KalVista Pharmaceuticals Reports Fiscal Third Quarter Results
– Oral Hereditary Angioedema Franchise Phase 2 Clinical Trials on Track –
“Our work to bring multiple best-in-class oral therapies to patients with hereditary angioedema is advancing well,” said
Third Quarter and Recent Business Highlights:
- Announced results of the Phase 2 trial of KVD001, an intravitreal candidate for treatment of diabetic macular edema (DME). KVD001 did not meet its primary endpoint in the overall study population, but it did demonstrate a protection against vision loss and a pre-specified subgroup analysis showed a clinical benefit on vision. The trial was designed to evaluate patients who were poor responders to previous treatment with anti-VEGF therapy. KVD001 was generally safe and well tolerated with no drug-related serious adverse events. Both KVD001 and future oral DME molecules were subject to an option agreement with Merck, which subsequently expired in February.
-
Selected KVD824 for development as an oral prophylactic treatment for hereditary angioedema (HAE). KVD824 is a highly potent and selective plasma kallikrein inhibitor which achieved high exposures and a favorable safety and tolerability profile in a first-in-human study.
KalVista intends to initiate a Phase 2 clinical trial in the second half of 2020.
Fiscal Third Quarter Financial Results:
-
Revenue: Revenue was
$1.6 million for the three months endedJanuary 31, 2020 , compared to$3.9 million for the same period in 2019. Revenue in the three months endedJanuary 31, 2020 consisted of the recognition of a portion of the upfront payment from Merck related to the agreement signed inOctober 2017 . -
R&D Expenses: Research and development expenses were
$11.2 million for the three months endedJanuary 31, 2020 , compared to$7.7 million for the same period in 2019. The increase in R&D expense primarily reflects the ongoing clinical trial for KVD900 and an increase in expense related to preclinical activities in relation to the development of KVD824. -
G&A Expenses: General and administrative expenses were
$3.1 million for the three months endedJanuary 31, 2020 , compared to$2.9 million for the same period in 2019. -
Net Loss: Net loss was
$9.3 million , or$(0.52) per basic and diluted share for the three months endedJanuary 31, 2020 , compared to a net loss of$4.0 million , or$(0.23) per basic and diluted share, for the same period in 2019. -
Cash: Cash, cash equivalents and marketable securities were
$80.6 million as ofJanuary 31, 2020 .
About
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
Condensed Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
(Unaudited) | ||||||||||
2020 |
2019 |
|||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents |
$ |
18,615 |
|
$ |
32,006 |
|
||||
Marketable securities |
|
61,955 |
|
|
68,805 |
|
||||
Research and development tax credit receivable |
|
14,803 |
|
|
11,315 |
|
||||
Prepaid expenses and other current assets |
|
3,632 |
|
|
3,420 |
|
||||
Total current assets |
|
99,005 |
|
|
115,546 |
|
||||
Right of use assets |
|
1,497 |
|
— | ||||||
Property and equipment, net |
|
2,260 |
|
|
2,413 |
|
||||
Other assets |
|
173 |
|
|
173 |
|
||||
Total assets |
$ |
102,935 |
|
$ |
118,132 |
|
||||
Liabilities and Stockholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable |
$ |
2,951 |
|
$ |
2,860 |
|
||||
Accrued expenses |
|
4,876 |
|
|
5,647 |
|
||||
Deferred revenue - current portion |
|
1,343 |
|
|
9,545 |
|
||||
Lease liability - current portion |
|
592 |
|
— | ||||||
Total current liabilities |
|
9,762 |
|
|
18,052 |
|
||||
Long-term liabilities: | ||||||||||
Deferred revenue - net of current portion |
|
2,500 |
|
|
3,342 |
|
||||
Lease liability - net of current portion |
|
926 |
|
— | ||||||
Total long-term liabilities |
|
3,426 |
|
|
3,342 |
|
||||
Stockholders’ equity: | ||||||||||
Common stock, |
|
18 |
|
|
17 |
|
||||
Additional paid-in capital |
|
206,119 |
|
|
191,123 |
|
||||
Accumulated deficit |
|
(115,008 |
) |
|
(92,476 |
) |
||||
Accumulated other comprehensive loss |
|
(1,382 |
) |
|
(1,926 |
) |
||||
Total stockholders’ equity |
|
89,747 |
|
|
96,738 |
|
||||
Total liabilities and stockholders' equity |
$ |
102,935 |
|
$ |
118,132 |
|
||||
Condensed Consolidated Statement of Operations | ||||||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||||||||||||
Revenue |
$ |
1,577 |
|
$ |
3,890 |
|
$ |
8,866 |
|
$ |
13,201 |
|
||||||||
Operating expenses: | ||||||||||||||||||||
Research and development |
|
11,233 |
|
|
7,650 |
|
|
30,709 |
|
|
23,882 |
|
||||||||
General and administrative |
|
3,068 |
|
|
2,900 |
|
|
9,733 |
|
|
7,879 |
|
||||||||
Total operating expenses |
|
14,301 |
|
|
10,550 |
|
|
40,442 |
|
|
31,761 |
|
||||||||
Operating loss |
|
(12,724 |
) |
|
(6,660 |
) |
|
(31,576 |
) |
|
(18,560 |
) |
||||||||
Other income: | ||||||||||||||||||||
Interest income |
|
372 |
|
|
723 |
|
|
1,467 |
|
|
1,016 |
|
||||||||
Foreign currency exchange gain |
|
138 |
|
|
248 |
|
|
245 |
|
|
83 |
|
||||||||
Other income |
|
2,923 |
|
|
1,733 |
|
|
7,332 |
|
|
5,171 |
|
||||||||
Total other income |
|
3,433 |
|
|
2,704 |
|
|
9,044 |
|
|
6,270 |
|
||||||||
Net loss |
$ |
(9,291 |
) |
$ |
(3,956 |
) |
$ |
(22,532 |
) |
$ |
(12,290 |
) |
||||||||
Net loss per share to common stockholders, basic and diluted |
$ |
(0.52 |
) |
$ |
(0.23 |
) |
$ |
(1.27 |
) |
$ |
(0.85 |
) |
||||||||
Weighted average common shares outstanding, basic and diluted |
|
17,838,872 |
|
|
17,231,449 |
|
|
17,717,057 |
|
|
14,379,872 |
|
||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||||
(in thousands, unaudited) | ||||||||||
Nine Months Ended | ||||||||||
2020 |
2019 |
|||||||||
Cash Flows from Operating Activities | ||||||||||
Net loss |
$ |
(22,532 |
) |
$ |
(12,290 |
) |
||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||
Depreciation and amortization |
|
382 |
|
|
256 |
|
||||
Stock-based compensation expense |
|
3,358 |
|
|
2,120 |
|
||||
Realized (gain) from available for sale securities |
|
(229 |
) |
— | ||||||
Amortization of right of use assets |
|
418 |
|
— | ||||||
Amortization of discount/premium on available for sale securities |
|
136 |
|
— | ||||||
Foreign currency exchange gain |
|
(224 |
) |
|
(20 |
) |
||||
Changes in operating assets and liabilities: | ||||||||||
Research and development tax credit receivable |
|
(3,405 |
) |
|
(2,409 |
) |
||||
Prepaid expenses and other current assets |
|
(187 |
) |
|
(2,475 |
) |
||||
Accounts payable |
|
133 |
|
|
1,748 |
|
||||
Accrued expenses |
|
(766 |
) |
|
417 |
|
||||
Lease obligations |
|
(416 |
) |
— | ||||||
Deferred revenue |
|
(8,866 |
) |
|
(13,201 |
) |
||||
Net cash used in operating activities |
|
(32,198 |
) |
|
(25,854 |
) |
||||
Cash Flows from Investing Activities | ||||||||||
Acquisition of property and equipment |
|
(212 |
) |
|
(806 |
) |
||||
Purchases of available for sale securities |
|
(45,114 |
) |
|
(55,419 |
) |
||||
Sales and maturities of available for sale securities |
|
52,052 |
|
|
850 |
|
||||
Net cash provided by (used in) investing activities |
|
6,726 |
|
|
(55,375 |
) |
||||
Cash Flows from Financing Activities | ||||||||||
Capital lease principal payments |
|
(53 |
) |
|
(155 |
) |
||||
Issuance of common stock from equity incentive plans |
|
214 |
|
|
132 |
|
||||
Issuance of common stock, net of offering expenses |
|
11,422 |
|
|
87,811 |
|
||||
Net cash provided by financing activities |
|
11,583 |
|
|
87,788 |
|
||||
Effect of exchange rate changes on cash and cash equivalents |
|
498 |
|
|
(1,269 |
) |
||||
Net (decrease) increase in cash and cash equivalents |
|
(13,391 |
) |
|
5,290 |
|
||||
Cash and cash equivalents at beginning of period |
|
32,006 |
|
|
51,055 |
|
||||
Cash and cash equivalents at end of period |
$ |
18,615 |
|
$ |
56,345 |
|
||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20200310005188/en/
Senior Director,
857-999-0808
leah.monteiro@kalvista.com
Source: