The components of loss before income tax are as follows:

The components of income tax provision (benefit) are as follows:

A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows:

The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows:

For periods prior to the Separation, the income tax provision was prepared on a separate return methodology and presented as if the Company was a standalone taxpayer in each of its tax jurisdictions. Accordingly, deferred tax assets as of December 31, 2018 represent the hypothetical deferred taxes that were applicable to the Company as it were a separate company during periods prior to the Separation. Within the Company’s deferred tax assets as of December 31, 2018 are amounts included for net operating loss carryforwards and research and development credits, as these are the amounts that would have been generated by the Company on a separate basis prior to the transaction for 2018 and 2017. These tax attributes were included as of December 31, 2018, based on the separate return methodology. As a result of the Separation, not all of the tax attributes that existed as of December 31, 2018 carried forward to the Company subsequent to the transaction. As of December 31, 2019, deferred tax assets represent the deferred taxes attributable to the Company following the Separation.

In assessing the realizability of the net deferred tax asset, the Company considers all relevant positive and negative evidence in determining whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the net operating loss carryforwards.

In 2019 and 2018, the Company evaluated the need for a valuation allowance against its U.S. and state deferred tax assets based on the available positive and negative evidence available as if the Company was a standalone entity for all periods presented. An important aspect of objective negative evidence evaluated was the Company’s historical operating results over its life to date. The Company is in a three-year cumulative loss position through December 31, 2019. Thus, it is more likely than not that the Company’s U.S. and state deferred tax assets will not be realized and a full valuation allowance has been recognized against the Company’s U.S. and state deferred tax assets.

The following table summarizes carryforwards of Federal net operating losses and tax credits as of December 31, 2019:

Under the Tax Reform Act of 1986, as amended (the “Act”), the utilization of a corporation’s net operating loss and research and development tax credit carryforwards is limited following a greater than 50% change in ownership during a three-year period. Any unused annual limitation may be carried forward to future years for the balance of the carryforward period. The Company has done an analysis to determine whether or not ownership changes, as defined by the Act, have occurred since inception. The Company determined that it experienced ownership changes, as defined by the Act, during the 2008, 2014 and 2016 tax years as a result of past financings; accordingly, the Company’s ability to utilize the aforementioned carryforwards will be limited. In addition, state net operating loss carryforwards may be further limited, including in Pennsylvania, which has a limitation of 30%, 35% or 40% of taxable income after modifications and apportionment on state net operating losses utilized in any one year during tax years beginning during 2017, 2018 or 2019 going forward, respectively.  

The Company will recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2019, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations.