KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
– Sebetralstat Phase 3 KONFIDENT Clinical Trial Achieves Target Enrollment; Data Readout Expected in Q4 –
– Company Funded Into 2025 With NDA Planned for H1 2024 –
“We have made a great deal of progress over the last fiscal year in the development of sebetralstat,” said
Fiscal 2023 and Recent Business Highlights:
Sebetralstat
-
In
June 2023 , the Company achieved its enrollment target of 114 patients in the phase 3 KONFIDENT trial.KalVista expects data from the event-driven trial in the fourth quarter of 2023 and, if successful, anticipates submitting an NDA to the FDA in the first half of 2024. -
Presented real-world patient data at the 13th
C1-inhibitor Deficiency & Angioedema Workshop and the 2023 Meeting of theEuropean Academy of Allergy and Clinical Immunology (EAACI) showing the persistent burden in patients receiving modern long-term prophylaxis, and the challenges associated with on-demand treatment decision-making during HAE attacks. - Received guidance from the Japanese regulatory authority (PMDA) on the clinical development pathway to a regulatory submission in that country. KONFIDENT is the first pivotal phase 3 global trial in HAE to include Japanese sites and patients.
-
Published sebetralstat phase 2 data evaluating the efficacy and safety of oral sebetralstat for the on-demand treatment of hereditary angioedema (HAE) attacks in
The Lancet . -
Reported positive phase 1 data for an oral disintegrating tablet (ODT) formulation of sebetralstat.
KalVista also received FDA feedback on its proposed ODT development program to support a supplemental NDA, which did not include a requirement to conduct efficacy trials. - Initiated KONFIDENT-S, a two-year open-label extension trial assessing the long-term safety and tolerability profile of sebetralstat. The study will also examine the potential use of sebetralstat as a treatment for short-term prophylaxis in medical and dental procedures.
Oral Factor XIIa Inhibitor Program
-
Reported promising preclinical data for the Company’s oral factor XIIa inhibitor program at the 2023
Congress ofThe International Society on Thrombosis and Haemostasis (ISTH). Data showed that KalVista’s potent and selective FXIIa inhibitor with high oral availability inhibited thrombosis in mice, the first oral FXIIa inhibitor shown to protect against thrombosis.
Organizational
-
Promoted
Benjamin L. Palleiko to the role of President ofKalVista . In addition to his other duties,Mr. Palleiko will now be responsible for leading broadly the Company’s future business growth, including development of the commercial organization for the intended worldwide launch of sebetralstat. -
Raised
$58 million in a registered direct offering, with the intent to use those proceeds to fund clinical trials, commercial sales development, research, working capital, capital expenditures and other general corporate purposes. With the financing,KalVista now expects to be able to fund operations into 2025. -
Appointed
Brian J.G. Pereira , M.D. as Chairman of the KalVista Board of Directors.
Fourth Quarter and Full Year Financial Results:
-
Revenue: No revenue was recognized for the three months and fiscal years ended
April 30, 2023 , orApril 30, 2022 , respectively. -
R&D Expenses: Research and development expenses were
$24.0 million for the three months endedApril 30, 2023 , compared to$19.2 million for the same period in the prior fiscal year. Research and development expenses were$80.3 million for the fiscal year endedApril 30, 2023 , compared to$70.2 million for the prior fiscal year. The increase in spending in the fiscal year endedApril 30, 2023 primarily reflects increased costs related to the ongoing clinical trial for sebetralstat, increased preclinical spending, and a headcount driven increase in personnel costs. -
G&A Expenses: General and administrative expenses were
$7.8 million for the three months endedApril 30, 2023 , compared to$7.6 million for the same period in the prior fiscal year. General and administrative expenses were$30.6 million for the fiscal year endedApril 30, 2023 , compared to$26.4 million for the prior fiscal year. The increase in G&A expenses was primarily due to an increase in commercial strategy expenses and to a lesser extent, increases in public relations costs and other administrative costs. -
Net Loss: Net loss was
$26.3 million , or$(0.77) per weighted average basic and diluted share, for the three months endedApril 30, 2023 , compared to net loss of$24.1 million , or$(0.98) per weighted average basic and diluted share for the same period in the prior fiscal year. Net loss was$92.9 million , or$(3.33) per weighted average basic and diluted share for the fiscal year endedApril 30, 2023 , compared to net loss of$82.3 million , or$(3.36) 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 increase in operating expenses, primarily research and development. -
Cash position: Cash, cash equivalents and marketable securities were
$149.4 million onApril 30, 2023 , compared to$166.2 million onApril 30, 2022 . The decrease in the net cash position over the fiscal year is primarily due to increased operating expenses.
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 |
$ |
56,238 |
|
$ |
30,732 |
|
|
Marketable securities |
|
93,137 |
|
|
135,470 |
|
|
Research and development tax credit receivable |
|
16,568 |
|
|
14,098 |
|
|
Prepaid expenses and other current assets |
|
6,383 |
|
|
13,347 |
|
|
Total current assets |
|
172,326 |
|
|
193,647 |
|
|
Property and equipment, net |
|
2,948 |
|
|
2,178 |
|
|
Right of use assets |
|
7,822 |
|
|
7,862 |
|
|
Other assets |
|
106 |
|
|
193 |
|
|
Total assets |
$ |
183,202 |
|
$ |
203,880 |
|
|
Liabilities and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable |
$ |
4,817 |
|
$ |
3,638 |
|
|
Accrued expenses |
|
9,128 |
|
|
6,961 |
|
|
Lease liability - current portion |
|
1,087 |
|
|
977 |
|
|
Total current liabilities |
|
15,032 |
|
|
11,576 |
|
|
Long-term liabilities: |
|||||||
Lease liability - net of current portion |
|
7,145 |
|
|
7,211 |
|
|
Total long-term liabilities |
|
7,145 |
|
|
7,211 |
|
|
Stockholders’ equity: | |||||||
Common stock, |
|
34 |
|
|
25 |
|
|
Additional paid-in capital |
|
507,133 |
|
|
439,104 |
|
|
Accumulated deficit |
|
(343,082 |
) |
|
(250,175 |
) |
|
Accumulated other comprehensive loss |
|
(3,060 |
) |
|
(3,861 |
) |
|
Total stockholders’ equity |
|
161,025 |
|
|
185,093 |
|
|
Total liabilities and stockholders' equity |
$ |
183,202 |
|
$ |
203,880 |
|
Condensed Consolidated Statement of Operations | |||||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||||
(Unaudited) | |||||||||||||||
Three Months Ended |
|
Years Ended |
|||||||||||||
|
|
|
|||||||||||||
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Revenue |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
|||
Operating expenses: | |||||||||||||||
Research and development |
|
23,951 |
|
|
19,213 |
|
|
80,276 |
|
|
70,167 |
|
|||
General and administrative |
|
7,777 |
|
|
7,598 |
|
|
30,595 |
|
|
26,446 |
|
|||
Total operating expenses |
|
31,728 |
|
|
26,811 |
|
|
110,871 |
|
|
96,613 |
|
|||
Operating loss |
|
(31,728 |
) |
|
(26,811 |
) |
|
(110,871 |
) |
|
(96,613 |
) |
|||
Other income: | |||||||||||||||
Interest income |
|
808 |
|
|
268 |
|
|
2,232 |
|
|
1,090 |
|
|||
Foreign currency exchange rate (loss) gain |
|
327 |
|
|
(1,008 |
) |
|
90 |
|
|
(1,537 |
) |
|||
Other income |
|
4,288 |
|
|
3,438 |
|
|
15,642 |
|
|
14,721 |
|
|||
Total other income |
|
5,423 |
|
|
2,698 |
|
|
17,964 |
|
|
14,274 |
|
|||
Net loss |
$ |
(26,305 |
) |
$ |
(24,113 |
) |
$ |
(92,907 |
) |
$ |
(82,339 |
) |
|||
Net loss per share, basic and diluted |
$ |
(0.77 |
) |
$ |
(0.98 |
) |
$ |
(3.33 |
) |
$ |
(3.36 |
) |
|||
Weighted average common shares outstanding, basic and diluted |
|
34,342,664 |
|
|
24,545,360 |
|
|
27,890,846 |
|
|
24,473,092 |
|
Condensed Consolidated Statements of Cash Flows | |||||||
(in thousands, unaudited) | |||||||
Years Ended |
|||||||
|
|||||||
|
2023 |
|
|
|
2022 |
|
|
Cash flows from operating activities | |||||||
Net loss |
$ |
(92,907 |
) |
$ |
(82,339 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization |
|
718 |
|
|
564 |
|
|
Stock-based compensation expense |
|
9,922 |
|
|
11,086 |
|
|
Realized loss (gain) from sale of marketable securities |
|
139 |
|
|
581 |
|
|
Non-cash operating lease expense |
|
84 |
|
|
179 |
|
|
Amortization of premium on marketable securities |
|
988 |
|
|
2,565 |
|
|
Foreign currency exchange loss (gain) |
|
(1,618 |
) |
|
1,552 |
|
|
Changes in operating assets and liabilities: | |||||||
Research and development tax credit receivable |
|
(2,316 |
) |
|
(5,201 |
) |
|
Prepaid expenses and other current assets |
|
6,690 |
|
|
(9,280 |
) |
|
Accounts payable |
|
1,107 |
|
|
1,687 |
|
|
Accrued expenses |
|
1,932 |
|
|
472 |
|
|
Net cash used in operating activities |
|
(75,261 |
) |
|
(78,134 |
) |
|
Cash flows from investing activities | |||||||
Purchases of marketable securities |
|
(98,246 |
) |
|
(136,920 |
) |
|
Sales and maturities of marketable securities |
|
140,857 |
|
|
195,711 |
|
|
Acquisition of property and equipment |
|
(1,196 |
) |
|
(931 |
) |
|
Net cash provided by investing activities |
|
41,415 |
|
|
57,860 |
|
|
Cash flows from financing activities | |||||||
Issuance of common stock, net of offering expenses of |
|
56,582 |
|
|
- |
|
|
Issuance of pre-funded warrants, net of offering expenses |
|
1,085 |
|
|
- |
|
|
Issuance of common stock from equity incentive plans |
|
449 |
|
|
1,581 |
|
|
Net cash provided by financing activities |
|
58,116 |
|
|
1,581 |
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
1,236 |
|
|
(1,167 |
) |
|
Net (decrease) increase in cash and cash equivalents |
|
25,506 |
|
|
(19,860 |
) |
|
Cash and cash equivalents at beginning of period |
|
30,732 |
|
|
50,592 |
|
|
Cash and cash equivalents at end of period |
$ |
56,238 |
|
$ |
30,732 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230707982024/en/
Vice President, Corporate Communications
(201) 705-0254
jarrod.aldom@kalvista.com
Head, Investor Relations
(617) 771-5001
ryan.baker@kalvista.com
Source: