Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 02, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | TPTX | |
Entity Registrant Name | Turning Point Therapeutics, Inc. | |
Entity Central Index Key | 0001595893 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 49,479,508 | |
Entity File Number | 001-38871 | |
Entity Tax Identification Number | 46-3826166 | |
Entity Address, Address Line One | 10628 Science Center Drive | |
Entity Address, Address Line Two | Ste. 200 | |
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 | 926-5251 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 404,203 | $ 554,101 |
Marketable securities | 631,811 | 568,407 |
Prepaid and other current assets | 11,127 | 8,171 |
Total current assets | 1,047,141 | 1,130,679 |
Property and equipment, net | 3,858 | 2,604 |
Right-of-use lease assets | 5,965 | 3,357 |
Other assets | 2,021 | 73 |
Total assets | 1,058,985 | 1,136,713 |
Current liabilities: | ||
Accounts payable | 3,188 | 5,225 |
Accrued expenses and other current liabilities | 23,045 | 9,183 |
Accrued compensation | 9,025 | 8,588 |
Current portion of operating lease liabilities | 3,495 | 1,396 |
Total current liabilities | 38,753 | 24,392 |
Operating lease liabilities, long-term | 2,895 | 2,423 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2021 and December 31, 2020, zero shares outstanding at September 30, 2021 and December 31, 2020 | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2021 and December 31, 2020; 49,464,156 and 48,678,540 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 5 | 5 |
Additional paid-in capital | 1,455,626 | 1,389,860 |
Accumulated other comprehensive (loss)/income | (16) | 209 |
Accumulated deficit | (438,278) | (280,176) |
Total stockholders' equity | 1,017,337 | 1,109,898 |
Total liabilities and stockholders’ equity | $ 1,058,985 | $ 1,136,713 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 49,464,156 | 48,678,540 |
Common stock, shares outstanding | 49,464,156 | 48,678,540 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Statement [Abstract] | ||||
Revenue | $ 460 | $ 25,000 | $ 30,829 | $ 25,000 |
Operating expenses: | ||||
Research and development | 48,889 | 32,213 | 134,802 | 79,136 |
General and administrative | 18,224 | 11,326 | 55,386 | 59,761 |
Total operating expenses | 67,113 | 43,539 | 190,188 | 138,897 |
Loss from operations | (66,653) | (18,539) | (159,359) | (113,897) |
Other income, net | 328 | 834 | 1,257 | 3,981 |
Net loss | (66,325) | (17,705) | (158,102) | (109,916) |
Unrealized (loss)/gain on marketable securities, net of tax | (18) | (606) | (225) | 141 |
Comprehensive loss | $ (66,343) | $ (18,311) | $ (158,327) | $ (109,775) |
Net loss per share, basic and diluted | $ (1.34) | $ (0.42) | $ (3.21) | $ (2.82) |
Weighted-average common shares outstanding, basic and diluted | 49,426,496 | 42,185,824 | 49,185,693 | 38,914,789 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance at Dec. 31, 2019 | $ 404,351 | $ 4 | $ 526,960 | $ 271 | $ (122,884) |
Balance, Shares at Dec. 31, 2019 | 35,915,119 | ||||
Option exercises | 25 | 25 | |||
Option exercises, Shares | 7,129 | ||||
Stock-based compensation expense | 38,365 | 38,365 | |||
Net loss | (60,718) | (60,718) | |||
Other comprehensive (loss) income | (316) | (316) | |||
Balance at Mar. 31, 2020 | 381,707 | $ 4 | 565,350 | (45) | (183,602) |
Balance, Shares at Mar. 31, 2020 | 35,922,248 | ||||
Balance at Dec. 31, 2019 | 404,351 | $ 4 | 526,960 | 271 | (122,884) |
Balance, Shares at Dec. 31, 2019 | 35,915,119 | ||||
Net loss | (109,916) | ||||
Balance at Sep. 30, 2020 | 701,588 | $ 5 | 933,971 | 412 | (232,800) |
Balance, Shares at Sep. 30, 2020 | 42,213,364 | ||||
Balance at Mar. 31, 2020 | 381,707 | $ 4 | 565,350 | (45) | (183,602) |
Balance, Shares at Mar. 31, 2020 | 35,922,248 | ||||
Option exercises | 31 | 31 | |||
Option exercises, Shares | 3,049 | ||||
Shares issued under employee stock purchase plan | 504 | 504 | |||
Shares issued under employee stock purchase plan, Shares | 14,425 | ||||
Issuance of common stock in connection with a public offering, net of underwriting discounts, commissions, and offering costs | 351,611 | $ 1 | 351,610 | ||
Issuance of common stock in connection with a public offering, net of underwriting discounts, commissions, and offering costs, Shares | 6,229,167 | ||||
Stock-based compensation expense | 7,404 | 7,404 | |||
Net loss | (31,493) | (31,493) | |||
Other comprehensive (loss) income | 1,063 | 1,063 | |||
Balance at Jun. 30, 2020 | 710,827 | $ 5 | 924,899 | 1,018 | (215,095) |
Balance, Shares at Jun. 30, 2020 | 42,168,889 | ||||
Option exercises | 508 | 508 | |||
Option exercises, Shares | 44,475 | ||||
Stock-based compensation expense | 8,564 | 8,564 | |||
Net loss | (17,705) | (17,705) | |||
Other comprehensive (loss) income | (606) | (606) | |||
Balance at Sep. 30, 2020 | 701,588 | $ 5 | 933,971 | 412 | (232,800) |
Balance, Shares at Sep. 30, 2020 | 42,213,364 | ||||
Balance at Dec. 31, 2020 | $ 1,109,898 | $ 5 | 1,389,860 | 209 | (280,176) |
Balance, Shares at Dec. 31, 2020 | 48,678,540 | 48,678,540 | |||
Option exercises | $ 9,679 | 9,679 | |||
Option exercises, Shares | 438,500 | ||||
Stock-based compensation expense | 17,278 | 17,278 | |||
Net loss | (35,504) | (35,504) | |||
Other comprehensive (loss) income | (186) | (186) | |||
Balance at Mar. 31, 2021 | 1,101,165 | $ 5 | 1,416,817 | 23 | (315,680) |
Balance, Shares at Mar. 31, 2021 | 49,117,040 | ||||
Balance at Dec. 31, 2020 | $ 1,109,898 | $ 5 | 1,389,860 | 209 | (280,176) |
Balance, Shares at Dec. 31, 2020 | 48,678,540 | 48,678,540 | |||
Option exercises, Shares | 758,580 | ||||
Net loss | $ (158,102) | ||||
Balance at Sep. 30, 2021 | $ 1,017,337 | $ 5 | 1,455,626 | (16) | (438,278) |
Balance, Shares at Sep. 30, 2021 | 49,464,156 | 49,464,156 | |||
Balance at Mar. 31, 2021 | $ 1,101,165 | $ 5 | 1,416,817 | 23 | (315,680) |
Balance, Shares at Mar. 31, 2021 | 49,117,040 | ||||
Option exercises | 8,398 | 8,398 | |||
Option exercises, Shares | 253,037 | ||||
Shares issued under employee stock purchase plan | 943 | 943 | |||
Shares issued under employee stock purchase plan, Shares | 21,661 | ||||
Stock-based compensation expense | 13,295 | 13,295 | |||
Net loss | (56,273) | (56,273) | |||
Other comprehensive (loss) income | (21) | (21) | |||
Balance at Jun. 30, 2021 | 1,067,507 | $ 5 | 1,439,453 | 2 | (371,953) |
Balance, Shares at Jun. 30, 2021 | 49,391,738 | ||||
Option exercises | 2,379 | 2,379 | |||
Option exercises, Shares | 72,418 | ||||
Stock-based compensation expense | 13,794 | 13,794 | |||
Net loss | (66,325) | (66,325) | |||
Other comprehensive (loss) income | (18) | (18) | |||
Balance at Sep. 30, 2021 | $ 1,017,337 | $ 5 | $ 1,455,626 | $ (16) | $ (438,278) |
Balance, Shares at Sep. 30, 2021 | 49,464,156 | 49,464,156 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Operating activities | ||
Net loss | $ (158,102) | $ (109,916) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 44,367 | 54,333 |
Depreciation | 846 | 647 |
Accretion of discount on marketable securities | 4,093 | 175 |
Amortization of right-of-use operating lease asset | 1,847 | 1,139 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (3,102) | (905) |
Accounts payable | (2,099) | 2,686 |
Accrued expenses and other current liabilities | 11,979 | 3,423 |
Accrued compensation | 437 | (929) |
Net cash used in operating activities | (99,734) | (49,347) |
Investing activities | ||
Purchases of marketable securities | (391,344) | (351,167) |
Sales and maturities of marketable securities | 323,624 | 312,986 |
Purchases of property and equipment | (2,040) | (874) |
Net cash used in investing activities | (69,760) | (39,055) |
Financing activities | ||
Proceeds from issuance of common stock under equity incentive plans | 21,399 | 1,068 |
Proceeds from issuance of common stock in public offering, net of offering costs | 351,611 | |
Costs paid in connection with financing | (114) | |
Net cash provided by financing activities | 21,399 | 352,565 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (148,095) | 264,163 |
Cash, cash equivalents and restricted cash at the beginning of period | 554,174 | 48,188 |
Cash, cash equivalents and restricted cash at the end of period | 406,079 | 312,351 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 1 | 1 |
Supplemental disclosure of non-cash investing and financing information: | ||
Purchases of property and equipment in accounts payable | 68 | 108 |
Costs incurred in connection with a public offering included in accounts payable and accrued expenses | $ 81 | |
Operating lease liabilities arising from obtaining right-of-use assets | $ 4,007 |
Formation and Business of the C
Formation and Business of the Company; Basis of Presentation | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Formation and Business of the Company; Basis of Presentation | 1. Formation and Business of the Company; Basis of Presentation Organization Turning Point Therapeutics, Inc. (the Company) was organized in 2013 and commenced operations in 2014. The Company is a clinical-stage precision oncology biopharmaceutical company designing and developing novel small molecule, targeted oncology therapies. The Company’s principal operations are in the United States and the Company operates in one segment, with its headquarters in San Diego, California. The Company’s primary activities since inception have been to build infrastructure, conduct research and development, including clinical trials, perform business and financial planning, and raise capital. Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, since they are interim statements, the accompanying condensed financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited interim financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The condensed balance sheet at December 31, 2020 has been derived from the audited financial statements at that date, but does not include all information and footnotes required by GAAP for complete financial statements. The operating results presented in these unaudited condensed financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K for the year ended December 31 2020 filed with the SEC. In the opinion of management, the unaudited condensed financial statements and notes thereto include all adjustments that are of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. Liquidity Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year from the financial statement issuance date. The Company determined that there are no conditions or events that raise substantial doubt about its ability to continue as a going concern within one year after the date that the unaudited condensed financial statements for the quarter ended September 30, 2021 are issued. The COVID-19 pandemic continues to rapidly evolve and has already resulted in a significant disruption of global financial markets. The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and further disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the pandemic. If such further disruption occurs, the Company could experience an inability to access additional capital. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 of the Notes to Financial Statements included in its Annual Report on Form 10‑K for the year ended December 31, 2020 . Revenue The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) Topic 606, Revenue From Contracts With Customers (ASC 606). Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. The Company assesses the goods or services promised within each contract and determines those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (SSP) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. For arrangements with licenses of intellectual property that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied. In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied, either at a point in time or over time, and if over time, recognition is based on the use of an output or input method. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent liabilities in the Company’s financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to determining the SSP of performance obligations associated with license arrangements, preclinical and clinical trial costs and accruals and stock-based compensation costs . Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Although the impact of the COVID-19 pandemic to the Company’s business and operating results presents additional uncertainty, the Company continues to use the best information available to update its critical accounting estimates. Cash, Cash Equivalents and Restricted Cash The following table presents a reconciliation of cash, cash equivalents and restricted cash to amounts shown in the unaudited condensed statement of cash flows (in thousands): September 30, 2021 September 30, 2020 Cash and cash equivalents $ 404,203 $ 312,278 Restricted cash, as part of other assets 1,876 73 Total cash, cash equivalents and restricted cash $ 406,079 $ 312,351 Concentration of Credit Risk Substantially all of the Company’s cash, cash equivalents, and marketable securities are held at two financial institutions. Due to the financial strength of the depository institutions, the Company believes these financial institutions represent minimal credit risk. Cash amounts held at financial institutions are insured by the Federal Deposit Insurance Corporation (FDIC) up to $ 250,000 . At September 30, 2021 , cash and cash equivalents and marketable securities totaling $ 1,035.8 million are either not subject to FDIC insurance, or exceed the FDIC insured limit. The Company’s cash and cash equivalents and marketable securities are invested in short term, high credit quality securities, and as a result, the Company believes represent a minimal credit risk. Clinical Trial Costs and Accruals A significant portion of the Company’s clinical trial costs relate to contracts with contract research organizations (CROs). The financial terms of the Company’s CRO contracts may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in the Company’s financial statements by matching those expenses with the period in which services and efforts are expended. As part of the process of preparing the Company’s financial statements, the Company evaluates cost information provided by the Company’s CROs concerning estimated monthly expenses for services rendered and unbilled obligations as the sponsor of the Company’s clinical trials. Accordingly, the Company’s clinical trial accrual is dependent upon the timely and accurate reporting of CROs and other third-party vendors, and the Company’s ability to accurately estimate any unbilled obligations. If the contracted amounts are modified, for instance, as a result of changes in the clinical trial protocol or scope of work to be performed, the Company modifies its accruals accordingly on a prospective basis. Revisions in the scope of a contract are charged to research and development expense in the period in which the facts that give rise to the revision become reasonably certain. Research and Development Expenses Research and development costs are expensed as incurred. These costs consist primarily of salaries and other personnel-related expenses, including stock-based compensation; facility-related expenses; depreciation of facilities and equipment; laboratory consumables; and services performed by clinical research organizations, research institutions, and other outside service providers. The Company recorded the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and include these costs in accrued expenses and other current liabilities in the balance sheet and within research and development expense in the statement of operations and comprehensive loss. As actual costs become known, the Company will adjust its accrued expenses and other current liabilities. Net Loss Per Share The Company computes basic loss per share by dividing the net loss available to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss assumes the conversion, exercise or issuance of all potential common stock equivalents, unless the effect of inclusion would be anti-dilutive. For purposes of this calculation, common stock equivalents include the Company’s stock options, restricted stock units (RSUs) and contingently issuable shares. The Company excluded stock options to purchase common stock, RSUs and contingently issuable shares from the number of shares used to calculate diluted shares outstanding because the inclusion of these potentially dilutive securities would have been antidilutive. Historical outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following: Nine Months Ended September 30, 2021 2020 Options to purchase common stock 5,436,104 6,669,220 RSUs 220,231 21,500 Total 5,656,335 6,690,720 |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2021 | |
Investments Debt And Equity Securities [Abstract] | |
Marketable Securities | 3. Marketable Securities T he Company invests its excess cash in marketable securities, including debt instruments of financial institutions, corporations with investment grade credit ratings, commercial paper and government agencies. At September 30, 2021 , marketable securities consisted of the following (in thousands): Unrealized Maturity in Years Amortized Cost Gains Losses Fair Value U.S. Treasuries 2 years or less 297,429 25 ( 85 ) 297,369 U.S. Government agency securities 2 years or less 151,314 56 ( 18 ) 151,352 Non-U.S. Government agency securities 2 years or less 23,899 — ( 9 ) 23,890 Corporate debt securities 2 years or less 97,190 22 ( 4 ) 97,208 Commercial paper Less than 1 61,992 — — 61,992 Total marketable securities $ 631,824 $ 103 $ ( 116 ) $ 631,811 At December 31, 2020, marketable securities consisted of the following (in thousands): Unrealized Maturity in Years Amortized Cost Gains Losses Fair Value U.S. Treasuries 2 years or less $ 113,662 $ 19 $ ( 1 ) $ 113,680 U.S. Government agency securities 2 years or less 173,583 100 — 173,683 Corporate debt securities 2 years or less 169,189 103 ( 27 ) 169,265 Commercial paper Less than 1 111,779 — — 111,779 Total marketable securities $ 568,213 $ 222 $ ( 28 ) $ 568,407 The Company segments its portfolio based on the underlying risk profiles of their current securities being held. The Company regularly reviews the securities in an unrealized loss position and evaluates the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, current and expected future economic conditions. As of September 30, 2021 , the Company did not record an allowance for credit loss related to its investment portfolio. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Fair value should maximize the use of observable inputs and minimize the use of unobservable inputs. The Company determines the fair value of financial assets and liabilities using three levels of inputs as follows: Level 1—Inputs which include quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2—Inputs (other than quoted market prices included in Level 1) that are either directly or indirectly observable, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the instrument’s anticipated life. Level 3—Unobservable inputs for assets or liabilities and include little or no market activity. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used for such measurements were as follows (in thousands): Fair Value Measurements at September 30, 2021 Using: Level 1 Level 2 Level 3 Total Money market funds $ 192,251 $ — $ — $ 192,251 U.S. Treasuries 297,369 — — 297,369 U.S. Government agency securities — 151,352 — 151,352 Non-U.S. Government securities — 23,890 — 23,890 Corporate debt securities — 97,208 — 97,208 Commercial paper — 273,519 — 273,519 Total cash equivalents and marketable securities $ 489,620 $ 545,969 $ — $ 1,035,589 Fair Value Measurements at December 31, 2020 Using: Level 1 Level 2 Level 3 Total Money market funds $ 299,571 $ — $ — $ 299,571 U.S. Treasuries 113,680 — — 113,680 U.S. Government agency securities — 173,683 — 173,683 Corporate debt securities — 180,718 — 180,718 Commercial paper — 354,223 — 354,223 Total cash equivalents and marketable securities $ 413,251 $ 708,624 $ — $ 1,121,875 |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net consisted of the following (in thousands) : September 30, December 31, 2021 2020 Laboratory equipment $ 3,110 $ 1,629 Computer equipment and software 1,275 956 Tenant improvements 1,407 1,108 Furniture and fixtures 358 357 Property and equipment 6,150 4,050 Less: accumulated depreciation ( 2,292 ) ( 1,446 ) Property and equipment, net $ 3,858 $ 2,604 Depreciation expense for the three months ended September 30, 2021 and 2020 was $ 0.3 million and $ 0.2 million, respectively. Depreciation expense for the nine months ended September 30, 2021 and 2020 was $ 0.8 million and $ 0.6 million, respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands) : September 30, December 31, 2021 2020 Accrued research and development expenses $ 20,895 $ 8,457 Accrued general and administrative expenses 2,072 682 Other current liabilities 78 44 Total $ 23,045 $ 9,183 |
Zai License Agreements
Zai License Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Research And Development [Abstract] | |
Zai License Agreements | 7. Zai License Agreements Zai Repotrectinib Agreement In July 2020, the Company entered into a license agreement (the Zai Repotrectinib Agreement) with Zai Lab (Shanghai) Co., Ltd. (Zai), pursuant to which the Company granted Zai exclusive rights to develop and commercialize products containing the Company’s drug candidate, repotrectinib (the Repotrectinib Products), in Mainland China, Hong Kong, Macau and Taiwan (collectively, the Zai Territory or Greater China). The Company retains exclusive rights to, among other things, develop, manufacture and commercialize the Repotrectinib Products outside the Zai Territory. The Company will supply or have supplied to Zai the Repotrectinib Products for use in the Zai Territory pursuant to a supply agreement for agreed upon consideration, except that Zai has the right, at its election, to package and label the Repotrectinib Products in or outside the Zai Territory for use in the Zai Territory . Pursuant to the terms of the Zai Repotrectinib Agreement, the Company has received an upfront cash payment of $ 25.0 million and is eligible to receive up to $ 151.0 million in development and sales milestone payments, consisting of up to $ 46.0 million of development milestones and up to $ 105.0 million of sales milestones. In addition, during the term of the Zai Repotrectinib Agreement, Zai is obligated to pay the Company tiered percentage royalties ranging from mid-to-high teens on annual net sales of the Repotrectinib Products in the Zai Territory, subject to adjustments in specified circumstances . Zai is responsible for conducting the development and commercialization activities in the Zai Territory related to the Repotrectinib Products at Zai’s own expense, subject to limited exceptions pursuant to which the Company may be responsible for the cost. The Company is responsible for global clinical studies of the Repotrectinib Products, including the portions that may be conducted in the Zai Territory, at the Company’s expense, except that Zai will participate in global clinical studies of the Repotrectinib Products through clinical trial sites in the Zai Territory as agreed as of the effective date of the Zai Repotrectinib Agreement and may, at Zai’s election, participate in future global clinical studies of the Repotrectinib Products through clinical trial sites in the Zai Territory, in each case at Zai’s expense. The Zai Repotrectinib Agreement will continue in effect until expiration of the last royalty term for a Repotrectinib Product in any region in the Zai Territory, where the royalty term for a Repotrectinib Product in a region continues until the later of (i) the date of the last-to-expire valid claim within Company’s patent rights that covers the Repotrectinib Product in such region in the Zai Territory; (ii) the expiry of the regulatory exclusivity for such Repotrectinib Product in such region; or (iii) the close of business of the day that is exactly 10 years after the date of the first commercial sale of such Repotrectinib Product in such region. Subject to the terms of the Zai Repotrectinib Agreement, Zai may terminate the Zai Repotrectinib Agreement for convenience by providing written notice to the Company, which termination will be effective following a prescribed notice period. In addition, the Company may terminate the Zai Repotrectinib Agreement under specified circumstances if Zai or certain other parties challenge the Company’s patent rights. Either party may terminate the Zai Repotrectinib Agreement for the other party’s uncured material breach of the Zai Repotrectinib Agreement, with a customary notice and cure period, for the other party’s insolvency or if the other party acquires a third party and the acquired party is engaged in activities with a competing product that is not divested or discontinued within a specified period. After termination (but not natural expiration), other than certain terminations by Zai for cause, the Company is entitled to retain a worldwide and perpetual license from Zai to exploit the Repotrectinib Products. Revenue Recognition The Company determined that two performance obligations existed: (1) the exclusive license, bundled with the associated know-how and (2) the Company's initial obligation to supply repotrectinib for clinical development in the Zai Territory. The total transaction price of $ 25.7 million was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company developed assumptions that require judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies. The Company delivered the license and technical know-how to Zai in the third quarter of 2020 to satisfy this performance obligation, and accordingly the Company recognized license revenue of $ 25.0 million in the third quarter of 2020. The $ 0.7 million in consideration allocable to the clinical supply performance obligation will be recognized when clinical trial material has been shipped by the Company and Zai obtains control of the goods, upon delivery, over the period of the obligation. For the three and nine months ended September 30, 2021 , the Company recognized $ 0.5 million and $ 0.8 million, respectively in revenue associated with the clinical supply performance obligation. The Company assessed the Zai Repotrectinib Agreement to determine whether a significant financing component exists and concluded that a significant financing component does not exist. For the nine months ended September 30, 2021 , the Company recognized $ 5.0 million in development milestones. The development milestones were subject to foreign tax withholdings. The Company recorded this tax expense to general and administrative expense in the condensed statements of operations and comprehensive loss. As of September 30, 2021 , the Company has no t recognized any revenue associated with sales milestones. Zai Elzovantinib Agreement On January 10, 2021, the Company entered into a license agreement with Zai, which was amended on March 31, 2021 (the Zai Elzovantinib Agreement), pursuant to which the Company granted Zai exclusive rights to develop and commercialize products containing the Company’s drug candidate, Elzovantinib (the Elzovantinib Products), in the Zai Territory. The Company retains exclusive rights to, among other things, develop, manufacture and commercialize the Elzovantinib Products outside the Zai Territory. Pursuant to the terms of the Zai Elzovantinib Agreement, the Company has received an upfront cash payment of $ 25.0 million and is eligible to receive up to $ 336.0 million in development and sales milestone payments, consisting of up to $ 121.0 million of development milestones and up to $ 215.0 million of sales milestones. In addition, during the term of the Zai Elzovantinib Agreement, Zai is obligated to pay the Company tiered percentage royalties ranging from mid-teens to low twenties on annual net sales of the Elzovantinib Products in the Zai Territory, subject to adjustments in specified circumstances . Zai is responsible for conducting the development and commercialization activities in the Zai Territory related to the Elzovantinib Products at Zai’s own expense, subject to limited exceptions pursuant to which the Company may be responsible for the cost. The Company is responsible for global clinical studies of the Elzovantinib Products, including the portions that may be conducted in the Zai Territory, at the Company’s expense, except that Zai will participate in global clinical studies of the Elzovantinib Products through clinical trial sites in the Zai Territory as agreed as of the effective date of the Zai Elzovantinib Agreement and may, at Zai’s election subject to specified exceptions, participate in future global clinical studies of the Elzovantinib Products through clinical trial sites in the Zai Territory, in each case at Zai’s expense. The Zai Elzovantinib Agreement will continue in effect until expiration of the last royalty term for a Elzovantinib Product in any region in the Zai Territory, where the royalty term for a Elzovantinib Product in a region continues until the later of (i) the date of the last-to-expire valid claim within Company’s patent rights that covers the Elzovantinib Product in such region in the Zai Territory; (ii) the expiry of the regulatory exclusivity for such Elzovantinib Product in such region; or (iii) the close of business of the day that is exactly 10 years after the date of the first commercial sale of such Elzovantinib Product in such region. Subject to the terms of the Zai Elzovantinib Agreement, Zai may terminate the Zai Elzovantinib Agreement for convenience by providing written notice to the Company, which termination will be effective following a prescribed notice period. In addition, the Company may terminate the Zai Elzovantinib Agreement under specified circumstances if Zai or certain other parties challenge the Company’s patent rights. Either party may terminate the Zai Elzovantinib Agreement for the other party’s uncured material breach of the Zai Elzovantinib Agreement, with a customary notice and cure period, for the other party’s insolvency or if the other party acquires a third party and the acquired party is engaged in activities with a competing product that is not divested or discontinued within a specified period. After termination (but not natural expiration), other than certain terminations by Zai for cause, the Company is entitled to retain a worldwide and perpetual license from Zai to exploit the Elzovantinib Products. Revenue Recognition The Company determined that two performance obligations existed: (1) the exclusive license, bundled with the associated know-how and (2) the Company’s initial obligation to supply e lzovantinib for clinical development in the Zai Territory. The total transaction price of $ 25.9 million was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company developed assumptions that require judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies. The Company delivered the license and technical know-how to Zai in the first quarter of 2021 to satisfy this performance obligation, and accordingly the Company recognized license revenue of $ 25.0 million in the first quarter of 2021. The $ 0.9 million in consideration allocable to the clinical supply performance obligation will be recognized when clinical trial material has been shipped by the Company and Zai obtains control of the goods, upon delivery, over the period of the obligation. As of September 30, 2021 , the Company has no t recognized any revenue associated with the clinical supply performance obligation under the Zai Elzovantinib Agreement. The Company assessed the Zai Elzovantinib Agreement to determine whether a significant financing component exists and concluded that a significant financing component does not exist. The upfront payment received by the Company was subject to foreign tax withholdings. The Company recorded this tax expense to general and administrative expense in the condensed statements of operations and comprehensive loss. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Operating Leases The Company has an operating lease for its corporate headquarters and laboratory space with a term that expires June 30, 2023 , which resulted in an initial lease liability of $ 4.0 million and a right-of-use asset of $ 3.7 million, which is net of $ 0.3 million of the Company’s deferred gain from the office and laboratory space surrendered in 2019. In connection with this operating lease, in lieu of a cash security deposit, the Company’s bank issued a letter of credit on its behalf, which is secured by a deposit totaling $ 0.1 million and is included in other assets on the condensed balance sheet. In February 2021, the Company entered into a lease agreement for additional office and laboratory space, which commenced on April 20, 2021 , with an initial expiration date of December 31, 2021 . In May 2021, the lease was amended to extend the expiration date to June 30, 2023 . The Company recorded an operating lease liability and corresponding right-of-use asset of approximately $ 1.2 million as of the lease commencement date. In April 2021, the Company entered into a lease agreement for additional office space, which commenced on May 24, 2021 and expires June 30, 2023 with no options to extend. In June 2021, the lease terms were amended to add additional office space which commenced on July 30, 2021 . The Company recorded an operating lease liability of approximately $ 2.8 million and a right-of-use asset of $ 2.9 million, which includes lease incentives. In May 2021, the Company entered into a lease agreement with HCP Callan Road, LLC (Landlord) for the lease of approximately 185,000 square feet of office and laboratory space, delivered in two phases, for the Company’s future principal executive offices and laboratory space. The term of the lease is approximately 11 years and nine months and is expected to commence in March 2023 , with an option by the Company to extend for an additional five years . The base rent will be $ 1.0 million per month, and the Landlord will provide the Company with a tenant improvement allowance of up to $ 220 per square foot. The Landlord's construction activity of the building was minimal as of September 30, 2021 . In connection with the lease, the Company is required to maintain a letter of credit for the benefit of the Landlord in the amount of $ 1.8 million, which was delivered in May 2021 and is included in other assets on the condensed balance sheet. Future minimum payments under the leases as of September 30, 2021 are as follows (in thousands) : Year Ending December 31, 2021 (remaining) 916 2022 3,897 2023 1,988 Total future minimum lease payments 6,801 Less: amounts representing interest ( 411 ) Total lease liability $ 6,390 Remaining lease term 1.8 years Amounts presented in the table above exclude non-cancelable future minimum lease payments for operating leases that have not commenced. Rent expense was $ 0.9 million and $ 0.4 million for the three months ended September 30, 2021 and 2020, respectively. The Company paid $ 0.7 million and $ 0.4 million of cash payments related to its operating lease agreements for each of the three months ended September 30, 2021 and 2020, respectively. Rent expense was $ 1.9 million and $ 1.1 million for the nine months ended September 30, 2021 and 2020, respectively. The Company paid $ 1.6 million and $ 1.2 million of cash payments related to its operating lease agreement for the nine months ended September 30, 2021 and 2020, respectively. The Company’s operating leases had a weighted average remaining lease term of 1.8 years as of September 30, 2021 and 2.6 years as of December 31, 2020, and a weighted average discount rate of 7.1 % as of September 30, 2021 and 8.5 % as of December 31, 2020. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity At the Market Offering In August 2020, the Company entered into an Open Market Sale Agreement SM with Jefferies LLC (ATM facility), under which the Company may offer and sell, from time to time, at its sole discretion, up to $ 250.0 million shares of the Company’s common stock. As of September 30, 2021, the Company had not yet sold any shares of common stock under the ATM facility. Equity Compensation Plans T he Company’s 2019 Equity Incentive Plan (the Plan) provides for the grant of stock options, restricted stock and other equity awards of the Company’s common stock to employees, officers, consultants, and directors. In addition, the number of shares of common stock available for issuance under the Plan will be automatically increased on the first day of each calendar year through January 1, 2029 , by an amount equal to 4 % of the outstanding number of shares of the Company’s common stock on December 31 of the preceding calendar year or such lesser amount as determined by the Company’s board of directors. On January 1, 2021, the Company added 1,947,141 shares to the Plan. At September 30, 2021, the Plan had 3,432,812 tot al shares available for issuance . Stock Options Options expire within a period of not more than ten years from the date of grant. Initial option grants to employees typically vest 25 % after one year and monthly thereafter over a three-year period and expire three months after employee termination . Subsequent option grants to employees and grants to non-employees typically vest monthly over a four-year period. The majority of options outstanding at September 30, 2021 had vesting periods of four years . The following summarizes option activity under the Plan for the periods presented: Outstanding Weighted Weighted Aggregate Balance as of December 31, 2020 5,790,713 $ 34.97 8.4 $ 503,114 Options granted 1,028,286 $ 104.81 Options exercised ( 758,580 ) $ 26.97 Options forfeited or cancelled ( 624,315 ) $ 57.81 Balance as of September 30, 2021 5,436,104 $ 46.64 7.6 $ 153,554 Options vested and exercisable as of September 30, 2021 2,444,354 $ 25.99 6.6 $ 103,814 The fair values of the employee stock options granted during the three and nine months ended September 30, 2021 and 2020 were estimated at the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Risk-free interest rate 0.94 % 0.40 % 0.83 % 1.27 % Volatility 79.3 % 80.4 % 80.2 % 79.3 % Expected term (in years) 6.08 6.08 6.05 6.06 Dividend yield — — — — The weighted-average grant-date fair value of options granted to employees was $ 47.79 and $ 44.97 for the three months ended September 30, 2021 and 2020, respectively and was $ 71.77 and $ 41.96 for the nine months ended September 30, 2021 and 2020, respectively. As of September 30, 2021, there was $ 123.7 million in total unrecognized compensation expense expected to be recognized over a weighted average period of 2.38 years. Restricted Stock Units The summary of the Company’s restricted stock unit activity for the periods presented is as follows: Restricted Stock Units Outstanding Weighted Average Grant Date Fair Value Aggregate Intrinsic Value (in thousands) Balance as of December 31, 2020 21,500 $ 59.94 $ 2,620 Granted 227,057 $ 112.51 Vested ( 5,375 ) $ 59.94 Forfeited ( 22,951 ) $ 131.96 Outstanding as of September 30, 2021 220,231 $ 106.63 $ 14,630 As of September 30, 2021, the total unrecognized compensation related to restricted stock units granted was $ 20.3 million, which the Company expects to recognize over a weighted-average period of approximately 3.43 years. Performance Stock Units The Company has granted performance stock units (PSUs) which vest based on the achievement of certain predefined Company-specific performance criteria and expire as of December 31, 2023 . The fair value of PSUs is estimated based on the closing sale price of the Company’s common stock on the date of grant. The Company will recognize expense in proportion to the number of PSUs that are deemed probable of vesting, based on the Company’s evaluation of the respective performance-based criteria, at each reporting date. The summary of the Company’s PSU activity for the periods presented is as follows: Performance Stock Units Outstanding Weighted Average Grant Date Fair Value Aggregate Intrinsic Value (in thousands) Balance as of December 31, 2020 — $ — $ — Granted 231,707 $ 125.57 Vested — $ — Forfeited ( 31,331 ) $ 137.33 Outstanding as of September 30, 2021 200,376 $ 123.73 $ 13,311 As of September 30, 2021 , the Company does not estimate that the achievement of any performance-based criteria is probable, and no PSUs vested during the nine months ended September 30, 2021. 2019 Employee Stock Purchase Plan In April 2019, the Company’s board of directors and stockholders approved and adopted the 2019 Employee Stock Purchase Plan (the ESPP). The ESPP became effective immediately prior to the date of the underwriting agreement related to the Company’s initial public offering. The ESPP permits eligible employees who elect to participate in an offering under the ESPP to have up to 15 % of their eligible earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the ESPP. The price of common stock purchased under the ESPP is equal to 85 percent of the lower of the fair market value of the common stock at the commencement date of each offering period or the relevant date of purchase. Each offering period is 24 months, with new offering periods commencing every six months on the dates of June 11 and December 11 of each year. Each offering period consists of four six month purchase periods (each a Purchase Period) during which payroll deductions of the participants are accumulated under the ESPP. The last business day of each Purchase Period is referred to as the “Purchase Date .” Purchase Dates are every six months on the dates of June 10 and December 10 of each year. As of September 30, 2021, a total of 228,156 shares of common stock were available for purchase under the ESPP. The assumptions used for the nine months ended September 30, 2021 and 2020 and the resulting estimates of weighted-average fair value per share for stock purchased under the ESPP during such periods were as follows : Nine Months Ended September 30, 2021 2020 Risk-free interest rate 0.04 - 0.16 % 0.17 - 2.13 % Volatility 69.9 - 79.8 % 70.6 - 91.6 % Expected term (in years) 0.50 - 2.00 0.50 - 2.00 Dividend yield — — Modifications to Outstanding Equity Awards On March 30, 2021, Sheila Gujrathi, M.D. and Jacob M. Chacko, M.D. resigned from the Board of Directors (the Board) of the Company, effective immediately, to focus on other endeavors. Dr. Gujrathi also resigned from her position as Chair of the Board and Dr. Chacko resigned from each committee of the Board for which he was a member. In connection with the foregoing, the Board approved an amendment to the option awards held by Drs. Gujrathi and Chacko to provide that (i) all shares subject to such option awards are fully vested and exercisable as of the resignation date and (ii) the post-resignation exercise period shall be extended to September 30, 2022 . The Company determined that the modification to extend the term of vested stock options was a Type I modification pursuant to ASC 718, Compensation – Stock Compensation (ASC 718). The acceleration of the vesting of the unvested stock options was deemed a Type III modification pursuant to ASC 718, because without Board approval, these stock options would have been forfeited on the date of resignation. As a result of these modifications the Company recognized $ 5.6 million in stock-based compensation expense in the first quarter of 2021 in general and administrative expenses in the condensed statements of operations and comprehensive loss. On January 9, 2020, the Company entered into a Transition Separation and Consulting Agreement (the Transition Agreement) with the Company’s former Chief Scientific Officer (CSO), Dr. Jingrong Jean Cui. In connection with this Transition Agreement, Dr. Cui resigned from her position as CSO effective January 31, 2020 and thereafter agreed to serve as a consultant to the Company on an as needed basis until June 30, 2020. In accordance with the terms of the Transition Agreement, the Company recorded $ 1.2 million in expense during the first quarter of 2020 representing the cash severance that was paid to Dr. Cui during 2020. The terms of the Transition Agreement allowed Dr. Cui to continue to vest her outstanding options through to the end of the consulting period on June 30, 2020. At the termination of the consulting period, Dr. Cui immediately received an additional eighteen months vesting of her stock options. In addition, the Company extended Dr. Cui’s period to exercise her vested stock options from 90 days to 12 months from the date of the termination of the consulting period. The Company determined that the modification to extend the term of vested stock options was a Type I modification pursuant to ASC 718. The acceleration of the vesting of the unvested stock options was deemed a Type III modification pursuant to ASC 718, because pursuant to Dr. Cui’s existing employment agreement as of her resignation date, these stock options would have been forfeited on the date of termination. As a result of these modifications the Company recognized $ 31.4 million in stock-based compensation expense in the first quarter of 2020. Because the services performed during the consulting period were considered nonsubstantive, the Company recognized the full $ 31.4 million in stock-based compensation expense on the date of the modification and presented this amount in general and administrative expenses in the statement of operations and comprehensive loss. Stock-Based Compensation Expense Stock-based compensation expense for awards granted under the Company’s equity plans totaled the following (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Research and development $ 7,014 $ 3,912 $ 19,996 $ 10,799 General and administrative 6,780 4,652 24,371 43,534 Total stock-based compensation expense $ 13,794 $ 8,564 $ 44,367 $ 54,333 Common Stock Reserved for Future Issuance Common stock reserved for future issuance consisted of the following: September 30, 2021 Options to purchase common stock 5,436,104 PSUs outstanding 200,376 RSUs outstanding 220,231 Options to purchase common stock available for issuance under the Plan 3,432,812 Shares available for purchase under ESPP 228,156 Total 9,517,679 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, since they are interim statements, the accompanying condensed financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited interim financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The condensed balance sheet at December 31, 2020 has been derived from the audited financial statements at that date, but does not include all information and footnotes required by GAAP for complete financial statements. The operating results presented in these unaudited condensed financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K for the year ended December 31 2020 filed with the SEC. In the opinion of management, the unaudited condensed financial statements and notes thereto include all adjustments that are of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. |
Revenue | Revenue The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) Topic 606, Revenue From Contracts With Customers (ASC 606). Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. The Company assesses the goods or services promised within each contract and determines those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (SSP) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. For arrangements with licenses of intellectual property that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied. In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied, either at a point in time or over time, and if over time, recognition is based on the use of an output or input method. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent liabilities in the Company’s financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to determining the SSP of performance obligations associated with license arrangements, preclinical and clinical trial costs and accruals and stock-based compensation costs . Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Although the impact of the COVID-19 pandemic to the Company’s business and operating results presents additional uncertainty, the Company continues to use the best information available to update its critical accounting estimates. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The following table presents a reconciliation of cash, cash equivalents and restricted cash to amounts shown in the unaudited condensed statement of cash flows (in thousands): September 30, 2021 September 30, 2020 Cash and cash equivalents $ 404,203 $ 312,278 Restricted cash, as part of other assets 1,876 73 Total cash, cash equivalents and restricted cash $ 406,079 $ 312,351 |
Concentration of Credit Risk | Concentration of Credit Risk Substantially all of the Company’s cash, cash equivalents, and marketable securities are held at two financial institutions. Due to the financial strength of the depository institutions, the Company believes these financial institutions represent minimal credit risk. Cash amounts held at financial institutions are insured by the Federal Deposit Insurance Corporation (FDIC) up to $ 250,000 . At September 30, 2021 , cash and cash equivalents and marketable securities totaling $ 1,035.8 million are either not subject to FDIC insurance, or exceed the FDIC insured limit. The Company’s cash and cash equivalents and marketable securities are invested in short term, high credit quality securities, and as a result, the Company believes represent a minimal credit risk. |
Clinical Trial Costs and Accruals | Clinical Trial Costs and Accruals A significant portion of the Company’s clinical trial costs relate to contracts with contract research organizations (CROs). The financial terms of the Company’s CRO contracts may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in the Company’s financial statements by matching those expenses with the period in which services and efforts are expended. As part of the process of preparing the Company’s financial statements, the Company evaluates cost information provided by the Company’s CROs concerning estimated monthly expenses for services rendered and unbilled obligations as the sponsor of the Company’s clinical trials. Accordingly, the Company’s clinical trial accrual is dependent upon the timely and accurate reporting of CROs and other third-party vendors, and the Company’s ability to accurately estimate any unbilled obligations. If the contracted amounts are modified, for instance, as a result of changes in the clinical trial protocol or scope of work to be performed, the Company modifies its accruals accordingly on a prospective basis. Revisions in the scope of a contract are charged to research and development expense in the period in which the facts that give rise to the revision become reasonably certain. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred. These costs consist primarily of salaries and other personnel-related expenses, including stock-based compensation; facility-related expenses; depreciation of facilities and equipment; laboratory consumables; and services performed by clinical research organizations, research institutions, and other outside service providers. The Company recorded the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and include these costs in accrued expenses and other current liabilities in the balance sheet and within research and development expense in the statement of operations and comprehensive loss. As actual costs become known, the Company will adjust its accrued expenses and other current liabilities. |
Net Loss Per Share | Net Loss Per Share The Company computes basic loss per share by dividing the net loss available to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss assumes the conversion, exercise or issuance of all potential common stock equivalents, unless the effect of inclusion would be anti-dilutive. For purposes of this calculation, common stock equivalents include the Company’s stock options, restricted stock units (RSUs) and contingently issuable shares. The Company excluded stock options to purchase common stock, RSUs and contingently issuable shares from the number of shares used to calculate diluted shares outstanding because the inclusion of these potentially dilutive securities would have been antidilutive. Historical outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following: Nine Months Ended September 30, 2021 2020 Options to purchase common stock 5,436,104 6,669,220 RSUs 220,231 21,500 Total 5,656,335 6,690,720 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash to Amounts | The following table presents a reconciliation of cash, cash equivalents and restricted cash to amounts shown in the unaudited condensed statement of cash flows (in thousands): September 30, 2021 September 30, 2020 Cash and cash equivalents $ 404,203 $ 312,278 Restricted cash, as part of other assets 1,876 73 Total cash, cash equivalents and restricted cash $ 406,079 $ 312,351 |
Schedule of Outstanding Anti-Dilutive Securities not Included in Diluted Net Loss Per Share Calculation | Historical outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following: Nine Months Ended September 30, 2021 2020 Options to purchase common stock 5,436,104 6,669,220 RSUs 220,231 21,500 Total 5,656,335 6,690,720 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Marketable Securities | At September 30, 2021 , marketable securities consisted of the following (in thousands): Unrealized Maturity in Years Amortized Cost Gains Losses Fair Value U.S. Treasuries 2 years or less 297,429 25 ( 85 ) 297,369 U.S. Government agency securities 2 years or less 151,314 56 ( 18 ) 151,352 Non-U.S. Government agency securities 2 years or less 23,899 — ( 9 ) 23,890 Corporate debt securities 2 years or less 97,190 22 ( 4 ) 97,208 Commercial paper Less than 1 61,992 — — 61,992 Total marketable securities $ 631,824 $ 103 $ ( 116 ) $ 631,811 At December 31, 2020, marketable securities consisted of the following (in thousands): Unrealized Maturity in Years Amortized Cost Gains Losses Fair Value U.S. Treasuries 2 years or less $ 113,662 $ 19 $ ( 1 ) $ 113,680 U.S. Government agency securities 2 years or less 173,583 100 — 173,683 Corporate debt securities 2 years or less 169,189 103 ( 27 ) 169,265 Commercial paper Less than 1 111,779 — — 111,779 Total marketable securities $ 568,213 $ 222 $ ( 28 ) $ 568,407 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets Subject to Fair Value Measurements on a Recurring Basis and the Level of Inputs | The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used for such measurements were as follows (in thousands): Fair Value Measurements at September 30, 2021 Using: Level 1 Level 2 Level 3 Total Money market funds $ 192,251 $ — $ — $ 192,251 U.S. Treasuries 297,369 — — 297,369 U.S. Government agency securities — 151,352 — 151,352 Non-U.S. Government securities — 23,890 — 23,890 Corporate debt securities — 97,208 — 97,208 Commercial paper — 273,519 — 273,519 Total cash equivalents and marketable securities $ 489,620 $ 545,969 $ — $ 1,035,589 Fair Value Measurements at December 31, 2020 Using: Level 1 Level 2 Level 3 Total Money market funds $ 299,571 $ — $ — $ 299,571 U.S. Treasuries 113,680 — — 113,680 U.S. Government agency securities — 173,683 — 173,683 Corporate debt securities — 180,718 — 180,718 Commercial paper — 354,223 — 354,223 Total cash equivalents and marketable securities $ 413,251 $ 708,624 $ — $ 1,121,875 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Summary of Property and Equipment, Net | Property and equipment, net consisted of the following (in thousands) : September 30, December 31, 2021 2020 Laboratory equipment $ 3,110 $ 1,629 Computer equipment and software 1,275 956 Tenant improvements 1,407 1,108 Furniture and fixtures 358 357 Property and equipment 6,150 4,050 Less: accumulated depreciation ( 2,292 ) ( 1,446 ) Property and equipment, net $ 3,858 $ 2,604 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Payables And Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands) : September 30, December 31, 2021 2020 Accrued research and development expenses $ 20,895 $ 8,457 Accrued general and administrative expenses 2,072 682 Other current liabilities 78 44 Total $ 23,045 $ 9,183 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Operating Leases Future Minimum Payments | Future minimum payments under the leases as of September 30, 2021 are as follows (in thousands) : Year Ending December 31, 2021 (remaining) 916 2022 3,897 2023 1,988 Total future minimum lease payments 6,801 Less: amounts representing interest ( 411 ) Total lease liability $ 6,390 Remaining lease term 1.8 years |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Schedule of Option Activity | The following summarizes option activity under the Plan for the periods presented: Outstanding Weighted Weighted Aggregate Balance as of December 31, 2020 5,790,713 $ 34.97 8.4 $ 503,114 Options granted 1,028,286 $ 104.81 Options exercised ( 758,580 ) $ 26.97 Options forfeited or cancelled ( 624,315 ) $ 57.81 Balance as of September 30, 2021 5,436,104 $ 46.64 7.6 $ 153,554 Options vested and exercisable as of September 30, 2021 2,444,354 $ 25.99 6.6 $ 103,814 |
Schedule of Fair Values of Employee Stock Options Granted | The fair values of the employee stock options granted during the three and nine months ended September 30, 2021 and 2020 were estimated at the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Risk-free interest rate 0.94 % 0.40 % 0.83 % 1.27 % Volatility 79.3 % 80.4 % 80.2 % 79.3 % Expected term (in years) 6.08 6.08 6.05 6.06 Dividend yield — — — — The assumptions used for the nine months ended September 30, 2021 and 2020 and the resulting estimates of weighted-average fair value per share for stock purchased under the ESPP during such periods were as follows : Nine Months Ended September 30, 2021 2020 Risk-free interest rate 0.04 - 0.16 % 0.17 - 2.13 % Volatility 69.9 - 79.8 % 70.6 - 91.6 % Expected term (in years) 0.50 - 2.00 0.50 - 2.00 Dividend yield — — |
Summary of Restricted Stock Unit Activity | The summary of the Company’s restricted stock unit activity for the periods presented is as follows: Restricted Stock Units Outstanding Weighted Average Grant Date Fair Value Aggregate Intrinsic Value (in thousands) Balance as of December 31, 2020 21,500 $ 59.94 $ 2,620 Granted 227,057 $ 112.51 Vested ( 5,375 ) $ 59.94 Forfeited ( 22,951 ) $ 131.96 Outstanding as of September 30, 2021 220,231 $ 106.63 $ 14,630 |
Summary of PSU Activity | The summary of the Company’s PSU activity for the periods presented is as follows: Performance Stock Units Outstanding Weighted Average Grant Date Fair Value Aggregate Intrinsic Value (in thousands) Balance as of December 31, 2020 — $ — $ — Granted 231,707 $ 125.57 Vested — $ — Forfeited ( 31,331 ) $ 137.33 Outstanding as of September 30, 2021 200,376 $ 123.73 $ 13,311 |
Schedule of Stock Based Compensation Expense | Stock-based compensation expense for awards granted under the Company’s equity plans totaled the following (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Research and development $ 7,014 $ 3,912 $ 19,996 $ 10,799 General and administrative 6,780 4,652 24,371 43,534 Total stock-based compensation expense $ 13,794 $ 8,564 $ 44,367 $ 54,333 |
Schedule of Common Stock Reserved for Future Issuance | Common stock reserved for future issuance consisted of the following: September 30, 2021 Options to purchase common stock 5,436,104 PSUs outstanding 200,376 RSUs outstanding 220,231 Options to purchase common stock available for issuance under the Plan 3,432,812 Shares available for purchase under ESPP 228,156 Total 9,517,679 |
Formation and Business of the_2
Formation and Business of the Company; Basis of Presentation - Additional Information (Details) | Oct. 08, 2013Segment |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash to Amounts (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Cash And Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 404,203 | $ 554,101 | $ 312,278 | |
Restricted Cash, as part of other assets | 1,876 | 73 | ||
Total cash, cash equivalents and restricted cash | $ 406,079 | $ 554,174 | $ 312,351 | $ 48,188 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Significant Accounting Policies [Line Items] | |
Exceed of federal deposits insurance limit | $ 1,035,800,000 |
Maximum | |
Significant Accounting Policies [Line Items] | |
Cash FDIC insured amount | $ 250,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Outstanding Anti-Dilutive Securities not Included in Diluted Net Loss Per Share Calculation (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities not included in the diluted net loss per share | 5,656,335 | 6,690,720 |
Options to purchase common stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities not included in the diluted net loss per share | 5,436,104 | 6,669,220 |
RSUs | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities not included in the diluted net loss per share | 220,231 | 21,500 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 631,824 | $ 568,213 |
Unrealized Gains | 103 | 222 |
Unrealized Losses | (116) | (28) |
Fair Value | $ 631,811 | $ 568,407 |
U.S. Treasuries | ||
Marketable Securities [Line Items] | ||
Maturity in Years | 2 years or less | 2 years or less |
Amortized Cost | $ 297,429 | $ 113,662 |
Unrealized Gains | 25 | 19 |
Unrealized Losses | (85) | (1) |
Fair Value | $ 297,369 | $ 113,680 |
U.S. Government Agency Securities | ||
Marketable Securities [Line Items] | ||
Maturity in Years | 2 years or less | 2 years or less |
Amortized Cost | $ 151,314 | $ 173,583 |
Unrealized Gains | 56 | 100 |
Unrealized Losses | (18) | |
Fair Value | $ 151,352 | $ 173,683 |
Non-U.S. Government Agency Securities | ||
Marketable Securities [Line Items] | ||
Maturity in Years | 2 years or less | |
Amortized Cost | $ 23,899 | |
Unrealized Losses | (9) | |
Fair Value | $ 23,890 | |
Corporate Debt Securities | ||
Marketable Securities [Line Items] | ||
Maturity in Years | 2 years or less | 2 years or less |
Amortized Cost | $ 97,190 | $ 169,189 |
Unrealized Gains | 22 | 103 |
Unrealized Losses | (4) | (27) |
Fair Value | $ 97,208 | $ 169,265 |
Commercial Paper | ||
Marketable Securities [Line Items] | ||
Maturity in Years | Less than 1 | Less than 1 |
Amortized Cost | $ 61,992 | $ 111,779 |
Fair Value | $ 61,992 | $ 111,779 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets Subject to Fair Value Measurements on a Recurring Basis and the Level of Inputs (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | $ 1,035,589 | $ 1,121,875 |
Money Market Funds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 192,251 | 299,571 |
U.S. Treasuries | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 297,369 | 113,680 |
U.S Government Agency Securities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 151,352 | 173,683 |
Non U S Government Securities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 23,890 | |
Corporate Debt Securities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 97,208 | 180,718 |
Commercial Paper | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 273,519 | 354,223 |
Level 1 | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 489,620 | 413,251 |
Level 1 | Money Market Funds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 192,251 | 299,571 |
Level 1 | U.S. Treasuries | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 297,369 | 113,680 |
Level 2 | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 545,969 | 708,624 |
Level 2 | U.S Government Agency Securities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 151,352 | 173,683 |
Level 2 | Non U S Government Securities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 23,890 | |
Level 2 | Corporate Debt Securities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | 97,208 | 180,718 |
Level 2 | Commercial Paper | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Cash equivalents and market securities | $ 273,519 | $ 354,223 |
Property and Equipment, Net - S
Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 6,150 | $ 4,050 |
Less: accumulated depreciation | (2,292) | (1,446) |
Property and equipment, net | 3,858 | 2,604 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 3,110 | 1,629 |
Computer Equipment and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,275 | 956 |
Tenant Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,407 | 1,108 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 358 | $ 357 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation | $ 300 | $ 200 | $ 846 | $ 647 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued research and development expenses | $ 20,895 | $ 8,457 |
Accrued general and administrative expenses | 2,072 | 682 |
Other current liabilities | 78 | 44 |
Total | $ 23,045 | $ 9,183 |
Zai License Agreements - Additi
Zai License Agreements - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Jan. 10, 2021 | Jul. 31, 2020 | |
Zai Repotrectinib Agreement | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Upfront cash payment received | $ 25,000,000 | |||||
Total transaction price allocated to performance obligation | $ 25,700,000 | $ 25,700,000 | ||||
Zai Repotrectinib Agreement | License | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Revenue recognized | $ 25,000,000 | |||||
Zai Repotrectinib Agreement | Clinical Supply | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Total transaction price allocated to performance obligation | 700,000 | 700,000 | ||||
Revenue recognized | 500,000 | 800,000 | ||||
Zai Repotrectinib Agreement | Maximum | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Milestone payments eligible to receive | 151,000,000 | |||||
Zai Repotrectinib Agreement | Development Milestones | Maximum | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Milestone payments eligible to receive | 46,000,000 | |||||
Zai Repotrectinib Agreement | Sales Milestones | Maximum | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Milestone payments eligible to receive | $ 105,000,000 | |||||
Zai Elzovantinib Agreement | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Upfront cash payment received | $ 25,000,000 | |||||
Total transaction price allocated to performance obligation | 25,900,000 | 25,900,000 | ||||
Zai Elzovantinib Agreement | License | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Revenue recognized | $ 25,000,000 | |||||
Zai Elzovantinib Agreement | Clinical Supply | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Total transaction price allocated to performance obligation | $ 900,000 | 900,000 | ||||
Revenue recognized | 0 | |||||
Zai Elzovantinib Agreement | Maximum | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Milestone payments eligible to receive | 336,000,000 | |||||
Zai Elzovantinib Agreement | Development Milestones | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Revenue recognized | 5,000,000 | |||||
Zai Elzovantinib Agreement | Development Milestones | Maximum | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Milestone payments eligible to receive | 121,000,000 | |||||
Zai Elzovantinib Agreement | Sales Milestones | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Revenue recognized | $ 0 | |||||
Zai Elzovantinib Agreement | Sales Milestones | Maximum | ||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||
Milestone payments eligible to receive | $ 215,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | Jul. 01, 2019USD ($) | Jun. 30, 2021 | May 31, 2021USD ($)ft² | Apr. 30, 2021USD ($) | Feb. 28, 2021USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Apr. 20, 2021USD ($) | Dec. 31, 2020USD ($) |
Commitment And Contingencies [Line Items] | |||||||||||
Right-of-use lease assets | $ 3,700,000 | $ 2,900,000 | $ 1,200,000 | $ 5,965,000 | $ 5,965,000 | $ 1,200,000 | $ 3,357,000 | ||||
Operating lease right-to-use liability | $ 4,000,000 | $ 2,800,000 | $ 1,200,000 | 6,390,000 | 6,390,000 | $ 1,200,000 | |||||
Operating lease expiration date | Jun. 30, 2023 | Jun. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2021 | |||||||
Deferred gain | $ 300,000 | ||||||||||
Operating lease commencement date | Jul. 30, 2021 | May 24, 2021 | Apr. 20, 2021 | ||||||||
Lessee, Operating Lease, Existence of Option to Extend [true false] | false | ||||||||||
Rent expense | 900,000 | $ 400,000 | 1,900,000 | $ 1,100,000 | |||||||
Operating lease, cash payments | $ 700,000 | $ 400,000 | $ 1,600,000 | $ 1,200,000 | |||||||
Operating lease, remaining lease term | 1 year 9 months 18 days | 1 year 9 months 18 days | 2 years 7 months 6 days | ||||||||
Operating lease, discount rate | 7.10% | 7.10% | 8.50% | ||||||||
HCP Callan Road, LLC | |||||||||||
Commitment And Contingencies [Line Items] | |||||||||||
Operating lease commencement date | Mar. 31, 2023 | ||||||||||
Rentable area | ft² | 185,000 | ||||||||||
Operating lease, lease term | 11 years 9 months | ||||||||||
Lessee operating lease option to extend lease term | 5 years | ||||||||||
Base rent | $ 1,000,000 | ||||||||||
Tenant improvement allowance per square foot | 220 | ||||||||||
Other Assets | |||||||||||
Commitment And Contingencies [Line Items] | |||||||||||
Letter of credit, secured deposit | $ 100,000 | ||||||||||
Other Assets | HCP Callan Road, LLC | |||||||||||
Commitment And Contingencies [Line Items] | |||||||||||
Letter of credit, secured deposit | $ 1,800,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Operating Leases Future Minimum Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Apr. 30, 2021 | Apr. 20, 2021 | Feb. 28, 2021 | Dec. 31, 2020 | Jul. 01, 2019 |
Commitments And Contingencies Disclosure [Abstract] | ||||||
2021 (remaining) | $ 916 | |||||
2022 | 3,897 | |||||
2023 | 1,988 | |||||
Total future minimum lease payments | 6,801 | |||||
Less: amounts representing interest | (411) | |||||
Total lease liability | $ 6,390 | $ 2,800 | $ 1,200 | $ 1,200 | $ 4,000 | |
Remaining lease term | 1 year 9 months 18 days | 2 years 7 months 6 days |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2021 | Aug. 01, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of shares available for issuance | 3,432,812 | 3,432,812 | ||||||
Weighted-average grant-date fair value of options granted to employees | $ 47.79 | $ 44.97 | $ 71.77 | $ 41.96 | ||||
Unrecognized compensation expense related to unvested options | $ 123,700 | $ 123,700 | ||||||
Unrecognized compensation expense, weighted-average period for recognition | 2 years 4 months 17 days | |||||||
Common stock available for purchase | 9,517,679 | 9,517,679 | ||||||
Stock-based compensation expense | $ 13,794 | $ 8,564 | $ 44,367 | $ 54,333 | ||||
Resignation of Board of Directors | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Options exercise period extended date | Sep. 30, 2022 | |||||||
General and Administrative Expenses | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | 6,780 | $ 4,652 | $ 24,371 | $ 43,534 | ||||
General and Administrative Expenses | Resignation of Board of Directors | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | $ 5,600 | |||||||
Restricted Stock Units | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Unrecognized compensation expense, weighted-average period for recognition | 3 years 5 months 4 days | |||||||
Number of awards vested | 5,375 | |||||||
Unrecognized compensation expense related to unvested awards | $ 20,300 | $ 20,300 | ||||||
Performance Stock Units | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Plan expiration date | Dec. 31, 2023 | |||||||
Number of awards vested | 0 | |||||||
Chief Scientific Officer | Transition Agreement | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Options vesting period | 18 months | |||||||
Cash severance expense | $ 1,200 | |||||||
Chief Scientific Officer | General and Administrative Expenses | Transition Agreement | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | $ 31,400 | |||||||
Chief Scientific Officer | Maximum | Transition Agreement | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Extended options vesting period | 12 months | |||||||
Chief Scientific Officer | Minimum | Transition Agreement | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Extended options vesting period | 90 days | |||||||
2019 Equity Incentive Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share-based award, description | The Company’s 2019 Equity Incentive Plan (the Plan) provides for the grant of stock options, restricted stock and other equity awards of the Company’s common stock to employees, officers, consultants, and directors. In addition, the number of shares of common stock available for issuance under the Plan will be automatically increased on the first day of each calendar year through January 1, 2029, by an amount equal to 4% of the outstanding number of shares of the Company’s common stock on December 31 of the preceding calendar year or such lesser amount as determined by the Company’s board of directors. On January 1, 2021, the Company added 1,947,141 shares to the Plan. At September 30, 2021, the Plan had 3,432,812 total shares available for issuance | |||||||
Plan expiration date | Jan. 1, 2029 | |||||||
Percentage of outstanding common stock added to plan each year | 4.00% | |||||||
Number of shares added to plan | 1,947,141 | |||||||
Number of shares available for issuance | 3,432,812 | 3,432,812 | ||||||
2019 Equity Incentive Plan | After 2nd year | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Options expiration period | 3 months | |||||||
2019 Equity Incentive Plan | Maximum | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Options expiration period | 10 years | |||||||
2019 Equity Incentive Plan | Employees | After one year | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights | Initial option grants to employees typically vest 25% after one year and monthly thereafter over a three-year period and expire three months after employee termination | |||||||
Exercise price of options as percentage | 25.00% | |||||||
2019 Equity Incentive Plan | Employees | After 2nd year | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Options vesting period | 3 years | |||||||
2019 Equity Incentive Plan | Employees and non - employees | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights | Subsequent option grants to employees and grants to non-employees typically vest monthly over a four-year period. The majority of options outstanding at September 30, 2021 had vesting periods of four years | |||||||
Options vesting period | 4 years | |||||||
2019 Employee Stock Purchase Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Percentage of eligible earnings withholding | 15.00% | 15.00% | ||||||
Percentage of price of common stock purchased under ESPP | 85.00% | |||||||
Common stock available for purchase | 228,156 | 228,156 | ||||||
ATM Facility | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Common stock authorized for issuance yet to issue | $ 250,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Option Activity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | |
Outstanding Options | ||
Balance as of December 31, 2020 | shares | 5,790,713 | |
Options granted | shares | 1,028,286 | |
Options exercised | shares | (758,580) | |
Options forfeited or cancelled | shares | (624,315) | |
Balance as of September 30, 2021 | shares | 5,436,104 | 5,790,713 |
Options vested and exercisable as of September 30, 2021 | shares | 2,444,354 | |
Weighted Average Exercise Price Per Share | ||
Balance as of December 31, 2020 | $ / shares | $ 34.97 | |
Options granted | $ / shares | 104.81 | |
Options exercised | $ / shares | 26.97 | |
Options forfeited or cancelled | $ / shares | 57.81 | |
Balance as of September 30, 2021 | $ / shares | 46.64 | $ 34.97 |
Options vested and exercisable as of September 30, 2021 | $ / shares | $ 25.99 | |
Weighted average remaining contractual term | ||
Weighted average remaining contractual term | 7 years 7 months 6 days | 8 years 4 months 24 days |
Options vested and exercisable as of September 30, 2021 | 6 years 7 months 6 days | |
Aggregate Intrinsic Value | ||
Balance | $ | $ 153,554 | $ 503,114 |
Options vested and exercisable as of September 30, 2021 | $ | $ 103,814 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Fair Values of Employee Stock Options Granted (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Risk-free interest rate | 0.94% | 0.40% | 0.83% | 1.27% |
Volatility | 79.30% | 80.40% | 80.20% | 79.30% |
Expected term (in years) | 6 years 29 days | 6 years 29 days | 6 years 18 days | 6 years 21 days |
2019 Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Risk-free interest rate. minimum | 0.04% | 0.17% | ||
Risk-free interest rate. maximum | 0.16% | 2.13% | ||
Volatility, minimum | 69.90% | 70.60% | ||
Volatility, maximum | 79.80% | 91.60% | ||
Minimum | 2019 Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 months | 6 months | ||
Maximum | 2019 Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 2 years | 2 years |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Restricted Stock Unit Activity (Details) - RSUs - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Stock Units Outstanding | ||
Balance as of December 31, 2020 | 21,500 | |
Granted | 227,057 | |
Vested | (5,375) | |
Forfeited | (22,951) | |
Outstanding as of September 30, 2021 | 220,231 | |
Weighted Average Grant Date Fair Value | ||
Balance as of December 31, 2020 | $ 59.94 | |
Granted | 112.51 | |
Vested | 59.94 | |
Forfeited | 131.96 | |
Outstanding as of September 30, 2021 | $ 106.63 | |
Aggregate Intrinsic Value | ||
Outstanding | $ 14,630 | $ 2,620 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of PSU Activity (Details) - PSUs $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | |
Stock Units Outstanding | |
Granted | 231,707 |
Vested | 0 |
Forfeited | (31,331) |
Outstanding as of September 30, 2021 | 200,376 |
Weighted Average Grant Date Fair Value | |
Granted | $ / shares | $ 125.57 |
Forfeited | $ / shares | 137.33 |
Outstanding as of September 30, 2021 | $ / shares | $ 123.73 |
Aggregate Intrinsic Value | |
Outstanding | $ | $ 13,311 |
Stockholders' Equity - Schedu_3
Stockholders' Equity - Schedule of Stock Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 13,794 | $ 8,564 | $ 44,367 | $ 54,333 |
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 7,014 | 3,912 | 19,996 | 10,799 |
General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 6,780 | $ 4,652 | $ 24,371 | $ 43,534 |
Stockholders' Equity - Schedu_4
Stockholders' Equity - Schedule of Common Stock Reserved for Future Issuance (Details) - shares | Sep. 30, 2021 | Dec. 31, 2020 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Options to purchase common stock | 5,436,104 | 5,790,713 |
Options to purchase common stock available for issuance under the Plan | 3,432,812 | |
Shares available for purchase under ESPP | 228,156 | |
Total | 9,517,679 | |
PSUs | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Awards outstanding | 200,376 | |
RSUs | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Awards outstanding | 220,231 | 21,500 |