Highlights 

  • EKTERLY generates 13.7M USD in revenue during third-quarter US launch. 
  • 937 patient start forms submitted, reflecting adoption of oral HAE therapy. 
  • Cash and marketable securities of 309M USD expected to support operations through profitability. 

KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) released its financial results for Q3 2025 and shared an operational update. The US launch of EKTERLY® (sebetralstat) began on July 7, 2025. By October 31, 2025, the company had received 937 patient start forms and activated 423 unique prescribers. 

CEO Ben Palleiko commented, “The US launch of EKTERLY is progressing with significant momentum, driven by strong early demand and rapid adoption among physicians and people living with HAE. We continue to see encouraging trends, with both new patient starts and repeat prescriptions increasing consistently, reflecting sustained uptake and confidence in the clinical value of EKTERLY as the first and only oral on-demand treatment for hereditary angioedema.” 

European and Australian Market Approvals 
In September 2025, EKTERLY received approval from the European Commission and Swissmedic for the treatment of acute HAE attacks in adults and adolescents aged 12 and older. The EC approval applies across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. The company launched EKTERLY in Germany in October, with initial shipments delivered to patients. 

The Therapeutic Goods Administration of Australia also approved EKTERLY in October 2025 for the treatment of HAE attacks caused by C1 inhibitor deficiency or dysfunction in patients aged 12 years and older. 

Clinical Data Updates 
At the 2025 American College of Allergy, Asthma & Immunology Annual Scientific Meeting, KalVista presented new data on pediatric use and patient satisfaction: 

  • KONFIDENT-KID trial interim results showed a median dosing time of 30 minutes and median time to symptom relief of 1.5 hours in pediatric patients aged 2–11. 
  • In KONFIDENT-S, patients switching from injectable on-demand treatments reported satisfaction with 84% of 1,089 treated attacks, and the median treatment satisfaction score was 2 (very satisfied). 

Organizational Developments 
KalVista announced leadership changes with Bilal Arif joining as Chief Operating Officer and Linea Aspesi as Chief People Officer. Bethany L. Sensenig was appointed to the Board of Directors and the Audit Committee. 

Q3 2025 Financial Overview 
The company recorded 13.7M USD in net product revenue for Q3 2025. Cost of revenue amounted to 1.2M USD, including EKTERLY manufacturing and post-approval inventory expenses. Research and development expenses were 12.0M USD, down from 18.7M USD in Q3 2024, primarily due to lower clinical trial costs. Selling, general, and administrative expenses increased to 46.5M USD from 24.8M USD, driven by commercialization-related spending. 

As of September 30, 2025, KalVista held approximately 309.2M USD in cash, cash equivalents, and marketable securities, which the company expects will fund operations until profitability. 

About EKTERLY® (sebetralstat) 
EKTERLY is an oral plasma kallikrein inhibitor approved in the US, EU, UK, Switzerland, and Australia for treating acute HAE attacks in patients 12 years and older. Ongoing clinical studies are evaluating its use in children aged 2–11.