TIDMPRTC
PureTech Health PLC
17 August 2021
17 August 2021
PureTech Health plc
PureTech Founded Entity Akili Enters Strategic Licensing
Agreement with TALi, Extending Akili Portfolio and Industry
Leadership in Prescription Digital Therapeutics for Cognitive
Impairments
Akili to license TALi's technology for use in the U.S. as part
of the agreement
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company today
announced that its Founded Entity, Akili Interactive ("Akili"),
maker of EndeavorRx(R), the first and only prescription video game
treatment, and Australian digital health company TALi(R) (ASX:TD1),
("TALi"), completed an agreement for Akili to license TALi's
technology designed to address early childhood attention
impairments.
The license is intended to build on the companies' collective
clinical development experience and Akili's success in bringing
EndeavorRx through the U.S. regulatory process and to market. The
companies plan to work together to execute clinical trials of the
TALi technology in pediatric ADHD in the United States and pursue
U.S. Food and Drug Administration ("FDA") regulatory clearance.
Under the terms of the agreement, Akili will lead potential U.S.
commercialization and roll-out.
Through this agreement, Akili expects to expand its leadership
in prescription digital therapeutics ("PDTs") for cognitive
impairments and chart a path for a new patient demographic to
benefit from innovative technologies proven to improve attention.
TALi's technology builds on Akili's product portfolio and
complements its flagship product EndeavorRx, which is FDA-cleared
to improve attention function in children ages 8-12 with ADHD (full
indication below).
The full text of the announcement from Akili is as follows:
Akili Enters Strategic Licensing Agreement with TALi, Extending
Akili Portfolio and Industry Leadership in Prescription Digital
Therapeutics for Cognitive Impairments
Through their shared focus on rigorous clinical validation and
high-end user experience, the companies will continue to
revolutionize the treatment of children with
attention-deficit/hyperactivity disorder (ADHD)
Akili will license TALi's technology for use in the U.S. in a
deal estimated at $37.5M in future contingent milestone payments
plus royalties
BOSTON, Mass. and Melbourne, Australia - August 17, 2021 - Akili
Interactive ("Akili"), a leading prescription digital therapeutics
company and maker of EndeavorRx (R), the first and only
prescription video game treatment, and Australian Securities
Exchange listed digital health company TALi(R) (ASX:TD1) ,
("TALi"), today announced they have completed an agreement for
Akili to license TALi's technology designed to address early
childhood attention impairments.
TALi's patented technology utilizes new mechanisms specifically
engineered to assess, target, and improve attention in early
childhood (ages 3-8) and is delivered through an engaging video
game experience. Combining over 25 years of research in
developmental psychology and cognitive neuroscience, TALi's
training program has demonstrated improved attention in both
neurodiverse and neurotypical children, specifically showing
improvements in numeracy skills, gains in selective attention
skills, and behavioral improvements in a classroom setting. Study
data have been published in multiple peer-reviewed papers . The
technology is currently available in Australia, India, Singapore
and Hong Kong, marketed as TALi DETECT(R) (screening) and TALi
TRAIN(R) (attention training).
The terms of the deal, estimated at $37.5M in future contingent
milestone payments plus royalties on potential revenues, are
structured to leverage each organization's expertise. Building on
their collective clinical development experience and Akili's
success in bringing EndeavorRx through the U.S. regulatory process
and to market, the companies will work together to execute clinical
trials of the TALi technology in pediatric ADHD and pursue U.S.
Food and Drug Administration (FDA) regulatory clearance. Under the
terms of the agreement, Akili will lead U.S. commercialization and
roll-out.
Through this agreement, Akili is expanding its leadership in
prescription digital therapeutics (PDTs) for cognitive impairments
and charting a path for a new patient demographic to benefit from
innovative technologies proven to improve attention. TALi's
technology builds on Akili's product portfolio and complements its
flagship product EndeavorRx(R), which is FDA-cleared to improve
attention function in children ages 8-12 with ADHD (full indication
below).
"Akili is continuously seeking opportunities to expand our suite
of targeted treatments for cognitive impairments, including through
strategic collaborations with companies that share our commitment
to delivering high-quality patient experiences built on scientific
rigor," stated Eddie Martucci, PhD, Akili's co-founder and CEO.
"Focused on early childhood intervention targeting attention,
TALi's impressive technology is an ideal addition to Akili's
portfolio. We are committed to changing the way people think about
medicine, and strategic agreements like this will allow us to
expand our vision to treat cognitive impairments in entirely new
ways and usher in the next generation of digital therapeutics."
"Akili is leading the digital therapeutics industry with its
ability to dramatically scale into mainstream medicine while
maximizing value to patients and to the business, making it an
ideal partner for expanding the reach and impact of our
technology," said Glenn Smith, Managing Director of TALi. "We're
looking forward to working with the Akili team to provide solutions
that deliver digital-first support to the millions of children
living with attention issues."
Understanding Prescription Digital Therapeutics
Prescription Digital Therapeutics (PDTs) are clinically
validated software-based interventions that prevent, manage, or
treat a medical disease or disorder. PDTs are approved by
regulators and available by prescription for use alone or alongside
other medications or medical devices. Akili is creating PDTs
informed by decades of neuroscience and cognitive research and
delivered through high-quality video game experiences to treat
cognitive impairments across multiple diseases and disorders.
EndeavorRx (R) Indication and Overview
EndeavorRx is the first-and-only FDA-cleared treatment delivered
through a video game experience. EndeavorRx is indicated to improve
attention function as measured by computer-based testing in
children ages 8-12 years old with primarily inattentive or
combined-type ADHD, who have a demonstrated attention issue.
Patients who engage with EndeavorRx demonstrate improvements in a
digitally assessed measure Test of Variables of Attention (TOVA(R))
of sustained and selective attention and may not display benefits
in typical behavioral symptoms, such as hyperactivity. EndeavorRx
should be considered for use as part of a therapeutic program that
may include clinician-directed therapy, medication, and/or
educational programs, which further address symptoms of the
disorder. EndeavorRx is available by prescription only. It is not
intended to be used as a stand-alone therapeutic and is not a
substitution for a child's medication. To learn more about
EndeavorRx, please visit www.EndeavorRx.com .
About TALi Digital
TALi [TALi Digital Limited (ASX: TD1)] is an Australian digital
health company delivering diagnostic and therapeutic solutions for
cognitive function and behavior. TALi's patented technology
initially targets attention in early childhood through its
breakthrough evidence and video game-based TALi screening
(DETECT(R)) and training (TRAIN(R)) products. The targeting of
attention and early intervention underpins the TALi technology that
is allowing the company to develop a series of products across
multiple diseases and disorders. TALi solutions aim to deliver
foundational advances in human cognitive function and behavior only
dreamt of a few short years ago. For more information, please visit
www.talidigital.com
About Akili
Akili is combining scientific and clinical rigor with the
ingenuity of the tech and entertainment industries to challenge the
status quo of medicine. Akili is pioneering the development of
digital treatments and care solutions to help people affected by
cognitive impairments. Akili's treatments are designed to directly
activate the networks in the brain responsible for cognitive
function and have been rigorously tested in extensive clinical
studies, including prospective randomized, controlled trials.
Driven by Akili's belief that effective medicine can also be fun
and engaging, Akili's treatments are delivered through captivating
action video game experiences. For more information, please visit
www.akiliinteractive.com .
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, among others. The Company has
created a broad and deep pipeline through the expertise of its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders. This pipeline,
which is being advanced both internally and through PureTech's
Founded Entities, is comprised of 26 therapeutics and therapeutic
candidates, including two that have received FDA clearance and
European marketing authorization, as of the date of PureTech's most
recently filed Annual Report on Form 20-F. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and
then advanced by the PureTech team through key validation points
based on the Company's unique insights into the biology of the
brain, immune and gut, or BIG, systems and the
interface between those systems, referred to as the BIG
Axis.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be
forward-looking statements, including statements that relate to the
company's future prospects, developments, and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks and uncertainties that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, expectations regarding the potential therapeutic benefits of
Akili's therapeutic candidates, expectations regarding the benefits
of Akili's licensing agreement with TALi, expectations regarding
terms of Akili's licensing agreement with TALi, including the
execution of clinical trials of the TALi technology in pediatric
ADHD and pursuit of FDA regulatory clearance, potential
commercialization and those risks and uncertainties described in
the risk factors included in the regulatory filings for PureTech
Health plc. These forward-looking statements are based on
assumptions regarding the present and future business strategies of
the company and the environment in which it will operate in the
future. Each forward-looking statement speaks only as at the date
of this press release. Except as required by law and regulatory
requirements, neither the company nor any other party intends to
update or revise these forward-looking statements, whether as a
result of new information, future events or otherwise.
Contact:
Investors EU media
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
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