–Provides up to $184 million investment to
support commercial launch of sebetralstat which, if approved, will
be the first and only oral on-demand therapy for HAE –
–Strengthens financial position as KalVista
establishes global footprint for expected launches in multiple
geographies in 2025–
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) (“KalVista”),
today announced the closing of a synthetic royalty financing
agreement with DRI Healthcare Trust (“DRI”) for up to $179 million,
comprised of a $100 million upfront payment, a one-time $22 million
optional payment upon U.S. product approval, and up to $57 million
in a sales-based milestone payment. The proceeds of this
transaction will be used to fund the commercialization of
sebetralstat, which, if approved, is expected to be the first
approved oral on-demand therapy to treat hereditary angioedema
(“HAE”). KalVista has a New Drug Application for sebetralstat under
review by the U.S. Food and Drug Administration (the “FDA”) with a
Prescription Drug User Free Act (“PDUFA”) target action date of
June 17, 2025.
DRI has also indicated an interest in investing up to $5 million
in KalVista’s common stock in a private placement transaction.
However, this indication of interest is not binding agreement or
commitment to purchase KalVista’s common stock and DRI may decide
to purchase more, less or no shares of KalVista’s common stock and
KalVista may decide to not sell shares of its common stock to
DRI.
“This financing arrangement is a pivotal step for KalVista,
enabling us to continue building a global commercial organization
ahead of the potential U.S. launch of sebetralstat in June 2025,”
said Ben Palleiko, Chief Executive Officer of KalVista. “Moving
forward, we are well-positioned to achieve long-term sustainable
growth as we focus on delivering a potentially transformative
treatment for people living with HAE. We appreciate DRI’s
confidence in KalVista and sebetralstat to make this their first
pre-approval investment.”
“Our royalty investment reflects DRI’s research-driven belief
that sebetralstat has the potential to be the foundational
treatment for all people living with HAE. We are excited to support
the KalVista team’s continued transformation toward a commercial
organization at this important stage,” said Navin Jacob, Chief
Investment Officer of DRI.
“Acquiring a synthetic royalty on such a high-quality asset like
sebetralstat showcases DRI’s willingness to develop partnerships
with companies like KalVista who are seeking to meaningfully
improve patients’ lives,” said Ali Hedayat, Acting Chief Executive
Officer of DRI.
Synthetic Royalty Financing Terms
Under the terms of the synthetic royalty financing agreement,
KalVista will immediately receive $100 million and be obligated to
pay DRI a tiered royalty of 5.00% of annual global net sales up to
and including $500 million, 1.10% of annual global net sales above
$500 million and up to and including $750 million, and 0.25% of
annual global net sales above $750 million. KalVista is entitled to
a potential one-time sales-based milestone payment of $50 million
if annual global net sales of sebetralstat meet or exceed $550
million in any calendar year before January 1, 2031.
If sebetralstat is approved prior to October 1, 2025, KalVista
will have the option to receive a one-time payment of $22 million.
If KalVista chooses to receive this optional payment, the royalty
rate on net sales up to and including $500 million will increase
from 5.00% to 6.00%, and the sales-based milestone amount will
increase from $50 million to $57 million.
Jefferies LLC acted as exclusive financial advisor to KalVista
on the synthetic royalty financing.
About Sebetralstat
Discovered and developed entirely by the scientific team at
KalVista, sebetralstat is a novel, investigational oral plasma
kallikrein inhibitor for the on-demand treatment of HAE.
Sebetralstat received Fast Track and Orphan Drug Designations from
the FDA, as well as Orphan Drug Designation and an approved
Pediatric Investigational Plan from the European Medicines Agency
(“EMA”).
About Hereditary Angioedema
HAE is a rare genetic disease resulting in deficiency or
dysfunction in the C1 esterase inhibitor (“C1INH”) protein and
subsequent uncontrolled activation of the kallikrein-kinin system.
People living with HAE experience painful and debilitating attacks
of tissue swelling in various locations of the body that can be
life-threatening depending on the location affected. All currently
approved on-demand treatment options require either intravenous or
subcutaneous administration.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical
company whose mission is to develop and deliver life-changing oral
medicines for people affected by rare diseases with significant
unmet need. Sebetralstat, KalVista’s novel, investigational
candidate for the oral, on-demand treatment of hereditary
angioedema, is under regulatory review by the FDA with a PDUFA goal
date of June 17, 2025. In addition, KalVista has completed
marketing authorization application (“MAA”) submissions for
sebetralstat to the EMA as well as regulatory authorities in the
United Kingdom, Switzerland, Australia, and Singapore, and KalVista
anticipates filing a MAA in Japan in late 2024.
For more information about KalVista, please visit
www.kalvista.com or follow on social media at @KalVista and
LinkedIn.
About DRI Healthcare Trust
DRI is managed by DRI Capital Inc. (“DRI Healthcare”), a pioneer
in global pharmaceutical royalty monetization. Since its initial
public offering in 2021, the Trust has deployed more than US$1.0
billion, acquiring more than 25 royalties on 20-plus drugs,
including Eylea, Orserdu, Omidria, Spinraza, Stelara, Vonjo, Zejula
and Zytiga. DRI’s units are listed and trade on the Toronto Stock
Exchange in Canadian dollars under the symbol “DHT.UN” and in U.S.
dollars under the symbol “DHT.U”. To learn more, visit
drihealthcare.com or follow DRI on LinkedIn.
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 KalVista expects. Examples
of forward-looking statements include, among others, the potential
and timing of royalty payments, the potential timing of an equity
investment in KalVista’s common stock, expectations regarding
KalVista’s regulatory submissions, the anticipated royalty income
and anticipated sales of products underlying such royalties, timing
or outcomes of communications with the FDA, the success of any
efforts to commercialize sebetralstat, and the ability of
sebetralstat and other candidates in development to treat HAE or
other diseases. Further information on potential risk factors that
could affect KalVista’s business and financial results are detailed
in its filings with the Securities and Exchange Commission,
including in its annual report on Form 10-K for the year ended
April 30, 2024, its quarterly reports on Form 10-Q, and its other
reports that KalVista may make from time to time with the
Securities and Exchange Commission. KalVista undertakes 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241104880996/en/
Jenn Snyder Vice President, Corporate Affairs (617) 448-0281
jsnyder@kalvista.com
Ryan Baker Head, Investor Relations (617) 771-5001
ryan.baker@kalvista.com
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