Annual report pursuant to Section 13 and 15(d)

Going Concern and Plan of Operation

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Going Concern and Plan of Operation
12 Months Ended
Dec. 31, 2016
Plan Of Operations And Going Concern [Abstract]  
Plan Of Operations And Going Concern [Text Block]
NOTE B - Going Concern and Plan of Operation
 
The accompanying financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going concern.
 
The Company has experienced net losses and negative cash flows from operations each period since its inception. Through December 31, 2016, the Company had an accumulated deficit of approximately $35.2 million. The Company’s operations have been financed primarily through the sale of equity securities. The Company’s net loss for the year ended December 31, 2016 was approximately $7.6 million and $9.1 million for the year ended December 31, 2015.
 
The Company has been engaged in developing a pipeline of product candidates since 2011. To date, the Company has not obtained regulatory approval for any of its product candidates nor generated any revenue from products and the Company expects to incur significant expenses to complete development of its product candidates. The Company may never be able to obtain regulatory approval for the marketing of any of its product candidates in any indication in the United States or internationally and there can be no assurance that the Company will generate revenues or ever achieve profitability.
 
Assuming the Company obtains FDA approval for one or more of its product candidates, which the Company does not expect to receive until 2021 at the earliest, the Company expects that its expenses will continue to increase once the Company reaches commercial launch. The Company also expects that its research and development expenses will continue to increase as it moves forward for other indications for its lead product candidates and diversifies its R&D portfolio. As a result, the Company expects to continue to incur substantial losses for the foreseeable future, and that these losses will be increasing.
 
The Company will need to secure additional capital in order to fund operations and to continue and complete its planned clinical and operational activities related to the product candidates and technologies that the Company recently acquired from Aquarius. The Company can provide no assurances that such additional financing will be available to the Company on acceptable terms, or at all. On January 13, 2017, the Company completed its warrant tender offer, with gross cash proceeds of $ 13.5 million and net proceeds estimated at $ 12.7 million (see Footnote J for additional details). The Company anticipates that current cash on hand at December 31, 2016 plus the proceeds from the warrant tender offer would be sufficient to meet its operating obligations through the second quarter of 2018.