Operating Company Akili Interactive Labs Raises $30.5 Million to Advance Product Development and Build Commercial Infrastructure

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PureTech Health plc ("PureTech", LSE: PRTC), a cross-disciplinary healthcare company developing novel medicines to tackle fundamental healthcare needs in disruptive ways, is pleased to note that its operating company, Akili Interactive Labs, Inc. ("Company"), today announced it has raised $30.5 million in new equity investments.

Several investors, including JAZZ Venture PartnersCanepa Advanced Healthcare Fund and PureTech participated in the financing.

Proceeds of the financing will be used to support the further development of the Company's late-stage products and build-out of a commercial infrastructure for a potential product launch in 2017.

Daphne Zohar, CEO of PureTech said: "This successful fundraising represents a meaningful inflection point for Akili, and will support the Company's product development across multiple patient populations as well as the commercial build-out as Akili prepares for the potential launch of its lead product candidate in paediatric ADHD."

The full text of the announcement from Akili Interactive Labs is as follows:

 

Digital Medicine Company Akili Interactive Labs Raises $30.5 Million to Advance Product Development and Build Commercial Infrastructure

Funds will Support Development Towards Launch of First-in-Class Digital Treatments for Multiple Cognitive Conditions

BOSTON, Massachusetts, January 22, 2016 – Akili Interactive Labs, Inc. ("Akili"), a company focused on developing clinically validated digital medicine for cognitive assessment and personalised treatment, announced today that it has raised $30.5 million in new equity investments to support the further clinical development of the company's late-stage products and build a commercial infrastructure for a potential U.S. Food and Drug Administration (FDA) clearance and product launch in 2017.  Several investors, including JAZZ Venture PartnersCanepa Advanced Healthcare Fund and PureTech Health participated in the financing.

Akili is currently conducting multiple clinical trials of its digital medicine platform across a variety of patient populations, including paediatric attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (in strategic collaboration with Autism Speaks), depression, Alzheimer's disease (in strategic collaboration with Pfizer, Inc.) and traumatic brain injury.

"The need for safe and effective treatment of cognitive disorders, including ADHD and autism, continues to grow, and new modalities are needed for millions of patients. Particularly in paediatric populations, we see a significant demand for non-pharmacological options," said Eddie Martucci, Co-founder and Chief Executive Officer of Akili. "We're excited that, with the support of our new and existing investors, we can continue to advance our adaptive software platform towards clinical validation and commercialisation as a fundamentally new type of mainstream medicine."

Akili develops mobile software-based treatments and monitors that are designed to function as action video games.  Akili intends to develop its products in billion-dollar drug markets, starting in paediatric ADHD. Akili's lead product candidate, Project: EVO, is based on a platform technology exclusively licensed from the lab of Dr. Adam Gazzaley at the University of California, San Francisco, and was previously published as the cover story of the journal Nature. The proprietary platform targets cognitive interference processing while also adapting difficulty automatically in real-time, allowing individuals of wide-ranging ability levels to interact with the product in their homes without the need for physician calibration or additional hardware.

In a recent open-label pilot study of Project: EVO in paediatric ADHD, results demonstrated that Project: EVO improved attention, inhibition and working memory in children with ADHD. Based on these promising data, and the results of the earlier randomised, controlled study conducted by Gazzaley on the technology platform, Akili will initiate a large, randomised, controlled pivotal study to further validate the efficacy and safety of Project: EVO as a treatment for paediatric ADHD.  Results from the pivotal study are expected in 2017, which, if successful, will potentially position Akili for a product launch by year-end 2017.

"We're seeing the emergence of an entirely new category of non-pharmacological therapies, and Akili is leading the charge. We love their ability to target some of the most under-served patient populations and disrupt massive markets at the same time," said John Spinale, former SVP of Social Games at Disney, and Partner at JAZZ Venture Partners.

ADHD is the most common neurobehavioral disorder of childhood. It is usually first diagnosed in childhood and often lasts into adulthood. ADHD impacts children's performance in school, their ability to make and keep friends and their ability to function in society. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately one in 10 children is diagnosed with ADHD.  

About Akili Interactive Labs

Akili is building clinically validated cognitive therapeutics, assessments and diagnostics that look and feel like high-quality video games. Leveraging medical-grade science and consumer-grade software technology, the company is seeking to produce a new type of healthcare product that is both highly-effective and highly-engaging. The company was founded by PureTech Health, together with leading neuroscientists and game designers. Akili has garnered investment from Shire PLC and has strategic partnerships with Pfizer Inc. and Autism Speaks.

About PureTech Health

PureTech Health (PureTech Health plc, PRTC.L) is a cross-disciplinary healthcare company, developing innovative products that could improve the lives of billions of patients. PureTech has a pipeline of 12 operating companies, seven of which are "growth stage" with external validation including strategic partnerships, outside funding, proof-of-concept or peer review in prestigious scientific journals. PureTech also has a pipeline of ten "concept phase" initiatives resulting from review of more than 650 ideas annually. PureTech is focused on areas including immune and inflammatory disorders, cognitive and psychiatric disorders, diabetes and obesity, oncology and infectious diseases, and has over 110 patents and patent applications. PureTech's leading team and board, along with an advisory network of more than 50 expert founder-scientists and advisors across multiple disciplines, gives PureTech access to potentially ground-breaking science and technological innovation. For more information, visit www.puretechhealth.com and connect with us on Twitter.

Ownership Information

As a result of PureTech's additional equity contribution of approximately $22.0 million (in two approximately equal tranches in 2016), PureTech's percentage ownership of Akili will increase to approximately 63% on a diluted basis1.

Additionally, PureTech's ownership adjusted value will increase by approximately $30 million from the previously reported balance2.

(1) This calculation of PureTech's holding includes issued and outstanding shares as well as options to purchase shares, but excludes unallocated shares authorised to be issued pursuant to equity incentive plans.

(2) Ownership adjusted value represents PureTech's interest in the equity value of Akili = (Business Enterprise Value – Debt + Cash) x PureTech's percentage ownership after additional equity contribution.

Forward Looking Statement

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, 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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For further information please contact:

 

PureTech

 

Julie DiCarlo, Senior Vice President, Communications and Investor Relations

 

+1 617 456 0032

FTI Consulting (Communications adviser to PureTech)

Ben Atwell / Matthew Cole

 

+44 (0)20 3727 1000