Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical
company revolutionizing the delivery of therapies to the back of
the eye through the suprachoroidal space (SCS®), announced today it
has entered into a Royalty Interest Purchase and Sale Agreement
(the agreement) with HealthCare Royalty Partners (HealthCare
Royalty).
Clearside intends to use the proceeds from the
agreement to support ongoing clinical development of its pipeline,
including CLS-AX (axitinib injectable suspension) administered by
suprachoroidal injection via Clearside’s SCS Microinjector®.
“The approval and launch of our first commercial
product, XIPERE, provides the opportunity to access this meaningful
non-dilutive capital which adds financial flexibility as we advance
our development pipeline,” said George Lasezkay, Pharm.D., J.D.,
Clearside’s President and Chief Executive Officer. “We are pleased
to partner with HealthCare Royalty to support the funding of
further clinical trials of CLS-AX, our proprietary small molecule
suspension of the tyrosine kinase inhibitor, axitinib, delivered
suprachoroidally by our SCS Microinjector.”
Under the terms of the agreement, Clearside will
receive an initial payment of $32.5 million, less certain expenses.
At the same time, an additional $12.5 million will be deposited in
an escrow account to be released to Clearside upon attainment of a
pre-specified sales milestone for XIPERE® (triamcinolone acetonide
injectable suspension) for suprachoroidal use. The terms of the
agreement also provide for an additional milestone payment of $20
million to Clearside upon attainment of a second pre-specified 2024
sales milestone for XIPERE.
In exchange for the payments described above,
HealthCare Royalty will receive all royalties and milestone
payments due to Clearside from XIPERE and certain SCS Microinjector
license agreements, subject to a cap of 2.5 times the total
purchase price paid by HealthCare Royalty under the agreement; the
cap may be increased under certain circumstances. The arrangement
with HealthCare Royalty specifically excludes all Clearside’s
internal development programs, including CLS-AX, as well as any
future in-licensed assets.
“We are pleased to partner with Clearside
Biomedical to support their platform delivering therapies to the
back of the eye through the suprachoroidal space,” said Clarke
Futch, Chairman and Chief Executive Officer of HealthCare Royalty.
“Our investment reflects our belief in the strong value of
Clearside’s SCS injection platform and XIPERE, the first approved
therapeutic delivered into the suprachoroidal space. This
underscores our mission to facilitate innovation by high growth
biopharmaceutical companies globally.”
The agreement includes customary provisions for
a transaction of this nature, a repayment provision at Clearside's
option, and change of control provisions. Clearside has
concurrently filed a Form 8-K which includes further details.
Clearside expects to close the transaction in August 2022.
JMP Securities LLC served as a financial advisor
to Clearside on this transaction.
About XIPERE®
(triamcinolone acetonide injectable suspension) for
suprachoroidal use
XIPERE® (triamcinolone
acetonide injectable suspension) for suprachoroidal use is a
proprietary suspension of the corticosteroid triamcinolone
acetonide for administration to the suprachoroidal space for the
treatment of macular edema associated with uveitis. Bausch + Lomb,
a leading global eye health company dedicated to helping people see
better to live better, has the exclusive license for the
commercialization and development of XIPERE in the United States
and Canada. Arctic Vision, a specialty ophthalmology company based
in China, has the exclusive license for the commercialization and
development of XIPERE, which they refer to as Arcatus™, in Greater
China, South Korea, Australia, New Zealand, India and the ASEAN
Countries. XIPERE was approved by the U.S. Food and Drug
Administration in October 2021 and is commercially available in the
U.S.
About CLS-AX (axitinib injectable
suspension)
CLS-AX (axitinib injectable suspension) is a
proprietary suspension of axitinib for suprachoroidal injection.
Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to
treat renal cell cancer that achieves pan-VEGF blockade, directly
inhibiting VEGF receptors-1, -2, and -3 with high potency and
specificity. Clearside believes this broad VEGF blockade may have
efficacy advantages over existing retinal therapies by acting at a
different level of the angiogenesis cascade, and may benefit
patients who sub-optimally respond to current, more narrowly
focused anti-VEGF therapies. Suprachoroidal injection of this
proprietary suspension of axitinib has demonstrated meaningful
potential in preclinical studies in multiple species. Preclinical
results from Clearside and independent investigators have shown
pharmacodynamic effects with reduced growth of experimental
neovascularization and decreased fluorescein leakage. With
suprachoroidal administration of axitinib, there is the potential
to achieve prolonged duration and targeted delivery to affected
tissue layers to potentially treat VEGF-driven disorders such as
wet AMD, diabetic macular edema and diabetic retinopathy.
About Clearside’s SCS
Microinjector®
Clearside’s patented, proprietary suprachoroidal
space (SCS®) injection treatment approach offers unprecedented
access to the back of the eye where sight-threatening disease often
occurs. Clearside’s proprietary SCS Microinjector® can be used to
inject a wide variety of drug candidates that are specifically
formulated to be delivered via suprachoroidal injection. The SCS
Microinjector provides targeted delivery to potentially improve
efficacy and compartmentalization of medication to reduce or
eliminate toxic effects on non-diseased cells. The SCS
Microinjector is composed of a syringe and two 30-gauge hollow
microneedles of varying lengths, each less than 1.2 millimeters,
within a custom-designed hub that optimizes insertion and
suprachoroidal administration of drugs.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company revolutionizing the delivery of therapies
to the back of the eye through the suprachoroidal space (SCS®).
Clearside’s SCS injection platform, utilizing the Company’s
proprietary SCS Microinjector®, enables an in-office, repeatable,
non-surgical procedure for the targeted and compartmentalized
delivery of a wide variety of therapies to the macula, retina or
choroid to potentially preserve and improve vision in patients with
sight-threatening eye diseases. Clearside is developing its own
pipeline of small molecule product candidates for administration
via its SCS Microinjector and strategically partners its SCS
injection platform with companies utilizing other ophthalmic
therapeutic innovations. Clearside’s first product, XIPERE®
(triamcinolone acetonide injectable suspension) for suprachoroidal
use, is commercially available in the U.S. For more information,
please visit www.clearsidebio.com.
About HealthCare Royalty
Partners
HealthCare Royalty purchases royalties and uses
debt-like structures to invest in commercial or near-commercial
stage life science assets. HealthCare Royalty has $6.2 billion in
cumulative capital commitments with offices in Stamford (CT), San
Francisco, Boston and London. For more information, visit
www.healthcareroyalty.com. HEALTHCARE ROYALTY PARTNERS® is a
registered trademark of HealthCare Royalty Management, LLC in the
U.S. and a trademark in other countries.
Cautionary Note Regarding
Forward-Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe”, “expect”, “may”, “plan”,
“potential”, “will”, and similar expressions, and are based on
Clearside’s current beliefs and expectations. These forward-looking
statements include statements regarding the Company’s expected use
of the proceeds from the agreement with HealthCare Royalty, the
potential benefits of therapies using Clearside’s SCS
Microinjector® and statements regarding the clinical development of
CLS-AX,. These statements involve risks and uncertainties that
could cause actual results to differ materially from those
reflected in such statements. Risks and uncertainties that may
cause actual results to differ materially include uncertainties
inherent in the conduct of clinical trials, Clearside’s reliance on
third parties over which it may not always have full control,
uncertainties regarding the COVID-19 pandemic and other risks and
uncertainties that are described in Clearside’s Annual Report on
Form 10-K for the year ended December 31, 2021, filed with the U.S.
Securities and Exchange Commission (SEC) on March 11, 2022, and
Clearside’s other Periodic Reports filed with the SEC. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Clearside as of
the date of this release, and Clearside assumes no obligation to,
and does not intend to, update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Investor and Media Contacts:Jenny Kobin Remy
Bernarda ir@clearsidebio.com(678) 430-8206
Source: Clearside Biomedical, Inc.
Clearside Biomedical (NASDAQ:CLSD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Clearside Biomedical (NASDAQ:CLSD)
Historical Stock Chart
From Apr 2023 to Apr 2024