Akili, Inc. announced that it has received authorization from the U.S. Food and Drug Administration (FDA) to expand the label for EndeavorRx(R) from 8 to 12 year-old patients with primarily inattentive or combined-type ADHD who have a demonstrated attention issue to include older children aged 13 - 17. This increased age range is expected to more than double the number of pediatric patients with ADHD who are now eligible for EndeavorRx -- the only FDA-authorized, game-based digital therapeutic -- with a prescription from a healthcare provider. (Akili also offers a non-prescription product for adults with ADHD, using the same technology, EndeavorOTC(TM).

The clinical study on which the FDA's label expansion authorization for EndeavorRx is based involved 162 adolescents with a verified diagnosis of inattentive and combined-type ADHD who all received EndeavorRx for 4 weeks and subsequently demonstrated significant improvements in TOVA-measured attentional control. EndeavorOTC is available under the U.S. Food & Drug Administration's current Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. EndeavorOTC has not been cleared or authorized by the U.S. Food.

Food and Drug Administration for any indications. The most common side effect observed in children in EndeavorRx's clinical trials was a feeling of frustration, as the game can be quite challenging at times. Akili's approach of 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.

These forward-looking statements include, without limitation, statements in this press release related to: expectations regarding the number of pediatric patients withAD who can now access EndeavorRx and ability to expand the use of EndeavorRx in those patients in connection with the label expansion for EndeavorRx to include adolescents ages 13 to 17 with ADHD; that the adoption and efficacy of Endeavor Rx in patients aged 13 to 17 with ADHD will be similar to younger patients; and that the results of clinical studies are predictive of future clinical trials or results. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: ability to continue to commercialize EndeavorRx in patients aged 13 to17; ability to obtain regulatory clearance from FDA to convert products to over-the-counter-labeling; ability to successfully create, and navigate, a new category of medicine and to achieve broad adoption of digital therapeutics among customers and healthcare providers; ability to continue to advance clinical development pipeline; ability to defend intellectual property and satisfy various FDA and other regulatory requirements in and outside of the United States; the risk of adverse macroeconomic or political changes and a changing regulatory landscape in the highly competitive industry in which company operate; the timing and results expected from and partners' clinical trials and its reliance on third parties for certain aspects of business; and other risks identified in current filings and any subsequent filings made with the Securities and Exchange Commission.