Business
Kodiak Sciences Announces Fourth Quarter and Full Year 2019 Financial Results and Recent Business Highlights
PALO ALTO, Calif., March 16, 2020 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a clinical stage biopharmaceutical company specializing in novel
About this update from Kodiak Sciences Inc
[{"type":"text","content":"PALO ALTO, Calif., March 16, 2020 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a clinical stage biopharmaceutical company specializing in novel therapeutics to treat chronic, high-prevalence retinal diseases, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2019.\n\"We made tremendous progress this past year toward our goal of developing a next generation platform for retinal medicines,\" said Victor Perlroth, MD, CEO of Kodiak Sciences. \"We remain very pleased with the emerging clinical profile of KSI-301, our first product candidate built on our ABC Platform. We continue to see impressive safety, efficacy and durability data across our active clinical studies. We initiated our first pivotal clinical study (DAZZLE) assessing KSI-301 in wet age-related macular degeneration (wet AMD) patients. We held a productive End-of-Phase 2 meeting with the FDA in which we reached agreement on an innovative clinical plan for registration. We secured substantive resources to fund accelerated clinical, manufacturing, and commercial plans for KSI-301. We look forward to initiating four more pivotal studies for KSI-301 later this year. We remain focused on achieving our 2022 Vision of filing a BLA in wet AMD, Diabetic Macular Edema (DME), and Retinal Vein Occlusion (RVO) in 2022.\"\nIn 2019 and into the first quarter of 2020, highlights of our activities included: \nInitiation of enrollment and on-going recruitment in our pivotal DAZZLE clinical trial of KSI-301 in patients with treatment naïve wet AMD. As of March 6, 2020, more than 175 patients have been enrolled in the study randomized 1:1 between KSI-301 and Eylea; Completion of recruitment into our ongoing Phase 1b study of KSI-301 in 121 treatment-naïve patients with wet AMD, DME and RVO; Presentation of promising on-going clinical safety, efficacy and durability data at the American Society of Retina Specialists 2019 Annual Meeting, the Macula Society 2019 Annual Meeting, the American Academy of Ophthalmology 2019 Annual Meeting Retina Subspecialty Day, and the Angiogenesis, Exudation, and Degeneration 2020 Annual Meeting; Completion of a Type B (End of Phase 2 or EOP) meeting with FDA where we discussed and agreed on: Certain recommended clinical, non-clinical, and manufacturing activities to support the potential li...