75 On July 24, 2023, Kodiak announced that although high proportions of patients on meaningful f ly longer treatment intervals were observed with tarcocimab, a with half of patients on every r 24-week dosing at the primary r endpoint, the GLEAM and GLIMMER studi t es did not meet their primary effi f cacy endpoints of showing non-inferior visual acuity gains for tarcocimab a dosed every 8 to 24 weeks afte f r 3 monthly loading doses compared to aflib f ercept given every r 8 weeks afte f r 5 monthly loading doses. At the primary effi f cacy endpoint of the GLEAM study, t patients treated with tarcocimab gained an observed average of 6.4 eye chart letters (to 73.1 letters), compared with 10.3 letters for patients treated with aflib f ercept (to 76.5 letters). In GLIMMER, patients treated with tarcocimab a gained an observed average of 7.4 eye chart letters at the primary r endpoint (to 72.5 letters) compared with 12.2 letters (to 76.4 letters) for patients treated with afli f bercept. An unexpected increase in cataract adverse events was reported over time in the tarcocimab arms of both GLEAM and GLIMMER, with 19% on tarcocimab a versus 9% on afli f bercept at the primary endpoint based on the pooled safety population. Kodiak’s evaluation suggested that the decline in visual acuity associated with cataracts likely contributed meaningful f ly to the failure of each study. t Half of tarcocimab a treated patients in the GLEAM and GLIMMER studi t es were on every r 24-week dosing at the primary r endpoint, two-thirds achieved at least one 6-month dosing interval during the studi t es, and three-quarters achieved at least one 5-month or longer treatment interval. Intraocular inflammation was rare, occurring in 1.3% and 0.2% of tarcocimab and aflib f ercept treated patients, respectively. No cases of intraocular inflammation with vasculitis or vascular occlusion were observed. DAZZLE – Phase 2b/3/ Study in Patientst with Treatment-Naïve Wet AMD M The DAZZLE study t was a global, multi-center, randomized pivotal study t designed to evaluate the durability, effi f cacy and safety of tarcocimab a in patients with treatment-naïve wet AMD. In Februa r ry 2022 Kodiak announced that this initial pivotal study t did not meet its primary effi f cacy endpoint of non-inferior visual acuity gains for subj u ects dosed on extended regimens every r 12-, 16- or 20 weeks with tarcocimab compared to subj u ects given aflib f ercept every r 8 weeks. Following this announcement, Kodiak discontinued the study t and concluded remaining trial-associated activities. Given we have three successful f Phase 3 studi t es across three different diseases, an additional successful f pivotal study t in one of these indications is required for regulatory r approval. We believe tarcocimab a demonstrated strong and consistent durability of approximately 6 months for the majo a rity of patients and favorable safety across the full pivotal program, and we believe tarcocimab has the potential to become an important medicine for patients and a meaningful f ly differentiated product in the marketpl t ace. Therefor f e, we have activated GLOW2, a Phase 3 study t in diabetic retinopathy (“DR”). The GLOW2 stud t y has a similar design as GLOW1 with the benefit of an additional, third monthly loading dose (weeks 0, 4 and 8). We discussed the study t design with the FDA, and the study t is currently recrui r ting patients. Additionally, in light of the importance of wet AMD in today’s anti-VEGF market, we also plan to study t tarcocimab a as a second investigational arm in the KSI-501 Phase 3 DAYBREAK study t to evaluate its durability, strengthen its competitive position in wet AMD and bolster our ex-US regulatory r dossier. We are discussing the study t design of DAYBREAK with the FDA and plan to initiate the study t as soon as regulatory r alignment is completed, which we hope is mid-2024. We made adju d stments to the tarcocimab a product that improve the manufact f ur t ability in a prefille f d syringe and we believe may also enhance the utility of the product. We believe now is the time to implement these changes given the additional clinical studi t es we plan to conduct, and the FDA has agreed that these additional clinical studi t es should be sufficient to bridge the former material to the go-to-market material we would like to commercialize going forward. Both GLOW2 and DAYBREAK will be run using our go-to-market formulation of tarcocimab. a Antibody Biopolym l er Conjugatet Drug Substan t ce Manufac f turing i In August 2020, we entered into a manufac f turing agreement with Lonza Ltd (“Lonza”) for the clinical and commercial suppl u y of the Company’s antibody biopolymer conjugate drug r subs u tance which included a custom-built manufact f ur t ing facility. The manufactur t ing agreement has an initial term of 8 years, and the Company has the right to extend the term up to a total of 16 years. The Company and Lonza each have the ability to terminate this agreement upon the occurrence of certain events. In April 2021, the agreement was amended to provide for greater manufac f turing flexibility, to define a comprehensive mandate as an antibody biopolymer conjugates manufact f ur t ing facility to be used for the Company’s antibody biopolymer conjugates pipeline, at clinical as well as commercial scales, across a broad capacity range under the tight quality controls required for ophthalmology and retinal medicines, and to allow for future process and equipment changes as needed.