KalVista Pharmaceuticals(KALV) - 2024 Q4 - Annual Results

Drug Development and Regulatory Submissions - KalVista submitted a New Drug Application (NDA) for sebetralstat to the FDA in June 2024, aiming for approval and launch in the US in the first half of 2025[1]. - The KONFIDENT phase 3 trial results for sebetralstat were published in the New England Journal of Medicine, supporting its potential as a therapy for hereditary angioedema (HAE) attacks[1]. - The company is on track for Market Authorization Application submissions to the European Medicines Agency and UK Medicines and Healthcare Products Regulatory Agency in Q3 2024[7]. - A pediatric clinical trial (KONFIDENT-KID) for sebetralstat is underway, enrolling approximately 24 children aged 2 to 11 years across seven countries[1]. - KalVista plans to submit a JNDA to the Japanese Pharmaceuticals and Medical Devices Agency in Q4 2024[8]. - The company is evaluating the potential for further development of its preclinical Factor XIIa inhibitor program[9]. Financial Performance - Net loss for the fiscal year ended April 30, 2024, was $126.6 million, or$(3.44) per share, compared to a net loss of $92.9 million, or$(3.33) per share in the prior fiscal year[5]. - The net loss for the three months ended April 2024 was $(44,650,000), compared to a net loss of$(26,305,000) in the same period last year, indicating a deterioration of 70%[25]. - The net loss per share, basic and diluted, was $(1.02) for April 2024, compared to$(0.77) for April 2023, representing a decline of 32.5%[25]. - The company reported a total operating loss of $48,455,000 for the three months ended April 2024, compared to$31,728,000 for the same period last year, an increase of 52.7%[25]. Expenses - Research and development expenses increased to $86.2 million for the fiscal year ended April 30, 2024, up from$80.3 million in the prior fiscal year, primarily due to the KONFIDENT trial[5]. - General and administrative expenses rose to $54.3 million for the fiscal year ended April 30, 2024, compared to$30.6 million in the prior fiscal year, driven by employee-related and commercial planning expenses[5]. - Research and development expenses for the three months ended April 2024 were $25,248,000, up from$23,951,000 in the same period last year, an increase of 5.4%[25]. - General and administrative expenses surged to $23,207,000 in April 2024, compared to$7,777,000 in April 2023, reflecting a significant increase of 198%[25]. Assets and Liabilities - Cash, cash equivalents, and marketable securities totaled $210.4 million on April 30, 2024, compared to$149.4 million on April 30, 2023, reflecting proceeds from a February 2024 stock offering[5]. - Total current assets increased to $225,690,000 in April 2024 from$172,326,000 in April 2023, representing a growth of 31%[23]. - Total liabilities increased to $28,822,000 in April 2024 from$22,177,000 in April 2023, marking a rise of 30%[23]. - Stockholders' equity rose to $206,582,000 in April 2024, up from$161,025,000 in April 2023, an increase of 28.2%[23]. Other Income and Shares - Total other income decreased to $3,805,000 in April 2024 from$5,423,000 in April 2023, a decline of 30%[25]. - Weighted average common shares outstanding increased to 43,590,657 in April 2024 from 34,342,664 in April 2023, an increase of 27%[25].