22 ITEM 1A. RISK FACTORS You should consider careful f ly the following risk factors, together with all the other information in this Annual Report on Form 10-K, including the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section and our consolidated financial statements and notes thereto. The occurrence of any events described in the following risk factors and the risks described elsewhere in this Annual Report on Form 10-K could harm our business, operating results, financial condition, and/or growth prospects or cause our actual results to differ materially from those contained in forward- looking statements that we have made in this Annual Report on Form 10-K and those may make from time to time. You should consider all of the risk factors described when evaluating our business. Risks Related to the Discovery, Development and Commercialization of Our Product Candidates We are in the clin l ical stage t of drug developm l ent and have a very r limite i d operating i hist i or t y r and no productst approved for commercial sale,e which may a make it diffi i cult to evaluatet our current busine i ss and predic d t our future success and viability i .y We are a clinical stage biopharmaceutical company committed to researching, developing and commercializing transfor f mative therapeutics to treat high prevalence retinal diseases. We commenced operations in June 2009, have no products approved for commercial sale and have not generated any revenue. Drug r development is a highly uncertain undertaking and involves a subs u tantial degree of risk. We have conducted clinical trials, including Phase 3 pivotal clinical trials, of tarcocimab a in patients with wet AMD, DME, NPDR and RVO. Certain of our trials did not meet their primary effi f cacy endpoints, and in July 2023 we announced a business decision to wind-down development of tarcocimab. a Following additional positive results from other on-going tarcocimab a clinical trials, we plan to resume the tarcocimab a development program. To date, we have not obtained marketing approval for any product candidates, including tarcocimab a and KSI-501, our dual inhibitor antibody biopolymer conjugate targeting both IL-6 (anti-IL-6 antibody) and VEGF (VEGF-trap), manufac f tured a commercial scale product, or conducted sales and marketing activities necessary r for successful f product commercialization. Our limited operating history r as a company and early stage of drug r development make any assessment of our future success and viability subj u ect to significant uncertainty. We will encounter risks and difficulties frequently experienced by early-stage biopharmaceutical companies in rapi a dly evolving fields, and we have not yet demonstrated an ability to successful f ly overcome such risks and difficulties. If we do not address these risks and difficulties successful f ly, our business will suffer. Our prospe s ctst are heavily depe e nden d t on our tarcocimab and KSI- S 501 product candid d at d es t ,s which are currently t in clin l ical developm l ent for multiple indications. Our prospects will be heavily dependent on our tarcocimab and KSI-501 product candidates and the results of planned or pending clinical studi t es. We cannot be certain that our product candidates will be successful f in any of the planned or pending clinical trials. Our early preclinical and Phase 1/1b clinical trial results are not necessarily predictive of the results of our ongoing or future discovery programs or any future preclinical or clinical studi t es. Our ability to demonstrate effi f cacy, safety and clinical durability in pivotal studi t es may be affe f cted by the patient populations sampled and the design of our pivotal studi t es. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical studi t es afte f r achieving positive results in early-stage development, including early-stage clinical studi t es, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical studi t es were underway or safety or effi f cacy observations made in preclinical studi t es and clinical studi t es, including previously unreported or unobserved adverse events as more patients are treated and followed for longer periods of time. For example, in our Phase 2b/3 clinical trial evaluating the effi f cacy, durability and safety of tarcocimab a in treatment- naïve subj u ects with neovascular wet AMD and in our Phase 3 GLEAM and GLIMMER studi t es, tarcocimab did not meet the primary effi f cacy endpoint of showing non-inferior visual acuity gains. There can be significant variability in safety or effi f cacy results between different clinical studi t es of the same product candidate due to numerous factors, including changes in study t procedur d es set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical study t protocols and the rate of dropout among clinical study t participants. Moreover, preclinical and clinical data are ofte f n susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfac f torily in preclinical studi t es and clinical studi t es nonetheless failed to obtain FDA approval. If approved, clinical study t designs and data are not necessarily predictive of the final marketed product labe a l. FDA may not approve a labe a l for a particular dosing frequency, even if we believe the data demonstrate suppor u t for that dosing.