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Mar 31, 2022
Kodiak Sciences Q1 2022 Earnings Report
Reported business highlights and financial results for the quarter ended March 31, 2022.
Key Takeaways
Kodiak Sciences reported a net loss of $95.7 million for the first quarter of 2022 and ended the quarter with $671.7 million in cash and cash equivalents. The company is progressing with its KSI-301 Phase 3 program and anticipates four Phase 3 study readouts in 2022 and 2023.
Implemented changes to ongoing Phase 3 studies of KSI-301 to mitigate potential risk of undertreatment.
Completed mechanical completion of purpose-built bioconjugation facility in Visp, Switzerland.
Progressing pipeline product candidates KSI-501 and KSI-601, with IND submission for KSI-501 expected in 2H 2022.
Top-line data for BEACON, Phase 3 pivotal study of KSI-301 in RVO, expected in 3Q 2022.
Kodiak Sciences
Kodiak Sciences
Forward Guidance
Kodiak anticipates several milestones in the near future, including announcing top-line data for the BEACON study, completing enrollment for the GLOW study, and submitting an IND for KSI-501.
Positive Outlook
- Announce top-line data for BEACON, Phase 3 pivotal study of KSI-301 in RVO, in 3Q 2022
- Complete enrollment for GLOW, Phase 3 pivotal study of KSI-301 in non-proliferative diabetic retinopathy (NPDR), in 3Q 2022
- Submit IND for KSI-501, a novel bispecific antibody biopolymer conjugate, in 2H 2022
- Changes to the DME program that we believe will mitigate the potential risk of undertreatment in high-need patients
- Regulatory strategy remains intact, and we intend to include data from the BEACON, GLEAM, GLIMMER and DAYLIGHT studies in a single initial BLA, if successful
Challenges Ahead
- Phase 2b/3 study in wet AMD did not meet its primary endpoint
- Not allowing treatment more frequent than every 12 weeks (q12w) was a fundamental flaw in the study design
- Critical undertreatment in a minority of patients
- Potential risk of undertreatment in high-need patients
- Studies may be insufficient to support regulatory submissions or approval