Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 25, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | SNDX | ||
Entity Registrant Name | Syndax Pharmaceuticals, Inc. | ||
Entity Central Index Key | 0001395937 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Title of 12(b) Security | Common Stock | ||
Entity Common Stock, Shares Outstanding | 55,012,245 | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Entity File Number | 001-37708 | ||
Entity Tax Identification Number | 32-0162505 | ||
Entity Address, Address Line One | 35 Gatehouse Drive | ||
Entity Address, Address Line Two | Building D | ||
Entity Address, Address Line Three | Floor 3 | ||
Entity Address, City or Town | Waltham | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02451 | ||
City Area Code | 781 | ||
Local Phone Number | 419-1400 | ||
Entity Interactive Data Current | Yes | ||
Entity Incorporation, State or Country Code | DE | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Security Exchange Name | NASDAQ | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | Yes | ||
ICFR Auditor Attestation Flag | true | ||
Entity Public Float | $ 833.4 | ||
Auditor Name | Deloitte & Touche LLP | ||
Auditor Location | New York, New York | ||
Auditor Firm ID | 34 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement for its 2022 Annual Meeting of Stockholders, which the registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year ended December 31, 2021, are incorporated by reference into Part III of this Annual Report on Form 10-K. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 221,965,000 | $ 115,243,000 |
Restricted cash | 115,000 | 115,000 |
Short-term investments | 217,971,000 | 177,822,000 |
Prepaid expenses and other current assets | 8,345,000 | 5,684,000 |
Total current assets | 448,396,000 | 298,864,000 |
Property and equipment, net | 278,000 | 192,000 |
Right-of-use asset | 983,000 | 290,000 |
Other assets | 1,267,000 | |
Total assets | 449,657,000 | 300,613,000 |
Current liabilities: | ||
Accounts payable | 5,669,000 | 3,508,000 |
Accrued expenses and other current liabilities | 14,466,000 | 11,246,000 |
Current portion of deferred revenue | 1,517,000 | |
Current portion of right-of-use liability | 361,000 | 316,000 |
Current portion of term loan | 2,285,000 | |
Derivative liability | 187,000 | |
Total current liabilities | 20,683,000 | 18,872,000 |
Long-term liabilities: | ||
Deferred revenue, less current portion | 11,617,000 | |
Right-of-use liability, less current portion | 711,000 | 101,000 |
Term loan, less current portion | 19,894,664 | 17,834,000 |
Other long-term liabilities | 1,000 | |
Total long-term liabilities | 20,606,000 | 29,553,000 |
Total liabilities | 41,289,000 | 48,425,000 |
Commitments, contingencies and guarantees (Note 16) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; 0 shares outstanding at December 31, 2021 and December 31, 2020, respectively | ||
Common stock, $0.0001 par value, 100,000,000 shares authorized; 54,983,105 and 47,881,223 shares outstanding at December 31, 2021 and December 31, 2020, respectively | 6,000 | 5,000 |
Additional paid-in capital | 952,019,000 | 820,815,000 |
Accumulated other comprehensive loss | 45,000 | (4,000) |
Accumulated deficit | (543,702,000) | (568,628,000) |
Total stockholders' equity | 408,368,000 | 252,188,000 |
Total liabilities and stockholders' equity | $ 449,657,000 | $ 300,613,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
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 | 54,983,105 | 47,881,223 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues: | |||
Total revenues | $ 139,709 | $ 1,517 | $ 1,517 |
Type of revenue [extensible list] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | |||
Research and development | $ 88,248 | $ 50,435 | $ 42,994 |
General and administrative | 25,241 | 22,505 | 16,062 |
Total operating expenses | 113,489 | 72,940 | 59,056 |
Income (loss) from operations | 26,220 | (71,423) | (57,539) |
Other (expense) income: | |||
Interest expense | (1,899) | (2,357) | |
Interest income | 403 | 841 | 1,571 |
Other (expense) income: | 202 | (219) | (79) |
Total other (expense) income | (1,294) | (1,735) | 1,492 |
Net income (loss) | 24,926 | (73,158) | (56,047) |
Net income (loss) attributable to common stockholders | $ 24,926 | $ (77,064) | $ (56,047) |
Net income (loss) Per Share: | |||
Basic earnings (loss) per share attributable to common stockholders | $ 0.48 | $ (1.87) | $ (1.84) |
Diluted earnings (loss) per share attributable to common stockholders | $ 0.46 | $ (1.87) | $ (1.84) |
Weighted-average common shares used in calculating: | |||
Basic earnings (loss) per share attributable to common stockholders | 52,064,809 | 41,308,242 | 30,490,783 |
Diluted earnings (loss) per share attributable to common stockholders | 53,622,904 | 41,308,242 | 30,490,783 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net income (loss) | $ 24,926 | $ (73,158) | $ (56,047) |
Other comprehensive gain (loss): | |||
Unrealized gains (losses) on marketable securities, net of tax | 49 | (4) | 25 |
Comprehensive income (loss) | $ 24,975 | $ (73,162) | $ (56,022) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Direct Placement Offering [Member] | Follow-on Public Offering One [Member] | Follow-on Public Offering Two [Member] | Incyte Share Purchase Agreement [Member] | Common Stock [Member] | Common Stock [Member]Direct Placement Offering [Member] | Common Stock [Member]Follow-on Public Offering One [Member] | Common Stock [Member]Follow-on Public Offering Two [Member] | Common Stock [Member]Incyte Share Purchase Agreement [Member] | Additional Paid-In Capital [Member] | Additional Paid-In Capital [Member]Direct Placement Offering [Member] | Additional Paid-In Capital [Member]Follow-on Public Offering One [Member] | Additional Paid-In Capital [Member]Follow-on Public Offering Two [Member] | Additional Paid-In Capital [Member]Incyte Share Purchase Agreement [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2018 | $ 53,047 | $ 2 | $ 492,493 | $ (25) | $ (439,423) | ||||||||||||
Beginning balance, Shares at Dec. 31, 2018 | 24,835,951 | ||||||||||||||||
Proceeds from "At-the-market" offering, net, Value | 830 | 830 | |||||||||||||||
Proceeds from "At-the-market" offering, net, Shares | 140,819 | ||||||||||||||||
Proceeds from direct offering, net, value | 10,902 | $ 1 | 10,901 | ||||||||||||||
Proceeds from direct offering,net, Shares | 2,095,039 | ||||||||||||||||
Proceeds from pre-funded common stock warrant from direct offering, net, value | 13,032 | 13,032 | |||||||||||||||
Issuance of common stock warrant with direct offering, value | 3,446 | 3,446 | |||||||||||||||
Stock purchase under ESPP, Shares | 42,818 | ||||||||||||||||
Stock-based compensation expense | 6,005 | 6,005 | |||||||||||||||
Unrealized gains (losses) on short-term investments | 25 | 25 | |||||||||||||||
Employee withholdings ESPP | 182 | 182 | |||||||||||||||
Proceeds from exercise of stock options | $ 178 | 178 | |||||||||||||||
Proceeds from exercise of stock options, Shares | 25,857 | 25,857 | |||||||||||||||
Net income (loss) | $ (56,047) | (56,047) | |||||||||||||||
Ending balance at Dec. 31, 2019 | 31,600 | $ 3 | 527,067 | (495,470) | |||||||||||||
Ending balance, Shares at Dec. 31, 2019 | 27,140,484 | ||||||||||||||||
Proceeds from direct offering, net, value | $ 24,201 | $ 107,868 | $ 134,981 | $ 1 | $ 1 | $ 24,201 | $ 107,867 | $ 134,980 | |||||||||
Proceeds from direct offering,net, Shares | 3,036,719 | 6,388,889 | 6,250,000 | ||||||||||||||
Proceeds from pre-funded common stock warrant from direct offering, net, value | 10,665 | 10,665 | |||||||||||||||
Proceeds from pre-funded common stock warrant from direct offering, net, Shares | 2,280,318 | ||||||||||||||||
Deemed dividend from repricing Series 1 and 2 warrants | 3,906 | 3,906 | |||||||||||||||
Repricing Series 1 and 2 warrants | (3,906) | (3,906) | |||||||||||||||
Stock purchase under ESPP, Shares | 33,706 | ||||||||||||||||
Stock-based compensation expense | 9,057 | 9,057 | |||||||||||||||
Unrealized gains (losses) on short-term investments | (4) | (4) | |||||||||||||||
Exercise of Series 1 and Series 2 warrants, Shares | 1,995,941 | ||||||||||||||||
Employee withholdings ESPP | 345 | 345 | |||||||||||||||
Proceeds from exercise of stock options | $ 6,633 | 6,633 | |||||||||||||||
Proceeds from exercise of stock options, Shares | 755,166 | 755,166 | |||||||||||||||
Net income (loss) | $ (73,158) | (73,158) | |||||||||||||||
Ending balance at Dec. 31, 2020 | 252,188 | $ 5 | 820,815 | (4) | (568,628) | ||||||||||||
Ending balance, Shares at Dec. 31, 2020 | 47,881,223 | ||||||||||||||||
Proceeds from "At-the-market" offering, net, Value | 5,131 | 5,131 | |||||||||||||||
Proceeds from "At-the-market" offering, net, Shares | 277,629 | ||||||||||||||||
Proceeds from direct offering, net, value | $ 81,206 | $ 1 | $ 81,205 | ||||||||||||||
Proceeds from direct offering,net, Shares | 3,802,144 | ||||||||||||||||
Proceeds from pre-funded common stock warrant from direct offering, net, Shares | 725,784 | ||||||||||||||||
Stock purchase under ESPP, Shares | 26,878 | ||||||||||||||||
Proceeds from Incyte Share Purchase Agreement | $ 24,848 | $ 24,848 | |||||||||||||||
Proceeds from Incyte Share Purchase Agreement, Shares | 1,421,523 | ||||||||||||||||
Stock-based compensation expense | 13,317 | 13,317 | |||||||||||||||
Unrealized gains (losses) on short-term investments | 49 | 49 | |||||||||||||||
Vesting of RSU,Shares | 5,500 | ||||||||||||||||
Employee withholdings ESPP | 367 | 367 | |||||||||||||||
Proceeds from exercise of stock options | $ 6,336 | 6,336 | |||||||||||||||
Proceeds from exercise of stock options, Shares | 842,424 | 842,424 | |||||||||||||||
Net income (loss) | $ 24,926 | 24,926 | |||||||||||||||
Ending balance at Dec. 31, 2021 | $ 408,368 | $ 6 | $ 952,019 | $ 45 | $ (543,702) | ||||||||||||
Ending balance, Shares at Dec. 31, 2021 | 54,983,105 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 |
At-the-market, offering expenses | $ 34 | ||
Direct offering, common stock warrants | 1,571 | ||
Direct offering, offering expenses | 98 | ||
Pre-funded common stock warrants | 1,875 | ||
Pre-funded common stock warrants offering expenses | $ 159 | $ 41 | $ 93 |
Direct Placement Offering [Member] | |||
Direct offering, offering expenses | $ 5,332 | 93 | |
Follow-on Public Offering One [Member] | |||
Direct offering, offering expenses | 7,132 | ||
Follow-on Public Offering Two [Member] | |||
Direct offering, offering expenses | $ 8,770 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows | 12 Months Ended | ||
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net income (loss) | $ 24,926,000 | $ (73,158,000) | $ (56,047,000) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation | 43,000 | 89,000 | 92,000 |
Amortization and accretion of investments | 644,000 | (130,000) | (780,000) |
Non-cash operating lease expense | 413,000 | 426,000 | 359,000 |
Non-cash interest expense | (225,000) | 389,000 | |
Changes in fair value of derivate liability | (389,000) | ||
Stock-based compensation | 13,317,000 | 9,057,000 | 6,005,000 |
Other | (1,000) | 1,000 | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other assets | (1,394,000) | (4,314,000) | (52,000) |
Accounts payable | 2,161,000 | (2,670,000) | 4,739,000 |
Deferred revenue | (13,133,000) | (1,517,000) | (1,517,000) |
Accrued expenses and other liabilities | 2,769,000 | 567,000 | (3,411,000) |
Net cash provided by (used in) operating activities | 29,131,000 | (71,260,000) | (50,612,000) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property and equipment | (129,000) | ||
Purchases of short-term investments | (294,719,000) | (278,937,000) | (104,018,000) |
Proceeds from sales and maturities of short-term investments | 253,975,000 | 136,407,000 | 116,799,000 |
Net cash (used in) provided by investing activities | (40,873,000) | (142,530,000) | 12,781,000 |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from term loan agreement, net | 19,730,000 | ||
Proceeds from Employee Stock Purchase Plan | 367,000 | 345,000 | 182,000 |
Proceeds from exercise of stock options | 6,336,000 | 6,633,000 | 178,000 |
Other | 1,000 | ||
Net cash provided by financing activities | 118,464,000 | 304,424,000 | 28,570,000 |
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 106,722,000 | 90,634,000 | (9,261,000) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH—beginning of year | 115,358,000 | 24,724,000 | 33,985,000 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH—end of year | 222,080,000 | 115,358,000 | 24,724,000 |
Cash and cash equivalents | 221,965,000 | 115,243,000 | 24,609,000 |
Restricted cash included in current and noncurrent assets | 115,000 | 115,000 | 115,000 |
Incyte Share Purchase Agreement [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock, net | 24,848,000 | ||
Follow-on Public Offerings [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock, net | 81,206,000 | 242,849,000 | |
At-the-Market Offering [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock, net | 5,131,000 | 830,000 | |
Derivative Liability [Member] | Incyte Share Purchase Agreement [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock, net | $ 576,000 | ||
Private Placement [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock, net | $ 34,866,000 | $ 27,380,000 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business | 1. Nature of Business Syndax Pharmaceuticals, Inc. (“the Company” or “Syndax”) is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company is developing SNDX-5613, targeting the binding interaction of menin with the mixed lineage leukemia 1 (MLL1) protein for the treatment of MLL-rearranged, or MLLr, acute leukemias and nucleophosmin 1, or NPM1, mutant acute myeloid leukemia (AML), as well as axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1, or CSF-1 receptor. The Company has deprioritized the development of entinostat, a once-weekly, oral, small molecule, Class I HDAC inhibitor, to focus resources on advancing the remainder of our pipeline. 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. Since its inception, the Company has devoted its efforts principally to research and development and raising capital. The Company is subject to risks common to companies in the development stage, including, but not limited to, successful development of therapeutics, obtaining additional funding, protection of proprietary therapeutics, compliance with government regulations, fluctuations in operating results, dependence on key personnel and collaborative partners, and risks associated with industry changes. The Company’s long-term success is dependent upon its ability to successfully develop and market its product candidates, expand its oncology drug pipeline, earn revenue, obtain additional capital when needed, and ultimately, achieve profitable operations. The Company anticipates that it will be several years before any of its product candidates is approved, if ever, and the Company begins to generate revenue from sales of such product candidates. Accordingly, management expects to incur substantial losses on the ongoing development of its product candidates and does not expect to achieve positive cash flow from operations for the foreseeable future, if ever. As a result, the Company will continue to require additional capital to move forward with its business plan. While certain amounts of this additional capital were raised in the past, there can be no assurance that funds necessary beyond these amounts will be available in amounts or on terms sufficient to ensure ongoing operations. The Company’s management believes that the cash, cash equivalents and short-term investments balances as of December 31, 2021, should enable the Company to maintain its planned operations for at least twelve months from the date these financial statements were issued. The Company’s ability to fund all of its planned operations internally beyond that date, including the completion of its ongoing and planned clinical trial activities, may be substantially dependent upon whether the Company can obtain sufficient funding on terms acceptable to the Company. Proceeds from additional capital transactions would allow the Company to accelerate and/or expand its planned research and development activities. In the event that sufficient funds were not available, the Company may be required to delay or reduce expenditures to conserve cash, which could involve scaling back or curtailing development and general and administrative activities. With the global spread of the ongoing COVID-19 pandemic in 2021, the Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on its business. The Company anticipates that the COVID-19 pandemic could have an impact on the clinical development timelines for one or more of its clinical programs. The extent to which the COVID-19 pandemic impacts the Company’s business, clinical development, manufacturing of clinical and commercial drug substance and drug product, and regulatory efforts, the corporate development objectives and the value of and market for the Company’s common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States, Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on its business, financial condition, results of operations and growth prospects. In addition, the Company is subject to other challenges and risks specific to its business and ability to execute on the strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of the Company’s late-stage product candidate; delays or problems in the supply of the Company’s products, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing the Company’s intellectual property rights; complying with applicable regulatory requirements. In addition, to the extent the ongoing COVID-19 pandemic adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above . |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The Company has prepared the accompanying consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of costs and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements. Cash Equivalents Cash equivalents include all highly liquid investments maturing within 90 days or less from the date of purchase. Cash equivalents include money market funds, corporate debt securities, U.S. government agency notes, and overnight deposits. Restricted Cash The Company classifies as restricted cash all cash pledged as collateral to secure long-term obligations and all cash whose use is otherwise limited by contractual provisions. Amounts are reported as non-current unless restrictions are expected to be released in the next 12 months. Short-Term Investments Short-term investments include marketable securities with maturities of less than one year or where management’s intent is to use the investments to fund current operations or to make them available for current operations. All investments in marketable securities are classified as available-for-sale and are reported at fair value with unrealized gains and losses excluded from earnings and reported net of tax in accumulated other comprehensive income, which is a component of stockholders’ equity. Unrealized losses that are determined to be other-than-temporary, based on current and expected market conditions, are recognized in earnings. Declines in fair value determined to be credit related are charged to earnings. The cost of marketable securities sold is determined by the specific identification method. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. The Company has one operating segment. Concentrations of Credit Risk Cash and cash equivalents, restricted cash, and short-term investments are financial instruments that potentially subject the Company to concentrations of credit risk. Substantially all of the Company’s cash, cash equivalents, and short-term investments were deposited in accounts at two financial institutions, and at times, such deposits may exceed federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company’s available-for-sale investments primarily consist of government money market funds, corporate debt securities, commercial paper, credit card asset-backed securities and overnight deposits and potentially subject the Company to concentrations of credit risk. Property and Equipment Property and equipment are recorded at cost. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets (three to five years). Assets under capital leases are amortized over the shorter of their useful lives or lease term using the straight-line method. Major replacements and improvements are capitalized, while general repairs and maintenance are expensed as incurred. Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If this comparison indicates that there is impairment, the amount of impairment is calculated as the difference between the carrying value and fair value. To date, no such impairments have been recognized. Debt Issuance Cost Debt issuance costs consist of payments made to secure commitments under certain debt financing arrangements. These amounts are recognized as interest expense over the period of the financing arrangement using the effective interest method. If the financing arrangement is cancelled or forfeited, or if the utility of the arrangement to the Company is otherwise compromised, these costs are recognized as interest expense immediately. The Company’s consolidated financial statements present debt issuance costs related to a recognized debt liability as a direct reduction from the carrying amount of that debt liability. Derivative Financial Instruments The Company accounts for derivative financial instruments as either equity or liabilities in accordance with Accounting Standards Codification Topic 815, Derivatives and Hedging Revenue Recognition The Company enters into license agreements for the development and commercialization of its product candidates. License agreements may include non-refundable upfront payments, contingent payments based on the occurrence of specified events under the Company’s license arrangements, partial or complete reimbursement of research and development expenses, license fees and royalties on sales of entinostat if they are successfully approved and commercialized. The Company’s performance obligations under the license agreements may include the transfer 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. The Company recognizes revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. We recognize revenue following the five – step model prescribed under FASB Accounting Standards Codification ( ASC 606), Revenue from Contracts with Customers : (i) identify contract(s) with customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligations. 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. 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. For additional information on our collaboration and license arrangements, please read Note 4, Collaboration and License Agreements Research and Development Research and development costs are expensed as incurred. Research and development expenses include payroll and personnel expenses, consulting costs, external contract research and development expenses, and allocated overhead, including rent, equipment depreciation, and utilities. Research and development costs that are paid in advance of performance are capitalized as a prepaid expense and amortized over the service period as the services are provided. The Company expenses upfront license payments related to acquired technologies that have not yet reached technological feasibility and have no alternative future use. In instances where the Company enters into cost-sharing arrangements, all research and development costs reimbursed by the collaborators are accounted for as reductions to research and development expense. During the year ended December 31, 2021 and 2020, the Company incurred no external costs related to cost-sharing collaborations. During the year ended December 31, 2019, the Company incurred $2.0 million in external costs related to cost-sharing collaborations, of which $1.0 million has been recorded as a reduction to research and development expense. Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or other information provided to us by our vendors. Income Taxes The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences reverse. A valuation allowance is provided to reduce the net deferred tax assets to the amount that will more likely than not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. Guarantees and Indemnifications As permitted under Delaware law, the Company indemnifies its officers, directors, and employees for certain events or occurrences that happen by reason of the relationship with, or position held at, the Company. The Company has standard indemnification arrangements under office leases (as described in Note 5) that require it to indemnify the landlord against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation, or nonperformance of any covenant or condition of the Company’s lease. Through December 31, 2021, the Company had not experienced any losses related to these indemnification obligations and no claims were outstanding. The Company does not expect significant claims related to these indemnification obligations, and consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. Stock-Based Compensation The Company accounts for all stock option awards granted to employees and non-employees using a fair value method. Stock-based compensation is measured at the grant date fair value of the stock option grants and is recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. For equity awards that have a performance condition, the Company recognizes compensation expense based on its assessment of the probability that the performance condition will be achieved. The Company accounts for forfeitures as they occur. Earnings (Loss) Per Share Basic earnings per share is computed by dividing undistributed net income attributable to Syndax by the weighted-average number of common shares outstanding during the period. Diluted earnings per share is computed based on the treasury method by dividing net income by the weighted-average number of common shares outstanding during the period plus potentially dilutive common equivalent shares outstanding. Recently Issued and Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board FASB or other accounting standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed below, we do not believe that the adoption of recently issued standards have or may have a material impact on our consolidated statements or disclosures. Income Taxes : In December 2019, the FASB issued Accounting Standards Update (“ASU”) 2019-12, This standard removes certain exceptions to the general principles in Topic 740 and simplifies certain other aspects of the accounting for income taxes. This standard became effective for us on January 1, 2021 and did not have a material impact on our consolidated financial statements and related disclosures. |
Collaborative Research and Lice
Collaborative Research and License Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Research And Development [Abstract] | |
Collaborative Research and License Agreements | 4. Collaborative Research and License Agreements Incyte Collaboration In September 2021, the Company entered into the Incyte License and Collaboration Agreement with Incyte covering the worldwide development and commercialization of SNDX-6352 (axatilimab). Also, in September 2021 the Company entered into a share purchase agreement with Incyte, or Incyte Share Purchase Agreement. These agreements are collectively referred to as the Incyte Agreements. Under the terms of the Incyte Agreements, Incyte will receive exclusive commercialization rights outside of the United States, subject to its royalty payment obligations set forth below. In the United States, Incyte and the Company will co-commercialize axatilimab, with the Company having the right to co-promote axatilimab with Incyte, subject to the Company’s exercise of its co-promotion option. Incyte will be responsible for leading all aspects of commercialization of axatilimab in the United States. The Company and Incyte will share equally the profits and losses from co-commercialization efforts in the United States. The Company and Incyte have agreed to co-develop axatilimab and to share development costs associated with global and U.S. – specific clinical trials, with Incyte responsible for 55% of such costs and the Company responsible for 45% of such costs. Incyte is responsible for 100% of future development costs for trials that are specific to ex-U.S. countries. Each company will be responsible for funding any of its own independent development activities. All development costs related to the collaboration will be subject to a joint development plan. Under the terms of the Incyte Agreement, Incyte paid the Company a non-refundable cash payment of $117 million. The Company is eligible to receive up to $220 million in future contingent development and regulatory milestones and up to $230 million in commercialization milestones as well as tiered royalties ranging in the mid-teens percentage on net sales of the licensed product comprising axatilimab in Europe and Japan and low double digit percentage in the rest of the world outside of the United States. The Company’s right to receive royalties in any particular country will expire upon the last to occur of (a) the expiration of licensed patent rights covering the licensed product in that particular country, (b) a specified period of time after the first post – marketing authorization sale of a licensed product in that country, and (c) the expiration of any regulatory exclusivity for that licensed product in that country. In December 2021, the Company and Incyte signed a Letter A greement. Upon the signing of the Letter Agreement both the Incyte Agreement and Incyte Share Purchase Agreement became effective. As a result, the Company received the upfront fee of $ 117 million and the Company issued 1,421,523 shares of common stock for an aggregate purchase price of $ 35 million, or $ 24.62 per share, for total cash consideration $ 152 million. The Incyte Agreement and the Incyte Share Purchase Agreement were executed on the same date and negotiated simultaneously. Management therefore concluded that the Incyte Agreements are to be combined for accounting purposes and therefore allocated the total consideration to the units of account identified. The common stock issued to Incyte was recorded at fair value of $24.8 million. Pursuant to the Letter Agreement, Incyte is permitted to terminate the Incyte Agreement, if, prior to March 23, 2022 either Incyte or the Company receives a notification from any governmental authority (including the Federal Trade Commission or the Department of Justice, Antitrust Division), challenging the transactions completed by the Incyte Agreements, hereafter referred to as the Termination Right. If such challenge occurs and Incyte exercises the Termination Right, the Incyte Agreement will be rescinded, and the Company will return the $117 million upfront payment to Incyte. In addition, Incyte will be required to sell the Syndax common shares that it received under the Incyte Share Purchase Agreement and remit the net proceeds to the Company. To the extent that the net proceeds from the sale of the Syndax common stock by Incyte is greater or less than the proceeds received by the Company in the Incyte Share Purchase Agreement, or $35 million, a cash payment will be made to make the parties whole. The Company determined that the cash settlement feature of the Letter Agreement represents an embedded derivative requiring bifurcation and separate accounting recognition at fair value. Accordingly, the Company allocated $0.6 million of the total consideration received to the derivative liability, see Note 9 for further discussion of the derivative liability. The Company evaluated the terms of the Incyte Agreement and determined it is within the scope of Accounting Standard Update 2018-18, Collaborative Arrangements (Topic 808) Topic 606 Topic 808 The Company identified the following promises in the Incyte Agreements that were evaluated under the scope of Topic 606 The Company assessed the above promises and determined that the license for SNDX-6532 represents the only performance obligation within the scope of Topic 606 Topic 606 The Company considers the collaborative research and development activities and manufacturing activities to be separate units of account within the scope of Topic 808 Topic 606 Under the scope of Topic 606 standalone selling price of the license to be the entire $ 126.6 million, based on a n application of the income approach by measuring the fair value of the discounted cash flow s from commercialization . Significant assumptions included in t he valuation included judgments relating to the probability of achieving both regulatory and commercial milestones, forecasted future cash flows and the election of the discount rate. As the Company concluded the license was distinct, revenue o f $ 126.6 million was recognized upon transfer of the license to Incyte in the year ended December 31, 2021 . The Company used the most likely amount method to estimate variable consideration and estimated that the most likely amount for each potential preclinical, development, and regulatory variable consideration milestone payment under this agreement is zero, as achievement of those milestones is uncertain and highly susceptible to factors outside the Company’s control. Accordingly, all such milestone payments were excluded from the transaction price. Management will reevaluate the transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur, will adjust the transaction price as necessary. Sales based royalties, including milestones based on the level of sales, were also excluded from the transaction price, as the license is deemed to be the predominant item to which the royalties relate. The company will recognize such revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). KKC Agreement On December 19, 2014 (the “Effective Date”), the Company entered into the KKC License Agreement, under which the Company granted KKC an exclusive license to develop and commercialize entinostat in Japan and Korea. Under the terms of the KKC 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 KKC 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, KKC will receive the right to the intellectual property when and if available. KKC will conduct the development, regulatory approval filings, and commercialization activities of entinostat in Japan and Korea. KKC 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, KKC 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 KKC 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, KKC paid the Company a $5.0 million milestone payment which the Company received in December 2017. The Company determined that the performance obligations associated with the KKC 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 KKC 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. 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 KKC 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, KKC 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 KKC 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 KKC , 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. To date no commercial milestone payments or royalties have been achieved. In September 2021, KKC informed the Company that it is discontinuing its development of entinostat in Japan and Korea and terminating the KKC License Agreement. As a result, the Company recognized all remaining deferred revenue of $12.4 million in September 2021. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Lessee Disclosure [Abstract] | |
Leases | 5. Leases Leases The Company accounts for leases in accordance with ASC 842, Leases The Company identified two existing long-term building leases on the adoption date of ASC 842 that are classified as operating leases. In September 2016, the Company entered into a five-year In December 2015, the Company entered into a 62-month operating lease for 4,039 square feet of space in New York, New York, which commenced on January 1, 2016. In February 2021, the Company signed an 18-month extension to the lease for the New York office, with aggregate payments of $270,000, with a lease commencement date of March 1, 2021.The remaining lease terms as of December 31, 2021, for the facility in Waltham, Massachusetts and New York, New York, were 38 months and 8 months, respectively. As of December 31, 2021, the consolidated balance sheet includes a $1.0 million operating lease ROU asset and a $1.1 million ROU liability. The Company used a weighted average discount rate of 14% to calculate its lease obligations, and an increase or decrease in the rate does not have a significant impact on the ROU asset or ROU liability. The ROU asset is amortized on a straight-line basis over the remainder of the lease term. For the year ended December 31, 2021, the Company recorded approximately $413,000 in operating lease expense and made approximately $544,000 in lease payments. Future minimum lease payments under the Company’s operating leases, were as follows: Maturity of lease liabilities As of As of (in thousands) December 31, 2021 December 31, 2020 2021 $ 394 2022 $ 473 59 2023 376 — Thereafter 454 — Total lease payments $ 1,303 $ 453 Less: imputed interest (231 ) (36 ) Total operating lease liability $ 1,072 $ 417 Future minimum lease payments under the Company’s capital leases as of December 31, 2021, and 2020, were $ 1,000 and $5,000, respectively. |
Earnings (Loss) per Share
Earnings (Loss) per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Earnings (Loss) per Share | 6. Earnings (Loss) per Share Basic and diluted earnings (loss) per share are calculated as follows (in 000s): Years Ended December 31, 2021 2020 2019 Numerator: Net income (loss) $ 24,926 $ (73,158 ) $ (56,047 ) Deemed dividend due to warrant reset - (3,906 ) — Net income (loss) attributable to common stockholders $ 24,926 $ (77,064 ) $ (56,047 ) Denominator: Weighted-average common shares outstanding 52,065 41,308 30,491 Effective of Dilutive Securities Options to purchase common stock 1,429 - - Non - vested restricted stock units (RSUs) 118 - - ESPP to purchase common stock 11 - - Dilutive potential common shares 1,558 - - Shares used in calculating diluted earnings (loss) per share 53,623 41,308 30,491 The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding for 2020 and 2019, because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares): December 31, 2020 2019 Options to purchase common stock 6,379,235 6,057,011 Warrants to purchase common stock - 4,595,039 Employee Stock Purchase Plan 16,382 15,223 Non - vested restricted stock units (RSUs) 18,500 - As discussed in Note 12, in June 2018, the Company signed an exchange agreement with an investor under which the investor exchanged 2,000,000 shares of common stock for 2,000,000 pre-funded warrant shares. Further, in March 2019, the Company sold an additional 2,500,000 pre-funded warrant shares. The pre-funded warrants are exercisable into shares of common stock for $0.0001 per share. The shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing earnings per share. In January 2020, the Company sold 3,036,719 shares of common stock at a price of $8.00 per share and pre-funded warrants to purchase 1,338,287 shares of our common stock. During the year ended December 31, 2021, 475,784 pre-funded warrants were exchanged for shares of common stock in a cashless exercise and 250,000 pre-funded warrants were exchanged for shares of common stock in a cash excercise. As of December 31, 2021, 3,975,024 pre-funded warrants were considered issued and outstanding. |
Significant Agreements
Significant Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Significant Agreements | 7. Significant Agreements Vitae Pharmaceuticals, Inc. In October 2017, the Company entered into a license agreement (the “Allergan License Agreement”) with Vitae Pharmaceuticals, Inc., a subsidiary of Allergan (“Allergan”), under which Allergan granted the Company an exclusive, sublicensable, worldwide license to a portfolio of preclinical, orally available, small molecule inhibitors of the interaction of menin with Mixed Lineage Leukemia (“MLL”) protein (the “Menin Assets”). The Company made a nonrefundable upfront payment of $5.0 million to Allergan in the fourth quarter of 2017. Additionally, subject to the achievement of certain milestone events, the Company may be required to pay Allergan up to $99.0 million in one-time development and regulatory milestone payments over the term of the Allergan License Agreement. In the event that the Company or any of its affiliates or sublicensees commercializes the Menin Assets, the Company will also be obligated to pay Allergan low single to low double-digit royalties on sales, subject to reduction in certain circumstances, as well as up to an aggregate of $70.0 million in potential one-time, sales-based milestone payments based on achievement of certain annual sales thresholds. Under certain circumstances, the Company may be required to share a percentage of non-royalty income from sublicensees, subject to certain deductions, with Allergan. The Company is solely responsible for the development and commercialization of the Menin Assets. Each party may terminate the Allergan License Agreement for the other party’s uncured material breach or insolvency; and the Company may terminate the Allergan License Agreement at will at any time upon advance written notice to Allergan. Allergan may terminate the Allergan License Agreement if the Company or any of its affiliates or sublicensees institutes a legal challenge to the validity, enforceability, or patentability of the licensed patent rights. Unless terminated earlier in accordance with its terms, the Allergan License Agreement will continue on a country-by-country and product-by-product basis until the later of: (i) the expiration of all of the licensed patent rights in such country; (ii) the expiration of all regulatory exclusivity applicable to the product in such country; and (iii) 10 years from the date of the first commercial sale of the product in such country. As of the date of the Allergan License Agreement, the asset acquired had no alternative future use nor had it reached a stage of technological feasibility. As the processes or activities that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. As a result, in 2017, the upfront payment of $5.0 million was recorded as research and development expense in the consolidated statements of operations. In June 2019, the Company achieved certain development and regulatory milestones. As a result, in June 2019, the Company recorded $4.0 million as research and development expense. The amount was paid in 2020. UCB Biopharma Sprl In July 2016, the Company entered into a license agreement (the “UCB License Agreement”) with UCB Biopharma Sprl (“UCB”), under which UCB granted to the Company a worldwide, sublicenseable, exclusive license to UCB6352, which the Company refers to as SNDX-6352 or axatilimab, an IND-ready anti-CSF-1R monoclonal antibody. The Company made a nonrefundable upfront payment of $5.0 million to UCB in the third quarter of 2016. Additionally, subject to the achievement of certain milestone events, the Company may be required to pay UCB up to $119.5 million in one-time development and regulatory milestone payments over the term of the UCB License Agreement. In the event that the Company or any of its affiliates or sublicensees commercializes SNDX-6352, the Company will also be obligated to pay UCB low double-digit royalties on sales, subject to reduction in certain circumstances, as well as up to an aggregate of $250.0 million in potential one-time, sales-based milestone payments based on achievement of certain annual sales thresholds. Under certain circumstances, the Company may be required to share a percentage of non-royalty income from sublicensees, subject to certain deductions, with UCB. The Company will be solely responsible for the development and commercialization of SNDX-6352, except that UCB is performing a limited set of transitional chemistry, manufacturing and control tasks related to SNDX-6352. Each party may terminate the UCB License Agreement for the other party’s uncured material breach or insolvency; and the Company may terminate the UCB License Agreement at will at any time upon advance written notice to UCB. UCB may terminate the UCB License Agreement if the Company or any of its affiliates or sublicensees institutes a legal challenge to the validity, enforceability, or patentability of the licensed patent rights. Unless terminated earlier in accordance with its terms, the UCB License Agreement will continue on a country-by-country and product-by-product basis until the later of: (i) the expiration of all of the licensed patent rights in such country; (ii) the expiration of all regulatory exclusivity applicable to the product in such country; and (iii) 10 years from the date of the first commercial sale of the product in such country. As of the date of the UCB License Agreement, the asset acquired had no alternative future use nor had it reached a stage of technological feasibility. As the processes or activities that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. As a result, in 2016, the upfront payment of $5.0 million was recorded as research and development expense in the consolidated statements of operations. In July 2020, the Company achieved certain development and regulatory milestones. As a result, in July 2020, the Company recorded $2.0 million as research and development expense, which has been fully paid. In March and September 2021, the Company recorded $2.0 million, respectively, as research and development expenses for the achievement of certain development milestones. The Company fully paid the March 2021 milestone in the second quarter of 2021. The September 2021 milestone of $2.0 million is recorded as an accrued expense as of December 31, 2021. Eastern Cooperative Oncology Group In March 2014, the Company entered into the “ECOG Agreement with Eastern Cooperative Oncology Group, a contracting entity for the Eastern Cooperative Oncology Group—American College of Radiology Imaging Network Cancer Research Group (“ECOG-ACRIN”), that describes the parties’ obligations with respect to the NCI-sponsored pivotal Phase 3 clinical trial of entinostat. Under the terms of the ECOG Agreement, ECOG-ACRIN will perform this clinical trial in accordance with the clinical trial protocol and a mutually agreed scope of work. The Company will provide a fixed level of financial support for the clinical trial through an upfront payment of $0.7 million and a series of payments of up to $1.0 million each that are comprised of milestone payments through the completion of enrollment and time-based payments through the completion of patient monitoring post-enrollment. In addition, the Company is obligated to supply entinostat and placebo to ECOG-ACRIN for use in the clinical trial. From the second quarter of 2016 through the fourth quarter of 2018, the Company has entered into a number of amendments to the agreement to provide for additional study activities resulting in an increase of the contractual obligation of $5.3 million. The Company has agreed to provide this additional financial support to fund the additional activities required to ensure that the E2112 clinical trial will satisfy FDA registration requirements. In May 2020, the Company announced that the E2112 trial did not achieve the primary endpoint of demonstrating a statistically significant overall survival benefit over hormone therapy alone. As a result, the Company has decided to deprioritize the entinostat program to focus resources on advancing the remainder of its pipeline. As of December 31, 2021, the Company’s aggregate payment obligations under this agreement are approximately $24.7 million; and its maximum remaining payment obligations are $3.2 million, which are estimated to be paid over a period of approximately one year. As of December 31, 2021, the Company has accrued $3.0 million related to the ECOG Agreement. 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 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 of consummation of the clinical trial or the services completed. Bayer Pharma AG (formerly known as Bayer Schering Pharma AG) In March 2007, the Company entered into a license agreement (the “Bayer Agreement”) with Bayer Schering Pharma AG (“Bayer”) for a worldwide, exclusive license to develop and commercialize entinostat and any other products containing the same active ingredient. Under the terms of the Bayer Agreement, the Company paid a nonrefundable up-front license fee of $2.0 million and is responsible for the development and marketing of entinostat. The Company recorded the $2.0 million license fee as research and development expense during the year ended December 31, 2007, as it had no alternative future use. The Company will pay Bayer royalties on a sliding scale based on net sales, if any, and make future milestone payments to Bayer of up to $150.0 million in the event that certain specified development and regulatory goals and sales levels are achieved. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, net | 8. Property and Equipment, net Property and equipment, net, consisted of the following (in thousands): December 31, 2021 2020 Equipment $ 386 $ 256 Leasehold improvements 167 167 Furniture and fixtures 134 134 Office and computer equipment 21 21 Office equipment under capital lease 13 13 Total property and equipment 721 591 Accumulated depreciation (443 ) (399 ) Property and equipment, net $ 278 $ 192 Depreciation expense was $43,000 and $90,000 for years ended December 31, 2021 and 2020. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 9. 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 (unadjusted) 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. The table below presents information about the Company’s assets and liabilities that are regularly measured and carried at fair value and indicate the level within the fair value hierarchy of valuation techniques the Company utilized to determine such fair values (in thousands): Fair Value Measurements Using Total Carrying Value Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) December 31, 2021 Assets: Cash equivalents $ 221,964 $ 96,816 $ 125,148 $ — Short-term investments 217,971 — 217,971 — Total assets $ 439,935 $ 96,816 $ 343,119 $ — Liabilities: Derivative Liability 187 — — 187 Total Liabilities $ 187 $ — $ — $ 187 December 31, 2020 Assets: Cash equivalents $ 115,243 $ 110,246 $ 4,997 $ — Short-term investments 177,822 — 177,822 — Total assets $ 293,065 $ 110,246 $ 182,819 $ — There have been no material impairments of our assets measured and carried at fair value during the years ended December 31, 2021, and 2020. In addition, there have been no changes in valuation techniques during the years ended December 31, 2021, and 2020. The fair value of Level 1 instruments classified as cash equivalents are valued using quoted market prices in active markets. The fair value of Level 2 instruments classified as cash equivalents and short-term investments was determined other than quoted prices in active markets, which are either directly or indirectly observable as of the reporting date and fair value is determined using models or other valuation methodologies. The fair value of the Level 3 instrument is determined using unobservable inputs and the Company utilized a Black Scholes valuation model as of December 9, 2021 (initial recognition) and December 31, 2021 respectively. The following table summarizes the significant unobservable inputs in the fair value measurement of the Company’s contingent consideration obligations as of December 31, 2021: As of December 31, 2021 Fair Value Unobservable Input Range Weighted Average (in thousands) Liabilities: Derivative Liability $ 187 Discount Rate Volatility Expected timing of the Termination Right 4-5% 58-61% 9 months 4.5% 59.5% 9 months The following table summarizes the fair value rollforward (in thousands): Fair Value Derivative Liability: Beginning Balance 1/1/2021 $ — Additions 576 Change in fair value (389 ) Ending Balance 12/31/2021 $ 187 The short-term investments are classified as available-for-sale securities. As of December 31, 2021, the remaining contractual maturities of the available-for-sale securities were less than 12 months, and the balance in the Company’s accumulated other comprehensive income was comprised solely of activity related to the Company’s available-for-sale securities. There were no realized gains or losses recognized on the sale or maturity of available-for-sale securities during the three years ended December 31, 2021. As a result, the Company did not reclassify any amounts out of accumulated other comprehensive income for the same periods. The Company has a limited number of available-for-sale securities in insignificant loss positions as of December 31, 2021, which the Company does not intend to sell and has concluded will not be required to sell before recovery of the amortized cost for the investment at maturity The following table summarizes the available-for-sale securities (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2021 Commercial paper $ 306,715 $ 70 $ (17 ) $ 306,768 Corporate bonds 22,147 — (6 ) 22,141 US treasury 14,212 — (2 ) 14,210 $ 343,074 $ 70 $ (25 ) $ 343,119 December 31, 2020 Commercial paper $ 154,176 $ 13 $ (16 ) $ 154,173 Corporate bonds 22,617 2 (3 ) 22,616 US treasury 6,030 — — 6,030 $ 182,823 $ 15 $ (19 ) $ 182,819 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2021 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | 10. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2021 2020 Short-term deposits $ 6,894 $ 4,683 Prepaid insurance 642 427 Interest receivable on investments 429 175 Prepaid clinical supplies - 58 Reimbursable costs - 24 Other 380 317 Total prepaid expenses and other current assets $ 8,345 $ 5,684 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 11. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued clinical costs $ 7,760 $ 7,132 Accrued compensation and related costs 4,342 3,213 Accrued professional fees 662 373 Other 1,702 528 Total accrued expenses $ 14,466 $ 11,246 |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Common Stock | 12. Common Stock The Company is authorized to issue 100,000,000 shares of common stock. The holders of each share of common stock are entitled to one vote per share held and are entitled to receive dividends, if and when declared by the Board, and to share ratably in the Company’s assets available for distribution to stockholders, in the event of liquidation. In March 2021, the Company entered into a new sales agreement with Cowen and Company, LLC (“Cowen”) under which the Company may issue and sell shares of its common stock having aggregate sales proceeds of up to $75.0 million from time to time through Cowen, acting as agent, in a series of one or more ATM equity offerings (the “2021 ATM Program”). Cowen is not required to sell any specific amount but acts as the Company’s sales agent using commercially reasonable efforts consistent with its normal trading and sales practices. Shares sold pursuant to the sales agreement will be sold pursuant to a shelf registration statement on Form S-3ASR (Registration No. 333-254661), which became automatically effective upon filing on March 24, 2021. The Company’s common stock will be sold at prevailing market prices at the time of sale; and as a result, prices may vary. For the year ended December 31, 2021, the Company sold 277,629 common shares of common stock under the 2021 ATM Program, with net proceeds of approximately $5.1 million. On June 18, 2018, the Company signed an exchange agreement with Biotechnology Value Fund and certain affiliated funds (“BVF”) under which BVF exchanged 2,000,000 shares of common stock for 2,000,000 Pre-Funded Warrant shares. The Company recorded the issuance of the pre-funded warrants and the retirement of the common stock at fair value within additional paid-in capital. BVF can exercise the Pre-Funded Warrants at an exercise price per share equal to $0.0001 per share and the Pre-Funded Warrants expire 20 years from issuance. Per the terms of the warrant agreement, the outstanding Pre-Funded Warrants may not be exercised if the holder's ownership of the Company’s common stock would exceed 9.99 % following such exercise. In March 2019, the Company issued 2,095,039 shares of its common stock and pre-funded warrants to purchase 2,500,000 shares of common stock (the “Pre-Funded Warrants”) to certain investors in a registered direct offering. The Pre-Funded Warrants are exercisable immediately upon issuance at an exercise price of $0.0001 per share and have a term of 20 years. The Company sold the shares of common stock and Pre-Funded Warrants together with two series of warrants, Series 1 Warrants and Series 2 Warrants, to purchase an aggregate of 4,595,039 shares of the Company’s common stock (the “Series Warrants”). The offering price for the securities was $6.00 per share (or $5.9999 for each Pre-Funded Warrant). The aggregate gross proceeds to the Company from this offering were $27.6 million, excluding any proceeds the Company may receive upon exercise of the Pre-Funded Warrants and Series Warrants and offering costs of $0.2 million. No underwriter or placement agent participated in the offering. The Series Warrants are immediately exercisable. Each Series 1 Warrant has an initial exercise price of $12.00 per share of common stock and each Series 2 Warrant has an initial exercise price of $18.00 per share of common stock, in each case subject to certain adjustments. All Series 1 and Series 2 warrants were exercised in 2020. The Pre-Funded Warrants and the Series Warrants may not be exercised by the holder to the extent that the holder, together with its affiliates, would beneficially own, after such exercise more than 9.99% of the shares of the Company’s common stock then outstanding (subject to the right of the holder to increase or decrease such beneficial ownership limitation upon notice to the Company, provided that such limitation cannot exceed 19.99%) and provided that any increase in the beneficial ownership limitation shall not be effective until 61 days The Series Warrants were classified as a component of permanent equity and were recorded at the issuance date using a relative fair value allocation method. The Series Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permits the holders to receive a fixed number of common shares upon exercise. In addition, such warrants do not provide any guarantee of value or return. The Company valued the Series Warrants at issuance using the Black Scholes option pricing model and determined the fair value of the 4,595,039 Series Warrants at $3.4 million. The key inputs to the valuation model included the weighted average volatility of 89.1% and the weighted average expected term of 1.4 years. During 2020, holders of Series 1 warrants and Series 2 warrants exercised 4,595,039 Series Warrants in exchange for 1,995,941 shares of the Company’s common stock. As of December 31, 2020, all Series Warrants have been exercised. In January 2020, the Company sold 3,036,719 shares of common stock, par value per share $0.0001 and Pre-Funded Warrants to purchase 1,338,287 shares of common stock. The offering price for the securities was $ 8.00 per share or $ 7.9999 for each pre-funded warrant. As a result of this offering, the exercise price of Series 1 and Series 2 Warrants outstanding reset from $ 12.00 per share to $ 10.00 per share and from $ 18.00 per share to $ 13.00 , respectively. The Company recorded $ 3.9 million as a deemed dividend which represents the value transferred to the warrant holders due to the Series Warrant adjustment mechanisms being triggered. The deemed dividend was recorded as both an increase and a decrease in Additional Paid in Capital and reduced net income available to common stockholders by the same amount. The key inputs to the validation model included the weighted volatility of 96.74 % and weighted average expected term of 0.4 years . In May 2020, the Company sold 6,388,889 shares of common stock, par value $0.0001 per share, at $18.00 per share, with net proceeds of approximately $107.9 million. In December 2020, the Company sold 6,250,000 shares of common stock, par value $0.0001 per share, at $23.00 per share, with net proceeds of approximately $135.0 million. In December 2021, the Company issued 3,802,144 shares of common stock and Pre-Funded Warrants to purchase 1,142,856 shares of common stock. The offering price for the securities was $17.50 per share or $17.4999 for each Pre-Funded Warrant, In December 2021, in connection with the Incyte License and Collaboration Agreement and Share Purchase Agreement, the Company issued 1,421,523 shares of common stock, with net proceeds of approximately $35.0 million. The Company recorded the equity issuance at a fair value of $24.8 million based on the market price of the stock on the date of issuance. The Company has reserved for future issuance the following shares of common stock related to the potential warrant exercise, exercise of stock options, and the employee stock purchase plan: December 31, 2021 Common stock issuable under pre-funded warrants 3,975,024 Options to purchase common stock 8,071,089 Employee Stock Purchase Plan 1,296,410 Total 13,342,523 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 13. Stock-Based Compensation In September 2015, the Company’s board of directors adopted its 2015 Omnibus Incentive Plan (“2015 Plan”), which was subsequently approved by its stockholders and became effective upon the closing of the IPO on March 8, 2016. The 2015 Plan replaced the 2007 Stock Plan (“2007 Plan”) and allows for the granting of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock, unrestricted stock, stock units, dividend equivalent rights, performance awards, annual incentive awards, and other equity-based awards to the Company’s executives and other employees, non-employee members of the board of directors, and consultants of the Company. Any options or awards outstanding under the Company’s 2007 Plan remains outstanding and effective. Any shares of common stock related to awards outstanding under the 2007 Plan that thereafter terminate by expiration, forfeiture, cancellation or otherwise without the issuance of such shares will be added to, and included in, the 2015 Plan reserve amount. The Company initially reserved 1,750,000 shares of its common stock for the issuance of awards under the 2015 Plan. As of December 31, 2021, there were 1,017,242 shares available for issuance under the 2015 Plan. The 2015 Plan provides that the number of shares reserved and available for issuance under the 2015 Plan will automatically increase each January 1, beginning on January 1, 2017, by 4% of the outstanding number of shares of common stock on the immediately preceding December 31 or such lesser number of shares as determined by the Company’s board of directors. On January 1, 2022, the shares available for issuance under the 2015 Plan were increased to 3,215,376. The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and related to the Employee Stock Purchase Plan in the consolidated statements of operations as follows (in thousands): Years Ended December 31, 2021 2020 2019 Research and development $ 4,398 $ 2,400 $ 2,061 General and administrative 8,919 6,657 3,944 Total $ 13,317 $ 9,057 $ 6,005 Stock Options and Restricted Stock Units As of December 31, 2021, there was $25.7 million of unrecognized compensation cost related to employee and non-employee unvested stock options and restricted stock units (“RSU’s”) granted under the 2007 and 2015 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. As of December 31, 2021, there was $0.9 million of unrecognized compensation cost related to performance-based options, and $24.8 million of unrecognized compensation expense related to service-based options. Our stock-based awards are subject to either service or performance-based vesting conditions. Compensation expense related to awards to employees, directors and non-employees with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to employees with performance-based vesting conditions is recognized based on the grant date fair value over the requisite service period using the straight-line method to the extent achievement of the performance condition is probable. In 2017, the Company granted 60,000 options with performance conditions (“2017 Performance Awards”), 13,333 of which vested in 2019 and 6,667 which were cancelled as of December 31, 2019. On January 1, 2021, the Company determined that a second performance had not been achieved. As a result of this, the Company cancelled 20,000 options. In the years ended December 31, 2021, 2020 and 2019 the Company recorded approximately $25,000, $9,000, and $88,000, respectively of stock compensation associated with these awards. In 2019, the Company granted to certain employees 583,000 stock options that contain performance-based vesting criteria (“2019 Performance Awards”), primarily related to the achievement of certain clinical and regulatory development milestones related to product candidates. Recognition of stock-based compensation expense associated with these performance-based stock options commences when the performance condition is considered probable of achievement, using management’s best estimates, which consider the inherent risk and uncertainty regarding the future outcomes of the milestones. In the fourth quarter of 2020 one of the performance milestones for the 2019 Performance Awards was achieved and of the associated 194,331 stock options, 64,777 stock options vested, and 388,669 options were cancelled. In 2021, 64,780 stock options vested with the remaining 64,774 options to vest in 2022. The Company recorded approximately $257,000 and $207,000 of stock compensation expense associated with these awards for the years ended December 31, 2021 and 2020, respectively. For the remaining performance milestones, achievement of the performance conditions was not met as of December 31, 2021. Therefore no expense has been recognized related to these performance milestones for the year ended December 31, 2021, and no options were cancelled in 2021. In October 2021, in connection with the retirement of two employees, the Company entered into severance and consulting agreements. Under these agreements the Company extended vesting term for a total of 34,728 unvested options unvested options, which would not have otherwise vested and extended the exercise period of the vested options post termination of the consulting agreement . The Company accounted for the change as a modification of an equity award under ASC 718. As a result of the modifications, the Company recognized approximately $ million of incremental stock compensation expense in 2021 . The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model with the weighted-average assumptions noted in the table below. Expected volatility for the Company’s common stock was determined based on an average of the historical volatility of a peer group of similar public companies. The Company estimated Years Ended December 31, 2021 2020 2019 Expected term (in years) 6.02 5.97 5.97 Volatility rate 85.84 % 81.59 % 76.95 % Risk-free interest rate 0.67 % 1.20 % 2.29 % Expected dividend yield 0.00 % 0.00 % 0.00 % A summary of employee and non-employee option activity under the Company’s equity award plans is presented below (in thousands, except share data): Number Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding — 6,379,235 $ 9.40 7.1 $ 81,940 Granted 1,595,400 $ 20.61 Exercised (842,424 ) $ 7.82 Canceled, forfeited or expired (210,697 ) $ 15.57 Outstanding — 6,921,514 6.9 $ 68,609 Exercisable — 4,547,354 6.0 $ 54,012 Options vested, exercisable or expected to vest — 6,921,514 6.9 $ 68,609 The weighted-average grant date fair value of options granted during the years ended December 31, 2021, 2020 and 2019, was $14.70, $7.88, and $4.81 per share, respectively. The fair value is being expensed over the vesting period of the options (usually three to four years) on a straight-line basis as the services are being provided. There were 842,424 options exercised for the year ended December 31, 2021, resulting in total proceeds of $6.3 million; 755,166 options exercised for the year ended December 31, 2020, resulting in total proceeds of $6.6 million; and 25,857 options exercised for the year ended December 31, 2019, resulting in total proceeds of $178,000. The intrinsic value of options exercised during the years ended December 31, 2021, 2020 and 2019 was $10.1 million, $7.1 million, and $9,000, respectively. In accordance with the Company’s policy, the shares were issued from a pool of shares reserved for issuance under the 2007 and 2015 Plans. Restricted Stock Units RSUs awarded to Board of Directors or employees vest on either i) one – year anniversary date of the related grant or ii) 25% on each anniversary for 4 years. The following table summarizes our RSU activity: Number Shares Weighted Average Grant Date Fair Value Unvested — 18,500 $ 10.48 Granted 119,333 $ 21.19 Vested (5,500 ) $ 11.17 Forfeited - $ - Unvested—December 31, 2021 132,333 (1) RSUs granted in 2021 primarily represent RSUs granted in conjunction with our annual awards made in February 2021granted to our Board of Directors. RSU’s granted in 2021 and 2020 had a weighted average grant date fair value of $21.19 and $10.48, respectively. There were no RSU’s granted in 2019. The fair values of RSU’s vested in 2021 totaled $60,000. There were no RSU’s vested in 2020. Employee Stock Purchase Plan In September 2015, the Company’s Board adopted the Employee Stock Purchase Plan (the “ESPP”), which was subsequently approved by the Company’s stockholders in February 2016 and became effective upon the closing of the IPO on March 8, 2016. The ESPP authorizes the initial issuance of up to a total of 250,000 shares of common stock to the Company’s employees. The Company issued 26,878 and 33,706 shares during 2021 and 2020, respectively. On January 1, 2022, the shares of common stock reserved for issuance under the ESPP was increased to 1,546,410. Under the terms of the ESPP, eligible employees can elect to acquire shares of the Company’s common stock through periodic payroll deductions during a series of six month offering periods. Purchases under the ESPP are affected on the last business day of each offering period at a 15% discount to the lower of closing price on that day or the closing price on the first day of the offering period. The ESPP is considered a compensatory plan with the related compensation cost expensed over the six-month offering period. For the years ended December 31, 2021, 2020 and 2019 the Company recorded stock-based compensation expense related to the ESPP of $175,000, $203,000 and $113,000 respectively. Employee Benefit Plan The Company has a Section 401(k) defined contribution savings plan for its employees. The plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pretax basis, subject to legal limitations. Company contributions to the plan may be made at the discretion of the Board. For the years ended December 31, 2021, 2020 and 2019, the Company made $444,000, $250,000 and $119,000 contributions to the plan, respectively. |
Loan Payable
Loan Payable | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Loan Payable | 14. Loan Payable In February 2020, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), which provided for aggregate maximum borrowings of up to $30.0 million, consisting of (i) a term loan of up to $20.0 million, which was funded on February 7, 2020 (the “Initial Advance”), and (ii) subject to Hercules’ investment committee approval, an additional term loan of up to $10.0 million, available for borrowing from February 7, 2020 to December 15, 2020 (the “Tranche 2 Advance”). The Company elected not to draw the additional term of $10.0 million. Borrowings under the Loan Agreement bear interest at an annual rate equal to the greater of (i) 9.85% or (ii) 5.10% plus the Wall Street Journal prime rate. The company paid a $100,000 facility charge upon closing, which is being expensed over the term of the debt. On December 22, 2021, the Company entered into Amendment No. 1 to the Company’s Loan and Security Agreement (the “ ” Agreement dated as of February 7, 2020 (the “ Loan Agreement , ” as amended by the First Amendment, the “ Amended Loan Agreement ”) among the Borrower, the Lender and the Agent. The First Amendment was accounted for a modification during the year ended December 31, 2021. The First Amendment increases the amount that the Company may borrow by $50.0 million, from up to $30.0 million to up to $80.0 million, in multiple tranches. The First Amendment increases the second tranche (“Tranche 2 Additionally, the First Amendment, among other things, (i) extended the expiration of the period in which interest-only payments on borrowings under the Loan Agreement are required from October 1, 2021 to January 1, 2023, which is further extendable to December 31, 2023 upon the partial or full draw of Tranche 2 (the “Interest-Only Period”), (ii) extended the maturity date of Loan Agreement from September 1, 2023 to April 1, 2024, (iii) decreased the annual interest rate from the greater of (w) 9.85% or (x) 5.10% plus the Wall Street Journal the Wall Street Journal Borrowings under the Amended Loan Agreement are collateralized by substantially all of the Company’s and its subsidiaries personal property and other assets, other than its intellectual property. The Amended Loan Agreement includes a minimum cash covenant of $12.5 million that has applied since October 1, 2020, subject to reduction upon satisfaction of certain conditions as set forth in the Amended Loan Agreement. As of December 31, 2020, the conditions set forth in the Loan Agreement were met. The cash covenant of $12.5 million was waived. In addition, the Amended Loan Agreement includes customary affirmative and restrictive covenants and representations and warranties, including a minimum cash covenant applicable on the occurrence of certain events, a covenant against the occurrence of a “change in control,” financial reporting obligations, and certain limitations on indebtedness, liens (including a negative pledge on intellectual property and other assets), investments, distributions (including dividends), collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, and deposit accounts. The Amended Loan Agreement also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the Amended Loan Agreement, cross acceleration to third-party indebtedness and certain events relating to bankruptcy or insolvency. Upon the occurrence of an event of default, a default interest rate of an additional 5.0% may be applied to the outstanding principal balance, and Hercules may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the Amended Loan Agreement. In connection with the Amended Loan Agreement, the Company was required to enter into separate deposit account control agreements with the lender in order to perfect the lender’s security interest in the cash collateral in the Company’s operating accounts. In the event of a default under the Amended Loan Agreement, the lender would have the right to take control of the operating accounts and restrict the Company’s access to the operating accounts and the funds therein. During the year ended December 31, 2021 the Company recognized $1.9 million of interest expense related to the Initial Advance pursuant to the Amended Loan Agreement. As of December 31, 2021, the Company’s maturities of principal obligations under its long-term debt are as follows: Amount 2022 $ — 2023 14,764,764 2024 5,235,236 Total principal outstanding 20,000,000 Amortized final fee 17,591 Unamortized debt issuance costs (122,927 ) Total 19,894,664 Term loan, current portion - Term loan, less current portion $ 19,894,664 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 15. Income Taxes The Company has not recorded any net tax provision for the periods presented due to the utilization of tax attributes to offset current year federal and state taxable income, the historical losses incurred, and the need for a full valuation allowance on deferred tax assets. The Company’s current year profit and historical losses before income tax for the periods presented was generated entirely in the United States. A reconciliation of the provision for income taxes computed at the statutory federal income tax rate to the provision for income taxes as reflected in the financial statements is as follows: Years Ended December 31, 2021 2020 2019 Income tax computed at federal statutory rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 2.9 % 1.8 % 2.1 % General business credit carryovers -5.0 % 0.9 % 0.9 % Non-deductible expenses -0.5 % 0.0 % -0.8 % Change in valuation allowance -19.2 % -23.7 % -22.8 % Other 0.8 % 0.0 % -0.4 % 0.0 % 0.0 % 0.0 % The significant components of the Company’s deferred tax are as follows (in thousands): Years Ended December 31, 2021 2020 Deferred tax assets (liabilities): Net operating loss carryforwards $ 17,642 $ 22,794 Research and development credits 6,113 4,856 Capitalized start-up and other costs 34,898 28,854 Capitalized research and development costs 31,365 35,632 Deferred revenue — 2,989 Equity based compensation 6,277 5,117 Accruals 845 1,657 Other temporary differences 10 29 Deferred tax assets before valuation allowance 97,150 101,928 Valuation allowances (97,150 ) (101,928 ) Net deferred tax assets $ — $ — The Company has provided a valuation allowance for the full amount of the net deferred tax assets as the realization of the deferred tax assets is not determined to be more likely than not. The valuation allowance decreased by $4.8 million in 2021 due to the decrease in deferred tax assets, primarily driven by the utilization of tax attributes to offset federal and state taxable income, partially offset by an increase to other deferred tax assets. The valuation allowance increased by $17.5 million in 2020 due to the increase in deferred tax assets, primarily driven by net operating loss carryforwards and capitalized research and development costs. As of December 31, 2021, the Company had approximately $73.5 million and $34.6 million in federal and state Net Operating Losses (“NOLs”), respectively, which may be available to offset future taxable income. The Company has generated federal NOLs of $48.5 million which have an indefinite carryforward period. The remaining $25.0 million of federal NOLs and the Company’s state NOLs will begin to expire at various dates starting in 2026. As of December 31, 2021, the Company had federal and state research credits of $4.1 million and $2.5 million, respectively, which begin to expire in 2022. Realization of future tax benefits is dependent on many factors, including the Company’s ability to generate taxable income within the net operating loss carryforward period. Under the Internal Revenue Code provisions, certain substantial changes in the Company’s ownership, including the sale of the Company or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss carryforwards which could be used annually to offset future taxable income. The Company completed an analysis through December 31, 2020 and determined that on March 30, 2007, August 21, 2015 and May 4, 2020 ownership changes had occurred. The Company may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. As a result, its ability to use its pre-change NOLs to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. As of December 31, 2021, and 2020, the Company had uncertain tax positions of $0.2 million related to research and development credits, which reduce the deferred tax assets with a corresponding decrease to the valuation allowance. The Company has elected to recognize interest and penalties related to income tax matters as a component of income tax expense, of which no interest or penalties were recorded for the years ended December 31, 2021 and 2020. The Company expects none of the unrecognized tax benefits to decrease within the next 12 months related to expired statutes or settlement with the taxing authorities. Due to the Company’s valuation allowance as of December 31, 2021, none of the Company’s unrecognized tax benefits, if recognized, would affect the effective tax rate. A reconciliation of the Company’s unrecognized tax benefits is as follows (in thousands): Years Ended December 31, 2021 2020 2019 Unrecognized tax benefit--beginning of year $ 163 $ 163 $ 163 Decreases related to prior period positions — — — Unrecognized tax benefit--end of year $ 163 $ 163 $ 163 The Company files tax returns in the United States, Massachusetts, California, New Jersey, New York, Rhode Island and Pennsylvania. All tax years since inception (October 11, 2005) remain open to examination by major tax jurisdictions to which the Company is subject, as carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service or state tax authorities if they have or will be used in a future period. The Company is currently not under examination by the Internal Revenue Service or any other jurisdictions for any tax years. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 16. Commitments and Contingencies License Agreements Incyte – In September 2021, the Company entered into the Incyte Agreement and Incyte Stock Purchase Agreement. Under the terms of the Incyte Agreement, Incyte will receive exclusive commercialization rights of axatilimab outside of the United States. In the United States, Incyte and the Company will co-commercialize axatilimab, with the Company having the right to co-promote the product with Incyte. In exchange for these rights, Incyte agreed to pay a non-refundable cash payment of $ 117 million and in addition a $ 35 million equity investment. In certain cases, the Company is required to assist Incyte and is responsible for 45 % of development costs associated with global and U.S. specific clinical trials. NovaMedica—In August 2013, in connection with the third tranche of its Series B-1 financing, the Company entered into a Technology Transfer Agreement (the “Tech Transfer Agreement”) with Domain Russia Investments Limited (“DRI”). Pursuant to the Tech Transfer Agreement, in exchange for nominal payment, the Company assigned to DRI certain patent applications and granted to DRI a license to develop and commercialize entinostat in certain Eastern European countries (the “Covered Territory”). The Company concurrently entered into a sublicense agreement with DRI (the “DRI Sublicense”) and a sublicense agreement (the “NovaMedica Sublicense”) with NovaMedica LLC (“NovaMedica”), which is jointly owned by Rusnano Medinvest LLC and DRI. Pursuant to the DRI Sublicense, the Company granted to DRI an exclusive sublicense to develop, manufacture and commercialize entinostat in the Russian Federation. Pursuant to the NovaMedica Sublicense, the Company granted to NovaMedica an exclusive sublicense to develop, manufacture and commercialize entinostat in the rest of the Covered Territory. Immediately thereafter, the Company, DRI and NovaMedica executed an assignment and assumption agreement, pursuant to which the assigned patents and all of DRI’s rights and obligations under the Tech Transfer Agreement and the DRI Sublicense were transferred to NovaMedica. Under the Tech Transfer Agreement, in certain cases, the Company is required to assist NovaMedica, and NovaMedica is required to reimburse the Company for any out-of-pocket expenses incurred in providing this assistance, including travel-related expenses. Eddingpharm—In April 2013, the Company entered into a License and Development Agreement (the “Eddingpharm License Agreement”) and a Series B-1 purchase agreement (the “Eddingpharm Purchase Agreement”) with Eddingpharm International Company Limited (“Eddingpharm”). Under the terms of the Eddingpharm License Agreement, Eddingpharm, in exchange for rights to develop and commercialize entinostat in China and certain other Asian countries, purchased $5.0 million of Series B-1 and agreed to make certain contingent milestone and royalty payments based on revenue targets. In certain cases, the Company is required to assist Eddingpharm, and Eddingpharm is required to reimburse the Company for any out-of-pocket expenses incurred in providing this assistance, including reimbursement for person-hours above a certain cap. |
Supplemental Cash Flow Informat
Supplemental Cash Flow Information | 12 Months Ended |
Dec. 31, 2021 | |
Supplemental Cash Flow Elements [Abstract] | |
Supplemental Cash Flow Information | 17. Supplemental Cash Flow Information Years Ended December 31, 2021 2020 2019 (In thousands) Supplemental Disclosures of Cash Flow Information Interest paid $ 1,997 $ 1,631 $ — Supplemental Disclosures of Non-Cash Investing and Financing Activities: Issuance costs included in accounts payable and accrued expenses $ 134 $ 43 $ — |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Estimates | Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of costs and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements. |
Cash Equivalents | Cash Equivalents Cash equivalents include all highly liquid investments maturing within 90 days or less from the date of purchase. Cash equivalents include money market funds, corporate debt securities, U.S. government agency notes, and overnight deposits. |
Restricted Cash | Restricted Cash The Company classifies as restricted cash all cash pledged as collateral to secure long-term obligations and all cash whose use is otherwise limited by contractual provisions. Amounts are reported as non-current unless restrictions are expected to be released in the next 12 months. |
Short-Term Investments | Short-Term Investments Short-term investments include marketable securities with maturities of less than one year or where management’s intent is to use the investments to fund current operations or to make them available for current operations. All investments in marketable securities are classified as available-for-sale and are reported at fair value with unrealized gains and losses excluded from earnings and reported net of tax in accumulated other comprehensive income, which is a component of stockholders’ equity. Unrealized losses that are determined to be other-than-temporary, based on current and expected market conditions, are recognized in earnings. Declines in fair value determined to be credit related are charged to earnings. The cost of marketable securities sold is determined by the specific identification method. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. The Company has one operating segment. |
Concentrations of Credit Risk | Concentrations of Credit Risk Cash and cash equivalents, restricted cash, and short-term investments are financial instruments that potentially subject the Company to concentrations of credit risk. Substantially all of the Company’s cash, cash equivalents, and short-term investments were deposited in accounts at two financial institutions, and at times, such deposits may exceed federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company’s available-for-sale investments primarily consist of government money market funds, corporate debt securities, commercial paper, credit card asset-backed securities and overnight deposits and potentially subject the Company to concentrations of credit risk. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets (three to five years). Assets under capital leases are amortized over the shorter of their useful lives or lease term using the straight-line method. Major replacements and improvements are capitalized, while general repairs and maintenance are expensed as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If this comparison indicates that there is impairment, the amount of impairment is calculated as the difference between the carrying value and fair value. To date, no such impairments have been recognized. |
Debt Issuance Cost | Debt Issuance Cost Debt issuance costs consist of payments made to secure commitments under certain debt financing arrangements. These amounts are recognized as interest expense over the period of the financing arrangement using the effective interest method. If the financing arrangement is cancelled or forfeited, or if the utility of the arrangement to the Company is otherwise compromised, these costs are recognized as interest expense immediately. The Company’s consolidated financial statements present debt issuance costs related to a recognized debt liability as a direct reduction from the carrying amount of that debt liability. |
Derivative Financial Instruments | Derivative Financial Instruments The Company accounts for derivative financial instruments as either equity or liabilities in accordance with Accounting Standards Codification Topic 815, Derivatives and Hedging |
Revenue Recognition | Revenue Recognition The Company enters into license agreements for the development and commercialization of its product candidates. License agreements may include non-refundable upfront payments, contingent payments based on the occurrence of specified events under the Company’s license arrangements, partial or complete reimbursement of research and development expenses, license fees and royalties on sales of entinostat if they are successfully approved and commercialized. The Company’s performance obligations under the license agreements may include the transfer 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. The Company recognizes revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. We recognize revenue following the five – step model prescribed under FASB Accounting Standards Codification ( ASC 606), Revenue from Contracts with Customers : (i) identify contract(s) with customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligations. 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. 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. For additional information on our collaboration and license arrangements, please read Note 4, Collaboration and License Agreements |
Research and Development | Research and Development Research and development costs are expensed as incurred. Research and development expenses include payroll and personnel expenses, consulting costs, external contract research and development expenses, and allocated overhead, including rent, equipment depreciation, and utilities. Research and development costs that are paid in advance of performance are capitalized as a prepaid expense and amortized over the service period as the services are provided. The Company expenses upfront license payments related to acquired technologies that have not yet reached technological feasibility and have no alternative future use. In instances where the Company enters into cost-sharing arrangements, all research and development costs reimbursed by the collaborators are accounted for as reductions to research and development expense. During the year ended December 31, 2021 and 2020, the Company incurred no external costs related to cost-sharing collaborations. During the year ended December 31, 2019, the Company incurred $2.0 million in external costs related to cost-sharing collaborations, of which $1.0 million has been recorded as a reduction to research and development expense. |
Clinical Trial Costs | Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or other information provided to us by our vendors. |
Income Taxes | Income Taxes The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences reverse. A valuation allowance is provided to reduce the net deferred tax assets to the amount that will more likely than not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. |
Guarantees and Indemnifications | Guarantees and Indemnifications As permitted under Delaware law, the Company indemnifies its officers, directors, and employees for certain events or occurrences that happen by reason of the relationship with, or position held at, the Company. The Company has standard indemnification arrangements under office leases (as described in Note 5) that require it to indemnify the landlord against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation, or nonperformance of any covenant or condition of the Company’s lease. Through December 31, 2021, the Company had not experienced any losses related to these indemnification obligations and no claims were outstanding. The Company does not expect significant claims related to these indemnification obligations, and consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for all stock option awards granted to employees and non-employees using a fair value method. Stock-based compensation is measured at the grant date fair value of the stock option grants and is recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. For equity awards that have a performance condition, the Company recognizes compensation expense based on its assessment of the probability that the performance condition will be achieved. The Company accounts for forfeitures as they occur. |
Earnings (Loss) Per Share | Earnings (Loss) Per Share Basic earnings per share is computed by dividing undistributed net income attributable to Syndax by the weighted-average number of common shares outstanding during the period. Diluted earnings per share is computed based on the treasury method by dividing net income by the weighted-average number of common shares outstanding during the period plus potentially dilutive common equivalent shares outstanding. |
Recently Issued and Adopted Accounting Pronouncements | Recently Issued and Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board FASB or other accounting standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed below, we do not believe that the adoption of recently issued standards have or may have a material impact on our consolidated statements or disclosures. Income Taxes : In December 2019, the FASB issued Accounting Standards Update (“ASU”) 2019-12, This standard removes certain exceptions to the general principles in Topic 740 and simplifies certain other aspects of the accounting for income taxes. This standard became effective for us on January 1, 2021 and did not have a material impact on our consolidated financial statements and related disclosures. |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Lessee Disclosure [Abstract] | |
Summary of Future Minimum Lease Payments under Operating Leases | Future minimum lease payments under the Company’s operating leases, were as follows: Maturity of lease liabilities As of As of (in thousands) December 31, 2021 December 31, 2020 2021 $ 394 2022 $ 473 59 2023 376 — Thereafter 454 — Total lease payments $ 1,303 $ 453 Less: imputed interest (231 ) (36 ) Total operating lease liability $ 1,072 $ 417 |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Earnings (Loss) per Share | Basic and diluted earnings (loss) per share are calculated as follows (in 000s): Years Ended December 31, 2021 2020 2019 Numerator: Net income (loss) $ 24,926 $ (73,158 ) $ (56,047 ) Deemed dividend due to warrant reset - (3,906 ) — Net income (loss) attributable to common stockholders $ 24,926 $ (77,064 ) $ (56,047 ) Denominator: Weighted-average common shares outstanding 52,065 41,308 30,491 Effective of Dilutive Securities Options to purchase common stock 1,429 - - Non - vested restricted stock units (RSUs) 118 - - ESPP to purchase common stock 11 - - Dilutive potential common shares 1,558 - - Shares used in calculating diluted earnings (loss) per share 53,623 41,308 30,491 |
Potential Dilutive Securities Excluded from Computation of Diluted Net Earnings (Loss) Loss per Common Share | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding for 2020 and 2019, because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares): December 31, 2020 2019 Options to purchase common stock 6,379,235 6,057,011 Warrants to purchase common stock - 4,595,039 Employee Stock Purchase Plan 16,382 15,223 Non - vested restricted stock units (RSUs) 18,500 - |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment, net, consisted of the following (in thousands): December 31, 2021 2020 Equipment $ 386 $ 256 Leasehold improvements 167 167 Furniture and fixtures 134 134 Office and computer equipment 21 21 Office equipment under capital lease 13 13 Total property and equipment 721 591 Accumulated depreciation (443 ) (399 ) Property and equipment, net $ 278 $ 192 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Values of Financial Assets and Liabilities Measured at Fair Value | The table below presents information about the Company’s assets and liabilities that are regularly measured and carried at fair value and indicate the level within the fair value hierarchy of valuation techniques the Company utilized to determine such fair values (in thousands): Fair Value Measurements Using Total Carrying Value Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) December 31, 2021 Assets: Cash equivalents $ 221,964 $ 96,816 $ 125,148 $ — Short-term investments 217,971 — 217,971 — Total assets $ 439,935 $ 96,816 $ 343,119 $ — Liabilities: Derivative Liability 187 — — 187 Total Liabilities $ 187 $ — $ — $ 187 December 31, 2020 Assets: Cash equivalents $ 115,243 $ 110,246 $ 4,997 $ — Short-term investments 177,822 — 177,822 — Total assets $ 293,065 $ 110,246 $ 182,819 $ — |
Significant Unobservable Inputs in the Fair Value Measurement | The following table summarizes the significant unobservable inputs in the fair value measurement of the Company’s contingent consideration obligations as of December 31, 2021: As of December 31, 2021 Fair Value Unobservable Input Range Weighted Average (in thousands) Liabilities: Derivative Liability $ 187 Discount Rate Volatility Expected timing of the Termination Right 4-5% 58-61% 9 months 4.5% 59.5% 9 months |
Summary of Fair Value | The following table summarizes the fair value rollforward (in thousands): Fair Value Derivative Liability: Beginning Balance 1/1/2021 $ — Additions 576 Change in fair value (389 ) Ending Balance 12/31/2021 $ 187 |
Summary of Available-for-Sale Securities | The following table summarizes the available-for-sale securities (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2021 Commercial paper $ 306,715 $ 70 $ (17 ) $ 306,768 Corporate bonds 22,147 — (6 ) 22,141 US treasury 14,212 — (2 ) 14,210 $ 343,074 $ 70 $ (25 ) $ 343,119 December 31, 2020 Commercial paper $ 154,176 $ 13 $ (16 ) $ 154,173 Corporate bonds 22,617 2 (3 ) 22,616 US treasury 6,030 — — 6,030 $ 182,823 $ 15 $ (19 ) $ 182,819 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2021 2020 Short-term deposits $ 6,894 $ 4,683 Prepaid insurance 642 427 Interest receivable on investments 429 175 Prepaid clinical supplies - 58 Reimbursable costs - 24 Other 380 317 Total prepaid expenses and other current assets $ 8,345 $ 5,684 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued clinical costs $ 7,760 $ 7,132 Accrued compensation and related costs 4,342 3,213 Accrued professional fees 662 373 Other 1,702 528 Total accrued expenses $ 14,466 $ 11,246 |
Common Stock (Tables)
Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | The Company has reserved for future issuance the following shares of common stock related to the potential warrant exercise, exercise of stock options, and the employee stock purchase plan: December 31, 2021 Common stock issuable under pre-funded warrants 3,975,024 Options to purchase common stock 8,071,089 Employee Stock Purchase Plan 1,296,410 Total 13,342,523 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share Based Compensation Expense Related to Issuance of Stock Option Awards to Employees and Non Employees Related to Employee Stock Purchase Plan | The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and related to the Employee Stock Purchase Plan in the consolidated statements of operations as follows (in thousands): Years Ended December 31, 2021 2020 2019 Research and development $ 4,398 $ 2,400 $ 2,061 General and administrative 8,919 6,657 3,944 Total $ 13,317 $ 9,057 $ 6,005 |
Grant Date Fair Values of Options Issued to Employees and Non-employees Estimated Using Black-Scholes Option Pricing Model | The grant date fair values of options issued to employees and non-employees were estimated using the Black-Scholes option-pricing model with the following assumptions: Years Ended December 31, 2021 2020 2019 Expected term (in years) 6.02 5.97 5.97 Volatility rate 85.84 % 81.59 % 76.95 % Risk-free interest rate 0.67 % 1.20 % 2.29 % Expected dividend yield 0.00 % 0.00 % 0.00 % |
Summary of Employee and Non-Employee Option Activity | A summary of employee and non-employee option activity under the Company’s equity award plans is presented below (in thousands, except share data): Number Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding — 6,379,235 $ 9.40 7.1 $ 81,940 Granted 1,595,400 $ 20.61 Exercised (842,424 ) $ 7.82 Canceled, forfeited or expired (210,697 ) $ 15.57 Outstanding — 6,921,514 6.9 $ 68,609 Exercisable — 4,547,354 6.0 $ 54,012 Options vested, exercisable or expected to vest — 6,921,514 6.9 $ 68,609 |
Summary of Restricted Stock Units Activity | The following table summarizes our RSU activity: Number Shares Weighted Average Grant Date Fair Value Unvested — 18,500 $ 10.48 Granted 119,333 $ 21.19 Vested (5,500 ) $ 11.17 Forfeited - $ - Unvested—December 31, 2021 132,333 (1) RSUs granted in 2021 primarily represent RSUs granted in conjunction with our annual awards made in February 2021granted to our Board of Directors. |
Loan Payable (Tables)
Loan Payable (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Summary of Maturities of Principal Obligations Under Long-term Debt | As of December 31, 2021, the Company’s maturities of principal obligations under its long-term debt are as follows: Amount 2022 $ — 2023 14,764,764 2024 5,235,236 Total principal outstanding 20,000,000 Amortized final fee 17,591 Unamortized debt issuance costs (122,927 ) Total 19,894,664 Term loan, current portion - Term loan, less current portion $ 19,894,664 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Reconciliation of Provision for Income Taxes Computed at Statutory Federal Income Tax Rate to Provision for Income Taxes | A reconciliation of the provision for income taxes computed at the statutory federal income tax rate to the provision for income taxes as reflected in the financial statements is as follows: Years Ended December 31, 2021 2020 2019 Income tax computed at federal statutory rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 2.9 % 1.8 % 2.1 % General business credit carryovers -5.0 % 0.9 % 0.9 % Non-deductible expenses -0.5 % 0.0 % -0.8 % Change in valuation allowance -19.2 % -23.7 % -22.8 % Other 0.8 % 0.0 % -0.4 % 0.0 % 0.0 % 0.0 % |
Components of Deferred Tax | The significant components of the Company’s deferred tax are as follows (in thousands): Years Ended December 31, 2021 2020 Deferred tax assets (liabilities): Net operating loss carryforwards $ 17,642 $ 22,794 Research and development credits 6,113 4,856 Capitalized start-up and other costs 34,898 28,854 Capitalized research and development costs 31,365 35,632 Deferred revenue — 2,989 Equity based compensation 6,277 5,117 Accruals 845 1,657 Other temporary differences 10 29 Deferred tax assets before valuation allowance 97,150 101,928 Valuation allowances (97,150 ) (101,928 ) Net deferred tax assets $ — $ — |
Summary of Reconciliation of Company's Unrecognized Tax Benefits | A reconciliation of the Company’s unrecognized tax benefits is as follows (in thousands): Years Ended December 31, 2021 2020 2019 Unrecognized tax benefit--beginning of year $ 163 $ 163 $ 163 Decreases related to prior period positions — — — Unrecognized tax benefit--end of year $ 163 $ 163 $ 163 |
Supplemental Cash Flow Inform_2
Supplemental Cash Flow Information (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Supplemental Cash Flow Elements [Abstract] | |
Supplemental Disclosures of Cash Flow Information | Years Ended December 31, 2021 2020 2019 (In thousands) Supplemental Disclosures of Cash Flow Information Interest paid $ 1,997 $ 1,631 $ — Supplemental Disclosures of Non-Cash Investing and Financing Activities: Issuance costs included in accounts payable and accrued expenses $ 134 $ 43 $ — |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2021USD ($)SegmentClaim | Dec. 31, 2019USD ($) | Dec. 31, 2020USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Number of operating segments | Segment | 1 | ||
Impairment charge | $ 0 | ||
ASU No. 2019-12 [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 1, 2021 | ||
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true | ||
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false] | true | ||
Guarantees and Indemnifications [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Indemnification obligations, claims outstanding | Claim | 0 | ||
Indemnification obligations claims, reserves established | $ 0 | ||
Cost-Sharing Collaborations [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
External costs related to cost-sharing collaborations | $ 0 | $ 2,000,000 | $ 0 |
Cost-sharing collaborations recorded as a reduction to research and development expense | $ 1,000,000 | ||
Minimum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful lives | 3 years | ||
Percentage of income tax contingency realized | 50.00% | ||
Maximum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful lives | 5 years |
Collaborative Research and Li_2
Collaborative Research and License Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Dec. 31, 2021 | Sep. 30, 2021 | Jan. 31, 2020 | Oct. 31, 2017 | Dec. 19, 2014 | Dec. 31, 2021 | Dec. 31, 2017 | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Common stock shares purchased | 3,802,144 | 3,036,719 | |||||
Purchase price per share | $ 8 | ||||||
Aggregate purchase price | $ 81,200,000 | ||||||
Kyowa Kirin Co., Ltd. [Member] | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Milestone payment agreement terms | In accordance with the terms of the license agreement | ||||||
Incyte Agreement [Member] | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
License agreement upfront payment received | $ 117,000,000 | $ 117,000,000 | |||||
Common stock shares purchased | 1,421,523 | ||||||
Purchase price per share | $ 24.62 | $ 24.62 | |||||
Aggregate purchase price | $ 35,000,000 | $ 35,000,000 | |||||
Total cash consideration | 152,000,000 | ||||||
Common stock issued at fair value | 24,800,000 | 24,848,000 | |||||
Allocated consideration received to derivative liability | 600,000 | ||||||
Upfront payments returned upon termination of agreement | 117,000,000 | ||||||
Total transaction price | 126,600,000 | ||||||
Estimated standalone selling price of license agreement | 126,600,000 | ||||||
Revenue recognized upon transfer of license agreement | 126,600,000 | ||||||
Incyte Agreement [Member] | Non-Refundable Cash Payments [Member] | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Upfront milestone payable | $ 117,000,000 | ||||||
Incyte Agreement [Member] | Maximum [Member] | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Potential milestone payments to be made | 220,000,000 | ||||||
Commercialization milestones and tiered royalties | $ 230,000,000 | ||||||
Incyte Agreement [Member] | Global and U.S. [Member] | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Development costs associated with clinical trials | 45.00% | ||||||
Incyte Agreement [Member] | Global and U.S. [Member] | Incyte Corporation [Member] | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Development costs associated with clinical trials | 55.00% | ||||||
Incyte Agreement [Member] | Ex-U.S. Countries [Member] | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Development costs associated with clinical trials | 100.00% | ||||||
License Agreement [Member] | Kyowa Kirin Co., Ltd. [Member] | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
License agreement upfront payment received | $ 25,000,000 | ||||||
Up-front payment allocated to equity purchase | 7,500,000 | ||||||
Up-front license fee received | $ 17,500,000 | ||||||
Period of termination after first commercial sale of first licensed product | 15 years | ||||||
Up-front payment allocated to preferred stock value | $ 7,700,000 | ||||||
Up-front payment allocated to license fee | 17,300,000 | ||||||
Milestone payment received | $ 5,000,000 | $ 5,000,000 | |||||
Upfront payment allocation to performance obligation | $ 17,300,000 | $ 17,300,000 | |||||
Performance obligation period | 2029 | 2029 | |||||
Deferred revenue | $ 12,400,000 | ||||||
License Agreement [Member] | Kyowa Kirin Co., Ltd. [Member] | Maximum [Member] | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Milestone payment receivable upon achievement of development and commercial milestone | $ 75,000,000 |
Leases - Additional Information
Leases - Additional Information (Detail) | Aug. 17, 2021USD ($) | Feb. 28, 2021USD ($) | Sep. 30, 2016ft² | Dec. 31, 2015ft² | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Lessee Lease Description [Line Items] | ||||||
Lease option to extend | true | |||||
Lease option to termination | true | |||||
Lease Commencement Date | Mar. 1, 2021 | |||||
Right-of-use asset, net | $ 983,000 | $ 290,000 | ||||
Lease liability | $ 1,072,000 | 417,000 | ||||
Operating lease discount rate | 14.00% | |||||
Operating lease expense | $ 413,000 | |||||
Lease payments | $ 270,000 | $ 544,000 | ||||
Lessee, Operating Lease, Option to Extend | In February 2021, the Company signed an 18-month extension to the lease for the New York office, with aggregate payments of $270,000, with a lease commencement date of March 1, 2021. | |||||
Future minimum lease payments under capital leases | $ 1,000 | $ 5,000 | ||||
Waltham, Massachusetts [Member] | ||||||
Lessee Lease Description [Line Items] | ||||||
Operating lease term of contract | 5 years | |||||
Area of leased property | ft² | 12,207 | |||||
Lease Commencement Date | Mar. 1, 2022 | Mar. 1, 2017 | ||||
Remaining lease term | 38 months | |||||
Lease payments | $ 1,600,000 | |||||
Lessee, Operating Lease, Option to Extend | . On August 17, 2021, the Company signed a 36-month extension to the lease for the Waltham, Massachusetts office with aggregate payments of $1.6 million, with a lease commencement date of March 1, 2022. | |||||
New York [Member] | ||||||
Lessee Lease Description [Line Items] | ||||||
Operating lease term of contract | 62 months | |||||
Area of leased property | ft² | 4,039 | |||||
Lease Commencement Date | Jan. 1, 2016 | |||||
Remaining lease term | 8 months |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Lease Payments under Operating Leases (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Operating Lease Liabilities Payments Due [Abstract] | ||
2021 | $ 394 | |
2022 | $ 473 | 59 |
2023 | 376 | |
Thereafter | 454 | |
Total lease payments | 1,303 | 453 |
Less: imputed interest | (231) | (36) |
Lease liability | $ 1,072 | $ 417 |
Earnings (Loss) per Share - Com
Earnings (Loss) per Share - Computation of Basic and Diluted Earnings (Loss) per Share (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator: | |||
Net income (loss) | $ 24,926 | $ (73,158) | $ (56,047) |
Deemed dividend due to warrant reset | (3,906) | ||
Net income (loss) attributable to common stockholders | $ 24,926 | $ (77,064) | $ (56,047) |
Denominator: | |||
Weighted-average common shares outstanding | 52,064,809 | 41,308,242 | 30,490,783 |
Dilutive potential common shares | 1,558,000 | ||
Shares used in calculating diluted earnings (loss) per share | 53,622,904 | 41,308,242 | 30,490,783 |
Options to Purchase Common Stock [Member] | |||
Denominator: | |||
Dilutive potential common shares | 1,429,000 | ||
Non-Vested Restricted Stock Units (RSUs) [Member] | |||
Denominator: | |||
Dilutive potential common shares | 118,000 | ||
ESPP to Purchase Common Stock | |||
Denominator: | |||
Dilutive potential common shares | 11,000 |
Earnings (Loss) per Share - Pot
Earnings (Loss) per Share - Potential Dilutive Securities Excluded from Computation of Diluted Net Loss per Common Share (Detail) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
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 | 6,379,235 | 6,057,011 |
Warrants 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 | 4,595,039 | |
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 | 16,382 | 15,223 |
Non-Vested Restricted Stock Units (RSUs) [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 | 18,500 |
Earnings (Loss) per Share - Add
Earnings (Loss) per Share - Additional Information (Detail) - $ / shares | Jun. 18, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | May 31, 2020 | Jan. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2021 |
Earnings Per Share Basic [Line Items] | |||||||
Common stock shares purchased | 3,802,144 | 3,036,719 | |||||
Purchase price per share | $ 8 | ||||||
Pre-funded warrants exchange | 250,000 | ||||||
Pre-funded warrants cashless exchange | 475,784 | ||||||
Biotechnology Value Fund, L.P. [Member] | |||||||
Earnings Per Share Basic [Line Items] | |||||||
Number of common stock converted to warrants | 2,000,000 | ||||||
Number of common stock warrants issued | 2,000,000 | ||||||
Common stock shares purchased | 6,250,000 | 6,388,889 | |||||
Pre-Funded Warrants [Member] | |||||||
Earnings Per Share Basic [Line Items] | |||||||
Warrant issued | 1,338,287 | 2,500,000 | 3,975,024 | ||||
Warrant exercise price per share | $ 0.0001 | ||||||
Warrants outstanding | 3,975,024 | 3,975,024 | |||||
Pre-Funded Warrants [Member] | Biotechnology Value Fund, L.P. [Member] | |||||||
Earnings Per Share Basic [Line Items] | |||||||
Number of common stock converted to warrants | 2,000,000 | ||||||
Number of common stock warrants issued | 2,000,000 | ||||||
Warrant exercise price per share | $ 0.0001 |
Significant Agreements - Additi
Significant Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 30 Months Ended | ||||||||||||
Sep. 30, 2021 | Mar. 31, 2021 | Jul. 31, 2020 | Jun. 30, 2019 | Oct. 31, 2017 | Jul. 31, 2016 | Mar. 31, 2014 | Dec. 31, 2007 | Mar. 31, 2007 | Dec. 31, 2017 | Sep. 30, 2016 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2016 | Dec. 31, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Research and development expense | $ 88,248,000 | $ 50,435,000 | $ 42,994,000 | |||||||||||||
Allergan License Agreement [Member] | Vitae Pharmaceuticals Inc [Member] | ||||||||||||||||
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 | |||||||||||||||
Research and development expense | $ 4,000,000 | $ 5,000,000 | ||||||||||||||
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 | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | $ 5,000,000 | ||||||||||||
Accrued milestone expenses | 2,000,000 | |||||||||||||||
Clinical Trial [Member] | Eastern Cooperative Oncology Group [Member] | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Upfront milestone payable | $ 700,000 | |||||||||||||||
Milestone payment payable | $ 1,000,000 | |||||||||||||||
Increase in contractual obligation | $ 5,300,000 | |||||||||||||||
Aggregate payment obligation | $ 24,700,000 | |||||||||||||||
Period of contractual obligation | 1 year | |||||||||||||||
Accrued contractual obligation | $ 3,000,000 | |||||||||||||||
Clinical Trial [Member] | Eastern Cooperative Oncology Group [Member] | Maximum [Member] | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Remaining contractual obligation | $ 3,200,000 | |||||||||||||||
License Agreement [Member] | Bayer Pharma AG [Member] | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Research and development expense | $ 2,000,000 | |||||||||||||||
Up-front license fee paid | $ 2,000,000 | |||||||||||||||
License Agreement [Member] | Bayer Pharma AG [Member] | Maximum [Member] | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Aggregate payment obligation | $ 150,000,000 |
Property and Equipment, Net - P
Property and Equipment, Net - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 721 | $ 591 |
Accumulated depreciation | (443) | (399) |
Property and equipment, net | 278 | 192 |
Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 386 | 256 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 167 | 167 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 134 | 134 |
Office and Computer Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 21 | 21 |
Office Equipment Under Capital Lease [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 13 | $ 13 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expense | $ 43,000 | $ 90,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Values of Financial Assets and Liabilities Measured at Fair Value (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 217,971 | $ 177,822 |
Carrying Value [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 221,964 | 115,243 |
Short-term investments | 217,971 | 177,822 |
Total assets | 439,935 | 293,065 |
Derivative Liability | 187 | |
Total Liabilities | 187 | |
Quoted Prices in Active Markets Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 96,816 | 110,246 |
Total assets | 96,816 | 110,246 |
Significant Other Observable Inputs Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 125,148 | 4,997 |
Short-term investments | 217,971 | 177,822 |
Total assets | 343,119 | $ 182,819 |
Significant Unobservable Inputs Level 3 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Derivative Liability | 187 | |
Total Liabilities | $ 187 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) | 36 Months Ended |
Dec. 31, 2021USD ($) | |
Fair Value Disclosures [Abstract] | |
Realized gains or losses recognized on the sale or maturity of available-for-sale securities | $ 0 |
Fair Value Measurements - Signi
Fair Value Measurements - Significant Unobservable Inputs in the Fair Value Measurement (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Fair Value Measurements [Line Items] | |
Derivative liability | $ 187 |
Black Scholes Model [Member] | Significant Unobservable Inputs Level 3 [Member] | |
Fair Value Measurements [Line Items] | |
Derivative liability | $ 187 |
Black Scholes Model [Member] | Significant Unobservable Inputs Level 3 [Member] | Measurement Input, Expected Term [Member] | |
Fair Value Measurements [Line Items] | |
Expected timing of the Termination Right | 9 months |
Minimum [Member] | Black Scholes Model [Member] | Significant Unobservable Inputs Level 3 [Member] | Discount Rate [Member] | |
Fair Value Measurements [Line Items] | |
Derivative Liability, Measurement Input | 0.04 |
Minimum [Member] | Black Scholes Model [Member] | Significant Unobservable Inputs Level 3 [Member] | Volatility [Member] | |
Fair Value Measurements [Line Items] | |
Derivative Liability, Measurement Input | 0.58 |
Weighted Average [Member] | Black Scholes Model [Member] | Significant Unobservable Inputs Level 3 [Member] | Discount Rate [Member] | |
Fair Value Measurements [Line Items] | |
Derivative Liability, Measurement Input | 0.045 |
Weighted Average [Member] | Black Scholes Model [Member] | Significant Unobservable Inputs Level 3 [Member] | Volatility [Member] | |
Fair Value Measurements [Line Items] | |
Derivative Liability, Measurement Input | 0.595 |
Weighted Average [Member] | Black Scholes Model [Member] | Significant Unobservable Inputs Level 3 [Member] | Measurement Input, Expected Term [Member] | |
Fair Value Measurements [Line Items] | |
Expected timing of the Termination Right | 9 months |
Maximum [Member] | Black Scholes Model [Member] | Significant Unobservable Inputs Level 3 [Member] | Discount Rate [Member] | |
Fair Value Measurements [Line Items] | |
Derivative Liability, Measurement Input | 0.05 |
Maximum [Member] | Black Scholes Model [Member] | Significant Unobservable Inputs Level 3 [Member] | Volatility [Member] | |
Fair Value Measurements [Line Items] | |
Derivative Liability, Measurement Input | 0.61 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Derivative Liability: | |
Beginning Balance 1/1/2021 | $ 0 |
Additions | 576 |
Change in fair value | (389) |
Ending Balance 12/31/2021 | $ 187 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 343,074 | $ 182,823 |
Unrealized Gains | 70 | 15 |
Unrealized Losses | (25) | (19) |
Fair Value | 343,119 | 182,819 |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 306,715 | 154,176 |
Unrealized Gains | 70 | 13 |
Unrealized Losses | (17) | (16) |
Fair Value | 306,768 | 154,173 |
Corporate Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 22,147 | 22,617 |
Unrealized Gains | 2 | |
Unrealized Losses | (6) | (3) |
Fair Value | 22,141 | 22,616 |
U.S. Treasury [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 14,212 | 6,030 |
Unrealized Losses | (2) | |
Fair Value | $ 14,210 | $ 6,030 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Short-term deposits | $ 6,894 | $ 4,683 |
Prepaid insurance | 642 | 427 |
Interest receivable on investments | 429 | 175 |
Prepaid clinical supplies | 58 | |
Reimbursable costs | 24 | |
Other | 380 | 317 |
Total prepaid expenses and other current assets | $ 8,345 | $ 5,684 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued clinical costs | $ 7,760 | $ 7,132 |
Accrued compensation and related costs | 4,342 | 3,213 |
Accrued professional fees | 662 | 373 |
Other | 1,702 | 528 |
Total accrued expenses | $ 14,466 | $ 11,246 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) $ / shares in Units, $ in Thousands | Jun. 18, 2018$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($)$ / sharesshares | May 31, 2020USD ($)$ / sharesshares | Jan. 31, 2020USD ($)$ / sharesshares | Mar. 31, 2019USD ($)Seriesofwarrant$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019$ / shares | Mar. 08, 2016shares |
Class Of Stock [Line Items] | |||||||||||
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 | 100,000,000 | |||||||
Proceeds from issuance of common stock in follow-on public stock offering, net | $ | $ 81,200 | ||||||||||
Common stock, new shares issued | 3,802,144 | 3,036,719 | |||||||||
Number of series of warrants | Seriesofwarrant | 2 | ||||||||||
Gross proceeds from offering | $ | $ 27,600 | ||||||||||
Offering costs | $ | $ 200 | ||||||||||
Weighted average expected term | 1 year 4 months 24 days | 4 months 24 days | 1 year 4 months 24 days | ||||||||
Deemed dividend transferred to the warrant holders | $ | $ 3,900 | $ 3,906 | |||||||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||
Incyte Collaboration Agreement and Share Purchase Agreement [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock in follow-on public stock offering, net | $ | $ 35,000 | ||||||||||
Common stock, new shares issued | 1,421,523 | ||||||||||
Common stock issued at fair value | $ | $ 24,800 | ||||||||||
Volatility [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrants and rights outstanding, measurement input | 0.891 | 0.9674 | 0.891 | ||||||||
Pre-Funded Warrants [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrant exercise price per share | $ / shares | $ 0.0001 | ||||||||||
Warrants issued (in shares) | 1,142,856 | 1,338,287 | 2,500,000 | 1,142,856 | |||||||
Warrant term | 20 years | ||||||||||
Offering price | $ / shares | $ 17.4999 | $ 7.9999 | $ 5.9999 | ||||||||
Maximum period allowed to increase beneficial ownership limitation after notice | 61 days | ||||||||||
Minimum percentage of common stock can be held upon exercise of warrant | 9.99% | ||||||||||
Maximum beneficial ownership limitation percentage | 19.99% | ||||||||||
Common Stock [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Common stock, new shares issued | 2,095,039 | ||||||||||
Shares issued for exercise of warrants | 1,995,941 | ||||||||||
Series Warrants [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrants issued (in shares) | 4,595,039 | 4,595,039 | 4,595,039 | ||||||||
Offering price | $ / shares | $ 17.50 | 8 | $ 6 | ||||||||
Maximum period allowed to increase beneficial ownership limitation after notice | 61 days | ||||||||||
Minimum percentage of common stock can be held upon exercise of warrant | 9.99% | ||||||||||
Maximum beneficial ownership limitation percentage | 19.99% | ||||||||||
Total fair value of warrant | $ | $ 3,400 | ||||||||||
Series 1 Warrants [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrant exercise price per share | $ / shares | 12 | $ 12 | |||||||||
Series 1 Warrants [Member] | Maximum [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrant exercise price per share | $ / shares | 12 | ||||||||||
Series 1 Warrants [Member] | Minimum [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrant exercise price per share | $ / shares | 10 | ||||||||||
Series 2 Warrants [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrant exercise price per share | $ / shares | $ 18 | $ 18 | |||||||||
Series 2 Warrants [Member] | Maximum [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrant exercise price per share | $ / shares | 18 | ||||||||||
Series 2 Warrants [Member] | Minimum [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrant exercise price per share | $ / shares | $ 13 | ||||||||||
Series 1 and Series 2 Warrants [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrants exercised period | 2020 | ||||||||||
Warrants exercised | 4,595,039 | ||||||||||
Shares issued for exercise of warrants | 1,995,941 | ||||||||||
Biotechnology Value Fund, L.P. [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock in follow-on public stock offering, net | $ | $ 135,000 | $ 107,900 | |||||||||
Common stock, new shares issued | 6,250,000 | 6,388,889 | |||||||||
Number of common stock converted to warrants | 2,000,000 | ||||||||||
Number of common stock warrants issued | 2,000,000 | ||||||||||
Offering price | $ / shares | $ 23 | $ 18 | |||||||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||
Biotechnology Value Fund, L.P. [Member] | Pre-Funded Warrants [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Warrant exercise price per share | $ / shares | $ 0.0001 | ||||||||||
Number of common stock converted to warrants | 2,000,000 | ||||||||||
Number of common stock warrants issued | 2,000,000 | ||||||||||
Warrant expiration period | 20 years | ||||||||||
Maximum percentage of common stock can be held upon exercise of warrant | 9.99% | ||||||||||
At The Market Equity Offering Sales Agreement [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock in follow-on public stock offering, net | $ | $ 5,100 | ||||||||||
Common stock, new shares issued | 277,629 | ||||||||||
Cowen and Company LLC [Member] | At The Market Equity Offering Sales Agreement [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock in follow-on public stock offering, net | $ | $ 75,000 | ||||||||||
Initial Public Offering [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Common stock, shares authorized | 100,000,000 |
Common Stock - Schedule of Comm
Common Stock - Schedule of Common Stock Reserved for Future Issuance (Detail) | Dec. 31, 2021shares |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 13,342,523 |
Pre-Funded Warrants [Member] | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 3,975,024 |
Options to Purchase Common Stock [Member] | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 8,071,089 |
Employee Stock Purchase Plan [Member] | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 1,296,410 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | Jan. 01, 2022shares | Jan. 01, 2021shares | Oct. 31, 2021USD ($)Employeeshares | Sep. 30, 2015shares | Dec. 31, 2020shares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2017shares | Dec. 31, 2022shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares available for issuance | 13,342,523 | |||||||||
Share-based compensation, stock options granted | 1,595,400 | |||||||||
Share-based compensation, stock options vested | 6,921,514 | |||||||||
Stock compensation expense | $ | $ 13,317,000 | $ 9,057,000 | $ 6,005,000 | |||||||
Weighted-average grant date fair value of options granted | $ / shares | $ 14.70 | $ 7.88 | $ 4.81 | |||||||
Stock options exercised, shares | 842,424 | 755,166 | 25,857 | |||||||
Stock options exercised | $ | $ 6,336,000 | $ 6,633,000 | $ 178,000 | |||||||
Intrinsic value of options exercised | $ | 10,100,000 | 7,100,000 | 9,000 | |||||||
Contributions by the company | $ | 444,000 | 250,000 | $ 119,000 | |||||||
Performance Based Shares [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Unrecognized compensation expense related to stock option | $ | 900,000 | |||||||||
Service Based Options [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Unrecognized compensation expense related to stock option | $ | 24,800,000 | |||||||||
2017 Performance Awards [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based compensation, stock options granted | 60,000 | |||||||||
Share-based compensation, stock options vested | 13,333 | |||||||||
Share-based compensation, stock options cancelled | 20,000 | 6,667 | ||||||||
Stock compensation expense | $ | $ 25,000 | $ 9,000 | $ 88,000 | |||||||
2019 Performance Awards | Employees [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock option granted to certain employees | 583,000 | |||||||||
Non-Vested Restricted Stock Units (RSUs) [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period | 1 year | |||||||||
Restricted stock units granted | 119,333 | 0 | ||||||||
Fair value of restricted stock units vested | $ | $ 60,000 | |||||||||
Restricted stock units vested | 5,500 | 0 | ||||||||
Weighted average grant date fair value per share | $ / shares | $ 21.19 | $ 10.48 | ||||||||
Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period | 4 years | |||||||||
Minimum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period | 3 years | |||||||||
2015 Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Common stock reserved for issuance | 1,750,000 | |||||||||
Shares available for issuance | 1,017,242 | |||||||||
Common stock outstanding | 4.00% | |||||||||
2015 Plan [Member] | Maximum [Member] | Subsequent Event [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares available for issuance | 3,215,376 | |||||||||
2007 and 2015 [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Unrecognized compensation expense related to stock option | $ | $ 25,700,000 | |||||||||
Weighted average period to recognize compensation expense | 2 years 9 months 18 days | |||||||||
2007 Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based compensation, stock options vested | 34,728 | |||||||||
Number of employees retirement | Employee | 2 | |||||||||
Stock compensation expense | $ | $ 800,000 | |||||||||
2007 Plan [Member] | 2019 Performance Awards | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based compensation, stock options granted | 194,331 | |||||||||
Share-based compensation, stock options vested | 64,777 | 64,780 | 64,777 | |||||||
Share-based compensation, stock options cancelled | 388,669 | 0 | ||||||||
Stock compensation expense | $ | $ 257,000 | $ 207,000 | ||||||||
Recognized compensation expense related to stock option not met | $ | 0 | |||||||||
2007 Plan [Member] | 2019 Performance Awards | Scenario Forecast [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based compensation, stock options vested | 64,774 | |||||||||
Employee Stock Purchase Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock compensation expense | $ | $ 175,000 | $ 203,000 | $ 113,000 | |||||||
Number of shares issued under plan | 26,878 | 33,706 | ||||||||
Employee Stock Purchase Plan [Member] | Subsequent Event [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Periodic payroll deductions offering periods | 6 months | |||||||||
Offering period discount rate | 15.00% | |||||||||
Employee Stock Purchase Plan [Member] | Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares authorized for issuance | 250,000 | |||||||||
Employee Stock Purchase Plan [Member] | Maximum [Member] | Subsequent Event [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares available for issuance | 1,546,410 |
Stock-Based Compensation - Shar
Stock-Based Compensation - Share Based Compensation Expense Related to Issuance of Stock Option Awards to Employees and Non Employees Related to Employee Stock Purchase Plan (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation expense, total | $ 13,317 | $ 9,057 | $ 6,005 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation expense, total | 4,398 | 2,400 | 2,061 |
General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation expense, total | $ 8,919 | $ 6,657 | $ 3,944 |
Stock-Based Compensation - Gran
Stock-Based Compensation - Grant Date Fair Values of Options Issued to Employees and Non-employees Estimated Using Black-Scholes Option Pricing Model (Detail) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions And Methodology [Abstract] | |||
Expected term (in years) | 6 years 7 days | 5 years 11 months 19 days | 5 years 11 months 19 days |
Volatility rate | 85.84% | 81.59% | 76.95% |
Risk-free interest rate | 0.67% | 1.20% | 2.29% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Company's Stock Option Activity (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Arrangements To Obtain Goods And Services [Abstract] | |||
Options outstanding, Beginning balance | 6,379,235 | ||
Options granted | 1,595,400 | ||
Options exercised | (842,424) | (755,166) | (25,857) |
Options canceled, forfeited or expired | (210,697) | ||
Options outstanding, Ending balance | 6,921,514 | 6,379,235 | |
Options exercisable, Ending balance | 4,547,354 | ||
Options vested, exercisable or expected to vest, Ending balance | 6,921,514 | ||
Options outstanding, Weighted Average Exercise Price, Beginning balance | $ 9.40 | ||
Options granted, Weighted Average Exercise Price | 20.61 | ||
Options exercised, Weighted Average Exercise Price | 7.82 | ||
Options canceled, forfeited or expired, Weighted Average Exercise Price | $ 15.57 | ||
Options outstanding, Weighted Average Exercise Price, Ending balance | $ 9.40 | ||
Options outstanding, Weighted Average Remaining Contractual Term | 6 years 10 months 24 days | 7 years 1 month 6 days | |
Options exercisable, Weighted Average Remaining Contractual Term, Ending balance | 6 years | ||
Options vested, exercisable or expected to vest, Weighted Average Remaining Contractual Term, Ending balance | 6 years 10 months 24 days | ||
Options outstanding, Aggregate Intrinsic Value | $ 68,609,000 | $ 81,940,000 | |
Options Exercised, Aggregate Intrinsic Value | 10,100,000 | $ 7,100,000 | $ 9,000 |
Options exercisable, Aggregate Intrinsic Value | 54,012,000 | ||
Options vested, exercisable or expected to vest, Aggregate Intrinsic Value | $ 68,609,000 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - Non-Vested Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Unvested, Beginning balance | 18,500 | ||
Number of Shares, Granted | 119,333 | 0 | |
Number of Shares, Vested | (5,500) | 0 | |
Number of Shares, Unvested, Ending balance | 132,333 | 18,500 | |
Weighted Average Grant Date Fair Value, Unvested, Beginning balance | $ 10.48 | ||
Weighted Average Grant Date Fair Value, Granted | 21.19 | ||
Weighted Average Grant Date Fair Value, Vested | $ 11.17 | ||
Weighted Average Grant Date Fair Value, Unvested, Ending balance | $ 10.48 |
Loan Payable - Additional Infor
Loan Payable - Additional Information (Detail) - USD ($) | Dec. 22, 2021 | Oct. 01, 2020 | Feb. 29, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | |||||
Borrowings to date | $ 20,000,000 | ||||
Hercules [Member] | Loan Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate maximum borrowings | $ 30,000,000 | ||||
Interest rate description | Borrowings under the Loan Agreement bear interest at an annual rate equal to the greater of (i) 9.85% or (ii) 5.10% plus the Wall Street Journal prime rate. | ||||
Facility charge paid | $ 100,000 | ||||
Interest-only period expiration date | Oct. 1, 2021 | ||||
Maturity date | Sep. 1, 2023 | ||||
Minimum cash covenant | $ 12,500,000 | ||||
Minimum cash covenant waived | $ 12,500,000 | ||||
Default interest rate | 5.00% | ||||
Interest expense related to the loan agreement | $ 1,900,000 | ||||
Hercules [Member] | Loan Agreement [Member] | Wall Street Journal Prime Rate [Member] | |||||
Debt Instrument [Line Items] | |||||
Basis spread on variable rate | 5.10% | ||||
Hercules [Member] | Loan Agreement [Member] | Minimum [Member] | |||||
Debt Instrument [Line Items] | |||||
Interest rate | 9.85% | ||||
Hercules [Member] | Loan Agreement [Member] | Term Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate maximum borrowings | $ 20,000,000 | ||||
Hercules [Member] | Loan Agreement [Member] | Additional Term Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate maximum borrowings | 10,000,000 | ||||
Line of credit facility elected not to draw | $ 10,000,000 | ||||
Hercules [Member] | First Amendment to Loan Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate maximum borrowings | $ 80,000,000 | ||||
Interest rate description | decreased the annual interest rate from the greater of (w) 9.85% or (x) 5.10% plus the Wall Street Journal prime rate to the greater of (y) 9.25% or (z) 6.00% plus the Wall Street Journal prime rate | ||||
Aggregate maximum borrowing capacity increase | $ 50,000,000 | ||||
Interest-only period, terms | extended the expiration of the period in which interest-only payments on borrowings under the Loan Agreement are required from October 1, 2021 to January 1, 2023, which is further extendable to December 31, 2023 upon the partial or full draw of Tranche 2 (the “Interest-Only Period”) | ||||
Interest-only period expiration date | Jan. 1, 2023 | ||||
Interest-only period, extendable upon partial or full draw of Tranche 2 | Dec. 31, 2023 | ||||
Maturity date | Apr. 1, 2024 | ||||
Percentage of prepayment premium of principal amount outstanding in first year | 2.00% | ||||
Percentage of prepayment premium of principal amount outstanding in second year | 1.50% | ||||
Percentage of prepayment premium of principal amount outstanding thereafter prior to maturity date | 1.00% | ||||
Percentage of facility charge of future draws | 0.50% | ||||
Hercules [Member] | First Amendment to Loan Agreement [Member] | Minimum [Member] | |||||
Debt Instrument [Line Items] | |||||
Interest rate | 9.25% | ||||
Hercules [Member] | First Amendment to Loan Agreement [Member] | Maximum [Member] | |||||
Debt Instrument [Line Items] | |||||
Percentage of end of term charge to future draws | 4.99% | ||||
Hercules [Member] | First Amendment to Loan Agreement [Member] | Term Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Borrowings to date | $ 20,000,000 | ||||
Hercules [Member] | First Amendment to Loan Agreement [Member] | Tranche 2 [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate maximum borrowings | $ 30,000,000 | ||||
Hercules [Member] | First Amendment to Loan Agreement [Member] | Tranche 2 [Member] | Available through April 30, 2022 [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate maximum borrowings | 15,000,000 | ||||
Hercules [Member] | First Amendment to Loan Agreement [Member] | Tranche 2 [Member] | Available through November 30, 2022 [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate maximum borrowings | 15,000,000 | ||||
Hercules [Member] | First Amendment to Loan Agreement [Member] | Tranche 3 [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate maximum borrowings | $ 30,000,000 | ||||
Hercules [Member] | First Amendment to Loan Agreement [Member] | Wall Street Journal Prime Rate [Member] | |||||
Debt Instrument [Line Items] | |||||
Basis spread on variable rate | 6.00% |
Loan Payable - Summary of Matur
Loan Payable - Summary of Maturities of Principal Obligations Under Long-term Debt (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
2023 | $ 14,764,764 | |
2024 | 5,235,236 | |
Total principal outstanding | 20,000,000 | |
Amortized final fee | 17,591 | |
Unamortized debt issuance costs | (122,927) | |
Total | 19,894,664 | |
Current portion of term loan | $ 2,285,000 | |
Term loan, less current portion | $ 19,894,664 | $ 17,834,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes [Line Items] | ||
Net tax provision | $ 0 | $ 0 |
Increase (decrease) in valuation allowance | $ (4,800,000) | 17,500,000 |
Valuation allowance for deferred tax assets, description | The Company has provided a valuation allowance for the full amount of the net deferred tax assets as the realization of the deferred tax assets is not determined to be more likely than not. The valuation allowance decreased by $4.8 million in 2021 due to the decrease in deferred tax assets, primarily driven by the utilization of tax attributes to offset federal and state taxable income, partially offset by an increase to other deferred tax assets. The valuation allowance increased by $17.5 million in 2020 due to the increase in deferred tax assets, primarily driven by net operating loss carryforwards and capitalized research and development costs. | |
Federal net operating losses | $ 73,500,000 | |
State net operating losses | 34,600,000 | |
Internal Revenue Service [Member] | ||
Income Taxes [Line Items] | ||
Uncertain tax positions | 200,000 | 200,000 |
Interest or penalties recorded during the period | 0 | $ 0 |
Unrecognized income tax benefits that would affect effective tax rate | $ 0 | |
Federal [Member] | ||
Income Taxes [Line Items] | ||
Operating loss carryforward expiration period | 2026 | |
Deferred tax assets research credits | $ 4,100,000 | |
Deferred tax assets research credits expiration period | 2022 | |
Federal [Member] | Indefinite Carryforward Period [Member] | ||
Income Taxes [Line Items] | ||
Federal net operating losses | $ 48,500,000 | |
Federal [Member] | Begin to Expire in 2026 [Member] | ||
Income Taxes [Line Items] | ||
Federal net operating losses | $ 25,000,000 | |
State [Member] | ||
Income Taxes [Line Items] | ||
Operating loss carryforward expiration period | 2026 | |
Deferred tax assets research credits | $ 2,500,000 | |
Deferred tax assets research credits expiration period | 2022 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Provision for Income Taxes Computed at Statutory Federal Income Tax Rate to Provision for Income Taxes (Detail) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Effective Income Tax Rate Continuing Operations Tax Rate Reconciliation [Abstract] | |||
Income tax computed at federal statutory rate | 21.00% | 21.00% | 21.00% |
State taxes, net of federal benefit | 2.90% | 1.80% | 2.10% |
General business credit carryovers | (5.00%) | 0.90% | 0.90% |
Non-deductible expenses | (0.50%) | 0.00% | (0.80%) |
Change in valuation allowance | (19.20%) | (23.70%) | (22.80%) |
Other | 0.80% | 0.00% | (0.40%) |
Effective income tax rate | 0.00% | 0.00% | 0.00% |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets (liabilities): | ||
Net operating loss carryforwards | $ 17,642 | $ 22,794 |
Research and development credits | 6,113 | 4,856 |
Capitalized start-up and other costs | 34,898 | 28,854 |
Capitalized research and development costs | 31,365 | 35,632 |
Deferred revenue | 2,989 | |
Equity based compensation | 6,277 | 5,117 |
Accruals | 845 | 1,657 |
Other temporary differences | 10 | 29 |
Deferred tax assets before valuation allowance | 97,150 | 101,928 |
Valuation allowances | $ (97,150) | $ (101,928) |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of Company's Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns Roll Forward | |||
Unrecognized tax benefit--beginning of year | $ 163 | $ 163 | $ 163 |
Decreases related to prior period positions | 0 | 0 | 0 |
Unrecognized tax benefit--end of year | $ 163 | $ 163 | $ 163 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | |||
Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Apr. 30, 2013 | |
Commitment And Contingencies [Line Items] | ||||
Contingent liabilities | $ 0 | $ 0 | ||
Eddingpharm Purchase Agreement [Member] | ||||
Commitment And Contingencies [Line Items] | ||||
Purchase agreement obligation | $ 5,000,000 | |||
Incyte Agreement [Member] | Global and U.S. [Member] | ||||
Commitment And Contingencies [Line Items] | ||||
Development costs associated with clinical trials | 45.00% | |||
Incyte Agreement [Member] | Non-Refundable Cash Payments [Member] | ||||
Commitment And Contingencies [Line Items] | ||||
Upfront milestone payable | $ 117,000,000 | |||
Incyte Agreement [Member] | Equity Investment [Member] | ||||
Commitment And Contingencies [Line Items] | ||||
Upfront milestone payable | $ 35,000,000 |
Supplemental Cash Flow Inform_3
Supplemental Cash Flow Information - Supplemental Disclosures of Cash Flow (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Supplemental Disclosures of Non-Cash Investing and Financing Activities: | ||
Interest paid | $ 1,997 | $ 1,631 |
Issuance costs included in accounts payable and accrued expenses | $ 134 | $ 43 |