Income Taxes | 9. Income Taxes For the years ended December 31, 2021 and 2020, the Company recorded income tax expense of $ 2,000 and $ 3,000 , respectively. The Company has incurred net operating losses for all periods presented. The Company has not reflected any benefit of such net operating loss carryforwards in the accompanying consolidated financial statements. The U.S. federal and state deferred tax assets generated from the Company have been fully reserved, as the Company believes it is not more likely than not that the benefit will be realized. The effective tax rate of the provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2021 2020 U.S. federal taxes at statutory rate 21.0 % 21.0 % State taxes (net of federal benefit) 0.8 2.3 Non-deductible expenses ( 0.2 ) ( 0.3 ) Credits 8.1 11.9 Change in valuation allowance ( 13.1 ) ( 34.9 ) Derecognition due to Section 383 Limitations ( 16.7 ) — Other 0.1 — Effective tax rate —% — % Deferred Tax Assets The tax effects of temporary differences and carryforwards that give rise to significant portions of deferred tax assets are as follows: December 31, 2021 2020 (in thousands) Deferred tax assets: Net operating loss carryforwards $ 24,827 $ 16,007 Tax credits carryforwards 3,997 7,661 Capitalized start-up costs 546 644 Accrued expenses 436 198 Stock-based compensation 316 64 Other 5 1 Total gross deferred tax assets 30,127 24,575 Less: valuation allowance ( 30,127 ) ( 24,575 ) Total deferred tax assets, net $ — $ — The realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. The Company has established a valuation allowance to offset deferred tax assets as of December 31, 2021 and 2020 due to the uncertainty of realizing future tax benefits from its net operating loss carryforwards and other deferred tax assets. Accordingly, the deferred tax assets have been fully offset by a valuation allowance. The changes in the valuation allowance for the years ended December 31, 2021 and 2020 were $ 5.6 million and $ 6.2 million, respectively. Net Operating Loss and Tax Credit Carryforwards The Company has federal net operating loss carryforwards, or NOLs, of $ 106.9 million as of December 31, 2021 which will begin to expire in 2033 except for $ 76.9 million of the NOLs that can be carried forward indefinitely . As a result of the U.S. Tax Cuts and Jobs Act, for U.S. income tax purposes, federal NOLs generated in tax years beginning before January 1, 2018 can still be carried forward for up to 20 years , but NOLs generated for tax years beginning after December 31, 2017 can be carryforward indefinitely and are limited to 80 % utilization against taxable income. As of December 31, 2021, the Company has state NOLs for California of $ 0.4 million, Massachusetts of $ 34.1 million, and New Hampshire of $ 2.7 million. The state NOLs, if not utilized, will expire beginning in 2033 and 2034 . If the Company experiences a greater than 50 percentage point aggregate change in ownership over a three-year period (a Section 382 ownership change), utilization of its pre-change NOL carryforwards are subject to annual limitation under Section 382 of the Internal Revenue Code, or IRC. The annual limitation is deemed by multiplying the value of the Company’s stock at the time of such ownership change by the applicable long-term tax-exempt rate. Such limitations may result in expiration of a portion of the NOL carryforwards before utilization. As of December 31, 2020, the Company determined that ownership changes occurred on October 30, 2014 and November 12, 2020. As a result of the ownership changes, none of the NOLs will expire unutilized for federal, California and Massachusetts purposes, respectively. During the year ended December 31, 2021, the Company completed an analysis and determined that no ownership change occurred under Section 382. Therefore, no derecognized NOL related deferred tax assets in the tax effected amounts for federal and California purposes, respectively. The ability of the Company to use its remaining NOL carryforwards may be further limited if the Company experiences a Section 382 ownership change as a result of future changes in its stock ownership. As of December 31, 2021, Company has federal research and development, or R&D, credit carryforwards of approximately $ 0.1 million which will begin to expire in 2040 for federal tax purposes. As of December 31, 2021, the Company has California R&D credit carryforwards of approximately $ 0.4 million which can be carried forward indefinitely and Massachusetts R&D credit carryforwards of approximately $ 0.2 million which will expire in 2032 . Research and development credits are subject to IRC Section 383. In the event of a change in ownership as defined by this code section, the usage of the credits may be limited. As a result of the previously mentioned ownership changes, the Company has derecognized approximately $ 0.5 million of the gross federal research and development credit-related deferred tax assets due to the Section 383 limitation as of December 31, 2021. The Company has no t derecognized any of the California or Massachusetts research and development credit-related deferred tax assets because the credits do not expire. As of December 31, 2021, the Company has federal orphan drug credit carryforwards of approximately $ 4.8 million available to reduce future taxable income, if any, which will begin to expire in 2037 for federal tax purposes. Research and development credits are subject to IRC Section 383. In the event of a change in ownership as defined by this code section, the usage of the credits may be limited. As a result of the previously mentioned ownership changes, the Company has derecognized $ 8.4 million of the gross federal research and development credit-related deferred tax assets due to the Section 383 limitation as of December 31, 2021. Unrecognized Tax Benefits The Company has unrecognized tax benefits of $ 1.4 million and $ 2.1 million as of December 31, 2021 and 2020, which would affect the effective tax rate if recognized; however, recognition would be in the form of a deferred tax attribute which would be offset by a valuation allowance with no impact to tax expense. The Company does not anticipate any significant changes to unrecognized tax benefits over the next 12 months. The Company has recognized no interest or penalties related to uncertain tax positions for the periods presented. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: December 31, 2021 2020 (in thousands) Unrecognized tax benefits, beginning of period $ 2,104 $ 1,391 Gross increases related to prior tax positions 2 23 Gross decreases related to prior tax positions ( 1,894 ) — Lapse of statute of limitations — ( 17 ) Gross increases related to current tax positions 1,174 707 Unrecognized tax benefits, end of period $ 1,386 $ 2,104 The Company files income tax returns in the United States, Alabama, California, Massachusetts, New Hampshire, New Jersey, New York and Texas. The Company is not currently under examination by income tax authorities in federal state or other jurisdictions. All tax returns remain open for examination by the federal and state authorities for three and four years , respectively, from the date of utilization of any NOLs or credits. Other Income Tax Related On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act, or the CARES Act, or the Act, was signed into law. The Act includes provisions relating to refundable payroll tax credits, deferment of the employer portion of certain payroll taxes, net operating loss carryback periods, alternative minimum tax credit refunds, and modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. The company has evaluated the current legislation and at this time, does not anticipate the Act to have a material impact on its consolidated financial statements. On June 29, 2020, the California Governor signed Assembly Bill 85 or A.B. 85, which now becomes California law. A.B. 85, which includes several tax measures, provides for a three-year suspension of the use of net operating losses for medium and large businesses and a three-year cap on the use of business incentive tax credits to offset no more than $ 5.0 million of tax per year. Generally, A.B. 85 suspends the use of net operating losses for taxable years 2020, 2021, and 2022 for taxpayers with taxable income of $ 1.0 million or more. Since the Company is not expected to generate California source taxable income of more than $ 1.0 million, no material impact is anticipated at this time. On December 27, 2020, the Consolidated Appropriations Act, 2021, or the CAA, was signed into law. The CAA includes provisions meant to clarify and modify certain items put forth in the CARES Act, while providing aid to businesses affected by the pandemic. The CAA allows deductions for expenses paid for by the Paycheck Protection Program, or PPP, and Economic Injury Disaster Loan Program, or EIDL, clarifies forgiveness of EIDL advances, and other business pr ovisions. The Company analyzed the provisions of the CAA and determined there was no significant impact to its 2021 tax provision. |