KalVista Pharmaceuticals Reports Fiscal First Quarter Results

– KVD900 Phase 2 On Track to Begin in 2018 for Potential On-Demand
Treatment of Acute Attacks in Patients with Hereditary Angioedema –

– Intravitreal Diabetic Macular Edema Candidate KVD001 Enrollment
On Track with Data Expected in H2 2019 –

– Over $87 million Net Proceeds from Two Recent Equity Offerings –

CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–$KALV–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
first quarter ended July 31, 2018.

“Our two recent financings provide significant additional capital for
late stage development of KVD900, our oral plasma kallikrein inhibitor
for potential treatment of on-demand acute attacks in patients with
hereditary angioedema, or HAE,” said Andrew Crockett, Chief Executive
Officer of KalVista. “KVD001, our intravitreal candidate for potential
treatment of diabetic macular edema, or DME, currently enrolling a Phase
2 clinical trial, continues with data expected as planned in the second
half of 2019. Additionally, we remain committed to our work in
discovering and developing oral plasma kallikrein inhibitors for
prophylactic treatment of HAE as well as DME. Finally, we recently moved
to our new facility in Porton Down, England, which is intended to
support our scientific team as they continue to work on discovery and
development of additional drug programs.”

First Quarter and Recent Business Highlights:

  • Raised $78.2 million in gross proceeds from a previously announced
    public offering of 4.6 million shares of common stock at a price of
    $17.00 per share. The Company expects to receive approximately $73.3
    million in net proceeds from the offering after deducting underwriting
    fees and expenses, which is anticipated to fund operations into 2021.
  • Occupied a new, 8,873 square foot laboratory and office facility in
    Porton Science Park, Salisbury, England. The opening of this facility
    is an important step in our planned growth, and reflects the ongoing
    commitment to our internal research capabilities as a key strategic
    strength of the Company. The KalVista research team has decades of
    experience in discovering and developing protease inhibitors, and this
    new facility will significantly expand our capacity and capabilities.
  • Selected KVD900 to advance to a Phase 2 proof-of-concept clinical
    trial for potential on-demand treatment of acute attacks in patients
    with HAE.
  • In July 2018, announced the sale of approximately $14.6 million in
    common stock to Venrock Healthcare Capital Partners and BVF Partners
    L.P. in a registered direct transaction. This transaction was closed
    in August.

Fiscal First Quarter Financial Results:

  • Revenue: Revenue was $3.7 million for the three months ended July 31,
    2018, compared to $0.1 million for the same period in 2017. Revenue in
    the three months ended July 31, 2018 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 $8.4 million for
    the three months ended July 31, 2018, compared to $3.5 million for the
    same period in 2017. The increase in R&D expense primarily reflects
    the ongoing clinical trials for KVD001 and KVD900.
  • G&A Expenses: General and administrative expenses were $2.4 million
    for the three months ended July 31, 2018, compared to $2.1 million for
    the same period in 2017. The increase was primarily due to an increase
    in payroll related expenses and expenses related to our new facility
    in the U.K. in the three months ended July 31, 2018 compared to those
    incurred in the same period in 2017.
  • Net Loss: Net loss was $5.0 million, or $(0.47) per basic and diluted
    share for the three months ended July 31, 2018, compared to a net loss
    of $4.9 million, or $(0.51) per basic and diluted share, for the same
    period in 2017.
  • Cash: Cash and cash equivalents were $48.1 million as of July 31,
    2018. The cash balance at July 31, 2018 includes $5.0 million of
    proceeds from the $14.6 million registered direct financing, which
    closed on August 2, 2018.

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 into Phase 1 clinical trials for HAE. The
Company has selected KVD900 as its program to be advanced as an
on-demand therapy for acute HAE attacks, and anticipates commencing 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 report data 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.

 
KalVista Pharmaceuticals Inc.
Condensed Consolidated
Balance Sheets

(in thousands, except share and per share
amounts)

(Unaudited)
               
July 31, April 30,
2018 2018
Assets
Current assets:
Cash and cash equivalents $ 48,070 $ 51,055
Research and development tax credit receivable 5,604 6,834
Prepaid expenses and other current assets   1,511     1,491  
Total current assets 55,185 59,380
Other assets 173 173
Property and equipment, net   2,260     1,836  
Total assets $ 57,618   $ 61,389  
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 2,345 $ 1,433
Accrued expenses 3,137 3,087
Deferred revenue – current portion 17,207 18,475
Capital lease liability – current portion   214     221  
Total current liabilities   22,903     23,216  
Long-term liabilities:
Deferred revenue – net of current portion 8,465 10,862
Capital lease liability – net of current portion       58  
Total long-term liabilities   8,465     10,920  
Stockholders’ equity:
Common stock, $0.001 par value 11 11
Additional paid-in capital 105,358 100,011
Accumulated deficit (76,690 ) (71,660 )
Accumulated other comprehensive loss   (2,429 )   (1,109 )
Total stockholders’ equity   26,250     27,253  
Total liabilities and stockholders’ equity $ 57,618   $ 61,389  
 
 
KalVista Pharmaceuticals Inc.
Condensed Consolidated
Statement of Operations

(in thousands, except share and
per share amounts)

(Unaudited)
               
Three Months Ended
July 31,
2018 2017
 
 
Revenue $ 3,718 $ 96
Operating expenses:
Research and development 8,356 3,476
General and administrative   2,371     2,073  
Total operating expenses   10,727     5,549  
Operating loss   (7,009 )   (5,453 )
 
Other income:
Interest income 89 2
Foreign currency exchange rate gain (loss) 67 (32 )
Other income   1,823     555  
Total other income   1,979     525  
Net loss $ (5,030 ) $ (4,928 )
 
Net loss per share to common stockholders, basic and diluted $ (0.47 ) $ (0.51 )
 
Weighted average common shares outstanding, basic and diluted 10,799,895 9,713,042
 
 
KalVista Pharmaceuticals Inc.
Condensed Consolidated
Statements of Cash Flows

(in thousands, unaudited)
               
Three Months Ended
July 31
2018 2017
 
Cash Flows from Operating Activities
Net loss $ (5,030 ) $ (4,928 )
Adjustments to reconcile net loss to net cash used in operating
activities
Depreciation and amortization 50 32
Stock-based compensation expense 347 221
Foreign currency remeasurement loss 6 32
Changes in operating assets and liabilities:
Research and development tax credit receivable 919 (530 )
Prepaid expenses and other current assets (69 ) (85 )
Grants and other receivables 224
Accounts payable 1,126 771
Accrued expenses 157 (185 )
Deferred revenue   (3,718 )    
Net cash used in operating activities   (6,212 )   (4,448 )
 
Cash Flows from Investing Activities
Acquisition of property and equipment   (565 )   (110 )
Net cash used in investing activities   (565 )   (110 )
 
Cash Flows from Financing Activities
Capital lease principal payments (52 )
Proceeds from issuance of common stock   5,000      
Net cash provided by financing activities   4,948      
Effect of exchange rate changes on cash and cash equivalents   (1,156 )   64  
Net decrease in cash and cash equivalents (2,985 ) (4,494 )
Cash and cash equivalents, beginning of period   51,055     30,950  
Cash and cash equivalents, end of period $ 48,070   $ 26,456  

Contacts

KalVista Pharmaceuticals, Inc.
Leah Monteiro, 857-999-0808
Director,
Corporate Communications & Investor Relations
leah.monteiro@kalvista.com