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Sep 30, 2024
Kodiak Sciences Q3 2024 Earnings Report
Reported business highlights and financial results for the quarter ended September 30, 2024.
Key Takeaways
Kodiak Sciences reported a net loss of $43.9 million for the third quarter of 2024, with cash and cash equivalents of $197.9 million. The company is focused on advancing its clinical programs, including tarcocimab, KSI-501, and KSI-101, and expects current cash to support operations into 2026.
Hosted an Investor R&D Day presenting new clinical data of tarcocimab with an ocular half-life in patients of 20 days.
Announced the new phase 3 GLOW2 study is enrolling patients in diabetic retinopathy and the new phase 3 DAYBREAK study is enrolling patients in wet AMD.
Announced the new unconjugated bispecific antibody KSI-101 clinical program is enrolling patients with macular edema secondary to inflammation in our APEX study.
Continued enrollment of subjects across all three clinical programs with the objective to complete enrollment for the Phase 3 GLOW2 and DAYBREAK studies in the first half of 2025.
Kodiak Sciences
Kodiak Sciences
Forward Guidance
Kodiak Sciences is focused on advancing its clinical programs and expects to complete enrollment for the Phase 3 GLOW2 and DAYBREAK studies in the first half of 2025. The company plans to file a single Biologics License Application for three diseases with data from five successful Phase 3 studies with tarcocimab, assuming successful outcomes. For KSI-101, the company hopes to select two dose levels to progress into the pivotal program and to activate the twin PEAK and PINNACLE pivotal studies in the second quarter of 2025.
Positive Outlook
- GLOW2 and DAYBREAK studies designed to maximize probability of success.
- KSI-101 showing meaningful clinical responses in sick patients with macular edema secondary to inflammation.
- Goal to complete enrollment for GLOW2 and DAYBREAK studies in the first half of 2025.
- Plan to file a single BLA for three diseases with data from five successful Phase 3 studies with tarcocimab.
- Hope to select two dose levels for KSI-101 and activate twin PEAK and PINNACLE pivotal studies in Q2 2025.
Challenges Ahead
- Success of GLOW2 and DAYBREAK is necessary for BLA filing.
- Selection of dose levels for KSI-101 and activation of PEAK and PINNACLE studies are not guaranteed.
- Clinical responses in APEX study are early and may not persist or translate to later-stage studies.
- Regulatory approval of BLA is subject to FDA review and may be delayed or denied.
- Continued enrollment in clinical trials is essential for achieving study objectives.