definiens: within the meaning of the Private Secur ities Litigation Reform Act of 1995 . Because such s tatements are subject to risks and uncertainties, actual resu lts may differ materially from those expressed or i mplied by such forward - looking statements . Such statements include, but are not limited to, statements regarding deve lopment of our product candidates, our regulatory applications and estimated timelines associated therewith . Risk s that contribute to the uncertain nature of the forward - l ooking statements include : failure to obtain regula tory approval for one or more of our product candidates, failure to achieve U.S. FDA approval in a timely and suffic ient manner to receive the additional $ 100 million in funding f rom HCR, whether or not there will be sales of or r oyalties on andexanet alfa, our belief that the funds will be s ufficient to fund our operations, our expectation t hat we will incur losses for the foreseeable future and needs for add itional funds to commercialize one or more of our p roduct candidates ; the results of our clinical trials rela ted to the efficacy and safety of our product candi dates ; our potential inability to manufacture our product candidates on a commercial scale in a timely or cost - efficient ma nner ; the accuracy of our estimates regarding expenses and ca pital requirements ; regulatory developments in the United States and foreign countries ; our ability to obtain and maintain intellectual property protection for our product candidates ; and our ability to retain key scientifi c or management personnel . These and other risks an d uncertainties are described more fully in our most recent filings with the Securities and Exchange Com mission, including our most recent quarterly report on Form 10 - Q, which was filed on November 7, 2016 . All forw ard - looking statements contained in this press release speak only as of the date on which they were made . We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made