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-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)

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 Ready⁷

AKL-T04

Initial Indication(s):

Major depressive disorder

Stage of Development:

Preclinical

ADHD Insight™

Initial Indication(s):

ADHD caregiver app

Stage of Development:

Released

7. Future clinical research plans and priorities in process.

SELECT PROGRAM:

EndeavorRx™

Akili’s investigational product candidates

Digital therapeutics for people living with cognitive impairment

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 to reinvent medicine. Akili is pioneering the development of treatments with direct therapeutic activity, delivered not through a traditional pill but via a high-quality action video game experience. Akili is a founding member of the Digital Therapeutic Alliance.

We are advancing a broad pipeline of programs to treat cognitive deficiency and improve symptoms associated with medical conditions across neurology and psychiatry, including attention-deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), autism spectrum disorder (ASD), multiple sclerosis (MS) and various other neuroinflammatory diseases. We are also developing associated clinical monitors and measurement-based care applications. Our lead, patented technology platform is exclusively licensed from the lab of Dr. Adam Gazzaley at the University of California, San Francisco (UCSF), and augmented by proprietary adaptive algorithms developed by our team.

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 identified and in-licensed from University of California, San Francisco (UCSF) the intellectual property invented by 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 product, the EndeavorRx^TM treatment (AKL-T01), is covered by a patent family 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 this condition 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 nearly five percent of children in Europe are diagnosed with ADHD. Akili believes that this market represents a significant opportunity for the company.
Innovative Approach to Solving the Problem
- Akili’s platform is based on a patented technology that deploys sensory and motor stimuli designed to 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 experience 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.
- Akili was granted clearance by the FDA for EndeavorRx^TM, which 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 also received approval to market EndeavorRx in Europe, and, through a collaboration and development agreement with Shionogi, is seeking regulatory approval in Japan.
Milestones Achieved
- In June 2020, Akili announced that it has received a Conformité Européenne (CE) Mark for EndeavorRx^TM as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD). While EndeavorRx is not yet available in Europe, the CE Mark enables Akili to market EndeavorRx in European Economic Area (EEA) member countries.
- In June 2020, Akili announced that the U.S. Food and Drug Administration (FDA) has granted clearance for EndeavorRx (AKL-T01), which 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. The EndeavorRx research program includes three studies in ADHD (STARS-ADHD, STARS-Adjunct and ADHD-POC) and two pilot studies in ADHD with different comorbidities (Sensory Processing Disorder and Autism Spectrum Disorder). The pivotal STARS-ADHD study was a multi-center, randomized, blinded, controlled study in 348 children diagnosed with ADHD, and results were recently published in The Lancet Digital Health journal. In the pivotal study, EndeavorRx showed a statistically significant improvement compared to an educational-style video game control (p=0.006) on a change in the Attention Performance Index (API) of the Test of Variables of Attention (TOVA®), a computerized test cleared by FDA to evaluate the effects of interventions in ADHD. In the STARS-Adjunct open-label study, statistically significant improvement was seen in the IRS (a parent-reported clinician-administered scale of ADHD impairments) from baseline to after 4-weeks of treatment in both children on stimulants and off any ADHD medication. No serious adverse events have been associated with EndeavorRx in any study to date. Some study participants (9.3%) experienced non-serious treatment-related adverse events with EndeavorRx, including frustration, headache, dizziness, emotional reaction, nausea or aggression.
- In March 2019, Akili entered into a strategic partnership with Shionogi for the development and commercialization of EndeavorRx and AKL-T02 (in development for children with ADHD and Autism Spectrum Disorder, respectively), 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 begun work on product localization and clinical study design in preparation for a regulatory submission in Japan.
- In January 2020, Akili announced topline results from its multi-site open-label study to evaluate the effects of EndeavorRx in children with ADHD when used with and without stimulant medication. The effects of increasing the duration of treatment were also studied. The study achieved its predefined primary efficacy outcome, demonstrating a statistically significant improvement in the ADHD Impairment Rating Scale (IRS) from baseline after one month of treatment (p<0.001) in both children taking stimulant medications and in those not taking stimulants.
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’s EndeavorRx^TM app is an FDA-cleared prescription treatment that 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. EndeavorRx has also received Conformité Européenne (CE) Mark certification in Europe.