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Sep 30, 2022
Kodiak Sciences Q3 2022 Earnings Report
Reported business highlights and financial results for the quarter ended September 30, 2022.
Key Takeaways
Kodiak Sciences reported a net loss of $77.0 million for the third quarter of 2022 and ended the quarter with $537.4 million in cash, cash equivalents and marketable securities. The company is focused on advancing its Phase 3 clinical program for tarcocimab tedromer.
Continued to advance ongoing, fully-enrolled Phase 3 pivotal studies for tarcocimab tedromer.
Four Phase 3 studies on track to read out topline data in 2023.
Continued manufacturing scale up activities of tarcocimab tedromer to support a potential commercial launch.
Continued progressing pipeline product candidates, in particular KSI-501, with IND filing expected in Q4 2022 and Phase 1 clinical study in early 2023.
Kodiak Sciences
Kodiak Sciences
Forward Guidance
Kodiak Sciences is on track to report topline results for all of the ongoing Phase 3 studies in diabetic macular edema, wet age-related macular degeneration and non-proliferative diabetic retinopathy over the next 12 months. The company expects to file the IND for KSI-501 in the fourth quarter of 2022 and to begin the Phase 1 clinical study in early 2023.
Positive Outlook
- GLEAM / GLIMMER topline data expected in mid-2023 and if successful are designed to serve as the primary basis for a licensing application and potential regulatory approval of tarcocimab.
- DAYLIGHT topline results expected in mid-2023 and if successful, we expect DAYLIGHT to contribute data to support approval of tarcocimab in wet AMD.
- GLOW topline results expected in the second half of 2023 and if successful, we expect GLOW to contribute data to support approval of tarcocimab in NPDR with the potential to be the longest-interval intravitreal therapeutic option in this disease.
- BEACON study results are intended to serve as the basis for the potential approval of tarcocimab in RVO.
- KSI-501 IND filing expected in Q4 2022 and Phase 1 clinical study in early 2023.
Challenges Ahead
- Preliminary safety, efficacy and durability data for tarcocimab tedromer product candidate may not continue or persist.
- Tarcocimab tedromer may not have the anti-VEGF effect or impact on the treatment of patients as expected.
- Cessation or delay of any of the ongoing clinical studies and/or our development of tarcocimab tedromer may occur, including as a result of the ongoing COVID-19 pandemic.
- ABC Platform may not extend treatment intervals in retinal disorders as anticipated, or at all.
- Future potential regulatory milestones of tarcocimab tedromer, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval.