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EX - 99.1 2 kalv - ex99_1.htm EX - 99.1 Exhibit 99.1 KalVista Pharmaceuticals Reports Second Fiscal Quarter Results - Preparing for Initiation of KVD900 Phase 3 Clinical Trial- – KVD824 Phase 2 KOMPLETE Clinical Trial Enrolling – - - Funded Beyond Data on Both HAE Trials – Cambridge , MA and Salisbury , England , December 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 second fiscal quarter ended October 31 , 2021 . “ This quarter we made great strides in advancing the two distinct compounds in our oral hereditary angioedema franchise into later stage trials . We are very pleased with the Phase 3 trial design for KVD900 , our candidate for on - demand HAE therapy , where we believe the primary endpoint is both meaningful to patients and was successful in our Phase 2 trial . The KVD824 KOMPLETE Phase 2 protocol for prophylactic treatment of HAE has regulatory approvals in 12 of the 13 countries where the trial will be conducted , ” said Andrew Crockett , Chief Executive Officer of KalVista . “ Importantly , we are funded into at least early 2024 , beyond both the KVD900 Phase 3 and KVD824 Phase 2 clinical trial data sets . " Second Fiscal Quarter and Recent Business Highlights : Initiated KOMPLETE , the Phase 2 clinical trial of KVD824 that is currently enrolling patients . Presented Phase 2 data for KVD900 at American College of Allergy , Asthma & Immunology ( ACAAI ) Annual Scientific Meeting . Data presentations included an oral presentation and poster presentation on Phase 2 clinical trial data . The data showed that KVD900 was rapidly absorbed which was associated with a significantly shorter median time to initial symptom relief with KVD900 than with placebo . Patient reported outcomes captured in the phase 2 trial suggested that attack symptom improvement with use of KVD900 was clinically meaningful from the patients ' perspective . Completed an End - of - Phase 2 meeting with the FDA which confirmed that KalVista's Phase 3 trial design , similar to the successful Phase 2 trial , is expected to be appropriate to support an NDA submission . The primary endpoint of this Phase 3 trial is time to beginning of symptom relief using the PGI - C scale that was one of the endpoints in the Phase 2 study . The trial is expected to be conducted at more than 50 sites worldwide and recruit approximately 100 patients , consistent with late stage trials of approved on - demand treatments for HAE . The trial is intended to evaluate all HAE attacks , including laryngeal attacks and breakthrough attacks for patients using prophylaxis . Similar to the