Kodiak Sciences: KSI-301 fails primary endpoint in wet AMD Phase 2b/3 trial

Kodiak Sciences Inc.

Primary endpoint not met: KSI-301 failed to show non-inferior visual acuity gains vs aflibercept in wet AMD.
Cash and cash equivalents at Dec 31, 2021 were approximately $731.5M.
Pre-specified secondary analysis: 59% of KSI-301 patients achieved 5-month dosing with comparable visual acuity and anatomic improvements.
Safety: KSI-301 generally safe; intraocular inflammation in 3.2% vs 0% for aflibercept; all resolved.
Trial randomized 559 participants, ~80% in US; flexible long-interval regimen for KSI-301 vs fixed 2-month for aflibercept.

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