Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 30, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | MERUS N.V. | |
Trading Symbol | MRUS | |
Entity Central Index Key | 0001651311 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Interactive Data Current | Yes | |
Entity Common Stock, Shares Outstanding | 57,732,814 | |
Entity File Number | 001-37773 | |
Entity Incorporation, State or Country Code | P7 | |
Entity Tax Identification Number | 00-0000000 | |
Entity Address, Address Line One | Uppsalalaan 17 | |
Entity Address, City or Town | Utrecht | |
Entity Address, Postal Zip Code | 3584 CT | |
Entity Address, Country | NL | |
City Area Code | +31 85 | |
Local Phone Number | 016 2500 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Common shares, nominal value €0.09 per share | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 241,868 | $ 147,749 |
Marketable securities | 146,702 | 142,480 |
Accounts receivable | 3,434 | 4,051 |
Prepaid expenses and other current assets | 12,828 | 12,163 |
Total current assets | 404,832 | 306,443 |
Marketable securities | 57,259 | 36,457 |
Property and equipment, net | 12,176 | 12,222 |
Operating lease right-of-use assets | 11,323 | 12,618 |
Intangible assets, net | 1,771 | 1,950 |
Deferred tax assets | 702 | 2,041 |
Other assets | 4,123 | 4,811 |
Total assets | 492,186 | 376,542 |
Current liabilities: | ||
Accounts payable | 3,843 | 9,834 |
Accrued expenses and other liabilities | 35,712 | 35,590 |
Income taxes payable | 137 | 2,400 |
Current portion of lease obligation | 1,607 | 1,684 |
Current portion of deferred revenue | 23,019 | 29,418 |
Total current liabilities | 64,318 | 78,926 |
Lease obligation | 10,506 | 11,790 |
Deferred revenue, net of current portion | 23,974 | 38,771 |
Total liabilities | 98,798 | 129,487 |
Commitments and contingencies - Note 6 | ||
Stockholders’ equity: | ||
Common shares, Euro 0.09 par value; 67,500,000 shares authorized at September 30, 2023 and December 31, 2022; 57,729,180 and 46,310,589 shares issued and outstanding as at September 30, 2023 and December 31, 2022, respectively | 5,874 | 4,751 |
Additional paid-in capital | 1,117,855 | 870,874 |
Accumulated other comprehensive income | (37,433) | (30,448) |
Accumulated deficit | (692,908) | (598,122) |
Total stockholders’ equity | 393,388 | 247,055 |
Total liabilities and stockholders’ equity | $ 492,186 | $ 376,542 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (Parenthetical) - € / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common shares, par value | € 0.09 | € 0.09 |
Common shares, authorized | 67,500,000 | 67,500,000 |
Common shares, issued | 57,729,180 | 46,310,589 |
Common shares, outstanding | 57,729,180 | 46,310,589 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Total revenue | $ 11,033 | $ 6,581 | $ 35,008 | $ 30,920 |
Operating expenses: | ||||
Research and development | 36,810 | 42,307 | 99,973 | 100,378 |
General and administrative | 12,591 | 12,469 | 44,040 | 36,917 |
Total operating expenses | 49,401 | 54,776 | 144,013 | 137,295 |
Operating loss | (38,368) | (48,195) | (109,005) | (106,375) |
Other income, net: | ||||
Interest income, net | 4,522 | 866 | 9,312 | 1,288 |
Foreign exchange gains (loss) | 11,952 | 23,041 | 7,062 | 55,378 |
Other gains, net | 0 | 0 | 0 | 1,059 |
Total other income (loss), net | 16,474 | 23,907 | 16,374 | 57,725 |
Net loss before income taxes | (21,894) | (24,288) | (92,631) | (48,650) |
Income tax expense | 1,118 | 327 | 2,155 | 572 |
Net loss | (23,012) | (24,615) | (94,786) | (49,222) |
Other comprehensive loss: | ||||
Currency translation adjustment | (10,722) | (19,475) | (6,985) | (45,444) |
Comprehensive loss | $ (33,734) | $ (44,090) | $ (101,771) | $ (94,666) |
Net loss per share attributable to common stockholders: | ||||
Basic | $ (0.43) | $ (0.53) | $ (1.91) | $ (1.11) |
Diluted | $ (0.43) | $ (0.53) | $ (1.91) | $ (1.11) |
Weighted-average common shares outstanding: | ||||
Basic | 53,869,762 | 46,056,719 | 49,532,722 | 44,451,997 |
Diluted | 53,869,762 | 46,056,719 | 49,532,722 | 44,451,997 |
Collaboration Revenue [Member] | ||||
Total revenue from contracts with customers | $ 11,033 | $ 6,581 | $ 35,008 | $ 30,920 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (94,786) | $ (49,222) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization of property and equipment | 1,752 | 778 |
Amortization of intangible assets | 170 | 195 |
Foreign exchange gain | (3,548) | (68,654) |
Stock-based compensation expense | 19,518 | 18,521 |
Amortization (accretion) of discount on investments | (3,899) | 243 |
Deferred tax expense (benefit) | 1,340 | (19) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 602 | 3,031 |
Operating lease right-of-use assets and lease obligations | (62) | 846 |
Prepaid expenses and other current assets | (14) | (8,987) |
Accounts payable | (4,482) | (9,067) |
Accrued expenses and other liabilities | (1,273) | 12,514 |
Deferred revenue | (21,177) | (19,566) |
Net cash used in operating activities | (105,859) | (119,387) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of marketable securities | (204,087) | (170,692) |
Proceeds from maturities of marketable securities | 183,192 | 178,169 |
Purchases of property and equipment | (4,008) | (5,531) |
Net cash provided by (used in) investing activities | (24,903) | 1,946 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, net | 225,945 | 57,972 |
Payments of offering costs | (443) | (231) |
Proceeds from stock options exercised | 3,084 | 1,213 |
Net cash provided by financing activities | 228,586 | 58,954 |
Foreign exchange impact on cash, cash equivalents and restricted cash | (3,648) | 8,866 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 94,176 | (49,621) |
Cash, cash equivalents, and restricted cash, beginning of period | 148,439 | 241,749 |
Cash, cash equivalents, and restricted cash, end of period | 242,615 | 192,128 |
SUPPLEMENTAL DISCLOSURES: | ||
Lease liabilities arising from obtaining right-of-use assets | 0 | 11,493 |
Income taxes paid | 3,103 | 0 |
Non-cash purchases of property, equipment and intangibles | 0 | 2 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH | ||
Cash and cash equivalents | 241,868 | 190,980 |
Restricted cash included in non-current other assets | 747 | 1,148 |
Cash, cash equivalents, and restricted cash, end of period | $ 242,615 | $ 192,128 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($) $ in Thousands | Total | Public Offerings, Net of Underwriting Discounts and Commissions and Offering Cost [Member] | Common Stock [Member] | Common Stock [Member] Public Offerings, Net of Underwriting Discounts and Commissions and Offering Cost [Member] | Additional Paid-In Capital [Member] | Additional Paid-In Capital [Member] Public Offerings, Net of Underwriting Discounts and Commissions and Offering Cost [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] |
Beginning balance at Dec. 31, 2021 | $ 316,201 | $ 4,481 | $ 787,869 | $ (466,928) | $ (9,221) | |||
Beginning balance, shares at Dec. 31, 2021 | 43,467,052 | |||||||
Exercise of stock options and vesting of restricted stock units | 879 | $ 8 | 871 | |||||
Exercise of stock options and vesting of restricted stock units, shares | 82,273 | |||||||
Stock-based compensation | 5,334 | 5,334 | ||||||
Currency translation adjustment | (6,048) | (6,048) | ||||||
Net loss | (18,893) | (18,893) | ||||||
Ending balance at Mar. 31, 2022 | 297,473 | $ 4,489 | 794,074 | (485,821) | (15,269) | |||
Ending balance, shares at Mar. 31, 2022 | 43,549,325 | |||||||
Beginning balance at Dec. 31, 2021 | 316,201 | $ 4,481 | 787,869 | (466,928) | (9,221) | |||
Beginning balance, shares at Dec. 31, 2021 | 43,467,052 | |||||||
Currency translation adjustment | (45,444) | |||||||
Net loss | (49,222) | |||||||
Ending balance at Sep. 30, 2022 | 298,777 | $ 4,750 | 864,842 | (516,150) | (54,665) | |||
Ending balance, shares at Sep. 30, 2022 | 46,302,877 | |||||||
Beginning balance at Mar. 31, 2022 | 297,473 | $ 4,489 | 794,074 | (485,821) | (15,269) | |||
Beginning balance, shares at Mar. 31, 2022 | 43,549,325 | |||||||
Issuance of common stock | $ 47,925 | $ 220 | $ 47,705 | |||||
Issuance of common stock, shares | 2,298,906 | |||||||
Exercise of stock options and vesting of restricted stock units | 184 | $ 2 | 182 | |||||
Exercise of stock options and vesting of restricted stock units, shares | 18,589 | |||||||
Stock-based compensation | 6,662 | 6,662 | ||||||
Currency translation adjustment | (19,921) | (19,921) | ||||||
Net loss | (5,714) | (5,714) | ||||||
Ending balance at Jun. 30, 2022 | 326,609 | $ 4,711 | 848,623 | (491,535) | (35,190) | |||
Ending balance, shares at Jun. 30, 2022 | 45,866,820 | |||||||
Issuance of common stock | 9,583 | $ 38 | 9,545 | |||||
Issuance of common stock, shares | 421,940 | |||||||
Exercise of stock options and vesting of restricted stock units | 150 | $ 1 | 149 | |||||
Exercise of stock options and vesting of restricted stock units, shares | 14,117 | |||||||
Stock-based compensation | 6,525 | 6,525 | ||||||
Currency translation adjustment | (19,475) | (19,475) | ||||||
Net loss | (24,615) | (24,615) | ||||||
Ending balance at Sep. 30, 2022 | 298,777 | $ 4,750 | 864,842 | (516,150) | (54,665) | |||
Ending balance, shares at Sep. 30, 2022 | 46,302,877 | |||||||
Beginning balance at Dec. 31, 2022 | 247,055 | $ 4,751 | 870,874 | (598,122) | (30,448) | |||
Beginning balance, shares at Dec. 31, 2022 | 46,310,589 | |||||||
Exercise of stock options and vesting of restricted stock units | 217 | $ 3 | 214 | |||||
Exercise of stock options and vesting of restricted stock units, shares | 30,592 | |||||||
Stock-based compensation | 5,750 | 5,750 | ||||||
Currency translation adjustment | 4,242 | 4,242 | ||||||
Net loss | (39,741) | (39,741) | ||||||
Ending balance at Mar. 31, 2023 | 217,523 | $ 4,754 | 876,838 | (637,863) | (26,206) | |||
Ending balance, shares at Mar. 31, 2023 | 46,341,181 | |||||||
Beginning balance at Dec. 31, 2022 | 247,055 | $ 4,751 | 870,874 | (598,122) | (30,448) | |||
Beginning balance, shares at Dec. 31, 2022 | 46,310,589 | |||||||
Currency translation adjustment | (6,985) | |||||||
Net loss | (94,786) | |||||||
Ending balance at Sep. 30, 2023 | 393,388 | $ 5,874 | 1,117,855 | (692,908) | (37,433) | |||
Ending balance, shares at Sep. 30, 2023 | 57,729,180 | |||||||
Beginning balance at Mar. 31, 2023 | 217,523 | $ 4,754 | 876,838 | (637,863) | (26,206) | |||
Beginning balance, shares at Mar. 31, 2023 | 46,341,181 | |||||||
Issuance of common stock | 63,719 | $ 322 | 63,397 | |||||
Issuance of common stock, shares | 3,272,280 | |||||||
Exercise of stock options and vesting of restricted stock units | 2,248 | $ 23 | 2,225 | |||||
Exercise of stock options and vesting of restricted stock units, shares | 240,198 | |||||||
Stock-based compensation | 6,453 | 6,453 | ||||||
Currency translation adjustment | (505) | (505) | ||||||
Net loss | (32,033) | (32,033) | ||||||
Ending balance at Jun. 30, 2023 | 257,405 | $ 5,099 | 948,913 | (669,896) | (26,711) | |||
Ending balance, shares at Jun. 30, 2023 | 49,853,659 | |||||||
Issuance of common stock | $ 161,783 | $ 771 | $ 161,012 | |||||
Issuance of common stock, shares | 7,840,909 | |||||||
Exercise of stock options and vesting of restricted stock units | 619 | $ 4 | 615 | |||||
Exercise of stock options and vesting of restricted stock units, shares | 34,612 | |||||||
Stock-based compensation | 7,315 | 7,315 | ||||||
Currency translation adjustment | (10,722) | (10,722) | ||||||
Net loss | (23,012) | (23,012) | ||||||
Ending balance at Sep. 30, 2023 | $ 393,388 | $ 5,874 | $ 1,117,855 | $ (692,908) | $ (37,433) | |||
Ending balance, shares at Sep. 30, 2023 | 57,729,180 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||||||
Net Income (Loss) | $ (23,012) | $ (32,033) | $ (39,741) | $ (24,615) | $ (5,714) | $ (18,893) | $ (94,786) | $ (49,222) |
Insider Trading Arrangements
Insider Trading Arrangements | 9 Months Ended |
Sep. 30, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Overview
Overview | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Overview | 1. Overview Merus N.V. is a clinical-stage oncology company developing innovative antibody therapeutics, headquartered in Utrecht, the Netherlands. Merus US, Inc. is a wholly-owned subsidiary of Merus N.V. located at 139 Main Street, Cambridge, Massachusetts, United States (collectively, the “Company”). Since inception, the Company has generated an accumulated deficit of $ 692.9 million as of September 30, 2023. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as its antibody candidates advance through discovery, pre-clinical development and clinical trials and as it seeks regulatory approval and pursues commercialization of any approved antibody candidate. As a result, the Company may need additional financing to support its continuing operations. Until the Company can generate significant revenue from product sales, if ever, the Company expects to finance its operations through public equity offerings, debt financings, or other sources, which may include collaborations, business development and licensing opportunities with third parties. Adequate additional financing may not be available to the Company on acceptable terms, or at all. The Company’s inability to raise capital as and when needed would have a negative impact on its financial condition and ability to pursue its business strategy. The Company will need to generate significant revenues to achieve profitability and may never do so. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The principal accounting policies applied in the preparation of these unaudited condensed consolidated financial statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 28, 2023 (the “Annual Report on Form 10-K”). There have been no material changes in the Company’s significant accounting policies during the nine months ended September 30, 2023. Basis of Presentation The Company prepared its unaudited consolidated condensed financial statements in compliance with generally accepted accounting principles in the U.S. ("U.S. GAAP"). Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification ("ASC") and Accounting Standards Update ("ASU") of the Financial Accounting Standards Board ("FASB"). The unaudited condensed consolidated financial statements include the accounts of Merus N.V. and its wholly owned, controlled subsidiary, Merus US, Inc. All intercompany transactions and balances of subsidiaries have been eliminated in consolidation. In the opinion of management, these financial statements reflect all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the results for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the unaudited condensed consolidated financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The three months ended September 30, 2023 and 2022 are referred to as the third quarter of 2023 and 2022, respectively. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period. The unaudited condensed consolidated financial statements presented herein do not contain the required disclosures under U.S. GAAP for annual financial statements. Therefore, these unaudited condensed consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended December 31, 2022, included in the Annual Report on Form 10-K. Going Concern At each reporting period, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company is required to make certain additional disclosures if it concludes substantial doubt exists and it is not alleviated by the Company’s plans or when its plans alleviate substantial doubt about the Company’s ability to continue as a going concern. The Company’s evaluation entails analyzing prospective operating budgets and forecasts for expectations of the Company’s cash needs, and comparing those needs to the current cash, cash equivalent and marketable security balances. After considering the Company’s current research and development plans and the timing expectations related to the progress of its clinical-stage programs and its plans to pursue commercialization of any antibody candidate, if approved, and after considering its existing cash, cash equivalents and marketable securities as of September 30, 2023 , the Company did not identify conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these financial statements were issued. Additional details of the Company’s cash runway are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. New Accounting Pronouncements The Company considers the applicability and impact of any recent Accounting Standards Update ("ASU") issued by the Financial Accounting Standards Board ("FASB"). Based on the assessment, the ASUs were determined to be either not applicable or are expected to have minimal impact on the Company's condensed consolidated financial statements. |
Investments in Debt Securities
Investments in Debt Securities | 9 Months Ended |
Sep. 30, 2023 | |
Debt Securities [Abstract] | |
Investments in Debt Securities | 3. Investments in Debt Securities The following tables summarize the Company’s investments in debt securities and their presentation in the condensed consolidated balance sheet: September 30, December 31, (in thousands) Money market funds $ 20,499 $ 18,404 Corporate paper and notes 134,511 126,102 U.S. government agency securities 52,669 34,364 U.S. treasuries 21,482 18,471 Total $ 229,161 $ 197,341 Fair value of debt securities $ 228,314 $ 196,345 September 30, December 31, (in thousands) Cash equivalents $ 25,200 $ 18,404 Current marketable securities 146,702 142,480 Non-current marketable securities 57,259 36,457 Total $ 229,161 $ 197,341 The Company does not intend to sell and it is unlikely that the Company will be required to sell the above investments before recovery of their amortized cost bases, which may be at maturity. The Company determined that there was no material change in the credit risk of any of its investments. The fair value of money market funds is determined based on publicly available market price for these funds (Level 1). The fair value of other debt securities is determined based on the publicly available inputs which includes a market price for the same or similar instruments adjusted for estimates in interest yield (Level 2). |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Supplemental Balance Sheet Information | 4. Supplemental Balance Sheet Information Prepaid expenses and other current assets consisted of the following: September 30, December 31, (In thousands) Prepaid research and development expenses $ 4,296 $ 6,372 Prepaid general and administrative expenses 5,960 2,940 Interest receivable 1,173 647 Other 1,399 2,204 Total $ 12,828 $ 12,163 Accrued expenses and other liabilities consisted of the following: September 30, December 31, (In thousands) Accrued research and development expenses $ 27,760 $ 26,159 Accrued personnel costs 5,145 5,778 Accrued general and administrative expenses 2,734 3,615 Other 73 38 Total $ 35,712 $ 35,590 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 5. Income Taxes The Company files income tax returns in the U.S. federal and Massachusetts jurisdictions as well as in the Netherlands. The components of the income tax expense (benefit) from continuing operations are as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 (In thousands) (In thousands) U.S. federal $ ( 871 ) $ 370 $ 580 $ 420 U.S. state ( 366 ) 152 235 171 Total current income tax benefit $ ( 1,237 ) $ 522 $ 815 $ 591 U.S. federal $ 1,665 $ ( 137 ) $ 947 $ ( 13 ) U.S. state 690 ( 58 ) 393 ( 6 ) Total deferred income tax expense (benefit) $ 2,355 $ ( 195 ) $ 1,340 $ ( 19 ) Total income tax expense (benefit) $ 1,118 $ 327 $ 2,155 $ 572 After consideration of all positive and negative evidence, we believe that it is more-likely-than-not that the Netherlands deferred tax assets, that are not supported by reversing temporary differences, will not be realized. As a result, we established a full valuation allowance against deferred tax assets of the Netherlands. Under Dutch tax law, net operating loss carryforwards may be used to offset future taxable income in full up to € 1.0 million and 50 % of taxable income that exceeds € 1.0 million. Effective as of January 1, 2022, these losses can be carried forward indefinitely. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Litigation From time to time, the Company may be involved in various claims and legal proceedings relating to or arising out of the Company’s operations. The Company is not currently a party to any material legal proceedings. On August 19, 2022, Kymab Limited, a subsidiary of Sanofi, filed a notice of opposition against the Company's EP3456190 patent (the "'190 patent"), entitled "Antibody Producing Transgenic Murine Animal," in the European Opposition Division of the European Patent Office (the "EPO"). The notice asserted, as applicable, the '190 patent is contrary to the provision of Article 123(2) EPC, Article 75(1) EPC and Article 100(c) EPC, and alleges the '190 patent lacks novelty and/or is obvious contrary to the provisions of Articles 54 and/or 56 EPC, and Article 100(a) EPC, and that the specification of the '190 patent does not provide sufficient disclosure of the subject matter of the inventions contravening Article 83 EPC and Article 100(b). On January 17, 2023, the Company timely filed a response before the European Opposition Division of the EPO contesting each of these assertions, with further oral proceedings scheduled to follow on January 18, 2024. On June 2, 2023, the European Opposition Division issued a non-binding preliminary decision finding the claims as granted in the '190 patent mostly fulfills the requirements of Art. 123(2) and Art. 76(1), that the opponent has failed to provide serious doubts substantiated by verifiable facts in support of an allegation that the '190 patent claims lack sufficiency of disclosure under Art. 100(b) and Art. 83, and that further issues of claim construction, novelty and inventive step are to be discussed during the oral proceedings. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | 7. Leases The Company has noncancelable operating leases for offices and lab spaces expiring at various dates through 2032. On December 7, 2022, the Company signed a second lease amendment terminating the lease for the former corporate headquarters as of January 1, 2023. The Company continued to make payments through mid-February 2023. The Company accounted for the second amendment as a lease modification and reduced the lease liability and right-of-use asset by approximately $ 0.1 million to equal to the remaining lease payments. As of March 31, 2023, the lease liability and right-of-use asset for the former corporate headquarters was $ 0 . In July 2019, the Company entered into a lease agreement with Kadans Science Partner XIII B.V. for the Accelerator headquarters, which commenced in April 2022. During the three months ended June 30, 2023, in accordance with the terms of the lease agreement, the annual rent for the Accelerator lease increased due to increases in the consumer price index (CPI). The portion of the rent payments related to the CPI index are included within variable lease costs. There have been no changes in the Company’s lease arrangements for the three months ended September 30, 2023. The components of lease expense for the three and nine months ended September 30, 2023 and 2022 are as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 (In thousands) (In thousands) Lease cost Operating lease cost $ 517 $ 701 $ 1,743 $ 1,816 Variable lease cost 53 83 137 282 Total lease cost included in operating expenses $ 570 $ 784 $ 1,880 $ 2,098 Other information Cash paid for amounts included in the measurement of lease liabilities included in operating cash flows $ 544 $ 733 $ 1,828 $ 1,881 |
Collaborations
Collaborations | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborations | 8. Collaborations Lilly On January 18, 2021, Eli Lilly and Company (“Lilly”) agreed to pay the Company a $ 40.0 million, non-refundable upfront payment, and purchased 706,834 common shares at a stated price per share of $ 28.295 , for an aggregate purchase price of $ 20.0 million. The Company and Lilly agreed to collaborate with respect to the discovery and research of bispecific antibodies utilizing the Company’s proprietary Biclonics® bispecific technology platform. The collaboration encompasses up to three (3) independent programs directed to the generation of T-cell re-directing bispecific antibodies that bind CD3 and a tumor associated antigen target selected by Lilly to be the subject of each program. The objective of each program is to develop a lead compound that Lilly would be able to continue to develop through clinical trials. Lilly agreed to fund the research activities the Company conducts for each program under an agreed research plan and budget. Lilly receives an exclusive, worldwide, royalty-bearing, sublicensable license, under certain patent rights and know-how to exploit certain compounds and products directed to designated targets in combination with targeting CD3, or directed to such designated target(s) alone as a monospecific antibody or monospecific antibody drug conjugate, subject to rights granted by Merus to third parties under one or more existing third party agreements. Merus retains all rights not granted to Lilly. Lilly has certain rights to replace selected targets, including the right to substitute a target selection after initial selection for a period of time. The Company may be entitled to further milestones and royalties in the future dependent on development and commercialization of any resulting product. The initial term of the arrangement includes a three-year research term for the Company to perform research and development activities, subject to two extension terms of six months at Lilly’s discretion. While the arrangement may be terminated in its entirety or on a program-by-program basis at will by Lilly, there are no direct costs or penalties to Lilly to terminate the arrangement prior to the end of the initial term. At inception of the arrangement, the Company identified a single performance obligation comprised of a combined delivery of a license and related activities, including research activities associated with a product candidate against the first target and the activities of the joint steering committee. The Company also identified two other combined performance obligations relating to options exercisable by Lilly to select a second and third target to advance a second and third product candidate against the selected targets through discovery and research. The transaction price at inception was comprised of fixed consideration of $ 43.5 million that was derived from the $ 40.0 million upfront payment and $ 20.0 million share purchase proceeds, net of the fair value of shares of the shares delivered to Lilly of $ 16.5 million, and variable consideration associated with the funding of research services for the product candidate against the first target at inception. All other consideration under the arrangement was determined to be variable consideration and fully constrained at inception. The fixed consideration was allocated equally amongst the three performance obligations and the variable consideration associated with each target was allocated to the performance obligation of each respective target. The equal allocation of the fixed consideration was based on the estimated standalone selling price of each performance obligation as each was materially the same. On February 12, 2021, the Company and Lilly completed the initial exchange of fixed consideration and transfer of common shares. The Company initially deferred $ 43.5 million allocated to the performance obligations to be recognized as revenue over time using a cost-to-cost measure of progress toward the development of a lead compound for each respective target, anticipated to be recognized as revenue within the initial research term, along with research funding. Development milestones, commercialization milestones and royalties are variable consideration, fully constrained, to be included in the transaction price for each performance obligation and recognized in future periods in accordance with the Company’s revenue recognition policy. The revenue recognized relating to each combined performance obligation is presented in the notes according to the source of consideration received (upfront, reimbursement revenue, milestone), reflective of their differing timing of receipt. During the year ended December 31, 2022 , Lilly substituted one of the target programs. The program timeline is expected to extend beyond the original research term. Under the current research plan, for the program to be completed in collaboration with Merus, Lilly would be required to extend the research term to 2025, subject to its discretion. Lilly exercised the first six month extension in October 2023. The program timeline is expected to extend beyond this first extension, and such an extension into 2025 would result in a fee of $ 0.5 million. As a result of the program substitution in 2022, the Company increased the transaction price for one of the programs by $ 0.5 million during the year ended December 31, 2022. As of September 30, 2023, research activities were on-going, and no milestones have been achieved. Incyte On January 23, 2017, the Company completed the sale of shares and exchange of a license with Incyte Corporation (“Incyte”). The Company initially deferred $ 152.6 million of the transaction price allocated to the license and related performance obligation as deferred revenue, to be recognized as revenue over time as the primary benefit of the license to Incyte is access to the Company’s intellectual property covering its Biclonics® technology platform for the generation of potential product candidates. Development milestones, commercialization milestones and royalties are variable consideration, fully constrained, to be recognized in future periods in accordance with the Company’s revenue recognition policy. Cost reimbursements for research services are recognized as they are performed over time as these are considered a separate performance obligation. In January 2022, the Company announced that Incyte elected to opt-out of its ex-U.S. development of MCLA-145, from the parties joint collaboration agreement executed in 2017. At inception of the collaboration, for the designated product candidate (MCLA-145), the Company retained the exclusive right to develop and commercialize products and product candidates in the United States, while Incyte obtained the exclusive right to develop and commercialize products and product candidates arising from such program outside the United States. For MCLA-145, the parties conducted and shared equally the costs of mutually agreed global development activities. Incyte’s opt-out of ex-U.S. rights to MCLA-145 provides the Company the exclusive right to develop and commercialize potential MCLA-145 products globally. Under the collaboration, Incyte continued to support the program for a limited time while ex-U.S. activities transitioned to the Company. Incyte will retain a right to a residual royalty of up to 4 % on sales of future commercialization of MCLA-145, if approved. During the three months ended September 30, 2023 , the Company recognized a $ 2.5 million milestone from Incyte related to the initiation of a Phase 1 study with respect to a novel target pair program and a $ 1.0 million milestone from Incyte related to candidate nomination. During the nine months ended September 30, 2023 , the Company has recognized $ 6.0 million in milestones from Incyte. Ono In April 2014, the Company granted Ono Pharmaceutical Co., Ltd. (“Ono”) an exclusive, worldwide, royalty-bearing license, with the right to sublicense, research, test, make, use and market a limited number of bispecific antibody candidates based on the Company’s Biclonics® technology platform against two undisclosed targets directed to a particular undisclosed target combination. On March 14, 2018, the Company granted Ono an exclusive, worldwide, royalty-bearing license, with the right to sublicense, research, test, make, use and market a limited number of bispecific antibody candidates based on the Company’s Biclonics® technology platform against two undisclosed targets directed to a particular undisclosed target combination. Ono agreed to pay the Company an upfront, non-refundable payment of € 0.7 million. In addition, the Company was entitled to € 0.3 million intended to compensate the Company for research services already completed upon entering into the agreement, and € 0.2 million to be paid to the Company over time for full-time equivalent funding. The Company is entitled to research and development milestones in addition to potential royalties on future sales of any bispecific antibody candidate that may be approved. The Company identified performance obligations for: (1) provision of a license for the target combination, and (2) research and development services. The Company concluded that Ono would be able to develop and benefit from the license, independent of the research and development services. Certain of the research and development services are capable of being performed by third parties with an appropriate sub-license, and are recognized over time as these services are delivered. Milestone payments are fully constrained as variable consideration to be recognized in future periods in accordance with the Company’s revenue recognition policy. Amounts related to the provision of the licenses were amortized over the intended period of use. There were no development or commercialization milestones achieved during the three months or nine months ended September 30, 2023. Simcere In January 2018, the Company granted Simcere Pharmaceuticals Group (“Simcere”) an exclusive license to develop and commercialize up to three bispecific antibodies in China to be produced by Merus utilizing the Company’s Biclonics® technology platform (the “Simcere Agreement”). The Company received an upfront, non-refundable payment of $ 2.75 million, relating to three separate research programs. At inception of the arrangement, the Company identified three performance obligations comprised of the combined delivery of a license and performance of research and development activities with respect to each program. The Company performed research and development activities to achieve candidate nomination. The Company concluded that these activities were not distinct from the underlying license for each program as Simcere would not be able to benefit from the license apart from research and development activities at this phase of development. The transaction price under the arrangement comprised fixed consideration of $ 2.75 million. The transaction price was allocated to each separate performance obligation on a relative standalone fair value basis. The Company deferred the portion of the upfront payment allocated to the three performance obligations as deferred revenue, to be recognized over time. Compensation for research and development services prior to candidate nomination are allocated to each program performance obligation and also recognized over time. Development milestone payments allocated to each of the program performance obligations are constrained as variable consideration to be recognized in future periods in accordance with the Company’s revenue recognition policy. The Company has achieved three milestones under this agreement and has received an aggregate of $ 1.8 million in milestone payments. In January 2022, the Company and Simcere terminated the Simcere Agreement, effective March 30, 2022. Contract Assets and Liabilities The following tables provide amounts by year indicated and by line item included in the Company's accompanying condensed consolidated financial statements attributable to transactions arising from its collaboration arrangements. The dollar amounts in the tables below are in thousands. Incyte Lilly Other Total CONTRACT ASSETS Accounts receivable Balance at January 1, 2023 $ — $ — $ 1,068 $ 1,068 Billings 10,779 3,497 68 14,344 Cash receipts ( 9,779 ) ( 3,497 ) ( 1,142 ) ( 14,418 ) Adjustments — — — — Foreign exchange — — 6 6 Balance at September 30, 2023 $ 1,000 $ — $ — $ 1,000 Unbilled receivables Balance at January 1, 2023 $ 1,987 $ 808 $ 189 $ 2,984 Accrued receivables 10,152 3,541 — 13,693 Billings ( 10,779 ) ( 3,497 ) — ( 14,276 ) Adjustments 44 ( 7 ) — 37 Foreign exchange — — ( 4 ) ( 4 ) Balance at September 30, 2023 $ 1,404 $ 845 $ 185 $ 2,434 CONTRACT LIABILITIES Deferred revenue Balance at January 1, 2023 $ 52,059 $ 16,130 $ — $ 68,189 Additions to contract consideration — — — — Revenue recognized in the period ( 12,912 ) ( 8,270 ) — ( 21,182 ) Foreign exchange ( 68 ) 54 — ( 14 ) Balance at September 30, 2023 39,079 7,914 — 46,993 Less: current portion ( 16,882 ) ( 6,137 ) — ( 23,019 ) Non-current balance at September 30, 2023 $ 22,197 $ 1,777 $ — $ 23,974 The balance of unbilled receivables predominantly represents reimbursement revenue under the Company’s collaboration arrangements earned in the period to be billed and collected in the next period, generally quarterly. Contract Revenues and Expenses Three Months Ended September 30, 2023 (In thousands) Third Party Incyte Lilly Other Total Upfront payments $ 4,371 $ 789 $ — $ 5,160 Reimbursement revenue 1,547 847 — 2,394 Milestones 3,479 — — 3,479 Other — — — — Total collaboration revenue $ 9,397 $ 1,636 $ — $ 11,033 Operating expenses: Research and development expense $ — $ — $ — $ — General and administrative expense — — — — Total operating expenses from collaborations $ — $ — $ — $ — Revenue recognized that was included in deferred revenue at $ 4,371 $ 789 $ — $ 5,160 Three Months Ended September 30, 2022 (In thousands) Third Party Incyte Lilly Other Total Upfront payments $ 4,045 $ ( 551 ) $ — $ 3,494 Reimbursement revenue 2,300 787 — 3,087 Milestones — — — — Other — — — — Total collaboration revenue $ 6,345 $ 236 $ — $ 6,581 Operating expenses: Research and development expense $ 162 $ — $ — $ 162 General and administrative expense — — — — Total operating expenses from collaborations $ 162 $ — $ — $ 162 Revenue recognized that was included in deferred revenue at $ 4,045 $ ( 551 ) $ — $ 3,494 Nine Months Ended September 30, 2023 (In thousands) Third Party Incyte Lilly Other Total Upfront payments $ 12,912 $ 8,270 $ — $ 21,182 Reimbursement revenue 4,248 3,543 — 7,791 Milestones 5,980 — — 5,980 Other — — 55 55 Total collaboration revenue $ 23,140 $ 11,813 $ 55 $ 35,008 Operating expenses: Research and development expense $ 24 $ — $ — $ 24 General and administrative expense — — — — Total operating expenses from collaborations $ 24 $ — $ — $ 24 Revenue recognized that was included in deferred revenue at $ 12,912 $ 8,270 $ — $ 21,182 Nine Months Ended September 30, 2022 (In thousands) Third Party Incyte Lilly Other Total Upfront payments $ 12,677 $ 7,634 $ 222 $ 20,533 Reimbursement revenue 6,514 2,823 — 9,337 Milestones 1,000 — — 1,000 Other — — 50 50 Total collaboration revenue $ 20,191 $ 10,457 $ 272 $ 30,920 Operating expenses: Research and development expense $ 712 $ — $ — $ 712 General and administrative expense — — — — Total operating expenses from collaborations $ 712 $ — $ — $ 712 Revenue recognized that was included in deferred revenue at $ 12,677 $ 7,634 $ 222 $ 20,533 |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Common Stock | 9. Common Stock Share Issuances In May 2021, the Company entered into an Open Market Sale Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) to sell from time to time up to $ 125.0 million of the Company’s common stock through an “at the market” offering program under which Jefferies acts as the sales agent. Subject to the terms and conditions of the Sales Agreement, Jefferies could sell the common stock by any method deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”). Jefferies was entitled to compensation at a commission rate of up to 3.0 % of the gross proceeds of shares sold under the Sales Agreement. In connection with the sale of the common shares on our behalf, Jefferies was deemed to be an “underwriter” within the meaning of the Securities Act and the compensation of Jefferies was deemed to be underwriting commissions or discounts. The Company agreed to provide indemnification and contribution to Jefferies with respect to certain liabilities, including liabilities under the Securities Act or the Securities Exchange Act of 1934, as amended, or the Exchange Act. As of December 31, 2022 , the Company, pursuant to the Sales Agreement, had issued and sold an aggregate of 2,720,846 shares of its common stock resulting in gross proceeds of $ 59.5 million, before deducting sales agent fees of $ 1.7 million. During the three months ended June 30, 2023, the Company sold 3,272,280 shares of its common stock under the Sales Agreement for gross proceeds of approximately $ 65.5 million and net proceeds of approximately $ 63.8 million, after deducting sales agent fees. Having sold approximately $ 124.9 million of the $ 125.0 million available under the Sales Agreement, on May 22, 2023, the Company delivered written notice to Jefferies, effective as of such date, to terminate the Sales Agreement. The Company was not subject to any termination penalties related to the termination of the Sales Agreement. On August 9, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, BofA Securities, Inc., Guggenheim Securities, LLC and William Blair & Company, L.L.C., as representatives of the several underwriters named therein (collectively, the “Underwriters”), in connection with the issuance and sale by the Company in a public offering of 6,818,182 common shares of the Company, nominal value € 0.09 per share, at a public offering price of $ 22.00 per share, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3 and accompanying prospectus (Registration No. 333-255903), which became effective upon filing on May 7, 2021, and a prospectus supplement thereunder. Under the terms of the Underwriting Agreement, the Company also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 1,022,727 common shares at the public offering price, less underwriting discounts and commissions. On August 10, 2023, the Underwriters exercised this option in full. The offering closed on August 14, 2023, and the Company received net proceeds of $ 162.2 million, after deducting underwriting discounts and fees. |
Employee Benefits
Employee Benefits | 9 Months Ended |
Sep. 30, 2023 | |
Retirement Benefits [Abstract] | |
Employee Benefits | 10. Employee Benefits Stock-Based Compensation Stock-based compensation expense is classified in the condensed consolidated statements of operations and comprehensive loss as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 (In thousands) (In thousands) Research and development $ 2,959 $ 2,690 $ 8,859 $ 8,025 General and administrative 4,356 3,835 10,659 10,496 Total $ 7,315 $ 6,525 $ 19,518 $ 18,521 The weighted-average grant date fair value of options, estimated as of the grant date using the Black Scholes option pricing model was $ 11.67 per option for the 2,625,427 options granted during the nine months ended September 30, 2023 . The following assumptions were used to estimate the fair value of the options granted during the nine months ended September 30, 2023. Volatility 68.3 % Risk-free interest rate 3.6 % Expected holding period (in years) 6.2 Dividend yield - Executive Settlement In April 2020, Mark Throsby, Ph.D. resigned as the Executive Vice President and Chief Scientific Officer of the Company effective July 31, 2020. In connection with his departure, Mr. Throsby entered into a Settlement Agreement with the Company, pursuant to which Mr. Throsby received a severance payment equal to 8 months of his annual salary and amortized bonus aggregating approximately $ 0.3 million. Further, subject to Mr. Throsby’s continued compliance with the terms and conditions of the Settlement Agreement, Mr. Throsby’s unvested equity awards continued to vest until October 31, 2020 as if Mr. Throsby had continued in full time service with the Company through such date. The post-termination exercise period of Mr. Throsby's options was extended to March 31, 2021. The Company incrementally recognized $ 0.1 million in respect of the severance payment and a net reversal of $ 0.4 million of stock-based compensation expense in respect of share-based payments in research and development expense in the consolidated statement of operations in the prior year. In March 2021, the Company and Mr. Throsby amended the Settlement Agreement and a Consulting Agreement, extending the post-termination expiration period of his outstanding options to extend to October 31, 2021, three months following his performance of certain consulting services through July 31, 2021. As a result, additional compensation cost of $ 0.2 million was recognized for the quarter ended March 31, 2021. In July 2021, the Company and Mr. Throsby entered into the 2nd Amendment to the Consulting Agreement, extending Mr. Throsby’s consulting services period to February 28, 2022, extending the post-termination period of his outstanding options to May 2022. As the modification occurred in Mr. Throsby’s post-employment period, the options cease to be within the scope of ASC 718 and are recharacterized as an issuance of a standalone derivative instrument. The Company recognized a $ 0.4 million net gain associated with the derivative instrument included as other income in the statement of operations for the three months ended March 31, 2022. The Company did no t recognize any further gains or expenses during the three months ended September 30, 2023 and the Company does not expect to incur any further expenses as Mr. Throsby's option to exercise expired in May 2022. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Preparation | Basis of Presentation The Company prepared its unaudited consolidated condensed financial statements in compliance with generally accepted accounting principles in the U.S. ("U.S. GAAP"). Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification ("ASC") and Accounting Standards Update ("ASU") of the Financial Accounting Standards Board ("FASB"). The unaudited condensed consolidated financial statements include the accounts of Merus N.V. and its wholly owned, controlled subsidiary, Merus US, Inc. All intercompany transactions and balances of subsidiaries have been eliminated in consolidation. In the opinion of management, these financial statements reflect all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the results for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the unaudited condensed consolidated financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The three months ended September 30, 2023 and 2022 are referred to as the third quarter of 2023 and 2022, respectively. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period. The unaudited condensed consolidated financial statements presented herein do not contain the required disclosures under U.S. GAAP for annual financial statements. Therefore, these unaudited condensed consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended December 31, 2022, included in the Annual Report on Form 10-K. |
Going Concern | Going Concern At each reporting period, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company is required to make certain additional disclosures if it concludes substantial doubt exists and it is not alleviated by the Company’s plans or when its plans alleviate substantial doubt about the Company’s ability to continue as a going concern. The Company’s evaluation entails analyzing prospective operating budgets and forecasts for expectations of the Company’s cash needs, and comparing those needs to the current cash, cash equivalent and marketable security balances. After considering the Company’s current research and development plans and the timing expectations related to the progress of its clinical-stage programs and its plans to pursue commercialization of any antibody candidate, if approved, and after considering its existing cash, cash equivalents and marketable securities as of September 30, 2023 , the Company did not identify conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these financial statements were issued. Additional details of the Company’s cash runway are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. |
New Accounting Pronouncements | New Accounting Pronouncements The Company considers the applicability and impact of any recent Accounting Standards Update ("ASU") issued by the Financial Accounting Standards Board ("FASB"). Based on the assessment, the ASUs were determined to be either not applicable or are expected to have minimal impact on the Company's condensed consolidated financial statements. |
Investments in Debt Securities
Investments in Debt Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Securities [Abstract] | |
Summary of Investments in Debt Securities in Condensed Consolidated Balance Sheet | The following tables summarize the Company’s investments in debt securities and their presentation in the condensed consolidated balance sheet: September 30, December 31, (in thousands) Money market funds $ 20,499 $ 18,404 Corporate paper and notes 134,511 126,102 U.S. government agency securities 52,669 34,364 U.S. treasuries 21,482 18,471 Total $ 229,161 $ 197,341 Fair value of debt securities $ 228,314 $ 196,345 September 30, December 31, (in thousands) Cash equivalents $ 25,200 $ 18,404 Current marketable securities 146,702 142,480 Non-current marketable securities 57,259 36,457 Total $ 229,161 $ 197,341 |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following: September 30, December 31, (In thousands) Prepaid research and development expenses $ 4,296 $ 6,372 Prepaid general and administrative expenses 5,960 2,940 Interest receivable 1,173 647 Other 1,399 2,204 Total $ 12,828 $ 12,163 |
Summary of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following: September 30, December 31, (In thousands) Accrued research and development expenses $ 27,760 $ 26,159 Accrued personnel costs 5,145 5,778 Accrued general and administrative expenses 2,734 3,615 Other 73 38 Total $ 35,712 $ 35,590 |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Summary of Components of Expense for (Benefit) from Income Taxes | The components of the income tax expense (benefit) from continuing operations are as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 (In thousands) (In thousands) U.S. federal $ ( 871 ) $ 370 $ 580 $ 420 U.S. state ( 366 ) 152 235 171 Total current income tax benefit $ ( 1,237 ) $ 522 $ 815 $ 591 U.S. federal $ 1,665 $ ( 137 ) $ 947 $ ( 13 ) U.S. state 690 ( 58 ) 393 ( 6 ) Total deferred income tax expense (benefit) $ 2,355 $ ( 195 ) $ 1,340 $ ( 19 ) Total income tax expense (benefit) $ 1,118 $ 327 $ 2,155 $ 572 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Summary of Components of Lease Cost | The components of lease expense for the three and nine months ended September 30, 2023 and 2022 are as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 (In thousands) (In thousands) Lease cost Operating lease cost $ 517 $ 701 $ 1,743 $ 1,816 Variable lease cost 53 83 137 282 Total lease cost included in operating expenses $ 570 $ 784 $ 1,880 $ 2,098 Other information Cash paid for amounts included in the measurement of lease liabilities included in operating cash flows $ 544 $ 733 $ 1,828 $ 1,881 |
Collaborations (Tables)
Collaborations (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Company's Accompanying Condensed Consolidated Financial Statements Attributable to Transactions Arising From Collaboration Arrangements | The following tables provide amounts by year indicated and by line item included in the Company's accompanying condensed consolidated financial statements attributable to transactions arising from its collaboration arrangements. The dollar amounts in the tables below are in thousands. Incyte Lilly Other Total CONTRACT ASSETS Accounts receivable Balance at January 1, 2023 $ — $ — $ 1,068 $ 1,068 Billings 10,779 3,497 68 14,344 Cash receipts ( 9,779 ) ( 3,497 ) ( 1,142 ) ( 14,418 ) Adjustments — — — — Foreign exchange — — 6 6 Balance at September 30, 2023 $ 1,000 $ — $ — $ 1,000 Unbilled receivables Balance at January 1, 2023 $ 1,987 $ 808 $ 189 $ 2,984 Accrued receivables 10,152 3,541 — 13,693 Billings ( 10,779 ) ( 3,497 ) — ( 14,276 ) Adjustments 44 ( 7 ) — 37 Foreign exchange — — ( 4 ) ( 4 ) Balance at September 30, 2023 $ 1,404 $ 845 $ 185 $ 2,434 CONTRACT LIABILITIES Deferred revenue Balance at January 1, 2023 $ 52,059 $ 16,130 $ — $ 68,189 Additions to contract consideration — — — — Revenue recognized in the period ( 12,912 ) ( 8,270 ) — ( 21,182 ) Foreign exchange ( 68 ) 54 — ( 14 ) Balance at September 30, 2023 39,079 7,914 — 46,993 Less: current portion ( 16,882 ) ( 6,137 ) — ( 23,019 ) Non-current balance at September 30, 2023 $ 22,197 $ 1,777 $ — $ 23,974 |
Summary of Company's Collaboration Arrangements Earned in Period to Be Billed and Collected in Next Period | Contract Revenues and Expenses Three Months Ended September 30, 2023 (In thousands) Third Party Incyte Lilly Other Total Upfront payments $ 4,371 $ 789 $ — $ 5,160 Reimbursement revenue 1,547 847 — 2,394 Milestones 3,479 — — 3,479 Other — — — — Total collaboration revenue $ 9,397 $ 1,636 $ — $ 11,033 Operating expenses: Research and development expense $ — $ — $ — $ — General and administrative expense — — — — Total operating expenses from collaborations $ — $ — $ — $ — Revenue recognized that was included in deferred revenue at $ 4,371 $ 789 $ — $ 5,160 Three Months Ended September 30, 2022 (In thousands) Third Party Incyte Lilly Other Total Upfront payments $ 4,045 $ ( 551 ) $ — $ 3,494 Reimbursement revenue 2,300 787 — 3,087 Milestones — — — — Other — — — — Total collaboration revenue $ 6,345 $ 236 $ — $ 6,581 Operating expenses: Research and development expense $ 162 $ — $ — $ 162 General and administrative expense — — — — Total operating expenses from collaborations $ 162 $ — $ — $ 162 Revenue recognized that was included in deferred revenue at $ 4,045 $ ( 551 ) $ — $ 3,494 Nine Months Ended September 30, 2023 (In thousands) Third Party Incyte Lilly Other Total Upfront payments $ 12,912 $ 8,270 $ — $ 21,182 Reimbursement revenue 4,248 3,543 — 7,791 Milestones 5,980 — — 5,980 Other — — 55 55 Total collaboration revenue $ 23,140 $ 11,813 $ 55 $ 35,008 Operating expenses: Research and development expense $ 24 $ — $ — $ 24 General and administrative expense — — — — Total operating expenses from collaborations $ 24 $ — $ — $ 24 Revenue recognized that was included in deferred revenue at $ 12,912 $ 8,270 $ — $ 21,182 Nine Months Ended September 30, 2022 (In thousands) Third Party Incyte Lilly Other Total Upfront payments $ 12,677 $ 7,634 $ 222 $ 20,533 Reimbursement revenue 6,514 2,823 — 9,337 Milestones 1,000 — — 1,000 Other — — 50 50 Total collaboration revenue $ 20,191 $ 10,457 $ 272 $ 30,920 Operating expenses: Research and development expense $ 712 $ — $ — $ 712 General and administrative expense — — — — Total operating expenses from collaborations $ 712 $ — $ — $ 712 Revenue recognized that was included in deferred revenue at $ 12,677 $ 7,634 $ 222 $ 20,533 |
Employee Benefits (Tables)
Employee Benefits (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Retirement Benefits [Abstract] | |
Summary of Stock-based Compensation Expense Classified in Condensed Consolidated Statements of Operations and Comprehensive Loss | Stock-based compensation expense is classified in the condensed consolidated statements of operations and comprehensive loss as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 (In thousands) (In thousands) Research and development $ 2,959 $ 2,690 $ 8,859 $ 8,025 General and administrative 4,356 3,835 10,659 10,496 Total $ 7,315 $ 6,525 $ 19,518 $ 18,521 |
Summary of Assumptions Used to Estimate Fair Value of Options Granted | The following assumptions were used to estimate the fair value of the options granted during the nine months ended September 30, 2023. Volatility 68.3 % Risk-free interest rate 3.6 % Expected holding period (in years) 6.2 Dividend yield - |
Overview - Additional Informati
Overview - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ (692,908) | $ (598,122) |
Investments in Debt Securitie_2
Investments in Debt Securities - Summary of Investments in Debt Securities in Condensed Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Schedule Of Held To Maturity Securities [Line Items] | ||
Total | $ 229,161 | $ 197,341 |
Fair value of debt securities | 228,314 | 196,345 |
Cash equivalents [member] | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Total | 25,200 | 18,404 |
Current marketable securities [member] | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Total | 146,702 | 142,480 |
Non-current marketable securities [member] | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Total | 57,259 | 36,457 |
Money market funds [member] | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Total | 20,499 | 18,404 |
Corporate paper and notes [member] | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Total | 134,511 | 126,102 |
U.S. government agency securities [member] | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Total | 52,669 | 34,364 |
U.S. treasuries [member] | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Total | $ 21,482 | $ 18,471 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development expenses | $ 4,296 | $ 6,372 |
Prepaid general and administrative expenses | 5,960 | 2,940 |
Interest receivable | 1,173 | 647 |
Other | 1,399 | 2,204 |
Total | $ 12,828 | $ 12,163 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information - Summary of Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued research and development expenses | $ 27,760 | $ 26,159 |
Accrued personnel costs | 5,145 | 5,778 |
Accrued general and administrative expenses | 2,734 | 3,615 |
Other | 73 | 38 |
Total | $ 35,712 | $ 35,590 |
Income Taxes - Summary of Compo
Income Taxes - Summary of Components of Expense for (Benefit) from Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
U.S. federal | $ (871) | $ 370 | $ 580 | $ 420 |
U.S. state | (366) | 152 | 235 | 171 |
Total current income tax benefit | (1,237) | 522 | 815 | 591 |
U.S. federal | 1,665 | (137) | 947 | (13) |
U.S. state | 690 | (58) | 393 | (6) |
Total deferred income tax expense (benefit) | 2,355 | (195) | 1,340 | (19) |
Total income tax expense (benefit) | $ 1,118 | $ 327 | $ 2,155 | $ 572 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - Dutch Tax Law € in Millions | 9 Months Ended |
Sep. 30, 2023 EUR (€) | |
Income Tax Disclosure [Line Items] | |
Taxable income that exceeds €1.0 million, percentage | 50% |
Maximum | |
Income Tax Disclosure [Line Items] | |
Future taxable income offset limit | € 1 |
Minimum | |
Income Tax Disclosure [Line Items] | |
Future taxable income exceeding limit | € 1 |
Leases (Additional Information)
Leases (Additional Information) (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Lessee, Lease, Description [Line Items] | ||
Lessee, Operating Lease, Liability, to be Paid, Total | $ 100,000 | |
Former Corporate Headquarters | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease liability | $ 0 |
Leases - Summary of Components
Leases - Summary of Components of Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Lease cost | ||||
Operating lease cost | $ 517 | $ 701 | $ 1,743 | $ 1,816 |
Variable lease cost | 53 | 83 | 137 | 282 |
Total lease cost included in operating expenses | 570 | 784 | 1,880 | 2,098 |
Other information | ||||
Cash paid for amounts included in the measurement of lease liabilities included in operating cash flows | $ 544 | $ 733 | $ 1,828 | $ 1,881 |
Collaborations - Additional Inf
Collaborations - Additional Information (Details) $ / shares in Units, € in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Jan. 18, 2021 USD ($) $ / shares shares | Aug. 31, 2018 USD ($) | Mar. 14, 2018 EUR (€) | Jan. 23, 2017 USD ($) | Jan. 31, 2022 | Jan. 31, 2018 USD ($) PerformanceObligation Antibody Milestone | Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Feb. 12, 2021 USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Development milestones achieved | $ 2,500,000 | ||||||||||
Lilly Collaborations Agreement | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Non-refundable upfront payment receivable | $ 40,000,000 | ||||||||||
Issuance of common stock, shares | shares | 706,834 | ||||||||||
Common stock stated purchase price per share | $ / shares | $ 28.295 | ||||||||||
Proceeds from issuance of common stock, net | $ 20,000,000 | ||||||||||
Fixed consideration | 43,500,000 | $ 43.5 | |||||||||
Fee incurred for extension of research term | $ 500,000 | ||||||||||
Increase in transaction price | $ 500,000 | ||||||||||
Upfront payment | 40,000,000 | ||||||||||
Net fair value of shares | $ 16,500,000 | ||||||||||
Incyte Collaboration and License Agreement | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Development milestones achieved | 1,000,000 | $ 6,000,000 | |||||||||
Incyte Collaboration and License Agreement | Maximum | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Residual royalty percentage | 4% | ||||||||||
Incyte Collaboration and License Agreement | License and Related Activities | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaborations, transaction price as deferred revenue | $ 152,600,000 | ||||||||||
Second ONO Research and License Agreement | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Non-refundable upfront payment receivable | € | € 0.7 | ||||||||||
Payment to compensate research services | € | 0.3 | ||||||||||
Over time payment for full time equivalent funding | € | € 0.2 | ||||||||||
Development milestones achieved | $ 0 | $ 0 | |||||||||
Simcere Collaboration and License Agreement | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Number of bispecific antibodies under collaboration and license agreement | Antibody | 3 | ||||||||||
Non-refundable upfront payment received | $ 2,750,000 | ||||||||||
Collaborations, transaction price as revenue | $ 2,750,000 | ||||||||||
Milestone payments received | $ 1,800,000 | ||||||||||
Number of milestones achieved | Milestone | 3 | ||||||||||
Simcere Collaboration and License Agreement | License and Performance | Research and Development | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Number of performance obligation | PerformanceObligation | 3 |
Collaborations - Summary of Com
Collaborations - Summary of Company's Accompanying Consolidated Financial Statements Attributable to Transactions Arising From Collaboration Arrangements (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Incyte | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Revenue recognized in the period | $ 4,371 | $ 4,045 | $ 12,912 | $ 12,677 | |
Incyte | Accounts Receivable | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Billings | 10,779 | ||||
Cash receipts | (9,779) | ||||
Balance at September 30, 2023 | 1,000 | 1,000 | |||
Incyte | Unbilled Receivables | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Balance at January 1, 2023 | 1,987 | ||||
Accrued receivables | 10,152 | ||||
Billings | (10,779) | ||||
Adjustments | 44 | ||||
Balance at September 30, 2023 | 1,404 | 1,404 | |||
Incyte | Deferred Revenue | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Balance at January 1, 2023 | 39,079 | 39,079 | $ 52,059 | ||
Foreign exchange | (68) | ||||
Revenue recognized in the period | (12,912) | ||||
Balance at September 30, 2023 | 39,079 | 39,079 | 52,059 | ||
Less: current portion | (16,882) | (16,882) | |||
Non-current balance at September 30, 2023 | 22,197 | 22,197 | |||
Lilly | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Revenue recognized in the period | 789 | (551) | 8,270 | 7,634 | |
Lilly | Accounts Receivable | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Billings | 3,497 | ||||
Cash receipts | (3,497) | ||||
Lilly | Unbilled Receivables | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Balance at January 1, 2023 | 808 | ||||
Accrued receivables | 3,541 | ||||
Billings | (3,497) | ||||
Adjustments | (7) | ||||
Balance at September 30, 2023 | 845 | 845 | |||
Lilly | Deferred Revenue | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Balance at January 1, 2023 | 7,914 | 7,914 | 16,130 | ||
Foreign exchange | 54 | ||||
Revenue recognized in the period | (8,270) | ||||
Balance at September 30, 2023 | 7,914 | 7,914 | 16,130 | ||
Less: current portion | (6,137) | (6,137) | |||
Non-current balance at September 30, 2023 | 1,777 | 1,777 | |||
Other | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Revenue recognized in the period | 0 | 0 | 0 | 222 | |
Other | Accounts Receivable | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Balance at January 1, 2023 | 1,068 | ||||
Billings | 68 | ||||
Cash receipts | (1,142) | ||||
Foreign exchange | 6 | ||||
Other | Unbilled Receivables | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Balance at January 1, 2023 | 189 | ||||
Foreign exchange | (4) | ||||
Balance at September 30, 2023 | 185 | 185 | |||
Collaboration Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Revenue recognized in the period | 5,160 | $ 3,494 | 21,182 | $ 20,533 | |
Collaboration Agreement | Accounts Receivable | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Balance at January 1, 2023 | 1,068 | ||||
Billings | 14,344 | ||||
Cash receipts | (14,418) | ||||
Foreign exchange | 6 | ||||
Balance at September 30, 2023 | 1,000 | 1,000 | |||
Collaboration Agreement | Unbilled Receivables | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Balance at January 1, 2023 | 2,984 | ||||
Accrued receivables | 13,693 | ||||
Billings | (14,276) | ||||
Adjustments | 37 | ||||
Foreign exchange | (4) | ||||
Balance at September 30, 2023 | 2,434 | 2,434 | |||
Collaboration Agreement | Deferred Revenue | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Balance at January 1, 2023 | 46,993 | 46,993 | 68,189 | ||
Foreign exchange | (14) | ||||
Revenue recognized in the period | (21,182) | ||||
Balance at September 30, 2023 | 46,993 | 46,993 | $ 68,189 | ||
Less: current portion | (23,019) | (23,019) | |||
Non-current balance at September 30, 2023 | $ 23,974 | $ 23,974 |
Collaborations - Summary of C_2
Collaborations - Summary of Company's Collaboration Arrangements Earned in Period to Be Billed and Collected in Next Period (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating expenses: | ||||
Research and development | $ 36,810 | $ 42,307 | $ 99,973 | $ 100,378 |
General and administrative | 12,591 | 12,469 | 44,040 | 36,917 |
Total operating expenses | 49,401 | 54,776 | 144,013 | 137,295 |
Incyte | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Upfront payments | 4,371 | 4,045 | 12,912 | 12,677 |
Reimbursement revenue | 1,547 | 2,300 | 4,248 | 6,514 |
Milestones | 3,479 | 0 | 5,980 | 1,000 |
Other | 0 | 0 | 0 | 0 |
Total collaboration revenue | 9,397 | 6,345 | 23,140 | 20,191 |
Operating expenses: | ||||
Research and development | 0 | 162 | 24 | 712 |
General and administrative | 0 | 0 | 0 | 0 |
Total operating expenses | 0 | 162 | 24 | 712 |
Revenue recognized in the period | 4,371 | 4,045 | 12,912 | 12,677 |
Lilly | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Upfront payments | 789 | (551) | 8,270 | 7,634 |
Reimbursement revenue | 847 | 787 | 3,543 | 2,823 |
Milestones | 0 | 0 | 0 | 0 |
Other | 0 | 0 | 0 | 0 |
Total collaboration revenue | 1,636 | 236 | 11,813 | 10,457 |
Operating expenses: | ||||
Research and development | 0 | 0 | 0 | 0 |
General and administrative | 0 | 0 | 0 | 0 |
Total operating expenses | 0 | 0 | 0 | 0 |
Revenue recognized in the period | 789 | (551) | 8,270 | 7,634 |
Other | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Upfront payments | 0 | 0 | 0 | 222 |
Reimbursement revenue | 0 | 0 | 0 | 0 |
Milestones | 0 | 0 | 0 | 0 |
Other | 0 | 0 | 0 | 50 |
Total collaboration revenue | 0 | 0 | 0 | 272 |
Operating expenses: | ||||
Research and development | 0 | 0 | 0 | 0 |
General and administrative | 0 | 0 | 0 | 0 |
Total operating expenses | 0 | 0 | 0 | 0 |
Revenue recognized in the period | 0 | 0 | 0 | 222 |
Collaboration Agreement | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Upfront payments | 5,160 | 3,494 | 21,182 | 20,533 |
Reimbursement revenue | 2,394 | 3,087 | 7,791 | 9,337 |
Milestones | 3,479 | 0 | 5,980 | 1,000 |
Other | 0 | 0 | 55 | 50 |
Total collaboration revenue | 11,033 | 6,581 | 35,008 | 30,920 |
Operating expenses: | ||||
Research and development | 0 | 162 | 24 | 712 |
General and administrative | 0 | 0 | 0 | 0 |
Total operating expenses | 0 | 162 | 24 | 712 |
Revenue recognized in the period | $ 5,160 | $ 3,494 | $ 21,182 | $ 20,533 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
Aug. 14, 2023 USD ($) | Aug. 09, 2023 € / shares shares | May 22, 2023 USD ($) | May 31, 2021 USD ($) | Jun. 30, 2023 USD ($) shares | Dec. 31, 2022 USD ($) | Sep. 30, 2023 € / shares | Sep. 30, 2023 USD ($) shares | Aug. 09, 2023 $ / shares | Dec. 31, 2022 € / shares | Dec. 31, 2022 USD ($) shares | |
Class of Stock [Line Items] | |||||||||||
Common stock, value, issued | $ 5,874,000 | $ 4,751,000 | |||||||||
Common shares, issued | shares | 57,729,180 | 46,310,589 | |||||||||
Common shares, par value | € / shares | € 0.09 | € 0.09 | |||||||||
Sales Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common shares, issued | shares | 2,720,846 | ||||||||||
Common shares, sold | shares | 3,272,280 | ||||||||||
Gross proceeds, before deducting sales agent commissions | $ 65,500,000 | $ 59,500,000 | |||||||||
Sales agent commissions | $ 1,700,000 | ||||||||||
Net proceeds, after deducting sales agent fees, underwriting discounts and commissions | $ 124,900,000 | $ 63,800,000 | |||||||||
Sales Agreement | Maximum | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock sale agreement authorized amount | $ 125,000,000 | $ 125,000,000 | |||||||||
Underwriting commissions rate of gross proceeds of shares sold | 3% | ||||||||||
Underwriting Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common shares, sold | shares | 6,818,182 | ||||||||||
Net proceeds, after deducting sales agent fees, underwriting discounts and commissions | $ 162,200,000 | ||||||||||
Sale of stock, price per share | $ / shares | $ 22 | ||||||||||
Common shares, par value | € / shares | € 0.09 | ||||||||||
Additional common shares at public offering price | shares | 1,022,727 |
Employee Benefits - Summary of
Employee Benefits - Summary of Stock-based Compensation Expense Classified in Condensed Consolidated Statements of Operations and Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total | $ 7,315 | $ 6,525 | $ 19,518 | $ 18,521 |
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total | 2,959 | 2,690 | 8,859 | 8,025 |
General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total | $ 4,356 | $ 3,835 | $ 10,659 | $ 10,496 |
Employee Benefits - Additional
Employee Benefits - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Apr. 30, 2020 | Sep. 30, 2023 | Mar. 31, 2022 | Mar. 31, 2021 | Sep. 30, 2023 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Weighted-average fair value of options granted | $ 11.67 | |||||
Share-based payment award, fair value assumptions, method used | Black Scholes option pricing model | |||||
Number of options granted | 2,625,427 | |||||
Severance payment | $ 100,000 | |||||
Additional compensation cost | $ 200,000 | |||||
Net gain associated with the derivative instrument | $ 0 | $ 400,000 | ||||
Derivative, Gain, Statement of Income or Comprehensive Income [Extensible Enumeration] | Nonoperating Income (Expense) | |||||
Research and Development | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Net reversal of stock-based compensation expense | $ 400,000 | |||||
Postemployment Retirement Benefits | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Executive settlements, cash compensation paid | $ 300,000 |
Employee Benefits - Summary o_2
Employee Benefits - Summary of Assumptions Used to Estimate Fair Value of Options Granted (Details) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Volatility | 68.30% |
Risk-free interest rate | 3.60% |
Expected holding period (in years) | 6 years 2 months 12 days |