KalVista Pharmaceuticals(KALV) - 2024 Q3 - Quarterly Report

Clinical Trials and Drug Development - The Phase 3 KONFIDENT clinical trial for sebetralstat enrolled 136 patients across 66 clinical sites in 20 countries, making it the largest trial conducted for hereditary angioedema (HAE) to date[67]. - Sebetralstat demonstrated a median time to symptom relief of 1.61 hours for the 300 mg dose and 1.79 hours for the 600 mg dose, compared to 6.72 hours for placebo, achieving statistical significance (p<0.0001 for 300 mg, p=0.0013 for 600 mg)[68]. - The company plans to submit a New Drug Application (NDA) for sebetralstat to the FDA in the first half of 2024, with additional filings expected in the European Union and Japan later in 2024[69]. - The company has received Fast Track and Orphan Drug designations from the FDA for sebetralstat, along with Orphan Drug Designation from the European Medicines Agency[72]. - The company is developing an oral Factor XIIa inhibitor program, which targets a key enzyme in the HAE biochemical pathway, with potential future applications in other therapeutic areas[73]. - Research and development expenses for the sebetralstat program increased significantly due to ongoing Phase 3 trials, with expectations to maintain expenses at current levels[90]. Financial Performance and Revenue - 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[78]. - Revenue for the three months ended January 31, 2024, was $0, consistent with the same period in 2023[88]. - Other income decreased by$1.5 million to $4.1 million for the three months ended January 31, 2024, largely due to a reduction in research and development tax credits[95]. Expenses and Losses - Research and development expenses increased by$2.5 million to $22.5 million for the three months ended January 31, 2024, driven by personnel costs and sebetralstat spending[89]. - General and administrative expenses rose by$3.7 million to $10.6 million for the three months ended January 31, 2024, primarily due to employee-related expenses[94]. - For the nine months ended January 31, 2024, research and development expenses totaled$60.9 million, an increase of $4.6 million compared to the prior year[96]. - The net cash used in operating activities was$74.1 million for the nine months ended January 31, 2024, compared to $52.6 million in the same period in 2023[107]. - The company anticipates continued losses as it develops and seeks regulatory approvals for product candidates, with sufficient funding to operate for at least the next twelve months[111]. Capital and Financing - The company raised approximately$57.7 million from a registered direct offering of 9,484,199 shares at $6.00 per share in December 2022[74]. - An underwriting agreement was entered into on February 14, 2024, to sell 7,016,312 shares at$15.25 per share, with net proceeds expected to be approximately $150.1 million[76]. - The company expects to finance cash needs through equity and debt financings, collaborations, strategic partnerships, and licensing arrangements[112]. - Additional capital raised through stock or convertible debt may dilute existing stockholders' ownership interests[112]. - Debt financing may involve increased fixed payment obligations and covenants that restrict business operations[112]. Accounting and Reporting - Financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions that may affect reported amounts[114]. - Actual results may differ from estimates based on various factors, impacting the carrying value of assets and liabilities[114]. - Recent accounting pronouncements and their expected effects on operations and financial condition are detailed in the Interim Financial Statements[115]. - The company is classified as a smaller reporting company and is not required to provide certain market risk information[116].