KalVista Pharmaceuticals Reports Third Fiscal Quarter Results
- Enrollment in sebetralstat KONFIDENT phase 3 trial passes 50% milestone; data remains H2 2023–
- Sebetralstat phase 2 data published in
- Company funded into 2025 –
“We have made significant advances at
Third Fiscal Quarter and Recent Business Highlights:
-
Reported new data in five posters at the 2023
American Academy of Allergy , Asthma & Immunology (AAAAI) Annual Meeting. The data showed the impact of HAE attacks on anxiety and quality of life in people living with HAE, that sebetralstat significantly decreased cumulative attack and symptom severity while increasing cumulative symptom relief of HAE attacks relative to placebo over a 24-hour period following administration, and that phase 1 data for an orally disintegrating tablet formulation supported further clinical development of that formulation. -
Provided multiple progress updates on sebetralstat development, including the announcement that
KalVista has enrolled more than 50% of the targeted number of patients in the pivotal phase 3 KONFIDENT clinical trial. In addition, the Company received FDA regulatory guidance that efficacy trials are not required to support a supplemental NDA (sNDA) filing for the orally disintegrating tablet (ODT) formulation of sebetralstat.KalVista also received guidance from the Japanese regulatory authority (PMDA) on the clinical development pathway to a regulatory submission in that country. -
Published a manuscript in
The Lancet focused on the phase 2 clinical trial results for sebetralstat. -
Presented data at
Western Society of Allergy , Asthma & Immunology (WSAAI) 60th Annual Scientific Session examining the use of sebetralstat as a possible treatment for short-term prophylaxis (STP) as part of the KONFIDENT-S open-label extension clinical trial. Other data assessed the pharmacokinetic and pharmacodynamic parameters of sebetralstat in Japanese adults supporting the expansion of the KONFIDENT phase 3 trial toJapan and delineated a post hoc analysis of phase 2 trial data demonstrating that sebetralstat provided similar symptom relief, reduction in attack severity, and use of rescue regardless of abdominal or peripheral attack location. -
Promoted Chief Financial/Business Officer
Benjamin L. Palleiko to President ofKalVista and tasked him with the development of the Company’s commercial and business organization. -
Announced
$58 million of new funding via a registered direct offering.KalVista intends to use the proceeds of this$58 million offering to fund clinical trials, commercial sales development, research, working capital, capital expenditures and other general corporate purposes. With the financing, the Company now expects to be able to fund operations into 2025.
Third Fiscal Quarter Financial Results:
Revenue: No revenue was recognized for the three months ended
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Cash Position: Cash, cash equivalents and marketable securities were
About
For more information about
For more information on the sebetralstat HAE on-demand Phase 3 KONFIDENT study, please visit www.konfidentstudy.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) | ||||||||
|
|
|
||||||
2023 |
|
2022 |
||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents |
$ |
85,049 |
$ |
30,732 |
||||
Marketable securities |
|
86,636 |
|
135,470 |
||||
Research and development tax credit receivable |
|
11,892 |
|
14,098 |
||||
Prepaid expenses and other current assets |
|
8,556 |
|
13,347 |
||||
Total current assets |
|
192,133 |
|
193,647 |
||||
Property and equipment, net |
|
3,037 |
|
2,178 |
||||
Right of use assets |
|
8,101 |
|
7,862 |
||||
Other assets |
|
197 |
|
193 |
||||
Total assets |
$ |
203,468 |
$ |
203,880 |
||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable |
$ |
1,698 |
$ |
3,638 |
||||
Accrued expenses |
|
8,851 |
|
6,961 |
||||
Lease liability - current portion |
|
1,057 |
|
977 |
||||
Total current liabilities |
|
11,606 |
|
11,576 |
||||
Long-term liabilities: | ||||||||
Lease liability - net of current portion |
|
7,421 |
|
7,211 |
||||
Total long-term liabilities |
|
7,421 |
|
7,211 |
||||
Stockholders’ equity: | ||||||||
Common stock, |
|
34 |
|
25 |
||||
Additional paid-in capital |
|
504,725 |
|
439,104 |
||||
Accumulated deficit |
|
(316,777) |
|
(250,175) |
||||
Accumulated other comprehensive loss |
|
(3,541) |
|
(3,861) |
||||
Total stockholders’ equity |
|
184,441 |
|
185,093 |
||||
Total liabilities and stockholders' equity |
$ |
203,468 |
$ |
203,880 |
||||
Condensed Consolidated Statement of Operations | ||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended |
|
Nine Months Ended |
||||||||||||||
|
|
|
||||||||||||||
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||||
Revenue |
$ |
— |
$ |
— |
$ |
— |
$ |
— |
||||||||
Operating expenses: | ||||||||||||||||
Research and development |
|
20,063 |
|
19,738 |
|
56,325 |
|
50,954 |
||||||||
General and administrative |
|
6,882 |
|
6,945 |
|
22,818 |
|
18,848 |
||||||||
Total operating expenses |
|
26,945 |
|
26,683 |
|
79,143 |
|
69,802 |
||||||||
Operating loss |
|
(26,945) |
|
(26,683) |
|
(79,143) |
|
(69,802) |
||||||||
Other income: | ||||||||||||||||
Interest income |
|
732 |
|
258 |
|
1,424 |
|
822 |
||||||||
Foreign currency exchange rate (loss) gain |
|
597 |
|
(198) |
|
(237) |
|
(529) |
||||||||
Other income |
|
4,313 |
|
4,156 |
|
11,354 |
|
11,283 |
||||||||
Total other income |
|
5,642 |
|
4,216 |
|
12,541 |
|
11,576 |
||||||||
Net loss |
$ |
(21,303) |
$ |
(22,467) |
$ |
(66,602) |
$ |
(58,226) |
||||||||
Net loss per share, basic and diluted |
$ |
(0.75) |
$ |
(0.92) |
$ |
(2.58) |
$ |
(2.38) |
||||||||
Weighted average common shares outstanding, basic and diluted |
|
28,278,453 |
|
24,479,660 |
|
25,810,369 |
|
24,449,788 |
||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||
(in thousands, unaudited) | ||||||||
Nine Months Ended |
||||||||
|
||||||||
2023 |
|
2022 |
||||||
Cash flows from operating activities | ||||||||
Net loss |
$ |
(66,602) |
$ |
(58,226) |
||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization |
|
530 |
|
408 |
||||
Stock-based compensation expense |
|
7,481 |
|
8,432 |
||||
Realized loss (gain) from sale of marketable securities |
|
84 |
|
296 |
||||
Non-cash operating lease expense |
|
52 |
|
153 |
||||
Amortization of premium on marketable securities |
|
890 |
|
2,081 |
||||
Foreign currency exchange loss (gain) |
|
(1,339) |
|
698 |
||||
Changes in operating assets and liabilities: | ||||||||
Research and development tax credit receivable |
|
2,049 |
|
(1,477) |
||||
Prepaid expenses and other current assets |
|
4,440 |
|
(3,659) |
||||
Accounts payable |
|
(1,911) |
|
228 |
||||
Accrued expenses |
|
1,701 |
|
(279) |
||||
Net cash used in operating activities |
|
(52,625) |
|
(51,345) |
||||
Cash flows from investing activities | ||||||||
Purchases of marketable securities |
|
(63,757) |
|
(84,415) |
||||
Sales and maturities of marketable securities |
|
112,509 |
|
130,686 |
||||
Acquisition of property and equipment |
|
(1,127) |
|
(845) |
||||
Net cash provided by investing activities |
|
47,625 |
|
45,426 |
||||
Cash flows from financing activities | ||||||||
Issuance of common stock from equity incentive plans |
|
482 |
|
1,443 |
||||
Issuance of common stock, net of offering expenses of |
|
56,582 |
|
- |
||||
Issuance of pre-funded warrants, net of offering expenses |
|
1,085 |
|
- |
||||
Net cash provided by financing activities |
|
58,149 |
|
1,443 |
||||
Effect of exchange rate changes on cash and cash equivalents |
|
1,168 |
|
(539) |
||||
Net (decrease) increase in cash and cash equivalents |
|
54,317 |
|
(5,015) |
||||
Cash and cash equivalents at beginning of period |
|
30,732 |
|
50,592 |
||||
Cash and cash equivalents at end of period |
$ |
85,049 |
$ |
45,577 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230309005246/en/
Vice President, Corporate Communications
(201) 705-0254
jarrod.aldom@kalvista.com
Source: