– First pre-approval royalty acquisition and
first equity investment highlight evolving investment strategy
–
– Up to US$184
million investment brings capital deployment to over
US$1 billion since IPO –
– Long-term asset in new therapeutic area
further increases portfolio duration and diversification –
TORONTO, Nov. 4, 2024
/CNW/ - DRI Healthcare Trust (TSX: DHT.UN) (TSX: DHT.U) (the
"Trust"), a global leader in providing financing to advance
innovation in the life sciences industry, has acquired a royalty
interest in the worldwide net sales of all formulations of
sebetralstat from KalVista Pharmaceuticals ("KalVista") for an
aggregate purchase price of up to US$179
million, comprised of a US$100
million upfront payment, up to US$57
million in a sales-based milestone payment and a one-time
US$22 million optional payment.
Additionally, the Trust is making a US$5
million investment in KalVista's common stock in a private
placement transaction.
If approved, sebetralstat would be the first and only oral
on-demand therapy for treating attacks associated with hereditary
angioedema ("HAE"). HAE is a rare genetic disorder characterized by
recurring episodes of severe swelling in various parts of the body,
including the face, extremities, gastrointestinal tract, and
airways. Sebetralstat was developed by KalVista, a publicly listed
(NASDAQ: KALV) biopharmaceutical company headquartered in
Cambridge, Massachusetts. KalVista
operates in both the United States
and the United Kingdom with
approximately 150 employees.
Sebetralstat has a highly attractive clinical profile and has
exhibited significant efficacy and favourable safety in clinical
trials. The efficacy of sebetralstat has been evaluated in a phase
II trial as well as the phase III KONFIDENT trial, a randomized,
double-blind, placebo-controlled, three-way crossover design which
enrolled 136 adult and adolescent HAE patients. Sebetralstat showed
statistically and clinically significant efficacy in time reduction
to beginning of symptom relief, time reduction in attack severity
and time to complete attack resolution compared to placebo. On the
safety front, sebetralstat showed a safety profile similar to that
of placebo.
The U.S. Food and Drug Administration ("FDA") has accepted
KalVista's New Drug Application ("NDA") submission for
sebetralstat, and the agency set a Prescription Drug User Fee Act
("PDUFA") date of June 17, 2025.
Additionally, the European Medicines Agency ("EMA") has validated
the submission of the Marketing Authorization Application ("MAA")
for sebetralstat, and KalVista has submitted further MAAs in the
United Kingdom, Switzerland, Australia, and Singapore. KalVista will
use the proceeds of this transaction to fund the continued clinical
development and commercialization of sebetralstat.
"We are excited to add our first pre-approval asset to the
portfolio," said Ali Hedayat, Acting
Chief Executive Officer of the Trust's investment manager.
"Creating this synthetic royalty on such a high-quality asset like
sebetralstat showcases our ability to expand our addressable market
by seeking out opportunities with new partners like KalVista.
Sebetralstat has exhibited robust clinical data, and we are excited
about the potential long duration of cash flows that this deal
presents to our unitholders. We continue creating deal structures
that add further accretive value to all stakeholders within our
curated and well-diversified portfolio."
"We create solutions with high-quality partners working to
benefit the lives of patients around the world with high unmet
medical needs," said Navin
Jacob, Chief Investment Officer of the investment manager.
"Our royalty investment reflects our research driven belief that
sebetralstat has the potential to be the foundational treatment for
all people living with HAE. We would like to thank the KalVista
team for working together to craft a mutually beneficial deal for
both organizations."
The transaction entitles the Trust to a tiered royalty of 5.00%
on net sales up to and including US$500
million, 1.10% on net sales above US$500 million and up to and including
US$750 million, and 0.25% on net
sales above US$750 million. KalVista
is entitled to a potential one-time sales-based milestone payment
of US$50 million if annual worldwide
net sales of sebetralstat meet or exceed US$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 US$22
million. If KalVista chooses to receive this optional
payment, the royalty rate on net sales up to and including
US$500 million will increase from
5.00% to 6.00%, and the sales-based milestone amount will increase
to from US$50 to US$57 million.
Royalty receipts will be collected quarterly on a one-quarter
lag, with the first royalty receipt being paid to the Trust in the
quarter immediately following the launch of sebetralstat. Royalty
receipts are anticipated to be collected through at least 2041.
The Trust will also invest US$5
million in KalVista's common stock in a private placement
transaction. The private placement transaction is expected to close
on November 5, 2024, subject to the
satisfaction of customary closing conditions.
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 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 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
The Trust 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. The Trust'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 us
on LinkedIn.
Caution concerning forward-looking statements
This news release may contain forward-looking information within
the meaning of applicable securities legislation. Forward-looking
information can generally be identified by the use of words such as
"expect", "continue", "anticipate", "intend", "aim", "plan",
"believe", "budget", "estimate", "forecast", "foresee", "close to",
"target" or negative versions thereof and similar expressions. Some
of the specific forward-looking information in this news release
may include, among other things, the potential and timing of
royalty payments, the timing of closing of the private
placement transaction in KalVista's common stock, expectations
regarding KalVista's regulatory submissions, the anticipated
royalty income and anticipated sales of the products underlying
such royalties. This forward-looking information is subject to a
number of assumptions, including, but not limited to: statements
regarding the terms and conditions of our transaction being based
on the transaction documentation, statements with respect to
royalty income, total income and future sales of the products
underlying our existing royalties being based on assumptions with
respect to timing of generic drugs entering the market, competitor
drugs receiving approval and entering the market, and regulatory
measures under the Inflation Reduction Act, and is subject to a
number of risks and uncertainties, many of which are beyond the
Trust's control, that could cause actual results to differ
materially from those that are disclosed in or implied by such
forward-looking information. These risks and uncertainties include,
but are not limited to, those that are disclosed in the Trust's
most recent annual information form. All forward-looking
information in this news release speaks as of the date of this news
release. The Trust does not undertake to update any such
forward-looking information whether as a result of new information,
future events or otherwise except as required by law. Additional
information about these assumptions and risks and uncertainties is
contained in the Trust's filings with securities regulators,
including its latest annual information form and management's
discussion and analysis. These filings are also available on the
Trust's website at drihealthcare.com.
SOURCE DRI Healthcare Trust
