Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 02, 2024 | |
Cover [Abstract] | ||
Entity Registrant Name | FATE THERAPEUTICS, INC. | |
Entity Central Index Key | 0001434316 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2024 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Trading Symbol | FATE | |
Entity Common Stock, Shares Outstanding | 113,831,969 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
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 | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 121,322 | $ 41,870 |
Accounts receivable | 858 | 1,826 |
Short-term investments | 262,222 | 273,305 |
Prepaid expenses and other current assets | 9,973 | 14,539 |
Total current assets | 394,375 | 331,540 |
Long-term investments | 7,595 | 980 |
Property and equipment, net | 92,116 | 96,836 |
Operating lease right-of-use assets | 60,620 | 61,675 |
Restricted cash | 15,177 | 15,177 |
Other assets | 9 | 9 |
Total assets | 569,892 | 506,217 |
Current liabilities: | ||
Accounts payable | 6,765 | 4,719 |
Accrued expenses | 32,043 | 27,514 |
Deferred revenue | 159 | 685 |
Operating lease liabilities, current portion | 6,402 | 6,176 |
Total current liabilities | 45,369 | 39,094 |
Operating lease liabilities, net of current portion | 95,668 | 97,360 |
Stock price appreciation milestones | 2,740 | 1,346 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; authorized shares - 5,000,000 at March 31, 2024 and December 31, 2023; Class A Convertible Preferred shares issued and outstanding - 2,761,108 at March 31, 2024 and December 31, 2023 | 3 | 3 |
Common stock, $0.001 par value; authorized shares - 250,000,000 at March 31, 2024 and December 31, 2023; issued and outstanding - 113,798,942 at March 31, 2024 and 98,627,076 at December 31, 2023 | 114 | 99 |
Additional paid-in capital | 1,685,928 | 1,580,032 |
Accumulated other comprehensive income (loss) | (194) | 15 |
Accumulated deficit | (1,259,736) | (1,211,732) |
Total stockholders’ equity | 426,115 | 368,417 |
Total liabilities and stockholders’ equity | $ 569,892 | $ 506,217 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
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 | 113,798,942 | 98,627,076 |
Common stock, outstanding shares | 113,798,942 | 98,627,076 |
Convertible Preferred Stock | ||
Preferred stock, issued shares | 2,761,108 | 2,761,108 |
Preferred stock, outstanding shares | 2,761,108 | 2,761,108 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Statement [Abstract] | ||
Collaboration revenue | $ 1,925 | $ 58,980 |
Type of Revenue [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | ||
Research and development | $ 32,138 | $ 65,629 |
General and administrative | 20,855 | 21,943 |
Total operating expenses | 52,993 | 87,572 |
Loss from operations | (51,068) | (28,592) |
Other income (expense): | ||
Interest income | 4,149 | 3,694 |
Change in fair value of stock price appreciation milestones | (1,394) | 1,718 |
Other income | 309 | 4,299 |
Total other income | 3,064 | 9,711 |
Net loss | (48,004) | (18,881) |
Other comprehensive income (loss): | ||
Unrealized gain (loss) on available-for-sale securities, net | (209) | 1,208 |
Comprehensive loss | $ (48,213) | $ (17,673) |
Net loss per common share, basic | $ (0.47) | $ (0.19) |
Net loss per common share, diluted | $ (0.47) | $ (0.19) |
Weighted-average common shares used to compute basic net loss per share | 101,104,345 | 98,054,687 |
Weighted-average common shares used to compute diluted net loss per share | 101,104,345 | 98,054,687 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating activities | ||
Net loss | $ (48,004) | $ (18,881) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 4,821 | 4,191 |
Stock-based compensation | 10,981 | 10,983 |
Accretion and amortization of premiums and discounts on investments, net | (2,631) | (2,295) |
Amortization of collaboration contract assets | 0 | 7,196 |
Deferred revenue | (525) | (40,488) |
Change in fair value of stock price appreciation milestones | 1,394 | (1,718) |
Grant income from 2018 CIRM Award | 0 | (4,000) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 968 | 24,980 |
Prepaid expenses and other assets | 4,565 | 11,901 |
Accounts payable and accrued expenses | (4,507) | (20,393) |
Right-of-use assets and lease liabilities, net | (412) | (336) |
Net cash used in operating activities | (33,350) | (28,860) |
Investing activities | ||
Purchases of property and equipment | (86) | (3,208) |
Purchases of investments | (86,335) | (114,452) |
Maturities of investments | 103,735 | 127,000 |
Net cash provided by investing activities | 17,314 | 9,340 |
Financing activities | ||
Issuance of common stock from equity incentive plans, net of issuance costs | 299 | 207 |
Proceeds from public offering of common stock, net of issuance costs | 75,193 | 0 |
Proceeds from issuance of pre-funded warrants, net of issuance costs | 19,996 | 0 |
Net cash provided by financing activities | 95,488 | 207 |
Net change in cash, cash equivalents and restricted cash | 79,452 | (19,313) |
Cash, cash equivalents and restricted cash at beginning of the period | 57,047 | 76,560 |
Cash, cash equivalents and restricted cash at end of the period | 136,499 | 57,247 |
Supplemental schedule of noncash investing and financing activities | ||
Purchases of property and equipment in accounts payable | 14 | 612 |
Accrued issuance costs included in additional paid-in-capital | $ 558 | $ 0 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (48,004) | $ (18,881) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 shares | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | On March 26, 2024 , Yuan Xu , a m ember of our board of directors , entered into a 10b5-1 trading plan . Dr. Xu’s plan provides for the sale of up to 633 shares of the Company’s common stock. Sales of the shares of the Company’s common stock set forth in Dr. Xu’s trading plan, if any, will be made at or above specified market prices. The trading plan will expire on March 6, 2025 . Dr. Xu’s trading plan was entered into during an open insider trading window and is intended to satisfy Rule 10b5-1(c) under the Exchange Act and the Company’s policies regarding insider transactions. |
Yuan Xu [Member] | |
Trading Arrangements, by Individual | |
Name | Yuan Xu |
Title | ember of our board of directors |
Rule 10b5-1 Arrangement Adopted | true |
Non-Rule 10b5-1 Arrangement Adopted | false |
Adoption Date | March 26, 2024 |
Aggregate Available | 633 |
Expiration Date | March 6, 2025 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
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, induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients for the treatment of cancer and autoimmune diseases. As of March 31, 2024, 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. Public Equity Offering In March 2024, the Company completed a public offering of common stock in which investors purchased 14,545,454 shares of the Company’s common stock at a public offering price of $ 5.50 per share under a shelf registration statement. Gross proceeds from the public offering were approximately $ 80.0 million, and, after giving effect to $ 5.3 million of costs related to the public offering, net proceeds were approximately $ 74.7 million. Private Placement of Pre-Funded Warrants In March 2024, in conjunction with the public offering, the Company issued in a private placement, in lieu of common stock to certain investors, pre-funded warrants to purchase 3,636,364 shares of the Company’s common stock (2024 Pre-Funded Warrants) (see Note 8). The purchase price of the 2024 Pre-Funded Warrants was $ 5.499 per pre-funded warrant, which equals the per share public offering price for the shares of common stock issued in the March 2024 public offering, less the $ 0.001 exercise price for each pre-funded warrant, for aggregate net proceeds of approximately $ 20.0 million. Use of Estimates The Company’s unaudited condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States (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 March 31, 2024 and 2023 (in thousands): Three Months Ended March 31, 2024 2023 Cash and cash equivalents $ 121,322 $ 42,020 Restricted cash 15,177 15,227 Total cash, cash equivalents, and restricted cash shown in the unaudited condensed consolidated statement of cash flows $ 136,499 $ 57,247 For each of the three months ended March 31, 2024 and 2023, the restricted cash balance includes cash-collateralized irrevocable standby letters of credit for $ 15.2 million associated with the Company’s facilities leases. 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 U.S. 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, 2023, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company with the SEC on February 26, 2024. 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 months ended March 31, 2024 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. 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 Company’s 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. 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. 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 3,893,674 pre-funded warrants associated with the January 2021 public equity offering and the private placement concurrent with the March 2024 public equity offering (see Note 8) are included in the weighted-average common shares outstanding 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. Basic and diluted net loss per share attributable to stockholders for the three months ended March 31, 2024 and 2023 are calculated as follows (in thousands, except share and per share data): Three Months Ended March 31, 2024 2023 Numerator: Net loss $ ( 48,004 ) $ ( 18,881 ) Denominator: Shares used to compute net loss per share, basic and diluted Weighted-average common shares outstanding 100,447,435 97,797,377 Weighted-average pre-funded warrants 656,910 257,310 Weighted-average common shares outstanding used to 101,104,345 98,054,687 Net loss per share, basic and diluted Basic and diluted $ ( 0.47 ) $ ( 0.19 ) The following weighted-average outstanding shares of potentially dilutive securities are excluded from the computation of diluted net loss per share for the periods presented because including them would have been anti-dilutive: Three Months Ended March 31, 2024 2023 Convertible preferred stock 13,805,540 13,972,745 Outstanding options to purchase common stock 13,308,902 11,874,180 Outstanding restricted stock units 3,468,958 3,970,765 Total 30,583,400 29,817,690 |
Collaboration and License Agree
Collaboration and License Agreements | 3 Months Ended |
Mar. 31, 2024 | |
Collaboration And License Agreements Disclosure [Abstract] | |
Collaboration and License Agreements | 2. Collaboration and License Agreements Ono Collaboration and Option Agreement On September 14, 2018, the Company entered into a Collaboration and Option Agreement (the Ono Agreement) with Ono Phar maceutical 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 2022 Ono Amendment). Pursuant to the 2022 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 2022 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. On November 7, 2022, Ono exercised its option for continued development of Candidate 2. Upon Ono’s exercise of the option, 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 research and development expenses. During the three months ended March 31, 2024 , the Company recognized contra-research and development expense of $ 0.8 million. As of March 31, 2024 , the Company has received $ 8.0 million in aggregate cost-sharing payments from Ono. On November 30, 2023, the Company entered into an amendment with Ono to the Ono Agreement (the 2023 Ono Amendment and collectively with the 2022 Ono Amendment, the Ono Amendments). Under the 2023 Ono Amendment, aggregate estimated research and development fees payable by Ono to the Company have been increased by approximately $ 1.4 million, for a total estimated $ 30.7 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 Amendments), for Candidate 2 and for Candidate 3 (subject to exercis e 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 Amendments 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 Amendments 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. 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 2023 Ono Amendment equaled $ 40.7 million, consisting of the upfront, non-refundable and non-creditable payment of $ 10.0 million and the aggregate estimated research and development fees of $ 30.7 million. The upfront payment of $ 10.0 million was recorded as deferred revenue and was 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 was 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. As a direct result of the Company’s entry into the Ono Agreement, the Ono Amendments, and the Ono Letter Agreement, the Company incurred an aggregate of $ 7.8 million in sublicense consideration to existing licensors. 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. The Company recognized no such expense during the three months ended March 31, 2024 and 2023. The Company recognized revenue of $ 1.9 million under the Ono Agreement for the three months ended March 31, 2024. All such revenue was associated with research services for the three months ended March 31, 2024. During the three months ended March 31, 2023 , the Company recognized revenue of $ 6.7 million under the Ono Agreement. All of such revenue was associated with research services for the three months ended March 31, 2023. As of March 31, 2024 , aggregate deferred revenue related to the research services under the Ono Agreement was $ 0.2 million, all of which is classified as current. As of March 31, 2024 , the Company has received $ 34.1 million in aggregate research and development fees from Ono. 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). 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. 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. 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. Additionally, the Company received 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. In connection with the Janssen Agreement, the Company incurred $ 17.1 million in sublicense fees to certain of its existing licensors. 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 March 31, 2023 , the Company recognized $ 7.2 million of such expense. As of March 31, 2024, 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 three months ended March 31, 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 three months ended March 31, 2023. Prior to termination of the Janssen Agreement, the Company had received $ 82.0 million in aggregate research and development fees from Janssen. Memorial Sloan Kettering Cancer Center License Agreement On May 15, 2018, the Company entered into an Amended and Restated Exclusive License Agreement (Amended MSKCC License) with MSKCC. The Amended MSKCC License amends and restates the Exclusive License Agreement entered into between the Company and MSKCC on August 19, 2016 (Original MSKCC License), pursuant to which the Company entered into an exclusive license agreement with MSKCC 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 MSKCC License, MSKCC 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 MSKCC License, in which case it is obligated to pay MSKCC a percentage of certain sublicense income received by the Company. The Company is obligated to pay to MSKCC 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, MSKCC 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 MSKCC 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 MSKCC License, adjusted for any stock splits, cash dividends, stock dividends, other distributions, combinations, recapitalizations, or similar events. Under the terms of the Amended MSKCC 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 MSKCC 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 MSKCC 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 MSKCC 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 March 31, 2024: As of March 31, As of December 31, 2024 2023 Risk-free interest rate 4.3 % 4.0 % Expected volatility 84.1 % 84.0 % Estimated term (in years) 14.8 15.0 Closing stock price as of remeasurement date $ 7.34 $ 3.74 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 months ended March 31, 2024 and 2023, the Company recorded $ 1.4 million of expense and $ 1.7 million of income, respectively, associated with the change in fair value of the stock price appreciation milestones. As of March 31, 2024 and December 31, 2023, the Company recorded a liability of $ 2.7 million and $ 1.3 million, respectively, associated with the stock price appreciation milestones for the Amended MSKCC License. |
California Institute for Regene
California Institute for Regenerative Medicine Award | 3 Months Ended |
Mar. 31, 2024 | |
Award From California Institute For Regenerative Medicine Abstract | |
California Institute for Regenerative Medicine Award | 3. California Institute for Regenerative Medicine Awards 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 2018 CIRM Award). The 2018 CIRM 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 2018 CIRM Award. Pursuant to the terms of the 2018 CIRM Award, the Company, in its sole discretion, has the option to treat the 2018 CIRM Award either as a loan or as a grant. During the first quarter of 2023, the Company elected to treat the 2018 CIRM Award as a grant and derecognized the liability associated with the 2018 CIRM Award and recorded such amount in other income during the three months ended March 31, 2023. On February 22, 2024, the Company received approval from CIRM for funding of a $ 7.9 million grant (the 2024 CIRM Award) to support the conduct of the Company’s Phase 1 study of FT819 in patients with systemic lupus erythematosus (SLE). The Company finalized and executed the Award agreement in April 2024. Pursuant to the terms of the 2024 CIRM Award and certain co-funding requirements, the Company will receive five disbursements in varying amounts, with one disbursement receivable upon the execution of the 2024 CIRM Award, and four disbursements receivable based on the completion of certain development milestones throughout the project period of the Award, which is estimated to be from April 1, 2024 to March 31, 2028 (the Project Period). The Company is required to provide CIRM progress and financial update reports throughout the Project Period. |
Investments
Investments | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 and December 31, 2023 (in thousands, except for maturity in years): Maturity Amortized Unrealized Unrealized Estimated March 31, 2024 Classified as current assets: Money market fund 1 or less $ 101,163 $ — $ — $ 101,163 U.S. Treasury debt securities 1 or less 45,844 ( 33 ) — 45,811 Municipal securities 1 or less 3,212 ( 1 ) — 3,211 Corporate debt securities 1 or less 87,415 ( 86 ) 7 87,336 Commercial paper 1 or less 133,581 ( 101 ) 14 133,494 Total short-term investments $ 371,215 $ ( 221 ) $ 21 $ 371,015 Classified as non-current assets: U.S. Treasury debt securities Greater than 1 $ 1,957 $ ( 5 ) $ — $ 1,952 Corporate debt securities Greater than 1 5,636 ( 4 ) 11 5,643 Total long-term investments $ 7,593 $ ( 9 ) $ 11 $ 7,595 December 31, 2023 Classified as current assets: Money market fund 1 or less $ 35,273 $ — $ — $ 35,273 U.S. Treasury debt securities 1 or less 82,811 ( 34 ) 27 82,804 Non-US government securities 1 or less 999 — — 999 Municipal securities 1 or less 5,000 ( 3 ) — 4,997 Corporate debt securities 1 or less 47,144 ( 51 ) 14 47,107 Commercial paper 1 or less 137,339 ( 62 ) 121 137,398 Total short-term investments $ 308,566 $ ( 150 ) $ 162 $ 308,578 Classified as non-current assets: Corporate debt securities Greater than 1 $ 977 $ — $ 3 $ 980 Total long-term investments $ 977 $ — $ 3 $ 980 As of March 31, 2024 and December 31, 2023, the Company had $ 0.9 million and $ 0.9 million, respectively, of accrued interest on investments recorded in prepaid expenses and other assets on the unaudited condensed consolidated balance sheets. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements The following table presents the Company’s financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2024 and December 31, 2023 (in thousands): Fair Value Measurements at Total Quoted Prices Significant Significant As of March 31, 2024 Financial assets: Money market funds $ 101,163 $ 101,163 $ — $ — U.S. Treasury debt securities 47,763 47,763 — — Municipal securities 3,211 — 3,211 — Corporate debt securities 92,979 — 92,979 — Commercial paper 133,494 — 133,494 — Total financial assets measured at fair value on a recurring basis $ 378,610 $ 148,926 $ 229,684 $ — Financial liabilities: Stock price appreciation milestones $ 2,740 $ — $ — $ 2,740 Total financial liabilities measured at fair value on a recurring basis $ 2,740 $ — $ — $ 2,740 As of December 31, 2023 Financial assets: Money market funds $ 35,273 $ 35,273 $ — $ — U.S. Treasury debt securities 82,804 82,804 — — Non-U.S. government securities 999 — 999 — Municipal securities 4,997 — 4,997 — Corporate debt securities 48,087 — 48,087 — Commercial paper 137,398 — 137,398 — Total assets measured at fair value on a recurring basis $ 309,558 $ 118,077 $ 191,481 $ — Financial liabilities: Stock price appreciation milestones $ 1,346 $ — $ — $ 1,346 Total financial liabilities measured at fair value on a recurring basis $ 1,346 $ — $ — $ 1,346 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 March 31, 2024. Level 3 liabilities consisted of stock price appreciation milestones associated with the Amended MSKCC License as described in detail in Note 2. The following table presents the changes in fair value of the Company’s Level 3 stock price appreciation milestones liability for the three months ended March 31, 2024 (in thousands): Balance at December 31, 2023 $ 1,346 Changes in fair value of stock price appreciation milestones liability 1,394 Balance at March 31, 2024 $ 2,740 The following table presents the changes in fair value of the Company’s Level 3 stock price appreciation milestones liability for the three months ended March 31, 2023 (in thousands): Balance at December 31, 2022 $ 3,861 Changes in fair value of stock price appreciation milestones liability ( 1,718 ) Balance at March 31, 2023 $ 2,143 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued Expenses Current accrued expenses consist of the following (in thousands): March 31, December 31, Accrued clinical trial related costs $ 7,975 $ 8,833 Accrued payroll and other employee benefits 5,414 10,563 Accrued other 18,654 8,118 Total current accrued expenses $ 32,043 $ 27,514 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024, future undiscounted mini mum contractual payments under the Company’s operating leases were $ 159.3 million, which will be paid over a remaining weighted-average lease term of 10.5 years. The weighted-average discount rate for the operating lease liabilities was 8.35 %, 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 2024 2023 Straight-line lease expense $ 3,221 $ 3,318 Variable lease expense 887 613 Total operating lease expense $ 4,108 $ 3,931 No short-term lease expense was recognized during the three months ended March 31, 2024 and 2023. Future undiscounted minimum lease payments under the Company’s operating leases as of March 31, 2024 are as follows (in thousands): Operating Remaining 2024 $ 11,025 2025 15,087 2026 15,540 2027 16,006 2028 15,057 2029 10,602 Thereafter 75,978 Total undiscounted lease payments $ 159,295 Less: imputed interest ( 57,225 ) Total lease liability $ 102,070 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 months ended March 31, 2024 and 2023 was as follows (in thousands): Three Months Ended 2024 2023 Sublease income $ 273 $ — |
Convertible Preferred Stock and
Convertible Preferred Stock and Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
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 of the Class A Preferred. 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). 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 (2021 Pre-Funded Warrants). The purchase price for the 2021 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 2021 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. In March 2024, in conjunction with a public offering, the Company issued in a private placement , in lieu of common stock to certain investors, pre-funded warrants to purchase 3,636,364 shares of the Company’s common stock (2024 Pre-Funded Warrants, and collectively with the 2021 Pre-Funded Warrants, the Pre-Funded Warrants). The purchase price for the 2024 Pre-Funded Warrants was $ 5.499 per pre-funded warrant, which equals the per share public offering price for the shares of common stock issued in the March 2024 public offering, less the $ 0.001 exercise price for each such pre-funded warrant. Given that the 2024 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 March 31, 2024, there wer e 3,893,674 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 period ended March 31, 2024: Number of Weighted- Balance at December 31, 2023 9,850,841 $ 13.71 Granted 3,745,625 6.77 Exercised ( 45,438 ) 6.57 Cancelled ( 242,126 ) 10.96 Balance at March 31, 2024 13,308,902 $ 11.83 Restricted stock unit activity under all equity and stock option plans is summarized as follows: Number of Weighted- Balance at December 31, 2023 3,065,087 $ 37.96 Granted 1,076,100 6.76 Vested ( 580,974 ) 31.49 Cancelled ( 91,255 ) 27.87 Balance at March 31, 2024 3,468,958 $ 29.63 The allocation of stock-based compensation for all stock awards is as follows (in thousands): Three Months Ended 2024 2023 Research and development $ 5,716 $ 5,056 General and administrative 5,265 5,927 Total $ 10,981 $ 10,983 As of March 31, 2024, the unrecognized compensation cost related to outstanding options was $ 36.5 million and is expected to be recognized as expense over a weighted-average period of approximately 2.2 years. As of March 31, 2024, the unrecognized compensation cost related to restricted stock units was $ 38.4 million which is expected to be recognized as expense over a weighted-average period of approximately 2.1 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: Three Months Ended 2024 2023 Risk-free interest rate 3.8 % 3.8 % Expected volatility 87.1 % 89.9 % Expected term (in years) 6.4 6.4 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 months ended March 31, 2024 (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, 2023 2,761,108 $ 3 98,627,076 $ 99 $ 1,580,032 $ 15 $ ( 1,211,732 ) $ 368,417 Exercise of stock options, net of issuance costs — — 45,438 — 299 — — 299 Issuance of common stock upon vesting of restricted stock units — — 580,974 — — — — — Stock-based compensation — — — — 10,981 — — 10,981 Public offering of common stock, net of issuance costs — — 14,545,454 15 74,620 — — 74,635 Private placement of pre-funded warrants, net of issuance costs — — — — 19,996 — — 19,996 Unrealized loss on investments — — — — — ( 209 ) — ( 209 ) Net loss — — — — — — ( 48,004 ) ( 48,004 ) Balance at March 31, 2024 2,761,108 $ 3 113,798,942 $ 114 $ 1,685,928 $ ( 194 ) $ ( 1,259,736 ) $ 426,115 The following table summarizes the Company’s changes in stockholders’ equity accounts for the three months ended March 31, 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 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | 9. Subsequent Events In May 2024, the Company achieved a development milestone in accordance with the Ono Agreement. The Company is entitled to a milestone payment of $ 5.0 million from Ono. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Public Equity Offering | Public Equity Offering In March 2024, the Company completed a public offering of common stock in which investors purchased 14,545,454 shares of the Company’s common stock at a public offering price of $ 5.50 per share under a shelf registration statement. Gross proceeds from the public offering were approximately $ 80.0 million, and, after giving effect to $ 5.3 million of costs related to the public offering, net proceeds were approximately $ 74.7 million. |
Private Placement of Pre-Funded Warrants | Private Placement of Pre-Funded Warrants In March 2024, in conjunction with the public offering, the Company issued in a private placement, in lieu of common stock to certain investors, pre-funded warrants to purchase 3,636,364 shares of the Company’s common stock (2024 Pre-Funded Warrants) (see Note 8). The purchase price of the 2024 Pre-Funded Warrants was $ 5.499 per pre-funded warrant, which equals the per share public offering price for the shares of common stock issued in the March 2024 public offering, less the $ 0.001 exercise price for each pre-funded warrant, for aggregate net proceeds of approximately $ 20.0 million. |
Use of Estimates | Use of Estimates The Company’s unaudited condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States (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 March 31, 2024 and 2023 (in thousands): Three Months Ended March 31, 2024 2023 Cash and cash equivalents $ 121,322 $ 42,020 Restricted cash 15,177 15,227 Total cash, cash equivalents, and restricted cash shown in the unaudited condensed consolidated statement of cash flows $ 136,499 $ 57,247 For each of the three months ended March 31, 2024 and 2023, the restricted cash balance includes cash-collateralized irrevocable standby letters of credit for $ 15.2 million associated with the Company’s facilities leases. |
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 U.S. 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, 2023, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company with the SEC on February 26, 2024. 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 months ended March 31, 2024 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. |
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 Company’s 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. |
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. |
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 3,893,674 pre-funded warrants associated with the January 2021 public equity offering and the private placement concurrent with the March 2024 public equity offering (see Note 8) are included in the weighted-average common shares outstanding 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. Basic and diluted net loss per share attributable to stockholders for the three months ended March 31, 2024 and 2023 are calculated as follows (in thousands, except share and per share data): Three Months Ended March 31, 2024 2023 Numerator: Net loss $ ( 48,004 ) $ ( 18,881 ) Denominator: Shares used to compute net loss per share, basic and diluted Weighted-average common shares outstanding 100,447,435 97,797,377 Weighted-average pre-funded warrants 656,910 257,310 Weighted-average common shares outstanding used to 101,104,345 98,054,687 Net loss per share, basic and diluted Basic and diluted $ ( 0.47 ) $ ( 0.19 ) The following weighted-average outstanding shares of potentially dilutive securities are excluded from the computation of diluted net loss per share for the periods presented because including them would have been anti-dilutive: Three Months Ended March 31, 2024 2023 Convertible preferred stock 13,805,540 13,972,745 Outstanding options to purchase common stock 13,308,902 11,874,180 Outstanding restricted stock units 3,468,958 3,970,765 Total 30,583,400 29,817,690 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of 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 March 31, 2024 and 2023 (in thousands): Three Months Ended March 31, 2024 2023 Cash and cash equivalents $ 121,322 $ 42,020 Restricted cash 15,177 15,227 Total cash, cash equivalents, and restricted cash shown in the unaudited condensed consolidated statement of cash flows $ 136,499 $ 57,247 |
Schedule of Basic and Diluted Net Loss per Share Attributable to Stockholders | Basic and diluted net loss per share attributable to stockholders for the three months ended March 31, 2024 and 2023 are calculated as follows (in thousands, except share and per share data): Three Months Ended March 31, 2024 2023 Numerator: Net loss $ ( 48,004 ) $ ( 18,881 ) Denominator: Shares used to compute net loss per share, basic and diluted Weighted-average common shares outstanding 100,447,435 97,797,377 Weighted-average pre-funded warrants 656,910 257,310 Weighted-average common shares outstanding used to 101,104,345 98,054,687 Net loss per share, basic and diluted Basic and diluted $ ( 0.47 ) $ ( 0.19 ) |
Schedule of Anti-Dilutive Securities not Included in Calculation of Net Loss per Common Share | The following weighted-average outstanding shares of potentially dilutive securities are excluded from the computation of diluted net loss per share for the periods presented because including them would have been anti-dilutive: Three Months Ended March 31, 2024 2023 Convertible preferred stock 13,805,540 13,972,745 Outstanding options to purchase common stock 13,308,902 11,874,180 Outstanding restricted stock units 3,468,958 3,970,765 Total 30,583,400 29,817,690 |
Collaboration and License Agr_2
Collaboration and License Agreements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024: As of March 31, As of December 31, 2024 2023 Risk-free interest rate 4.3 % 4.0 % Expected volatility 84.1 % 84.0 % Estimated term (in years) 14.8 15.0 Closing stock price as of remeasurement date $ 7.34 $ 3.74 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Investments [Abstract] | |
Summary of Investments | The following table summarizes the Company’s investments accounted for as available-for-sale securities as of March 31, 2024 and December 31, 2023 (in thousands, except for maturity in years): Maturity Amortized Unrealized Unrealized Estimated March 31, 2024 Classified as current assets: Money market fund 1 or less $ 101,163 $ — $ — $ 101,163 U.S. Treasury debt securities 1 or less 45,844 ( 33 ) — 45,811 Municipal securities 1 or less 3,212 ( 1 ) — 3,211 Corporate debt securities 1 or less 87,415 ( 86 ) 7 87,336 Commercial paper 1 or less 133,581 ( 101 ) 14 133,494 Total short-term investments $ 371,215 $ ( 221 ) $ 21 $ 371,015 Classified as non-current assets: U.S. Treasury debt securities Greater than 1 $ 1,957 $ ( 5 ) $ — $ 1,952 Corporate debt securities Greater than 1 5,636 ( 4 ) 11 5,643 Total long-term investments $ 7,593 $ ( 9 ) $ 11 $ 7,595 December 31, 2023 Classified as current assets: Money market fund 1 or less $ 35,273 $ — $ — $ 35,273 U.S. Treasury debt securities 1 or less 82,811 ( 34 ) 27 82,804 Non-US government securities 1 or less 999 — — 999 Municipal securities 1 or less 5,000 ( 3 ) — 4,997 Corporate debt securities 1 or less 47,144 ( 51 ) 14 47,107 Commercial paper 1 or less 137,339 ( 62 ) 121 137,398 Total short-term investments $ 308,566 $ ( 150 ) $ 162 $ 308,578 Classified as non-current assets: Corporate debt securities Greater than 1 $ 977 $ — $ 3 $ 980 Total long-term investments $ 977 $ — $ 3 $ 980 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 and December 31, 2023 (in thousands): Fair Value Measurements at Total Quoted Prices Significant Significant As of March 31, 2024 Financial assets: Money market funds $ 101,163 $ 101,163 $ — $ — U.S. Treasury debt securities 47,763 47,763 — — Municipal securities 3,211 — 3,211 — Corporate debt securities 92,979 — 92,979 — Commercial paper 133,494 — 133,494 — Total financial assets measured at fair value on a recurring basis $ 378,610 $ 148,926 $ 229,684 $ — Financial liabilities: Stock price appreciation milestones $ 2,740 $ — $ — $ 2,740 Total financial liabilities measured at fair value on a recurring basis $ 2,740 $ — $ — $ 2,740 As of December 31, 2023 Financial assets: Money market funds $ 35,273 $ 35,273 $ — $ — U.S. Treasury debt securities 82,804 82,804 — — Non-U.S. government securities 999 — 999 — Municipal securities 4,997 — 4,997 — Corporate debt securities 48,087 — 48,087 — Commercial paper 137,398 — 137,398 — Total assets measured at fair value on a recurring basis $ 309,558 $ 118,077 $ 191,481 $ — Financial liabilities: Stock price appreciation milestones $ 1,346 $ — $ — $ 1,346 Total financial liabilities measured at fair value on a recurring basis $ 1,346 $ — $ — $ 1,346 |
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 for the three months ended March 31, 2024 (in thousands): Balance at December 31, 2023 $ 1,346 Changes in fair value of stock price appreciation milestones liability 1,394 Balance at March 31, 2024 $ 2,740 The following table presents the changes in fair value of the Company’s Level 3 stock price appreciation milestones liability for the three months ended March 31, 2023 (in thousands): Balance at December 31, 2022 $ 3,861 Changes in fair value of stock price appreciation milestones liability ( 1,718 ) Balance at March 31, 2023 $ 2,143 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Current accrued expenses consist of the following (in thousands): March 31, December 31, Accrued clinical trial related costs $ 7,975 $ 8,833 Accrued payroll and other employee benefits 5,414 10,563 Accrued other 18,654 8,118 Total current accrued expenses $ 32,043 $ 27,514 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Schedule of Components of Lease Expense | The components of lease expense were as follows (in thousands): Three Months Ended 2024 2023 Straight-line lease expense $ 3,221 $ 3,318 Variable lease expense 887 613 Total operating lease expense $ 4,108 $ 3,931 |
Schedule of Future Minimum Payments Under Non-cancelable Operating Leases | Future undiscounted minimum lease payments under the Company’s operating leases as of March 31, 2024 are as follows (in thousands): Operating Remaining 2024 $ 11,025 2025 15,087 2026 15,540 2027 16,006 2028 15,057 2029 10,602 Thereafter 75,978 Total undiscounted lease payments $ 159,295 Less: imputed interest ( 57,225 ) Total lease liability $ 102,070 |
Schedule of sublease Income | Sublease income is recognized in other income. Sublease income for the three months ended March 31, 2024 and 2023 was as follows (in thousands): Three Months Ended 2024 2023 Sublease income $ 273 $ — |
Convertible Preferred Stock a_2
Convertible Preferred Stock and Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 period ended March 31, 2024: Number of Weighted- Balance at December 31, 2023 9,850,841 $ 13.71 Granted 3,745,625 6.77 Exercised ( 45,438 ) 6.57 Cancelled ( 242,126 ) 10.96 Balance at March 31, 2024 13,308,902 $ 11.83 |
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, 2023 3,065,087 $ 37.96 Granted 1,076,100 6.76 Vested ( 580,974 ) 31.49 Cancelled ( 91,255 ) 27.87 Balance at March 31, 2024 3,468,958 $ 29.63 |
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 2024 2023 Research and development $ 5,716 $ 5,056 General and administrative 5,265 5,927 Total $ 10,981 $ 10,983 |
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: Three Months Ended 2024 2023 Risk-free interest rate 3.8 % 3.8 % Expected volatility 87.1 % 89.9 % Expected term (in years) 6.4 6.4 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 months ended March 31, 2024 (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, 2023 2,761,108 $ 3 98,627,076 $ 99 $ 1,580,032 $ 15 $ ( 1,211,732 ) $ 368,417 Exercise of stock options, net of issuance costs — — 45,438 — 299 — — 299 Issuance of common stock upon vesting of restricted stock units — — 580,974 — — — — — Stock-based compensation — — — — 10,981 — — 10,981 Public offering of common stock, net of issuance costs — — 14,545,454 15 74,620 — — 74,635 Private placement of pre-funded warrants, net of issuance costs — — — — 19,996 — — 19,996 Unrealized loss on investments — — — — — ( 209 ) — ( 209 ) Net loss — — — — — — ( 48,004 ) ( 48,004 ) Balance at March 31, 2024 2,761,108 $ 3 113,798,942 $ 114 $ 1,685,928 $ ( 194 ) $ ( 1,259,736 ) $ 426,115 The following table summarizes the Company’s changes in stockholders’ equity accounts for the three months ended March 31, 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 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Gross proceeds from the public offering | $ 80,000 | $ 75,193 | $ 0 |
Net proceeds from issuance of shares after related cash costs | 74,700 | ||
Costs related to equity offering | 5,300 | ||
Net loss | $ (48,004) | $ (18,881) | |
Anti-dilutive securities (in shares) | 30,583,400 | 29,817,690 | |
Letters of credit outstanding amount | $ 15,200 | $ 15,200 | $ 15,200 |
Pre-funded warrants | 3,893,674 | ||
Operating Expenses | $ 52,993 | $ 87,572 | |
Restricted Stock Units (RSUs) | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Anti-dilutive securities (in shares) | 3,468,958 | 3,970,765 | |
Class A Convertible Preferred Stock | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Anti-dilutive securities (in shares) | 13,805,540 | 13,972,745 | |
Maximum | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Short-term leases term excluded from calculation of ROU and lease liabilities | 12 months | ||
Common Stock [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Issuance of common stock in conjunction with public offering (in shares) | 14,545,454 | ||
Share issue price (in dollars per share) | $ 5.5 | $ 5.5 | |
Warrant [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Number of shares to be purchased | 3,636,364 | 3,636,364 | |
Purchase price of prefunded warrants | $ 5.499 | ||
Exercise price of warrants | $ 0.001 | $ 0.001 | |
Net proceeds from issuance of shares after related cash costs | $ 20,000 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies (Details 1) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Cash and cash equivalents | $ 121,322 | $ 41,870 | $ 42,020 | |
Restricted cash | 15,177 | 15,227 | ||
Total cash, cash equivalents, and restricted cash shown in the unaudited condensed consolidated statement of cash flows | $ 136,499 | $ 57,047 | $ 57,247 | $ 76,560 |
Organization and Summary of S_6
Organization and Summary of Significant Accounting Policies (Details 2) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Numerator: | ||
Net Income (Loss) | $ (48,004) | $ (18,881) |
Denominator: | ||
Weighted-average common shares outstanding | 100,447,435 | 97,797,377 |
Weighted-average pre-funded warrants | 656,910 | 257,310 |
Weighted-average common shares used to compute basic net loss per share | 101,104,345 | 98,054,687 |
Weighted-average common shares used to compute diluted net loss per share | 101,104,345 | 98,054,687 |
Net loss per share, basic and diluted | ||
Net loss per share, basic | $ (0.47) | $ (0.19) |
Net loss per share, diluted | $ (0.47) | $ (0.19) |
Organization and Summary of S_7
Organization and Summary of Significant Accounting Policies (Details 3) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 30,583,400 | 29,817,690 |
Common Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 13,308,902 | 11,874,180 |
Restricted Stock Units (RSUs) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 3,468,958 | 3,970,765 |
Convertible Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 13,805,540 | 13,972,745 |
Collaboration and License Agr_3
Collaboration and License Agreements (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | 1 Months Ended | 3 Months Ended | |||||||||||
Nov. 07, 2022 | Apr. 02, 2020 | Sep. 14, 2018 | Sep. 14, 2018 | Jun. 30, 2022 | Jun. 30, 2020 | Sep. 30, 2018 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Nov. 30, 2023 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaboration agreement | |||||||||||||
Revenue recognized | $ 1,925 | $ 58,980 | |||||||||||
Research and development fees cash payments received | 82,000 | ||||||||||||
Proceeds from issuance of private placement | 19,996 | ||||||||||||
Income expense in change in fair value of the stock price appreciation milestones | 3,064 | 9,711 | |||||||||||
Commercial option exercise | |||||||||||||
Collaboration agreement | |||||||||||||
Revenue recognized | 10,000 | ||||||||||||
Ono Pharmaceutical Company Ltd | |||||||||||||
Collaboration agreement | |||||||||||||
Non-refundable upfront payments recorded as deferred revenue | $ 10,000 | ||||||||||||
Non-refundable upfront payments recorded as deferred revenue | $ 10,000 | 10,000 | |||||||||||
Aggregate research and development fees payments receivable | 20,000 | 20,000 | |||||||||||
Collaborative arrangement annual payments receivable recorded as deferred revenue | $ 5,000 | ||||||||||||
Collaborative arrangement potential additional milestones | 30,700 | $ 30,700 | |||||||||||
Transaction price of the agreement | $ 40,700 | ||||||||||||
Collaboration contract asset | 7,800 | ||||||||||||
Revenue recognized | 1,900 | 6,700 | |||||||||||
Research and development fees cash payments received | 34,100 | ||||||||||||
Contra research and development expenses | 800 | ||||||||||||
Proceeds from collaboration partner | 8,000 | ||||||||||||
Option exercise payment | $ 12,500 | ||||||||||||
Amortization of sublicense consideration | 0 | 0 | |||||||||||
Ono Pharmaceutical Company Ltd | Candidate 1 | |||||||||||||
Collaboration agreement | |||||||||||||
Percentage of reduction on milestone payments | 50% | ||||||||||||
Ono Pharmaceutical Company Ltd | Minimum | Candidate 1 | |||||||||||||
Collaboration agreement | |||||||||||||
Profits and losses sharing percentage | 50% | ||||||||||||
Collaborative arrangement potential additional milestones | $ 9,300 | $ 1,400 | |||||||||||
Ono Pharmaceutical Company Ltd | Maximum | Candidate 1 | |||||||||||||
Collaboration agreement | |||||||||||||
Collaborative arrangement potential additional milestones | $ 29,300 | $ 30,700 | |||||||||||
Ono Pharmaceutical Company Ltd | Maximum | Candidate 2 | |||||||||||||
Collaboration agreement | |||||||||||||
Aggregate milestone payments | $ 843,000 | ||||||||||||
Janssen Biotech Inc | |||||||||||||
Collaboration agreement | |||||||||||||
Collaboration contract asset | 17,100 | ||||||||||||
Revenue recognized | 52,300 | ||||||||||||
Amortization of sublicense consideration | 7,200 | ||||||||||||
Deferred revenue | 41,200 | ||||||||||||
Janssen Biotech Inc | Janssen Agreement | |||||||||||||
Collaboration agreement | |||||||||||||
Sublicense consideration represents an asset under ASC, other assets and deferred costs | 17,100 | ||||||||||||
Janssen Biotech Inc | Research and Development | |||||||||||||
Collaboration agreement | |||||||||||||
Revenue recognized | 11,100 | ||||||||||||
Janssen Biotech Inc | Upfront Fee and Equity Premium | |||||||||||||
Collaboration agreement | |||||||||||||
Revenue recognized | 31,200 | ||||||||||||
Amended Mskcc License | |||||||||||||
Collaboration agreement | |||||||||||||
Enterprise value milestone payment | 75,000 | ||||||||||||
Stock price appreciation milestone payable | $ 20,000 | ||||||||||||
Enterprise value milestones liability at fair value | 2,700 | $ 1,300 | |||||||||||
Amended MSK License | |||||||||||||
Collaboration agreement | |||||||||||||
Income expense in change in fair value of the stock price appreciation milestones | 1,400 | $ 1,700 | |||||||||||
Ono Letter Agreement | Ono Pharmaceutical Company Ltd | |||||||||||||
Collaboration agreement | |||||||||||||
Milestone payments | $ 10,000 | ||||||||||||
Deferred revenue | 200 | ||||||||||||
Ono Letter Agreement | Ono Pharmaceutical Company Ltd | Sublicense Consideration | |||||||||||||
Collaboration agreement | |||||||||||||
Sublicense consideration paid | $ 7,800 | ||||||||||||
Johnson Johnson Innovation J J D C Inc | Stock Purchase Agreement | |||||||||||||
Collaboration agreement | |||||||||||||
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 | ||||||||||||
Aggregate purchase price of common stock | $ 50,000 | ||||||||||||
Issuance of common stock during period for private placements (in shares) | 1.8 | ||||||||||||
Common stock per share | $ 28.31 |
Collaboration and License Agr_4
Collaboration and License Agreements (Details 1) - Amended MSK License $ / shares in Units, $ in Millions | 3 Months Ended |
Mar. 31, 2024 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_5
Collaboration and License Agreements (Details 2) - Amended MSK License - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Determine the estimated fair value of the enterprise value milestone payments | ||
Risk-free interest rate | 4.30% | 4% |
Expected volatility | 84.10% | 84% |
Estimated term (in years) | 14 years 9 months 18 days | 15 years |
Closing stock price as of remeasurement date | $ 7.34 | $ 3.74 |
California Institute For Rege_2
California Institute For Regenerative Medicine Award (Details) - California Institute for Regenerative Medicine - USD ($) $ in Millions | Feb. 22, 2024 | Apr. 05, 2018 |
FT516 | ||
Award from California institute for regenerative medicine | ||
Award agreement executed date | Apr. 05, 2018 | |
Award for first-in-human clinical trial | $ 4 | |
FT819 [Member] | ||
Award from California institute for regenerative medicine | ||
Grant awarded | $ 7.9 |
Investments (Details)
Investments (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Prepaid Expenses And Other Assets | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Accured Interest on investments | $ 0.9 | $ 0.9 |
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 1)
Investments (Details 1) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Money market funds | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 101,163 | $ 35,273 |
Unrealized Losses | 0 | |
Unrealised Gains | 0 | |
Estimated Fair Value | $ 101,163 | $ 35,273 |
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 | $ 45,844 | $ 82,811 |
Unrealized Losses | (33) | (34) |
Unrealised Gains | 27 | |
Estimated Fair Value | $ 45,811 | $ 82,804 |
U.S. Treasury debt securities | Non-current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | Greater than 1 | |
Amortized Cost | $ 1,957 | |
Unrealized Losses | (5) | |
Unrealised Gains | ||
Estimated Fair Value | $ 1,952 | |
Non-U.S. government securities | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | |
Amortized Cost | $ 999 | |
Unrealized Losses | 0 | |
Unrealised Gains | 0 | |
Estimated Fair Value | $ 999 | |
Municipal securities | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 3,212 | $ 5,000 |
Unrealized Losses | (1) | (3) |
Unrealised Gains | 0 | |
Estimated Fair Value | $ 3,211 | $ 4,997 |
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 | $ 87,415 | $ 47,144 |
Unrealized Losses | (86) | (51) |
Unrealised Gains | 7 | 14 |
Estimated Fair Value | $ 87,336 | $ 47,107 |
Corporate debt securities | Non-current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | Greater than 1 | Greater than 1 |
Amortized Cost | $ 5,636 | $ 977 |
Unrealized Losses | (4) | 0 |
Unrealised Gains | 11 | 3 |
Estimated Fair Value | $ 5,643 | $ 980 |
Commercial Paper | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 133,581 | $ 137,339 |
Unrealized Losses | (101) | (62) |
Unrealised Gains | 14 | 121 |
Estimated Fair Value | 133,494 | 137,398 |
Short-term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 371,215 | 308,566 |
Unrealized Losses | (221) | (150) |
Unrealised Gains | 21 | 162 |
Estimated Fair Value | 371,015 | 308,578 |
Long-term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 7,593 | 977 |
Unrealized Losses | (9) | 0 |
Unrealised Gains | 11 | 3 |
Estimated Fair Value | $ 7,595 | $ 980 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Fair Value Measurements Recurring - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Financial assets: | ||
Total financial assets measured at fair value on a recurring basis | $ 378,610 | $ 309,558 |
Financial liabilities: | ||
Total financial liabilities measured at fair value on a recurring basis | 2,740 | 1,346 |
Stock price appreciation milestones | ||
Financial liabilities: | ||
Stock price appreciation milestones | 2,740 | 1,346 |
Money market funds | ||
Financial assets: | ||
Money market funds | 101,163 | 35,273 |
U.S. Treasury debt securities | ||
Financial assets: | ||
Investment | 47,763 | 82,804 |
Non-U.S. government securities | ||
Financial assets: | ||
Investment | 999 | |
Municipal securities | ||
Financial assets: | ||
Investment | 3,211 | 4,997 |
Corporate debt securities | ||
Financial assets: | ||
Investment | 92,979 | 48,087 |
Commercial paper | ||
Financial assets: | ||
Investment | 133,494 | 137,398 |
Quoted prices in Active Market for Identical Assets (Level 1) | ||
Financial assets: | ||
Total financial assets measured at fair value on a recurring basis | 148,926 | 118,077 |
Quoted prices in Active Market for Identical Assets (Level 1) | Money market funds | ||
Financial assets: | ||
Money market funds | 101,163 | 35,273 |
Quoted prices in Active Market for Identical Assets (Level 1) | U.S. Treasury debt securities | ||
Financial assets: | ||
Investment | 47,763 | 82,804 |
Significant Other Observable Inputs (Level 2) | ||
Financial assets: | ||
Total financial assets measured at fair value on a recurring basis | 229,684 | 191,481 |
Significant Other Observable Inputs (Level 2) | Non-U.S. government securities | ||
Financial assets: | ||
Investment | 999 | |
Significant Other Observable Inputs (Level 2) | Municipal securities | ||
Financial assets: | ||
Investment | 3,211 | 4,997 |
Significant Other Observable Inputs (Level 2) | Corporate debt securities | ||
Financial assets: | ||
Investment | 92,979 | 48,087 |
Significant Other Observable Inputs (Level 2) | Commercial paper | ||
Financial assets: | ||
Investment | 133,494 | 137,398 |
Significant Unobservable Inputs (Level 3) | ||
Financial liabilities: | ||
Total financial liabilities measured at fair value on a recurring basis | 2,740 | 1,346 |
Significant Unobservable Inputs (Level 3) | Stock price appreciation milestones | ||
Financial liabilities: | ||
Stock price appreciation milestones | $ 2,740 | $ 1,346 |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details 1) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Change in fair value of stock price appreciation milestones | $ 1,394 | $ (1,718) |
Fair Value Measurements (Deta_3
Fair Value Measurements (Details 2) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Change in fair value of stock price appreciation milestones | $ 1,394 | $ (1,718) |
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 | 1,346 | 3,861 |
Change in fair value of stock price appreciation milestones | 1,394 | (1,718) |
Balance at the end of the period | $ 2,740 | $ 2,143 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current accrued expenses | ||
Accrued clinical trial related costs | $ 7,975 | $ 8,833 |
Accrued payroll and other employee benefits | 5,414 | 10,563 |
Accrued other | 18,654 | 8,118 |
Total current accrued expenses | $ 32,043 | $ 27,514 |
Leases (Details)
Leases (Details) | 3 Months Ended | ||
Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | 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 | ||
Future minimum payments under the operating leases | $ 159,295,000 | ||
Remaining weighted-average lease term | 10 years 6 months | ||
Operating lease liabilities, weighted-average discount rate | 8.35% | ||
Total short-term lease expense | $ 0 | $ 0 | |
Net Rentable Area | ft² | 18,913 | ||
Minimum | |||
Lessee Lease Description [Line Items] | |||
Future minimum payments under the operating leases | $ 159,300 | ||
Maximum | |||
Lessee Lease Description [Line Items] | |||
Lease term | 16 years | ||
Maximum | The Premises 2020 Lease Agreement | |||
Lessee Lease Description [Line Items] | |||
Renewal term | 10 years |
Leases (Details 1)
Leases (Details 1) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Leases [Abstract] | ||
Sublease income | $ 273 | $ 0 |
Leases (Details 2)
Leases (Details 2) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Lease, Cost [Abstract] | ||
Straight-line lease expense | $ 3,221 | $ 3,318 |
Variable lease expense | 887 | 613 |
Total operating lease expense | $ 4,108 | $ 3,931 |
Leases (Details 3)
Leases (Details 3) $ in Thousands | Mar. 31, 2024 USD ($) |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | |
Remaining 2024 | $ 11,025 |
2025 | 15,087 |
2026 | 15,540 |
2027 | 16,006 |
2028 | 15,057 |
2029 | 10,602 |
Thereafter | 75,978 |
Total undiscounted lease payments | 159,295 |
Less: imputed interest | (57,225) |
Total lease liability | $ 102,070 |
Convertible Preferred Stock a_3
Convertible Preferred Stock and Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |||||
Mar. 31, 2024 | Apr. 30, 2023 | Jan. 31, 2021 | Nov. 30, 2016 | Mar. 31, 2024 | Dec. 31, 2023 | May 02, 2017 | |
Convertible preferred stock | |||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Employee And Non Employee Stock Option | |||||||
Convertible preferred stock | |||||||
Unrecognized compensation cost related to outstanding options | $ 36.5 | $ 36.5 | |||||
Expected recognition weighted average period of unrecognized compensation cost | 2 years 2 months 12 days | ||||||
Restricted Stock Units (RSUs) | |||||||
Convertible preferred stock | |||||||
Unrecognized compensation cost related to outstanding options | $ 38.4 | $ 38.4 | |||||
Expected recognition weighted average period of unrecognized compensation cost | 2 years 1 month 6 days | ||||||
Pre-Funded Warrants | |||||||
Convertible preferred stock | |||||||
Number of shares to be purchased | 3,893,674 | 257,310 | 3,893,674 | ||||
Purchase price of prefunded warrants | $ 5.499 | $ 85.499 | |||||
Exercise price of warrants | $ 0.001 | $ 0.001 | $ 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% | 9.99% | |||||
Maximum percentage of common stock ownership after change upon notice | 19.99% | 19.99% | |||||
Common Stock | |||||||
Convertible preferred stock | |||||||
Share issue price (in dollars per share) | $ 5.5 | $ 5.5 | |||||
Public offering of common stock, net of issuance costs (in shares) | 14,545,454 | ||||||
Conversion of preferred shares to common stock | 167,205 | ||||||
Warrant [Member] | |||||||
Convertible preferred stock | |||||||
Number of shares to be purchased | 3,636,364 | 3,636,364 | |||||
Purchase price of prefunded warrants | $ 5.499 | ||||||
Exercise price of warrants | $ 0.001 | $ 0.001 | |||||
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% | ||||||
Convertible Preferred Stock | |||||||
Convertible preferred stock | |||||||
Preferred stock, issued shares | 2,761,108 | 2,761,108 | 2,761,108 | ||||
Percentage of common stock ownership upon preferred stock conversion | 14.99% | ||||||
Conversion of preferred shares to common stock | 33,441 | ||||||
Convertible Preferred Stock | 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 | ||||||
Public offering of common stock, net of issuance costs (in shares) | 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 (Details 1) - Employee And Non Employee Stock Option | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Number of Options | |
Balance at the beginning of the period | shares | 9,850,841 |
Granted | shares | 3,745,625 |
Exercised | shares | (45,438) |
Cancelled | shares | (242,126) |
Balance at the end of the period | shares | 13,308,902 |
Weighted-Average Price | |
Balance at the beginning of the period | $ / shares | $ 13.71 |
Granted | $ / shares | 6.77 |
Exercised | $ / shares | 6.57 |
Cancelled | $ / shares | 10.96 |
Balance at the end of the period | $ / shares | $ 11.83 |
Convertible Preferred Stock a_5
Convertible Preferred Stock and Stockholders' Equity (Details 2) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Number of Restricted Stock Units | |
Balance at the beginning of the period | shares | 3,065,087 |
Granted | shares | 1,076,100 |
Vested | shares | (580,974) |
Cancelled | shares | (91,255) |
Balance at the end of the period | shares | 3,468,958 |
Weighted-Average Grant Date Fair Value per Share | |
Balance at the beginning of the period | $ / shares | $ 37.96 |
Granted | $ / shares | 6.76 |
Vested | $ / shares | 31.49 |
Cancelled | $ / shares | 27.87 |
Balance at the end of the period | $ / shares | $ 29.63 |
Convertible Preferred Stock a_6
Convertible Preferred Stock and Stockholders' Equity (Details 3) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Convertible preferred stock | ||
Total stock-based compensation expense | $ 10,981 | $ 10,983 |
Research and Development | ||
Convertible preferred stock | ||
Total stock-based compensation expense | 5,716 | 5,056 |
General and Administrative | ||
Convertible preferred stock | ||
Total stock-based compensation expense | $ 5,265 | $ 5,927 |
Convertible Preferred Stock a_7
Convertible Preferred Stock and Stockholders' Equity (Details 4) - Employee And Non Employee Stock Option | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Weighted-average assumptions to determine fair value of stock options | ||
Risk-free interest rate | 3.80% | 3.80% |
Expected volatility | 87.10% | 89.90% |
Expected term (in years) | 6 years 4 months 24 days | 6 years 4 months 24 days |
Expected dividend yield | 0% | 0% |
Convertible Preferred Stock a_8
Convertible Preferred Stock and Stockholders' Equity (Details 5) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Class Of Stock [Line Items] | ||
Beginning Balance | $ 368,417 | $ 483,939 |
Exercise of stock options, net of issuance costs | 299 | 222 |
Issuance of common stock upon vesting of restricted stock units | 1 | |
Stock-based compensation | 10,981 | 10,983 |
Public offering of common stock, net of issuance costs | 74,635 | |
Private placement of pre-funded warrants, net of issuance costs | 19,996 | |
Unrealized gain loss on investments | (209) | 1,208 |
Net loss | 48,004 | 18,881 |
Ending Balance | 426,115 | 477,472 |
Preferred Stock | Convertible Preferred Stock | ||
Class Of Stock [Line Items] | ||
Beginning Balance | $ 3 | $ 3 |
Beginning Balance (in shares) | 2,761,108 | 2,794,549 |
Ending Balance | $ 3 | $ 3 |
Ending Balance (in shares) | 2,761,108 | 2,794,549 |
Common Stock | ||
Class Of Stock [Line Items] | ||
Beginning Balance | $ 99 | $ 97 |
Beginning Balance (in shares) | 98,627,076 | 97,294,917 |
Exercise of stock options, net of issuance costs (in shares) | 45,438 | 68,847 |
Issuance of common stock upon vesting of restricted stock units | $ 1 | |
Issuance of common stock upon vesting of restricted stock units (in shares) | 580,974 | 827,251 |
Public offering of common stock, net of issuance costs | $ 15 | |
Public offering of common stock, net of issuance costs (in shares) | 14,545,454 | |
Ending Balance | $ 114 | $ 98 |
Ending Balance (in shares) | 113,798,942 | 98,191,015 |
Additional Paid In Capital | ||
Class Of Stock [Line Items] | ||
Beginning Balance | $ 1,580,032 | $ 1,536,497 |
Exercise of stock options, net of issuance costs | 299 | 222 |
Stock-based compensation | 10,981 | 10,983 |
Public offering of common stock, net of issuance costs | 74,620 | |
Private placement of pre-funded warrants, net of issuance costs | 19,996 | |
Ending Balance | 1,685,928 | 1,547,702 |
Accumulated Other Comprehensive Gain (Loss) | ||
Class Of Stock [Line Items] | ||
Beginning Balance | 15 | (1,854) |
Unrealized gain loss on investments | (209) | 1,208 |
Ending Balance | (194) | (646) |
Accumulated Deficit | ||
Class Of Stock [Line Items] | ||
Beginning Balance | (1,211,732) | (1,050,804) |
Net loss | 48,004 | 18,881 |
Ending Balance | $ (1,259,736) | $ (1,069,685) |
Subsequent Events (Details)
Subsequent Events (Details) $ in Millions | May 01, 2024 USD ($) |
Subsequent Event [Member] | |
Subsequent Event [Line Items] | |
Milestone payments | $ 5 |