GRI Bio Enters into Asset Purchase Agreement with Aardvark Therapeutics, Inc. for the Sale of Legacy Asset, ADAIR
23 Agosto 2023 - 8:00AM
GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a
biotechnology company advancing an innovative pipeline of Natural
Killer T (“NKT”) cell modulators for the treatment of inflammatory,
fibrotic and autoimmune diseases, today announced that the Company
has entered into an asset purchase agreement pursuant to which
Aardvark Therapeutics, Inc. (“Aardvark”) will acquire certain
assets and intellectual property of the Company that pertain to
ADAIR (Abuse Deterrent Amphetamine Immediate Release). Aardvark
intends to utilize the ADAIR formation technology for the
development of certain follow-on pipeline programs.
ADAIR, a legacy asset from the merger with
Vallon Pharmaceuticals, Inc. (“Vallon”), is a proprietary
abuse-deterrent formulation of immediate release dextroamphetamine
for the treatment of attention deficit hyperactivity disorder
(“ADHD”) designed to deter attempts to crush and snort it or take
it by other non-oral routes that can produce a greater “high.”
Under the terms of the agreement, Aardvark will
assume responsibility for and endeavor to develop and commercialize
the purchased assets. Exclusive license rights to develop and
commercialize ADAIR in Europe and the UK were previously licensed
to Medice Arzneimittel Pütter GmbH, a leader in the European ADHD
market. GRI Bio will receive a modest up-front payment and the
potential to earn milestone payments for achievements in
development and commercialization from Aardvark up to approximately
$80 million.
“This agreement represents a great opportunity
for GRI Bio as it allows us to optimize our non-strategic asset
that we acquired through our merger with Vallon, while allowing us
to maintain our focus on advancing our pipeline of novel assets in
development for inflammatory and fibrotic diseases. We believe in
the potential of ADAIR and are pleased to have it continue on in
its development at Aardvark,” commented Marc Hertz, PhD, Chief
Executive Officer of GRI Bio.
“There continues to be an unmet need for
effective products that address the significant and growing problem
of stimulant misuse and abuse. ADAIR has demonstrated abuse
deterrent properties, but did not surmount the established
threshold in its most recent clinical trial to support pursuing an
FDA approval. However, we believe there is a real opportunity to
utilize Aardvark’s proprietary ARD-101 technology with its
established clinical safety profile to provide a new formulation to
substantially boost the deterrent effect of ADAIR to ultimately
gain regulatory approval,” added Tien Lee, M.D., Chief Executive
Officer of Aardvark.
As the current lead programs utilizing ARD-101
as an orally administered therapeutic agent for Prader-Willi
Syndrome will be continuing at Aardvark unabated, Aardvark is
considering establishing a separate entity to continue development
of ADAIR with ARD-101 to address the urgent need for effective
products that will deter stimulant abuse.
About Aardvark Therapeutics,
Inc.
Aardvark Therapeutics is a clinical stage
biopharmaceutical company focused on developing novel small
molecule therapeutics to activate innate homeostatic pathways for
the treatment of metabolic diseases, inflammation, and other
indications. Founded in 2017, the company has now advanced ARD-101
to Phase II clinical trials. Aardvark has multiple other programs
in its pipeline.
For more information visit
www.aardvarktherapeutics.com.
About GRI Bio, Inc.
GRI Bio is a clinical-stage biopharmaceutical
company focused on fundamentally changing the way inflammatory,
fibrotic and autoimmune diseases are treated. GRI Bio’s therapies
are designed to target the activity of NKT cells, which are key
regulators earlier in the inflammatory cascade, to interrupt
disease progression and restore the immune system to homeostasis.
NKT cells are innate-like T cells that share properties of both NK
and T cells and are a functional link between the innate and
adaptive immune responses. Type I invariant NKT (“iNKT”) cells play
a critical role in propagating the injury, inflammatory response,
and fibrosis observed in inflammatory and fibrotic indications. GRI
Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity
and is being developed as a novel oral therapeutic for the
treatment of idiopathic pulmonary fibrosis, a serious disease with
significant unmet need. The Company is also developing a pipeline
of novel type 2 NKT agonists for the treatment of systemic lupus
erythematosus. Additionally, with a library of over 500 proprietary
compounds, GRI Bio has the ability to fuel a growing pipeline.
Forward Looking Statements
This press release contains “forward-looking
statements” within the meaning of the “safe harbor” provisions of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by the use of words
such as “anticipate,” “believe,” “contemplate,” “could,”
“estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,”
“potential,” “predict,” “project,” “target,” “aim,” “should,”
“will,” “would,” or the negative of these words or other similar
expressions. These forward-looking statements are based on the
Company’s current beliefs and expectations. Forward-looking
statements include, but are not limited to, statements regarding:
the Company’s expectations with respect to development and
commercialization of the Company’s or Aardvark’s product
candidates, the initiation or completion of clinical trials, the
potential benefits and impact of the Company’s or Aardvark’s
product candidates, any estimate or implication as to potential
market size or potential revenue, and any reference to potential
milestone achievements or related contingent payments, which may or
may not be achieved, paid or received in the future. Actual results
may differ from the forward-looking statements expressed by the
Company or Aardvark in this press release and consequently, you
should not rely on these forward-looking statements as predictions
of future events. These forward-looking statements are subject to
inherent uncertainties, risks and assumptions that are difficult to
predict, including, without limitation: (1) the inability to
maintain the listing of the Company’s common stock on Nasdaq; (2)
changes in applicable laws or regulations; (3) the inability of the
Company to raise financing in the future; (4) the success, cost and
timing of the Company’s or Aardvark’s product development
activities; (5) the inability of the Company or Aardvark to obtain
and maintain regulatory clearance or approval for their respective
products, and any related restrictions and limitations of any
cleared or approved product; (6) the inability of the Company to
identify, in-license or acquire additional technology; (7) the
inability of the Company or Aardvark to compete with other
companies currently marketing or engaged in the development of
products and services that the Company or Aardvark are currently
developing; (8) the size and growth potential of the markets for
the Company’s or Aardvark’s products and services, and their
respective ability to serve those markets, either alone or in
partnership with others; (9) the failure to achieve any milestones
or receive any milestone payments under the asset purchase
agreement; (10) inaccuracy in the Company’s or Aardvark’s estimates
regarding expenses, future revenue, capital requirements and needs
for and the ability to obtain additional financing; (11) the
Company’s or Aardvark’s ability to protect and enforce its
intellectual property portfolio, including any newly issued
patents; and (12) other risks and uncertainties indicated from time
to time in the Company’s filings with the U.S. Securities and
Exchange Commission (the “SEC”), including the risks and
uncertainties described in the “Risk Factors” section of the
Company’s most recent Annual Report on Form 10-K filed with the SEC
on February 24, 2023 and subsequently filed reports.
Forward-looking statements contained in this announcement are made
as of this date, and the Company undertakes no duty to update such
information except as required under applicable law.
Investor Contact:JTC Team,
LLCJenene Thomas(833) 475-8247GRI@jtcir.com
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