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EX - 99.1 2 kalv - ex991_6.htm EX - 99.1 KalVista Pharmaceuticals Reports First Fiscal Quarter Results Exhibit 99.1 - FDA End - of - Phase 2 Meeting for KVD900 Oral HAE Phase 3 Program Scheduled for This Month - – KVD824 Phase 2 KOMPLETE Clinical Trial Enrolling – Cambridge , MA and Salisbury , England , September 9 , 2021 – KalVista Pharmaceuticals , Inc. ( NASDAQ : KALV ) , a clinical stage pharmaceutical company focused on the discovery , development , and commercialization of small molecule protease inhibitors , today provided an operational update and released financial results for the first fiscal quarter ended July 31 , 2021 . " We have made excellent progress in the rollout of our Phase 2 KOMPLETE clinical trial for KVD824 , " said Andrew Crockett , Chief Executive Officer of KalVista . “ Site initiations are underway , and patients are being enrolled in the trial to evaluate KVD824 as a potential oral prophylactic treatment for HAE . We will be having an end - of - Phase 2 meeting with the FDA later this month regarding KVD900 , our oral on - demand candidate for treatment of HAE attacks and are ready to initiate the Phase 3 study quickly afterwards . We look forward to advancing both of these compounds as we continue with our strategy of bringing a full spectrum of oral treatment options to HAE patients . " First Fiscal Quarter and Recent Business Highlights : • • • • . Presented Phase 2 data for KVD900 in late - breaking session at European Academy of Allergy and Clinical Immunology ( EAACI ) Congress . The data showed that a single on - demand treatment with orally administered KVD900 significantly slows progression and accelerates resolution of attacks in patients with hereditary angioedema ( HAE ) . KalVista also presented four other posters at EAACI related to the HAE clinical landscape and unmet needs , as well as preclinical data from other oral molecules . Scheduled an end - of - Phase 2 meeting with the U.S. Food and Drug Administration ( FDA ) to review the proposed development plans for KVD900 , KalVista's oral on - demand candidate for treatment of HAE attacks , expected to take place in September 2021. KVD900 also received Orphan Drug Designation from the FDA . Presented data at the International Society on Thrombosis and Haemostasis ( ISTH ) Virtual Congress showcasing small molecule Factor XIIa inhibitor research . Provided a progress update on the KVD824 Phase 2 KOMPLETE Clinical Trial . KVD824 is in development for oral prophylactic treatment of HAE . Regulatory submissions have been approved in Canada , Australia , and the UK with patient enrollment now underway . KalVista also submitted a response to the clinical hold related to the U.S. Investigational New Drug ( IND ) filing for KVD824 and is prepared to initiate the study in the U.S. upon clearance from the FDA . Presented KVD001 data at American Chemical Society ( ACS ) Meeting . First Fiscal Quarter Financial Results : • Revenue : No revenue was recognized for the three months ended July 31 , 2021 or July 31 , 2020 .