KalVista Pharmaceuticals Reports First Fiscal Quarter Results
– KVD900 On-Demand Data Expected Q4 2020 –
“We are pleased that our KVD900 Phase 2 trial has met its enrollment target and data is expected before the end of this year. We believe KVD900 can bring the first effective and well-tolerated oral on-demand treatment option to patients suffering from hereditary angioedema attacks,” said
First Fiscal Quarter and Recent Business Highlights:
- Met enrollment target for the Phase 2 clinical trial intended to evaluate the safety and efficacy of KVD900 compared to placebo in the treatment of HAE attacks. This trial is expected to provide data in the fourth quarter of 2020.
-
Submitted a Pediatric Investigational Plan (PIP) to the
European Medicines Agency (EMA) for KVD900.
First Fiscal Quarter Financial Results:
-
Revenue: No revenue was recognized for the three months ended
July 31, 2020 , compared to$3.4 million for the same period in the prior fiscal year. The decrease of$3.4 million was due to the expiration of the Merck Option Agreement inFebruary 2020 . No future revenue remains under this agreement. -
R&D Expenses: Research and development expenses were
$11.2 million for the three months endedJuly 31, 2020 , compared to$9.7 million for the same period in the prior fiscal year. The increase in spending during the quarter primarily reflects increased costs related to the ongoing clinical trial for KVD900 as well as increased expenses in relation to the development of KVD824, primarily offset by a decrease in spending on KVD001 which concluded a Phase 2 clinical trial inDecember 2019 , and a decrease in spending on preclinical activities. -
G&A Expenses: General and administrative expenses were
$3.3 million for the three months endedJuly 31, 2020 , compared to$3.2 million for the same period in the prior fiscal year. -
Net Loss: Net loss was
$10.8 million , or$(0.61) per weighted average basic and diluted share, for the three months endedJuly 31, 2020 , compared to net loss of$7.3 million , or$(0.42) per weighted average basic and diluted share, for the same period in the prior fiscal year. The increase in net loss and net loss per share in the three months endedJuly 31, 2020 as compared to the same period in the prior fiscal year primarily due to the decrease in revenue and increase in research and development expenses in the three months endedJuly 31, 2020 . -
Cash: Cash, cash equivalents and marketable securities were
$64.3 million as ofJuly 31, 2020 , compared to$67.7 million as ofApril 30, 2020 . The decrease in net cash position was due to increased spending, primarily on research and development activities.
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 |
|
|
2020 |
|
|||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents |
$ |
18,014 |
|
$ |
15,789 |
|
||
| Marketable securities |
|
46,317 |
|
|
51,925 |
|
||
| Research and development tax credit receivable |
|
12,638 |
|
|
16,527 |
|
||
| Prepaid expenses and other current assets |
|
3,256 |
|
|
4,455 |
|
||
| Total current assets |
|
80,225 |
|
|
88,696 |
|
||
| Property and equipment, net |
|
2,019 |
|
|
2,043 |
|
||
| Right of use assets |
|
1,480 |
|
|
1,612 |
|
||
| Other assets |
|
178 |
|
|
178 |
|
||
| Total assets |
$ |
83,902 |
|
$ |
92,529 |
|
||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable |
$ |
1,774 |
|
$ |
1,677 |
|
||
| Accrued expenses |
|
6,170 |
|
|
5,455 |
|
||
| Lease liability - current portion |
|
513 |
|
|
588 |
|
||
| Total current liabilities |
|
8,457 |
|
|
7,720 |
|
||
| Long-term liabilities: | ||||||||
| Lease liability - net of current portion |
|
1,010 |
|
|
1,057 |
|
||
| Total long-term liabilities |
|
1,010 |
|
|
1,057 |
|
||
| Stockholders’ equity: | ||||||||
| Common stock, |
|
18 |
|
|
18 |
|
||
| Additional paid-in capital |
|
208,442 |
|
|
207,208 |
|
||
| Accumulated deficit |
|
(132,406 |
) |
|
(121,592 |
) |
||
| Accumulated other comprehensive loss |
|
(1,619 |
) |
|
(1,882 |
) |
||
| Total stockholders’ equity |
|
74,435 |
|
|
83,752 |
|
||
| Total liabilities and stockholders' equity |
$ |
83,902 |
|
$ |
92,529 |
|
||
| Condensed Consolidated Statement of Operations | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended | ||||||||
|
|
2020 |
|
|
2019 |
|
|||
| Revenue |
$ |
— |
|
$ |
3,369 |
|
||
| Operating expenses: | ||||||||
| Research and development |
|
11,165 |
|
|
9,686 |
|
||
| General and administrative |
|
3,278 |
|
|
3,247 |
|
||
| Total operating expenses |
|
14,443 |
|
|
12,933 |
|
||
| Operating loss |
|
(14,443 |
) |
|
(9,564 |
) |
||
| Other income: | ||||||||
| Interest income |
|
259 |
|
|
590 |
|
||
| Foreign currency exchange rate gain (loss) |
|
438 |
|
|
(453 |
) |
||
| Other income |
|
2,932 |
|
|
2,089 |
|
||
| Total other income |
|
3,629 |
|
|
2,226 |
|
||
| Net loss |
$ |
(10,814 |
) |
$ |
(7,338 |
) |
||
| Net loss per share, basic and diluted |
$ |
(0.61 |
) |
$ |
(0.42 |
) |
||
| Weighted average common shares outstanding, basic and diluted |
|
17,848,583 |
|
|
17,488,997 |
|
||
| Condensed Consolidated Statements of Cash Flows | ||||||||
| (in thousands, unaudited) | ||||||||
| Three Months Ended | ||||||||
|
|
2020 |
|
|
2019 |
|
|||
| Cash flows from operating activities | ||||||||
| Net loss |
$ |
(10,814 |
) |
$ |
(7,338 |
) |
||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization |
|
128 |
|
|
121 |
|
||
| Stock-based compensation expense |
|
1,188 |
|
|
1,074 |
|
||
| Realized gain from sale of marketable securities |
|
(70 |
) |
|
(29 |
) |
||
| Non-cash operating lease expense |
|
8 |
|
|
1 |
|
||
| Amortization of premium on marketable securities |
|
68 |
|
|
35 |
|
||
| Foreign currency exchange (gain) loss |
|
(432 |
) |
|
454 |
|
||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable |
|
4,462 |
|
|
(2,060 |
) |
||
| Prepaid expenses and other current assets |
|
1,301 |
|
|
561 |
|
||
| Accounts payable |
|
35 |
|
|
392 |
|
||
| Accrued expenses |
|
538 |
|
|
(1,117 |
) |
||
| Deferred revenue |
|
— |
|
|
(3,369 |
) |
||
| Net cash used in operating activities |
|
(3,588 |
) |
|
(11,275 |
) |
||
| Cash flows from investing activities | ||||||||
| Purchases of marketable securities |
|
(9,807 |
) |
|
(19,646 |
) |
||
| Sales and maturities of marketable securities |
|
15,342 |
|
|
18,214 |
|
||
| Acquisition of property and equipment |
|
(22 |
) |
|
(98 |
) |
||
| Net cash provided by (used in) investing activities |
|
5,513 |
|
|
(1,530 |
) |
||
| Cash flows from financing activities | ||||||||
| Issuance of common stock, net of offering expenses |
|
— |
|
|
11,422 |
|
||
| Issuance of common stock from equity incentive plans |
|
46 |
|
|
32 |
|
||
| Finance lease principal payments |
|
— |
|
|
(54 |
) |
||
| Net cash provided by financing activities |
|
46 |
|
|
11,400 |
|
||
| Effect of exchange rate changes on cash and cash equivalents |
|
254 |
|
|
(494 |
) |
||
| Net increase (decrease) in cash and cash equivalents |
|
2,225 |
|
|
(1,899 |
) |
||
| Cash and cash equivalents at beginning of period |
|
15,789 |
|
|
32,006 |
|
||
| Cash and cash equivalents at end of period |
$ |
18,014 |
|
$ |
30,107 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005221/en/
Senior Director,
857-999-0808
leah.monteiro@kalvista.com
Source:
