Note 2 – Liquidity and Management’s Plans

As of December 31, 2017, the Company had a cash and investments balance of $8,452,459 and working capital and stockholders’ equity of $7,372,427 and $7,618,913, respectively. During the year ended December 31, 2017, the Company incurred a net loss of $9,833,152.  The Company has not generated any revenues, has incurred net losses since inception and does not expect to generate revenues in the near term. Factors such as these and the Company’s projected cash burn raise substantial doubt about the entity’s ability to continue as a going concern for at least one year from the issuance of these financial statements. Management’s plans, including the raising of debt and equity financing (see Note 13) and reducing certain expenses, alleviated the substantial doubt.  The Company believes that it has sufficient capital to meet its operating expenses and obligations for the next twelve months from the date of this filing.  However, if other unanticipated difficulties arise the Company may be required to raise additional capital to support its operations, curtail its research and development activities until such time as additional capital becomes available and delay its target for its upcoming FDA filings and clinical activities.  These activities would necessitate the Company to slow its rate of spending and extend its use of cash until additional capital is raised.  There can be no assurance that such a plan will be successful. There is no assurance that additional financing will be available when needed or that the Company will be able to obtain such financing on reasonable terms.