KalVista Pharmaceuticals Reports Third Fiscal Quarter Results
– Recent KVD900 Phase 2 Clinical Trial Results Statistically and Clinically Significant –
– IND Submitted for Oral Prophylactic HAE Treatment Candidate KVD824; Phase 2 Expected to Initiate in Q2 2021 –
– Following Upsized Public Offering, Funded to KVD900 NDA Filing –
“We are making excellent progress in our commitment to providing those with hereditary angioedema a complete set of oral options to manage their disease. The data announced last month for KVD900 as an oral on-demand therapy were overwhelmingly positive and show that patients don’t have to compromise on efficacy or rely on injectables. We view this data as validation of our work in oral plasma kallikrein inhibition, which also includes KVD824 as a development candidate for an oral prophylactic treatment for HAE,” said
Third Fiscal Quarter and Recent Business Highlights:
- Reported positive results for KVD900 in a Phase 2 clinical trial demonstrating statistically and clinically significant responses across primary and secondary endpoints as an oral on-demand treatment for HAE attacks. The trial met its primary endpoint comparing the time to use of conventional attack treatment within 12 hours on KVD900 versus placebo (p=0.0010) with rates of use at 12 hours of 15.1% following treatment with KVD900 versus 30.2% after placebo. The trial also met all secondary endpoints: reduced worsening of attacks (p<0.0001; PGI-S or use of rescue) and reduced time to onset of symptom relief measured using both patient’s global impression of change (PGI-C) (p<0.0001) and visual analogue scale (VAS) (p<0.0001). The trial included 126 administrations of KVD900 and 55 of placebo. During the uncontrolled, open label phase, 5 of 68 patients dosed reported 8 adverse events suspected to be related to treatment. During the randomized, placebo-controlled phase, 5 patients reported adverse events suspected to be treatment-related (3 of 58 dosed with KVD900 and 2 of 55 dosed with placebo).
-
Closed an upsized public offering of common stock and full exercise of the underwriters’ options to purchase additional shares. The gross proceeds, before deducting the underwriting discounts and commissions and other offering expenses were approximately
$222.5 million based on 6,181,250 shares at a price to the public of$36.00 per share.
Third Fiscal Quarter Financial Results:
-
Revenue: No revenue was recognized for the three months ended
January 31, 2021 , compared to$1.6 million for the same period in the prior fiscal year. The decrease of$1.6 million was due to the expiration of the Merck Option Agreement inFebruary 2020 . No future revenue remains to be recognized under this agreement. -
R&D Expenses: Research and development expenses were
$9.1 million for the three months endedJanuary 31, 2021 , compared to$11.2 million for the same period in the prior fiscal year. The decrease in expenses during the quarter primarily reflect a decrease in spending on KVD001, which concluded a Phase 2 clinical trial inDecember 2019 , a decrease in spending on KVD900, and a decrease in spending on preclinical activities. These decreases were somewhat offset by increased spending related to the development of KVD824. -
G&A Expenses: General and administrative expenses were
$3.6 million for the three months endedJanuary 31, 2021 , compared to$3.1 million for the same period in the prior fiscal year. The$0.5 million increase in expenses primarily reflects an increase in employee related and commercial development expenses. -
Net Loss: Net loss was
$10.1 million , or$(0.56) per weighted average basic and diluted share, for the three months endedJanuary 31, 2021 , compared to net loss of$9.3 million , or$(0.52) 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 endedJanuary 31, 2021 compared to the same period in the prior fiscal year was primarily due to decreases in revenue and other income in the three months endedJanuary 31, 2021 , somewhat offset by the decrease in research and development expenses. -
Cash: Cash, cash equivalents and marketable securities were
$50.3 million as ofJanuary 31, 2021 , 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.
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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) |
||||||||
|
|
|||||||
2021 |
2020 |
|||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents |
$ |
17,727 |
|
$ |
15,789 |
|
||
Marketable securities |
|
32,584 |
|
|
51,925 |
|
||
Research and development tax credit receivable |
|
7,589 |
|
|
16,527 |
|
||
Prepaid expenses and other current assets |
|
4,604 |
|
|
4,455 |
|
||
Total current assets |
|
62,504 |
|
|
88,696 |
|
||
Property and equipment, net |
|
1,868 |
|
|
2,043 |
|
||
Right of use assets |
|
1,653 |
|
|
1,612 |
|
||
Other assets |
|
181 |
|
|
178 |
|
||
Total assets |
$ |
66,206 |
|
$ |
92,529 |
|
||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable |
$ |
641 |
|
$ |
1,677 |
|
||
Accrued expenses |
|
5,285 |
|
|
5,455 |
|
||
Lease liability - current portion |
|
592 |
|
|
588 |
|
||
Total current liabilities |
|
6,518 |
|
|
7,720 |
|
||
Long-term liabilities: | ||||||||
Lease liability - net of current portion |
|
1,123 |
|
|
1,057 |
|
||
Total long-term liabilities |
|
1,123 |
|
|
1,057 |
|
||
Stockholders’ equity: | ||||||||
Common stock, |
|
18 |
|
|
18 |
|
||
Additional paid-in capital |
|
212,694 |
|
|
207,208 |
|
||
Accumulated deficit |
|
(152,880 |
) |
|
(121,592 |
) |
||
Accumulated other comprehensive loss |
|
(1,267 |
) |
|
(1,882 |
) |
||
Total stockholders’ equity |
|
58,565 |
|
|
83,752 |
|
||
Total liabilities and stockholders' equity |
$ |
66,206 |
|
$ |
92,529 |
|
||
|
||||||||||||||||
Condensed Consolidated Statement of Operations |
||||||||||||||||
(in thousands, except share and per share amounts) |
||||||||||||||||
(Unaudited) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
|
|
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
Revenue |
$ |
— |
|
$ |
1,577 |
|
$ |
— |
|
$ |
8,866 |
|
||||
Operating expenses: | ||||||||||||||||
Research and development |
|
9,097 |
|
|
11,233 |
|
|
29,409 |
|
|
30,709 |
|
||||
General and administrative |
|
3,560 |
|
|
3,068 |
|
|
10,472 |
|
|
9,733 |
|
||||
Total operating expenses |
|
12,657 |
|
|
14,301 |
|
|
39,881 |
|
|
40,442 |
|
||||
Operating loss |
|
(12,657 |
) |
|
(12,724 |
) |
|
(39,881 |
) |
|
(31,576 |
) |
||||
Other income: | ||||||||||||||||
Interest income |
|
137 |
|
|
372 |
|
|
589 |
|
|
1,467 |
|
||||
Foreign currency exchange rate gain (loss) |
|
301 |
|
|
138 |
|
|
715 |
|
|
245 |
|
||||
Other income |
|
2,171 |
|
|
2,923 |
|
|
7,289 |
|
|
7,332 |
|
||||
Total other income |
|
2,609 |
|
|
3,433 |
|
|
8,593 |
|
|
9,044 |
|
||||
Net loss |
$ |
(10,048 |
) |
$ |
(9,291 |
) |
$ |
(31,288 |
) |
$ |
(22,532 |
) |
||||
Net loss per share, basic and diluted |
$ |
(0.56 |
) |
$ |
(0.52 |
) |
$ |
(1.75 |
) |
$ |
(1.27 |
) |
||||
Weighted average common shares outstanding, basic and diluted |
|
17,961,802 |
|
|
17,838,872 |
|
|
17,905,926 |
|
|
17,717,057 |
|
|
||||||||
Condensed Consolidated Statements of Cash Flows |
||||||||
(in thousands, unaudited) |
||||||||
Nine Months Ended |
||||||||
|
||||||||
2021 |
2020 |
|||||||
Cash flows from operating activities | ||||||||
Net loss |
$ |
(31,288 |
) |
$ |
(22,532 |
) |
||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization |
|
397 |
|
|
382 |
|
||
Stock-based compensation expense |
|
3,677 |
|
|
3,358 |
|
||
Realized gain from sale of marketable securities |
|
(192 |
) |
|
(229 |
) |
||
Non-cash operating lease expense |
|
25 |
|
|
2 |
|
||
Amortization of premium on marketable securities |
|
247 |
|
|
136 |
|
||
Foreign currency exchange (gain) loss |
|
(441 |
) |
|
(224 |
) |
||
Changes in operating assets and liabilities: | ||||||||
Research and development tax credit receivable |
|
10,135 |
|
|
(3,405 |
) |
||
Prepaid expenses and other current assets |
|
35 |
|
|
(187 |
) |
||
Accounts payable |
|
(1,182 |
) |
|
133 |
|
||
Accrued expenses |
|
(539 |
) |
|
(766 |
) |
||
Deferred revenue |
|
— |
|
|
(8,866 |
) |
||
Net cash used in operating activities |
|
(19,126 |
) |
|
(32,198 |
) |
||
Cash flows from investing activities | ||||||||
Purchases of marketable securities |
|
(26,814 |
) |
|
(45,114 |
) |
||
Sales and maturities of marketable securities |
|
45,692 |
|
|
52,052 |
|
||
Acquisition of property and equipment |
|
(49 |
) |
|
(212 |
) |
||
Net cash provided by (used in) investing activities |
|
18,829 |
|
|
6,726 |
|
||
Cash flows from financing activities | ||||||||
Issuance of common stock, net of offering expenses |
|
1,648 |
|
|
11,422 |
|
||
Issuance of common stock from equity incentive plans |
|
161 |
|
|
214 |
|
||
Finance lease principal payments |
|
— |
|
|
(53 |
) |
||
Net cash provided by financing activities |
|
1,809 |
|
|
11,583 |
|
||
Effect of exchange rate changes on cash and cash equivalents |
|
426 |
|
|
498 |
|
||
Net increase (decrease) in cash and cash equivalents |
|
1,938 |
|
|
(13,391 |
) |
||
Cash and cash equivalents at beginning of period |
|
15,789 |
|
|
32,006 |
|
||
Cash and cash equivalents at end of period |
$ |
17,727 |
|
$ |
18,615 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210311005223/en/
Senior Director,
857-999-0808
leah.monteiro@kalvista.com
Source: