Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 02, 2024 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | NewAmsterdam Pharma Company N.V. | |
Entity Central Index Key | 0001936258 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity File Number | 001-41562 | |
Entity Tax Identification Number | 00-0000000 | |
Entity Address, Address Line One | Gooimeer 2-35 | |
Entity Address, City or Town | Naarden | |
Entity Address, Country | NL | |
Entity Address, Postal Zip Code | 1411 DC | |
City Area Code | +31 | |
Local Phone Number | (0) 35 206 2971 | |
Entity Incorporation, State or Country Code | P7 | |
Document Transition Report | false | |
Entity Common Stock, Shares Outstanding | 90,015,357 | |
Ordinary Shares, Nominal Value €0.12 Per Share | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Ordinary Shares, nominal value €0.12 per share | |
Trading Symbol | NAMS | |
Security Exchange Name | NASDAQ | |
Warrants to Purchase Ordinary Shares | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Warrants to purchase Ordinary Shares | |
Trading Symbol | NAMSW | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash | $ 430,708 | $ 340,450 |
Prepayments and other receivables | 14,644 | 6,341 |
Total current assets | 445,352 | 346,791 |
Property, plant and equipment, net | 234 | 46 |
Operating right of use asset | 554 | 55 |
Intangible assets | 542 | 170 |
Long term prepaid expenses | 8 | 35 |
Total assets | 446,690 | 347,097 |
Current liabilities: | ||
Accounts payable | 5,275 | 16,923 |
Accrued expenses and other current liabilities | 10,194 | 11,398 |
Deferred revenue, current | 6,059 | 8,942 |
Lease liability, current | 234 | 60 |
Derivative warrant liabilities | 23,545 | 12,574 |
Total current liabilities | 45,307 | 49,897 |
Deferred revenue, net of current portion | 222 | 1,019 |
Lease liability, net of current portion | 328 | |
Derivative earnout liability | 13,394 | 7,788 |
Total liabilities | 59,251 | 58,704 |
Commitments and contingencies (Note 10) | ||
Shareholders' Equity (deficit): | ||
Ordinary shares | 11,151 | 10,173 |
Additional paid-in capital | 821,613 | 590,771 |
Accumulated loss | (449,747) | (316,973) |
Accumulated other comprehensive income | 4,422 | 4,422 |
Total shareholders' equity | 387,439 | 288,393 |
Total liabilities and shareholders' equity | $ 446,690 | $ 347,097 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - € / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Ordinary shares, par value | € 0.12 | € 0.12 |
Ordinary shares, authorized | 400,000,000 | 400,000,000 |
Ordinary shares, issued | 90,015,357 | 82,469,768 |
Ordinary shares, outstanding | 90,015,357 | 82,469,768 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Statement [Abstract] | ||||
Revenue | $ 2,279 | $ 1,717 | $ 3,680 | $ 10,346 |
Operating expenses: | ||||
Research and development expenses | 38,379 | 34,341 | 80,809 | 74,761 |
Selling, general and administrative expenses | 16,475 | 9,858 | 30,928 | 17,920 |
Total operating expenses | 54,854 | 44,199 | 111,737 | 92,681 |
Operating loss | (52,575) | (42,482) | (108,057) | (82,335) |
Other income (expense): | ||||
Interest income | 4,870 | 4,613 | 7,953 | 5,556 |
Fair value change - earnout and warrants | 9,692 | (350) | (29,258) | (6,525) |
Foreign exchange gains/(losses) | (994) | (72) | (3,412) | 2,995 |
Loss before tax | (39,007) | (38,291) | (132,774) | (80,309) |
Loss for the year | (39,007) | (38,291) | (132,774) | (80,309) |
Other comprehensive income (loss) | ||||
Loss and comprehensive loss for the period | $ (39,007) | $ (38,291) | $ (132,774) | $ (80,309) |
Net loss per ordinary share | ||||
Basic | $ (0.41) | $ (0.47) | $ (1.45) | $ (0.98) |
Diluted | $ (0.41) | $ (0.47) | $ (1.45) | $ (0.98) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Shareholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Loss [Member] | Cumulative Translation Adjustments [Member] |
Beginning Balance at Dec. 31, 2022 | $ 430,066 | $ 10,055 | $ 555,625 | $ (140,036) | $ 4,422 |
Beginning Balance, shares at Dec. 31, 2022 | 81,559,780 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of warrants | 2,698 | $ 27 | 2,671 | ||
Exercise of warrants, shares | 208,032 | ||||
Share-based compensation | 7,663 | 7,663 | |||
Total profit or loss and comprehensive loss for the year | (42,018) | (42,018) | |||
Ending Balance at Mar. 31, 2023 | 398,409 | $ 10,082 | 565,959 | (182,054) | 4,422 |
Ending Balance, shares at Mar. 31, 2023 | 81,767,812 | ||||
Beginning Balance at Dec. 31, 2022 | 430,066 | $ 10,055 | 555,625 | (140,036) | 4,422 |
Beginning Balance, shares at Dec. 31, 2022 | 81,559,780 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Total profit or loss and comprehensive loss for the year | (80,309) | ||||
Ending Balance at Jun. 30, 2023 | 373,343 | $ 10,154 | 579,112 | (220,345) | 4,422 |
Ending Balance, shares at Jun. 30, 2023 | 82,324,331 | ||||
Beginning Balance at Mar. 31, 2023 | 398,409 | $ 10,082 | 565,959 | (182,054) | 4,422 |
Beginning Balance, shares at Mar. 31, 2023 | 81,767,812 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of warrants | 7,514 | $ 70 | 7,444 | ||
Exercise of warrants, shares | 541,609 | ||||
Exercise of stock options | 105 | $ 2 | 103 | ||
Exercise of stock options, shares | 14,910 | ||||
Share-based compensation | 5,606 | 5,606 | |||
Total profit or loss and comprehensive loss for the year | (38,291) | (38,291) | |||
Ending Balance at Jun. 30, 2023 | 373,343 | $ 10,154 | 579,112 | (220,345) | 4,422 |
Ending Balance, shares at Jun. 30, 2023 | 82,324,331 | ||||
Beginning Balance at Dec. 31, 2023 | 288,393 | $ 10,173 | 590,771 | (316,973) | 4,422 |
Beginning Balance, shares at Dec. 31, 2023 | 82,469,768 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of ordinary shares and pre-funded warrants | 189,966 | $ 759 | 189,207 | ||
Stock Issuance of Ordinary Shares and Pre-funded Warrants, Shares | 5,871,909 | ||||
Exercise of warrants | 19,795 | $ 121 | 19,674 | ||
Exercise of warrants, shares | 926,698 | ||||
Exercise of stock options | (549) | $ 60 | (609) | ||
Exercise of stock options, shares | 452,461 | ||||
Share-based compensation | 7,965 | 7,965 | |||
Total profit or loss and comprehensive loss for the year | (93,767) | (93,767) | |||
Ending Balance at Mar. 31, 2024 | 411,803 | $ 11,113 | 807,008 | (410,740) | 4,422 |
Ending Balance, shares at Mar. 31, 2024 | 89,720,836 | ||||
Beginning Balance at Dec. 31, 2023 | $ 288,393 | $ 10,173 | 590,771 | (316,973) | 4,422 |
Beginning Balance, shares at Dec. 31, 2023 | 82,469,768 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options, shares | 546,403 | ||||
Total profit or loss and comprehensive loss for the year | $ (132,774) | ||||
Ending Balance at Jun. 30, 2024 | 387,439 | $ 11,151 | 821,613 | (449,747) | 4,422 |
Ending Balance, shares at Jun. 30, 2024 | 90,015,357 | ||||
Beginning Balance at Mar. 31, 2024 | 411,803 | $ 11,113 | 807,008 | (410,740) | 4,422 |
Beginning Balance, shares at Mar. 31, 2024 | 89,720,836 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of warrants | 6,306 | $ 38 | 6,268 | ||
Exercise of warrants, shares | 294,521 | ||||
Share-based compensation | 8,337 | 8,337 | |||
Total profit or loss and comprehensive loss for the year | (39,007) | (39,007) | |||
Ending Balance at Jun. 30, 2024 | $ 387,439 | $ 11,151 | $ 821,613 | $ (449,747) | $ 4,422 |
Ending Balance, shares at Jun. 30, 2024 | 90,015,357 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Operating Activities: | ||
Loss for the period | $ (132,774) | $ (80,309) |
Non-cash adjustments to reconcile loss before tax to net cash flows: | ||
Depreciation and amortization | 34 | 22 |
Non-cash rent expense | 3 | 3 |
Fair value change - derivative earnout and warrants | 29,258 | 6,525 |
Foreign exchange (gains)/losses | 3,412 | (2,995) |
Share-based compensation | 16,208 | 13,174 |
Changes in working capital: | ||
Changes in prepayments (current and non-current) and other receivables | (8,276) | 4,038 |
Changes in accounts payable | (11,656) | 1,410 |
Changes in accrued expenses and other current liabilities | (1,110) | 1,925 |
Changes in deferred revenue | (3,680) | (4,961) |
Net cash (used in)/provided by operating activities | (108,581) | (61,168) |
Investing activities: | ||
Purchase of property, plant and equipment, including internal use software | (594) | (12) |
Net cash used in investing activities | (594) | (12) |
Financing activities: | ||
Proceeds from offering of Ordinary shares and Pre-Funded Warrants | 190,481 | |
Transaction costs on issue of Ordinary Shares and Pre-Funded Warrants | (515) | |
Proceeds from exercise of warrants | 13,421 | 8,621 |
Proceeds from exercise of options | 440 | 105 |
Payment of withholding taxes related to net share settlement of exercised options | (989) | |
Net cash provided by financing activities | 202,838 | 8,726 |
Net change in cash | 93,663 | (52,454) |
Foreign exchange differences | (3,405) | 1,432 |
Cash at the beginning of the period | 340,450 | 467,728 |
Cash at the end of the period | 430,708 | $ 416,706 |
Noncash financing and investing activities | ||
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 562 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||
Net Income (Loss) | $ (39,007) | $ (38,291) | $ (132,774) | $ (80,309) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 shares | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | Rule 10b5-1 Trading Arrangements Except as set forth below, during the three months ended June 30, 2024, none of our officers or directors adopted, amended or terminated a “Rule 10b5-1 trading arrangement,” as defined in Item 408(c) of Regulation S-K, each of which is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. On June 27, 2024 , Louise Kooij , our Chief Accounting Officer , adopted a Rule 10b5-1 trading arrangement for the potential sale of up to 213,073 Ordinary Shares, subject to certain price thresholds and other conditions. The arrangement's expiration date is June 26, 2026 . There were no “non-Rule 10b5-1 trading arrangement,” as defined in Item 408(c) of Regulation S-K, entered into or terminated during the three months ended June 30, 2024 . |
Non-Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Louise Kooij | |
Trading Arrangements, by Individual | |
Name | Louise Kooij |
Title | Chief Accounting Officer |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | June 27, 2024 |
Rule 10b5-1 Arrangement Terminated | true |
Termination Date | June 26, 2026 |
Aggregate Available | 213,073 |
The Company
The Company | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Company | Note 1. The Company NewAmsterdam Pharma Company N.V. (“NewAmsterdam Pharma” or the “Company”) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well-tolerated. The Company was incorporated in the Netherlands as a Dutch private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) under the name NewAmsterdam Pharma Company B.V. on June 10, 2022. On November 21, 2022, the Company’s corporate form was converted to a Dutch public limited liability company (naamloze vennootschap) and its name was changed to NewAmsterdam Pharma Company N.V. The Company’s ordinary shares, nominal value € 0.12 per share (the "Ordinary Shares") are listed on the Nasdaq Global Market ("Nasdaq") and trade under the symbol “NAMS.” The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, development by competitors of more advanced or effective therapies, dependence on key executives, protection of and dependence on intellectual property, compliance with government regulations and ability to secure additional capital to fund operations. Significant additional research and development efforts and regulatory approval will be required prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited condensed consolidated financial statements should be read together with our audited financial statements and accompanying notes for year ended December 31, 2023, included in our Annual Report on Form 10-K (the "Annual Report"), filed with the SEC on February 28, 2024. Any terms not defined herein take the meaning as defined in the Annual Report. The Company’s unaudited condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2023 included herein has been derived from the audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments which are necessary for a fair statement of the Company’s financial information. The interim results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any other interim period or for any other future year. The unaudited condensed consolidated financial statements comprise the financial statements of the Company and its subsidiaries. Any reference in these notes to the 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 the Company and its wholly owned subsidiaries, after elimination of intercompany accounts and transactions. Prior to 2023, the Company prepared its financial statements in accordance with the International Financial Reporting Standards as issued by the International Accounting Standard Board (“IFRS”) as permitted in the United States based on the Company’s qualification as a foreign private issuer under the rules and regulations of the SEC. In connection with the loss of the Company’s status as a foreign private issuer effective on January 1, 2024, the Company, as a domestic filer, prepared these financial statements in accordance with U.S. GAAP. The transition to U.S. GAAP was made retrospectively for all periods from the Company’s inception. Except for the policy described below, the accounting policies of the Company are consistent with those described in Note 2 of the consolidated financial statements included within the Annual Report. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of Ordinary Shares outstanding during the period. For the purposes of calculating the weighted-average number of Ordinary Shares outstanding, the Ordinary Shares underlying the Pre-Funded Warrants issued in the Offering (as defined in Note 7 below) are included. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented. |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2024 | |
Principal Transaction Revenue [Line Items] | |
Revenue | Note 3. Revenue Revenue consisted of the following: Three months ended June 30, Six months ended June 30, (In thousands of USD) 2024 2023 2024 2023 License revenue attributed from license performance obligation — — — 5,385 License revenue attributed from R&D performance obligation 2,279 1,717 3,680 4,961 Total revenue 2,279 1,717 3,680 10,346 All revenue recognized from the R&D performance obligation was included within deferred revenue on the consolidated balance sheet as of the beginning of the applicable reporting period. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 4. Fair Value Measurements As at June 30, 2024 and December 31, 2023, the Company’s financial liabilities recognized at fair value on a recurring basis consisted of the following: As at June 30, 2024 (In thousands of USD) Level 1 Level 2 Level 3 Total Derivative warrant liability (Public Warrants) 22,089 — — 22,089 Derivative warrant liability (Private Placement Warrants) — 1,456 — 1,456 Derivative earnout liability — — 13,394 13,394 Total financial liabilities 22,089 1,456 13,394 36,939 As at December 31, 2023 (In thousands of USD) Level 1 Level 2 Level 3 Total Derivative warrant liability (Public Warrants) 12,051 — — 12,051 Derivative warrant liability (Private Placement Warrants) — 523 — 523 Derivative earnout liability — — 7,788 7,788 Total financial liabilities 12,051 523 7,788 20,362 The estimated fair value of the derivative earnout liability was determined using Level 3 inputs, other than the Company's share price as a Level 1 input, as no observable market inputs were available. The derivative earnout liability has been measured at fair value using a Black-Scholes pricing model. Given the assumed zero dividend rate and the fact that no strike price exists that would have led to any volatility measure relative to the Company's share price, the fair value of the earnout liability resulting from the Black-Scholes pricing model is entirely driven by the Company’s closing share price as a Level 1 input and the probability of milestone completion as a Level 3 input. As such, the relevant inputs to the fair value of the derivative earnout liability are as follows: June 30, 2024 December 31, 2023 Ordinary Share value (USD) $ 19.21 $ 11.17 Probability of milestone completion 40 % 40 % Dividend yield 0 % 0 % Strike price (USD) 0.00 0.00 As management's judgment of the probability of milestone completion remained constant during the period, the change in fair value resulted from the Company’s price per share between valuation dates. The following table presents a reconciliation of the derivative earnout liability measured on a recurring basis using Level 3 inputs as of June 30, 2024: Balance on December 31, 2023 7,788 Change in fair value recognized through profit and loss 5,606 Balance on June 30, 2024 13,394 All changes in fair value recognized in the statement of operations are unrealized. There were no sales, purchases, settlements or transfers into or out of Level 3 of the fair value hierarchy related to the derivative earnout liability during the period ended June 30, 2024 . |
Prepayments and Other Receivabl
Prepayments and Other Receivables | 6 Months Ended |
Jun. 30, 2024 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepayments and Other Receivables | Note 5. Prepayments and Other Receivables Prepayments and other receivables consisted of the following: (In thousands of USD) June 30, December 31, Prepaid research and development costs 6,994 2,337 Other prepaid expenses 2,244 2,123 Value added tax receivable 3,272 1,006 Other receivables 2,134 875 Total prepayments and other receivables 14,644 6,341 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Accounts Payable and Accrued Liabilities, Current [Abstract] | |
Accrued Expenses and Other Current Liabilities | Note 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: (in thousands of USD) June 30, December 31, Accrued research and development materials and services 6,419 5,945 Accrued compensation and benefits 2,317 3,384 Accrued professional fees and other 1,458 2,069 Total accrued expenses and other current liabilities 10,194 11,398 |
Shareholders' Equity
Shareholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Shareholders' Equity | Note 7. Shareholders’ Equity Follow-on Offering On February 16, 2024, the Company completed an underwritten public offering (the “Offering”) of 5,871,909 Ordinary Shares at a public offering price of $ 19.00 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, pre-funded warrants ( the “Pre-Funded Warrants”) to purchase 4,736,841 Ordinary Shares at a public offering price of $ 18.9999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares, less the $ 0.0001 per share exercise price for each such Pre-Funded Warrant. Of the 5,871,909 Ordinary Shares issued and sold in the offering, 1,383,750 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share. The Ordinary Shares and Pre-Funded Warrants were issued and sold pursuant to an underwriting agreement, among the Company and Jefferies LLC, Leerink Partners LLC, Piper Sandler & Co. and RBC Capital Markets, LLC, as representatives of the several underwriters listed on Schedule A thereto. The net proceeds to the Company from the Offering were $ 190.0 million after deducting underwriting discounts and commissions and offering expenses payable by the Company. |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Note 8. Share-Based Compensation The Company has four Share-based payment plans and one restricted share award in place as at June 30, 2024: • The Company’s Long-Term Incentive Plan (the “Plan”); • The Company’s Supplementary Long-Term Incentive Plan (the “Supplementary Plan”); • The Company’s Rollover Option Plan (the “Rollover Plan,”); • The Company's Inducement Plan (the “Inducement Plan,” together with the Plan, the Supplementary Plan and the Rollover Plan, the “Plans”); and • Chief Executive Officer Restricted Share Award. The Plans The Plans are equity-settled, and the Company may grant various forms of equity awards, including the granting of options to purchase Ordinary Shares (“Company Options”) and restricted stock units (“RSUs”), pursuant to the Plans. In total, as of June 30, 2024 a maximum of 22,049,356 Ordinary Shares may be reserved for issuance pursuant to the Plans. The number of Ordinary Shares reserved for grant under the Plan will increase annually on January 1 of each calendar year by 5 % of the then issued and outstanding Ordinary Shares or such lower number as may be determined by the Company's Board of Directors. The contractual term is 10 years from grant date for options granted under the Plans. In general, each Company Option has a four-year vesting period with 25 % vesting after one year and the remaining 75 % vesting in equal monthly installments over the next following three years . The changes for the six months ended June 30, 2023 in the number of Company Options outstanding related to Ordinary Shares and their related weighted average exercise prices are as follows: Number of options Weighted average exercise price Weighted average remaining contractual term Aggregate intrinsic value Outstanding as at December 31, 2023 15,783,509 $ 7.98 Granted 4,541,148 $ 13.61 Exercised ( 546,403 ) $ 1.27 Outstanding as at June 30, 2024 19,778,254 $ 9.45 8.5 195,399 Options exercisable as at June 30, 2024 6,888,620 $ 6.01 7.8 90,930 The weighted average grant date fair value of Company Options, estimated as of the grant date using the Black-Scholes option pricing model, was $ 6.30 , and $ 4.86 per option for options granted during the six months ended June 30, 2024 and 2023, respectively. The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of Company Options exercised during the six months ended June 30, 2024 and 2023 was $ 8.0 million and $ 0.1 million, respectively. Weighted average assumptions used to apply this pricing model were as follows: Six months ended June 30, 2024 2023 Expected life (years) 6.1 6.1 Risk-free rate 3.9 % 3.9 % Volatility 41.4 % 38.4 % Dividend yield 0.0 % 0.0 % Expected Term The Company’s expected term represents the period that the Company’s stock-based awards are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). The Company utilizes this method due to lack of historical exercise data and the plain-vanilla nature of the Company’s stock-based awards. Expected Volatility Since the Company was privately held through November 2022, it alone does not have sufficient relevant company-specific historical data to support its expected volatility alone. In prior periods, due to the insufficiency of historical volatility data on the Company’s own securities, the expected volatility input was determined using comparable companies alone. Beginning on January 1, 2024 expected volatility input was determined using a weighted average calculation considering the volatility of the Company’s own securities and the volatilities of a representative group of publicly traded biopharmaceutical companies over a period equal to the expected term of the stock option grants. Initially, the volatility of the Company’s Ordinary Shares is assigned a weighting of 10 %. This weighting will be increased by 5 % per calendar quarter until the expected volatility input is based entirely on the historical volatility of the Company’s Ordinary Shares. For purposes of identifying comparable companies, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected life of the stock-based awards. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. Risk-Free Interest Rate The risk-free interest rate is based upon the U.S. Treasury yield curve in effect at the time of grant, with a term that approximates the expected life of the Company Option. Expected Dividend The expected dividend rate is zero as the Company currently has no history or expectation of declaring dividends on its Ordinary Shares. Share-based compensation is classified in the consolidated statement of operations and comprehensive loss as follows: Three months ended June 30, Six months ended June 30, (in thousands of USD) 2024 2023 2024 2023 Research and development expenses 2,992 3,730 6,471 8,219 Selling, general and administrative expenses 5,298 1,828 9,737 4,955 Total 8,290 5,558 16,208 13,174 As of June 30, 2024, there was $ 37.7 million of unrecognized compensation cost related to Company Options that have not yet vested. These costs are expected to be recognized over a weighted average period of 3.2 years until fully vested. Restricted Stock Units As at June 30, 2024 and December 31, 2023, the Company had allocated 143,002 Earnout Shares to be granted to Participating Optionholders if and when a certain clinical development milestone is achieved during the earnout period. These Earnout Shares will be delivered in the form of awards of RSUs granted pursuant to the Plan to such Participating Optionholders who are at the time of achievement of such milestone still providing services to the Company. The development milestone consists of the achievement and public announcement of positive Phase 3 data for each of the Company’s BROADWAY clinical trial and BROOKLYN clinical trial at any time during the period beginning on November 22, 2022 and ending on the date that is five years after such date. There is no impact on these financial statements with respect to these RSUs due to the uncertainty of achieving the clinical development milestone. Chief Executive Officer Restricted Share Award In July 2021, the Company's chief executive officer, Michael Davidson, M.D., paid the fair market value of the underlying Ordinary Shares (in aggregate $ 838,806 ) when he made an investment in restricted shares issued through Depositary Receipts. The total fair value of these equity-settled share-based payment awards amounts to nil and there will be no expenses recognized in the income statement. This award had a four year vesting period with 25 % vesting on August 1, 2021 and the remaining 75 % vesting in equal monthly installments over the following three years . In connection with the award arrangement, if Dr. Davidson leaves the Company, all unvested Ordinary Shares will be cancelled against payment by the Company to him of the lower of the (i) the purchase price paid and (ii) the fair market value of such Ordinary Shares at the time of forfeiture. In order to reflect the consideration paid and the possibility that the Ordinary Shares would be repurchased if Dr. Davidson becomes a “Good Leaver” (as such term is defined in the award agreement) during the vesting period, the Company has recognized the consideration as a financial liability until the award has fully vested, at which time it will be reclassified to equity provided that Dr. Davidson remains with the Company. This liability is measured at the lower of (i) the purchase price paid and (ii) the fair market value of the Ordinary Shares at the end of the reporting period. The liability for unvested Ordinary Shares as at June 30, 2024 and December 31, 2023 amounted to $ 0.0 million and $ 0.1 million, respectively. For the six months ended June 30, 2024, the movements in the number of Ordinary Shares outstanding are as follows: Outstanding as at December 31, 2023 608,779 Granted/purchased during the period — Outstanding as at June 30, 2024 608,779 As of June 30, 2024 and December 31, 2023, a total of 596,096 and 519,999 Ordinary Shares had vested, respectively. |
Net Loss Per Ordinary Share
Net Loss Per Ordinary Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss per Ordinary Share | Note 9. Net Loss per Ordinary Share For the purposes of calculating the weighted-average number of Ordinary Shares outstanding, the Ordinary Shares underlying the Pre-Funded Warrants issued in the Offering are included. Basic and diluted net loss per Ordinary Share was calculated as follows: Three months ended June 30, Six months ended June 30, (In thousands of USD, except share and per share amounts) 2024 2023 2024 2023 Net loss ( 39,007 ) ( 38,291 ) ( 132,774 ) ( 80,309 ) Weighted average Ordinary Shares outstanding, basic and diluted 94,711,604 82,064,519 91,611,785 81,850,662 Net loss per Ordinary Share, basic and diluted ( 0.41 ) ( 0.47 ) ( 1.45 ) ( 0.98 ) The following potentially dilutive securities have been excluded from the computation of diluted weighted-average Ordinary Shares outstanding as they would be anti-dilutive: As at June 30, 2024 2023 Stock options 19,778,254 13,966,164 Outstanding warrants 2,700,152 4,017,321 Total 22,478,406 17,983,485 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 10. Commitments and Contingencies Commitments The Company has entered into a variety of agreements and financial commitments in the normal course of business with contract research organizations, contract manufacturing organizations, and other third parties for preclinical and clinical development and manufacturing services. The terms generally provide the Company with the option to cancel, reschedule and adjust our requirements based on the Company's business needs, prior to the delivery of goods or performance of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancellable obligations of the Company's service providers, up to the date of cancellation. However, some of the Company's service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at June 30, 2024 they are estimated to be a maximum of $ 18.1 million. According to the terms of the Menarini License the Company will be responsible for development and commercialization costs related to Licensed Products other than those in the Menarini Territory. In addition, under specified conditions of the agreement, the Company agreed to bear 50 % of certain development costs incurred by the other party in the development of the Licensed Products in the Menarini Territory. |
Related Parties
Related Parties | 6 Months Ended |
Jun. 30, 2024 | |
Related Party Transactions [Abstract] | |
Related Parties | Note 11. Related Parties In the ordinary course of business, the Company may enter into transactions with entities that are associated with a party that meets the criteria of a related party of the Company. These transactions are reviewed quarterly and to date have not been material to the Company’s consolidated financial statements. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 12. Subsequent Events On July 29, 2024 the Company announced positive topline results from its Phase 3 BROOKLYN clinical trial. Positive results from the BROOKLYN trial is a component of the milestone which is required in order for the Earnout Shares to be granted. The probability of achieving the milestone is a key input into the Level 3 fair value measurement of the derivative earnout liability as described in Note 4 - Fair Value Measurements. The Company has determined that the reporting of positive data from the BROOKLYN clinical trial increases the probability of achieving the milestone from 40 %, as described in Note 4, to 65 %. Based upon this updated probability of success and the closing price of the Ordinary Shares on July 29, 2024, the fair value of the earnout liability is equal to $ 19.5 million as of that date. This represents an increase in fair value of $ 6.2 million from the fair value of the liability as of June 30, 2024 which is recognized through earnings. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements should be read together with our audited financial statements and accompanying notes for year ended December 31, 2023, included in our Annual Report on Form 10-K (the "Annual Report"), filed with the SEC on February 28, 2024. Any terms not defined herein take the meaning as defined in the Annual Report. The Company’s unaudited condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2023 included herein has been derived from the audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments which are necessary for a fair statement of the Company’s financial information. The interim results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any other interim period or for any other future year. The unaudited condensed consolidated financial statements comprise the financial statements of the Company and its subsidiaries. Any reference in these notes to the 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 the Company and its wholly owned subsidiaries, after elimination of intercompany accounts and transactions. Prior to 2023, the Company prepared its financial statements in accordance with the International Financial Reporting Standards as issued by the International Accounting Standard Board (“IFRS”) as permitted in the United States based on the Company’s qualification as a foreign private issuer under the rules and regulations of the SEC. In connection with the loss of the Company’s status as a foreign private issuer effective on January 1, 2024, the Company, as a domestic filer, prepared these financial statements in accordance with U.S. GAAP. The transition to U.S. GAAP was made retrospectively for all periods from the Company’s inception. Except for the policy described below, the accounting policies of the Company are consistent with those described in Note 2 of the consolidated financial statements included within the Annual Report. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of Ordinary Shares outstanding during the period. For the purposes of calculating the weighted-average number of Ordinary Shares outstanding, the Ordinary Shares underlying the Pre-Funded Warrants issued in the Offering (as defined in Note 7 below) are included. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented. |
Revenue (Tables)
Revenue (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Revenue from Contract with Customer [Abstract] | |
Summary of License Revenue | Revenue consisted of the following: Three months ended June 30, Six months ended June 30, (In thousands of USD) 2024 2023 2024 2023 License revenue attributed from license performance obligation — — — 5,385 License revenue attributed from R&D performance obligation 2,279 1,717 3,680 4,961 Total revenue 2,279 1,717 3,680 10,346 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Liabilities Recognized at Fair Value on Recurring Basis | As at June 30, 2024 and December 31, 2023, the Company’s financial liabilities recognized at fair value on a recurring basis consisted of the following: As at June 30, 2024 (In thousands of USD) Level 1 Level 2 Level 3 Total Derivative warrant liability (Public Warrants) 22,089 — — 22,089 Derivative warrant liability (Private Placement Warrants) — 1,456 — 1,456 Derivative earnout liability — — 13,394 13,394 Total financial liabilities 22,089 1,456 13,394 36,939 As at December 31, 2023 (In thousands of USD) Level 1 Level 2 Level 3 Total Derivative warrant liability (Public Warrants) 12,051 — — 12,051 Derivative warrant liability (Private Placement Warrants) — 523 — 523 Derivative earnout liability — — 7,788 7,788 Total financial liabilities 12,051 523 7,788 20,362 |
Schedule of Estimated Fair Value of Derivative Earnout Liability | As such, the relevant inputs to the fair value of the derivative earnout liability are as follows: June 30, 2024 December 31, 2023 Ordinary Share value (USD) $ 19.21 $ 11.17 Probability of milestone completion 40 % 40 % Dividend yield 0 % 0 % Strike price (USD) 0.00 0.00 |
Summary of Reconciliation of Derivative Earnout Liability Measured on Recurring Basis Using Level 3 Inputs | The following table presents a reconciliation of the derivative earnout liability measured on a recurring basis using Level 3 inputs as of June 30, 2024: Balance on December 31, 2023 7,788 Change in fair value recognized through profit and loss 5,606 Balance on June 30, 2024 13,394 All changes in fair value recognized in the statement of operations are unrealized. There were no sales, purchases, settlements or transfers into or out of Level 3 of the fair value hierarchy related to the derivative earnout liability during the period ended June 30, 2024 . |
Prepayments and Other Receiva_2
Prepayments and Other Receivables (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Schedule of Prepayments and Other Receivables | Prepayments and other receivables consisted of the following: (In thousands of USD) June 30, December 31, Prepaid research and development costs 6,994 2,337 Other prepaid expenses 2,244 2,123 Value added tax receivable 3,272 1,006 Other receivables 2,134 875 Total prepayments and other receivables 14,644 6,341 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accounts Payable and Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following: (in thousands of USD) June 30, December 31, Accrued research and development materials and services 6,419 5,945 Accrued compensation and benefits 2,317 3,384 Accrued professional fees and other 1,458 2,069 Total accrued expenses and other current liabilities 10,194 11,398 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | The changes for the six months ended June 30, 2023 in the number of Company Options outstanding related to Ordinary Shares and their related weighted average exercise prices are as follows: Number of options Weighted average exercise price Weighted average remaining contractual term Aggregate intrinsic value Outstanding as at December 31, 2023 15,783,509 $ 7.98 Granted 4,541,148 $ 13.61 Exercised ( 546,403 ) $ 1.27 Outstanding as at June 30, 2024 19,778,254 $ 9.45 8.5 195,399 Options exercisable as at June 30, 2024 6,888,620 $ 6.01 7.8 90,930 |
Schedule of Weighted Average Assumptions for Stock Options | Weighted average assumptions used to apply this pricing model were as follows: Six months ended June 30, 2024 2023 Expected life (years) 6.1 6.1 Risk-free rate 3.9 % 3.9 % Volatility 41.4 % 38.4 % Dividend yield 0.0 % 0.0 % |
Schedule of Impact on Results of Operations and Comprehensive Loss of Recording Stock-Based Compensation | Share-based compensation is classified in the consolidated statement of operations and comprehensive loss as follows: Three months ended June 30, Six months ended June 30, (in thousands of USD) 2024 2023 2024 2023 Research and development expenses 2,992 3,730 6,471 8,219 Selling, general and administrative expenses 5,298 1,828 9,737 4,955 Total 8,290 5,558 16,208 13,174 |
Schedule of Restricted Stock Unit Activity | For the six months ended June 30, 2024, the movements in the number of Ordinary Shares outstanding are as follows: Outstanding as at December 31, 2023 608,779 Granted/purchased during the period — Outstanding as at June 30, 2024 608,779 |
Net Loss Per Ordinary Share (Ta
Net Loss Per Ordinary Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Schedule Of Basic And Diluted Net Loss Per Ordinary Share | Basic and diluted net loss per Ordinary Share was calculated as follows: Three months ended June 30, Six months ended June 30, (In thousands of USD, except share and per share amounts) 2024 2023 2024 2023 Net loss ( 39,007 ) ( 38,291 ) ( 132,774 ) ( 80,309 ) Weighted average Ordinary Shares outstanding, basic and diluted 94,711,604 82,064,519 91,611,785 81,850,662 Net loss per Ordinary Share, basic and diluted ( 0.41 ) ( 0.47 ) ( 1.45 ) ( 0.98 ) |
Schedule of Antidilutive Securities Excluded from Computation of Diluted Weighted-average Ordinary Shares Outstanding | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average Ordinary Shares outstanding as they would be anti-dilutive: As at June 30, 2024 2023 Stock options 19,778,254 13,966,164 Outstanding warrants 2,700,152 4,017,321 Total 22,478,406 17,983,485 |
The Company - Additional Inform
The Company - Additional Information (Details) $ in Thousands | Jun. 30, 2024 USD ($) | Jun. 30, 2024 € / shares | Dec. 31, 2023 USD ($) | Dec. 31, 2023 € / shares |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Ordinary shares, par value | € / shares | € 0.12 | € 0.12 | ||
Accumulated deficit | $ 449,747 | $ 316,973 | ||
Cash | $ 430,708 | $ 340,450 |
Revenue - License Revenue (Deta
Revenue - License Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | ||||
License revenue attributed from license performance obligation | $ 5,385 | |||
License revenue attributed from R&D performance obligation | $ 2,279 | $ 1,717 | $ 3,680 | 4,961 |
Total revenue | $ 2,279 | $ 1,717 | $ 3,680 | $ 10,346 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Liabilities Recognized at Fair Value on Recurring Basis (Details) - Recurring - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Total financial liabilities | $ 36,939 | $ 20,362 |
Derivative | ||
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Derivative earnout liability | 13,394 | 7,788 |
Derivative | Public Warrants | ||
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Total financial liabilities | 22,089 | 12,051 |
Derivative | Private Placement Warrants | ||
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Total financial liabilities | 1,456 | 523 |
Level 1 | ||
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Total financial liabilities | 22,089 | 12,051 |
Level 1 | Derivative | Public Warrants | ||
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Total financial liabilities | 22,089 | 12,051 |
Level 2 | ||
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Total financial liabilities | 1,456 | 523 |
Level 2 | Derivative | Private Placement Warrants | ||
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Total financial liabilities | 1,456 | 523 |
Level 3 | ||
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Total financial liabilities | 13,394 | 7,788 |
Level 3 | Derivative | ||
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Derivative earnout liability | $ 13,394 | $ 7,788 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Estimated Fair Value of Derivative Earnout Liability (Details) | Jun. 30, 2024 | Dec. 31, 2023 |
Share Value (USD) | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 19.21 | 11.17 |
Probability of Milestone Completion | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 40 | 40 |
Dividend Yield | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0 | 0 |
Strike Price (USD) | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0 | 0 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Reconciliation of Earnout Liability Measured on Recurring Basis Using Level 3 Inputs (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Change in fair value | $ (6,200) |
Recurring | Level 3 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Beginning balance | 7,788 |
Change in fair value | $ 5,606 |
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Change in Fair Value of Earnout and Warrants |
Ending balance | $ 13,394 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Level 3 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Sales, purchase and settlements | $ 0 |
Prepayments and Other Receiva_3
Prepayments and Other Receivables - Schedule of Prepayments and Other Receivables (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development costs | $ 6,994 | $ 2,337 |
Other prepaid expenses | 2,244 | 2,123 |
Value added tax receivable | 3,272 | 1,006 |
Other receivables | 2,134 | 875 |
Total prepayments and other receivables | $ 14,644 | $ 6,341 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accounts Payable and Accrued Liabilities, Current [Abstract] | ||
Accrued research and development materials and services | $ 6,419 | $ 5,945 |
Accrued compensation and benefits | 2,317 | 3,384 |
Accrued professional fees and other | 1,458 | 2,069 |
Total accrued expenses and other current liabilities | $ 10,194 | $ 11,398 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) $ / shares in Units, $ in Millions | Feb. 16, 2024 USD ($) $ / shares shares | Jun. 30, 2024 € / shares shares | Dec. 31, 2023 € / shares shares |
Class of Stock [Line Items] | |||
Ordinary shares, authorized | 400,000,000 | 400,000,000 | |
Ordinary shares, par value | € / shares | € 0.12 | € 0.12 | |
Shares outstanding | 90,015,357 | 82,469,768 | |
Pre-Funded Warrants | |||
Class of Stock [Line Items] | |||
Offering price | $ / shares | $ 18.9999 | ||
Exercise price of pre-funded warrant | $ / shares | $ 0.0001 | ||
Number of warrants to purchase of ordinary shares | 4,736,841 | ||
Underwritten Public Offering | |||
Class of Stock [Line Items] | |||
Ordinary shares issued | 5,871,909 | ||
Offering price | $ / shares | $ 19 | ||
Shares issued | 5,871,909 | ||
Ordinary shares issued and sold in offering | 1,383,750 | ||
Net proceeds from offering | $ | $ 190 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) | 6 Months Ended | 12 Months Ended | |||
Jul. 21, 2021 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Jan. 01, 2024 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of options, granted | 4,541,148 | ||||
Weighted average grant date fair value of options | $ 6.3 | $ 4.86 | |||
Total intrinsic value of stock options exercised | $ 8,000,000 | $ 100,000 | |||
Weighted average remaining vesting period | 3 years 2 months 12 days | ||||
Unrecognized Compensation Cost | $ 37,700,000 | ||||
Underlying ordinary shares | $ 838,806 | ||||
Liability for unvested ordinary shares | 100,000 | ||||
Ordinary shares vested | 596,096 | 519,999 | |||
Volatility ordinary shares | 10% | ||||
Increase in volatility weight percentage of ordinary share per calendar quarter | 5% | ||||
Chief Executive Officer | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
Liability for unvested ordinary shares | 0 | ||||
Share-Based Payment Arrangement, Tranche One | Chief Executive Officer | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Award vesting percentage | 25% | ||||
Share-Based Payment Arrangement, Tranche Two | Chief Executive Officer | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
Award vesting percentage | 75% | ||||
Employee Stock Option | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Ordinary shares reserved for issuance | 22,049,356 | ||||
Percentage of ordinary shares reserved for grant will increase annually of issued and outstanding shares | 5% | ||||
Contractual term | 10 years | ||||
Vesting period | 4 years | ||||
Employee Stock Option | Share-Based Payment Arrangement, Tranche One | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Award vesting percentage | 25% | ||||
Employee Stock Option | Share-Based Payment Arrangement, Tranche Two | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
Award vesting percentage | 75% | ||||
Restricted Stock Units (RSUs) | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Earnout shares | 143,002 | 143,002 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Stock Options Outstanding (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | |
Number of options, beginning balance | shares | 15,783,509 |
Number of options, granted | shares | 4,541,148 |
Number of options, exercised | shares | (546,403) |
Number of options, ending balance | shares | 19,778,254 |
Number of options, exercisable | shares | 6,888,620 |
Weighted average exercise price, beginning balance | $ / shares | $ 7.98 |
Weighted average exercise price, granted | $ / shares | 13.61 |
Weighted average exercise price, exercised | $ / shares | 1.27 |
Weighted average exercise price, ending balance | $ / shares | 9.45 |
Weighted average exercise price, exercisable | $ / shares | $ 6.01 |
Weighted average remaining contractual term (in years) | 8 years 6 months |
Weighted average remaining contractual term (in years), exercisable | 7 years 9 months 18 days |
Aggregate intrinsic value | $ | $ 195,399 |
Aggregate intrinsic value, exercisable | $ | $ 90,930 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Weighted Average Assumptions (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | ||
Expected life (years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Risk-free rate | 3.90% | 3.90% |
Volatility | 41.40% | 38.40% |
Dividend yield | $ 0 | $ 0 |
Share-Based Compensation - Su_3
Share-Based Compensation - Summary of Share-based Compensation As Classified In The Consolidated Statement Of Operations And Comprehensive Loss (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 | $ 8,290 | $ 5,558 | $ 16,208 | $ 13,174 |
Research and Development Expense | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total | 2,992 | 3,730 | 6,471 | 8,219 |
Selling, General and Administrative Expenses | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total | $ 5,298 | $ 1,828 | $ 9,737 | $ 4,955 |
Share-Based Compensation - Su_4
Share-Based Compensation - Summary of Movements In The Number Of Ordinary Shares Outstanding (Details) | Jun. 30, 2024 shares |
Share-Based Payment Arrangement [Abstract] | |
Outstanding, Beginning Balance | 608,779 |
Outstanding, Ending Balance | 608,779 |
Net Loss Per Ordinary Share - S
Net Loss Per Ordinary Share - Summary of Basic And Diluted Net Loss Per Ordinary Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Earnings Per Share [Abstract] | ||||
Net Income (Loss) | $ (39,007) | $ (38,291) | $ (132,774) | $ (80,309) |
Weighted Average Ordinary Shares Outstanding, Basic | 94,711,604 | 82,064,519 | 91,611,785 | 81,850,662 |
Weighted Average Ordinary Shares Outstanding, Diluted | 94,711,604 | 82,064,519 | 91,611,785 | 81,850,662 |
Net Loss Per Ordinary Share, Basic | $ (0.41) | $ (0.47) | $ (1.45) | $ (0.98) |
Net Loss Per Ordinary Share, Diluted | $ (0.41) | $ (0.47) | $ (1.45) | $ (0.98) |
Net Loss Per Ordinary Share -_2
Net Loss Per Ordinary Share - Summary of Potentially Dilutive Securities Have Been Excluded From The Computation Of Diluted Weighted-average Ordinary Shares Outstanding (Details) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 22,478,406 | 17,983,485 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 19,778,254 | 13,966,164 |
Outstanding warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,700,152 | 4,017,321 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Loss Contingencies [Line Items] | |
Estimated maximum cancellation fees | $ 18.1 |
Percentage of development costs incurred | 50% |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) $ in Millions | 6 Months Ended | ||
Jun. 30, 2024 USD ($) | Jul. 29, 2024 USD ($) | Dec. 31, 2023 | |
Subsequent Event [Line Items] | |||
Change in fair value recognized through earnings | $ 6.2 | ||
Probability of Milestone Completion | |||
Subsequent Event [Line Items] | |||
Derivative liability, measurement input | 40 | 40 | |
Subsequent Event | |||
Subsequent Event [Line Items] | |||
Fair value of earnout liability | $ 19.5 | ||
Subsequent Event | Probability of Milestone Completion | |||
Subsequent Event [Line Items] | |||
Derivative liability, measurement input | 65 |