CAMBRIDGE, Mass. & SALISBURY, England / Jul 10, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today provided an operational update and released financial results for the fiscal year ended April 30, 2025.
“The FDA approval of EKTERLY represents a major milestone—not only as the first commercial product for KalVista, but more importantly, as the first and only oral on-demand therapy for people living with HAE,” said Ben Palleiko, CEO of KalVista Pharmaceuticals. “EKTERLY delivers a long-awaited treatment that is safe, effective, and easy to administer. Our commercial team is actively engaging in the field, leveraging their expertise to educate and activate patients and physicians to enable timely access, drive awareness, and support informed treatment decisions around this important new therapy. With commercial partners now in place in Canada and Japan, and six global regulatory submissions under review, we believe EKTERLY is poised to become the foundational therapy for HAE management worldwide.”
Recent Business Highlights
EKTERLY® (sebetralstat)
Organizational
Financial Results for Fiscal Year Ended April 30, 2025:
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. In the U.S., KalVista markets EKTERLY®, the first and only oral on-demand treatment for hereditary angioedema (HAE). The Company has multiple regulatory applications under review in key global markets. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram.
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, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, our expectations about the safety and efficacy of sebetralstat and our other product candidates, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE , 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, 2025, 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. Consolidated Balance Sheets April 30, 2025 and 2024 (in thousands except share and per share amounts) (Unaudited) | ||||||||
|
| 2025 |
|
| 2024 |
| ||
Cash, cash equivalents & Marketable securities |
| $ | 220,617 |
|
| $ | 210,401 |
|
Other current assets |
|
| 21,073 |
|
|
| 15,289 |
|
Total current assets |
|
| 241,690 |
|
|
| 225,690 |
|
Other assets |
|
| 9,080 |
|
|
| 9,714 |
|
Total assets |
| $ | 250,770 |
|
| $ | 235,404 |
|
|
|
|
|
|
|
| ||
Current liabilities |
| $ | 45,167 |
|
| $ | 22,807 |
|
Long-term liabilities |
|
| 110,212 |
|
|
| 6,015 |
|
Total Liabilities |
| 155,379 |
|
| 28,822 |
| ||
Stockholders’ equity |
|
| 95,391 |
|
|
| 206,582 |
|
Total liabilities and stockholders’ equity |
| $ | 250,770 |
|
| $ | 235,404 |
|
KALVISTA PHARMACEUTICALS, INC. Consolidated Statements of Operations and Comprehensive Loss Years Ended April 30, 2025 and 2024 (in thousands, except share and per share amounts) (Unaudited) | ||||||||
|
| 2025 |
|
| 2024 |
| ||
Research and development |
| $ | 71,709 |
|
| $ | 86,167 |
|
General and administrative |
|
| 116,286 |
|
|
| 54,278 |
|
Total operating expenses |
|
| 187,995 |
|
|
| 140,445 |
|
Operating loss |
|
| (187,995 | ) |
|
| (140,445 | ) |
Other income: |
|
|
|
|
|
| ||
Interest income |
|
| 6,435 |
|
|
| 3,896 |
|
Interest (expense) |
|
| (5,785 | ) |
|
| — |
|
Foreign currency exchange gain (loss) |
|
| 2,481 |
|
|
| 138 |
|
Other income (expenses), net |
|
| 4,812 |
|
|
| 9,767 |
|
Total other income |
|
| 7,943 |
|
|
| 13,801 |
|
Loss before income taxes |
|
| (180,052 | ) |
|
| (126,644 | ) |
Income tax (benefit) expense |
|
| 3,392 |
|
|
| — |
|
Net loss |
| $ | (183,444 | ) |
| $ | (126,644 | ) |
Net loss per share, basic and diluted |
| $ | (3.69 | ) |
| $ | (3.44 | ) |
Weighted average common shares outstanding, basic and diluted |
|
| 49,652,878 |
|
|
| 36,786,575 |
|
Last Trade: | US$15.51 |
Daily Change: | -0.48 -3.00 |
Daily Volume: | 1,969,843 |
Market Cap: | US$771.160M |
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