Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | May 08, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | SNDX | |
Entity Registrant Name | SYNDAX PHARMACEUTICALS INC | |
Entity Central Index Key | 1,395,937 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 24,705,794 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 27,981 | $ 35,168 |
Restricted cash | 100 | 106 |
Short-term investments | 85,242 | 94,806 |
Prepaid expenses and other current assets | 5,983 | 3,362 |
Total current assets | 119,306 | 133,442 |
Long-term investments | 3,246 | |
Property and equipment, net | 422 | 267 |
Other assets | 229 | 231 |
Total assets | 119,957 | 137,186 |
Current liabilities: | ||
Accounts payable | 2,590 | 2,232 |
Accrued expenses and other current liabilities | 12,800 | 11,993 |
Current portion of deferred revenue | 1,517 | 1,573 |
Total current liabilities | 16,907 | 15,798 |
Long-term liabilities: | ||
Deferred revenue, less current portion | 15,788 | 16,759 |
Other long-term liabilities | 312 | 310 |
Total long-term liabilities | 16,100 | 17,069 |
Total liabilities | 33,007 | 32,867 |
Commitments | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; 0 shares outstanding at March 31, 2018 and December 31, 2017 | ||
Common stock, $0.0001 par value, 100,000,000 shares authorized; 24,697,944 and 24,390,033 shares outstanding at March 31, 2018 and December 31, 2017, respectively | 2 | 2 |
Additional paid-in capital | 472,026 | 470,571 |
Accumulated other comprehensive loss | (218) | (143) |
Accumulated deficit | (384,860) | (366,111) |
Total stockholders’ equity | 86,950 | 104,319 |
Total liabilities and stockholders’ equity | $ 119,957 | $ 137,186 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 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 | 24,697,944 | 24,390,033 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenue: | ||
License fees | $ 379 | $ 305 |
Total revenues | 379 | 305 |
Operating expenses: | ||
Research and development | 15,339 | 9,552 |
General and administrative | 4,791 | 3,930 |
Total operating expenses | 20,130 | 13,482 |
Loss from operations | (19,751) | (13,177) |
Other income (expense): | ||
Interest income, net | 475 | 259 |
Other income (expense) | (122) | (53) |
Total other income (expense) | 353 | 206 |
Net loss | (19,398) | (12,971) |
Other comprehensive (loss) income: | ||
Unrealized (losses) gains on marketable securities | (75) | (58) |
Comprehensive loss | (19,473) | (13,029) |
Net loss attributable to common stockholders | $ (19,398) | $ (12,971) |
Net loss per share attributable to common stockholders—basic and diluted | $ (0.79) | $ (0.71) |
Weighted-average number of common shares used to compute net loss per share attributable to common stockholders—basic and diluted | 24,478,269 | 18,231,602 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (19,398) | $ (12,971) |
Adjustments to reconcile net loss to net cash from operating activities: | ||
Depreciation, amortization and accretion | (62) | 6 |
Stock-based compensation | 1,421 | 1,377 |
Other | 1 | 7 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (2,622) | (1,141) |
Accounts payable | 358 | 366 |
Deferred revenue | (379) | (305) |
Accrued expenses and other liabilities | 811 | (7) |
Net cash used in operating activities | (19,870) | (12,668) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (173) | |
Purchases of short-term investments | (11,683) | (14,081) |
Proceeds from sales and maturities of short-term investments | 24,500 | 25,095 |
Net cash provided by investing activities | 12,644 | 11,014 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from stock option exercises | 118 | |
Proceeds from Employee Stock Purchase Plan | 34 | |
Other | (1) | (1) |
Net cash provided by financing activities | 33 | 117 |
NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (7,193) | (1,537) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH—beginning of period | 35,389 | 24,110 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH —end of period | $ 28,196 | 22,573 |
SUPPLEMENTAL DISCLOSURES OF NONCASH INVESTING AND FINANCING ACTIVITIES: | ||
Issuance costs included in accounts payable and accrued expenses | 135 | |
Vesting of restricted stock | $ 11 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 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 a portfolio of potent and selective inhibitors targeting the binding interaction of Menin with MLLr. The Company plans to continue to leverage the technical and business expertise of its management team and scientific collaborators to license, acquire and develop additional cancer therapies to expand its pipeline. In 2016 and 2017, the Company raised approximately $99.0 million of net proceeds from two underwritten public offerings, including our initial public offering, (“IPO”) in March 2016. In October 2017, the Company also raised approximately $24.9 million of net proceeds through a purchase agreement with Biotech Value Fund, L.P. (“BVF”) and certain entities affiliated with BVF. 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”) 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. In 2017, we raised approximately $1.7 million of net proceeds through sales under the ATM program. As of March 31, 2018, we had cash, cash equivalents and short-term investments of $113.2 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 may be one or more years before any of our product candidates are approved, if ever, and the Company begins to generate revenue from sales of any of our product candidates. Accordingly, management expects to incur substantial losses on the ongoing development of our 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 March 31, 2018 should enable the Company to maintain its planned operations for at least 12 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 | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The Company has prepared the accompanying condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. The interim unaudited condensed financial statements have been prepared on the same basis as the annual audited financial statements and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2018, and the results of operations and comprehensive loss for the three months ended March 31, 2018 and 2017, and cash flows for the three months ended March 31, 2018 and 2017. The results for the three months ended March 31, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2017, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K that was filed with the Securities and Exchange Commission (“SEC”) on March 8, 2018. 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 condensed 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 | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Significant Accounting Policies The Company’s significant accounting policies, which are disclosed in the audited consolidated financial statements for the year ended December 31, 2017 and the notes thereto are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 8, 2018. Certain amounts reported in the previous year have been recast as a result of the retrospective adoption of new accounting standards in the first quarter of 2018. Refer to Recently Issued and Adopted Accounting Pronouncements and for further discussion. Revenue Recognition The Company adopted Accounting Standards Codification rule 606, or ASC 606, Revenue from Contracts with Customers, 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”) (the “KHK License Agreement”), under which the Company granted KHK an exclusive license to develop and commercialize entinostat in Japan and Korea. The KHK License Agreement is discussed further in Footnote 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, and license fees and royalties on sales 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. Use of Estimates The preparation of condensed 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 condensed 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. Recently Issued and Adopted Accounting Pronouncements In May 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 March 31, 2018 December 31, 2017 (In thousands) Cash and cash equivalents $ 27,981 $ 35,168 Restricted cash included in current and noncurrent assets 215 221 Cash, cash equivalents and restricted cash $ 28,196 $ 35,389 In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) In May 2014, the Financial Accounting Standards Board (FASB) issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 3 Months Ended |
Mar. 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 Topic 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 condensed consolidated balance sheet, statement of income and cash flows, as of and for the three months ended March 31, 2018, for pro-forma amounts had the previous guidance been in effect (in thousands): Financial Statement Line Item * Increase (Decrease) Condensed Consolidated Statement of Income Three months ended March 31, 2018 License fee (14 ) Net loss (14 ) Comprehensive loss (14 ) Condensed Consolidated Balance Sheet ** March 31, 2018 Current portion of deferred revenue (56 ) Deferred revenue, less current portion (579 ) Accumulated deficit 635 * 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 Condensed Consolidated Statement of Cash Flows. ** Balance sheet line item amounts include the cumulative-effect adjustment recorded on December 31, 2017. Impact to 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 March 31, 2018. Deferred revenue related to the KHK License Agreement was $17.3 million as of March 31, 2018 and will be recognized over the remainder of the contract term. The Company recognized license fees revenue of $0.4 million during the three months ended March 31, 2018 that were included in the deferred revenue balance as of January 1, 2018. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 3 Months Ended |
Mar. 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 per share attributable to common stockholders 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 all periods presented, 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: Three Months Ended March 31, 2018 2017 (In thousands, except share and per share data) Numerator—basic and diluted: Net loss $ (19,398 ) $ (12,971 ) Net loss attributable to common stockholders— basic and diluted $ (19,398 ) $ (12,971 ) Net loss per share attributable to common stockholders—basic and diluted $ (0.79 ) $ (0.71 ) Denominator—basic and diluted: Weighted-average common shares used to compute net loss per share—basic and diluted 24,478,269 18,231,602 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): March 31, 2018 2017 Options to purchase common stock 4,206,832 3,147,793 Common stock warrant — 357,840 Restricted stock subject to future vesting — 7,006 Employee Stock Purchase Plan 15,804 — |
Significant Agreements
Significant Agreements | 3 Months Ended |
Mar. 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 plc (“Allergan”), under which Allergan granted the Company an exclusive, sublicenseable, worldwide license to, a portfolio of preclinical, orally available, small molecule inhibitors of the interaction of Menin with the 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 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. UCB Biopharma Sprl In 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 investigational new drug (“IND”) ready anti-CSF-1R monoclonal antibody. The Company made a nonrefundable upfront payment of $5.0 million to UCB in 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 is 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 of these findings, in 2016, the upfront payment of $5.0 million has been recorded as research and development expense in the condensed consolidated statement of comprehensive loss. Kyowa Hakko Kirin Co., Ltd. On December 19, 2014 (the “Effective Date”), the Company entered into a license agreement (the “KHK 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. 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 license 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, 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 is providing 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. During the second quarter of 2016, the ECOG Agreement was amended to provide additional study activities and the contractual obligation increased by $0.8 million. During the first quarter of 2017, the ECOG Agreement was amended to expand the study to include enrollments from sites in Korea and to provide additional study activities and the contractual obligation increased by $2.0 million. As of March 31, 2018, the Company’s aggregate payment obligations under this agreement were approximately $24.3 million; and its remaining payment obligations are approximately $11.9 million over an estimated period of approximately four 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 U.S. Food and Drug Administration (“FDA”) or National Cancer Institute (“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 upfront 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. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 7. 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 periods 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 for any of periods presented. A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows: Fair Value Measurements Using Quoted Significant Prices Other Significant Total in Active Observable Unobservable Carrying Markets Inputs Inputs Value (Level 1) (Level 2) (Level 3) (In thousands) March 31, 2018 Assets: Cash and cash equivalents $ 27,981 $ 26,982 $ 999 $ — Short-term investments 85,242 — 85,242 — Total assets $ 113,223 $ 26,982 $ 86,241 $ — December 31, 2017 Assets: Cash and 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 $27.0 million and $25.0 million as of March 31, 2018 and December 31, 2017, respectively, 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 $1.0 million and $10.2 million as of March 31, 2018 and December 31, 2017, respectively, 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 $85.2 million and $94.8 million as of March 31, 2018 and December 31, 2017, respectively, 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 investments are classified as available-for-sale securities. As of March 30, 2018, the remaining contractual maturities of the available-for-sale securities were less than one year, 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 months ended March 31, 2018 and 2017. 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 March 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: Amortized Unrealized Unrealized Cost Gains Losses Fair Value (In thousands) March 31, 2018 Commercial paper $ 31,390 $ — $ (40 ) $ 31,350 Corporate bonds 54,070 — (178 ) $ 53,892 $ 85,460 $ — $ (218 ) $ 85,242 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 | 3 Months Ended |
Mar. 31, 2018 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | 8. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following: March 31, 2018 December 31, 2017 (In thousands) Short-term deposits $ 771 $ 1,286 Prepaid clinical supplies 2,044 220 Interest receivable on investments 325 377 Reimbursable costs 1,870 1,029 Prepaid insurance 623 192 Other 350 258 Total prepaid expenses and other current assets $ 5,983 $ 3,362 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 9. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: March 31, 2018 December 31, 2017 (In thousands) Accrued professional fees $ 540 $ 265 Accrued compensation and related costs 1,094 2,393 Accrued clinical costs 10,973 9,177 Other 193 158 Total prepaid expenses and other current assets $ 12,800 $ 11,993 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation In January 2018, the number of shares of common stock available for issuance under the 2015 Omnibus Incentive Plan (“2015 Plan”), was increased by 975,601 shares due to the automatic annual provision to increase shares available under the 2015 Plan. As of March 31, 2018, the total number of shares of common stock available for issuance under the 2015 Plan was 1,477,002. The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and related to the 2015 Employee Stock Purchase Plan (“ESPP”) in the condensed consolidated statements of comprehensive loss as follows: Three Months Ended March 31, 2018 2017 (In thousands) Research and development $ 451 $ 283 General and administrative 970 1,094 Total $ 1,421 $ 1,377 Compensation expense by type of award in the three months ended March 31, 2018 was as follows: Three Months Ended March 31, 2018 2017 (In thousands) Stock options $ 1,393 $ 1,377 Employee Stock Purchase Plan 28 — Total $ 1,421 $ 1,377 During the three months ended March 31, 2018, the Company granted 815,000 stock options to certain executives and employees. The grant date fair value of these options was $5.2 million, or $6.38 per share on a weighted-average basis, and will be recognized as compensation expense over the requisite service period of three to four years. There were no options exercised during the three months ended March 31, 2018. As of March 31, 2018, there was $12.5 million of unrecognized compensation cost related to employee and non-employee unvested stock options and unvested restricted stock share-based compensation arrangements granted under the 2015 and 2007 Plans, which is expected to be recognized over a weighted-average remaining service period of 2.8 years. Stock compensation costs have not been capitalized by the Company. |
Employee Stock Purchase Plan
Employee Stock Purchase Plan | 3 Months Ended |
Mar. 31, 2018 | |
Postemployment Benefits [Abstract] | |
Employee Stock Purchase Plan | 11. Employee Stock Purchase Plan In January 2018, the number of shares of common stock available for issuance under the ESPP, was increased by 243,900 shares as a result of the automatic increase provision of the ESPP. As of March 31, 2018, the total number of shares of common stock available for issuance under the ESPP was 667,441. The first offering period commenced on August 1, 2017 and the first purchase took place on January 31, 2018. The issued 8,696 shares during the first three months of 2018. The ESPP is considered a compensatory plan with the related compensation cost expensed over the six-month offering period. The compensation expense related to the ESPP for the three months ended March 31, 2018 was approximately $28,000. There was no compensation expense related to the ESPP recorded in the three months ended March 31, 2017. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | 12. Stockholders’ Equity The following table presents the changes in stockholders’ equity for the three months ended March 31, 2018: Common Stock $0.0001 Par Value Additional Paid-In Capital Accumulated Other Comprehensive Income Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance as of December 31, 2017 24,390,033 $ 2 $ 470,571 $ (143 ) $ (366,111 ) $ 104,319 Stock purchase under ESPP 8,696 — — — — — Stock-based compensation expense — — 1,421 — — 1,421 Stock issuance due to warrant exercise, cashless 299,215 — — — — — Unrealized losses on short-term investments — — — (75 ) — (75 ) Employee withholdings ESPP — — 34 — — 34 Cumulative effect adjustment of adoption ASU 2014-09 — — — — 649 649 Net loss — — — — (19,398 ) (19,398 ) Balance as of March 31, 2018 24,697,944 $ 2 $ 472,026 $ (218 ) $ (384,860 ) $ 86,950 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 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 net 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. In the first quarter of 2018 we completed our evaluation of the accounting for the tax effects of enactment of the Tax Cuts and Jobs Act of 2017 (the “Act”). 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%. As of December 31, 2017, the Company determined it had no accumulated unrepatriated foreign earnings, and therefore had recorded no liability for the repatriation transition tax. No changes have been made to the estimates recorded in fiscal 2017. |
Related-Party Transactions
Related-Party Transactions | 3 Months Ended |
Mar. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 14. Related-Party Transactions The Company’s chief executive officer and member of the board of directors is also a managing director at MPM Asset Management, LLC, which holds an investment in the Company’s common stock. |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Event | 15. Subsequent Event The Company considers events and transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The Company has completed an evaluation of all subsequent events through the date of this filing of this Quarterly Report on Form 10-Q. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 3 Months Ended |
Mar. 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 condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies, which are disclosed in the audited consolidated financial statements for the year ended December 31, 2017 and the notes thereto are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 8, 2018. Certain amounts reported in the previous year have been recast as a result of the retrospective adoption of new accounting standards in the first quarter of 2018. Refer to Recently Issued and Adopted Accounting Pronouncements and for further discussion. |
Revenue Recognition | Revenue Recognition The Company adopted Accounting Standards Codification rule 606, or ASC 606, Revenue from Contracts with Customers, 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”) (the “KHK License Agreement”), under which the Company granted KHK an exclusive license to develop and commercialize entinostat in Japan and Korea. The KHK License Agreement is discussed further in Footnote 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, and license fees and royalties on sales 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. |
Use of Estimates | Use of Estimates The preparation of condensed 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 condensed 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. |
Recently Issued and Adopted Accounting Pronouncements | Recently Issued and Adopted Accounting Pronouncements In May 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 March 31, 2018 December 31, 2017 (In thousands) Cash and cash equivalents $ 27,981 $ 35,168 Restricted cash included in current and noncurrent assets 215 221 Cash, cash equivalents and restricted cash $ 28,196 $ 35,389 In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) In May 2014, the Financial Accounting Standards Board (FASB) issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) |
Summary of Significant Accoun22
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 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 March 31, 2018 and December 31, 2017, as shown above: March 31, 2018 December 31, 2017 (In thousands) Cash and cash equivalents $ 27,981 $ 35,168 Restricted cash included in current and noncurrent assets 215 221 Cash, cash equivalents and restricted cash $ 28,196 $ 35,389 |
Revenue from Contracts with C23
Revenue from Contracts with Customers (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Standards Update 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 Topic 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 condensed consolidated balance sheet, statement of income and cash flows, as of and for the three months ended March 31, 2018, for pro-forma amounts had the previous guidance been in effect (in thousands): Financial Statement Line Item * Increase (Decrease) Condensed Consolidated Statement of Income Three months ended March 31, 2018 License fee (14 ) Net loss (14 ) Comprehensive loss (14 ) Condensed Consolidated Balance Sheet ** March 31, 2018 Current portion of deferred revenue (56 ) Deferred revenue, less current portion (579 ) Accumulated deficit 635 * 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 Condensed Consolidated Statement of Cash Flows. ** Balance sheet line item amounts include the cumulative-effect adjustment recorded on December 31, 2017. |
Net Loss per Share Attributab24
Net Loss per Share Attributable to Common Stockholders (Tables) | 3 Months Ended |
Mar. 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: Three Months Ended March 31, 2018 2017 (In thousands, except share and per share data) Numerator—basic and diluted: Net loss $ (19,398 ) $ (12,971 ) Net loss attributable to common stockholders— basic and diluted $ (19,398 ) $ (12,971 ) Net loss per share attributable to common stockholders—basic and diluted $ (0.79 ) $ (0.71 ) Denominator—basic and diluted: Weighted-average common shares used to compute net loss per share—basic and diluted 24,478,269 18,231,602 |
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): March 31, 2018 2017 Options to purchase common stock 4,206,832 3,147,793 Common stock warrant — 357,840 Restricted stock subject to future vesting — 7,006 Employee Stock Purchase Plan 15,804 — |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 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: Fair Value Measurements Using Quoted Significant Prices Other Significant Total in Active Observable Unobservable Carrying Markets Inputs Inputs Value (Level 1) (Level 2) (Level 3) (In thousands) March 31, 2018 Assets: Cash and cash equivalents $ 27,981 $ 26,982 $ 999 $ — Short-term investments 85,242 — 85,242 — Total assets $ 113,223 $ 26,982 $ 86,241 $ — December 31, 2017 Assets: Cash and 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: Amortized Unrealized Unrealized Cost Gains Losses Fair Value (In thousands) March 31, 2018 Commercial paper $ 31,390 $ — $ (40 ) $ 31,350 Corporate bonds 54,070 — (178 ) $ 53,892 $ 85,460 $ — $ (218 ) $ 85,242 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 Cu26
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 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: March 31, 2018 December 31, 2017 (In thousands) Short-term deposits $ 771 $ 1,286 Prepaid clinical supplies 2,044 220 Interest receivable on investments 325 377 Reimbursable costs 1,870 1,029 Prepaid insurance 623 192 Other 350 258 Total prepaid expenses and other current assets $ 5,983 $ 3,362 |
Accrued Expenses and Other Cu27
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following: March 31, 2018 December 31, 2017 (In thousands) Accrued professional fees $ 540 $ 265 Accrued compensation and related costs 1,094 2,393 Accrued clinical costs 10,973 9,177 Other 193 158 Total prepaid expenses and other current assets $ 12,800 $ 11,993 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 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 and Related to the 2015 Employee Stock Purchase Plan (“ESPP”) | The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and related to the 2015 Employee Stock Purchase Plan (“ESPP”) in the condensed consolidated statements of comprehensive loss as follows: Three Months Ended March 31, 2018 2017 (In thousands) Research and development $ 451 $ 283 General and administrative 970 1,094 Total $ 1,421 $ 1,377 |
Compensation Expense by Type of Award | Compensation expense by type of award in the three months ended March 31, 2018 was as follows: Three Months Ended March 31, 2018 2017 (In thousands) Stock options $ 1,393 $ 1,377 Employee Stock Purchase Plan 28 — Total $ 1,421 $ 1,377 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Equity [Abstract] | |
Summary of Changes in Stockholders' Equity | The following table presents the changes in stockholders’ equity for the three months ended March 31, 2018: Common Stock $0.0001 Par Value Additional Paid-In Capital Accumulated Other Comprehensive Income Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance as of December 31, 2017 24,390,033 $ 2 $ 470,571 $ (143 ) $ (366,111 ) $ 104,319 Stock purchase under ESPP 8,696 — — — — — Stock-based compensation expense — — 1,421 — — 1,421 Stock issuance due to warrant exercise, cashless 299,215 — — — — — Unrealized losses on short-term investments — — — (75 ) — (75 ) Employee withholdings ESPP — — 34 — — 34 Cumulative effect adjustment of adoption ASU 2014-09 — — — — 649 649 Net loss — — — — (19,398 ) (19,398 ) Balance as of March 31, 2018 24,697,944 $ 2 $ 472,026 $ (218 ) $ (384,860 ) $ 86,950 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) $ in Millions | 1 Months Ended | 12 Months Ended | 24 Months Ended | ||
Oct. 31, 2017USD ($) | Apr. 30, 2017USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2017USD ($) | Mar. 31, 2018USD ($)UnderwrittenPublicOffering | |
Nature of Business [Line Items] | |||||
Proceeds from public stock offerings | $ 24.9 | $ 99 | |||
Number of underwritten public offerings | UnderwrittenPublicOffering | 2 | ||||
Cash, cash equivalents and short-term investments | $ 113.2 | ||||
At The Market Equity Offering Sales Agreement [Member] | |||||
Nature of Business [Line Items] | |||||
Proceeds from public stock offerings | $ 1.7 | ||||
Cowen and Company LLC [Member] | At The Market Equity Offering Sales Agreement [Member] | |||||
Nature of Business [Line Items] | |||||
Proceeds from public stock offerings | $ 50 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash Balances (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | Mar. 31, 2017 | Dec. 31, 2016 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 27,981 | $ 35,168 | ||
Restricted cash included in current and noncurrent assets | 215 | 221 | ||
Cash, cash equivalents and restricted cash | $ 28,196 | $ 35,389 | $ 22,573 | $ 24,110 |
Revenue from Contracts with C32
Revenue from Contracts with Customers - Schedule of Impact on Consolidated Balance Sheet of Adopting ASC 606 (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Current liabilities: | |||
Current portion of deferred revenue | $ 1,517 | $ 1,573 | |
Total current liabilities | 16,907 | 15,798 | |
Long-term liabilities: | |||
Deferred revenue, less current portion | 15,788 | 16,759 | |
Total long-term liabilities | 16,100 | 17,069 | |
Total liabilities | 33,007 | 32,867 | |
Stockholders’ equity: | |||
Accumulated deficit | (384,860) | (366,111) | |
Total stockholders’ equity | 86,950 | 104,319 | |
Total liabilities and stockholders’ equity | $ 119,957 | $ 137,186 | |
Accounting Standards Update 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 | ||
Accounting Standards Update 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 C33
Revenue from Contracts with Customers - Schedule of Impact of New Revenue Guidance on Financial Statement Line Items (Detail) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2018 | Mar. 31, 2017 | Jan. 01, 2018 | Dec. 31, 2017 | |
Condensed Consolidated Statement of Income | ||||
License fees | $ 379 | $ 305 | ||
Net loss | (19,398) | (12,971) | ||
Comprehensive loss | (19,473) | $ (13,029) | ||
Condensed Consolidated Balance Sheet | ||||
Current portion of deferred revenue | 1,517 | $ 1,573 | ||
Deferred revenue, less current portion | 15,788 | 16,759 | ||
Accumulated deficit | (384,860) | $ (366,111) | ||
Accounting Standards Update 2014-09 [Member] | ||||
Condensed Consolidated Balance Sheet | ||||
Current portion of deferred revenue | $ 1,517 | |||
Deferred revenue, less current portion | 16,166 | |||
Accumulated deficit | $ (365,462) | |||
Accounting Standards Update 2014-09 [Member] | Pro Forma had the Previous Accounting Been in Effect [Member] | ||||
Condensed Consolidated Statement of Income | ||||
License fees | (14) | |||
Net loss | (14) | |||
Comprehensive loss | (14) | |||
Condensed Consolidated Balance Sheet | ||||
Current portion of deferred revenue | (56) | |||
Deferred revenue, less current portion | (579) | |||
Accumulated deficit | $ 635 |
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 | |
Dec. 31, 2017 | Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 | |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||
Licenses fees revenue | $ 379 | $ 305 | ||
Kyowa Hakko Kirin Co., Ltd. [Member] | ||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||
Milestone payment received | $ 5,000 | |||
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 | |||
Performance obligation period | 2,029 | |||
Milestone payment received | $ 5,000 | |||
Deferred revenue | $ 17,300 | |||
Licenses fees revenue | $ 400 |
Net Loss per Share Attributab35
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 | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Numerator—basic and diluted: | ||
Net loss | $ (19,398) | $ (12,971) |
Net loss attributable to common stockholders— basic and diluted | $ (19,398) | $ (12,971) |
Net loss per share attributable to common stockholders—basic and diluted | $ (0.79) | $ (0.71) |
Denominator—basic and diluted: | ||
Weighted-average number of common shares used to compute net loss per share attributable to common stockholders—basic and diluted | 24,478,269 | 18,231,602 |
Net Loss per Share Attributab36
Net Loss per Share Attributable to Common Stockholders - Potential Dilutive Securities Excluded from Computation of Diluted Net Loss per Common Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
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 | 4,206,832 | 3,147,793 |
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 | |
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 | 7,006 | |
Employee Stock Purchase Plan [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 | 15,804 |
Significant Agreements - Additi
Significant Agreements - Additional Information (Detail) - USD ($) | Mar. 01, 2018 | Dec. 31, 2017 | Oct. 31, 2017 | Dec. 19, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2007 | Mar. 31, 2007 | Mar. 31, 2018 | Dec. 31, 2017 | Mar. 31, 2017 | Jun. 30, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2017 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||
Research and development expense | $ 15,339,000 | $ 9,552,000 | |||||||||||||
Proceeds from public stock offerings | $ 24,900,000 | $ 99,000,000 | |||||||||||||
Common Stock [Member] | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||
Issuance of common stock upon utilizing net exercise feature of warrant | 299,215 | ||||||||||||||
Kyowa Hakko Kirin Co., Ltd. [Member] | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||
Milestone payment received | $ 5,000,000 | ||||||||||||||
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 equity purchase | $ 7,700,000 | ||||||||||||||
Up-front payment allocated to license fee | 17,300,000 | ||||||||||||||
Milestone payment received | $ 5,000,000 | ||||||||||||||
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 exercisable | $ 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 | $ 2,000,000 | $ 800,000 | |||||||||||||
Aggregate payment obligation | $ 24,300,000 | ||||||||||||||
Remaining contractual obligation | $ 11,900,000 | ||||||||||||||
Period of contractual obligation | 4 years |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Values of Financial Assets and Liabilities Measured at Fair Value (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 85,242 | $ 94,806 |
Long-term investments | 3,246 | |
Carrying Value [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 27,981 | 35,168 |
Short-term investments | 85,242 | 94,806 |
Long-term investments | 3,246 | |
Total assets | 113,223 | 133,220 |
Quoted Prices in Active Markets Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 26,982 | 24,972 |
Total assets | 26,982 | 24,972 |
Significant Other Observable Inputs Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 999 | 10,196 |
Short-term investments | 85,242 | 94,806 |
Long-term investments | 3,246 | |
Total assets | $ 86,241 | $ 108,248 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 | |
Fair Value Measurements [Line Items] | |||
Available for sale debt securities fair value | $ 85,242,000 | $ 108,248,000 | |
Realized gains or losses recognized on the sale or maturity of available-for-sale securities | 0 | $ 0 | |
Quoted Prices in Active Markets Level 1 [Member] | |||
Fair Value Measurements [Line Items] | |||
Cash equivalents fair value | 26,982,000 | 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 | 27,000,000 | 25,000,000 | |
Significant Other Observable Inputs Level 2 [Member] | |||
Fair Value Measurements [Line Items] | |||
Cash equivalents fair value | 999,000 | 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 | 1,000,000 | 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 | $ 85,200,000 | 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 | Mar. 31, 2018 | Dec. 31, 2017 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 85,460 | $ 108,391 |
Unrealized Losses | (218) | (143) |
Fair Value | 85,242 | 108,248 |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 31,390 | 36,567 |
Unrealized Losses | (40) | (40) |
Fair Value | 31,350 | 36,527 |
Corporate Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 54,070 | 71,824 |
Unrealized Losses | (178) | (103) |
Fair Value | $ 53,892 | $ 71,721 |
Prepaid Expenses and Other Cu41
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Short-term deposits | $ 771 | $ 1,286 |
Prepaid clinical supplies | 2,044 | 220 |
Interest receivable on investments | 325 | 377 |
Reimbursable costs | 1,870 | 1,029 |
Prepaid insurance | 623 | 192 |
Other | 350 | 258 |
Total prepaid expenses and other current assets | $ 5,983 | $ 3,362 |
Accrued Expenses and Other Cu42
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Accrued professional fees | $ 540 | $ 265 |
Accrued compensation and related costs | 1,094 | 2,393 |
Accrued clinical costs | 10,973 | 9,177 |
Other | 193 | 158 |
Total prepaid expenses and other current assets | $ 12,800 | $ 11,993 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |
Mar. 31, 2018 | Jan. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock options exercised, shares | 0 | |
2015 Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares available for issuance | 975,601 | |
2015 Plan [Member] | Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares available for issuance | 1,477,002 | |
2007 Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock option granted to certain executives and employees | 815,000 | |
Options grant date fair value amount | $ 5.2 | |
Weighted average grant date fair value of options | $ 6.38 | |
2015 and 2007 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense related to stock option | $ 12.5 | |
Weighted average period to recognize compensation expense | 2 years 9 months 18 days |
Stock-Based Compensation - Shar
Stock-Based Compensation - Share Based Compensation Expense Related to Issuance of Stock Option Awards to Employees and Non Employees (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | $ 1,421 | $ 1,377 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | 451 | 283 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | $ 970 | $ 1,094 |
Stock-Based Compensation - Comp
Stock-Based Compensation - Compensation Expense by Type of Award (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | $ 1,421,000 | $ 1,377,000 |
Options to Purchase Common Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | 1,393,000 | 1,377,000 |
Employee Stock Purchase Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | $ 28,000 | $ 0 |
Employee Stock Purchase Plan -
Employee Stock Purchase Plan - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | |
Jan. 31, 2018 | Mar. 31, 2018 | Mar. 31, 2017 | |
Employee Benefit Plans [Line Items] | |||
Compensation expense | $ 1,421,000 | $ 1,377,000 | |
Employee Stock Purchase Plan [Member] | |||
Employee Benefit Plans [Line Items] | |||
Common stock available for issuance | 243,900 | ||
Number of shares issued under plan | 8,696 | ||
Compensation expense | $ 28,000 | $ 0 | |
Employee Stock Purchase Plan [Member] | Maximum [Member] | |||
Employee Benefit Plans [Line Items] | |||
Common stock available for issuance | 667,441 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Changes in Stockholders' Equity (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Class of Stock [Line Items] | ||
Beginning balance | $ 104,319 | |
Stock-based compensation expense | 1,421 | |
Unrealized losses on short-term investments | (75) | $ (58) |
Employee withholdings ESPP | 34 | |
Cumulative effect adjustment of adoption ASU 2014-09 | 649 | |
Net loss | (19,398) | $ (12,971) |
Ending balance | 86,950 | |
Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Beginning balance | $ 2 | |
Beginning balance, Shares | 24,390,033 | |
Stock purchase under ESPP, Shares | 8,696 | |
Stock issuance due to warrant exercise, cashless, Shares | 299,215 | |
Ending balance | $ 2 | |
Ending balance, Shares | 24,697,944 | |
Additional Paid-In Capital [Member] | ||
Class of Stock [Line Items] | ||
Beginning balance | $ 470,571 | |
Stock-based compensation expense | 1,421 | |
Employee withholdings ESPP | 34 | |
Ending balance | 472,026 | |
Accumulated Other Comprehensive Income [Member] | ||
Class of Stock [Line Items] | ||
Beginning balance | (143) | |
Unrealized losses on short-term investments | (75) | |
Ending balance | (218) | |
Accumulated Deficit [Member] | ||
Class of Stock [Line Items] | ||
Beginning balance | (366,111) | |
Cumulative effect adjustment of adoption ASU 2014-09 | 649 | |
Net loss | (19,398) | |
Ending balance | $ (384,860) |
Stockholders' Equity - Summar48
Stockholders' Equity - Summary of Changes in Stockholders' Equity (Parenthetical) (Detail) - $ / shares | Mar. 31, 2018 | Dec. 31, 2017 |
Equity [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Net tax provision | $ 0 | $ 0 | |
Federal income tax rate | 21.00% | 35.00% | |
Tax Cuts and Jobs Act of 2017, accounting complete, true or false | true | ||
Accumulated unrepatriated foreign earnings | $ 0 | ||
Tax Cuts and Jobs Act of 2017, liability for repartriated transition tax | $ 0 |