KalVista Pharmaceuticals Provides Operational Update and Reports Fiscal Fourth Quarter and Full Year Financial Results
July 27 2017 - 3:01PM
– Oral Plasma Kallikrein Inhibitor
Portfolio for Treatment of Hereditary Angioedema Continues to
Advance –
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 fourth quarter and full year ended April 30, 2017.
“KalVista has been making substantial advances
with our portfolio of oral small molecule plasma kallikrein
inhibitors for treatment of hereditary angioedema (HAE), and our
intravitreal program in diabetic macular edema (DME),” said Andrew
Crockett, Chief Executive Officer of KalVista. “The first HAE
program in the portfolio, KVD818, is nearing the end of its
first-in-human study and we continue to progress the next
candidate, KVD900, to the clinic. Our scientific team plans
to bring at least one additional HAE program to the clinic in 2018
as we continue to evaluate all of these molecules with the goal of
providing a best-in-class oral therapy for patients. We are
also making preparations to initiate the Phase 2 proof-of-concept
trial for our intravitreal DME program, KVD001, later this
year.”
Fiscal 2017 Business
Highlights:
- Closed merger with Carbylan Therapeutics, Inc. on November 21,
2016, becoming listed on NASDAQ under the ticker symbol
“KALV”.
- Built out executive team with key hires Benjamin L. Palleiko as
Chief Financial Officer, Edward P. Feener, Ph.D. as Chief
Scientific Officer and Andreas Maetzel, M.D., M.Sc., Ph.D. as
Senior Vice President, Medical.
HAE Portfolio:
- KalVista continues to pursue a strategy of developing a
portfolio of oral molecules and evaluating multiple candidates in
the clinic to provide a best-in-class therapy for HAE patients. As
part of this strategy, we will select molecules whose properties
can support multiple therapies for HAE patients, such as for
prophylactic as well as acute treatment.
- KVD818: The initial clinical candidate in our HAE portfolio is
nearing completion of the first-in-human study. Early data for
KVD818 indicate good exposure and a good tolerability profile. We
intend to evaluate final data and determine future development
plans while the other molecules in the portfolio advance.
- KVD900: Anticipated to be the next program to enter clinical
testing, with regulatory filing before end of the calendar year.
KVD900 represents the continual evolution of the portfolio, with a
differentiated set of properties compared to KVD818 that may
support development in multiple regimens of HAE therapy.
- A diverse and expanding portfolio containing multiple
additional oral candidates is under development and will continue
to be advanced as progression criteria are met. We anticipate
at least one additional candidate will enter the clinic in
2018.
DME Programs:
- KVD001: Intravitreal therapy for DME advancing into a Phase 2
trial this year. This trial is expected to evaluate DME patients
who experience an inadequate response to VEGF inhibitors. This will
be a sham-controlled trial, with patients receiving four injections
over a period of three months. The primary efficacy endpoint will
be a change in BCVA (Best Corrected Visual Acuity) which measures a
patient’s ability to read a standardized chart of letters. Other
endpoints will include optical computerized tomography to assess
changes in retinal thickness due to edema. We expect to provide
additional details when the trial commences.
- We continue to take steps in designing an oral plasma
kallikrein therapy for DME, based upon the knowledge gained through
our oral HAE portfolio as well as research conducted by our Chief
Scientific Officer, Dr. Edward Feener. We believe that an orally
delivered therapeutic could provide significant clinical benefit to
DME patients compared to the current approved DME drugs, which are
all delivered via injection.
Recent and Upcoming Events:
- Edward Feener, Ph.D., gave a talk at the International Society
on Thrombosis and Haemostasis (ISTH) Congress entitled “Contact
System in Diabetic Retinopathy,” on July 9, 2017 in Berlin,
Germany.
- Wedbush PacGrow Healthcare Conference on August 15, 2017 in New
York, NY.
- 19th Royal Society of Chemistry Medicinal Chemistry Symposium,
presenting KVD001 data on September 10, 2017 in Cambridge, United
Kingdom.
- Cambridge Healthtech Institute’s Fifth Annual Targeting Ocular
Disorders Conference presentation “Plasma Kallikrein Inhibition as
a VEGF-Independent Treatment for Diabetic Macular Edema,” on
September 28, 2017 in Boston, MA.
Fourth Quarter and Full Year Financial
Results:
- Revenue: Revenue/Grant income was $0.1 million for the three
months ended April 30, 2017, compared to $0.3 million for the same
period in the prior year. Grant income was $1.5 million for the
fiscal year ended April 30, 2017, compared to $2.1 million in the
prior year. 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 $3.0
million for the three months ended April 30, 2017, compared to $4.4
million for the same period in the prior year. Research and
development expenses were $12.7 million for the fiscal year ended
April 30, 2017, compared to $14.7 million in the prior year. The
decline in R&D expense primarily reflects the completion of a
trial for KVD001 that was ongoing in 2016 and lower spending on
other programs, as well as the impact of a decline in the value of
the British Pound on the costs of KalVista’s scientific operations
in the U.K.
- G&A Expenses: General and administrative expenses were $2.2
million for the three months ended April 30, 2017, compared to $1.0
million for the same period in the prior year. General and
administrative expenses were $11.2 million for the fiscal year
ended April 30, 2017, compared to $2.7 million in the prior year.
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 expanded the management team and other key
positions, and incur costs associated with operations as a public
company.
- Net Loss: Net loss was $4.2 million, or $0.43 per weighted
average basic and diluted share, for the three months ended April
30, 2017, compared to net loss of $4.9 million, or $9.37 per share
for the same period in the prior year. Net loss was $18.6 million,
or $4.47 per weighted average basic and diluted share for the
fiscal year ended April 30, 2017, compared to a net loss of $11.4
million, or $26.17 per weighted average basic and diluted share in
the prior year. This increase in the net loss 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 Position: Cash and cash equivalents were $31.0 million as
of April 30, 2017, compared to $21.8 million as of April 30,
2016.
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 candidate of
this planned portfolio of programs, KVD818, is currently in a
first-in-human study 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) |
|
|
|
|
|
April 30, |
|
April 30, |
|
2017 |
|
2016 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
30,950 |
|
|
$ |
21,764 |
|
Research
and development tax credit receivable |
|
2,250 |
|
|
|
1,883 |
|
Grants
receivable |
|
297 |
|
|
|
356 |
|
Prepaid
expenses and other current assets |
|
751 |
|
|
|
668 |
|
Total current assets |
|
34,248 |
|
|
|
24,671 |
|
|
|
|
|
Property
and equipment, net |
|
97 |
|
|
|
74 |
|
Total assets |
$ |
34,345 |
|
|
$ |
24,745 |
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
1,153 |
|
|
$ |
1,135 |
|
Accrued
expenses |
|
1,865 |
|
|
|
2,114 |
|
Total current liabilities |
|
3,018 |
|
|
|
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 |
|
89,815 |
|
|
|
212 |
|
Accumulated deficit |
|
(55,855 |
) |
|
|
(37,252 |
) |
Accumulated other comprehensive loss |
|
(2,643 |
) |
|
|
(75 |
) |
Total stockholders’ equity (deficit) |
|
31,327 |
|
|
|
(37,112 |
) |
Total liabilities and stockholders' equity |
$ |
34,345 |
|
|
$ |
24,745 |
|
|
|
|
|
KalVista Pharmaceuticals Inc. |
Condensed Consolidated Statement of
Operations |
(in thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Years Ended |
|
April 30, |
|
April 30, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant
income |
$ |
114 |
|
|
$ |
314 |
|
|
$ |
1,504 |
|
|
$ |
2,133 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
|
2,996 |
|
|
|
4,414 |
|
|
|
12,666 |
|
|
|
14,661 |
|
General
and administrative |
|
2,204 |
|
|
|
986 |
|
|
|
11,177 |
|
|
|
2,653 |
|
Total operating expenses |
|
5,200 |
|
|
|
5,400 |
|
|
|
23,843 |
|
|
|
17,314 |
|
Operating loss |
|
(5,086 |
) |
|
|
(5,086 |
) |
|
|
(22,339 |
) |
|
|
(15,181 |
) |
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
Interest
income |
|
5 |
|
|
|
18 |
|
|
|
36 |
|
|
|
50 |
|
Foreign
currency exchange rate gain (loss) |
|
(140 |
) |
|
|
(508 |
) |
|
|
1,371 |
|
|
|
1,661 |
|
Other
income |
|
1,019 |
|
|
|
707 |
|
|
|
2,329 |
|
|
|
2,034 |
|
Total other income |
|
884 |
|
|
|
217 |
|
|
|
3,736 |
|
|
|
3,745 |
|
Net loss |
$ |
(4,202 |
) |
|
$ |
(4,869 |
) |
|
$ |
(18,603 |
) |
|
$ |
(11,436 |
) |
|
|
|
|
|
|
|
|
Net loss
per share to common stockholders, basic and diluted |
$ |
(0.43 |
) |
|
$ |
(9.37 |
) |
|
$ |
(4.47 |
) |
|
$ |
(26.17 |
) |
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, basic and diluted |
|
9,713,042 |
|
|
|
630,921 |
|
|
|
4,646,764 |
|
|
|
591,298 |
|
KalVista Pharmaceuticals Inc. |
|
Condensed Consolidated Statements of Cash
Flows |
|
(in thousands, unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended |
|
|
April 30 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
Cash Flows from
Operating Activities |
|
|
|
|
Net loss |
$ |
(18,603 |
) |
|
$ |
(11,436 |
) |
|
Adjustments to
reconcile net loss to net cash used in operating activities |
|
|
|
|
Depreciation expense |
|
40 |
|
|
|
33 |
|
|
Stock-based compensation |
|
394 |
|
|
|
118 |
|
|
Foreign
currency exchange rate gain |
|
(1,371 |
) |
|
|
(1,661 |
) |
|
Changes
in operating assets and liabilities: |
|
|
|
|
Research
and development tax credit receivable |
|
(600 |
) |
|
|
(1,148 |
) |
|
Prepaid
expenses and other current assets |
|
(81 |
) |
|
|
(137 |
) |
|
Grants
receivable |
|
29 |
|
|
|
(475 |
) |
|
Accounts
payable |
|
(1,599 |
) |
|
|
374 |
|
|
Accrued
expenses |
|
(1,931 |
) |
|
|
1,176 |
|
|
Net cash used in
operating activities |
|
(23,722 |
) |
|
|
(13,156 |
) |
|
|
|
|
|
|
Cash Flows from
Investing Activities |
|
|
|
|
Cash
acquired in transaction |
|
34,139 |
|
|
|
- |
|
|
Purchases
of property and equipment |
|
(74 |
) |
|
|
(11 |
) |
|
Net cash provided by
(used in) investing activities |
|
34,065 |
|
|
|
(11 |
) |
|
|
|
|
|
|
Cash Flows from
Financing Activities |
|
|
|
|
Proceeds
from issuance of preferred stock |
|
- |
|
|
|
33,002 |
|
|
Proceeds
from issuance of common stock |
|
2 |
|
|
|
1 |
|
|
Net cash provided by
financing activities |
|
2 |
|
|
|
33,003 |
|
|
Effect of exchange rate
changes on cash |
|
(1,159 |
) |
|
|
(598 |
) |
|
Net increase in cash
and cash equivalents |
|
9,186 |
|
|
|
19,238 |
|
|
Cash and cash
equivalents, beginning of year |
|
21,764 |
|
|
|
2,526 |
|
|
Cash and cash
equivalents, end of year |
$ |
30,950 |
|
|
$ |
21,764 |
|
|
|
|
|
|
|
Contact:
KalVista Pharmaceuticals, Inc.
Leah Monteiro, Corporate Communications & Investor Relations
857-999-0808
lmm@KalVista.com
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From Apr 2024 to May 2024
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From May 2023 to May 2024