2.	Basis of Presentation

Basis of Presentation

These financial statements are expressed in U.S. dollars. The Company is organized into one operating and one reporting segment.

The financial statements were prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”).

Going Concern

As of December 31, 2015, the Company had $12,006,075 in cash and cash equivalents. Net cash used in operating activities was $9,599,585 for the year ended December 31, 2015. Net loss for the year ended December 31, 2015 was $23,820,675. As of December 31, 2015, the Company had working capital of $10,971,423. On January 8, 2016, in connection with the Merger described in Note 17, the Company paid $3,261,044 in severance payments to former executives and employees. The Company expects to incur losses for the next several years as it plans to develop its TSC product candidate. The Company is unable to predict the extent of any further losses or when the Company will become profitable, if at all.

These financial statements have been prepared under the assumption that the Company will continue as a going concern. Due to the Company’s recurring and expected continuing losses from operations and its present financial resources, the Company has concluded that there is substantial doubt in the Company’s ability to continue as a going concern within one year of issuance on these financial statements without additional capital becoming available to fund planned Phase 2/3 and Phase 3 clinical trials, attain further operating efficiencies and, ultimately, to generate revenue. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The Company will be required to raise additional capital within the next year to develop its trans sodium crocetinate product candidate and to fund operations at current cash expenditure levels. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company raises additional funds by issuing equity securities, its stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company’s ability to conduct its business. If the Company is unable to obtain additional financing when needed, (i) it may be required to delay, scale back or discontinue the development and/or commercialization of one or more product candidates; (ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to technologies, product candidates or products that we would otherwise seek to develop or commercialize itself on unfavorable terms.