Core Insights - KalVista Pharmaceuticals reported strong momentum in the US launch of EKTERLY®, achieving $13.7 million in net product revenue for the third quarter of 2025, with 937 patient start forms received by October 31, 2025 [1][3][9] - The company has successfully launched EKTERLY in Germany, with initial orders indicating positive demand, and has received regulatory approval in Australia, expanding its global footprint [2][3] - As of September 30, 2025, KalVista has approximately $309 million in cash, expected to fund operations until profitability [1][9] Commercial Progress - The US commercial launch of EKTERLY began on July 7, 2025, with 423 unique prescribers activated [3] - EKTERLY is the first and only oral on-demand treatment for hereditary angioedema (HAE) approved in the US, EU, Switzerland, and Australia [6][9] - The European Commission and Swissmedic approved EKTERLY for treating acute HAE attacks in adults and adolescents aged 12 and older [3] Financial Performance - For the three months ended September 30, 2025, KalVista reported a net product revenue of $13.7 million, with a cost of revenue of $1.2 million [9][12] - Research and development expenses decreased to $12 million from $18.7 million in the same period of 2024, primarily due to reduced clinical trial costs [9][12] - Selling, general and administrative expenses increased to $46.5 million from $24.8 million, attributed to commercialization efforts for EKTERLY [9][12] Organizational Updates - The company appointed Bilal Arif as Chief Operating Officer and Linea Aspesi as Chief People Officer [9] - Bethany L. Sensenig joined KalVista's Board of Directors and the Audit Committee [9] Clinical Highlights - Interim results from the KONFIDENT-KID trial showed a median time to dosing of 30 minutes and a median time to symptom relief of 1.5 hours for pediatric patients [9] - In the KONFIDENT-S trial, 84% of treated attacks were rated as satisfied by patients who switched from injectable treatments [9]

Core Viewpoint - KalVista Pharmaceuticals has received approval from the European Commission and Swissmedic for EKTERLY (sebetralstat), marking it as the first oral on-demand treatment for hereditary angioedema in Europe [1] Company Summary - KalVista Pharmaceuticals, Inc. is focused on developing treatments for rare diseases, specifically targeting hereditary angioedema with its new product EKTERLY [1] - The approval of EKTERLY is significant as it provides a new therapeutic option for adults and adolescents aged 12 years and older suffering from acute attacks of hereditary angioedema [1] Industry Summary - The approval of EKTERLY highlights advancements in the treatment options available for hereditary angioedema, a condition that has limited treatment alternatives [1] - The introduction of an oral plasma kallikrein inhibitor like EKTERLY may shift treatment paradigms within the rare disease market, particularly for hereditary angioedema [1]

Core Viewpoint - KalVista Pharmaceuticals has received approval from the European Commission and Swissmedic for EKTERLY (sebetralstat), marking it as the first and only oral on-demand treatment for hereditary angioedema (HAE) in Europe [1] Company Summary - KalVista Pharmaceuticals, Inc. is focused on developing innovative treatments for rare diseases, specifically targeting hereditary angioedema with its new product EKTERLY [1] - The approval of EKTERLY is significant as it provides a new therapeutic option for adults and adolescents aged 12 years and older suffering from acute attacks of HAE [1] Industry Summary - The approval of EKTERLY highlights advancements in the treatment of hereditary angioedema, a condition that has limited treatment options available [1] - The introduction of an oral plasma kallikrein inhibitor represents a shift in the management of HAE, potentially improving patient compliance and outcomes [1]