Loading...
•
Jun 30, 2020
Kiniksa Q2 2020 Earnings Report
Kiniksa reported its second quarter 2020 financial results and highlighted recent pipeline and corporate activity.
Key Takeaways
Kiniksa had a successful first half of 2020, with positive results from studies of rilonacept and vixarelimab, as well as mavrilimumab data published in The Lancet Rheumatology. The company is planning to submit an sBLA to the FDA for rilonacept in recurrent pericarditis this year. Evaluations of mavrilimumab and vixarelimab are progressing, and data is expected in the fourth quarter from the mavrilimumab GCA trial and the KPL-404 program. Recent capital raises and financial discipline are expected to extend the company's cash runway into 2023.
Statistically significant results from the pivotal Phase 3 study of rilonacept in recurrent pericarditis.
Positive results from the Phase 2a study of vixarelimab in prurigo nodularis.
COVID-19 mavrilimumab data published in The Lancet Rheumatology.
sBLA submission to the FDA for rilonacept in recurrent pericarditis planned for this year.
Forward Guidance
Kiniksa expects a catalyst-filled second half of the year with multiple data readouts and a planned sBLA submission.
Positive Outlook
- Potential to bring rilonacept as a potential treatment option for patients with recurrent pericarditis
- Planned clinical trials and timing thereof, including a potential dose-ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis
- Planned clinical trials and timing thereof, including a Phase 2 trial evaluating the investigational combination of Yescarta® (axicabtagene ciloleucel) and mavrilimumab in relapsed or refractory large B-cell lymphoma
- Projected timeframe for funding our current operating plan with current cash, cash equivalents and short-term investments
- Advancement of clinical-stage product candidates, rilonacept, mavrilimumab, vixarelimab and KPL-404
Challenges Ahead
- Potential 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
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...