TO OUR KODIAK STOCKHOLDERS, EMPLOYEES, AND PARTNERS: 2022 was a difficult year with strong headwinds: for the global economy, for the biotech industry and for Kodiak. Rising interest rates, plunging valuations and a constrained biotech capital market all contributed to an environment that led many biotech peers to abort their original course and seek strategic alternatives. At Kodiak, having financed well before the headwinds, we were fortunate and were able to make what we believe to be important progress despite a clinical setback. KODIAK SCIENCES INC. Continued Progress on Tarcocimab Tedromer Pivotal Program In 2022 we advanced the tarcocimab tedromer clinical program across six pivotal studies and reported primary results from two pivotal studies. We were very disappointed when our Phase 2b/3 study in wet age-related macular degeneration did not meet its primary endpoint, although the study did demonstrate strong durability with 59% of tarcocimab treated patients achieving strong vision gains while on every five-month dosing. We were encouraged by the positive topline results in our Phase 3 BEACON study in patients with retinal vein occlusion (RVO). Tarcocimab dosed every two months met the primary endpoint of non-inferior visual acuity gains compared to aflibercept dosed every month. Tarcocimab is the first anti-VEGF therapy to show non-inferior efficacy while doubling the treatment interval in patients with RVO. Meeting the endpoint was important, especially because we did not allow high-need patients to be rescued to a monthly regime matched to the comparator, an approach taken by some other sponsors. We completed enrollment in all four of our ongoing Phase 3 studies, namely our paired Phase 3 GLEAM and GLIMMER studies in diabetic macular edema (DME), our Phase 3 GLOW study in non-proliferative diabetic retinopathy (NPDR) and our Phase 3 DAYLIGHT study in wet AMD. Durability clearly matters to the community of retina patients, physicians and payors, and our Phase 3 program is testing the longest treatment intervals of any intravitreal biologic while preserving dosing flexibility for high-need patients. With the promising durability demonstrated in both our Phase 1b and Phase 3 BEACON studies, we hope to demonstrate tarcocimab can enable twice a year (6-month) dosing for the majority of patients. This would be an unprecedented level of durability for a biopharmaceutical. It would rival the promise many believed could be achieved only with in-dwelling ocular devices and gene therapies, both of which appear to be further behind in development as of the end of 2022 than where they started the year. It is true the commercial landscape for intravitreal anti-VEGF biopharmaceuticals is becoming more complex with established competitors launching follow-on products. That said, tarcocimab to date remains the only biologic purposefully built with a science of durability, in our case the science of our Antibody Biopolymer Conjugate (ABC) Platform, and the only biologic we are aware of exploring every 6-month dosing. Three of our four Phase 3 studies scheduled to reach their primary endpoint this year are in diabetic eye disease, where we hope to showcase a strong first-line profile. Diabetic eye disease represents 35% of the $15 billion anti-VEGF market today and, looking to the future, diabetic eye disease is estimated to represent 40+% of the expected growth in the market. More than 100 million Americans are estimated to be living with diabetes or prediabetes today, and it is the leading cause of irreversible blindness among working-age adults. Almost one-third of adult diabetic patients have diabetic retinopathy. Durability is paramount in diabetic eye disease as it draws from working age populations. Patients in our ongoing diabetic eye disease pivotal studies (Gleam, Glimmer and Glow) include physicians, plumbers and even long-haul truck drivers. These are all professions where maintaining vision is a lifeline to livelihood. Yet one-third of anti-VEGF treated diabetic patients discontinue therapy in any given year, and so the promise of the anti-VEGF mechanism is not being achieved. As such, we believe that the opportunity to improve visual outcomes for this important population is poised for the right medicine. From the beginning of our clinical experience, investigators have reached out to us to describe the strong immediacy and durability they were seeing with tarcocimab in patients with diabetic eye disease.
Kodiak Ophthalmology Medicines Company 2022 Annual Report Page 1 Page 3