KalVista Pharmaceuticals(KALV) - 2025 Q3 - Quarterly Report

Drug Development and Regulatory Approvals - The company has filed a New Drug Application (NDA) for sebetralstat, seeking approval as the first oral, on-demand therapy for hereditary angioedema (HAE) with a PDUFA notification date of June 17, 2025[79]. - A Marketing Authorization Application (MAA) for sebetralstat has been submitted to the European Medicines Agency (EMA) and is currently under review, with submissions also made to regulatory authorities in the UK, Switzerland, Australia, and Singapore[80]. - The company has received Fast Track and Orphan Drug designations from the FDA for sebetralstat, indicating regulatory support for its development[84]. - The company initiated a pediatric clinical trial for sebetralstat in June 2024, with plans to submit a supplemental NDA for pediatric use in 2026[81]. - The company is conducting a strategic review of its preclinical oral Factor XIIa inhibitor program to evaluate future development potential[85]. Financial Performance and Expenses - The company recorded an income tax expense of $4.1 million for the three months ended January 31, 2025, due to an increase in the valuation allowance against deferred tax assets[99]. - Research and development expenses decreased by $9.9 million to $12.6 million for the three months ended January 31, 2025, compared to $22.5 million in the same period in 2024[101]. - General and administrative expenses increased by $19.7 million to $30.3 million for the three months ended January 31, 2025, primarily due to increases in personnel costs and commercial expenses[104]. - For the nine months ended January 31, 2025, research and development expenses totaled $55.8 million, a decrease of $5.1 million from $60.9 million in the same period in 2024[106]. - General and administrative expenses for the nine months ended January 31, 2025, increased by $46.1 million to $77.1 million, driven by higher personnel and commercial strategy expenses[109]. Cash Flow and Funding - Net cash used in operating activities was $112.5 million for the nine months ended January 31, 2025, compared to $74.1 million for the same period in 2024[118]. - Net cash provided by investing activities was $94.4 million for the nine months ended January 31, 2025, compared to $41.5 million in the prior year[119]. - Net cash provided by financing activities was $155.1 million for the nine months ended January 31, 2025, significantly higher than $0.6 million in the same period in 2024[120]. - The company anticipates sufficient funding to operate for at least the next twelve months based on current capital resources[122]. Revenue and Losses - 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[122]. Accounting Policies - The company prepares its financial statements in accordance with U.S. GAAP, requiring estimates and assumptions that impact reported amounts of assets and liabilities[125]. - There have been no material changes to critical accounting policies and significant estimates in the nine months ended January 31, 2025, except for the deferred royalty obligation and its embedded derivative liability[125]. - The company is classified as a smaller reporting company and is not required to provide specific market risk information[127]. Sales and Payment Structure - The company received an upfront payment of $100.0 million from a Purchase and Sale Agreement (PSA) related to future worldwide net sales of sebetralstat, with tiered payments based on sales performance[87]. - The tiered payment structure includes 5.00% on annual net sales up to $500.0 million, 1.10% on sales between $500.0 million and $750.0 million, and 0.25% on sales above $750.0 million[87]. Future Expectations - The company expects general and administrative expenses to increase as it builds infrastructure to support the commercialization of sebetralstat[96]. - The company anticipates continued significant spending on research and development activities as it conducts clinical development and manufacturing studies[93]. Other Income - Other income decreased by $5.4 million, primarily due to an increase in net interest expense and a decrease in foreign currency exchange rate gains[105].