17. Income Taxes

For the years ending December 31, 2025, and December 31, 2024, the Company recognized current state income tax expense of $0.4 million and $0.3 million, respectively, recorded under selling, general and administrative expense. The Company’s current year profit and historical losses before income tax for the periods presented was generated entirely in the United States.

 

Reconciliation of the differences between the effective income tax rate and federal statutory rate for the year ended December 31, 2025 (in thousands):

 

 

 

Amount

 

 

Percent

 

 

Income tax computed at federal statutory rate

 

$

(59,830

)

 

 

21.0

 

 %

State taxes, net of federal benefit

 

 

342

 

 

 

(0.1

)

 

Tax Credits

 

 

 

 

 

 

 

Research and development

 

 

2,529

 

 

 

(0.9

)

 

Orphan drug

 

 

(26,991

)

 

 

9.5

 

 

Nontaxable or Nondeductible items

 

 

 

 

 

 

 

Stock option deduction

 

 

3,060

 

 

 

(1.1

)

 

Non-deductible officer compensation

 

 

3,234

 

 

 

(1.1

)

 

Other

 

 

202

 

 

 

(0.1

)

 

Other Adjustments

 

 

 

 

 

 

 

Other

 

 

363

 

 

 

(0.1

)

 

Change in valuation allowance

 

 

77,524

 

 

 

(27.3

)

 

Effective tax rate

 

$

433

 

 

 

(0.2

)

 %

 

As previously disclosed for the years ended December 31, 2024, and 2023, prior to the adoption of ASU 2023-09, the following is a reconciliation of the difference between the effective income tax rate and the federal statutory rate:

 

 

 

Years Ended December 31,

 

 

 

2024

 

 

2023

 

Income tax computed at federal statutory rate

 

 

21.0

%

 

 

21.0

%

State taxes, net of federal benefit

 

 

-0.1

%

 

 

13.2

%

General business credit carryovers

 

 

1.1

%

 

 

1.5

%

Non-deductible expenses

 

 

-1.0

%

 

 

-1.0

%

Change in valuation allowance

 

 

-17.3

%

 

 

-34.9

%

Return to provision true up

 

 

-3.8

%

 

 

0.0

%

Other

 

 

0.0

%

 

 

0.0

%

 

 

 

-0.1

%

 

 

-0.2

%

 

The significant components of the Company’s deferred tax are as follows (in thousands):

 

 

 

Years Ended
December 31,

 

 

 

2025

 

 

2024

 

Deferred tax assets (liabilities):

 

 

 

 

 

 

Net operating loss carryforwards

 

$

135,517

 

 

$

43,362

 

Research and development credits

 

 

13,519

 

 

 

16,074

 

Orphan drug credits

 

 

26,991

 

 

 

 

Capitalized start-up and other costs

 

 

80,089

 

 

 

84,870

 

Capitalized research and development costs

 

 

59,475

 

 

 

97,780

 

Equity based compensation

 

 

15,348

 

 

 

13,687

 

Accruals

 

 

5,021

 

 

 

2,829

 

Disallowed interest

 

 

2,489

 

 

 

 

Other temporary differences

 

 

1,257

 

 

 

36

 

Deferred tax assets before valuation allowance

 

 

339,706

 

 

 

258,638

 

Valuation allowances

 

 

(339,706

)

 

 

(258,638

)

Net deferred tax assets

 

$

 

 

$

 

 

Supplemental disclosure of cash paid during the period for income taxes (net of refunds received):

 

 

 

Year Ended December 31,

 

 

 

2025

 

Tennessee

 

$

0.07

 

New York

 

 

0.06

 

Massachusetts

 

 

0.01

 

Other

 

 

0.01

 

Total cash taxes paid, net of refunds received

 

$

0.15

 

 

The One Big Beautiful Bill Act, or OBBBA, was signed into law on July 4, 2025. The OBBBA includes significant changes affecting business taxpayers, with various effective dates. Among the provisions impacting the Company is Section 174A, which permits current expensing of domestic research and experimental, or R&E, expenditures. The Company elected to currently deduct domestic R&E costs incurred during the year and did not elect to accelerate deductions for domestic R&E costs capitalized in prior years. Foreign R&E expenditures continue to be amortized over 15 years under Section 174.

 

For the fiscal year ended December 31, 2025, the Company was subject to the Section 163(j) business interest expense limitation based on its average annual gross receipts (as determined under Section 448(c)). For tax

years beginning after December 31, 2024, the OBBBA modifies the Section 163(j) Adjusted Taxable Income (“ATI”) calculation to allow an add-back for depreciation and amortization.

 

The Company has provided a valuation allowance for the full amount of the net deferred tax assets as the realization of the deferred tax assets is not determined to be more likely than not. The valuation allowance increased by $81.1 million in 2025 due to the increase in deferred tax assets, primarily driven by the generation of net operating losses, and capitalized research expenses. The valuation allowance increased by $52.7 million in 2024 due to the increase in deferred tax assets, primarily driven by the generation of net operating losses and capitalized research expenses, and capitalized start-up costs.

 

As of December 31, 2025, the Company had approximately $585.3 million and $227.7 million in federal and state net operating losses, or NOLs, respectively, which may be available to offset future taxable income. The Company has generated federal NOLs of $563.2 million and state NOLs of $8.7 million which have indefinite carryforward period. The remaining $22.1 million of federal NOLs and $219.0 million the Company’s state NOLs will begin to expire at various dates starting in 2026. Effective January 1, 2024, the Company has been reclassified as an active trade or business for tax purposes. This resulted in a reclassification of capitalized start-up and other costs to net operating losses and valuation allowance in the 2025 tax statements.

 

As of December 31, 2025, the Company had available research and development and orphan drug tax credits of approximately $9.8 million and $27.0 million, respectively. Income tax credits began to expire in 2024.

 

Realization of future tax benefits is dependent on many factors, including the Company’s ability to generate taxable income within the net operating loss carryforward period. Under the Internal Revenue Code provisions, certain substantial changes in the Company’s ownership, including the sale of the Company or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss carryforwards which could be used annually to offset future taxable income. The Company last completed an analysis from January 1, 2023 through December 31, 2023 and determined that no ownership changes had occurred in that period. Prior analyses determined that on March 30, 2007, August 21, 2015 and May 4, 2020, ownership changes had occurred. The Company may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. As a result, its ability to use its pre- change NOLs to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed.

As of December 31, 2025, and 2024, the Company had uncertain tax positions of $0.1 million related to research and development credits, which reduce the deferred tax assets with a corresponding decrease to the valuation allowance. The Company has elected to recognize interest and penalties related to income tax matters as a component of income tax expense, of which no interest or penalties were recorded for the years ended December 31, 2025 and 2024. The Company expects none of the unrecognized tax benefits to decrease within the next 12 months related to expired statutes or settlement with the taxing authorities. Due to the Company’s valuation allowance as of December 31, 2025, none of the Company’s unrecognized tax benefits, if recognized, would affect the effective tax rate.

 

A reconciliation of the Company’s unrecognized tax benefits is as follows (in thousands):

 

 

 

Years Ended December 31,

 

 

 

2025

 

 

2024

 

 

2023

 

Unrecognized tax benefit--beginning of year

 

$

143

 

 

$

143

 

 

$

143

 

Decreases related to prior period positions

 

 

 

 

 

 

 

 

 

Unrecognized tax benefit--end of year

 

$

143

 

 

$

143

 

 

$

143

 

The Company files tax returns in the U.S. and various states. All tax years since inception (October 11, 2005) remain open to examination by major tax jurisdictions to which the Company is subject, as carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service or state tax authorities if they have or will be used in a future period. The Company is currently not under examination by the Internal Revenue Service or any other jurisdictions for any tax years.

Historical Timeline

Fiscal YearFiled
2025Feb 26, 2026Showing above
2024Mar 3, 2025
2023Feb 27, 2024
2022Feb 28, 2023
2021Mar 1, 2022
2020Mar 12, 2021
2019Mar 5, 2020
2018Mar 7, 2019
2017Mar 8, 2018
2016Mar 14, 2017

About Income Taxes Disclosures

The income tax disclosure reveals how much a company actually pays in taxes versus what the statutory rate would predict. Analysts focus on the effective tax rate (ETR) reconciliation, which breaks down every item driving the gap between the 21% federal rate and the company's reported ETR — including R&D credits, foreign rate differentials, and state taxes. Deferred tax assets (DTAs) and their valuation allowances signal management's confidence in future profitability: a rising allowance suggests the company doubts it can use accumulated tax benefits. Uncertain tax benefit (UTB) reserves quantify exposure to IRS challenges on aggressive positions.

Key signals to watch: sudden ETR drops without clear operational reasons, large increases in valuation allowances, growing UTB balances, and significant unremitted foreign earnings. Post-TCJA, pay attention to GILTI and BEAT provisions that affect multinational tax structures. Compare the cash taxes paid (from the cash flow statement) against the income tax provision to gauge earnings quality.