Annual report pursuant to Section 13 and 15(d)

NOTE 2 - GOING CONCERN AND MANAGEMENT???S LIQUIDITY PLANS

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NOTE 2 - GOING CONCERN AND MANAGEMENT’S LIQUIDITY PLANS
12 Months Ended
Dec. 31, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Substantial Doubt about Going Concern [Text Block]

NOTE 2 – GOING CONCERN AND MANAGEMENT’S LIQUIDITY PLANS


As of December 31, 2018, the Company had cash of $4,450,160 and working capital of $3,431,039. The Company raised $9,139,721 through the sale of common stock and warrants, $1,492,969 through the sale of Series E preferred stock and warrants and $2,832,997 through the exercise of warrants and options in 2018 (Note 9). Subsequent to December 31, 2018, the Company raised $8,619,278 from sale of common stock and $418,718 from the exercise of previous issued warrants (Note 13). During the year ended December 31, 2018, the Company used net cash in operating activities of $10,255,427.  These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management believes that the Company has sufficient funds to meet its research and development and other funding requirements for at least the next 9 months.


The Company’s primary source of operating funds since inception has been cash proceeds from private placements of common and preferred stock. The Company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future. The Company has stockholders’ deficiencies at December 31, 2018 and requires additional financing to fund future operations. Further, the Company does not have any commercial products available for sale and there is no assurance that if approval of their products is received that the Company will be able to generate cash flow to fund operations. In addition, there can be no assurance that the Company’s research and development will be successfully completed or that any product will be commercially viable.


Accordingly, the accompanying consolidated financial statements have been prepared in conformity with U.S. GAAP, which contemplates continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in the consolidated financial statements do not necessarily purport to represent realizable or settlement values. The consolidated financial statements do not include any adjustment that might result from the outcome of this uncertainty.