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Jun 30, 2020
Kodiak Sciences Q2 2020 Earnings Report
Reported business highlights and financial results for the second quarter ended June 30, 2020.
Key Takeaways
Kodiak Sciences reported a net loss of $26.0 million for the second quarter of 2020. The company ended the quarter with $417.1 million in cash, cash equivalents and marketable securities, estimating sufficient funds to execute on current operating plans into 2022.
Finalized the design of pivotal study program and intend to conduct two Phase 3 studies in DME, one study in wet AMD, one study in RVO, and one study in non-proliferative diabetic retinopathy without DME.
Recruitment into DAZZLE pivotal study in wet AMD was robust, with over 375 patients enrolled as of July 30, 2020, and EU patient enrollment commenced in June 2020.
Updated safety and efficacy results from ongoing Phase 1b trial of KSI-301 were presented at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting in July 2020.
Negotiated a long-term agreement with Lonza for the manufacture of KSI-301, providing Kodiak with a custom-built bioconjugation facility with a capacity to supply millions of doses per year.
Kodiak Sciences
Kodiak Sciences
Forward Guidance
Kodiak expects to initiate several pivotal Phase 3 studies in 2020, including studies for Diabetic Macular Edema (GLEAM and GLIMMER), Retinal Vein Occlusion (BEACON), and potentially non-proliferative Diabetic Retinopathy without DME (GLOW). They also aim to complete enrollment in the DAZZLE study.
Positive Outlook
- Initiate two pivotal Phase 3 randomized head-to-head studies of KSI-301 against aflibercept in treatment naïve Diabetic Macular Edema patients (GLEAM and GLIMMER)
- Initiate one pivotal Phase 3 randomized head-to-head study of KSI-301 against aflibercept in treatment naïve Retinal Vein Occlusion patients (BEACON)
- Complete enrollment in DAZZLE pivotal Phase 2b/3 randomized head-to-head study of KSI-301 against aflibercept in treatment naïve wet macular degeneration patients.
- The Lonza-Kodiak Ibex facility will provide Kodiak with the facility needed for commercial-scale manufacturing of KSI-301.
- Sufficient funds to execute on current operating plans into 2022.
Challenges Ahead
- Preliminary safety, efficacy and durability data for our KSI-301 product candidate will not continue or persist
- Cessation or delay of any of the ongoing clinical studies and/or our development of KSI-301 may occur, including as a result of the COVID-19 pandemic
- Future potential regulatory milestones of KSI-301, including those related to current and planned clinical studies may be insufficient to support regulatory submissions or approval
- Adverse conditions in the general domestic and global economic markets, including the COVID-19 pandemic, which may significantly impact our business and operations
- Our research and development efforts and our ability to advance our product candidates into later stages of development may fail