Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations and timing regarding vimseltinib and enrollment for the pivotal Phase 3 MOTION study in TGCT patients, the potential for vimseltinib to be a best-in-class treatment for TGCT, presenting updated vimseltinib data from our phase 1/2 study in TGCT patients, initial data from the dose escalation phase of the Phase 1 study of DCC-3116, plans to initiate the trametinib combination dose expansion portion of the Phase 1 study of DCC-3116, plans to expand the ongoing Phase 1 study of DCC-3116 to add a combination with a mutant KRAS G12C inhibitor in NSCLC patients subject to feedback from regulatory authorities, plans to present additional pre-clinical data for DCC-3116, exploration of additional pre-clinical combinations of DCC-3116, our belief that DCC-3116 has the potential to address a broad range of human cancers, nominating a development candidate for our pan-RAF research program, plans to continue to establish QINLOCK as the fourth-line standard of care in the U.S. and key European markets, ex-U.S. strategies including executing on our commercial launch of QINLOCK in fourth-line GIST in Germany and our plans to transition to a post-approval paid access program in France and our plans to present INTRIGUE data for our second-line GIST study for QINLOCK at the ASCO plenary session in January 2022. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to our ability to provide access to QINLOCK in European countries other than Germany and France through other channels, the severity and duration of the impact of COVID-19 on our business and operations, our ability to successfully demonstrate the efficacy and safety of our drug or drug candidates, the preclinical or clinical results for our product candidates, which may not support further development of such product candidates, comments, feedback and actions of regulatory agencies, our ability to commercialize QINLOCK and execute on our marketing plans for any drugs or indications that may be approved in the future, the inherent uncertainty in estimates of patient populations, competition from other products, our ability to obtain and maintain reimbursement for any approved product and the extent to which patient assistance programs are utilized and other risks identified in our Securities and Exchange Commission (SEC) filings, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are registered trademarks of Deciphera Pharmaceuticals, LLC.
