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®, the first and only prescription video game treatment, and Australian digital health company TALi® (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®, the first and only prescription video game treatment, and Australian Securities Exchange listed digital health company TALi® (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® (screening) and TALi TRAIN® (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®, 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® 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®) 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®) and training (TRAIN®) 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.

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