Friday, June 19, 2020 9:42:20 PM
Going Concern
The Company has incurred recurring losses and negative cash flows from operations since inception and expects to continue to incur net losses for the
foreseeable future until such time, if ever, that it can generate significant revenues from the sale of Gimoti. Although the Company had approximately $4.1
million in cash and cash equivalents at March 31, 2020, the Company anticipates that it will continue to incur losses from operations due to pre-approval
and pre-commercialization activities, including interactions with FDA on the Company’s NDA resubmission for Gimoti, potentially manufacturing
commercial batches of Gimoti, and general and administrative costs to support operations. As a result, the Company believes that there is substantial doubt
about its ability to continue as a going concern for one year after the date these financial statements are issued. The financial statements do not include any
adjustments that may result from the outcome of this uncertainty.
The determination as to whether the Company can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the
normal course of business. In its report on the Company’s financial statements for the year ended December 31, 2019, the Company’s independent
registered public accounting firm included an explanatory paragraph expressing substantial doubt regarding the Company’s ability to continue as a going
concern.
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