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-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. 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.
- 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 these conditions is only partially served, or not served at all, by currently available medications or by in-person behavioral therapy.
- There are approximately 1.5 million children with autism, 17 million adults with MDD and approximately 900,000 people with MS. Akili believes that this market – and other markets where Akili’s cognitive dysfunction targeting products may act as a stand-alone medical treatment, add-on therapy, or digital biomarker – represent significant opportunities 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, 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.
- Akili has a broad pipeline of programs to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is evaluating its platform technology in studies of various sizes across a variety of patient populations suffering from cognitive dysfunction, including ASD, multiple sclerosis, or MS, major depression disorder, or MDD, Parkinson’s-related mild cognitive impairment, or MCI, and traumatic brain injury, or TBI. Akili is also developing complementary and integrated monitoring and measurement-based care applications. The ADHD Insight^TM mobile app is a monitoring and measurement-based care application currently being developed and tested by Akili both as an independent product and as a complement to the EndeavorRx^TM treatment.
Milestones Achieved
- In March 2019, Akili entered into a strategic partnership with Shionogi for the development and commercialization of EndeavorRx^TM 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 December 2019, Akili presented the results from a trial of AKL-T03 as a potential treatment for cognitive impairments adjunct to anti-depressant medication in adults with Major Depressive Disorder (MDD) at the 58^th Annual Meeting of the American College of Neuropsychopharmacology. 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 building the first-of-its-kind digital medicine development and commercial platform that will serve as an independent prescription and patient access system designed specifically for digital therapeutics. The platform will integrate patient service, data processing and distribution functions to allow flexibility, learning and iteration. Akili will be at the center of the modular platform, which will allow the company to deliver a better experience for patients, physicians and payors, using the latest technology to allow multiple ways of engaging with customers to fit into their busy lives. Akili’s Shionogi partnership is structured to enable the implementation of this localized platform in Japan.

Akili is advancing a broad pipeline of programs to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is evaluating its platform technology in studies of various sizes across a variety of patient populations suffering from cognitive dysfunction, including ASD, multiple sclerosis, major depression disorder, Parkinson’s-related mild cognitive impairment and traumatic brain injury.