– Regulatory Filing Submitted for Second
Candidate in Oral Hereditary Angioedema (HAE) Plasma Kallikrein
Inhibitor Portfolio –
– Cash Through Data Inflection Points in Both
HAE and Diabetic Macular Edema Programs –
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:
- 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:
- 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.
- 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.
- 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.
- 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.
- 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 StatementsThis 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.
KalVista Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets (in thousands,
except share and per share amounts) (Unaudited)
October 31, April 30, 2017 2017
Assets Current assets: Cash and cash equivalents $ 28,128 $
30,950 Research and development tax credit receivable 3,718 2,250
Grants and other receivables 893 297 Prepaid expenses and other
current assets 1,400 751
Total
current assets 34,139 34,248 Property and equipment, net
602 97
Total assets $
34,741 $ 34,345
Liabilities and Stockholders' Equity Accounts payable
$ 1,040 $ 1,153 Accrued expenses 2,253 1,865 Capital lease
liability - current portion 220 -
Total current liabilities 3,513 3,018
Long-term liabilities: Capital lease liability, net of
current portion 149 -
Total
long-term liabilities 149 -
Stockholders’ equity Common stock, $0.001 par value 11 10
Additional paid-in capital 99,408 89,815 Accumulated deficit
(65,769 ) (55,855 ) Accumulated other comprehensive loss
(2,571 ) (2,643 )
Total stockholders’ equity
31,079 31,327
Total liabilities and
stockholders' equity $ 34,741 $
34,345
KalVista Pharmaceuticals Inc. Condensed
Consolidated Statements of Operations (in thousands, except
share and per share amounts) (Unaudited)
Three Months Ended Six Months Ended October
31, October 31, 2017 2016 2017
2016 Revenue $ 1,127
$ 197 $ 1,223 $ 1,141
Operating expenses: Research and development 4,361 2,929
7,837 6,330 General and administrative 2,703
1,293 4,776 3,946
Total
operating expenses 7,064 4,222
12,613 10,276
Operating loss
(5,937 ) (4,025 )
(11,390 ) (9,135 ) Other
income (expense): Interest income 1 10 3 24 Foreign currency
exchange gain (loss) 83 352 51 1,706 Other income 867
368 1,422 650
Total
other income 951 730 1,476
2,380
Net loss $ (4,986
) $ (3,295 ) $ (9,914
) $ (6,755 ) Net loss per share
to common stockholders, basic and diluted
$ (0.50
) $ (5.98 ) $ (1.01
) $ (12.66 ) Weighted average
common shares outstanding, basic and diluted 10,003,963 709,500
9,858,502 690,719
KalVista
Pharmaceuticals Inc. Condensed Consolidated Statements of
Cash Flows (in thousands, unaudited)
Six Months Ended October 31 2017 2016
Cash Flows from Operating Activities Net loss $
(9,914 ) $ (6,756 ) Adjustments to reconcile net loss to net cash
used in operating activities: Depreciation expense 79 19
Stock-based compensation 494 67 Foreign currency exchange rate
(gain) loss 31 (1,706 ) Changes in operating assets and
liabilities: Research and development tax credit receivable (1,397
) (650 ) Prepaid expenses and other current assets (636 ) 272
Grants and other receivables (590 ) 148 Accounts payable (139 ) (74
) Accrued expenses 365 (1,122 ) Due to related parties -
(39 ) Net cash used in operating activities
(11,707 ) (9,841 )
Cash Flows from Investing
Activities Acquisition of property and equipment (161 )
(61 ) Net cash used in investing activities (161 )
(61 )
Cash Flows from Financing Activities
Capital lease principal payments (49 ) - Issuance of common stock
9,100 - Net cash provided by financing
activities 9,051 - Effect of exchange
rate changes on cash (5 ) (1,177 ) Net decrease in
cash and cash equivalents (2,822 ) (11,079 ) Cash and cash
equivalents, beginning of year 30,950 21,764
Cash and cash equivalents, end of year $ 28,128 $
10,685
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171214005189/en/
KalVista Pharmaceuticals, Inc.Leah Monteiro,
857-999-0808Director, Corporate Communications & Investor
Relationsleah.monteiro@kalvista.com
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