Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2024 | Oct. 24, 2024 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | DAY ONE BIOPHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001845337 | |
Securities Act File Number | 001-40431 | |
Entity Tax Identification Number | 83-2415215 | |
Entity Incorporation, State or Country Code | DE | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Address, Address Line One | 2000 Sierra Point Parkway | |
Entity Address, Address Line Two | Suite 501 | |
Entity Address, City or Town | Brisbane | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94005 | |
City Area Code | 650 | |
Local Phone Number | 484-0899 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | DAWN | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 100,846,294 |
Condensed Balance Sheets (unaud
Condensed Balance Sheets (unaudited) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 422,765 | $ 230,784 |
Short-term investments | 135,618 | 135,563 |
Accounts receivable, net | 8,695 | 0 |
Inventory | 2,735 | 0 |
Prepaid expenses and other current assets | 11,183 | 8,927 |
Total current assets | 580,996 | 375,274 |
Property and equipment, net | 904 | 208 |
Operating lease right-of-use asset | 2,574 | 352 |
Intangible assets, net | 16,216 | 0 |
Deposits and other long-term assets | 117 | 214 |
Total assets | 600,807 | 376,048 |
Current Liabilities: | ||
Accounts payable | 3,017 | 2,576 |
Accrued expenses and other current liabilities | 35,189 | 26,524 |
Current portion of deferred revenue | 1,462 | |
Current portion of operating lease liabilities | 77 | 408 |
Total current liabilities | 39,745 | 29,508 |
Long-term portion of deferred revenue | 3,061 | 0 |
Long-term portion of operating lease liabilities | 2,538 | 0 |
Total liabilities | 45,344 | 29,508 |
Commitments and contingencies (Note 6) | ||
Stockholders' equity | ||
Common stock, $0.0001 par value; 500,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 100,810,357 and 87,227,132 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively. | 10 | 9 |
Additional paid-in-capital | 1,043,826 | 805,107 |
Accumulated other comprehensive (loss) income | (6) | 9 |
Accumulated deficit | (488,367) | (458,585) |
Total stockholders' equity | 555,463 | 346,540 |
Total liabilities and stockholders' equity | $ 600,807 | $ 376,048 |
Condensed Balance Sheets (una_2
Condensed Balance Sheets (unaudited) (Parenthetical) - $ / shares | Sep. 30, 2024 | Dec. 31, 2023 |
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized | 500,000,000 | 500,000,000 |
Common Stock, Shares Issued | 100,810,357 | 87,227,132 |
Common Stock, Shares Outstanding | 100,810,357 | 87,227,132 |
Condensed Statements of Operati
Condensed Statements of Operations (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Revenue: | ||||
Total revenues | $ 93,761 | $ 0 | $ 101,953 | $ 0 |
Cost and operating expenses: | ||||
Cost of product revenue | 1,590 | 0 | 2,297 | 0 |
Research and development | 33,563 | 33,163 | 165,879 | 93,173 |
Selling, general and administrative | 28,972 | 18,275 | 85,715 | 53,374 |
Total cost and operating expenses | 64,125 | 51,438 | 253,891 | 146,547 |
Income (loss) from operations | 29,636 | (51,438) | (151,938) | (146,547) |
Non-operating income: | ||||
Gain from sale of priority review voucher | 0 | 0 | 108,000 | 0 |
Investment income, net | 5,322 | 5,291 | 13,649 | 12,163 |
Other income (expense), net | 1,197 | (3) | 1,177 | (22) |
Total non-operating income, net | 6,519 | 5,288 | 122,826 | 12,141 |
Income (loss) before income taxes | 36,155 | (46,150) | (29,112) | (134,406) |
Income tax benefit (expense) | 882 | 0 | (670) | 0 |
Net income (loss) | $ 37,037 | $ (46,150) | $ (29,782) | $ (134,406) |
Net income (loss) per share - basic | $ 0.38 | $ (0.54) | $ (0.33) | $ (1.73) |
Net income (loss) per share - diluted | $ 0.38 | $ (0.54) | $ (0.33) | $ (1.73) |
Weighted-average number of common shares used in net income (loss) per share - basic | 96,623,123 | 85,952,501 | 90,164,895 | 77,682,237 |
Weighted-average number of common shares used in net income (loss) per share - diluted | 96,937,759 | 85,952,501 | 90,164,895 | 77,682,237 |
Product revenue, net [Member] | ||||
Revenue: | ||||
Total revenues | $ 20,070 | $ 0 | $ 28,262 | $ 0 |
License revenue [Member] | ||||
Revenue: | ||||
Total revenues | $ 73,691 | $ 0 | $ 73,691 | $ 0 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Net Income (Loss) | $ 37,037 | $ (46,150) | $ (29,782) | $ (134,406) |
Other comprehensive income: | ||||
Unrealized gain (loss) on available-for-sale securities | 16 | 2 | (15) | 64 |
Total comprehensive income (loss) | $ 37,053 | $ (46,148) | $ (29,797) | $ (134,342) |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands | Total | Common Shares [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2022 | $ 332,039 | $ 7 | $ 601,771 | $ (71) | $ (269,668) |
Beginning Balance (In shares) at Dec. 31, 2022 | 73,458,176 | ||||
Issuance of common stock upon exercise of stock options (share) | 75,184 | ||||
Issuance of common stock upon exercise of stock options, Amount | 1,184 | 1,184 | |||
Issuance of common stock upon release of restricted stock units, shares | 60,673 | ||||
Unvested common stock forfeiture | (21,400) | ||||
Share-based compensation expenses | 9,447 | 9,447 | |||
Unrealized gain (loss) on available-for-sale securities | 138 | 138 | |||
Net Income (Loss) | (42,393) | (42,393) | |||
Ending Balance at Mar. 31, 2023 | 300,415 | $ 7 | 612,402 | 67 | (312,061) |
Ending Balance (In shares) at Mar. 31, 2023 | 73,572,633 | ||||
Beginning Balance at Dec. 31, 2022 | 332,039 | $ 7 | 601,771 | (71) | (269,668) |
Beginning Balance (In shares) at Dec. 31, 2022 | 73,458,176 | ||||
Unrealized gain (loss) on available-for-sale securities | 64 | ||||
Net Income (Loss) | (134,406) | ||||
Ending Balance at Sep. 30, 2023 | 389,627 | $ 9 | 793,699 | (7) | (404,074) |
Ending Balance (In shares) at Sep. 30, 2023 | 87,042,933 | ||||
Beginning Balance at Mar. 31, 2023 | 300,415 | $ 7 | 612,402 | 67 | (312,061) |
Beginning Balance (In shares) at Mar. 31, 2023 | 73,572,633 | ||||
Issuance of common stock upon exercise of stock options (share) | 2,704 | ||||
Issuance of common stock upon exercise of stock options, Amount | 39 | 39 | |||
Issuance of common stock upon release of restricted stock units, shares | 69,020 | ||||
Share-based compensation expenses | 9,477 | 9,477 | |||
Unrealized gain (loss) on available-for-sale securities | (76) | (76) | |||
Issuance of common stock pursuant to follow-on offering, net of issuance costs, Shares | 13,269,231 | ||||
Issuance of common stock pursuant to follow-on offering, net of issuance costs, Amount | 161,409 | $ 2 | 161,407 | ||
Issuance of common stock pursuant to Employee Stock Purchase Plan, Shares | 57,740 | ||||
Issuance of common stock pursuant to Employee Stock Purchase Plan, Amount | 653 | 653 | |||
Net Income (Loss) | (45,863) | (45,863) | |||
Ending Balance at Jun. 30, 2023 | 426,054 | $ 9 | 783,978 | (9) | (357,924) |
Ending Balance (In shares) at Jun. 30, 2023 | 86,971,328 | ||||
Issuance of common stock upon exercise of stock options (share) | 10,571 | ||||
Issuance of common stock upon exercise of stock options, Amount | 115 | 115 | |||
Issuance of common stock upon release of restricted stock units, shares | 61,034 | ||||
Share-based compensation expenses | 9,606 | 9,606 | |||
Unrealized gain (loss) on available-for-sale securities | 2 | 2 | |||
Net Income (Loss) | (46,150) | (46,150) | |||
Ending Balance at Sep. 30, 2023 | 389,627 | $ 9 | 793,699 | (7) | (404,074) |
Ending Balance (In shares) at Sep. 30, 2023 | 87,042,933 | ||||
Beginning Balance at Dec. 31, 2023 | 346,540 | $ 9 | 805,107 | 9 | (458,585) |
Beginning Balance (In shares) at Dec. 31, 2023 | 87,227,132 | ||||
Issuance of common stock upon exercise of stock options (share) | 4,862 | ||||
Issuance of common stock upon exercise of stock options, Amount | 48 | 48 | |||
Issuance of common stock upon release of restricted stock units, shares | 157,724 | ||||
Unvested common stock forfeiture | (12,555) | ||||
Share-based compensation expenses | 12,644 | 12,644 | |||
Unrealized gain (loss) on available-for-sale securities | (14) | (14) | |||
Net Income (Loss) | (62,412) | (62,412) | |||
Ending Balance at Mar. 31, 2024 | 296,806 | $ 9 | 817,799 | (5) | (520,997) |
Ending Balance (In shares) at Mar. 31, 2024 | 87,377,163 | ||||
Beginning Balance at Dec. 31, 2023 | 346,540 | $ 9 | 805,107 | 9 | (458,585) |
Beginning Balance (In shares) at Dec. 31, 2023 | 87,227,132 | ||||
Unrealized gain (loss) on available-for-sale securities | (15) | ||||
Net Income (Loss) | (29,782) | ||||
Ending Balance at Sep. 30, 2024 | 555,463 | $ 10 | 1,043,826 | (6) | (488,367) |
Ending Balance (In shares) at Sep. 30, 2024 | 100,810,357 | ||||
Beginning Balance at Mar. 31, 2024 | 296,806 | $ 9 | 817,799 | (5) | (520,997) |
Beginning Balance (In shares) at Mar. 31, 2024 | 87,377,163 | ||||
Issuance of common stock upon exercise of stock options (share) | 22,151 | ||||
Issuance of common stock upon exercise of stock options, Amount | 324 | 324 | |||
Issuance of common stock upon release of restricted stock units, shares | 211,635 | ||||
Unvested common stock forfeiture | (12,860) | ||||
Share-based compensation expenses | 13,052 | 13,052 | |||
Unrealized gain (loss) on available-for-sale securities | (17) | (17) | |||
Issuance of common stock pursuant to Employee Stock Purchase Plan, Shares | 94,827 | ||||
Issuance of common stock pursuant to Employee Stock Purchase Plan, Amount | 973 | 973 | |||
Net Income (Loss) | (4,407) | (4,407) | |||
Ending Balance at Jun. 30, 2024 | 306,731 | $ 9 | 832,148 | (22) | (525,404) |
Ending Balance (In shares) at Jun. 30, 2024 | 87,692,916 | ||||
Issuance of common stock upon exercise of stock options (share) | 67,540 | ||||
Issuance of common stock upon exercise of stock options, Amount | 977 | 977 | |||
Issuance of common stock upon release of restricted stock units, shares | 156,688 | ||||
Issuance of common stock in connection with private placement, net of placement agent fees and offering costs(Share) | 12,893,213 | ||||
Issuance of common stock in connection with private placement, net of placement agent fees and offering costs(Value) | 178,177 | $ 1 | 178,176 | ||
Issuance of prefunded warrants to purchase common stock in connection with private placement, net of issuance costs | 20,941 | 20,941 | |||
Share-based compensation expenses | 11,584 | 11,584 | |||
Unrealized gain (loss) on available-for-sale securities | 16 | 16 | |||
Net Income (Loss) | 37,037 | 37,037 | |||
Ending Balance at Sep. 30, 2024 | $ 555,463 | $ 10 | $ 1,043,826 | $ (6) | $ (488,367) |
Ending Balance (In shares) at Sep. 30, 2024 | 100,810,357 |
Condensed Statements of Stock_2
Condensed Statements of Stockholders' Equity (unaudited) (Parenthetical) $ in Thousands | 3 Months Ended |
Jun. 30, 2023 USD ($) | |
Common Stock | |
Stock issuance costs | $ 10,827 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2024 | Sep. 30, 2023 | |
Cash flows from operating activities | ||
Net Income (Loss) | $ (29,782) | $ (134,406) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Acquired in-process research and development assets | 55,000 | 3,000 |
Share-based compensation expense | 37,228 | 28,530 |
Depreciation expense | 54 | 23 |
Accretion of discounts on short-term investments, net | (3,566) | (8,502) |
Amortization of intangible assets | 884 | 0 |
Amortization of operating right-of-use asset | 332 | 257 |
Gain from sale of priority review voucher | (108,000) | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (8,695) | 0 |
Inventory | (2,683) | 0 |
Prepaid expenses and other current assets | (2,326) | (2,148) |
Deposits and other long-term assets | 97 | 236 |
Accounts payable | 441 | 3,131 |
Accrued expenses and other current liabilities | 8,665 | 4,697 |
Deferred revenue | 4,523 | 0 |
Operating lease liability | (277) | (299) |
Net cash used in operating activities | (48,105) | (105,481) |
Cash flows from investing activities | ||
Cash paid for purchase of short-term investments | (383,395) | (344,701) |
Proceeds from maturity of short-term investments | 307,482 | 445,915 |
Proceeds from sale of short-term investments | 79,409 | 0 |
Cash paid for acquired intangible assets | (17,100) | 0 |
Proceeds from sale of priority review voucher | 108,000 | 0 |
Cash paid for acquired in-process research and development assets | (55,000) | (3,000) |
Cash paid for purchase of property and equipment | (750) | (216) |
Net cash provided by investing activities | 38,646 | 97,998 |
Cash flows from financing activities | ||
Proceeds from issuance of common stock in connection with private placement, net of placement agent fees and offering costs | 178,177 | 0 |
Proceeds from issuance of prefunded warrants to purchase common stock, net of issuance costs | 20,941 | 0 |
Proceeds from the issuance of common stock, net | 0 | 161,409 |
Proceeds from issuance of common stock upon stock option exercises | 1,349 | 1,338 |
Proceeds from issuance of common stock upon Employee Stock Purchase Plan purchase | 973 | 653 |
Cash provided by financing activities | 201,440 | 163,400 |
Net increase in cash and cash equivalents | 191,981 | 155,917 |
Cash and cash equivalents, beginning of period | 230,784 | 85,262 |
Cash and cash equivalents, end of period | 422,765 | 241,179 |
Supplemental disclosure of cash flow information: | ||
IncomeTaxesPaid | 883 | 0 |
Cash Flow, Noncash Investing and Financing Activities Disclosure [Abstract] | ||
Right-of-use asset obtained in exchange for new operating lease liabilities | 2,554 | 0 |
Deferred offering costs not yet paid | 66 | 0 |
Purchases of property and equipment included in accrued expenses and other current liabilities | $ 0 | $ 41 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2024 | Jun. 30, 2024 | Mar. 31, 2024 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Pay vs Performance Disclosure | ||||||||
Net Income (Loss) | $ 37,037 | $ (4,407) | $ (62,412) | $ (46,150) | $ (45,863) | $ (42,393) | $ (29,782) | $ (134,406) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Description of Business and Org
Description of Business and Organization | 9 Months Ended |
Sep. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Organization | 1. Description of Business and Organization Organization and Business Day One Biopharmaceuticals, Inc., or the Company, is a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted cancer therapies for people of all ages with life-threatening diseases. The Company was founded in November 2018 and is headquartered in Brisbane, CA. |
Summary Of Significant Account
Summary Of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, for interim financial information and Article 10 of Regulation S-X of the Securities and Exchange Commission, or SEC, and should be read in conjunction with the Company's consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 26, 2024. The condensed financial statements presented in this Quarterly Report on Form 10-Q are unaudited; however, in the opinion of management, such financial statements reflect all adjustments, consisting solely of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in Accounting Standards Codification, or ASC, and Accounting Standards Updates, or ASU, of the Financial Accounting Standards Board, or FASB. Use of Estimates The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements, and the reported amounts of expenses during the reporting period. Estimates and assumptions made in the accompanying condensed financial statements include, but are not limited to, accruals for research and development expenses, variable consideration and other relevant inputs impacting the gross and net revenue recognition, the valuation of share-based awards, and the valuation of deferred tax assets. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable. Actual results may differ from those estimates or assumptions. Segments The Company has determined that its chief executive officer is the chief operating decision maker, or CODM. The Company operates and manages the business as one reporting and one operating segment, which is the business of developing and commercializing targeted therapies for people of all ages with genomically-defined cancers. The Company’s CODM reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All of the Company’s assets are located in the United States. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, short-term investments, and accounts receivable. Amounts on deposit may at times exceed federally insured limits. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash, cash equivalents and short-term investments that are recorded on its balance sheet. Per policy, the Company mitigates its risk by investing in high-grade instruments and limiting the concentration in any one non-United States government or government backed issuer, which limits its exposure. The Company has not experienced any losses on its cash, cash equivalents and short-term investments. For the three months ended September 30, 2024, three individual customers accounted for 100.0 % of total net product revenue, with these individual customers representing 69.0 %, 23.0 %, and 8.0 % of the Company's total net product revenue. For the nine months ended September 30, 2024, three individual customers accounted for 100.0 % of total net product revenue, with these individual customers representing 66.6 %, 27.0 %, and 6.4 % of the Company's total net product revenue. As of September 30, 2024, three customers accounted for 100.0 % of the accounts receivable balance, with these individual customers representing 55.0 %, 25.7 %, and 19.3 % of the accounts receivable balance. No other individual customers account for more than 10.0 % of net product sales or accounts receivable. The Company monitors the financial condition of its customers so that it can appropriately respond to changes in their creditworthiness. To date, the Company has not experienced any losses with respect to the collection of its accounts receivable. The Company is subject to certain risks and uncertainties and believes that changes in any of the following areas could have a material adverse effect on the Company's future financial position or results of its operations: ability to obtain future financing; regulatory requirements for approval and market acceptance of, and reimbursement for, product candidates; performance of third-party clinical research organizations and manufacturers upon which the Company relies; development of sales channels; protection of the Company’s intellectual property; litigation or claims against the Company based on intellectual property, patent, product, regulatory or other factors; changes to the market landscape; and the Company’s ability to attract and retain employees necessary to support its growth. The Company is dependent on third-party manufacturers to supply products for commercial and research and development activities in its programs. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. These programs could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients and formulated drugs. Accounts Receivable, Net Accounts receivable, net consists of trade receivables which are amounts due from the Company's specialty pharmacy and specialty distributor customers related to product sales. The Company records trade receivables net of discounts, chargebacks, and any allowances for potential credit losses. An allowance for credit losses is determined based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established over a longer period of time. For the three and nine months ended September 30, 2024 , the Company did no t record any expected credit losses related to outstanding accounts receivable. Inventory The Company began capitalizing inventory for OJEMDA upon approval by the U.S. Food and Drug Administration, or FDA, in April 2024. OJEMDA is approved for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma, or pLGG, harboring a BRAF fusion rearrangement, or BRAF V600 mutation. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. Inventory is comprised of raw materials, work-in-process and finished goods, and includes costs related to third-party contract manufacturing, packaging, freight-in and overhead. Inventory is stated at the lower of cost or net realizable value with cost based on the first-in-first-out method. Raw and intermediate materials that may be used for either research and development or commercial purposes where the intended use is not yet known are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is used or otherwise allocated for research and development, it is expensed as research and development in the period that determination is made. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of product revenue. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as a cost of product revenue in the statements of operations. There were no expenses recorded for excess inventory or other impairments during the three and nine months ended September 30, 2024 . Intangible Assets, Net Upon FDA approval and commercial launch of OJEMDA in April 2024, the Company capitalized the $ 9.0 million milestone payment to Viracta Therapeutics, Inc. (f/k/a Sunesis Pharmaceuticals, Inc.), or Viracta, for a specified regulatory milestone as a finite-lived intangible asset. Upon the sale of the Priority Review Voucher, or PRV, in May 2024 to fully satisfy PRV-related obligations of the Company's license agreement with Viracta, dated December 16, 2019, as amended, the Company capitalized the $ 8.1 million payment to Viracta as a finite-lived intangible asset. The intangible assets will be amortized on a straight-line basis over each of the estimated useful life of the underlying intellectual property of 7.3 years. Amortization expense will be recorded as cost of product revenue. Revenue Recognition The Company recognizes net product and license revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, or ASC 606, which outlines a five-step process for recognizing revenue from contracts with customers: (i) identify the contract with the customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the separate performance obligations in the contract, and (v) recognize revenue associated with the performance obligations as they are satisfied. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606, the Company determines the performance obligations that are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to each respective performance obligation when the performance obligation is satisfied. Product Revenue, Net The Company recognizes net product revenue from OJEMDA for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion rearrangement, or BRAF V600 mutation, which it began selling in May 2024 through contractual arrangements with its specialty pharmacy and specialty distributor customers. The Company has determined that the delivery of OJEMDA to its customers constitutes a single performance obligation. There are no other promises to deliver goods or services beyond what is specified in each accepted customer order. Net product revenue is recognized at the transaction price when the customer obtains control of the Company’s product, which occurs at a point in time upon delivery of the product to the customer. The Company has assessed the existence of a significant financing component in the agreements with its customers. The trade payment terms with the Company’s customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. Net product revenues from the sale of OJEMDA are recorded at the transaction price, which include adjustments for discounts and allowances, including estimated cash discounts, government chargebacks, government rebates, specialty distributor fees, copay assistance, and returns. These adjustments represent variable consideration under ASC 606 and are estimated using the expected value method or most likely amount method and are recorded when revenue is recognized on the sale of the product. These adjustments are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Adjustments for variable consideration are determined based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price, only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s original estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Cash Discounts — The Company estimates cash discounts based on contractual terms and expectations regarding future customer payment patterns. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Government Chargebacks — Chargebacks for fees and discounts to qualified government healthcare providers represent the estimated obligations resulting from contractual commitments to sell products to qualified U.S. Department of Veterans Affairs hospitals and 340B entities at prices lower than the list prices charged to customers who directly purchase the product from the Company. The 340B Drug Discount Program is a U.S. federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. Customers charge the Company for the difference between what they pay for the product and the statutory selling price to the qualified government entity. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivables, net. Chargeback amounts are generally determined at the time of resale to the qualified government healthcare provider by customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of chargebacks that customers have claimed, but for which the Company has not yet issued a credit and credits that the Company expects to issue for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Government Rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. For Medicaid programs, the Company estimates the portion of sales attributed to Medicaid patients and records a liability for the rebates to be paid to the respective state Medicaid programs. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Specialty Distributor Fees — The Company pays fees to our specialty distributor customers for distribution services provided in connection with the sales of OJEMDA. These specialty distributor fees are based on a contractually determined fixed percentage of sales. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. Copay Assistance — The Company offers a co-pay assistance program, which is intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as accrued expenses and other current liabilities. Product Returns — Consistent with industry practice, the Company’s contracts with customers for OJEMDA generally provide for returns only if the product is damaged or defective upon delivery, if there is a shipment error, and for certain customers, if the product is within an eligible expiry window. The Company currently estimates product return reserves using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company believes the returns of OJEMDA will be minimal because our customers often carry limited inventory given the price of our products, and the limited number of patients. These reserves are established in the same period that the related revenue is recognized. License Revenue The Company generates license revenue from the Ipsen License Agreement, pursuant to which, the Company licensed to Ipsen Pharma SAS, or Ipsen, the right to commercialize tovorafenib in all territories outside the United States and agreed to provide certain research and development and manufacturing services. Under the terms of the Ipsen License Agreement, (i) Ipsen paid the Company an upfront license fee in the amount of $ 70.8 million and (ii) Ipsen Biopharmaceuticals, Inc., or the Investor, a fully-owned United States affiliate of Ipsen, purchased 2,341,495 shares of the Company’s common stock in a private placement for $ 40.0 million, at a price per share representing a 17.0 % premium to the volume weighted average price, or VWAP, of the Company’s common stock as traded on The Nasdaq Stock Market LLC for the ten consecutive trading days prior to and including the date of the Company’s public release of U.S. GAAP revenue for the quarter ended June 30, 2024 on July 30, 2024, or the Revenue Release, and the ten consecutive trading days following the Revenue Release, in accordance with the terms set forth in an investment agreement by and between the Company and the Investor dated July 23, 2024. The Company is also eligible to receive up to approximately $ 350.0 million in additional commercial launch and sales-based milestone payments, as well as tiered, double-digit royalty payments starting at mid-teens percentage of annual net sales of tovorafenib, subject to customary adjustments specified in the Ipsen License Agreement. The commercial launch milestones related to first commercial sale(s) in certain territories, sales-based milestones and royalties are recognized as revenue when the related sales occur as the license of intellectual property is deemed to be the predominant item to which the commercial launch milestones, sales-based milestones and royalties relate. Upon execution of the Ipsen License Agreement, the transaction price was determined to be $ 78.2 million, representing the aggregate of the upfront license fee of $ 70.8 million and the premium paid by Ipsen on its equity investment in the Company of $ 7.4 million (the excess of the value of the shares of the Company issued to Ipsen), representing additional consideration from Ipsen for the rights under the Ipsen License Agreement. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue against each performance obligation as or when the performance obligations under the contract are satisfied. If a license to the Company's intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the license as revenue upon transfer of control of the license. All other promised goods or services in the agreement are evaluated to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. Optional future services where any additional consideration paid to the Company reflects their standalone selling prices do not provide the customer with a material right, and, therefore, are not considered performance obligations. If optional future services are priced in a manner which provides the customer with a significant or incremental discount, they are material rights, and are accounted for as separate performance obligations. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded within deferred revenue. Contract liabilities within deferred revenue are recognized as revenue after control of the goods or services is transferred to the customer and all revenue recognition criteria have been met. Cost of Product Revenue Our cost of product revenue includes the cost of inventory sold, amortization expense of intangible assets and third-party royalties payable on our net product revenue. Cost of product revenue may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, which requires incremental disclosure of segment information on an interim and annual basis. This ASU is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Retrospective application to all prior periods presented in the financial statements is required for public entities. The Company is currently evaluating the effect of this update on its financial statement disclosures. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures, which enhances the transparency and decision usefulness of income tax disclosures by requiring disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. The ASU is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. The Company is currently evaluating the effect of this update on its financial statement disclosures. |
Recurring Fair Value Measuremen
Recurring Fair Value Measurements | 9 Months Ended |
Sep. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Recurring Fair Value Measurements | 3. Recurring Fair Value Measurements The following table sets forth the Company’s financial instruments as of September 30, 2024 and December 31, 2023, which are measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): September 30, 2024 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 249,276 $ — $ — $ 249,276 U.S. treasury securities — 194,476 — 194,476 U.S. government agency securities — 91,498 — 91,498 Total assets measured at fair value $ 249,276 $ 285,974 $ — $ 535,250 December 31, 2023 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 47,003 $ — $ — $ 47,003 U.S. treasury securities — 246,208 — 246,208 U.S. government agency securities — 63,202 — 63,202 Total assets measured at fair value $ 47,003 $ 309,410 $ — $ 356,413 The Company's money market funds are classified as Level 1 because they are measured using observable inputs from active markets for identical assets. The Company's U.S. treasury securities and U.S. government agency securities are classified as Level 2 because they are measured with inputs that are either directly or indirectly observable for the asset which include quoted prices for similar assets in active markets and quoted prices for identical or similar assets in markets that are not active. There were no assets or liabilities classified as Level 3 as of September 30, 2024 and December 31, 2023. There were no transfers between Level 1, Level 2 or Level 3 categories during the periods presented. The following tables summarize the estimated fair value of the Company's cash equivalents, available-for-sale securities classified as short-term investments, and associated unrealized gains and losses (in thousands): September 30, 2024 Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value Cash equivalents: Money market funds $ 249,276 $ — $ — $ 249,276 U.S. government agency securities 81,762 — — 81,762 U.S. treasury securities 68,594 — — 68,594 Total cash equivalents 399,632 — — 399,632 Short-term investments U.S. government agency securities 9,733 4 ( 1 ) 9,736 U.S. treasury securities 125,890 27 ( 35 ) 125,882 Total short-term investments $ 135,623 $ 31 $ ( 36 ) $ 135,618 December 31, 2023 Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value Cash equivalents: Money market funds $ 47,003 $ — $ — $ 47,003 U.S. government agency securities 63,202 — — 63,202 U.S. treasury securities 110,645 — — 110,645 Total cash equivalents 220,850 — — 220,850 Short-term investments U.S. treasury securities 135,554 9 — 135,563 Total short-term investments $ 135,554 $ 9 $ — $ 135,563 The following table summarizes the maturities of our cash equivalents and available-for-sale securities (in thousands): September 30, 2024 Amortized Cost Fair Value Mature in one year or less $ 535,255 $ 535,250 Total $ 535,255 $ 535,250 December 31, 2023 Amortized Cost Fair Value Mature in one year or less $ 356,404 $ 356,413 Total $ 356,404 $ 356,413 The Company regularly reviews the changes to the rating of its securities and monitors the surrounding economic conditions to assess the risk of expected credit losses. As of September 30, 2024 and December 31, 2023 , there were no securities that were in an unrealized loss position for more than 12 months. As of September 30, 2024 , the unrealized losses, if any, on the Company’s short-term investments were primarily caused by interest rate increases. The Company does not expect the issuers to settle any security at a price less than the amortized cost basis of the investment with the contractual cash flows of these investments guaranteed by the issuer. No allowance for credit losses has been recorded since it is not more-likely-than-not that the Company will be required to sell the investments before recovery of their amortized cost basis. Realized gains and losses were immaterial for the three and nine months ended September 30, 2024. There were no realized gains and losses for the three and nine months ended September 30, 2023. |
Balance Sheet Items
Balance Sheet Items | 9 Months Ended |
Sep. 30, 2024 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Items | 4. Balance Sheet Items Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, Prepaid research and development expenses $ 6,382 $ 5,657 Prepaid insurance 1,355 918 Other prepaid expenses and other assets 3,446 2,352 Total prepaid expenses and other current assets $ 11,183 $ 8,927 Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, December 31, Accrued research and development expenses $ 16,299 $ 12,643 Accrued payroll related expenses 11,502 9,165 Accrued professional service expenses 2,893 3,675 Other 4,495 1,041 Total accrued expenses and other current liabilities $ 35,189 $ 26,524 |
Significant Agreements
Significant Agreements | 9 Months Ended |
Sep. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Significant Agreements | 5. Significant Agreements Takeda asset purchase agreement On December 16, 2019, a subsidiary of the Company entered into an asset purchase agreement, or the Takeda Asset Agreement, with Millennium Pharmaceuticals, Inc., a related party and an affiliate of Takeda Pharmaceutical Company Limited, or Takeda. Effective December 31, 2021, the subsidiary was merged with and into the Company, with the Company being the surviving corporation and assuming the subsidiary’s obligations under the Takeda Asset Agreement. Pursuant to the Takeda Asset Agreement, the Company purchased certain technology rights and know-how related to TAK-580 (which is now OJEMDA (tovorafenib)) that provides a new approach for treating patients with primary brain tumors or brain metastases of solid tumors. The Company also received clinical inventory supplies to use in the Company's research and development activities of such RAF-inhibitor and an assigned investigator clinical trial agreement. Takeda also assigned to the Company its exclusive license agreement, or the Viracta License Agreement, with Viracta. Takeda also granted the Company a worldwide, sublicensable exclusive license under specified patents and know-how and non-exclusive license under other patents and know-how generated by Takeda under the Takeda Asset Agreement. The Company also granted Takeda a grant back license, as defined in the Takeda Asset Agreement, which is terminable either automatically or by the Company in the event Takeda does not achieve specified development milestones within the applicable timeframes set forth under the Takeda Asset Agreement. This grant back license to Takeda was terminated at the time of conversion in connection with the Millennium Stock Exchange Agreement. The term of the Takeda Asset Agreement will expire on a country-by-country basis upon expiration of all assigned patent rights and all licensed patent rights in such country. Takeda may terminate the Takeda Asset Agreement prior to the Company's first commercial sale of a product if the Company ceases conducting any development activities for a continuous and specified period of time and such cessation is not agreed upon by the parties and is not done in response to guidance from a regulatory authority. Additionally, Takeda can terminate the Takeda Asset Agreement in the event of the Company's bankruptcy. In the event of termination of the Takeda Asset Agreement by Takeda as a result of the Company's cessation of development or bankruptcy, all assigned patents, know-how and contracts (other than the Viracta License Agreement) will be assigned back to Takeda and Takeda will obtain a reversion license under patents and know-how generated to exploit all such terminated products. In consideration for the sale and assignment of assets and the grant of the license under the Takeda Asset Agreement, the Company made an upfront payment of $ 1.0 million in cash and issued 9,857,143 shares of Series A redeemable convertible preferred stock in the Company’s subsidiary in December 2019. The fair value of issued shares was estimated as $ 9.9 million, based on the price paid by other investors for issued shares in the Series A financing of the Company’s subsidiary. Based on the terms of the Millennium Stock Exchange Agreement, Takeda exchanged the 9,857,143 shares of Series A redeemable convertible preferred stock of the Company’s subsidiary for 6,470,382 shares of the Company's common stock upon the effectiveness of the conversion, on May 26, 2021. License agreement with Viracta On December 16, 2019, a subsidiary of the Company amended and restated the Viracta License Agreement that was assigned pursuant to the Takeda Asset Agreement. Effective December 31, 2021, the subsidiary was merged with and into the Company, with the Company being the surviving corporation and assuming the subsidiary’s obligations under Viracta License Agreement. Under the Viracta License Agreement, the Company received a worldwide exclusive license under specified patent rights and know-how to develop, use, manufacture, and commercialize products containing compounds binding the RAF protein family. The term of the Viracta License Agreement will expire on a licensed product-by-licensed product and country-by-country basis upon the expiration of the Company’s obligation to pay royalties to Viracta with respect to such product in such country. The Company has the right to terminate the Viracta License Agreement with respect to any or all of the licensed products at will upon a specified notice period. The Company paid $ 2.0 million upfront in cash to Viracta, which was recorded as research and development expenses as the technology does not have an alternative future use. On March 4, 2024, the Company entered into an amendment to the Viracta License Agreement. As part of the amendment, the Company made a one-time payment in March 2024 to Viracta of $ 5.0 million, which was recorded as research and development expenses during the nine months ended September 30, 2024, in exchange for reduced future payment obligations ranging from the mid-teens to the high single-digit percentage related to the future sale or use of the rare pediatric disease PRV received. On April 23, 2024, the FDA approved OJEMDA (a tablet formulation and powder solution formulation of tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The indication was approved under accelerated approval based on response rate and duration of response. With the approval, the Company received a rare pediatric disease PRV from the FDA. The Company made a $ 9.0 million milestone payment to Viracta in May 2024 for the achievement of this milestone. The $ 9.0 million milestone was accounted for as a finite-lived intangible asset and will be amortized over the life of the underlying asset. Related amortization expense will be recorded as cost of product revenue in the Company’s statements of operations. On May 29, 2024, the Company sold its rare pediatric disease PRV for $ 108.0 million to an undisclosed buyer. As part of the transaction, $ 8.1 million of the total consideration received from the sale of the rare pediatric disease PRV was paid to Viracta to fully satisfy PRV-related obligations under the Viracta License Agreement. The gross proceeds of $ 108.0 million were recorded as a gain from sale of priority review voucher in the accompanying condensed statements of operations during the nine months ended September 30, 2024. As of September 30, 2024 , the $ 8.1 million paid to satisfy PRV-related obligations was capitalized as a finite-lived intangible asset, which will be amortized on a straight-line basis over its estimated useful life. Related amortization expense will be recorded as cost of product revenue in the Company’s statements of operations. As of September 30, 2024 , the Company could be required to make additional milestone payments of up to $ 40.0 million upon achievement of specified development and regulatory milestones for each licensed product in two indications, with milestones payable for the second indication upon achievement of a specified milestone event being lower than milestones payable for the first indication. Commencing with the first commercial sale of OJEMDA in a country, the Company is obligated to pay tiered royalties ranging in the mid-single-digit percentages on net sales of licensed products. The obligation to pay royalties will end on a country-by-country and licensed product-by-licensed product basis commencing on the first commercial sale in a country and continuing until the later of: (i) the expiration of the last valid claim of the Viracta licensed patents, jointly owned collaboration patents or specified patents owned by the Company covering the use or sale of such product in such country, (ii) the expiration of the last statutory exclusivity pertaining to such product in such country or (iii) the tenth anniversary of the first commercial sale of such product in such country. License agreement with Merck KGaA, Darmstadt, Germany On February 10, 2021, a subsidiary of the Company entered into a license agreement, or the MRKDG License Agreement, with Merck KGaA, Darmstadt, Germany, a pharmaceutical corporation located in Darmstadt, Germany. Effective December 31, 2021, the subsidiary was merged with and into the Company, with the Company being the surviving corporation and assuming the subsidiary’s obligations under the MRKDG License Agreement. Under the MRKDG License Agreement, Merck KGaA, Darmstadt, Germany granted to the Company an exclusive worldwide license, with the right to grant sublicenses through multiple tiers, under specified patent rights and know-how for the Company to research, develop, manufacture and commercialize products containing and comprising the pimasertib and MSC2015103B compounds. The Company also received clinical inventory supplies to use in its research and development activities. The Company's exclusive license grant is subject to a non-exclusive license granted by Merck KGaA, Darmstadt, Germany’s affiliate to a cancer research organization and Merck KGaA, Darmstadt, Germany retains the right to conduct, directly or indirectly, certain ongoing clinical studies relating to pimasertib. Under the MRKDG License Agreement, the Company has obligations to use commercially reasonable efforts to develop and commercialize at least two licensed products in at least two specified major market countries by the year 2029. The term of the MRKDG License Agreement will expire on a licensed product-by-licensed product and country-by-country basis upon the expiration of the Company's obligation to pay royalties to the licensor with respect to such licensed product in such country and will expire in its entirety upon the expiration of all of the Company's payment obligations with respect to all licensed products and all countries under the MRKDG License Agreement. In consideration for the rights granted under the MRKDG License Agreement and clinical supplies, the Company made an upfront payment of $ 8.0 million, which was recorded as research and development expenses, as the technology does not have an alternative future use and supplies are used for research activities. As of September 30, 2024 , the Company could be required to make additional payments of up to $ 364.5 million based upon the achievement of specified development, regulatory, and commercial milestones, as well a high, single-digit royalty percentage on future net sales of licensed products, if any. Milestones and royalties are contingent upon future events and will be recorded when the milestones are achieved and when payments are due. In November 2023, the Company discontinued its monotherapy substudy due to a limited duration of response in this rare patient population despite observing responses with a generally well tolerated therapy. In July 2024, the Company decided to close the program as the Company determined that the benefit/risk profile, as well as the market opportunity, did not justify the significant investment required to continue the trial despite observing some clinical responses. Research collaboration and license agreement with Sprint Bioscience AB On August 15, 2023, the Company entered into a research collaboration and license agreement, or the Sprint License Agreement, with Sprint Bioscience AB, or Sprint, a Swedish corporation located in Huddinge, Sweden. Under the Sprint License Agreement, Sprint granted to the Company an exclusive, worldwide license, with the right to grant sublicenses through multiple tiers, to research, develop, and commercialize pharmaceutical products and to engage in research aimed at discovery, optimization and development of Vaccinia Related Kinase 1, or VRK1. The term of the Sprint License Agreement will expire on a licensed product and country basis upon the expiration of the royalty term with respect to such licensed product and such country, unless terminated earlier. The Company has the right to terminate the Sprint License Agreement in its entirety, or on a licensed product-by-licensed product basis, at will upon a specified notice period. The Company paid $ 3.0 million upfront in cash to Sprint, which was recorded as research and development expenses as the technology does not have an alternative future use. As of September 30, 2024 , the Company could be required to make milestone payments of up to $ 309.0 million based upon achievement of specified development, regulatory, and commercial milestones for each licensed product, as well as tiered royalties ranging in the single-digit percentages on future net sales of licensed products, if any. Milestones and royalties are contingent upon future events and will be recorded when the milestones are achieved and when payments are due. License agreement with MabCare Therapeutics On June 17, 2024, the Company entered into a license agreement, or the MabCare License Agreement, with MabCare Therapeutics, or MabCare, a pharmaceutical corporation located in Shanghai, China. Under the MabCare License Agreement, MabCare granted to the Company an exclusive worldwide license, excluding Greater China, with the right to grant sublicenses through multiple tiers, under specified patent rights and know-how for the Company to develop, manufacture and commercialize DAY301 (formerly MTX-13), a novel Antibody Drug Conjugate, or ADC, targeting protein-tyrosine kinase 7, or PTK7. The Company will also receive clinical inventory supplies to use in its research and development activities. Under the MabCare License Agreement, the Company has obligations to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize at least one licensed product in one indication in each of the United States, Japan, and three European countries. The term of the MabCare License Agreement will expire in its entirety upon the expiration of the last to expire royalty term with respect to all licensed products in the Company's territory, unless terminated earlier. Following the expiration of the royalty term for a licensed product in a country, the license grant to the Company shall become non-exclusive, fully paid-up, royalty-free, perpetual, and irrevocable for such licensed product in such country. Upon the expiration of the term, the license granted to the Company shall become non-exclusive, transferable, sublicensable, fully paid, royalty free, perpetual, and irrevocable in its entirety. In consideration for the rights granted under the MabCare License Agreement, the Company made a $ 55.0 million upfront payment in July 2024. The upfront payment was recorded as research and development expenses, as the technology and supplies licensed do not have an alternative future use. As of September 30, 2024 , the Company could be required to make additional payments of $ 1,152.0 million based upon the achievement of specified development, regulatory, and commercial success-based milestones plus low-to-mid single-digit royalties on net sales outside of Greater China. Milestones and royalties are contingent upon future events and will be recorded when the milestones are achieved and when payments are due. License agreement with Ipsen Pharma SAS On July 23, 2024, the Company entered into the Ipsen License Agreement, pursuant to which, the Company licensed to Ipsen, on an exclusive basis, the right to commercialize tovorafenib in all territories outside the United States and agreed to provide certain research and development and manufacturing services. Ipsen shall have the right to grant sublicenses to third-parties. Under the terms of the Ipsen License Agreement, (i) Ipsen paid the Company an upfront license fee in the amount of $ 70.8 million and (ii) the Investor, a fully-owned United States affiliate of Ipsen, purchased 2,341,495 shares of the Company’s common stock in a private placement for $ 40.0 million, at a price per share representing a 17.0 % premium to the VWAP of the Company’s common stock as traded on The Nasdaq Stock Market LLC for the ten consecutive trading days prior to and including the date of the Revenue Release, and the ten consecutive trading days following the Revenue Release, in accordance with the terms set forth in an investment agreement by and between the Company and the Investor dated July 23, 2024. As of September 30, 2024 , the Company is also eligible to receive up to approximately $ 350.0 million in additional commercial launch and sales-based milestone payments, as well as tiered, double-digit royalty payments starting at mid-teens percentage of annual net sales of tovorafenib, subject to customary adjustments specified in the Ipsen License Agreement. The royalty payment obligations under the Ipsen License Agreement expire on a country-by-country basis no earlier than ten years following the first commercial sale of tovorafenib in the applicable country. In addition, the Ipsen License Agreement provides that the Company will supply to Ipsen, and Ipsen will purchase from the Company, all required quantities of tovorafenib for all territories outside the United States in accordance with a supply agreement to be entered into by and between the Company and Ipsen, or the Ipsen Supply Agreement. The Company determined that the cost-plus rate to be charged for the supply of tovorafenib does not represent a material right. Ipsen has the right to request a manufacturing technology transfer of the then-current manufacturing process of tovorafenib under the Ipsen License Agreement, such consent shall not be unreasonably withheld, such that upon completion of the manufacturing technology transfer, Ipsen or a third-party would be solely responsible for the manufacture of tovorafenib for all territories outside the United States. Following the two-year anniversary of July 23, 2024, the effective date of the Ipsen License Agreement, Ipsen may terminate the Ipsen License Agreement for convenience with six months’ prior written notice or for certain other specified reasons. The Company may terminate the Ipsen License Agreement if Ipsen or any of its affiliates challenge the validity of any patents controlled by the Company that are licensed under the Ipsen License Agreement. Both Ipsen and the Company may terminate the Ipsen License Agreement (i) for material breach by the other party and a failure to cure such breach within the time period specified in the Ipsen License Agreement or (ii) the other party’s bankruptcy event. The Company evaluated the Ipsen License Agreement under Accounting Standards Codification, or ASC, 606 and concluded that Ipsen represents a customer in the transaction. The Company identified two distinct performance obligations for licenses to intellectual property in the form of the exclusive license to commercialize tovorafenib outside the United States for both (i) relapsed or refractory and (ii) front-line pLGG; and three distinct research and development performance obligations related to tovorafenib for completion of (i) the pivotal Phase 2 relapsed or refractory pLGG trial, or FIREFLY-1, (ii) the pivotal Phase 3 front-line pLGG trial, or FIREFLY-2, and (iii) the European Union, or EU, companion diagnostic for pLGG. Both the FIREFLY-1 and FIREFLY-2 trials related to pLGG pertain to later-stage intellectual property and only involve validating the efficacy of tovorafenib with respect to each distinct designation and are not expected to significantly modify or customize the licensed intellectual property. The FIREFLY-1 and FIREFLY-2 trials, and EU companion diagnostic research and development services related to pLGG could be performed by a third-party. The Company determined that the promise of the manufacturing technology transfer is a customer option that does not represent a material right given the value of the services is not material and fulfillment of this promise is ancillary to the main transaction. Accordingly, the manufacturing technology transfer is not a performance obligation at the outset of the arrangement. Upon execution of the Ipsen License Agreement, the transaction price was determined to be $ 78.2 million, representing the aggregate of the upfront license fee of $ 70.8 million and the premium paid by Ipsen on its equity investment in the Company of $ 7.4 million (the excess of the value of the shares of the Company issued to Ipsen), representing additional consideration from Ipsen for the rights under the Ipsen License Agreement. Commercial launch milestones related to first commercial sale(s) in certain territories, sales-based milestones and royalties on net sales upon commercialization by Ipsen were excluded from the transaction price and will be recognized when the related sales occur as they were determined to predominantly relate to the intellectual property and, therefore, have been excluded from the transaction price in accordance with the sales-based royalty exception. The Company allocated the transaction price to the performance obligations based on their relative standalone selling price. The Company developed the estimated stand-alone selling price for each license using discounted cash flow models. In developing this estimate, the Company applied judgment in the determination of the assumptions relating to forecasted future revenues, the discount rate, and the probability of success. The stand-alone selling price for each of the research and development services was estimated based on the Company’s forecasted costs to be incurred to fulfill the obligations plus a reasonable margin. The portion of the transaction price allocable to the relapsed or refractory and front-line pLGG licenses to intellectual property was determined to be $ 73.5 million and was recognized as license revenue at the point in time in which Ipsen had the right to use the license/know-how, which occurred during the third quarter of 2024. The portion of the transaction price allocable to the relapsed or refractory, front-line and companion diagnostic research and develop ment services performance obligations was determined to be $ 4.7 million, which will be recognized over time as the services are delivered based on costs incurred relative to the total estimated cost to deliver the services. During the three and nine months ended September 30, 2024, $ 0.2 million of deferred revenue was recognized as license revenue related to the research and development services performance obligations with $ 1.4 million and $ 3.1 million of the undelivered services included in current and non-current deferred revenue, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Leases In April 2022, the Company entered into a lease agreement for approximately 12,000 square feet of general use office space in Brisbane, California. Such agreement was determined to be a lease since the right to control the use of the identified asset was conveyed to the Company for a period of time in exchange for consideration. The term of the lease is 31 months and commenced in May 2022. There is no option to extend the lease term nor is there an option to terminate the lease term prior to its expiration. The Company is obligated to pay monthly rent expense and its pro rata share of the landlord's operating expenses which include utilities, common area maintenance expenses, and property taxes. Such expenses are a non-lease component and a variable consideration and included in the Company's operating expenses as incurred. The Company concluded that this lease is also an operating lease. The total payments for base rent over the term of the lease is approximately $ 1.1 million. Upon execution of the agreement, the Company paid a security deposit of approximately $ 40,000 classified as deposits and other long-term assets on the condensed balance sheet. In June 2024, the Company entered into a lease agreement for approximately 19,000 square feet of general use office space in Brisbane, California. Such agreement was determined to be a lease since the right to control the use of the identified asset was conveyed to the Company for a period of time in exchange for consideration. The term of the lease is approximately 7.4 years and commenced in August 2024. There is no option to extend the lease term nor is there an option to terminate the lease term prior to its expiration. The Company is obligated to pay monthly rent expense and its pro rata share of the landlord's operating expenses which include utilities, common area maintenance expenses, and property taxes. Such expenses are a non-lease component and a variable consideration and included in the Company's operating expenses as incurred. The Company concluded that this lease is also an operating lease. The total payments for base rent over the term of the lease is approximately $ 4.4 million. Upon execution of the agreement, the Company paid a security deposit of approximately $ 86,000 classified as deposits and other long-term assets on the condensed balance sheet. The Company determined the lease incremental borrowing rate, or IBR, based on the information available at the applicable lease commencement date as the Company’s leases do not provide an implicit rate. The IBR is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment where the asset is located. As of September 30, 2024, the weighted-average remaining lease term and weighted-average discount rate were 7.0 years and 12.7 % , respectively. The Company’s lease does not require any contingent rental payments, impose financial restrictions, or contain any residual value guarantees. Lease expense of right-of-use assets is recognized on a straight-line basis over the applicable lease term. Lease expense was $ 0.2 million and $ 0.1 million for the three months ended September 30, 2024 and 2023, respectively, and was $ 0.4 million and $ 0.3 million for the nine months ended September 30, 2024 and 2023, respectively. Cash paid for amounts included in the measurement of operating lease liabilities was $ 0.4 million and $ 0.3 million for the nine months ended September 30, 2024 and 2023, respectively. Variable payments expensed during the three and nine months ended September 30, 2024 and 2023 were immaterial. As of September 30, 2024, the future lease obligations were as follows (in thousands): Year Ending December 31, 2024 (Remaining) $ 147 2025 352 2026 435 2027 448 2028 461 Thereafter 2,613 Total future minimum lease payments 4,456 Less: imputed interest ( 1,841 ) Present value of operating lease liabilities 2,615 Less: current portion of operating lease liabilities ( 77 ) Operating lease liabilities $ 2,538 Research and Development Agreements The Company enters into contracts in the normal course of business with clinical research organizations, contract manufacturing organizations, and other third-party vendors for clinical trial, manufacturing, testing, and other research and development activities. These contracts generally provide for termination on notice, with the exception of one vendor where certain costs are non-cancellable after the approval of the project. As of September 30, 2024 and December 31, 2023 , there were no amounts accrued related to termination and cancellation charges as these are not probable. License Agreements The Company entered into license agreements, as disclosed in Note 5, with various parties under which it is obligated to make contingent and non-contingent payments. Purchase Commitments To support product needs for OJEMDA, the Company has entered into a manufacturing and supply agreement with Quotient Sciences - Philadelphia, LLC in July 2023 that requires the Company to meet minimum purchase obligations on an annual basis. The amount of future minimum purchase obligations under the manufacturing and supply agreement over the next five years is approximately $ 15.2 million , in aggregate, as of September 30, 2024. For the nine months ended September 30, 2024, the Company made purchases of $ 2.0 million under the purchase obligation. Legal Proceedings The Company, from time to time, may be party to litigation, claims and assessments arising in the ordinary course of business. The Company accrues liabilities for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. The Company is not subject to any material legal proceedings, and to the best of its knowledge, no material legal proceedings are currently pending or threatened. Indemnification Agreements In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for indemnification for certain liabilities. The exposure under these agreements is unknown because it involves claims that may be made against it in the future but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company also has indemnification obligations to its directors and executive officers for specified events or occurrences, subject to some limits, while they are serving at its request in such capacities. There have been no claims to date, and the Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company had no t recorded any liabilities for these agreements as of September 30, 2024 and December 31, 2023 . |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2024 | |
Stockholders' Equity Note [Abstract] | |
Common Stock | 7. Common Stock Pursuant to its certificate of incorporation, the Company is authorized to issue 500 .0 million shares of common stock at a par value of $ 0.0001 per share. As of September 30, 2024, 100,810,357 shares of common stock were issued and outstanding. The Company has reserved shares of common stock for future issuances as follows: September 30, Common stock options issued and outstanding 11,926,321 Common stock available for future grants 3,799,351 Common stock available for ESPP 2,498,360 Restricted stock units issued and outstanding 1,887,246 Total 20,111,278 2024 Private Placement In July 2024, the Company entered into a securities purchase agreement with certain institutional and accredited investors, or the Investors, pursuant to which the Company agreed to sell and issue to the Investors in a private placement, or the Private Placement, an aggregate of (i) 10,551,718 shares, or the Shares, of the Company’s common stock, par value $ 0.0001 per share, o r the Common Stock , at a purchase price of $ 14.50 per share and (ii) 1,517,241 pre-funded warrants, or the Pre-Funded Warrants, to purchase up to an aggregate of 1,517,241 shares of Common Stock , or the Warrant Shares, at a purchase price of $ 14.4999 per Pre-Funded Warrant. Each Pre-Funded Warrant has an exercise price of $ 0.0001 per Warrant Share. The Pre-Funded Warrants are exercisable at any time after their original issuance at the option of each holder, in such holder’s discretion, by (i) payment in full in immediately available funds for the number of shares of common stock purchased upon such exercise or (ii) a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the Pre-Funded Warrant. A holder will not be entitled to exercise any portion of any Pre-Funded Warrant if the holder’s ownership of the Company’s common stock would exceed 9.99 % following such exercise. In the event of certain fundamental transactions, the holders of the Pre-Funded Warrants will be entitled to receive upon exercise of the Pre-Funded Warrants the kind of amounts of securities, cash or other property that the holders would have received had they exercised the Pre-Funded Warrants immediately prior to such fundamental transaction without regard to any limitations on exercise contained in the Pre-Funded Warrants. The Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in capital and were recorded at the issuance date using a relative fair value allocation method. The Pre-Funded Warrants are equity classified because they (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holders to receive a fixed number of shares of common stock upon exercise, (v) are indexed to the Company’s common stock and (vi) meet the equity classification criteria. In addition, such Pre-Funded Warrants do not provide any guarantee of value or return. The Company valued the Pre-Funded Warrants at issuance, concluding that their sales price approximated their fair value, and allocated net proceeds from the Private Placement proportionately to the Common Stock and Pre-Funded Warrants. The Private Placement closed on August 1, 2024 and the Company received net proceeds of $ 166.5 million, after deducting underwriting discounts, commissions, and offering costs, of which $ 145.6 million was allocated to the Common Stock and $ 20.9 million was allocated to the Pre-Funded Warrants. The net proceeds were recorded as a component of additional paid-in capital. Investment agreement with Ipsen Biopharmaceuticals, Inc. In July 2024, the Company entered into the Ipsen License Agreement, pursuant to which, the Company licensed to Ipsen, on an exclusive basis, the right to commercialize tovorafenib in all territories outside the United States and agreed to provide certain research and development and manufacturing services. Under the terms of the Ipsen License Agreement, (i) Ipsen paid the Company an upfront license fee in the amount of $ 70.8 million and (ii) the Investor, a fully-owned United States affiliate of Ipsen, purchased 2,341,495 shares of the Company’s common stock in a private placement for $ 40.0 million, at a price per share representing a 17.0 % premium to the VWAP of the Company’s common stock as traded on The Nasdaq Stock Market LLC for the ten consecutive trading days prior to and including the date of the Revenue Release, and the ten consecutive trading days following the Revenue Release, in accordance with the terms set forth in an investment agreement by and between the Company and the Investor dated July 23, 2024. The Company valued the shares at issuance at $ 32.6 million, concluding that the Company's common stock price as traded on The Nasdaq Stock Market LLC on the close date of the transaction approximated fair value, which was recorded as a component of additional paid-in capital. June 2023 Follow-On Offering In June 2023, the Company completed a follow-on offering and issued and sold 13,269,231 shares of common stock (including the exercise by the underwriters of their option to purchase an additional 1,730,769 shares of common stock) at a price to the public of $ 13.00 per share for net proceeds of approximately $ 161.4 million, after deducting underwriting discounts, commissions, and offering costs. At-The-Market Offering The Company has entered into an equity distribution agreement, or the Equity Distribution Agreement, with Piper Sandler & Co. and JonesTrading Institutional Services LLC, as sales agents, relating to the issuance and sale of shares of the Company’s common stock for an aggregate offering price of up to $ 250.0 million under an at-the-market offering program, or the ATM. The Company has no obligation to sell any shares and could at any time suspend solicitations and offers under the ATM. No shares of the Company’s common stock have been sold under the ATM as of September 30, 2024 . |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Sep. 30, 2024 | |
Stockholders' Equity Note [Abstract] | |
Share-based Compensation | 8. Share-based Compensation Share-based compensation expense recorded in the accompanying condensed statements of operations is as follows (in thousands): Three Months Ended Nine Months Ended 2024 2023 2024 2023 Research and development expense $ 3,816 $ 3,312 $ 13,178 $ 10,102 Selling, general and administrative expense 7,738 6,294 24,050 18,428 Total share-based compensation expense $ 11,554 $ 9,606 $ 37,228 $ 28,530 2022 Equity Inducement Plan In October 2022, the board of directors and stockholders approved the 2022 Equity Inducement Plan, or the 2022 Plan. The 2022 Plan provides for the grant of non-statutory stock options and restricted stock units. The number of shares of common stock reserved for issuance under the 2022 Plan is 1,000,000 shares. 2021 Equity Incentive Plan In May 2021, in connection with the IPO, the board of directors and stockholders approved, the 2021 Equity Incentive Plan, or the 2021 Plan, which became effective on the day before the date of the effectiveness of the IPO. The 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, awards of restricted stock, restricted stock units and other share-based awards. The number of shares of common stock reserved for issuance under the 2021 Plan is equal to the sum of: (x) 6,369,000 shares of common stock; plus (y) 4,719,605 shares of common stock issued in respect of the conversion of incentive shares that were subject to vesting immediately prior to the effectiveness of the registration statement for the IPO that expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased by us at their original issuance price pursuant to a contractual repurchase right. The number of shares available for grant and issuance under the 2021 Plan will be automatically increased on the first day of each fiscal year, beginning with the fiscal year commencing on January 1, 2021 and continuing for each fiscal year until, and including, the fiscal year commencing on January 1, 2031, by the lesser of (a) 5 % of the number of shares of all classes of the Company’s common stock, plus the total number of shares of Company common stock issuable upon conversion of any preferred stock or exercise of any warrants to acquire shares of Company common stock for a nominal exercise price issued and outstanding on each December 31 immediately prior to the date of increase or (b) such number of shares determined by the board of directors. Stock Options The following table provides a summary of stock option activity during the nine months ended September 30, 2024. Options Weighted-Average Weighted-Average Aggregate Outstanding at December 31, 2023 10,211,758 $ 17.10 Granted 2,830,362 $ 14.31 Exercised ( 94,553 ) $ 14.26 $ 134 Forfeiture ( 1,021,246 ) $ 16.62 Outstanding at September 30, 2024 11,926,321 $ 16.51 7.9 $ 2,367 Vested and expected to vest at September 30, 2024 11,926,321 $ 16.51 7.9 $ 2,367 Exercisable at September 30, 2024 6,722,507 $ 16.66 7.4 $ 1,224 Aggregate intrinsic value represents the difference between the estimated fair value of the underlying common stock and the exercise price of outstanding, in-the-money options. The total intrinsic value of options exercised during the nine months ended September 30, 2024 and 2023 was less than $ 0.1 million and $ 0.6 million , respectively. The total fair value of options that vested during the nine months ended September 30, 2024 and 2023 was $ 25.7 million and $ 19.8 million , respectively. The weighted-average grant date fair value of options granted during the nine months ended September 30, 2024 and 2023 was $ 9.24 per share and $ 13.37 per share, respectively. Unamortized share-based compensation for stock options as of September 30, 2024 was $ 53.3 million , which is expected to be recognized over a weighted-average period of 2.3 years. The Company used the Black-Scholes option pricing model to estimate the fair value of stock option awards granted with the following assumptions: Three Months Ended Nine Months Ended 2024 2023 2024 2023 Expected term (in years) 6.06 - 6.11 5.65 - 6.14 5.27 - 6.74 5.27 - 6.25 Expected volatility 68.46 % - 68.72 % 68.82 % - 71.43 % 68.27 % - 70.57 % 68.82 % - 81.98 % Risk-free interest rate 3.43 % - 4.40 % 4.02 % - 4.56 % 3.43 % - 4.47 % 3.47 % - 4.56 % Expected dividend yield — — — — Restricted Stock Units The following table provides a summary of restricted stock units activity during the nine months ended September 30, 2024: Number of Weighted Average Unvested restricted stock units at December 31, 2023 1,031,545 $ 18.27 Granted 1,584,280 $ 14.38 Vested ( 526,047 ) $ 16.52 Forfeiture ( 202,532 ) $ 16.14 Unvested restricted stock units at September 30, 2024 1,887,246 $ 15.72 Unamortized share-based compensation for restricted stock units as of September 30, 2024 was $ 27.9 million , which is expected to be recognized over a weighted-average period of 2.8 years. Restricted Stock Awards The following table provides a summary of the unvested common stock awards activity during the nine months ended September 30, 2024. Number of Weighted Average Unvested common stock as of December 31, 2023 747,679 $ 16.00 Vested ( 556,424 ) $ 16.00 Forfeiture ( 25,415 ) $ 16.00 Unvested common stock as of September 30, 2024 165,840 $ 16.00 Unamortized share-based compensation for restricted stock awards as of September 30, 2024 was $ 1.1 million , which is expected to be recognized over a weighted-average period of 0.5 years. 2021 Employee Stock Purchase Plan In May 2021, the board of directors adopted and the stockholders approved the 2021 Employee Stock Purchase Plan, or the ESPP, which became effective on May 26, 2021. A total of 603,000 shares of common stock were initially reserved for issuance under the ESPP. The number of shares of the common stock reserved for issuance under the ESPP will automatically increase on the first day of each fiscal year, beginning with the fiscal year commencing on January 1, 2021 and continuing for each fiscal year until, and including, the fiscal year commencing on January 1, 2031, by the lesser of: (a) 1 % of the total number of outstanding shares of common stock of the Company (on an as converted basis outstanding on the immediately preceding December 31 (rounded down to the nearest whole share)) and (b) an amount determined by the board of directors. 331,014 shares have been issued under the ESPP as of September 30, 2024. The Company recognized compensation expense related to the ESPP of $ 0.2 million and $ 0.1 million for the three months ended September 30, 2024 and 2023, respectively, and $ 0.6 million and $ 0.6 million for the nine months ended September 30, 2024 and 2023, respectively. The fair value of our common stock to be issued under the ESPP is estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions: Nine Months Ended 2024 2023 Expected term (in years) 0.5 0.5 Expected volatility 63.45 % 63.57 % Risk-free interest rate 5.40 % 5.24 % Expected dividend yield — — |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. Income Taxes For the three months ended September 30, 2024, the Company recognized an income tax benefit of $ 0.9 million on pre-tax book income for the period, resulting in an effective tax rate of ( 2.4 )% . For the nine months ended September 30, 2024, the Company recognized income tax expense of $ 0.7 million on a pre-tax book loss for the period, resulting in an effective tax rate of ( 2.3 )% . The primary reconciling items between the federal statutory rate of 21.0 % for the three and nine months ended September 30, 2024 and the Company’s overall effective tax rate of ( 2.4 )% and ( 2.3 )% , respectively, was the effect of equity compensation, generation of tax credits, deferred state income taxes and the valuation allowance recorded against the full amount of its net deferred tax assets . The Company did no t record an income tax provision for the three and nine months ended September 30, 2023 as it generated tax losses during each of the periods. A valuation allowance is established when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company continues to establish a valuation allowance against the full amount of its net deferred tax assets since it is more likely than not that benefits will not be realized, including those benefits created in the current year. This assessment is based on the Company's historical cumulative losses, which provide strong objective evidence that cannot be overcome with projections of income, as well as the fact the Company expects continuing losses in the future. |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 9 Months Ended |
Sep. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | 10. Net Income (Loss) Per Share Basic and diluted net income (loss) per share attributable to common stockholders is calculated as follows (in thousands except share and per share amounts): Three Months Ended Nine Months Ended 2024 2023 2024 2023 Net income (loss) - basic and diluted $ 37,037 $ ( 46,150 ) $ ( 29,782 ) $ ( 134,406 ) Weighted average shares outstanding - basic 96,623,123 85,952,501 90,164,895 77,682,237 Effect of dilutive securities: Stock options 57,455 — — — Restricted stock units 107,935 — — — Restricted stock awards 149,246 — — — Weighted average shares outstanding - diluted 96,937,759 85,952,501 90,164,895 77,682,237 Net income (loss) per share - basic $ 0.38 $ ( 0.54 ) $ ( 0.33 ) $ ( 1.73 ) Net income (loss) per share - diluted $ 0.38 $ ( 0.54 ) $ ( 0.33 ) $ ( 1.73 ) The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net income (loss) per share, as their effect is anti-dilutive: Three Months Ended Nine Months Ended 2024 2023 2024 2023 Stock options 11,454,704 10,039,940 11,926,321 10,039,940 Unvested common shares — 956,719 165,840 956,719 Restricted stock units 406,092 1,001,313 1,887,246 1,001,313 Shares committed under ESPP 88,832 69,578 88,832 69,578 Total 11,949,628 12,067,550 14,068,239 12,067,550 |
Defined Contribution Plan
Defined Contribution Plan | 9 Months Ended |
Sep. 30, 2024 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan | 11. Defined Contribution Plan The Company maintains an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code. All employees are eligible to participate provided that they meet the requirements of the plan. For each of the three months ended September 30, 2024 and 2023, the Company made matching contributions of $ 0.4 million and $ 0.2 million , respectively. For the nine months ended September 30, 2024 and 2023, the Company made matching contributions of $ 1.4 million and $ 1.0 million , respectively. |
Summary of Significant Accou_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, for interim financial information and Article 10 of Regulation S-X of the Securities and Exchange Commission, or SEC, and should be read in conjunction with the Company's consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 26, 2024. The condensed financial statements presented in this Quarterly Report on Form 10-Q are unaudited; however, in the opinion of management, such financial statements reflect all adjustments, consisting solely of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in Accounting Standards Codification, or ASC, and Accounting Standards Updates, or ASU, of the Financial Accounting Standards Board, or FASB. |
Use of Estimates | Use of Estimates The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements, and the reported amounts of expenses during the reporting period. Estimates and assumptions made in the accompanying condensed financial statements include, but are not limited to, accruals for research and development expenses, variable consideration and other relevant inputs impacting the gross and net revenue recognition, the valuation of share-based awards, and the valuation of deferred tax assets. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable. Actual results may differ from those estimates or assumptions. |
Segments | Segments The Company has determined that its chief executive officer is the chief operating decision maker, or CODM. The Company operates and manages the business as one reporting and one operating segment, which is the business of developing and commercializing targeted therapies for people of all ages with genomically-defined cancers. The Company’s CODM reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All of the Company’s assets are located in the United States. |
Concentration of credit risk and other risks and uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, short-term investments, and accounts receivable. Amounts on deposit may at times exceed federally insured limits. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash, cash equivalents and short-term investments that are recorded on its balance sheet. Per policy, the Company mitigates its risk by investing in high-grade instruments and limiting the concentration in any one non-United States government or government backed issuer, which limits its exposure. The Company has not experienced any losses on its cash, cash equivalents and short-term investments. For the three months ended September 30, 2024, three individual customers accounted for 100.0 % of total net product revenue, with these individual customers representing 69.0 %, 23.0 %, and 8.0 % of the Company's total net product revenue. For the nine months ended September 30, 2024, three individual customers accounted for 100.0 % of total net product revenue, with these individual customers representing 66.6 %, 27.0 %, and 6.4 % of the Company's total net product revenue. As of September 30, 2024, three customers accounted for 100.0 % of the accounts receivable balance, with these individual customers representing 55.0 %, 25.7 %, and 19.3 % of the accounts receivable balance. No other individual customers account for more than 10.0 % of net product sales or accounts receivable. The Company monitors the financial condition of its customers so that it can appropriately respond to changes in their creditworthiness. To date, the Company has not experienced any losses with respect to the collection of its accounts receivable. The Company is subject to certain risks and uncertainties and believes that changes in any of the following areas could have a material adverse effect on the Company's future financial position or results of its operations: ability to obtain future financing; regulatory requirements for approval and market acceptance of, and reimbursement for, product candidates; performance of third-party clinical research organizations and manufacturers upon which the Company relies; development of sales channels; protection of the Company’s intellectual property; litigation or claims against the Company based on intellectual property, patent, product, regulatory or other factors; changes to the market landscape; and the Company’s ability to attract and retain employees necessary to support its growth. The Company is dependent on third-party manufacturers to supply products for commercial and research and development activities in its programs. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. These programs could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients and formulated drugs. |
Accounts Receivable, Net | Accounts Receivable, Net Accounts receivable, net consists of trade receivables which are amounts due from the Company's specialty pharmacy and specialty distributor customers related to product sales. The Company records trade receivables net of discounts, chargebacks, and any allowances for potential credit losses. An allowance for credit losses is determined based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established over a longer period of time. For the three and nine months ended September 30, 2024 , the Company did no t record any expected credit losses related to outstanding accounts receivable. |
Inventory | Inventory The Company began capitalizing inventory for OJEMDA upon approval by the U.S. Food and Drug Administration, or FDA, in April 2024. OJEMDA is approved for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma, or pLGG, harboring a BRAF fusion rearrangement, or BRAF V600 mutation. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. Inventory is comprised of raw materials, work-in-process and finished goods, and includes costs related to third-party contract manufacturing, packaging, freight-in and overhead. Inventory is stated at the lower of cost or net realizable value with cost based on the first-in-first-out method. Raw and intermediate materials that may be used for either research and development or commercial purposes where the intended use is not yet known are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is used or otherwise allocated for research and development, it is expensed as research and development in the period that determination is made. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of product revenue. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as a cost of product revenue in the statements of operations. There were no expenses recorded for excess inventory or other impairments during the three and nine months ended September 30, 2024 . |
Intangible Assets, Net | Intangible Assets, Net Upon FDA approval and commercial launch of OJEMDA in April 2024, the Company capitalized the $ 9.0 million milestone payment to Viracta Therapeutics, Inc. (f/k/a Sunesis Pharmaceuticals, Inc.), or Viracta, for a specified regulatory milestone as a finite-lived intangible asset. Upon the sale of the Priority Review Voucher, or PRV, in May 2024 to fully satisfy PRV-related obligations of the Company's license agreement with Viracta, dated December 16, 2019, as amended, the Company capitalized the $ 8.1 million payment to Viracta as a finite-lived intangible asset. The intangible assets will be amortized on a straight-line basis over each of the estimated useful life of the underlying intellectual property of 7.3 years. Amortization expense will be recorded as cost of product revenue. |
Revenue Recognition | Revenue Recognition The Company recognizes net product and license revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, or ASC 606, which outlines a five-step process for recognizing revenue from contracts with customers: (i) identify the contract with the customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the separate performance obligations in the contract, and (v) recognize revenue associated with the performance obligations as they are satisfied. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606, the Company determines the performance obligations that are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to each respective performance obligation when the performance obligation is satisfied. Product Revenue, Net The Company recognizes net product revenue from OJEMDA for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion rearrangement, or BRAF V600 mutation, which it began selling in May 2024 through contractual arrangements with its specialty pharmacy and specialty distributor customers. The Company has determined that the delivery of OJEMDA to its customers constitutes a single performance obligation. There are no other promises to deliver goods or services beyond what is specified in each accepted customer order. Net product revenue is recognized at the transaction price when the customer obtains control of the Company’s product, which occurs at a point in time upon delivery of the product to the customer. The Company has assessed the existence of a significant financing component in the agreements with its customers. The trade payment terms with the Company’s customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. Net product revenues from the sale of OJEMDA are recorded at the transaction price, which include adjustments for discounts and allowances, including estimated cash discounts, government chargebacks, government rebates, specialty distributor fees, copay assistance, and returns. These adjustments represent variable consideration under ASC 606 and are estimated using the expected value method or most likely amount method and are recorded when revenue is recognized on the sale of the product. These adjustments are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Adjustments for variable consideration are determined based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price, only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s original estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Cash Discounts — The Company estimates cash discounts based on contractual terms and expectations regarding future customer payment patterns. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Government Chargebacks — Chargebacks for fees and discounts to qualified government healthcare providers represent the estimated obligations resulting from contractual commitments to sell products to qualified U.S. Department of Veterans Affairs hospitals and 340B entities at prices lower than the list prices charged to customers who directly purchase the product from the Company. The 340B Drug Discount Program is a U.S. federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. Customers charge the Company for the difference between what they pay for the product and the statutory selling price to the qualified government entity. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivables, net. Chargeback amounts are generally determined at the time of resale to the qualified government healthcare provider by customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of chargebacks that customers have claimed, but for which the Company has not yet issued a credit and credits that the Company expects to issue for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Government Rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. For Medicaid programs, the Company estimates the portion of sales attributed to Medicaid patients and records a liability for the rebates to be paid to the respective state Medicaid programs. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Specialty Distributor Fees — The Company pays fees to our specialty distributor customers for distribution services provided in connection with the sales of OJEMDA. These specialty distributor fees are based on a contractually determined fixed percentage of sales. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. Copay Assistance — The Company offers a co-pay assistance program, which is intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as accrued expenses and other current liabilities. Product Returns — Consistent with industry practice, the Company’s contracts with customers for OJEMDA generally provide for returns only if the product is damaged or defective upon delivery, if there is a shipment error, and for certain customers, if the product is within an eligible expiry window. The Company currently estimates product return reserves using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company believes the returns of OJEMDA will be minimal because our customers often carry limited inventory given the price of our products, and the limited number of patients. These reserves are established in the same period that the related revenue is recognized. License Revenue The Company generates license revenue from the Ipsen License Agreement, pursuant to which, the Company licensed to Ipsen Pharma SAS, or Ipsen, the right to commercialize tovorafenib in all territories outside the United States and agreed to provide certain research and development and manufacturing services. Under the terms of the Ipsen License Agreement, (i) Ipsen paid the Company an upfront license fee in the amount of $ 70.8 million and (ii) Ipsen Biopharmaceuticals, Inc., or the Investor, a fully-owned United States affiliate of Ipsen, purchased 2,341,495 shares of the Company’s common stock in a private placement for $ 40.0 million, at a price per share representing a 17.0 % premium to the volume weighted average price, or VWAP, of the Company’s common stock as traded on The Nasdaq Stock Market LLC for the ten consecutive trading days prior to and including the date of the Company’s public release of U.S. GAAP revenue for the quarter ended June 30, 2024 on July 30, 2024, or the Revenue Release, and the ten consecutive trading days following the Revenue Release, in accordance with the terms set forth in an investment agreement by and between the Company and the Investor dated July 23, 2024. The Company is also eligible to receive up to approximately $ 350.0 million in additional commercial launch and sales-based milestone payments, as well as tiered, double-digit royalty payments starting at mid-teens percentage of annual net sales of tovorafenib, subject to customary adjustments specified in the Ipsen License Agreement. The commercial launch milestones related to first commercial sale(s) in certain territories, sales-based milestones and royalties are recognized as revenue when the related sales occur as the license of intellectual property is deemed to be the predominant item to which the commercial launch milestones, sales-based milestones and royalties relate. Upon execution of the Ipsen License Agreement, the transaction price was determined to be $ 78.2 million, representing the aggregate of the upfront license fee of $ 70.8 million and the premium paid by Ipsen on its equity investment in the Company of $ 7.4 million (the excess of the value of the shares of the Company issued to Ipsen), representing additional consideration from Ipsen for the rights under the Ipsen License Agreement. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue against each performance obligation as or when the performance obligations under the contract are satisfied. If a license to the Company's intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the license as revenue upon transfer of control of the license. All other promised goods or services in the agreement are evaluated to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. Optional future services where any additional consideration paid to the Company reflects their standalone selling prices do not provide the customer with a material right, and, therefore, are not considered performance obligations. If optional future services are priced in a manner which provides the customer with a significant or incremental discount, they are material rights, and are accounted for as separate performance obligations. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded within deferred revenue. Contract liabilities within deferred revenue are recognized as revenue after control of the goods or services is transferred to the customer and all revenue recognition criteria have been met. |
Cost of Product Revenue | Cost of Product Revenue Our cost of product revenue includes the cost of inventory sold, amortization expense of intangible assets and third-party royalties payable on our net product revenue. Cost of product revenue may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, which requires incremental disclosure of segment information on an interim and annual basis. This ASU is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Retrospective application to all prior periods presented in the financial statements is required for public entities. The Company is currently evaluating the effect of this update on its financial statement disclosures. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures, which enhances the transparency and decision usefulness of income tax disclosures by requiring disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. The ASU is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. The Company is currently evaluating the effect of this update on its financial statement disclosures. |
Recurring Fair Value Measurem_2
Recurring Fair Value Measurement (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value, assets and liabilities measured on recurring basis | The following table sets forth the Company’s financial instruments as of September 30, 2024 and December 31, 2023, which are measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): September 30, 2024 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 249,276 $ — $ — $ 249,276 U.S. treasury securities — 194,476 — 194,476 U.S. government agency securities — 91,498 — 91,498 Total assets measured at fair value $ 249,276 $ 285,974 $ — $ 535,250 December 31, 2023 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 47,003 $ — $ — $ 47,003 U.S. treasury securities — 246,208 — 246,208 U.S. government agency securities — 63,202 — 63,202 Total assets measured at fair value $ 47,003 $ 309,410 $ — $ 356,413 |
Schedule of cash equivalents, marketable securities, and unrealized gains and losses | The following tables summarize the estimated fair value of the Company's cash equivalents, available-for-sale securities classified as short-term investments, and associated unrealized gains and losses (in thousands): September 30, 2024 Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value Cash equivalents: Money market funds $ 249,276 $ — $ — $ 249,276 U.S. government agency securities 81,762 — — 81,762 U.S. treasury securities 68,594 — — 68,594 Total cash equivalents 399,632 — — 399,632 Short-term investments U.S. government agency securities 9,733 4 ( 1 ) 9,736 U.S. treasury securities 125,890 27 ( 35 ) 125,882 Total short-term investments $ 135,623 $ 31 $ ( 36 ) $ 135,618 December 31, 2023 Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value Cash equivalents: Money market funds $ 47,003 $ — $ — $ 47,003 U.S. government agency securities 63,202 — — 63,202 U.S. treasury securities 110,645 — — 110,645 Total cash equivalents 220,850 — — 220,850 Short-term investments U.S. treasury securities 135,554 9 — 135,563 Total short-term investments $ 135,554 $ 9 $ — $ 135,563 |
Schedule of maturities of available-for-sale marketable securities | The following table summarizes the maturities of our cash equivalents and available-for-sale securities (in thousands): September 30, 2024 Amortized Cost Fair Value Mature in one year or less $ 535,255 $ 535,250 Total $ 535,255 $ 535,250 December 31, 2023 Amortized Cost Fair Value Mature in one year or less $ 356,404 $ 356,413 Total $ 356,404 $ 356,413 |
Balance Sheet Items (Tables)
Balance Sheet Items (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, Prepaid research and development expenses $ 6,382 $ 5,657 Prepaid insurance 1,355 918 Other prepaid expenses and other assets 3,446 2,352 Total prepaid expenses and other current assets $ 11,183 $ 8,927 |
Schedule of Accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, December 31, Accrued research and development expenses $ 16,299 $ 12,643 Accrued payroll related expenses 11,502 9,165 Accrued professional service expenses 2,893 3,675 Other 4,495 1,041 Total accrued expenses and other current liabilities $ 35,189 $ 26,524 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Future Lease Obligations | As of September 30, 2024, the future lease obligations were as follows (in thousands): Year Ending December 31, 2024 (Remaining) $ 147 2025 352 2026 435 2027 448 2028 461 Thereafter 2,613 Total future minimum lease payments 4,456 Less: imputed interest ( 1,841 ) Present value of operating lease liabilities 2,615 Less: current portion of operating lease liabilities ( 77 ) Operating lease liabilities $ 2,538 |
Common Stock (Tables)
Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Common Stock Shares Reserved for Future Issuance | The Company has reserved shares of common stock for future issuances as follows: September 30, Common stock options issued and outstanding 11,926,321 Common stock available for future grants 3,799,351 Common stock available for ESPP 2,498,360 Restricted stock units issued and outstanding 1,887,246 Total 20,111,278 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Summary of Restricted Stock Units Activity | The following table provides a summary of restricted stock units activity during the nine months ended September 30, 2024: Number of Weighted Average Unvested restricted stock units at December 31, 2023 1,031,545 $ 18.27 Granted 1,584,280 $ 14.38 Vested ( 526,047 ) $ 16.52 Forfeiture ( 202,532 ) $ 16.14 Unvested restricted stock units at September 30, 2024 1,887,246 $ 15.72 |
Summary of Share/Stock-based Compensation Expense Recorded in The Accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss | Share-based compensation expense recorded in the accompanying condensed statements of operations is as follows (in thousands): Three Months Ended Nine Months Ended 2024 2023 2024 2023 Research and development expense $ 3,816 $ 3,312 $ 13,178 $ 10,102 Selling, general and administrative expense 7,738 6,294 24,050 18,428 Total share-based compensation expense $ 11,554 $ 9,606 $ 37,228 $ 28,530 |
Summary of The Unvested Common Stock | The following table provides a summary of the unvested common stock awards activity during the nine months ended September 30, 2024. Number of Weighted Average Unvested common stock as of December 31, 2023 747,679 $ 16.00 Vested ( 556,424 ) $ 16.00 Forfeiture ( 25,415 ) $ 16.00 Unvested common stock as of September 30, 2024 165,840 $ 16.00 |
Schedule of fair value of our common stock to be issued under the ESPP | The fair value of our common stock to be issued under the ESPP is estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions: Nine Months Ended 2024 2023 Expected term (in years) 0.5 0.5 Expected volatility 63.45 % 63.57 % Risk-free interest rate 5.40 % 5.24 % Expected dividend yield — — |
Summary of The Black-Scholes Option Pricing Model to Estimate The Fair Value of Stock Option Granted | The Company used the Black-Scholes option pricing model to estimate the fair value of stock option awards granted with the following assumptions: Three Months Ended Nine Months Ended 2024 2023 2024 2023 Expected term (in years) 6.06 - 6.11 5.65 - 6.14 5.27 - 6.74 5.27 - 6.25 Expected volatility 68.46 % - 68.72 % 68.82 % - 71.43 % 68.27 % - 70.57 % 68.82 % - 81.98 % Risk-free interest rate 3.43 % - 4.40 % 4.02 % - 4.56 % 3.43 % - 4.47 % 3.47 % - 4.56 % Expected dividend yield — — — — |
2021 Equity Incentive Plan | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Summary of Stock Option Activity | The following table provides a summary of stock option activity during the nine months ended September 30, 2024. Options Weighted-Average Weighted-Average Aggregate Outstanding at December 31, 2023 10,211,758 $ 17.10 Granted 2,830,362 $ 14.31 Exercised ( 94,553 ) $ 14.26 $ 134 Forfeiture ( 1,021,246 ) $ 16.62 Outstanding at September 30, 2024 11,926,321 $ 16.51 7.9 $ 2,367 Vested and expected to vest at September 30, 2024 11,926,321 $ 16.51 7.9 $ 2,367 Exercisable at September 30, 2024 6,722,507 $ 16.66 7.4 $ 1,224 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Earnings Per Share [Abstract] | |
Summary of Basic and Diluted Net Loss Per Share Attributable to Common Shareholders/Stockholders | Basic and diluted net income (loss) per share attributable to common stockholders is calculated as follows (in thousands except share and per share amounts): Three Months Ended Nine Months Ended 2024 2023 2024 2023 Net income (loss) - basic and diluted $ 37,037 $ ( 46,150 ) $ ( 29,782 ) $ ( 134,406 ) Weighted average shares outstanding - basic 96,623,123 85,952,501 90,164,895 77,682,237 Effect of dilutive securities: Stock options 57,455 — — — Restricted stock units 107,935 — — — Restricted stock awards 149,246 — — — Weighted average shares outstanding - diluted 96,937,759 85,952,501 90,164,895 77,682,237 Net income (loss) per share - basic $ 0.38 $ ( 0.54 ) $ ( 0.33 ) $ ( 1.73 ) Net income (loss) per share - diluted $ 0.38 $ ( 0.54 ) $ ( 0.33 ) $ ( 1.73 ) |
Summary of Outstanding Potentially Dilutive Securities Have Been Excluded From Calculation of Diluted Net Loss Per Share | The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net income (loss) per share, as their effect is anti-dilutive: Three Months Ended Nine Months Ended 2024 2023 2024 2023 Stock options 11,454,704 10,039,940 11,926,321 10,039,940 Unvested common shares — 956,719 165,840 956,719 Restricted stock units 406,092 1,001,313 1,887,246 1,001,313 Shares committed under ESPP 88,832 69,578 88,832 69,578 Total 11,949,628 12,067,550 14,068,239 12,067,550 |
Summary of Significant Accou_3
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Apr. 23, 2024 | Sep. 30, 2024 | Sep. 30, 2024 | Dec. 31, 2023 | |
Accounting Policies [Line Items] | ||||
Accounts receivable, credit losses | $ 0 | $ 0 | ||
Other expenses | $ 0 | 0 | ||
Milestone payment, capitalized | $ 9,000 | |||
Intangible asset useful life | 7 years 3 months 18 days | 7 years 3 months 18 days | ||
Share Purchased | 100,810,357 | 100,810,357 | 87,227,132 | |
Viracta License Agreement | ||||
Accounting Policies [Line Items] | ||||
Milestone payment, capitalized | $ 8,100 | |||
Payment of Milestones | $ 9,000 | |||
Ipsen License Agreement | ||||
Accounting Policies [Line Items] | ||||
Premium Received On License Agreement | 7,400 | |||
Aggregate Of Upfront License Fee Received | $ 70,800 | |||
Share Purchased | 2,341,495 | 2,341,495 | ||
Payment to private placement | $ 40,000 | |||
Volume weighted average price | 17% | |||
Payment of Milestones | $ 350,000 | |||
Transaction Price | $ 78,200 | |||
One Customer [Member] | Revenue Benchmark [Member] | Concentration of Credit Risk and Other Risks and Uncertainties [Member] | ||||
Accounting Policies [Line Items] | ||||
Concentration risk percentage of net product revenue and accounts receivable | 69% | 66.60% | ||
One Customer [Member] | Accounts Receivable [Member] | Concentration of Credit Risk and Other Risks and Uncertainties [Member] | ||||
Accounting Policies [Line Items] | ||||
Concentration risk percentage of net product revenue and accounts receivable | 55% | |||
Two Customer [Member] | Revenue Benchmark [Member] | Concentration of Credit Risk and Other Risks and Uncertainties [Member] | ||||
Accounting Policies [Line Items] | ||||
Concentration risk percentage of net product revenue and accounts receivable | 23% | 27% | ||
Two Customer [Member] | Accounts Receivable [Member] | Concentration of Credit Risk and Other Risks and Uncertainties [Member] | ||||
Accounting Policies [Line Items] | ||||
Concentration risk percentage of net product revenue and accounts receivable | 25.70% | |||
Three Customer [Member] | Revenue Benchmark [Member] | Concentration of Credit Risk and Other Risks and Uncertainties [Member] | ||||
Accounting Policies [Line Items] | ||||
Concentration risk percentage of net product revenue and accounts receivable | 8% | 6.40% | ||
Three Customer [Member] | Accounts Receivable [Member] | Concentration of Credit Risk and Other Risks and Uncertainties [Member] | ||||
Accounting Policies [Line Items] | ||||
Concentration risk percentage of net product revenue and accounts receivable | 19.30% | |||
Other Individual Customer [Member] | Net Product Revenue and Accounts Receivable [Member] | Concentration of Credit Risk and Other Risks and Uncertainties [Member] | Maximum [Member] | ||||
Accounting Policies [Line Items] | ||||
Concentration risk percentage of net product revenue and accounts receivable | 10% | |||
Individual Customer [Member] | Revenue Benchmark [Member] | Concentration of Credit Risk and Other Risks and Uncertainties [Member] | ||||
Accounting Policies [Line Items] | ||||
Concentration risk percentage of net product revenue and accounts receivable | 100% | 100% | ||
Individual Customer [Member] | Accounts Receivable [Member] | Concentration of Credit Risk and Other Risks and Uncertainties [Member] | ||||
Accounting Policies [Line Items] | ||||
Concentration risk percentage of net product revenue and accounts receivable | 100% |
Recurring Fair Value Measurem_3
Recurring Fair Value Measurement - Schedule of fair value, assets and liabilities measured on recurring basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | $ 249,276 | $ 47,003 |
U.S. treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 68,594 | 110,645 |
U.S. government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 81,762 | 63,202 |
Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 535,250 | 356,413 |
Fair Value, Recurring | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 249,276 | 47,003 |
Fair Value, Recurring | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 285,974 | 309,410 |
Fair Value, Recurring | Fair Value, Inputs, Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Fair Value, Recurring | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 249,276 | 47,003 |
Fair Value, Recurring | Money market funds | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 249,276 | 47,003 |
Fair Value, Recurring | Money market funds | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Fair Value, Recurring | Money market funds | Fair Value, Inputs, Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Fair Value, Recurring | U.S. treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 194,476 | 246,208 |
Fair Value, Recurring | U.S. treasury securities | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Fair Value, Recurring | U.S. treasury securities | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 194,476 | 246,208 |
Fair Value, Recurring | U.S. treasury securities | Fair Value, Inputs, Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Fair Value, Recurring | U.S. government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 91,498 | 63,202 |
Fair Value, Recurring | U.S. government agency securities | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Fair Value, Recurring | U.S. government agency securities | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | 91,498 | 63,202 |
Fair Value, Recurring | U.S. government agency securities | Fair Value, Inputs, Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents, fair value disclosure | $ 0 | $ 0 |
Recurring Fair Value Measurem_4
Recurring Fair Value Measurement - Schedule of cash equivalents, marketable securities, and unrealized gains and losses (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2024 | Dec. 31, 2023 | |
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents, amortized cost | $ 422,765 | $ 230,784 |
Marketable securities | ||
Cash and Cash Equivalents [Line Items] | ||
Debt securities, available-for-sale, amortized cost | 135,623 | 135,554 |
Debt securities, available-for-sale, unrealized gain | 31 | 9 |
Debt securities, available-for-sale, unrealized loss | (36) | 0 |
Debt securities, available-for-sale, estimated fair value | 135,618 | 135,563 |
Cash equivalents | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents, amortized cost | 399,632 | 220,850 |
Cash equivalents, unrealized gains | 0 | 0 |
Cash equivalents, unrealized losses | 0 | 0 |
Cash and cash equivalents, fair value disclosure | 399,632 | 220,850 |
Money market funds | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents, amortized cost | 249,276 | 47,003 |
Cash equivalents, unrealized gains | 0 | 0 |
Cash equivalents, unrealized losses | 0 | 0 |
Cash and cash equivalents, fair value disclosure | 249,276 | 47,003 |
U.S. government agency securities | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents, amortized cost | 81,762 | 63,202 |
Cash equivalents, unrealized gains | 0 | 0 |
Cash equivalents, unrealized losses | 0 | 0 |
Cash and cash equivalents, fair value disclosure | 81,762 | 63,202 |
Debt securities, available-for-sale, amortized cost | 9,733 | |
Debt securities, available-for-sale, unrealized gain | 4 | |
Debt securities, available-for-sale, unrealized loss | (1) | |
Debt securities, available-for-sale, estimated fair value | 9,736 | |
U.S. treasury securities | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents, amortized cost | 68,594 | 110,645 |
Cash equivalents, unrealized gains | 0 | 0 |
Cash equivalents, unrealized losses | 0 | 0 |
Cash and cash equivalents, fair value disclosure | 68,594 | 110,645 |
Debt securities, available-for-sale, amortized cost | 125,890 | 135,554 |
Debt securities, available-for-sale, unrealized gain | 27 | 9 |
Debt securities, available-for-sale, unrealized loss | (35) | 0 |
Debt securities, available-for-sale, estimated fair value | $ 125,882 | $ 135,563 |
Recurring Fair Value Measurem_5
Recurring Fair Value Measurement - Schedule of maturities of available-for-sale marketable securities (Details) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Cash and Cash Equivalents [Line Items] | ||
Amortized cost, mature in one year or less | $ 535,255 | $ 356,404 |
Amortized cost, total | 535,255 | 356,404 |
Fair value, mature in one year or less | 535,250 | 356,413 |
Fair value, total | $ 535,250 | $ 356,413 |
Recurring Fair Value Measurem_6
Recurring Fair Value Measurement - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Fair value, measurement recurring basis, asset, transfers, net | $ 0 | $ 0 | ||
Unrealized losses twelve months or greater | $ 0 | $ 0 | ||
Realized gains and losses | $ 0 | $ 0 |
Balance Sheet Items - Summary o
Balance Sheet Items - Summary of Prepaid and Other Current Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development expenses | $ 6,382 | $ 5,657 |
Prepaid insurance | 1,355 | 918 |
Other prepaid expenses and other assets | 3,446 | 2,352 |
Total prepaid expenses and other current assets | $ 11,183 | $ 8,927 |
Balance Sheet Items - Summary_2
Balance Sheet Items - Summary of Accrued expenses and other current liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued license agreement upfront payment | $ 16,299 | $ 12,643 |
Accrued payroll related expenses | 11,502 | 9,165 |
Accrued professional service expenses | 2,893 | 3,675 |
Other | 4,495 | 1,041 |
Total accrued expenses and other current liabilities | $ 35,189 | $ 26,524 |
Significant Agreements - Additi
Significant Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Jul. 23, 2024 | May 29, 2024 | Apr. 23, 2024 | Mar. 04, 2024 | May 26, 2021 | Dec. 16, 2019 | Jul. 31, 2024 | Sep. 30, 2024 | Sep. 30, 2024 | Sep. 30, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Proceeds From sale of PRV | $ 108,000 | $ 0 | ||||||||
Proceeds from issuance of private placement | 178,177 | 0 | ||||||||
Deferred revenue | 4,523 | $ 0 | ||||||||
Takeda Asset Agreement [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Upfront of cash payment | $ 1,000 | |||||||||
Takeda Asset Agreement [Member] | Common Stock [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Issuance of Series B redeemable convertible preferred shares for cash, net of issuance costs, shares | 6,470,382 | |||||||||
Takeda Asset Agreement [Member] | Series A Redeemable Convertible Preferred Stock [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Share Issuance | 9,857,143 | |||||||||
Common stock issued, share issuance costs | $ 9,900 | |||||||||
Issuance of Series B redeemable convertible preferred shares for cash, net of issuance costs, shares | 9,857,143 | |||||||||
Merck License Agreement [Member] | Research And Development Expense | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Upfront payment | 8,000 | |||||||||
Merck License Agreement [Member] | Research And Development Expense | Maximum [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Milestone payments not yet paid | 364,500 | |||||||||
Viracta License Agreement [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Payment of Milestones | $ 9,000 | |||||||||
Viracta License Agreement [Member] | Other Intangible Assets [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Payment of Milestones | 9,000 | |||||||||
Viracta License Agreement [Member] | PRV | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Payment of Milestones | 8,100 | |||||||||
Proceeds From sale of PRV | $ 108,000 | 108,000 | ||||||||
Payment of PRV related obligations | $ 8,100 | |||||||||
Viracta License Agreement [Member] | Research And Development Expense | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Upfront payment | $ 5,000 | |||||||||
Upfront of cash payment | 2,000 | |||||||||
Sprint Bioscience Agreement [Member] | Research And Development Expense | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Upfront payment | 3,000 | |||||||||
Payment of Milestones | 40,000 | |||||||||
Sprint Bioscience Agreement [Member] | Research And Development Expense | Maximum [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Milestone payments not yet paid | 309,000 | |||||||||
MabCare License Agreement [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Upfront payment | $ 55,000 | |||||||||
MabCare License Agreement [Member] | Research And Development Expense | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Milestone payments not yet paid | 1,152,000 | |||||||||
License agreement with Ipsen Pharma SAS [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Payment of Milestones | 350,000 | |||||||||
Proceeds from issuance of private placement | $ 40,000 | |||||||||
Transaction Price | 78,200 | |||||||||
Equity Investment | 7,400 | |||||||||
Deferred revenue | $ 200 | 200 | ||||||||
License agreement with Ipsen Pharma SAS [Member] | Current Member | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Deferred revenue | 1,400 | 1,400 | ||||||||
License agreement with Ipsen Pharma SAS [Member] | Noncurrent Member | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Deferred revenue | $ 3,100 | 3,100 | ||||||||
License agreement with Ipsen Pharma SAS [Member] | Obligations | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Frontline Payment | 4,700 | |||||||||
License agreement with Ipsen Pharma SAS [Member] | License revenue [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Upfront payment | $ 70,800 | |||||||||
Aggregate Of Upfront License Fee Received | $ 73,500 | |||||||||
License agreement with Ipsen Pharma SAS [Member] | Common Stock [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Share Issuance | 2,341,495 | |||||||||
Volume weighted average price | 17% |
Commitments and Contingencies -
Commitments and Contingencies - Summary of Future Lease Obligations (Detail) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | ||
2024 (Remaining) | $ 147 | |
2025 | 352 | |
2026 | 435 | |
2027 | 448 | |
2028 | 461 | |
Thereafter | 2,613 | |
Total future minimum lease payments | 4,456 | |
Less: Imputed interest | (1,841) | |
Present value of operating lease liabilities | 2,615 | |
Less: current portion of operating lease liabilities | (77) | $ (408) |
Operating lease liabilities | $ 2,538 | $ 0 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Apr. 30, 2022 USD ($) ft² | Sep. 30, 2024 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2024 USD ($) | Sep. 30, 2023 USD ($) | Aug. 31, 2024 | Jun. 30, 2024 USD ($) ft² | Dec. 31, 2023 USD ($) | |
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease term | 31 months | 7 years 4 months 24 days | ||||||
Amortization of operating right-of-use assets | $ 332,000 | $ 257,000 | ||||||
Operating lease payments | $ 1,100,000 | $ 4,400,000 | ||||||
Weighted average remaining lease term | 7 years | 7 years | ||||||
Weighted average discount rate percent | 12.70% | 12.70% | ||||||
Research And Development Agreements | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Termination and cancellation charges payable | $ 0 | $ 0 | $ 0 | |||||
Indemnification Agreement | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Termination and cancellation charges payable | 0 | 0 | $ 0 | |||||
Purchase Commitments | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Aggregate amount of future minimum purchase obligations | 15,200,000 | 15,200,000 | ||||||
Purchases under the purchase obligation | 2,000,000 | |||||||
Brisbane, California | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Sublease agreement area | ft² | 12,000 | 19,000 | ||||||
Security deposit | $ 40,000 | $ 86,000 | ||||||
Lease For Corporate Office Facility | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Amortization of operating right-of-use assets | $ 200,000 | $ 100,000 | 400,000 | 300,000 | ||||
Operating lease payments | $ 400,000 | $ 300,000 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 9 Months Ended | ||||
Aug. 01, 2024 | Jun. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Jul. 31, 2024 | Dec. 31, 2023 | |
Class of Stock [Line Items] | ||||||
Common Stock, Shares Authorized | 500,000,000 | 500,000,000 | ||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | ||||
Common Stock, Shares Issued | 100,810,357 | 87,227,132 | ||||
Common Stock, Shares Outstanding | 100,810,357 | 87,227,132 | ||||
Common stock shares reserved for future issuance | 20,111,278 | |||||
Proceeds from the issuance of common stock, net | $ 0 | $ 161,409 | ||||
Proceeds from issuance of private placement | 178,177 | 0 | ||||
Common Stock Value | 10 | $ 9 | ||||
Proceeds from issuance of prefunded warrants to purchase common stock, net of issuance costs | $ 20,941 | $ 0 | ||||
2024 Private Placement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Common Stock, Shares Issued | 10,551,718 | |||||
Proceeds from issuance of private placement | $ 166,500 | |||||
2024 Private Placement [Member] | Pre-Funded Warrant [Member] | ||||||
Class of Stock [Line Items] | ||||||
Ownership percentage | 9.99% | |||||
Investment Agreement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Upfront license fee | $ 70,800 | |||||
Number of Common Stock Shares Purchased | 2,341,495 | |||||
Common Stock Value | $ 32,600 | |||||
Weighted Average Price of Company's common Stock | 17% | |||||
Common Shares Purchase Agreement | ||||||
Class of Stock [Line Items] | ||||||
Common Stock, Shares Authorized | 500,000,000 | |||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | |||||
Sales Agreement with Piper Sandler and Jones Services LLC | ||||||
Class of Stock [Line Items] | ||||||
Common Stock, Par or Stated Value Per Share | $ 13 | |||||
Common Stock, Shares Issued | 13,269,231 | |||||
Common stock shares reserved for future issuance | 1,730,769 | |||||
Proceeds from the issuance of common stock, net | $ 161,400 | $ 250,000 | ||||
Pre-Funded Warrants [Member] | ||||||
Class of Stock [Line Items] | ||||||
Purchase Price of Common Stock Per Share | $ 14.4999 | |||||
Number of Pre-funded warrants purchased | 1,517,241 | |||||
Excersise price of pre-funded warrants | $ 0.0001 | |||||
Pre-Funded Warrants [Member] | 2024 Private Placement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Proceeds from issuance of prefunded warrants to purchase common stock, net of issuance costs | 20,900 | |||||
Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Common Stock, Par or Stated Value Per Share | 0.0001 | |||||
Common stock shares reserved for future issuance | 11,926,321 | |||||
Purchase Price of Common Stock Per Share | $ 14.5 | |||||
Number of Pre-funded warrants purchased | 1,517,241 | |||||
Common Stock [Member] | 2024 Private Placement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Proceeds from the issuance of common stock, net | $ 145,600 | |||||
Common Stock [Member] | Investment Agreement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Common Stock Value | $ 40,000 |
Common Stock - Schedule of Comm
Common Stock - Schedule of Common Stock Shares Reserved for Future Issuance (Details) (Details) | Sep. 30, 2024 shares |
Class of Stock [Line Items] | |
Common stock shares reserved for future issuance | 20,111,278 |
Employee Stock Option | |
Class of Stock [Line Items] | |
Common stock shares reserved for future issuance | 3,799,351 |
Restricted Stock Units (RSUs) | |
Class of Stock [Line Items] | |
Common stock shares reserved for future issuance | 1,887,246 |
Employee Stock Purchase Plan | |
Class of Stock [Line Items] | |
Common stock shares reserved for future issuance | 2,498,360 |
Common Stock | |
Class of Stock [Line Items] | |
Common stock shares reserved for future issuance | 11,926,321 |
Share-based Compensation - Summ
Share-based Compensation - Summary of Share/Stock-based Compensation Expense Recorded in The Accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | $ 11,554 | $ 9,606 | $ 37,228 | $ 28,530 |
Research and development expense | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | 3,816 | 3,312 | 13,178 | 10,102 |
Selling, general and administrative expense | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | $ 7,738 | $ 6,294 | $ 24,050 | $ 18,428 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||||
May 31, 2021 | Sep. 30, 2024 | Jun. 30, 2024 | Mar. 31, 2024 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Oct. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Issuance of common stock upon exercise of stock options, Amount | $ 977 | $ 324 | $ 48 | $ 115 | $ 39 | $ 1,184 | ||||
Common stock shares reserved for future issuance | 20,111,278 | 20,111,278 | ||||||||
Allocated share based compensation expense | $ 11,554 | 9,606 | $ 37,228 | $ 28,530 | ||||||
Restricted Stock [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Unamortized stock-based compensation for stock options | 27,900 | $ 27,900 | ||||||||
Weighted-average period expected to be recognized | 2 years 9 months 18 days | |||||||||
2021 Equity Incentive Plan | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Issuance of common stock upon exercise of stock options, Amount | $ 100 | 600 | ||||||||
Total fair value of options | $ 25,700 | $ 19,800 | $ 25,700 | $ 19,800 | ||||||
Share based compensation by share based payment award fair value assumptions dividend yield | 0% | 0% | 0% | 0% | ||||||
Number of shares issued upon conversion | 4,719,605 | |||||||||
Common stock shares reserved for future issuance | 6,369,000 | |||||||||
Share based compensation by share based payment arrangement non vested options granted during the period | 2,830,362 | |||||||||
Weighted-average period expected to be recognized | 7 years 10 months 24 days | |||||||||
Granted | 2,830,362 | |||||||||
2021 Equity Incentive Plan | PSOs | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Share based compensation by share based payment arrangement non vested options granted during the period weighted average grant date fair value | $ 9.24 | $ 13.37 | ||||||||
Unamortized stock-based compensation for stock options | $ 53,300 | $ 53,300 | ||||||||
Weighted-average period expected to be recognized | 2 years 3 months 18 days | |||||||||
2021 Equity Incentive Plan | Incremental Shares Reserved for Future Issuance [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Percentage of Outstanding Stock Maximum | 5% | |||||||||
2021 Employee Stock Purchase Plan | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Common stock shares reserved for future issuance | 603,000 | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Percentage of Outstanding Stock Maximum | 1% | |||||||||
Allocated share based compensation expense | 200 | $ 100 | $ 600 | $ 600 | ||||||
Stock Issued During Period, Shares, Employee Stock Ownership Plan | 331,014 | |||||||||
2022 Equity Inducement Plan | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Common stock shares reserved for future issuance | 1,000,000 | |||||||||
Unvested Common Stock [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Unamortized stock-based compensation for stock options | $ 1,100 | $ 1,100 | ||||||||
Weighted-average period expected to be recognized | 6 months |
Share-based Compensation - Su_2
Share-based Compensation - Summary of Stock Option Activity (Detail) - 2021 Equity Incentive Plan - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2024 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares, Beginning Balance | 10,211,758 |
Granted | 2,830,362 |
Exercised | (94,553) |
Forfeiture | (1,021,246) |
Outstanding at September 30, 2024 | 11,926,321 |
Vested and expected to vest at September 30, 2024 | 11,926,321 |
Exercisable at September 30, 2024 | 6,722,507 |
Weighted Average Exercise Price Per Share, Beginning Balance | $ 17.1 |
Granted | 14.31 |
Exercised | 14.26 |
Forfeiture | 16.62 |
Weighted Average Exercise Price Per Share, Ending Balance | 16.51 |
Weighted Average Exercise Price Per Share, Vested and expected to vest at September 30, 2024 | 16.51 |
Exercisable at September 30, 2024 | $ 16.66 |
Weighted-Average Remaining Contractual Term, Outstanding at September 30, 2024 | 7 years 10 months 24 days |
Weighted-Average Remaining Contractual Term, Vested and expected to vest at September 30, 2024 | 7 years 10 months 24 days |
Weighted-Average Remaining Contractual Term, Exercisable at September 30, 2024 | 7 years 4 months 24 days |
Exercised | $ 134 |
Outstanding at September 30, 2024 Aggregate Intrinsic Value | 2,367 |
Vested and expected to vest at September 30, 2024, Aggregate Intrinsic Value | 2,367 |
Exercisable at September 30, 2024 | $ 1,224 |
Share-based Compensation - Su_3
Share-based Compensation - Summary of The Black-Scholes Option Pricing Model to Estimate The Fair Value of Stock Option Granted (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Two Thousand And Twenty One Equity Incentive Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected dividend yield | 0% | 0% | 0% | 0% |
Two Thousand And Twenty One Equity Incentive Plan [Member] | Maximum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 1 month 9 days | 6 years 1 month 20 days | 6 years 8 months 26 days | 6 years 3 months |
Expected volatility | 68.72% | 71.43% | 70.57% | 81.98% |
Risk-free interest rate | 4.40% | 4.56% | 4.47% | 4.56% |
Two Thousand And Twenty One Equity Incentive Plan [Member] | Minimum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 21 days | 5 years 7 months 24 days | 5 years 3 months 7 days | 5 years 3 months 7 days |
Expected volatility | 68.46% | 68.82% | 68.27% | 68.82% |
Risk-free interest rate | 3.43% | 4.02% | 3.43% | 3.47% |
Two Thousand Twenty One Employee Stock Purchase Plan | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 months | 6 months | ||
Expected dividend yield | 0% | 0% |
Share-based Compensation - Su_4
Share-based Compensation - Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units - 2021 Equity Incentive Plan | 9 Months Ended |
Sep. 30, 2024 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Unvested restricted stock, beginning balance | shares | 1,031,545 |
Granted | shares | 1,584,280 |
Vested | shares | (526,047) |
Forfeiture | shares | (202,532) |
Unvested restricted stock, ending balance | shares | 1,887,246 |
Weighted Average Grant Date Fair Value Per Share, Beginning Balance | $ / shares | $ 18.27 |
Grant date fair value | $ / shares | 14.38 |
Vested | $ / shares | 16.52 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 16.14 |
Weighted Average Grant Date Fair Value Per Share, Ending Balance | $ / shares | $ 15.72 |
Share-based Compensation - Su_5
Share-based Compensation - Summary of The Unvested Common Stock (Detail) - Unvested Common Stock [Member] | 9 Months Ended |
Sep. 30, 2024 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares, Unvested Common Stock, Beginning balance | shares | 747,679 |
Vested | shares | (556,424) |
Number of Shares, Forfeited | shares | (25,415) |
Number of Shares, Unvested Common Stock, Ending balance | shares | 165,840 |
Weighted Average Grant Date Fair Value Per Share, Beginning Balance | $ / shares | $ 16 |
Vested | $ / shares | 16 |
Forfeiture | $ / shares | 16 |
Weighted Average Grant Date Fair Value Per Share, Ending Balance | $ / shares | $ 16 |
Share-based Compensation - Fair
Share-based Compensation - Fair value of our common stock to be issued under the ESPP (Details) - 2021 Employee Stock Purchase Plan [Member] | 9 Months Ended | |
Sep. 30, 2024 | Sep. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term (in years) | 6 months | 6 months |
Expected volatility | 63.45% | 63.57% |
Risk-free interest rate | 5.40% | 5.24% |
Expected dividend yield | 0% | 0% |
Income Taxes (Additional Inform
Income Taxes (Additional Information) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | ||||
Income tax expense | $ (882) | $ 0 | $ 670 | $ 0 |
Recognized income tax benefit | $ 900 | |||
Effective income tax rate | 2.40% | 2.30% | ||
Federal statutory rate | 21% | 21% |
Net Income (Loss) Per Share - S
Net Income (Loss) Per Share - Summary of Basic and Diluted Net Loss Per Share Attributable to Common Shareholders/Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2024 | Jun. 30, 2024 | Mar. 31, 2024 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Net income (loss) - basic and diluted | $ 37,037 | $ (4,407) | $ (62,412) | $ (46,150) | $ (45,863) | $ (42,393) | $ (29,782) | $ (134,406) |
Weighted average shares outstanding - basic | 96,623,123 | 85,952,501 | 90,164,895 | 77,682,237 | ||||
Weighted average shares outstanding - diluted | 96,937,759 | 85,952,501 | 90,164,895 | 77,682,237 | ||||
Net income (loss) per share - basic | $ 0.38 | $ (0.54) | $ (0.33) | $ (1.73) | ||||
Net income (loss) per share - diluted | $ 0.38 | $ (0.54) | $ (0.33) | $ (1.73) | ||||
Employee Stock Option | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Effect of dilutive securities: | 57,455 | 0 | 0 | 0 | ||||
Restricted Stock Units | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Effect of dilutive securities: | 107,935 | 0 | 0 | 0 | ||||
Restricted stock awards | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Effect of dilutive securities: | 149,246 |
Net Income (Loss) Per Share -_2
Net Income (Loss) Per Share - Summary of Outstanding Potentially Dilutive Securities Have Been Excluded From Calculation of Diluted Net Loss Per Share (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock options | 11,949,628 | 12,067,550 | 14,068,239 | 12,067,550 |
Employee Stock Option | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock options | 11,454,704 | 10,039,940 | 11,926,321 | 10,039,940 |
Unvested common shares | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock options | 0 | 956,719 | 165,840 | 956,719 |
Restricted Stock Units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock options | 406,092 | 1,001,313 | 1,887,246 | 1,001,313 |
Shares committed under ESPP | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock options | 88,832 | 69,578 | 88,832 | 69,578 |
Defined Contribution Plan (Addi
Defined Contribution Plan (Additional Information) (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Retirement Benefits [Abstract] | ||||
Matching Contribution | $ 0.4 | $ 0.2 | $ 1.4 | $ 1 |
Subsequent Event (Additional In
Subsequent Event (Additional Information) (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |||
Sep. 30, 2024 | Sep. 30, 2023 | Jul. 31, 2024 | Dec. 31, 2023 | |
Subsequent Event [Line Items] | ||||
Proceeds from issuance of common stock in connection with private placement, net of placement agent fees and offering costs | $ 178,177 | $ 0 | ||
Common stock par value per share | $ 0.0001 | $ 0.0001 | ||
Common Stock [Member] | ||||
Subsequent Event [Line Items] | ||||
Common stock par value per share | $ 0.0001 |