| Item 7.01 | Regulation FD Disclosure. |
On June 7, 2023, Akili, Inc. (the “Company”) announced the release of EndeavorOTCTM, an immersive mobile video game treatment that has shown significant improvements in attention, ADHD symptoms, and quality of life for adults with ADHD in clinical trials. EndeavorOTC is built on the same technology as Akili’s EndeavorRx® product and is now available without a prescription for adults 18 years and older nationwide. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Information. |
In parallel with regulatory submission preparations following recent clinical trial data in adults with ADHD, the Company introduced yesterday and is testing commercialization strategies for EndeavorOTC, a non-prescription treatment for adults with ADHD, under FDA guidance entitled “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” (the “COVID-19 Guidance”), which allows for the marketing of certain digital therapeutics without premarket clearance, de novo classification, or approval so long as certain criteria are met for the duration of the COVID-19 Guidance. The COVID-19 Guidance is expected to remain in effect until November 7, 2023. Additional FDA guidance allows for the continued distribution of devices falling under the COVID-19 Guidance without marketing authorization so long as the manufacturer has submitted a marketing submission to FDA, the submission has been accepted by FDA prior to November 7, 2023 and FDA has not taken a final action on the marketing submission. We are making EndeavorOTC available as a non-prescription product under the COVID-19 Guidance to enable immediate availability to adult patients struggling with ADHD symptoms, and will evaluate and test various pricing, marketing and distribution strategies for our video game treatment in adults with ADHD. Feedback and observations from patients’ use of EndeavorOTC will be used to inform our regulatory path as we plan for an FDA regulatory submission in the third quarter of 2023.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Forward-Looking Statements
This Current Report on Form 8-K and the accompanying exhibit contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements include, without limitation, statements in this Current Report on Form 8-K and the accompanying exhibit related to: the ability of EndeavorOTC to improve attention function, ADHD symptoms and quality of life in adults with ADHD and the growing need for ADHD treatment and non-pharmacological options; the Company’s evaluation and testing of various pricing, marketing and distribution strategies for video game treatment in adults with ADHD and the Company’s future plans for development, regulatory path for an FDA regulatory submission, potential regulatory approval, and commercialization. Any forward-looking statements in
