Forward-looking statements
Statements in this Current Report contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this Current Report may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words. Examples of forward-looking statements include, among others, statements the Company makes regarding its business plans and prospects; results, conduct, progress and timing of its research and development programs and clinical trials; expectations with respect to enrollment and dosing in its clinical trials, and plans and expectations regarding future data updates, clinical trials, regulatory meetings and regulatory submissions. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond the Company’s control, difficult to predict and could cause actual results to differ materially from what the Company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies; the Company’s dependence on the success of its CAB technology platform; the Company’s ability to enroll patients in its ongoing and future clinical trials; the successful selection and prioritization of assets to focus development on selected product candidates and indications; the Company’s ability to form collaborations and partnerships with third parties and the success of such collaborations and partnerships; the Company’s reliance on third parties for the manufacture and supply of its product candidates for clinical trials; the Company’s reliance on third parties to conduct its clinical trials and some aspects of its research and preclinical testing; potential adverse impacts due to any resurgence of COVID-19 and its variants and those other risks and uncertainties described in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 23, 2023, in its Quarterly Reports on Form 10-Q filed with the SEC on May 11, 2023, August 1, 2023 and November 7, 2023 and its other reports as filed with the SEC. Forward-looking statements contained in this Current Report are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
Item 9.01 | Financial Statements and Exhibits. |