(6)

Income Taxes

(a)

Income Tax Expense

Income tax expense consists of:

	Current		Deferred		Total

Year ended December 31, 2015:
U.S. federal	$	-	$	-	$	-
State and local		200				200
	$	200	$	-	$	200
Year ended December 31, 2014:
U.S. federal	$	-	$	-	$	-
State and local		200		-		200
	$	200	$	-	$	200

(b)

Tax Rate Reconciliation

Income tax expense was $200 for each of the years ended December 31, 2015 and 2014 and differed from the amounts computed by applying the U.S. federal income tax rate of 34% to pretax income from continuing operations as a result of the following:

	December 31,
	2015		2014

Computed "expected" tax expense (benefit)	$	(6,190,781)	$	(6,926,642)
Increase (reduction) in income taxes resulting from:
Change in valuation allowance		6,691,992		7,748,579
Adjustment of tax attributes due to change in ownership		-		(127,572)
State and local income taxes, net of federal income
tax benefit		132		132
Stock expense		102,221		45,097
Research and development tax credits		(452,609)		(743,186)
Orphan drug tax credit		(155,452)		-
Other, net		4,697		3,792
	$	200	$	200

(c)

Significant Components of Deferred Taxes

The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2015 and 2014 are presented below.

	December 31,
	2015		2014

Deferred tax assets:
Stock-based compensation	$	1,713,608	$	1,851,668
Net operating loss carryforwards		23,677,332		17,479,654
Employee benefits		59,472		41,568
Research and development tax credits		2,052,662		1,419,165
Orphan drug tax credits		485,789		-
Other deductible tempory differences		215,638		97,656
Total gross deferred tax assets		28,204,501		20,889,711
Less valuation allowance		(28,200,857)		(20,886,811)
Net deferred tax assets		3,644		2,900
Deferred tax liabilities:
Plant and equipment		(3,644)		(2,900)
Total gross deferred tax liabilities		(3,644)		(2,900)
Net deferred tax liabilities	$	-	$	-

On December 18, 2015, the Protecting Americans from Tax Hikes Act of 2015 was signed into law. The act made permanent the research and experimentation tax credit for amounts paid or incurred after December 31, 2014, with no substantive changes to the credit.

The valuation allowance for deferred tax assets as of December 31, 2015 and 2014 was $28.2 million and $20.9 million. The net change in the valuation allowance was an increase of $7.3 million and $9.2 million in 2015 and 2014. A valuation allowance has been provided for the full amount of the Company’s net deferred tax assets as the Company believes it is more likely than not that these benefits will not be realized. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities (including the impact of available carryback and carryforward periods), projected future taxable income, and tax planning strategies in making this assessment.

During the year ended December 31, 2013, the Company experienced a change in ownership, as defined by the Internal Revenue Code, as amended (the “Code”) under Section 382. A change of ownership occurs when ownership of a company increases by more than 50 percentage points over a three-year testing period of certain stockholders. As a result of this ownership change we determined that our annual limitation on the utilization of our federal net operating loss (“NOL”) and credit carryforwards is approximately $1.1 million per year. We will only be able to utilize $20.2 million of our pre-ownership change NOL carryforwards and will forgo utilizing $5.5 million of our pre-ownership change NOL carryforwards and $1.2 million of our pre-change credit carryforwards as a result of this ownership change. We do not account for forgone NOL and credit carryovers in our deferred tax assets and only account for the NOL and credit carryforwards that will not expire unutilized as a result of the restrictions of Code Section 382.

As of December 31, 2015, we had NOL and research and development credit carryforwards for U.S. federal income tax reporting purposes of approximately $59.9 million and $1.4 million, respectively. Approximately $10.2 million of the NOLs will begin to expire in 2023 with the balance expiring from 2024 through 2035 and the research and development credits will expire in 2033 through 2035. As a result of the exercise of options the company has a windfall tax benefit of approximately $568,000 which is separately stated as component of the NOL because we are not able to reduce our current tax liability due to NOL carryforwards.

We also have state NOL and research and development credit carry-forwards of approximately $65.9 million and $689,000, respectively. Approximately $12.4 million of the Company's state NOLs expire in 2018 with the remaining balance expiring from 2019 through 2030. The state research and development credits expire in 2023 through 2029. We have orphan drug credit carry forwards of approximately $486,000 which will expire if unused in 2035.

The Company's federal and state income tax returns for December 31, 2012 through 2015 are open tax years.

A reconciliation of the beginning and ending amount of total unrecognized tax contingencies, excluding interest and penalties, for the years ended December 31, 2015 and 2014 are as follows:

		December 31
		2015		2014
Balance, beginning of year	$	-	$	-

Balance, end of year	$	-	$	-