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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 |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
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Registrant’s Telephone Number, Including Area Code: |
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On July 11, 2024, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal year ended April 30, 2024. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information furnished with Item 2.02 of this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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KALVISTA PHARMACEUTICALS, INC. |
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Date: |
July 11, 2024 |
By: |
/s/ Benjamin L. Palleiko |
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Benjamin L. Palleiko |
Exhibit 99.1
KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
– Submitted NDA for sebetralstat as first-ever, oral on-demand treatment for HAE attacks, a pivotal moment for the HAE community –
Cambridge, MA and Salisbury, England, July 11, 2024 – 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
Exhibit 99.1
Oral Factor XIIa Inhibitor Program
Organizational
Fourth Quarter and Full Year Financial Results:
Exhibit 99.1
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.
Contact:
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
Exhibit 99.1
KalVista Pharmaceuticals Inc. |
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Condensed Consolidated Balance Sheets |
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(in thousands, except share and per share amounts) |
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(Unaudited) |
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April 30, |
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April 30, |
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2024 |
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2023 |
Assets |
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Current assets: |
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Cash and cash equivalents |
$31,789 |
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$56,238 |
Marketable securities |
178,612 |
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93,137 |
Research and development tax credit receivable |
8,439 |
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16,568 |
Prepaid expenses and other current assets |
6,850 |
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6,383 |
Total current assets |
225,690 |
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172,326 |
Property and equipment, net |
2,227 |
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2,948 |
Right of use assets |
6,920 |
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7,822 |
Other assets |
567 |
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106 |
Total assets |
$235,404 |
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$183,202 |
Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable |
$9,107 |
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$4,817 |
Accrued expenses |
12,398 |
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9,128 |
Lease liability - current portion |
1,302 |
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1,087 |
Total current liabilities |
22,807 |
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15,032 |
Long-term liabilities: |
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Lease liability - net of current portion |
6,015 |
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7,145 |
Total long-term liabilities |
6,015 |
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7,145 |
Stockholders’ equity: |
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Common stock, $0.001 par value |
42 |
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34 |
Additional paid-in capital |
679,754 |
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507,133 |
Accumulated deficit |
(469,726) |
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(343,082) |
Accumulated other comprehensive loss |
(3,488) |
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(3,060) |
Total stockholders’ equity |
206,582 |
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161,025 |
Total liabilities and stockholders' equity |
$235,404 |
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$183,202 |
Exhibit 99.1
KalVista Pharmaceuticals Inc. |
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Condensed Consolidated Statement of Operations |
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(in thousands, except share and per share amounts) |
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(Unaudited) |
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Three Months Ended |
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Years Ended |
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April 30, |
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April 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenue |
$— |
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$— |
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$— |
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$— |
Operating expenses: |
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Research and development |
25,248 |
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23,951 |
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86,167 |
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80,276 |
General and administrative |
23,207 |
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7,777 |
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54,278 |
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30,595 |
Total operating expenses |
48,455 |
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31,728 |
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140,445 |
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110,871 |
Operating loss |
(48,455) |
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(31,728) |
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(140,445) |
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(110,871) |
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Other income: |
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Interest income |
1,513 |
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808 |
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3,896 |
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2,232 |
Foreign currency exchange rate (loss) gain |
(140) |
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327 |
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138 |
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90 |
Other income |
2,432 |
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4,288 |
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9,767 |
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15,642 |
Total other income |
3,805 |
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5,423 |
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13,801 |
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17,964 |
Net loss |
$(44,650) |
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$(26,305) |
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$(126,644) |
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$(92,907) |
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Net loss per share, basic and diluted |
$(1.02) |
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$(0.77) |
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$(3.44) |
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$(3.33) |
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Weighted average common shares outstanding, basic and diluted |
43,590,657 |
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34,342,664 |
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36,786,575 |
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27,890,846 |
Exhibit 99.1
KalVista Pharmaceuticals Inc. |
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Condensed Consolidated Statements of Cash Flows |
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(in thousands, unaudited) |
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Years Ended |
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April 30, |
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2024 |
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2023 |
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Cash flows from operating activities |
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Net loss |
$(126,644) |
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$(92,907) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
816 |
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718 |
Stock-based compensation expense |
21,915 |
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9,922 |
Realized (gain) loss from sale of marketable securities |
(1,325) |
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139 |
Non-cash operating lease expense |
(12) |
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84 |
Amortization of premium on marketable securities |
92 |
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988 |
Foreign currency exchange loss (gain) |
760 |
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(1,618) |
Changes in operating assets and liabilities: |
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Research and development tax credit receivable |
8,176 |
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(2,316) |
Prepaid expenses and other current assets |
(538) |
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6,690 |
Accounts payable |
4,320 |
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1,107 |
Accrued expenses |
3,209 |
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1,932 |
Net cash used in operating activities |
(89,231) |
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(75,261) |
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Cash flows from investing activities |
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Purchases of marketable securities |
(189,231) |
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(98,246) |
Sales and maturities of marketable securities |
104,955 |
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140,857 |
Acquisition of property and equipment |
(42) |
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(1,196) |
Capitalized website development costs |
(401) |
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- |
Net cash provided by investing activities |
(84,719) |
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41,415 |
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Cash flows from financing activities |
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Issuance of common stock, net of offering expenses |
106,560 |
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56,582 |
Issuance of pre-funded warrants, net of offering expenses |
43,508 |
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1,085 |
Issuance of common stock from equity incentive plans |
646 |
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449 |
Net cash provided by financing activities |
150,714 |
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58,116 |
Effect of exchange rate changes on cash and cash equivalents |
(1,213) |
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1,236 |
Net (decrease) increase in cash and cash equivalents |
(24,449) |
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25,506 |
Cash and cash equivalents at beginning of period |
56,238 |
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30,732 |
Cash and cash equivalents at end of period |
$31,789 |
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$56,238 |
Document And Entity Information |
Jul. 11, 2024 |
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Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Jul. 11, 2024 |
Entity Registrant Name | KALVISTA PHARMACEUTICALS, INC. |
Entity Central Index Key | 0001348911 |
Entity Emerging Growth Company | false |
Entity File Number | 001-36830 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 20-0915291 |
Entity Address, Address Line One | 55 Cambridge Parkway |
Entity Address, Address Line Two | Suite 901E |
Entity Address, City or Town | Cambridge |
Entity Address, State or Province | MA |
Entity Address, Postal Zip Code | 02142 |
City Area Code | 857 |
Local Phone Number | 999-0075 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common Stock, $0.001 par value per share |
Trading Symbol | KALV |
Security Exchange Name | NASDAQ |
1 Year KalVista Pharmaceuticals Chart |
1 Month KalVista Pharmaceuticals Chart |
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