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KalVista Pharmaceuticals Provides Operational Update and Reports Fiscal Quarter Financial Results -EKTERLY now approved in the US and UK; first and only oral on-demand therapy for acute attacks of hereditary angioedema-

Key Takeaway: KalVista Pharmaceuticals Provides Operational Update and Reports Fiscal Quarter Financial Results -EKTERLY now approved in the US and UK; first and only oral on-demand therapy for acute attacks of hereditary angioedema- -Initiated US EKTERLY launch in July; received 460 patien

Full Press Release Details

KalVista Pharmaceuticals Provides Operational Update and Reports Fiscal Quarter Financial Results
-EKTERLY now approved in the US and UK; first and only oral on-demand therapy for acute attacks of hereditary angioedema-
-Initiated US EKTERLY launch in
July; received 460 patient start forms through August-
-European Medicines Agency adopted a positive opinion recommending approval
of sebetralstat and confirmed maintenance of orphan designation in EU; decision expected early October-
-$191M in cash, providing
-Management to host conference call today at 8:30 a.m. ET-
Framingham, MA and Salisbury, England, September 11, 2025 - KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today
provided an operational update and released financial results for the fiscal quarter ended July 31, 2025.
"This quarter marked a defining
moment in the history of KalVista with the FDA approval of EKTERLY-the first and only oral on-demand treatment for HAE," stated Ben Palleiko, CEO of KalVista. "Approval and launch on the same
day propelled us immediately into our next chapter of growth as a commercial company, and the response has been extraordinary. In just eight weeks following approval, we have received 460 patient start forms, representing almost five percent of the
reported HAE patient population in the US. This early demand has exceeded our expectations, validating both the urgent unmet need that EKTERLY addresses and its potential to redefine management of HAE. Backed by a strong balance sheet and a
world-class team, we are well positioned to maximize the global opportunity for EKTERLY to become the foundational therapy for people living with HAE."
Recent Business Highlights
EKTERLY (sebetralstat)
First Fiscal Quarter Financial Results
Earnings Conference Call and Webcast
KalVista management will host a webcast today, September 11, 2025, at 8:30 a.m. ET. The webcast will be available on the Investors and News section of
KalVista's website at https://ir.kalvista.com. A replay of the webcast will be archived and available for at least 30 days following the event.
About EKTERLY (sebetralstat) EKTERLY (sebetralstat) is a novel plasma
kallikrein inhibitor approved in the United States and United Kingdom for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral
on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory
applications under review in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide. For more information, including the full U.S. Prescribing Information, visit EKTERLY.com.
About KalVista Pharmaceuticals, Inc.
KalVista is a global
pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed
EKTERLY -the first and only oral on-demand treatment for hereditary angioedema (HAE)- and continues to work closely with the global HAE
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," "position," "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, including revenues from sales of EKTERLY, 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.
Head, Investor Relations
Director, Corporate Communications
KALVISTA PHARMACEUTICALS, INC.
Consolidated Balance Sheets
(in thousands except share and per share amounts)
July 31, 2025 April 30, 2025
Cash, cash equivalents & Marketable securities $ 191,465 $ 220,617
Other current assets 14,431 21,073
Total current assets 205,896 241,690
Other assets 9,609 9,080
Total assets $ 215,505 $ 250,770
Current liabilities $ 38,375 $ 45,167
Long-term liabilities 136,340 110,212
Total Liabilities 174,715 155,379
Stockholders' equity 40,790 95,391
Total liabilities and stockholders' equity $ 215,505 $ 250,770
KALVISTA PHARMACEUTICALS, INC.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
For the Three Months Ended
July 31,
2025 2024
Product revenue, net $ 1,426 $ -
Cost of revenue 590 -
Research and development 15,162 26,614
Selling, general and administrative 44,683 17,601
Total operating expenses 60,435 44,215
Operating loss (59,009 ) (44,215 )
Other income:
Interest income 1,849 1,692
Interest expense (3,522 ) -
Foreign currency exchange gain 1,925 514
Other income, net 818 1,566
Total other income 1,070 3,772
Loss before income taxes (57,939 ) (40,443 )
Income tax expense 2,157 -
Net loss $ (60,096 ) $ (40,443 )
Net loss per share, basic and diluted $ (1.12 ) $ (0.87 )
Weighted average common shares outstanding, basic and diluted 53,497,128 46,232,977
Last updated: Sep 11, 2025