Akili - Investigational Product Candidates

Advancing digital diagnostics, treatments and monitors for cognitive impairments across disease and disorders

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Pioneering the development of cognitive treatments through game-changing technologies

14.6% Equity

COMMERCIAL

Description

Pioneering the development of cognitive treatments through game-changing technologies

Puretech Ownership¹

14.6% Equity

Stage of Development

COMMERCIAL

¹ As of May 5, 2023, PureTech’s percentage ownership of Akili was approximately 14.6%.

² These therapeutic candidates are regulated as devices and their development has been approximately equated to phases of clinical development. With the exception of EndeavorRx, candidates are investigational and have not been cleared by the FDA for use in the U.S.

³ EndeavorRx® is a digital therapeutic 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. There were no serious adverse events; 9.3% of subjects experienced side effects, including frustration, headache, dizziness, emotional reaction, nausea or aggression. EndeavorRx is only available to your patients through a prescription, and is not intended as a stand-alone therapeutic or a substitute for your patient’s medication.

⁴ Multiple IRBs have determined AKL-T01 to be a non-significant risk device. Akili has obtained IRB approval independently or in collaboration with independent clinical research institutions for all past and ongoing human data collection for clinical research in the United States. We do not control the clinical or regulatory development of Akili’s product candidates. We do not have a direct interest in Akili’s therapeutic or therapeutic candidates. Our interest in Akili’s therapeutic and therapeutic candidates is limited to our equity interest in Akili and any potential appreciation in the value of such equity interest, and we do not control the clinical or regulatory development of Akili’s therapeutic candidates. Akili is well-protected with a robust intellectual property portfolio. Akili was incorporated in February 2012.

ENDEAVORRX

AKILI'S INVESTIGATIONAL THERAPEUTIC CANDIDATES

Advancing digital diagnostics, treatments and monitors for cognitive impairments across disease and disorders

Akili is pioneering the development of cognitive treatments through game-changing technologies. Akili’s approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device but experienced like entertainment.

Program Discovery Process by the PureTech Team
- We engaged with leading neuroscientists and clinicians who had been studying the effects of video games on cognition and the underlying neural processes accessible by sensory stimulation and we collaborated with Dr. Adam Gazzaley, M.D., Ph.D., to translate the underlying academic device into a medical intervention, including overseeing the initial product development and design and the implementation of the initial proof-of-concept studies.
Milestones Achieved & Developmental Status
- In August 2022, Akili, Inc. began trading on the Nasdaq Stock Market under the ticker symbol “AKLI”.
- In November 2022, Akili deployed the first wave of its EndeavorRx®¹ go-to-market sales force in 14 priority territories across the US with a focus on Integrated Behavioral Health Centers and pediatric providers.
- In June 2020, Akili announced that the FDA granted clearance to market EndeavorRx as a prescription treatment for improving attention function in children with attention-deficit/hyperactivity disorder (ADHD) and received approval to market EndeavorRx in Europe.
- In January 2023, Akili shared topline results of the STARS-ADHD-Adolescents label expansion study evaluating the efficacy and safety of EndeavorRx in adolescents ages 13-17 with ADHD. The pivotal study achieved its predefined primary efficacy outcome, showing statistically significant improvement in attentional functioning after four weeks of treatment.
- In May 2023, Akili shared topline results of the STARS-ADHD-Adult clinical trial evaluating the efficacy and safety of EndeavorRx in adults with ADHD. The trial demonstrated statistically significant improvement in attention functioning after six weeks of treatment, achieving its predefined primary efficacy outcome.
- In May 2023, Akili submitted data from STARS-ADHD-Adolescents to FDA to expand its current EndeavorRx label to include adolescents.
- In January 2023, Akili announced its 2023 operating plan to focus the company’s resources primarily on supporting the commercialization and growth of EndeavorRx as well as efforts related to the potential label expansion for EndeavorRx in broader ADHD populations. This resulted in a reduction of expenses, including a reduction in the company’s workforce by approximately 30% and pipeline reprioritization.
Expected Milestones
- Akili expects to share topline data from two COVID fog trials of the company’s technology being conducted by outside academic research institutions in the first half of 2023.
- Akili expects Shionogi pivotal trial data in 6-17 year old children with ADHD in Japan in the second half of 2023.

Note: Multiple IRBs have determined AKL-T01 to be a non-significant risk device. Akili has obtained IRB approval independently or in collaboration with independent clinical research institutions for all past and ongoing human data collection for clinical research in the United States. We do not control the clinical or regulatory development of Akili’s product candidates. We do not have a direct interest in Akili’s therapeutic or therapeutic candidates. Our interest in Akili’s therapeutic and therapeutic candidates is limited to our equity interest in Akili and any potential appreciation in the value of such equity interest, and we do not control the clinical or regulatory development of Akili’s therapeutic candidates. Akili is well-protected with a robust intellectual property portfolio. Akili was incorporated in February 2012.

¹ EndeavorRx is the first-and-only FDA-authorized treatment delivered through a video game experience. EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8 to 12 years old wit 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 cliniciandirected 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. The most common side effect observed in children in EndeavorRx’s clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider. To learn more about EndeavorRx, please visit EndeavorRx.com.

Akili is leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device, but experienced like entertainment.