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04-Jan-2019

KalVista Pharmaceuticals Provides Development Update and 2019 Clinical Plans

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today provided a development update on its oral plasma kallikrein inhibitor portfolio.

“In December we filed with regulatory authorities to begin our Phase 2 study of KVD900 as a potential oral acute treatment for hereditary angioedema, or HAE. As previously announced, this enlarged study is expected to provide data in late 2019. We continue to be excited by the potential for KVD900 to provide a safe, oral on-demand option for HAE patients to more conveniently and effectively manage their disease,” said Andrew Crockett, Chief Executive Officer of KalVista. “We are also pleased to announce that we made the regulatory filings for our next oral plasma kallikrein inhibitor, KVD824, and expect to begin dosing that first-in-human trial soon. We expect to provide a further update on KVD824 around mid-year.”

Following the necessary regulatory approvals, the Phase 2 trial evaluating KVD900 as an on-demand treatment for HAE attacks will begin dosing in approximately 50 patients at over 10 European clinical sites. The study will recruit type 1 and 2 HAE patients who have had three attacks in 90 days prior to enrollment. During the first part of this two-part study patients will receive a single 600 mg dose of KVD900 to explore pharmacokinetic and pharmacodynamic properties. All patients will then enter part two of the study, which is a crossover investigation in which the efficacy of KVD900 will be assessed versus placebo across two attacks. Patients experiencing an attack will take a single dose of 600 mg of KVD900 or placebo within one hour of the start of the attack. The second attack will be dosed with the other treatment. For all attacks, symptom severity will be monitored and additional data points will be collected for at least 24 hours. Patients will use their normal, on-demand treatment as required.

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. The Company has selected KVD900 as its program to be advanced as an on-demand therapy for HAE attacks, and commenced a Phase 2 proof-of-concept study in HAE patients in late 2018. In DME, KalVista’s most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, began a Phase 2 clinical trial in 2017 that is anticipated to complete in the second half of 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 and 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 30, 2018 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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Last Updated: 04-Jan-2019