Quarterly report pursuant to Section 13 or 15(d)

Liquidity and??Plan of Operations

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Liquidity and Plan of Operations
6 Months Ended
Jun. 30, 2017
Plan Of Operations And Going Concern [Abstract]  
Liquidity And Plan Of Operations [Text Block]
NOTE B – Liquidity and Plan of Operations
 
The accompanying financial statements have been prepared in conformity with generally accepted accounting principles.
 
The Company has experienced net losses and negative cash flows from operations each period since its inception. Through June 30, 2017, the Company had an accumulated deficit of approximately $43.6 million. The Company’s operations have been financed primarily through the sale of equity securities. The Company’s net loss for the six months ended June 30, 2017 and 2016 was approximately $8.5 million and $3.9 million, respectively.
 
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 2022 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 with additional clinical studies for its current product candidates and developing additional product candidates. 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 its continuing operations. 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 D for additional details). The Company anticipates that current cash on hand at June 30, 2017 and anticipated proceeds from future sales of our common stock through the Controlled Equity Offering Sales Agreement would be sufficient to meet its operating obligations through August 2018. The Company has entered into a Controlled Equity OfferingSM  Sales Agreement with Cantor Fitzgerald & Co. “Cantor”, which allows the Company, subject to certain limited restrictions and daily sales limits, to sell shares of common stock having an offering price of up to $30 million, which if fully utilized would finance the Company’s operations into 2019. 
 
Through August 7, 2017, the Company has sold zero shares of common stock pursuant to the Controlled Equity OfferingSM  Sales Agreement with Cantor.
 
Management believes it can control the timing and amount of certain expenditures and it can utilize the Sales agreement to fund the continuing operations of the Company beyond August 2018. A registration statement (Form S-3) was filed on April 3, 2017 as well as a prospectus covering the possible sales of these shares.