KalVista Pharmaceuticals Highlights Strategic Plans for Coming Fiscal Year
01 May 2024 - 8:30PM
Business Wire
- Regulatory filings planned for US, EU, UK and
Japan to enable multiple 2025 commercial launches –
- Development strategy refined for oral Factor
XIIa program –
- Organizational focus to drive results and set
path to positive cash flow –
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
- New Drug Application submission to US FDA planned for June
2024
- Market Authorization Application submissions to both European
Medicines Agency and UK MHRA planned for Q3 2024
- JNDA submission to Japanese Pharmaceuticals and Medical Devices
Agency planned for Q4 2024
- Regulatory review timelines enable potential launches of
sebetralstat in these territories in calendar 2025 and early
2026
- To enable the broadest possible global launch, we intend to
engage commercial partners in certain international markets,
targeting to select initial partners over the course of 2024
Continued lifecycle extension activities for sebetralstat, to
grow the market opportunity
- Commence pediatric trial (KONFIDENT-KID) in Q3 2024, using an
orally disintegrating tablet (ODT) formulation developed
specifically for pediatric use. If approved, sebetralstat would be
the first oral therapy in pediatric patients under age 18. In
addition, sebetralstat would be only the second FDA-approved
on-demand therapy of any type in this population
- Conversion of adolescent and adult participants in the ongoing
KONFIDENT-S study to an ODT formulation in Q4 2024, enabling a
potential 2026 sNDA approval. If approved, the ODT formulation
would provide people living with HAE with an additional novel
option for oral on-demand treatment
Resources focused on sebetralstat for on-demand HAE with goal
of positive cash flow
- Following a strategic review of the preclinical oral Factor
XIIa program, we have determined that the most promising
indications for development lie outside the Company’s core
capabilities. Therefore, further development of the program will be
dependent upon collaboration with a strategic partner with
expertise and resources to support advancement of the clinical
candidates in these potential indications. We intend to engage with
potential partners over the course of 2024 and will provide updates
as warranted
- Based on this prioritization we intend to reduce spending on
discovery and preclinical activities by more than 75%, to less than
$5 million per year
- We believe that these portfolio and investment prioritization
decisions, in combination with the anticipated launch of
sebetralstat, can support the Company becoming cash flow positive
within the first few years of the anticipated sebetralstat
commercial launch
Upcoming medical & patient organization meetings at which
KalVista will present data
- EAC 2024 (May 30 – June 2, Palm Beach, FL)
- EAACI Congress 2024 (May 31 – June 3, Valencia, Spain)
- Bradykinin Symposium 2024 (September 5-6, Berlin, Germany)
- HAEi Global Leadership Workshop (October 3-6, Copenhagen,
Denmark)
- ACAAI Conference 2024 (October 24-28, Boston)
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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version on businesswire.com: https://www.businesswire.com/news/home/20240501899140/en/
KalVista Pharmaceuticals, Inc. Jarrod Aldom Vice
President, Corporate Communications (201) 705-0254
jarrod.aldom@kalvista.com
Ryan Baker Head, Investor Relations (617) 771-5001
ryan.baker@kalvista.com
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