23 While a Phase 1 study t of KSI-501 has completed the dosing phase in patients in the United States to evaluate the safety, tolerabi a lity and bioactivity of KSI-501 in DME, it may be years before a registrational-type trial is completed, if at all. We may in the future develop other product candidates, advance additional product candidates into clinical trials and terminate such trials prior to their completion. It will take additional investment and time for such programs to reach the same stage of development as tarcocimab a and KSI-501. Our plan l for the developm l ent of tarcocimab may a be unsuccessful f .l We discontinued further development of tarcocimab a in mid-2023 pending the outcomes of two other trials that were then underway. While those other trials produced favorable results and we have resumed development of tarcocimab, that development may not be successful f . In connection with our development program, we developed an enhanced, commercial formulation of tarcocimab to improve manufactur t ability and usability by reducing inje n ction time from 7-10 seconds to 2-3 seconds. While we believe that doing so does not affe f ct the applicability of prior test results, we cannot be sure that the FDA, EMA or comparable foreign regulatory authorities would agree or accept our planned BLA even if our planned additional trial is successful f . The failure of pi f votal studie d s of tarcocimab to meet theiri primary effi f cacy endpoint i st may a lead us to pause,e change or disc i ontinue developm o ent of othe t r product candid d at d es t based on our ABC Plat l fo t rm. In July 2023, we announced that two of our pivotal Phase 3 clinical trials of tarcocimab a did not meet their primary effi f cacy endpoints and, as a result, we paused further development of tarcocimab a pending review of data from the BEACON study t in patients with macular edema due to RVO and the GLOW1 study t patients with diabetic retinopathy. Although we have resumed the development of tarcocimab, we may again determine to discontinue development of tarcocimab a or our ABC Platform or other product candidates using our ABC Platform based on future information or trials results, which could prevent us from, or significantly delay, achieving profita f bi a lity and could result in disrupt r ions to our business including potential impairment charges, restructur t ing costs, or costs that are greater than expected. Research and developm l ent of biopharma r ceutical productst is inherently t risk i y. k We cannot give any n assurance that any n of our product candid d at d es t will i receive regu e latory,y includin d g marketin t g, approval,l which is necessary r befo e re they can be commercialized.d We are at an early stage of development of our product candidates. Our future success is dependent on our ability to successful f ly develop, obtain regulatory approval for, and then successful f ly commercialize our product candidates, and we may fail to do so for many reasons, including the following: • our product candidates have in the past and may in the future not successful f ly complete preclinical studi t es or clinical trials; • if a product candidate obtains regulatory r approval, approval may be for indications, dosage and administration or patient populations that are not as broad as intended or desired; • a product candidate may, on further study, t be shown to have harmful side effe f cts or other characteristics that indicate it is unlikely to be effe f ctive or otherwise does not meet applicable regulatory r criteria, for example a positive benefit-risk profile f ; • our competitors may develop therapeutics that render our product candidates obsolete or less attractive; • our competitors may develop platform technologies that render our ABC Platform obsolete or less attractive; • the product candidates and ABC Platform that we develop may not be sufficiently covered by intellectua t l property for which we hold exclusive rights or may be covered by third party patents or other intellectua t l property or exclusive rights; • the market for a product candidate may change so that the continued development of that product candidate is no longer reasonabl a e or commercially attractive; • a product candidate may not be capable of being produced in commercial quantities at an acceptabl a e cost, or at all; • if a product candidate obtains regulatory approval, we may be unable to establ a ish sales and marketing capabilities, or successful f ly market such approved product candidate, to gain market acceptance; and • a product candidate may not be accepted as safe and effe f ctive by patients, the medical community or third-party payors, if applicable. If any of these events occurs, we may be forced to abandon our development effo f rts for a product candidate or candidates, which would have a material adverse effe f ct on our business and could potentially cause us to cease operations.