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Jun 30, 2023
Kodiak Sciences Q2 2023 Earnings Report
Kodiak Sciences reported a net loss for Q2 2023 and provided updates on its tarcocimab and KSI-501 clinical programs.
Key Takeaways
Kodiak Sciences Inc. reported its second quarter 2023 financial results, highlighting a net loss of $80.2 million, progress with the KSI-501 clinical program, and the decision to wind down ongoing tarcocimab studies due to unfavorable Phase 3 GLEAM and GLIMMER study results.
Phase 3 GLEAM and GLIMMER studies of tarcocimab in diabetic macular edema did not meet primary efficacy endpoints due to an unexpected increase in cataract adverse events.
Phase 3 DAYLIGHT study of tarcocimab in wet age-related macular degeneration met the primary efficacy endpoint.
Kodiak Sciences will wind down ongoing clinical studies of tarcocimab.
Phase 1 study of KSI-501, a first-in-class bispecific investigational medicine, has completed enrollment of patients across all dose levels.
Kodiak Sciences
Kodiak Sciences
Forward Guidance
Kodiak Sciences is focused on the potential benefits of KSI-501 and is planning to explore an accelerated development pathway. The company is also evaluating future options for the tarcocimab program and planning to expand the research pipeline.
Positive Outlook
- KSI-501 has the potential to be a first-in-class bispecific investigational medicine inhibiting both VEGF and IL-6.
- Kodiak Sciences can apply a tailored clinical development plan to KSI-501 based on learnings from the tarcocimab clinical program and the ABC platform.
- The company expects to seek an accelerated development pathway through orphan and/or breakthrough therapy designation applications with KSI-501.
- Kodiak Sciences plans to expand its research pipeline.
- Company is exploring development of KSI-501 in two therapeutic forms.
Challenges Ahead
- Cessation or delay of any of the ongoing clinical studies and our development of KSI-501 may occur.
- Future potential regulatory milestones of tarcocimab or KSI-501 may be insufficient to support regulatory submissions or approval.
- Research and development efforts and our ability to advance our product candidates into later stages of development may fail.
- KSI-501 may not inhibit VEGF and IL-6 or have an impact on the treatment of patients as expected.
- Manufacturing facilities may not operate as expected.