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Sep 30, 2020
Kiniksa Q3 2020 Earnings Report
Kiniksa reported financial results for Q3 2020 and highlighted recent pipeline and corporate activity.
Key Takeaways
Kiniksa continues to advance its pipeline, preparing for the potential commercial launch of rilonacept in recurrent pericarditis in the first half of 2021, pending FDA approval. The mavrilimumab Phase 2 trial in giant cell arteritis achieved statistical significance in primary and secondary efficacy endpoints. All cohorts have been dosed in the Phase 1 study of KPL-404, with data expected from the first cohorts this quarter.
Preparing for the commercial launch of rilonacept in recurrent pericarditis in the first half of 2021, if approved by the FDA.
Mavrilimumab Phase 2 trial in giant cell arteritis achieved statistical significance in primary and secondary efficacy endpoints.
All cohorts have been dosed in the Phase 1 study of KPL-404.
Data from the first cohorts of KPL-404 Phase 1 study expected this quarter.
Forward Guidance
Kiniksa provided forward-looking statements regarding plans and timing of clinical trial data readouts, potential commercial launch of rilonacept, planned clinical trials and timing thereof, regulatory milestones and related payments, and projected timeframe for funding the current operating plan.
Positive Outlook
- Plans and timing of clinical trial data readouts
- Potential commercial launch of rilonacept in recurrent pericarditis, if approved by the FDA under priority review
- Planned clinical trials and timing thereof, including a potential dose-ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis
- Regulatory milestones and related payments under our License Agreement with Regeneron upon achievement of certain specified events
- Projected timeframe for funding our current operating plan with current cash, cash equivalents and short-term investments
Challenges Ahead
- Delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials
- Potential complications in coordinating among requirements, regulations and guidelines of regulatory authorities across a number of jurisdictions for our global clinical trials
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