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
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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 7, 2023, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal year ended April 30, 2023. 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 7, 2023 |
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
– Sebetralstat Phase 3 KONFIDENT Clinical Trial Achieves Target Enrollment; Data Readout Expected in Q4 –
Cambridge, MA and Salisbury, England, July 7, 2023 – KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal year ended April 30, 2023.
“We have made a great deal of progress over the last fiscal year in the development of sebetralstat,” said Andrew Crockett, Chief Executive Officer of KalVista. “Consistent with prior guidance, we have achieved the target enrollment for the sebetralstat phase 3 KONFIDENT trial. We expect to have data readout in the fourth quarter of this year and submit an NDA in the first half of 2024. In addition, we continue to expand the potential of our oral Factor XIIa inhibitor program beyond HAE by presenting positive preclinical data in several other therapeutic areas, including thrombosis. We remain well-capitalized, with funding into 2025.”
Fiscal 2023 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 pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista is developing sebetralstat as an oral on-demand therapy for HAE attacks and has achieved target enrollment for the phase 3 KONFIDENT clinical trial. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE and other diseases.
For more information about KalVista, please visit www.kalvista.com.
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 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 Phase 3 KONFIDENT trial, 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, 2022, 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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2023 |
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2022 |
Assets |
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Current assets: |
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Cash and cash equivalents |
$56,238 |
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$30,732 |
Marketable securities |
93,137 |
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135,470 |
Research and development tax credit receivable |
16,568 |
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14,098 |
Prepaid expenses and other current assets |
6,383 |
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13,347 |
Total current assets |
172,326 |
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193,647 |
Property and equipment, net |
2,948 |
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2,178 |
Right of use assets |
7,822 |
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7,862 |
Other assets |
106 |
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193 |
Total assets |
$183,202 |
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$203,880 |
Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable |
$4,817 |
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$3,638 |
Accrued expenses |
9,128 |
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6,961 |
Lease liability - current portion |
1,087 |
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977 |
Total current liabilities |
15,032 |
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11,576 |
Long-term liabilities: |
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Lease liability - net of current portion |
7,145 |
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7,211 |
Total long-term liabilities |
7,145 |
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7,211 |
Stockholders’ equity: |
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Common stock, $0.001 par value |
34 |
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25 |
Additional paid-in capital |
507,133 |
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439,104 |
Accumulated deficit |
(343,082) |
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(250,175) |
Accumulated other comprehensive loss |
(3,060) |
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(3,861) |
Total stockholders’ equity |
161,025 |
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185,093 |
Total liabilities and stockholders' equity |
$183,202 |
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$203,880 |
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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2023 |
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2022 |
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2023 |
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2022 |
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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 |
23,951 |
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19,213 |
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80,276 |
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70,167 |
General and administrative |
7,777 |
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7,598 |
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30,595 |
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26,446 |
Total operating expenses |
31,728 |
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26,811 |
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110,871 |
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96,613 |
Operating loss |
(31,728) |
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(26,811) |
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(110,871) |
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(96,613) |
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Other income: |
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Interest income |
808 |
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268 |
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2,232 |
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1,090 |
Foreign currency exchange rate (loss) gain |
327 |
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(1,008) |
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90 |
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(1,537) |
Other income |
4,288 |
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3,438 |
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15,642 |
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14,721 |
Total other income |
5,423 |
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2,698 |
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17,964 |
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14,274 |
Net loss |
$(26,305) |
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$(24,113) |
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$(92,907) |
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$(82,339) |
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Net loss per share, basic and diluted |
$(0.77) |
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$(0.98) |
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$(3.33) |
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$(3.36) |
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Weighted average common shares outstanding, basic and diluted |
34,342,664 |
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24,545,360 |
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27,890,846 |
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24,473,092 |
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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2023 |
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2022 |
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Cash flows from operating activities |
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Net loss |
$(92,907) |
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$(82,339) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
718 |
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564 |
Stock-based compensation expense |
9,922 |
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11,086 |
Realized loss (gain) from sale of marketable securities |
139 |
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581 |
Non-cash operating lease expense |
84 |
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179 |
Amortization of premium on marketable securities |
988 |
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2,565 |
Foreign currency exchange loss (gain) |
(1,618) |
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1,552 |
Changes in operating assets and liabilities: |
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Research and development tax credit receivable |
(2,316) |
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(5,201) |
Prepaid expenses and other current assets |
6,690 |
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(9,280) |
Accounts payable |
1,107 |
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1,687 |
Accrued expenses |
1,932 |
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472 |
Net cash used in operating activities |
(75,261) |
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(78,134) |
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Cash flows from investing activities |
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Purchases of marketable securities |
(98,246) |
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(136,920) |
Sales and maturities of marketable securities |
140,857 |
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195,711 |
Acquisition of property and equipment |
(1,196) |
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(931) |
Net cash provided by investing activities |
41,415 |
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57,860 |
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Cash flows from financing activities |
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Issuance of common stock, net of offering expenses of $0.3 million |
56,582 |
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Issuance of pre-funded warrants, net of offering expenses |
1,085 |
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Issuance of common stock from equity incentive plans |
449 |
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1,581 |
Net cash provided by financing activities |
58,116 |
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1,581 |
Effect of exchange rate changes on cash and cash equivalents |
1,236 |
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(1,167) |
Net (decrease) increase in cash and cash equivalents |
25,506 |
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(19,860) |
Cash and cash equivalents at beginning of period |
30,732 |
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50,592 |
Cash and cash equivalents at end of period |
$56,238 |
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$30,732 |