Kodiak Sciences Q1 2023 Earnings Report
Key Takeaways
Kodiak Sciences reported a net loss of $70.8 million for the first quarter of 2023, with cash, cash equivalents, and marketable securities totaling $421.2 million.
Continued Phase 3 studies of tarcocimab towards primary endpoint readouts, exploring 6-month durability in diabetic eye disease.
Expanded development pipeline with dosing of patients in the Phase 1 study of KSI-501, a bispecific ABC designed to inhibit both VEGF-mediated angiogenesis and IL-6-mediated inflammation.
Shared scientific presentations on clinical and research pipeline programs at the ARVO 2023 Annual Meeting in April.
Began manufacturing commercial scale cGMP batches in Ursus, a custom-built commercial scale manufacturing facility, in the first quarter of 2023.
Kodiak Sciences
Kodiak Sciences
Forward Guidance
Kodiak Sciences anticipates topline data announcements for ongoing Phase 3 pivotal studies of tarcocimab, including GLEAM, GLIMMER, and DAYLIGHT studies expected in July 2023, and the GLOW study expected in September 2023. If successful, the company expects to file a single Biologics Licensing Applications (BLA) for tarcocimab in the four major retinal vascular disease indications, with the potential for flexible dosing regimens from every month to every 6 months.
Positive Outlook
- Potential for tarcocimab to be an important medicine for the 37 million people living with diabetes in the U.S. who are at risk of developing diabetic eye disease and losing vision.
- Tarcocimab pivotal program explores the potential for 6-month durability in patients with diabetic eye disease.
- KSI-501 has the potential to become a new category of retinal medicines with greater therapeutic efficacy than existing therapies.
- Ursus is expected to have the capacity to supply over 10 million dose equivalents annually.
- Potential for a single BLA submission in multiple retinal vascular disease indications, with the potential for flexible dosing regimens from every month to every 6 months.
Challenges Ahead
- Risk that cessation or delay of any of the ongoing clinical studies and our development of tarcocimab or KSI-501 may occur.
- Risk that preliminary safety, efficacy and durability data for our tarcocimab product candidate may not continue or persist.
- Risk that tarcocimab may not have the impact on the treatment of diabetic eye diseases or improve outcomes for patients with retinal vascular diseases as expected.
- Future potential regulatory milestones of tarcocimab or KSI-501, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval.
- Our research and development efforts and our ability to advance our product candidates into later stages of development may fail.