earnings
confidence high
sentiment positive
materiality 0.85
KalVista FY2025: FDA approved EKTERLY; cash $220.6M; R&D down, G&A up
KalVista Pharmaceuticals, Inc.
- FDA approved EKTERLY (sebetralstat) on July 7, 2025 as first oral on-demand HAE treatment; U.S. launch underway.
- Cash and marketable securities $220.6M at April 30, 2025, providing runway into 2027.
- R&D expenses $71.7M (down from $86.2M); G&A expenses $116.3M (up from $54.3M) driven by pre-commercial costs.
- Entered licensing agreements for sebetralstat in Japan (Kaken, $11M upfront) and Canada (Pendopharm).
- Six global regulatory submissions under review; new clinical data presented at EAACI, C1-INH, and EAC.