NEW YORK, Nov. 24, 2021 /PRNewswire/ -- Seelos
Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage
biopharmaceutical company focused on the development of therapies
for central nervous system disorders and rare diseases, today
announced it has entered into an exclusive license agreement
(License Agreement), whereby it acquired a worldwide license
(excluding China, Taiwan, Macau
and Hong Kong) from iX Biopharma
Ltd (iX Biopharma) for Wafermine™, a sublingual racemic ketamine
wafer, and a worldwide license for other sublingual ketamine
wafers, delivered using a proprietary fast-dissolving wafer-based
drug delivery platform technology known as WaferiX™.
Seelos plans to evaluate sublingual ketamine, now named SLS-003,
in pain indications such as chronic neuropathic pain and Complex
Regional Pain Syndrome (CRPS) and in additional psychiatric
disorders, including post-traumatic stress disorder (PTSD).
The US Food and Drug Administration (FDA) has granted Wafermine™
Orphan Drug designation for the treatment of CRPS.
"Our licensing of this new program broadens Seelos' ketamine
franchise with a formulation that we believe will be more suitable
for chronic dosing in indications like CRPS and PTSD, which are
both very difficult indications to treat effectively," said Raj
Mehra, Ph.D., Chairman and CEO of Seelos. "The pharmacokinetic,
pharmacodynamic and safety profiles of SLS-003 that have been
demonstrated to date suggest a formulation with the potential of
being prescribed with less restrictions than current formulations.
Our team is very excited to be developing both acute, in SLS-002,
and a potentially chronic, in SLS-003, ketamine-based therapy
programs. We look forward to initiating studies with SLS-003 in
2022 and our recent capital raises have accounted for the expected
development costs for initiating
studies."
"We are delighted to collaborate with Seelos Therapeutics, whose
deep insights in ketamine drug development make them an ideal
partner to further the development of Wafermine™ and the other
sublingual ketamine products," said Eddy
Lee, Chairman and CEO of iX Biopharma. "Licensing our
WaferiX™-based pharmaceutical drugs to suitable third parties for
development and commercialization is a core strategy to unlock the
value of our assets. We are therefore excited that this
commercially significant agreement with Seelos is a validation of
our ability to deliver on this strategy."
Pursuant to the License Agreement, Seelos will pay iX Biopharma
a one-time, upfront fee of $9,000,000, comprised of $3,500,000 in cash and $5,500,000 in restricted shares of Seelos' common
stock for the worldwide license for Wafermine™ (excluding
China, Taiwan, Macau
and Hong Kong), the worldwide
license for WaferiX™ in other ketamine formulations,
and clinical supplies. Seelos will also pay iX Biopharma certain
milestone payments contingent on achievement by Seelos of certain
development, regulatory and commercial milestones and a low
double-digit royalty on future net sales of certain licensed
products.
About iX Biopharma LTD
iX Biopharma is a specialty pharmaceutical and nutraceutical
company listed on the Catalist board of the Singapore Exchange
Securities Trading Limited (SGX-ST), operating a fully integrated
business model from drug development to manufacturing and supply,
with facilities in Australia. The
Group is focused on the development and commercialization of
therapies for diseases of the central nervous system using novel,
patent-protected formulations for sublingual delivery.
For more information about iX Biopharma LTD, please visit their
website: https://www.ixbiopharma.com/.
About WaferiX™
The licensed products utilize iX Biopharma's patented sublingual
wafer technology, known as WaferiX™, to disintegrate under the
tongue rapidly for faster therapeutic action and predictable
dosing. In pharmacokinetic studies, sublingual delivery using
WaferiX™ increased bioavailability of active compounds when
compared to oral administration, while avoiding excessively high
peak plasma concentrations typical of IV bolus dosing.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on the development and advancement of novel
therapeutics to address unmet medical needs for the benefit of
patients with central nervous system (CNS) disorders and other rare
disorders. The Company's robust portfolio includes several
late-stage clinical assets targeting psychiatric and movement
disorders, including orphan diseases. Seelos is based in
New York, New York.
For more information, please visit our website:
http://seelostherapeutics.com, the content of which is not
incorporated herein by reference.
Forward Looking Statements
Statements made in this press release, which are not historical
in nature, constitute forward-looking statements for purposes of
the safe harbor provided by the Private Securities Litigation
Reform Act of 1995. These statements include, among others, those
related to the efficacy and potential applications for the Licensed
Products and associated Wafermine technology; the satisfaction of
the conditions related to any contingent milestone or royalty
payments; and the funding of all future development, manufacturing
and commercialization of the Licensed Products. These
statements are based on Seelos' current expectations and beliefs
and are subject to a number of risks and uncertainties that could
cause actual results to differ materially from those described in
the forward-looking statements. Risks associated with Seelos'
business and plans described herein include, but are not limited
to, the risks that Seelos will not realize the expected benefits
from the license with iX Biopharma, risks associated with the
implementation of Seelos' business strategy, the risks related to
raising capital to fund its development plans and ongoing
operations, risks related to Seelos' current stock price, risks
related to the global impact of COVID-19, as well as other factors
expressed in Seelos' periodic filings with the U.S. Securities and
Exchange Commission, including its most recent Annual Report on
Form 10-K and Quarterly Reports on Form 10-Q. Although we believe
that the expectations reflected in our forward-looking statements
are reasonable, we do not know whether our expectations will prove
correct. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
even if subsequently made available by us on our website or
otherwise. We do not undertake any obligation to update, amend or
clarify these forward-looking statements, whether as a result of
new information, future events or otherwise, except as may be
required under applicable securities laws.
Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
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