| For the three months ended September 30, | For the nine months ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (In thousands of USD, except per share amounts) | |||||||||||||||
| Revenue | 29,111 | 2,941 | 32,791 | 13,287 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development expenses | 35,702 | 43,371 | 116,511 | 118,132 | |||||||||||
| Selling, general and administrative expenses | 18,412 | 9,128 | 49,340 | 27,048 | |||||||||||
| Total operating expenses | 54,114 | 52,499 | 165,851 | 145,180 | |||||||||||
| Operating loss | (25,003) | (49,558) | (133,060) | (131,893) | |||||||||||
| Other income (expense): | |||||||||||||||
| Interest income | 4,443 | 3,059 | 12,396 | 8,615 | |||||||||||
| Fair value change – earnout and warrants | (770) | 2,521 | (30,028) | (4,004) | |||||||||||
| Foreign exchange gains/(losses) | 4,682 | (3,155) | 1,270 | (160) | |||||||||||
| Loss before tax | (16,648) | (47,133) | (149,422) | (127,442) | |||||||||||
| Income tax expense | (1) | — | (1) | — | |||||||||||
| Loss and comprehensive loss for the period | (16,647) | (47,133) | (149,421) | (127,442) | |||||||||||
| Net loss per ordinary share | |||||||||||||||
| Basic and diluted | $ | (0.18) | $ | (0.57) | $ | (1.61) | $ | (1.55) | |||||||
| For the nine months ended September 30, | |||||||
| 2024 | 2023 | ||||||
| (In thousands of USD) | |||||||
| Operating activities: | |||||||
| Loss for the period | (149,421) | (127,442) | |||||
| Non-cash adjustments to reconcile loss before tax to net cash flows: | |||||||
| Depreciation and amortization | 62 | 36 | |||||
| Non-cash rent expense | 8 | 5 | |||||
| Fair value change - derivative earnout and warrants | 30,028 | 4,004 | |||||
| Foreign exchange (gains)/losses | (1,270) | 160 | |||||
| Share-based compensation | 24,204 | 18,566 | |||||
| Changes in working capital: | |||||||
| Changes in prepayments (current and non-current) and other receivables | (8,769) | 988 | |||||
| Changes in accounts payable | (9,751) | (7,824) | |||||
| Changes in accrued expenses and other current liabilities | (708) | 11,266 | |||||
| Changes in deferred revenue | (5,466) | (7,903) | |||||
| Net cash (used in)/provided by operating activities | (121,083) | (108,144) | |||||
| Investing activities: | |||||||
| Purchase of property, plant and equipment, including internal use software | (669) | (21) | |||||
| Net cash used in investing activities | (669) | (21) | |||||
| 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 | 8,622 | |||||
| Proceeds from exercise of options | 498 | 290 | |||||
| Payment of withholding taxes related to net share settlement of exercised options | (989) | — | |||||
| Net cash provided by financing activities | 202,896 | 8,912 | |||||
| Net change in cash | 81,144 | (99,253) | |||||
| Foreign exchange differences | 1,135 | (168) | |||||
| Cash at the beginning of the period | 340,450 | 467,728 | |||||
| Cash at the end of the period | 422,729 | 368,307 | |||||
| Noncash financing and investing activities | |||||||
| Right-of-use assets obtained in exchange for new operating lease liabilities | 562 | — | |||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| (In thousands of USD) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| License revenue attributed from license performance obligation | 27,325 | — | 27,325 | 5,385 | ||||||||||||
| License revenue attributed from R&D performance obligation | 1,786 | 2,941 | 5,466 | 7,902 | ||||||||||||
| Total revenue | 29,111 | 2,941 | 32,791 | 13,287 | ||||||||||||
| For the three months ended September 30, | ||||||||||||
| (In thousands of USD) | 2024 | 2023 | Change | |||||||||
| Clinical expenses | 24,083 | 30,638 | (6,555) | |||||||||
| Non-clinical expenses | 707 | 1,168 | (461) | |||||||||
| Personnel expenses | 5,448 | 4,666 | 782 | |||||||||
| Manufacturing costs | 4,612 | 6,554 | (1,942) | |||||||||
| Regulatory expenses | 819 | 301 | 518 | |||||||||
| Other research and development costs | 33 | 44 | (11) | |||||||||
| Total research and development expenses | 35,702 | 43,371 | (7,669) | |||||||||
| For the three months ended September 30, | ||||||||||||
| (In thousands of USD) | 2024 | 2023 | Change | |||||||||
| Personnel expense | 10,729 | 4,263 | 6,466 | |||||||||
| Intellectual property | 640 | 500 | 140 | |||||||||
| Legal costs | 639 | 769 | (130) | |||||||||
| Finance and administration | 1,135 | 1,275 | (140) | |||||||||
| Marketing and communication | 3,546 | 1,142 | 2,404 | |||||||||
| Commission expense | 49 | 121 | (72) | |||||||||
| Facility-related and other costs | 1,674 | 1,058 | 616 | |||||||||
| Total selling, general and administrative expenses | 18,412 | 9,128 | 9,284 | |||||||||
