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

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.

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Screen shot of TALi training product (Photo: Business Wire)

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.

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AKILI Julie DiCarlo [e-mail]

TALi Glenn Smith [e-mail]