KalVista Pharmaceuticals(KALV) - 2025 Q1 - Quarterly Report

Revenue Generation - The company has not generated any revenue in the current fiscal year and does not expect to do so until regulatory approval and commercialization of its product candidates[55]. - The company has not generated any revenue from product sales and expects to continue incurring losses as it develops and seeks regulatory approvals for product candidates[77]. Research and Development Expenses - Research and development expenses increased by $7.3 million to$26.6 million for the three months ended July 31, 2024, compared to $19.3 million in the same period in the prior fiscal year[65]. - The increase in research and development expenses was driven by$3.3 million in spending on the sebetralstat program, $2.3 million in personnel costs, and$1.9 million in preclinical and other activities[65]. - Research and development expenses totaled $26.6 million for the three months ended July 31, 2024, an increase of$7.3 million compared to $19.3 million in the same period of 2023[66]. - Personnel expenses rose by$2.3 million to $9.1 million, driven by higher headcount in research and development and medical teams[67]. - The increase in research and development tax credit receivable was$1.3 million for the three months ended July 31, 2024[71]. General and Administrative Expenses - General and administrative expenses rose by $7.8 million to$17.6 million for the three months ended July 31, 2024, compared to $9.8 million in the same period in the prior fiscal year[65]. - General and administrative expenses increased by$7.8 million, primarily due to a $4.5 million rise in commercial expenses and a$2.5 million increase in employee-related expenses[68]. Clinical Trials and Regulatory Approvals - The company filed a New Drug Application (NDA) with the FDA in June 2024 for sebetralstat, with a PDUFA notification date of June 17, 2025[47]. - The KONFIDENT clinical trial for sebetralstat enrolled 136 patients across 66 clinical sites in 20 countries, meeting all primary and key secondary endpoints[46]. - The European Medicines Agency (EMA) is currently reviewing the Marketing Authorization Application (MAA) for sebetralstat, with plans to file for approval in the U.K., Japan, and other countries later in 2024[48]. - The company initiated a pediatric clinical trial (KONFIDENT-KID) for an orally disintegrating tablet formulation of sebetralstat, targeting patients aged 2 to 11 years old[51]. - The company has received Fast Track and Orphan Drug designations from the FDA for sebetralstat, indicating its potential significance in treating HAE[52]. Financial Activities - The company raised approximately $150.1 million from a stock offering in February 2024, selling 7,016,312 shares at$15.25 per share[53]. - Net cash used in operating activities was $40.2 million for the three months ended July 31, 2024, compared to$26.7 million for the same period in 2023[71]. - Net cash provided by investing activities was $37.2 million for the three months ended July 31, 2024, compared to$19.6 million in the prior year[72]. - The company anticipates sufficient funding to operate for at least the next twelve months based on current capital resources[69]. - In February 2024, the company raised approximately $150.1 million from the sale of 7,016,312 shares at$15.25 per share[70]. - The company filed a Registration Statement in July 2024 to offer securities with an aggregate public offering price of up to $300 million[70].