KalVista Pharmaceuticals Reports Fiscal Third Quarter Results

– Oral Hereditary Angioedema (HAE) Candidate KVD900 Phase 2 Trial
Progressing –

– Intravitreal Diabetic Macular Edema (DME) Candidate KVD001 Phase
2 Trial Completion Expected H2 2019 –

– Oral Plasma Kallikrein Inhibitor Candidate KVD824 Dosing in
First-in-Human Trial –

CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24KALV&src=ctag" target="_blank"gt;$KALVlt;/agt;–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, 2019.

“We are pleased with the progress of the Phase 2 trial of KVD900 as we
move through the regulatory and site set-up process,” said Andrew
Crockett, Chief Executive Officer of KalVista. “KVD900 is our most
advanced candidate for oral treatment of HAE and we continue to expect
data late this year. Our latest oral plasma kallikrein inhibitor
candidate, KVD824, has begun dosing in a first-in-human trial and we
expect to provide an update on this around mid-year. In other ongoing
clinical activity, enrollment is on track for our Phase 2 trial of
KVD001, our intravitreal DME candidate.”

Third Quarter and Recent Business Highlights:

• Provided a clinical update on oral plasma kallikrein inhibitors
  currently in the clinic. KVD900 was advanced into a Phase 2 clinical
  trial as a potential oral on-demand therapy, which will investigate
  efficacy in at least 50 type 1 and type 2 HAE patients. The trial will
  be conducted at 10-15 sites in the UK, Germany and other European
  countries. This two-part study will evaluate the pharmacodynamic and
  pharmacokinetic properties of KVD900 as well as the efficacy of the
  drug versus placebo. KVD824 was named as the next oral plasma
  kallikrein inhibitor candidate and has commenced dosing in a
  first-in-human trial. The Company expects to give an update on KVD824
  around mid-2019.
• Appointed Brian J. G. Pereira to Board of Directors. Brian is a
  veteran biopharmaceutical and healthcare leader with experience in
  financing and growing companies. He has been President and CEO of
  Visterra, Inc. since 2013 and previously served as President and CEO
  of AMAG Pharmaceuticals. Dr. Pereira’s experience in medical matters,
  clinical development and commercial infrastructure will be of great
  value to KalVista as we approach late stage development for our
  programs.
• Announced data from a poster presentation given at the American
  Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The
  Company provided additional data from a Phase 1 single ascending dose
  study of KVD900, evaluating the efficacy and safety of tablet and
  capsule formulations of the drug in healthy adult males, with a
  food-effect crossover study. The data showed that a single 600 mg dose
  of KVD900 provided >90% inhibition of plasma kallikrein within 30
  minutes of dosing and protected against high molecular weight
  kininogen cleavage for at least 10 hours. No significant food effect
  was observed on the pharmacodynamic profile of the 600 mg KVD900
  tablet in fed and fasted states.

Upcoming Events:

• Presenting during a poster session at the Association for Research in
  Vision and Ophthalmology (ARVO) Annual Meeting, April 28 – May 2,
  2019, in Vancouver, Canada:

  Presentation Date: Monday,
  April 29, 2019
  Presentation Time: 4.00pm-5.45pm EST
  Abstract
  Title: Novel oral plasma kallikrein (PKa) inhibitors KV998052 and
  KV998054 ameliorate VEGF-induced retinal thickening in a murine model
  of retina edema.
  Session: 289
  Session Title:
  Retinal Vascular Diseases II

Fiscal Third Quarter Financial Results:

• Revenue: Revenue was $3.9 million for the three months ended January
  31, 2019, compared to $2.3 million for the same period in 2018.
  Revenue in the three months ended January 31, 2019 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 $7.7 million for
  the three months ended January 31, 2019, compared to $4.5 million for
  the same period in 2018. The increase in R&D expense primarily
  reflects the ongoing clinical trials for KVD001 and KVD900 and
  preparation for KVD824 to enter the clinic.
• G&A Expenses: General and administrative expenses were $2.9 million
  for the three months ended January 31, 2019, compared to $2.1 million
  for the same period in 2018.
• Net Loss: Net loss was $4.0 million, or $(0.23) per basic and diluted
  share for the three months ended January 31, 2019, compared to a net
  loss of $5.2 million, or $(0.49) per basic and diluted share, for the
  same period in 2018.
• Cash: Cash, cash equivalents and investments were $111.1 million as of
  January 31, 2019.

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,
is enrolling a Phase 2 clinical trial 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.

Contacts

KalVista Pharmaceuticals, Inc.
Leah Monteiro
Director,
Corporate Communications & Investor Relations
857-999-0808
[email protected]