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Akili Market Update.
A copy of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current
Report on Form 8-K and is incorporated herein by reference. This Exhibit 99.1 shall be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and
shall be incorporated by reference in all appropriate filings under the Securities Act of 1933, as amended, except for the last sentence of the second paragraph, the full text of the third and fourth paragraphs and the full text in the first, second
and fourth bullet points included under the header Financial Guidance, each of which shall be furnished and not filed.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
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No. |
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Description of Exhibit |
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99.1 |
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Press Release issued by Akili, Inc. on September 13, 2023 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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 Companys strategic business shift and related
restructuring, including its expectations regarding severance and termination-related costs; the Companys plans to transition to a non-prescription model and to pursue regulatory approval for over-the-counter labeling for its products on certain timelines; that the consumer demand and engagement for EndeavorOTC in its initial three months on the market will
continue in the future; the Companys plans to invest in activities to drive consumer awareness and capital-efficient expansion of the business; the Companys expectations regarding its ability to increase patient access to its treatments
and to reduce its reliance on intermediaries; the Companys expectations regarding its ability to reduce operating expenses and improve the gross margin profile of its business, including the Companys expectations that by late 2025, its non-prescription model can operate at 60-70% gross margins; the Companys expectation that its existing cash, cash equivalents, and short-term investments will be
sufficient to fund the Companys current and planned operations into the second half of 2025; the Companys projections for 2023 and 2024 non-GAAP total operating expenses; the Companys
expectations regarding the revenue recognition policy that will be applicable to EndeavorOTC; and the Companys expectations that EndeavorOTC and EndeavorRx will remain on the market while the Company pursues regulatory approval from FDA for
EndeavorOTC and conversion of its pediatric prescription product, EndeavorRx, to an over-the-counter product. Any forward-looking statements in this Current Report on
Form 8-K and the accompanying exhibit are based on managements 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: the Companys ability to successfully further
commercialize and obtain approval from FDA for EndeavorOTC; the Companys ability to successfully create, and navigate, a new category of medicine and to achieve broad adoption of digital therapeutics among healthcare providers, caregivers, and
patients; the Companys ability to successfully commercialize and support its EndeavorRx prescription product and to obtain further FDA approval to successfully convert its EndeavorRx product to an over-the-counter product; the Companys ability to defend its intellectual property and satisfy various FDA and other regulatory requirements in and outside of the United States; the risk of downturns
and a changing regulatory