Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Cover [Abstract] | ||
Entity Registrant Name | FATE THERAPEUTICS, INC. | |
Entity Central Index Key | 0001434316 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2023 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Trading Symbol | FATE | |
Entity Common Stock, Shares Outstanding | 98,601,966 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-36076 | |
Entity Tax Identification Number | 65-1311552 | |
Entity Address, Address Line One | 12278 Scripps Summit Drive | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92131 | |
City Area Code | 858 | |
Local Phone Number | 875-1800 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 33,334 | $ 61,333 |
Accounts receivable | 1,538 | 38,480 |
Short-term investments and related maturity receivables | 316,400 | 374,894 |
Prepaid expenses and other current assets | 12,902 | 27,367 |
Total current assets | 364,174 | 502,074 |
Long-term investments | 0 | 4,942 |
Property and equipment, net | 101,707 | 110,020 |
Operating lease right-of-use assets | 62,721 | 66,069 |
Restricted cash | 15,177 | 15,227 |
Collaboration contract assets | 0 | 7,196 |
Other assets | 9 | 33 |
Total assets | 543,788 | 705,561 |
Current liabilities: | ||
Accounts payable | 5,706 | 8,265 |
Accrued expenses | 28,540 | 53,932 |
CIRM award liability, current portion | 0 | 4,000 |
Deferred revenue | 1,110 | 42,226 |
Operating lease liabilities, current portion | 5,977 | 5,628 |
Total current liabilities | 41,333 | 114,051 |
Operating lease liabilities, net of current portion | 98,977 | 103,710 |
Stock price appreciation milestones | 701 | 3,861 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; authorized shares - 5,000,000 at September 30, 2023 and December 31, 2022; Class A Convertible Preferred shares issued and outstanding - 2,761,108 at September 30, 2023 and 2,794,549 December 31, 2022 | 3 | 3 |
Common stock, $0.001 par value; authorized shares - 250,000,000 at September 30, 2023 and December 31, 2022; issued and outstanding - 98,585,750 at September 30, 2023 and 97,294,917 at December 31, 2022 | 99 | 97 |
Additional paid-in capital | 1,570,784 | 1,536,497 |
Accumulated other comprehensive loss | (499) | (1,854) |
Accumulated deficit | (1,167,610) | (1,050,804) |
Total stockholders’ equity | 402,777 | 483,939 |
Total liabilities and stockholders’ equity | $ 543,788 | $ 705,561 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized shares | 250,000,000 | 250,000,000 |
Common stock issued | 98,585,750 | 97,294,917 |
Common stock, outstanding shares | 98,585,750 | 97,294,917 |
Class A Convertible Preferred Shares | ||
Preferred stock, issued shares | 2,761,108 | 2,794,549 |
Preferred stock, outstanding shares | 2,761,108 | 2,794,549 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Collaboration revenue | $ 1,944 | $ 14,981 | $ 61,857 | $ 51,944 |
Type of Revenue [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | ||||
Research and development | $ 34,275 | $ 79,817 | $ 140,780 | $ 233,263 |
General and administrative | 18,948 | 21,555 | 63,513 | 62,648 |
Total operating expenses | 53,223 | 101,372 | 204,293 | 295,911 |
Loss from operations | (51,279) | (86,391) | (142,436) | (243,967) |
Other income: | ||||
Interest income | 4,697 | 1,787 | 12,772 | 2,962 |
Change in fair value of stock price appreciation milestones | 1,049 | 891 | 3,160 | 15,131 |
Other income | 363 | 150 | 9,698 | 516 |
Total other income | 6,109 | 2,828 | 25,630 | 18,609 |
Net loss | (45,170) | (83,563) | (116,806) | (225,358) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale securities, net | 88 | 128 | 1,355 | (2,491) |
Comprehensive loss | $ (45,082) | $ (83,435) | $ (115,451) | $ (227,849) |
Net loss per common share, basic | $ (0.46) | $ (0.86) | $ (1.19) | $ (2.33) |
Net loss per common share, diluted | $ (0.46) | $ (0.86) | $ (1.19) | $ (2.33) |
Weighted-average common shares used to compute, basic net loss per share | 98,568,012 | 97,023,506 | 98,342,898 | 96,692,974 |
Weighted-average common shares used to compute diluted net loss per share | 98,568,012 | 97,023,506 | 98,342,898 | 96,692,974 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating activities | ||
Net loss | $ (116,806) | $ (225,358) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 13,397 | 8,916 |
Stock-based compensation | 33,984 | 59,341 |
Accretion and amortization of premiums and discounts on investments, net | (8,492) | 989 |
Amortization of collaboration contract assets | 7,196 | 1,546 |
Deferred revenue | (41,116) | (959) |
Changes in fair value of stock price appreciation milestones liability | (3,160) | (15,131) |
Grant income from CIRM award | (4,000) | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 36,942 | (1,547) |
Prepaid expenses and other assets | 14,512 | (10,924) |
Accounts payable and accrued expenses | (27,047) | 10,865 |
Right-of-use assets and lease liabilities, net | (1,036) | (557) |
Net cash used in operating activities | (95,626) | (172,819) |
Investing activities | ||
Purchases of property and equipment | (5,972) | (28,889) |
Purchases of investments | (308,844) | (297,694) |
Maturities of investments | 382,128 | 440,222 |
Net cash provided by investing activities | 67,312 | 113,639 |
Financing activities | ||
Issuance of common stock from equity incentive plans, net of issuance costs | 265 | 7,690 |
Net cash provided by financing activities | 265 | 7,690 |
Net change in cash, cash equivalents and restricted cash | (28,049) | (51,490) |
Cash, cash equivalents and restricted cash at beginning of the period | 76,560 | 148,810 |
Cash, cash equivalents and restricted cash at end of the period | 48,511 | 97,320 |
Supplemental schedule of noncash investing and financing activities | ||
Purchases of property and equipment in accounts payable | 168 | 1,988 |
Right-of use assets obtained in exchange for lease obligations | $ 62 | $ 682 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||||||
Net Income (Loss) | $ (45,170) | $ (52,755) | $ (18,881) | $ (83,563) | $ (76,105) | $ (65,690) | $ (116,806) | $ (225,358) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Organization Fate Therapeutics, Inc. (the Company) was incorporated in the state of Delaware on April 27, 2007, and has its principal operations in San Diego, California. The Company is a clinical-stage biopharmaceutical company dedicated to bringing off-the-shelf, multiplexed-engineered, iPSC-derived natural killer (NK) and T-cell product candidates to patients for the treatment of cancer and autoimmune disease. As of September 30, 2023, the Company has devoted substantially all of its efforts to product development, raising capital and building infrastructure and has not generated any revenues from any sales of its therapeutic product candidates. To date, the Company’s revenues have been derived from collaboration agreements and government grants. In January 2023, the Company implemented a corporate restructuring to streamline operations, reduce operating expenses, extend cash runway and focus resources on the Company's most promising programs. In connection with the restructuring, the Company reduced its workforce by 60 %. Affected employees were informed on January 5, 2023. The restructuring was complete d by March 31, 2023. The Company incurred charges o f $ 12.9 million during the nine months ended September 30, 2023 for severance and other employee termination-related costs, of which $ 10.9 million were related to research and development expenses and $ 2.0 million were related to general and administrative expenses. As of September 30, 2023, all restructuring and related expenses have been fully recognized by the Company. The Company has also evaluated the impact of the corporate restructuring and the overall micro- and macro-economic climate on the carrying value of its long-lived assets, property and equipment and operating lease assets. This process includes evaluating whether or not indicators of impairment exist. If the Company determines that indicators of impairment exist, the Company will begin a process that includes evaluating the estimated remaining lives of the long-lived assets, assessing any significant changes in their use, and determining any impairment charges related to its long-lived assets. Based on its evaluation, the Company determined that its long-lived assets were not impaired as of September 30, 2023. Use of Estimates The Company’s unaudited condensed consolidated financial statements are prepared in accordance with United States generally accepted accounting principles (U.S. GAAP). The preparation of the Company’s unaudited condensed consolidated financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s unaudited condensed consolidated financial statements and accompanying notes. The most significant estimates and assumptions in the Company’s unaudited condensed consolidated financial statements relate to its stock price appreciation milestone obligations, contracts containing leases, and accrued expenses. 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. Principles of Consolidation The unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries. To date, the aggregate operations of these subsidiaries have not been significant and all intercompany transactions and balances have been eliminated in consolidation. Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents include cash in readily available operating accounts, money market accounts and money market funds. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the unaudited condensed consolidated balance sheets that sum to the total of the same such amounts shown in the unaudited condensed consolidated statements of cash flows as of September 30, 2023 and 2022 (in thousands): Nine Months Ended September 30, 2023 2022 Cash and cash equivalents $ 33,334 $ 82,093 Restricted cash 15,177 15,227 Total cash, cash equivalents, and restricted cash shown in the unaudited condensed consolidated statement of cash flows $ 48,511 $ 97,320 For each of the nine months ended September 30, 2023 and 2022, the restricted cash balance includes cash-collateralized irrevocable standby letters of credit for $ 15.2 million associated with the Company’s facilities leases. Investments Investments are accounted for as available-for-sale securities and are carried at fair value on the unaudited condensed consolidated balance sheets. Upon initial recognition of the investment and at each reporting period, the Company evaluates whether any unrealized losses on investments are attributable to a credit loss or other factors. Any unrealized losses attributable to credit loss are recorded through an allowance for credit losses, limited to the amount by which the fair value is below amortized cost, with the offsetting amount recorded in other income or expense in the unaudited condensed consolidated statement of operations and comprehensive loss. Unrealized losses not attributable to an expected credit loss and unrealized gains on investments are recorded in other comprehensive income (loss) on the unaudited condensed consolidated statements of operations and comprehensive loss. Realized gains and losses, if any, on investments classified as available-for-sale securities are included in other income or expense. The amortized cost of investments classified as available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. Unaudited Interim Financial Information The accompanying interim condensed consolidated financial statements are unaudited. These unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and following the requirements of the United States Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required can be condensed or omitted. The interim unaudited condensed consolidated financial statements should be read in conjunction with the Company’s financial statements and accompanying notes for the fiscal year ended December 31, 2022, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed by the Company with the SEC on February 28, 2023. In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results expected for the full fiscal year or any other interim period or any future year or period. Collaborative Arrangements The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC Topic 808, Collaborative Arrangements (ASC 808), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company assesses whether aspects of the arrangement between the Company and its collaboration partner are within the scope of other accounting literature, including ASC Topic 606, Revenue from Contracts with Customers (ASC 606). If it is concluded that some or all aspects of the arrangement represent a transaction with a customer, the Company will account for those aspects of the arrangement within the scope of ASC 606. ASC 808 provides guidance for the presentation and disclosure of transactions in collaborative arrangements, but it does not provide recognition or measurement guidance. Therefore, if the Company concludes a counterparty to a transaction is not a customer or otherwise not within the scope of ASC 606, the Company considers the guidance in other accounting literature as applicable or by analogy to account for such transaction. The classification of transactions under the Company’s arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. Revenue Recognition The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. If the Company concludes that some or all aspects of the arrangement represent a transaction with a customer, the Company accounts for those aspects of the arrangement within the scope of ASC 606. For arrangements attributable to ASC 606, the Company recognizes revenue in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration the Company is entitled to receive in exchange for such product or service. In doing so, the Company follows a five-step approach: (i) identify the contract with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service. The Company considers the terms of a contract and all relevant facts and circumstances when applying the revenue recognition standard. The Company applies the revenue recognition standard, including the use of any practical expedients, consistently to contracts with similar characteristics and in similar circumstances. A customer is a party that has entered into a contract with the Company, where the purpose of the contract is to obtain a product or a service that is an output of the Company’s ordinary activities in exchange for consideration. To be considered a contract, (i) the contract must be approved (in writing, orally, or in accordance with other customary business practices), (ii) each party’s rights regarding the product or the service to be transferred can be identified, (iii) the payment terms for the product or the service to be transferred can be identified, (iv) the contract must have commercial substance (that is, the risk, timing or amount of future cash flows is expected to change as a result of the contract), and (v) it is probable that the Company will collect substantially all of the consideration to which it is entitled to receive in exchange for the transfer of the product or the service. A performance obligation is defined as a promise to transfer a product or a service to a customer. The Company identifies each promise to transfer a product or a service (or a bundle of products or services, or a series of products and services that are substantially the same and have the same pattern of transfer) that is distinct. A product or a service is distinct if both (i) the customer can benefit from the product or the service either on its own or together with other resources that are readily available to the customer and (ii) the Company’s promise to transfer the product or the service to the customer is separately identifiable from other promises in the contract. Each distinct promise to transfer a product or a service is a unit of accounting for revenue recognition. If a promise to transfer a product or a service is not separately identifiable from other promises in the contract, such promises should be combined into a single performance obligation. The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to a customer. To determine the transaction price, the Company considers the existence of any significant financing component, the effects of any variable elements, noncash considerations and consideration payable to the customer. If a significant financing component exists, the transaction price is adjusted for the time value of money. If an element of variability exists, the Company must estimate the consideration it expects to receive and uses that amount as the basis for recognizing revenue as the product or the service is transferred to the customer. There are two methods for determining the amount of variable consideration: (i) the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts, and (ii) the mostly likely amount method, which identifies the single most likely amount in a range of possible consideration amounts. If a contract has multiple performance obligations, the Company allocates the transaction price to each distinct performance obligation in an amount that reflects the consideration the Company is entitled to receive in exchange for satisfying each distinct performance obligation. For each distinct performance obligation, revenue is recognized when (or as) the Company transfers control of the product or the service applicable to such performance obligation. In those instances where the Company first receives consideration in advance of satisfying its performance obligation, the Company classifies such consideration as deferred revenue until (or as) the Company satisfies such performance obligation. In those instances where the Company first satisfies its performance obligation prior to its receipt of consideration, the consideration is recorded as accounts receivable. The Company expenses incremental costs of obtaining and fulfilling a contract as and when incurred if the expected amortization period of the asset that would be recognized is one year or less, or if the amount of the asset is immaterial. Otherwise, such costs are capitalized as contract assets if they are incremental to the contract and amortized to expense proportionate to revenue recognition of the underlying contract. Stock Price Appreciation Milestones The Company estimates the fair value of the stock price appreciation milestones associated with the Amended and Restated Exclusive License Agreement with Memorial Sloan Kettering Cancer Center using a Monte Carlo simulation model, which relies on the Company’s current stock price as well as significant estimates and assumptions to determine the estimated liability associated with the contingent milestone payments. The Company accounts for the fair value of the stock price appreciation milestones in accordance with ASC 815, Derivatives and Hedging, with fair value marked to market at each reporting date. The assumptions used to calculate the fair value of the stock price appreciation milestones are subject to a significant amount of judgment including the probability of achieving a specified clinical milestone, the expected volatility of the Company’s common stock, the risk-free interest rate, and the estimated term, which is based in part on the last valid patent claim date. The Company remeasures the fair value of the stock price appreciation milestones at each balance sheet date, with changes in fair value recorded in earnings as non-operating income or expense on the unaudited condensed consolidated statements of operations and comprehensive loss. Leases The Company determines if a contract contains a lease at the inception of the contract. The Company currently has leases related to its facilities leased for office and laboratory space, which are classified as operating leases. These leases result in operating right-of-use (ROU) assets, current operating lease liabilities, and non-current operating lease liabilities in the unaudited condensed consolidated balance sheets. The Company does not have any financing leases. Leases with a term of 12 months or less are considered short-term and ROU assets and lease obligations are not recognized. Payments associated with short-term leases are expensed on a straight-line basis over the lease term. Lease liabilities represent an obligation to make lease payments arising from the lease, and ROU assets represent the right to use the underlying asset identified in the lease for the lease term. Lease liabilities are measured at the present value of the lease payments not yet paid discounted using the discount rate for the lease established at the lease commencement date. To determine the present value, the implicit rate is used when readily determinable. For those leases where the implicit rate is not provided, the Company determines an incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. ROU assets are measured as the present value of the lease payments and also include any prepaid lease payments made and any other indirect costs incurred, and exclude any lease incentives received. Lease terms may include the impact of options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The Company aggregates all lease and non-lease components for each class of underlying assets into a single lease component. Employee Retention Credit The Coronavirus Aid, Relief and Economic Security (CARES) Act provides an employee retention credit (ERC), which is a refundable tax credit against certain employment taxes of up to $ 5,000 per employee for eligible employers. The tax credit is equal to 50 % of qualified wages paid to employees during a quarter, capped at $ 10,000 of qualified wages per employee through December 31, 2020. Additional relief provisions were passed by the United States government, which extend and slightly expand the qualified wage caps on these credits through December 31, 2021. Based on these additional provisions, the tax credit is now equal to 70 % of qualified wages paid to employees during a quarter, and the limit on qualified wages per employee has been increased to $ 10,000 of qualified wages per quarter. The Company qualifies for the tax credit under the CARES Act for qualified wages through December 31, 2021. In connection with the CARES Act, the Company adopted a policy to recognize an ERC when it is reasonably assumed the Company will comply with the conditions and the grant will be received and include in other income in the statement of operations. During the three months ended September 30, 2023 , the Company did not record any such other income. The Company received a cash payment and recorded $ 0.2 million of other income during the three months ended September 30, 2022 , and $ 5.1 million and $ 0.5 million of other income during the nine months ended September 30, 2023 and 2022 , respectively. Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of employee stock option and restricted stock unit grants recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. Performance-based stock units/awards represent a right to receive a certain number of shares of the Company's common stock based on the achievement of corporate performance goals and continued employment during the vesting period. At each reporting period, and to the extent achievement of one or any of the performance conditions is probable, the Company reassesses the probability of the achievement of such corporate performance goals and any increase or decrease in share-based compensation expense resulting from an adjustment in the estimated shares to be released is treated as a cumulative catch-up in the period of adjustment. For stock awards for which vesting is subject to both performance-based milestones and market conditions, expense is recorded over the derived service period after the point when the achievement of the performance-based milestone is probable or the performance condition has been achieved. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, with the exception of option grants for which vesting is subject to both performance-based milestones and market conditions, which are valued using a lattice-based model. The fair value of restricted stock units, including performance-based restricted stock units, is based on the closing price of the Company’s common stock as reported on The Nasdaq Global Market on the date of grant. The Company recognizes forfeitures for all awards as such forfeitures occur. Convertible Preferred Stock The Company applies the relevant accounting standards to distinguish liabilities from equity when assessing the classification and measurement of preferred stock. Preferred shares subject to mandatory redemptions are considered liabilities and measured at fair value. Conditionally redeemable preferred shares are considered temporary equity. All other preferred shares are considered as stockholders’ equity. The Company applies the relevant accounting standards for derivatives and hedging (in addition to distinguishing liabilities from equity) when accounting for hybrid contracts that contain conversion options. Conversion options must be bifurcated from the host instruments and accounted for as free-standing financial instruments according to certain criteria. These criteria include circumstances when (i) the economic characteristics and risks of the embedded derivative instruments are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable accounting principles with changes in fair value reported in earnings as they occurred, and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently measured at fair value at each reporting date, with the changes in fair value reported in earnings. Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non‑owner sources. Other comprehensive loss includes unrealized gains and losses, other than losses attributable to a credit loss which are included in other income and expense, on investments classified as available-for-sale securities, which was the only difference between net loss and comprehensive loss for the applicable periods. Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for common stock equivalents. The pre-funded warrants (Pre-Funded Warrants) associated with the January 2021 public equity offering (see Note 8) are considered outstanding shares in the basic earnings per share calculation given their nominal exercise price. Dilutive common stock equivalents for the periods presented include convertible preferred stock, warrants for the purchase of common stock, and common stock options and restricted stock units outstanding under the Company’s stock option and incentive plans. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. For the three and nine months ended September 30, 2023, the Company realized a net loss of $ 45.2 million and $ 116.8 million, respectively. Shares of potentially dilutive securities totaled 27.5 million for the three and nine months ended September 30, 2023 , including 13.8 million shares associated with a hypothetical conversion of all outstanding shares of the Company’s Class A Convertible Preferred Stock, and an aggregate of 13.7 million shares of common stock issuable upon the exercise of outstanding stock options and the vesting of outstanding restricted stock units. For the three and nine months ended September 30, 2022 , the Company realized a net loss of $ 83.6 million and $ 225.4 million, respectively. Shares of potentially dilutive securities totaled 27.3 million for the three and nine months ended September 30, 2022 , including 14.0 million shares associated with a hypothetical conversion of all outstanding shares of the Company’s Class A Convertible Preferred Stock, and an aggregate of 13.3 million shares of common stock issuable upon the exercise of outstanding stock options and the vesting of outstanding restricted stock units. Going Concern Assessment 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 for a period of at least twelve months from the date of issuance of these financial statements. |
Collaboration and License Agree
Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Collaboration And License Agreements Disclosure [Abstract] | |
Collaboration and License Agreements | 2. Collaboration and License Agreements Janssen Collaboration and Option Agreement On April 2, 2020 (the Janssen Agreement Effective Date), the Company entered into a Collaboration and Option Agreement (the Janssen Agreement) with Janssen Biotech, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Additionally, on the Janssen Agreement Effective Date, the Company entered into a Stock Purchase Agreement (the Stock Purchase Agreement) with Johnson & Johnson Innovation - JJDC, Inc. (JJDC). Under the terms of the Janssen Agreement and the Stock Purchase Agreement taken together, the Company received $ 100.0 million, of which $ 50.0 million was an upfront cash payment and $ 50.0 million was in the form of an equity investment by JJDC. Additionally, the Company was entitled to receive full funding for the conduct of all research, preclinical development and Investigational New Drug Application (IND)-enabling activities performed by the Company under the Janssen Agreement. The Company determined the common stock purchase by JJDC represented a premium of $ 9.93 per share, or $ 16.0 million in aggregate (the Equity Premium), and the remaining $ 34.0 million was recorded as issuance of common stock in shareholders’ equity. In addition, under the Stock Purchase Agreement, the Company exercised the right to require JJDC to purchase an aggregate of $ 50.0 million in shares in a private placement at the same price per share as paid by investors in a public offering. In June 2020, JJDC purchased 1.8 million shares of the Company's common stock at a price of $ 28.31 per share. On January 3, 2023, the Company received notice of termination from Janssen of the Janssen Agreement. The termination took effect on April 3, 2023, and during the three months ended March 31, 2023, the Company performed wind-down activities including discontinuing development of all collaboration product candidates under the Janssen Agreement. The Company was reimbursed for all wind-down activities. In connection with the Janssen Agreement, the Company has incurred $ 17.1 million in sublicense fees to certain of its existing licensors as of September 30, 2023 . The $ 17.1 million in sublicense consideration represents an asset under ASC Topic 340, Other Assets and Deferred Costs (ASC 340) and was amortized to research and development expense ratably with the Company’s revenue recognition under the Janssen Agreement. During the three months ended September 30, 2023 , the Company recognized no such expense. During the three months ended September 30, 2022 , the Company recognized $ 0.8 million of such expense. During the nine months ended September 30, 2023 and 2022 , the Company recognized $ 7.2 million and $ 3.1 million of such expense, respectively. As of September 30, 2023, there was no remaining balance on the Janssen Agreement contract asset. The Company recognized revenue of $ 52.3 million under the Janssen Agreement for the nine months ended September 30, 2023 , of which $ 41.2 million was previously deferred. Such revenue comprised $ 11.1 million associated with research and development services, $ 31.2 million associated with the upfront fee and Equity Premium, and $ 10.0 million associated with a commercial option exercise for the nine months ended September 30, 2023 . The Company did no t recognize any revenue during the three months ended September 30, 2023 . The Company recognized revenue of $ 14.2 million and $ 48.3 million for three and nine months ended September 30, 2022, respectively. Such revenue comprised $ 10.0 million associated with research and development services and $ 4.2 million associated with the upfront fee and Equity Premium for the three months ended September 30, 2022, and, $ 31.2 million associated with research and development services and $ 17.1 million associated with the upfront fee and Equity Premium for the nine months ended September 30, 2022. As of September 30, 2023 , the Company has received $ 82.0 million in aggregate research and development fees from Janssen. Ono Collaboration and Option Agreement On September 14, 2018, the Company entered into a Collaboration and Option Agreement (the Ono Agreement) with Ono Pharmaceutical Co., Ltd. (Ono) for the joint development and commercialization of two off-the-shelf iPSC-derived CAR T-cell product candidates (Candidate 1 and Candidate 2). Pursuant to the terms of the Ono Agreement, the Company received an upfront, non-refundable and non-creditable payment of $ 10.0 million. Additionally, the Company is entitled to receive funding for the conduct of research and development under a joint development plan, which fees were estimated to be $ 20.0 million in aggregate. In December 2020, the Company entered into a letter agreement with Ono pursuant to which Ono delivered proprietary antigen binding domains targeting an antigen expressed on certain solid tumors for incorporation into Candidate 2 and paid the Company a milestone fee of $ 10.0 million for further research and development of Candidate 2. In addition, Ono terminated all further research and development with respect to Candidate 1, and the Company retained all rights to research, develop and commercialize Candidate 1 throughout the world without any obligation to Ono. In June 2022, the Company entered into an amendment with Ono to the Ono Agreement (the Ono Amendment). Pursuant to the Ono Amendment, the companies agreed to designate an additional antigen expressed on certain solid tumors for research and preclinical development, and Ono agreed to contribute proprietary antigen binding domains targeting such additional solid tumor antigen (Candidate 3). In addition, for both Candidate 2 and Candidate 3, Ono and the Company expanded the scope of the collaboration to include the research and development of iPSC-derived CAR NK cell product candidates (in addition to iPSC-derived CAR T-cell product candidates) targeting the designated solid tumor antigens. Similar to Candidate 2, the Company granted to Ono, during a specified period of time, a preclinical option to obtain an exclusive license under certain intellectual property rights, subject to payment of an option exercise fee to the Company by Ono, to develop and commercialize Candidate 3 in all territories of the world, where the Company retains rights to co-develop and co-commercialize Candidate 3 in the United States and Europe under a joint arrangement with Ono under which the Company is eligible to share at least 50 % of the profits and losses. The Company will continue to receive committed funding from Ono through September 2024 and has maintained worldwide rights of manufacture for Candidate 3. The preclinical option expires upon the earlier of: (a) September 30, 2024 or (b) the achievement of the pre-defined preclinical milestone under the joint development plan for Candidate 3. Subject to payment of an extension fee by Ono, Ono may choose to defer its decision to exercise the preclinical option until no later than June 2026. Under the Ono Amendment, aggregate estimated research and development fees have been increased by approximately $ 9.3 million, for a total estimated $ 29.3 million in aggregate research and development fees over the course of the joint development plan. Under the terms of the Ono Agreement (as amended by the Ono Amendment), for Candidate 2 and for Candidate 3 (subject to exercise by Ono of its preclinical option to Candidate 3), the Company is eligible to receive additional payments upon the achievement of certain clinical, regulatory and commercial milestones (the Ono Milestones) with respect to each Candidate in an amount up to $ 843.0 million in aggregate, with the applicable milestone payments for the United States and Europe subject to reduction by 50 % if the Company elects to co-develop and co-commercialize the Candidate in the United States and Europe as described above. In addition, in those territories where Ono has exclusive rights of commercialization, the Company is eligible to receive tiered royalties (Royalties) ranging from the mid-single digits to the low-double digits based on annual net sales by Ono for each Candidate in such territories, with the Royalties subject to certain reductions. The Ono Agreement will terminate with respect to a Candidate if Ono does not exercise its option for a candidate within the option period, or in its entirety if Ono does not exercise any of its options for the candidates within their respective option periods. In addition, either party may terminate the Ono Agreement in the event of breach, insolvency or patent challenges by the other party; provided, that Ono may terminate the Ono Agreement in its sole discretion (x) on a Candidate-by-Candidate basis at any time after the second anniversary of the effective date of the Ono Agreement or (y) on a Candidate-by-Candidate or country-by-country basis at any time after the expiration of the option period, subject to certain limitations. The Ono Agreement will expire on a Candidate-by-Candidate and country-by-country basis upon the expiration of the applicable Royalty term, or in its entirety upon the expiration of all applicable payment obligations under the agreement. The Company determined that the Ono Agreement, Ono Letter Agreement, and Ono Amendment were within the scope of ASC 808 and applicable to such guidance. The Company concluded that certain units of account within the Ono Agreement and Ono Amendment represented a customer and applied relevant guidance from ASC 606 to evaluate the appropriate accounting for those units of account. In accordance with this guidance, the Company identified its performance obligations, including its grant of a license to Ono to certain of its intellectual property subject to certain conditions, its conduct of research services, and its participation in a joint steering committee. The Company determined that its grant of a license to Ono to certain of its intellectual property subject to certain conditions was not distinct from other performance obligations because such grant is dependent on the conduct and results of the research services. Additionally, the Company determined that its conduct of research services was not distinct from other performance obligations since such conduct is dependent on the guidance of the joint steering committee. Accordingly, the Company determined that all performance obligations should be accounted for as one combined performance obligation, and that the combined performance obligation is transferred over the expected term of the conduct of the research services, which is estimated to be four years . The termination of the Ono Agreement with respect to Candidate 1 did not impact this assessment . In accordance with ASC 606, the Company determined that the initial transaction price under the Ono Amendment equals $ 39.3 million, consisting of the upfront, non-refundable and non-creditable payment of $ 10.0 million and the aggregate estimated research and development fees of $ 29.3 million. The upfront payment of $ 10.0 million was recorded as deferred revenue and is being recognized as revenue over time in conjunction with the Company’s conduct of research services as the research services are the primary component of the combined performance obligations. Revenue associated with the upfront payment will be recognized based on actual costs incurred as a percentage of the estimated total costs expected to be incurred over the expected term of conduct of the research services. The Company recorded the $ 5.0 million prepayment of the first-year research and development fees as deferred revenue, and such fees were recognized as revenue as the research services were delivered. On November 7, 2022, Ono exercised its option for continued development of Candidate 2. Upon Ono's exercise, the Company granted Ono a license to develop and commercialize Candidate 2. The Company elected its preclinical option to co-develop and co-commercialize Candidate 2. As a result, the Company received an Option Exercise Payment (as defined under the Ono Agreement) of $ 12.5 million. The Company determined the exercise represented an option with no material right under the Ono Agreement. The Company has completed its performance obligations with respect to the exercise of the option and accordingly, recognized the Option Exercise Payment as revenue for the year ended December 31, 2022. The Company and Ono will proceed with a joint development plan for the ongoing development of Candidate 2. The costs of this development plan are accounted for in accordance with ASC 808, and cost sharing payments to the Company from Ono are recorded net into r esearch and development expenses. During the three and nine months ended September 30, 2023 , the Company recognized contra-research and development expense of $ 2.1 million and $ 5.9 million, respectively. As of September 30, 2023 , the Company has received $ 4.4 million in aggregate cost-sharing payments from Ono. As a direct result of the Company’s entry into the Ono Agreement and the Ono Letter Agreement, the Company incurred an aggregate of $ 7.8 million in sublicense consideration to existing licensors as of September 30, 2023 . The $ 7.8 million in sublicense consideration represents an asset under ASC 340 and was amortized to research and development expense ratably with the Company’s revenue recognition under the Ono Agreement. During the three and nine months ended September 30, 2023 , the Company recognized no such expense, and during the three and nine months ended September 30, 2022 , the Company recognized no such expense and $ 0.3 million of such expense, respectively. The Company recognized revenue of $ 1.9 million and $ 9.5 million under the Ono Agreement for the three and nine months ended September 30, 2023, respectively. All such revenue was associated with research services for the three and nine months ended September 30, 2023. During the three and nine months ended September 30, 2022 , the Company recognized revenue of $ 0.8 million and $ 3.7 million under the Ono Agreement, respectively. Such revenue comprised $ 0.6 million associated with research services and $ 0.2 million associated with the upfront payment for the three months ended September 30, 2022 , and $ 2.0 million associated with research services and $ 1.7 million associated with upfront payment for the nine months ended September 30, 2022. As of September 30, 2023 , the Company has received $ 31.5 million in aggregate research and development fees from Ono. Memorial Sloan Kettering Cancer Center License Agreement On May 15, 2018, the Company entered into an Amended and Restated Exclusive License Agreement (Amended MSK License) with Memorial Sloan Kettering Cancer Center (MSK). The Amended MSK License amends and restates the Exclusive License Agreement entered into between the Company and MSK on August 19, 2016, pursuant to which the Company entered into an exclusive license agreement with MSK for rights relating to compositions and methods covering iPSC-derived cellular immunotherapy, including T-cells and NK-cells derived from iPSCs engineered with chimeric antigen receptors (CARs). Pursuant to the Amended MSK License, MSK granted to the Company additional licenses to certain patents and patent applications relating to new CAR constructs and off-the-shelf CAR T-cells, including the use of clustered regularly interspaced short palindromic repeat and other innovative technologies for their production, in each case to research, develop, and commercialize licensed products in the field of all human therapeutic uses worldwide. The Company has the right to grant sublicenses to certain licensed rights in accordance with the terms of the Amended MSK License, in which case it is obligated to pay MSK a percentage of certain sublicense income received by the Company. The Company is obligated to pay to MSK an annual license maintenance fee during the term of the agreement, and is required to make milestone payments upon the achievement of specified clinical, regulatory and commercial milestones for licensed products as well as royalty payments on net sales of licensed products. In the event a licensed product achieves a specified clinical milestone, MSK is then eligible to receive certain milestone payments totaling up to $ 75.0 million based on the price of the Company’s common stock, where the amount of such payments owed to MSK is contingent upon certain increases in the price of the Company’s common stock following the date of achievement of such clinical milestone. These payments are based on common stock price multiples, with the numerator being the fair value of the ten-trading day trailing average closing price of the Company’s common stock and the denominator being the ten-trading day trailing average closing price of the Company’s common stock as of the effective date of the Amended MSK License, adjusted for any stock splits, cash dividends, stock dividends, other distributions, combinations, recapitalizations, or similar events. Under the terms of the Amended MSK License, upon a change of control of the Company, in certain circumstances, the Company may be required to pay a portion of these payments to MSK based on the price of the Company’s common stock in connection with such change of control. The following table summarizes the common stock multiples and the stock price appreciation milestone payments under the terms of the agreement: Common stock multiple 5.0x 10.0x 15.0x Ten-trading day trailing average common stock price $ 50.18 $ 100.36 $ 150.54 Stock price appreciation milestone payment (in millions) $ 20.0 $ 30.0 $ 25.0 In July 2021, the Company achieved the specified clinical milestone for a licensed product under the Amended MSK License and the Company’s ten-trading day trailing average common stock price exceeded the first pre-specified threshold. As a result, the Company remitted the first milestone payment of $ 20.0 million to MSK during the year ended December 31, 2021. To determine the estimated fair value of the remaining stock price appreciation milestones, the Company uses a Monte Carlo simulation methodology which models future Company common stock prices based on the current stock price and several key variables. The following variables were incorporated in the calculation of the estimated fair value of the stock price appreciation milestones as of September 30, 2023: As of September 30, As of December 31, 2023 2022 Risk-free interest rate 4.8 % 4.0 % Expected volatility 83.2 % 78.1 % Estimated term (in years) 15.3 16.0 Closing stock price as of remeasurement date $ 2.12 $ 10.09 The key inputs to the Monte Carlo simulation to determine the fair value of the stock price appreciation milestones include the Company’s stock price as of the measurement date; the estimated term, which is based in part on the last valid patent claim date; the expected volatility of the Company’s common stock, estimated using the Company’s historical common stock volatility as of the remeasurement date; and the risk-free rate based on the U.S. Treasury yield for the estimated term determined. Fair value measurements are highly sensitive to changes in these inputs and significant changes could result in a significantly higher or lower fair value and resulting expense or gain. At each balance sheet date, the Company remeasures the fair value of the stock price appreciation milestones, with changes in fair value recognized as a component of other income (expense) in the unaudited condensed consolidated statements of operations and comprehensive loss. Amounts are included in current or non-current liabilities based on the estimated timeline associated with the individual potential payments. During the three and nine months ended September 30, 2023, the Company recorded $ 1.0 million and $ 3.2 million of income, respectively, associated with the change in fair value of the stock price appreciation milestones. As of September 30, 2023, the Company recorded a liability of $ 0.7 million associated with the stock price appreciation milestones for the Amended MSK License. |
California Institute for Regene
California Institute for Regenerative Medicine Award | 9 Months Ended |
Sep. 30, 2023 | |
Award From California Institute For Regenerative Medicine Abstract | |
California Institute for Regenerative Medicine Award | 3. California Institute for Regenerative Medicine Award On April 5, 2018 , the Company executed an award agreement with the California Institute for Regenerative Medicine (CIRM) pursuant to which CIRM awarded the Company $ 4.0 million to advance the Company’s FT516 product candidate into a first-in-human clinical trial for the treatment of subjects with advanced solid tumors, including in combination with monoclonal antibody therapy (the Award). The Award is subject to certain co-funding requirements by the Company, and the Company is required to provide CIRM progress and financial update reports under the Award. Pursuant to the terms of the Award, the Company, in its sole discretion, has the option to treat the Award either as a loan or as a grant. During the first quarter of 2023, the Company elected to treat the Award as a grant and reversed the liability associated with the Award and recorded such amount in other income during the nine months ended September 30, 2023 . |
Investments
Investments | 9 Months Ended |
Sep. 30, 2023 | |
Investments [Abstract] | |
Investments | 4. Investments The Company invests portions of excess cash in United States treasuries, commercial paper, non-U.S. government securities, municipal securities, and corporate debt securities with maturities ranging from three to thirty-six months from the purchase date. These investments are accounted for as available-for-sale securities and are classified as short-term and long-term investments in the accompanying consolidated balance sheets based on each security’s contractual maturity date. The following table summarizes the Company’s investments accounted for as available-for-sale securities as of September 30, 2023 and December 31, 2022 (in thousands, except for maturity in years): Maturity Amortized Unrealized Unrealized Estimated September 30, 2023 Classified as current assets: U.S. Treasury debt securities 1 or less $ 73,474 $ ( 91 ) $ — $ 73,383 Municipal securities 1 or less 32,197 ( 44 ) — 32,153 Corporate debt securities 1 or less 54,230 ( 157 ) — 54,073 Commercial paper 1 or less 156,998 ( 207 ) — 156,791 Total short-term investments $ 316,899 $ ( 499 ) $ — $ 316,400 December 31, 2022 Classified as current assets: U.S. Treasury debt securities 1 or less $ 79,251 $ ( 263 ) $ 37 $ 79,025 Non-US government securities 1 or less 2,425 ( 2 ) — 2,423 Municipal securities 1 or less 18,963 ( 208 ) — 18,755 Corporate debt securities 1 or less 123,996 ( 1,138 ) 3 122,861 Commercial paper 1 or less 152,056 ( 230 ) 4 151,830 Total short-term investments $ 376,691 $ ( 1,841 ) $ 44 $ 374,894 Classified as non-current assets: Municipal securities Greater than 1 $ 5,000 $ ( 58 ) $ — $ 4,942 Total long-term investments $ 5,000 $ ( 58 ) $ — $ 4,942 As of September 30, 2023 and December 31, 2022, the Company had $ 1.0 million and $ 0.8 million, respectively, of accrued interest on investments recorded in prepaid expenses and other assets on the unaudited condensed consolidated balance sheets. The following tables present gross unrealized losses and fair values for those investments that were in an unrealized loss position as of September 30, 2023 and December 31, 2022, aggregated by investment category and the length of time that individual securities have been in a continuous loss position (in thousands): Less Than 12 Months 12 Months or Greater Total Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses September 30, 2023 U.S. Treasury debt securities $ 69,394 $ ( 91 ) $ — $ — $ 69,394 $ ( 91 ) Municipal securities 21,266 ( 17 ) 4,973 ( 27 ) 26,239 ( 44 ) Corporate debt securities 54,073 ( 157 ) — — 54,073 ( 157 ) Commercial paper 118,402 ( 207 ) — — 118,402 ( 207 ) Total $ 263,135 $ ( 472 ) $ 4,973 $ ( 27 ) $ 268,108 $ ( 499 ) December 31, 2022 U.S. Treasury debt securities $ 51,246 $ ( 163 ) $ 9,898 $ ( 100 ) $ 61,144 $ ( 263 ) Non-U.S. government securities 2,424 ( 2 ) — — 2,424 ( 2 ) Municipal securities 14,765 ( 193 ) 8,933 ( 73 ) 23,698 ( 266 ) Corporate debt securities 45,621 ( 174 ) 71,625 ( 964 ) 117,246 ( 1,138 ) Commercial paper 66,455 ( 230 ) — — 66,455 ( 230 ) Total $ 180,511 $ ( 762 ) $ 90,456 $ ( 1,137 ) $ 270,967 $ ( 1,899 ) The Company reviews its investment holdings at the end of each reporting period and evaluates any unrealized losses using the expected credit loss model to determine if the unrealized loss is a result of a credit loss or other factors. The Company also evaluates its investment holdings for impairment using a variety of factors including the Company’s intent to sell the underlying securities prior to maturity and whether it is more likely than not that the Company would be required to sell the securities before the recovery of their amortized basis. During each of the three and nine months ended September 30, 2023 and 2022 , the Company did no t recognize any impairment or realized gains or losses on sales of investments, and the Company did no t record an allowance for, or recognize, any expected credit losses. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements The Company’s financial instruments consist primarily of cash and cash equivalents, marketable securities, accounts receivable, stock price appreciation milestones, accounts payable, and accrued liabilities. The carrying amounts of accounts receivable, accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the relatively short-term nature of those instruments. The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, which are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in reclassification of levels for certain securities within the fair value hierarchy. The following table presents the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 (in thousands): Fair Value Measurements at Total Quoted Prices Significant Significant As of September 30, 2023 Financial assets: Money market funds $ 33,334 $ 33,334 $ — $ — U.S. Treasury debt securities 73,383 73,383 — — Municipal securities 32,153 — 32,153 — Corporate debt securities 54,073 — 54,073 — Commercial paper 156,791 — 156,791 — Total financial assets measured at fair value on a recurring basis $ 349,734 $ 106,717 $ 243,017 $ — Financial liabilities: Stock price appreciation milestones $ 701 $ — $ — $ 701 Total financial liabilities measured at fair value on a recurring basis $ 701 $ — $ — $ 701 As of December 31, 2022 Financial assets: Money market funds $ 61,333 $ 61,333 $ — $ — U.S. Treasury debt securities 79,025 79,025 — — Non-U.S. government securities 2,423 — 2,423 — Municipal securities 23,697 — 23,697 — Corporate debt securities 122,861 — 122,861 — Commercial paper 151,830 — 151,830 — Total assets measured at fair value on a recurring basis $ 441,169 $ 140,358 $ 300,811 $ — Financial liabilities: Stock price appreciation milestones $ 3,861 $ — $ — $ 3,861 Total financial liabilities measured at fair value on a recurring basis $ 3,861 $ — $ — $ 3,861 Level 1 assets consisted of money market funds and U.S. Treasury securities measured at fair value based on quoted prices in active markets as provided by the Company’s investment managers. Level 2 assets consisted of corporate debt securities, commercial paper, municipal securities, and non-U.S. government securities measured at fair value using standard observable inputs, including reported trades, broker/dealer quotes, and bids and/or offers. The Company validates the quoted market prices provided by its investment managers by comparing the investment managers’ assessment of the fair values of the Company's investment portfolio balance against the fair values of the Company's investment portfolio balance obtained from an independent source. There were no Level 3 assets held by the Company as of September 30, 2023. Level 3 liabilities consisted of stock price appreciation milestones associated with the Amended MSK License as described in detail in Note 2. To determine the estimated fair value of the stock price appreciation milestones, the Company uses a Monte Carlo simulation methodology which models future Company common stock prices based on several key variables. The assumptions used to calculate the fair value of the stock price appreciation milestones are subject to a significant amount of judgment including the expected volatility of the Company’s common stock and estimated term, which is based in part on the last valid patent claim date. Fair value measurements are highly sensitive to changes in these inputs and significant changes could result in a significantly higher or lower fair value and resulting expense or gain. Further, because the stock price appreciation milestones are first contingent upon the achievement of a specified clinical milestone, the Company also estimates the fair value of the stock price appreciation milestones based on the probability of achieving the clinical milestone. This assessment is based on several factors including the successful achievement of technological, manufacturing, and regulatory requirements. A small change in the assumptions and other inputs, such as the price of the Company’s common stock, may have a relatively large change in the estimated fair value of the stock price appreciation milestones and associated liability and expense. For example, keeping all other variables constant, a hypothetical 10 % increase in the stock price at September 30, 2023 from $ 2.12 to $ 2.33 per share would have decreased the income recorded during the three months ended September 30, 2023 by $ 0.1 million related to the stock price appreciation milestones. Keeping all other variables constant, a hypothetical 10 % decrease in the stock price at September 30, 2023 from $ 2.12 to $ 1.91 per share would have increased the income recorded during the three months ended September 30, 2023 by $ 0.1 million related to the stock price appreciation milestones. The following table presents the changes in fair value of the Company’s Level 3 stock price appreciation milestones liability (in thousands): Balance at December 31, 2022 $ 3,861 Changes in fair value of stock price appreciation milestones liability ( 3,160 ) Balance at September 30, 2023 $ 701 None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued Expenses Current accrued expenses consist of the following (in thousands): September 30, December 31, Accrued clinical trial related costs $ 10,851 $ 16,858 Accrued payroll and other employee benefits 9,055 17,899 Accrued other 8,634 19,175 Total current accrued expenses $ 28,540 $ 53,932 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | 7. Leases The Company has lease agreements for office, laboratory and manufacturing spaces that are classified as operating leases on the unaudited condensed consolidated balance sheets. These leases have terms varying from one to approximately sixteen years , with renewal options of up to ten years , as well as early termination options. Extension and termination options are included in the total lease term when the Company is reasonably certain to exercise them. The leases are subject to additional variable charges, including common area maintenance, property taxes, property insurance and other variable costs. Given the variable nature of such costs, they are recognized as expense as incurred. Additionally, some of the Company’s leases are subject to certain fixed fees which the Company has determined to be non-lease components. The Company has elected to combine and account for lease and non-lease components as a single-lease component for purposes of determining the total future lease payments. As of September 30, 2023, future undiscounted mini mum contractual payments under the Company’s operating leases were $ 166.5 million, which will be paid over a remaining weighted-average lease term of 10.9 years. The weighted-average discount rate for the operating lease liabilities was 8.34 %, which was the Company’ s incremental borrowing rate at lease commencement, as the discount rates implicit in the leases could not be readily determined. The components of lease expense were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Straight-line lease expense $ 3,456 $ 3,620 $ 6,817 $ 10,754 Variable lease expense 467 615 1,578 1,910 Total operating lease expense $ 3,923 $ 4,235 $ 8,395 $ 12,664 No short-term lease expense was recognized during the three and nine months ended September 30, 2023 and 2022. Future undiscounted minimum lease payments under the Company’s operating leases as of September 30, 2023 are as follows (in thousands): Operating Remaining 2023 $ 3,614 2024 14,659 2025 15,087 2026 15,540 2027 16,006 2028 15,057 Thereafter 86,579 Total undiscounted lease payments $ 166,542 Less: imputed interest ( 61,588 ) Total lease liability $ 104,954 In April 2023, the Company entered into an agreement to sublease approximately 18,913 square feet of space, which sublease agreement commenced in April 2023 and expires in December 2028 with no option to extend the sublease term. Under the sublease agreement, rent is subject to scheduled annual increases and the subtenant is responsible for certain operating expenses and taxes throughout the term of the sublease. Sublease income is recognized in other income. Sublease income for the three and nine months ended September 30, 2023 and 2022 was as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Sublease income $ 273 $ — $ 456 $ — |
Convertible Preferred Stock and
Convertible Preferred Stock and Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Convertible Preferred Stock And Stockholders Deficit Disclosure [Abstract] | |
Convertible Preferred Stock and Stockholders’ Equity | 8. Convertible Preferred Stock and Stockholders’ Equity Convertible Preferred Stock In November 2016, the Company completed a private placement of stock in which investors, including investors affiliated with the directors and officers of the Company, purchased convertible preferred stock and common stock of the Company (the November 2016 Placement). The Company issued 2,819,549 shares of Class A Convertible Preferred Stock, $ 0.001 par value per share (the Class A Preferred), at $ 13.30 per share, each of which is convertible into five shares of common stock upon certain conditions defined in the Certificate of Designation of Preferences, Rights and Limitations of the Class A Preferred filed with the Delaware Secretary of State on November 22, 2016 (the CoD). The Class A Preferred were purchased exclusively by entities affiliated with Redmile Group, LLC (collectively, Redmile). The terms of the CoD prohibited Redmile from converting the Class A Preferred into shares of the Company’s common stock if, as a result of conversion, Redmile, together with its affiliates, would own more than 9.99 % of the Company’s common stock then issued and outstanding (the Redmile Percentage Limitation), which percentage could change at Redmile’s election upon 61 days’ notice to the Company to (i) any other number less than or equal to 19.99 % or (ii) subject to approval of the Company’s stockholders to the extent required in accordance with the NASDAQ Global Market rules, any number in excess of 19.99 %. On May 2, 2017, the Company’s stockholders approved the issuance of up to an aggregate of 14,097,745 shares of common stock upon the conversion of the outstanding shares of Class A Preferred. As a result, Redmile has the right to increase the Redmile Percentage Limitation to any percentage in excess of 19.99 % at its election. The Company also issued 7,236,837 shares of common stock at $ 2.66 per share as part of the November 2016 Placement. In April 2023, the Company filed with the office of the Secretary of State of the State of Delaware a Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitations of Class A Convertible Preferred Stock which amends the definition of Beneficial Ownership Limitation to be 14.99 % of the number of shares of the Company's common stock outstanding immediately after giving effect to the issuance of shares of common stock pursuant to a Notice of Conversion. In April 2023, 33,441 shares of the Company's Class A Preferred were converted into 167,205 shares of the Company's common stock. The Class A Preferred are non-voting shares and are convertible into five shares of the Company’s common stock at a conversion price of $ 2.66 per share, which was the fair value of the Company’s common stock on the date of issuance. Holders of the Class A Preferred have the same dividend rights as holders of the Company’s common stock. Additionally, the liquidation preferences of the Class A Preferred are pari passu among holders of the Company’s common stock and holders of the Class A Preferred, pro rata based on the number of shares held by each such holder (treated for this purpose as if the Class A Preferred had been converted to common stock). During the year ended December 31, 2019, 25,000 shares of the Class A Preferred were converted into 125,000 shares of the Company's common stock. Pre-Funded Warrants In January 2021, in conjunction with a public offering, the Company issued Pre-Funded Warrants, in lieu of common stock to certain investors, to purchase 257,310 shares of the Company’s common stock. The purchase price for the Pre-Funded Warrants was $ 85.499 per Pre-Funded Warrant, which equals the per share public offering price for the shares of common stock less the $ 0.001 exercise price for each such Pre-Funded Warrant. Given that the Pre-Funded Warrants are indexed to the Company’s own shares of common stock (and otherwise meet the requirements to be classified in equity), the Company recorded the consideration received from the issuance of the warrants as additional paid-in capital on the Company’s unaudited condensed consolidated balance sheets. The Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of Pre-Funded Warrants may not exercise the Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 9.99 % of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants may increase or decrease this percentage not in excess of 19.99 % by providing at least 61 days’ prior notice to the Company . As of September 30, 2023, there wer e 257,310 Pre- Funded Warrants outstanding. Stock Options and Restricted Stock Unit Awards The following table summarizes stock option activity and related information under all equity plans for the year ended September 30, 2023: Number of Weighted- Balance at December 31, 2022 7,267,226 $ 22.37 Granted 5,525,000 6.66 Exercised ( 93,787 ) 3.24 Cancelled ( 2,361,503 ) 22.23 Balance at September 30, 2023 10,336,936 $ 14.17 Restricted stock unit activity under all equity and stock option plans is summarized as follows: Number of Weighted- Balance at December 31, 2022 5,862,733 $ 48.13 Granted 1,161,540 6.68 Vested ( 1,029,841 ) 42.83 Cancelled ( 2,626,107 ) 45.02 Balance at September 30, 2023 3,368,325 $ 37.77 The allocation of stock-based compensation for all stock awards is as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 4,783 $ 12,446 $ 16,690 $ 38,710 General and administrative 5,321 7,022 17,294 20,631 Total $ 10,104 $ 19,468 $ 33,984 $ 59,341 As of September 30, 2023, the unrecognized compensation cost related to outstanding options was $ 27.7 million and is expected to be recognized as expense over a weighted-average period of approximately 2.0 years. As of September 30, 2023, the unrecognized compensation cost related to restricted stock units was $ 49.1 million which is expected to be recognized as expense over a weighted-average period of approximately 2.2 years. The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee and nonemployee stock option grants were as follows: Nine Months Ended 2023 2022 Risk-free interest rate 3.8 % 1.9 % Expected volatility 89.6 % 76.2 % Expected term (in years) 6.4 5.8 Expected dividend yield 0.0 % 0.0 % Reconciliation of Consolidated Stockholders’ Equity Accounts The following table summarizes the Company’s changes in stockholders’ equity accounts for the three and nine months ended September 30, 2023 (in thousands, except share data): Convertible Common Additional Accumulated Accumulated Total Stockholders' Shares Amount Shares Amount Capital Gain (Loss) Deficit Equity Balance at December 31, 2022 2,794,549 $ 3 97,294,917 $ 97 $ 1,536,497 $ ( 1,854 ) $ ( 1,050,804 ) $ 483,939 Exercise of stock options, net of issuance costs — — 68,847 — 222 — — 222 Issuance of common stock upon vesting of restricted stock units — — 827,251 1 — — — 1 Stock-based compensation — — — — 10,983 — — 10,983 Unrealized gain on investments — — — — — 1,208 — 1,208 Net loss — — — — — — ( 18,881 ) ( 18,881 ) Balance at March 31, 2023 2,794,549 $ 3 98,191,015 $ 98 $ 1,547,702 $ ( 646 ) $ ( 1,069,685 ) $ 477,472 Exercise of stock options, net of issuance costs — — 24,940 — 81 — — 81 Issuance of common stock upon vesting of restricted stock units — — 139,558 — — — — — Conversion of preferred shares to common stock ( 33,441 ) — 167,205 1 — — — 1 Stock-based compensation — — — — 12,897 — — 12,897 Unrealized gain on investments — — — — — 59 — 59 Net loss — — — — — — ( 52,755 ) ( 52,755 ) Balance at June 30, 2023 2,761,108 $ 3 98,522,718 $ 99 $ 1,560,680 $ ( 587 ) $ ( 1,122,440 ) $ 437,755 Exercise of stock options, net of issuance costs — — — — — — — — Issuance of common stock upon vesting of restricted stock units — — 63,032 — — — — — Stock-based compensation — — — — 10,104 — — 10,104 Unrealized gain on investments — — — — — 88 — 88 Net loss — — — — — — ( 45,170 ) ( 45,170 ) Balance at September 30, 2023 2,761,108 $ 3 98,585,750 $ 99 $ 1,570,784 $ ( 499 ) $ ( 1,167,610 ) $ 402,777 The following table summarizes the Company’s changes in stockholders’ equity accounts for the three and nine months ended September 30, 2022 (in thousands, except share data): Convertible Common Additional Accumulated Accumulated Total Stockholders' Shares Amount Shares Amount Capital Gain (Loss) Deficit Equity Balance at December 31, 2021 2,794,549 $ 3 95,726,962 $ 96 $ 1,448,584 $ ( 762 ) $ ( 769,083 ) $ 678,838 Exercise of stock options, net of issuance costs — — 398,415 — 3,001 — — 3,001 Issuance of common stock upon vesting of restricted stock units — — 412,707 1 — — — 1 Stock-based compensation — — — — 19,331 — — 19,331 Unrealized loss on investments — — — — — ( 2,088 ) — ( 2,088 ) Net loss — — — — — — ( 65,690 ) ( 65,690 ) Balance at March 31, 2022 2,794,549 $ 3 96,538,084 $ 97 $ 1,470,916 $ ( 2,850 ) $ ( 834,773 ) $ 633,393 Exercise of stock options, net of issuance costs — — 251,486 — 3,184 — — 3,184 Issuance of common stock upon vesting of restricted stock units — — 73,227 — — — — — Stock-based compensation — — — — 20,542 — — 20,542 Unrealized loss on investments — — — — — ( 531 ) — ( 531 ) Net loss — — — — — — ( 76,105 ) ( 76,105 ) Balance at June 30, 2022 2,794,549 $ 3 96,862,797 $ 97 $ 1,494,642 $ ( 3,381 ) $ ( 910,878 ) $ 580,483 Exercise of stock options, net of issuance costs — — 181,688 — 1,487 — — 1,487 Issuance of common stock upon vesting of restricted stock units — — 67,724 — — — — — Stock-based compensation — — — — 19,468 — — 19,468 Issuance costs from public offering of common stock — — — — — — — — Unrealized gain on investments — — — — — 128 — 128 Net loss — — — — — — ( 83,563 ) ( 83,563 ) Balance at September 30, 2022 2,794,549 $ 3 97,112,209 $ 97 $ 1,515,597 $ ( 3,253 ) $ ( 994,441 ) $ 518,003 |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Use of Estimates | Use of Estimates The Company’s unaudited condensed consolidated financial statements are prepared in accordance with United States generally accepted accounting principles (U.S. GAAP). The preparation of the Company’s unaudited condensed consolidated financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s unaudited condensed consolidated financial statements and accompanying notes. The most significant estimates and assumptions in the Company’s unaudited condensed consolidated financial statements relate to its stock price appreciation milestone obligations, contracts containing leases, and accrued expenses. 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. |
Principles of Consolidation | Principles of Consolidation The unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries. To date, the aggregate operations of these subsidiaries have not been significant and all intercompany transactions and balances have been eliminated in consolidation. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents include cash in readily available operating accounts, money market accounts and money market funds. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the unaudited condensed consolidated balance sheets that sum to the total of the same such amounts shown in the unaudited condensed consolidated statements of cash flows as of September 30, 2023 and 2022 (in thousands): Nine Months Ended September 30, 2023 2022 Cash and cash equivalents $ 33,334 $ 82,093 Restricted cash 15,177 15,227 Total cash, cash equivalents, and restricted cash shown in the unaudited condensed consolidated statement of cash flows $ 48,511 $ 97,320 For each of the nine months ended September 30, 2023 and 2022, the restricted cash balance includes cash-collateralized irrevocable standby letters of credit for $ 15.2 million associated with the Company’s facilities leases. |
Investments | Investments Investments are accounted for as available-for-sale securities and are carried at fair value on the unaudited condensed consolidated balance sheets. Upon initial recognition of the investment and at each reporting period, the Company evaluates whether any unrealized losses on investments are attributable to a credit loss or other factors. Any unrealized losses attributable to credit loss are recorded through an allowance for credit losses, limited to the amount by which the fair value is below amortized cost, with the offsetting amount recorded in other income or expense in the unaudited condensed consolidated statement of operations and comprehensive loss. Unrealized losses not attributable to an expected credit loss and unrealized gains on investments are recorded in other comprehensive income (loss) on the unaudited condensed consolidated statements of operations and comprehensive loss. Realized gains and losses, if any, on investments classified as available-for-sale securities are included in other income or expense. The amortized cost of investments classified as available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim condensed consolidated financial statements are unaudited. These unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and following the requirements of the United States Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required can be condensed or omitted. The interim unaudited condensed consolidated financial statements should be read in conjunction with the Company’s financial statements and accompanying notes for the fiscal year ended December 31, 2022, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed by the Company with the SEC on February 28, 2023. In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results expected for the full fiscal year or any other interim period or any future year or period. |
Collaborative Arrangements | Collaborative Arrangements The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC Topic 808, Collaborative Arrangements (ASC 808), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company assesses whether aspects of the arrangement between the Company and its collaboration partner are within the scope of other accounting literature, including ASC Topic 606, Revenue from Contracts with Customers (ASC 606). If it is concluded that some or all aspects of the arrangement represent a transaction with a customer, the Company will account for those aspects of the arrangement within the scope of ASC 606. ASC 808 provides guidance for the presentation and disclosure of transactions in collaborative arrangements, but it does not provide recognition or measurement guidance. Therefore, if the Company concludes a counterparty to a transaction is not a customer or otherwise not within the scope of ASC 606, the Company considers the guidance in other accounting literature as applicable or by analogy to account for such transaction. The classification of transactions under the Company’s arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. |
Revenue Recognition | Revenue Recognition The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. If the Company concludes that some or all aspects of the arrangement represent a transaction with a customer, the Company accounts for those aspects of the arrangement within the scope of ASC 606. For arrangements attributable to ASC 606, the Company recognizes revenue in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration the Company is entitled to receive in exchange for such product or service. In doing so, the Company follows a five-step approach: (i) identify the contract with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service. The Company considers the terms of a contract and all relevant facts and circumstances when applying the revenue recognition standard. The Company applies the revenue recognition standard, including the use of any practical expedients, consistently to contracts with similar characteristics and in similar circumstances. A customer is a party that has entered into a contract with the Company, where the purpose of the contract is to obtain a product or a service that is an output of the Company’s ordinary activities in exchange for consideration. To be considered a contract, (i) the contract must be approved (in writing, orally, or in accordance with other customary business practices), (ii) each party’s rights regarding the product or the service to be transferred can be identified, (iii) the payment terms for the product or the service to be transferred can be identified, (iv) the contract must have commercial substance (that is, the risk, timing or amount of future cash flows is expected to change as a result of the contract), and (v) it is probable that the Company will collect substantially all of the consideration to which it is entitled to receive in exchange for the transfer of the product or the service. A performance obligation is defined as a promise to transfer a product or a service to a customer. The Company identifies each promise to transfer a product or a service (or a bundle of products or services, or a series of products and services that are substantially the same and have the same pattern of transfer) that is distinct. A product or a service is distinct if both (i) the customer can benefit from the product or the service either on its own or together with other resources that are readily available to the customer and (ii) the Company’s promise to transfer the product or the service to the customer is separately identifiable from other promises in the contract. Each distinct promise to transfer a product or a service is a unit of accounting for revenue recognition. If a promise to transfer a product or a service is not separately identifiable from other promises in the contract, such promises should be combined into a single performance obligation. The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to a customer. To determine the transaction price, the Company considers the existence of any significant financing component, the effects of any variable elements, noncash considerations and consideration payable to the customer. If a significant financing component exists, the transaction price is adjusted for the time value of money. If an element of variability exists, the Company must estimate the consideration it expects to receive and uses that amount as the basis for recognizing revenue as the product or the service is transferred to the customer. There are two methods for determining the amount of variable consideration: (i) the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts, and (ii) the mostly likely amount method, which identifies the single most likely amount in a range of possible consideration amounts. If a contract has multiple performance obligations, the Company allocates the transaction price to each distinct performance obligation in an amount that reflects the consideration the Company is entitled to receive in exchange for satisfying each distinct performance obligation. For each distinct performance obligation, revenue is recognized when (or as) the Company transfers control of the product or the service applicable to such performance obligation. In those instances where the Company first receives consideration in advance of satisfying its performance obligation, the Company classifies such consideration as deferred revenue until (or as) the Company satisfies such performance obligation. In those instances where the Company first satisfies its performance obligation prior to its receipt of consideration, the consideration is recorded as accounts receivable. The Company expenses incremental costs of obtaining and fulfilling a contract as and when incurred if the expected amortization period of the asset that would be recognized is one year or less, or if the amount of the asset is immaterial. Otherwise, such costs are capitalized as contract assets if they are incremental to the contract and amortized to expense proportionate to revenue recognition of the underlying contract. |
Stock Price Appreciation Milestones | Stock Price Appreciation Milestones The Company estimates the fair value of the stock price appreciation milestones associated with the Amended and Restated Exclusive License Agreement with Memorial Sloan Kettering Cancer Center using a Monte Carlo simulation model, which relies on the Company’s current stock price as well as significant estimates and assumptions to determine the estimated liability associated with the contingent milestone payments. The Company accounts for the fair value of the stock price appreciation milestones in accordance with ASC 815, Derivatives and Hedging, with fair value marked to market at each reporting date. The assumptions used to calculate the fair value of the stock price appreciation milestones are subject to a significant amount of judgment including the probability of achieving a specified clinical milestone, the expected volatility of the Company’s common stock, the risk-free interest rate, and the estimated term, which is based in part on the last valid patent claim date. The Company remeasures the fair value of the stock price appreciation milestones at each balance sheet date, with changes in fair value recorded in earnings as non-operating income or expense on the unaudited condensed consolidated statements of operations and comprehensive loss. |
Leases | Leases The Company determines if a contract contains a lease at the inception of the contract. The Company currently has leases related to its facilities leased for office and laboratory space, which are classified as operating leases. These leases result in operating right-of-use (ROU) assets, current operating lease liabilities, and non-current operating lease liabilities in the unaudited condensed consolidated balance sheets. The Company does not have any financing leases. Leases with a term of 12 months or less are considered short-term and ROU assets and lease obligations are not recognized. Payments associated with short-term leases are expensed on a straight-line basis over the lease term. Lease liabilities represent an obligation to make lease payments arising from the lease, and ROU assets represent the right to use the underlying asset identified in the lease for the lease term. Lease liabilities are measured at the present value of the lease payments not yet paid discounted using the discount rate for the lease established at the lease commencement date. To determine the present value, the implicit rate is used when readily determinable. For those leases where the implicit rate is not provided, the Company determines an incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. ROU assets are measured as the present value of the lease payments and also include any prepaid lease payments made and any other indirect costs incurred, and exclude any lease incentives received. Lease terms may include the impact of options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The Company aggregates all lease and non-lease components for each class of underlying assets into a single lease component. |
Employee Retention Credit | Employee Retention Credit The Coronavirus Aid, Relief and Economic Security (CARES) Act provides an employee retention credit (ERC), which is a refundable tax credit against certain employment taxes of up to $ 5,000 per employee for eligible employers. The tax credit is equal to 50 % of qualified wages paid to employees during a quarter, capped at $ 10,000 of qualified wages per employee through December 31, 2020. Additional relief provisions were passed by the United States government, which extend and slightly expand the qualified wage caps on these credits through December 31, 2021. Based on these additional provisions, the tax credit is now equal to 70 % of qualified wages paid to employees during a quarter, and the limit on qualified wages per employee has been increased to $ 10,000 of qualified wages per quarter. The Company qualifies for the tax credit under the CARES Act for qualified wages through December 31, 2021. In connection with the CARES Act, the Company adopted a policy to recognize an ERC when it is reasonably assumed the Company will comply with the conditions and the grant will be received and include in other income in the statement of operations. During the three months ended September 30, 2023 , the Company did not record any such other income. The Company received a cash payment and recorded $ 0.2 million of other income during the three months ended September 30, 2022 , and $ 5.1 million and $ 0.5 million of other income during the nine months ended September 30, 2023 and 2022 , respectively. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of employee stock option and restricted stock unit grants recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. Performance-based stock units/awards represent a right to receive a certain number of shares of the Company's common stock based on the achievement of corporate performance goals and continued employment during the vesting period. At each reporting period, and to the extent achievement of one or any of the performance conditions is probable, the Company reassesses the probability of the achievement of such corporate performance goals and any increase or decrease in share-based compensation expense resulting from an adjustment in the estimated shares to be released is treated as a cumulative catch-up in the period of adjustment. For stock awards for which vesting is subject to both performance-based milestones and market conditions, expense is recorded over the derived service period after the point when the achievement of the performance-based milestone is probable or the performance condition has been achieved. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, with the exception of option grants for which vesting is subject to both performance-based milestones and market conditions, which are valued using a lattice-based model. The fair value of restricted stock units, including performance-based restricted stock units, is based on the closing price of the Company’s common stock as reported on The Nasdaq Global Market on the date of grant. The Company recognizes forfeitures for all awards as such forfeitures occur. |
Convertible Preferred Stock | Convertible Preferred Stock The Company applies the relevant accounting standards to distinguish liabilities from equity when assessing the classification and measurement of preferred stock. Preferred shares subject to mandatory redemptions are considered liabilities and measured at fair value. Conditionally redeemable preferred shares are considered temporary equity. All other preferred shares are considered as stockholders’ equity. The Company applies the relevant accounting standards for derivatives and hedging (in addition to distinguishing liabilities from equity) when accounting for hybrid contracts that contain conversion options. Conversion options must be bifurcated from the host instruments and accounted for as free-standing financial instruments according to certain criteria. These criteria include circumstances when (i) the economic characteristics and risks of the embedded derivative instruments are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable accounting principles with changes in fair value reported in earnings as they occurred, and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently measured at fair value at each reporting date, with the changes in fair value reported in earnings. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non‑owner sources. Other comprehensive loss includes unrealized gains and losses, other than losses attributable to a credit loss which are included in other income and expense, on investments classified as available-for-sale securities, which was the only difference between net loss and comprehensive loss for the applicable periods. |
Net Loss per Common Share | Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for common stock equivalents. The pre-funded warrants (Pre-Funded Warrants) associated with the January 2021 public equity offering (see Note 8) are considered outstanding shares in the basic earnings per share calculation given their nominal exercise price. Dilutive common stock equivalents for the periods presented include convertible preferred stock, warrants for the purchase of common stock, and common stock options and restricted stock units outstanding under the Company’s stock option and incentive plans. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. For the three and nine months ended September 30, 2023, the Company realized a net loss of $ 45.2 million and $ 116.8 million, respectively. Shares of potentially dilutive securities totaled 27.5 million for the three and nine months ended September 30, 2023 , including 13.8 million shares associated with a hypothetical conversion of all outstanding shares of the Company’s Class A Convertible Preferred Stock, and an aggregate of 13.7 million shares of common stock issuable upon the exercise of outstanding stock options and the vesting of outstanding restricted stock units. For the three and nine months ended September 30, 2022 , the Company realized a net loss of $ 83.6 million and $ 225.4 million, respectively. Shares of potentially dilutive securities totaled 27.3 million for the three and nine months ended September 30, 2022 , including 14.0 million shares associated with a hypothetical conversion of all outstanding shares of the Company’s Class A Convertible Preferred Stock, and an aggregate of 13.3 million shares of common stock issuable upon the exercise of outstanding stock options and the vesting of outstanding restricted stock units. |
Going Concern Assessment | Going Concern Assessment 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 for a period of at least twelve months from the date of issuance of these financial statements. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the unaudited condensed consolidated balance sheets that sum to the total of the same such amounts shown in the unaudited condensed consolidated statements of cash flows as of September 30, 2023 and 2022 (in thousands): Nine Months Ended September 30, 2023 2022 Cash and cash equivalents $ 33,334 $ 82,093 Restricted cash 15,177 15,227 Total cash, cash equivalents, and restricted cash shown in the unaudited condensed consolidated statement of cash flows $ 48,511 $ 97,320 |
Collaboration and License Agr_2
Collaboration and License Agreements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Collaboration And License Agreements Disclosure [Abstract] | |
Summary of all Possible Stock Price Appreciation Milestone Payments | The following table summarizes the common stock multiples and the stock price appreciation milestone payments under the terms of the agreement: Common stock multiple 5.0x 10.0x 15.0x Ten-trading day trailing average common stock price $ 50.18 $ 100.36 $ 150.54 Stock price appreciation milestone payment (in millions) $ 20.0 $ 30.0 $ 25.0 |
Schedule of Determine the Estimated Fair Value of the Stock Price Appreciation Milestones Payments | The following variables were incorporated in the calculation of the estimated fair value of the stock price appreciation milestones as of September 30, 2023: As of September 30, As of December 31, 2023 2022 Risk-free interest rate 4.8 % 4.0 % Expected volatility 83.2 % 78.1 % Estimated term (in years) 15.3 16.0 Closing stock price as of remeasurement date $ 2.12 $ 10.09 |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments [Abstract] | |
Summary of Investments | The following table summarizes the Company’s investments accounted for as available-for-sale securities as of September 30, 2023 and December 31, 2022 (in thousands, except for maturity in years): Maturity Amortized Unrealized Unrealized Estimated September 30, 2023 Classified as current assets: U.S. Treasury debt securities 1 or less $ 73,474 $ ( 91 ) $ — $ 73,383 Municipal securities 1 or less 32,197 ( 44 ) — 32,153 Corporate debt securities 1 or less 54,230 ( 157 ) — 54,073 Commercial paper 1 or less 156,998 ( 207 ) — 156,791 Total short-term investments $ 316,899 $ ( 499 ) $ — $ 316,400 December 31, 2022 Classified as current assets: U.S. Treasury debt securities 1 or less $ 79,251 $ ( 263 ) $ 37 $ 79,025 Non-US government securities 1 or less 2,425 ( 2 ) — 2,423 Municipal securities 1 or less 18,963 ( 208 ) — 18,755 Corporate debt securities 1 or less 123,996 ( 1,138 ) 3 122,861 Commercial paper 1 or less 152,056 ( 230 ) 4 151,830 Total short-term investments $ 376,691 $ ( 1,841 ) $ 44 $ 374,894 Classified as non-current assets: Municipal securities Greater than 1 $ 5,000 $ ( 58 ) $ — $ 4,942 Total long-term investments $ 5,000 $ ( 58 ) $ — $ 4,942 |
Aggregated by investment category and the length of time | The following tables present gross unrealized losses and fair values for those investments that were in an unrealized loss position as of September 30, 2023 and December 31, 2022, aggregated by investment category and the length of time that individual securities have been in a continuous loss position (in thousands): Less Than 12 Months 12 Months or Greater Total Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses September 30, 2023 U.S. Treasury debt securities $ 69,394 $ ( 91 ) $ — $ — $ 69,394 $ ( 91 ) Municipal securities 21,266 ( 17 ) 4,973 ( 27 ) 26,239 ( 44 ) Corporate debt securities 54,073 ( 157 ) — — 54,073 ( 157 ) Commercial paper 118,402 ( 207 ) — — 118,402 ( 207 ) Total $ 263,135 $ ( 472 ) $ 4,973 $ ( 27 ) $ 268,108 $ ( 499 ) December 31, 2022 U.S. Treasury debt securities $ 51,246 $ ( 163 ) $ 9,898 $ ( 100 ) $ 61,144 $ ( 263 ) Non-U.S. government securities 2,424 ( 2 ) — — 2,424 ( 2 ) Municipal securities 14,765 ( 193 ) 8,933 ( 73 ) 23,698 ( 266 ) Corporate debt securities 45,621 ( 174 ) 71,625 ( 964 ) 117,246 ( 1,138 ) Commercial paper 66,455 ( 230 ) — — 66,455 ( 230 ) Total $ 180,511 $ ( 762 ) $ 90,456 $ ( 1,137 ) $ 270,967 $ ( 1,899 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets Measured at Fair Value on Recurring Basis | The following table presents the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 (in thousands): Fair Value Measurements at Total Quoted Prices Significant Significant As of September 30, 2023 Financial assets: Money market funds $ 33,334 $ 33,334 $ — $ — U.S. Treasury debt securities 73,383 73,383 — — Municipal securities 32,153 — 32,153 — Corporate debt securities 54,073 — 54,073 — Commercial paper 156,791 — 156,791 — Total financial assets measured at fair value on a recurring basis $ 349,734 $ 106,717 $ 243,017 $ — Financial liabilities: Stock price appreciation milestones $ 701 $ — $ — $ 701 Total financial liabilities measured at fair value on a recurring basis $ 701 $ — $ — $ 701 As of December 31, 2022 Financial assets: Money market funds $ 61,333 $ 61,333 $ — $ — U.S. Treasury debt securities 79,025 79,025 — — Non-U.S. government securities 2,423 — 2,423 — Municipal securities 23,697 — 23,697 — Corporate debt securities 122,861 — 122,861 — Commercial paper 151,830 — 151,830 — Total assets measured at fair value on a recurring basis $ 441,169 $ 140,358 $ 300,811 $ — Financial liabilities: Stock price appreciation milestones $ 3,861 $ — $ — $ 3,861 Total financial liabilities measured at fair value on a recurring basis $ 3,861 $ — $ — $ 3,861 |
Summary of Changes in the Fair Value of the Company's Level 3 Enterprise Fair Value Milestone Payment Liability | The following table presents the changes in fair value of the Company’s Level 3 stock price appreciation milestones liability (in thousands): Balance at December 31, 2022 $ 3,861 Changes in fair value of stock price appreciation milestones liability ( 3,160 ) Balance at September 30, 2023 $ 701 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Current accrued expenses consist of the following (in thousands): September 30, December 31, Accrued clinical trial related costs $ 10,851 $ 16,858 Accrued payroll and other employee benefits 9,055 17,899 Accrued other 8,634 19,175 Total current accrued expenses $ 28,540 $ 53,932 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of Components of Lease Expense | The components of lease expense were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Straight-line lease expense $ 3,456 $ 3,620 $ 6,817 $ 10,754 Variable lease expense 467 615 1,578 1,910 Total operating lease expense $ 3,923 $ 4,235 $ 8,395 $ 12,664 |
Schedule of Future Minimum Payments Under Non-cancelable Operating Leases | Future undiscounted minimum lease payments under the Company’s operating leases as of September 30, 2023 are as follows (in thousands): Operating Remaining 2023 $ 3,614 2024 14,659 2025 15,087 2026 15,540 2027 16,006 2028 15,057 Thereafter 86,579 Total undiscounted lease payments $ 166,542 Less: imputed interest ( 61,588 ) Total lease liability $ 104,954 |
Schedule of sublease Income | Sublease income is recognized in other income. Sublease income for the three and nine months ended September 30, 2023 and 2022 was as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Sublease income $ 273 $ — $ 456 $ — |
Convertible Preferred Stock a_2
Convertible Preferred Stock and Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Convertible Preferred Stock And Stockholders Equity Disclosure [Abstract] | |
Summary of stock option activity and related information under all equity plans | The following table summarizes stock option activity and related information under all equity plans for the year ended September 30, 2023: Number of Weighted- Balance at December 31, 2022 7,267,226 $ 22.37 Granted 5,525,000 6.66 Exercised ( 93,787 ) 3.24 Cancelled ( 2,361,503 ) 22.23 Balance at September 30, 2023 10,336,936 $ 14.17 |
Summary of restricted stock unit activity under the Plan | Restricted stock unit activity under all equity and stock option plans is summarized as follows: Number of Weighted- Balance at December 31, 2022 5,862,733 $ 48.13 Granted 1,161,540 6.68 Vested ( 1,029,841 ) 42.83 Cancelled ( 2,626,107 ) 45.02 Balance at September 30, 2023 3,368,325 $ 37.77 |
Schedule of allocation of stock-based compensation for all stock awards | The allocation of stock-based compensation for all stock awards is as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 4,783 $ 12,446 $ 16,690 $ 38,710 General and administrative 5,321 7,022 17,294 20,631 Total $ 10,104 $ 19,468 $ 33,984 $ 59,341 |
Schedule of weighted-average assumptions used to determine the fair value of employee and nonemployee stock option grants | The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee and nonemployee stock option grants were as follows: Nine Months Ended 2023 2022 Risk-free interest rate 3.8 % 1.9 % Expected volatility 89.6 % 76.2 % Expected term (in years) 6.4 5.8 Expected dividend yield 0.0 % 0.0 % |
Summary of changes in stockholders' equity | The following table summarizes the Company’s changes in stockholders’ equity accounts for the three and nine months ended September 30, 2023 (in thousands, except share data): Convertible Common Additional Accumulated Accumulated Total Stockholders' Shares Amount Shares Amount Capital Gain (Loss) Deficit Equity Balance at December 31, 2022 2,794,549 $ 3 97,294,917 $ 97 $ 1,536,497 $ ( 1,854 ) $ ( 1,050,804 ) $ 483,939 Exercise of stock options, net of issuance costs — — 68,847 — 222 — — 222 Issuance of common stock upon vesting of restricted stock units — — 827,251 1 — — — 1 Stock-based compensation — — — — 10,983 — — 10,983 Unrealized gain on investments — — — — — 1,208 — 1,208 Net loss — — — — — — ( 18,881 ) ( 18,881 ) Balance at March 31, 2023 2,794,549 $ 3 98,191,015 $ 98 $ 1,547,702 $ ( 646 ) $ ( 1,069,685 ) $ 477,472 Exercise of stock options, net of issuance costs — — 24,940 — 81 — — 81 Issuance of common stock upon vesting of restricted stock units — — 139,558 — — — — — Conversion of preferred shares to common stock ( 33,441 ) — 167,205 1 — — — 1 Stock-based compensation — — — — 12,897 — — 12,897 Unrealized gain on investments — — — — — 59 — 59 Net loss — — — — — — ( 52,755 ) ( 52,755 ) Balance at June 30, 2023 2,761,108 $ 3 98,522,718 $ 99 $ 1,560,680 $ ( 587 ) $ ( 1,122,440 ) $ 437,755 Exercise of stock options, net of issuance costs — — — — — — — — Issuance of common stock upon vesting of restricted stock units — — 63,032 — — — — — Stock-based compensation — — — — 10,104 — — 10,104 Unrealized gain on investments — — — — — 88 — 88 Net loss — — — — — — ( 45,170 ) ( 45,170 ) Balance at September 30, 2023 2,761,108 $ 3 98,585,750 $ 99 $ 1,570,784 $ ( 499 ) $ ( 1,167,610 ) $ 402,777 The following table summarizes the Company’s changes in stockholders’ equity accounts for the three and nine months ended September 30, 2022 (in thousands, except share data): Convertible Common Additional Accumulated Accumulated Total Stockholders' Shares Amount Shares Amount Capital Gain (Loss) Deficit Equity Balance at December 31, 2021 2,794,549 $ 3 95,726,962 $ 96 $ 1,448,584 $ ( 762 ) $ ( 769,083 ) $ 678,838 Exercise of stock options, net of issuance costs — — 398,415 — 3,001 — — 3,001 Issuance of common stock upon vesting of restricted stock units — — 412,707 1 — — — 1 Stock-based compensation — — — — 19,331 — — 19,331 Unrealized loss on investments — — — — — ( 2,088 ) — ( 2,088 ) Net loss — — — — — — ( 65,690 ) ( 65,690 ) Balance at March 31, 2022 2,794,549 $ 3 96,538,084 $ 97 $ 1,470,916 $ ( 2,850 ) $ ( 834,773 ) $ 633,393 Exercise of stock options, net of issuance costs — — 251,486 — 3,184 — — 3,184 Issuance of common stock upon vesting of restricted stock units — — 73,227 — — — — — Stock-based compensation — — — — 20,542 — — 20,542 Unrealized loss on investments — — — — — ( 531 ) — ( 531 ) Net loss — — — — — — ( 76,105 ) ( 76,105 ) Balance at June 30, 2022 2,794,549 $ 3 96,862,797 $ 97 $ 1,494,642 $ ( 3,381 ) $ ( 910,878 ) $ 580,483 Exercise of stock options, net of issuance costs — — 181,688 — 1,487 — — 1,487 Issuance of common stock upon vesting of restricted stock units — — 67,724 — — — — — Stock-based compensation — — — — 19,468 — — 19,468 Issuance costs from public offering of common stock — — — — — — — — Unrealized gain on investments — — — — — 128 — 128 Net loss — — — — — — ( 83,563 ) ( 83,563 ) Balance at September 30, 2022 2,794,549 $ 3 97,112,209 $ 97 $ 1,515,597 $ ( 3,253 ) $ ( 994,441 ) $ 518,003 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands, shares in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Percentage of number of employee reduced | 60% | |||||||||
Net loss | $ (45,170) | $ (52,755) | $ (18,881) | $ (83,563) | $ (76,105) | $ (65,690) | $ (116,806) | $ (225,358) | ||
Potentially dilutive securities (in shares) | 27.5 | 27.3 | 27.5 | 27.3 | ||||||
Letters of credit outstanding amount | $ 15,200 | $ 15,200 | $ 15,200 | $ 15,200 | ||||||
Employee termination related costs | 12,900 | 12,900 | ||||||||
Research and development expense | 10,900 | |||||||||
General And Administrative Expense | 2,000 | |||||||||
Operating Expenses | 53,223 | 101,372 | $ 204,293 | $ 295,911 | ||||||
Restricted Stock Units (RSUs) | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Potentially dilutive securities (in shares) | 13.7 | 13.3 | ||||||||
Class A Convertible Preferred Stock | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Net loss | $ 45,200 | 83,600 | $ 116,800 | $ 225,400 | ||||||
Potentially dilutive securities (in shares) | 13.8 | 14 | ||||||||
Employee Retention Credit | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Percentage of tax credit | 70% | 50% | ||||||||
Wages per employee | $ 10,000 | $ 10,000 | ||||||||
Other Income | $ 200 | $ 5,100 | $ 500 | |||||||
Employee Retention Credit | Maximum | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Refundable tax credit | $ 5,000 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies (Details 2) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Cash and cash equivalents | $ 33,334 | $ 61,333 | $ 82,093 | |
Restricted cash | 15,177 | 15,227 | ||
Total cash, cash equivalents, and restricted cash shown in the unaudited condensed consolidated statement of cash flows | $ 48,511 | $ 76,560 | $ 97,320 | $ 148,810 |
Collaboration and License Agr_3
Collaboration and License Agreements - Janssen Collaboration and Option Agreement (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Apr. 02, 2020 | Jun. 30, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Collaboration contract asset | $ 0 | $ 0 | $ 7,196 | ||||
Revenue recognized | 1,944 | $ 14,981 | 61,857 | $ 51,944 | |||
Research and development fees cash payments received | 82,000 | ||||||
Commercial option exercise | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue recognized | 10,000 | ||||||
Janssen Biotech Inc | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Collaboration contract asset | 17,100 | 17,100 | |||||
Amortization of sublicense consideration | 0 | 800 | 7,200 | 3,100 | |||
Revenue recognized | 0 | 14,200 | 52,300 | 48,300 | |||
Deferred revenue | 41,200 | 41,200 | |||||
Janssen Biotech Inc | Research And Development | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue recognized | 10,000 | 11,100 | 31,200 | ||||
Janssen Biotech Inc | Upfront Fee and Equity Premium | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue recognized | 4,200 | 31,200 | 17,100 | ||||
Janssen Biotech Inc | Janssen Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Sublicense consideration represents an asset under ASC, other assets and deferred costs | 17,100 | ||||||
Ono Pharmaceutical Co. Ltd | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Collaboration contract asset | 7,800 | 7,800 | |||||
Amortization of sublicense consideration | 0 | 0 | 0 | 300 | |||
Revenue recognized | $ 1,900 | $ 800 | 9,500 | $ 3,700 | |||
Research and development fees cash payments received | $ 31,500 | ||||||
Johnson Johnson Innovation J J D C Inc | Stock Purchase Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Common stock per share | $ 28.31 | ||||||
Aggregate purchase price of common stock | $ 50,000 | ||||||
Company received payment | 100,000 | ||||||
Upfront cash payment | 50,000 | ||||||
Equity method investment, underlying equity in net assets | $ 50,000 | ||||||
Equity premium per share | $ 9.93 | ||||||
Aggregate equity premium on shares | $ 16,000 | ||||||
Proceeds from issuance of private placement | $ 34,000 | ||||||
Issuance of common stock during period for private placements (in shares) | 1.8 |
Collaboration and License Agr_4
Collaboration and License Agreements - Ono Collaboration and Option Agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Nov. 07, 2022 | Sep. 14, 2018 | Jun. 30, 2022 | Oct. 31, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2020 | |
Collaboration agreement | ||||||||||
Collaboration contract asset | $ 0 | $ 0 | $ 7,196 | |||||||
Revenue recognized | 1,944 | $ 14,981 | $ 61,857 | $ 51,944 | ||||||
Expected Ressarch Services Period | 4 years | |||||||||
Research and development fees cash payments received | $ 82,000 | |||||||||
Ono Pharmaceutical Co. Ltd | ||||||||||
Collaboration agreement | ||||||||||
Collaborative arrangement annual payments receivable recorded as deferred revenue | $ 10,000 | |||||||||
Non-refundable upfront payments recorded as deferred revenue | 10,000 | |||||||||
Aggregate research and development fees payments receivable | 20,000 | |||||||||
Collaborative arrangement annual payments receivable recorded as deferred revenue | $ 5,000 | |||||||||
Transaction price of the agreement | $ 39,300 | |||||||||
Collaboration contract asset | 7,800 | 7,800 | ||||||||
Revenue recognized | 1,900 | 800 | 9,500 | 3,700 | ||||||
Research and development fees cash payments received | 31,500 | |||||||||
Contra research and development expenses | 2,100 | 5,900 | ||||||||
Proceeds from related party | 4,400 | |||||||||
Option exercise payment | $ 12,500 | |||||||||
Ono Pharmaceutical Co. Ltd | Candidate 2 | ||||||||||
Collaboration agreement | ||||||||||
Percentage of reduction on milestone payments | 50% | |||||||||
Ono Pharmaceutical Co. Ltd | Minimum | Candidate 1 | ||||||||||
Collaboration agreement | ||||||||||
Profits and losses sharing percentage | 50% | |||||||||
Collaborative arrangement potential additional milestones | $ 9,300 | |||||||||
Ono Pharmaceutical Co. Ltd | Maximum | Candidate 1 | ||||||||||
Collaboration agreement | ||||||||||
Collaborative arrangement potential additional milestones | $ 29,300 | $ 29,300 | ||||||||
Ono Pharmaceutical Co. Ltd | Maximum | Candidate 2 | ||||||||||
Collaboration agreement | ||||||||||
Aggregate milestone payments | $ 843,000 | |||||||||
Ono Pharmaceutical Co. Ltd | Collaborative Arrangement | Upfront Fee | ||||||||||
Collaboration agreement | ||||||||||
Revenue recognized | 200 | 1,700 | ||||||||
Ono Letter Agreement | Ono Pharmaceutical Co. Ltd | ||||||||||
Collaboration agreement | ||||||||||
Milestone payments | $ 10,000 | |||||||||
Revenue recognized | $ 600 | $ 2,000 | ||||||||
Ono Letter Agreement | Ono Pharmaceutical Co. Ltd | Sublicense Consideration | ||||||||||
Collaboration agreement | ||||||||||
Sublicense consideration paid | $ 7,800 | $ 7,800 |
Collaboration and License Agr_5
Collaboration and License Agreements - Memorial Sloan Kettering Cancer Center License Agreement (Details) - Amended MSK License - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2021 | |
Collaboration agreement | |||
Enterprise value milestone payment | $ 75 | $ 75 | |
Stock price appreciation milestone payable | $ 20 | ||
Enterprise value milestones liability at fair value | 0.7 | 0.7 | |
Stock price appreciation milestone, income | $ 1 | $ 3.2 |
Collaboration and License Agr_6
Collaboration and License Agreements (Details 1) - Amended MSK License $ / shares in Units, $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares | |
Milestone One | |
Collaboration agreement | |
Common stock multiple | 5.0x |
Ten-trading day trailing average common stock price | $ / shares | $ 50.18 |
Stock price appreciation milestone payment (in millions) | $ | $ 20 |
Milestone Two | |
Collaboration agreement | |
Common stock multiple | 10.0x |
Ten-trading day trailing average common stock price | $ / shares | $ 100.36 |
Stock price appreciation milestone payment (in millions) | $ | $ 30 |
Milestone Three | |
Collaboration agreement | |
Common stock multiple | 15.0x |
Ten-trading day trailing average common stock price | $ / shares | $ 150.54 |
Stock price appreciation milestone payment (in millions) | $ | $ 25 |
Collaboration and License Agr_7
Collaboration and License Agreements (Details 2) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Determine the estimated fair value of the enterprise value milestone payments | ||
Closing stock price as of re measurement date | $ 2.12 | |
Amended MSK License | ||
Determine the estimated fair value of the enterprise value milestone payments | ||
Risk-free interest rate | 4.80% | 4% |
Expected volatility | 83.20% | 78.10% |
Estimated term (in years) | 15 years 3 months 18 days | 16 years |
Closing stock price as of re measurement date | $ 2.12 | $ 10.09 |
California Institute For Rege_2
California Institute For Regenerative Medicine Award (Details) - California Institute for Regenerative Medicine - FT516 $ in Millions | Apr. 05, 2018 USD ($) |
Award from California institute for regenerative medicine | |
Award agreement executed date | Apr. 05, 2018 |
Award for first-in-human clinical trial | $ 4 |
Investments (Details)
Investments (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Schedule Of Available For Sale Securities [Line Items] | |||||
Available-for-sale securities, impairment | $ 0 | $ 0 | |||
Available-for-sale securities, realized gains (losses) on sales | $ 0 | $ 0 | |||
Available-for-sale securities, recognition of expected credit losses | 0 | $ 0 | 0 | $ 0 | |
Prepaid Expenses And Other Assets | |||||
Schedule Of Available For Sale Securities [Line Items] | |||||
Accured Interest on investments | $ 1,000,000 | $ 1,000,000 | $ 800,000 | ||
Treasuries, Non-U.S. Government Securities, Municipal Securities, Corporate Debt Securities and Commercial Paper | |||||
Schedule Of Available For Sale Securities [Line Items] | |||||
Short term investments, maturity start range | 3 months | ||||
Short term investments, maturity end range | 36 months |
Investments (Details 2)
Investments (Details 2) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
U.S. Treasury debt securities | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 73,474 | $ 79,251 |
Unrealized Losses | (91) | (263) |
Unrealised Gains | 0 | 37 |
Estimated Fair Value | $ 73,383 | $ 79,025 |
Non-U.S. government securities | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | |
Amortized Cost | $ 2,425 | |
Unrealized Losses | (2) | |
Unrealised Gains | 0 | |
Estimated Fair Value | $ 2,423 | |
Municipal securities | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 32,197 | $ 18,963 |
Unrealized Losses | (44) | (208) |
Unrealised Gains | 0 | 0 |
Estimated Fair Value | $ 32,153 | $ 18,755 |
Municipal securities | Non-current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | Greater than 1 | |
Amortized Cost | $ 5,000 | |
Unrealized Losses | (58) | |
Unrealised Gains | 0 | |
Estimated Fair Value | $ 4,942 | |
Corporate debt securities | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 54,230 | $ 123,996 |
Unrealized Losses | (157) | (1,138) |
Unrealised Gains | 0 | 3 |
Estimated Fair Value | $ 54,073 | $ 122,861 |
Commercial Paper | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 156,998 | $ 152,056 |
Unrealized Losses | (207) | (230) |
Unrealised Gains | 0 | 4 |
Estimated Fair Value | 156,791 | 151,830 |
Short-term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 316,899 | 376,691 |
Unrealized Losses | (499) | (1,841) |
Unrealised Gains | 0 | 44 |
Estimated Fair Value | $ 316,400 | 374,894 |
Long-term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 5,000 | |
Unrealized Losses | (58) | |
Unrealised Gains | 0 | |
Estimated Fair Value | $ 4,942 |
Investments (Details 3) - Short
Investments (Details 3) - Short Term Investment (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, Total | $ 268,108 | $ 270,967 |
Unrealized Losses, Total | (499) | (1,899) |
U.S. Treasury debt securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, Total | 69,394 | 61,144 |
Unrealized Losses, Total | (91) | (263) |
Non-U.S. government securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, Total | 2,424 | |
Unrealized Losses, Total | (2) | |
Municipal securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Unrealized Losses, 12 Months or Greater | (27) | |
Estimated Fair Value, Total | 26,239 | 23,698 |
Unrealized Losses, Total | (44) | (266) |
Corporate debt securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Unrealized Losses, 12 Months or Greater | 0 | |
Estimated Fair Value, Total | 54,073 | 117,246 |
Unrealized Losses, Total | (157) | (1,138) |
Commercial Paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Unrealized Losses, 12 Months or Greater | 0 | |
Estimated Fair Value, Total | 118,402 | 66,455 |
Unrealized Losses, Total | (207) | (230) |
Short-term Investments [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 263,135 | 180,511 |
Unrealized Losses, Less Than 12 Months | (472) | (762) |
Short-term Investments [Member] | U.S. Treasury debt securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 69,394 | 51,246 |
Unrealized Losses, Less Than 12 Months | (91) | (163) |
Short-term Investments [Member] | Non-U.S. government securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 2,424 | |
Unrealized Losses, Less Than 12 Months | (2) | |
Short-term Investments [Member] | Municipal securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 21,266 | 14,765 |
Unrealized Losses, Less Than 12 Months | (17) | (193) |
Short-term Investments [Member] | Corporate debt securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 54,073 | 45,621 |
Unrealized Losses, Less Than 12 Months | (157) | (174) |
Short-term Investments [Member] | Commercial Paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 118,402 | 66,455 |
Unrealized Losses, Less Than 12 Months | (207) | (230) |
Long-term Investments [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 4,973 | 90,456 |
Unrealized Losses, 12 Months or Greater | (27) | (1,137) |
Long-term Investments [Member] | U.S. Treasury debt securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 0 | 9,898 |
Unrealized Losses, 12 Months or Greater | 0 | (100) |
Long-term Investments [Member] | Non-U.S. government securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 0 | |
Unrealized Losses, 12 Months or Greater | 0 | |
Long-term Investments [Member] | Municipal securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 4,973 | 8,933 |
Unrealized Losses, 12 Months or Greater | (73) | |
Long-term Investments [Member] | Corporate debt securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 0 | 71,625 |
Unrealized Losses, 12 Months or Greater | (964) | |
Long-term Investments [Member] | Commercial Paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | $ 0 | 0 |
Unrealized Losses, 12 Months or Greater | $ 0 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Quoted prices in Active Market for Identical Assets (Level 1) | Money market funds | ||
Financial assets: | ||
Money market funds | $ 33,334 | $ 61,333 |
Quoted prices in Active Market for Identical Assets (Level 1) | U.S. Treasury debt securities | ||
Financial assets: | ||
Investment | 73,383 | 79,025 |
Significant Other Observable Inputs (Level 2) | Non-U.S. government securities | ||
Financial assets: | ||
Investment | 2,423 | |
Significant Other Observable Inputs (Level 2) | Municipal securities | ||
Financial assets: | ||
Investment | 32,153 | 23,697 |
Significant Other Observable Inputs (Level 2) | Corporate debt securities | ||
Financial assets: | ||
Investment | 54,073 | 122,861 |
Significant Other Observable Inputs (Level 2) | Commercial paper | ||
Financial assets: | ||
Investment | 156,791 | 151,830 |
Fair Value Measurements Recurring | ||
Financial assets: | ||
Total financial assets measured at fair value on a recurring basis | 349,734 | 441,169 |
Financial liabilities: | ||
Total financial liabilities measured at fair value on a recurring basis | 701 | 3,861 |
Fair Value Measurements Recurring | Stock price appreciation milestones | ||
Financial liabilities: | ||
Stock price appreciation milestones | 701 | 3,861 |
Fair Value Measurements Recurring | Money market funds | ||
Financial assets: | ||
Money market funds | 33,334 | 61,333 |
Fair Value Measurements Recurring | U.S. Treasury debt securities | ||
Financial assets: | ||
Investment | 73,383 | 79,025 |
Fair Value Measurements Recurring | Non-U.S. government securities | ||
Financial assets: | ||
Investment | 2,423 | |
Fair Value Measurements Recurring | Municipal securities | ||
Financial assets: | ||
Investment | 32,153 | 23,697 |
Fair Value Measurements Recurring | Corporate debt securities | ||
Financial assets: | ||
Investment | 54,073 | 122,861 |
Fair Value Measurements Recurring | Commercial paper | ||
Financial assets: | ||
Investment | 156,791 | 151,830 |
Fair Value Measurements Recurring | Quoted prices in Active Market for Identical Assets (Level 1) | ||
Financial assets: | ||
Total financial assets measured at fair value on a recurring basis | 106,717 | 140,358 |
Fair Value Measurements Recurring | Significant Other Observable Inputs (Level 2) | ||
Financial assets: | ||
Total financial assets measured at fair value on a recurring basis | 243,017 | 300,811 |
Fair Value Measurements Recurring | Significant Unobservable Inputs (Level 3) | ||
Financial liabilities: | ||
Total financial liabilities measured at fair value on a recurring basis | 701 | 3,861 |
Fair Value Measurements Recurring | Significant Unobservable Inputs (Level 3) | Stock price appreciation milestones | ||
Financial liabilities: | ||
Stock price appreciation milestones | $ 701 | $ 3,861 |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details 2) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Closing stock price as of re measurement date | $ 2.12 | $ 2.12 | ||
Changes in fair value of stock price appreciation milestones liability | $ (1,049,000) | $ (891,000) | $ (3,160,000) | $ (15,131,000) |
Fair value assets level 1 to level 2 transfers amounts | 0 | 0 | ||
Fair value assets level 2 to level 1 transfers amounts | 0 | 0 | ||
Fair Value Measurements Nonrecurring | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Changes in fair value of stock price appreciation milestones liability | 100,000 | |||
Financial assets/ Non-financial assets | 0 | $ 0 | ||
Stock price increased by 10% per share | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Sensitivity analysis fair value inputs stock price increase/decrease | 10% | |||
Sensitivity analysis share price fair value input | $ 2.33 | |||
Changes in fair value of stock price appreciation milestones liability | $ 100 | |||
Stock price decreased by 10% per share | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Sensitivity analysis fair value inputs stock price increase/decrease | 10% | |||
Sensitivity analysis share price fair value input | $ 1.91 |
Fair Value Measurements (Deta_3
Fair Value Measurements (Details 3) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Changes in fair value of stock price appreciation milestones liability | $ (1,049) | $ (891) | $ (3,160) | $ (15,131) |
Significant Unobservable Inputs (Level 3) | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Balance at the beginning of the period | 3,861 | |||
Changes in fair value of stock price appreciation milestones liability | (3,160) | |||
Balance at the end of the period | $ 701 | $ 701 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current accrued expenses | ||
Accrued clinical trial related costs | $ 10,851 | $ 16,858 |
Accrued payroll and other employee benefits | 9,055 | 17,899 |
Accrued other | 8,634 | 19,175 |
Total current accrued expenses | $ 28,540 | $ 53,932 |
Leases (Additional Information)
Leases (Additional Information) (Details) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Apr. 30, 2023 ft² | |
Lessee Lease Description [Line Items] | |||||
Lessee, operating lease, option to extend | These leases have terms varying from one to approximately sixteen years, with renewal options of up to ten years | ||||
Lessee, operating lease, existence of option to extend | true | ||||
Future minimum payments under the operating leases | $ 166,542,000 | $ 166,542,000 | |||
Remaining weighted-average lease term | 10 years 10 months 24 days | 10 years 10 months 24 days | |||
Operating lease liabilities, weighted-average discount rate | 8.34% | 8.34% | |||
Total short-term lease expense | $ 0 | $ 0 | $ 0 | $ 0 | |
Net Rentable Area | ft² | 18,913 | ||||
Minimum | |||||
Lessee Lease Description [Line Items] | |||||
Future minimum payments under the operating leases | $ 166,500 | $ 166,500 | |||
Maximum | |||||
Lessee Lease Description [Line Items] | |||||
Lease term | 16 years | 16 years | |||
Maximum | The Premises 2020 Lease Agreement | |||||
Lessee Lease Description [Line Items] | |||||
Renewal term | 10 years | 10 years |
Leases - Schedule of sublease i
Leases - Schedule of sublease income (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||||
Sublease income | $ 273 | $ 0 | $ 456 | $ 0 |
Leases (Details 1)
Leases (Details 1) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Lease, Cost [Abstract] | ||||
Straight-line lease expense | $ 3,456 | $ 3,620 | $ 6,817 | $ 10,754 |
Variable lease expense | 467 | 615 | 1,578 | 1,910 |
Total operating lease expense | $ 3,923 | $ 4,235 | $ 8,395 | $ 12,664 |
Leases (Details 2)
Leases (Details 2) $ in Thousands | Sep. 30, 2023 USD ($) |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | |
Remaining 2023 | $ 3,614 |
2024 | 14,659 |
2025 | 15,087 |
2026 | 15,540 |
2027 | 16,006 |
2028 | 15,057 |
Thereafter | 86,579 |
Total undiscounted lease payments | 166,542 |
Less: imputed interest | (61,588) |
Total lease liability | $ 104,954 |
Convertible Preferred Stock a_3
Convertible Preferred Stock and Stockholders' Equity (Additional information) (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Apr. 30, 2023 | Jan. 31, 2021 | Nov. 30, 2016 | Sep. 30, 2023 | Dec. 31, 2019 | Dec. 31, 2022 | May 02, 2017 | |
Convertible preferred stock | |||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||||
Employee And Non Employee Stock Option | |||||||
Convertible preferred stock | |||||||
Unrecognized compensation cost related to outstanding options | $ 27.7 | ||||||
Expected recognition weighted average period of unrecognized compensation cost | 2 years | ||||||
Restricted Stock Units (RSUs) | |||||||
Convertible preferred stock | |||||||
Expected recognition weighted average period of unrecognized compensation cost | 2 years 2 months 12 days | ||||||
Unrecognized compensation cost related to unvested restricted shares | $ 49.1 | ||||||
Pre-Funded Warrants | |||||||
Convertible preferred stock | |||||||
Number of shares to be purchased | 257,310 | 257,310 | |||||
Purchase price of prefunded warrants | $ 85.499 | ||||||
Exercise price of warrants | $ 0.001 | ||||||
Terms of exercise | The Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of Pre-Funded Warrants may not exercise the Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to the Company | ||||||
Maximum percentage of common stock ownership together with affiliates allowable after exercise of prefunded warrants | 9.99% | ||||||
Maximum percentage of common stock ownership after change upon notice | 19.99% | ||||||
Common Stock | |||||||
Convertible preferred stock | |||||||
Conversion of preferred shares to common stock | 167,205 | 125,000 | |||||
Non-Voting Class A Preferred Stock | Redmile Group, LLC and Affiliates | |||||||
Convertible preferred stock | |||||||
Percentage of common stock ownership upon preferred stock conversion | 19.99% | ||||||
Terms of conversion | The Class A Preferred were purchased exclusively by entities affiliated with Redmile Group, LLC (collectively, Redmile). The terms of the CoD prohibited Redmile from converting the Class A Preferred into shares of the Company’s common stock if, as a result of conversion, Redmile, together with its affiliates, would own more than 9.99% of the Company’s common stock then issued and outstanding (the Redmile Percentage Limitation), which percentage could change at Redmile’s election upon 61 days’ notice to the Company to (i) any other number less than or equal to 19.99% or (ii) subject to approval of the Company’s stockholders to the extent required in accordance with the NASDAQ Global Market rules, any number in excess of 19.99%. On May 2, 2017, the Company’s stockholders approved the issuance of up to an aggregate of 14,097,745 shares of common stock upon the conversion of the outstanding shares of Class A Preferred. As a result, Redmile has the right to increase the Redmile Percentage Limitation to any percentage in excess of 19.99% at its election. | ||||||
Non-Voting Class A Preferred Stock | Maximum | |||||||
Convertible preferred stock | |||||||
Number of shares to be issued upon conversion | 14,097,745 | ||||||
Non-Voting Class A Preferred Stock | Maximum | Redmile Group, LLC and Affiliates | |||||||
Convertible preferred stock | |||||||
Percentage of common stock ownership upon preferred stock conversion | 9.99% | ||||||
Preferred shares converted into common stock percentage of ownership change upon notice | 19.99% | ||||||
Class A Convertible Preferred Shares | |||||||
Convertible preferred stock | |||||||
Preferred stock, issued shares | 2,761,108 | 2,794,549 | |||||
Percentage of common stock ownership upon preferred stock conversion | 14.99% | ||||||
Conversion of preferred shares to common stock | 33,441 | 25,000 | |||||
Class A Convertible Preferred Shares | Redmile Group, LLC and Affiliates | |||||||
Convertible preferred stock | |||||||
Percentage of common stock ownership upon preferred stock conversion | 19.99% | ||||||
November 2016 Placement | Common Stock | |||||||
Convertible preferred stock | |||||||
Share issue price (in dollars per share) | $ 2.66 | ||||||
Common stock issued | 7,236,837 | ||||||
November 2016 Placement | Non-Voting Class A Preferred Stock | |||||||
Convertible preferred stock | |||||||
Preferred stock, issued shares | 2,819,549 | ||||||
Share issue price (in dollars per share) | $ 13.3 | ||||||
Number of shares to be issued upon conversion | 5 | ||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | ||||||
Conversion price | $ 2.66 |
Convertible Preferred Stock a_4
Convertible Preferred Stock and Stockholders' Equity - Stock option activity under all equity and stock option plans (Details) - Employee And Non Employee Stock Option | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Number of Options | |
Balance at the beginning of the period | shares | 7,267,226 |
Granted | shares | 5,525,000 |
Exercised | shares | (93,787) |
Cancelled | shares | (2,361,503) |
Balance at the end of the period | shares | 10,336,936 |
Weighted-Average Price | |
Balance at the beginning of the period | $ / shares | $ 22.37 |
Granted | $ / shares | 6.66 |
Exercised | $ / shares | 3.24 |
Cancelled | $ / shares | 22.23 |
Balance at the end of the period | $ / shares | $ 14.17 |
Convertible Preferred Stock a_5
Convertible Preferred Stock and Stockholders' Equity - Restricted stock unit activity under all equity and stock option plans (Details) - Restricted Stock Units (RSUs) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Number of Restricted Stock Units | |
Balance at the beginning of the period | shares | 5,862,733 |
Granted | shares | 1,161,540 |
Vested | shares | (1,029,841) |
Cancelled | shares | (2,626,107) |
Balance at the end of the period | shares | 3,368,325 |
Weighted-Average Grant Date Fair Value per Share | |
Balance at the beginning of the period | $ / shares | $ 48.13 |
Granted | $ / shares | 6.68 |
Vested | $ / shares | 42.83 |
Cancelled | $ / shares | 45.02 |
Balance at the end of the period | $ / shares | $ 37.77 |
Convertible Preferred Stock a_6
Convertible Preferred Stock and Stockholders' Equity - Stock based compensation for all stock awards (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Convertible preferred stock | ||||
Total stock-based compensation expense | $ 10,104 | $ 19,468 | $ 33,984 | $ 59,341 |
Research And Development | ||||
Convertible preferred stock | ||||
Total stock-based compensation expense | 4,783 | 12,446 | 16,690 | 38,710 |
General And Administrative | ||||
Convertible preferred stock | ||||
Total stock-based compensation expense | $ 5,321 | $ 7,022 | $ 17,294 | $ 20,631 |
Convertible Preferred Stock a_7
Convertible Preferred Stock and Stockholders' Equity - Weighted average assumptions used in the Black-Scholes option pricing model (Details) - Employee And Non Employee Stock Option | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Weighted-average assumptions to determine fair value of stock options | ||
Risk-free interest rate | 3.80% | 1.90% |
Expected volatility | 89.60% | 76.20% |
Expected term (in years) | 6 years 4 months 24 days | 5 years 9 months 18 days |
Expected dividend yield | 0% | 0% |
Convertible Preferred Stock a_8
Convertible Preferred Stock and Stockholders' Equity (Details 6) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Class Of Stock [Line Items] | ||||||||
Balance | $ 437,755 | $ 477,472 | $ 483,939 | $ 580,483 | $ 633,393 | $ 678,838 | $ 483,939 | $ 678,838 |
Balance (in shares) | 2,761,108 | |||||||
Exercise of stock options, net of issuance costs | 81 | 222 | 1,487 | 3,184 | 3,001 | |||
Issuance of common stock upon vesting of restricted stock units | 1 | 1 | ||||||
Stock-based compensation | $ 10,104 | $ 12,897 | 10,983 | 19,468 | 20,542 | 19,331 | ||
Conversion of preferred shares to common stock Shares | (33,441) | |||||||
Conversion of preferred shares to common stock Value | $ 1 | |||||||
Unrealized gain (loss) on investments | 88 | 59 | 1,208 | 128 | (531) | (2,088) | ||
Net loss | 45,170 | 52,755 | 18,881 | 83,563 | 76,105 | 65,690 | 116,806 | 225,358 |
Balance | $ 402,777 | $ 437,755 | $ 477,472 | $ 518,003 | $ 580,483 | $ 633,393 | $ 402,777 | $ 518,003 |
Balance (in shares) | 2,761,108 | 2,761,108 | 2,761,108 | |||||
Class A Convertible Preferred Shares | ||||||||
Class Of Stock [Line Items] | ||||||||
Balance (in shares) | 2,794,549 | 2,794,549 | 2,794,549 | 2,794,549 | 2,794,549 | 2,794,549 | 2,794,549 | |
Net loss | $ (45,200) | $ (83,600) | $ (116,800) | $ (225,400) | ||||
Balance (in shares) | 2,794,549 | 2,794,549 | 2,794,549 | 2,794,549 | 2,794,549 | |||
Preferred Stock | Class A Convertible Preferred Shares | ||||||||
Class Of Stock [Line Items] | ||||||||
Balance | 3 | $ 3 | $ 3 | $ 3 | $ 3 | $ 3 | 3 | $ 3 |
Balance | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 |
Common Stock | ||||||||
Class Of Stock [Line Items] | ||||||||
Balance | $ 99 | $ 98 | $ 97 | $ 97 | $ 97 | $ 96 | $ 97 | $ 96 |
Balance (in shares) | 98,522,718 | 98,191,015 | 97,294,917 | 96,862,797 | 96,538,084 | 95,726,962 | 97,294,917 | 95,726,962 |
Exercise of stock options, net of issuance costs (in shares) | 24,940 | 68,847 | 181,688 | 251,486 | 398,415 | |||
Issuance of common stock upon vesting of restricted stock units | $ 1 | $ 1 | ||||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 63,032 | 139,558 | 827,251 | 67,724 | 73,227 | 412,707 | ||
Conversion of preferred shares to common stock Shares | 167,205 | |||||||
Conversion of preferred shares to common stock Value | $ 1 | |||||||
Balance | $ 99 | $ 99 | $ 98 | $ 97 | $ 97 | $ 97 | $ 99 | $ 97 |
Balance (in shares) | 98,585,750 | 98,522,718 | 98,191,015 | 97,112,209 | 96,862,797 | 96,538,084 | 98,585,750 | 97,112,209 |
Additional Paid In Capital | ||||||||
Class Of Stock [Line Items] | ||||||||
Balance | $ 1,560,680 | $ 1,547,702 | $ 1,536,497 | $ 1,494,642 | $ 1,470,916 | $ 1,448,584 | $ 1,536,497 | $ 1,448,584 |
Exercise of stock options, net of issuance costs | 81 | 222 | 1,487 | 3,184 | 3,001 | |||
Stock-based compensation | 10,104 | 12,897 | 10,983 | 19,468 | 20,542 | 19,331 | ||
Balance | 1,570,784 | 1,560,680 | 1,547,702 | 1,515,597 | 1,494,642 | 1,470,916 | 1,570,784 | 1,515,597 |
Accumulated Other Comprehensive Gain (Loss) | ||||||||
Class Of Stock [Line Items] | ||||||||
Balance | (587) | (646) | (1,854) | (3,381) | (2,850) | (762) | (1,854) | (762) |
Unrealized gain (loss) on investments | 88 | 59 | 1,208 | (128) | (531) | (2,088) | ||
Balance | (499) | (587) | (646) | (3,253) | (3,381) | (2,850) | (499) | (3,253) |
Accumulated Deficit | ||||||||
Class Of Stock [Line Items] | ||||||||
Balance | (1,122,440) | (1,069,685) | (1,050,804) | (910,878) | (834,773) | (769,083) | (1,050,804) | (769,083) |
Net loss | (45,170) | (52,755) | (18,881) | (83,563) | (76,105) | (65,690) | ||
Balance | $ (1,167,610) | $ (1,122,440) | $ (1,069,685) | $ (994,441) | $ (910,878) | $ (834,773) | $ (1,167,610) | $ (994,441) |