Akili Investigational Product Candidates

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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.
Patient Need & Market Potential
- Cognitive dysfunction is a key feature of many neuropsychiatric disorders, including ASD, MS, MDD, MCI, TBI and AD. 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.
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
- Akili has evaluated its SSME technology across a variety of patient populations, including pediatric and adult ASD, MS, MDD, MCI and TBI.
- 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.
- In December 2019, Akili presented results from a trial of AKL-T03 as a potential treatment for cognitive impairments adjunct to anti-depressant medication in adults with MDD. In the trial, AKL-T03 demonstrated a statistically significant improvement in sustained attention compared to control. AKL-T03 is designed to improve specific cognitive functions and may play a complementary role to antidepressants in the holistic treatment of MDD.
Expected Milestones
- Akili is planning to build its own commercial distribution platform for its digital therapeutic products to enable launch in a variety of commercial models. The company is building Akili Care, an integrated system for patient service, data processing, and distribution functions for its initial product launch, to allow flexibility, learning, and iteration as it continues to invest in the delivery of digital therapeutic solutions to the market. Akili’s Shionogi partnership is structured to enable the implementation of this localized platform in Japan.

Akili has evaluated its platform technology in studies of various sizes across a variety of patient populations suffering from cognitive dysfunction, including adult ADHD, ASD, multiple sclerosis (MS) major depression disorder (MDD) Parkinson’s-related mild cognitive impairment (MCI) and traumatic brain injury (TBI).