– KVD900 On-Demand Data Expected Q4 2020 –
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 first fiscal quarter ended July 31, 2020.
“We are pleased that our KVD900 Phase 2 trial has met its
enrollment target and data is expected before the end of this year.
We believe KVD900 can bring the first effective and well-tolerated
oral on-demand treatment option to patients suffering from
hereditary angioedema attacks,” said Andrew Crockett, Chief
Executive Officer of KalVista. “Our portfolio of oral options
intended to treat HAE also includes prophylactic treatment
candidate KVD824, for which we are completing our formulation
studies which include dosing in subjects. We look forward to
providing additional pharmacokinetic and pharmacodynamic data for
KVD824 later this year in advance of starting a Phase 2 clinical
trial. Similar to KVD900, our goal with KVD824 is to conduct a
robust Phase 2 trial to provide proof-of-concept and potentially an
expedited development pathway. We will provide further details on
our plans as we prepare to initiate the trial.”
First Fiscal Quarter and Recent Business Highlights:
- Met enrollment target for the Phase 2 clinical trial intended
to evaluate the safety and efficacy of KVD900 compared to placebo
in the treatment of HAE attacks. This trial is expected to provide
data in the fourth quarter of 2020.
- Submitted a Pediatric Investigational Plan (PIP) to the
European Medicines Agency (EMA) for KVD900.
First Fiscal Quarter Financial Results:
- Revenue: No revenue was recognized for the three months ended
July 31, 2020, compared to $3.4 million for the same period in the
prior fiscal year. The decrease of $3.4 million was due to the
expiration of the Merck Option Agreement in February 2020. No
future revenue remains under this agreement.
- R&D Expenses: Research and development expenses were $11.2
million for the three months ended July 31, 2020, compared to $9.7
million for the same period in the prior fiscal year. The increase
in spending during the quarter primarily reflects increased costs
related to the ongoing clinical trial for KVD900 as well as
increased expenses in relation to the development of KVD824,
primarily offset by a decrease in spending on KVD001 which
concluded a Phase 2 clinical trial in December 2019, and a decrease
in spending on preclinical activities.
- G&A Expenses: General and administrative expenses were $3.3
million for the three months ended July 31, 2020, compared to $3.2
million for the same period in the prior fiscal year.
- Net Loss: Net loss was $10.8 million, or $(0.61) per weighted
average basic and diluted share, for the three months ended July
31, 2020, compared to net loss of $7.3 million, or $(0.42) per
weighted average basic and diluted share, for the same period in
the prior fiscal year. The increase in net loss and net loss per
share in the three months ended July 31, 2020 as compared to the
same period in the prior fiscal year primarily due to the decrease
in revenue and increase in research and development expenses in the
three months ended July 31, 2020.
- Cash: Cash, cash equivalents and marketable securities were
$64.3 million as of July 31, 2020, compared to $67.7 million as of
April 30, 2020. The decrease in net cash position was due to
increased spending, primarily on research and development
activities.
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). KalVista 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
fourth quarter of 2020. KVD824 is in development for prophylactic
treatment of HAE with a Phase 2 clinical trial planned to commence
in late 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, including the
potential impact of COVID-19, that could cause actual results to
differ materially from what we expect. Examples of forward-looking
statements include, among others, KalVista’s expectations about
future clinical trial timing and results, its ability to commence
or complete clinical studies and to obtain regulatory approvals for
KVD824, the ability of KVD900 and KVD824 to treat HAE, and the
sufficiency of our cash, cash equivalents and investments to fund
our operations. Further information on potential risk factors that
could affect our business and its financial results are detailed in
our annual report on Form 10-K filed on July 1, 2020, our quarterly
report on Form 10-Q for the three months ended July 31, 2020, when
filed, and other filings we may make 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,
2020
2020
Assets Current assets: Cash and cash equivalents
$
18,014
$
15,789
Marketable securities
46,317
51,925
Research and development tax credit receivable
12,638
16,527
Prepaid expenses and other current assets
3,256
4,455
Total current assets
80,225
88,696
Property and equipment, net
2,019
2,043
Right of use assets
1,480
1,612
Other assets
178
178
Total assets
$
83,902
$
92,529
Liabilities and stockholders' equity Current liabilities:
Accounts payable
$
1,774
$
1,677
Accrued expenses
6,170
5,455
Lease liability - current portion
513
588
Total current liabilities
8,457
7,720
Long-term liabilities: Lease liability - net of current portion
1,010
1,057
Total long-term liabilities
1,010
1,057
Stockholders’ equity: Common stock, $0.001 par value
18
18
Additional paid-in capital
208,442
207,208
Accumulated deficit
(132,406
)
(121,592
)
Accumulated other comprehensive loss
(1,619
)
(1,882
)
Total stockholders’ equity
74,435
83,752
Total liabilities and stockholders' equity
$
83,902
$
92,529
KalVista Pharmaceuticals Inc. Condensed Consolidated
Statement of Operations (in thousands, except share and per
share amounts) (Unaudited) Three Months
Ended July 31,
2020
2019
Revenue
$
—
$
3,369
Operating expenses: Research and development
11,165
9,686
General and administrative
3,278
3,247
Total operating expenses
14,443
12,933
Operating loss
(14,443
)
(9,564
)
Other income: Interest income
259
590
Foreign currency exchange rate gain (loss)
438
(453
)
Other income
2,932
2,089
Total other income
3,629
2,226
Net loss
$
(10,814
)
$
(7,338
)
Net loss per share, basic and diluted
$
(0.61
)
$
(0.42
)
Weighted average common shares outstanding, basic and
diluted
17,848,583
17,488,997
KalVista Pharmaceuticals Inc. Condensed Consolidated
Statements of Cash Flows (in thousands, unaudited)
Three Months Ended July 31,
2020
2019
Cash flows from operating activities Net loss
$
(10,814
)
$
(7,338
)
Adjustments to reconcile net loss to net cash used in operating
activities: Depreciation and amortization
128
121
Stock-based compensation expense
1,188
1,074
Realized gain from sale of marketable securities
(70
)
(29
)
Non-cash operating lease expense
8
1
Amortization of premium on marketable securities
68
35
Foreign currency exchange (gain) loss
(432
)
454
Changes in operating assets and liabilities: Research and
development tax credit receivable
4,462
(2,060
)
Prepaid expenses and other current assets
1,301
561
Accounts payable
35
392
Accrued expenses
538
(1,117
)
Deferred revenue
—
(3,369
)
Net cash used in operating activities
(3,588
)
(11,275
)
Cash flows from investing activities Purchases of
marketable securities
(9,807
)
(19,646
)
Sales and maturities of marketable securities
15,342
18,214
Acquisition of property and equipment
(22
)
(98
)
Net cash provided by (used in) investing activities
5,513
(1,530
)
Cash flows from financing activities Issuance of
common stock, net of offering expenses
—
11,422
Issuance of common stock from equity incentive plans
46
32
Finance lease principal payments
—
(54
)
Net cash provided by financing activities
46
11,400
Effect of exchange rate changes on cash and cash equivalents
254
(494
)
Net increase (decrease) in cash and cash equivalents
2,225
(1,899
)
Cash and cash equivalents at beginning of period
15,789
32,006
Cash and cash equivalents at end of period
$
18,014
$
30,107
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200914005221/en/
KalVista Pharmaceuticals, Inc. Leah Monteiro Senior
Director, Corporate Communications & Investor Relations
857-999-0808 leah.monteiro@kalvista.com
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From Mar 2024 to Apr 2024
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From Apr 2023 to Apr 2024