Income Taxes
For the three years in the period ended December 31, 2025, domestic and foreign pre-tax loss were:
| | | | | | | | | | | | | | | | | |
| Year ended December 31, |
| 2025 | | 2024 | | 2023 |
| Loss before income taxes - Domestic | $ | (453,630) | | | $ | (297,441) | | | $ | (208,829) | |
| Loss before income taxes - Foreign | (11,507) | | | (497) | | | (502) | |
| Loss before income taxes - Consolidated | $ | (465,137) | | | $ | (297,938) | | | $ | (209,331) | |
The components of income tax expense are as follows in the period ended December 31, 2025:
| | | | | | | | | | | | | | | | | |
| Year ended December 31, |
| 2025 | | 2024 | | 2023 |
| Current expense: | | | | | |
| U.S. Federal | $ | — | | | $ | — | | | $ | — | |
| State | — | | | — | | | — | |
| Foreign | 180 | | | — | | | — | |
| Total current expense (benefit) | 180 | | | — | | | — | |
| | | | | |
| Deferred expense: | — | | | — | | | — | |
| U.S. Federal | — | | | — | | | — | |
| State | — | | | — | | | — | |
| Foreign | — | | | — | | | — | |
| Total deferred expense (benefit) | — | | | — | | | — | |
| | | | | |
| Total expense (benefit) | $ | 180 | | | $ | — | | | $ | — | |
A reconciliation of income tax expense to the amount computed by applying the statutory federal income tax rate to the loss from operations for the three years in the period ended December 31, 2025 is as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| Year ended December 31, |
| 2025 | | 2024 | | 2023 |
| Tax computed at federal statutory rate | $ | (97,679) | | 21.00 | % | | $ | (62,666) | | 21.00 | % | | $ | (45,051) | | 21.00 | % |
| State tax, net of federal income tax effect (1) | (884) | | 0.19 | % | | (593) | | 0.20 | % | | (375) | | 0.17 | % |
| Foreign tax effects | 2,595 | | (0.56) | % | | 104 | (0.03) | % | | 105 | (0.05) | % |
| Non-taxable or nondeductible items | | | | | | | | |
| Stock-based compensation | 104 | | (0.02) | % | | (7,395) | | 2.47 | % | | 1,252 | | (0.58) | % |
| Other | 4,208 | | (0.90) | % | | 2,487 | | (0.84) | % | | 167 | | (0.08) | % |
| Changes in valuation allowance | 108,651 | | (23.36) | % | | 84,071 | | (28.17) | % | | 56,780 | | (26.47) | % |
| Tax credits | | | | | | | | |
| Federal R&D credits (2) | (20,550) | | 4.42 | % | | (19,527) | | 6.54 | % | | (15,455) | | 7.20 | % |
| Other tax credits | (240) | | 0.05 | % | | — | | — | % | | — | | — | % |
| Changes in unrecognized tax benefits | 3,966 | | (0.85) | % | | 3,515 | | (1.18) | % | | 2,691 | | (1.25) | % |
| Other adjustments | | | | | | | | |
| Other | 9 | | (0.01) | % | | 4 | | 0.01 | % | | (114) | | 0.06 | % |
| Provision for income taxes | $ | 180 | | (0.04) | % | | $ | — | | — | % | | $ | — | | — | % |
(1) The states that contribute to the majority (greater than 50%) of the tax effect in this category include California for 2025, 2024, and 2023.
(2) Federal R&D credits include research and development and orphan drug credits.
A summary of income taxes paid, net of refunds received, for the year ended December 31, 2025, 2024, and 2023 are as follows:
| | | | | | | | | | | | | | | | | |
| Year ended December 31, |
| 2025 | | 2024 | | 2023 |
| Foreign | | | | | |
| Australia | 89 | | | — | | | — | |
| Income taxes paid, net | $ | 89 | | | $ | — | | | $ | — | |
Deferred tax assets and liabilities
Net deferred tax assets are comprised of the following as of December 31, 2025 and 2024:
| | | | | | | | | | | |
| December 31, |
| 2025 | | 2024 |
| Deferred tax assets: | | | |
| Net operating loss carryforwards | $ | 201,110 | | | $ | 109,135 | |
| Capitalized research expenses | 71,799 | | | 83,785 | |
| R&D and other tax credits | 79,999 | | | 57,901 | |
| Stock-based compensation | 23,420 | | | 18,090 | |
| Lease liabilities | 10,490 | | | 11,592 | |
| Accrued expenses and other, net | 11,035 | | | 7,488 | |
| Equity method investment | 3,418 | | | 3,544 | |
| Total deferred tax assets | 401,271 | | | 291,535 | |
| Less: valuation allowance | (392,031) | | | (281,784) | |
| Total deferred tax assets after valuation allowance | 9,240 | | | 9,751 | |
| Deferred tax liabilities: | | | |
| Right-of use assets | (8,750) | | | (9,751) | |
| Other deferred tax liabilities | (490) | | | — | |
| Total deferred tax liabilities | (9,240) | | | (9,751) | |
| | | |
| Net deferred tax assets | $ | — | | | $ | — | |
Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use existing deferred tax assets. Based on the weight of available evidence, including the Company's history of operating losses, management has determined that it is more likely than not that the Company’s net deferred tax assets will not be realized. Accordingly, a valuation allowance has been established by the Company to fully offset these net deferred tax assets.
The Company is subject to taxation in the U.S., various state jurisdictions, Australia, Switzerland, Germany, Netherlands and Brazil; however, as it has operated at a loss since inception, it has not paid income taxes in any of the jurisdictions in which it has operated, except Australian withholding taxes. At December 31, 2025, the Company had federal, state, and foreign net operating loss (“NOL”) carryforwards of approximately $861.8 million, $258.1 million and $14.2 million, respectively. The federal loss carryforwards generated after 2017 of $855.4 million will carry forward indefinitely and can be used to offset up to 80% of future annual taxable income, while those loss carryforwards generated prior to 2018 begin expiring in 2035, unless previously utilized. $5.1 million of the state loss carryforwards will carry forward indefinitely. The other state loss carryforwards begin expiring in 2035, unless previously utilized. Of the Company's foreign loss carryforwards, $10.1 million begin expiring in 2032, unless previously utilized, and the remaining loss carryforwards do not expire. The Company also has federal and California R&D credit carryforwards and federal Orphan Drug Credits totaling $42.4 million, $21.5 million, and $34.5 million, respectively. The federal R&D credits begin to expire in 2030, unless previously utilized, while the state credits do not expire. The federal Orphan Drug credit carryforwards will begin to expire in 2040, unless previously utilized.
The Company’s NOL and credit carryforwards to offset future taxable income may be subject to a substantial annual limitation upon future utilization as a result of ownership changes that could occur in the future pursuant to Internal Revenue Code Sections 382 and 383. These ownership changes may limit the amount of NOL and credit carryforwards that can be utilized to offset future taxable income and tax, respectively. In general, an 'ownership change' as defined by the tax code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percent of the outstanding stock of a company by certain stockholders or public groups. During 2020, the Company completed a study to assess whether an ownership change within the meaning of Section 382 had occurred for the time period prior to July 15, 2020. The study identified several such ownership changes during the study period, which resulted in limitations on the annual utilization of the Company's NOL and credit carryforwards, or the “Tax Attribute” carryforwards; however, the study findings also indicated that none of the Company's Tax Attribute carryforwards generated during the study period would expire solely as a result of annual limitations on the utilization of such Tax
Attribute carryforwards. The Company updated the study for 2022 through 2025 and did not identify any additional ownership changes. Future ownership changes could still occur which might place further limits on the Company's ability to utilize its Tax Attribute carryforwards.
The Company’s federal income tax returns from 2023 forward, state income tax returns from 2022 forward, and its Australian tax returns beginning in 2022 are subject to examination by tax authorities; however, the Company's tax attribute carryforwards such as NOLs and R&D credits generated in closed years remain subject to adjustment by the taxing authorities until the future tax years in which those attributes are utilized are closed to statute. No such audits are underway.
Changes to the Company’s unrecognized tax benefits are summarized in the following table:
| | | | | | | | | | | | | | | | | |
| Year ended December 31, |
| 2025 | | 2024 | | 2023 |
| Beginning balance | $ | 10,689 | | | $ | 6,946 | | | $ | 4,110 | |
| Increase (decrease) for prior year tax positions | (20) | | | (85) | | | 188 | |
| Increase (decrease) for current year tax positions | 4,083 | | | 3,828 | | | 2,648 | |
| Decreases due to settlements | — | | | — | | | — | |
| Expiration of the statute of limitations for the assessment of taxes | — | | | — | | | — | |
| Ending balance | $ | 14,752 | | | $ | 10,689 | | | $ | 6,946 | |
Due to the existence of the valuation allowance, future changes in unrecognized tax benefits would not have any effect on the Company’s effective tax rate. There have been no decreases in unrecognized tax benefits due to settlements or expiration of statute of limitations for the assessment of taxes during the years ended December 31, 2025, 2024 and 2023.
The Company’s policy is to recognize the interest expense and/or penalties related to income tax matters as a component of income tax expense. The Company had no accrual for interest or penalties on its consolidated balance sheets as of December 31, 2025 or December 31, 2024, and has not recognized interest and/or penalties in its consolidated statements of operations for the years ended December 31, 2025, 2024, and 2023 as the unrecognized tax benefits relate to tax positions for which no cash tax liability has been reduced.
Deferred income taxes have not been provided for undistributed earnings of the Company’s consolidated foreign subsidiaries because the Parent entity would not be required to include the distribution into income as the amount would be tax free. The Company has no foreign withholding tax liability as of December 31, 2025 as a result of losses in foreign subsidiaries.
The Tax Cuts and Jobs Act subjects a U.S. shareholder to tax on Global Intangible Low-Taxed Income ("GILTI") earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740 No. 5. Accounting for Global Intangible Low-Taxed Income, states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. We have elected to account for GILTI in the year the tax is incurred.