---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-200742"
form_type: "8-K"
ticker: "KALV"
cik: "0001348911"
company_name: "KalVista Pharmaceuticals, Inc."
filed_at: "2025-09-11T23:59:59+00:00"
generated_at: "2026-05-17T06:51:47.541012+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# KalVista Q1: EKTERLY approved in US/UK; 460 patient start forms; positive CHMP opinion

## Summary
- EKTERLY (sebetralstat) FDA approved July 7, 2025; UK MHRA authorized same month; positive CHMP opinion; EU decision expected Oct 2025.
- Received 460 patient start forms through August 29, 2025 (nearly 5% of US HAE patients).
- Net product revenue $1.4M from US sales; R&D expenses $15.2M (down 43% YoY); SG&A $44.7M (up 154% YoY due to commercialization).
- Cash and marketable securities $191.5M as of July 31, 2025; runway into 2027.
- Orphan designation maintained in EU; 10 years market exclusivity; one of only two HAE medicines with orphan status.

## SEC filing metadata
- accession: 0001193125-25-200742
- form_type: 8-K
- ticker: KALV
- cik: 0001348911
- company_name: KalVista Pharmaceuticals, Inc.
- filed_at: 2025-09-11T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1348911/000119312525200742/0001193125-25-200742-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1348911/000119312525200742/d12074d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-200742
- JSON: https://secwatch.observer/filing/0001193125-25-200742.json
- Plain text: https://secwatch.observer/filing/0001193125-25-200742.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.