NVUS 2018 Annual Report

In this Annual Report on Form 10-K, Annual Report, unless the context requires otherwise, "Novus Therapeutics", “Novus”, the "Company", the “combined company”, "we", "our", and "us" means Otic Pharma, Ltd. prior to the consummation of the Reverse Merger, and Novus Therapeutics, Inc., upon the consummation of the Reverse Merger described herein. The term “Tokai” refers to Tokai Pharmaceuticals, Inc., and its subsidiaries prior to the Reverse Merger. The market data and certain other statistical information used in this Annual Report are based on independent industry publications, governmental publications, reports by market research firms or other independent sources. Some data are also based on our good faith estimates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Forward-Looking Statements This Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. Any statements in this Annual Report on Form 10-K about the C RPSDQ\¶V future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, the review of strategic alternatives and WKH RXWFRPH RI VXFK UHYLHZ DQG RWKHU VWDWHPHQWV FRQWDLQLQJ WKH ZRUGV ³EHOLHYHV ´ ³DQWLFLSDWHV ´ ³SODQV ´ ³H[SHFWV ´ ³HVWLPDWHV ´ ³LQWHQGV ´ ³SUHGLFWV ´ ³SURMHFWV ´ ³WDUJHWV ´ ³FRXOG ´ ³PD\ ´ DQG VLPLODU H[SUHVVLRQV FRQVWLWXWH IRUZDUG -looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward-looking statements include such identifying words. Forward-looking statements include, but are not limited to statements regarding: x expectations regarding the timing for the commencement and completion of product development or clinical trials; x the rate and degree of market acceptance and clinical utility of the C RPSDQ\¶V products; x the C RPSDQ\¶V commercialization, marketing and manufacturing capabilities and strategy; x the Company ¶V LQWHOOHFWXDO SURSHUW\ SRVLWLRQ DQG VWUDWHJ\ x the Company ¶V DELOLW\ WR LGHQWLI\ DGGLWLRQDO SURGXFWV RU SURGXFW FDQGLGDWHV with significant commercial potential; x the Company ¶V HVWLPDWHV UHJDUGLQJ H[SHQVHV IXWXUH UHYHQXH FDSLWDO UHTXLUHPHQWV DQG QHHGV IRU DGGLWLRQDO financing; x developments relating to the Company ¶V FRPSHWLWRUV DQG LQGXVWU\ DQG x the impact of government laws and regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the ability to develop commercially viable product formulations; the sufficiency of the Company ¶V FDVK UHVRXUF es; the ability to obtain necessary regulatory and ethics approvals to commence additional clinical trials; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether the results of clinical trials will warrant submission for regulatory approval of any investigational product; whether any such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and, if we are able to obtain such approval for an investigational product, whether it will be successfully distributed and marketed. These risks and uncertainties, as well as other risks and uncertainties that could cause the Company ¶V DFWXDO UHVXOWV WR GLIIHU VLJQLILFDQWO\ from the forward-looking statements contained herein, are described in greater detail in Part I, Item 1A. Risk Factors in this Annual Report on Form 10-K. Any forward-looking statements contained in this Annual Report on Form 10-K speak only as of the date hereof and not of any future date, and the Company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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