Puretech Ownership1
Therapeutic Candidate2
Initial Indication(s)
Stage of Development
14.6% Equity
EndeavorRx®3 (AKL-T01)4
Pediatric ADHD 8-12 y/o (U.S.)
Commercial
SDT-001
Pediatric ADHD 6-17 y/o (Japan)
Phase 3 study initiated
AKL-T01, AKL-T03
Cognitive dysfunction in MDD
Proof-of-concept completed
Cognitive dysfunction in MS
Proof-of-concept completed
AKL-T02
Attention in ASD
Proof-of-concept completed
AKL-T01
Post-COVID acute cognitive dysfunction
Early scientific and clinical research
Post-ICU acute cognitive dysfunction
Early scientific and clinical research
Cancer-related acute cognitive dysfunction
Early scientific and clinical research
Pediatric ADHD 13-17 y/o (U.S.)
Pivotal
Adult ADHD 18+ y/o (U.S.)
Pivotal
AKL-M01
Cognitive monitoring
Proof-of-concept completed
1 As of March 3, 2023, PureTech’s percentage ownership of Akili was approximately 14.6%.
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.
EndeavorRx®
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.
- Akili’s FDA-cleared product, EndeavorRx, is based on a patented 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, Ph.D., 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.
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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, PTSD, COVID fog, traumatic brain injury, or TBI, and AD, among others. 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.
- Within ADHD, there is a large and growing opportunity for innovative non-drug treatments. Current ADHD treatment options represent a $10 billion market with over 70 million prescriptions written every year for drugs in the U.S. According to the U.S. Centers for Disease Control and Prevention, nearly half the pediatric ADHD population uses behavioral therapy as well. The total ADHD population in the U.S. is 10.8 million and Akili’s initial target population includes those with inattentive or combined type ADHD, or 8.1 million of the total U.S. ADHD population. EndeavorRx is currently cleared in the U.S. to treat patients in the 8-12 age group, which represent approximately 22% (1.8 million) of Akili’s target 8.1 million ADHD population.
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Milestones Achieved & Development Status
- Akili, Inc. began trading on the Nasdaq Stock Market under the ticker symbol “AKLI” on August 22, 2022.
- 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.
- In January 2023, Akili announced topline results from STARS-ADHD-Adolescents, its pivotal trial of EndeavorRx (AKL-T01) in adolescents ages 13-17 with ADHD. The study showed robust improvements in attention and broader clinical outcomes, including attention improvements that were nearly three times as large as those seen in Akili’s pivotal trial that served as the basis for EndeavorRx’s FDA authorization for children with ADHD ages 8-12.
- In December 2022, Akili announced the appointment of Scott Kollins, Ph.D., as Chief Medical Officer. Dr. Kollins spent more than 20 years on the faculty in the Department of Psychiatry and Behavioral Sciences at the Duke University School of Medicine, where he maintains an adjunct faculty appointment. He was also the co-lead for the Digital Health Solutions Initiative at the Duke Clinical Research Institute (DCRI). His ADHD expertise combined with his experience in innovative approaches to clinical evidence generation will help guide Akili’s growth and the company’s work to advance new treatments for cognitive impairments across indications, starting with EndeavorRx in ADHD.
- In October 2022, Akili announced the appointment of Mary Hentges as chair of the Audit Committee and a member of the Compensation Committee. Ms. Hentges has extensive executive-level and financial experience with both public and private companies. Ms. Hentges’ proven track record serving as chief financial officer at several high-growth companies will support Akili as it enters its next phase of growth with the commercialization of its flagship product, EndeavorRx.
- In July 2022, Akili announced the nominees for its future board of directors, effective upon the closing of Akili's business combination with Social Capital Suvretta Holdings Corp. I ("SCS") (Nasdaq: DNAA), subject to customary closing conditions.
- In May 2022, Akili and Roblox, a global platform bringing millions of people together through shared experiences, announced a collaboration that connects patients' medical treatments to their favorite virtual worlds. Initially, the companies will establish an exclusive Roblox rewards exchange tied to Akili's EndeavorRx app. The companies are exploring additional novel approaches and opportunities to engage Akili patients through Roblox integrations.
- In May 2021, Akili announced the closing of a $160 million combined equity and debt financing. With the completion of the oversubscribed Series D financing, the funding is expected to accelerate commercialization of EndeavorRx, enable expansion of core technologies to treat acute and chronic cognitive disorders and drive further research and development of potential new digital therapeutics.
- In March 2021, the full data from a multi-site open-label study (the STARS Adjunct study) evaluating the impact of EndeavorRx (AKL-T01) on symptoms and functional impairments in children with ADHD was published in Nature Digital Medicine. Statistically significant improvement was demonstrated in all predetermined endpoints of the study, which included parent and clinician ratings of children’s ADHD symptoms related impairments in daily life.
- In February 2022, Akili announced the publication of full data in the medical journal PLOS ONE from a single arm, unblinded study conducted by Dr. Elysa Marco at Cortica Healthcare and Drs. Joaquin Anguera and Courtney Gallen at the University of California, San Francisco. Data from the study show that EndeavorRx treatment resulted in increased brain activity related to attention function, as measured by electroencephalography (EEG), which correlated with improvements in objective behavioral measures of attention.
- 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 July 2021, Akili introduced new gaming features and functionalities to its EndeavorRx treatment. Akili is releasing these new gameplay features as it expands its pre-launch activities to bring EndeavorRx to families and healthcare professionals.
- 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 August 2021, Akili and Australian digital health company TALi® (ASX: TD1), completed an agreement for Akili to license TALi’s technology designed to address early childhood attention impairments. The companies plan to work together to execute clinical trials of the TALi technology in pediatric ADHD in the U.S. and pursue FDA regulatory clearance. Under the terms of the agreement, Akili will lead potential U.S. commercialization and roll-out.
- 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 June 2022, Akili announced the appointment of industry veteran Matt Franklin in the newly created role of President and Chief Operating Officer. As President and COO, Franklin will join Eddie Martucci, CEO and Co-Founder of Akili, and Akili's executive leadership team to scale the organization and bring Akili's diverse pipeline of cognitive treatments to market, with an initial focus on the commercial launch of EndeavorRx. He will lead the day-to-day operations of the company, and oversee Commercial, Product, Engineering, Medical and People Operations.
- In June 2020, Akili announced that the FDA has granted clearance to market 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 issue7.
- The FDA clearance followed the April 2020 announcement that ENDEAVOR 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.
- 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 (T.O.V.A.®) compared to an expectancy matched digital control (p=0.006). There were no serious adverse events (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 its STARS Adjunct trial 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 IRS from baseline after one month of treatment (p<0.001) in both children taking stimulant medications and in those not taking stimulants. In the March 2021 post-period, Nature Digital Medicine published the full results from the STARS Adjunct trial.
- 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.
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Expected Milestones
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Akili expects to file a label expansion with the FDA for EndeavorRx in 13-17 y/o children with ADHD in 2023.
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Akili expects to expand its sales presence to approximately 15 additional U.S. territories by the end of the first quarter of 2023.
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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.
Akili’s EndeavorRx® treatment has been granted clearance by the FDA for marketing as a prescription treatment and has received a CE Mark certification in Europe as a prescription-only digital therapeutic. It 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.
Press Releases
PureTech Founded Entity Akili to List on Nasdaq Following Successful Business Combination with Social Capital Suvretta Holdings Corp. I
August 22, 2022
PureTech Founded Entity Akili Announces Phase 3 Study of Digital Treatment in Children with ADHD Begun by Shionogi in Japan
August 1, 2022
PureTech Founded Entity Akili Announces the Journal Lupus Publishes Investigator-Initiated Study Results Demonstrating Improved Executive Function in Patients with Systemic Lupus Erythematosus Following Use of AKL-T01 Product Candidate
July 14, 2022
PureTech Founded Entity Akili Announces Public Company Board of Director Nominees
July 11, 2022
PureTech Founded Entity Akili Announces Veteran Life Sciences Executive Matt Franklin in Newly Created Role of President and Chief Operating Officer
June 6, 2022
PureTech Founded Entity Akili Integrates First-of-its-Kind Prescription Video Game Treatment with the Virtual World Through Partnership with Roblox
May 26, 2022
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 Therapeutics
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