Kodiak Sciences Q4 2023 Earnings Report
Key Takeaways
Kodiak Sciences reported a net loss of $59.5 million for the fourth quarter of 2023 and ended the year with $285.5 million in cash and cash equivalents. The company is progressing its three clinical assets towards Phase 3 value inflection points, including new Phase 3 studies for tarcocimab and KSI-501.
Kodiak ended Q4 2023 with $285.5 million in cash and cash equivalents, expected to fund operations into 2026.
GLOW1 Phase 3 study of tarcocimab in diabetic retinopathy met its primary endpoint.
Phase 1 study results for KSI-501 in diabetic macular edema were positive, supporting further clinical development.
New Phase 3 DAYBREAK study in wet AMD to include KSI-501 and tarcocimab investigational groups versus aflibercept targeted to start recruitment mid-2024
Kodiak Sciences
Kodiak Sciences
Forward Guidance
Kodiak Sciences believes that its current cash will support operations into 2026 and is focused on progressing its late-stage clinical assets.
Positive Outlook
- Existing cash will support operations into 2026.
- Advancing KSI-501 into a Phase 3 pivotal study (DAYBREAK) in patients with wet AMD later this year
- Planning to advance KSI-101 into a Phase 1b study to evaluate its safety and tolerability
- Initiated a GLOW2 Phase 3 pivotal study which is already actively enrolling patients
- Both DAYBREAK and GLOW2 will use tarcocimab’s new go-to-market formulation.
Challenges Ahead
- Cessation or delay of any of the on-going clinical studies and our development of tarcocimab or KSI-501 may occur
- The BEACON and/or GLOW1 and/or GLOW2 and/or DAYLIGHT results may not provide the evidence, insights, or benefits as anticipated
- Safety, efficacy, and durability data observed in our product candidates in current or prior studies may not continue or persist
- A BLA may not be accepted by, or receive approval from, the FDA or foreign regulatory agencies when expected, or at all
- Our manufacturing facilities may not operate as expected