Kodiak Sciences Announces 3rd Quarter 2022 Financial Results and Recent Business Highlights.

PALO ALTO, Calif: Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, today reported business highlights and financial results for the quarter ended September 30, 2022.

"We continue to execute on our comprehensive pivotal clinical program for tarcocimab tedromer and remain on track to report topline results for all of the ongoing Phase 3 studies in diabetic macular edema, wet age-related macular degeneration and non-proliferative diabetic retinopathy over the next 12 months," said Victor Perlroth, MD, Chief Executive Officer of Kodiak Sciences. "The retinal vascular disease treatment landscape continues to evolve as new data become available on anti-VEGF therapies from incumbent players. These Phase 3 and commercial anti-VEGF medicines do not appear to be designed with a science of durability and currently are delivering an every 3 to 4-month dosing interval. We remain focused on the vision for tarcocimab, designed from the ground up with a science of durability, to deliver strong efficacy and solid safety while bringing a majority of patients to every 5 and 6-month dosing, which we continue to view as a first-line profile. To this point, in our BEACON study, tarcocimab tedromer is the only anti-VEGF therapy that in clinical trials demonstrated non-inferior vision outcomes in retinal vein occlusion with a doubling of the treatment interval for all patients versus monthly aflibercept. And in our DAZZLE study in patients with wet age-related macular degeneration, although the study demonstrated that a minority of patients may have benefited from treatment with tarcocimab more frequently than every 3 months, the study also indicated that the majority of patients receiving tarcocimab every 5 months could obtain and maintain excellent visual outcomes. If approved, tarcocimab has the potential to provide best in class durability thereby resulting in improved patient outcomes and quality of life."

Recent Business Highlights

Update on Tarcocimab tedromer Clinical Program: We continued to advance our ongoing, fully-enrolled Phase 3 pivotal studies, with four Phase 3 studies on track to read out topline data in 2023:

GLEAM / GLIMMER: Our paired Phase 3 long-interval (as infrequently as every 6 months) studies GLEAM and GLIMMER in diabetic macular edema ("DME") are expected to report topline data in mid-2023 and...