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KalVista Pharmaceuticals(KALV) - 2024 Q2 - Quarterly Report
KALVKalVista Pharmaceuticals(KALV)2023-12-07 21:07

Revenue Generation - The company has not generated any revenue in the current fiscal year and does not expect to do so until regulatory approval is obtained for its product candidates[67]. - The company has not generated any revenue from product sales and anticipates continued losses as it develops and seeks regulatory approvals for product candidates[101]. Research and Development Expenses - Research and development expenses for the three months ended October 31, 2023, were 19.1million,anincreaseof19.1 million, an increase of 1.0 million compared to 18.1millioninthesameperiodof2022[78].−Researchanddevelopmentexpensesincreasedby18.1 million in the same period of 2022[78]. - Research and development expenses increased by 0.9 million due to the impact of exchange rates in the three months ended October 31, 2023, compared to the same period in the prior fiscal year[79]. - For the six months ended October 31, 2023, total research and development expenses were 38.4million,anincreaseof38.4 million, an increase of 2.1 million (5.8%) from 36.3millionintheprioryear[86].−Sebetralstatprogramexpensesincreasedby36.3 million in the prior year[86]. - Sebetralstat program expenses increased by 3.3 million to 8.3millionduetoongoingPhase3KONFIDENTandKONFIDENT−Strials[80].−KVD824expensesdecreasedby8.3 million due to ongoing Phase 3 KONFIDENT and KONFIDENT-S trials[80]. - KVD824 expenses decreased by 1.8 million to 0.5millionfollowingtheterminationofthePhase2KOMPLETEclinicaltrial[81].GeneralandAdministrativeExpenses−Generalandadministrativeexpensesincreasedto0.5 million following the termination of the Phase 2 KOMPLETE clinical trial[81]. General and Administrative Expenses - General and administrative expenses increased to 10.7 million for the three months ended October 31, 2023, compared to 7.8millioninthesameperiodof2022,reflectinganincreaseof7.8 million in the same period of 2022, reflecting an increase of 2.9 million[78]. - General and administrative expenses rose by 2.8millionto2.8 million to 20.4 million, driven by employee-related expenses and commercial strategy costs[84]. Clinical Trials and Regulatory Approvals - The company achieved the target of 252 treated attacks in the KONFIDENT trial and expects topline data readout in early 2024, with an NDA submission anticipated in the first half of 2024[59]. - Sebetralstat has received Fast Track and Orphan Drug designation from the FDA, and Orphan Drug designation in the E.U., indicating regulatory support for its development[62]. - The company is developing an oral disintegrating tablet formulation of sebetralstat, with FDA feedback received on the proposed development program[61]. - The company has treated over 600 attacks across the KONFIDENT and KONFIDENT-S trials to date, supporting the safety database for the planned NDA filing[61]. - The company has not completed the development of any product candidates and is subject to risks related to obtaining regulatory approvals[66]. Financing and Cash Flow - The company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. for an aggregate offering price of up to 100million,buthasconductednosalesunderthisagreement[64].−CashflowsusedinoperatingactivitiesforthesixmonthsendedOctober31,2023,were100 million, but has conducted no sales under this agreement[64]. - Cash flows used in operating activities for the six months ended October 31, 2023, were 46.6 million, compared to 43.3millioninthesameperiodof2022[97].−Netcashprovidedbyinvestingactivitieswas43.3 million in the same period of 2022[97]. - Net cash provided by investing activities was 48.2 million for the six months ended October 31, 2023, primarily from sales and maturities of marketable securities[99]. - The company expects to finance its cash needs through a combination of equity and debt financings, collaborations, and strategic partnerships[102]. Other Income - Other income decreased by $1.5 million due to changes in the U.K. research and development tax credit program, reducing tax credit rates from 130% to 86%[85].