The Company's Condensed Consolidated Financial Statements are prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) applicable to a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. As of January 31, 2018, the Company had an accumulated deficit of $94,668,675 and incurred a net loss for the nine months ended January 31, 2018 of $5,533,373.

During the nine months ended January 31, 2018, funding was provided by investors to maintain and expand the Company. The remaining challenges, beyond the regulatory and clinical aspects, include accessing funding for the Company to cover its future capital requirements. During the previous fiscal year and through the nine months ended January 31, 2018, the Company continued to acquire funds through sales of the Company’s common stock pursuant to the Company’s Registration Statement on Form S-3 under which the Company’s placement agent sold shares of the Company’s common stock “at-the-market” or pursuant to “block trades” in a program structured to provide up to $50 million in funding to the Company less certain commissions.

The Company requires substantial additional capital to finance its planned business operations and expects to incur operating losses in future periods due to the expenses related to the Company’s core businesses. The Company has not realized any revenue since it commenced doing business in the biotechnology sector, and there can be no assurance that it will be successful in generating revenues in the future in this sector.

The Company believes its cash on hand at January 31, 2018, sales of registered and unregistered shares of its common stock and any public offerings of common stock in which the Company may engage in will provide sufficient capital to meet the Company’s capital requirements and to fund the Company’s operations through March 31, 2019.

The Company will continue to be dependent on outside capital to fund its research and operating expenditures for the foreseeable future. If the Company fails to generate positive cash flows or fails to obtain additional capital when required, the Company may need to modify, delay or abandon some or all its business plans.

The Company’s ability to use its current Form S-3 will be retested at the time of the Company’s filing of its Form 10-K for fiscal year 2018. If the Company does not meet the eligibility requirements of its current Form S-3, it will not be eligible to continue to use it to raise capital. In such event, the Company would need to raise capital pursuant to a Form S-1 or pursuant to private placements. Either method could entail greater time periods to raise capital and could entail increased total costs.