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Share Name | Share Symbol | Market | Type |
---|---|---|---|
KalVista Pharmaceuticals Inc | NASDAQ:KALV | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.35 | 2.46% | 14.55 | 14.20 | 15.86 | 14.645 | 14.18 | 14.24 | 195,582 | 01:00:00 |
– Submitted NDA for sebetralstat as first-ever, oral on-demand treatment for HAE attacks, a pivotal moment for the HAE community –
– Potential FDA approval and launch of sebetralstat in first half 2025 -
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today provided an operational update and released financial results for the fiscal year ended April 30, 2024.
“This last fiscal quarter was the most important in the history of KalVista,” said Ben Palleiko, CEO of KalVista. “Not only did we submit the NDA for sebetralstat to the FDA, but the KONFIDENT phase 3 trial results were published in The New England Journal of Medicine, supporting our view on the importance of this potential therapy. We look forward to building on these milestones as we submit additional marketing authorization applications to other national health authorities throughout 2024 and anticipate approval and launch in the US in the first half of 2025.”
Fiscal 2024 and Recent Business Highlights:
Sebetralstat
Oral Factor XIIa Inhibitor Program
Organizational
Fourth Quarter and Full Year 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 for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024 and submitted an NDA with the FDA in June 2024. KalVista expects to file for approval in the UK, the European Union, and Japan later in 2024.
For more information about KalVista, please visit www.kalvista.com.
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, 2023, 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) April 30, April 30,
2024
2023
Assets Current assets: Cash and cash equivalents
$
31,789
$
56,238
Marketable securities
178,612
93,137
Research and development tax credit receivable
8,439
16,568
Prepaid expenses and other current assets
6,850
6,383
Total current assets
225,690
172,326
Property and equipment, net
2,227
2,948
Right of use assets
6,920
7,822
Other assets
567
106
Total assets
$
235,404
$
183,202
Liabilities and stockholders' equity Current liabilities: Accounts payable
$
9,107
$
4,817
Accrued expenses
12,398
9,128
Lease liability - current portion
1,302
1,087
Total current liabilities
22,807
15,032
Long-term liabilities: Lease liability - net of current portion
6,015
7,145
Total long-term liabilities
6,015
7,145
Stockholders’ equity: Common stock, $0.001 par value
42
34
Additional paid-in capital
679,754
507,133
Accumulated deficit
(469,726
)
(343,082
)
Accumulated other comprehensive loss
(3,488
)
(3,060
)
Total stockholders’ equity
206,582
161,025
Total liabilities and stockholders' equity
$
235,404
$
183,202
KalVista Pharmaceuticals Inc. Condensed Consolidated Statement of Operations (in thousands, except share and per share amounts) (Unaudited) Three Months Ended Years Ended April 30, April 30,
2024
2023
2024
2023
Revenue
$
—
$
—
$
—
$
—
Operating expenses: Research and development
25,248
23,951
86,167
80,276
General and administrative
23,207
7,777
54,278
30,595
Total operating expenses
48,455
31,728
140,445
110,871
Operating loss
(48,455
)
(31,728
)
(140,445
)
(110,871
)
Other income: Interest income
1,513
808
3,896
2,232
Foreign currency exchange rate (loss) gain
(140
)
327
138
90
Other income
2,432
4,288
9,767
15,642
Total other income
3,805
5,423
13,801
17,964
Net loss
$
(44,650
)
$
(26,305
)
$
(126,644
)
$
(92,907
)
Net loss per share, basic and diluted$
(1.02
)
$
(0.77
)
$
(3.44
)
$
(3.33
)
Weighted average common shares outstanding, basic and diluted
43,590,657
34,342,664
36,786,575
27,890,846
KalVista Pharmaceuticals Inc. Condensed Consolidated Statements of Cash Flows (in thousands, unaudited) Years Ended April 30,
2024
2023
Cash flows from operating activities Net loss
$
(126,644
)
$
(92,907
)
Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization
816
718
Stock-based compensation expense
21,915
9,922
Realized (gain) loss from sale of marketable securities
(1,325
)
139
Non-cash operating lease expense
(12
)
84
Amortization of premium on marketable securities
92
988
Foreign currency exchange loss (gain)
760
(1,618
)
Changes in operating assets and liabilities: Research and development tax credit receivable
8,176
(2,316
)
Prepaid expenses and other current assets
(538
)
6,690
Accounts payable
4,320
1,107
Accrued expenses
3,209
1,932
Net cash used in operating activities
(89,231
)
(75,261
)
Cash flows from investing activities Purchases of marketable securities
(189,231
)
(98,246
)
Sales and maturities of marketable securities
104,955
140,857
Acquisition of property and equipment
(42
)
(1,196
)
Capitalized website development costs
(401
)
-
Net cash provided by investing activities
(84,719
)
41,415
Cash flows from financing activities Issuance of common stock, net of offering expenses
106,560
56,582
Issuance of pre-funded warrants, net of offering expenses
43,508
1,085
Issuance of common stock from equity incentive plans
646
449
Net cash provided by financing activities
150,714
58,116
Effect of exchange rate changes on cash and cash equivalents
(1,213
)
1,236
Net (decrease) increase in cash and cash equivalents
(24,449
)
25,506
Cash and cash equivalents at beginning of period
56,238
30,732
Cash and cash equivalents at end of period
$
31,789
$
56,238
View source version on businesswire.com: https://www.businesswire.com/news/home/20240711453276/en/
KalVista Pharmaceuticals, Inc. Jarrod Aldom Vice President, Corporate Communications (201) 705-0254 jarrod.aldom@kalvista.com Ryan Baker Head, Investor Relations (617) 771-5001 ryan.baker@kalvista.com
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