KalVista Pharmaceuticals Reports Eight Months Fiscal Year 2025 Financial Results and Provides Corporate Update
1,702 patient start forms received in the US from launch through end of February, reflecting continued rapid adoption of first and only oral on-demand treatment for hereditary angioedema (HAE)
EKTERLY launched in
Company to host conference call today at
“As we enter the next phase of the EKTERLY launch, we are seeing the benefits of disciplined execution and increasing real-world experience with the first and only oral on-demand therapy for HAE,” said
EKTERLY® (sebetralstat) Commercial Progress
-
Initiated the US commercial launch of EKTERLY on
July 7, 2025 , with$49.1 million global net product revenue throughDecember 31, 2025 . -
Recorded 1,702 patient start forms, representing almost 20% of the US patient population, and activated 724 unique prescribers in the US through
February 28, 2026 . - In the fourth quarter of 2025, the majority of revenue was due to patients receiving refills of EKTERLY.
- German launch is exhibiting similar characteristics to the US launch as adoption, utilization, and growth continue to build.
-
EKTERLY has launched in
Japan through the Company’s partner, Kaken Pharmaceutical Co., Ltd., and has been listed on theNational Health Insurance (NHI) drug reimbursement price list. EKTERLY is the first and only oral on-demand therapy available inJapan .
Clinical and Regulatory Progress
-
Completed enrollment in the Phase 3 KONFIDENT-KID trial of sebetralstat in pediatric HAE patients aged 2 to 11 years a full year ahead of schedule. New interim analysis data to be presented as a late-breaking oral presentation at the 2026
Global Angioedema Leadership Conference taking place inMadrid, Spain from March 26–29, 2026.KalVista expects to file a US new drug application in the third quarter of 2026 with a launch anticipated in 2027. - Announced recommendation of EKTERLY as a first-line therapy for adolescents 12 and older in the International Pediatric HAE Guideline, which emphasizes ensuring on-demand treatment is available anytime, anywhere, and prioritizing early self-administration.
-
Presented new sebetralstat clinical data at the 2026
American Academy of Allergy , Asthma & Immunology (AAAAI) Annual Meeting and theWestern Society of Allergy , Asthma & Immunology (WSAAI) 63rd Annual Scientific Session, demonstrating high patient satisfaction, sustained effectiveness with repeat use and the importance of early treatment as the strongest predictor of symptom relief.
Transition Period Financial Results
-
Recognized
$49.1 million in net product revenue for the eight months endedDecember 31, 2025 . -
Cost of revenue was
$3.1 million for the eight months endedDecember 31, 2025 . -
Research and development expenses were
$33.4 million and$52.2 million in the eight months endedDecember 31, 2025 , and 2024, respectively. The decrease in R&D was primarily attributable to reduced clinical trial expenses and recognizing expenses associated with EKTERLY pre-commercial awareness within selling, general and administrative expenses. -
Selling, general and administrative expenses were
$124.7 million and$64.9 million in the eight months endedDecember 31, 2025 , and 2024, respectively. The increase in SG&A was primarily attributable to commercialization expenses related to EKTERLY. -
As of
December 31, 2025 , the Company had cash, cash equivalents and marketable securities of approximately$300.2 million . We anticipate that cash, cash equivalents and marketable securities as ofDecember 31, 2025 , along with projected revenues associated with the sale of EKTERLY will fund the Company through profitability.
Earnings Conference Call and Webcast
About EKTERLY® (sebetralstat)
EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in
About
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the
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2025 |
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2025 |
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Cash, cash equivalents & Marketable securities |
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$ |
300,214 |
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$ |
220,617 |
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Other current assets |
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19,933 |
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21,073 |
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Total current assets |
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320,147 |
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241,690 |
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Other assets |
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15,228 |
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9,080 |
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Total assets |
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$ |
335,375 |
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$ |
250,770 |
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Current liabilities |
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$ |
57,355 |
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$ |
45,167 |
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Long-term liabilities |
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280,731 |
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|
110,212 |
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Total Liabilities |
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338,086 |
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155,379 |
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Stockholders’ (deficit) equity |
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(2,711 |
) |
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95,391 |
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Total liabilities and stockholders’ (deficit) equity |
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$ |
335,375 |
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$ |
250,770 |
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For the Eight Months Ended |
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2025 |
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2024 |
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Product revenue, net |
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$ |
49,078 |
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$ |
— |
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Cost of revenue |
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3,081 |
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— |
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Research and development |
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33,371 |
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52,166 |
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Selling, general and administrative |
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124,663 |
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64,864 |
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Total operating expenses |
|
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161,115 |
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|
117,030 |
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Operating loss |
|
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(112,037 |
) |
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(117,030 |
) |
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Total other income |
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1,480 |
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6,576 |
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Loss before income taxes |
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(110,557 |
) |
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(110,454 |
) |
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Income tax (benefit) expense |
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(1,033 |
) |
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— |
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Net loss |
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$ |
(109,524 |
) |
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$ |
(110,454 |
) |
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Net loss per share, basic and diluted |
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$ |
(2.03 |
) |
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$ |
(2.30 |
) |
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Weighted average common shares outstanding, basic and diluted |
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53,870,007 |
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47,958,970 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20260325488975/en/
Investors:
Head, Investor Relations
(617) 771-5001
ryan.baker@kalvista.com
Media:
Sr. Director, Corporate Communications
(857) 356-0164
molly.cameron@kalvista.com
Source: