ii SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains “for f ward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or Exchange Act. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affe f cting the financial condition of our business. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward- looking statements are based on information availabl a e at the time those statements are made and/or management’s good faith beliefs as of that time with respect to future events, and are subj u ect to risks and uncertainties that could cause actua t l performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify f forward- looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “proje o ct,” “target,” “design,” “estimate,” “predict,” “potential,” “plan”, “hope” or the negative of these terms, or similar expressions and comparable terminology intended to identify f forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subj u ect to risks and uncertainties, including those set forth under the section titled “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Forward-looking statements include, but are not limited to, statements about: • the success, cost and timing of our development activities, preclinical studi t es, clinical trials and regulatory r filings; • the translation of our preclinical results and data and early clinical trial results in particular relating to safety, effi f cacy and durability into future clinical trials in humans; • the continued durability, effi f cacy and safety of our product candidates; • the portfol f io of clinical trials planned for subm u ission in our Biologics License Application, or BLA, of tarcocimab tedromer (formerly KSI-301, also known as tarcocimab); • the scope, progress, results and costs of developing any product candidates we have or may develop, and conducting preclinical studi t es and clinical trials; • our and Lonza’s ability to successful f ly execute on our manufact f ur t ing development plan; • the number, size and design of clinical trials that regulatory r authorities may require to obtain marketing approval, including the order and number of clinical studi t es required to suppor u t a BLA in retinal vein occlusion, or RVO, diabetic retinopathy, or DR, and wet age-related macular degeneration, or wet AMD, or any of our current or future product candidates, including the sufficiency of a single additional pivotal study t of tarcocimab a tedromer and a single BLA for wet AMD, RVO and DR together; • our expectations regarding chemistry r manufac f turing and controls, or CMC, requirements of the United States Food and Drug r Administration, or FDA, and other regulatory r bodies to suppor u t any BLA subm u ission and potential commercial launch; • our expectations regarding enhancements and benefits of new formulations of tarcocimab, KSI-501 or other ABC Platform derived molecules; • the timing or likelihood of regulatory r filings and approvals, including the potential to achieve FDA approval of any product candidates; • our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the labe a l of any approved product candidate; • our ability to obtain funding for our operations, including funding necessary r to develop, manufac f ture and commercialize our product candidates; • the rate and degree of market acceptance of our product candidates; • the success of competing produc d ts or platform technologies that are or may become availabl a e; • our plans and ability to establ a ish sales, marketing and distribution infrastructur t e to commercialize any product candidates for which we obtain approval; • our expectation as to the concentration of retinal specialists in the United States and its impact on our sales and marketing plans; • our expectations regarding our ability to enter into manufact f ur t ing-related commitments, and the timing thereof;
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