Kalvista waarvan sommige hoopvol zijn ...
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Sep. 14, 2020-- 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, 2020.
“We are pleased that our KVD900 Phase 2 trial has met its enrollment target and data is expected before the end of this year. We believe KVD900 can bring the first effective and well-tolerated oral on-demand treatment option to patients suffering from hereditary angioedema attacks,” said Andrew Crockett, Chief Executive Officer of KalVista. “Our portfolio of oral options intended to treat HAE also includes prophylactic treatment candidate KVD824, for which we are completing our formulation studies which include dosing in subjects. We look forward to providing additional pharmacokinetic and pharmacodynamic data for KVD824 later this year in advance of starting a Phase 2 clinical trial. Similar to KVD900, our goal with KVD824 is to conduct a robust Phase 2 trial to provide proof-of-concept and potentially an expedited development pathway. We will provide further details on our plans as we prepare to initiate the trial.”
First Fiscal Quarter and Recent Business Highlights:
Met enrollment target for the Phase 2 clinical trial intended to evaluate the safety and efficacy of KVD900 compared to placebo in the treatment of HAE attacks. This trial is expected to provide data in the fourth quarter of 2020.
Submitted a Pediatric Investigational Plan (PIP) to the European Medicines Agency (EMA) for KVD900.
First Fiscal Quarter Financial Results:
Revenue: No revenue was recognized for the three months ended July 31, 2020, compared to $3.4 million for the same period in the prior fiscal year. The decrease of $3.4 million was due to the expiration of the Merck Option Agreement in February 2020. No future revenue remains under this agreement.
R&D Expenses: Research and development expenses were $11.2 million for the three months ended July 31, 2020, compared to $9.7 million for the same period in the prior fiscal year. The increase in spending during the quarter primarily reflects increased costs related to the ongoing clinical trial for KVD900 as well as increased expenses in relation to the development of KVD824, primarily offset by a decrease in spending on KVD001 which concluded a Phase 2 clinical trial in December 2019, and a decrease in spending on preclinical activities.
G&A Expenses: General and administrative expenses were $3.3 million for the three months ended July 31, 2020, compared to $3.2 million for the same period in the prior fiscal year.
Net Loss: Net loss was $10.8 million, or $(0.61) per weighted average basic and diluted share, for the three months ended July 31, 2020, compared to net loss of $7.3 million, or $(0.42) per weighted average basic and diluted share, for the same period in the prior fiscal year. The increase in net loss and net loss per share in the three months ended July 31, 2020 as compared to the same period in the prior fiscal year primarily due to the decrease in revenue and increase in research and development expenses in the three months ended July 31, 2020.
Cash: Cash, cash equivalents and marketable securities were $64.3 million as of July 31, 2020, compared to $67.7 million as of April 30, 2020. The decrease in net cash position was due to increased spending, primarily on research and development activities.