2. GOING CONCERN AND MANAGEMENT’S PLANS

As of September 30, 2016, the Company had a cash balance, a working capital deficiency and an accumulated deficit of $9,132, $22,166,473 and $82,527,579, respectively. During the three and nine months ended September 30, 2016, the Company incurred a net loss of $2,408,156 and $9,154,924, respectively. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

Since inception, the Company’s operations have primarily been funded through proceeds received in equity and debt financings. Although management believes that the Company has access to capital resources, there are currently no commitments in place for new financing at this time, except as described below, and there is no assurance that the Company will be able to obtain funds on commercially acceptable terms, if at all. There is also no assurance that the amount of funds the Company might raise will enable the Company to complete its development initiatives or attain profitable operations. If the Company is unable to obtain additional financing on a timely basis, it may have to curtail its development, marketing and promotional activities, which would have a material adverse effect on the Company’s business, financial condition and results of operations, and ultimately the Company could be forced to discontinue its operations and liquidate.

The accompanying condensed consolidated financial statements have been prepared in conformity with U.S. GAAP, which contemplate continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustment that might become necessary should the Company be unable to continue as a going concern.

Subsequent to September 30, 2016, the Company received an aggregate of $500,000 associated with the issuance of a note payable. In addition, pursuant to the note, an additional $3,225,000 is payable to the Company upon the completion of certain milestones, as specified in the note. See Note 11 – Subsequent Events – Note Payable for additional details. There can be no assurance that the Company will be successful in completing the milestones. The Company is currently funding its operations on a month-to-month basis. While there can be no assurance that it will be successful, the Company is in active negotiations to raise additional capital.