KalVista Pharmaceuticals報告了第一財務季度的業績和業務更新

美國食品和藥物管理局接受了sebetralstat的新藥申請，用於口服按需治療HAE；設定了2025年6月17日的PDUFA目標日期。

歐洲藥品管理局（EMA）通過了sebetralstat的上市授權申請（MAA）的提交。

2024年9月5日，KalVista製藥公司（納斯達克股票代碼：KALV）今天提供了第一個財政季度截至2024年7月31日的業務更新，併發布了財務業績。

“過去幾個月我們取得了穩步進展，包括最近FDA接受我們的新藥申請，歐洲藥品管理局（EMA）驗證了我們的MAA，”KalVista首席執行官Ben Palleiko表示。“我們期待在這些重要里程碑基礎上繼續前行，力爭在2024年晚些時候向英國、日本和其他國家提交批准申請，並計劃於2025年6月首次商業推出sebetralstat。我對KalVista整個團隊的辛勤工作表示感激，我們致力於為患有HAE的人羣提供這一重要治療。”

第一個財政季度和最近的業務亮點：

Sebetralstat

首個財季財務業績

關於KalVista藥品公司。

KalVista Pharmaceuticals, Inc.是一家專注於開發和提供口服藥物的全球藥品公司，用於重大未滿足需求的疾病。KalVista於2024年2月公佈了其新治療藥物sebetralstat在HAE的KONFIDENt試驗的積極3期數據。該藥物的新藥申請（NDA）已經被FDA接受，並計劃於2025年6月17日通過PDUFA目標日期。KalVista於2024年8月獲得了歐洲藥品管理局（EMA）對其申請的驗證。KalVista預計於2024年後期在英國、日本和其他國家提出申請。

有關KalVista的更多信息，請訪問www.kalvista.com或關注社交媒體@KalVista和LinkedIn。

前瞻性聲明

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.

媒體：

Jenn Snyder
企業事務副總裁
(857) 356-0479

jennifer.snyder@kalvista.com

投資者：

Ryan Baker

投資者關係主管

(617) 771-5001

ryan.baker@kalvista.com