Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 24, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
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 | false | ||
Entity Emerging Growth Company | false | ||
Title of 12(b) Security | Common Stock | ||
Entity Common Stock, Shares Outstanding | 68,442.572 | ||
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 | $ 1,084,471,643 | ||
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 2023 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, 2022, are incorporated by reference into Part III of this Annual Report on Form 10-K. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 74,356 | $ 221,965 |
Restricted cash | 0 | 115 |
Short-term investments | 401,446 | 217,971 |
Short-term deposits | 8,595 | 6,894 |
Collaboration receivable, net | 3,474 | 0 |
Prepaid expenses and other current assets | 1,915 | 1,451 |
Total current assets | 489,786 | 448,396 |
Long-Term Investments | 5,469 | 0 |
Property and equipment, net | 20 | 278 |
Right-of-use asset | 1,039 | 983 |
Restricted cash | 115 | 0 |
Other assets | 807 | 0 |
Total assets | 497,236 | 449,657 |
Current liabilities: | ||
Accounts payable | 4,350 | 5,669 |
Accrued expenses and other current liabilities | 24,276 | 14,465 |
Current portion of right-of-use liability | 434 | 361 |
Current Portion Of Capital Lease | 5 | 1 |
Derivative liability | 0 | 187 |
Total current liabilities | 29,065 | 20,683 |
Long-term liabilities: | ||
Right-of-use liability, less current portion | 709 | 711 |
Capital Lease Less Current Portion | 13 | 0 |
Term loan, less current portion | 0 | 19,895 |
Total long-term liabilities | 722 | 20,606 |
Total liabilities | 29,787 | 41,289 |
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, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.0001 par value, 100,000,000 shares authorized; 68,111,385 and 54,983,105 shares outstanding at December 31, 2022 and December 31, 2021, respectively | 7 | 6 |
Additional paid-in capital | 1,161,288 | 952,019 |
Accumulated other comprehensive (loss) income | (806) | 45 |
Accumulated deficit | (693,040) | (543,702) |
Total stockholders' equity | 467,449 | 408,368 |
Total liabilities and stockholders' equity | $ 497,236 | $ 449,657 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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 | 68,111,385 | 54,983,105 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues: | |||
License fees | $ 139,709 | $ 1,517 | |
Total revenues | $ 139,709 | $ 1,517 | |
Type of revenue [extensible list] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | |||
Research and development | $ 118,499 | $ 88,248 | $ 50,435 |
General and administrative | 33,258 | 25,241 | 22,505 |
Total operating expenses | 151,757 | 113,489 | 72,940 |
(Loss) income from operations | (151,757) | 26,220 | (71,423) |
Other income (expense): | |||
Interest expense | (3,137) | (1,899) | (2,357) |
Interest income | 5,872 | 403 | 841 |
Other (expense) income: | (316) | 202 | (219) |
Total other income (expense) | 2,419 | (1,294) | (1,735) |
Net (loss) income | (149,338) | 24,926 | (73,158) |
Net (loss) income attributable to common stockholders | $ (149,338) | $ 24,926 | $ (77,064) |
Net (loss) income Per Share: | |||
Basic (loss) earnings per share attributable to common stockholders | $ (2.46) | $ 0.48 | $ (1.87) |
Diluted (loss) earnings per share attributable to common stockholders | $ (2.46) | $ 0.46 | $ (1.87) |
Weighted-average common shares used in calculating: | |||
Basic (loss) earnings per share attributable to common stockholders | 60,760,906 | 52,064,809 | 41,308,242 |
Diluted (loss) earnings per share attributable to common stockholders | 60,760,906 | 53,622,904 | 41,308,242 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | |||
Net income (loss) | $ (149,338) | $ 24,926 | $ (73,158) |
Other comprehensive gain (loss): | |||
Unrealized gains (losses) on marketable securities, net of tax | (851) | 49 | (4) |
Comprehensive income (loss) | $ (150,189) | $ 24,975 | $ (73,162) |
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] | 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] | 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] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2019 | $ 31,600 | $ 3 | $ 527,067 | $ (495,470) | ||||||||||
Beginning 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 | ||||||||||||
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 | |||||||||||||
Pre-funded warrant exercise, shares | 2,280,318 | |||||||||||||
Stock-based compensation expense | 9,057 | 9,057 | ||||||||||||
Unrealized loss 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 | |||||||||||||
Stock purchase under ESPP, Shares | 26,878 | |||||||||||||
Pre-funded warrant exercise, shares | 725,784 | |||||||||||||
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 loss 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 | |||||||||||||
Proceeds from "at-the-market" offering, net, Value | 19,425 | $ 0 | 19,425 | |||||||||||
Proceeds from "at-the-market" offering, net, Shares | 1,111,111 | |||||||||||||
Proceeds from direct offering, net, value | $ 161,966 | $ 1 | $ 161,965 | |||||||||||
Proceeds from direct offering,net, Shares | 7,840,909 | |||||||||||||
Stock purchase under ESPP, Shares | 28,999 | |||||||||||||
Pre-funded warrant exercise, shares | 2,832,151 | |||||||||||||
Stock-based compensation expense | 16,019 | 16,019 | ||||||||||||
Unrealized loss on short-term investments | (851) | (851) | ||||||||||||
Vesting of RSU, Shares | 38,749 | |||||||||||||
Employee withholdings ESPP | 401 | 401 | ||||||||||||
Proceeds from exercise of stock options | $ 11,459 | 11,459 | ||||||||||||
Proceeds from exercise of stock options, Shares | 1,276,361 | 1,276,361 | ||||||||||||
Net income (loss) | $ (149,338) | (149,338) | ||||||||||||
Ending balance at Dec. 31, 2022 | $ 467,449 | $ 7 | $ 1,161,288 | $ (806) | $ (693,040) | |||||||||
Ending balance, Shares at Dec. 31, 2022 | 68,111,385 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Common stock, par value | $ 0.0001 | $ 0.0001 | |
At-the-market, offering expenses | $ 159 | ||
Pre-funded common stock warrants offering expenses | $ 41 | ||
Direct Placement Offering [Member] | |||
Direct offering, offering expenses | $ 10,535,000 | $ 5,332 | 93 |
Follow-on Public Offering One [Member] | |||
Direct offering, offering expenses | $ 600 | 7,132 | |
Follow-on Public Offering Two [Member] | |||
Direct offering, offering expenses | $ 8,770 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net income (loss) | $ (149,338) | $ 24,926 | $ (73,158) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation | 33 | 43 | 89 |
(Accretion) and Amortization of investments | (3,382) | 644 | (130) |
Non-cash operating lease expense | 421 | 413 | 426 |
Non-cash interest expense | 1,103 | (225) | 389 |
Changes in fair value of derivative liability | (187) | (389) | 0 |
Stock-based compensation | 16,019 | 13,317 | 9,057 |
Other | 0 | (1) | 1 |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other assets | (2,972) | (1,394) | (4,314) |
Collaboration receivable, net | (3,474) | 0 | 0 |
Accounts payable | (1,319) | 2,161 | (2,670) |
Deferred revenue | 0 | (13,133) | (1,517) |
Accrued expenses and other liabilities | 9,421 | 2,769 | 567 |
Net cash provided by (used in) operating activities | (133,675) | 29,131 | (71,260) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property and equipment | 0 | (129) | 0 |
Proceeds from Sale of Machinery and Equipment | 225 | 0 | 0 |
Purchases of short-term investments | (495,346) | (294,719) | (278,937) |
Proceeds from sales and maturities of short-term investments | 308,933 | 253,975 | 136,407 |
Net cash used in investing activities | (186,188) | (40,873) | (142,530) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Payment on term loan | (20,996) | 0 | 0 |
Proceeds from term loan agreement, net | 0 | 0 | 19,730 |
Proceeds from ESPP | 401 | 367 | 345 |
Proceeds from stock option exercises | 11,459 | 6,336 | 6,633 |
Other | 0 | 1 | |
Net cash provided by financing activities | 172,254 | 118,464 | 304,424 |
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (147,609) | 106,722 | 90,634 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH—beginning of year | 222,080 | 115,358 | 24,724 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH—end of year | 74,471 | 222,080 | 115,358 |
Cash and cash equivalents | 74,356 | 221,965 | 115,243 |
Restricted cash | 115 | 0 | |
Restricted cash | 115 | 115 | 115 |
Incyte Share Purchase Agreement [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock in follow-on public stock offering, net | 0 | 24,848 | 0 |
Follow-on Public Offerings [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock in follow-on public stock offering, net | 161,965 | 81,206 | 242,849 |
At-the-Market Offering [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock in follow-on public stock offering, net | 19,425 | 5,131 | 0 |
Derivative Liability [Member] | Incyte Share Purchase Agreement [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock in follow-on public stock offering, net | 0 | 576 | 0 |
Private Placement [Member] | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock in follow-on public stock offering, net | $ 0 | $ 0 | $ 34,866 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2022 | |
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's two lead product candidates are revumenib (SNDX-5613) and axatilimab (SNDX-6352). The Company is developing revumenib, a small molecule inhibitor of the menin-mixed lineage leukemia 1, or menin-MLL1, binding interaction for the treatment of KMT2A rearranged, or KMT2Ar, acute leukemias and nucleophosmin 1, or NPM1, mutant acute myeloid leukemia, or AML. The Company is also developing axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1, or CSF-1 receptor, in chronic graft-versus-host disease, or cGVHD, as well as idiopathic pulmonary fibrosis, or IPF. 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 therapeutics 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, 2022, should enable the Company to maintain its planned operations for at least 12 months from the issuance date of these financial statements. 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. The Company is subject to 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. |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 | |
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 consolidated 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. Marketable Securities 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 and long-term investments are financial instruments that potentially subject the Company to concentrations of credit risk. Substantially all of the Company’s cash, cash equivalents, and short and long-term investments were deposited in accounts at two financial institutions, and at times, such deposits may exceed federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company’s available-for-sale investments primarily consist of 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 FASB Accounting Standards Codification (ASC 815) , Derivatives and Hedging , based on the characteristics and provisions of each instrument. The derivative liability is recorded at fair value, which is estimated using a Black Scholes model. The liability is measured quarterly with any change in fair value being recognized in the statement of operations. We do not hold or issue derivative instruments for trading or speculative purposes. Revenue Recognition The Company recognizes revenue when its 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. The Company 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. Licenses of Intellectual Property : Revenue from non-refundable, up-front fees allocated to the licenses related to the Company's intellectual property, 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 : The Company evaluates whether 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. 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, Collaborative Research and License Agreements , to these consolidated financial statements. 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, 2022, the Company has incurred external costs related to Incyte cost-sharing collaboration. During the years ended December 31,2021 and 2020 , the Company incurred no external costs related to cost-sharing collaborations. Clinical Costs Clinical study and trial costs are a component of research and development expenses. The Company expenses clinical trial activities performed by third parties based on an evaluation of the progress to completion of specific contract tasks using data such as patient enrollment, clinical site activations, or other information provided to us by our vendors. Depending on the progression of the contract and timing of invoicing and payment the research and development expense can be an accrued expense or a prepaid expense. Prepaid clinical study and trial costs are included in short-term deposits on the accompanying consolidated balance sheet. 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, 2022 , 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 financial statements or disclosures. |
Collaborative Research and Lice
Collaborative Research and License Agreements | 12 Months Ended |
Dec. 31, 2022 | |
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 the 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. Each company will be responsible for funding any of its own independent development activities. Incyte is responsible for 100 % of future development costs for trials that are specific to ex-U.S. countries. All development costs related to the collaboration will be subject to a joint development plan. Under the terms of the Incyte Agreements, 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 Agreement. 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, under circumstances under which the upfront payment of $ 117 million would be returned to Incyte and a cash settlement on the sale of the Company's common stock would be made to make the parties whole (the “Letter Agreement”). In connection with the closing of this transaction in December 2021, the Company determined that the cash settlement feature of the Letter Agreement represented an embedded derivative requiring bifurcation and separate accounting recognition at fair value. The Letter Agreement terminated in March 2022. Accordingly, the Company initially allocated $ 0.6 million of the total consideration received to the derivative liability, see Note 9 for further discussion of the derivative liability. As of December 31, 2022, the fair value of the derivative is zero. 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) , and has elements that are within the scope of Topic 606 and Topic 808 . The Company identified the following promises in the Incyte Agreements that were evaluated under the scope of Topic 606 : (i) delivery of a license for SNDX-6532 to develop, commercialize, and conduct medical affairs and (ii) services to be performed in accordance with the development plan. The Company also evaluated whether certain options outlined within the Incyte Agreements represented material rights that would give rise to a performance obligation and concluded that none of the options convey a material right to Incyte and therefore are not considered separate performance obligations within the Incyte Agreements. 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 . The license for SNDX-6532 is considered functional intellectual property and distinct from other promises under the contract as Incyte can benefit from the license on its own or together with other readily available resources. The services performed by the Company to obtain regulatory approval of SNDX-6532 are not complex or specialized, could be performed by another qualified third party, are not expected to significantly modify or customize the license given that SNDX-6532 is late-stage intellectual property that has completed its Phase 1/2 trial and is currently enrolling in a global pivotal Phase 2 trial, and the services are expected to be performed over a short period of time. Therefore, the license represents a separate performance obligation within a contract with a customer under the scope of Topic 606 at contract inception. The Company considers the collaborative research and development activities and manufacturing activities to be separate units of account within the scope of Topic 808 and are not deliverables under Topic 606 . The Company and Incyte are both active participants in the activities and are exposed to significant risks and rewards that are dependent on the commercial success of the activities in the arrangement. Under the scope of Topic 606 , the Company identified contract promises for the license of intellectual property and know-how rights for SNDX-6352. The Company determined that the license was capable of being distinct from the ongoing collaboration activities. After the allocation to the common stock and derivative liability, the total transaction price to be allocated to the Incyte Agreement is $ 126.6 million. The Company estimated the standalone selling price of the license to be the entire $ 126.6 million, based on an application of the income approach by measuring the fair value of the discounted cash flows from commercialization. Significant assumptions included in the 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 of $ 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). |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Lessee Disclosure [Abstract] | |
Leases | 5. Leases Leases The Company accounts for leases in accordance with ASC 842, Leases , and determines whether an arrangement is a lease at inception. Operating lease right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Lease agreements with lease and non-lease components are accounted for separately. For leases that do not provide an implicit rate, the Company uses the incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Leases with an initial term of 12 months or less are not recorded on the balance sheet as the Company has elected to apply the short-term lease exemption. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. 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 operating lease for 12,207 square feet of office space in Waltham, Massachusetts, with a lease commencement date of March 1, 2017 . 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 . 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, which commenced on March 1, 2021 . In August 2022, the Company signed a 36 -month extension to the lease for the New York office, with aggregate payments of $ 689,000 , with a lease commencement date of September 1, 2022 . The remaining lease terms as of December 31, 2022, for the facility in Waltham, Massachusetts and New York, New York, were 26 months and 32 months, respectively. As of December 31, 2022, 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, 2022, the Company recorded approximately $ 440,000 in operating lease expense and made approximately $ 567,000 in lease payments. Future minimum lease payments under the Company’s operating leases, were as follows: Maturity of lease liabilities As of (in thousands) December 31, 2022 2023 $ 567 2024 585 Thereafter 199 Total lease payments $ 1,351 Less: imputed interest ( 208 ) Total operating lease liability $ 1,143 Future minimum lease payments under the Company’s capital leases as of December 31, 2022, and 2021, were $ 22,441 and $ 1,000 , respectively. |
Earnings (Loss) per Share
Earnings (Loss) per Share | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 2021 2020 Numerator: Net (loss) income $ ( 149,338 ) $ 24,926 $ ( 73,158 ) Deemed dividend due to warrant reset — — ( 3,906 ) Net (loss) income attributable to common stockholders $ ( 149,338 ) $ 24,926 $ ( 77,064 ) Denominator: Weighted-average common shares outstanding 60,761 52,065 41,308 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 60,761 53,623 41,308 The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares, in 000s): December 31, 2022 2021 2020 Options to purchase common 7,982 — 6,380 Non-vested restricted stock units (RSUs) 131 — 19 ESPP to purchase common stock 17 — 16 For additional information related to the Company's common stock see Note 12. |
Significant Agreements
Significant Agreements | 12 Months Ended |
Dec. 31, 2022 | |
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. Since the inception of the agreement, the Company achieved certain development and regulatory milestones resulting in $ 8.0 million in expense, which included $ 2.0 million in expense paid in February 2022. Additionally, in the fourth quarter 2022, the Company achieved certain development and regulatory milestones resulting in a $ 2.0 million expense, which has been recorded in accrued expenses as of December 31. 2022. The amount was paid in the first quarter of 2023. 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, sublicensable, 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. Since the start of the license agreement, the Company achieved certain development and regulatory milestones and has recorded $ 6.0 million as research and development expense. Additionally, in connection with its most recent amendment of the UCB License Agreement, in the second quarter of 2022 the Company paid UCB $ 5.8 million, which is recognized as a milestone expense. 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, 2022 | |
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, 2022 2021 Equipment $ 84 $ 386 Leasehold improvements 167 167 Furniture and fixtures 134 134 Office and computer equipment 34 21 Office equipment under capital lease — 13 Total property and equipment 419 721 Accumulated depreciation ( 399 ) ( 443 ) Property and equipment, net $ 20 $ 278 Depreciation expense was $ 33,000 and $ 43,000 for years ended December 31, 2022, and 2021 , respectively. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
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 Quoted Significant Significant December 31, 2022 Assets: Cash equivalents $ 74,356 $ 59,496 $ 14,860 $ — Short-term investments 401,446 — 401,446 — Long-term investments 5,469 — 5,469 — Total assets $ 481,271 $ 59,496 $ 421,775 $ — 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 There have been no material impairments of our assets measured and carried at fair value during the years ended December 31, 2022, and 2021. In addition, there have been no changes in valuation techniques during the years ended December 31, 2022, and 2021. 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 and long-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 4 - 5 % 58 - 61 % 9 months 4.5 % 59.5 % 9 months The following table summarizes the fair value rollforward (in thousands): As of December 31 2022 2021 Derivative Liability: Beginning Balance 1/1 $ 187 $ — Additions - 576 Change in fair value ( 187 ) ( 389 ) Ending Balance 12/31 $ — $ 187 The short-term and long-term investments are classified as available-for-sale securities. As of December 31, 2022 , the remaining contractual maturities of the available-for-sale securities were 1 to 15 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, 2022. 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, 2022, 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 Unrealized Unrealized Fair December 31, 2022 Commercial paper $ 321,630 $ — $ ( 205 ) $ 321,425 US Treasury 64,759 — ( 566 ) 64,193 Federal bonds 36,192 — ( 35 ) 36,157 $ 422,581 $ — $ ( 806 ) $ 421,775 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 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 2021 Prepaid insurance $ 692 $ 642 Interest receivable on investments 583 429 Prepaid subscriptions 446 230 Other 194 150 Total prepaid expenses and other current assets $ 1,915 $ 1,451 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 2021 Accrued clinical study and trial costs $ 14,375 $ 5,760 Accrued compensation and related costs 5,945 4,342 Accrued professional fees 1,352 662 Accrued milestone costs 2,000 2,000 Other 604 1,701 Total accrued expense and other current liabilities $ 24,276 $ 14,465 |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2022 | |
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. In the year ended December 31, 2022, the Company sold 1,111,111 common shares of common stock under the 2021 ATM Program, with net proceeds of approximately $ 19.4 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, with net proceeds of approximately $ 81.2 million. As of December 31, 2022, 1,142,856 pre-funded warrants were considered issued and outstanding. On January 24, 2023, 86,000 Pre-Funded Warrants were exercised for 85,998 shares of common stock, under a cashless exercise. As of February 24, 2023, the pre-funded warrants considered issued and outstanding were 1,056,856 . 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. In December 2022, the Company issued 7,840,909 shares of common stock. The offering price for the securities was $ 22.00 per share, with gross proceeds of approximately $ 172.5 million, offset by $ 10.5 million of issuance cost. 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, 2022 Common stock issuable under pre-funded warrants 1,142,856 Options to purchase common stock 8,924,365 Employee Stock Purchase Plan 1,517,411 Total 11,584,632 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [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, 2022, there were 1,349,150 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, 2023, the shares available for issuance under the 2015 Plan were increased to 4,073,605 . 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, 2022 2021 2020 Research and development $ 6,016 $ 4,398 $ 2,400 General and administrative 10,003 8,919 6,657 Total $ 16,019 $ 13,317 $ 9,057 Stock Options and Restricted Stock Units As of December 31, 2022, there was $ 43.0 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 3.0 years. Stock compensation costs have not been capitalized by the Company. As of December 31, 2022, there was $ 0.3 million of unrecognized compensation cost related to performance-based options, and $ 42.7 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, 2022, 2021 and 2020 the Company recorded approximately $ 6,000 , $ 25,000 , and $ 9,000 , respectively of stock compensation associated with these awards. As of December 31, 2022, no options remain to vest under the 2017 Performance 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. Additionally, in 2022, the Company granted to certain employees 140,000 performance-based stock options (“2022 Performance Awards”), primarily related to the achievement of certain 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 performance milestone, for the 2019 Performance Awards, was achieved. The Company recorded approximately $ 128,000 and $ 257,000 of stock compensation related to the achievement of the performance milestone for years ended December 31, 2022, and 2021. All other performance milestones were not achieved, and the associated awards have been cancelled. As of December 31, 2022, no options remain to vest under the 2019 Performance awards. In the first quarter of 2022, management estimated one of the milestones, for the 2022 Performance Awards, was probable of achievement and, as such, the Company recorded approximately $ 479,000 of stock compensation expense for these awards for the year ended December 31, 2022. As of December 31, 2022, 140,000 stock options outstanding were unvested, and no options had been cancelled. 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 the vesting term for an aggregate of 34,728 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 $ 0.8 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 the Company's public stock price. The Company estimated the expected term of its employee stock options using the “simplified” method, whereby, the expected term equals the average of the vesting term and the original contractual term of the option. The contractual life of the option was used for the estimated life of the non-employee grants. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. The risk-free interest rate for periods within the expected life of the option is based upon the U.S. Treasury yield curve in effect at the time of grant. The Company accounts for forfeitures when they occur. The grant date fair values of options issued to employees and non-employees were estimated using the Black-Scholes option-pricing model with the following assumptions: Years Ended December 31, 2022 2021 2020 Expected term (in years) 6.04 6.02 5.97 Volatility rate 77.87 % 85.84 % 81.59 % Risk-free interest rate 2.52 % 0.67 % 1.20 % 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 of Weighted Weighted Aggregate Outstanding — January 1, 2022 6,921,514 $ 11.99 6.9 $ 68,609 Granted 3,020,850 $ 18.39 Exercised ( 1,276,361 ) $ 8.78 Cancelled, forfeited or expired ( 684,326 ) $ 17.84 Outstanding — December 31, 2022 7,981,677 7.3 $ 88,016 Exercisable — December 31, 2022 4,313,997 5.9 $ 61,851 Options vested, or expected to — December 31, 2022 7,981,677 7.3 $ 88,016 The weighted-average grant date fair value of options granted during the years ended December 31, 2022, 2021 and 2020, was $ 12.64 , $ 14.70 , and $ 7.88 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 1.3 million options exercised for the year ended December 31, 2022, resulting in total proceeds of $ 11.5 million ; 842,424 options exercised for the year ended December 31, 2021 , resulting in total proceeds of $ 6.3 million; and 755,166 options exercised for the year ended December 31, 2020 , resulting in total proceeds of 6.6 million. The intrinsic value of options exercised during the years ended December 31, 2022, 2021 and 2020 was $ 17.0 million , $ 10.1 million, and $ 7.1 million, respectively. In accordance with the Company’s policy, the shares were issued from a pool of shares reserved for issuance under the 2007 and 2015 Plans. 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 of Weighted Unvested — December 31, 2021 132,333 $ 20.11 Granted (1) 131,205 $ 15.79 Vested ( 38,750 ) $ 17.61 Unvested—December 31, 2022 224,788 $ 18.02 (1) RSU’s granted in 2022 and 2021 had a weighted average grant date fair value of $ 15.79 and $ 21.19 , respectively. The fair values of RSU’s vested in 2022 and 2021 totaled $ 705,000 and $ 60,000 , respectively. 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 and became effective in 2016. The ESPP authorized the initial issuance of up to a total of 250,000 shares of common stock to the Company’s employees. The number of shares of common stock available under the ESPP will automatically increase on January 1st of each year, continuing until the expiration of the ESPP, in an amount equal to the lesser of (a) 1 % of the total number of shares of common stock outstanding on December 31st of the preceding calendar year, or (b) 250,000 shares. On January 1, 2023, the shares of common stock reserved for issuance under the ESPP was increased to 1,767,411 . 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 Company issued 28,999 and 26,878 shares during 2022 and 2021, respectively. 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, 2022, 2021 and 2020 the Company recorded stock-based compensation expense related to the ESPP of $ 166,000 , $ 175,000 , and $ 203,000 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, 2022, 2021 and 2020, the Company made $ 712,000 , $ 444,000 , and $ 250,000 contributions to the plan, respectively. |
Loan Payable
Loan Payable | 12 Months Ended |
Dec. 31, 2022 | |
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”). In December 2021, the Company entered into Amendment No. 1 to the Company’s Loan Agreement (the “First Amendment” and the Loan Agreement, as amended, the “Amended Loan Agreement”) with several banks and financial institutions or entities from time-to-time party thereto (collectively, the “Lender”) and Hercules, in its capacity as administrative agent for itself and the Lender. The Company terminated the Amended Loan Agreement in September 2022. The First Amendment provided for an aggregate maximum borrowing of up to $ 80.0 million, consisting of three tranches, including a term loan of up to $ 20.0 million (the “Initial Advance”). Borrowings under the Amended Loan Agreement were collateralized by substantially all of the Company's and its subsidiaries personal property and other assets, other than its intellectual property. The Company was obligated to make monthly interest-only payments through January 1, 2023. Borrowings under the Amended Loan Agreement bore interest at an annual interest rate from the greater of (y) 9.25 % or (z) 6.00 % plus the Wall Street Journal prime rate . After the Interest-Only Period (as defined in the Amended Loan Agreement), borrowings under the Amended Loan Agreement were repayable in equal monthly payments of principal and accrued interest until the maturity date of the loan. At the Company’s option, the Company could prepay all, but not less than all, of the outstanding borrowings, subject to a prepayment premium equal to (i) 2.0 % of the principal amount outstanding if the prepayment occurs during the first year following the First Amendment, (ii) 1.5 % of the principal amount outstanding if the prepayment occurs during the second year following the First Amendment, and (iii) 1.0 % of the principal amount outstanding at any time thereafter but prior to the maturity date. The Amended Loan Agreement also applied a 4.99 % end of term charge to any future draws payable on the maturity date. The Company was accruing the final payment over the term of the debt. On September 23, 2022, the Company made a prepayment of $ 21.5 million to satisfy in full all of the Company's principal and interest obligations and related fees under the Amended Loan Agreement. The payoff amount paid by the Company in connection with the termination of the Amended Loan Agreement was pursuant to a payoff letter with Hercules and included payment of (a) $ 1.0 million as an end-of term fee and (b) $ 0.4 million as a pre-payment fee. Hercules released all security interests held on the assets of the Company and its subsidiaries. The Amended Loan Agreement was fully terminated as of September 23, 2022. During the years ended December 31, 2022 and 2021, the Company recognized $ 2.1 million , which included $ 0.4 million of pre-payment fee, and $1.9 million, respectively, of interest expense related to the Initial Advance pursuant to the Amended Loan Agreement. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 2021 2020 Income tax computed at federal statutory rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 2.5 % 2.9 % 1.8 % General business credit carryovers 1.0 % - 5.0 % 0.9 % Non-deductible expenses - 0.2 % - 0.5 % 0.0 % Change in valuation allowance - 24.1 % - 19.2 % - 23.7 % Return to provision true up - 0.2 % 0.0 % 0.0 % Other 0.0 % 0.8 % 0.0 % 0.0 % 0.0 % 0.0 % The significant components of the Company’s deferred tax are as follows (in thousands): Years Ended 2022 2021 Deferred tax assets (liabilities): Net operating loss carryforwards $ 23,650 $ 17,642 Research and development credits 8,124 6,113 Capitalized start-up and other costs 45,374 34,898 Capitalized research and development costs 48,917 31,365 Equity based compensation 5,004 6,277 Accruals 1,985 845 Other temporary differences 27 10 Deferred tax assets before valuation allowance 133,081 97,150 Valuation allowances ( 133,081 ) ( 97,150 ) 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 increased by $ 35.9 million in 2022 due to the increase in deferred tax assets, primarily driven by the generation of net operating losses and capitalized start-up costs, partially offset by a decrease to other deferred tax assets. The valuation allowance decreased by $ 4.8 million in 2021 due to the decrease in deferred tax assets, primarily driven by utilization of tax attributes to offset federal and state taxable income, partially offset by an increase to other deferred tax assets. As of December 31, 2022, the Company had approximately $ 99.6 million and $ 42.8 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 $ 77.5 million which have an indefinite carryforward period. The remaining $ 22.1 million of federal NOLs and the Company’s state NOLs will begin to expire at various dates starting in 2026 . As of December 31, 2022, the Company had federal and state research credits of $ 5.7 million and $ 3.2 million , respectively, which began 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. The Coronavirus Aid, Relief and Economic Security Act (CARES Act) was enacted in the United States on March 27, 2020. The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund a nationwide effort to curtail the effect of COVID-19. While the CARES Act provides extensive tax changes in response to the COVID-19 pandemic, the provisions did not have a significant impact on the Company's financial results. Beginning in 2022, the Tax Cuts and Jobs Act of 2017 (“TCJA”) eliminates the option to deduct research and development expenditures currently and requires taxpayers to amortize them, over five years for domestically incurred expenditures and over fifteen years for foreign incurred expenditures, pursuant to IRC Section 174. As of December 31, 2022, the Company has recorded a deferred tax asset of $ 48.9 million related to the Capitalized IRC Section 174 expenditures, of which $ 22.2 million relate to expenses required to be capitalized under the TCJA. As of December 31, 2022, and 2021, the Company had uncertain tax positions of $ 0.1 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, 2022 and 2021. 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, 2022 , 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, 2022 2021 2020 Unrecognized tax benefit--beginning of year $ 163 $ 163 $ 163 Decreases related to prior period positions ( 20 ) — — Unrecognized tax benefit--end of year $ 143 $ 163 $ 163 The Company files tax returns in the U.S. and various states. 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, 2022 | |
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. 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. From time to time, the Company may be subject to various claims and proceedings in the ordinary course of business. If the potential loss from any claim, asserted or unasserted, or proceeding is considered probable and the amount is reasonably estimable, the Company will accrue a liability for the estimated loss. There were no contingent liabilities recorded as of December 31, 2022, or 2021 . |
Supplemental Cash Flow Informat
Supplemental Cash Flow Information | 12 Months Ended |
Dec. 31, 2022 | |
Supplemental Cash Flow Elements [Abstract] | |
Supplemental Cash Flow Information | 17. Supplemental Cash Flow Information Years Ended December 31, 2022 2021 2020 (In thousands) Supplemental Disclosures of Cash Flow Information Interest paid $ 2,059 $ 1,997 $ 1,631 Supplemental Disclosures of Non-Cash Investing and Financing Issuance costs included in accounts payable and accrued expenses $ 131 $ 134 $ 43 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
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 consolidated 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. |
Marketable Securities | 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 and long-term investments are financial instruments that potentially subject the Company to concentrations of credit risk. Substantially all of the Company’s cash, cash equivalents, and short and long-term investments were deposited in accounts at two financial institutions, and at times, such deposits may exceed federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company’s available-for-sale investments primarily consist of 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 FASB Accounting Standards Codification (ASC 815) , Derivatives and Hedging , based on the characteristics and provisions of each instrument. The derivative liability is recorded at fair value, which is estimated using a Black Scholes model. The liability is measured quarterly with any change in fair value being recognized in the statement of operations. We do not hold or issue derivative instruments for trading or speculative purposes. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue when its 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. The Company 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. Licenses of Intellectual Property : Revenue from non-refundable, up-front fees allocated to the licenses related to the Company's intellectual property, 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 : The Company evaluates whether 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. 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, Collaborative Research and License Agreements , to these consolidated financial statements. |
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, 2022, the Company has incurred external costs related to Incyte cost-sharing collaboration. During the years ended December 31,2021 and 2020 , the Company incurred no external costs related to cost-sharing collaborations. |
Clinical Costs | Clinical Costs Clinical study and trial costs are a component of research and development expenses. The Company expenses clinical trial activities performed by third parties based on an evaluation of the progress to completion of specific contract tasks using data such as patient enrollment, clinical site activations, or other information provided to us by our vendors. Depending on the progression of the contract and timing of invoicing and payment the research and development expense can be an accrued expense or a prepaid expense. Prepaid clinical study and trial costs are included in short-term deposits on the accompanying consolidated balance sheet. |
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, 2022 , 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 financial statements or disclosures. |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 (in thousands) December 31, 2022 2023 $ 567 2024 585 Thereafter 199 Total lease payments $ 1,351 Less: imputed interest ( 208 ) Total operating lease liability $ 1,143 |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 2021 2020 Numerator: Net (loss) income $ ( 149,338 ) $ 24,926 $ ( 73,158 ) Deemed dividend due to warrant reset — — ( 3,906 ) Net (loss) income attributable to common stockholders $ ( 149,338 ) $ 24,926 $ ( 77,064 ) Denominator: Weighted-average common shares outstanding 60,761 52,065 41,308 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 60,761 53,623 41,308 |
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 because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares, in 000s): December 31, 2022 2021 2020 Options to purchase common 7,982 — 6,380 Non-vested restricted stock units (RSUs) 131 — 19 ESPP to purchase common stock 17 — 16 For additional information related to the Company's common stock see Note 12. |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment, net, consisted of the following (in thousands): December 31, 2022 2021 Equipment $ 84 $ 386 Leasehold improvements 167 167 Furniture and fixtures 134 134 Office and computer equipment 34 21 Office equipment under capital lease — 13 Total property and equipment 419 721 Accumulated depreciation ( 399 ) ( 443 ) Property and equipment, net $ 20 $ 278 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 Quoted Significant Significant December 31, 2022 Assets: Cash equivalents $ 74,356 $ 59,496 $ 14,860 $ — Short-term investments 401,446 — 401,446 — Long-term investments 5,469 — 5,469 — Total assets $ 481,271 $ 59,496 $ 421,775 $ — 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 |
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 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): As of December 31 2022 2021 Derivative Liability: Beginning Balance 1/1 $ 187 $ — Additions - 576 Change in fair value ( 187 ) ( 389 ) Ending Balance 12/31 $ — $ 187 |
Summary of Available-for-Sale Securities | The following table summarizes the available-for-sale securities (in thousands): Amortized Unrealized Unrealized Fair December 31, 2022 Commercial paper $ 321,630 $ — $ ( 205 ) $ 321,425 US Treasury 64,759 — ( 566 ) 64,193 Federal bonds 36,192 — ( 35 ) 36,157 $ 422,581 $ — $ ( 806 ) $ 421,775 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 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 2021 Prepaid insurance $ 692 $ 642 Interest receivable on investments 583 429 Prepaid subscriptions 446 230 Other 194 150 Total prepaid expenses and other current assets $ 1,915 $ 1,451 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 2021 Accrued clinical study and trial costs $ 14,375 $ 5,760 Accrued compensation and related costs 5,945 4,342 Accrued professional fees 1,352 662 Accrued milestone costs 2,000 2,000 Other 604 1,701 Total accrued expense and other current liabilities $ 24,276 $ 14,465 |
Common Stock (Tables)
Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 Common stock issuable under pre-funded warrants 1,142,856 Options to purchase common stock 8,924,365 Employee Stock Purchase Plan 1,517,411 Total 11,584,632 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [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, 2022 2021 2020 Research and development $ 6,016 $ 4,398 $ 2,400 General and administrative 10,003 8,919 6,657 Total $ 16,019 $ 13,317 $ 9,057 |
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, 2022 2021 2020 Expected term (in years) 6.04 6.02 5.97 Volatility rate 77.87 % 85.84 % 81.59 % Risk-free interest rate 2.52 % 0.67 % 1.20 % 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 of Weighted Weighted Aggregate Outstanding — January 1, 2022 6,921,514 $ 11.99 6.9 $ 68,609 Granted 3,020,850 $ 18.39 Exercised ( 1,276,361 ) $ 8.78 Cancelled, forfeited or expired ( 684,326 ) $ 17.84 Outstanding — December 31, 2022 7,981,677 7.3 $ 88,016 Exercisable — December 31, 2022 4,313,997 5.9 $ 61,851 Options vested, or expected to — December 31, 2022 7,981,677 7.3 $ 88,016 |
Summary of Restricted Stock Units Activity | The following table summarizes our RSU activity: Number of Weighted Unvested — December 31, 2021 132,333 $ 20.11 Granted (1) 131,205 $ 15.79 Vested ( 38,750 ) $ 17.61 Unvested—December 31, 2022 224,788 $ 18.02 (1) RSU’s granted in 2022 and 2021 had a weighted average grant date fair value of $ 15.79 and $ 21.19 , respectively. The fair values of RSU’s vested in 2022 and 2021 totaled $ 705,000 and $ 60,000 , respectively. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 2021 2020 Income tax computed at federal statutory rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 2.5 % 2.9 % 1.8 % General business credit carryovers 1.0 % - 5.0 % 0.9 % Non-deductible expenses - 0.2 % - 0.5 % 0.0 % Change in valuation allowance - 24.1 % - 19.2 % - 23.7 % Return to provision true up - 0.2 % 0.0 % 0.0 % Other 0.0 % 0.8 % 0.0 % 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 2022 2021 Deferred tax assets (liabilities): Net operating loss carryforwards $ 23,650 $ 17,642 Research and development credits 8,124 6,113 Capitalized start-up and other costs 45,374 34,898 Capitalized research and development costs 48,917 31,365 Equity based compensation 5,004 6,277 Accruals 1,985 845 Other temporary differences 27 10 Deferred tax assets before valuation allowance 133,081 97,150 Valuation allowances ( 133,081 ) ( 97,150 ) 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, 2022 2021 2020 Unrecognized tax benefit--beginning of year $ 163 $ 163 $ 163 Decreases related to prior period positions ( 20 ) — — Unrecognized tax benefit--end of year $ 143 $ 163 $ 163 |
Supplemental Cash Flow Inform_2
Supplemental Cash Flow Information (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Supplemental Cash Flow Elements [Abstract] | |
Supplemental Disclosures of Cash Flow Information | Years Ended December 31, 2022 2021 2020 (In thousands) Supplemental Disclosures of Cash Flow Information Interest paid $ 2,059 $ 1,997 $ 1,631 Supplemental Disclosures of Non-Cash Investing and Financing Issuance costs included in accounts payable and accrued expenses $ 131 $ 134 $ 43 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2022 USD ($) Claim Segment | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
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, 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 | $ 0 | |
Minimum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful lives | 3 years | ||
Percentage of income tax contingency realized | 50% | ||
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, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2021 | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||
Proceeds from Incyte Share Purchase Agreement shares | 7,840,909 | 3,802,144 | ||
Aggregate purchase price | $ 81,200,000 | |||
Common stock issued at fair value | $ 24,848,000 | |||
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 | ||
Proceeds from Incyte Share Purchase Agreement shares | 1,421,523 | |||
Purchase price per share | $ 24.62 | $ 24.62 | ||
Aggregate purchase price | $ 35,000,000 | |||
Total cash consideration | 152,000,000 | |||
Common stock issued at fair value | 24,800,000 | |||
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 | $ 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% | |||
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% | |||
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% |
Leases - Additional Information
Leases - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | |||||
Aug. 17, 2021 USD ($) | Aug. 31, 2022 USD ($) | Feb. 28, 2021 | Sep. 30, 2016 ft² | Dec. 31, 2015 ft² | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Lessee Lease Description [Line Items] | |||||||
Lease option to extend | true | ||||||
Lease option to termination | true | ||||||
Right-of-use asset, net | $ 1,039,000 | $ 983,000 | |||||
Operating lease liabilities | $ 1,143,000 | ||||||
Operating lease discount rate | 14% | ||||||
Operating lease expense | $ 440,000 | ||||||
Lease payments | 567,000 | ||||||
Future minimum lease payments under capital leases | $ 22,441 | $ 1,000 | |||||
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. 01, 2022 | Mar. 01, 2017 | |||||
Remaining lease term | 26 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 | 36 years | 18 months | 62 months | ||||
Area of leased property | ft² | 4,039 | ||||||
Lease Commencement Date | Sep. 01, 2022 | Mar. 01, 2021 | Jan. 01, 2016 | ||||
Remaining lease term | 32 years | ||||||
Lease payments | $ 689,000 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Lease Payments under Operating Leases (Detail) $ in Thousands | Dec. 31, 2022 USD ($) |
Lessee, Operating Lease, Liability, to be Paid [Abstract] | |
2023 | $ 567 |
2024 | 585 |
Thereafter | 199 |
Total lease payments | 1,351 |
Less: imputed interest | (208) |
Total operating lease liability | $ 1,143 |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator: | |||
Net Income (Loss) Attributable to Parent | $ (149,338) | $ 24,926 | $ (73,158) |
Deemed dividend due to warrant reset | (3,906) | ||
Net (loss) income attributable to common stockholders | $ (149,338) | $ 24,926 | $ (77,064) |
Denominator: | |||
Weighted-average common shares outstanding | 60,760,906 | 52,064,809 | 41,308,242 |
Dilutive potential common shares | 1,558,000 | ||
Shares used in calculating diluted earnings (loss) per share | 60,760,906 | 53,622,904 | 41,308,242 |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
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 | 7,982 | 6,380 | |
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 | 17 | 16 | |
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 | 131 | 19 |
Earnings (Loss) per Share - Add
Earnings (Loss) per Share - Additional Information (Detail) - shares | 1 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share Basic [Line Items] | ||
Proceeds from Incyte Share Purchase Agreement shares | 7,840,909 | 3,802,144 |
Significant Agreements - Additi
Significant Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||
Jul. 31, 2020 | Oct. 31, 2017 | Jul. 31, 2016 | Dec. 31, 2007 | Mar. 31, 2007 | Jun. 30, 2022 | Dec. 31, 2017 | Sep. 30, 2016 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2017 | Dec. 31, 2016 | Feb. 28, 2022 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Research and development expense | $ 118,499,000 | $ 88,248,000 | $ 50,435,000 | |||||||||||
Development and regulaotry milestones expenses | $ 2,000,000 | |||||||||||||
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 | $ 5,000,000 | |||||||||||||
Development and regulaotry milestones expenses | $ 8,000,000 | |||||||||||||
Milestone expenses paid | $ 2,000,000 | |||||||||||||
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 | $ 6,000,000 | $ 5,000,000 | ||||||||||||
Milestone payment payable | $ 5,800,000 | |||||||||||||
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, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 419 | $ 721 |
Accumulated depreciation | (399) | (443) |
Property and equipment, net | 20 | 278 |
Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 84 | 386 |
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 | 34 | 21 |
Office Equipment Under Capital Lease [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 0 | $ 13 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 33,000 | $ 43,000 |
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, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 401,446 | $ 217,971 |
Long-term investments | 5,469 | $ 0 |
Derivative Liability, Statement of Financial Position [Extensible Enumeration] | Derivative Liability, Current | |
Carrying Value [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 74,356 | $ 221,964 |
Short-term investments | 401,446 | 217,971 |
Long-term investments | 5,469 | |
Total assets | 481,271 | 439,935 |
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 | 59,496 | 96,816 |
Total assets | 59,496 | 96,816 |
Significant Other Observable Inputs Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 14,860 | 125,148 |
Short-term investments | 401,446 | 217,971 |
Long-term investments | 5,469 | |
Total assets | $ 421,775 | 343,119 |
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 - Signi
Fair Value Measurements - Significant Unobservable Inputs in the Fair Value Measurement (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 USD ($) | Dec. 31, 2022 USD ($) | |
Fair Value Measurements [Line Items] | ||
Derivative liability | $ 187 | $ 0 |
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) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Derivative Liability: | ||
Beginning Balance 1/1/2022 | $ 187 | |
Additions | 576 | |
Change in fair value | (187) | (389) |
Ending Balance 12/31/2022 | $ 187 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Fair Value Disclosures [Abstract] | |
Realized gains or losses recognized on the sale or maturity of available-for-sale securities | $ 0 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 422,581 | $ 343,074 |
Unrealized Gains | 70 | |
Unrealized Losses | (806) | (25) |
Fair Value | 421,775 | 343,119 |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 321,630 | 306,715 |
Unrealized Gains | 70 | |
Unrealized Losses | (205) | (17) |
Fair Value | 321,425 | 306,768 |
US Treasury and Federal Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 64,759 | |
Unrealized Losses | (566) | |
Fair Value | 64,193 | |
Federal Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 36,192 | |
Unrealized Losses | (35) | |
Fair Value | $ 36,157 | |
Corporate Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 22,147 | |
Unrealized Losses | (6) | |
Fair Value | 22,141 | |
U.S. Treasury [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 14,212 | |
Unrealized Losses | (2) | |
Fair Value | $ 14,210 |
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, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Short-term deposits | $ 8,595 | $ 6,894 |
Prepaid insurance | 692 | 642 |
Interest receivable on investments | 583 | 429 |
PrepaidSubscriptions | 446 | 230 |
Other | 194 | 150 |
Total prepaid expenses and other current assets | $ 1,915 | $ 1,451 |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | |||
Accrued clinical study and trial costs | $ 14,375 | $ 5,760 | |
Accrued compensation and related costs | 5,945 | 4,342 | |
Accrued professional fees | 1,352 | 662 | |
Accrued milestone costs | 2,000 | 2,000 | |
Other | 604 | 1,701 | |
Total accrued expenses and other current liabilities | $ 24,276 | $ 14,465 | $ 24,276 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 24, 2023 | Mar. 08, 2016 | |
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 | 7,840,909 | 3,802,144 | ||||||
Common Stock, Capital Shares Reserved for Future Issuance | 11,584,632 | 11,584,632 | ||||||
Offering price | $ 22 | |||||||
Gross proceeds from offering | $ 172,500 | |||||||
Deemed dividend transferred to the warrant holders | $ 3,906 | |||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||
Common stock issued at fair value | $ 24,848 | |||||||
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 | $ 10,500 | ||||||
Pre-Funded Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 1,142,856 | 1,142,856 | ||||||
Warrants issued (in shares) | 1,142,856 | 1,142,856 | ||||||
Offering price | $ 17.4999 | |||||||
Common Stock [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Common stock, new shares issued | 1,421,523 | |||||||
Stock Issued During Period Shares Exercise Of Warrants | 1,995,941 | |||||||
Series Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Offering price | $ 17.50 | |||||||
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 | $ 19,400 | |||||||
Common stock, new shares issued | 1,111,111 | |||||||
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 | |||||||
Subsequent Event [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Number Of Pre Funded Warrants Exercised For Common Stock | 85,998 | |||||||
Subsequent Event [Member] | Pre-Funded Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Number Of Pre Funded Warrants Exercised For Common Stock | 86,000 | |||||||
Warrants outstanding | 1,056,856 | |||||||
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, 2022 shares |
Class Of Stock [Line Items] | |
Common Stock, Capital Shares Reserved for Future Issuance | 11,584,632 |
Pre-Funded Warrants [Member] | |
Class Of Stock [Line Items] | |
Common Stock, Capital Shares Reserved for Future Issuance | 1,142,856 |
Options to Purchase Common Stock [Member] | |
Class Of Stock [Line Items] | |
Common Stock, Capital Shares Reserved for Future Issuance | 8,924,365 |
Employee Stock Purchase Plan [Member] | |
Class Of Stock [Line Items] | |
Common Stock, Capital Shares Reserved for Future Issuance | 1,517,411 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
Jan. 01, 2023 shares | Jan. 01, 2021 shares | Oct. 31, 2021 USD ($) Employee shares | Sep. 30, 2015 shares | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2020 USD ($) $ / shares shares | Dec. 31, 2019 shares | Dec. 31, 2017 shares | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares available for issuance | 11,584,632 | ||||||||||
Share-based compensation, stock options granted | 3,020,850 | ||||||||||
Share-based compensation, stock options vested | 7,981,677 | ||||||||||
Stock compensation expense | $ | $ 16,019,000 | $ 13,317,000 | $ 9,057,000 | ||||||||
Weighted-average grant date fair value of options granted | $ / shares | $ 12.64 | $ 14.70 | $ 7.88 | ||||||||
Stock options exercised, shares | 1,276,361 | 842,424 | 755,166 | ||||||||
Stock options exercised | $ | $ 11,459,000 | $ 6,336,000 | $ 6,633,000 | ||||||||
Intrinsic value of options exercised | $ | 17,000,000 | 10,100,000 | 7,100,000 | ||||||||
Contributions by the company | $ | 712,000 | 444,000 | 250,000 | ||||||||
Performance Based Shares [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Unrecognized compensation expense related to stock option | $ | 300,000 | ||||||||||
Service Based Options [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Unrecognized compensation expense related to stock option | $ | 42,700,000 | ||||||||||
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 | $ | $ 6,000 | 25,000 | 9,000 | ||||||||
2019 Performance Awards | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based compensation, stock options vested | 0 | ||||||||||
Stock compensation expense | $ | $ 128,000 | $ 257,000 | |||||||||
2019 Performance Awards | Employees [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock option granted to certain employees | 583,000 | ||||||||||
2022 Performance Awards [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based compensation, stock options vested | 140,000 | ||||||||||
Share-based compensation, stock options cancelled | 0 | ||||||||||
Stock compensation expense | $ | $ 479,000 | ||||||||||
Stock option granted to certain employees | 140,000 | ||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Vesting period | 1 year | ||||||||||
Vesting period, description | one – year anniversary date of the related grant or ii) 25% on each anniversary for 4 years | ||||||||||
Restricted stock units granted | [1] | 131,205 | |||||||||
Fair value of restricted stock units vested | $ | $ 705,000 | $ 60,000 | |||||||||
Restricted stock units vested | 38,750 | ||||||||||
Weighted average grant date fair value per share | $ / shares | $ 15.79 | $ 21.19 | |||||||||
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 | 1,349,150 | ||||||||||
Common stock outstanding | 4% | ||||||||||
2015 Plan [Member] | Maximum [Member] | Subsequent Event [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares available for issuance | 4,073,605 | ||||||||||
2007 and 2015 [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Unrecognized compensation expense related to stock option | $ | $ 43,000,000 | ||||||||||
Weighted average period to recognize compensation expense | 3 years | ||||||||||
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 | ||||||||||
Employee Stock Purchase Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock compensation expense | $ | $ 166,000 | $ 175,000 | $ 203,000 | ||||||||
Number of shares issued under plan | 28,999 | 26,878 | |||||||||
Expiration of the ESPP | 1% | ||||||||||
expiration of the ESPP shares | 250,000 | ||||||||||
Employee Stock Purchase Plan [Member] | Subsequent Event [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Periodic payroll deductions offering periods | 6 months | ||||||||||
Offering period discount rate | 15% | ||||||||||
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 | 1,767,411 | ||||||||||
[1] RSU’s granted in 2022 and 2021 had a weighted average grant date fair value of $ 15.79 and $ 21.19 , respectively. The fair values of RSU’s vested in 2022 and 2021 totaled $ 705,000 and $ 60,000 , respectively. |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation expense, total | $ 16,019 | $ 13,317 | $ 9,057 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation expense, total | 6,016 | 4,398 | 2,400 |
General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation expense, total | $ 10,003 | $ 8,919 | $ 6,657 |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions and Methodology [Abstract] | |||
Expected term (in years) | 6 years 14 days | 6 years 7 days | 5 years 11 months 19 days |
Volatility rate | 77.87% | 85.84% | 81.59% |
Risk-free interest rate | 2.52% | 0.67% | 1.20% |
Expected dividend yield | 0% | 0% | 0% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Company's Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Payment Arrangement, Disclosure [Abstract] | |||
Options outstanding, Beginning balance | 6,921,514 | ||
Options granted | 3,020,850 | ||
Options exercised | (1,276,361) | (842,424) | (755,166) |
Options canceled, forfeited or expired | (684,326) | ||
Options outstanding, Ending balance | 7,981,677 | 6,921,514 | |
Options exercisable, Ending balance | 4,313,997 | ||
Options vested, exercisable or expected to vest, Ending balance | 7,981,677 | ||
Options outstanding, Weighted Average Exercise Price, Beginning balance | $ 11.99 | ||
Options granted, Weighted Average Exercise Price | 18.39 | ||
Options exercised, Weighted Average Exercise Price | 8.78 | ||
Options canceled, forfeited or expired, Weighted Average Exercise Price | $ 17.84 | ||
Options outstanding, Weighted Average Exercise Price, Ending balance | $ 11.99 | ||
Options outstanding, Weighted Average Remaining Contractual Term | 7 years 3 months 18 days | 6 years 10 months 24 days | |
Options exercisable, Weighted Average Remaining Contractual Term, Ending balance | 5 years 10 months 24 days | ||
Options vested, exercisable or expected to vest, Weighted Average Remaining Contractual Term, Ending balance | 7 years 3 months 18 days | ||
Options outstanding, Aggregate Intrinsic Value | $ 88,016 | $ 68,609 | |
Options Exercised, Aggregate Intrinsic Value | 17,000 | $ 10,100 | $ 7,100 |
Options exercisable, Aggregate Intrinsic Value | 61,851 | ||
Options vested, exercisable or expected to vest, Aggregate Intrinsic Value | $ 88,016 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - Non-Vested Restricted Stock Units (RSUs) [Member] | 12 Months Ended | |
Dec. 31, 2022 $ / shares shares | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Shares, Unvested, Beginning balance | shares | 132,333 | |
Number of Shares, Granted | shares | 131,205 | [1] |
Number of Shares, Vested | shares | (38,750) | |
Number of Shares, Unvested, Ending balance | shares | 224,788 | |
Weighted Average Grant Date Fair Value, Unvested, Beginning balance | $ / shares | $ 20.11 | |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 15.79 | [1] |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 17.61 | |
Weighted Average Grant Date Fair Value, Unvested, Ending balance | $ / shares | $ 18.02 | |
[1] RSU’s granted in 2022 and 2021 had a weighted average grant date fair value of $ 15.79 and $ 21.19 , respectively. The fair values of RSU’s vested in 2022 and 2021 totaled $ 705,000 and $ 60,000 , respectively. |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Parenthetical) (Details) - Restricted Stock Units (RSUs) [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Weighted average grant date fair value per share | $ 15.79 | $ 21.19 |
Fair value of restricted stock units vested | $ 705,000 | $ 60,000 |
Loan Payable - Additional Infor
Loan Payable - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Sep. 23, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | ||||
Payment on term loan | $ 20,996 | $ 0 | $ 0 | |
Prepayment Fee | 400 | |||
Hercules [Member] | Loan Agreement [Member] | ||||
Debt Instrument [Line Items] | ||||
Payment on term loan | $ 21,500 | |||
Payment for end-of term fees | 1,000 | |||
Payments for Other Fees | $ 400 | |||
Interest expense related to the loan agreement | 2,100 | |||
Hercules [Member] | First Amendment to Loan Agreement [Member] | ||||
Debt Instrument [Line Items] | ||||
Aggregate maximum borrowings | $ 80,000 | |||
Interest rate description | Borrowings under the Amended Loan Agreement bore interest at an annual interest rate from the greater of (y) 9.25% or (z) 6.00% plus the Wall Street Journal prime rate | |||
Percentage of prepayment premium of principal amount outstanding in first year | 2% | |||
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% | |||
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] | Maximum [Member] | Wall Street Journal Prime Rate [Member] | ||||
Debt Instrument [Line Items] | ||||
Basis spread on variable rate | 6% | |||
Hercules [Member] | First Amendment to Loan Agreement [Member] | Term Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Aggregate maximum borrowings | $ 20,000 |
Loan Payable - Summary of Matur
Loan Payable - Summary of Maturities of Principal Obligations Under Long-term Debt (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Term loan, less current portion | $ 0 | $ 19,895 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes [Line Items] | |||
Net tax provision | $ 0 | $ 0 | |
Increase (decrease) in valuation allowance | $ 35,900,000 | 4,800,000 | |
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 increased by $35.9 million in 2022 due to the increase in deferred tax assets, primarily driven by the generation of net operating losses and capitalized start-up costs, partially offset by a decrease to other deferred tax assets. The valuation allowance decreased by $4.8 million in 2021 due to the decrease in deferred tax assets, primarily driven by utilization of tax attributes to offset federal and state taxable income, partially offset by an increase to other deferred tax assets. | ||
Federal net operating losses | $ 99,600,000 | ||
State net operating losses | 42,800,000 | ||
Uncertain tax positions | 100,000 | ||
Deferred tax asset | 48,900,000 | ||
Deferred tax assets, Expenses required to be capitalized | 22,200,000 | ||
Internal Revenue Service [Member] | |||
Income Taxes [Line Items] | |||
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 | $ 5,700,000 | ||
Deferred tax assets research credits expiration period | 2022 | ||
Federal [Member] | Indefinite Carryforward Period [Member] | |||
Income Taxes [Line Items] | |||
Federal net operating losses | $ 77,500,000 | ||
Federal [Member] | Begin to Expire in 2026 [Member] | |||
Income Taxes [Line Items] | |||
Federal net operating losses | $ 22,100,000 | ||
State [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforward expiration period | 2026 | ||
Deferred tax assets research credits | $ 3,200,000 | ||
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
Income tax computed at federal statutory rate | 21% | 21% | 21% |
State taxes, net of federal benefit | 2.50% | 2.90% | 1.80% |
General business credit carryovers | 1% | (5.00%) | 0.90% |
Non-deductible expenses | (0.20%) | (0.50%) | 0% |
Change in valuation allowance | (24.10%) | (19.20%) | (23.70%) |
Return to provision true up | (0.20%) | 0% | 0% |
Other | 0% | 0.80% | 0% |
Effective income tax rate | (0.00%) | 0% | 0% |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets (liabilities): | ||
Net operating loss carryforwards | $ 23,650 | $ 17,642 |
Research and development credits | 8,124 | 6,113 |
Capitalized start-up and other costs | 45,374 | 34,898 |
Capitalized research and development costs | 48,917 | 31,365 |
Equity based compensation | 5,004 | 6,277 |
Accruals | 1,985 | 845 |
Other temporary differences | 27 | 10 |
Deferred tax assets before valuation allowance | 133,081 | 97,150 |
Valuation allowances | (133,081) | (97,150) |
Net deferred tax assets | $ 0 | $ 0 |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
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 | (20) | 0 | 0 |
Unrecognized tax benefit--end of year | $ 143 | $ 163 | $ 163 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2022 | 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% | |||
Incyte Agreement [Member] | Non-Refundable Cash Payments [Member] | ||||
Commitment And Contingencies [Line Items] | ||||
Upfront milestone payable | $ 117,000,000 | $ 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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Supplemental Disclosures of Non-Cash Investing and Financing Activities: | |||
Interest paid | $ 2,059 | $ 1,997 | $ 1,631 |
Issuance costs included in accounts payable and accrued expenses | $ 131 | $ 134 | $ 43 |