Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 08, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-41696 | |
Entity Registrant Name | ACELYRIN, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 85-2406735 | |
Entity Address, Address Line One | 4149 Liberty Canyon Road | |
Entity Address, City or Town | Agoura Hills | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 91301 | |
City Area Code | 805 | |
Local Phone Number | 730-0360 | |
Title of 12(b) Security | Common Stock ($0.00001 par value) | |
Trading Symbol | SLRN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 99,808,262 | |
Entity Central Index Key | 0001962918 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets | ||
Cash and cash equivalents | $ 128,211 | $ 218,097 |
Short-term marketable securities | 507,029 | 503,229 |
Prepaid expenses and other current assets | 13,021 | 15,312 |
Total current assets | 648,261 | 736,638 |
Prepaid expenses and other assets, non-current | 325 | 2,678 |
Operating lease right-of-use asset | 1,101 | 1,195 |
Property, plant and equipment, net | 1,509 | 2,179 |
Restricted cash | 543 | 0 |
Total assets | 651,739 | 742,690 |
Current liabilities | ||
Accounts payable | 40,722 | 41,920 |
Accrued research and development expenses | 35,117 | 35,436 |
Accrued compensation and other current liabilities | 5,479 | 6,833 |
Severance liability | 1,134 | 970 |
Total current liabilities | 82,452 | 85,159 |
Operating lease liability, non-current | 1,069 | 1,194 |
Total liabilities | 83,521 | 86,353 |
Stockholders’ equity | ||
Common stock, par value of $0.00001 per share; 790,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 99,570,421 and 97,865,890 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 1 | 1 |
Additional paid-in capital | 1,177,748 | 1,144,893 |
Accumulated other comprehensive income (loss) | (167) | 162 |
Accumulated deficit | (609,364) | (488,719) |
Total stockholders' equity | 568,218 | 656,337 |
Total liabilities, redeemable convertible preferred stock and stockholders’ equity | $ 651,739 | $ 742,690 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Common stock, authorized (in shares) | 790,000,000 | 790,000,000 |
Common stock, issued (in shares) | 99,570,421 | 97,865,890 |
Common stock, outstanding (in shares) | 99,570,421 | 97,865,890 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating expenses: | ||||
Research and development | $ 76,382 | $ 30,030 | $ 134,414 | $ 197,950 |
General and administrative | 16,643 | 12,666 | 41,385 | 24,579 |
Total operating expenses | 93,025 | 42,696 | 175,799 | 222,529 |
Loss from operations | (93,025) | (42,696) | (175,799) | (222,529) |
Change in fair value of derivative tranche liability | 0 | 10,144 | 0 | 10,291 |
Interest income | 8,447 | 6,685 | 17,597 | 9,984 |
Other income (expense), net | (1,094) | (172) | 37,557 | (235) |
Net loss | (85,672) | (26,039) | (120,645) | (202,489) |
Other comprehensive gain (loss) | ||||
Unrealized gain (loss) on short-term marketable securities, net | (62) | 44 | (329) | 130 |
Total other comprehensive gain (loss) | (62) | 44 | (329) | 130 |
Net loss and other comprehensive loss | $ (85,734) | $ (25,995) | $ (120,974) | $ (202,359) |
Net loss per share attributable to common stockholder, basic (in shares) | $ (0.86) | $ (0.40) | $ (1.22) | $ (4.71) |
Net loss per share attributable to common stockholder, diluted (in shares) | $ (0.86) | $ (0.40) | $ (1.22) | $ (4.71) |
Weighted-average common shares outstanding, basic (in shares) | 99,161,710 | 65,210,117 | 98,537,685 | 42,974,640 |
Weighted-average common shares outstanding, diluted (in shares) | 99,161,710 | 65,210,117 | 98,537,685 | 42,974,640 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Beginning balance (in shares) at Dec. 31, 2022 | 40,743,522 | ||||
Beginning balance at Dec. 31, 2022 | $ 396,593 | ||||
Ending balance (in shares) at Mar. 31, 2023 | 40,743,522 | ||||
Ending balance at Mar. 31, 2023 | $ 396,593 | ||||
Beginning balance (in shares) at Dec. 31, 2022 | 2,767,359 | ||||
Beginning balance at Dec. 31, 2022 | (102,862) | $ 0 | $ 4,302 | $ (107,078) | $ (86) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock in connection with ValenzaBio acquisition (in shares) | 18,885,731 | ||||
Issuance of common stock in connection with ValenzaBio acquisition | 128,735 | 128,735 | |||
Stock-based compensation expense | 7,139 | 7,139 | |||
Net loss | (176,450) | (176,450) | |||
Unrealized gain (losses) on short-term marketable securities, net | 86 | 86 | |||
Ending balance (in shares) at Mar. 31, 2023 | 21,653,090 | ||||
Ending balance at Mar. 31, 2023 | $ (143,352) | $ 0 | 140,176 | (283,528) | 0 |
Beginning balance (in shares) at Dec. 31, 2022 | 40,743,522 | ||||
Beginning balance at Dec. 31, 2022 | $ 396,593 | ||||
Ending balance (in shares) at Jun. 30, 2023 | 0 | ||||
Ending balance at Jun. 30, 2023 | $ 0 | ||||
Beginning balance (in shares) at Dec. 31, 2022 | 2,767,359 | ||||
Beginning balance at Dec. 31, 2022 | $ (102,862) | $ 0 | 4,302 | (107,078) | (86) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Conversion of redeemable convertible preferred stock into common stock in connection with initial public offering (in shares) | 40,743,522 | ||||
Net loss | $ (202,489) | ||||
Unrealized gain (losses) on short-term marketable securities, net | 130 | ||||
Ending balance (in shares) at Jun. 30, 2023 | 97,199,849 | ||||
Ending balance at Jun. 30, 2023 | $ 801,066 | $ 1 | 1,110,588 | (309,567) | 44 |
Beginning balance (in shares) at Mar. 31, 2023 | 40,743,522 | ||||
Beginning balance at Mar. 31, 2023 | $ 396,593 | ||||
Redeemable Convertible Preferred Stock | |||||
Conversion of redeemable convertible preferred stock into common stock in connection with initial public offering (in shares) | (40,743,522) | ||||
Conversion of redeemable convertible preferred stock into common stock in connection with initial public offering | $ (396,593) | ||||
Ending balance (in shares) at Jun. 30, 2023 | 0 | ||||
Ending balance at Jun. 30, 2023 | $ 0 | ||||
Beginning balance (in shares) at Mar. 31, 2023 | 21,653,090 | ||||
Beginning balance at Mar. 31, 2023 | (143,352) | $ 0 | 140,176 | (283,528) | 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon initial public offering, net of underwriting discounts commissions and issuance costs (in shares) | 34,500,000 | ||||
Issuance of common stock upon initial public offering, net of underwriting discounts commissions and issuance costs of $47,354 | 573,644 | 573,644 | |||
Conversion of redeemable convertible preferred stock into common stock in connection with initial public offering (in shares) | 40,743,522 | ||||
Conversion of redeemable convertible preferred stock into common stock in connection with initial public offering | 396,593 | $ 1 | 396,592 | ||
Issuance of common stock upon settlement of restricted stock units, net of shares withheld for taxes (in shares) | 303,237 | ||||
Issuance of common stock upon settlement of restricted stock units, net of shares withheld for taxes | (8,325) | (8,325) | |||
Stock-based compensation expense | 8,501 | 8,501 | |||
Net loss | (26,039) | (26,039) | |||
Unrealized gain (losses) on short-term marketable securities, net | 44 | 44 | |||
Ending balance (in shares) at Jun. 30, 2023 | 97,199,849 | ||||
Ending balance at Jun. 30, 2023 | $ 801,066 | $ 1 | 1,110,588 | (309,567) | 44 |
Beginning balance (in shares) at Dec. 31, 2023 | 0 | ||||
Beginning balance at Dec. 31, 2023 | $ 0 | ||||
Ending balance (in shares) at Mar. 31, 2024 | 0 | ||||
Ending balance at Mar. 31, 2024 | $ 0 | ||||
Beginning balance (in shares) at Dec. 31, 2023 | 97,865,890 | 97,865,890 | |||
Beginning balance at Dec. 31, 2023 | $ 656,337 | $ 1 | 1,144,893 | (488,719) | 162 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon settlement of restricted stock units (in shares) | 47,639 | ||||
Stock-based compensation expense | 20,163 | 20,163 | |||
Issuance of common stock upon exercise of options (in shares) | 945,471 | ||||
Issuance of common stock upon exercise of options | 2,807 | 2,807 | |||
Net loss | (34,973) | (34,973) | |||
Unrealized gain (losses) on short-term marketable securities, net | (267) | (267) | |||
Ending balance (in shares) at Mar. 31, 2024 | 98,859,000 | ||||
Ending balance at Mar. 31, 2024 | $ 644,067 | $ 1 | 1,167,863 | (523,692) | (105) |
Beginning balance (in shares) at Dec. 31, 2023 | 0 | ||||
Beginning balance at Dec. 31, 2023 | $ 0 | ||||
Ending balance (in shares) at Jun. 30, 2024 | 0 | ||||
Ending balance at Jun. 30, 2024 | $ 0 | ||||
Beginning balance (in shares) at Dec. 31, 2023 | 97,865,890 | 97,865,890 | |||
Beginning balance at Dec. 31, 2023 | $ 656,337 | $ 1 | 1,144,893 | (488,719) | 162 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of options (in shares) | 215,128 | ||||
Net loss | $ (120,645) | ||||
Unrealized gain (losses) on short-term marketable securities, net | $ (329) | ||||
Issuance of common stock under the employee stock purchase plan | 100,827 | ||||
Ending balance (in shares) at Jun. 30, 2024 | 99,570,421 | 99,570,421 | |||
Ending balance at Jun. 30, 2024 | $ 568,218 | $ 1 | 1,177,748 | (609,364) | (167) |
Beginning balance (in shares) at Mar. 31, 2024 | 0 | ||||
Beginning balance at Mar. 31, 2024 | $ 0 | ||||
Ending balance (in shares) at Jun. 30, 2024 | 0 | ||||
Ending balance at Jun. 30, 2024 | $ 0 | ||||
Beginning balance (in shares) at Mar. 31, 2024 | 98,859,000 | ||||
Beginning balance at Mar. 31, 2024 | 644,067 | $ 1 | 1,167,863 | (523,692) | (105) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon settlement of restricted stock units, net of shares withheld for taxes (in shares) | 459,808 | ||||
Issuance of common stock upon settlement of restricted stock units, net of shares withheld for taxes | (1,937) | (1,937) | |||
Stock-based compensation expense | 10,174 | 10,174 | |||
Issuance of common stock upon exercise of options (in shares) | 150,786 | ||||
Issuance of common stock upon exercise of options | 1,289 | 1,289 | |||
Net loss | (85,672) | (85,672) | |||
Unrealized gain (losses) on short-term marketable securities, net | $ (62) | (62) | |||
Issuance of common stock under the employee stock purchase plan | 100,827 | 100,827 | |||
Issuance of common stock under the employee stock purchase plan | $ 359 | 359 | |||
Ending balance (in shares) at Jun. 30, 2024 | 99,570,421 | 99,570,421 | |||
Ending balance at Jun. 30, 2024 | $ 568,218 | $ 1 | $ 1,177,748 | $ (609,364) | $ (167) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) (Parenthetical) $ in Thousands | 3 Months Ended |
Jun. 30, 2023 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Underwriting discounts, commissions and offering costs | $ 47,354 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (120,645) | $ (202,489) |
Adjustments to reconcile net loss to net cash used in operations: | ||
Stock-based compensation expense | 30,337 | 15,640 |
Income from sale of asset | (7,000) | 0 |
Expense related to acquired in-process research and development assets | 0 | 133,057 |
Net amortization of premiums and accretion of discounts on marketable securities | (10,415) | (911) |
Change in fair value of derivative tranche liability | 0 | (10,291) |
Depreciation and amortization expense | 171 | 27 |
Loss on disposal of property, plant and equipment | 1,369 | 0 |
Non-cash lease expense | 94 | 15 |
Changes in assets and liabilities: | ||
Prepaid expense and other current assets | 2,995 | (3,246) |
Prepaid expenses and other assets, non-current | 2,353 | 2,129 |
Accounts payable | (1,198) | 1,120 |
Accrued research and development expenses | (319) | 7,733 |
Accrued compensation and other current liabilities | (1,354) | (2,064) |
Operating lease liability | (125) | 40 |
Severance liability | 164 | 2,291 |
Net cash used in operating activities | (103,574) | (56,949) |
Cash flows from investing activities | ||
Proceeds from sale of asset | 7,000 | 0 |
ValenzaBio assets acquisition cash acquired, net of acquisition costs | 0 | 10,007 |
Cash paid to acquire in-process research and development assets | 0 | (10,000) |
Purchase of marketable securities | (491,965) | (266,112) |
Proceeds from maturities of short-term marketable securities | 491,465 | 47,773 |
Sales of marketable securities | 6,082 | 0 |
Purchase of property, plant and equipment | (869) | (1,999) |
Net cash provided by (used in) investing activities | 11,713 | (220,331) |
Cash flows from financing activities | ||
Proceeds from exercise of common stock options and issuance of common stock upon settlement of restricted stock unites, net of shares withheld for taxes, and under the employee stock purchase plan | 2,518 | 0 |
Taxes paid related to net share settlement of restricted stock units | 0 | (8,325) |
Issuance of common stock upon initial public offering, net of commissions and issuance costs | 0 | 574,664 |
Net cash provided by financing activities | 2,518 | 566,339 |
Net increase (decrease) in cash, cash equivalents and restricted cash | (89,343) | 289,059 |
Cash, cash equivalents and restricted cash at beginning of period | 218,097 | 267,110 |
Cash, cash equivalents and restricted cash at end of period | 128,754 | 556,169 |
Supplemental disclosure of cash flow information: | ||
Conversion of 40,743,522 redeemable convertible preferred stock upon the closing of initial public offering | 0 | 396,593 |
Initial public offering costs included in accounts payable | 0 | 530 |
Common stock issued in connection with ValenzaBio acquisition | 0 | 128,735 |
Right-of-use assets obtained in exchange for operating lease liability | 0 | 1,348 |
Property and equipment purchase in accounts payable and accrued liabilities | $ 301 | $ 0 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (parenthetical) | 6 Months Ended |
Jun. 30, 2023 shares | |
Statement of Cash Flows [Abstract] | |
Conversion of redeemable convertible preferred stock into common stock in connection with initial public offering (in shares) | 40,743,522 |
Description of Business, Organi
Description of Business, Organization and Liquidity | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business, Organization and Liquidity | Description of Business, Organization and Liquidity Organization and Business ACELYRIN, INC. (the “Company”) is a late-stage clinical biopharma company focused on identifying, acquiring, and accelerating the development and commercialization of transformative medicines. The Company was incorporated in the State of Delaware on July 27, 2020. Since its inception, the Company has devoted substantially all of its resources to organizing the Company, hiring personnel, business planning, acquiring and developing its product candidates, performing research and development, enabling manufacturing activities in support of its product development efforts, establishing and protecting its intellectual property portfolio, raising capital, and providing general and administrative support for these activities. The Company did not have any significant operations from the inception date until August 2021. On August 9, 2021, the Company entered into the License and Collaboration Agreement with Affibody AB, a Swedish company, and licensed worldwide development, manufacturing and commercialization rights to a therapeutic candidate, izokibep, for use in the treatment of inflammatory and autoimmune disorders, excluding rights in certain Asian and Nordic countries. See Note 7 for further details. On January 4, 2023, the Company closed the acquisition of ValenzaBio, Inc. (“ValenzaBio”) and issued as consideration 18,885,731 shares of its Class A common stock (“Class A Common Stock”). ValenzaBio was a privately held company developing therapies for autoimmune and inflammatory diseases. The ValenzaBio acquisition added additional assets to the Company’s portfolio, including lonigutamab and SLRN-517. See Note 3 for further details. Reverse Stock Split In April 2023, the Company effected a reverse split of shares of the Company’s outstanding common stock and redeemable convertible preferred stock at a ratio 1.972-for-1 (the “Reverse Stock Split”). The number of authorized shares and par value per share were not adjusted as a result of the Reverse Stock Split. All references to shares, restricted stock units (“RSUs”) and restricted stock awards (“RSAs”), options to purchase common stock, share data, per share data, and related information contained in the condensed consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented. Initial Public Offering On May 4, 2023, the Company’s Form S-1 Registration Statement for its initial public offering (the “IPO”) was declared effective, and on May 9, 2023, the Company closed its IPO and issued 34,500,000 shares of common stock at a price to the public of $18.00 per share, including 4,500,000 shares issued upon the exercise of underwriters’ option to purchase additional shares of common stock. The Company received gross proceeds of $621.0 million. Net proceeds were approximately $573.6 million, after deducting underwriting discounts and commissions and offering costs of $47.4 million. The common stock began trading on the Nasdaq Global Select Market on May 5, 2023, under the symbol “SLRN”. Immediately prior to the IPO closing, each share of the Company’s redeemable convertible preferred stock then outstanding converted into an equivalent number of shares of Class A Common Stock, and thereafter each share of Class A Common Stock then issued and outstanding was reclassified and became one share of the Company’s common stock. Liquidity The Company has incurred significant losses and negative cash flows from operations since its inception. During the six months ended June 30, 2024 and 2023, the Company incurred net losses of $120.6 million and $202.5 million, respectively. The net loss of $120.6 million in the six months ended June 30, 2024 includes $37.0 million of other income related to payments in the first quarter of 2024. The net loss of $202.5 million in the six months ended June 30, 2023 includes $123.1 million of expenses related to acquired in-process research and development assets without alternative future use and a $10.0 million license fee payment to Pierre Fabre incurred in connection with the ValenzaBio acquisition. As of June 30, 2024, the Company had an accumulated deficit of $609.4 million. Cash used in operating activities was $103.6 million and $56.9 million for the six months ended June 30, 2024 and 2023, respectively. The Company has historically financed its operations primarily through the sale of shares of its redeemable convertible preferred stock in private placements and the sale of shares of its common stock in its IPO. As of June 30, 2024, the Company had cash, cash equivalents, restricted cash and short-term marketable securities of $635.8 million. The Company does not have any products approved for sale and has not generated any revenue from product sales to date. The Company expects to continue to incur significant and increasing expenses and substantial losses for the foreseeable future as it continues its development of and seeks regulatory approvals for its product candidates and commercializes any approved products, seeks opportunities to selectively expand its product pipeline and invests in its organization. The Company’s ability to achieve and sustain profitability will depend on its ability to successfully develop, obtain regulatory approval for and commercialize its product candidates. There can be no assurance that the Company will ever earn revenue or achieve profitability, or if achieved, that the revenue or profitability will be sustained on a continuing basis. Unless and until it does, the Company will need to continue to raise additional capital. Based on its current operating plan, management estimates that its existing cash, cash equivalents and restricted cash, including the proceeds from the IPO, will be sufficient to fund its operating plan and capital expenditure requirements for at least the next 12 months from the date of issuance of these condensed consolidated financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 28, 2024, (the “Annual Report on Form 10-K”) except for the updates to the following: Basis of Presentation The condensed consolidated financial statements and accompanying notes are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. The accompanying financial statements are consolidated and include the accounts of ACELRYIN, INC. and its wholly owned subsidiary, WH2, LLC. The subsidiary has not had any operations or any balances from its inception. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report. The information as of December 31, 2023 included in the condensed consolidated balance sheets was derived from the Company’s audited consolidated financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial statements. The results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 or for any other interim period or for any other future year. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates estimates and assumptions, including but not limited to those related to the fair value of its derivative tranche liability, the fair value of its common stock, stock-based compensation expense, accruals for research and development expenses, valuation of deferred tax assets, and uncertain income tax positions. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from those estimates. Concentration of Credit Risk Cash, cash equivalents, restricted cash and short-term marketable securities are financial instruments that potentially subject the Company to concentrations of credit risk. As of June 30, 2024 and December 31, 2023, cash consists of cash deposited with one financial institution, and account balances exceed federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial strength of this institution. The Company also has investments in money market funds, U.S. Treasury obligations, corporate debt obligations, and federal agency obligations, which can be subject to certain credit risks. The Company mitigates the risks by investing in high-grade instruments, limiting its exposure to any one issuer and monitoring the ongoing creditworthiness of the financial institutions and issuers. The Company has not experienced any losses on its financial instruments. |
ValenzaBio Acquisition
ValenzaBio Acquisition | 6 Months Ended |
Jun. 30, 2024 | |
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] | |
ValenzaBio Acquisition | ValenzaBio Acquisition On December 20, 2022, the Company entered into the Agreement and the Plan of Merger and Reorganization (the “Merger Agreement”) to acquire ValenzaBio. In connection with the planned ValenzaBio acquisition, the Company formed two wholly owned subsidiaries, WH1, Inc. and WH2 LLC in November 2022. Through the two-step merger and restructuring, WH1 Inc. was merged with and into ValenzaBio with WH1 Inc. ceasing to exist, and ValenzaBio was then merged with and into WH2 LLC, with WH2 LLC continuing as the legal successor to ValenzaBio. (the “Acquisition”). The Acquisition closed on January 4, 2023 (the “Closing Date”). The Company concluded that the Acquisition is an asset acquisition as substantially all of the fair value of the gross assets acquired, excluding cash, was concentrated in a single asset, lonigutamab, and the Company did not acquire a workforce or any substantive process capable of significantly contributing to the ability to create outputs. As consideration, the Company issued 18,885,731 shares of its Class A Common Stock to ValenzaBio stockholders, of which 2,013,673 were being held by Seller LLC for any post-acquisition costs and general indemnities for 12 months from the Closing Date (“Holdback Release Date”), and paid $7,663 in cash to one non-accredited investor. The Company also incurred $1.2 million of acquisition-related costs that were included in the total consideration and capitalized to assets acquired. The Company assumed options of certain ValenzaBio option holders who entered into consulting agreements with the Company, which became options for the purchase of an aggregate 1,249,811 shares of the Company’s Class A Common Stock upon the closing of the Acquisition on January 4, 2023. The assumed options vested in full on March 31, 2023. Each assumed option is exercisable until the earlier of (i) 12 months following the termination of the option holder’s continuous service with the Company, or (ii) the original expiration date of such assumed option. Outstanding ValenzaBio shares were exchanged into shares of the Company’s Class A Common Stock and the options described above assumed at an exchange ratio of 0.8027010-for-one. The following table represents the total purchase consideration (in thousands): Issued Class A Common Stock (1) $ 128,735 Transaction costs (2) 1,271 Cash (3) 8 Total $ 130,014 (1) Shares were issued for consideration at $6.86 per share, including 2,013,673 shares that were being held by Seller LLC until the Holdback Release Date. The Company used a third party valuation specialist to assist management in determining the fair value of the shares of Class A Common Stock at the Closing Date. (2) Legal and advisory transaction costs of $1.3 million incurred by the Company in connection with the Acquisition, including $0.1 million payable in cash to Seller LLC for the expense fund. (3) Cash payment of $7,663 to one non-accredited investor for settlement of vested ValenzaBio options. The following is the allocation of the purchase consideration to the acquired assets and liabilities (in thousands): Cash $ 11,369 Prepaid expenses and other current assets 2,074 In-process research and development assets 123,057 Accounts payable (1,628) Accrued research and development expenses (4,805) Accrued compensation and other current liabilities (53) Total net asset acquired $ 130,014 In-process research and development (“IPR&D) assets were related to acquired product candidates: lonigutamab in clinical trials and SLRN-517 in preclinical development. The fair value of in-process research and development assets was based on the present value of future discounted cash flows, which was based on significant estimates. These estimates included the number of potential patients and market prices of future product candidates, costs required to conduct clinical trials, future milestones and royalties payable under acquired license agreements, costs to receive regulatory approval and potentially commercialize product candidates, as well as estimates for probability of success and the discount rate. The estimated fair values of lonigutamab and SLRN-517 assets were $114.8 million and $8.2 million, respectively. The Company concluded that acquired assets do not have an alternative future use and recognized the full amount of $123.1 million as research and development expenses in the condensed consolidated statement of operations and comprehensive loss in January 2023. There are a number of additional obligations under the Merger Agreement that are separate from the assets and liabilities acquired, including the following: Assumed options . The assumed options, discussed above, did not have substantive service requirement, and were accounted as a separate transaction from the Acquisition. The fair values of assumed options of $3.1 million and $1.8 million was expensed as research and development and general and administrative expenses, respectively, in the condensed consolidated statement of operations and comprehensive loss for the three months ended March 31, 2023. Settled equity awards . In accordance with the severance obligations of ValenzaBio and per the terms of the Merger Agreement, certain unvested options and restricted stock awards of former ValenzaBio employees, who did not enter into consulting agreements with the Company, were accelerated and net exercised upon the closing of the Acquisition and termination of employment of such ValenzaBio employees. The fair value of unvested equity awards of $0.9 million was expensed as general and administrative expense in the condensed consolidated statement of operations and comprehensive loss for the three months ended March 31, 2023. Payments in cash to one non-accredited investor for settlement of unvested ValenzaBio options and one former ValenzaBio employee to whom options were promised but not granted at the Closing Date of $8,387 and $30,000, respectively, were expensed as general and administrative expenses in the condensed consolidated statement of operations and comprehensive loss for the three months ended March 31, 2023. Severance payment obligation . In accordance with the severance plan of ValenzaBio, the Company was obligated to make severance payments to certain former ValenzaBio employees of approximately $5.1 million, including estimated taxes, for a period of three As of June 30, 2024, no ValenzaBio severance plan payments obligations were outstanding to ValenzaBio employees. As of December 31, 2023, ValenzaBio severance plan payments obligations of $0.3 million were included in the condensed consolidated balance sheets. Amendment to Pierre Fabre Agreement. The Company, ValenzaBio and Pierre Fabre Medicament SAS (“Pierre Fabre”) entered into an amendment to the license and commercialization agreement, which became effective on the |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1 — Quoted prices in active markets for identical assets or liabilities. Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s financial instruments measured at fair value on a recurring basis consist of Level 1, Level 2, and Level 3 financial instruments. Usually, short term marketable securities are considered Level 2 when their fair values are determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. Corporate debt obligations, commercial paper, government agency obligations and asset-backed securities are valued primarily using market prices of comparable securities, bid/ask quotes, interest rate yields and prepayment spreads and are included in Level 2. Financial assets and liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies, or similar techniques, and at least one significant model assumption or input is unobservable. The following table sets forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): Fair Value Measurements as of June 30, 2024 As of June 30, 2024: Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash and cash equivalents) $ 31,911 $ 31,911 $ - $ - U.S. Treasury obligations ($31,786 included in cash and cash equivalents) 399,255 - 399,255 - Corporate debt obligations ($29,270 included in cash and cash equivalents) 144,934 - 144,934 - Federal agency obligations ($13,319 included in cash and cash equivalents) 37,215 - 37,215 - Total fair value of assets $ 613,315 $ 31,911 $ 581,404 $ - Fair Value Measurements as of December 31, 2023 As of December 31, 2023: Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash and cash equivalents) $ 23,205 $ 23,205 $ - $ - U.S. Treasury obligations ($146,497 included in cash and cash equivalents) 525,353 - 525,353 - Corporate debt obligations ($23,313 included in cash and cash equivalents) 135,284 - 135,284 - Federal agency obligations ($15,344 included in cash and cash equivalents) 27,746 - 27,746 - Total fair value of assets $ 711,588 $ 23,205 $ 688,383 $ - Classified as: June 30, 2024 December 31, 2023 Cash and cash equivalents $ 106,286 $ 208,359 Short-term marketable securities $ 507,029 $ 503,229 Total cash equivalents and marketable securities $ 613,315 $ 711,588 |
Cash, Cash Equivalents, Restric
Cash, Cash Equivalents, Restricted Cash and Available-For-Sale Marketable Securities | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash, Cash Equivalents, Restricted Cash and Available-For-Sale Marketable Securities | Cash, Cash Equivalents, Restricted Cash and Available-For-Sale Marketable Securities Cash, cash equivalents and restricted cash The following table provides a reconciliation of the Company’s cash and cash equivalents and non-current portion of restricted cash reported within the unaudited condensed consolidated balance sheets that sum to the total cash, cash equivalents and restricted cash shown in the Company’s condensed consolidated statement of cash flows: June 30, December 31, Cash and cash equivalents $ 128,211 $ 218,097 Restricted cash 543 — Total cash, cash equivalents and restricted cash $ 128,754 $ 218,097 Restricted cash represents cash held at a financial institution that is pledged as collateral for a stand-by letter of credit for $0.2 million for lease commitments and $0.3 million for the Company’s corporate credit card program. The cash will be restricted until the termination or modification of the lease agreement and corporate credit card program, respectively. Restricted cash is included in non-current assets. Available-for-sale securities marketable securities The following tables summarize the estimated fair value of the Company’s available-for-sale marketable securities as of June 30, 2024 and December 31, 2023 (in thousands): As of June 30, 2024: Total Total Unrealized Gain Total Total Money market funds (included in cash and cash equivalents) $ 31,911 $ — $ - $ 31,911 U.S. Treasury obligations ($31,786 included in cash and cash equivalents) 399,353 5 (103) 399,255 Corporate debt obligations ($29,270 included in cash and cash equivalents) 144,989 10 (65) 144,934 Federal agency obligations ($13,319 included in cash and cash equivalents) 37,229 — (14) 37,215 Total available for sale marketable securities $ 613,482 $ 15 $ (182) $ 613,315 As of December 31, 2023: Total Total Unrealized Gain Total Unrealized Loss Total Money market funds (included in cash and cash equivalents) $ 23,205 $ — $ - $ 23,205 U.S. Treasury obligations ($146,497 included in cash and cash equivalents) 525,198 156 (1) 525,353 Corporate debt obligations ($23,313 included in cash and cash equivalents) 135,288 36 (40) 135,284 Federal agency obligations ($15,344 included in cash and cash equivalents) 27,735 12 (1) 27,746 Total available for sale marketable securities $ 711,426 $ 204 $ (42) $ 711,588 As of June 30, 2024 and December 31, 2023, no significant facts or circumstances were present to indicate a deterioration in the creditworthiness of the issuers of the marketable securities, and the Company has no requirement or intention to sell these securities before maturity or recovery of their amortized cost basis. The Company considered the current and expected future economic and market conditions and determined that its investments were not significantly impacted. For all securities with a fair value less than its amortized cost basis, the Company determined the decline in fair value below amortized cost basis to be immaterial and non-credit related, and therefore no allowance for losses has been recorded. During the six months ended June 30, 2024 and for the year ended December 31, 2023, the Company did not recognize any impairment losses on its investments. The Company presents accrued interest receivable related to the available-for-sale marketable securities in prepaid expenses and other current assets As of June 30, 2024, all available for sale marketable securities mature within one year. |
Consolidated Balance Sheet Comp
Consolidated Balance Sheet Components | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Consolidated Balance Sheet Components | Consolidated Balance Sheet Components Prepaid expenses and other current assets Prepaid expenses and other current assets consist of the following (in thousands): June 30, December 31, Prepaid research and development expenses $ 3,379 $ 8,184 Value-Added Tax ("VAT") receivable 4,136 3,985 Prepaid insurance and other current assets 2,763 1,712 Interest receivable 1,385 764 Prepaid other services 1,358 667 Total $ 13,021 $ 15,312 Prepaid expenses and other assets, non-current Other non-current assets consist of the following (in thousands): June 30, December 31, Prepaid research and development expenses, non-current $ 291 $ 2,644 Security deposits 34 34 Total $ 325 $ 2,678 Property, plant and equipment, net Property, plant and equipment consisted of the following (in thousands): June 30, 2024 December 31, 2023 Construction in progress $ 804 $ 1,460 Computer and other equipment 416 407 Furniture and fixtures 371 306 Leasehold improvements 144 121 Total property, plant and equipment, gross 1,735 2,294 Less: accumulated depreciation and amortization (226) (115) Property, plant and equipment, net $ 1,509 $ 2,179 Accrued research and development expenses Accrued research and development expenses are comprised of the following (in thousands): June 30, 2024 December 31, 2023 Accrued clinical manufacturing expenses $ 24,665 $ 22,232 Accrued clinical expenses 10,452 13,204 Total $ 35,117 $ 35,436 Accrued compensation and other current liabilities Accrued compensation and other current liabilities consist of the following (in thousands): June 30, December 31, Accrued compensation $ 3,965 $ 5,417 Accrued professional service fees 1,259 1,099 Other accrued expenses and current liabilities 255 317 Total $ 5,479 $ 6,833 |
Significant Agreements
Significant Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Significant Agreements | Significant Agreements Affibody License and Collaboration Agreement On August 9, 2021, the Company entered into a license agreement with Affibody AB (“Affibody”) (the “Affibody Agreement”) under which Affibody granted the Company exclusive, sublicensable licenses to develop, commercialize and manufacture products containing izokibep for all human therapeutic uses on a worldwide basis, subject to a pre-existing agreement with Inmagene Biopharmaceuticals (“Inmagene”) with respect to certain Asian countries. The Company chairs a global joint steering committee composed of designees from Affibody, Inmagene and the Company and retains final decision-making authority for izokibep global development. In doing so, the Company is obligated to use commercially reasonable efforts (i) to develop products containing izokibep worldwide, excluding certain defined territories, (ii) for the conduct and finalization of certain ongoing clinical trials, and (iii) to commercialize products containing izokibep for all human therapeutic uses worldwide, excluding certain defined territories, after obtaining the applicable marketing authorization. The Company is responsible for manufacturing both the clinical and commercial supply of licensed product globally. In connection with the Affibody Agreement, the Company paid a non-refundable upfront license fee in the aggregate amount of $3.0 million in August 2021 and September 2021, and $22.0 million in October 2021. The Company is also obligated to pay Affibody (i) an aggregate of up to $280.0 million, $30.0 million of which would be due prior to the first approval in the United States, upon the achievement of various development, regulatory and commercialization milestones, $15.0 million of which was paid in November 2023 and (ii) high single-digit to low-teens royalties on net sales of licensed products in the territory where the Company has commercialization rights, subject to certain reductions. Royalties will be due on a licensed product-by-licensed product and country-by-country basis beginning after the first commercial sale of the licensed product, except in Mainland China, Hong Kong, Macau, Taiwan and South Korea, and lasting until the later of (a) the expiration of all valid patent claims or regulatory exclusivity covering the licensed product in that country and (b) ten years after such first commercial sale. In the event the U.S. Food and Drug Administration (“FDA”) grants the Company (or its affiliates or sublicensees) a priority review voucher for a licensed product, the Company will pay Affibody either: (a) if the Company sells or transfer such priority review voucher to a third-party, approximately one third of the proceeds received from the sale, net of taxes, or (b) if the Company uses the priority review voucher for an indication or product outside the scope of the Affibody Agreement, approximately one third of the fair market value of the priority review voucher as determined in accordance with the Affibody Agreement. Unless earlier terminated, the Affibody Agreement will continue on a licensed product-by-licensed product basis and country-by-country basis until there are no more royalty payments owed to Affibody on any licensed product thereunder. The acquisition of the exclusive license was accounted for as an in-process research and development asset acquisition and as the acquired technology did not have an alternative use, the total consideration of $25.0 million was recorded as research and development expense in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2021. Milestone payments are contingent consideration and are accrued when contingent events occur and achievement of milestones is probable. In November 2023, the Company paid a total amount of $15.0 million in relation with attaining one of the development milestones described above and recorded the payment within research and development expenses in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2023. Royalties will be recognized as cost of sales when products are sold and royalties are payable. No royalties or additional milestones were probable and estimable as of June 30, 2024 and December 31, 2023. Pierre Fabre License and Commercialization Agreement Upon the closing of the Acquisition, the Company became the successor to ValenzaBio’s rights under the March 25, 2021 license and commercialization agreement between ValenzaBio and Pierre Fabre, as amended (the “Pierre Fabre Agreement”). The Company received certain exclusive worldwide licenses with the right to sublicense to certain patents, know-how and other intellectual property to develop, manufacture, use and commercialize lonigutamab for non-oncology therapeutic indications. The license from Pierre Fabre extends to any product containing lonigutamab (excluding any fragments or derivatives) as its sole active ingredient (each, a “PF Licensed Product”). The Pierre Fabre Agreement prohibits the Company from using the licensed intellectual property in any antibody drug conjugate, multi-specific antibodies or any other derivatives of lonigutamab. In the event the Company decides to sublicense the rights to develop or commercialize a PF Licensed Product in any territory outside of the United States and Canada, Pierre Fabre retains the right of first negotiation to acquire such development and commercialization rights in one or more countries in such territory. Subject to the validation of certain clinical trial criteria by a joint steering committee, Pierre Fabre has the option to reclaim all exclusive rights to develop, commercialize and exploit the PF Licensed Product in such territories and to obtain an exclusive sublicensable license in such territories for any improvements and trademarks to such PF Licensed Product, and to exploit such PF Licensed Product for non-oncology therapeutic indications, subject to certain payment obligations. The joint steering committee validated such clinical trial criteria in May 2024, triggering the commencement of the option period in October 2024. If Pierre Fabre exercises such option, Pierre Fabre has the right to require the Company to buy out its right to the option for a one-time payment of $31.0 million, or the Company has the right to choose to buy out Pierre Fabre’s option by making the one-time payment of $31.0 million, in each case within 30 days from Pierre Fabre’s notice of exercise of such option. If Pierre Fabre does not exercise its option within the option period or if the Company buys out Pierre Fabre’s right to the option, the option will expire or terminate, respectively. If Pierre Fabre exercises such option, acquires such development and commercialization rights in any territory outside of the United States and Canada, and thereafter intends to sublicense such rights, the Company has the right of first negotiation to acquire such development and commercialization rights as to that territory. The Company is solely responsible for the development, regulatory approvals and commercialization of each PF Licensed Product except to the extent that Pierre Fabre reclaims rights to a PF Licensed Product in the option territory. As consideration for the amendment to the Pierre Fabre Agreement, which became effective upon the closing of the Acquisition (see Note 3), the Company paid Pierre Fabre an aggregate license payment of $10.0 million. The Company is also obligated to (i) make payments of up to $99.5 million upon the achievement of various development and regulatory milestones, (ii) make milestone payments of up to $390.0 million upon the achievement of certain commercial milestones, and (iii) pay tiered royalties in the high single-digit to low-teen percentages to Pierre Fabre on worldwide net sales in a given calendar year. Royalties will be payable for each PF Licensed Product in a given country during a period commencing upon the first commercial sale of such PF Licensed Product in such country and continuing until the latest of (a) 10 years after such first commercial sale, (b) expiration of last-to-expire valid claim in a licensed patent in such country and (c) expiration of regulatory exclusivity for such PF Licensed Product in such country. In the event the Company enters into a sublicense with a third party, the Company must also share with Pierre Fabre a percentage of any revenues from option fees, upfront payments, license maintenance fees, milestone payments or the like generated from the sublicense. Such percentage may be between the high single-digits to the low thirties based on which stage of development of a PF Licensed Product the sublicense relates to. Unless earlier terminated, the Pierre Fabre Agreement will continue on a PF Licensed Product-by-PF Licensed Product and country-by-country basis until there are no more royalty payments owed to Pierre Fabre on any PF Licensed Product thereunder. Either party may terminate the Pierre Fabre Agreement upon an uncured material breach, or upon the bankruptcy or insolvency of the other party. Pierre Fabre may also terminate the agreement if the Company or any of its affiliates institutes a patent challenge against the licensed patents from Pierre Fabre. The Company may also terminate the Pierre Fabre Agreement with or without cause upon nine months’ prior written notice, so long as there is no ongoing clinical trial for any PF Licensed Product. As of June 30, 2024, no milestones were probable and accrued in the condensed consolidated balance sheet. Novelty Nobility License and Commercialization Agreement Upon the closing of the Acquisition, the Company became the successor to an exclusive license agreement between ValenzaBio and Novelty Nobility (the “Novelty License Agreement”) and obtained a worldwide exclusive license for the development and commercialization of SLRN-517, an unmodified IgG1 monoclonal antibody, as a therapeutic treatment. In connection with the arrangement, the Company is obligated to (i) make development and regulatory milestones of up to $44.3 million, (ii) make commercial sales milestone payments of up to $682.0 million and (iii) pay tiered royalties of a low single-digit to high-single-digit percentage on future worldwide net sales. The Novelty License Agreement is effective on a licensed product-by-licensed product and country-by-country basis until the expiration of the latest to expire royalty term, unless early terminated. The royalty term, with respect to a licensed product and a country is the period commencing on the first commercial sale of such product in such country, and ending upon the latest to occur of: a) there being no patent right in such country that had at least one valid claim covering the licensed product in whole or in part, or the manufacture or use thereof; b) 10 years from the first commercial sale of such product worldwide; or c) expiration of regulatory exclusivity for such product in such country. The agreement can be early terminated upon (i) a material breach, (ii) abandonment of development by the Company, in which the Company ceases all development activities for the licensed product, (iii) termination by patent challenge, and (iv) insolvency. The Company may terminate the contract at any point, upon 30 days prior written notice to Novelty Nobility, Inc. As of June 30, 2024, no milestones were probable and accrued in the condensed consolidated balance sheet. |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | Commitments and Contingent Liabilities License Agreements The Company is required to pay certain milestones upon the achievement of specific development and regulatory events, upon products commercialization and products’ royalties under its license agreements, including its agreements with Affibody, Pierre Fabre, Novelty Nobility and other non-exclusive license agreements. None of the milestones, other than the $15.0 million Affibody milestone in November 2023, were achieved or probable, all products were in development, as such, no milestones or royalties were accrued in the condensed consolidated balance sheets as of June 30, 2024 and December 31, 2023. Research and Development Agreements The Company enters into various agreements in the ordinary course of business, such as those with suppliers, contract research organizations, contract manufacturing organizations, and clinical trial sites. These contracts generally provide for termination on notice or may have a potential termination fee if a purchase order is canceled within a specified time. The total value of non-cancellable obligations under contracts was $87.9 million and $142.3 million as of June 30, 2024, and December 31, 2023, respectively. This presentation of non-cancellable purchase obligations does not include any estimates of potential reduction of such liabilities related to mitigation obligations of the counter-parties in the event of cancellation under the terms of our engagements. In July 2024, the Company and a vendor entered into an agreement to terminate a supply agreement for events that existed as of the balance sheet date of June 30, 2024. All post-termination activities are expected to be completed in the third and fourth quarter of 2024. The Company estimates $14.3 million to be the full amount of such costs to be incurred and recognized these costs in the quarter ended June 30, 2024, the period in which the obligation was incurred. These contract termination costs were included in research and development in the Condensed Consolidated Statement of Operations and Comprehensive Loss for the quarter ended June 30, 2024. No other amounts related to termination and cancellation changes were accrued during the three and six months ended June 30, 2024, and year ended December 31, 2023, as the Company has not determined cancellation under any other agreements to be probable. Lease In January 2023, the Company entered into a lease agreement to rent approximately 10,012 square feet of office space in southern California. The term of the lease is 65 months with an option to extend it for an additional three years. Monthly rent payments are approximately $30,500, subject to an annual 3.0% increase and six months rental abatement during the first year. In addition to the base rent, the Company is obligated to pay variable costs related to its share of operating expenses and taxes. In connection with the lease agreement, the Company made a security deposit of $34,000, that is included in prepaid expenses and other assets, non-current in the condensed consolidated balance sheet as of June 30, 2024 and December 31, 2023 . As of the lease commencement date the Company recorded $1.3 million as right-of-use (“ROU”) asset and operating lease liability, non-current, in the condensed consolidated balance sheet. Operating lease costs were $0.2 million and $0.1 million for the six months ended June 30, 2024 and 2023 and were recorded in general and administrative expenses and research and development expenses in the condensed consolidated statements of operations and comprehensive loss. The following table summarizes a maturity analysis of the Company’s operating lease liabilities showing the aggregate lease payments as of June 30, 2024 (in thousands): 2024 (remainder of the year) $ 189 2025 386 2026 398 2027 409 2028 280 Total future lease payments 1,662 Less imputed interest (353) Total operating lease liability balance 1,309 Less current portion of lease liability (240) Operating lease liability, non-current $ 1,069 The weighted-average remaining lease term was 50 months and the weighted-average discount rate was 12%. Cash paid for amounts included in the measurement of lease liabilities was $0.2 million. Legal Contingencies On November 15, 2023, a purported federal securities class action lawsuit was commenced in the United States District Court for the Central District of California. An amended complaint was filed on March 26, 2024 (Boukadoum v. Acelyrin, Inc. et al., No. 2:23-cv-09672-FMO-MAA), naming us and current and former executive officers and directors as defendants. The complaint alleges that the defendants violated the Exchange Act and Securities Act by misleading investors about the Phase 2b trial of izokibep in HS. The original complaint was filed following our announcement of the week 16 results from the Part B portion of such Phase 2b trial. The complaint seeks damages and an award of reasonable costs and expenses, including attorneys' fees, expert fees and other costs, as well as such other and further relief as the court may deem just and proper. It is possible that additional suits will be filed, or allegations made by stockholders, with respect to these same or other matters and also naming the Company and/or its officers and directors as defendants. This lawsuit and any other potential lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of this lawsuit is necessarily uncertain. The Company could be forced to expend significant resources in the defense against this and any other related lawsuits and the Company may not prevail. The Company currently is not able to estimate the possible loss to the Company from this lawsuit, as this lawsuit is currently at an early stage, and such amounts could be material to the Company’s financial statements even if the Company prevails in the defense against this lawsuit. The Company cannot be certain how long it may take to resolve this lawsuit or the possible amount of any damages that the Company may be required to pay. The Company does not consider any payment to be probable or reasonably estimable and has not accrued for any potential liability relating to this lawsuit. From time to time, the Company may become involved in additional legal proceedings or be subject to claims arising in the ordinary course of business. The Company records a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. Guarantees and Indemnifications In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. Its exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. To the extent permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at a request in such capacity. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. As of June 30, 2024, the Company did not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities. |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Common Stock | Common Stock On May 9, 2023, immediately prior to the IPO closing, each share of the Company’s Class A Common Stock then issued and outstanding was reclassified and became one share of the Company’s common stock. As of December 31, 2023, there were no shares of Class B Common Stock outstanding. As of June 30, 2024 and December 31, 2023, Common Stock reserved for future issuance by the Company was as follows: June 30, December 31, 2024 2023 Shares available for future grants under Equity Incentive Plan 5,038,988 3,526,392 Outstanding stock options 14,726,755 9,630,623 Performance-based restricted stock units 1 928,328 2,964,072 Outstanding restricted stock units 1,763,751 2,166,016 Options assumed upon ValenzaBio acquisition 57,311 938,440 ESPP Shares available for future grants 1,753,667 875,836 Total shares reserved for future issuance 24,268,800 20,101,379 1. The performance-based restricted stock units balance is based on the target number of shares. Founders’ Common Stock On the IPO closing date, each share of the founders’ Class A common stock issued and outstanding was reclassified and became one share of the Company’s common stock; no vesting or other terms were modified. In July 2020, the Company issued 2,839,749 shares of its common stock to founders at a price of $0.00002 per share. The issuance price was the estimated fair value of the shares as the shares were issued at inception and no intellectual property was contributed by the founders. The founders have voting rights and rights to receive dividends regardless of the vesting of the shares. Issued shares vested monthly over 48 months, as founders continued providing services to the Company. The Company had the right to repurchase unvested shares at the price paid by the founders if services are terminated. Stock-based compensation expense was minimal for these shares. In December 2022, the Company repurchased 591,613 restricted common shares at the original purchase price that were unvested as of the date of repurchase in connection with one founder’s resignation. As of June 30, 2024 and December 31, 2023, zero and 207,060 shares were unvested, respectively. During the six months ended June 30, 2024 and year ended December 31, 2023, 207,060 and 354,972 founders’ shares vested. |
Equity Incentive Plan
Equity Incentive Plan | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Equity Incentive Plan | Equity Incentive Plan In April 2023, the Company’s board of directors adopted, and stockholders approved, the 2023 Equity Incentive Plan (the “2023 Plan”) that became effective on May 4, 2023. The Company reserved 12,000,000 new shares of common stock for issuance under the 2023 Plan. In addition, 6,920,846 shares issued and outstanding under the Company’s 2020 Equity Incentive Plan, as amended (the “2020 Plan”), have been added to the 2023 Plan as such shares become available from time to time if awards terminate, expire, or lapse for any reason without the delivery of shares, or are reacquired or withheld (or not issued) to satisfy a tax withholding obligation or the purchase or exercise price. The 2023 Plan also provides that the number of shares initially reserved and available for issuance will automatically increase each January 1, beginning on January 1, 2024 and ending on January 1, 2033, by an amount equal to the lesser of (i) 5% of the shares of common stock outstanding on the last day of the immediately preceding fiscal year, and (ii) such smaller number of shares of stock as determined by the Company’s board of directors. On January 1, 2024, 5,230,473 additional shares of common stock became available for issuance under the 2023 Plan pursuant to the provision. No more than 56,762,538 shares of stock may be issued upon the exercise of incentive stock options under the 2023 Plan. The Company may grant incentive stock options, nonstatutory stock options (“NSOs”), restricted stock units (“RSUs”), restricted stock awards (“RSAs”), stock appreciation rights (“SARs”), performance awards and other awards to the Company’s officers, employees, directors and consultants. Options under the 2023 Plan may be granted for periods of up to 10 years at exercise prices no less than the fair market value of the common stock on the date of grant and usually vest over four years. The exercise price of an option granted to a 10% stockholder may not be less than 110% of the fair market value of the shares on the date of grant and such option may not be exercisable after the expiration of five years from the date of grant. The grant date fair market value of all awards made under our 2023 Plan and all cash compensation paid by us to any non-employee director for services as a director in any fiscal year may not exceed $750,000, increased to $1,000,000 in the fiscal year of their initial service as a non-employee director. The 2023 Plan is the successor to and continuation of the 2020 Plan and no additional awards may be granted under the 2020 Plan. All outstanding awards granted under the 2020 Plan will remain subject to the terms of the 2020 Plan. The 2020 Plan provided for the grant of incentive stock options, nonstatutory stock options, RSUs and RSAs to the Company’s officers, employees, directors and consultants. As of June 30, 2024 and December 31, 2023, 5,038,988 and 3,526,392 shares of the Company’s common stock remained available for issuance under the 2023 Plan. In April 2023, the Company’s board of directors and stockholders adopted the 2023 Employee Stock Purchase Plan (the “ESPP”), which became effective on May 4, 2023. The ESPP authorized issuance of up to 900,000 shares of common stock. The ESPP permits participants to purchase common stock through payroll deductions of up to 15% of their eligible compensation. Employees purchase shares of common stock at a price per share equal to 85% of the lower of the fair market value at the start or end of six-month purchase and offering consecutive periods. The aggregate number of shares reserved for sale under the 2023 ESPP will increase automatically on January 1 for a period of up to 10 calendar years, commencing on January 1, 2024, by the number of shares equal to the lesser of 1% of the Company's total outstanding shares of common stock on the immediately preceding December 31st, and 2,700,000 shares or a lesser number of shares as may be determined by the board of directors. On January 1, 2024, the Company registered 978,658 additional shares of its Common Stock under the ESPP pursuant to the provision. There were 1,753,667 and 875,836 ESPP shares available for future grants as of June 30, 2024 and December 31, 2023, respectively. Stock Options Stock options issued under the 2020 and 2023 Plan generally vest over a four-year period and expire ten years from the date of grant. Certain options provide for accelerated vesting if there is a change in control, as defined in the individual award agreements. A summary of option activity under the 2020 and 2023 Plan is as follows: Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2023 9,630,623 $ 10.4619 9.0 $ 12,007 Options granted 8,602,808 6.5348 Options exercised (215,128) 2.4375 Options expired (50,217) 6.9078 Options forfeited (3,241,331) 10.1166 Outstanding at June 30, 2024 14,726,755 $ 8.3731 8.4 $ 1,922 Exercisable at June 30, 2024 3,510,502 $ 9.0101 5.5 $ 880 Vested and expected to vest at June 30, 2024 14,726,755 $ 8.3731 8.4 $ 1,922 The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the estimated fair value of the Company’s common stock for those stock options that had exercise prices lower than the estimated fair value of the Company’s common stock at June 30, 2024 and December 31, 2023. Fair value of shares vested during the three months ended June 30, 2024 was $12.8 million. The weighted-average grant date fair value of options granted in three months ended June 30, 2024 was $3.8440. ValenzaBio 2020 Stock Option Plan On January 4, 2023, in connection with the Acquisition, the Company assumed the ValenzaBio 2020 Stock Option Plan and options to issue 1,249,811 shares of the Company’s Class A Common Stock to ValenzaBio option holders, who entered into consulting agreements with the Company. The weighted-average exercise price of assumed options was $3.6736 per share. Under the terms of the Merger Agreement, the assumed options vested in full on March 31, 2023. A total of 881,129 options assumed under the ValenzaBio 2020 Stock Option Plan having the weighted-average exercise price of $4.0538 were exercised for the three months ended June 30, 2024. The Company recognized the full amount of stock-based compensation expense of $4.9 million, including $3.1 million as research and development expenses and $1.8 million as general administrative expenses, related to assumed options in the consolidated statement of operations for the months ended June 30, 2023. Restricted Stock Units A summary of unvested RSU activity is presented in the following table: Number of RSUs Weighted-Average Grant Date Fair Value Unvested at December 31, 2023 2,166,016 $ 22.90 Granted 2,134,396 6.59 Vested (944,140) 8.77 Forfeited (1,592,521) 20.06 Unvested at June 30, 2024 1,763,751 $ 13.29 Performance-Based Restricted Stock Units In August 2023, the Company granted PSUs to certain employees and officers of the Company. The PSUs may vest over several years subject to the achievement of (i) certain clinical development milestones over a performance period from the grant date to May 2027 (the “Performance Period”) or (ii) market conditions (i.e., stock price hurdle) based on pre-specified volume-weighted average stock price measurements as of each vesting performance measurement date, and continued employment with the Company through the applicable vesting date(s). The target number of shares under the PSUs at grant date was 3,135,104. The ultimate number of PSU shares that may vest, in the aggregate over the Performance Period, could in certain cases be up to 150% of the target number of shares upon the achievement of certain market or performance conditions. A summary of PSU activity based on the target number of shares is presented in the following table: Number of PSUs Weighted-Average Grant Date Fair Value* Outstanding at December 31, 2023 2,964,072 $ 27.43 Granted — — Vested — — Forfeited (2,035,744) 27.43 Outstanding at June 30, 2024 928,328 $ 27.43 *The grant date fair value is based only on the PSUs with market conditions and does not factor in any performance conditions. As the PSUs granted in 2023 are subject to a market condition, the grant date fair value for such PSUs was based on a Monte Carlo simulation model. The Company estimated the fair value of PSUs based on the grant date price of its common stock of $26.97 and the following assumptions: expected volatility of 87.71%, risk-free-rate of 4.47%, and zero expected dividend yield. In 2023, the Company granted PSUs to employees with a weighted-average grant date fair value of $27.43. The unvested awards will expire if it is determined that the vesting conditions have not been met during the applicable three-year performance period. 2023 Employee Stock Purchase Plan The second purchase period commenced on December 15, 2023 and ended on June 14, 2024. The third purchase period commenced on June 15, 2024 and will end on December 14, 2024. The Company recorded less than $0.1 million in accrued liabilities as of June 30, 2024. Under the 2023 ESPP, 100,827 shares were issued for both the three and six months ended June 30, 2024. Stock-Based Compensation Expense The Company used Black-Scholes option pricing model to estimate fair value of each option at the grant date based on the following assumptions for the three and six months ended June 30, 2024 and 2023: Three Months Ended Three Months Ended Six Months Ended Six Months Ended 2024 2023 2024 2023 Expected volatility 84.48% - 86.76% 75.30% - 91.92% 84.48% - 87.76% 75.30% - 92.20% Expected dividend yield 0 % 0 % 0 % 0 % Expected term (in years) 5.41 - 6.06 5.77 – 6.08 5.41 - 6.08 5.77 – 6.08 Risk-free interest rate 4.35% - 4.52% 3.30% - 3.47% 3.98% - 4.52% 3.30% - 4.12% The following table presents the classification of stock-based compensation expense related to awards granted under equity incentive options (in thousands): Three Months ended June 30, Six Months ended June 30, 2024 2023 2024 2023 Research and development expenses $ 4,851 $ 1,325 $ 9,442 $ 5,090 General and administrative expenses 5,323 7,176 20,895 10,550 Total stock-based compensation expense $ 10,174 $ 8,501 $ 30,337 $ 15,640 The stock-based compensation expense for the three and six months ended June 30, 2024 was impacted by the departure of our founder and former CEO in May 2024. The departure resulted in a reversal of $13.5 million of PSU and PSO related expense offset by a $12.7 million net increase in stock-based compensation expense due to the partial accelerated vesting and modification of options and RSUs. The stock-based compensation expense (in thousands) relates to the following equity-based awards: Three Months ended June 30, Six Months ended June 30, 2024 2023 2024 2023 Restricted stock units $ 8,824 $ 5,539 $ 13,239 $ 5,539 Performance-based restricted stock units (11,698) — (1,798) — Stock options 13,113 2,946 18,864 10,008 ESPP 82 16 179 16 Restricted stock awards — — — 77 Performance-based options $ (147) $ — $ (147) $ — Total stock-based compensation expense $ 10,174 $ 8,501 $ 30,337 $ 15,640 In the six months ended June 30,2023, the Company recognized $4.9 million of stock-based compensation expense related to assumed ValenzaBio options and $0.9 million related to unvested options and RSAs net-settled at the closing of the Acquisition. As of June 30, 2024 there was $63.4 million of unrecognized stock-based compensation expense related to granted stock options, which is expected to be recognized over a weighted-average period of 2.9 years. As of June 30, 2024, there was $21.3 million of unrecognized stock-based compensation expense related to RSUs which is expected to be recognized over a weighted-average period of 2.7 years. The Company recognized a net reversal of $11.7 million in stock-based compensation expense during the three months ended June 30, 2024 related to PSUs. This expense is related to both the market and performance conditions associated with the PSUs and includes a reversal of $13.4 million related to the departure of our founder and former CEO in May 2024. As of June 30, 2024, the Company evaluated the clinical development milestone performance conditions and determined certain conditions to be probable of achievement. As of June 30, 2024, total compensation cost not yet recognized related to unvested PSUs was $17.3 million, which is expected to be recognized over a weighted-average period of 1.8 years. Total stock-based compensation expense not recognized related to unvested PSUs can increase up to $21.4 million depending on the future achievement of PSUs performance conditions. |
Net Loss Per Share Attributable
Net Loss Per Share Attributable to Common Stockholders | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share Attributable to Common Stockholders | Net Loss Per Share Attributable to Common Stockholders The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Numerator: Net loss $ (85,672) $ (26,039) $ (120,645) $ (202,489) Denominator: Weighted average common shares outstanding 99,215,994 65,652,851 98,653,080 43,461,494 Less: Weighted-average common shares subject to repurchase (54,284) (442,734) (115,395) (486,854) Weighted-average common shares outstanding, basic and diluted 99,161,710 65,210,117 98,537,685 42,974,640 Net loss per share attributable to common stockholders, basic and diluted $ (0.86) $ (0.40) $ (1.22) $ (4.71) The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: As of June 30, 2024 2023 Outstanding options to purchase common stock 14,726,755 8,051,662 Unvested RSUs outstanding 1,763,751 466,797 Unvested PSUs expected to vest 208,874 — Outstanding options to purchase common stock assumed upon acquisition of ValenzaBio 57,311 1,249,811 Common stock subject to repurchase — 384,547 ESPP 127,121 — Total 16,883,812 10,152,817 The PSUs included above represent the expected payout at the reporting date under the current performance vesting conditions assessment (see Note 10). |
Other Income
Other Income | 6 Months Ended |
Jun. 30, 2024 | |
Other Income and Expenses [Abstract] | |
Other Income | Other Income Arrangements with Vendors In March 2024, the Company entered into arrangements with certain vendors where the Company received a payment of $30.0 million and a $5.0 million service credit. The $30.0 million payment received from these arrangements was recorded as a gain in other income (expense), net in the condensed consolidated statement of operations and comprehensive loss for the six months ended June 30, 2024 and included in the cash flows from operating activities in the condensed consolidated statement of cash flows for the same period. The $5.0 million service credit was recorded as a credit within research and development expenses. Asset sale In January 2024, the Company entered into an asset purchase agreement (“Purchase Agreement”) with Tenet Medicines, Inc. (“Tenet”). The Company recorded $7.0 million cash received as other income (expense), net in the condensed consolidated statement of operations and comprehensive loss for the six months ended June 30, 2024. In consideration for the licenses and other rights Tenet received under the Purchase Agreement, the Company is entitled to receive development, regulatory and commercial milestone payments of up to $157.5 million, royalty on worldwide net sales and payments on sublicense income. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events On August 10, 2024, the Company’s Board of Directors approved a plan to suspend new internal investment in the development of izokibep in hidradenitis suppurativa (“HS”), psoriatic arthritis (“PsA”) and axial spondyloarthritis (“AxSpA”), pursuant to which the Company will focus its efforts primarily on its lonigutamab clinical program in thyroid eye disease and will implement an associated workforce reduction (the “Restructuring Plan”). As part of the Restructuring Plan, the Company’s workforce will be reduced by approximately 40 people, or approximately 1/3 of the Company’s existing headcount. The Company expects to incur charges related to the Restructuring Plan. In this regard, the Company estimates that it will incur approximately $4.5 million in cash-based expenses related to employee severance payments and benefits related to the workforce reduction. The Company expects that the majority of the restructuring charges related to the workforce reduction will be incurred in the third quarter of 2024 and that the implementation of the workforce reduction, including cash payments, will be substantially complete by the end of the fourth quarter of 2024. The Company has not yet completed its analysis of expected additional charges associated with implementation of the Restructuring Plan, and therefore is not able to make a good faith determination of an estimate of the amount, or range of amounts, of additional charges such as contract termination costs that the Company expects to incur in connection with the Restructuring Plan. The estimates of the charges and cash expenditures that the Company expects to incur in connection with the Restructuring Plan, and the timing thereof, are subject to a number of assumptions and actual amounts may differ materially from estimates. In addition, the Company may incur other charges or cash expenditures not currently contemplated due to unanticipated events that may occur, including in connection with the implementation of the Restructuring Plan. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The condensed consolidated financial statements and accompanying notes are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. The accompanying financial statements are consolidated and include the accounts of ACELRYIN, INC. and its wholly owned subsidiary, WH2, LLC. The subsidiary has not had any operations or any balances from its inception. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report. The information as of December 31, 2023 included in the condensed consolidated balance sheets was derived from the Company’s audited consolidated financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial statements. The results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 or for any other interim period or for any other future year. |
Use of Estimates | The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates estimates and assumptions, including but not limited to those related to the fair value of its derivative tranche liability, the fair value of its common stock, stock-based compensation expense, accruals for research and development expenses, valuation of deferred tax assets, and uncertain income tax positions. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from those estimates. |
Concentration of Credit Risk | Cash, cash equivalents, restricted cash and short-term marketable securities are financial instruments that potentially subject the Company to concentrations of credit risk. As of June 30, 2024 and December 31, 2023, cash consists of cash deposited with one financial institution, and account balances exceed federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial strength of this institution. The Company also has investments in money market funds, U.S. Treasury obligations, corporate debt obligations, and federal agency obligations, which can be subject to certain credit risks. The Company mitigates the risks by investing in high-grade instruments, limiting its exposure to any one issuer and monitoring the ongoing creditworthiness of the financial institutions and issuers. The Company has not experienced any losses on its financial instruments. |
Fair Value Measurements | The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1 — Quoted prices in active markets for identical assets or liabilities. Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s financial instruments measured at fair value on a recurring basis consist of Level 1, Level 2, and Level 3 financial instruments. Usually, short term marketable securities are considered Level 2 when their fair values are determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. Corporate debt obligations, commercial paper, government agency obligations and asset-backed securities are valued primarily using market prices of comparable securities, bid/ask quotes, interest rate yields and prepayment spreads and are included in Level 2. |
ValenzaBio Acquisition (Tables)
ValenzaBio Acquisition (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] | |
Schedule of Asset Acquisition | The following table represents the total purchase consideration (in thousands): Issued Class A Common Stock (1) $ 128,735 Transaction costs (2) 1,271 Cash (3) 8 Total $ 130,014 (1) Shares were issued for consideration at $6.86 per share, including 2,013,673 shares that were being held by Seller LLC until the Holdback Release Date. The Company used a third party valuation specialist to assist management in determining the fair value of the shares of Class A Common Stock at the Closing Date. (2) Legal and advisory transaction costs of $1.3 million incurred by the Company in connection with the Acquisition, including $0.1 million payable in cash to Seller LLC for the expense fund. (3) Cash payment of $7,663 to one non-accredited investor for settlement of vested ValenzaBio options. The following is the allocation of the purchase consideration to the acquired assets and liabilities (in thousands): Cash $ 11,369 Prepaid expenses and other current assets 2,074 In-process research and development assets 123,057 Accounts payable (1,628) Accrued research and development expenses (4,805) Accrued compensation and other current liabilities (53) Total net asset acquired $ 130,014 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Instruments Measured on Recurring Basis | The following table sets forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): Fair Value Measurements as of June 30, 2024 As of June 30, 2024: Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash and cash equivalents) $ 31,911 $ 31,911 $ - $ - U.S. Treasury obligations ($31,786 included in cash and cash equivalents) 399,255 - 399,255 - Corporate debt obligations ($29,270 included in cash and cash equivalents) 144,934 - 144,934 - Federal agency obligations ($13,319 included in cash and cash equivalents) 37,215 - 37,215 - Total fair value of assets $ 613,315 $ 31,911 $ 581,404 $ - Fair Value Measurements as of December 31, 2023 As of December 31, 2023: Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash and cash equivalents) $ 23,205 $ 23,205 $ - $ - U.S. Treasury obligations ($146,497 included in cash and cash equivalents) 525,353 - 525,353 - Corporate debt obligations ($23,313 included in cash and cash equivalents) 135,284 - 135,284 - Federal agency obligations ($15,344 included in cash and cash equivalents) 27,746 - 27,746 - Total fair value of assets $ 711,588 $ 23,205 $ 688,383 $ - Classified as: June 30, 2024 December 31, 2023 Cash and cash equivalents $ 106,286 $ 208,359 Short-term marketable securities $ 507,029 $ 503,229 Total cash equivalents and marketable securities $ 613,315 $ 711,588 |
Cash, Cash Equivalents, Restr_2
Cash, Cash Equivalents, Restricted Cash and Available-For-Sale Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Restrictions on Cash and Cash Equivalents | The following table provides a reconciliation of the Company’s cash and cash equivalents and non-current portion of restricted cash reported within the unaudited condensed consolidated balance sheets that sum to the total cash, cash equivalents and restricted cash shown in the Company’s condensed consolidated statement of cash flows: June 30, December 31, Cash and cash equivalents $ 128,211 $ 218,097 Restricted cash 543 — Total cash, cash equivalents and restricted cash $ 128,754 $ 218,097 |
Schedule of Cash and Cash Equivalents | The following table provides a reconciliation of the Company’s cash and cash equivalents and non-current portion of restricted cash reported within the unaudited condensed consolidated balance sheets that sum to the total cash, cash equivalents and restricted cash shown in the Company’s condensed consolidated statement of cash flows: June 30, December 31, Cash and cash equivalents $ 128,211 $ 218,097 Restricted cash 543 — Total cash, cash equivalents and restricted cash $ 128,754 $ 218,097 |
Schedule of Available-for-Sale Marketable Securities | The following tables summarize the estimated fair value of the Company’s available-for-sale marketable securities as of June 30, 2024 and December 31, 2023 (in thousands): As of June 30, 2024: Total Total Unrealized Gain Total Total Money market funds (included in cash and cash equivalents) $ 31,911 $ — $ - $ 31,911 U.S. Treasury obligations ($31,786 included in cash and cash equivalents) 399,353 5 (103) 399,255 Corporate debt obligations ($29,270 included in cash and cash equivalents) 144,989 10 (65) 144,934 Federal agency obligations ($13,319 included in cash and cash equivalents) 37,229 — (14) 37,215 Total available for sale marketable securities $ 613,482 $ 15 $ (182) $ 613,315 As of December 31, 2023: Total Total Unrealized Gain Total Unrealized Loss Total Money market funds (included in cash and cash equivalents) $ 23,205 $ — $ - $ 23,205 U.S. Treasury obligations ($146,497 included in cash and cash equivalents) 525,198 156 (1) 525,353 Corporate debt obligations ($23,313 included in cash and cash equivalents) 135,288 36 (40) 135,284 Federal agency obligations ($15,344 included in cash and cash equivalents) 27,735 12 (1) 27,746 Total available for sale marketable securities $ 711,426 $ 204 $ (42) $ 711,588 |
Consolidated Balance Sheet Co_2
Consolidated Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure | Prepaid expenses and other current assets consist of the following (in thousands): June 30, December 31, Prepaid research and development expenses $ 3,379 $ 8,184 Value-Added Tax ("VAT") receivable 4,136 3,985 Prepaid insurance and other current assets 2,763 1,712 Interest receivable 1,385 764 Prepaid other services 1,358 667 Total $ 13,021 $ 15,312 Other non-current assets consist of the following (in thousands): June 30, December 31, Prepaid research and development expenses, non-current $ 291 $ 2,644 Security deposits 34 34 Total $ 325 $ 2,678 |
Schedule of Property, Plant and Equipment | Property, plant and equipment consisted of the following (in thousands): June 30, 2024 December 31, 2023 Construction in progress $ 804 $ 1,460 Computer and other equipment 416 407 Furniture and fixtures 371 306 Leasehold improvements 144 121 Total property, plant and equipment, gross 1,735 2,294 Less: accumulated depreciation and amortization (226) (115) Property, plant and equipment, net $ 1,509 $ 2,179 |
Schedule of Accrued Research and Development Expense | Accrued research and development expenses are comprised of the following (in thousands): June 30, 2024 December 31, 2023 Accrued clinical manufacturing expenses $ 24,665 $ 22,232 Accrued clinical expenses 10,452 13,204 Total $ 35,117 $ 35,436 |
Schedule of Other Current Liabilities | Accrued compensation and other current liabilities consist of the following (in thousands): June 30, December 31, Accrued compensation $ 3,965 $ 5,417 Accrued professional service fees 1,259 1,099 Other accrued expenses and current liabilities 255 317 Total $ 5,479 $ 6,833 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Lessee, Operating Lease, Liability, to be Paid, Maturity | The following table summarizes a maturity analysis of the Company’s operating lease liabilities showing the aggregate lease payments as of June 30, 2024 (in thousands): 2024 (remainder of the year) $ 189 2025 386 2026 398 2027 409 2028 280 Total future lease payments 1,662 Less imputed interest (353) Total operating lease liability balance 1,309 Less current portion of lease liability (240) Operating lease liability, non-current $ 1,069 |
Common Stock (Tables)
Common Stock (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | As of June 30, 2024 and December 31, 2023, Common Stock reserved for future issuance by the Company was as follows: June 30, December 31, 2024 2023 Shares available for future grants under Equity Incentive Plan 5,038,988 3,526,392 Outstanding stock options 14,726,755 9,630,623 Performance-based restricted stock units 1 928,328 2,964,072 Outstanding restricted stock units 1,763,751 2,166,016 Options assumed upon ValenzaBio acquisition 57,311 938,440 ESPP Shares available for future grants 1,753,667 875,836 Total shares reserved for future issuance 24,268,800 20,101,379 1. The performance-based restricted stock units balance is based on the target number of shares. |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | A summary of option activity under the 2020 and 2023 Plan is as follows: Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2023 9,630,623 $ 10.4619 9.0 $ 12,007 Options granted 8,602,808 6.5348 Options exercised (215,128) 2.4375 Options expired (50,217) 6.9078 Options forfeited (3,241,331) 10.1166 Outstanding at June 30, 2024 14,726,755 $ 8.3731 8.4 $ 1,922 Exercisable at June 30, 2024 3,510,502 $ 9.0101 5.5 $ 880 Vested and expected to vest at June 30, 2024 14,726,755 $ 8.3731 8.4 $ 1,922 |
Schedule of Restricted Stock Unit Activity | A summary of unvested RSU activity is presented in the following table: Number of RSUs Weighted-Average Grant Date Fair Value Unvested at December 31, 2023 2,166,016 $ 22.90 Granted 2,134,396 6.59 Vested (944,140) 8.77 Forfeited (1,592,521) 20.06 Unvested at June 30, 2024 1,763,751 $ 13.29 |
Schedule of Performance Share Activity | A summary of PSU activity based on the target number of shares is presented in the following table: Number of PSUs Weighted-Average Grant Date Fair Value* Outstanding at December 31, 2023 2,964,072 $ 27.43 Granted — — Vested — — Forfeited (2,035,744) 27.43 Outstanding at June 30, 2024 928,328 $ 27.43 *The grant date fair value is based only on the PSUs with market conditions and does not factor in any performance conditions. |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions | The Company used Black-Scholes option pricing model to estimate fair value of each option at the grant date based on the following assumptions for the three and six months ended June 30, 2024 and 2023: Three Months Ended Three Months Ended Six Months Ended Six Months Ended 2024 2023 2024 2023 Expected volatility 84.48% - 86.76% 75.30% - 91.92% 84.48% - 87.76% 75.30% - 92.20% Expected dividend yield 0 % 0 % 0 % 0 % Expected term (in years) 5.41 - 6.06 5.77 – 6.08 5.41 - 6.08 5.77 – 6.08 Risk-free interest rate 4.35% - 4.52% 3.30% - 3.47% 3.98% - 4.52% 3.30% - 4.12% |
Schedule of Share-Based Payment Arrangement, Expensed and Capitalized, Amount | The following table presents the classification of stock-based compensation expense related to awards granted under equity incentive options (in thousands): Three Months ended June 30, Six Months ended June 30, 2024 2023 2024 2023 Research and development expenses $ 4,851 $ 1,325 $ 9,442 $ 5,090 General and administrative expenses 5,323 7,176 20,895 10,550 Total stock-based compensation expense $ 10,174 $ 8,501 $ 30,337 $ 15,640 The stock-based compensation expense (in thousands) relates to the following equity-based awards: Three Months ended June 30, Six Months ended June 30, 2024 2023 2024 2023 Restricted stock units $ 8,824 $ 5,539 $ 13,239 $ 5,539 Performance-based restricted stock units (11,698) — (1,798) — Stock options 13,113 2,946 18,864 10,008 ESPP 82 16 179 16 Restricted stock awards — — — 77 Performance-based options $ (147) $ — $ (147) $ — Total stock-based compensation expense $ 10,174 $ 8,501 $ 30,337 $ 15,640 |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable to Common Stockholders (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Numerator: Net loss $ (85,672) $ (26,039) $ (120,645) $ (202,489) Denominator: Weighted average common shares outstanding 99,215,994 65,652,851 98,653,080 43,461,494 Less: Weighted-average common shares subject to repurchase (54,284) (442,734) (115,395) (486,854) Weighted-average common shares outstanding, basic and diluted 99,161,710 65,210,117 98,537,685 42,974,640 Net loss per share attributable to common stockholders, basic and diluted $ (0.86) $ (0.40) $ (1.22) $ (4.71) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: As of June 30, 2024 2023 Outstanding options to purchase common stock 14,726,755 8,051,662 Unvested RSUs outstanding 1,763,751 466,797 Unvested PSUs expected to vest 208,874 — Outstanding options to purchase common stock assumed upon acquisition of ValenzaBio 57,311 1,249,811 Common stock subject to repurchase — 384,547 ESPP 127,121 — Total 16,883,812 10,152,817 |
Description of Business, Orga_2
Description of Business, Organization and Liquidity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||||
May 09, 2023 USD ($) $ / shares shares | Apr. 25, 2023 | Jan. 04, 2023 USD ($) shares | Jun. 30, 2024 USD ($) | Mar. 31, 2024 USD ($) | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | Jul. 31, 2020 $ / shares | |
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Reverse stock split, conversion ratio | 0.5071 | ||||||||||
Sale of stock, price (in dollars per share) | $ / shares | $ 0.00002 | ||||||||||
Underwriting discounts, commissions and offering costs | $ 47,354 | ||||||||||
Temporary equity, convertible, conversion ratio | 100% | 100% | |||||||||
Net losses | $ 85,672 | $ 34,973 | 26,039 | $ 176,450 | $ 120,645 | $ 202,489 | |||||
Other nonoperating income | $ 37,000 | ||||||||||
Research and development | 76,382 | $ 30,030 | 134,414 | 197,950 | |||||||
Payments to acquire in-process research and development | 0 | 10,000 | |||||||||
Accumulated deficit | 609,364 | 609,364 | $ 488,719 | ||||||||
Cash used in operating activities | 103,574 | 56,949 | |||||||||
Cash, cash equivalents, and marketable securities | $ 635,800 | $ 635,800 | |||||||||
Pierre Fabre | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Payments to acquire in-process research and development | $ 10,000 | 10,000 | |||||||||
ValenzaBio Asset Acquisition | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Shares issued (in shares) | shares | 2,013,673 | ||||||||||
Research and development | $ 123,100 | $ 123,100 | |||||||||
ValenzaBio Asset Acquisition | Common Class A | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Shares issued (in shares) | shares | 18,885,731 | ||||||||||
IPO | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Number of shares issued in transaction (in shares) | shares | 34,500,000 | ||||||||||
Sale of stock, price (in dollars per share) | $ / shares | $ 18 | ||||||||||
Gross proceeds received on transaction | $ 621,000 | ||||||||||
Net proceeds received on transaction | 573,600 | ||||||||||
Underwriting discounts, commissions and offering costs | $ 47,400 | ||||||||||
Over-Allotment Option | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Number of shares issued in transaction (in shares) | shares | 4,500,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | Jun. 30, 2024 institution |
Accounting Policies [Abstract] | |
Number of financial institutions with cash deposits | 1 |
ValenzaBio Acquisition - Narrat
ValenzaBio Acquisition - Narrative (Details) | 3 Months Ended | 6 Months Ended | ||||||
Jan. 04, 2023 USD ($) shares | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | Dec. 20, 2022 subsidiary | |
Asset Acquisition [Line Items] | ||||||||
Number of subsidiaries formed | subsidiary | 2 | |||||||
Expense related to acquired in-process research and development assets | $ 0 | $ 133,057,000 | ||||||
Research and development | $ 76,382,000 | $ 30,030,000 | 134,414,000 | 197,950,000 | ||||
Severance payable, current | $ 0 | 0 | $ 300,000 | |||||
Payments to acquire in-process research and development | $ 0 | 10,000,000 | ||||||
Minimum | ||||||||
Asset Acquisition [Line Items] | ||||||||
Severance payment obligation period | 3 months | |||||||
Maximum | ||||||||
Asset Acquisition [Line Items] | ||||||||
Severance payment obligation period | 18 months | |||||||
Unvested Equity Awards | ||||||||
Asset Acquisition [Line Items] | ||||||||
Separately recognized expenses | $ 900,000 | |||||||
Severance Payment Obligation | ||||||||
Asset Acquisition [Line Items] | ||||||||
Liabilities recognized | $ 5,100,000 | |||||||
Severance Payment Obligation | Measurement Input, Discount Rate [Member] | ||||||||
Asset Acquisition [Line Items] | ||||||||
Measurement input | 8% | |||||||
Research and Development Expense | Assumed Options | ||||||||
Asset Acquisition [Line Items] | ||||||||
Separately recognized expenses | 3,100,000 | |||||||
Research and Development Expense | Severance Payment Obligation | ||||||||
Asset Acquisition [Line Items] | ||||||||
Separately recognized expenses | 2,500,000 | |||||||
General and Administrative Expense | Assumed Options | ||||||||
Asset Acquisition [Line Items] | ||||||||
Separately recognized expenses | 1,800,000 | |||||||
General and Administrative Expense | Severance Payment Obligation | ||||||||
Asset Acquisition [Line Items] | ||||||||
Separately recognized expenses | 2,400,000 | |||||||
Non-Accredited Investor | General and Administrative Expense | ||||||||
Asset Acquisition [Line Items] | ||||||||
Separately recognized expenses | 8,387 | |||||||
Former ValenzaBio Employee | General and Administrative Expense | ||||||||
Asset Acquisition [Line Items] | ||||||||
Separately recognized expenses | $ 30,000 | |||||||
Pierre Fabre | ||||||||
Asset Acquisition [Line Items] | ||||||||
Payments to acquire in-process research and development | $ 10,000,000 | 10,000,000 | ||||||
ValenzaBio Asset Acquisition | ||||||||
Asset Acquisition [Line Items] | ||||||||
Shares issued (in shares) | shares | 2,013,673 | |||||||
Share holdback (in shares) | shares | 2,013,673 | |||||||
Shares issued, withholding period | 12 months | |||||||
Asset acquisition payment | $ 7,663 | |||||||
Transaction cost, net | $ 1,200,000 | |||||||
Options exercisable (in shares) | shares | 1,249,811 | |||||||
Option exercisable period | 12 months | |||||||
Options exchange ratio | 0.008027010 | |||||||
Research and development | $ 123,100,000 | $ 123,100,000 | ||||||
ValenzaBio Asset Acquisition | Common Class A | ||||||||
Asset Acquisition [Line Items] | ||||||||
Shares issued (in shares) | shares | 18,885,731 | |||||||
ValenzaBio Asset Acquisition | lonigutamab | ||||||||
Asset Acquisition [Line Items] | ||||||||
Expense related to acquired in-process research and development assets | $ 114,800,000 | |||||||
ValenzaBio Asset Acquisition | SLRN-517 | ||||||||
Asset Acquisition [Line Items] | ||||||||
Expense related to acquired in-process research and development assets | $ 8,200,000 |
ValenzaBio Acquisition - Schedu
ValenzaBio Acquisition - Schedule of Total Purchase Consideration (Details) - ValenzaBio Asset Acquisition | Jan. 04, 2023 USD ($) $ / shares shares |
Asset Acquisition [Line Items] | |
Issued common stock | $ 128,735,000 |
Transaction costs | 1,271,000 |
Cash | 7,663 |
Total | $ 130,014,000 |
Shares issued (in dollars per share) | $ / shares | $ 6.86 |
Shares issued (in shares) | shares | 2,013,673 |
Contingent consideration | $ 100,000 |
ValenzaBio Acquisition - Sche_2
ValenzaBio Acquisition - Schedule of Allocation of Purchase Consideration (Details) - ValenzaBio Asset Acquisition $ in Thousands | Jan. 04, 2023 USD ($) |
Asset Acquisition [Line Items] | |
Cash | $ 11,369 |
Prepaid expenses and other current assets | 2,074 |
In-process research and development assets | 123,057 |
Accounts payable | (1,628) |
Accrued research and development expenses | (4,805) |
Accrued compensation and other current liabilities | (53) |
Total net asset acquired | $ 130,014 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Instruments Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Assets: | ||
Money market funds (included in cash and cash equivalents) | $ 613,315 | $ 711,588 |
Total fair value of assets | 613,315 | 711,588 |
Cash and cash equivalents | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 106,286 | 208,359 |
Money market funds (included in cash and cash equivalents) | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 31,911 | 23,205 |
U.S. Treasury obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 399,255 | 525,353 |
U.S. Treasury obligations | Cash and cash equivalents | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 31,786 | 146,497 |
Corporate debt obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 144,934 | 135,284 |
Corporate debt obligations | Cash and cash equivalents | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 29,270 | 23,313 |
Federal agency obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 37,215 | 27,746 |
Federal agency obligations | Cash and cash equivalents | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 13,319 | 15,344 |
Level 1 | ||
Assets: | ||
Total fair value of assets | 31,911 | 23,205 |
Level 1 | Money market funds (included in cash and cash equivalents) | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 31,911 | 23,205 |
Level 1 | U.S. Treasury obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 0 | 0 |
Level 1 | Corporate debt obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 0 | 0 |
Level 1 | Federal agency obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 0 | 0 |
Level 2 | ||
Assets: | ||
Total fair value of assets | 581,404 | 688,383 |
Level 2 | Money market funds (included in cash and cash equivalents) | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 0 | 0 |
Level 2 | U.S. Treasury obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 399,255 | 525,353 |
Level 2 | Corporate debt obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 144,934 | 135,284 |
Level 2 | Federal agency obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 37,215 | 27,746 |
Level 3 | ||
Assets: | ||
Total fair value of assets | 0 | 0 |
Level 3 | Money market funds (included in cash and cash equivalents) | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 0 | 0 |
Level 3 | U.S. Treasury obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 0 | 0 |
Level 3 | Corporate debt obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | 0 | 0 |
Level 3 | Federal agency obligations | ||
Assets: | ||
Money market funds (included in cash and cash equivalents) | $ 0 | $ 0 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Cash and Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents and marketable securities | $ 613,315 | $ 711,588 |
Cash and cash equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents and marketable securities | 106,286 | 208,359 |
Short-term marketable securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents and marketable securities | $ 507,029 | $ 503,229 |
Cash, Cash Equivalents, Restr_3
Cash, Cash Equivalents, Restricted Cash and Available-For-Sale Marketable Securities - Schedule of Restrictions on Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||||
Cash and cash equivalents | $ 128,211 | $ 218,097 | ||
Restricted cash | 543 | 0 | ||
Total cash, cash equivalents and restricted cash | $ 128,754 | $ 218,097 | $ 556,169 | $ 267,110 |
Cash, Cash Equivalents, Restr_4
Cash, Cash Equivalents, Restricted Cash and Available-For-Sale Marketable Securities - Schedule of Available-for-Sale Marketable Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Debt Securities, Available-for-Sale [Line Items] | ||
Total Amortized Cost | $ 613,482 | $ 711,426 |
Total Unrealized Gain | 15 | 204 |
Total Unrealized Loss | (182) | (42) |
Total Estimated Fair Value | 613,315 | 711,588 |
Cash and cash equivalents | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Total Estimated Fair Value | 106,286 | 208,359 |
Money market funds (included in cash and cash equivalents) | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Total Amortized Cost | 31,911 | 23,205 |
Total Unrealized Gain | 0 | 0 |
Total Unrealized Loss | 0 | 0 |
Total Estimated Fair Value | 31,911 | 23,205 |
U.S. Treasury obligations | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Total Amortized Cost | 399,353 | 525,198 |
Total Unrealized Gain | 5 | 156 |
Total Unrealized Loss | (103) | (1) |
Total Estimated Fair Value | 399,255 | 525,353 |
U.S. Treasury obligations | Cash and cash equivalents | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Total Estimated Fair Value | 31,786 | 146,497 |
Corporate debt obligations | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Total Amortized Cost | 144,989 | 135,288 |
Total Unrealized Gain | 10 | 36 |
Total Unrealized Loss | (65) | (40) |
Total Estimated Fair Value | 144,934 | 135,284 |
Corporate debt obligations | Cash and cash equivalents | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Total Estimated Fair Value | 29,270 | 23,313 |
Federal agency obligations | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Total Amortized Cost | 37,229 | 27,735 |
Total Unrealized Gain | 0 | 12 |
Total Unrealized Loss | (14) | (1) |
Total Estimated Fair Value | 37,215 | 27,746 |
Federal agency obligations | Cash and cash equivalents | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Total Estimated Fair Value | $ 13,319 | $ 15,344 |
Cash, Cash Equivalents, Restr_5
Cash, Cash Equivalents, Restricted Cash and Available-For-Sale Marketable Securities - Narrative (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
Debt Securities, Available-for-Sale [Line Items] | |||
Restricted cash | $ 543,000 | $ 543,000 | $ 0 |
Allowance for credit loss | 0 | 0 | |
Accrued interest receivable | $ 1,400,000 | $ 1,400,000 | $ 800,000 |
Debt Securities, Available-for-Sale, Accrued Interest, after Allowance for Credit Loss, Current, Statement of Financial Position [Extensible Enumeration] | Prepaid expenses and other current assets | Prepaid expenses and other current assets | Prepaid expenses and other current assets |
Accrued interest writeoff | $ 0 | $ 0 | |
Cash Pledged as Collateral for Stand-by Letter of Credit | |||
Debt Securities, Available-for-Sale [Line Items] | |||
Restricted cash | 200,000 | 200,000 | |
Corporate Credit Card Program | |||
Debt Securities, Available-for-Sale [Line Items] | |||
Restricted cash | $ 300,000 | $ 300,000 |
Consolidated Balance Sheet Co_3
Consolidated Balance Sheet Components - Schedule of Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Prepaid research and development expenses | $ 3,379 | $ 8,184 |
Value-Added Tax ("VAT") receivable | 4,136 | 3,985 |
Prepaid insurance and other current assets | 2,763 | 1,712 |
Interest receivable | 1,385 | 764 |
Prepaid other services | 1,358 | 667 |
Total | $ 13,021 | $ 15,312 |
Consolidated Balance Sheet Co_4
Consolidated Balance Sheet Components - Schedule of Prepaid and Other Noncurrent Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Prepaid research and development expenses, non-current | $ 291 | $ 2,644 |
Security deposits | 34 | 34 |
Total | $ 325 | $ 2,678 |
Consolidated Balance Sheet Co_5
Consolidated Balance Sheet Components - Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | $ 1,735 | $ 2,294 |
Less: accumulated depreciation and amortization | (226) | (115) |
Property, plant and equipment, net | 1,509 | 2,179 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | 804 | 1,460 |
Computer and other equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | 416 | 407 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | 371 | 306 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | $ 144 | $ 121 |
Consolidated Balance Sheet Co_6
Consolidated Balance Sheet Components - Accrued Research and Development Expense (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued clinical manufacturing expenses | $ 24,665 | $ 22,232 |
Accrued clinical expenses | 10,452 | 13,204 |
Total | $ 35,117 | $ 35,436 |
Consolidated Balance Sheet Co_7
Consolidated Balance Sheet Components - Schedule of Accrued Compensation and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued compensation | $ 3,965 | $ 5,417 |
Accrued professional service fees | 1,259 | 1,099 |
Other accrued expenses and current liabilities | 255 | 317 |
Total | $ 5,479 | $ 6,833 |
Significant Agreements (Details
Significant Agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||
Jan. 04, 2023 | Mar. 25, 2021 | Nov. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2021 | Dec. 31, 2023 | Oct. 31, 2021 | Sep. 30, 2021 | Aug. 30, 2021 | Aug. 09, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development | $ 76,382,000 | $ 30,030,000 | $ 134,414,000 | $ 197,950,000 | |||||||||
Affibody | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Aggregate milestone payments | $ 22,000,000 | $ 3,000,000 | $ 3,000,000 | ||||||||||
Maximum aggregate milestone payments | $ 280,000,000 | ||||||||||||
Payment due prior to milestone | $ 30,000,000 | ||||||||||||
Research and development | $ 15,000,000 | $ 25,000,000 | |||||||||||
Aggregate milestone payments, period | 10 years | ||||||||||||
Contingent payments, percentage | 33.33% | ||||||||||||
Fair value threshold percentage | 33.33% | ||||||||||||
Probable milestone payments | 0 | 0 | $ 0 | ||||||||||
Pierre Fabre | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Aggregate milestone payments | $ 10,000,000 | ||||||||||||
Aggregate milestone payments, period | 10 years | ||||||||||||
Probable milestone payments | 0 | 0 | |||||||||||
One-time payment | $ 31,000,000 | ||||||||||||
One-time payment, period | 30 days | ||||||||||||
Termination period | 9 months | ||||||||||||
Pierre Fabre | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Development and Regulatory Milestone Payments | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Maximum aggregate milestone payments | $ 99,500,000 | ||||||||||||
Pierre Fabre | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Commercial Sales Milestone Payments | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Maximum aggregate milestone payments | $ 390,000,000 | ||||||||||||
Novelty Nobility | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Aggregate milestone payments, period | 10 years | ||||||||||||
Probable milestone payments | $ 0 | $ 0 | |||||||||||
Contract termination, period | 30 days | ||||||||||||
Novelty Nobility | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Development and Regulatory Milestone Payments | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Maximum aggregate milestone payments | $ 44,300,000 | ||||||||||||
Novelty Nobility | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Commercial Sales Milestone Payments | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Maximum aggregate milestone payments | $ 682,000,000 |
Commitments and Contingent Li_3
Commitments and Contingent Liabilities - Narrative (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Nov. 30, 2023 USD ($) | Jan. 31, 2023 USD ($) ft² | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2023 USD ($) | |
Other Commitments [Line Items] | ||||||||
Research and development | $ 76,382,000 | $ 30,030,000 | $ 134,414,000 | $ 197,950,000 | ||||
Unrecorded unconditional purchase obligation | 87,900,000 | 87,900,000 | $ 142,300,000 | |||||
Loss on contract termination | 14,300,000 | |||||||
Office space leased (in square feet) | ft² | 10,012 | |||||||
Term of contract | 65 months | 65 months | ||||||
Renewal term | 3 years | |||||||
Monthly payments | $ 30,500 | |||||||
Annual rent increase | 3% | |||||||
Rent abatement, term | 6 months | |||||||
Security deposit | 34,000 | 34,000 | 34,000 | |||||
Operating lease right-of-use asset | $ 1,300,000 | 1,101,000 | 1,101,000 | 1,195,000 | ||||
Operating lease liability, non-current | $ 1,300,000 | $ 1,069,000 | 1,069,000 | $ 1,194,000 | ||||
Operating lease costs (less than) | $ 200,000 | $ 100,000 | ||||||
Weighted average remaining lease term | 50 months | 50 months | ||||||
Discount rate | 12% | 12% | ||||||
Lease liability measurement (less than) | $ 200,000 | |||||||
Affibody | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Other Commitments [Line Items] | ||||||||
Research and development | $ 15,000,000 | $ 25,000,000 |
Commitments and Contingent Li_4
Commitments and Contingent Liabilities - Summary of Maturity Analysis of Operating Lease Liability (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | Jan. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | |||
2024 (remainder of the year) | $ 189 | ||
2025 | 386 | ||
2026 | 398 | ||
2027 | 409 | ||
2028 | 280 | ||
Total future lease payments | 1,662 | ||
Less imputed interest | (353) | ||
Total operating lease liability balance | 1,309 | ||
Less current portion of lease liability | (240) | ||
Operating lease liability, non-current | $ 1,069 | $ 1,194 | $ 1,300 |
Common Stock - Narrative (Detai
Common Stock - Narrative (Details) | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||
Dec. 31, 2022 shares | Jul. 31, 2020 $ / shares shares | Jun. 30, 2024 shares | Dec. 31, 2023 shares | May 09, 2023 | |
Class of Stock [Line Items] | |||||
Conversion of stock, ratio | 1 | ||||
Common stock, outstanding (in shares) | 99,570,421 | 97,865,890 | |||
Stock issued during period, issued for services (in shares) | 2,839,749 | ||||
Sale of stock, price (in dollars per share) | $ / shares | $ 0.00002 | ||||
Common Class B | |||||
Class of Stock [Line Items] | |||||
Common stock, outstanding (in shares) | 0 | ||||
Restricted stock awards | |||||
Class of Stock [Line Items] | |||||
Vesting period | 48 months | ||||
Forfeited in period (in shares) | 591,613 | ||||
Shares unvested (in shares) | 0 | 207,060 | |||
Vested (in shares) | 207,060 | 354,972 |
Common Stock - Schedule of Comm
Common Stock - Schedule of Common Stock Reserved for Future Issuance (Details) - shares | Jun. 30, 2024 | Dec. 31, 2023 |
Class of Stock [Line Items] | ||
Total shares reserved for future issuance (in shares) | 24,268,800 | 20,101,379 |
Outstanding stock options | ||
Class of Stock [Line Items] | ||
Total shares reserved for future issuance (in shares) | 14,726,755 | 9,630,623 |
Performance-based restricted stock units | ||
Class of Stock [Line Items] | ||
Total shares reserved for future issuance (in shares) | 928,328 | 2,964,072 |
Outstanding restricted stock units | ||
Class of Stock [Line Items] | ||
Total shares reserved for future issuance (in shares) | 1,763,751 | 2,166,016 |
ESPP Shares available for future grants | ||
Class of Stock [Line Items] | ||
Total shares reserved for future issuance (in shares) | 1,753,667 | 875,836 |
Shares available for future grants under Equity Incentive Plan | ||
Class of Stock [Line Items] | ||
Total shares reserved for future issuance (in shares) | 5,038,988 | 3,526,392 |
Options assumed upon ValenzaBio acquisition | Outstanding stock options | ||
Class of Stock [Line Items] | ||
Total shares reserved for future issuance (in shares) | 57,311 | 938,440 |
Equity Incentive Plan - Narrati
Equity Incentive Plan - Narrative (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||
Jan. 01, 2024 | May 04, 2023 | Jan. 04, 2023 | May 31, 2024 | Aug. 31, 2023 | Apr. 30, 2023 | Jul. 31, 2020 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Total shares reserved for future issuance (in shares) | 24,268,800 | 24,268,800 | 20,101,379 | |||||||||
Common stock, issued (in shares) | 99,570,421 | 99,570,421 | 97,865,890 | |||||||||
Common stock, outstanding (in shares) | 99,570,421 | 99,570,421 | 97,865,890 | |||||||||
Share-based and cash-based compensation, maximum | $ 750,000 | |||||||||||
Fair value of shares vested | $ 12,800,000 | |||||||||||
Weighted-average grant date fair value, grants in period (in dollars per share) | $ 3.8440 | |||||||||||
Options granted (in shares) | 8,602,808 | |||||||||||
Exercisable (in dollars per share) | $ 9.0101 | $ 9.0101 | ||||||||||
Exercises in period (in shares) | 215,128 | |||||||||||
Options expired (in dollars per share) | $ 6.9078 | |||||||||||
Stock based compensation expense | $ 10,174,000 | $ 8,501,000 | $ 30,337,000 | $ 15,640,000 | ||||||||
Expected dividend yield | 0% | 0% | 0% | 0% | ||||||||
Accrued compensation and other current liabilities | $ 5,479,000 | $ 5,479,000 | $ 6,833,000 | |||||||||
Issuance of common stock under the employee stock purchase plan | 100,827 | 100,827 | ||||||||||
Research and Development Expense | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock based compensation expense | $ 4,851,000 | $ 1,325,000 | $ 9,442,000 | $ 5,090,000 | ||||||||
General and Administrative Expense | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock based compensation expense | $ 5,323,000 | 7,176,000 | $ 20,895,000 | 10,550,000 | ||||||||
Share-Based Payment Arrangement, Nonemployee | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Share-based and cash-based compensation, maximum | $ 1,000,000 | |||||||||||
Stock options | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Total shares reserved for future issuance (in shares) | 14,726,755 | 14,726,755 | 9,630,623 | |||||||||
Expiration period | 10 years | |||||||||||
Stock based compensation expense | $ 13,113,000 | 2,946,000 | $ 18,864,000 | 10,008,000 | ||||||||
Employee Stock | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Total shares reserved for future issuance (in shares) | 1,753,667 | 1,753,667 | 875,836 | |||||||||
Additional shares authorized (in shares) | 978,658 | |||||||||||
Purchase price of common stock | 85% | |||||||||||
Number of shares authorized (in shares) | 900,000 | |||||||||||
Percentage of eligible compensation for payroll deductions to purchase stock | 15% | |||||||||||
Purchase period | 6 months | |||||||||||
Annual increase, period | 10 years | |||||||||||
Annual increase as percentage of shares outstanding | 1% | |||||||||||
Maximum number of shares available over award term | 2,700,000 | |||||||||||
Stock based compensation expense | $ 82,000 | 16,000 | $ 179,000 | 16,000 | ||||||||
Accrued compensation and other current liabilities | $ 100,000 | $ 100,000 | ||||||||||
Restricted stock units | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Total shares reserved for future issuance (in shares) | 1,763,751 | 1,763,751 | 2,166,016 | |||||||||
Stock based compensation expense | $ 8,824,000 | 5,539,000 | $ 13,239,000 | 5,539,000 | ||||||||
Granted (in dollars per share) | $ 6.59 | |||||||||||
Share-based payment arrangement, accelerated and plan modification, cost | $ 12,700,000 | |||||||||||
Performance Shares | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Total shares reserved for future issuance (in shares) | 928,328 | 928,328 | 2,964,072 | |||||||||
Expiration period | 3 years | |||||||||||
Stock based compensation expense | $ (11,698,000) | 0 | $ (1,798,000) | 0 | ||||||||
Target number of shares (in shares) | 3,135,104 | |||||||||||
Target number of shares, percentage | 150% | |||||||||||
Share price (in usd per share) | $ 26.97 | $ 26.97 | ||||||||||
Expected volatility | 87.71% | |||||||||||
Risk-free interest rate | 4.47% | |||||||||||
Expected dividend yield | 0% | |||||||||||
Granted (in dollars per share) | $ 0 | $ 27.43 | ||||||||||
Share-based payment arrangement, reversal of expense | $ 13,400,000 | $ 11,700,000 | ||||||||||
Weighted-average recognition period | 1 year 9 months 18 days | |||||||||||
Unrecognized stock-based compensation expense | 17,300,000 | $ 17,300,000 | ||||||||||
Unrecognized stock-based compensation expense, maximum | 21,400,000 | 21,400,000 | ||||||||||
Restricted stock awards | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Vesting period | 48 months | |||||||||||
Stock based compensation expense | 0 | 0 | 0 | 77,000 | ||||||||
Performance Shares and Performance Options | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Share-based payment arrangement, reversal of expense | $ 13,500,000 | $ 13,500,000 | ||||||||||
Equity Incentive Plan 2023 | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Total shares reserved for future issuance (in shares) | 12,000,000 | |||||||||||
Percentage of outstanding stock maximum | 5% | |||||||||||
Vesting period | 4 years | |||||||||||
Equity Incentive Plan 2023 | Stock options | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Additional shares authorized (in shares) | 5,230,473 | |||||||||||
Shares issuable (in shares) | 56,762,538 | |||||||||||
Equity Incentive Plan 2023 | Stock options | Stockholder, 10% Or More | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Expiration period | 5 years | |||||||||||
Equity Incentive Plan 2023 | Stock options | Minimum | Stockholder, 10% Or More | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Purchase price of common stock | 110% | |||||||||||
2020 Equity Incentive Plan | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Common stock, issued (in shares) | 6,920,846 | |||||||||||
Common stock, outstanding (in shares) | 6,920,846 | |||||||||||
2020 Stock Option Plan | Stock options | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Expiration period | 10 years | |||||||||||
Vesting period | 4 years | |||||||||||
ValenaBio 2020 Stock Option Plan | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Options granted (in shares) | 1,249,811 | |||||||||||
Exercisable (in dollars per share) | $ 3.6736 | |||||||||||
Exercises in period (in shares) | 881,129 | |||||||||||
Options expired (in dollars per share) | $ 4.0538 | |||||||||||
Unrecognized stock-based compensation expense | $ 63,400,000 | $ 63,400,000 | ||||||||||
ValenaBio 2020 Stock Option Plan | ValenzaBio Asset Acquisition | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock based compensation expense | 4,900,000 | |||||||||||
ValenaBio 2020 Stock Option Plan | ValenzaBio Asset Acquisition | Research and Development Expense | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock based compensation expense | 3,100,000 | |||||||||||
ValenaBio 2020 Stock Option Plan | ValenzaBio Asset Acquisition | General and Administrative Expense | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock based compensation expense | $ 1,800,000 | |||||||||||
ValenaBio 2020 Stock Option Plan | Stock options | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Total shares reserved for future issuance (in shares) | 57,311 | 57,311 | 938,440 | |||||||||
Weighted-average recognition period | 2 years 10 months 24 days | |||||||||||
ValenaBio 2020 Stock Option Plan | Stock options | ValenzaBio Asset Acquisition | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock based compensation expense | 4,900,000 | |||||||||||
ValenaBio 2020 Stock Option Plan | Restricted stock units | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Weighted-average recognition period | 2 years 8 months 12 days | |||||||||||
Unrecognized stock-based compensation expense | $ 21,300,000 | $ 21,300,000 | ||||||||||
ValenaBio 2020 Stock Option Plan | Restricted stock awards | ValenzaBio Asset Acquisition | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock based compensation expense | $ 900,000 |
Equity Incentive Plan - Schedul
Equity Incentive Plan - Schedule of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | |
Number of Options | ||
Outstanding, beginning balance (in shares) | shares | 9,630,623 | |
Options granted (in shares) | shares | 8,602,808 | |
Options exercised (in shares) | shares | (215,128) | |
Options expired (in shares) | shares | (50,217) | |
Options forfeited (in shares) | shares | (3,241,331) | |
Outstanding, ending balance (in shares) | shares | 14,726,755 | 9,630,623 |
Exercisable (in shares) | shares | 3,510,502 | |
Vested and expected to vest (in shares) | shares | 14,726,755 | |
Weighted-Average Exercise Price Per Share | ||
Outstanding, beginning balance (in dollars per share) | $ / shares | $ 10.4619 | |
Granted (in dollars per share) | $ / shares | 6.5348 | |
Options exercised (in dollars per share) | $ / shares | 2.4375 | |
Options expired (in dollars per share) | $ / shares | 6.9078 | |
Options forfeited (in dollars per share) | $ / shares | 10.1166 | |
Outstanding, ending balance (in dollars per share) | $ / shares | 8.3731 | $ 10.4619 |
Exercisable (in dollars per share) | $ / shares | 9.0101 | |
Vested and expected to vest (in dollars per share) | $ / shares | $ 8.3731 | |
Weighted-Average Remaining Contractual Term | ||
Outstanding | 8 years 4 months 24 days | 9 years |
Exercisable | 5 years 6 months | |
Vested and expected to vest | 8 years 4 months 24 days | |
Aggregate Intrinsic Value | ||
Outstanding | $ | $ 1,922 | $ 12,007 |
Exercisable | $ | 880 | |
Vested and expected to vest | $ | $ 1,922 |
Equity Incentive Plan - Sched_2
Equity Incentive Plan - Schedule of Restricted Stock Unit Activity (Details) - Restricted stock units | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Number of Shares | |
Outstanding at beginning of period (in shares) | shares | 2,166,016 |
Shares granted (in shares) | shares | 2,134,396 |
Vested (in shares) | shares | (944,140) |
Forfeited (in shares) | shares | (1,592,521) |
Outstanding at end of period (in shares) | shares | 1,763,751 |
Weighted-Average Grant Date Fair Value | |
Outstanding at beginning of period (in dollars per share) | $ / shares | $ 22.90 |
Granted (in dollars per share) | $ / shares | 6.59 |
Vested (in dollars per share) | $ / shares | 8.77 |
Forfeited (in dollars per share) | $ / shares | 20.06 |
Outstanding at end of period (in dollars per share) | $ / shares | $ 13.29 |
Equity Incentive Plan - Sched_3
Equity Incentive Plan - Schedule of Performance Share Activity (Details) - Performance Shares - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Number of Shares | ||
Outstanding at beginning of period (in shares) | 2,964,072 | |
Shares granted (in shares) | 0 | |
Vested (in shares) | 0 | |
Forfeited (in shares) | (2,035,744) | |
Outstanding at end of period (in shares) | 928,328 | 2,964,072 |
Weighted-Average Grant Date Fair Value | ||
Outstanding at beginning of period (in dollars per share) | $ 27.43 | |
Granted (in dollars per share) | 0 | $ 27.43 |
Vested (in dollars per share) | 0 | |
Forfeited (in dollars per share) | 27.43 | |
Outstanding at end of period (in dollars per share) | $ 27.43 | $ 27.43 |
Equity Incentive Plan - Sched_4
Equity Incentive Plan - Schedule of Valuation Assumptions (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected volatility minimum | 84.48% | 75.30% | 84.48% | 75.30% |
Expected volatility maximum | 86.76% | 91.92% | 87.76% | 92.20% |
Expected dividend yield | 0% | 0% | 0% | 0% |
Risk-free interest rate minimum | 4.35% | 3.30% | 3.98% | 3.30% |
Risk-free interest rate maximum | 4.52% | 3.47% | 4.52% | 4.12% |
Minimum | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 4 months 28 days | 5 years 9 months 7 days | 5 years 4 months 28 days | 5 years 9 months 7 days |
Maximum | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 21 days | 6 years 29 days | 6 years 29 days | 6 years 29 days |
Equity Incentive Plan - Sched_5
Equity Incentive Plan - Schedule of Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 10,174 | $ 8,501 | $ 30,337 | $ 15,640 |
Restricted stock units | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 8,824 | 5,539 | 13,239 | 5,539 |
Performance-based restricted stock units | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | (11,698) | 0 | (1,798) | 0 |
Stock options | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 13,113 | 2,946 | 18,864 | 10,008 |
ESPP | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 82 | 16 | 179 | 16 |
Restricted stock awards | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 0 | 0 | 0 | 77 |
Performance-based options | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | (147) | 0 | (147) | 0 |
Research and development expenses | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 4,851 | 1,325 | 9,442 | 5,090 |
General and administrative expenses | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 5,323 | $ 7,176 | $ 20,895 | $ 10,550 |
Net Loss Per Share Attributab_3
Net Loss Per Share Attributable to Common Stockholders - Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Numerator: | ||||||
Net loss | $ (85,672) | $ (34,973) | $ (26,039) | $ (176,450) | $ (120,645) | $ (202,489) |
Denominator: | ||||||
Weighted average common shares outstanding (in shares) | 99,215,994 | 65,652,851 | 98,653,080 | 43,461,494 | ||
Less: Weighted-average common shares subject to repurchase (in shares) | (54,284) | (442,734) | (115,395) | (486,854) | ||
Weighted-average common shares outstanding, basic (in shares) | 99,161,710 | 65,210,117 | 98,537,685 | 42,974,640 | ||
Weighted-average common shares outstanding, diluted (in shares) | 99,161,710 | 65,210,117 | 98,537,685 | 42,974,640 | ||
Net loss per share attributable to common stockholder, basic (in shares) | $ (0.86) | $ (0.40) | $ (1.22) | $ (4.71) | ||
Net loss per share attributable to common stockholder, diluted (in shares) | $ (0.86) | $ (0.40) | $ (1.22) | $ (4.71) |
Net Loss Per Share Attributab_4
Net Loss Per Share Attributable to Common Stockholders - Schedule of Outstanding Shares of Potentially Dilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 16,883,812 | 10,152,817 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 14,726,755 | 8,051,662 |
Stock options | ValenzaBio Asset Acquisition | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 57,311 | 1,249,811 |
Unvested RSUs outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,763,751 | 466,797 |
Unvested PSUs expected to vest | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 208,874 | 0 |
Common stock subject to repurchase | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 0 | 384,547 |
ESPP | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 127,121 | 0 |
Other Income (Details)
Other Income (Details) - USD ($) | 1 Months Ended | 6 Months Ended | ||
Mar. 31, 2024 | Jan. 31, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | |
Other Income and Expenses [Abstract] | ||||
Other nonrecurring income | $ 30,000,000 | $ 30,000,000 | ||
Research and development expense, vendor service credit | $ 5,000,000 | 5,000,000 | ||
Income from sale of asset | $ 7,000,000 | 7,000,000 | $ 0 | |
Disposal group, including discontinued operation, consideration | $ 157,500,000 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event $ in Millions | Aug. 10, 2024 USD ($) people |
Subsequent Event [Line Items] | |
Number of positions eliminated | people | 40 |
Number of positions eliminated, percent | 33.33% |
Restructuring plan, expected cost | $ | $ 4.5 |