ADHD
Major depressive disorder
Multiple sclerosis
Autism spectrum disorder
Acute cognitive dysfunction
1 As of December 31, 2021, PureTech’s percentage ownership of Akili was approximately 22.3% on a diluted basis. This calculation includes outstanding shares, options, and warrants, but excludes unallocated shares authorized to be issued pursuant to equity incentive plans.
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.
Akili’s investigational therapeutic candidates
Advancing digital diagnostics, treatments and monitors for cognitive impairments across disease and disorders
- Akili is pioneering the development of game-changing technologies to usher in a new era of cognitive medicine. Focused on delivering cutting-edge digital diagnostics, treatments and monitors for cognitive impairments across disease and disorders, Akili is combining scientific and clinical rigor with the ingenuity of the technology and entertainment industries and challenging the status quo of medicine. Akili’s treatments are designed to directly activate the networks in the brain responsible for cognitive function and have been rigorously tested in extensive clinical studies, including prospective randomized, controlled trials. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences.
- 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 is leveraging new digital platforms for its digital therapeutic products to enable launch in a variety of models. The company is offering Akili Assist®, integrated components that enable streamlined patient service, data processing and distribution functions in 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.
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Program Discovery Process by the PureTech Team
- We were interested in identifying novel approaches to measure and improve cognition in a safe and non-invasive manner. 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 identified and in-licensed from the University of California, San Francisco, or UCSF, the intellectual property invented by Dr. Adam Gazzaley, M.D., Ph.D., Professor of Neurology, Psychiatry and Physiology at UCSF and the inventor of the SSME platform technology, in October 2013 before his work was published as a cover story in the journal Nature. We 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. We helped to build development and commercial teams and raise funds. One of the core PureTech team members who helped lead the identification and platform development is now the Chief Executive Officer of Akili.
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Patient Need & Market Potential
- Cognitive dysfunction is a key feature of many neuropsychiatric disorders, including ADHD, ASD, MS, major depressive disorder, or MDD, mild cognitive impairment, or MCI, traumatic brain injury, or 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. There are approximately 6.4 million pediatric ADHD patients in the U.S. 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.
- Evidence is mounting on long-term neurological and cognitive symptoms that can persist in some COVID-19 patients after initial diagnosis, even after the virus is no longer detected in the body. A study published in Neuropsychopharmacology led by Drs. Abhishek Jaywant and Faith Gunning at Weill Cornell Medicine and New York-Presbyterian found that difficulties in attention, multitasking and processing speed were common in hospitalized patients recovering from COVID-195. Of the patients in their study, 81% exhibited some degree of cognitive impairment5. Recent research also shows these cognitive impairments may persist post-hospitalization and commonly occur in “post-COVID long haulers” or “Long COVID” patients. These impairments can have a significant impact on survivors’ daily functioning and quality of life, impacting the ability of most COVID-19 long haulers to work for six months or more according to a recent study6.
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Milestones Achieved & Development Status
- In January 2022, Akili entered into a definitive agreement to become publicly traded via a merger with Social Capital Suvretta Holdings Corp. I (“SCS”) (Nasdaq: DNAA), a special purpose acquisition company. The transaction is expected to close in mid-2022, after which Akili will be listed on the Nasdaq stock market under the new ticker symbol “AKLI”. The transaction implies a post-money equity value of the combined company of up to approximately $1 billion and is expected to deliver up to $412 million in gross cash proceeds to Akili, including the contribution of up to $250 million of cash held in SCS’s trust account and approximately $162 million from PIPE investors at $10 per share.
- In September 2021, Akili announced topline results of a Phase 2 study of SDT-001 (Japanese version of AKL-T01). The study, conducted by Akili partner Shionogi, was designed to evaluate the feasibility, safety and efficacy of the digital therapeutic in children with ADHD and to inform the design of a potential pivotal study. To enable this clinical trial, Akili localized its AKL-T01 technology for use in the Japanese market, which included adapting for language and culture and establishing infrastructure in Japan to support the product. Results showed the treatment was well-received by patients and demonstrated improvements in ADHD inattention symptoms consistent with those seen across previous studies of AKL-T01.
- In April 2022, findings from the STARS-MDD clinical trial evaluating AKL-T03 as a potential treatment for attention impairments in adults with major depressive disorder (MDD) when used alongside antidepressant medication were published in the American Journal of Psychiatry. The STARS-MDD study enrolled 80 adults, ages 25-55, who were stably treated with an antidepressant medication yet were still experiencing mild to moderate symptoms of depression as well as cognitive impairments. Patients were randomized 1:1 to AKL-T03 or a digital control designed to have an equal expectation of benefit. Results of the study demonstrated that the addition of AKL-T03 to antidepressant therapy significantly improved sustained attention in adults diagnosed with MDD compared to the control (p=0.005), as measured by the Test of Variables of Attention (TOVA), which is a computerized test cleared by FDA to assess attention deficits and evaluate the effects of interventions in ADHD.
- In April 2021, Akili announced collaborations with Weill Cornell Medicine, New York-Presbyterian Hospital and Vanderbilt University Medical Center to evaluate Akili digital therapeutic AKL-T01 as a treatment for patients with cognitive dysfunction following COVID-19 (also known as “COVID fog”). Under each collaboration, Akili will work with research teams at each institution to conduct two separate randomized, controlled clinical studies evaluating AKL-T01’s ability to target and improve cognitive functioning in COVID-19 survivors who have exhibited a deficit in cognition.
- In March 2022, Akili appointed Jon David as Chief Product Officer. A 20-year veteran of the games industry, Mr. David joins Akili to develop and execute the strategic vision of Akili’s future product pipeline after serving as Vice President and General Manager at Glu Mobile, acquired in 2021 by Electronic Arts, where he led the development of both new IP and hit franchises including Covet Fashion and Diner Dash Adventures.
- In March 2019, Akili entered into a strategic partnership with Shionogi for the development and commercialization of AKL-T01 (in development for children with ADHD) 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 antidepressant 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.
- Akili is leveraging new digital platforms for its digital therapeutic products to enable launch in a variety of models. The company is offering AkiliCare™, integrated components that enable streamlined patient service, data processing and distribution functions in 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.
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.
5 Jaywant et al. Neuropsychopharmacol. (2021).
6 David et al. Preprint. (2020).
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.
Press Releases
PureTech Founded Entity Akili Announces American Journal of Psychiatry Publication of Data Demonstrating its Digital Therapeutic AKL-T03 Improves Cognitive Impairments in Adults with Major Depressive Disorder When Combined with Antidepressant Medication
April 12, 2022
PureTech Founded Entity Akili Appoints Game Industry Veteran Behind Bejeweled, Plants vs. Zombies as Chief Product Officer
March 17, 2022
PureTech Founded Entity Akili Named to Fast Company's Annual List of the World's 50 Most Innovative Companies for 2022
March 8, 2022
PureTech Founded Entity Akili Announces PLOS ONE Publication of Clinical Study Results and EEG Data Showing Akili Digital Therapeutic EndeavorRx® Activates Systems in Brain Key to Attentional Functioning
February 17, 2022
PureTech Founded Entity Akili Interactive Announces Filing of Registration Statement on S-4 in Connection with its Proposed Business Combination with Social Capital Suvretta Holdings Corp. I
February 15, 2022
PureTech Founded Entity Akili Interactive, a Leader in Digital Medicine, to Become Publicly Traded Through Combination with Social Capital Suvretta Holdings Corp. I
January 26, 2022
PureTech Founded Entity Akili Announces Topline Results from Shionogi Phase 2 Study in Japan
September 29, 2021
PureTech Founded Entity Akili Enters Strategic Licensing Agreement with TALi, Extending Akili Portfolio and Industry Leadership in Prescription Digital Therapeutics for Cognitive Impairments
August 17, 2021
PureTech Founded Entity Akili Releases New Gameplay Features in the First and Only FDA-Cleared Video Game Treatment for Children with ADHD
July 22, 2021
PureTech Founded Entity Akili Secures $160 Million in Financing; Poised to Deliver on the Promise of Digital Therapeutic
May 26, 2021
PureTech Founded Entity Akili Collaborates with Weill Cornell Medicine, NewYork-Presbyterian Hospital and Vanderbilt University Medical Center to Study Digital Therapeutic AKL-T01 as Potential Treatment for Patients with COVID Brain Fog
April 7, 2021
PureTech Founded Entity Akili Announces the Results of EndeavorRx™ Clinical Study in Pediatric ADHD Published in Nature Digital Medicine
March 26, 2021
PureTech Founded Entity Akili Announces Presentation of New Outcome Data for Digital Therapeutic EndeavorRx™ in Paediatric ADHD
October 21, 2020
PureTech Founded Entity Akili Announces Appointment of Chief Marketing Officer
October 7, 2020
PureTech Founded Entity Akili Receives Approval to Market EndeavorRx™ in Europe as a Digital Treatment for Children with ADHD
June 23, 2020
PureTech Founded Entity Akili Announces FDA Clearance of EndeavorRx™ for Children with ADHD, the First Prescription Treatment Delivered Through a Video Game
June 16, 2020
PureTech Founded Entity Akili Announces ENDEAVOR™ Digital Attention Treatment is Now Available for Children with Attention Deficit Hyperactivity Disorder (ADHD) under FDA’s COVID-19 Enforcement Discretion Guidance
April 22, 2020
The Lancet Digital Health Publishes Akili AKL-T01 ADHD Pivotal Study Results
February 25, 2020
PureTech Affiliate Akili Announces New AKL-T01 Study Achieved Primary Endpoint in Children with ADHD
January 15, 2020
PureTech Affiliate Akili Announces AKL-T03 Achieved Primary Endpoint, Improving Cognitive Impairments in Major Depressive Disorder Trial
December 13, 2019
PureTech Health Affiliate Akili Appoints Chief Financial Officer and General Counsel to Leadership Team
April 11, 2019
PureTech’s Independent Affiliate Akili Announces Partnership with Shionogi to Develop and Commercialise Digital Therapeutics in Certain Asian Markets
March 7, 2019
Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD
March 2021
A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial
February 2020
Characterizing cognitive control abilities in children with 16p11.2 deletion using adaptive ‘video game’ technology: a pilot study
September 2016
The use and effectiveness of mobile apps for depression: Results from a fully remote clinical trial
February 2016
Games to do you good
February 2013