Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 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 | CRNX | ||
Entity Registrant Name | Crinetics Pharmaceuticals, Inc. | ||
Entity Central Index Key | 0001658247 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 53,908,865 | ||
Entity Public Float | $ 1 | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-38583 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 26-3744114 | ||
Entity Address, Address Line One | 10222 Barnes Canyon Road | ||
Entity Address, Address Line Two | Bldg. #2 | ||
Entity Address, City or Town | San Diego | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92121 | ||
City Area Code | 858 | ||
Local Phone Number | 450-6464 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
ICFR Auditor Attestation Flag | true | ||
Documents Incorporated by Reference | Certain sections of the registrant’s definitive proxy statement for the 2023 annual meeting of stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after end of the fiscal year covered by this Form 10-K are incorporated by reference into Part III of this Form 10-K. | ||
Auditor Firm ID | 243 | ||
Auditor Name | BDO USA, LLP | ||
Auditor Location | San Diego |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 32,672 | $ 200,695 |
Investment securities | 301,753 | 133,012 |
Prepaid expenses and other current assets | 10,759 | 11,013 |
Total current assets | 345,184 | 344,720 |
Property and equipment, net | 3,500 | 2,825 |
Operating lease right-of-use asset | 1,486 | 1,892 |
Derivative asset | 668 | 68 |
Investment in Radionetics | 0 | 1,010 |
Restricted cash | 1,301 | 500 |
Other assets | 37 | 0 |
Total assets | 352,176 | 351,015 |
Current liabilities: | ||
Accounts payable and accrued expenses | 15,351 | 8,468 |
Accrued compensation and related expenses | 9,081 | 6,588 |
Deferred revenue | 2,240 | 0 |
Other current liabilities | 1,051 | 939 |
Total current liabilities | 27,723 | 15,995 |
Operating lease liability, non-current | 2,024 | 3,074 |
Deferred revenue, non-current | 6,101 | 0 |
Unvested stock liability | 0 | 2 |
Total liabilities | 35,848 | 19,071 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par; 10,000 shares authorized, no shares issued or outstanding at December 31, 2022 or 2021 | 0 | 0 |
Common stock and paid-in capital, $0.001 par; 200,000 shares authorized, 53,877 shares issued and outstanding at December 31, 2022; 47,598 and 47,597 shares issued and outstanding at December 31, 2021 | 759,432 | 607,581 |
Accumulated other comprehensive (loss) income | (3,931) | (382) |
Accumulated deficit | (439,173) | (275,255) |
Total stockholders’ equity | 316,328 | 331,944 |
Total liabilities and stockholders’ equity | $ 352,176 | $ 351,015 |
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 issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock and paid-in capital, par value | $ 0.001 | $ 0.001 |
Common stock and paid-in capital, shares authorized | 200,000,000 | 200,000,000 |
Common stock and paid-in capital, shares issued | 53,877,000 | 47,598,000 |
Common stock and paid-in capital, shares outstanding | 53,877,000 | 47,597,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | |||
Revenues | $ 4,737 | $ 1,078 | $ 0 |
Grant revenues | 0 | 0 | 71 |
Total revenues | 4,737 | 1,078 | 71 |
Operating expenses: | |||
Research and development | 130,225 | 84,255 | 56,998 |
General and administrative | 42,394 | 24,525 | 18,026 |
Total operating expenses | 172,619 | 108,780 | 75,024 |
Loss from operations | (167,882) | (107,702) | (74,953) |
Other income (expense): | |||
Interest income | 4,317 | 157 | 991 |
Change in fair value of derivative asset | 600 | 0 | 0 |
Other income (expense), net | 57 | (96) | 150 |
Total other income, net | 4,974 | 61 | 1,141 |
Loss Before Equity Method Investment, Total | (162,908) | (107,641) | (73,812) |
Loss on equity method investment | (1,010) | 0 | 0 |
Net loss | $ (163,918) | $ (107,641) | $ (73,812) |
Earnings Per Share [Abstract] | |||
Basic | $ (3.15) | $ (2.80) | $ (2.42) |
Diluted | $ (3.15) | $ (2.80) | $ (2.42) |
Basic - Weighted Average | 51,982 | 38,436 | 30,448 |
Diluted - Weighted Average | 51,982 | 38,436 | 30,448 |
Other comprehensive income (loss): | |||
Unrealized gain (loss) on investment securities | $ (3,549) | $ (407) | $ (123) |
Comprehensive net loss | $ (167,467) | $ (108,048) | $ (73,935) |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Common stock and Paid-In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit |
Beginning Balance, Shares at Dec. 31, 2019 | 24,263,000 | ||||
Beginning Balance at Dec. 31, 2019 | $ 117,139 | $ 210,793 | $ 148 | $ (93,802) | |
Issuance of common stock, net of transaction costs | 114,283 | 114,283 | |||
Issuance of common stock, net of transaction costs, shares | 8,499,000 | ||||
Vesting of shares subject to repurchase | 26 | 26 | |||
Vesting of shares subject to repurchase, shares | 17,000 | ||||
Exercise of stock options | 288 | 288 | |||
Exercise of stock options, shares | 171,000 | ||||
Stock issued under Stock Purchase Plan | 691 | 691 | |||
Issuance of stock under Stock Purchase Plan, shares | 51,000 | ||||
Stock-based compensation | 10,427 | 10,427 | |||
Comprehensive income (loss) | (123) | (123) | |||
Net loss | (73,812) | (73,812) | |||
Ending Balance at Dec. 31, 2020 | 168,919 | 336,508 | 25 | (167,614) | |
Ending Balance, Shares at Dec. 31, 2020 | 33,001,000 | ||||
Issuance of common stock, net of transaction costs | 249,542 | 249,542 | |||
Issuance of common stock, net of transaction costs, shares | 14,126,000 | ||||
Vesting of shares subject to repurchase | 21 | 21 | |||
Vesting of shares subject to repurchase, shares | 15,000 | ||||
Exercise of stock options | 3,137 | 3,137 | |||
Exercise of stock options, shares | 364,000 | ||||
Stock issued under Stock Purchase Plan | 1,021 | 1,021 | |||
Issuance of stock under Stock Purchase Plan, shares | 91,000 | ||||
Stock-based compensation | 17,352 | 17,352 | |||
Comprehensive income (loss) | (407) | (407) | |||
Net loss | (107,641) | (107,641) | |||
Ending Balance at Dec. 31, 2021 | 331,944 | 607,581 | 382 | (275,255) | |
Ending Balance, Shares at Dec. 31, 2021 | 47,597,000 | ||||
Issuance of common stock, net of transaction costs | 117,242 | 117,242 | |||
Issuance of common stock, net of transaction costs, shares | 5,626,000 | ||||
Vesting of shares subject to repurchase | 2 | 2 | |||
Vesting of shares subject to repurchase, shares | 1,000 | ||||
Exercise of stock options | $ 4,721 | 4,721 | |||
Exercise of stock options, shares | 524,774,000 | 524,000 | |||
Stock issued under Stock Purchase Plan | $ 1,618 | 1,618 | |||
Issuance of stock under Stock Purchase Plan, shares | 129,000 | ||||
Stock-based compensation | 28,268 | 28,268 | |||
Comprehensive income (loss) | (3,549) | (3,549) | |||
Net loss | (163,918) | (163,918) | |||
Ending Balance at Dec. 31, 2022 | $ 316,328 | $ 759,432 | $ (3,931) | $ (439,173) | |
Ending Balance, Shares at Dec. 31, 2022 | 53,877,000 |
Consolidated Statements of Co_2
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Stockholders' Equity [Abstract] | |||
Issuance of common stock, of transaction costs | $ 7.8 | $ 12.9 | $ 7.5 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities: | |||
Net loss | $ (163,918) | $ (107,641) | $ (73,812) |
Reconciliation of net loss to net cash used in operating activities: | |||
Stock-based compensation | 28,268 | 17,352 | 10,427 |
Depreciation and amortization | 983 | 922 | 948 |
Noncash lease expense | 406 | 340 | 278 |
Accretion of purchase discounts and amortization of premiums on investment securities, net | 34 | 422 | (227) |
Noncash license revenues | (1,078) | ||
Loss on equity method investment | 1,010 | 0 | 0 |
Change in fair value of derivative asset | (600) | 0 | 0 |
Other, net | (1) | (17) | |
Increase (decrease) in cash resulting from changes in: | |||
Prepaid expenses and other assets | 215 | (4,361) | (1,623) |
Accounts payable and accrued expenses, compensation and related expenses | 10,994 | 6,293 | 2,723 |
Deferred revenue | 8,341 | ||
Operating lease liability | (938) | (836) | (724) |
Net cash used in operating activities | (115,205) | (88,588) | (62,027) |
Investing activities: | |||
Purchases of investment securities | (329,817) | (125,404) | (135,592) |
Maturities of investment securities | 157,493 | 69,357 | 135,995 |
Purchases of property and equipment | (1,656) | (436) | (186) |
Net cash (used in) provided by investing activities | (173,980) | (56,483) | 217 |
Financing activities: | |||
Proceeds from issuance of common stock, net of $13.0 million (2021) and $7.5 million (2020) transaction costs | 117,242 | 249,542 | 114,283 |
Proceeds from exercise of stock options | 4,721 | 3,137 | 288 |
Net cash provided by financing activities | 121,963 | 252,679 | 114,571 |
Net change in cash, cash equivalents and restricted cash | (167,222) | 107,608 | 52,761 |
Cash, cash equivalents and restricted cash - beginning of period | 201,195 | 93,587 | 40,826 |
Cash, cash equivalents and restricted cash - end of period | 33,973 | 201,195 | 93,587 |
Components of cash, cash equivalents and restricted cash: | |||
Cash and cash equivalents | 32,672 | 200,695 | 93,087 |
Restricted cash | 1,301 | 500 | 500 |
Cash, cash equivalents and restricted cash - end of period | 33,973 | 201,195 | 93,587 |
Non-cash financing activity: | |||
Investment in Radionetics | 0 | 1,010 | |
Derivative asset | 68 | ||
Stock issued under Stock Purchase Plan | 1,618 | 1,021 | 691 |
Amounts accrued for purchases of property and equipment | 130 | 6 | |
Change in unvested stock liability | $ 2 | $ 21 | $ 26 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Cash Flows [Abstract] | |||
Transaction costs | $ 7.8 | $ 12.9 | $ 7.5 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. ORGANIZATION AND BASIS OF PRESENTATION Description of Business Crinetics Pharmaceuticals, Inc. (the “Company”) is a clinical-stage pharmaceutical company incorporated in Delaware on November 18, 2008 and based in San Diego, California. The Company is focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. In January 2017, the Company established a wholly-owned Australian subsidiary, Crinetics Australia Pty Ltd (“CAPL”), in order to conduct various preclinical and clinical activities for its development candidates. Principles of Consolidation and Foreign Currency Transactions The consolidated financial statements include the accounts of the Company and CAPL. All intercompany accounts and transactions have been eliminated in consolidation. The functional currency of both the Company and CAPL is the U.S. dollar. Assets and liabilities that are not denominated in the functional currency are remeasured into U.S. dollars at foreign currency exchange rates in effect at the balance sheet date except for nonmonetary assets, which are remeasured at historical foreign currency exchange rates in effect at the date of transaction. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in other income (expense), in the accompanying consolidated statements of operations and comprehensive loss and were not material for all periods presented. Segment Reporting Operating segments are identified as components of an enterprise about which discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. Liquidity From inception, the Company has devoted substantially all of its efforts to drug discovery and development and conducting preclinical studies and clinical trials. The Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. The Company has experienced net losses and negative cash flows from operating activities since its inception and has an accumulated deficit of $ 439.2 million as of December 31, 2022. As of December 31, 2022 , the Company had $ 334.4 million in unrestricted cash, cash equivalents and investment securities. To date, the Company has been funded primarily through equity offerings. On August 13, 2019, the Company entered into a sales agreement and prospectus supplement filed on August 12, 2022, whereby the Company may offer and sell shares of its common stock from time to time up to $ 150.0 million through the sales agents (the “ATM Offering”). As of December 31, 2022 , 275,764 shares had been sold through the ATM Offering, for net proceeds of $ 6.4 million, after deducting commissions of $ 0.2 million, (see Note 9). The Company expects to continue to incur net losses for the foreseeable future and believes it will need to raise substantial additional capital to accomplish its business plan over the next several years. The Company plans to continue to fund its losses from operations and capital funding needs through a combination of equity offerings, debt financings or other sources, including potential collaborations, licenses and other similar arrangements. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations and future prospects. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future. COVID-19 The extent of the impact of COVID-19 on the Company's operational and financial performance will depend on certain developments, which are highly uncertain and cannot be predicted with confidence. The Company continues to actively monitor COVID-19 and may take further actions that alter its operations, including those that may be required by federal, state or local authorities, or that the Company determines are in the best interests of its employees and other third parties with whom the Company does business. For example, the recent lifting of COVID-19 restrictions and subsequent COVID-19 outbreaks in China have delayed the Company's planned recruitment of patients in our PATHFNDR-2 study. While COVID-19 has not had a material effect on the Company’s financial results, the degree to which COVID-19 or an outbreak of another highly infectious or contagious disease may impact the Company's future financial condition or results of operations is uncertain, and the Company may continue to experience disruptions that could impact its business, drug manufacturing, nonclinical activities, and clinical trials. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The Company’s consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of the Company’s consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to accrual of research and development expenses, valuation of stock-based awards, fair values of financial instruments, revenue recognition, and investment in Radionetics. Estimates are based on historical experiences or on forecasts, including information received from third parties and various other factors that the Company believes are reasonable under the circumstances. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates . Investment in Radionetics The Company first analyzes its investment in another entity to determine if the entity is a variable interest entity (“VIE”) and if so, whether the Company is the primary beneficiary requiring consolidation. An entity is considered a VIE if (1) the entity does not have enough equity to finance its own activities without additional support, (2) the entity’s at-risk equity holders lack the characteristics of a controlling financial interest, or (3) the entity is structured with non-substantive voting rights. VIEs are consolidated by the primary beneficiary, which is the entity that has both the power to direct the activities that most significantly impact the VIE’s economic performance and the obligation to absorb losses or the right to receive benefits from the VIE that potentially could be significant to the VIE. Variable interests in a VIE can be contractual, ownership, or other financial interests. The Company re-assesses its investment upon reconsideration events to determine whether the Company is the primary beneficiary of the VIE, in which case the Company would consolidate the VIE. If it has been determined that the Company is not the primary beneficiary or does not have control but does have the ability to exercise significant influence over the VIE, the Company accounts for the unconsolidated investment under the equity method of accounting. As discussed in Note 8, in October 2021, the Company, together with 5AM Ventures ("5AM") and Frazier Healthcare Partners ("Frazier"), announced the formation of Radionetics Oncology, Inc. ("Radionetics"). Radionetics aims to develop a deep pipeline of novel, targeted, nonpeptide radiopharmaceuticals for the treatment of a broad range of oncology indications. Radionetics is a VIE. The Company maintains an equity interest in Radionetics and accounts for its investment in Radionetics under the equity method of accounting. The Company records its share of Radionetics income (loss) outside of operations in the statements of operations and comprehensive loss on a quarterly lag. Since the Company’s investment in Radionetics was obtained on October 15, 2021, the Company recorded its share of income (loss) beginning in the first quarter of 2022. The Company's equity method investment in Radionetics was written down to zero during the first quarter of 2022 as a result of the allocation of the Company’s share of losses of the investee. Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets. Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions about risk and the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The carrying amounts of the Company’s current financial assets, restricted cash and current financial liabilities are considered to be representative of their respective fair values because of the short-term nature of those instruments. The Company recorded the derivative asset (see Note 8) and investment securities (see Note 3) at fair value. Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents include cash held in readily available checking and money market accounts, as well as short-term debt securities with maturities of three months or less when purchased. Restricted cash represents cash held as collateral for the Company’s facility leases and is reported as a long-term asset in the accompanying consolidated balance sheets. Investment Securities All investments have been classified as “available-for-sale” and are carried at fair value as determined based upon quoted market prices or pricing models for similar securities at period end. Investments with contractual maturities less than 12 months at the balance sheet date are considered short-term investments. Investments with contractual maturities beyond one year are also classified as short-term due to the Company’s ability to liquidate the investment for use in operations within the next 12 months. Realized gains and losses on investment securities are derived using the specific identification method for determining the cost of securities sold and are included in other income (expenses), net in the accompanying consolidated statements of operations and comprehensive loss. The Company has not realized any significant gains or losses on sales of available-for-sale investment securities during any of the periods presented. All of the Company’s investment holdings are in the form of debt securities, therefore unrealized gains and losses that are determined to be temporary in nature are reported as a component of accumulated other comprehensive income. Investment securities are evaluated periodically for impairment. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the establishment of a new cost basis for the security. Interest income is recognized when earned and is included in interest income in the accompanying consolidated statements of operations and comprehensive loss, as are the amortization of purchase premiums and accretion of purchase discounts on investment securities. Derivative Asset Derivatives are recorded at fair value and changes in fair value are recorded through the statements of operations and comprehensive loss each period. The Company has a single derivative instrument, a warrant (the "Radionetics Warrant") received on October 15, 2021, to purchase the greater of 3,407,285 additional shares of common stock or the number of additional shares of common stock that would allow the Company to maintain an aggregate equity interest of 22 % of the fully diluted capitalization of Radionetics, a private company. The Company records the Radionetics Warrant as long-term on the balance sheets due to the lack of marketability, such that it is not expected to be available for current operations. Changes in fair value of the Radionetics Warrant are recognized in other income (expense) in the accompanying consolidated statements of operations and comprehensive loss. Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and investment securities. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial position of the depository institution in which those deposits are held. Additionally, the Company has established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. Leases The Company determines if an arrangement is a lease at the inception of the arrangement. Leases with a term longer than 12 months that are determined to be operating leases are included in operating lease right-of-use assets, other current liabilities and noncurrent operating lease liabilities in the consolidated balance sheets at the commencement date of the arrangement. The Company accounts for each separate lease and non-lease component as a single lease component. When the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at commencement dates in determining the present value of lease payments. The incremental borrowing rate is the rate of interest that the Company would expect to pay to borrow over a similar term, and on a collateralized basis, an amount equal to the lease payments in a similar economic environment. The Company’s lease terms may include options to extend or terminate the lease when the Company is reasonably certain that it will exercise such options. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Lease agreements may contain variable costs such as common area maintenance, insurance, taxes or other costs. Such variable lease costs are expensed as incurred. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company assesses its leases to determine whether the arrangements contain lease incentives. Property and Equipment, Net Property and equipment consist of leasehold improvements, and lab and various other equipment. Such assets are stated at cost and depreciated on a straight-line basis over the estimated useful life of the related assets. The Company estimates its useful lives of its lab and other equipment as follows: lab equipment – three to five years ; office equipment - three to five years ; computer and software – three years . Leasehold improvements are amortized over the estimated useful life of the improvement or the remaining term of the associated lease. Repairs and maintenance costs are charged to expense as incurred and expenditures that materially extend the useful lives of assets are capitalized. Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets (or asset group) may not be fully recoverable. Factors considered in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. An impairment loss is recognized when estimated undiscounted future cash flows expected to result from the use of an asset (or asset group) are less than its carrying amount. If such assets are considered impaired, the impairment loss recognized is measured as the excess of the carrying value of the impaired asset over its fair value, determined based on future cash flows or appraised values, depending on the nature of the asset (or asset group). The Company has no t recognized any impairment losses in any of the periods presented in these consolidated financial statements. Revenue Recognition The Company has generated revenue from licensing and supply agreement arrangements. The Company recognizes revenues when, or as, the promised goods or services are transferred to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those services. To determine revenue recognition for arrangements, the Company performs the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligation(s) in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligation(s) in the contract; and (5) recognize revenue when (or as) the performance obligation(s) are satisfied. At contract inception, the Company assesses the goods or services promised within each contract, assesses whether each promised good or service is distinct and identifies those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. The Company has entered into licensing and collaboration agreements that mainly include the following: (i) upfront considerations; (ii) payments associated with achieving certain milestones; and (iii) royalties based on specified percentages of net product sales, if any. The Company has also entered into a manufacturing and supply arrangement that includes reimbursements of costs plus a pre-determined margin. At the initiation of an agreement, the Company analyzes each unit of account within the contract to determine if the counterparty is a customer in the context of the unit of account. The Company considers a variety of factors in determining the appropriate estimates and assumptions under the arrangements, such as whether the elements are distinct performance obligations, whether there are observable standalone prices, whether the license is functional or symbolic, and whether the Company is acting as the agent or principal. The Company evaluates each performance obligation to determine if it can be satisfied and recognized as revenue at a point in time or over time. At the inception of arrangements that include variable consideration, the Company uses judgment to estimate the amount of variable consideration to include in the transaction price using the most likely method. If it is probable that a significant revenue reversal will not occur, then the estimated amount is included in the transaction price. Milestone payments that are not within the Company's or the licensee’s control, such as regulatory approvals, are not included in the transaction price until those approvals are received. At the end of each reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint and, as necessary, adjusts the estimate of the overall transaction price. Any adjustments will be recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. The Company develops estimates of the standalone selling price for each distinct performance obligation. Variable consideration that relates specifically to efforts to satisfy specific performance obligations is allocated entirely to those performance obligations. Other components of the transaction price are allocated based on the relative standalone selling price, over which management has applied significant judgment. The Company determines the standalone selling price for license-related performance obligations using a market approach, which may include assumptions such as forecasted revenues, development timelines, discount rates and probabilities of success. The Company estimates the standalone selling price for the data exchange performance obligation (see Note 8) by forecasting the expected costs of satisfying a performance obligation plus a predetermined margin. In the case of a license that is a distinct performance obligation, the Company recognizes revenue allocated to the license from non-refundable, up-front fees at the point in time when the license is transferred to the licensee and the licensee can use and benefit from the license. For licenses that are bundled with other distinct or combined obligations, the Company uses judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. If the performance obligation is satisfied over time, then the Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The selection of the method to measure progress towards completion requires judgment and is based on the nature of the products or services to be provided. The Company has used the cost-to-cost measure of progress because it best depicts the transfer of control to the customer which occurs as the Company incurs costs. Under the cost-to-cost measure of progress, the extent of progress towards completion is measured based on the ratio of costs incurred to date to the total estimated costs at completion of the performance obligation, which is considered an input method. The Company uses judgment to estimate the total cost of these over time performance obligations, which include subcontractors’ costs, labor, materials, other direct costs and an allocation of indirect costs. The Company evaluates these cost estimates and the progress each reporting period and, as necessary, the Company adjusts the measure of progress and related revenue recognition. Sales-based milestones and royalties are recognized at the later of when the subsequent sale or usage occurs or the performance obligation for which some or all of the sales-based milestones and royalties have been allocated to has been satisfied or partially satisfied. The Company’s grant revenues are derived from Small Business Innovation Research Grants (“SBIR Grants”) from the National Institutes of Health. The Company's performance obligation under SBIR Grants consists of research activities and the Company recognizes SBIR Grant revenue over time as reimbursable grant costs are incurred up to pre-approved award limits within the budget period. The costs associated with these reimbursements are reflected as a component of research and development expense in the accompanying consolidated statements of operations and comprehensive loss. Earnings in excess of billings are included as a component of prepaid expenses and other current assets in the accompanying consolidated balance sheets. Research and Development Expenses Research and development (“R&D”) expenses consist primarily of salaries, payroll taxes, employee benefits and stock-based compensation for individuals involved in R&D efforts, as well as consulting expenses, third-party R&D expenses, laboratory supplies, clinical materials and overhead, including facilities and depreciation costs, offset by the Australian Tax Incentive discussed below. R&D expenses are charged to expense as incurred. Payments made prior to the receipt of goods or services to be used in R&D are capitalized until the goods or services are received and are recorded as prepaid expenses and other current assets. Costs incurred under contracts with contract research organizations that conduct and manage the Company’s clinical trials are also included in R&D expenses. The financial terms and activities of these agreements vary from contract to contract and may result in uneven expense levels. Generally, these agreements set forth activities that drive the recording of expenses such as start-up and initiation activities, enrollment and treatment of patients, or the completion of other clinical trial activities. Expenses related to clinical trials are accrued based on estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. If the amounts that the Company is obligated to pay under its clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), the Company adjusts its accruals accordingly on a prospective basis. Revisions to contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. Australian Tax Incentive CAPL is eligible to obtain a cash refund from the Australian Taxation Office for eligible R&D expenditures under the Australian R&D Tax Incentive Program (the “Australian Tax Incentive”). The Australian Tax Incentive is recognized as a reduction to R&D expense when there is reasonable assurance that the relevant expenditure has been incurred, the amount can be reliably measured and that the Australian Tax Incentive will be received. The Company recognized reductions to R&D expense of $ 0.8 million , $ 0.3 million and $ 0.6 million for the years ended December 31, 2022, 2021 and 2020 , respectively. Patent Costs All costs incurred for the filing of patent applications are recorded as general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss when incurred, as the recoverability of these expenses is uncertain. Stock-Based Compensati on Stock-based compensation expense represents the estimated grant date fair value of the Company’s equity awards, consisting of stock options, restricted stock units and shares issued under the Company’s Employee Stock Purchase Plan, recognized over the requisite service period of such awards (usually the vesting period) on a straight-line basis. The Company estimates the fair value of all stock option grants using the Black-Scholes option pricing model and recognizes forfeitures as they occur. Restricted stock units are valued using the grant date stock price. For stock awards for which vesting is subject to performance-based milestones, the expense is recorded over the remaining service period after the point when the achievement of the milestone is probable, or the performance condition has been achieved. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined based on the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense, and any accrued interest and penalties would be included within the related tax liability. No such costs were recorded during the three years ended December 31, 2022 . Comprehensive Loss Comprehensive loss is comprised of the Company’s net loss and the unrealized gains or losses on the Company’s available for sale investment securities for all periods presented. The cumulative amount of unrealized gains and losses is reflected as a separate component of stockholders' equity in the accompanying consolidated balance sheets as accumulated other comprehensive income (loss). There are no tax effects for the years ended December 31, 2022, 2021 and 2020 . Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury-stock. Dilutive common stock equivalents are comprised of common stock subject to repurchase, and options outstanding under the Company’s stock option plan. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities on loss per share would be antidilutive. Potentially dilutive securities (in common stock equivalent shares) not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows ( in thousands ): Year ended December 31, 2022 2021 2020 Stock options 9,757 6,554 4,422 Restricted stock units 290 — — Employee stock purchase plan 282 207 183 Unvested common stock subject to repurchase — 1 16 Total 10,329 6,762 4,621 Recently Adopted Accounting Pronouncements ASU 2021-04 In May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update ("ASU") 2021-04, Earnings Per Share ("Topic 260"), Debt-Modifications and Extinguishments ("Subtopic 470-50"), Compensation-Stock Compensation ("Topic 718"), and Derivatives and Hedging-Contracts in Entity’s Own Equity ("Subtopic 815-40"): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options ("ASU 2021-04"), which intends to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The Company adopted ASU 2021-04 as of January 1, 2022, which did not have an impact on its consolidated financial statements. Recent Accounting Pronouncements ASU 2016-13 In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ” (“Topic 326”). Topic 326 amends guidance on reporting credit losses for assets held at amortized cost basis and available for sale debt securities. For assets held at amortized cost basis, Topic 326 eliminates the probable initial recognition threshold in current GAAP and, instead, requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. For available for sale debt securities, credit losses should be measured in a manner similar to current GAAP, however Topic 326 will require that credit losses be presented as an allowance rather than as a write-down. This ASU update affects entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. This update is effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted ASU 2016-13 as of January 1, 2023, which did not have a material impact on the consolidated financial statements. |
Investment Securities
Investment Securities | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Investment Securities | 3. INVESTMENT SECURITIES The Company reports its available-for-sale investment securities at their estimated fair values. A vailable-for-sale investment securities consisted of the following as of December 31, 2022 and 2021 ( in thousands ): As of December 31, 2022 Amortized Gross Gross Fair Available-for-sale investment securities: U.S. government and agency obligations $ 154,228 $ 12 $ ( 1,510 ) $ 152,730 Certificates of deposit 4,629 — ( 94 ) 4,535 Corporate debt securities 145,330 — ( 2,336 ) 142,994 Asset-backed securities 1,497 — ( 3 ) 1,494 Total $ 305,684 $ 12 $ ( 3,943 ) $ 301,753 As of December 31, 2021 Amortized Gross Gross Fair Available-for-sale investment securities: U.S. government and agency obligations $ 54,637 $ — $ ( 180 ) 54,457 Certificates of deposit 5,735 1 ( 4 ) 5,732 Corporate debt securities 70,600 6 ( 204 ) 70,402 Asset-backed securities 2,421 — — 2,421 Total $ 133,393 $ 7 $ ( 388 ) $ 133,012 As of December 31, 2022 and 2021, available-for-sale investment securities by contractual maturity were as follows ( in thousands ): As of December 31, 2022 As of December 31, 2021 Amortized Fair Amortized Fair Available-for-sale investment securities: Due in one year or less $ 246,276 $ 243,542 $ 31,101 $ 31,078 Due after one year through five years 59,408 58,211 102,292 101,934 Total $ 305,684 $ 301,753 $ 133,393 $ 133,012 As of December 31, 2022, available-for-sale investment securities by length of time in a net loss position were as follows ( in thousands ): As of December 31, 2022 Less Than 12 Months More Than 12 Months Total Fair Gross Fair Gross Fair Gross Available-for-sale investment securities: U.S. government and agency obligations $ 95,933 $ ( 702 ) $ 36,681 $ ( 808 ) $ 132,614 $ ( 1,510 ) Certificates of deposit 2,399 ( 47 ) 2,136 ( 47 ) 4,535 ( 94 ) Corporate debt securities 96,663 ( 1,399 ) 43,330 ( 937 ) 139,993 ( 2,336 ) Asset-backed securities 1,494 ( 3 ) — — 1,494 ( 3 ) Total $ 196,489 $ ( 2,151 ) $ 82,147 $ ( 1,792 ) $ 278,636 $ ( 3,943 ) As of December 31, 2021, there were no available-for-sale investment securities at a loss position for a period of twelve months or more. The Company reviewed its investment holdings as of December 31, 2022 and 2021 and determined that its unrealized losses were not considered to be other-than-temporary based upon (i) the financial strength of the issuing institution, (ii) intent and ability of the securities to be held to maturity and (iii) the fact that the Company is expected to recover the amortized cost of its investment holdings. As such, the Company has not recognized any impairment in its financial statements related to its available-for-sale investment securities. During the years ended December 31, 2022, 2021, and 2020, the Company recognized ($ 86,000 ), $ 2,000 and $ 26,000 , respectively, of realized net gains (losses) in the accompanying statements of operations and comprehensive loss. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. FAIR VALUE MEASUREMENTS Investment Securities The Company holds investment securities that consist of highly liquid, investment grade debt securities. The Company determines the fair value of its investment securities based upon one or more valuations reported by its investment accounting and reporting service provider. The investment service provider values the securities using a hierarchical security pricing model that relies primarily on valuations provided by an industry-recognized valuation service. Such valuations may be based on trade prices in active markets for identical assets or liabilities (Level 1 inputs) or valuation models using inputs that are observable either directly or indirectly (Level 2 inputs), such as quoted prices for similar assets or liabilities, yield curves, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments or debt, and broker and dealer quotes, as well as other relevant economic measures. Derivative Asset On October 15, 2021, the Company received the Radionetics Warrant to purchase the greater of 3,407,285 additional shares of common stock or the number of additional shares of common stock that would allow the Company to maintain an aggregate equity interest of 22 % of the fully diluted capitalization of Radionetics. The valuation method and primary inputs used in valuing the Radionetics Warrant are discussed in Note 8. Such valuation is based on valuations provided by a third-party valuation specialist using unobservable inputs due to little to no market data (Level 3 inputs). During the year ended December 31, 2022, the Company recorded $ 0.6 million of i ncome in the accompanying consolidated statements of operations and comprehensive loss related to the change in value of the Radionetics Warrant. Financial assets measured at fair value on a recurring basis as of December 31, 2022 and 2021 were as follows (in thousands): As of December 31, 2022 Level 1 Level 2 Level 3 Total Investment securities: U.S. government and agency obligations $ 93,879 $ 58,851 $ — $ 152,730 Certificates of deposit — 4,535 — 4,535 Corporate debt securities — 142,994 — 142,994 Asset-backed securities — 1,494 — 1,494 Total Investment securities 93,879 207,874 — 301,753 Derivative Assets: Radionetics Warrant — — 668 668 Total assets measured at fair value $ 93,879 $ 207,874 $ 668 $ 302,421 As of December 31, 2021 Level 1 Level 2 Level 3 Total Investment securities: U.S. government and agency obligations $ 44,984 $ 9,473 $ — $ 54,457 Certificates of deposit — 5,732 — 5,732 Corporate debt securities — 70,402 — 70,402 Asset-backed securities — 2,421 — 2,421 Total Investment securities 44,984 88,028 — 133,012 Derivative Assets: Radionetics Warrant — — 68 68 Total assets measured at fair value $ 44,984 $ 88,028 $ 68 $ 133,080 The Company’s policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 3 during the years ended December 31, 2022 and 2021 . |
Balance Sheet Details
Balance Sheet Details | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | 5. BALANCE SHEET DETAILS Prepaid expenses and other current assets consisted of the following ( in thousands ): December 31, December 31, Prepaid clinical costs $ 2,567 $ 6,313 Prepaid research and development costs 2,293 $ 871 Australian tax incentive receivable 937 977 Prepaid insurance 939 888 Interest receivable 1,353 499 Due from Radionetics (Note 8) 135 553 Other 2,535 912 Total $ 10,759 $ 11,013 Property and equipment, net consisted of the following ( in thousands ): December 31, December 31, Leasehold improvements $ 3,516 $ 3,516 Lab equipment 3,168 1,889 Office equipment 859 859 Computers and software 41 41 Property and equipment at cost 7,584 6,305 Less accumulated depreciation and amortization ( 4,084 ) ( 3,480 ) Total $ 3,500 $ 2,825 Depreciation and amortization expense was $ 1.0 million, $ 0.9 million and $ 0.9 million for the years ended December 31, 2022, 2021 and 2020, respectively. Accounts payable and accrued expenses consisted of the following (in thousands): December 31, December 31, Accounts payable $ 6,883 $ 3,422 Accrued clinical costs 1,921 1,095 Accrued research and development costs 4,043 3,091 Accrued outside services and professional fees 1,810 537 Other accrued expenses 694 323 Total $ 15,351 $ 8,468 |
Operating Lease
Operating Lease | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Operating Lease | 6. OPERATING LEASE In February 2018, as amended in March 2018, the Company entered into a non-cancelable operating lease for a facility in San Diego, California (the "2018 Lease"). The 2018 Lease has an initial term of seven years which expires in August 2025 , and the Company has an option to extend the term of the 2018 Lease for an additional five years , a termination option subject to early termination fees and an option to sublease the facility. The 2018 Lease is subject to bas e lease payments and additional charges for common area maintenance and other costs and includes certain lease incentives and tenant improvement allowances. The Company’s estimated incremental fully collateralized borrowing rate of 8.0 % was used in its present value calculation as the 2018 Lease does not have a stated rate and the implicit rate was not readily determinable. On September 9, 2022, the Company entered into a lease agreement for laboratory and office space in San Diego, California (the "2022 Lease"). The Company expects to move its corporate headquarters to this new facility in the second half of 2023 upon the substantial completion of improvements. Under the terms of the 2022 Lease, the Company's expected future monthly minimum lease payments of $0.5 million, with six months of rent abatement in the first year, start on the earlier of (i) the date which is ten (10) months after substantial completion of demolition work, or (ii) the date of the substantial completion of improvements and first occupancy for business purposes, and the term expires on the date immediately preceding the one hundred thirty-seventh (137th) monthly anniversary of this lease payment start date. Lease payments are subject to annual 3% increase s. The Company is also responsible for certain operating expenses and taxes during the term of the 2022 Lease. The 2022 Lease provides the Company with specified tenant improvement and landlord work allowances. The Company has (i) two options to extend the term of the 2022 Lease for an additional period of five (5) years each, and (ii) a right of first offer on adjacent space to the new facility, subject to the terms and conditions of the 2022 Lease. As of December 31, 2022, the 2022 Lease did not commence because the construction of improvements to bring the facility to its intended use was ongoing and not substantially complete. Under the terms of the 2018 Lease and 2022 Lease, the Company provided the lessors with irrevocable letters of credit in the amounts of $ 0.5 million and $ 0.8 million, respectively. The lessors are entitled to draw on the letters of credit in the event of any default by the Company under the terms of the leases. As of December 31, 2022, future minimum payments under non-cancellable operating leases were as follows ( in thousands ): Year ending December 31, Minimum 2023 $ 1,244 2024 1,280 2025 871 Total future minimum lease payments 3,395 Less imputed interest ( 320 ) Total operating lease liabilities 3,075 Less operating lease liabilities, current ( 1,051 ) Operating lease liabilities, non-current $ 2,024 Operating lease cost was $ 1.0 million for each of the years ended December 31, 2022, 2021 and 2020. As of December 31, 2022 and 2021, the Company’s operating lease weighted average remaining term w as 2.6 years and 3.6 years, respectively. As of December 31, 2022 and 2021 , the Company’s weighted-average discount rate was 8 %. Cash paid for amounts included in the measurement of lease liabilities for operating cash flow from operating leases was $ 1.2 million, $ 1.2 million, and $ 1.1 million during each of the years ended years ended December 31, 2022, 2021 and 2020 . |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. COMMITMENTS AND CONTINGENCIES Litigation From time to time, the Company may be subject to various claims and suits arising in the ordinary course of business. The Company does not expect that the resolution of these matters will have a material adverse effect on its financial position or results of operations. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2022 | |
Revenues [Abstract] | |
Revenue Recognition | 8. REVENUE RECOGNITION Radionetics Oncology, Inc. Formation In October 2021, the Company, together with 5AM and Frazier, announced the formation of Radionetics. Radionetics aims to develop a deep pipeline of novel, targeted, nonpeptide radiopharmaceuticals for the treatment of a broad range of oncology indications. The Radionetics License The Company and Radionetics entered into the collaboration and license agreement (the “Radionetics License”), under which the Company granted to Radionetics an exclusive world-wide license to its radiotherapeutics technology platform and associated intellectual property for use in developing radiotherapeutics and related radio-imaging agents, including exclusive rights to the underlying intellectual property on certain preclinical drug candidates. Under the Radionetics License, the Company will not be supporting or maintaining the intellectual property and does not plan on continuing to undertake those activities from which the utility of the intellectual property is derived. The collaborative provisions per the Radionetics License are deemed to be protective measures for the advancement of the technology and not deemed to be a separate performance obligation. The Company assessed the Radionetics License and concluded that Radionetics is a customer within the Radionetics License. The performance obligation under the Radionetics License consisted of the license and know-how of the technology that was transferred at the inception of the Radionetics License. In exchange, the Company received 50,500,000 shares of common stock of Radionetics, which represents an initial majority stake in Radionetics of 64 %, and the Radionetics Warrant to purchase the greater of 3,407,285 additional shares of common stock or the number of additional shares of common stock that would allow the Company to maintain an aggregate equity interest of 22 % of the fully diluted capitalization of Radionetics. The exercise price of the Radionetics Warrant is $ 0.00001 and it is exercisable at any time and has a term of 10 years . As of December 31, 2022, the Company had a 56 % ownership stake in Radionetics. The upfront noncash consideration was valued at $ 1.1 million, which was comprised of $ 1.0 million for the Company's share of Radionetics common stock and $ 0.1 million for the Radionetics Warrant. The Radionetics License is for functional intellectual property which was transferred at the inception of the Radionetics License. The Company does not have an ongoing performance obligation to support or maintain the licensed intellectual property under the Radionetics License. In October 2021, the entire amount of the upfront noncash consideration of $ 1.1 million was recognized as license revenue upon the Company's transfer of the license under the Radionetics License. In addition to the upfront non-cash considerations, the Company may receive potential sales milestones in excess of $ 1.0 billion and single-digit royalties on net sales. As there have been no sales to date, no sales-based milestones or royalties were recognized to date. Valuation of Upfront Noncash Considerations The Company engaged a third-party valuation specialist to assist the Company with its determination of the estimated fair value of these upfront noncash considerations received. The valuation specialist utilized a cost approach to determine the implied value of Radionetics’ equity since it was newly formed with early development stage technology from the Radionetics License for which there are not reliable long-term forecasts. Next, the total equity value was allocated to various share classes using the current value method and option pricing method. The current value method allocates the value of the business to the shareholders' given consideration of senior obligations such as debt, equity certificates and other preferred equity. The option pricing method entails allocating the total shareholders’ equity value to the various share classes based upon their respective claims on a series of call options with strike prices at various value levels depending upon the rights and preferences of each class. The primary inputs used in valuing the Radionetics common stock and the Radionetics Warrant, were as follows: Derivative Asset December 31, 2022 October 15, 2021 and December 31, 2021 Expected term 1.8 years 3.0 years Expected volatility 116.6 % 111.4 % Risk free interest rate 4.5 % 0.7 % Marketability discount 51.0 % 30.0 % The Company estimated the expected term based on the expected time to a liquidity event. The risk-free interest rate was based on the yields of zero-coupon U.S. treasury securities. Volatility was estimated based upon an analysis of historical equity and asset volatilities of companies deemed comparable to Radionetics. The valuation amounts were adjusted by a discount for lack of marketability to account for the lack of liquidity an owner of the interest would experience for common stock in an early-stage company. The estimated value for the common stock of Radionetics and the Radionetics Warrant was $ 0.02 per share as of October 15, 2021 and December 31, 2021 and $ 0.20 per share as of December 31, 2022. Investment in Radionetics The Company applied the VIE model to its variable interests in Radionetics and concluded Radionetics is a VIE due to its insufficient equity to finance its activities without additional subordinated financial support. The Company then evaluated whether it is the primary beneficiary of Radionetics by identifying Radionetics’ key activities: (1) research and development activities, (2) financing decisions, and (3) determining the strategic direction of Radionetics. Power over research and development activities are made by unanimous vote by members of the research and development committee, in which no party has power. Power for financing decisions and setting strategic direction rests with the Radionetics’ board of directors, and no party was determined to be in control since the Radionetics board of directors is comprised of 4 members for which Crinetics, 5AM and Frazier are entitled to appoint (and replace, as needed) their board designee while the fourth independent member must be mutually agreed to by all three investors. Radionetics’ management is entirely separate from the Company and is determined by Radionetics’ board of directors. As the Company does not control any of Radionetics' key activities, it is not the primary beneficiary of the VIE and does not consolidate Radionetics. The Company accounted for its investment in Radionetics under the equity method of accounting due to its ability to exercise significant influence through its board seat and involvement in R&D activities, among other factors. The Company’s initial investment in Radionetics was recorded at the fair value of common stock received in the amount of $ 1.0 million. The Company's maximum exposure to loss of Radionetics is limited to carrying value of its equity method investment in Radionetics and the Radionetics Warrant. The Company has no obligation to fund the operations of Radionetics and has not provided significant explicit or implicit support to Radionetics that was not contractually required. The financial statements of Radionetics are not received sufficiently timely for the Company to record its portion of earnings or loss in the current consolidated financial statements and therefore the Company reports its portion of earnings or loss on a one quarter lag. The Company accounted for its share in Radionetics' loss as of December 31, 2021 during the first quarter of 2022. The Company's investment in Radionetics was written down to zero during the first quarter of 2022 as a result of the allocation of the Company’s share of losses of the investee. Other Radionetics Transactions During the year ended December 31, 2021, Radionetics completed a $ 30.0 million convertible notes financing with 5AM and Frazier as the sole participants. R. Scott Struthers, Ph.D. the Company’s President and Chief Executive Officer, serves as chairman of the Radionetics board of directors. Pursuant to such arrangement, Dr. Struthers received 1,000,000 shares of restricted common stock of Radionetics, which vest ratably over 36 months , subject to his continued service, and he receives a $ 50,000 annual retainer for his service as a board member of Radionetics. As of December 31, 2022 and 2021, the Company had approxima tely $ 0.1 million and $ 0.6 million, respectively, due from Radionetics for reimbursement of certain expenses paid on behalf of Radionetics. These amounts are recorded within prepaid expenses and other current assets in the accompanying consolidated balance sheets. During the years ended December 31, 2022 and 2021, the Company had approxima tely $ 0.4 million and $ 0.6 million, respectively, of reimbursements earned from Radionetics. The Company has evaluated these reimbursements and concluded that these reimbursements are not performance obligations for which the Company is acting as the principal and therefore these amounts have been included within operating expenses in the accompanying statements of operations and comprehensive loss in the period incurred. Sanwa Kagaku Kenkyusho Co., Ltd On February 25, 2022, the Company and Sanwa Kagaku Kenkyusho Co., Ltd. ("Sanwa"), entered into a license agreement (the “Sanwa License”) whereby the Company granted Sanwa an exclusive license to develop and commercialize paltusotine in Japan. Under the Sanwa License, Sanwa has the right to receive data obtained by the Company through certain paltusotine studies. The Company assessed the Sanwa License and concluded that Sanwa is a customer within the agreement. Sanwa will assume all costs associated with clinical trials and regulatory applications associated with these processes in Japan. Further, the Company retains all rights to develop and commercialize the product outside Japan. The Company also granted Sanwa the right to purchase supply of paltusotine for clinical and commercial requirements at cost plus a pre-negotiated percentage which was considered to be a market rate and therefore not a material right. The Company determined that its performance obligations under the Sanwa License comprised the license and data exchange. Certain professional services, such as the Company's participation on committees, were deemed to be immaterial to the context of the contract. In exchange, the Company received a $ 13.0 million nonrefundable, upfront payment and will be eligible to receive up to an additional $ 25.5 million in milestone payments related to the achievement of certain development, regulatory and commercial goals. In addition, upon market approval of paltusotine in Japan, the Company will be eligible to receive certain sales-based royalties. The Company determined that the transaction price amounted to the upfront payment of $ 13.0 million. As there have been no sales to date, no sales-based milestones or royalties were recognized to date. Further, using the most-likely-method, the developmental milestone payments were considered fully constrained. The control of the license was transferred to Sanwa at the inception of the contract and the Company does not have an ongoing performance obligation to support or maintain the licensed intellectual property. Revenue allocated to the data exchange obligation is recognized over time using the cost-to-cost measure as this method represents a faithful depiction of progress toward the ongoing paltusotine studies in the U.S. and related data transfer. Revenue is recognized on a gross basis as the Company is the principal. Licenses revenue for the year ended December 31, 2022 was comprised of $ 1.5 million at inception of the contract upon transferring the license at a point in time and $ 3.2 million recognized over time from the data exchange. As of December 31, 2022, $ 2.2 million and $ 6.1 million is included as current deferred revenues and non-current deferred revenues, respectively, in the accompanying consolidated balance sheets. Deferred revenues are expected to be recognized over the duration of certain paltusotine studies conducted by the Company. On June 14, 2022, the Company and Sanwa, entered into a clinical supply agreement (the "Sanwa Clinical Supply Agreement") whereby the Company is responsible for manufacturing and supplying certain materials to Sanwa for the completion of certain studies and trials under the Sanwa License. During the year ended December 31, 2022, the Company recognized $ 0.1 million of revenues through the Sanwa Clinical Supply Agreement. |
Stockholder's Equity
Stockholder's Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | 9. STOCKHOLDERS’ EQUITY Stock Offerings On April 17, 2020, the Company completed a public offering of 8,222,500 shares of its common stock at a public offering price of $ 14.00 per share. Proceeds from the offering were approximately $ 107.9 million, net of underwriting discounts and commissions and offering costs of $ 7.3 million. The shares were registered pursuant to the Company’s Shelf Registration Statement discussed below. On April 12, 2021, the Company completed an underwritten follow-on offering of 4,562,044 shares of its common stock at a price to the public of $ 16.44 per share. Proceeds from the offering were approximately $ 72.6 million, net of underwriting discounts and commissions and offering costs of $ 2.4 million. The shares were registered pursuant to the Company’s Shelf Registration Statement discussed below. On July 28, 2021, the Company entered into a stock purchase agreement for the private placement of 851,306 shares of its common stock at a price of $ 17.62 per share (the “Private Placement”), which shares were issued on July 30, 2021. Proceeds from the offering were approximately $ 15.0 million. On October 21, 2021, the Company completed an underwritten follow-on offering of 8,712,400 shares of its common stock at a price to the public of $ 19.80 per share. Proceeds from the offering were approximately $ 162.0 million, net of underwriting discounts and commissions and offering costs of $ 10.5 million. The shares were registered pursuant to the Company’s 2021 Shelf Registration Statement discussed below. On April 18, 2022, the Company completed an underwritten follow-on offering of 5,625,563 shares of its common stock at a price to the public of $ 22.22 per share. Net proceeds from the offering were approximately $ 117.2 million, after underwriting discounts and commissions and estimated offering costs of approximately $ 7.8 million. The shares were registered pursuant to the Company’s 2021 Shelf Registration Statement. Shelf Registration Statements and ATM Offering On August 13, 2019, the Company filed a registration statement on Form S-3 (the “2019 Shelf Registration Statement”), covering the offering of up to $ 300.0 million of common stock, preferred stock, debt securities, warrants and units. The 2019 Shelf Registration Statement became effective on August 29, 2019 . On August 13, 2019, the Company also entered into a Sales Agreement (the “Sales Agreement”) with SVB Leerink LLC and Cantor Fitzgerald & Co. (collectively, the “Sales Agents”), under which the Company may, from time to time, sell shares of its common stock through the Sales Agents (the “ATM Offering”). The 2019 Shelf Registration Statement included a prospectus covering the offering, i ssuance and sale of up to $ 75.0 million of the Company’s common stock from time to time through the ATM Offering. Pursuant to the 2019 Shelf Registration Statement, the Company has issued 275,764 shares of common stock in the ATM Offering for net proceeds of $ 6.4 million, after deducting commissions. The Company has not issued any additional shares of common stock in the ATM Offering since the first quarter of 2020. The 2019 Shelf Registration Statement expired on August 29, 2022. On August 10, 2021, the Company filed a registration statement on Form S-3 (the “2021 Shelf Registration Statement”), which became immediately effective upon filing, covering the offering of common stock, preferred stock, debt securities, warrants and units and the resale of up to 851,306 shares by the accredited investor who purchased shares in the Private Placement. On August 12, 2022, the Company filed with the SEC a prospectus supplement, dated August 12, 2022, to the 2021 Shelf Registration Statement pursuant to Rule 424(b) under the Securities Act of 1933, as amended, relating to the offer and sale of up to $ 150 million of shares of its common stock from time to time to or through the Sales Agents, pursuant to the Sales Agreement, in the ATM Offering. Following the expiration of the 2019 Shelf Registration Statement, the shares to be sold under the Sales Agreement may be issued and sold pursuant to the 2021 Shelf Registration Statement. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Equity Incentive Plans | 10. EQUITY INCENTIVE PLANS 2021 Employment Inducement Incentive Award Plan The Company adopted the 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan") in December 2021. The Company initially reserved 1,500,000 shares of the Company’s common stock for issuance pursuant to awards granted under the 2021 Inducement Plan. The terms of the 2021 Inducement Plan are substantially similar to the terms of the Company’s 2018 Incentive Award Plan with the exception that awards may only be made to an employee who has not previously been an employee or member of the board of directors of the Company if the award is in connection with commencement of employment. No awards were granted under the 2021 Inducement Plan during the year ended December 31, 2021. In 2022, the Company amended the 2021 Inducement Plan to increase the number of shares of the Company’s common stock available for future issuance under the 2021 Inducement Plan to 5,000,000 shares. As of December 31, 2022 , 2,315,100 shares of common stock were available for future issuance under the 2021 Inducement Plan. 2018 Incentive Award Plan The Company adopted the 2018 Incentive Award Plan (the “2018 Plan”) in July 2018. Under the 2018 Plan, which expires in July 2028 , the Company may grant equity-based awards to individuals who are employees, officers, directors or consultants of the Company. Options issued under the 2018 Plan will generally expire ten years from the date of grant and vest over a four-year period. As of December 31, 2022, an aggregate o f 2,167,691 shares of common stock were available for issuance under the 2018 Plan. The 2018 Plan contains a provision that allows annual increases in the number of shares available for issuance on the first day of each calendar year through January 1, 2028 in an amount equal to the lesser of: (i) 5 % of the aggregate number of shares of the Company’s common stock outstanding on December 31 of the immediately preceding calendar year, or (ii) such lesser amount determined by the Company. Under this evergreen provision, on January 1, 2023, an addition al 2,693,859 sh ares became available for future issuance under the 2018 Plan. 2015 Stock Incentive Plan The Company adopted the 2015 Stock Incentive Plan (the “2015 Plan”) in February 2015, which provided for the issuance of equity awards to the Company’s employees, members of its board of directors and consultants. In general, options issued under this plan vest over four years and expire after 10 years. Subsequent to the adoption of the 2018 Plan, no additional equity awards can be made under the 2015 Plan. Certain awards issued under the 2015 Plan allowed for exercise prior to vesting. Shares issued under such early-exercise provisions are subject to repurchase by the Company until they become fully vested. As of December 31, 2022, there were no unvested shares issued under early-exercise provisions were subject to repurchase by the Company. The consolidated balance sheet reflects an unvested stock liability of $ 2,000 as of December 31, 2021. 2018 Employee Stock Purchase Plan The Company adopted the 2018 Employee Stock Purchase Plan (the “ESPP”) in July 2018. The ESPP permits participants to purchase common stock through payroll deductions of up to 20 % of their eligible compensation. As of December 31, 2022 , an aggregate of 1,200,455 sh ares of common stock were available for issuance under the ESPP. The ESPP contains a provision that allows annual increases in the number of shares available for issuance on the first day of each calendar year through January 1, 2028 in an amount equal to the lesser of: (i) 1 % of the aggregate number of shares of the Company’s common stock outstanding on December 31 of the immediately preceding calendar year, or (ii) such lesser amount determined by the Company. Under this evergreen provision, on January 1, 2023, an additional 538,771 shares became available for future issuance under the ESPP. Stock Awards Stock Options Activity under the Company’s stock option plans during the yea r ended December 31, 2022 was as follows: Weighted- Weighted- Aggregate Average Average Intrinsic Options Exercise Remaining Value Outstanding Price Term (000’s) Balance at December 31, 2021 6,553,594 $ 16.07 Granted 4,139,204 $ 19.54 Exercised ( 524,774 ) $ 9.00 Forfeited and expired ( 410,695 ) $ 19.28 Balance at December 31, 2022 9,757,329 $ 17.79 8.0 $ 23,149 Vested and expected to vest at December 31, 2022 9,757,329 $ 17.79 8.0 $ 23,149 Exercisable at December 31, 2022 4,122,612 $ 15.90 6.6 $ 18,493 Aggregate intrinsic value is calculated as the difference between the closing price of the Company’s common stock at December 31, 2022 and the exercise price of stock options that had strike prices below the closing price. The total intrinsic value of options exercised during 2022, 2021 and 2020 was $ 5.9 million, $ 5.1 million and $ 2.5 million, respectively. The total fair value of options vested during 2022, 2021 and 2020 was $ 23.0 million, $ 16.3 million and $ 9.9 million, respectively. Restricted Stock Units The Company’s restricted stock unit activity during the year ended December 31, 2022 was as follows: Weighted- Restricted Stock Average Units Grant Date Outstanding Fair Value Balance at December 31, 2021 — $ — Granted 319,419 $ 19.90 Forfeited ( 29,108 ) $ 20.02 Balance at December 31, 2022 290,311 $ 19.88 Fair Value of Stock Awards The Company estimate the fair value of all stock option grants and ESPP using the Black-Scholes option pricing model and recognize forfeitures as they occur. The following table summarizes the weighted average assumptions used to estimate the fair value of stock options granted under the Company’s stock option plans and the shares purchasable under the ESPP d uring the periods presented: Year ended December 31, Stock Option Awards 2022 2021 2020 Expected term 6.1 years 6.0 years 6.0 years Expected volatility 88 % 86 % 78 % Risk free interest rate 2.8 % 1.0 % 0.8 % Expected dividend yield — % — % — % Year ended December 31, ESPP 2022 2021 2020 Expected term 1.3 years 1.6 years 1.4 years Expected volatility 87 % 91 % 84 % Risk free interest rate 4.1 % 0.3 % 0.2 % Expected dividend yield — % — % — % The weighted-average fair value of stock options granted to employees during the years ended December 31, 2022, 2021 and 2020 was $ 14.50 , $ 13.02 and $ 12.83 per share, respectively. The weighted-average fair value of awards under the ESPP during the years ended December 31, 2022, 2021 and 2020 was $ 9.39 , $ 12.52 and $ 8.07 per share, respectively. The key assumptions used in determining the fair value of equity awards, and the Company’s rationale, were as follows: (i) Expected term - the expected term for options represents the period that options are expected to be outstanding and has been estimated using the simplified method, which is an average of the contractual option term and its vesting period; the expected term for ESPP represents the term the awards are expected to be outstanding; (ii) Expected volatility - the expected volatility assumption is based on volatilities of a peer group of similar companies in the biotechnology industry whose share prices are publicly available. The Company computes the historical volatility data using the daily close prices for the selected companies’ shares during the equivalent period of the calculated expected term of the Company’s stock-based awards. The Company will continue to apply this process until sufficient historical information regarding the volatility of its common stock price becomes available or the Company believes the volatility of its own market-traded shares best represent expected volatility; (iii) Risk-free interest rate - the risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities that approximate the expected terms of awards; and (iv) Expected dividend yield - the expected dividend yield assumption is zero as the Company has never paid dividends and has no present intention to do so in the futur e. Restricted stock units are valued using the grant date stock price. Stock-Based Compensation Expense Stock-based compensation expense for the equity awards issued by the Company to employees and non-employees for the periods presented below was as follow s ( in thousands ): Year ended December 31, 2022 2021 2020 Included in research and development $ 15,078 $ 9,654 $ 5,218 Included in general and administrative 13,190 7,698 5,209 Total stock-based compensation expense $ 28,268 $ 17,352 $ 10,427 As of December 31, 2022 , unrecognized stock-based compensation cost related to option awards, restricted stock units, and ESPP was $ 72.5 million, $ 4.5 million and $ 2.8 million, respectively, which is expected to be recognized over a remaining weighted-average period of approximately 2.1 years, 3.1 years and 1.8 years, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. INCOME TAXES The Company is subject to taxation in the United States, various state jurisdictions and Australia; however, as it has operated at a loss since inception, it has not paid income taxes in any of the jurisdictions in which it has operated. At December 31, 2022, the Company had federal, state, and foreign net operating loss (“NOL”) carryforwards of approximately $ 254.5 million, $ 218.0 million and $ 1.3 million, respectively. The federal loss carryforwards generated after 2017 of $ 248.1 million will carryforward indefinitely and can be used to offset up to 80 % of future annual taxable income, while those loss carryforwards generated prior to 2018 begin expiring in 2035, unless previously utilized. $ 0.5 million of the state loss carryforwards will carryforward indefinitely. The other state loss carryforwards begin expiring in 2035, unless previously utilized. The Company's foreign loss carryforwards do not expire. The Company also has federal and California R&D credit carryforwards and federal Orphan Drug Credits totaling $ 8.8 million, $ 6.1 million, and $ 12.5 million, respectively. The federal R&D credits begin to expire in 2030 , unless previously utilized, while the state credits do not expire. The federal Orphan Drug credit carryforwards will begin to expire in 2040, unless previously utilized. The Company’s NOL and credit carryforwards to offset future taxable income may be subject to a substantial annual limitation upon future utilization as a result of ownership changes that could occur in the future pursuant to Internal Revenue Code Sections 382 and 383. These ownership changes may limit the amount of NOL and credit carryforwards that can be utilized to offset future taxable income and income tax, respectively. In general, an “ownership change” as defined by the tax code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percent of the outstanding stock of a company by certain stockholders or public groups. During 2020, the Company completed a study to assess whether an ownership change within the meaning of Section 382 had occurred for the time period prior to July 15, 2020. The study identified several such ownership changes during the study period, which resulted in limitations on the annual utilization of the Company’s NOL and credit carryforwards, or the “Tax Attribute” carryforwards; however, the study findings also indicated that none of the Company’s Tax Attribute carryforwards generated during the study period would expire solely as a result of annual limitations on the utilization of such Tax Attribute carryforwards. The Company updated the study for 2022 and did not identify any additional ownership changes. Future ownership changes could still occur which might place further limits on the Company’s ability to utilize its Tax Attribute carryforwards. The Company’s federal income tax returns from 2019 forward, state income tax returns from 2018 forward, and its Australian tax returns beginning in 2020 are subject to examination by tax authorities; however, the Company's tax attribute carryforwards such as NOLs and R&D credits generated in closed tax years remain subject to adjustment by the taxing authorities until the future tax years in which those attributes are utilized are closed to statute. No such audits are underway. Deferred tax assets and liabilities Net deferred tax assets are comprised of the following as of December 31, 2022 and 2021 ( in thousands ): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 69,044 $ 59,453 Capitalized research expenses 22,123 3,598 R&D and other tax credits 22,210 12,930 Stock-based compensation 8,168 5,899 Lease liability 648 1,125 Accrued expenses and other, net 4,208 3,309 Total deferred tax assets 126,401 86,314 Deferred tax liabilities: Right-of use asset ( 313 ) ( 531 ) Equity method investment ( 140 ) ( 302 ) Net of deferred tax assets and liabilities 125,948 85,481 Less: valuation allowance ( 125,948 ) ( 85,481 ) Net deferred tax assets $ — $ — Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use existing deferred tax assets. Based on the weight of available evidence, including the Company’s history of operating losses, management has determined that it is more likely than not that the Company’s net deferred tax assets will not be realized. Accordingly, a valuation allowance has been established by the Company to fully offset these net deferred tax assets. Income tax benefit For the three years in the period ended December 31, 2022, domestic and foreign pre-tax loss were ( in thousands ): Year ended December 31, 2022 2021 2020 Loss before income taxes - Domestic $ ( 163,175 ) $ ( 107,723 ) $ ( 71,769 ) Income (loss) before income taxes - Foreign ( 743 ) 82 ( 2,043 ) Loss before income taxes - Consolidated $ ( 163,918 ) $ ( 107,641 ) $ ( 73,812 ) A reconciliation of income tax expense to the amount computed by applying the statutory federal income tax rate to the loss from operations for the three years in the period ended December 31, 2022 is as follows ( in thousands ): Year ended December 31, 2022 2021 2020 Expected income tax benefit at federal statutory rate $ ( 34,423 ) $ ( 22,605 ) $ ( 15,417 ) State income tax benefit, net of federal benefit ( 128 ) ( 7,083 ) ( 4,886 ) Tax effect of Change in valuation allowance 39,733 34,495 22,242 R&D credit ( 10,918 ) ( 7,117 ) ( 2,597 ) Stock-based compensation 781 1,196 539 Australian tax incentive 266 27 215 State rate change 3,243 ( 8 ) ( 5 ) Other 1,446 1,095 ( 91 ) Provision for income taxes $ — $ — $ — Changes to the Company’s unrecognized tax benefits are summarized in the following table ( in thousands ): Year ended December 31, 2022 2021 2020 Beginning balance $ 1,553 $ 1,092 $ 886 Increase (decrease) for prior year tax positions 837 ( 34 ) ( 163 ) Increase (decrease) for current year tax positions 1,720 495 369 Ending balance $ 4,110 $ 1,553 $ 1,092 Due to the existence of the valuation allowance, future changes in unrecognized tax benefits would not have any effect on the Company’s effective tax rate. The Company does not foresee any material changes to its unrecognized tax benefits within the next twelve months. There have been no decreases in unrecognized tax benefits due to settlements or expiration of statute of limitations for the assessment of taxes during the years ended December 31, 2022, 2021 and 2020. The Company’s policy is to recognize the interest expense and/or penalties related to income tax matters as a component of income tax expense. The Company had no accrual for interest or penalties on its consolidated balance sheets as of December 31, 2022 or December 31, 2021, and has no t recognized interest and/or penalties in its consolidated statements of operations for the years ended December 31, 2022 and December 31, 2021 as the unrecognized tax benefits relate to tax positions for which no cash tax liability has been reduced. In response to the pandemic, the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was signed into law on March 27, 2020. The CARES Act, among other things, includes tax provisions relating to refundable payroll tax credits, deferment of employer’s social security payments, net operating loss utilization and carryback periods, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. The CARES Act did not have a material impact on our income tax provision for the year ended December 31, 2022, 2021, and 2020. Deferred income taxes have not been provided for undistributed earnings of the Company’s consolidated foreign subsidiary because the Parent entity would not be required to include the distribution into income as the amount would be tax free. The Tax Cuts and Jobs Act subjects a U.S. shareholder to tax on Global Intangible Low-Taxed Income ("GILTI") earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740 No. 5. Accounting for Global Intangible Low-Taxed Income , states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. We have elected to account for GILTI in the year the tax is incurred. |
Employee Savings Plan
Employee Savings Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Employee Savings Plan | 12. EMPLOYEE SAVINGS PLAN The Company has a defined contribution 401(k) benefit plan (the “401(k) Plan”) for all eligible employees, effective May 1, 2016 . The plan permits participants to contribute up to the amount allowable under federal limits of annual pre-tax compensation to the 401(k) Plan. Effective in 2021, discretionary matching contributions to the 401(k) Plan are permitted in an amount equal to 50% of the first 6% of the employee’s taxable income up to a maximum of $ 3,000 per year . The Company accrued approximately $ 0.5 and $ 0.3 million for matching contributions for the years ended December 31, 2022 and 2021 , respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Description of Business | Description of Business Crinetics Pharmaceuticals, Inc. (the “Company”) is a clinical-stage pharmaceutical company incorporated in Delaware on November 18, 2008 and based in San Diego, California. The Company is focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. In January 2017, the Company established a wholly-owned Australian subsidiary, Crinetics Australia Pty Ltd (“CAPL”), in order to conduct various preclinical and clinical activities for its development candidates. |
Principles of Consolidation and Foreign Currency Transactions | Principles of Consolidation and Foreign Currency Transactions The consolidated financial statements include the accounts of the Company and CAPL. All intercompany accounts and transactions have been eliminated in consolidation. The functional currency of both the Company and CAPL is the U.S. dollar. Assets and liabilities that are not denominated in the functional currency are remeasured into U.S. dollars at foreign currency exchange rates in effect at the balance sheet date except for nonmonetary assets, which are remeasured at historical foreign currency exchange rates in effect at the date of transaction. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in other income (expense), in the accompanying consolidated statements of operations and comprehensive loss and were not material for all periods presented. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. |
Liquidity | Liquidity From inception, the Company has devoted substantially all of its efforts to drug discovery and development and conducting preclinical studies and clinical trials. The Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. The Company has experienced net losses and negative cash flows from operating activities since its inception and has an accumulated deficit of $ 439.2 million as of December 31, 2022. As of December 31, 2022 , the Company had $ 334.4 million in unrestricted cash, cash equivalents and investment securities. To date, the Company has been funded primarily through equity offerings. On August 13, 2019, the Company entered into a sales agreement and prospectus supplement filed on August 12, 2022, whereby the Company may offer and sell shares of its common stock from time to time up to $ 150.0 million through the sales agents (the “ATM Offering”). As of December 31, 2022 , 275,764 shares had been sold through the ATM Offering, for net proceeds of $ 6.4 million, after deducting commissions of $ 0.2 million, (see Note 9). The Company expects to continue to incur net losses for the foreseeable future and believes it will need to raise substantial additional capital to accomplish its business plan over the next several years. The Company plans to continue to fund its losses from operations and capital funding needs through a combination of equity offerings, debt financings or other sources, including potential collaborations, licenses and other similar arrangements. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations and future prospects. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future. |
COVID-19 | COVID-19 The extent of the impact of COVID-19 on the Company's operational and financial performance will depend on certain developments, which are highly uncertain and cannot be predicted with confidence. The Company continues to actively monitor COVID-19 and may take further actions that alter its operations, including those that may be required by federal, state or local authorities, or that the Company determines are in the best interests of its employees and other third parties with whom the Company does business. For example, the recent lifting of COVID-19 restrictions and subsequent COVID-19 outbreaks in China have delayed the Company's planned recruitment of patients in our PATHFNDR-2 study. While COVID-19 has not had a material effect on the Company’s financial results, the degree to which COVID-19 or an outbreak of another highly infectious or contagious disease may impact the Company's future financial condition or results of operations is uncertain, and the Company may continue to experience disruptions that could impact its business, drug manufacturing, nonclinical activities, and clinical trials. |
Use of Estimates | Use of Estimates The Company’s consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of the Company’s consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to accrual of research and development expenses, valuation of stock-based awards, fair values of financial instruments, revenue recognition, and investment in Radionetics. Estimates are based on historical experiences or on forecasts, including information received from third parties and various other factors that the Company believes are reasonable under the circumstances. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates |
Investment in Radionetics | The Company first analyzes its investment in another entity to determine if the entity is a variable interest entity (“VIE”) and if so, whether the Company is the primary beneficiary requiring consolidation. An entity is considered a VIE if (1) the entity does not have enough equity to finance its own activities without additional support, (2) the entity’s at-risk equity holders lack the characteristics of a controlling financial interest, or (3) the entity is structured with non-substantive voting rights. VIEs are consolidated by the primary beneficiary, which is the entity that has both the power to direct the activities that most significantly impact the VIE’s economic performance and the obligation to absorb losses or the right to receive benefits from the VIE that potentially could be significant to the VIE. Variable interests in a VIE can be contractual, ownership, or other financial interests. The Company re-assesses its investment upon reconsideration events to determine whether the Company is the primary beneficiary of the VIE, in which case the Company would consolidate the VIE. If it has been determined that the Company is not the primary beneficiary or does not have control but does have the ability to exercise significant influence over the VIE, the Company accounts for the unconsolidated investment under the equity method of accounting. As discussed in Note 8, in October 2021, the Company, together with 5AM Ventures ("5AM") and Frazier Healthcare Partners ("Frazier"), announced the formation of Radionetics Oncology, Inc. ("Radionetics"). Radionetics aims to develop a deep pipeline of novel, targeted, nonpeptide radiopharmaceuticals for the treatment of a broad range of oncology indications. Radionetics is a VIE. The Company maintains an equity interest in Radionetics and accounts for its investment in Radionetics under the equity method of accounting. The Company records its share of Radionetics income (loss) outside of operations in the statements of operations and comprehensive loss on a quarterly lag. Since the Company’s investment in Radionetics was obtained on October 15, 2021, the Company recorded its share of income (loss) beginning in the first quarter of 2022. The Company's equity method investment in Radionetics was written down to zero during the first quarter of 2022 as a result of the allocation of the Company’s share of losses of the investee. |
Fair Value Measurements | Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets. Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions about risk and the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The carrying amounts of the Company’s current financial assets, restricted cash and current financial liabilities are considered to be representative of their respective fair values because of the short-term nature of those instruments. The Company recorded the derivative asset (see Note 8) and investment securities (see Note 3) at fair value. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents include cash held in readily available checking and money market accounts, as well as short-term debt securities with maturities of three months or less when purchased. Restricted cash represents cash held as collateral for the Company’s facility leases and is reported as a long-term asset in the accompanying consolidated balance sheets. |
Investment Securities | Investment Securities All investments have been classified as “available-for-sale” and are carried at fair value as determined based upon quoted market prices or pricing models for similar securities at period end. Investments with contractual maturities less than 12 months at the balance sheet date are considered short-term investments. Investments with contractual maturities beyond one year are also classified as short-term due to the Company’s ability to liquidate the investment for use in operations within the next 12 months. Realized gains and losses on investment securities are derived using the specific identification method for determining the cost of securities sold and are included in other income (expenses), net in the accompanying consolidated statements of operations and comprehensive loss. The Company has not realized any significant gains or losses on sales of available-for-sale investment securities during any of the periods presented. All of the Company’s investment holdings are in the form of debt securities, therefore unrealized gains and losses that are determined to be temporary in nature are reported as a component of accumulated other comprehensive income. Investment securities are evaluated periodically for impairment. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the establishment of a new cost basis for the security. Interest income is recognized when earned and is included in interest income in the accompanying consolidated statements of operations and comprehensive loss, as are the amortization of purchase premiums and accretion of purchase discounts on investment securities. |
Derivative Asset | Derivative Asset Derivatives are recorded at fair value and changes in fair value are recorded through the statements of operations and comprehensive loss each period. The Company has a single derivative instrument, a warrant (the "Radionetics Warrant") received on October 15, 2021, to purchase the greater of 3,407,285 additional shares of common stock or the number of additional shares of common stock that would allow the Company to maintain an aggregate equity interest of 22 % of the fully diluted capitalization of Radionetics, a private company. The Company records the Radionetics Warrant as long-term on the balance sheets due to the lack of marketability, such that it is not expected to be available for current operations. Changes in fair value of the Radionetics Warrant are recognized in other income (expense) in the accompanying consolidated statements of operations and comprehensive loss. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and investment securities. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial position of the depository institution in which those deposits are held. Additionally, the Company has established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. |
Leases | Leases The Company determines if an arrangement is a lease at the inception of the arrangement. Leases with a term longer than 12 months that are determined to be operating leases are included in operating lease right-of-use assets, other current liabilities and noncurrent operating lease liabilities in the consolidated balance sheets at the commencement date of the arrangement. The Company accounts for each separate lease and non-lease component as a single lease component. When the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at commencement dates in determining the present value of lease payments. The incremental borrowing rate is the rate of interest that the Company would expect to pay to borrow over a similar term, and on a collateralized basis, an amount equal to the lease payments in a similar economic environment. The Company’s lease terms may include options to extend or terminate the lease when the Company is reasonably certain that it will exercise such options. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Lease agreements may contain variable costs such as common area maintenance, insurance, taxes or other costs. Such variable lease costs are expensed as incurred. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company assesses its leases to determine whether the arrangements contain lease incentives. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment consist of leasehold improvements, and lab and various other equipment. Such assets are stated at cost and depreciated on a straight-line basis over the estimated useful life of the related assets. The Company estimates its useful lives of its lab and other equipment as follows: lab equipment – three to five years ; office equipment - three to five years ; computer and software – three years . Leasehold improvements are amortized over the estimated useful life of the improvement or the remaining term of the associated lease. Repairs and maintenance costs are charged to expense as incurred and expenditures that materially extend the useful lives of assets are capitalized. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets (or asset group) may not be fully recoverable. Factors considered in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. An impairment loss is recognized when estimated undiscounted future cash flows expected to result from the use of an asset (or asset group) are less than its carrying amount. If such assets are considered impaired, the impairment loss recognized is measured as the excess of the carrying value of the impaired asset over its fair value, determined based on future cash flows or appraised values, depending on the nature of the asset (or asset group). The Company has no t recognized any impairment losses in any of the periods presented in these consolidated financial statements. |
Revenue Recognition | Revenue Recognition The Company has generated revenue from licensing and supply agreement arrangements. The Company recognizes revenues when, or as, the promised goods or services are transferred to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those services. To determine revenue recognition for arrangements, the Company performs the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligation(s) in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligation(s) in the contract; and (5) recognize revenue when (or as) the performance obligation(s) are satisfied. At contract inception, the Company assesses the goods or services promised within each contract, assesses whether each promised good or service is distinct and identifies those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. The Company has entered into licensing and collaboration agreements that mainly include the following: (i) upfront considerations; (ii) payments associated with achieving certain milestones; and (iii) royalties based on specified percentages of net product sales, if any. The Company has also entered into a manufacturing and supply arrangement that includes reimbursements of costs plus a pre-determined margin. At the initiation of an agreement, the Company analyzes each unit of account within the contract to determine if the counterparty is a customer in the context of the unit of account. The Company considers a variety of factors in determining the appropriate estimates and assumptions under the arrangements, such as whether the elements are distinct performance obligations, whether there are observable standalone prices, whether the license is functional or symbolic, and whether the Company is acting as the agent or principal. The Company evaluates each performance obligation to determine if it can be satisfied and recognized as revenue at a point in time or over time. At the inception of arrangements that include variable consideration, the Company uses judgment to estimate the amount of variable consideration to include in the transaction price using the most likely method. If it is probable that a significant revenue reversal will not occur, then the estimated amount is included in the transaction price. Milestone payments that are not within the Company's or the licensee’s control, such as regulatory approvals, are not included in the transaction price until those approvals are received. At the end of each reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint and, as necessary, adjusts the estimate of the overall transaction price. Any adjustments will be recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. The Company develops estimates of the standalone selling price for each distinct performance obligation. Variable consideration that relates specifically to efforts to satisfy specific performance obligations is allocated entirely to those performance obligations. Other components of the transaction price are allocated based on the relative standalone selling price, over which management has applied significant judgment. The Company determines the standalone selling price for license-related performance obligations using a market approach, which may include assumptions such as forecasted revenues, development timelines, discount rates and probabilities of success. The Company estimates the standalone selling price for the data exchange performance obligation (see Note 8) by forecasting the expected costs of satisfying a performance obligation plus a predetermined margin. In the case of a license that is a distinct performance obligation, the Company recognizes revenue allocated to the license from non-refundable, up-front fees at the point in time when the license is transferred to the licensee and the licensee can use and benefit from the license. For licenses that are bundled with other distinct or combined obligations, the Company uses judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. If the performance obligation is satisfied over time, then the Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The selection of the method to measure progress towards completion requires judgment and is based on the nature of the products or services to be provided. The Company has used the cost-to-cost measure of progress because it best depicts the transfer of control to the customer which occurs as the Company incurs costs. Under the cost-to-cost measure of progress, the extent of progress towards completion is measured based on the ratio of costs incurred to date to the total estimated costs at completion of the performance obligation, which is considered an input method. The Company uses judgment to estimate the total cost of these over time performance obligations, which include subcontractors’ costs, labor, materials, other direct costs and an allocation of indirect costs. The Company evaluates these cost estimates and the progress each reporting period and, as necessary, the Company adjusts the measure of progress and related revenue recognition. Sales-based milestones and royalties are recognized at the later of when the subsequent sale or usage occurs or the performance obligation for which some or all of the sales-based milestones and royalties have been allocated to has been satisfied or partially satisfied. The Company’s grant revenues are derived from Small Business Innovation Research Grants (“SBIR Grants”) from the National Institutes of Health. The Company's performance obligation under SBIR Grants consists of research activities and the Company recognizes SBIR Grant revenue over time as reimbursable grant costs are incurred up to pre-approved award limits within the budget period. The costs associated with these reimbursements are reflected as a component of research and development expense in the accompanying consolidated statements of operations and comprehensive loss. Earnings in excess of billings are included as a component of prepaid expenses and other current assets in the accompanying consolidated balance sheets. |
Research and Development Expense | Research and Development Expenses Research and development (“R&D”) expenses consist primarily of salaries, payroll taxes, employee benefits and stock-based compensation for individuals involved in R&D efforts, as well as consulting expenses, third-party R&D expenses, laboratory supplies, clinical materials and overhead, including facilities and depreciation costs, offset by the Australian Tax Incentive discussed below. R&D expenses are charged to expense as incurred. Payments made prior to the receipt of goods or services to be used in R&D are capitalized until the goods or services are received and are recorded as prepaid expenses and other current assets. Costs incurred under contracts with contract research organizations that conduct and manage the Company’s clinical trials are also included in R&D expenses. The financial terms and activities of these agreements vary from contract to contract and may result in uneven expense levels. Generally, these agreements set forth activities that drive the recording of expenses such as start-up and initiation activities, enrollment and treatment of patients, or the completion of other clinical trial activities. Expenses related to clinical trials are accrued based on estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. If the amounts that the Company is obligated to pay under its clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), the Company adjusts its accruals accordingly on a prospective basis. Revisions to contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. |
Australian Tax Incentive | Australian Tax Incentive CAPL is eligible to obtain a cash refund from the Australian Taxation Office for eligible R&D expenditures under the Australian R&D Tax Incentive Program (the “Australian Tax Incentive”). The Australian Tax Incentive is recognized as a reduction to R&D expense when there is reasonable assurance that the relevant expenditure has been incurred, the amount can be reliably measured and that the Australian Tax Incentive will be received. The Company recognized reductions to R&D expense of $ 0.8 million , $ 0.3 million and $ 0.6 million for the years ended December 31, 2022, 2021 and 2020 , respectively. |
Patent Costs | Patent Costs All costs incurred for the filing of patent applications are recorded as general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss when incurred, as the recoverability of these expenses is uncertain. |
Stock-Based Compensation | Stock-Based Compensati on Stock-based compensation expense represents the estimated grant date fair value of the Company’s equity awards, consisting of stock options, restricted stock units and shares issued under the Company’s Employee Stock Purchase Plan, recognized over the requisite service period of such awards (usually the vesting period) on a straight-line basis. The Company estimates the fair value of all stock option grants using the Black-Scholes option pricing model and recognizes forfeitures as they occur. Restricted stock units are valued using the grant date stock price. For stock awards for which vesting is subject to performance-based milestones, the expense is recorded over the remaining service period after the point when the achievement of the milestone is probable, or the performance condition has been achieved. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined based on the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense, and any accrued interest and penalties would be included within the related tax liability. No such costs were recorded during the three years ended December 31, 2022 . |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is comprised of the Company’s net loss and the unrealized gains or losses on the Company’s available for sale investment securities for all periods presented. The cumulative amount of unrealized gains and losses is reflected as a separate component of stockholders' equity in the accompanying consolidated balance sheets as accumulated other comprehensive income (loss). There are no tax effects for the years ended December 31, 2022, 2021 and 2020 . |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury-stock. Dilutive common stock equivalents are comprised of common stock subject to repurchase, and options outstanding under the Company’s stock option plan. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities on loss per share would be antidilutive. Potentially dilutive securities (in common stock equivalent shares) not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows ( in thousands ): Year ended December 31, 2022 2021 2020 Stock options 9,757 6,554 4,422 Restricted stock units 290 — — Employee stock purchase plan 282 207 183 Unvested common stock subject to repurchase — 1 16 Total 10,329 6,762 4,621 |
Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements ASU 2021-04 In May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update ("ASU") 2021-04, Earnings Per Share ("Topic 260"), Debt-Modifications and Extinguishments ("Subtopic 470-50"), Compensation-Stock Compensation ("Topic 718"), and Derivatives and Hedging-Contracts in Entity’s Own Equity ("Subtopic 815-40"): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options ("ASU 2021-04"), which intends to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The Company adopted ASU 2021-04 as of January 1, 2022, which did not have an impact on its consolidated financial statements. Recent Accounting Pronouncements ASU 2016-13 In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ” (“Topic 326”). Topic 326 amends guidance on reporting credit losses for assets held at amortized cost basis and available for sale debt securities. For assets held at amortized cost basis, Topic 326 eliminates the probable initial recognition threshold in current GAAP and, instead, requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. For available for sale debt securities, credit losses should be measured in a manner similar to current GAAP, however Topic 326 will require that credit losses be presented as an allowance rather than as a write-down. This ASU update affects entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. This update is effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted ASU 2016-13 as of January 1, 2023, which did not have a material impact on the consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Potentially Dilutive Securities not Included in Calculation of Diluted Net Loss Per Share | Potentially dilutive securities (in common stock equivalent shares) not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows ( in thousands ): Year ended December 31, 2022 2021 2020 Stock options 9,757 6,554 4,422 Restricted stock units 290 — — Employee stock purchase plan 282 207 183 Unvested common stock subject to repurchase — 1 16 Total 10,329 6,762 4,621 |
Investment Securities (Tables)
Investment Securities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-For-Sale Investment Securities Held by the Company | A vailable-for-sale investment securities consisted of the following as of December 31, 2022 and 2021 ( in thousands ): As of December 31, 2022 Amortized Gross Gross Fair Available-for-sale investment securities: U.S. government and agency obligations $ 154,228 $ 12 $ ( 1,510 ) $ 152,730 Certificates of deposit 4,629 — ( 94 ) 4,535 Corporate debt securities 145,330 — ( 2,336 ) 142,994 Asset-backed securities 1,497 — ( 3 ) 1,494 Total $ 305,684 $ 12 $ ( 3,943 ) $ 301,753 As of December 31, 2021 Amortized Gross Gross Fair Available-for-sale investment securities: U.S. government and agency obligations $ 54,637 $ — $ ( 180 ) 54,457 Certificates of deposit 5,735 1 ( 4 ) 5,732 Corporate debt securities 70,600 6 ( 204 ) 70,402 Asset-backed securities 2,421 — — 2,421 Total $ 133,393 $ 7 $ ( 388 ) $ 133,012 |
Summary of Available-For-Sale Investment Securities By Contractual Maturity | As of December 31, 2022 and 2021, available-for-sale investment securities by contractual maturity were as follows ( in thousands ): As of December 31, 2022 As of December 31, 2021 Amortized Fair Amortized Fair Available-for-sale investment securities: Due in one year or less $ 246,276 $ 243,542 $ 31,101 $ 31,078 Due after one year through five years 59,408 58,211 102,292 101,934 Total $ 305,684 $ 301,753 $ 133,393 $ 133,012 |
Summary of Available-For-Sale Securities Investment | As of December 31, 2022, available-for-sale investment securities by length of time in a net loss position were as follows ( in thousands ): As of December 31, 2022 Less Than 12 Months More Than 12 Months Total Fair Gross Fair Gross Fair Gross Available-for-sale investment securities: U.S. government and agency obligations $ 95,933 $ ( 702 ) $ 36,681 $ ( 808 ) $ 132,614 $ ( 1,510 ) Certificates of deposit 2,399 ( 47 ) 2,136 ( 47 ) 4,535 ( 94 ) Corporate debt securities 96,663 ( 1,399 ) 43,330 ( 937 ) 139,993 ( 2,336 ) Asset-backed securities 1,494 ( 3 ) — — 1,494 ( 3 ) Total $ 196,489 $ ( 2,151 ) $ 82,147 $ ( 1,792 ) $ 278,636 $ ( 3,943 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets Measured at Fair Value on Recurring Basis | Financial assets measured at fair value on a recurring basis as of December 31, 2022 and 2021 were as follows (in thousands): As of December 31, 2022 Level 1 Level 2 Level 3 Total Investment securities: U.S. government and agency obligations $ 93,879 $ 58,851 $ — $ 152,730 Certificates of deposit — 4,535 — 4,535 Corporate debt securities — 142,994 — 142,994 Asset-backed securities — 1,494 — 1,494 Total Investment securities 93,879 207,874 — 301,753 Derivative Assets: Radionetics Warrant — — 668 668 Total assets measured at fair value $ 93,879 $ 207,874 $ 668 $ 302,421 As of December 31, 2021 Level 1 Level 2 Level 3 Total Investment securities: U.S. government and agency obligations $ 44,984 $ 9,473 $ — $ 54,457 Certificates of deposit — 5,732 — 5,732 Corporate debt securities — 70,402 — 70,402 Asset-backed securities — 2,421 — 2,421 Total Investment securities 44,984 88,028 — 133,012 Derivative Assets: Radionetics Warrant — — 68 68 Total assets measured at fair value $ 44,984 $ 88,028 $ 68 $ 133,080 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Components of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following ( in thousands ): December 31, December 31, Prepaid clinical costs $ 2,567 $ 6,313 Prepaid research and development costs 2,293 $ 871 Australian tax incentive receivable 937 977 Prepaid insurance 939 888 Interest receivable 1,353 499 Due from Radionetics (Note 8) 135 553 Other 2,535 912 Total $ 10,759 $ 11,013 |
Components of Property and Equipment, Net | Property and equipment, net consisted of the following ( in thousands ): December 31, December 31, Leasehold improvements $ 3,516 $ 3,516 Lab equipment 3,168 1,889 Office equipment 859 859 Computers and software 41 41 Property and equipment at cost 7,584 6,305 Less accumulated depreciation and amortization ( 4,084 ) ( 3,480 ) Total $ 3,500 $ 2,825 |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consisted of the following (in thousands): December 31, December 31, Accounts payable $ 6,883 $ 3,422 Accrued clinical costs 1,921 1,095 Accrued research and development costs 4,043 3,091 Accrued outside services and professional fees 1,810 537 Other accrued expenses 694 323 Total $ 15,351 $ 8,468 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revenues [Abstract] | |
Summary of primary inputs used in valuing the Radionetics common stock and the Radionetics Warrant | The primary inputs used in valuing the Radionetics common stock and the Radionetics Warrant, were as follows: Derivative Asset December 31, 2022 October 15, 2021 and December 31, 2021 Expected term 1.8 years 3.0 years Expected volatility 116.6 % 111.4 % Risk free interest rate 4.5 % 0.7 % Marketability discount 51.0 % 30.0 % |
Operating Lease (Tables)
Operating Lease (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Schedule of Future Minimum Payments Under Non-cancellable Operating Leases | As of December 31, 2022, future minimum payments under non-cancellable operating leases were as follows ( in thousands ): Year ending December 31, Minimum 2023 $ 1,244 2024 1,280 2025 871 Total future minimum lease payments 3,395 Less imputed interest ( 320 ) Total operating lease liabilities 3,075 Less operating lease liabilities, current ( 1,051 ) Operating lease liabilities, non-current $ 2,024 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Activity Under Stock Option Plans | Activity under the Company’s stock option plans during the yea r ended December 31, 2022 was as follows: Weighted- Weighted- Aggregate Average Average Intrinsic Options Exercise Remaining Value Outstanding Price Term (000’s) Balance at December 31, 2021 6,553,594 $ 16.07 Granted 4,139,204 $ 19.54 Exercised ( 524,774 ) $ 9.00 Forfeited and expired ( 410,695 ) $ 19.28 Balance at December 31, 2022 9,757,329 $ 17.79 8.0 $ 23,149 Vested and expected to vest at December 31, 2022 9,757,329 $ 17.79 8.0 $ 23,149 Exercisable at December 31, 2022 4,122,612 $ 15.90 6.6 $ 18,493 |
Weighted Average Assumptions Used to Estimate Fair Value of Stock Options Granted to Employees | The following table summarizes the weighted average assumptions used to estimate the fair value of stock options granted under the Company’s stock option plans and the shares purchasable under the ESPP d uring the periods presented: Year ended December 31, Stock Option Awards 2022 2021 2020 Expected term 6.1 years 6.0 years 6.0 years Expected volatility 88 % 86 % 78 % Risk free interest rate 2.8 % 1.0 % 0.8 % Expected dividend yield — % — % — % Year ended December 31, ESPP 2022 2021 2020 Expected term 1.3 years 1.6 years 1.4 years Expected volatility 87 % 91 % 84 % Risk free interest rate 4.1 % 0.3 % 0.2 % Expected dividend yield — % — % — % |
Summary of Stock-based Compensation Expense for the Equity Awards Issued to Employees and Non-Employees | Stock-based compensation expense for the equity awards issued by the Company to employees and non-employees for the periods presented below was as follow s ( in thousands ): Year ended December 31, 2022 2021 2020 Included in research and development $ 15,078 $ 9,654 $ 5,218 Included in general and administrative 13,190 7,698 5,209 Total stock-based compensation expense $ 28,268 $ 17,352 $ 10,427 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | Deferred tax assets and liabilities Net deferred tax assets are comprised of the following as of December 31, 2022 and 2021 ( in thousands ): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 69,044 $ 59,453 Capitalized research expenses 22,123 3,598 R&D and other tax credits 22,210 12,930 Stock-based compensation 8,168 5,899 Lease liability 648 1,125 Accrued expenses and other, net 4,208 3,309 Total deferred tax assets 126,401 86,314 Deferred tax liabilities: Right-of use asset ( 313 ) ( 531 ) Equity method investment ( 140 ) ( 302 ) Net of deferred tax assets and liabilities 125,948 85,481 Less: valuation allowance ( 125,948 ) ( 85,481 ) Net deferred tax assets $ — $ — |
Schedule of Domestic and Foreign Pre-Tax Loss | Income tax benefit For the three years in the period ended December 31, 2022, domestic and foreign pre-tax loss were ( in thousands ): Year ended December 31, 2022 2021 2020 Loss before income taxes - Domestic $ ( 163,175 ) $ ( 107,723 ) $ ( 71,769 ) Income (loss) before income taxes - Foreign ( 743 ) 82 ( 2,043 ) Loss before income taxes - Consolidated $ ( 163,918 ) $ ( 107,641 ) $ ( 73,812 ) |
Schedule of Reconciliation of Income Tax Expense | A reconciliation of income tax expense to the amount computed by applying the statutory federal income tax rate to the loss from operations for the three years in the period ended December 31, 2022 is as follows ( in thousands ): Year ended December 31, 2022 2021 2020 Expected income tax benefit at federal statutory rate $ ( 34,423 ) $ ( 22,605 ) $ ( 15,417 ) State income tax benefit, net of federal benefit ( 128 ) ( 7,083 ) ( 4,886 ) Tax effect of Change in valuation allowance 39,733 34,495 22,242 R&D credit ( 10,918 ) ( 7,117 ) ( 2,597 ) Stock-based compensation 781 1,196 539 Australian tax incentive 266 27 215 State rate change 3,243 ( 8 ) ( 5 ) Other 1,446 1,095 ( 91 ) Provision for income taxes $ — $ — $ — |
Schedule of Unrecognized Tax Benefits | Changes to the Company’s unrecognized tax benefits are summarized in the following table ( in thousands ): Year ended December 31, 2022 2021 2020 Beginning balance $ 1,553 $ 1,092 $ 886 Increase (decrease) for prior year tax positions 837 ( 34 ) ( 163 ) Increase (decrease) for current year tax positions 1,720 495 369 Ending balance $ 4,110 $ 1,553 $ 1,092 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
Aug. 12, 2022 USD ($) | Apr. 18, 2022 USD ($) | Aug. 13, 2019 USD ($) | Mar. 31, 2020 USD ($) shares | Dec. 31, 2022 USD ($) Segment shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) | |
Organization And Basis Of Presentation [Line Items] | |||||||
Number of operating segments | Segment | 1 | ||||||
Unrestricted cash, cash equivalents and investments securities | $ 334,400 | ||||||
Common stock and paid-in capital, shares issued | shares | 53,877,000 | 47,598,000 | |||||
Proceeds from issuance of common stock, net | $ 150,000 | $ 75,000 | $ 117,242 | $ 249,542 | $ 114,283 | ||
Accumulated deficit | $ 439,173 | $ 275,255 | |||||
ATM Offering | |||||||
Organization And Basis Of Presentation [Line Items] | |||||||
Common stock and paid-in capital, shares issued | shares | 275,764 | 275,764 | |||||
Proceeds from issuance of common stock, net | $ 6,400 | $ 6,400 | |||||
Commissions | 200 | ||||||
Common Stock | |||||||
Organization And Basis Of Presentation [Line Items] | |||||||
Proceeds from issuance of common stock, net | $ 117,200 | ||||||
Commissions | $ 7,800 | ||||||
Common Stock | Maximum | ATM Offering | |||||||
Organization And Basis Of Presentation [Line Items] | |||||||
Proceeds from sale of common stock | $ 150,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Oct. 15, 2021 | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Impairment losses of long-lived assets | $ 0 | $ 0 | $ 0 | |
Radionetics | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Aggregate equity interest | 22% | |||
Radionetics Warrant | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Additional common shares issued | 3,407,285 | |||
Australian Research and Development Tax Incentive | Australian Taxation Office | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Tax incentive receivable, reductions to research and development expense | $ 800,000 | $ 300,000 | $ 600,000 | |
Computer and Software | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Property and equipment, estimated useful life | 3 years | |||
Minimum [Member] | Lab Equipment | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Property and equipment, estimated useful life | 3 years | |||
Minimum [Member] | Office Equipment | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Property and equipment, estimated useful life | 3 years | |||
Maximum [Member] | Lab Equipment | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Property and equipment, estimated useful life | 5 years | |||
Maximum [Member] | Office Equipment | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Property and equipment, estimated useful life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities not Included in Calculation of Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 10,329,000 | 6,762,000 | 4,621,000 |
Employee Stock Purchase Plan | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 282,000 | 207,000 | 183,000 |
Restricted Stock Units | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 290,000 | 0 | 0 |
Stock Options | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 9,757,000 | 6,554,000 | 4,422,000 |
Unvested Common Stock Subject To Repurchase | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 0 | 1,000 | 16,000 |
Investment Securities - Summary
Investment Securities - Summary of Available-For-Sale Investment Securities Held by the Company (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale investment securities, Amortized Cost | $ 305,684 | $ 133,393 |
Available-for-sale investment securities, Gross Unrealized Gains | 12 | 7 |
Available-for-sale investment securities, Gross Unrealized Losses | (3,943) | (388) |
Available-for-sale investment securities, Fair Market Value | 301,753 | 133,012 |
U.S. Government and Agency Obligations | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale investment securities, Amortized Cost | 154,228 | 54,637 |
Available-for-sale investment securities, Gross Unrealized Gains | 12 | |
Available-for-sale investment securities, Gross Unrealized Losses | (1,510) | (180) |
Available-for-sale investment securities, Fair Market Value | 152,730 | 54,457 |
Certificates of Deposit | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale investment securities, Amortized Cost | 4,629 | 5,735 |
Available-for-sale investment securities, Gross Unrealized Gains | 1 | |
Available-for-sale investment securities, Gross Unrealized Losses | (94) | (4) |
Available-for-sale investment securities, Fair Market Value | 4,535 | 5,732 |
Corporate Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale investment securities, Amortized Cost | 145,330 | 70,600 |
Available-for-sale investment securities, Gross Unrealized Gains | 6 | |
Available-for-sale investment securities, Gross Unrealized Losses | (2,336) | (204) |
Available-for-sale investment securities, Fair Market Value | 142,994 | 70,402 |
Asset-Backed Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale investment securities, Amortized Cost | 1,497 | 2,421 |
Available-for-sale investment securities, Gross Unrealized Gains | ||
Available-for-sale investment securities, Gross Unrealized Losses | (3) | |
Available-for-sale investment securities, Fair Market Value | $ 1,494 | $ 2,421 |
Investment Securities - Summa_2
Investment Securities - Summary of Available-For-Sale Investment Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-Sale, Maturity, Allocated and Single Maturity Date, Fair Value [Abstract] | ||
Available-for-sale investment securities, Fair market Value, Due in one year or less | $ 243,542 | $ 31,078 |
Available-for-sale investment securities, Fair market Value, Due after one year through five years | 58,211 | 101,934 |
Debt Securities, Available-for-sale, Maturity, Allocated and Single Maturity Date, Fair Value, Total | 301,753 | 133,012 |
Available-for-sale investment securities, Amortized Cost, Due in one year or less | 246,276 | 31,101 |
Available-for-sale investment securities, Amortized Cost, Due after one year through five years | 59,408 | 102,292 |
Debt Securities, Available-for-sale, Maturity, Allocated and Single Maturity Date, Amortized Cost, Total | $ 305,684 | $ 133,393 |
Investment Securities - Additio
Investment Securities - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |||
Realized gains on securities | $ (86,000) | $ 2,000 | $ 26,000 |
Investment Securities - Summa_3
Investment Securities - Summary of Available-For-Sale Securities Investment (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Securities, Available-for-Sale [Line Items] | |
Available-for-sale investment securities, Less than 12 Months, Fair Market Value | $ 196,489 |
Available-for-sale investment securities, Gross Unrealized Loss, Less than 12 Months | (2,151) |
Available-for-sale investment securities, More Than 12 Months, Fair Value | 82,147 |
Available-for-sale investment securities, Gross Unrealized Loss, More Than 12 Months | (1,792) |
Available-for-sale investment securities, Fair Market Value | 278,636 |
Available-for-sale investment securities, Gross Unrealized Losses | (3,943) |
US Government Agencies Debt Securities [Member] | |
Debt Securities, Available-for-Sale [Line Items] | |
Available-for-sale investment securities, Less than 12 Months, Fair Market Value | 95,933 |
Available-for-sale investment securities, Gross Unrealized Loss, Less than 12 Months | (702) |
Available-for-sale investment securities, More Than 12 Months, Fair Value | 36,681 |
Available-for-sale investment securities, Gross Unrealized Loss, More Than 12 Months | (808) |
Available-for-sale investment securities, Fair Market Value | 132,614 |
Available-for-sale investment securities, Gross Unrealized Losses | (1,510) |
Certificates of Deposit [Member] | |
Debt Securities, Available-for-Sale [Line Items] | |
Available-for-sale investment securities, Less than 12 Months, Fair Market Value | 2,399 |
Available-for-sale investment securities, Gross Unrealized Loss, Less than 12 Months | (47) |
Available-for-sale investment securities, More Than 12 Months, Fair Value | 2,136 |
Available-for-sale investment securities, Gross Unrealized Loss, More Than 12 Months | (47) |
Available-for-sale investment securities, Fair Market Value | 4,535 |
Available-for-sale investment securities, Gross Unrealized Losses | (94) |
Corporate Debt Securities [Member] | |
Debt Securities, Available-for-Sale [Line Items] | |
Available-for-sale investment securities, Less than 12 Months, Fair Market Value | 96,663 |
Available-for-sale investment securities, Gross Unrealized Loss, Less than 12 Months | (1,399) |
Available-for-sale investment securities, More Than 12 Months, Fair Value | 43,330 |
Available-for-sale investment securities, Gross Unrealized Loss, More Than 12 Months | (937) |
Available-for-sale investment securities, Fair Market Value | 139,993 |
Available-for-sale investment securities, Gross Unrealized Losses | (2,336) |
Asset-Backed Securities [Member] | |
Debt Securities, Available-for-Sale [Line Items] | |
Available-for-sale investment securities, Less than 12 Months, Fair Market Value | 1,494 |
Available-for-sale investment securities, Gross Unrealized Loss, Less than 12 Months | (3) |
Available-for-sale investment securities, More Than 12 Months, Fair Value | |
Available-for-sale investment securities, Gross Unrealized Loss, More Than 12 Months | |
Available-for-sale investment securities, Fair Market Value | 1,494 |
Available-for-sale investment securities, Gross Unrealized Losses | $ (3) |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets Measured at Fair Value on Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | $ 302,421 | $ 133,080 |
Total Investment securities | 301,753 | 133,012 |
Level 1 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 93,879 | 44,984 |
Total Investment securities | 93,879 | 44,984 |
Level 2 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 207,874 | 88,028 |
Total Investment securities | 207,874 | 88,028 |
Level 3 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 668 | |
Total Investment securities | 0 | 0 |
U.S. Government and Agency Obligations | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 54,457 | |
Total Investment securities | 152,730 | |
U.S. Government and Agency Obligations | Level 1 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 44,984 | |
Total Investment securities | 93,879 | |
U.S. Government and Agency Obligations | Level 2 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 9,473 | |
Total Investment securities | 58,851 | |
U.S. Government and Agency Obligations | Level 3 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 0 | |
Total Investment securities | 0 | |
Certificates of Deposit | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 5,732 | |
Total Investment securities | 4,535 | |
Certificates of Deposit | Level 1 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 0 | |
Total Investment securities | 0 | |
Certificates of Deposit | Level 2 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 5,732 | |
Total Investment securities | 4,535 | |
Certificates of Deposit | Level 3 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 0 | |
Total Investment securities | 0 | |
Corporate Debt Securities | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 70,402 | |
Total Investment securities | 142,994 | |
Corporate Debt Securities | Level 1 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 0 | |
Total Investment securities | 0 | |
Corporate Debt Securities | Level 2 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 70,402 | |
Total Investment securities | 142,994 | |
Corporate Debt Securities | Level 3 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 0 | |
Total Investment securities | 0 | |
Asset-Backed Securities | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total Investment securities | 1,494 | 2,421 |
Asset-Backed Securities | Level 1 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total Investment securities | 0 | 0 |
Asset-Backed Securities | Level 2 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total Investment securities | 1,494 | 2,421 |
Asset-Backed Securities | Level 3 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total Investment securities | 0 | |
Radionetics Warrant | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 668 | 68 |
Radionetics Warrant | Level 1 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 0 | 0 |
Radionetics Warrant | Level 2 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | 0 | 0 |
Radionetics Warrant | Level 3 | ||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Total assets measured at fair value | $ 668 | $ 68 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Oct. 15, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Fair value assets transferred into level 3 | $ 0 | ||
Fair value assets transferred into level 3 | $ 0 | ||
Change in valuation of derivative asset | $ 600,000 | ||
Radionetics Warrant | |||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Equity interest percentage | 22% | ||
Additional common shares issued | 3,407,285 |
Balance Sheet Details - Compone
Balance Sheet Details - Components of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid clinical costs | $ 2,567 | $ 6,313 |
Prepaid research and development costs | 2,293 | 871 |
Australian tax incentive receivable | 937 | 977 |
Prepaid insurance | 939 | 888 |
Interest receivable | 1,353 | 499 |
Due from Radionetics (Note 8) | 135 | 553 |
Other | 2,535 | 912 |
Total | $ 10,759 | $ 11,013 |
Balance Sheet Details - Compo_2
Balance Sheet Details - Components of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property and equipment at cost | $ 7,584 | $ 6,305 |
Less accumulated depreciation and amortization | (4,084) | (3,480) |
Total | 3,500 | 2,825 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment at cost | 3,516 | 3,516 |
Lab Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment at cost | 3,168 | 1,889 |
Office Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment at cost | 859 | 859 |
Computers and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment at cost | $ 41 | $ 41 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accounts Payable and Accrued Liabilities, Current [Abstract] | ||
Accounts payable | $ 6,883 | $ 3,422 |
Accrued clinical costs | 1,921 | 1,095 |
Accrued research and development costs | 4,043 | 3,091 |
Accrued outside services and professional fees | 1,810 | 537 |
Other accrued expenses | 694 | 323 |
Total | $ 15,351 | $ 8,468 |
Balance Sheet Details - Additio
Balance Sheet Details - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 1 | $ 0.9 | $ 0.9 |
Operating Lease - Additional In
Operating Lease - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Leased Assets [Line Items] | |||
Rent expense | $ 1,000 | $ 1,000 | $ 1,000 |
Operating lease weighted average remaining term | 2 years 7 months 6 days | 3 years 7 months 6 days | |
Operating lease right-of-use asset | $ 1,486 | $ 1,892 | |
Operating lease liabilities | $ 2,024 | 3,074 | |
2018 Operating Lease | |||
Operating Leased Assets [Line Items] | |||
Operating lease, initial term | 7 years | ||
Operating lease expiration period | 2025-08 | ||
Operating lease, option to extend term | five years | ||
Lessee,operating lease, discount rate | 8% | ||
Irrevocable letter of credit | $ 500 | ||
2022 Operating Lease [Member] | |||
Operating Leased Assets [Line Items] | |||
Operating lease, option to extend term | The Company has (i) two options to extend the term of the 2022 Lease for an additional period of five (5) years each, and (ii) a right of first offer on adjacent space to the new facility, subject to the terms and conditions of the 2022 Lease. | ||
Irrevocable letter of credit | $ 800 | ||
Cash paid for operating lease liabilities | $ 1,200 | $ 1,200 | $ 1,100 |
Weighted-average discount rate | 8% | 8% | |
Operating Lease Description | Under the terms of the 2022 Lease, the Company's expected future monthly minimum lease payments of $0.5 million, with six months of rent abatement in the first year, start on the earlier of (i) the date which is ten (10) months after substantial completion of demolition work, or (ii) the date of the substantial completion of improvements and first occupancy for business purposes, and the term expires on the date immediately preceding the one hundred thirty-seventh (137th) monthly anniversary of this lease payment start date. Lease payments are subject to annual 3% increase |
Operating Lease - Schedule of F
Operating Lease - Schedule of Future Minimum Payments Under Non-cancellable Operating Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2023 | $ 1,244 | |
2024 | 1,280 | |
2025 | 871 | |
Total future minimum lease payments | 3,395 | |
Less imputed interest | (320) | |
Total operating lease liability | $ 3,075 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Liabilities, Current | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Operating lease liability, non-current | |
Less operating lease liability, current | $ (1,051) | |
Operating lease liability, non-current | 2,024 | $ 3,074 |
Total operating lease liabilities | $ 3,075 |
Convertible Preferred Stock - A
Convertible Preferred Stock - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Temporary Equity [Line Items] | |||
Convertible preferred stock, issuance costs | $ 7.8 | $ 12.9 | $ 7.5 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||||||||
Apr. 18, 2022 $ / shares shares | Feb. 25, 2022 USD ($) | Oct. 21, 2021 $ / shares shares | Apr. 12, 2021 $ / shares shares | Apr. 17, 2020 $ / shares shares | Oct. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2020 shares | Oct. 15, 2021 $ / shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Common Stock, Shares, Outstanding | shares | 53,877,000 | 47,597,000 | ||||||||
Due from Radionetics | $ 135,000 | $ 553,000 | ||||||||
Deferred revenue, current | 2,200,000 | |||||||||
Deferred revenue, non-current | 6,101,000 | $ 0 | ||||||||
Transferred at Point in Time [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Upfront payment as license revenue | 1,500,000 | |||||||||
Transferred over Time [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Upfront payment as license revenue | 3,200,000 | |||||||||
Radionetics [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Aggregate equity interest | 22% | |||||||||
Investment in Company | $ 1,000,000 | |||||||||
Common Stock [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Issuance of common stock, net of transaction costs, shares | shares | 5,625,563 | 5,626,000 | 14,126,000 | 8,499,000 | ||||||
Common stock price per share | $ / shares | $ 22.22 | |||||||||
Common Stock [Member] | IPO [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Issuance of common stock, net of transaction costs, shares | shares | 8,712,400 | 4,562,044 | 8,222,500 | |||||||
Common stock price per share | $ / shares | $ 19.80 | $ 16.44 | $ 14 | |||||||
Five A M Ventures And Frazier Healthcare Partners [Member] | Radionetics [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Upfront noncash considerations | $ 1,100,000 | |||||||||
Common stock value | $ 1,000,000 | |||||||||
Warrant Price | shares | 100,000 | |||||||||
Noncash Upfront Fee as License Revenues | $ 1,100,000 | |||||||||
Sales and royalties milestones | $ 1,000,000,000 | |||||||||
Sales to Date | $ 0 | |||||||||
Convertible notes financing | $ 30,000,000 | |||||||||
Exercise price of warrant | $ / shares | $ 0.00001 | |||||||||
Warrant exercisable term | 10 years | |||||||||
Five A M Ventures And Frazier Healthcare Partners [Member] | Common Stock [Member] | IPO [Member] | Radionetics [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Issuance of common stock, net of transaction costs, shares | shares | 50,500,000,000 | |||||||||
Aggregate equity interest | 64% | 56% | ||||||||
Common Stock Purchase | shares | 3,407,285,000 | |||||||||
Percentage of aggregate diluted capitalization | 22 | |||||||||
Dr. Struthers [Member] | Radionetics [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Vest ratably months | 36 months | |||||||||
Retainage Deposit | $ 50,000 | |||||||||
Dr. Struthers [Member] | Restricted Common Stock | Radionetics [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Common Stock, Shares, Outstanding | shares | 1,000,000,000 | |||||||||
Sanwa Kagaku Kenkyusho Co Ltd | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Revenues recognized | $ 100 | |||||||||
Sanwa Kagaku Kenkyusho Co Ltd | Radionetics [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Sales and royalties milestones | $ 13,000,000 | |||||||||
Non refundable, upfront payment | 13,000,000 | |||||||||
Additional milestone payments | $ 25,500,000 | |||||||||
Radionetics Oncology Inc [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Reimbursments Earned | 400,000 | 600,000 | ||||||||
Due from Radionetics | $ 100,000 | $ 600,000 | ||||||||
Radionetics Oncology Inc [Member] | Radionetics Warrant | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Common stock price per share | $ / shares | $ 0.20 | $ 0.02 | $ 0.02 |
Revenue Recognition - Radioneti
Revenue Recognition - Radionetics Common Stock and Warrant (Details) - Radionetics Oncology, Inc. | 12 Months Ended | ||
Oct. 15, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Radionetics Warrant | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Expected term | 1 year 9 months 18 days | 3 years | |
Expected volatility | 116.60% | 111.40% | |
Risk free interest rate | 4.50% | 0.70% | |
Marketability discount | 51% | 30% | |
Common Stock | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Expected term | 3 years | 1 year 9 months 18 days | |
Expected volatility | 111.40% | 116.60% | |
Risk free interest rate | 0.70% | 4.50% | |
Marketability discount | 30% | 51% |
Stockholder's Equity - Addition
Stockholder's Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Aug. 12, 2022 | Apr. 18, 2022 | Oct. 21, 2021 | Jul. 28, 2021 | Apr. 12, 2021 | Apr. 17, 2020 | Aug. 13, 2019 | Mar. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Aug. 10, 2021 | |
Subsidiary Sale Of Stock [Line Items] | ||||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | ||||||||||
Common stock and paid-in capital, par value | $ 0.001 | $ 0.001 | ||||||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||||||||
Proceeds from issuance of common stock, net | $ 150,000 | $ 75,000 | $ 117,242 | $ 249,542 | $ 114,283 | |||||||
Maximum amount of common stock preferred stock debt securities warrants and units to be issued | $ 300,000 | |||||||||||
Registration statement effective date | Aug. 29, 2019 | |||||||||||
Common stock and paid-in capital, shares issued | 53,877,000 | 47,598,000 | ||||||||||
Maximum shares of common stock preferred stock debt securities warrants and units to be issued | 851,306 | |||||||||||
Stock-based compensation expenses | $ 28,268 | $ 17,352 | $ 10,427 | |||||||||
Common Stock | ||||||||||||
Subsidiary Sale Of Stock [Line Items] | ||||||||||||
Sale of common stock | 5,625,563 | 5,626,000 | 14,126,000 | 8,499,000 | ||||||||
Common stock price per share | $ 22.22 | |||||||||||
Offering discounts commissions and offering costs net | $ 7,800 | |||||||||||
Issuance of common stock, net of transaction costs, shares | 5,625,563 | 5,626,000 | 14,126,000 | 8,499,000 | ||||||||
Common stock price per share | $ 22.22 | |||||||||||
Proceeds from issuance of common stock, net | $ 117,200 | |||||||||||
Initial Public Offering | ||||||||||||
Subsidiary Sale Of Stock [Line Items] | ||||||||||||
Offering discounts commissions and offering costs net | $ 2,400 | $ 7,300 | ||||||||||
Proceeds from issuance of common stock, net | $ 72,600 | $ 107,900 | ||||||||||
Initial Public Offering | Common Stock | ||||||||||||
Subsidiary Sale Of Stock [Line Items] | ||||||||||||
Sale of common stock | 8,712,400 | 4,562,044 | 8,222,500 | |||||||||
Common stock price per share | $ 19.80 | $ 16.44 | $ 14 | |||||||||
Offering discounts commissions and offering costs net | $ 10,500 | |||||||||||
Issuance of common stock, net of transaction costs, shares | 8,712,400 | 4,562,044 | 8,222,500 | |||||||||
Common stock price per share | $ 19.80 | $ 16.44 | $ 14 | |||||||||
Proceeds from issuance of common stock, net | $ 162,000 | |||||||||||
ATM Offering | ||||||||||||
Subsidiary Sale Of Stock [Line Items] | ||||||||||||
Offering discounts commissions and offering costs net | $ 200 | |||||||||||
Proceeds from issuance of common stock, net | $ 6,400 | $ 6,400 | ||||||||||
Common stock and paid-in capital, shares issued | 275,764 | 275,764 | ||||||||||
Private Placement [Member] | Common Stock | ||||||||||||
Subsidiary Sale Of Stock [Line Items] | ||||||||||||
Sale of common stock | 851,306 | |||||||||||
Common stock price per share | $ 17.62 | |||||||||||
Issuance of common stock, net of transaction costs, shares | 851,306 | |||||||||||
Common stock price per share | $ 17.62 | |||||||||||
Proceeds from issuance of common stock, net | $ 15,000 |
Equity Incentive Plans - Additi
Equity Incentive Plans - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jan. 01, 2023 | Feb. 28, 2015 | Jul. 31, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Total intrinsic value of options exercised | $ 5,900 | $ 5,100 | $ 2,500 | |||
Fair value of options vested | $ 23,000 | $ 16,300 | $ 9,900 | |||
Dividend yield | 0% | |||||
ESPP | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Annual increase in the number of shares available for issuance | 1% | |||||
Maximum percentage of eligible compensation to purchase common stock through payroll deductions | 20% | |||||
Dividend yield | 0% | 0% | 0% | |||
Weighted-average fair value of stock options granted to employees per share | $ 9.39 | $ 12.52 | $ 8.07 | |||
Unrecognized Stock-Based Compensation Cost 3 | $ 2,800 | |||||
2018 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Plan expiration period | 2028-07 | |||||
Plan expiration term | 10 years | |||||
Vesting period | 4 years | |||||
Annual increase in the number of shares available for issuance | 5% | |||||
Remaining shares available for issuance | 2,167,691,000 | |||||
2015 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Plan expiration term | 10 years | |||||
Vesting period | 4 years | |||||
Unvested stock liability | $ 2,000 | |||||
2021 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Remaining shares available for issuance | 2,315,100 | 0 | ||||
Additional shares available for future issuance | 1,500,000 | |||||
Restricted Stock Units | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Unrecognized Stock-Based Compensation Cost 3 | $ 4,500 | |||||
Restricted Stock Units | ESPP | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Unrecognized stock-based compensation cost | $ 72,500 | |||||
Weighted-average period of unrecognized stock-based compensation cost expected to be recognized over remaining period | 2 years 1 month 6 days | |||||
Weighted-average period of unrecognized stock-based compensation cost expected to be recognized over remaining period 3 | 1 year 9 months 18 days | |||||
Amended | 2021 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Remaining shares available for issuance | 5,000,000 | |||||
Common Stock | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Weighted-average fair value of stock options granted to employees per share | $ 14.50 | $ 13.02 | $ 12.83 | |||
Common Stock | ESPP | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Plan expiration date | Jan. 01, 2028 | |||||
Additional shares available for future issuance | 2,693,859,000 | |||||
Shares reserved for issuance, authorized | 1,200,455 | |||||
Additional shares available for future issuance | 538,771 | |||||
Common Stock | Restricted Stock Units | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Weighted-Average Period of Unrecognized Stock-Based Compensation Cost Expected to be Recognized Over Remaining Period 2 | 3 years 1 month 6 days |
Equity Incentive Plans - Summar
Equity Incentive Plans - Summary of Activity Under Stock Option Plans (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options Outstanding, Beginning balance | shares | 6,553,594 |
Options Outstanding, Granted | shares | 4,139,204 |
Options Outstanding, Exercised | shares | (524,774) |
Options Outstanding, Forfeited and expired | shares | (410,695) |
Options Outstanding, Ending balance | shares | 9,757,329 |
Options Outstanding,Vested and expected to vest | shares | 9,757,329 |
Options Exercisable, Ending balance | shares | 4,122,612 |
Weighted-Average Exercise Price, Beginning balance | $ / shares | $ 16.07 |
Weighted-Average Exercise Price, Granted | $ / shares | 19.54 |
Weighted Average Exercise Price, Exercised | $ / shares | 9 |
Weighted Average Exercise Price, Forfeited and expired | $ / shares | 19.28 |
Weighted-Average Exercise Price, Ending balance | $ / shares | 17.79 |
Weighted-Average Exercise Price, Vested and expected to vest | $ / shares | 17.79 |
Weighted-Average Exercise Price, Exercisable | $ / shares | $ 15.90 |
Weighted-Average Remaining Term, Ending balance | 8 years |
Weighted-Average Remaining Term, Vested and expected to vest | 8 years |
Weighted-Average Remaining Term, Exercisable | 6 years 7 months 6 days |
Aggregate Intrinsic Value, Ending balance | $ | $ 23,149 |
Aggregate Intrinsic Value, Vested and expected to vest | $ | 23,149 |
Aggregate Intrinsic Value, Exercisable | $ | $ 18,493 |
Restricted Stock Units | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options Outstanding, Beginning balance | shares | 0 |
Options Outstanding, Granted | shares | 319,419 |
Options Outstanding, Forfeited and expired | shares | (29,108) |
Options Outstanding, Ending balance | shares | 290,311 |
Weighted-Average Exercise Price, Beginning balance | $ / shares | $ 0 |
Weighted-Average Exercise Price, Granted | $ / shares | 19.90 |
Weighted Average Exercise Price, Forfeited and expired | $ / shares | 20.02 |
Weighted-Average Exercise Price, Ending balance | $ / shares | $ 19.88 |
Equity Incentive Plans - Weight
Equity Incentive Plans - Weighted Average Assumptions Used to Estimate Fair Value of Stock Options Granted to Employees (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected dividend yield | 0% | ||
ESPP | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected option term | 1 year 3 months 18 days | 1 year 7 months 6 days | 1 year 4 months 24 days |
Expected volatility | 87% | 91% | 84% |
Risk free interest rate | 4.10% | 0.30% | 0.20% |
Expected dividend yield | 0% | 0% | 0% |
Stock Options | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected option term | 6 years 1 month 6 days | 6 years | 6 years |
Expected volatility | 88% | 86% | 78% |
Risk free interest rate | 2.80% | 1% | 0.80% |
Expected dividend yield | 0% | 0% | 0% |
Equity Incentive Plans - Stock-
Equity Incentive Plans - Stock-based Compensation Expense Recognized (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 28,268 | $ 17,352 | $ 10,427 |
Included in Research and Development | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 15,078 | 9,654 | 5,218 |
Included in General and Administrative | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 13,190 | $ 7,698 | $ 5,209 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards [Line Items] | |||
Federal operating loss carryforwards | $ 254,500 | ||
State operating loss carryforwards | 218,000 | ||
Foreign operating loss carryforwards | 1,300 | ||
Federal loss carryforwards | 248,100 | ||
Research and development credit carryforwards | $ 22,210 | $ 12,930 | |
Operating loss and research and development credit carryforwards, limitations on use | These ownership changes may limit the amount of NOL and credit carryforwards that can be utilized to offset future taxable income and income tax, respectively. In general, an “ownership change” as defined by the tax code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percent of the outstanding stock of a company by certain stockholders or public groups. During 2020, the Company completed a study to assess whether an ownership change within the meaning of Section 382 had occurred for the time period prior to July 15, 2020. | ||
Cumulative change in ownership percentage | 50% | ||
Decreases in unrecognized tax benefits | $ 0 | 0 | $ 0 |
Accrual for interest or penalties | 0 | 0 | |
Recognized interest and penalties | $ 0 | 0 | |
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards, future taxable income, offset percentage | 80% | ||
Research and development credit carryforwards | $ 8,800 | $ 6,100 | $ 12,500 |
Research and development credit carryforwards, begin to expire | 2030 | ||
State | |||
Operating Loss Carryforwards [Line Items] | |||
State operating loss carryforwards | $ 500 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 69,044 | $ 59,453 |
Capitalized research expenses | 22,123 | 3,598 |
R&D and other tax credits | 22,210 | 12,930 |
Stock-based compensation | 8,168 | 5,899 |
Lease liability | 648 | 1,125 |
Accrued expenses and other, net | 4,208 | 3,309 |
Total deferred tax assets | 126,401 | 86,314 |
Deferred tax liabilities: | ||
Right-of use asset | (313) | (531) |
Equity method investment | (140) | (302) |
Net of deferred tax assets and liabilities | 125,948 | 85,481 |
Less: valuation allowance | (125,948) | (85,481) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Schedule of Dome
Income Taxes - Schedule of Domestic and Foreign Pre-Tax Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Loss before income taxes - Domestic | $ (163,175) | $ (107,723) | $ (71,769) |
Loss before income taxes - Foreign | (743) | 82 | (2,043) |
Loss before income taxes - Consolidated | $ (163,918) | $ (107,641) | $ (73,812) |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Expected income tax benefit at federal statutory rate | $ (34,423) | $ (22,605) | $ (15,417) |
State income tax benefit, net of federal benefit | (128) | (7,083) | (4,886) |
Change in valuation allowance | 39,733 | 34,495 | 22,242 |
R&D credit | (10,918) | (7,117) | (2,597) |
Stock-based compensation | 781 | 1,196 | 539 |
Australian tax incentive | 266 | 27 | 215 |
State rate change | 3,243 | (8) | (5) |
Other | (1,446) | 1,095 | (91) |
Provision for income taxes | $ 0 | $ 0 | $ 0 |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Beginning balance | $ 1,553 | $ 1,092 | $ 886 |
Increase (decrease) for prior year tax positions | (837) | (34) | (163) |
Increase (decrease) for current year tax positions | 1,720 | 495 | 369 |
Ending balance | $ 4,110 | $ 1,553 | $ 1,092 |
Employee Savings Plan - Additio
Employee Savings Plan - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | ||
Description of contributions to the plan | discretionary matching contributions to the 401(k) Plan are permitted in an amount equal to 50% of the first 6% of the employee’s taxable income up to a maximum of $3,000 per year | |
Employee's contributions to the plan | $ 3,000 | |
Accrued matching contributions | $ 500,000 | $ 300,000 |
Defined contribution benefit plan, effective date | May 01, 2016 |