KalVista Pharmaceuticals, Inc.

Our Company is a global biopharmaceutical company focused on developing and delivering oral therapies for individuals with rare diseases and significant unmet needs. On July 3, 2025, the U.S. Food and Drug Administration (FDA) approved EKTERLY® (sebetralstat) for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY (sebetralstat) is an orally delivered, small molecule plasma kallikrein inhibitor and is the first and only oral, on-demand therapy for HAE. The efficacy and safety of EKTERLY were established by results from the phase 3 KONFIDENT clinical trial, published in the New England Journal of Medicine in May 2024. The FDA considered the 600 mg dose of EKTERLY (sebetralstat) to be the optimal dose, based on KONFIDENT data and pharmacokinetic/pharmacodynamic studies. The KONFIDENT clinical trial met all primary and key secondary endpoints and showed a favorable safety profile. HAE attacks treated with 600 mg of sebetralstat achieved the primary endpoint of beginning of symptom relief significantly faster than placebo (p=0.0013), with a median time of 1.79 hours (CI 1.33, 2.27) compared to 6.72 hours with placebo (CI 2.33, >12). Sebetralstat was well-tolerated, with a safety profile similar to placebo. No patient withdrawals occurred due to adverse events, and no treatment-related serious adverse events (SAEs) were observed. Treatment-related adverse event rates were 2.2% for 600 mg sebetralstat and 4.8% for placebo. Key secondary endpoints showed attacks treated with 600mg of sebetralstat achieved a significantly faster time to a reduction in attack severity from baseline compared to placebo (p=0032), and a significantly faster time to complete attack resolution compared to placebo (p<0.0001).