Akili EndeavorRX

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34.0% Equity

EndeavorRx™

Initial Indication(s):

Pediatric ADHD

Stage of Development:

FDA Cleared,
European CE Mark Granted

AKL-T02

Initial Indication(s):

Pediatric autism

Stage of Development:

Phase 2 (POC)

AKL-T03

Initial Indication(s):

Multiple sclerosis

Stage of Development:

Phase 2 (POC)

Initial Indication(s):

Major depressive disorder

Stage of Development:

Pivotal Study Ready

AKL-T04

Initial Indication(s):

Major depressive disorder

Stage of Development:

Preclinical

AKL-T01

Initial Indication(s):

Parkinson’s/MCI

Stage of Development:

Phase 1 (Feasibility)

Initial Indication(s):

Traumatic brain injury

Stage of Development:

Phase 1 (Feasibility)

ADHD Insight™

Initial Indication(s):

ADHD caregiver app

Stage of Development:

Released

7. Following the FDA clearance of EndeavorRx and the evolving healthcare and mental health landscape, Akili is undergoing a pipeline prioritization strategic review which may result in a change in or the addition of product candidates and/or indications in the near term.

SELECT PROGRAM:

EndeavorRx™

Akili’s investigational product candidates

Digital therapeutics to improve cognitive impairment and related symptoms

Founded by PureTech, Akili is a leading digital therapeutics company, combining scientific and clinical rigor with the ingenuity of the tech industry with a goal of changing how medicine is developed, delivered and experienced. Akili is pioneering the development of treatments designed to have direct therapeutic activity, delivered not through a traditional pill but via a high-quality video game experience.

Program Discovery Process by the PureTech Team
- PureTech was interested in identifying novel approaches to measure and improve cognition in a safe and non-invasive manner. PureTech 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 the Company identified and in-licensed from the University of California, San Francisco, or UCSF, the intellectual property invented by Dr. Adam Gazzaley, MD, PhD, professor of neurology, psychiatry and physiology at UCSF and the inventor of this platform technology, in October 2013 before his work was published as a cover story in the journal Nature. PureTech then collaborated with Dr. Gazzaley to translate the underlying academic device into a medical intervention, including overseeing the initial product development and design and the implementation of the initial POC studies. PureTech helped to build development and commercial teams and raise funds, including from the investment arms of Amgen and Merck KGaA, Darmstadt, Germany as a part of Akili’s Series B financing round. One of the core PureTech team members who helped lead the identification and platform development is now the CEO of Akili.
- Akili’s FDA-cleared product, EndeavorRx, is based on a platform technology exclusively licensed from UCSF. 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. Dr. Gazzaley currently serves as the chief scientific advisor and a board member of Akili. Daphne Bavelier, PhD, associate professor in the Department of Brain and Cognitive Sciences at the University of Rochester and at the University of Geneva, is a co-founding scientific advisor.
Patient Need & Market Potential
- Cognitive dysfunction is a key feature of many neuropsychiatric disorders, including ADHD. The treatment of the cognitive dysfunction associated with these conditions is only partially served, or not served at all, by currently available medications or by in-person behavioral therapy.
- There are approximately 6.4 million pediatric ADHD patients in the United States and this market—and other markets where Akili’s cognitive dysfunction targeting products may address the cognitive dysfunction associated with neuropsychiatric disorders—represent significant potential opportunities for the company.
Innovative Approach to Solving the Problem
- Akili’s treatment is based on a patented technology that is designed to deploy sensory and motor stimuli that target and activate the neurological systems known to play a key role in certain cognitive functions, including attentional control. Akili’s approach aims to improve cognitive impairment and related symptoms through improving neural processing at the functional neurological level. The treatment is delivered through an immersive video game, resulting in non-invasive, patient-friendly medicine that can be used at home.
- By combining high quality neurological and clinical science, and consumer-grade entertainment, Akili is seeking to produce a new type of medical product that can potentially offer safe, effective, scalable and personalized treatments for patients across a range of neuropsychiatric conditions, and allow patients to experience medicine in a new way.
Milestones Achieved
- In June 2020, Akili announced that the FDA has granted clearance for EndeavorRx as a prescription treatment for improving attention function in children with ADHD. Delivered through a captivating 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. Akili expects that the EndeavorRx treatment will be available with a prescription to families soon. The FDA clearance followed the April announcement that ENDEAVOR^TM would be available for use for a limited time by children with ADHD and their families in response to new guidance from the FDA recognizing the need for access to certain low-risk clinically-validated digital health devices for psychiatric conditions, including ADHD, during the COVID-19 pandemic.
- Also in June 2020, Akili announced that it had received approval to market EndeavorRx in Europe. Akili received a CE Mark certification for EndeavorRx as a prescription-only digital therapeutic intended for the treatment of attention and inhibitory control deficits in pediatric patients with ADHD. The CE Mark approval enables the future marketing of EndeavorRx in European Economic Area member countries. With a near-term focus on launching the EndeavorRx prescription treatment in the U.S. first, Akili is exploring expansion opportunities in Europe as part of its global strategy.
- Akili’s EndeavorRx was evaluated in a multi-center, randomized, blinded, controlled pivotal study in 348 pediatric ADHD patients. In this study, AKL-T01 achieved its primary endpoint, showing a statistically significant change in the Attention Performance Index, a composite score of attention from the Test of Variables of Attention, or T.O.V.A.®, compared to an expectancy matched digital control (p=0.006). There were no SAEs or discontinuations. Of participants using EndeavorRx, 9.2 percent experienced TRAEs which were mild and included frustration (2.8 percent) and headache (1.7 percent). Mean patient compliance with AKL-T01 was 83 percent of instructed use. Subjective secondary outcome measures, including the ADHD Rating Scale and the Impairment Rating Scale, showed statistically significant improvements in both the treatment and control groups and there was no statistically significant separation on those measures between groups.
- In January 2020, Akili announced that a study achieved its primary endpoint evaluating the effects of EndeavorRx in children with ADHD when used with and without stimulant medication. The study achieved its predefined primary efficacy outcome, demonstrating a statistically significant improvement in the ADHD Impairment Rating Scale, or IRS, from baseline after one month of treatment (p<0.001) in both children taking stimulant medications and in those not taking stimulants.
- In March 2019, Akili entered into a strategic partnership with Shionogi for the development and commercialization of AKL-T01 and AKL-T02 (in development for children with ASD) in Japan and Taiwan. Under the terms of the agreement, Akili will build and own the platform technology and received upfront payments totaling $20 million with potential milestone payments for Japan and Taiwan commercialization of up to an additional $105 million in addition to royalties. Akili and Shionogi have initiated a clinical study in preparation for a regulatory submission in Japan.
Expected Milestones
- Akili’s EndeavorRx^TM treatment will be available with a prescription to families soon. EndeavorRx will be released as the centerpiece of the Endeavor^ⓇCare Program, which includes the EndeavorRx treatment and ADHD Insight^TM, a mobile tracking app and personal support services for caregivers. Easily accessible from home, EndeavorRx is downloaded from the App Store by families on their mobile devices and does not require any additional equipment.
- With a near-term focus on launching the EndeavorRx prescription treatment in the U.S., the company is exploring expansion opportunities in Europe as part of its global strategy.

EndeavorRx^TM Indication for Use: 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 Tests 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.

Akili received clearance from the FDA and European marketing authorization in June 2020 for EndeavorRx^TM (formerly known as AKL-T01) as a prescription treatment for children with ADHD. Delivered through a captivating 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.