Full Press Release Details
KalVista Pharmaceuticals Provides Operational Update and Reports Third Quarter Financial Results
US launch of EKTERLY gaining strong momentum with $13.7 million in net product
revenue for the third quarter
937 patient start forms received through October, reflecting rapid adoption as first and only oral on-demand treatment for hereditary angioedema (HAE)
Launched EKTERLY in Germany with initial
orders signaling encouraging demand
$309M in cash expected to fund the Company through profitability
Management to host conference call Tuesday, November 11th at 8:30 a.m. ET
FRAMINGHAM, Mass. & SALISBURY, England, November 10, 2025 - KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today provided
an operational update and reported financial results for the third quarter ended September 30, 2025.
"The US launch of EKTERLY is progressing
with significant momentum, driven by strong early demand and rapid adoption among physicians and people living with HAE. We continue to see encouraging trends, with both new patient starts and repeat prescriptions increasing consistently, reflecting
sustained uptake and confidence in the clinical value of EKTERLY as the first and only oral on-demand treatment for hereditary angioedema," said Ben Palleiko, CEO of KalVista. "We also recently
launched EKTERLY in Germany, with very positive initial demand. And with our most recent approval in Australia, we now hold five regulatory approvals and are on our way to making EKTERLY a truly global product. With the successful closing of our
recent $144 million convertible note offering, we have the financial resources to continue advancing our global launch strategy and building long-term growth."
Recent Business Highlights
EKTERLY (sebetralstat) Commercial Progress and Clinical Highlights
Organizational Updates
Third Quarter Financial Results
Earnings Conference Call and Webcast
KalVista management will host a conference call and webcast to discuss the results at 8:30 a.m. ET on Tuesday, November 11, 2025. The live audio webcast
will be accessible on the Investors section of the Company's website at www.ir.kalvista.com/event-calendar. An archived replay will be available on the site approximately two hours after completion of the event.
About EKTERLY (sebetralstat)
EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom, Switzerland and Australia 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.
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 community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.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," "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 additional 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, 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)
| September 30, 2025 | December 31, 2024 | |||||||
| Cash, cash equivalents & marketable securities | $ | 309,158 | $ | 268,345 | ||||
| Other current assets | 16,068 | 17,634 | ||||||
| Total current assets | 325,226 | 285,979 | ||||||
| Other assets | 14,705 | 8,837 | ||||||
| Total assets | $ | 339,931 | $ | 294,816 | ||||
| Current liabilities | $ | 45,069 | $ | 26,114 | ||||
| Long-term liabilities | 277,863 | 104,343 | ||||||
| Total Liabilities | 322,932 | 130,457 | ||||||
| Stockholders' equity | 16,999 | 164,359 | ||||||
| Total liabilities and stockholders' equity | $ | 339,931 | $ | 294,816 |
KALVISTA PHARMACEUTICALS, INC.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| For the Three Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| Product revenue, net | $ | 13,692 | $ | - | ||||
| Cost of revenue | 1,232 | - | ||||||
| Research and development | 11,993 | 18,680 | ||||||
| Selling, general and administrative | 46,517 | 24,800 | ||||||
| Total operating expenses | 59,742 | 43,480 | ||||||
| Operating loss | (46,050 | ) | (43,480 | ) | ||||
| Other (expense) income: | ||||||||
| Interest income | 1,875 | 1,580 | ||||||
| Interest expense | (4,757 | ) | - | |||||
| Foreign currency exchange (loss) gain | (884 | ) | 1,072 | |||||
| Other income, net | 2,491 | 1,744 | ||||||
| Total other (expense) income | (1,275 | ) | 4,396 | |||||
| Loss before income taxes | (47,325 | ) | (39,084 | ) | ||||
| Income tax expense | 2,157 | - | ||||||
| Net loss | $ | (49,482 | ) | $ | (39,084 | ) | ||
| Net loss per share, basic and diluted | $ | (0.92 | ) | $ | (0.84 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 53,883,681 | 46,590,514 |