KalVista Pharmaceuticals Reports Fiscal Third Quarter Results
March 16 2017 - 4:15PM
– Continuing to Develop a Portfolio
of Oral Plasma Kallikrein Inhibitors for HAE ––
Intravitreal DME Program Remains on Track for Phase 2 in 2017
–– Company Expects to be Well-Funded Through Data
Inflection Points –
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage
pharmaceutical company focused on the discovery, development, and
commercialization of small molecule protease inhibitors, today
reported financial results for the third quarter ended January 31,
2017 and recent business highlights.
“In the fiscal third quarter KalVista continued
our work of developing a portfolio of small molecule plasma
kallikrein inhibitors for treatment of hereditary angioedema (HAE)
and diabetic macular edema (DME),” said Andrew Crockett, Chief
Executive Officer of KalVista. “We are executing the first-in-human
study of KVD818, our first oral plasma kallikrein inhibitor.
We remain committed to our portfolio approach in development of a
best-in-class oral therapy for HAE and have multiple additional
preclinical candidates moving forward in IND-enabling studies.
Additionally, we continue to plan a Phase 2 clinical trial for our
intravitreal program, KVD001, in DME later this year. We anticipate
providing further information on the progress of KVD001, KVD818 and
our other programs early in the third quarter. With our quarter end
cash balance of over $33 million, we remain well-funded to execute
on these discovery and development activities and bring our
programs to significant data points.”
Third Quarter and Recent Business
Highlights:
- Closed merger with Carbylan Therapeutics, Inc. on November 21,
2016, becoming Nasdaq listed under the ticker symbol “KALV”.
- Built out management team with key hires Benjamin L. Palleiko
as Chief Financial Officer, Edward P. Feener, Ph.D. as Chief
Scientific Officer and, subsequent to the end of the quarter,
Andreas Maetzel, M.D., M.Sc., Ph.D. as Senior Vice President,
Medical. Mr. Palleiko has over twenty years of experience in the
industry, as both a senior life sciences investment banker and
Chief Financial Officer of several public and private life sciences
companies. Dr. Feener is a scientific co-founder of KalVista and a
recognized authority on plasma kallikrein. His laboratory at the
Joslin Diabetes Center has made groundbreaking discoveries on the
role of plasma kallikrein in vascular disorders and was the first
to identify plasma kallikrein as a potential therapeutic target for
diabetic macular edema. Dr. Maetzel joined the company in March,
bringing extensive experience in the field of HAE drug
development.
Fiscal Third Quarter Financial
Results:
- Revenue: Revenue was $0.2 million for the three months ended
January 31, 2017, compared to $0.3 million for the same period in
2016. Revenue in both periods consisted primarily of payments under
the terms of a research and development grant.
- R&D Expenses: Research and development expenses were $3.3
million for the three months ended January 31, 2017, compared to
$3.6 million for the same period in 2016. The decline in R&D
expense primarily reflects the impact of exchange rates on the
costs of the Company’s scientific operations in the U.K. On a
constant currency basis, overall R&D expenses increased
slightly as a result of the addition of research personnel in the
U.S.
- G&A Expenses: General and administrative expenses were $5.0
million for the three months ended January 31, 2017, compared to
$0.5 million for the same period in 2016. This was primarily due to
costs associated with the share purchase transaction completed in
November 2016 and additional payroll costs and other expenses as we
expand the management team and other key positions, and incur costs
associated with operations as a public company.
- Net Loss: Net loss was $7.6 million, or $1.03 per basic and
diluted share for the three months ended January 31, 2017, compared
to a net loss of $2.0 million, or $4.85 per basic and diluted
share, for the same period in 2016. This change was primarily due
to costs associated with the share purchase transaction completed
in November 2016 and additional payroll costs and other expenses as
we expand the management team and other key positions, and incur
costs associated with operations as a public company.
- Cash: Cash and cash equivalents were $33.5 million as of
January 31, 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. The first of this planned
portfolio of programs, KVD818, is currently in a first-in-human
study that commenced in the second half of 2016, and additional
program candidates are in preclinical development. 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
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 definitive proxy statement
filed on October 28, 2016, 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) |
|
|
|
|
|
|
|
January 31, |
|
April 30, |
|
|
2017 |
|
2016 |
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
33,498 |
|
|
$ |
21,764 |
|
Research
and development tax credit receivable |
|
|
2,840 |
|
|
|
1,883 |
|
Grants
receivable |
|
|
398 |
|
|
|
356 |
|
Prepaid
expenses and other current assets |
|
|
1,217 |
|
|
|
668 |
|
Total current assets |
|
|
37,953 |
|
|
|
24,671 |
|
|
|
|
|
|
Property
and equipment, net |
|
|
97 |
|
|
|
74 |
|
Total assets |
|
$ |
38,050 |
|
|
$ |
24,745 |
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
755 |
|
|
$ |
1,135 |
|
Accrued
expenses |
|
|
2,446 |
|
|
|
2,114 |
|
Total current liabilities |
|
|
3,201 |
|
|
|
3,249 |
|
|
|
|
|
|
Redeemable Convertible
Preferred Stock, $0.0016 par value |
|
|
- |
|
|
|
58,608 |
|
|
|
|
|
|
Stockholders’ equity
(deficit) |
|
|
|
|
Ordinary
shares, $0.0016 par value |
|
|
- |
|
|
|
3 |
|
Common
stock, $0.001 par value |
|
|
10 |
|
|
|
- |
|
Additional paid-in capital |
|
|
89,399 |
|
|
|
212 |
|
Accumulated deficit |
|
|
(51,653 |
) |
|
|
(37,252 |
) |
Accumulated other comprehensive loss |
|
|
(2,907 |
) |
|
|
(75 |
) |
Total stockholders’ equity (deficit) |
|
|
34,849 |
|
|
|
(37,112 |
) |
Total liabilities and shareholders' equity |
|
$ |
38,050 |
|
|
$ |
24,745 |
|
|
|
|
|
|
KalVista Pharmaceuticals Inc. |
Condensed Consolidated Statement of Operations
and Comprehensive Loss |
(in thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
January 31, |
|
January 31, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
Grant
income |
|
$ |
248 |
|
|
$ |
348 |
|
|
$ |
1,390 |
|
|
$ |
1,850 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
3,339 |
|
|
|
3,622 |
|
|
|
9,670 |
|
|
|
10,111 |
|
General
and administrative |
|
|
5,026 |
|
|
|
541 |
|
|
|
8,973 |
|
|
|
1,525 |
|
Total operating expenses |
|
|
8,365 |
|
|
|
4,163 |
|
|
|
18,643 |
|
|
|
11,636 |
|
Operating loss |
|
|
(8,117 |
) |
|
|
(3,815 |
) |
|
|
(17,253 |
) |
|
|
(9,786 |
) |
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest
income |
|
|
7 |
|
|
|
20 |
|
|
|
31 |
|
|
|
31 |
|
Foreign
currency exchange rate gain (loss) |
|
|
(195 |
) |
|
|
1,297 |
|
|
|
1,511 |
|
|
|
2,196 |
|
Other
income |
|
|
661 |
|
|
|
546 |
|
|
|
1,310 |
|
|
|
1,304 |
|
Total
other income |
|
|
473 |
|
|
|
1,863 |
|
|
|
2,852 |
|
|
|
3,531 |
|
Net loss |
|
$ |
(7,644 |
) |
|
$ |
(1,952 |
) |
|
$ |
(14,401 |
) |
|
$ |
(6,255 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
Currency
translation adjustments |
|
|
166 |
|
|
|
(3,622 |
) |
|
|
(2,832 |
) |
|
|
(4,529 |
) |
Comprehensive Loss |
|
$ |
(7,478 |
) |
|
$ |
(5,574 |
) |
|
$ |
(17,233 |
) |
|
$ |
(10,784 |
) |
Net loss
per share to common stockholders, basic and diluted |
|
$ |
(1.03 |
) |
|
$ |
(4.85 |
) |
|
$ |
(5.50 |
) |
|
$ |
(16.05 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
|
7,657,874 |
|
|
|
630,921 |
|
|
|
3,013,073 |
|
|
|
576,181 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KalVista Pharmaceuticals Inc. |
Condensed Consolidated Statements of Cash
Flows |
(in thousands, unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
January 31, |
|
|
2017 |
|
2016 |
|
|
|
|
|
Cash Flows from
Operating Activities |
|
|
|
|
Net loss |
|
$ |
(14,401 |
) |
|
$ |
(6,255 |
) |
Adjustments to
reconcile net loss to net cash used in operating activities |
|
|
|
|
Depreciation and amortization |
|
|
29 |
|
|
|
26 |
|
Stock-based compensation |
|
|
228 |
|
|
|
16 |
|
Foreign
currency remeasurement gain |
|
|
(1,464 |
) |
|
|
(2,230 |
) |
Changes
in operating assets and liabilities: |
|
|
|
|
Research
and development tax credit receivable |
|
|
(1,303 |
) |
|
|
(1,309 |
) |
Prepaid
expenses and other current assets |
|
|
(689 |
) |
|
|
(389 |
) |
Grants
receivable |
|
|
36 |
|
|
|
(53 |
) |
Accounts
payable |
|
|
(1,957 |
) |
|
|
(203 |
) |
Accrued
expenses |
|
|
(1,560 |
) |
|
|
(371 |
) |
Net cash used in
operating activities |
|
|
(21,081 |
) |
|
|
(10,768 |
) |
|
|
|
|
|
Cash Flows from
Investing Activities |
|
|
|
|
Cash
acquired in transaction, net |
|
|
34,139 |
|
|
|
- |
|
Acquisition of property and equipment |
|
|
(67 |
) |
|
|
(9 |
) |
Net cash provided by
(used in) investing activities |
|
|
34,072 |
|
|
|
(9 |
) |
|
|
|
|
|
Cash Flows from
Financing Activities |
|
|
|
|
Proceeds
from issuance of preferred stock |
|
|
- |
|
|
|
33,002 |
|
Proceeds
from issuance of common stock, net |
|
|
2 |
|
|
|
- |
|
Net cash provided by
financing activities |
|
|
2 |
|
|
|
33,002 |
|
Effect of exchange rate
changes on cash |
|
|
(1,259 |
) |
|
|
(583 |
) |
Net increase in cash
and cash equivalents |
|
|
11,734 |
|
|
|
21,642 |
|
Cash and cash
equivalents, beginning of period |
|
|
21,764 |
|
|
|
2,526 |
|
Cash and cash
equivalents, end of period |
|
$ |
33,498 |
|
|
$ |
24,168 |
|
|
|
|
|
|
Contact:
KalVista Pharmaceuticals, Inc.
Leah Monteiro, Corporate Communications & Investor Relations
857-999-0808
lmm@KalVista.com
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