–Announced seventh regulatory application submission and secured orphan drug designation for sebetralstat in Japan for hereditary angioedema–
– Presented new data that showed effectiveness of sebetralstat to address critical unmet needs in laryngeal attacks, adolescents with HAE and patients experiencing attacks despite long-term prophylaxis (LTP)–
–Will host virtual investor day to discuss commercialization strategy ahead of June PDUFA–
CAMBRIDGE, Mass. & SALISBURY, England, March 12, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today released financial results for the third fiscal quarter ended January 31, 2025, and provided an operational update.
"Sebetralstat is poised to be the first and only oral on-demand treatment for HAE, with the potential to become the foundational treatment for this disease," said Ben Palleiko, Chief Executive Officer of KalVista. "With seven regulatory submissions globally and the first regulatory approval expected in June, we are confident in our ability to achieve commercial success. Our robust data set, including recent presentations at WSAAI and AAAAI, demonstrates how sebetralstat could address critical unmet needs, particularly for vulnerable populations, such as those experiencing HAE attacks despite LTP, adolescents with HAE, and individuals facing laryngeal attacks. We continue to receive positive feedback from healthcare providers and people living with the disease, who share their excitement about the potential of an oral, on-demand option that offers both high efficacy and low treatment burden."
Third Fiscal Quarter and Recent Business Highlights
Sebetralstat
In January 2025, KalVista announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) granted Orphan Drug Designation to sebetralstat, alongside the Company's submission of a New Drug Application (NDA) for sebetralstat in that country. This marks the Company’s seventh regulatory submission since mid-2024, including to the U.S. FDA, which issued a PDUFA goal date of June 17, 2025. The Company has also completed submissions to the U.K., Switzerland, Australia, Singapore, and the European Medicines Agency, which validated the Marketing Authorization Application in August 2024.
KalVista continued to build on the extensive clinical evidence demonstrating the efficacy and safety of sebetralstat for HAE. The Company presented new sebetralstat data at the 2025 Western Society of Allergy, Asthma, and Immunology (WSAAI) and the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Key highlights from these medical congresses are outlined below:
WSAAI
Data from KONFIDENT-S showed patients on LTP averaged 1.7 HAE attacks per month and showed symptom relief for treated attacks with sebetralstat in a median of 1.3 hours. These results confirm that sebetralstat was shown to be effective for the on-demand treatment of HAE attacks regardless of the type of LTP therapy used.
AAAAI
Interim analysis from KONFIDENT-S showed sebetralstat enabled prompt treatment response of laryngeal HAE attacks with a median time of 1 hour and 16 minutes to onset of symptom relief. No patient reported difficulty swallowing the film-coated tablet.
Pooled survey analysis showed adolescents treated attacks with sebetralstat in a median of 4 minutes after onset of symptoms compared to over 3 hours based on international survey data presented at the meeting.
KalVista will host a virtual investor day on Tuesday, March 25th, at 8:00 a.m. ET, highlighting the commercialization strategy and launch plans for sebetralstat. The event will include presentations by members of the KalVista executive team and key healthcare experts in the field of HAE.
Organizational
In preparation for the anticipated U.S. commercial launch, KalVista has fully onboarded its field sales team, comprised of experts in HAE, allergy, and rare diseases.
Strengthening its leadership, the Company appointed Jeb Ledell as Chief Operating Officer and Chris Hamblett, PhD, Senior Vice President of Corporate Development.
In November 2024, KalVista raised a total of $160 million in aggregate gross proceeds through concurrent synthetic royalty financing and equity offerings. The synthetic royalty financing agreement with DRI Healthcare provides up to $179 million in non-dilutive funding, including $100 million upfront. In addition, the Company closed a public offering raising $55 million as well as $5 million in a private placement to DRI Healthcare.
Third Fiscal Quarter Financial Results
The Company did not record any revenue for the three months ended January 31, 2025 or three months ended January 31, 2024.
Research and development expenses were $12.6 million for the three months ended January 31, 2025, compared to $22.5 million for the same period in the prior fiscal year. The decrease was primarily attributable to reduced clinical trial expenses, preclinical activities and recognizing expense associated with sebetralstat pre-commercial awareness within General & Administrative.
General and administrative expenses were $30.3 million for the three months ended January 31, 2025, compared to $10.6 million for the same period in the prior fiscal year. The increase was primarily due to pre-commercial planning activities related to sebetralstat.
As of January 31, 2025, the Company had cash, cash equivalents and marketable securities of approximately $253.2 million.
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. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities.
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.
KalVista Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
January 31
April 30,
2025
2024
Cash, Cash Equivalents & Marketable Securities
$
253,203
$
210,401
Other Current Assets
14,156
15,289
Total Current Assets
267,359
225,690
Other Assets
8,634
9,714
Total Assets
$
275,993
$
235,404
Current Liabilities
25,615
22,807
Long-term Liabilities
105,252
6,015
Total Liabilities
130,867
28,822
Total Stockholders’ Equity
145,126
206,582
Total Liabilities and Stockholders' Equity
$
275,993
$
235,404
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
Nine Months Ended
January 31,
January 31,
2025
2024
2025
2024
Operating expenses:
Research and development
12,594
22,523
55,818
60,919
General and administrative
30,346
10,628
77,147
31,071
Total operating expenses
42,940
33,151
132,965
91,990
Operating loss
(42,940
)
(33,151
)
(132,965
)
(91,990
)
Other income:
Interest income
1,394
684
4,443
2,383
Interest expense related to the sale of future royalties
(2,842
)
-
(2,842
)
-
Foreign currency exchange rate (loss) gain
(983
)
1,120
(401
)
277
Other income
1,109
2,319
4,794
7,335
Total other income
(1,322
)
4,123
5,994
9,995
Net loss
$
(44,262
)
$
(29,028
)
$
(126,971
)
$
(81,995
)
Net loss per share, basic and diluted
$
(0.92
)
$
(0.84
)
$
(2.70
)
$
(2.37
)
Weighted average common shares outstanding, basic and diluted
