[December 14, 2017] |
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KalVista Pharmaceuticals Reports Fiscal Second 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 reported
operational and financial results for the fiscal second quarter ended
October 31, 2017.
"Since announcing the collaboration agreement with Merck, we have been
focused on finalizing a Phase 2 clinical trial design for KVD001 that
will enable our best chance for success, and we remain on track to
initiate that trial this year," said Andrew Crockett, Chief Executive
Officer of KalVista. "We also submitted the regulatory filing to enter
the clinic with our second oral plasma kallikrein inhibitor candidate
for potential treatment of hereditary angioedema, KVD900, and there will
be at least one additional HAE portfolio candidate entering the clinic
in 2018."
Recent Business Highlights:
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Announced collaboration with Merck for investigational plasma
kallikrein inhibitors for treatment of diabetic macular edema (DME).
Under the terms of the agreement, KalVista has granted to Merck
certain rights including an option to acquire KVD001 through a period
following completion of the Phase 2 proof-of-concept trial that
KalVista intends to commence this year. KalVista also granted to Merck
a similar option to acquire investigational orally delivered molecules
for DME that KalVista will continue to develop as part of its ongoing
research and development activities. Merck paid KalVista a $37 million
upfront fee and KalVista is further eligible to receive payments
associated with the exercise of the options by Merck and the
achievement of milestones for each program that potentially total up
to $715 million. KalVista also will receive tiered royalties on net
sales for therapeutic candidates commercialized under this agreement.
In addition to the collaboration, KalVista entered into a separate
$9.1 million private placement transaction with Merck under which
Merck acquired a 9.9% ownership stake in KalVista concurrent with the
execution of the Option Agreement.
Fiscal Second Quarter Financial Results:
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Revenue: Revenue was $1.1 million for the three months ended October
31, 2017, compared to $0.2 million for the same period in 2016. The
increase in revenue is primarily due to revenue recognized from the
Merck collaboration fee.
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R&D Expenses: Research and development expenses were $4.4 million for
the three months ended October 31, 2017, compared to $2.9 million for
the same period in 2016. The increase in R&D expense is due to an
overall increase in research activities, primarily driven by
preparations for the KVD001 Phase 2 trial as well as spending on our
other development programs.
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G&A Expenses: General and administrative expenses were $2.7 million
for the three months ended October 31, 2017, compared to $1.3 million
for the same period in 2016. The increase was primarily due to $1.2
million of payroll related expenses and $0.2 million of other
administrative expenses related to the increased cost of operations as
a public company.
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Net Loss: Net loss was $5.0 million, or $(0.50) per basic and diluted
share for the three months ended October 31, 2017, compared to a net
loss of $3.3 million, or $(5.98) per basic and diluted share, for the
same period in 2016.
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Cash: Cash and cash equivalents were $28.1 million as of October 31,
2017. The $37 million Merck upfront payment was received in November
2017.
About KalVista Pharmaceuticals, Inc. KalVista
Pharmaceuticals, Inc. is a pharmaceuticals 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 from which it
plans to select multiple drug candidates to advance into clinical trials
for HAE. KalVista's most advanced program, an intravitreally
administered plasma kallikrein inhibitor known as KVD001, has
successfully completed its first-in-human study in patients with DME and
is being prepared for Phase 2 studies in 2017.
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 27, 2017, our most recent Quarterly Report on Form 10-Q,
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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KalVista Pharmaceuticals Inc.
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Condensed Consolidated Balance Sheets
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(in thousands, except share and per share amounts)
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(Unaudited)
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October 31,
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April 30,
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2017
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2017
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Assets
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Current assets:
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Cash and cash equivalents
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$
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28,128
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$
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30,950
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Research and development tax credit receivable
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3,718
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2,250
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Grants and other receivables
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893
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297
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Prepaid expenses and other current assets
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1,400
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751
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Total current assets
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34,139
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34,248
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Property and equipment, net
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602
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97
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Total assets
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$
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34,741
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$
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34,345
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Liabilities and Stockholders' Equity
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Accounts payable
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$
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1,040
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$
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1,153
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Accrued expenses
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2,253
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1,865
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Capital lease liability - current portion
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220
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-
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Total current liabilities
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3,513
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3,018
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Long-term liabilities:
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Capital lease liability, net of current portion
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149
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-
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Total long-term liabilities
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149
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-
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Stockholders' equity
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Common stock, $0.001 par value
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11
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10
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Additional paid-in capital
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99,408
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89,815
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Accumulated deficit
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(65,769
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(55,855
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Accumulated other comprehensive loss
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(2,571
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)
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(2,643
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Total stockholders' equity
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31,079
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31,327
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Total liabilities and stockholders' equity
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$
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34,741
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$
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34,345
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KalVista Pharmaceuticals Inc.
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Condensed Consolidated Statements of Operations
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(in thousands, except share and per share amounts)
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(Unaudited)
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Three Months Ended
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Six Months Ended
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October 31,
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October 31,
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2017
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2016
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2017
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2016
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Revenue
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$
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1,127
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$
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197
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$
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1,223
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$
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1,141
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Operating expenses:
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Research and development
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4,361
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2,929
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7,837
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6,330
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General and administrative
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2,703
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1,293
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4,776
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3,946
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Total operating expenses
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7,064
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4,222
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12,613
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10,276
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Operating loss
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(5,937
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)
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(4,025
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(11,390
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(9,135
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)
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Other income (expense):
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Interest income
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1
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10
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3
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24
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Foreign currency exchange gain (loss)
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83
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352
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51
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1,706
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Other income
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867
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368
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1,422
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650
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Total other income
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951
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730
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1,476
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2,380
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Net loss
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$
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(4,986
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$
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(3,295
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$
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(9,914
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$
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(6,755
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Net loss per share to common stockholders, basic and diluted
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$
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(0.50
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$
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(5.98
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$
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(1.01
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$
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(12.66
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Weighted average common shares outstanding, basic and diluted
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10,003,963
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709,500
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9,858,502
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690,719
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KalVista Pharmaceuticals Inc.
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Condensed Consolidated Statements of Cash Flows
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(in thousands, unaudited)
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Six Months Ended
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October 31
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2017
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2016
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Cash Flows from Operating Activities
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Net loss
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$
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(9,914
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$
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(6,756
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Adjustments to reconcile net loss to net cash used in operating
activities:
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Depreciation expense
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79
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19
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Stock-based compensation
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494
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67
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Foreign currency exchange rate (gain) loss
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31
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(1,706
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Changes in operating assets and liabilities:
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Research and development tax credit receivable
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(1,397
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)
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(650
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)
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Prepaid expenses and other current assets
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(636
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)
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272
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Grants and other receivables
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(590
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)
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148
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Accounts payable
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(139
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)
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(74
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)
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Accrued expenses
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365
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(1,122
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)
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Due to related parties
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-
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(39
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Net cash used in operating activities
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(11,707
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(9,841
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Cash Flows from Investing Activities
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Acquisition of property and equipment
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(161
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(61
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)
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Net cash used in investing activities
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(161
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(61
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)
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Cash Flows from Financing Activities
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Capital lease principal payments
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(49
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-
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Issuance of common stock
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9,100
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-
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Net cash provided by financing activities
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9,051
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-
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Effect of exchange rate changes on cash
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(5
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)
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(1,177
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)
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Net decrease in cash and cash equivalents
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(2,822
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)
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(11,079
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Cash and cash equivalents, beginning of year
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30,950
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21,764
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Cash and cash equivalents, end of year
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$
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28,128
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$
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10,685
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View source version on businesswire.com: http://www.businesswire.com/news/home/20171214005189/en/
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