8. INCOME TAXES

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Deferred tax assets consisted of the following as of December 31:

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A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations is as follows:

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As of December 31, 2021, the Company had federal net operating loss (NOL) carryforwards of approximately $155,697,000. Federal NOLs generated as of December 31, 2017 will expire in 2021 through 2037, while NOLs generated during

2018 and later will be carried forward indefinitely until utilized. As of December 31, 2021, the Company had state NOL carryforwards of approximately $66,743,000. State NOL carryforwards will expire in 2028 through 2040.

As of December 31, 2021, the Company had federal research and development (R&D) and orphan drug credit carryforwards of approximately $9,600,000 which will expire in 2022 through 2041. As of December 31, 2021, the Company also had state credit carryforwards of approximately $883,000 which will expire in 2024 through 2035.

As of December 31, 2021, the Company had federal NOLs and R&D credit carryforwards of $1,300,575 and $42,355, respectively, that expired in 2021.

The NOL and R&D credit carryforwards may be, or may become subject to, an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Section 382 and 383 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions. This could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to an ownership change. Subsequent ownership changes may further affect the limitation in future years. If and when the Company utilizes the NOL carryforwards in a future period, it will perform an analysis to determine the effect, if any, of these loss limitation rules on the NOL carryforward balances.

The Company has evaluated the available evidence supporting the realization of its deferred tax assets, including the amount and timing of future taxable income, and has determined that it is more likely than not that its net deferred tax assets will not be realized. Due to uncertainties surrounding the realization of the deferred tax assets, the Company maintains a full valuation allowance against all of its net deferred tax assets. When the Company determines that it will be able to realize some portion or all of its deferred tax assets, an adjustment to its valuation allowance on its deferred tax assets would have the effect of increasing net income in the period such determination is made.

The Company did not have unrecognized tax benefits or accrued interest and penalties at any time during the years ended December 31, 2021 or 2020 and does not anticipate having unrecognized tax benefits over the next twelve months. The Company is subject to audit by the Internal Revenue Service and state taxing authorities for tax periods commencing January 1, 2017 as a result of its NOLs. However, any adjustment related to these periods would be limited to the amount of the NOL generated in the year(s) under examination.