26 We could also encounter delays if a clinical trial is suspended or terminated by us, by the data safety monitoring board for such trial or by the FDA, EMA or any other regulatory r authority, or if the IRBs of the institutions in which such trials are being conducted suspend or terminate the participation of their clinical investigators and sites subj u ect to their review. Regulatory r authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, EMA or other regulatory r authorities resulting in the imposition of a clinical hold, unfor f eseen safety issues or adverse side effe f cts, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. We may also face delays if we are unabl a e to reach agreement with the FDA, EMA or other regulatory r authorities regarding CMC matters, including methodologies for, and assessment of,f comparability of manufact f ur t ing procedur d es and lots. Delays in the commencement, conduct or completion of any clinical trial of our product candidates will increase our costs, slow down our product candidate development and approval process and delay or potentially jeopardize our ability to commence product sales and generate revenue. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory r approval of our product candidates. Our product candid d at d es t may a cause undesira i blel side effe f ctst or have othe t r propertie t s that couldl halt theiri clin l ical developm l ent, prevent theiri regu e latory approval,l limiti theiri commercial poten t tial or result in sign i ific f ant negat e iv t e consequences. Adverse events or other undesirabl a e side effe f cts caused by our product candidates could cause us or regulatory r authorities to interrupt r , delay or halt clinical trials and could result in a more restrictive labe a l or the delay or denial of regulatory r approval by the FDA, EMA or other comparable foreign regulatory r authorities. During the conduct of clinical trials, patients report changes in their health, including illnesses, inju n ries, and discomforts, to their study t doctor. Ofte f n, it is not possible to determine whether or not the product candidate being studi t ed caused these conditions. It is possible that as we test our product candidates in larger, longer and more extensive clinical trials, or as use of these product candidates becomes more widespread if they receive regulatory r approval, illnesses, inju n ries, discomforts and other adverse events that were not observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by patients. Many times, side effe f cts are only detectable afte f r investigational products are tested in large-scale Phase 3 clinical trials or, in some cases, afte f r they are made availabl a e to patients on a commercial scale afte f r approval. If additional clinical experience indicates that any of our product candidates has side effe f cts or causes serious or life- f threatening side effe f cts, the development of the product candidate may fail or be delayed, or, if the product candidate has received regulatory r approval, such approval may be revoked, which would severely harm our business, prospects, operating results and financial condition. For example, in the tarcocimab arms of our completed GLEAM AND GLIMMER clinical trials, we observed an unexpected increase in cataracts, which we believe may have contributed meaningfully to the failure of each study t to meet its primary effi f cacy endpoint. Our most advanced product candidate, tarcocimab, is an anti-VEGF biologic that we have studi t ed in wet AMD, DME, NPDR and RVO. KSI-501 is our investigational medicine and is a first-in-class bispecific f antibody conjugate designed to inhibit two mechanisms implicated in retinal diseases: interleukin-6 (IL-6) and vascular endothelial growth factor ("VEGF"). There are some potential side effe f cts associated with intravitreal anti-VEGF therapies such as intraocular hemorrhage, intraocular pressure elevation, retinal detachment, inflammation, vasculitis, artery occlusion or infection inside the eye, progression of cataract, and over-inhibition of VEGF, as well as the potential for potential systemic side effe f cts such as heart attack, stroke, wound healing problems and high blood pressure. Recent trends in the development of anti-VEGF therapies have favored increased molar dosages, as compared to currently marketed treatments. To date these heightened dosages have not exhibited a safety profil f e significantly worse than that of current treatments, as attributable to molar dose. However, anti- VEGF product candidates featur t ing higher molar dosages, including tarcocimab a and KSI-501 may heighten the risk of adverse effe f cts associated with anti-VEGF treatments generally, both in the eye and in the rest of the body. There are risks inherent in the intravitreal inje n ction procedur d e of drugs r like tarcocimab a and KSI-501 which can cause inju n ry to the eye and other complications including conjunctival hemorrhage, punctate keratitis, eye pain, conjunctival hyperemia, intra-ocular inflammation and endophthalmitis. Any additional toxicology signal observed, be it real or perceived, may negatively impact perceptions of utilization of tarcocimab a and KSI-501 in broader populations and impact clinical trial enrollment, regulatory r approval and commercial success.