CAMBRIDGE, Mass. & SALISBURY, England / Sep 05, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today provided an operational update and released financial results for the first fiscal quarter ended July 31, 2024.
“We are excited about the steady progress we’ve made over the last few months including the most recent acceptance of our NDA by FDA and the EMA’s validation of our MAA,” said Ben Palleiko, CEO of KalVista. “We look forward to building on these recent milestones as we move toward filing for approval in the UK, Japan, and other countries later in 2024 and aim for our first commercial launch of sebetralstat in June 2025. I am grateful for the hard work of the entire KalVista team as we remain dedicated to getting this important treatment to people living with HAE.”
First Fiscal Quarter and Recent Business Highlights:
Sebetralstat
First Fiscal Quarter Financial Results
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need. KalVista announced positive phase 3 data from the KONFIDENT trial for its oral, on-demand therapy, sebetralstat for HAE in February 2024. The Company’s NDA for sebetralstat has been accepted by the FDA with a PDUFA goal date of June 17, 2025. KalVista received validation of its MAA from the EMA in August 2024. KalVista expects to file for approval in the UK, Japan, and other countries later in 2024.
For more information about KalVista, please visit www.kalvista.com or follow on social media at @KalVista and LinkedIn.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
KalVista Pharmaceuticals Inc. | |||||||
Condensed Consolidated Balance Sheets | |||||||
(in thousands, except share and per share amounts) | |||||||
(Unaudited) | |||||||
July 31, | April 30, | ||||||
| 2024 |
|
| 2024 |
| ||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 31,848 |
| $ | 31,789 |
| |
Marketable securities |
| 142,424 |
|
| 178,612 |
| |
Research and development tax credit receivable |
| 9,908 |
|
| 8,439 |
| |
Prepaid expenses and other current assets |
| 7,454 |
|
| 6,850 |
| |
Total current assets |
| 191,634 |
|
| 225,690 |
| |
Property and equipment, net |
| 2,100 |
|
| 2,227 |
| |
Right of use assets |
| 5,859 |
|
| 6,920 |
| |
Other assets |
| 605 |
|
| 567 |
| |
Total assets | $ | 200,198 |
| $ | 235,404 |
| |
Liabilities and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 10,792 |
| $ | 9,107 |
| |
Accrued expenses |
| 10,355 |
|
| 12,398 |
| |
Lease liability - current portion |
| 1,264 |
|
| 1,302 |
| |
Total current liabilities |
| 22,411 |
|
| 22,807 |
| |
Long-term liabilities: | |||||||
Lease liability - net of current portion |
| 4,988 |
|
| 6,015 |
| |
Total long-term liabilities |
| 4,988 |
|
| 6,015 |
| |
Stockholders’ equity: | |||||||
Common stock, $0.001 par value |
| 43 |
|
| 42 |
| |
Additional paid-in capital |
| 685,794 |
|
| 679,754 |
| |
Accumulated deficit |
| (510,169 | ) |
| (469,726 | ) | |
Accumulated other comprehensive loss |
| (2,869 | ) |
| (3,488 | ) | |
Total stockholders’ equity |
| 172,799 |
|
| 206,582 |
| |
Total liabilities and stockholders' equity | $ | 200,198 |
| $ | 235,404 |
|
KalVista Pharmaceuticals Inc. | ||||||||
Condensed Consolidated Statement of Operations | ||||||||
(in thousands, except share and per share amounts) | ||||||||
(Unaudited) | ||||||||
Three Months Ended | ||||||||
July 31, | ||||||||
| 2024 |
|
| 2023 |
| |||
Revenue | $ | — |
| $ | — |
| ||
Operating expenses: | ||||||||
Research and development |
| 26,614 |
|
| 19,307 |
| ||
General and administrative |
| 17,601 |
|
| 9,786 |
| ||
Total operating expenses |
| 44,215 |
|
| 29,093 |
| ||
Operating loss |
| (44,215 | ) |
| (29,093 | ) | ||
Other income: | ||||||||
Interest income |
| 1,692 |
|
| 923 |
| ||
Foreign currency exchange gain |
| 514 |
|
| 456 |
| ||
Other income |
| 1,566 |
|
| 2,397 |
| ||
Total other income |
| 3,772 |
|
| 3,776 |
| ||
Net loss | $ | (40,443 | ) | $ | (25,317 | ) | ||
Net loss per share, basic and diluted | $ | (0.87 | ) | $ | (0.74 | ) | ||
Weighted average common shares outstanding, basic and diluted |
| 46,232,977 |
|
| 34,414,226 |
|
KalVista Pharmaceuticals Inc. | |||||||
Condensed Consolidated Statements of Cash Flows | |||||||
(in thousands, unaudited) | |||||||
Three Months Ended | |||||||
July 31, | |||||||
| 2024 |
|
| 2023 |
| ||
Cash flows from operating activities | |||||||
Net loss | $ | (40,443 | ) | $ | (25,317 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization |
| 224 |
|
| 193 |
| |
Stock-based compensation expense |
| 3,040 |
|
| 3,254 |
| |
Realized gain from sale of marketable securities |
| (317 | ) |
| (314 | ) | |
Non-cash operating lease (benefit) expense |
| (5 | ) |
| 6 |
| |
Amortization of premium on marketable securities |
| 5 |
|
| 62 |
| |
Foreign currency exchange gain |
| (414 | ) |
| (395 | ) | |
Changes in operating assets and liabilities: | |||||||
Research and development tax credit receivable |
| (1,253 | ) |
| (2,084 | ) | |
Prepaid expenses and other current assets |
| (783 | ) |
| (1,003 | ) | |
Accounts payable |
| 1,502 |
|
| 108 |
| |
Accrued expenses |
| (1,776 | ) |
| (1,240 | ) | |
Net cash used in operating activities |
| (40,220 | ) |
| (26,730 | ) | |
Cash flows from investing activities | |||||||
Purchases of marketable securities |
| (983 | ) |
| (25,767 | ) | |
Sales and maturities of marketable securities |
| 38,230 |
|
| 45,386 |
| |
Acquisition of property and equipment |
| (21 | ) |
| (6 | ) | |
Capitalized website development costs |
| (64 | ) |
| - |
| |
Net cash provided by investing activities |
| 37,162 |
|
| 19,613 |
| |
Cash flows from financing activities | |||||||
Issuance of common stock from equity incentive plans |
| 3,000 |
|
| 204 |
| |
Net cash provided by financing activities |
| 3,000 |
|
| 204 |
| |
Effect of exchange rate changes on cash and cash equivalents |
| 117 |
|
| 84 |
| |
Net increase (decrease) in cash and cash equivalents |
| 59 |
|
| (6,829 | ) | |
Cash and cash equivalents at beginning of period |
| 31,789 |
|
| 56,238 |
| |
Cash and cash equivalents at end of period | $ | 31,848 |
| $ | 49,409 |
|
Last Trade: | US$11.41 |
Daily Change: | 0.16 1.42 |
Daily Volume: | 401,157 |
Market Cap: | US$493.140M |
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