KalVista Pharmaceuticals Reports FDA Approval of EKTERLY and Financial Developments for Fiscal Year Ending April 30, 2025

KalVista Pharmaceuticals, Inc. reported significant developments in its fiscal year ending April 30, 2025, highlighted by the FDA's approval of its first product, EKTERLY (sebetralstat), on July 3, 2025. This novel oral therapy is designed for the treatment of acute attacks of hereditary angioedema (HAE) in patients aged 12 years and older. The approval followed the successful completion of the KONFIDENT clinical trial, which demonstrated that EKTERLY provided symptom relief significantly faster than placebo, with a median time to relief of 1.79 hours compared to 6.72 hours for placebo. Despite this milestone, the company reported no revenue for the fiscal years 2025 and 2024, as it had not yet commercialized any products prior to the approval.

Financially, KalVista experienced a net cash outflow of $152.9 million in operating activities for the year, an increase from $89.2 million in the previous year. The company's accumulated deficit reached $653.2 million as of April 30, 2025. Research and development expenses decreased to $71.7 million from $86.2 million, primarily due to reduced spending on sebetralstat and KVD824 as the company shifted focus towards commercialization efforts. In contrast, general and administrative expenses surged to $116.3 million, up from $54.3 million, driven by costs associated with building a commercial organization and increased employee-related expenses.

Strategically, KalVista entered into several agreements to enhance its market presence. In November 2024, it sold future royalty rights on sebetralstat to DRI Healthcare Acquisitions for an upfront payment of $100 million, with additional tiered payments based on sales performance. Furthermore, in April 2025, the company licensed commercialization rights for sebetralstat in Japan to Kaken Pharmaceutical, receiving an upfront payment of $11 million and potential milestone payments. These agreements are expected to support the company's financial position as it prepares for the commercial launch of EKTERLY.

As of April 30, 2025, KalVista employed 270 full-time staff, reflecting its growth as it builds out its commercial infrastructure. The company anticipates that its cash reserves, bolstered by recent financing activities, will be sufficient to fund operations for at least the next 12 months. Looking ahead, KalVista aims to leverage its recent FDA approval to establish EKTERLY as a foundational therapy for HAE, while also pursuing regulatory approvals in international markets, including Europe and Japan, where applications are currently under review. The company remains focused on expanding its product pipeline and enhancing its market position in the biopharmaceutical sector.