CAMBRIDGE, Mass. & SALISBURY, England / May 01, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced its strategic plans for fiscal year 2025, beginning May 1, including for sebetralstat, the Company’s investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).
“2024 has been an exciting and busy year for KalVista, as we achieved key milestones with our positive phase 3 KONFIDENT data and the completion of a substantial financing,” said Ben Palleiko, Chief Executive Officer of KalVista. “For the coming fiscal year, we have set a high bar as we finalize multiple regulatory filings for sebetralstat and plan for rapid commercialization upon approval. Given the scale of that opportunity, we will focus our resources on activities that support the launch, enabling sebetralstat to become the leading on-demand therapy for all people living with HAE and allowing us to work towards positive cash flow within the first few years of commercialization.”
Fiscal Year 2025 Strategic Plans:
Regulatory filings and commercial partners for sebetralstat, to support global launch plans
Continued lifecycle extension activities for sebetralstat, to grow the market opportunity
Resources focused on sebetralstat for on-demand HAE with goal of positive cash flow
Upcoming medical & patient organization meetings at which KalVista will present data
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need. KalVista disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024. The Company anticipates submitting a new drug application to the U.S. Food and Drug Administration (FDA) for sebetralstat in June 2024 and expects to file for approval in the UK, Europe and Japan later in 2024.
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," "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 or other international regulatory agencies, our expectations about safety and efficacy of our product candidates, our ability to obtain regulatory approvals for sebetralstat and other candidates in development within our expected timelines or at all, our success in engaging with potential commercial partners, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, our ability to commence pediatric trials of sebetralstat and develop an OTD formulation, the future progress and potential success of our oral Factor XIIa program, our ability to reduce spending on discovery and preclinical activities, and our expectation to become cash flow positive. 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, 2023, 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.
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