KODIAK SCIENCES INC. from a design standpoint, with opportunities and risks uncoupled from the Platform. We plan to initiate one Phase 1b study (APEX) and two Phase 3 studies (PEAK and PINNACLE) later this year. In short, we believe that we are emerging from our 2023 setbacks with a portfolio of three attractive clinical programs and an actionable and exciting plan to progress the portfolio rapidly to Phase 3 value inflection points. �� Tarcocimab: We plan to advance the clinical development of tarcocimab to enable marketing authorization application based on a new Phase 3 GLOW2 study in patients with diabetic retinopathy. We build on our successful GLOW1 study in diabetic retinopathy, and we think this maximizes the probability of success of the study. We also intend to study tarcocimab as a second investigational arm in the KSI-501 Phase 3 DAYBREAK study in wet AMD, the largest segment of the anti-VEGF market today. If successful, DAYBREAK would strengthen tarcocimab’s competitive position and bolster our ex-U.S. regulatory dossier for the molecule. �� KSI-501: We applied learnings from the tarcocimab pivotal program to our development strategy for KSI- 501, our anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate for high-prevalence retinal vascular diseases. KSI-501’s design has three tiers of innovation: (1) a first-in-class, bispecific mechanism of action; (2) the potential for six-month durability based on the ABC Platform; and (3) an enhanced formulation informed from the tarcocimab program. We conducted a multiple-ascending dose Phase 1 study of KSI- 501 last year in patients with diabetic macular edema. The study demonstrated that repeated monthly dosing of KSI-501 was safe and well tolerated, and KSI-501 showed meaningful, sustained vision benefits in both treatment-naïve and treatment-experienced patients. We plan to advance KSI-501 into the Phase 3 DAYBREAK study in wet AMD later this year. �� KSI-101: KSI-101 is the unconjugated anti-IL-6, VEGF-trap bispecific protein portion of KSI-501. With its bispecific anti-inflammatory mechanism of action, its high formulation strength at 100 mg/ml and the safety we have seen so far as part of the KSI-501 Phase 1 study, we believe KSI-101 can be a powerful medicine for the uveitic complex of diseases with macular edema and inflammation for which no available intravitreal biologic therapies exist today. We intend to advance KSI-101 into a dose-finding Phase 1b study (APEX) shortly with the goal of initiating dual pivotal Phase 3 studies (PEAK and PINNACLE) later this year. We continue to significantly advance our pharmaceutical manufacturing. Last year, we worked with Lonza and regulatory authorities to obtain regulatory approval for Ursus, our commercial-scale manufacturing facility. We released our first commercial-scale cGMP batch of tarcocimab in July 2023. In parallel, clinical material for both KSI-501 (50 mg/mL strength in our enhanced formulation) and KSI-101 (100 mg/mL strength) have been successfully manufactured. To be sure, we had disappointments in 2023, but we emerged with three main takeaways that we believe point to a bright future: First, the ABC Platform can deliver a meaningful Generation 2.0 profile. Second, we have a portfolio of three exciting clinical programs with diversified opportunities and risks that we intend to advance into Phase 3 studies this year. Third, we believe we can advance these three clinical programs and achieve meaningful BLA-facing inflection points within our existing cash runway. Drug development is obviously a complex, unpredictable business. We remain convinced that we are working in the right target market (retina), with the right team and agility of mind to make needed course-corrections, the right technology (our ABC Platform) and diversified portfolio (tarcocimab, KSI-501 and KSI-101), the right clinical capability and timelines, the right commercial manufacturing facility (Ursus) and partner (Lonza), and the right deeper technology pipeline powered by our maturing “duet/triplet” and “VETi” platforms. We recognize it will take time to rebuild our credibility, which is critical to investor confidence. We look forward to doing the hard work needed to achieve this, and we thank you for your continued support. Victor Perlroth, M.D. Chairman of the Board and Chief Executive Officer
Kodiak: 2023 Annual Report Page 2 Page 4