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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2025
Sep. 30, 2024
Sep. 30, 2025
Sep. 30, 2024
Revenue:        
Total revenue $ 13,129 $ 9,300 $ 36,219 $ 11,564
Operating costs and expenses:        
Cost of product revenue [1] 1,088 806 2,607 894
Research and development [2] 8,046 57,850 28,260 119,344
Selling, general and administrative 15,018 12,955 48,357 48,973
Total operating costs and expenses 24,152 71,611 79,224 169,211
Loss from operations (11,023) (62,311) (43,005) (157,647)
Other income:        
Other income, net [3] 553 1,572 1,586 6,165
Total other income, net 553 1,572 1,586 6,165
Net loss (10,470) (60,739) (41,419) (151,482)
Other comprehensive income (loss)        
Unrealized (loss), net of tax (2) (6) (36) (5)
Comprehensive loss $ (10,472) $ (60,745) $ (41,455) $ (151,487)
Net loss per share attributable to common stockholders, basic $ (0.06) $ (0.51) $ (0.3) $ (1.28)
Net loss per share attributable to common stockholders,diluted $ (0.06) $ (0.51) $ (0.3) $ (1.28)
Weighted-average common shares outstanding, basic 170,169,865 119,495,284 136,874,025 118,163,599
Weighted-average common shares outstanding, diluted 170,169,865 119,495,284 136,874,025 118,163,599
Product revenue        
Revenue:        
Total revenue $ 13,129 $ 9,300 $ 36,219 $ 11,564
[1] Includes related-party amounts of $525 and $1,449 for the three and nine months ended September 30, 2025, respectively, and related-party amounts of $463 for both the three and nine months ended September 30, 2024 (see Note 15).
[2] Includes related-party amounts of $1,158 and $3,426 for the three and nine months ended September 30, 2025, respectively, and $1,133 and $3,399 for the three and nine months ended September 30, 2024, respectively (see Note 15).
[3] Includes interest income of $554 and $1,563 for the three months ended September 30, 2025 and 2024, respectively and interest income of $1,587 and $6,325 for the nine months ended September 30, 2025 and 2024, respectively.