– Enrollment Ongoing for a Phase 2 Clinical
Trial of KVD001 in Diabetic Macular Edema (“DME”) and a Phase 1
Clinical Trial for the Second Candidate in the Oral Hereditary
Angioedema (“HAE”) Portfolio –
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 third
quarter ended January 31, 2018.
“We are pleased to have the second candidate from our oral
hereditary angioedema portfolio in a Phase 1 trial as we continue
to pursue a best-in-class therapy,” said Andrew Crockett, Chief
Executive Officer of KalVista. “Our diabetic macular edema compound
KVD001 is enrolling in a Phase 2 clinical trial for which we expect
to see data in the second half of 2019. The cash position of
KalVista continues to be sufficient to reach data readouts in both
of these ongoing trials.”
Recent Business Highlights:
- Announced initiation of two clinical
trials: A Phase 2 proof-of-concept clinical trial evaluating the
safety, tolerability, and efficacy of KVD001 as a treatment for
DME, as well as a Phase 1 trial for KVD900, the second clinical
candidate in the HAE portfolio. KalVista also intends to bring at
least one additional HAE drug candidate to the clinic before the
end of 2018.
- KalVista’s Chief Scientific Officer,
Edward Feener, Ph.D., presented at The International Symposium on
Ocular Pharmacology and Therapeutics (ISOPT) on March 2, 2018, in
Tel-Aviv, Israel.
Upcoming Events:
- Presenting “A Novel Oral Plasma
Kallikrein (PKal) Inhibitor KV123833 Blocks VEGF-Mediated Retinal
Vascular Hyperpermeability in a Murine Model of Retinal Edema,” at
The Association for Research in Vision and Ophthalmology (ARVO) on
May 1, 2018, in Honolulu, Hawaii.
Fiscal Third Quarter Financial Results:
- Revenue: Revenue was $2.3 million for
the three months ended January 31, 2018, compared to $0.2 million
for the same period in 2017. The increase in revenue is primarily
due to revenue recognized from the Merck option agreement.
- R&D Expenses: Research and
development expenses were $4.5 million for the three months ended
January 31, 2018, compared to $3.3 million for the same period in
2017. The increase in R&D expense is due to an overall increase
in research activities, primarily driven by the KVD001 Phase 2
trial as well as spending on our other development programs.
- G&A Expenses: General and
administrative expenses were $2.1 million for the three months
ended January 31, 2018, compared to $5.0 million for the same
period in 2017. The decrease was primarily due to a $2.1 million
decrease in professional fees and $0.7 million of severance and
payroll expenses related to the share purchase transaction with
Carbylan Therapeutics, Inc. in the prior year.
- Net Loss: Net loss was $5.2 million, or
$(0.49) per basic and diluted share for the three months ended
January 31, 2018, compared to a net loss of $7.6 million, or
$(1.03) per basic and diluted share, for the same period in
2017.
- Cash: Cash and cash equivalents were
$58.7 million as of January 31, 2018.
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). The Company has created a structurally diverse portfolio of
oral plasma kallikrein inhibitors, and is advancing multiple drug
candidates into Phase 1 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 began a Phase 2
clinical trial 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)
January 31, April 30, 2018 2017
Assets Current assets: Cash and cash equivalents $ 58,678 $
30,950 Research and development tax credit receivable 4,989 2,250
Grants and other receivables 40 297 Prepaid expenses and other
current assets 2,003 701
Total
current assets 65,710 34,198 Other assets 173 50
Property and equipment, net 774 97
Total assets $ 66,657 $
34,345 Liabilities and Stockholders'
Equity Accounts payable $ 1,575 $ 1,153 Accrued expenses
2,290 1,865 Deferred revenue - current portion 19,996 - Capital
lease liability - current portion 222 -
Total current liabilities 24,083 3,018
Long-term liabilities: Deferred revenue - net of current
portion 13,889 - Capital lease liability, net of current portion
117 -
Total long-term liabilities
14,006 - Stockholders’ equity Common
stock, $0.001 par value 11 10 Additional paid-in capital 99,696
89,815 Accumulated deficit (71,003 ) (55,855 ) Accumulated other
comprehensive loss (136 ) (2,643 )
Total
stockholders’ equity 28,568 31,327
Total liabilities and stockholders' equity $
66,657 $ 34,345
KalVista Pharmaceuticals Inc. Condensed Consolidated
Statements of Operations (in thousands, except share and per
share amounts) (Unaudited)
Three Months Ended
Nine Months Ended January 31, January 31,
2018 2017 2018 2017
Revenue $ 2,331 $ 248 $
3,554 $ 1,390 Operating expenses:
Research and development 4,548 3,339 12,385 9,670 General and
administrative 2,129 5,026 6,905
8,973
Total operating expenses
6,677 8,365 19,290 18,643
Operating loss (4,346 )
(8,117 ) (15,736 )
(17,253 ) Other income (expense): Interest
income 14 7 17 31 Foreign currency exchange gain (loss) (1,887 )
(195 ) (1,836 ) 1,511 Other income 985 661
2,407 1,310
Total other
income (888 ) 473 588
2,852
Net loss $ (5,234 )
$ (7,644 ) $ (15,148 )
$ (14,401 ) Net loss per share to
common stockholders, basic and diluted
$ (0.49
) $ (1.03 ) $ (1.49
) $ (5.50 ) Weighted average
common shares outstanding, basic and diluted 10,788,556 7,657,874
10,168,520 3,013,073
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows (in
thousands, unaudited)
Nine Months Ended January 31 2018 2017
Cash Flows from Operating Activities Net loss $
(15,148 ) $ (14,401 ) Adjustments to reconcile net loss to net cash
provided by (used in) operating activities: Depreciation and
amortization 129 29 Stock-based compensation 779 228 Foreign
currency remeasurement (gain) loss (500 ) (1,464 ) Changes in
operating assets and liabilities: Research and development tax
credit receivable (2,383 ) (1,303 ) Prepaid expenses and other
current assets (1,206 ) (689 ) Grants and other receivables 281 36
Other assets (123 ) - Accounts payable 548 (1,957 ) Accrued
expenses 332 (1,560 ) Deferred revenue 33,804
- Net cash provided by (used in) operating activities
16,513 (21,081 )
Cash Flows from Investing
Activities Cash acquired in transaction - 34,139 Acquisition of
property and equipment (343 ) (67 ) Net cash provided
by (used in) investing activities (343 ) 34,072
Cash Flows from Financing Activities Capital
lease principal payments (101 ) - Issuance of common stock
9,100 2 Net cash from financing activities
8,999 2 Effect of exchange rate changes
on cash 2,559 (1,259 ) Net increase in cash
and cash equivalents 27,728 11,734 Cash and cash equivalents,
beginning of period 30,950 21,764 Cash
and cash equivalents, end of period $ 58,678 $ 33,498
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180316005172/en/
KalVista Pharmaceuticals, Inc.Leah Monteiro,
857-999-0808Director, Corporate Communications & Investor
Relationsleah.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