KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
– FDA End-of-Phase 2 Meeting on KVD900 Oral HAE Phase 3 Program Scheduled for Late Q3 2021 –
– FDA Response Submission for KVD824 Phase 2 Clinical Hold Expected Q3 2021 –
“This past fiscal year we made great strides in providing data to support the development of the candidates in our oral hereditary angioedema franchise,” said
Fiscal 2021 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 hereditary angioedema (HAE) attacks. An end-of-Phase 2 meeting has been scheduled late in the third quarter of calendar year 2021 with the
Food and Drug Administration (FDA) to review the planned KVD900 Phase 3 program. -
Provided data on KVD824 as a twice-daily oral candidate for prophylactic treatment of HAE. Work to optimize the exposure profile of KVD824 yielded a formulation that maintained the plasma concentrations that
KalVista believes are required to compete with approved injectable therapies, while showing an encouraging safety and tolerability profile in up to 14 days of dosing. - Announced a novel oral Factor XIIa inhibitor program as the next area of focus. KalVista’s internal research team has discovered multiple series of oral Factor XIIa inhibitors, initially being advanced with the potential to provide the next generation of HAE therapeutics. Investigational New Drug (IND)-enabling studies for oral Factor XIIa inhibitor candidates are expected to commence in calendar year 2021.
-
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 . -
Appointed
Nancy Stuart to the Board of Directors of the Company. -
Submitted an IND for a Phase 2 clinical trial to evaluate KVD824 as a potential prophylactic treatment for the prevention of HAE attacks. The
U.S. FDA notified the Company in a letter that it has placed a clinical hold on the proposed Phase 2 clinical trial of KVD824. The FDA letter requested further information and analysis related to certain preclinical studies of KVD824 submitted to support the planned Phase 2 trial, as well as refinements to the intended KVD824 Phase 2 study protocol. The Company intends to submit its response to the FDA during the third quarter of calendar year 2021.KalVista also continues to progress regulatory filings for other countries where it plans to initiate sites for the KVD824 Phase 2. -
Expanded senior leadership team with appointment of
Paul K. Audhya , MD, MBA as Chief Medical Officer. -
Presented data from oral HAE franchise at the
C1-Inhibitor Deficiency & Angioedema Workshop .
Fourth Quarter and Full Year Financial Results:
-
Revenue: No revenue was recognized for the three months ended
April 30, 2021 , compared to$3.8 million for the same period in the prior fiscal year. No revenue was recognized for the fiscal year endedApril 30, 2021 , compared to$12.7 million for the prior fiscal year. All of the revenue recognized in the prior fiscal year was attributable to the revenue recognized from the Merck Option Agreement and the absence of revenue in the current year was due to the expiration of that agreement inFebruary 2020 . -
R&D Expenses: Research and development expenses were
$11.9 million for the three months endedApril 30, 2021 , compared to$9.5 million for the same period in the prior fiscal year. Research and development expenses were$41.3 million for the fiscal year endedApril 30, 2021 , compared to$40.2 million for the prior fiscal year. The increase in spending in the fiscal year endedApril 30, 2021 primarily reflects increased costs related to the ongoing clinical trials for KVD900 and KVD824, offset by a decrease in spending on KVD001 due to the conclusion of the Phase 2 clinical trial inDecember 2019 and a decrease in preclinical spending. -
G&A Expenses: General and administrative expenses were
$6.2 million for the three months endedApril 30, 2021 , compared to$3.3 million for the same period in the prior fiscal year. General and administrative expenses were$16.6 million for the fiscal year endedApril 30, 2021 , compared to$13.0 million for the prior fiscal year. The increase in G&A expenses was primarily due to an increase in compensation related expenses and to a lesser extent, increases in professional fees, insurance costs, facility costs and other administrative costs. -
Net Loss: Net loss was
$15.0 million , or$(0.65) per weighted average basic and diluted share, for the three months endedApril 30, 2021 , compared to net loss of$6.6 million , or$(0.37) per weighted average basic and diluted share for the same period in the prior fiscal year. Net loss was$46.2 million , or$(2.42) per weighted average basic and diluted share for the fiscal year endedApril 30, 2021 , compared to net loss of$29.1 million , or$(1.64) per weighted average basic and diluted share in the prior fiscal year. The increase in net loss and net loss per share primarily resulted from the absence of revenue in the current fiscal year due to the expiration of the Merck Option Agreement inFebruary 2020 , as well as increased spending on research and development activities in the current fiscal year. -
Cash Position: Cash, cash equivalents and marketable securities were
$248.9 million as ofApril 30, 2021 , compared to$67.7 million as ofApril 30, 2020 . The increase in the net cash position in the current fiscal year is primarily due to the proceeds received in theFebruary 2021 public offering of common stock.
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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 |
$ |
50,592 |
|
$ |
15,789 |
|
||
Marketable securities |
|
198,337 |
|
|
51,925 |
|
||
Research and development tax credit receivable |
|
10,418 |
|
|
16,527 |
|
||
Prepaid expenses and other current assets |
|
4,917 |
|
|
4,455 |
|
||
Total current assets |
|
264,264 |
|
|
88,696 |
|
||
Property and equipment, net |
|
1,791 |
|
|
2,043 |
|
||
Right of use assets |
|
5,758 |
|
|
1,612 |
|
||
Other assets |
|
200 |
|
|
178 |
|
||
Total assets |
$ |
272,013 |
|
$ |
92,529 |
|
||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable |
$ |
1,981 |
|
$ |
1,677 |
|
||
Accrued expenses |
|
6,930 |
|
|
5,455 |
|
||
Lease liability - current portion |
|
863 |
|
|
588 |
|
||
Total current liabilities |
|
9,774 |
|
|
7,720 |
|
||
Long-term liabilities: | ||||||||
Lease liability - net of current portion |
|
5,046 |
|
|
1,057 |
|
||
Total long-term liabilities |
|
5,046 |
|
|
1,057 |
|
||
Stockholders’ equity: | ||||||||
Common stock, |
|
24 |
|
|
18 |
|
||
Additional paid-in capital |
|
426,437 |
|
|
207,208 |
|
||
Accumulated deficit |
|
(167,836 |
) |
|
(121,592 |
) |
||
Accumulated other comprehensive loss |
|
(1,432 |
) |
|
(1,882 |
) |
||
Total stockholders’ equity |
|
257,193 |
|
|
83,752 |
|
||
Total liabilities and stockholders' equity |
$ |
272,013 |
|
$ |
92,529 |
|
Condensed Consolidated Statement of Operations | ||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended |
|
Years Ended |
||||||||||||||
|
|
|
||||||||||||||
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||||
Revenue |
$ |
- |
|
$ |
3,824 |
|
$ |
- |
|
$ |
12,690 |
|
||||
Operating expenses: | ||||||||||||||||
Research and development |
|
11,877 |
|
|
9,485 |
|
|
41,286 |
|
|
40,194 |
|
||||
General and administrative |
|
6,165 |
|
|
3,296 |
|
|
16,637 |
|
|
13,029 |
|
||||
Total operating expenses |
|
18,042 |
|
|
12,781 |
|
|
57,923 |
|
|
53,223 |
|
||||
Operating loss |
|
(18,042 |
) |
|
(8,957 |
) |
|
(57,923 |
) |
|
(40,533 |
) |
||||
Other income: | ||||||||||||||||
Interest income |
|
314 |
|
|
363 |
|
|
903 |
|
|
1,830 |
|
||||
Foreign currency exchange rate gain (loss) |
|
132 |
|
|
(613 |
) |
|
847 |
|
|
(367 |
) |
||||
Other income |
|
2,639 |
|
|
2,498 |
|
|
9,929 |
|
|
9,830 |
|
||||
Total other income |
|
3,085 |
|
|
2,248 |
|
|
11,679 |
|
|
11,293 |
|
||||
Loss before income taxes |
|
(14,957 |
) |
|
(6,709 |
) |
|
(46,244 |
) |
|
(29,240 |
) |
||||
Income tax (benefit) expense |
|
- |
|
|
(124 |
) |
|
- |
|
|
(124 |
) |
||||
Net loss |
$ |
(14,957 |
) |
$ |
(6,585 |
) |
$ |
(46,244 |
) |
$ |
(29,116 |
) |
||||
Net loss per share, basic and diluted |
$ |
(0.65 |
) |
$ |
(0.37 |
) |
$ |
(2.42 |
) |
$ |
(1.64 |
) |
||||
Weighted average common shares outstanding, basic and diluted |
|
23,118,127 |
|
|
17,845,599 |
|
|
19,094,440 |
|
|
17,748,666 |
|
Condensed Consolidated Statements of Cash Flows | ||||||||
(in thousands, unaudited) | ||||||||
Years Ended |
||||||||
|
||||||||
2021 |
|
2020 |
||||||
Cash flows from operating activities | ||||||||
Net loss |
$ |
(46,244 |
) |
$ |
(29,116 |
) |
||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization |
|
537 |
|
|
512 |
|
||
Stock-based compensation expense |
|
7,118 |
|
|
4,448 |
|
||
Realized (gain) from sale of marketable securities |
|
(153 |
) |
|
(300 |
) |
||
Non-cash operating lease expense |
|
114 |
|
|
13 |
|
||
Amortization of premium on available for sale securities |
|
685 |
|
|
193 |
|
||
Foreign currency exchange (gain) loss |
|
(574 |
) |
|
74 |
|
||
Changes in operating assets and liabilities: | ||||||||
Research and development tax credit receivable |
|
7,457 |
|
|
(5,781 |
) |
||
Prepaid expenses and other current assets |
|
(222 |
) |
|
(1,112 |
) |
||
Other assets |
|
(22 |
) |
|
(5 |
) |
||
Accounts payable |
|
150 |
|
|
(1,004 |
) |
||
Accrued expenses |
|
983 |
|
|
(48 |
) |
||
Deferred revenue |
|
- |
|
|
(12,690 |
) |
||
Net cash used in operating activities |
|
(30,171 |
) |
|
(44,816 |
) |
||
Cash flows from investing activities | ||||||||
Purchases of available for sale securities |
|
(201,210 |
) |
|
(49,797 |
) |
||
Sales and maturities of available for sale securities |
|
53,638 |
|
|
66,770 |
|
||
Acquisition of property and equipment |
|
(82 |
) |
|
(220 |
) |
||
Net cash provided by (used in) investing activities |
|
(147,654 |
) |
|
16,753 |
|
||
Cash flows from financing activities | ||||||||
Issuance of common stock, net of offering expenses |
|
210,582 |
|
|
11,422 |
|
||
Issuance of common stock from equity incentive plans |
|
1,535 |
|
|
216 |
|
||
Finance lease principal payments |
|
- |
|
|
(54 |
) |
||
Net cash provided by financing activities |
|
212,117 |
|
|
11,584 |
|
||
Effect of exchange rate changes on cash and cash equivalents |
|
511 |
|
|
262 |
|
||
Net increase (decrease) in cash and cash equivalents |
|
34,803 |
|
|
(16,217 |
) |
||
Cash and cash equivalents, beginning of year |
|
15,789 |
|
|
32,006 |
|
||
Cash and cash equivalents, end of year |
$ |
50,592 |
|
$ |
15,789 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210713005347/en/
Senior Director,
857-999-0808
leah.monteiro@kalvista.com
Source: