Annual report pursuant to Section 13 and 15(d)


12 Months Ended
Dec. 31, 2021
INCOME TAXES [Abstract]  




A reconciliation of income taxes at the U.S. federal statutory rate to the benefit for income taxes is as follows:




Year Ended December 31,








Benefit at U.S. federal statutory rate

  $ (15,045,999 )   $ (15,907,195 )

State taxes - deferred

    (251,839 )     (3,797,393 )

Increase in valuation allowance

    14,618,762       19,535,265  

Research and development credits

    (239,585 )     (246,989 )
Decrease in federal net operating loss
    623,679       -  


    294,982       416,312  

Benefit for income taxes

  $ -     $ -  


A summary of the Company’s deferred tax assets is as follows:




Year Ended December 31,








Federal and state net operating loss carryforwards

  $ 73,036,983     $ 59,114,928  

Federal and state research credits

    31,333       921,577  

Interest expense limitation carryforwards

    6,013,040       2,911,508  

Transaction costs

    977,046       1,080,041  

Deferred revenue

    519,819       563,956  

Accrued expenses and other

    1,030,064       2,397,513  

Total gross deferred tax assets

    81,608,285       66,989,523  

Less: valuation allowance for deferred tax assets

    (81,608,285 )     (66,989,523 )

Net deferred tax assets

  $ -     $ -  


As of December 31, 2021, the Company had federal and state (post-apportioned basis) net operating losses (“NOLs”) of $299.9 million and $185.0 million, respectively. Approximately $55.2 million and $77.8 million of the foregoing federal and state NOLs, respectively, will expire at various dates from 2027 through 2041, if not limited by triggering events prior to such time. Under the provisions of the Internal Revenue Code, changes in ownership of the Company, in certain circumstances, would limit the amount of federal NOLs that can be utilized annually in the future to offset taxable income. In particular, Section 382 of the Internal Revenue Code imposes limitations on an entity’s ability to use NOLs upon certain changes in ownership. If the Company is limited in its ability to use its NOLs in future years in which it has taxable income, then the Company will pay more taxes than if it were otherwise able to fully utilize its NOLs. The Company may experience ownership changes in the future as a result of subsequent shifts in ownership of the Company’s capital stock that the Company cannot predict or control that could result in further limitations being placed on the Company’s ability to utilize its federal NOLs. As of December 31, 2021, the Company performed an analysis of limitations imposed by Section 382 of the Internal Revenue Code and as a result has written off the deferred tax assets related to $3.0 million of federal NOLs, $1.0 million of federal research and development tax credits and $28.1 million of state NOLs which are limited by historical ownership changes. As a result, there was a $3.9 million reduction to the Company’s net deferred tax assets, which is offset by a corresponding $3.9 million reduction in the Company’s valuation allowance, resulting in no net impact to the Company’s provision for income taxes for the year ended December 31, 2021.


A valuation allowance, if needed, reduces deferred tax assets to the amount expected to be realized. When determining the amount of net deferred tax assets that are more likely than not to be realized, the Company assesses all available positive and negative evidence. This evidence includes, but is not limited to, prior earnings history, expected future earnings, carry-back and carry-forward periods and the feasibility of ongoing tax strategies that could potentially enhance the likelihood of the realization of a deferred tax asset. The weight given to the positive and negative evidence is commensurate with the extent the evidence may be objectively verified. As such, it is generally difficult for positive evidence regarding projected future taxable income, exclusive of reversing taxable temporary differences, to outweigh objective negative evidence of recent financial reporting losses. Based on these criteria and the relative weighting of both the positive and negative evidence available, management continues to maintain a full valuation allowance against its net deferred tax assets.

In accordance with U.S. GAAP, the Company is required to determine whether a tax position of the Company is more likely than not to be sustained upon examination by the applicable taxing authority, including resolution of any related appeals or litigation processes, based on the technical merits of the position. The tax benefit to be recognized is measured as the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. Derecognition of a tax benefit previously recognized could result in the Company recording a tax liability that would reduce net assets. The amount of the liability for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position. Components of the liability are classified as either a current or a long-term liability in the accompanying consolidated balance sheets based on when the Company expects each of the items to be settled. The Company does not have any unrecognized tax benefits as of December 31, 2021 and 2020, and does not anticipate a significant change in unrecognized tax benefits during the next 12 months.