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 December 5, 2024, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal quarter ended October 31, 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 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: |
December 5, 2024 |
By: |
/s/ Brian Piekos |
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Brian Piekos |
Exhibit 99.1
KalVista Pharmaceuticals Reports Second Fiscal Quarter Results and Provides Operational Update
–Continuing to build commercial infrastructure; on track for potential sebetralstat launch in Q2 2025–
–Multinational regulatory submissions for sebetralstat position Company to transform hereditary angioedema (HAE) treatment worldwide–
– Pro forma cash and cash equivalents of $292.2 million provide runway into second half 2027–
Cambridge, Mass., and Salisbury, England, December 5, 2024 – KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today released financial results for the second fiscal quarter ended October 31, 2024. The Company also provided an operational update, highlighted by the U.S. Food and Drug Administration (FDA) acceptance of a New Drug Application (NDA) for sebetralstat, a novel, investigational treatment for hereditary angioedema (HAE).
“KalVista is successfully executing on the key milestones we announced at the beginning of our fiscal year as we move towards multiple potential commercial launches of sebetralstat in 2025,” said Ben Palleiko, Chief Executive Officer of KalVista. “With six marketing authorization applications filed to date and the first potential approval expected next June, we remain focused on achieving our goal of making sebetralstat available to people living with HAE globally. In support of that goal, during the quarter, we presented additional data from our clinical program at multiple conferences, demonstrating that patients used sebetralstat to treat attacks early and that early treatment with on-demand therapy resulted in meaningful clinical benefit. Finally, the additional capital we recently raised, including the non-dilutive synthetic royalty financing, will support our continued planning for the potential launch of sebetralstat in multiple markets.”
Second Fiscal Quarter and Recent Business Highlights:
Sebetralstat
Exhibit 99.1
Organizational
Second Fiscal Quarter Financial Results
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company whose mission is to develop and deliver life-changing oral medicines for people affected by rare diseases with significant unmet needs. Sebetralstat, our novel, investigational candidate for the oral, on-demand treatment of hereditary angioedema, is under regulatory review by the FDA with a PDUFA goal date of June 17, 2025. We have also completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency
Exhibit 99.1
and multiple other countries. For more information, please visit www.kalvista.com or follow us on social media at @KalVista and LinkedIn.
About Sebetralstat
Discovered and developed entirely by KalVista, sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). Our initial goal is to deliver sebetralstat as the first oral, on-demand treatment for HAE in people aged 12 years and older. In addition, we are studying the potential of sebetralstat for the on-demand treatment of HAE in children aged 2 to 11 years. We believe that, if approved, sebetralstat has the potential to become the foundational therapy for HAE disease management globally.
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.
Media:
Jenn Snyder
Vice President, Corporate Affairs
(857) 356-0479
jennifer.snyder@kalvista.com
Investors:
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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October 31, |
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April 30, |
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2024 |
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2024 |
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Cash, Cash Equivalents & Marketable Securities |
$ |
135,776 |
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$ |
210,401 |
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Other Current Assets |
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16,491 |
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15,289 |
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Total Current Assets |
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152,267 |
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225,690 |
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Other Assets |
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8,564 |
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9,714 |
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Total Assets |
$ |
160,831 |
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$ |
235,404 |
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Current Liabilities |
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22,164 |
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22,807 |
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Long-term Liabilities |
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4,675 |
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6,015 |
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Total Liabilities |
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26,839 |
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28,822 |
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Total Stockholders’ Equity |
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133,992 |
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206,582 |
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Total Liabilities and Stockholders' Equity |
$ |
160,831 |
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$ |
235,404 |
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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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Six Months Ended |
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October 31, |
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October 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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16,610 |
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19,089 |
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43,225 |
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38,396 |
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General and administrative |
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29,201 |
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10,657 |
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46,801 |
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20,443 |
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Total operating expenses |
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45,811 |
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29,746 |
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90,026 |
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58,839 |
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Operating loss |
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(45,811 |
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(29,746 |
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(90,026 |
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(58,839 |
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Other income: |
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Interest income |
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1,357 |
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776 |
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3,050 |
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1,699 |
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Foreign currency exchange rate (loss) gain |
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67 |
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(1,299 |
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581 |
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(843 |
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Other income |
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2,119 |
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2,619 |
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3,685 |
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5,016 |
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Total other income |
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3,543 |
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2,096 |
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7,316 |
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5,872 |
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Net loss |
$ |
(42,268 |
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$ |
(27,650 |
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$ |
(82,710 |
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$ |
(52,967 |
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Net loss per share, basic and diluted |
$ |
(0.91 |
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$ |
(0.80 |
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$ |
(1.78 |
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$ |
(1.54 |
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Weighted average common shares outstanding, basic and diluted |
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46,695,220 |
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34,565,955 |
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46,464,099 |
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34,490,090 |
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