | $ 1 | $ 28 | $ (259,675) | $ 7,231 | ||
Beginning balance, Shares at Dec. 31, 2015 | 85,440 | 700,435 | |||||
Accretion for convertible preferred stock dividends | $ 2,598 | ||||||
Accretion for convertible preferred stock dividends | (2,598) | $ (1,452) | (1,146) | ||||
Proceeds from initial public offering, net of offering costs of $7,186, Value | 50,527 | 50,527 | |||||
Proceeds from initial public offering, net of offering costs of $7,186, Shares | 4,809,475 | ||||||
Conversion of preferred stock into common stock, Value | 321,711 | $ 1 | 328,941 | $ (321,711) | $ (7,231) | ||
Conversion of preferred stock into common stock, Shares | 12,872,551 | (12,732,466) | (700,435) | ||||
Reclassification of common stock warrant liability | 4,551 | 4,551 | |||||
Exercise of stock options, Value | $ 2,058 | 2,058 | |||||
Exercise of stock options, Shares | 441,573 | 441,573 | |||||
Vesting of restricted stock, Value | $ 42 | 42 | |||||
Vesting of restricted stock, Shares | 6,142 | ||||||
Stock-based compensation expense | 4,708 | 4,708 | |||||
Unrealized gain (losses) on short-term investments | 28 | 28 | |||||
Repurchase of fractional shares resulting from reverse stock splits | (1) | (1) | |||||
Net loss | (44,472) | (44,472) | |||||
Ending balance at Dec. 31, 2016 | 84,139 | $ 2 | 56 | 389,374 | (305,293) | ||
Ending balance, Shares at Dec. 31, 2016 | 18,215,181 | ||||||
Proceeds from follow on offering, net of offering cost of $3,665 | 48,675 | 48,675 | |||||
Proceeds from follow on offering, net of offering cost of $3,665, Shares | 3,950,190 | ||||||
Exercise of stock options, Value | $ 277 | 277 | |||||
Exercise of stock options, Shares | 46,680 | 46,680 | |||||
Vesting of restricted stock, Value | $ 59 | 59 | |||||
Vesting of restricted stock, Shares | 8,543 | ||||||
Stock-based compensation expense | 5,450 | 5,450 | |||||
Proceeds from "At-the-market" offering, net, Value | 1,705 | 1,705 | |||||
Proceeds from "At-the-market" offering, net, Shares | 148,421 | ||||||
Unrealized gain (losses) on short-term investments | (199) | (199) | |||||
Employee withholdings ESPP | 97 | 97 | |||||
Cumulative effect adjustment of adoption ASU | ASU 2016-09 [Member] | 16 | (16) | |||||
Proceeds from direct stock placement, net, Value | 24,918 | 24,918 | |||||
Proceeds from direct stock placement, net, Shares | 2,021,018 | ||||||
Net loss | (60,802) | (60,802) | |||||
Ending balance at Dec. 31, 2017 | 104,319 | $ 2 | (143) | 470,571 | (366,111) | ||
Ending balance, Shares at Dec. 31, 2017 | 24,390,033 | ||||||
Reclassification of common stock warrant liability | 16,780 | 16,780 | |||||
Exercise of stock options, Value | $ 26 | 26 | |||||
Exercise of stock options, Shares | 7,850 | 7,850 | |||||
Stock-based compensation expense | $ 6,201 | 6,201 | |||||
Proceeds from "At-the-market" offering, net, Value | 15,497 | 15,497 | |||||
Proceeds from "At-the-market" offering, net, Shares | 2,114,169 | ||||||
Stock issuance due to warrant exercise, cashless, Shares | 299,215 | ||||||
Stock purchase under ESPP, Shares | 24,684 | ||||||
Unrealized gain (losses) on short-term investments | 118 | 118 | |||||
Employee withholdings ESPP | 198 | 198 | |||||
Cumulative effect adjustment of adoption ASU | ASU 2014-09 [Member] | 649 | 649 | |||||
Retirement of common stock in exchange for common stock warrant | (16,780) | (16,780) | |||||
Retirement of common stock in exchange for common stock warrant, shares | (2,000,000) | ||||||
Net loss | (73,961) | (73,961) | |||||
Ending balance at Dec. 31, 2018 | $ 53,047 | $ 2 | $ (25) | $ 492,493 | $ (439,423) | ||
Ending balance, Shares at Dec. 31, 2018 | 24,835,951 |
Consolidated Statements of Co_2
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2018 | |
Preferred stock, par value | $ 0.001 | $ 0.001 | |
Common stock, par value | $ 0.0001 | $ 0.0001 | 0.0001 |
Offering costs | $ 7,186 | ||
Follow on offering cost | $ 3,665 | ||
Series A Convertible Preferred Stock [Member] | |||
Preferred stock, par value | $ 0.001 | $ 0.001 | 0.001 |
Convertible Preferred Stock [Member] | |||
Preferred stock, par value | $ 0.001 | $ 0.001 | $ 0.001 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (73,961,000) | $ (60,802,000) | $ (44,472,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 78,000 | 76,000 | 89,000 |
Amortization and accretion of investments | (558,000) | 223,000 | (126,000) |
Stock-based compensation | 6,201,000 | 5,450,000 | 4,708,000 |
Change in fair value of warrants | 1,703,000 | ||
Other | 11,000 | 8,000 | 25,000 |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other assets | 1,033,000 | (329,000) | (1,629,000) |
Accounts payable | (792,000) | (194,000) | 923,000 |
Deferred revenue | (1,517,000) | 2,892,000 | (1,220,000) |
Accrued expenses and other liabilities | 974,000 | 5,305,000 | 4,842,000 |
Net cash used in operating activities | (68,531,000) | (47,371,000) | (35,157,000) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property and equipment | (187,000) | (84,000) | (261,000) |
Purchases of short-term investments | (78,844,000) | (152,263,000) | (158,319,000) |
Proceeds from sales and maturities of short-term investments | 130,429,000 | 135,275,000 | 140,297,000 |
Net cash provided by (used in) investing activities | 51,398,000 | (17,072,000) | (18,283,000) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock in initial public offering, net | 52,148,000 | ||
Proceeds from Employee Stock Purchase Plan | 198,000 | 97,000 | |
Proceeds from exercise of stock options | 26,000 | 277,000 | 2,058,000 |
Other | 8,000 | (4,000) | |
Net cash provided by financing activities | 15,729,000 | 75,722,000 | 54,202,000 |
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (1,404,000) | 11,279,000 | 762,000 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH—beginning of year | 35,389,000 | 24,110,000 | 23,348,000 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH—end of year | 33,985,000 | 35,389,000 | $ 24,110,000 |
Follow-on Public Offering [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock, net | 48,675,000 | ||
At-the-Market Offering [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock, net | $ 15,497,000 | 1,755,000 | |
Direct Placement Offering [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock, net | $ 24,918,000 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business | 1. Nature of Business Syndax Pharmaceuticals, Inc. (the Company) is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company is developing its lead product candidate, entinostat, a once-weekly, oral, small molecule, Class I HDAC inhibitor, in combination with exemestane and several approved PD-1/PD-L1 antagonists. The Company’s pipeline also includes SNDX-6352, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, as well as SNDX-5613, a selective inhibitor targeting the binding interaction of Menin with the mixed lineage leukemia (“MLL”) protein. The Company plans to continue to leverage the technical and business expertise of our management team and scientific collaborators to license, acquire and develop additional cancer therapies to expand our pipeline. In March 2016, the Company completed its initial public offering (“IPO”) whereby it sold 4,809,475 shares of common stock at the initial public offering price of $12.00 per share. The aggregate net proceeds received by the Company from the offering were $50.5 million, net of underwriting discounts and commissions and offering expenses. In April 2017, the Company entered into a sales agreement with Cowen and Company, LLC (“Cowen”) under which the Company may issue and sell shares of our common stock having aggregate sales proceeds of up to $50.0 million from time to time through Cowen, acting as agent, in a series of one or more at-the-market (“ATM program”) equity offerings. Cowen is not required to sell any specific amount but acts as our sales agent using commercially reasonable efforts consistent with its normal trading and sales practices. Shares sold pursuant to the sales agreement will be sold pursuant to a shelf registration statement, which became effective on April 20, 2017. Our common stock will be sold at prevailing market prices at the time of the sale; and as a result, prices may vary. We will pay Cowen up to 3% of the gross proceeds from any common stock sold through the sales agreement. Since inception of the ATM program in 2017, though March 6, 2019, the Company has sold 2,403,409 shares of common stock pursuant to the ATM program, at an average price of $7.82 per share for gross proceeds of $18.8 million, resulting in net proceeds of $18.2 million after deducting sales commissions and offering expenses. As of December 31, 2018, $32.1 million of common stock remained available for sale under the ATM program. In 2019, the Company sold 140,819 shares of common stock pursuant to the ATM program, with net proceeds of $0.9 million. As of March 6, 2019, $31.2 million of common stock remained available for sale under the ATM program. In May 2017, the Company completed a follow-on public offering whereby the Company sold 3,950,190 shares of common stock at a price of $13.25 per share. The aggregate net proceeds received by the Company from the offering were approximately $48.7 million, net of underwriting discounts and commissions and estimated offering expenses payable by the Company. On October 13, 2017, the Company entered into a license agreement with Vitae Pharmaceuticals, Inc., a subsidiary of Allergan plc (“Allergan”), under which Allergan granted to the Company a worldwide, sublicenseable, exclusive license to a portfolio of preclinical, orally-available, small molecule inhibitors of the interaction of Menin with the MLL protein (the “Menin Assets”). The Company made a nonrefundable upfront payment of $5.0 million to Allergan in the fourth quarter of 2017. The Company is developing the Menin Assets to potentially treat two genetically defined acute leukemias: (i) a genetically-defined subset of acute leukemias with chromosomal rearrangements in the MLL gene (“MLL-r”) and (ii) acute myeloid leukemia (“AML”) with a mutated nucleophosmin 1 (“NPM1”). On October 17, 2017, the Company entered into a purchase agreement with Biotech Value Fund, L.P. (“BVF”) and certain entities affiliated with BVF (the “Purchase Agreement”). Pursuant to the Purchase Agreement, the Company issued directly to BVF in a registered direct offering (the “Offering”), 2,021,018 shares of the Company’s common stock at a price of $12.37 per share, representing the closing price of the Company’s shares on the Nasdaq Global Select Market on Friday, October 13, 2017. The net proceeds from the Offering, after deducting estimated expenses, were $24.9 million. Since its inception, the Company has devoted its efforts principally to research and development and raising capital. The Company is subject to risks common to companies in the development stage, including, but not limited to, successful development of therapeutics, obtaining additional funding, protection of proprietary therapeutics, compliance with government regulations, fluctuations in operating results, dependence on key personnel and collaborative partners, and risks associated with industry changes. The Company’s long-term success is dependent upon its ability to successfully develop and market its product candidates, expand its oncology drug pipeline, earn revenue, obtain additional capital when needed, and ultimately, achieve profitable operations. The Company anticipates that it will be several years before any of its product candidates is approved, if ever, and the Company begins to generate revenue from sales of such product candidates. Accordingly, management expects to incur substantial losses on the ongoing development of its product candidates and does not expect to achieve positive cash flow from operations for the foreseeable future, if ever. As a result, the Company will continue to require additional capital to move forward with its business plan. While certain amounts of this additional capital were raised in the past, there can be no assurance that funds necessary beyond these amounts will be available in amounts or on terms sufficient to ensure ongoing operations. The Company’s management believes that the cash, cash equivalents and short-term investments balances as of December 31, 2018 should enable the Company to maintain its planned operations for at least twelve months from the date these financial statements were issued. The Company’s ability to fund all of its planned operations internally beyond that date, including the completion of its ongoing and planned clinical trial activities, may be substantially dependent upon whether the Company can obtain sufficient funding on terms acceptable to the Company. Proceeds from additional capital transactions would allow the Company to accelerate and/or expand its planned research and development activities. In the event that sufficient funds were not available, the Company may be required to delay or reduce expenditures to conserve cash, which could involve scaling back or curtailing development and general and administrative activities. |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The Company has prepared the accompanying consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In 2011, the Company established a wholly owned subsidiary in the United Kingdom. There have been no activities for this entity to date. In 2014, the Company established a wholly owned U.S. subsidiary, Syndax Securities Corporation. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of costs and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. Cash Equivalents Cash equivalents include all highly liquid investments maturing within 90 days or less from the date of purchase. Cash equivalents include money market funds, corporate debt securities, U.S. government agency notes, and overnight deposits. Restricted Cash The Company classifies as restricted cash all cash pledged as collateral to secure long-term obligations and all cash whose use is otherwise limited by contractual provisions. Amounts are reported as non-current unless restrictions are expected to be released in the next 12 months. Short-Term and Long-Term Investments Short-term investments include marketable securities with maturities of less than one year or where management’s intent is to use the investments to fund current operations or to make them available for current operations. Long-term investments include marketable securities with remaining maturities greater than one year or that are due after one year from the balance sheet date. All investments in marketable securities are classified as available-for-sale and are reported at fair value with unrealized gains and losses excluded from earnings and reported net of tax in accumulated other comprehensive income, which is a component of stockholders’ equity (deficit). Unrealized losses that are determined to be other-than-temporary, based on current and expected market conditions, are recognized in earnings. Declines in fair value determined to be credit related are charged to earnings. The cost of marketable securities sold is determined by the specific identification method. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. The Company has one operating segment. Concentrations of Credit Risk Cash and cash equivalents, restricted cash, and short-term and long-term investments are financial instruments that potentially subject the Company to concentrations of credit risk. Substantially all of the Company’s cash, cash equivalents, and short-term and long-term investments were deposited in accounts at two financial institutions, and at times, such deposits may exceed federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company’s available-for-sale investments primarily consist of U.S. Treasury securities, U.S. government agency securities, corporate debt securities, certificates of deposit and overnight deposits and potentially subject the Company to concentrations of credit risk. Property and Equipment Property and equipment are recorded at cost. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets (three to five years). Assets under capital leases are amortized over the shorter of their useful lives or lease term using the straight-line method. Major replacements and improvements are capitalized, while general repairs and maintenance are expensed as incurred. Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If this comparison indicates that there is impairment, the amount of impairment is calculated as the difference between the carrying value and fair value. To date, no such impairments have been recognized. Revenue Recognition The Company adopted Accounting Standards Codification Rule 606 Revenue from Contracts with Customers (ASC 606), on January 1, 2018, using the modified retrospective method for all contracts not completed as of the date of adoption. The reported results for 2018 reflect the application of ASC 606 guidance while the reported results for 2017 were prepared under the guidance of ASC 605, Revenue Recognition (ASC 605). For the Company’s accounting policy for revenue recognition under ASC 605, refer to Item 8 of the Annual Report on Form 10-K for the year ended December 31, 2017. As of January 1, 2018, the Company had only one contract within the scope of ASC 606, a license agreement with Kyowa Hakko Kirin Co., Ltd. (“KHK”), under which the Company granted KHK an exclusive license to develop and commercialize entinostat in Japan and Korea (the “KHK License Agreement”). The KHK License Agreement is discussed further in Note 6. The Company enters into license agreements for the development and commercialization of its product candidates. License agreements may include non-refundable upfront payments, contingent payments based on the occurrence of specified events under the Company’s license arrangements, partial or complete reimbursement of research and development expenses, license fees and royalties on sales of entinostat if they are successfully approved and commercialized. The Company’s performance obligations under the license agreements may include the transfer of intellectual property rights in the form of licenses, obligations to provide research and development services and related materials and participation on certain development and/or commercialization committees. Revenue is recognized when, or as, performance obligations are satisfied, which occurs when control of the promised products or services is transferred to customers. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”). To the extent that the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing the most likely amount method. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available. The Company assesses the promises to determine if they are distinct performance obligations. Once the performance obligations are determined, the transaction price is allocated based on a relative standalone selling price basis. Milestone payments and royalties are typically considered variable consideration at the outset of the contract and are recognized in the transaction price either upon occurrence or when the constraint of a probable reversal is no longer applicable. Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. Arrangements containing licenses to the Company’s intellectual property typically provide for a know-how transfer period. These arrangements may or may not also include rights to future updates of that intellectual property and related know-how. Revenues from non-refundable, up-front fees allocated to the licenses are recognized as the license is transferred to the customer and the customer is able to use and benefit from the license. This generally takes place over the related know-how transfer period, or if applicable, over the term of transfer of future updates to the intellectual property. Development Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license fees and earnings in the period of adjustment. For development milestones related to the KHK Agreement, the Company does not take a substantive role or control the research, development or commercialization of any products generated by KHK. Therefore, the Company is not able to reasonably estimate when, if at all, any development milestone payments may be payable to the Company. As such, the development milestone payments associated with the KHK Agreement involve a substantial degree of uncertainty and risk that they may never be received. Commercial Milestone Payments and Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of commercial sales, and the license is deemed to be the predominant item to which the royalties or commercial milestones relate, the Company will recognize revenue at the later of when the related sales occur or when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date no commercial milestone payments or royalties have been achieved. When no performance obligations are required of the Company, or following the completion of the performance obligation period, such amounts are recognized as revenue upon transfer of control of the goods or services to the customer. Generally, all amounts received or due other than sales-based milestones and royalties are classified as license fees. Sales-based milestones and royalties will be recognized as royalty revenue at the later of when the related sales occur or when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Deferred revenue arises from amounts received in advance of the culmination of the earnings process and is recognized as revenue in future periods as performance obligations are satisfied. Deferred revenue expected to be recognized within the next twelve months is classified as a current liability. Upfront payment contract liabilities resulting from the Company’s license agreements do not represent a financing component as the payment is not financing the transfer of goods or services, and the technology underlying the licenses granted reflects research and development expenses already incurred by the Company. Research and Development Research and development costs are expensed as incurred. Research and development expenses include payroll and personnel expenses, consulting costs, external contract research and development expenses, and allocated overhead, including rent, equipment depreciation, and utilities. Research and development costs that are paid in advance of performance are capitalized as a prepaid expense and amortized over the service period as the services are provided. The Company expenses upfront license payments related to acquired technologies that have not yet reached technological feasibility and have no alternative future use. In instances where the Company enters into cost-sharing arrangements, all research and development costs reimbursed by the collaborators are accounted for as reductions to research and development expense. During the year ended December 31, 2018, the Company incurred $4.7 million in external costs related to cost-sharing collaborations, of which $2.4 million has been recorded as a reduction to research and development expense. During the year ended December 31, 2017, the Company incurred $3.0 million in external costs related to cost-sharing collaborations, of which $1.4 million has been recorded as a reduction to research and development expense. Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or other information provided to us by our vendors. Income Taxes The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences reverse. A valuation allowance is provided to reduce the net deferred tax assets to the amount that will more likely than not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. Guarantees and Indemnifications As permitted under Delaware law, the Company indemnifies its officers, directors, and employees for certain events or occurrences that happen by reason of the relationship with, or position held at, the Company. The Company has standard indemnification arrangements under office leases (as described in Note 14) that require it to indemnify the landlord against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation, or nonperformance of any covenant or condition of the Company’s lease. Through December 31, 2018, the Company had not experienced any losses related to these indemnification obligations and no claims were outstanding. The Company does not expect significant claims related to these indemnification obligations, and consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. Stock-Based Compensation The Company accounts for all stock option awards granted to employees and non-employees using a fair value method. Stock-based compensation is measured at the grant date fair value of employee stock option grants and is recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. Stock option awards to non-employees are subject to periodic revaluation over their vesting terms. The Company accounts for forfeitures as they occur. Convertible Preferred Stock Upon closing of the IPO, all of the outstanding shares of the Company’s outstanding convertible preferred stock converted into shares of the common stock. Prior to the IPO, the Company had classified certain series of convertible preferred stock as temporary equity in the consolidated balance sheets due to certain change in control events that were outside of the Company’s control, including liquidation, sale, or transfer of control of the Company, as holders of the convertible preferred stock could cause redemption of the shares in these situations. The carrying value of the convertible preferred stock was presented at its maximum redemption value. As of December 31, 2015, the Series A preferred stock had no liquidation preference and was presented in permanent equity. Recently Issued and Adopted Accounting Pronouncements In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting In November 2016, the FASB issued ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash” (“ASU 2016-18”). ASU 2016-18 requires that restricted cash and restricted cash equivalents be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The statement of cash flows must also explain the change during the period in the total of cash, cash equivalents, and restricted cash or restricted cash equivalents. The Company adopted ASU 2016-18 on January 1, 2018, utilizing the retrospective transition method and it did not have a material impact on its consolidated statement of cash flows. As part of the adoption of this guidance, the Company included restricted cash with cash and cash equivalent in the consolidated statement of cash flows for the periods ending December 31, 2018, 2017 and 2016. The following table provides a reconciliation of the cash, cash equivalents and restricted cash balances as of December 31, 2018, 2017 and 2016, as shown below: Years Ended December 31, 2018 2017 2016 (In thousands) Cash and cash equivalents $ 33,769 $ 35,168 $ 23,844 Restricted cash included in current and noncurrent assets 216 221 266 Cash, cash equivalents and restricted cash $ 33,985 $ 35,389 $ 24,110 In February 2016, the FASB issued ASU 2016-02, “ Leases (Topic 842) In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2018 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | 4. Revenue from Contracts with Customers Financial Statement Impact of Adopting ASC 606 On January 1, 2018, the Company adopted ASC 606 applying the modified retrospective method, which only impacted the accounting for the KHK License Agreement. As a result of applying the modified retrospective method to adopt the new revenue guidance, the following adjustments were made to accounts on the consolidated balance sheet as of January 1, 2018: As Reported at December 31, 2017 Adjustments Due to ASC 606 Balance at January 1, 2018 Liabilities and Stockholders' Equity Current liabilities: Current portion of deferred revenue 1,573 (56 ) 1,517 Total current liabilities 15,798 (56 ) 15,742 Long-term liabilities: Deferred revenue, less current portion 16,759 (593 ) 16,166 Total long-term liabilities 17,069 (593 ) 16,476 Total liabilities 32,867 (649 ) 32,218 Stockholders’ equity: Accumulated deficit (366,111 ) 649 (365,462 ) Total stockholders’ equity 104,319 649 104,968 Total liabilities and stockholders’ equity $ 137,186 — $ 137,186 Impact of New Revenue Guidance on Financial Statement Line Items Results for reporting periods beginning after January 1, 2018 were presented under ASC 606, while prior period amounts were not adjusted and reported under the accounting standards in effect for the prior periods. The following tables show the impact on the reported consolidated balance sheet for the year ended December 31, 2018, and the statements of operations and comprehensive loss for the year ended December 31, 2018, for pro-forma amounts had the previous guidance been in effect (in thousands): Financial Statement Line Item * Increase (Decrease) Consolidated Statements of Operations and Comprehensive Loss Year ended December 31, 2018 License fee (56 ) Net loss (56 ) Comprehensive loss (56 ) Consolidated Balance Sheet ** December 31, 2018 Current portion of deferred revenue (56 ) Deferred revenue, less current portion (537 ) Accumulated deficit 593 * Excludes line items that were not affected by the Company’s adoption of ASC 606. The adoption had no impact to cash provided by or used in net operating, investing or financing activities in the Consolidated Statement of Cash Flows. ** Balance sheet line item amounts include the cumulative-effect adjustment recorded on December 31, 2017. Impact on KHK License Agreement Revenue Under ASC 606, the Company determined that the performance obligations associated with the KHK License Agreement include (i) the combined license, rights to access and use materials and data, and rights to additional intellectual property, and (ii) the clinical supply obligation. All other goods or services promised to KHK are immaterial in the context of the agreement. Under ASC 606, the identification of the clinical supply obligation as a distinct performance obligation separate and apart from the license performance obligation resulted in a change in the performance period. The start of the performance period under ASC 606 was determined to be the contract inception date, December 19, 2014, as opposed to the initial delivery of the clinical trial materials in June 2015. The clinical supply was identified as a separate performance obligation under ASC 606 as (i) the Company is not providing a significant service of integration whereby the clinical supply and other promises are inputs into a combined output, (ii) the clinical supply does not significantly modify or customize the other promises nor is it significantly modified or customized by them and (iii) the clinical supply is not highly interdependent or highly interrelated with the other promises in the agreement as KHK could choose not to purchase the clinical supply from the Company without significantly affecting the other promised goods or services. The Company further concluded that the clinical supply represented an immaterial performance obligation and therefore the entire $17.3 million allocated to the upfront payment was allocated to the combined license and will be recognized ratably over the performance period, representing contract inception though 2029. In 2017, KHK achieved a development milestone, and was required to pay the Company $5.0 million. The Company is recognizing the development milestone consideration over the performance period coinciding with the license to intellectual property. As the Company determined that its performance obligations associated with the KHK Agreement at contract inception were not distinct and represented a single performance obligation, and that the obligations for goods and services provided would be completed over the performance period of the agreement, any payments received by the Company from KHK, including the upfront payment and progress-dependent development and regulatory milestone payments, are recognized as revenue using a time-based proportional performance model over the contract term (December 2014 through 2029) of the collaboration, within license fees. Contract liabilities consisted of deferred revenue, as presented on the consolidated balance sheet, as of December 31, 2018. Deferred revenue related to the KHK License Agreement was $16.2 million as of December 31, 2018 and will be recognized over the remainder of the contract term. The Company recognized license fees revenue of $1.5 million during the year ended December 31, 2018 that was included in the deferred revenue balance as of January 1, 2018. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | 5. Net Loss per Share Attributable to Common Stockholders Basic net loss attributable to common stockholders per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Because the Company has reported a net loss for the three years ended December 31, 2018, 2017, and 2016, diluted net loss per common share is the same as basic net loss per common share for those periods. The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company (in thousands, except per share data): Years Ended December 31, 2018 2017 2016 Numerator--basic and diluted: Net loss $ (73,961 ) $ (60,802 ) $ (44,472 ) Accretion of convertible preferred stock dividends — — (2,598 ) Net loss attributable to common stockholders--basic and diluted $ (73,961 ) $ (60,802 ) $ (47,070 ) Net loss per share—basic and diluted $ (2.92 ) $ (2.90 ) $ (3.22 ) Denominator—basic and diluted: Weighted-average common shares used to compute net loss per share—basic and diluted 25,371,511 20,997,211 14,619,716 The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares): December 31, 2018 2017 2016 Options to purchase common stock 4,252,983 3,391,832 2,560,737 Common stock warrant — 357,840 357,840 Restricted stock subject to future vesting — — 8,542 As discussed in Note 11, in June 2018, the Company signed an exchange agreement with an investor under which the investor exchanged 2,000,000 shares of common stock for 2,000,000 warrant shares. The warrants are exercisable into shares of common stock for $0.0001 per share. The shares of common stock into which the warrants may be exercised are considered outstanding for the purposes of computing earnings per share. |
Significant Agreements
Significant Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Significant Agreements | 6. Significant Agreements Vitae Pharmaceuticals, Inc. In October 2017, the Company entered into a license agreement (the “Allergan License Agreement”) with Vitae Pharmaceuticals, Inc., a subsidiary of Allergan (“Allergan”), under which Allergan granted the Company an exclusive, sublicensable, worldwide license to a portfolio of preclinical, orally available, small molecule inhibitors of the interaction of Menin with Mixed Lineage Leukemia (“MLL”) protein (the “Menin Assets”). The Company made a nonrefundable upfront payment of $5.0 million to Allergan in the fourth quarter of 2017. Additionally, subject to the achievement of certain milestone events, the Company may be required to pay Allergan up to $99.0 million in one-time development and regulatory milestone payments over the term of the Allergan License Agreement. In the event that the Company or any of its affiliates or sublicensees commercializes the Menin Assets, the Company will also be obligated to pay Allergan low single to low double-digit royalties on sales, subject to reduction in certain circumstances, as well as up to an aggregate of $70.0 million in potential one-time, sales-based milestone payments based on achievement of certain annual sales thresholds. Under certain circumstances, the Company may be required to share a percentage of non-royalty income from sublicensees, subject to certain deductions, with Allergan. The Company is solely responsible for the development and commercialization of the Menin Assets. Each party may terminate the Allergan License Agreement for the other party’s uncured material breach or insolvency; and the Company may terminate the Allergan License Agreement at will at any time upon advance written notice to Allergan. Allergan may terminate the Allergan License Agreement if the Company or any of its affiliates or sublicensees institutes a legal challenge to the validity, enforceability, or patentability of the licensed patent rights. Unless terminated earlier in accordance with its terms, the Allergan License Agreement will continue on a country-by-country and product-by-product basis until the later of: (i) the expiration of all of the licensed patent rights in such country; (ii) the expiration of all regulatory exclusivity applicable to the product in such country; and (iii) 10 years from the date of the first commercial sale of the product in such country. As of the date of the Allergan License Agreement, the asset acquired had no alternative future use nor had it reached a stage of technological feasibility. As the processes or activities that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. As a result, in 2017, the upfront payment of $5.0 million was recorded as research and development expense in the consolidated statements of operations. UCB Biopharma Sprl In July 2016, the Company entered into a license agreement (the “UCB License Agreement”) with UCB Biopharma Sprl (“UCB”), under which UCB granted to the Company a worldwide, sublicenseable, exclusive license to UCB6352, which the Company refers to as SNDX-6352, an IND-ready anti-CSF-1R monoclonal antibody. The Company made a nonrefundable upfront payment of $5.0 million to UCB in the third quarter of 2016. Additionally, subject to the achievement of certain milestone events, the Company may be required to pay UCB up to $119.5 million in one-time development and regulatory milestone payments over the term of the UCB License Agreement. In the event that the Company or any of its affiliates or sublicensees commercializes SNDX-6352, the Company will also be obligated to pay UCB low double-digit royalties on sales, subject to reduction in certain circumstances, as well as up to an aggregate of $250.0 million in potential one-time, sales-based milestone payments based on achievement of certain annual sales thresholds. Under certain circumstances, the Company may be required to share a percentage of non-royalty income from sublicensees, subject to certain deductions, with UCB. The Company will be solely responsible for the development and commercialization of SNDX-6352, except that UCB is performing a limited set of transitional chemistry, manufacturing and control tasks related to SNDX-6352. Each party may terminate the UCB License Agreement for the other party’s uncured material breach or insolvency; and the Company may terminate the UCB License Agreement at will at any time upon advance written notice to UCB. UCB may terminate the UCB License Agreement if the Company or any of its affiliates or sublicensees institutes a legal challenge to the validity, enforceability, or patentability of the licensed patent rights. Unless terminated earlier in accordance with its terms, the UCB License Agreement will continue on a country-by-country and product-by-product basis until the later of: (i) the expiration of all of the licensed patent rights in such country; (ii) the expiration of all regulatory exclusivity applicable to the product in such country; and (iii) 10 years from the date of the first commercial sale of the product in such country. As of the date of the UCB License Agreement, the asset acquired had no alternative future use nor had it reached a stage of technological feasibility. As the processes or activities that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. As a result, in 2016, the upfront payment of $5.0 million was recorded as research and development expense in the consolidated statements of operations. Kyowa Hakko Kirin Co., Ltd. On December 19, 2014 (the “Effective Date”), the Company entered into the KHK License Agreement, under which the Company granted KHK an exclusive license to develop and commercialize entinostat in Japan and Korea. Under the terms of the KHK License Agreement, the Company will be responsible for the manufacture and supply of the products during the development activities. In addition to the license and manufacturing obligations, the Company is obligated to provide KHK access to know-how and regulatory information the Company may develop over the life of the entinostat patent. Lastly, to the extent additional intellectual property is developed during the term of the agreement, KHK will receive the right to the intellectual property when and if available. KHK will conduct the development, regulatory approval filings, and commercialization activities of entinostat in Japan and Korea. KHK paid the Company $25.0 million upfront, which included a $7.5 million equity investment and a $17.5 million non-refundable cash payment. In addition, to the extent certain development and commercial milestones are achieved, KHK will be required to pay the Company up to $75.0 million in milestone payments over the term of the license agreement. The term of the agreement commenced on the Effective Date and, unless earlier terminated in accordance with the terms of the agreement, will continue on a country-by-country and product-by-product basis, until the later of: (i) the date all valid claims of the last effective patent among the Company’s patents expires or is abandoned, withheld, or is otherwise invalidated in such country; and (ii) 15 years from the date of the first commercial sale of a product in the Japan or Korea. The equity purchase and the up-front payment of the license fee were accounted for separately. The Company allocated the amount of consideration equal to the fair value of the shares on the Effective Date, which resulted in $7.7 million of proceeds allocated to the equity purchase and the remaining consideration of $17.3 million allocated to the up-front license fee. In October 2017, the Company announced that KHK enrolled the first Japanese patient into a local pivotal study of entinostat for the treatment of hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. In accordance with the terms of the agreement KHK paid the Company a $5.0 million milestone payment which the Company received in December 2017. Please refer to Note 4, Revenue from Contracts with Customers, for further discussion related to the accounting for the milestone. In October 2016, the Company entered into a clinical trial co-funding agreement with KHK under which the Company expanded its clinical trial agreement with Eastern Cooperative Oncology Group (the “ECOG Agreement”) to include enrollments from sites in Korea. Eastern Cooperative Oncology Group In March 2014, the Company entered into the “ECOG Agreement with Eastern Cooperative Oncology Group, a contracting entity for the Eastern Cooperative Oncology Group—American College of Radiology Imaging Network Cancer Research Group (“ECOG-ACRIN”), that describes the parties’ obligations with respect to the NCI-sponsored pivotal Phase 3 clinical trial of entinostat. Under the terms of the ECOG Agreement, ECOG-ACRIN will perform this clinical trial in accordance with the clinical trial protocol and a mutually agreed scope of work. The Company will provide a fixed level of financial support for the clinical trial through an upfront payment of $0.7 million and a series of payments of up to $1.0 million each that are comprised of milestone payments through the completion of enrollment and time-based payments through the completion of patient monitoring post-enrollment. In addition, the Company is obligated to supply entinostat and placebo to ECOG-ACRIN for use in the clinical trial. From the second quarter of 2016 through the fourth quarter of 2018, the Company has entered into a number of amendments to the agreement to provide for additional study activities resulting in an increase of the contractual obligation of $5.1 million. As of December 31, 2018, the Company’s aggregate payment obligations under this agreement were approximately $24.5 million; and as of December 31, 2018, the Company’s remaining payment obligations are approximately $9.6 million over an estimated period of approximately three years. Data and inventions from the Phase 3 clinical trial are owned by ECOG-ACRIN. The Company has access to the data generated in the clinical trial, both directly from ECOG-ACRIN under the ECOG Agreement as well as from the NCI. Additionally, ECOG-ACRIN has granted the Company a non-exclusive royalty-free license to any inventions or discoveries that are derived from entinostat as a result of its use during the clinical trial, along with a first right to negotiate an exclusive license to any of these inventions or discoveries. Either party may terminate the ECOG Agreement in the event of an uncured material breach by the other party or if the FDA or NCI withdraws the authorization to perform the clinical trial in the United States. The parties may jointly terminate the ECOG Agreement if the parties agree that safety-related issues support termination of the clinical trial. The Company records the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which the services and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by patient enrollment and the timing of various aspects of the clinical trial. The Company determines accrual estimates through financial models, taking into account discussion with applicable personnel and ECOG-ACRIN as to the progress or state of consummation of the clinical trial or the services completed. Bayer Pharma AG (formerly known as Bayer Schering Pharma AG) In March 2007, the Company entered into a license agreement (the “Bayer Agreement”) with Bayer Schering Pharma AG (“Bayer”) for a worldwide, exclusive license to develop and commercialize entinostat and any other products containing the same active ingredient. Under the terms of the Bayer Agreement, the Company paid a nonrefundable up-front license fee of $2.0 million and is responsible for the development and marketing of entinostat. The Company recorded the $2.0 million license fee as research and development expense during the year ended December 31, 2007, as it had no alternative future use. The Company will pay Bayer royalties on a sliding scale based on net sales, if any, and make future milestone payments to Bayer of up to $150.0 million in the event that certain specified development and regulatory goals and sales levels are achieved. In June 2014, a development milestone was achieved, and the Company recorded $2.0 million of research and development expense, which has been fully paid. In connection with the Bayer Agreement, the Company issued to Bayer a warrant to purchase the number of shares of the Company’s common stock equal to 1.75% of the shares of common stock outstanding on a fully diluted basis as of the earlier of the date the warrant was exercised or the closing of the IPO. The warrant contained anti-dilution protection to maintain Bayer’s potential ownership at 1.75% of the shares of common stock outstanding on a fully diluted basis, requiring that the actual number of shares of common stock issuable pursuant to the warrant be increased or decreased for any changes in the fully diluted shares of common stock outstanding. The warrant was exercisable at an exercise price of $1.54 per share and would have expired upon the earlier of the 10-year anniversary of the closing of the IPO or the date of the consummation of a disposition transaction. The warrant was classified as a long-term liability and recorded at fair value with the changes in the fair value recorded in other expense. The Company used the Black-Scholes option-pricing model to determine the fair value of the warrant. Upon the closing of the IPO, the anti-dilution protection for the warrant expired, resulting in the reclassification of the warrant liability to additional paid-in capital. The warrant was re-measured using current assumptions just prior to the reclassification. On March 1, 2018, Bayer notified the Company of its election to exercise the warrant utilizing the net exercise feature contained therein, resulting in the Company’s issuance to Bayer of 299,215 shares of the Company’s common stock for no net cash proceeds. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, net | 7. Property and Equipment, net Property and equipment, net, consisted of the following (in thousands): December 31, 2018 2017 Office and computer equipment $ 38 $ 68 Furniture and fixtures 134 134 Equipment 256 84 Office equipment under capital lease 13 13 Leasehold improvements 167 167 Total property and equipment 608 466 Accumulated depreciation (235 ) (199 ) Property and equipment, net $ 373 $ 267 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 8. Fair Value Measurements The carrying amounts of cash and cash equivalents, restricted cash, accounts payable, and accrued expenses approximated their estimated fair values due to the short-term nature of these financial instruments. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, which are the following: Level 1— Quoted prices in active markets that are accessible at the market date for identical unrestricted assets or liabilities. Level 2— Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs for which all significant inputs are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3— Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. During the years presented, the Company has not changed the manner in which it values assets and liabilities that are measured at fair value using Level 3 inputs. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy during the years ended December 31, 2018, 2017 and 2016. A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows (in thousands): Fair Value Measurements Using Total Carrying Value Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) December 31, 2018 Assets: Cash equivalents $ 33,769 $ 29,270 $ 4,499 $ — Short-term investments 47,142 — 47,142 — Total assets $ 80,911 $ 29,270 $ 51,641 $ — December 31, 2017 Assets: Cash equivalents $ 35,168 $ 24,972 $ 10,196 $ — Short-term investments 94,806 — $ 94,806 — Long-term investments 3,246 — 3,246 — Total assets $ 133,220 $ 24,972 $ 108,248 $ — Cash equivalents of $29.3 million as of December 31, 2018 and $25.0 million as of December 31, 2017 consisted of overnight investments and money market funds and are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets. Cash equivalents of $4.5 million as of December 31, 2018 and $10.2 million as of December 31, 2017 consisted of highly rated corporate bonds and commercial paper and are classified within Level 2 of the fair value hierarchy because pricing inputs are other than quoted prices in active markets, which are either directly or indirectly observable as of the reporting date; and fair value is determined through the use of models or other valuation methodologies. Short-term investments of $47.1 million as of December 31, 2018 and $94.8 million as of December 31, 2017, and long-term investments of $3.2 million as of December 31, 2017 consisted of commercial paper and highly rated corporate bonds and are classified within Level 2 of the fair value hierarchy because pricing inputs are other than quoted prices in active markets, which are either directly or indirectly observable as of the reporting date; and fair value is determined through the use of models or other valuation methodologies. The short-term and long-term investments are classified as available-for-sale securities. As of December 31, 2018, the remaining contractual maturities of the available-for-sale securities were less than 9 months, and the balance in the Company’s accumulated other comprehensive income was comprised solely of activity related to the Company’s available-for-sale securities. There were no realized gains or losses recognized on the sale or maturity of available-for-sale securities during the three years ended December 31, 2018. As a result, the Company did not reclassify any amounts out of accumulated other comprehensive income for the same periods. The Company has a limited number of available-for-sale securities in insignificant loss positions as of December 31, 2018, which the Company does not intend to sell and has concluded it will not be required to sell before recovery of the amortized cost for the investment at maturity. The following table summarizes the available-for-sale securities (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2018 Commercial paper $ 22,619 $ — $ (15 ) $ 22,604 Corporate bonds 29,047 2 (12 ) 29,037 $ 51,666 $ 2 $ (27 ) $ 51,641 December 31, 2017 Commercial paper $ 36,567 $ — $ (40 ) $ 36,527 Corporate bonds 71,824 — (103 ) 71,721 $ 108,391 $ — $ (143 ) $ 108,248 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2018 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | 9. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2018 2017 Short-term deposits $ 663 $ 1,286 Prepaid clinical supplies 101 220 Interest receivable on investments 253 377 Reimbursable costs 797 1,029 Prepaid insurance 188 192 Other 332 258 Total prepaid expenses and other current assets $ 2,334 $ 3,362 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 10. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2018 2017 Accrued professional fees $ 484 $ 265 Accrued compensation and related costs 2,804 2,393 Accrued clinical costs 9,726 9,177 Other 135 158 Total accrued expenses $ 13,149 $ 11,993 |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2018 | |
Text Block [Abstract] | |
Common Stock | 11. Common Stock In connection with the closing of the Company’s IPO, the Company filed an amended and restated certificate of incorporation and adopted amended and restated bylaws; and pursuant to the amended and restated certificate of incorporation, the Company is authorized to issue 100,000,000 shares of common stock. The holders of each share of common stock are entitled to one vote per share held and are entitled to receive dividends, if and when declared by the Board, and to share ratably in the Company’s assets available for distribution to stockholders, in the event of liquidation. On June 18, 2018, the Company signed an exchange agreement with Biotechnology Value Fund and certain affiliated funds (“BVF”) under which BVF exchanged 2,000,000 shares of common stock for 2,000,000 warrant shares. The Company recorded the issuance of the warrants and the retirement of the common stock at fair value within additional paid-in capital. BVF can exercise the warrant shares at an exercise price per share equal to $0.0001 per share and the warrant shares expire 20 years from issuance. Per the terms of the warrant agreement, the outstanding warrants to purchase shares of common stock may not be exercised if the holder's ownership of the Company's common stock would exceed 9.99 percent following such exercise. The Company has reserved for future issuance the following shares of common stock related to the potential warrant exercise, exercise of stock options, and the employee stock purchase plan: December 31, 2018 Common stock issuable under BVF warrant 2,000,000 Options to purchase common stock 5,675,984 Employee Stock Purchase Plan 651,453 Total 8,327,437 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 12. Stock-Based Compensation In September 2015, the Company’s board of directors adopted its 2015 Omnibus Incentive Plan (“2015 Plan”), which was subsequently approved by its stockholders and became effective upon the closing of the IPO on March 8, 2016. The 2015 Plan replaced the 2007 Stock Plan (“2007 Plan”) and allows for the granting of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock, unrestricted stock, stock units, dividend equivalent rights, performance awards, annual incentive awards, and other equity-based awards to the Company’s executives and other employees, non-employee members of the board of directors, and consultants of the Company. Any options or awards outstanding under the Company’s 2007 Plan remain outstanding and effective. Any shares of common stock related to awards outstanding under the 2007 Plan that thereafter terminate by expiration, forfeiture, cancellation or otherwise without the issuance of such shares will be added to, and included in, the 2015 Plan reserve amount. The Company initially reserved 1,750,000 shares of its common stock for the issuance of awards under the 2015 Plan. As of December 31, 2018, there were 1,423,001 shares available for issuance under the 2015 Plan. The 2015 Plan provides that the number of shares reserved and available for issuance under the 2015 Plan will automatically increase each January 1, beginning on January 1, 2017, by 4% of the outstanding number of shares of common stock on the immediately preceding December 31 or such lesser number of shares as determined by the Company’s board of directors. On January 1, 2019, the shares available for issuance under the 2015 Plan were increased to 2,416,439. The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and related to the Employee Stock Purchase Plan in the consolidated statements of operations as follows (in thousands): Years Ended December 31, 2018 2017 2016 Research and development $ 1,910 $ 1,363 $ 919 General and administrative 4,291 4,087 3,789 Total $ 6,201 $ 5,450 $ 4,708 Stock Options As of December 31, 2018, there was $8.8 million of unrecognized compensation cost related to employee and non-employee unvested stock options granted under the 2007 and 2015 Plans, which is expected to be recognized over a weighted-average remaining service period of 2.4 years. Stock compensation costs have not been capitalized by the Company. Our stock-based awards are subject to either service or performance-based vesting conditions. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to non-employees with service-based vesting conditions is recognized on the then-current fair value at each financial reporting date prior to the measurement date over the associated service period of the award, which is generally the vesting term, using the accelerated attribution method. Compensation expense related to awards to employees with performance-based vesting conditions is recognized based on the grant date fair value over the requisite service period using the straight-line method to the extent achievement of the performance condition is probable. To date, the Company has granted 60,000 options with performance conditions, none of which have vested as of December 31, 2018. The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model with the weighted-average assumptions noted in the table below. Expected volatility for the Company’s common stock was determined based on an average of the historical volatility of a peer group of similar public companies. The Company estimated the expected term of its employee stock options using the “simplified” method, whereby, the expected term equals the average of the vesting term and the original contractual term of the option. The contractual life of the option was used for the estimated life of the non-employee grants. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. The risk-free interest rate for periods within the expected life of the option is based upon the U.S. Treasury yield curve in effect at the time of grant. The Company accounts for forfeitures when they occur. The grant date fair values of options issued to employees and non-employees were estimated using the Black-Scholes option-pricing model with the following assumptions: Years Ended December 31, 2018 2017 2016 Expected term (in years) 5.90 6.02 5.85 Volatility rate 76.28 % 73.86 % 71.40 % Risk-free interest rate 2.69 % 2.02 % 1.41 % Expected dividend yield 0.00 % 0.00 % 0.00 % In determining the exercise prices for options granted, the Board has considered the fair value of the common stock as of each grant date. Prior to the Company’s IPO, the fair value of the common stock underlying the stock options was determined by the Board at each award grant date based upon a variety of factors, including the results obtained from an independent third-party valuation, the Company’s financial position and historical financial performance, the status of technological developments within the Company’s products, the composition and ability of the current clinical and management team, an evaluation or benchmark of the Company’s competition, the current business climate in the marketplace, the illiquid nature of the common stock, arm’s-length sales of the Company’s capital stock (including convertible preferred stock), the effect of the rights and preferences of the preferred stockholders, and the prospects of a liquidity event, among others. A summary of employee and non-employee option activity under the Company’s equity award plans is presented below (in thousands, except share data): Number Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding — 3,391,832 $ 9.28 7.7 $ 2,688 Granted 1,049,400 $ 9.37 Exercised (7,850 ) $ 3.33 Canceled or forfeited (180,399 ) $ 11.31 Outstanding — 4,252,983 $ 9.23 7.3 $ 66 Exercisable — 2,794,957 $ 8.92 6.6 $ 66 Options vested, exercisable or expected to vest — 4,232,982 $ 9.22 7.3 $ 66 The weighted-average grant date fair value of options granted during the years ended December 31, 2018, 2017 and 2016, was $6.17, $6.68, and $7.94 per share, respectively. The fair value is being expensed over the vesting period of the options (usually three to four years) on a straight-line basis as the services are being provided. There were 7,850 options exercised for the year ended December 31, 2018, resulting in total proceeds of $26,000; 46,680 options exercised for the year ended December 31, 2017, resulting in total proceeds of $0.3 million; and 441,573 options exercised for the year ended December 31, 2016, resulting in total proceeds of $2.1 million. The intrinsic value of options exercised during the years ended December 31, 2018, 2017 and 2016 was $0.1 million, $0.2 million, and $3.8 million, respectively. In accordance with the Company’s policy, the shares were issued from a pool of shares reserved for issuance under the 2007 and 2015 Plans. Upon the closing of the IPO in March 2016, the Company recorded $0.7 million of additional stock compensation expense related to certain options granted to two of the Company’s executives. Employee Stock Purchase Plan In September 2015, the Company’s Board adopted the Employee Stock Purchase Plan (the “ESPP”), which was subsequently approved by the Company’s stockholders in February 2016 and became effective upon the closing of the IPO on March 8, 2016. The ESPP authorizes the initial issuance of up to a total of 250,000 shares of common stock to the Company’s employees. The Company issued 24,684 shares during 2018. On January 1, 2019, the shares of common stock reserved for issuance under the ESPP was increased to 899,812. Under the terms of the ESPP, eligible employees can elect to acquire shares of the Company’s common stock through periodic payroll deductions during a series of six month offering periods. Purchases under the ESPP are effected on the last business day of each offering period at a 15% discount to the lower of closing price on that day or the closing price on the first day of the offering period. The ESPP is considered a compensatory plan with the related compensation cost expensed over the six-month offering period. In 2018 and 2017 the Company recorded stock-based compensation expense related to the ESPP of $132,000 and $42,000 respectively. There was zero expense for the year ended December 31, 2016. Employee Benefit Plan The Company has a Section 401(k) defined contribution savings plan for its employees. The plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pretax basis, subject to legal limitations. Company contributions to the plan may be made at the discretion of the Board. For the years ended December 31, 2018, 2017 and 2016, the Company made $126,000, $106,000 and $72,000 contributions to the plan, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes The Company has not recorded any net tax provision for the periods presented due to the losses incurred and the need for a full valuation allowance on deferred tax assets. The difference between the income tax expense at the U.S. federal statutory rate and the recorded provision is primarily due to the valuation allowance provided on all deferred tax assets. The Company’s loss before income tax for the periods presented was generated entirely in the United States. The significant components of the Company’s deferred tax are as follows (in thousands): Years Ended December 31, 2018 2017 Deferred tax assets (liabilities): Net operating loss carryforwards $ 12,684 $ 11,091 Research and development credits 3,443 2,380 Capitalized start-up and research and development costs 59,331 43,282 Deferred revenue 3,690 3,240 Depreciation and amortization (11,550 ) (8,610 ) Accruals 630 534 Other temporary differences 3,423 2,530 Deferred tax assets before valuation allowance 71,651 54,447 Valuation allowances (71,651 ) (54,447 ) Net deferred tax assets $ — $ — The Company has provided a valuation allowance for the full amount of the net deferred tax assets as the realization of the deferred tax assets is not determined to be more likely than not. The valuation allowance decreased by $5.9 million in 2017, due to the decrease in the federal tax rate, and increased by $17.2 million in 2018 due to the increase in deferred tax assets, primarily due to net operating loss carryforwards and capitalized research and development costs. As of December 31, 2018, the Company had approximately $51.7 million and $27.9 million in federal and state Net Operating Losses (“NOLs”), respectively, which begin to expire at various dates starting in 2025. As of December 31, 2018, the Company had federal and state research credits of $2.3 million and $1.4 million, respectively, which begin to expire in 2021. The Tax Cuts and Jobs Act (the “Act”) was enacted on December 22, 2017. The Act reduced the US federal corporate tax rate from 35% to 21%, required companies to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously tax deferred and creates new taxes on certain foreign sourced earnings. The only impact of the Act was the remeasurement of the Company’s deferred tax assets and liabilities, which was recorded in fiscal 2017 as a result of the reduction in U.S. corporate tax rates from 35% to 21%. The Company determined it had no accumulated unrepatriated foreign earnings, and therefore had recorded no liability for the repatriation transition tax. The Company has also completed its evaluation of and accounting for all other relevant changes resulting from the Act, and has determined that through December 31, 2018, these changes do not impact the Company’s deferred tax assets. No changes have been made to the estimates recorded in fiscal 2017. For the years ended December 31, 2017 and December 31, 2018, the Company recognized no transition tax. As a result of the Act, the Company re-measured certain deferred tax assets and liabilities based on the rates at which they are anticipated to reverse in the future, which is generally 21%. For the year end December 31, 2017, the provisional amount recorded related to the re-measurement of the deferred tax asset balance was a decrease of $28.8 million, with a corresponding reduction to the valuation allowance of $28.8 million for a net effect of $0. Realization of future tax benefits is dependent on many factors, including the Company’s ability to generate taxable income within the net operating loss carryforward period. Under the Internal Revenue Code provisions, certain substantial changes in the Company’s ownership, including the sale of the Company or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss carryforwards which could be used annually to offset future taxable income. The Company completed an analysis through December 31, 2017 and determined that on March 30, 2007 and August 21, 2015 ownership changes had occurred. The Company may also experience ownership changes in the future as a result of subsequent shifts in its stock ownership, some of which may be outside of the Company’s control. As a result, the Company’s ability to use its pre-change NOLs to offset U.S. federal taxable income may be subject to limitations, which could potentially result in an increased future tax liability. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. As of December 31, 2018, and 2017, the Company had uncertain tax positions of $0.2 million related to capitalized research and development costs and research and development credits, which reduce the deferred tax assets with a corresponding decrease to the valuation allowance. The Company has elected to recognize interest and penalties related to income tax matters as a component of income tax expense, of which no interest or penalties were recorded for the years ended December 31, 2018 and 2017. The Company expects none of the unrecognized tax benefits to decrease within the next 12 months related to expired statutes or settlement with the taxing authorities. Due to the Company’s valuation allowance as of December 31, 2018, none of the Company’s unrecognized tax benefits, if recognized, would affect the effective tax rate. A reconciliation of the Company’s unrecognized tax benefits is as follows (in thousands): Years Ended December 31, 2018 2017 2016 Unrecognized tax benefit--beginning of year $ 163 $ 241 $ 241 Decreases related to prior period positions — (78 ) — Unrecognized tax benefit--end of year $ 163 $ 163 $ 241 The Company files tax returns in the United States, Massachusetts, California, Pennsylvania, New Jersey and New York. All tax years since inception (October 11, 2005) remain open to examination by major tax jurisdictions to which the Company is subject, as carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service or state tax authorities if they have or will be used in a future period. The Company is currently not under examination by the Internal Revenue Service or any other jurisdictions for any tax years. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | 14. Commitments License Agreements NovaMedica—In August 2013, in connection with the third tranche of its Series B-1 financing, the Company entered into a Technology Transfer Agreement (the “Tech Transfer Agreement”) with Domain Russia Investments Limited (“DRI”). Pursuant to the Tech Transfer Agreement, in exchange for nominal payment, the Company assigned to DRI certain patent applications and granted to DRI a license to develop and commercialize entinostat in certain Eastern European countries (the “Covered Territory”). The Company concurrently entered into a sublicense agreement with DRI (the “DRI Sublicense”) and a sublicense agreement (the “NovaMedica Sublicense”) with NovaMedica LLC (“NovaMedica”), which is jointly owned by Rusnano Medinvest LLC and DRI. Pursuant to the DRI Sublicense, the Company granted to DRI an exclusive sublicense to develop, manufacture and commercialize entinostat in the Russian Federation. Pursuant to the NovaMedica Sublicense, the Company granted to NovaMedica an exclusive sublicense to develop, manufacture and commercialize entinostat in the rest of the Covered Territory. Immediately thereafter, the Company, DRI and NovaMedica executed an assignment and assumption agreement, pursuant to which the assigned patents and all of DRI’s rights and obligations under the Tech Transfer Agreement and the DRI Sublicense were transferred to NovaMedica. Under the Tech Transfer Agreement, in certain cases, the Company is required to assist NovaMedica, and NovaMedica is required to reimburse the Company for any out-of-pocket expenses incurred in providing this assistance, including travel-related expenses. Eddingpharm—In April 2013, the Company entered into a License and Development Agreement (the “Eddingpharm License Agreement”) and a Series B-1 purchase agreement (the “Eddingpharm Purchase Agreement”) with Eddingpharm International Company Limited (“Eddingpharm”). Under the terms of the Eddingpharm License Agreement, Eddingpharm, in exchange for rights to develop and commercialize entinostat in China and certain other Asian countries, purchased $5.0 million of Series B-1 and agreed to make certain contingent milestone and royalty payments based on revenue targets. In certain cases, the Company is required to assist Eddingpharm, and Eddingpharm is required to reimburse the Company for any out-of-pocket expenses incurred in providing this assistance, including reimbursement for person-hours above a certain cap. Lease Commitments In September 2016, the Company entered into a five-year operating lease for 12,207 square feet of office space in Waltham, Massachusetts, with a lease commencement date of March 1, 2017, and an option to extend the lease term once for an additional three years. The Company also has an option to cancel the lease after three years with the termination fee consisting of $55,000. The lease has monthly lease payments of $25,000 the first 12 months with annual rent escalations thereafter and provides a rent abatement of $0.2 million for the first year. The Company recorded the lease abatement as deferred rent and will amortize these amounts on a straight-line basis as a reduction of rent expense over the lease term. The Company paid the landlord a security deposit of $0.1 million in 2016, which will be returned without interest at the end of the lease. The Company recorded the security deposit as a long-term deposit on its consolidated balance sheet. In December 2015, the Company entered into a 62-month operating lease for 4,039 square feet of space in New York, New York, which commenced on January 1, 2016. The lease has monthly lease payments of $18,000 the first 12 months with an annual rent escalation each year thereafter and provides a rent abatement of $18,000 per month for the first two months. The Company recorded the lease abatement as deferred rent and will amortize these amounts on a straight-line basis as a reduction of rent expense over the lease term. In accordance with the lease, in December 2015, the Company entered into a cash-collateralized irrevocable standby letter of credit in the amount of $0.1 million naming the landlord as beneficiary. The Company also leases office equipment, which is accounted for as a capital lease and included in property and equipment at cost. Future annual minimum lease payments as of December 31, 2018, are as follows (in thousands): Operating Leases Capital Lease Obligations For the years ended December 31, 2019 569 $ 4 2020 588 4 2021 395 4 2022 59 1 2023 — — 2024 and thereafter — — Total minimum lease payments $ 1,611 13 Less amounts representing interest 2 Present value of net minimum lease payments $ 11 Rent expense recognized under all operating leases, including additional rent charges for utilities, maintenance, and real estate taxes, is calculated on a straight-line basis and amounted to $0.8 million, $0.8 million and $0.4 million for the years ended December 31, 2018, 2017, and 2016, respectively. |
Supplemental Cash Flow Informat
Supplemental Cash Flow Information | 12 Months Ended |
Dec. 31, 2018 | |
Supplemental Cash Flow Elements [Abstract] | |
Supplemental Cash Flow Information | 15. Supplemental Cash Flow Information Years Ended December 31, 2018 2017 2016 (In thousands) Supplemental Disclosures of Cash Flow Information Interest paid $ — $ — $ 2 Supplemental Disclosures of Non-Cash Investing and Financing Activities: Accretion of dividends on convertible preferred stock $ — $ — $ 2,598 Issuance costs included in accounts payable and accrued expenses $ — $ 50 $ — Vesting of restricted stock $ — $ 59 $ 42 Reclassification of common stock warrant liability to additional paid-in capital $ — $ — $ 4,551 Conversion of preferred stock to common stock upon closing of initial public offering $ — $ — $ 328,941 |
Related-Party Transactions
Related-Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 16. Related-Party Transactions In June 2015, the Company hired a Chief Executive Officer who was also appointed as a member of the Board. This individual is also a managing director at MPM Asset Management, LLC, which holds an investment in the Company’s common stock. |
Quarterly Financial Information
Quarterly Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information (Unaudited) | 17. Quarterly financial information (unaudited) The following table contains quarterly financial information for 2018 and 2017. The Company believes that the following information reflects all normal recurring adjustments necessary for a fair statement of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period. Three Months Ended 2018 In thousands, except per share data March 31 June 30 September 30 December 31 License fees $ 379 $ 379 $ 379 $ 380 Operating expenses: Research and development 15,339 14,851 14,095 15,821 General and administrative 4,791 4,479 4,125 3,892 Total expenses 20,130 19,330 18,220 19,713 Loss from operations (19,751 ) (18,951 ) (17,841 ) (19,333 ) Other income 353 563 503 496 Net loss $ (19,398 ) $ (18,388 ) $ (17,338 ) $ (18,837 ) Net loss per share attributable to common stockholders—basic and diluted $ (0.79 ) $ (0.74 ) $ (0.68 ) $ (0.70 ) Weighted-average shares--basic and diluted 24,478,269 24,705,441 25,471,587 26,804,089 Three Months Ended 2017 In thousands, except per share data March 31 June 30 September 30 December 31 License fees (1) $ 305 $ 305 $ 305 $ 1,193 Operating expenses: Research and development (2) 9,552 9,862 12,188 16,599 General and administrative 3,930 4,285 3,563 4,083 Total expenses 13,482 14,147 15,751 20,682 Loss from operations (13,177 ) (13,842 ) (15,446 ) (19,489 ) Other income 206 203 358 385 Net loss $ (12,971 ) $ (13,639 ) $ (15,088 ) $ (19,104 ) Net loss per share attributable to common stockholders—basic and diluted $ (2.85 ) $ (0.47 ) $ (0.84 ) $ (0.80 ) Weighted-average shares--basic and diluted 18,231,602 19,497,581 22,239,996 23,943,241 (1) License fees for the three months ended December 31, 2017 included $0.9 million for the partial recognition of the $5.0 million milestone received under the KHK License Agreement. (2) Research and development expenses for three months ended December 31, 2017 included the $5.0 million upfront payment related to the Vitae License Agreement. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | In 2011, the Company established a wholly owned subsidiary in the United Kingdom. There have been no activities for this entity to date. In 2014, the Company established a wholly owned U.S. subsidiary, Syndax Securities Corporation. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of costs and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. |
Cash Equivalents | Cash Equivalents Cash equivalents include all highly liquid investments maturing within 90 days or less from the date of purchase. Cash equivalents include money market funds, corporate debt securities, U.S. government agency notes, and overnight deposits. |
Restricted Cash | Restricted Cash The Company classifies as restricted cash all cash pledged as collateral to secure long-term obligations and all cash whose use is otherwise limited by contractual provisions. Amounts are reported as non-current unless restrictions are expected to be released in the next 12 months. |
Short-Term and Long-Term Investments | Short-Term and Long-Term Investments Short-term investments include marketable securities with maturities of less than one year or where management’s intent is to use the investments to fund current operations or to make them available for current operations. Long-term investments include marketable securities with remaining maturities greater than one year or that are due after one year from the balance sheet date. All investments in marketable securities are classified as available-for-sale and are reported at fair value with unrealized gains and losses excluded from earnings and reported net of tax in accumulated other comprehensive income, which is a component of stockholders’ equity (deficit). Unrealized losses that are determined to be other-than-temporary, based on current and expected market conditions, are recognized in earnings. Declines in fair value determined to be credit related are charged to earnings. The cost of marketable securities sold is determined by the specific identification method. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. The Company has one operating segment. |
Concentrations of Credit Risk | Concentrations of Credit Risk Cash and cash equivalents, restricted cash, and short-term and long-term investments are financial instruments that potentially subject the Company to concentrations of credit risk. Substantially all of the Company’s cash, cash equivalents, and short-term and long-term investments were deposited in accounts at two financial institutions, and at times, such deposits may exceed federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company’s available-for-sale investments primarily consist of U.S. Treasury securities, U.S. government agency securities, corporate debt securities, certificates of deposit and overnight deposits and potentially subject the Company to concentrations of credit risk. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets (three to five years). Assets under capital leases are amortized over the shorter of their useful lives or lease term using the straight-line method. Major replacements and improvements are capitalized, while general repairs and maintenance are expensed as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If this comparison indicates that there is impairment, the amount of impairment is calculated as the difference between the carrying value and fair value. To date, no such impairments have been recognized. |
Revenue Recognition | Revenue Recognition The Company adopted Accounting Standards Codification Rule 606 Revenue from Contracts with Customers (ASC 606), on January 1, 2018, using the modified retrospective method for all contracts not completed as of the date of adoption. The reported results for 2018 reflect the application of ASC 606 guidance while the reported results for 2017 were prepared under the guidance of ASC 605, Revenue Recognition (ASC 605). For the Company’s accounting policy for revenue recognition under ASC 605, refer to Item 8 of the Annual Report on Form 10-K for the year ended December 31, 2017. As of January 1, 2018, the Company had only one contract within the scope of ASC 606, a license agreement with Kyowa Hakko Kirin Co., Ltd. (“KHK”), under which the Company granted KHK an exclusive license to develop and commercialize entinostat in Japan and Korea (the “KHK License Agreement”). The KHK License Agreement is discussed further in Note 6. The Company enters into license agreements for the development and commercialization of its product candidates. License agreements may include non-refundable upfront payments, contingent payments based on the occurrence of specified events under the Company’s license arrangements, partial or complete reimbursement of research and development expenses, license fees and royalties on sales of entinostat if they are successfully approved and commercialized. The Company’s performance obligations under the license agreements may include the transfer of intellectual property rights in the form of licenses, obligations to provide research and development services and related materials and participation on certain development and/or commercialization committees. Revenue is recognized when, or as, performance obligations are satisfied, which occurs when control of the promised products or services is transferred to customers. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”). To the extent that the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing the most likely amount method. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available. The Company assesses the promises to determine if they are distinct performance obligations. Once the performance obligations are determined, the transaction price is allocated based on a relative standalone selling price basis. Milestone payments and royalties are typically considered variable consideration at the outset of the contract and are recognized in the transaction price either upon occurrence or when the constraint of a probable reversal is no longer applicable. Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. Arrangements containing licenses to the Company’s intellectual property typically provide for a know-how transfer period. These arrangements may or may not also include rights to future updates of that intellectual property and related know-how. Revenues from non-refundable, up-front fees allocated to the licenses are recognized as the license is transferred to the customer and the customer is able to use and benefit from the license. This generally takes place over the related know-how transfer period, or if applicable, over the term of transfer of future updates to the intellectual property. Development Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license fees and earnings in the period of adjustment. For development milestones related to the KHK Agreement, the Company does not take a substantive role or control the research, development or commercialization of any products generated by KHK. Therefore, the Company is not able to reasonably estimate when, if at all, any development milestone payments may be payable to the Company. As such, the development milestone payments associated with the KHK Agreement involve a substantial degree of uncertainty and risk that they may never be received. Commercial Milestone Payments and Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of commercial sales, and the license is deemed to be the predominant item to which the royalties or commercial milestones relate, the Company will recognize revenue at the later of when the related sales occur or when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date no commercial milestone payments or royalties have been achieved. When no performance obligations are required of the Company, or following the completion of the performance obligation period, such amounts are recognized as revenue upon transfer of control of the goods or services to the customer. Generally, all amounts received or due other than sales-based milestones and royalties are classified as license fees. Sales-based milestones and royalties will be recognized as royalty revenue at the later of when the related sales occur or when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Deferred revenue arises from amounts received in advance of the culmination of the earnings process and is recognized as revenue in future periods as performance obligations are satisfied. Deferred revenue expected to be recognized within the next twelve months is classified as a current liability. Upfront payment contract liabilities resulting from the Company’s license agreements do not represent a financing component as the payment is not financing the transfer of goods or services, and the technology underlying the licenses granted reflects research and development expenses already incurred by the Company. |
Research and Development | Research and Development Research and development costs are expensed as incurred. Research and development expenses include payroll and personnel expenses, consulting costs, external contract research and development expenses, and allocated overhead, including rent, equipment depreciation, and utilities. Research and development costs that are paid in advance of performance are capitalized as a prepaid expense and amortized over the service period as the services are provided. The Company expenses upfront license payments related to acquired technologies that have not yet reached technological feasibility and have no alternative future use. In instances where the Company enters into cost-sharing arrangements, all research and development costs reimbursed by the collaborators are accounted for as reductions to research and development expense. During the year ended December 31, 2018, the Company incurred $4.7 million in external costs related to cost-sharing collaborations, of which $2.4 million has been recorded as a reduction to research and development expense. During the year ended December 31, 2017, the Company incurred $3.0 million in external costs related to cost-sharing collaborations, of which $1.4 million has been recorded as a reduction to research and development expense. |
Clinical Trial Costs | Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or other information provided to us by our vendors. |
Income Taxes | Income Taxes The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences reverse. A valuation allowance is provided to reduce the net deferred tax assets to the amount that will more likely than not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. |
Guarantees and Indemnifications | Guarantees and Indemnifications As permitted under Delaware law, the Company indemnifies its officers, directors, and employees for certain events or occurrences that happen by reason of the relationship with, or position held at, the Company. The Company has standard indemnification arrangements under office leases (as described in Note 14) that require it to indemnify the landlord against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation, or nonperformance of any covenant or condition of the Company’s lease. Through December 31, 2018, the Company had not experienced any losses related to these indemnification obligations and no claims were outstanding. The Company does not expect significant claims related to these indemnification obligations, and consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for all stock option awards granted to employees and non-employees using a fair value method. Stock-based compensation is measured at the grant date fair value of employee stock option grants and is recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. Stock option awards to non-employees are subject to periodic revaluation over their vesting terms. The Company accounts for forfeitures as they occur. |
Convertible Preferred Stock | Convertible Preferred Stock Upon closing of the IPO, all of the outstanding shares of the Company’s outstanding convertible preferred stock converted into shares of the common stock. Prior to the IPO, the Company had classified certain series of convertible preferred stock as temporary equity in the consolidated balance sheets due to certain change in control events that were outside of the Company’s control, including liquidation, sale, or transfer of control of the Company, as holders of the convertible preferred stock could cause redemption of the shares in these situations. The carrying value of the convertible preferred stock was presented at its maximum redemption value. As of December 31, 2015, the Series A preferred stock had no liquidation preference and was presented in permanent equity. |
Recently Issued and Adopted Accounting Pronouncements | Recently Issued and Adopted Accounting Pronouncements In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting In November 2016, the FASB issued ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash” (“ASU 2016-18”). ASU 2016-18 requires that restricted cash and restricted cash equivalents be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The statement of cash flows must also explain the change during the period in the total of cash, cash equivalents, and restricted cash or restricted cash equivalents. The Company adopted ASU 2016-18 on January 1, 2018, utilizing the retrospective transition method and it did not have a material impact on its consolidated statement of cash flows. As part of the adoption of this guidance, the Company included restricted cash with cash and cash equivalent in the consolidated statement of cash flows for the periods ending December 31, 2018, 2017 and 2016. The following table provides a reconciliation of the cash, cash equivalents and restricted cash balances as of December 31, 2018, 2017 and 2016, as shown below: Years Ended December 31, 2018 2017 2016 (In thousands) Cash and cash equivalents $ 33,769 $ 35,168 $ 23,844 Restricted cash included in current and noncurrent assets 216 221 266 Cash, cash equivalents and restricted cash $ 33,985 $ 35,389 $ 24,110 In February 2016, the FASB issued ASU 2016-02, “ Leases (Topic 842) In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash Balances | The following table provides a reconciliation of the cash, cash equivalents and restricted cash balances as of December 31, 2018, 2017 and 2016, as shown below: Years Ended December 31, 2018 2017 2016 (In thousands) Cash and cash equivalents $ 33,769 $ 35,168 $ 23,844 Restricted cash included in current and noncurrent assets 216 221 266 Cash, cash equivalents and restricted cash $ 33,985 $ 35,389 $ 24,110 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
ASU 2014-09 [Member] | |
Schedule of Financial Statement Impact of Adopting ASC 606 | On January 1, 2018, the Company adopted ASC 606 applying the modified retrospective method, which only impacted the accounting for the KHK License Agreement. As a result of applying the modified retrospective method to adopt the new revenue guidance, the following adjustments were made to accounts on the consolidated balance sheet as of January 1, 2018: As Reported at December 31, 2017 Adjustments Due to ASC 606 Balance at January 1, 2018 Liabilities and Stockholders' Equity Current liabilities: Current portion of deferred revenue 1,573 (56 ) 1,517 Total current liabilities 15,798 (56 ) 15,742 Long-term liabilities: Deferred revenue, less current portion 16,759 (593 ) 16,166 Total long-term liabilities 17,069 (593 ) 16,476 Total liabilities 32,867 (649 ) 32,218 Stockholders’ equity: Accumulated deficit (366,111 ) 649 (365,462 ) Total stockholders’ equity 104,319 649 104,968 Total liabilities and stockholders’ equity $ 137,186 — $ 137,186 Results for reporting periods beginning after January 1, 2018 were presented under ASC 606, while prior period amounts were not adjusted and reported under the accounting standards in effect for the prior periods. The following tables show the impact on the reported consolidated balance sheet for the year ended December 31, 2018, and the statements of operations and comprehensive loss for the year ended December 31, 2018, for pro-forma amounts had the previous guidance been in effect (in thousands): Financial Statement Line Item * Increase (Decrease) Consolidated Statements of Operations and Comprehensive Loss Year ended December 31, 2018 License fee (56 ) Net loss (56 ) Comprehensive loss (56 ) Consolidated Balance Sheet ** December 31, 2018 Current portion of deferred revenue (56 ) Deferred revenue, less current portion (537 ) Accumulated deficit 593 * Excludes line items that were not affected by the Company’s adoption of ASC 606. The adoption had no impact to cash provided by or used in net operating, investing or financing activities in the Consolidated Statement of Cash Flows. ** Balance sheet line item amounts include the cumulative-effect adjustment recorded on December 31, 2017. |
Net Loss per Share Attributab_2
Net Loss per Share Attributable to Common Stockholders (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss per Share Attributable to Common Stockholders | The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company (in thousands, except per share data): Years Ended December 31, 2018 2017 2016 Numerator--basic and diluted: Net loss $ (73,961 ) $ (60,802 ) $ (44,472 ) Accretion of convertible preferred stock dividends — — (2,598 ) Net loss attributable to common stockholders--basic and diluted $ (73,961 ) $ (60,802 ) $ (47,070 ) Net loss per share—basic and diluted $ (2.92 ) $ (2.90 ) $ (3.22 ) Denominator—basic and diluted: Weighted-average common shares used to compute net loss per share—basic and diluted 25,371,511 20,997,211 14,619,716 |
Potential Dilutive Securities Excluded from Computation of Diluted Net Loss per Common Share | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares): December 31, 2018 2017 2016 Options to purchase common stock 4,252,983 3,391,832 2,560,737 Common stock warrant — 357,840 357,840 Restricted stock subject to future vesting — — 8,542 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment, net, consisted of the following (in thousands): December 31, 2018 2017 Office and computer equipment $ 38 $ 68 Furniture and fixtures 134 134 Equipment 256 84 Office equipment under capital lease 13 13 Leasehold improvements 167 167 Total property and equipment 608 466 Accumulated depreciation (235 ) (199 ) Property and equipment, net $ 373 $ 267 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Values of Financial Assets and Liabilities Measured at Fair Value | A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows (in thousands): Fair Value Measurements Using Total Carrying Value Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) December 31, 2018 Assets: Cash equivalents $ 33,769 $ 29,270 $ 4,499 $ — Short-term investments 47,142 — 47,142 — Total assets $ 80,911 $ 29,270 $ 51,641 $ — December 31, 2017 Assets: Cash equivalents $ 35,168 $ 24,972 $ 10,196 $ — Short-term investments 94,806 — $ 94,806 — Long-term investments 3,246 — 3,246 — Total assets $ 133,220 $ 24,972 $ 108,248 $ — |
Summary of Available-for-Sale Securities | The following table summarizes the available-for-sale securities (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2018 Commercial paper $ 22,619 $ — $ (15 ) $ 22,604 Corporate bonds 29,047 2 (12 ) 29,037 $ 51,666 $ 2 $ (27 ) $ 51,641 December 31, 2017 Commercial paper $ 36,567 $ — $ (40 ) $ 36,527 Corporate bonds 71,824 — (103 ) 71,721 $ 108,391 $ — $ (143 ) $ 108,248 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2018 2017 Short-term deposits $ 663 $ 1,286 Prepaid clinical supplies 101 220 Interest receivable on investments 253 377 Reimbursable costs 797 1,029 Prepaid insurance 188 192 Other 332 258 Total prepaid expenses and other current assets $ 2,334 $ 3,362 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2018 2017 Accrued professional fees $ 484 $ 265 Accrued compensation and related costs 2,804 2,393 Accrued clinical costs 9,726 9,177 Other 135 158 Total accrued expenses $ 13,149 $ 11,993 |
Common Stock (Tables)
Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Text Block [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | The Company has reserved for future issuance the following shares of common stock related to the potential warrant exercise, exercise of stock options, and the employee stock purchase plan: December 31, 2018 Common stock issuable under BVF warrant 2,000,000 Options to purchase common stock 5,675,984 Employee Stock Purchase Plan 651,453 Total 8,327,437 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share Based Compensation Expense Related to Issuance of Stock Option Awards to Employees and Non Employees Related to Employee Stock Purchase Plan | The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and related to the Employee Stock Purchase Plan in the consolidated statements of operations as follows (in thousands): Years Ended December 31, 2018 2017 2016 Research and development $ 1,910 $ 1,363 $ 919 General and administrative 4,291 4,087 3,789 Total $ 6,201 $ 5,450 $ 4,708 |
Grant Date Fair Values of Options Issued to Employees and Non-employees Estimated Using Black-Scholes Option Pricing Model | The grant date fair values of options issued to employees and non-employees were estimated using the Black-Scholes option-pricing model with the following assumptions: Years Ended December 31, 2018 2017 2016 Expected term (in years) 5.90 6.02 5.85 Volatility rate 76.28 % 73.86 % 71.40 % Risk-free interest rate 2.69 % 2.02 % 1.41 % Expected dividend yield 0.00 % 0.00 % 0.00 % |
Summary of Employee and Non-Employee Option Activity | A summary of employee and non-employee option activity under the Company’s equity award plans is presented below (in thousands, except share data): Number Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding — 3,391,832 $ 9.28 7.7 $ 2,688 Granted 1,049,400 $ 9.37 Exercised (7,850 ) $ 3.33 Canceled or forfeited (180,399 ) $ 11.31 Outstanding — 4,252,983 $ 9.23 7.3 $ 66 Exercisable — 2,794,957 $ 8.92 6.6 $ 66 Options vested, exercisable or expected to vest — 4,232,982 $ 9.22 7.3 $ 66 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Components of Deferred Tax | The significant components of the Company’s deferred tax are as follows (in thousands): Years Ended December 31, 2018 2017 Deferred tax assets (liabilities): Net operating loss carryforwards $ 12,684 $ 11,091 Research and development credits 3,443 2,380 Capitalized start-up and research and development costs 59,331 43,282 Deferred revenue 3,690 3,240 Depreciation and amortization (11,550 ) (8,610 ) Accruals 630 534 Other temporary differences 3,423 2,530 Deferred tax assets before valuation allowance 71,651 54,447 Valuation allowances (71,651 ) (54,447 ) Net deferred tax assets $ — $ — |
Summary of Reconciliation of Company's Unrecognized Tax Benefits | A reconciliation of the Company’s unrecognized tax benefits is as follows (in thousands): Years Ended December 31, 2018 2017 2016 Unrecognized tax benefit--beginning of year $ 163 $ 241 $ 241 Decreases related to prior period positions — (78 ) — Unrecognized tax benefit--end of year $ 163 $ 163 $ 241 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Annual Minimum Lease Payments | Future annual minimum lease payments as of December 31, 2018, are as follows (in thousands): Operating Leases Capital Lease Obligations For the years ended December 31, 2019 569 $ 4 2020 588 4 2021 395 4 2022 59 1 2023 — — 2024 and thereafter — — Total minimum lease payments $ 1,611 13 Less amounts representing interest 2 Present value of net minimum lease payments $ 11 |
Supplemental Cash Flow Inform_2
Supplemental Cash Flow Information (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Supplemental Cash Flow Elements [Abstract] | |
Supplemental Disclosures of Cash Flow Information | Years Ended December 31, 2018 2017 2016 (In thousands) Supplemental Disclosures of Cash Flow Information Interest paid $ — $ — $ 2 Supplemental Disclosures of Non-Cash Investing and Financing Activities: Accretion of dividends on convertible preferred stock $ — $ — $ 2,598 Issuance costs included in accounts payable and accrued expenses $ — $ 50 $ — Vesting of restricted stock $ — $ 59 $ 42 Reclassification of common stock warrant liability to additional paid-in capital $ — $ — $ 4,551 Conversion of preferred stock to common stock upon closing of initial public offering $ — $ — $ 328,941 |
Quarterly Financial Informati_2
Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | The following table contains quarterly financial information for 2018 and 2017. The Company believes that the following information reflects all normal recurring adjustments necessary for a fair statement of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period. Three Months Ended 2018 In thousands, except per share data March 31 June 30 September 30 December 31 License fees $ 379 $ 379 $ 379 $ 380 Operating expenses: Research and development 15,339 14,851 14,095 15,821 General and administrative 4,791 4,479 4,125 3,892 Total expenses 20,130 19,330 18,220 19,713 Loss from operations (19,751 ) (18,951 ) (17,841 ) (19,333 ) Other income 353 563 503 496 Net loss $ (19,398 ) $ (18,388 ) $ (17,338 ) $ (18,837 ) Net loss per share attributable to common stockholders—basic and diluted $ (0.79 ) $ (0.74 ) $ (0.68 ) $ (0.70 ) Weighted-average shares--basic and diluted 24,478,269 24,705,441 25,471,587 26,804,089 Three Months Ended 2017 In thousands, except per share data March 31 June 30 September 30 December 31 License fees (1) $ 305 $ 305 $ 305 $ 1,193 Operating expenses: Research and development (2) 9,552 9,862 12,188 16,599 General and administrative 3,930 4,285 3,563 4,083 Total expenses 13,482 14,147 15,751 20,682 Loss from operations (13,177 ) (13,842 ) (15,446 ) (19,489 ) Other income 206 203 358 385 Net loss $ (12,971 ) $ (13,639 ) $ (15,088 ) $ (19,104 ) Net loss per share attributable to common stockholders—basic and diluted $ (2.85 ) $ (0.47 ) $ (0.84 ) $ (0.80 ) Weighted-average shares--basic and diluted 18,231,602 19,497,581 22,239,996 23,943,241 (1) License fees for the three months ended December 31, 2017 included $0.9 million for the partial recognition of the $5.0 million milestone received under the KHK License Agreement. (2) Research and development expenses for three months ended December 31, 2017 included the $5.0 million upfront payment related to the Vitae License Agreement. |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) - USD ($) | Oct. 17, 2017 | May 31, 2017 | Apr. 30, 2017 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2016 | Mar. 06, 2019 | Dec. 31, 2018 |
Nature of Business [Line Items] | ||||||||||
Proceeds from public stock offering, net of issuance costs | $ 52,148,000 | |||||||||
Payment percentage of gross proceeds from sales agreement | 3.00% | |||||||||
Allergan License Agreement | Vitae Pharmaceuticals Inc | ||||||||||
Nature of Business [Line Items] | ||||||||||
Upfront milestone payable | $ 5,000,000 | |||||||||
At The Market Equity Offering Sales Agreement [Member] | ||||||||||
Nature of Business [Line Items] | ||||||||||
Common Stock available for sale | $ 32,100,000 | |||||||||
At The Market Equity Offering Sales Agreement [Member] | Subsequent Event [Member] | ||||||||||
Nature of Business [Line Items] | ||||||||||
Aggregate net proceeds received from the offering, net of underwriting discounts and commissions and estimated offering expenses payable | $ 18,200,000 | |||||||||
Common stock, new shares issued | 2,403,409 | |||||||||
Sale of stock, price per share | $ 7.82 | |||||||||
Gross proceeds from issuance of common stock | $ 18,800,000 | |||||||||
Common Stock available for sale | $ 31,200,000 | |||||||||
At The Market Equity Offering Sales Agreement [Member] | Scenario, Forecast [Member] | ||||||||||
Nature of Business [Line Items] | ||||||||||
Aggregate net proceeds received from the offering, net of underwriting discounts and commissions and estimated offering expenses payable | $ 900,000 | |||||||||
Common stock, new shares issued | 140,819 | |||||||||
Cowen and Company LLC [Member] | At The Market Equity Offering Sales Agreement [Member] | ||||||||||
Nature of Business [Line Items] | ||||||||||
Aggregate net proceeds received from the offering, net of underwriting discounts and commissions and estimated offering expenses payable | $ 50,000,000 | |||||||||
Initial Public Offering [Member] | ||||||||||
Nature of Business [Line Items] | ||||||||||
Common stock, shares issued | 2,021,018 | 4,809,475 | ||||||||
Sale of stock, price per share | $ 12.37 | $ 12 | ||||||||
Proceeds from public stock offering, net of issuance costs | $ 24,900,000 | $ 50,500,000 | ||||||||
Follow-on Public Offering [Member] | ||||||||||
Nature of Business [Line Items] | ||||||||||
Aggregate net proceeds received from the offering, net of underwriting discounts and commissions and estimated offering expenses payable | $ 48,700,000 | $ 48,675,000 | ||||||||
Common stock, new shares issued | 3,950,190 | |||||||||
Sale of stock, price per share | $ 13.25 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2018USD ($)SegmentClaim | Dec. 31, 2017USD ($) | Dec. 31, 2015USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Number of operating segments | Segment | 1 | ||
Impairment charge | $ 0 | ||
Series A [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Preferred stock, liquidation preference | $ 0 | ||
Guarantees and Indemnifications [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Indemnification obligations, claims outstanding | Claim | 0 | ||
Indemnification obligations claims, reserves established | $ 0 | ||
Cost-Sharing Collaborations [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
External costs related to cost-sharing collaborations | 4,700,000 | $ 3,000,000 | |
Cost-sharing collaborations recorded as a reduction to research and development expense | $ 2,400,000 | $ 1,400,000 | |
Minimum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful lives | three years | ||
Percentage of income tax contingency realized | 50.00% | ||
Minimum [Member] | ASU 2016-02 [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Expected recognition of right-of-use assets | $ 1,000,000 | ||
Expected recognition of lease, liability | $ 1,000,000 | ||
Maximum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful lives | five years | ||
Maximum [Member] | ASU 2016-02 [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Expected recognition of right-of-use assets | $ 1,500,000 | ||
Expected recognition of lease, liability | $ 1,500,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash Balances (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 33,769 | $ 35,168 | $ 23,844 | |
Restricted cash included in current and noncurrent assets | 216 | 221 | 266 | |
Cash, cash equivalents and restricted cash | $ 33,985 | $ 35,389 | $ 24,110 | $ 23,348 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Schedule of Impact on Consolidated Balance Sheet of Adopting ASC 606 (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Current liabilities: | |||||
Current portion of deferred revenue | $ 1,517 | $ 1,573 | |||
Total current liabilities | 16,105 | 15,798 | |||
Long-term liabilities: | |||||
Deferred revenue, less current portion | 14,650 | 16,759 | |||
Total long-term liabilities | 14,786 | 17,069 | |||
Total liabilities | 30,891 | 32,867 | |||
Stockholders' equity: | |||||
Accumulated deficit | (439,423) | (366,111) | |||
Total stockholders' equity | 53,047 | 104,319 | $ 84,139 | $ (252,415) | |
Total liabilities and stockholders' equity | $ 83,938 | $ 137,186 | |||
ASU 2014-09 [Member] | |||||
Current liabilities: | |||||
Current portion of deferred revenue | $ 1,517 | ||||
Total current liabilities | 15,742 | ||||
Long-term liabilities: | |||||
Deferred revenue, less current portion | 16,166 | ||||
Total long-term liabilities | 16,476 | ||||
Total liabilities | 32,218 | ||||
Stockholders' equity: | |||||
Accumulated deficit | (365,462) | ||||
Total stockholders' equity | 104,968 | ||||
Total liabilities and stockholders' equity | 137,186 | ||||
ASU 2014-09 [Member] | Adjustments Due to ASC 606 [Member] | |||||
Current liabilities: | |||||
Current portion of deferred revenue | (56) | ||||
Total current liabilities | (56) | ||||
Long-term liabilities: | |||||
Deferred revenue, less current portion | (593) | ||||
Total long-term liabilities | (593) | ||||
Total liabilities | (649) | ||||
Stockholders' equity: | |||||
Accumulated deficit | 649 | ||||
Total stockholders' equity | $ 649 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Schedule of Impact of New Revenue Guidance on Financial Statement Line Items (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 01, 2018 | |
Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||
License fee | $ 380 | $ 379 | $ 379 | $ 379 | $ 1,193 | $ 305 | $ 305 | $ 305 | $ 1,517 | $ 2,108 | $ 1,220 | |
Type of revenue [extensible list] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | |
Net loss | $ (18,837) | $ (17,338) | $ (18,388) | $ (19,398) | $ (19,104) | $ (15,088) | $ (13,639) | $ (12,971) | $ (73,961) | $ (60,802) | $ (44,472) | |
Comprehensive loss | (73,843) | (61,001) | $ (44,444) | |||||||||
Consolidated Balance Sheet | ||||||||||||
Current portion of deferred revenue | 1,517 | 1,573 | 1,517 | 1,573 | ||||||||
Deferred revenue, less current portion | 14,650 | 16,759 | 14,650 | 16,759 | ||||||||
Accumulated deficit | (439,423) | $ (366,111) | (439,423) | $ (366,111) | ||||||||
ASU 2014-09 [Member] | ||||||||||||
Consolidated Balance Sheet | ||||||||||||
Current portion of deferred revenue | $ 1,517 | |||||||||||
Deferred revenue, less current portion | 16,166 | |||||||||||
Accumulated deficit | $ (365,462) | |||||||||||
ASU 2014-09 [Member] | Pro Forma had the Previous Accounting Been in Effect [Member] | ||||||||||||
Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||
License fee | $ (56) | |||||||||||
Type of revenue [extensible list] | us-gaap:LicenseMember | |||||||||||
Net loss | $ (56) | |||||||||||
Comprehensive loss | (56) | |||||||||||
Consolidated Balance Sheet | ||||||||||||
Current portion of deferred revenue | (56) | (56) | ||||||||||
Deferred revenue, less current portion | (537) | (537) | ||||||||||
Accumulated deficit | $ 593 | $ 593 |
Revenue from Contract with Cust
Revenue from Contract with Customer - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Oct. 31, 2017 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||||||||
Licenses fees revenue | $ 380 | $ 379 | $ 379 | $ 379 | $ 1,193 | $ 305 | $ 305 | $ 305 | $ 1,517 | $ 2,108 | $ 1,220 | |
Type of revenue [extensible list] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | |
Kyowa Hakko Kirin Co., Ltd. [Member] | ||||||||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||||||||
Licenses fees revenue | $ 1,500 | |||||||||||
Type of revenue [extensible list] | us-gaap:LicenseMember | |||||||||||
License Agreement [Member] | Kyowa Hakko Kirin Co., Ltd. [Member] | ||||||||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||||||||
Upfront payment allocation to performance obligation | $ 17,300 | $ 17,300 | ||||||||||
Performance obligation period | 2,029 | 2,029 | ||||||||||
Milestone payment received | $ 5,000 | $ 5,000 | ||||||||||
Deferred revenue | $ 16,200 | $ 16,200 |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders - Computation of Basic and Diluted Net Loss per Share Attributable to Common Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Numerator--basic and diluted: | |||||||||||
Net loss | $ (18,837) | $ (17,338) | $ (18,388) | $ (19,398) | $ (19,104) | $ (15,088) | $ (13,639) | $ (12,971) | $ (73,961) | $ (60,802) | $ (44,472) |
Accretion of convertible preferred stock dividends | (2,598) | ||||||||||
Net loss attributable to common stockholders--basic and diluted | $ (73,961) | $ (60,802) | $ (47,070) | ||||||||
Net loss per share—basic and diluted | $ (0.70) | $ (0.68) | $ (0.74) | $ (0.79) | $ (0.80) | $ (0.84) | $ (0.47) | $ (2.85) | $ (2.92) | $ (2.90) | $ (3.22) |
Denominator—basic and diluted: | |||||||||||
Weighted-average common shares used to compute net loss per share—basic and diluted | 26,804,089 | 25,471,587 | 24,705,441 | 24,478,269 | 23,943,241 | 22,239,996 | 19,497,581 | 18,231,602 | 25,371,511 | 20,997,211 | 14,619,716 |
Net Loss per Share Attributab_4
Net Loss per Share Attributable to Common Stockholders - Potential Dilutive Securities Excluded from Computation of Diluted Net Loss per Common Share (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Options to Purchase Common Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of diluted net loss per common share | 4,252,983 | 3,391,832 | 2,560,737 |
Common Stock Warrant [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of diluted net loss per common share | 357,840 | 357,840 | |
Restricted Stock Subject to Future Vesting [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of diluted net loss per common share | 8,542 |
Net Loss per Share Attributab_5
Net Loss per Share Attributable to Common Stockholders - Additional Information (Detail) - Biotechnology Value Fund, L.P. [Member] | Jun. 18, 2018$ / sharesshares |
Earnings Per Share Basic [Line Items] | |
Number of common stock converted to warrants | 2,000,000 |
Number of common stock warrants issued | 2,000,000 |
Warrant exercise price per share | $ / shares | $ 0.0001 |
Significant Agreements - Additi
Significant Agreements - Additional Information (Detail) - USD ($) | Mar. 01, 2018 | Oct. 31, 2017 | Jul. 31, 2016 | Dec. 19, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2007 | Mar. 31, 2007 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Research and development expense | $ 15,821,000 | $ 14,095,000 | $ 14,851,000 | $ 15,339,000 | $ 16,599,000 | $ 12,188,000 | $ 9,862,000 | $ 9,552,000 | $ 60,106,000 | $ 48,201,000 | $ 31,665,000 | |||||||||
Up-front payment allocated to preferred stock value | ||||||||||||||||||||
Common Stock [Member] | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Issuance of common stock upon utilizing net exercise feature of warrant | 299,215 | |||||||||||||||||||
Vitae Pharmaceuticals Inc | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Research and development expense | $ 5,000,000 | |||||||||||||||||||
Kyowa Hakko Kirin Co., Ltd. [Member] | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Milestone payment agreement terms | In accordance with the terms of the agreement | |||||||||||||||||||
Type of Cost, Good or Service [Extensible List] | us-gaap:LicenseMember | |||||||||||||||||||
Allergan License Agreement | Vitae Pharmaceuticals Inc | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Upfront milestone payable | $ 5,000,000 | |||||||||||||||||||
Potential milestone payments to be made | 99,000,000 | |||||||||||||||||||
Aggregate potential milestone payable | $ 70,000,000 | |||||||||||||||||||
License expiration year | 10 years | |||||||||||||||||||
UCB License Agreement [Member] | UCB Biopharma [Member] | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Upfront milestone payable | $ 5,000,000 | |||||||||||||||||||
Potential milestone payments to be made | $ 119,500,000 | |||||||||||||||||||
Aggregate potential milestone payable | $ 250,000,000 | |||||||||||||||||||
License expiration year | 10 years | |||||||||||||||||||
Research and development expense | $ 5,000,000 | |||||||||||||||||||
License Agreement [Member] | Kyowa Hakko Kirin Co., Ltd. [Member] | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
License agreement upfront payment received | $ 25,000,000 | |||||||||||||||||||
Period of termination after first commercial sale of first licensed product | 15 years | |||||||||||||||||||
Up-front payment allocated to license fee | $ 17,300,000 | |||||||||||||||||||
Milestone payment received | $ 5,000,000 | $ 5,000,000 | ||||||||||||||||||
License Agreement [Member] | Kyowa Hakko Kirin Co., Ltd. [Member] | Series B-1 [Member] | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Up-front payment allocated to preferred stock value | 7,700,000 | |||||||||||||||||||
License Agreement [Member] | Kyowa Hakko Kirin Co., Ltd. [Member] | Maximum [Member] | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Milestone payment receivable upon achievement of development and commercial milestone | $ 75,000,000 | |||||||||||||||||||
License Agreement [Member] | Bayer Pharma AG [Member] | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Research and development expense | $ 2,000,000 | $ 2,000,000 | ||||||||||||||||||
Up-front license fee paid | $ 2,000,000 | |||||||||||||||||||
Percentage of shares issuable upon conversion of warrant | 1.75% | |||||||||||||||||||
Warrant exercise price per share | $ 1.54 | $ 1.54 | ||||||||||||||||||
Warrant expiration period | 10 years | |||||||||||||||||||
Proceeds from public stock offerings | $ 0 | |||||||||||||||||||
License Agreement [Member] | Bayer Pharma AG [Member] | Common Stock [Member] | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Issuance of common stock upon utilizing net exercise feature of warrant | 299,215 | |||||||||||||||||||
License Agreement [Member] | Bayer Pharma AG [Member] | Maximum [Member] | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Aggregate payment obligation | $ 150,000,000 | |||||||||||||||||||
Clinical Trial [Member] | Eastern Cooperative Oncology Group [Member] | ||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Upfront milestone payable | $ 700,000 | |||||||||||||||||||
Milestone payment payable | $ 1,000,000 | |||||||||||||||||||
Increase in contractual obligation | $ 5,100,000 | |||||||||||||||||||
Aggregate payment obligation | 24,500,000 | $ 24,500,000 | ||||||||||||||||||
Remaining contractual obligation | $ 9,600,000 | $ 9,600,000 | ||||||||||||||||||
Period of contractual obligation | 3 years |
Property and Equipment, Net - P
Property and Equipment, Net - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 608 | $ 466 |
Accumulated depreciation | (235) | (199) |
Property and equipment, net | 373 | 267 |
Office and Computer Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 38 | 68 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 134 | 134 |
Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 256 | 84 |
Office Equipment Under Capital Lease [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 13 | 13 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 167 | $ 167 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Values of Financial Assets and Liabilities Measured at Fair Value (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 47,142 | $ 94,806 |
Long-term investments | 3,246 | |
Carrying Value [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 33,769 | 35,168 |
Short-term investments | 47,142 | 94,806 |
Long-term investments | 3,246 | |
Total assets | 80,911 | 133,220 |
Quoted Prices in Active Markets Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 29,270 | 24,972 |
Total assets | 29,270 | 24,972 |
Significant Other Observable Inputs Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 4,499 | 10,196 |
Short-term investments | 47,142 | 94,806 |
Long-term investments | 3,246 | |
Total assets | $ 51,641 | $ 108,248 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 36 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value Measurements [Line Items] | ||
Available for sale debt securities fair value | $ 51,641,000 | $ 108,248,000 |
Realized gains or losses recognized on the sale or maturity of available-for-sale securities | 0 | |
Quoted Prices in Active Markets Level 1 [Member] | ||
Fair Value Measurements [Line Items] | ||
Cash equivalents fair value | 29,270,000 | 24,972,000 |
Quoted Prices in Active Markets Level 1 [Member] | Overnight Investments, Money Market Funds and Highly Rated Corporate Bonds Member] | ||
Fair Value Measurements [Line Items] | ||
Cash equivalents fair value | 29,300,000 | 25,000,000 |
Significant Other Observable Inputs Level 2 [Member] | ||
Fair Value Measurements [Line Items] | ||
Cash equivalents fair value | 4,499,000 | 10,196,000 |
Significant Other Observable Inputs Level 2 [Member] | Corporate Bonds and Commercial Paper [Member] | ||
Fair Value Measurements [Line Items] | ||
Cash equivalents fair value | 4,500,000 | 10,200,000 |
Significant Other Observable Inputs Level 2 [Member] | Corporate Bonds and Commercial Paper [Member] | Short-term Investments [Member] | ||
Fair Value Measurements [Line Items] | ||
Available for sale debt securities fair value | $ 47,100,000 | 94,800,000 |
Significant Other Observable Inputs Level 2 [Member] | Corporate Bonds and Commercial Paper [Member] | Long-term Investments [Member] | ||
Fair Value Measurements [Line Items] | ||
Available for sale debt securities fair value | $ 3,200,000 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 51,666 | $ 108,391 |
Unrealized Gains | 2 | |
Unrealized Losses | (27) | (143) |
Fair Value | 51,641 | 108,248 |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 22,619 | 36,567 |
Unrealized Losses | (15) | (40) |
Fair Value | 22,604 | 36,527 |
Corporate Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 29,047 | 71,824 |
Unrealized Gains | 2 | |
Unrealized Losses | (12) | (103) |
Fair Value | $ 29,037 | $ 71,721 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Short-term deposits | $ 663 | $ 1,286 |
Prepaid clinical supplies | 101 | 220 |
Interest receivable on investments | 253 | 377 |
Reimbursable costs | 797 | 1,029 |
Prepaid insurance | 188 | 192 |
Other | 332 | 258 |
Total prepaid expenses and other current assets | $ 2,334 | $ 3,362 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Accrued professional fees | $ 484 | $ 265 |
Accrued compensation and related costs | 2,804 | 2,393 |
Accrued clinical costs | 9,726 | 9,177 |
Other | 135 | 158 |
Total accrued expenses | $ 13,149 | $ 11,993 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - $ / shares | Jun. 18, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Class Of Stock [Line Items] | |||
Common stock, shares authorized | 100,000,000 | 100,000,000 | |
Biotechnology Value Fund, L.P. [Member] | |||
Class Of Stock [Line Items] | |||
Number of common stock converted to warrants | 2,000,000 | ||
Number of common stock warrants issued | 2,000,000 | ||
Warrant exercise price per share | $ 0.0001 | ||
Warrant expiration period | 20 years | ||
Maximum percentage of common stock can be held upon exercise of warrant | 9.99% | ||
Initial Public Offering [Member] | |||
Class Of Stock [Line Items] | |||
Common stock, shares authorized | 100,000,000 |
Common Stock - Schedule of Comm
Common Stock - Schedule of Common Stock Reserved for Future Issuance (Detail) | Dec. 31, 2018shares |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 8,327,437 |
Common Stock Issuable Under BVF Warrant [Member] | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 2,000,000 |
Options to Purchase Common Stock [Member] | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 5,675,984 |
Employee Stock Purchase Plan [Member] | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 651,453 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | Jan. 01, 2019shares | Mar. 31, 2016USD ($)Executive | Sep. 30, 2015shares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for issuance | 8,327,437 | |||||
Share-based compensation, stock options granted | 1,049,400 | |||||
Share-based compensation, stock options vested | 4,232,982 | |||||
Weighted-average grant date fair value of options granted | $ / shares | $ 6.17 | $ 6.68 | $ 7.94 | |||
Stock options exercised, shares | 7,850 | 46,680 | 441,573 | |||
Stock options exercised | $ | $ 26,000 | $ 277,000 | $ 2,058,000 | |||
Intrinsic value of options exercised | $ | 100,000 | 200,000 | 3,800,000 | |||
Share based compensation expense, total | $ | 6,201,000 | 5,450,000 | 4,708,000 | |||
Contributions by the company | $ | $ 126,000 | $ 106,000 | 72,000 | |||
Initial Public Offering [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of company executives | Executive | 2 | |||||
Additional stock compensation expense | $ | $ 700,000 | |||||
Performance Based Shares [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation, stock options granted | 60,000 | |||||
Share-based compensation, stock options vested | 0 | |||||
Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 4 years | |||||
Minimum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 3 years | |||||
2015 Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock reserved for issuance | 1,750,000 | |||||
Shares available for issuance | 1,423,001 | |||||
Common stock outstanding | 4.00% | |||||
2015 Plan [Member] | Subsequent Event [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for issuance | 2,416,439 | |||||
2007 and 2015 [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation expense related to stock option | $ | $ 8,800,000 | |||||
Weighted average period to recognize compensation expense | 2 years 4 months 24 days | |||||
Employee Stock Purchase Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares issued under plan | 24,684 | |||||
Share based compensation expense, total | $ | $ 132,000 | $ 42,000 | $ 0 | |||
Employee Stock Purchase Plan [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares authorized for issuance | 250,000 | |||||
Employee Stock Purchase Plan [Member] | Subsequent Event [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Periodic payroll deductions offering periods | 6 months | |||||
Offering period discount rate | 15.00% | |||||
Employee Stock Purchase Plan [Member] | Subsequent Event [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for issuance | 899,812 |
Stock-Based Compensation - Shar
Stock-Based Compensation - Share Based Compensation Expense Related to Issuance of Stock Option Awards to Employees and Non Employees Related to Employee Stock Purchase Plan (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation expense, total | $ 6,201 | $ 5,450 | $ 4,708 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation expense, total | 1,910 | 1,363 | 919 |
General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation expense, total | $ 4,291 | $ 4,087 | $ 3,789 |
Stock-Based Compensation - Gran
Stock-Based Compensation - Grant Date Fair Values of Options Issued to Employees and Non-employees Estimated Using Black-Scholes Option Pricing Model (Detail) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions And Methodology [Abstract] | |||
Expected term (in years) | 5 years 10 months 24 days | 6 years 7 days | 5 years 10 months 6 days |
Volatility rate | 76.28% | 73.86% | 71.40% |
Risk-free interest rate | 2.69% | 2.02% | 1.41% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Company's Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share Based Arrangements To Obtain Goods And Services [Abstract] | |||
Options outstanding, Beginning balance | 3,391,832 | ||
Options granted | 1,049,400 | ||
Options exercised | (7,850) | (46,680) | (441,573) |
Options cancelled or forfeited | (180,399) | ||
Options outstanding, Ending balance | 4,252,983 | 3,391,832 | |
Options exercisable, Ending balance | 2,794,957 | ||
Options vested, exercisable or expected to vest, Ending balance | 4,232,982 | ||
Options outstanding, Weighted Average Exercise Price, Beginning balance | $ 9.28 | ||
Options granted, Weighted Average Exercise Price | 9.37 | ||
Options exercised, Weighted Average Exercise Price | 3.33 | ||
Options canceled or forfeited, Weighted Average Exercise Price | 11.31 | ||
Options outstanding, Weighted Average Exercise Price, Ending balance | 9.23 | $ 9.28 | |
Options exercisable, Weighted Average Exercise Price, Ending balance | 8.92 | ||
Options vested, exercisable or expected to vest, Weighted Average Exercise Price, Ending balance | $ 9.22 | ||
Options outstanding, Weighted Average Remaining Contractual Term | 7 years 3 months 18 days | 7 years 8 months 12 days | |
Options exercisable, Weighted Average Remaining Contractual Term, Ending balance | 6 years 7 months 6 days | ||
Options vested, exercisable or expected to vest, Weighted Average Remaining Contractual Term, Ending balance | 7 years 3 months 18 days | ||
Options outstanding, Aggregate Intrinsic Value | $ 66 | $ 2,688 | |
Options exercisable, Aggregate Intrinsic Value | 66 | ||
Options vested, exercisable or expected to vest, Aggregate Intrinsic Value | $ 66 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Taxes [Line Items] | ||
Net tax provision | $ 0 | $ 0 |
Increase (decrease) in valuation allowance | $ 17,200,000 | $ (5,900,000) |
Valuation allowance for deferred tax assets, description | The Company has provided a valuation allowance for the full amount of the net deferred tax assets as the realization of the deferred tax assets is not determined to be more likely than not. The valuation allowance decreased by $5.9 million in 2017, due to the decrease in the federal tax rate, and increased by $17.2 million in 2018 due to the increase in deferred tax assets, primarily due to net operating loss carryforwards and capitalized research and development costs. | |
Federal net operating losses | $ 51,700,000 | |
State net operating losses | $ 27,900,000 | |
Operating loss carryforward expiration period | 2,025 | |
Federal income tax rate | 21.00% | 35.00% |
Tax Cuts and Jobs Act of 2017, accounting complete, true or false | true | |
Tax Cuts and Jobs Act of 2017, liability for the repatriation transition tax | $ 0 | |
Accumulated unrepatriated foreign earnings | 0 | |
Tax Cuts and Jobs Act of 2017, accounting complete, transition tax | 0 | $ 0 |
Tax Cuts and Jobs Act of 2017, incomplete accounting remeasurement of deferred tax asset | (28,800,000) | |
Tax Cuts and Jobs Act of 2017, incomplete accounting, reduction in deferred tax asset valuation allowance | 28,800,000 | |
Tax Cuts and Jobs act of 2017, incomplete accounting, reduction in deferred tax asset valuation allowance, net | 0 | |
Internal Revenue Service [Member] | ||
Income Taxes [Line Items] | ||
Uncertain tax positions | 200,000 | 200,000 |
Interest or penalties recorded during the period | 0 | $ 0 |
Unrecognized income tax benefits that would affect effective tax rate | 0 | |
Federal [Member] | ||
Income Taxes [Line Items] | ||
Deferred tax assets research credits | $ 2,300,000 | |
Deferred tax assets research credits expiration period | 2,021 | |
State [Member] | ||
Income Taxes [Line Items] | ||
Deferred tax assets research credits | $ 1,400,000 | |
Deferred tax assets research credits expiration period | 2,021 |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets (liabilities): | ||
Net operating loss carryforwards | $ 12,684 | $ 11,091 |
Research and development credits | 3,443 | 2,380 |
Capitalized start-up and research and development costs | 59,331 | 43,282 |
Deferred revenue | 3,690 | 3,240 |
Depreciation and amortization | (11,550) | (8,610) |
Accruals | 630 | 534 |
Other temporary differences | 3,423 | 2,530 |
Deferred tax assets before valuation allowance | 71,651 | 54,447 |
Valuation allowances | $ (71,651) | $ (54,447) |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of Company's Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns Roll Forward | |||
Unrecognized tax benefit--beginning of year | $ 163 | $ 241 | $ 241 |
Decreases related to prior period positions | 0 | (78) | 0 |
Unrecognized tax benefit--end of year | $ 163 | $ 163 | $ 241 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||||
Sep. 30, 2016USD ($)ft² | Dec. 31, 2015USD ($)ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Apr. 30, 2013USD ($) | |
Commitment And Contingencies [Line Items] | ||||||
Operating lease, rent expense | $ 800,000 | $ 800,000 | $ 400,000 | |||
Waltham, Massachusetts [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Term of contract | 5 years | |||||
Area of property leased | ft² | 12,207 | |||||
Lease commenced date | Mar. 1, 2017 | |||||
Description of lease arrangements | In September 2016, the Company entered into a five-year operating lease for 12,207 square feet of office space in Waltham, Massachusetts, with a lease commencement date of March 1, 2017, and an option to extend the lease term once for an additional three years. The Company also has an option to cancel the lease after three years with the termination fee consisting of $55,000. The lease has monthly lease payments of $25,000 the first 12 months with annual rent escalations thereafter and provides a rent abatement of $0.2 million for the first year. | |||||
Lease extension period | 3 years | |||||
Lease termination fee | $ 55,000 | |||||
Monthly lease payments | 25,000 | |||||
Rent abatement | $ 200,000 | |||||
Security deposit | $ 100,000 | |||||
New York [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Term of contract | 62 months | |||||
Area of property leased | ft² | 4,039 | |||||
Lease commenced date | Jan. 1, 2016 | |||||
Description of lease arrangements | In December 2015, the Company entered into a 62-month operating lease for 4,039 square feet of space in New York, New York, which commenced on January 1, 2016. The lease has monthly lease payments of $18,000 the first 12 months with an annual rent escalation each year thereafter and provides a rent abatement of $18,000 per month for the first two months. | |||||
Monthly lease payments | $ 18,000 | |||||
Monthly rent abatement | 18,000 | |||||
Cash-collateralized irrevocable standby letter of credit | $ 100,000 | |||||
Eddingpharm Purchase Agreement [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Purchase agreement obligation | $ 5,000,000 |
Commitments - Schedule of Futur
Commitments - Schedule of Future Annual Minimum Lease Payments (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
Operating Leases, 2019 | $ 569 |
Operating Leases, 2020 | 588 |
Operating Leases, 2021 | 395 |
Operating Leases, 2022 | 59 |
Operating Leases, 2023 | 0 |
Operating Leases, 2024 and thereafter | 0 |
Operating Leases, Total minimum lease payments | 1,611 |
Capital Lease Obligations, 2019 | 4 |
Capital Lease Obligations, 2020 | 4 |
Capital Lease Obligations, 2021 | 4 |
Capital Lease Obligations, 2022 | 1 |
Capital Lease Obligations, 2023 | 0 |
Capital Lease Obligations, 2024 and thereafter | 0 |
Capital Lease Obligations, Total minimum lease payments | 13 |
Capital Lease Obligations, Less amounts representing interest | 2 |
Capital Lease Obligations, Present value of net minimum lease payments | $ 11 |
Supplemental Cash Flow Inform_3
Supplemental Cash Flow Information - Supplemental disclosures of cash flow (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Supplemental Disclosures of Non-Cash Investing and Financing Activities: | ||
Interest paid | $ 2 | |
Accretion of dividends on convertible preferred stock | 2,598 | |
Issuance costs included in accounts payable and accrued expenses | $ 50 | |
Vesting of restricted stock | $ 59 | 42 |
Reclassification of common stock warrant liability to additional paid-in capital | 4,551 | |
Conversion of preferred stock to common stock upon closing of initial public offering | $ 328,941 |
Quarterly Financial Informati_3
Quarterly Financial Information (Unaudited) - Schedule of Quarterly Financial Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
License fees | $ 380 | $ 379 | $ 379 | $ 379 | $ 1,193 | $ 305 | $ 305 | $ 305 | $ 1,517 | $ 2,108 | $ 1,220 |
Type of revenue [extensible list] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | |||||||||||
Research and development | $ 15,821 | $ 14,095 | $ 14,851 | $ 15,339 | $ 16,599 | $ 12,188 | $ 9,862 | $ 9,552 | $ 60,106 | $ 48,201 | $ 31,665 |
General and administrative | 3,892 | 4,125 | 4,479 | 4,791 | 4,083 | 3,563 | 4,285 | 3,930 | 17,287 | 15,861 | 13,321 |
Total operating expenses | 19,713 | 18,220 | 19,330 | 20,130 | 20,682 | 15,751 | 14,147 | 13,482 | 77,393 | 64,062 | 44,986 |
Loss from operations | (19,333) | (17,841) | (18,951) | (19,751) | (19,489) | (15,446) | (13,842) | (13,177) | (75,876) | (61,954) | (43,766) |
Other income | 496 | 503 | 563 | 353 | 385 | 358 | 203 | 206 | 1,915 | 1,152 | (706) |
Net loss | $ (18,837) | $ (17,338) | $ (18,388) | $ (19,398) | $ (19,104) | $ (15,088) | $ (13,639) | $ (12,971) | $ (73,961) | $ (60,802) | $ (44,472) |
Net loss per share attributable to common stockholders—basic and diluted | $ (0.70) | $ (0.68) | $ (0.74) | $ (0.79) | $ (0.80) | $ (0.84) | $ (0.47) | $ (2.85) | $ (2.92) | $ (2.90) | $ (3.22) |
Weighted-average shares--basic and diluted | 26,804,089 | 25,471,587 | 24,705,441 | 24,478,269 | 23,943,241 | 22,239,996 | 19,497,581 | 18,231,602 | 25,371,511 | 20,997,211 | 14,619,716 |
Quarterly Financial Informati_4
Quarterly Financial Information (Unaudited) - Schedule of Quarterly Financial Information (Parenthetical) (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information [Line Items] | |||||||||||
License fees | $ 380 | $ 379 | $ 379 | $ 379 | $ 1,193 | $ 305 | $ 305 | $ 305 | $ 1,517 | $ 2,108 | $ 1,220 |
KHK License Agreement [Member] | |||||||||||
Quarterly Financial Information [Line Items] | |||||||||||
License fees | 900 | ||||||||||
Milestone payment received | 5,000 | ||||||||||
Vitae License Agreement [Member] | Research and Development Expense [Member] | |||||||||||
Quarterly Financial Information [Line Items] | |||||||||||
Upfront payment | $ 5,000 |