CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--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, 2020.

“We have completed the patient treatment phase of our KVD900 Phase 2 trial and are in the process of wrapping up that study. Data from this trial evaluating KVD900 as an oral on-demand treatment for hereditary angioedema is expected in the first quarter of 2021,” said Andrew Crockett, Chief Executive Officer of KalVista. “The formulation data recently shared for KVD824, our oral prophylactic treatment candidate for HAE, showed concentrations that we believe can lead to efficacy levels competitive with approved injectable therapies. We expect to submit an Investigational New Drug Application to the FDA for a Phase 2 clinical trial of KVD824 as a potential twice-daily oral treatment in the prevention of HAE attacks in the first quarter of 2021.”

Second Fiscal Quarter and Recent Business Highlights:

• Completed treatment of the planned target of 50 patients in a Phase 2 clinical trial intended to evaluate the safety and efficacy of KVD900 as an oral on-demand treatment of hereditary angioedema (HAE) attacks. This trial is expected to provide data in the first quarter of 2021. A Pediatric Investigational Plan (PIP) has also been approved by the European Medicines Agency (EMA) for KVD900.
• Provided data on KVD824 as a twice-daily oral candidate for prophylactic treatment of HAE. Work to optimize the exposure profile of KVD824 yielded a formulation that maintains the plasma concentrations KalVista believes are required to compete with approved injectable therapies, while showing an encouraging safety and tolerability profile in up to 14 days of dosing. An Investigational New Drug Application (IND) submission to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial is expected in the first quarter of 2021.
• Announced a novel oral Factor XIIa inhibitor program as the next area of development focus. KalVista’s internal research team has discovered multiple series of oral Factor XIIa inhibitors, initially being advanced with the potential to provide the next generation of HAE therapeutics. IND-enabling studies for potential oral Factor XIIa inhibitor candidates are expected in 2021.

Second Fiscal Quarter Financial Results:

• Revenue: No revenue was recognized for the three months ended October 31, 2020, compared to $3.9 million for the same period in the prior fiscal year. The decrease of $3.9 million was due to the expiration of the Merck Option Agreement in February 2020. No future revenue remains to be recognized under this agreement.
• R&D Expenses: Research and development expenses were $9.1 million for the three months ended October 31, 2020, compared to $9.8 million for the same period in the prior fiscal year. The decrease in expenses during the quarter primarily reflects a decrease in spending on KVD001, which concluded a Phase 2 clinical trial in December 2019, a decrease in spending on KVD900, and a decrease in spending on preclinical activities. These decreases were somewhat offset by increased spending related to the development of KVD824.
• G&A Expenses: General and administrative expenses were $3.6 million for the three months ended October 31, 2020, compared to $3.4 million for the same period in the prior fiscal year. The $0.2 million increase in expenses reflects an increase in employee related expenses.
• Net Loss: Net loss was $10.4 million, or $(0.58) per weighted average basic and diluted share, for the three months ended October 31, 2020, compared to net loss of $5.9 million, or $(0.33) 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 October 31, 2020 compared to the same period in the prior fiscal year was primarily due to the decrease in revenue in the three months ended October 31, 2020.
• Cash: Cash, cash equivalents and marketable securities were $55.9 million as of October 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.

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). KalVista is developing KVD900 as an on-demand therapy for acute HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients with data expected in the first quarter of 2021. KVD824 is in development for prophylactic treatment of HAE with an expected IND filing for a phase 2 clinical trial in the first quarter of 2021. KalVista’s recently announced oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment of HAE for patients. In DME, an intravitreally administered plasma kallikrein inhibitor known as KVD001, completed a Phase 2 clinical trial in 2019.

For more information, please visit www.kalvista.com.