KalVista Pharmaceuticals Reports Fiscal Third Quarter Results

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 fiscal third quarter ended January 31, 2020.

“Our work to bring multiple best-in-class oral therapies to patients with hereditary angioedema is advancing well,” said Andrew Crockett, Chief Executive Officer of KalVista. “First, we look forward to delivering data in the second quarter of this year from our Phase 2 clinical trial with KVD900, our on-demand therapy for HAE attacks. We believe KVD900 has the potential to offer patients an attractive option for control of their disease through a fast-acting tablet that can be taken at the earliest stages of an incipient attack. Second, we continue to make progress in our optimization of KVD824 as a potential oral prophylactic treatment. We still plan to initiate a Phase 2 trial of KVD824 for prophylaxis of HAE attacks in the second half of the year.”

Third Quarter and Recent Business Highlights:

• Announced results of the Phase 2 trial of KVD001, an intravitreal candidate for treatment of diabetic macular edema (DME). KVD001 did not meet its primary endpoint in the overall study population, but it did demonstrate a protection against vision loss and a pre-specified subgroup analysis showed a clinical benefit on vision. The trial was designed to evaluate patients who were poor responders to previous treatment with anti-VEGF therapy. KVD001 was generally safe and well tolerated with no drug-related serious adverse events. Both KVD001 and future oral DME molecules were subject to an option agreement with Merck, which subsequently expired in February.
• Selected KVD824 for development as an oral prophylactic treatment for hereditary angioedema (HAE). KVD824 is a highly potent and selective plasma kallikrein inhibitor which achieved high exposures and a favorable safety and tolerability profile in a first-in-human study. KalVista intends to initiate a Phase 2 clinical trial in the second half of 2020.

Fiscal Third Quarter Financial Results:

• Revenue: Revenue was $1.6 million for the three months ended January 31, 2020, compared to $3.9 million for the same period in 2019. Revenue in the three months ended January 31, 2020 consisted of the recognition of a portion of the upfront payment from Merck related to the agreement signed in October 2017.
• R&D Expenses: Research and development expenses were $11.2 million for the three months ended January 31, 2020, compared to $7.7 million for the same period in 2019. The increase in R&D expense primarily reflects the ongoing clinical trial for KVD900 and an increase in expense related to preclinical activities in relation to the development of KVD824.
• G&A Expenses: General and administrative expenses were $3.1 million for the three months ended January 31, 2020, compared to $2.9 million for the same period in 2019.
• Net Loss: Net loss was $9.3 million, or $(0.52) per basic and diluted share for the three months ended January 31, 2020, compared to a net loss of $4.0 million, or $(0.23) per basic and diluted share, for the same period in 2019.
• Cash: Cash, cash equivalents and marketable securities were $80.6 million as of January 31, 2020.

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. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body’s inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. KalVista has selected KVD900 as its program to be advanced 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 second quarter of 2020. KVD824 is in development for prophylactic treatment of HAE and is expected to enter a Phase 2 clinical trial in the second half of 2020. 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.

Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding, our cash runway, potential future clinical trial timing and results. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on July 16, 2019, the quarterly report on Form 10-Q filed on March 10, 2020, and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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