0001193125-24-123749.txt : 20240430 0001193125-24-123749.hdr.sgml : 20240430 20240430081402 ACCESSION NUMBER: 0001193125-24-123749 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20240426 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240430 DATE AS OF CHANGE: 20240430 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Akili, Inc. CENTRAL INDEX KEY: 0001850266 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 923654772 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40558 FILM NUMBER: 24894122 BUSINESS ADDRESS: STREET 1: 71 COMMERCIAL STREET STREET 2: MAILBOX 312 CITY: BOSTON STATE: MA ZIP: 02109 BUSINESS PHONE: 617-456-0597 MAIL ADDRESS: STREET 1: 71 COMMERCIAL STREET STREET 2: MAILBOX 312 CITY: BOSTON STATE: MA ZIP: 02109 FORMER COMPANY: FORMER CONFORMED NAME: Social Capital Suvretta Holdings Corp. I DATE OF NAME CHANGE: 20210310 8-K 1 d830697d8k.htm 8-K 8-K
NASDAQ false 0001850266 0001850266 2024-04-26 2024-04-26

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported):

April 30, 2024 (April 26, 2024)

 

 

Akili, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-40558   92-3654772

(State or Other Jurisdiction

of Incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

71 Commercial Street, Mailbox 312

Boston, MA

   02109
(Address of Principal Executive Offices)   (Zip Code)

(617) 313-8853

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e- 4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

  

Trading
Symbol(s)

  

Name of each exchange

on which registered

Common stock, par value $0.0001 per share   AKLI   Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 1.01

Entry Into a Material Definitive Agreement.

Akili, Inc.’s (the “Company”) wholly owned subsidiary Akili Interactive Labs, Inc., and third party Shionogi & Co., Ltd. (“Shionogi”), previously entered into a December 2018 Option and Collaboration Agreement (as previously amended, the “Shionogi Agreement”) pursuant to which the Company and Shionogi agreed to collaborate in the clinical development and commercialization of certain Company digital therapeutic products in Japan and Taiwan (the “Shionogi Territory”). On April 26, 2024, the Company and Shionogi entered into a further amendment (the “Shionogi Amendment”, and such date the “Amendment Effective Date”) to the Shionogi Agreement, modifying certain payment terms and obligations (the Shionogi Agreement as amended by the Shionogi Amendment referred to herein as the “Amended Shionogi Agreement”).

The Shionogi Amendment modified the financial terms of the Shionogi Agreement to provide for the following:

 

  •  

Shionogi will pay the Company $10.5 million within 30 business days of the Amendment Effective Date, in consideration for the elimination of (i) all future royalty payments that had been provided for under the Shionogi Agreement and (ii) certain future regulatory and sales milestone payments that had been provided for under the Shionogi Agreement.

 

  •  

In consideration for the Company entering into the Shionogi Amendment, and effective as of the Amendment Effective Date, Shionogi and the Company canceled the $5.0 million corporate bond previously issued by the Company to Shionogi and terminated the corresponding bond subscription agreement, resulting in the elimination of all Company repayment obligations under such corporate bond.

 

  •  

The Company is entitled to receive up to a total of $3.5 million from Shionogi by the end of 2025 in consideration of certain development and support services to be performed by the Company, as well as an additional $1.0 million from Shionogi payable in the event that the Company delivers to Shionogi an updated version of SDT-001 within 11 months of the Amendment Effective Date. Of the above $3.5 million, at least $1.5 million shall be paid to the Company within 30 business days of the Amendment Effective Date.

 

  •  

The Company is entitled to receive up to a total of $3.0 million from Shionogi in potential regulatory milestone payments.

The products licensed to Shionogi under the Amended Shionogi Agreement consist of the Company’s proprietary software referred to as AKL-T01 (marketed as EndeavorRx® in the U.S.), where the parties refer to the Japanese localized version of such software as SDT-001. Shionogi continues to be primarily responsible for the clinical development, commercialization, and distribution of SDT-001 at its own cost and expense in the Shionogi Territory in the licensed field of the treatment of inattention and inhibitory control in (i) patients with attention-deficit/hyperactivity disorder (“ADHD”) and (ii) patients diagnosed for a condition classified as belonging to the autism spectrum disorder (together, the “Shionogi Field”).

Under the Amended Shionogi Agreement, the parties have agreed to work towards a transition, from the Company to Shionogi, of the Company’s product maintenance and regulatory support obligations, with a target date for completion of such transition in 2025.

Under the Amended Shionogi Agreement, Shionogi has agreed to use commercially reasonable efforts to (i) obtain certain specified regulatory approval for SDT-001 in Japan and (ii) obtain certain specified pricing reimbursement for SDT-001 in Japan from the Central Social Insurance Medical Council (CSIMC), each of the foregoing as to the treatment of inattention and inhibitory control in pediatric patients with ADHD.

Unless earlier terminated, in accordance with the terms of the Shionogi Agreement, the Amended Shionogi Agreement will continue in effect so long as Shionogi develops and commercializes the licensed products in the Shionogi Territory.

The foregoing description of certain terms of the Shionogi Amendment (and the Amended Shionogi Agreement) does not purport to be complete and is qualified in its entirety by reference to the Shionogi Amendment that the Company intends to file as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ending June 30, 2024.

Item 2.05

Costs Associated with Exit or Disposal Activities.

On April 26, 2024, the Board of Directors of the Company (the “Board”) approved a revised operating plan and budget for the remainder of 2024 and a related restructuring that will result in a reduction of the Company’s operating expenses. As part of this plan, the Company’s workforce will be reduced by approximately 46% across different areas and functions, including eliminating the Company’s marketing and medical affairs teams.

This workforce reduction was communicated to employees on April 30, 2024 and is expected to be completed by the end of the second quarter of 2024. Affected employees will be offered severance and other benefits, and the Company estimates that these severance and restructuring-related costs will be approximately $2.3 – $2.8 million and expects to record these charges in the second quarter of 2024. The Company also expects that payment of most of these costs will be made in 2024.

 

Item 8.01

Other Information.

On April 30, 2024, the Company issued a press release announcing the Shionogi Amendment, a shift in corporate strategy and related restructuring, and an ongoing process initiated by the Board to evaluate potential strategic alternatives. In addition, the Company announced that it would release financial results for the first quarter of 2024 on May 14, 2024 via press release after the market closes and will not be hosting an earnings conference call.

A copy of the press release issued on April 30, 2024 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, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

No.

    Description of Exhibit
99.1    Press Release issued by Akili, Inc. on April 30, 2024
104    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,” “evaluate,” “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 benefits expected from the amendment of the Company’s agreement with its partner, Shionogi; the Company’s shift in corporate strategy; the Company’s and Board’s exploration of strategic alternatives; and the Company’s revised operating plan and budget for the remainder of 2024 and related restructuring including a significant workforce reduction; the Company’s estimates of severance and restructuring-related costs and expectations regarding the timing of the completion of the restructuring and payments of the related costs; the Company’s plans to focus on supporting the Shionogi partnership and to eliminate the Company’s marketing and medical affairs teams; the Company’s expectations regarding its ability to lower operating expenses; and the Company’s expectations that EndeavorOTC and EndeavorRx will remain on the market while the Company continues to pursue regulatory approval from the U.S. Food and Drug Administration (the “FDA”) for EndeavorOTC in parallel with exploration of broader strategic options. Any forward-looking statements in this Current Report on Form 8-K and accompanying exhibit 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

Current Report on Form 8-K and accompanying exhibit, including, without limitation, risks and uncertainties related to: the Company’s ability to successfully support and generate revenue from its EndeavorOTC and EndeavorRx products and its partnerships; the Company’s ability to successfully perform its obligations and achieve the milestones under the Amended Shionogi Agreement and Shionogi’s ability to successfully obtain regulatory approval of the SDT-001 product; the Company’s ability to complete the evaluation of potential strategic alternatives and to identify, pursue, and complete a transaction on terms that are in the best interests of and favorable to the Company and its stockholders, if at all; the Company’s ability to manage its business as a result of the workforce reduction; the Company’s ability to successfully obtain approval from the FDA for EndeavorOTC; the Company’s 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 Company’s 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 landscape in the highly competitive industry in which the Company operates; the timing and results expected from the Company’s and its partners’ clinical trials and its reliance on third parties for certain aspects of its business; the Company’s ability to accurately estimate expenses, capital requirements, and needs for additional financing; and other risks identified in the Company’s current filings and any subsequent filings made with the Securities and Exchange Commission. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof and should not be relied upon as representing the Company’s views as of any subsequent date. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Akili, Inc.
By:  

/s/ Matthew Franklin

Name:   Matthew Franklin
Title:   President and Chief Executive Officer

Date: April 30, 2024

EX-99.1 2 d830697dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

Akili Announces Amended Agreement with Shionogi, Shift in Corporate Strategy and Release Date for First Quarter 2024 Financial Results

Shionogi amendment provides Akili with near-term cash payments and cancellation of debt obligation

Company announces exploration of strategic alternatives and associated workforce reduction

Company to release first quarter 2024 financial results on May 14, 2024

BOSTON, Mass. –April 30, 2024– Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today provided several corporate updates, including an amendment to its strategic distribution agreement with Shionogi & Co., Ltd. (“Shionogi”), a leading global pharmaceutical company. Under the terms of the amended agreement, Shionogi has canceled and forgiven a $5.0 million long-term debt obligation and agreed to make certain payments for SDT-001 (the Japanese, localized version of Akili’s AKL-T01 digital treatment, marketed as EndeavorRx® in the United States). Per the amendment, Akili will receive an upfront payment of $10.5 million in consideration for the elimination of future royalty payments and certain future milestone payments. Akili will also be eligible to receive up to a total of $4.5 million from Shionogi in consideration of Akili development and support services, with at least $1.5 million of such services fees payable up front, and up to a total of $3.0 million from Shionogi in potential regulatory milestone payments. SDT-001 is currently under marketing approval review in Japan as a potential digital treatment for children and adolescents with attention-deficit/hyperactivity disorder (“ADHD”).

In parallel, Akili’s board of directors has initiated a process that is currently ongoing to evaluate potential strategic alternatives to maximize shareholder value. As part of the process, the board of directors will evaluate, together with its external advisors, a range of potential strategic alternatives. There can be no assurance that this process will result in Akili pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms, if at all. The Company does not intend, assume any obligation, or promise to publicly update or revise any information regarding this strategic review process or communicate a timetable for completion of the evaluation process.

As a part of this evaluation of strategic alternatives, Akili announced today that its board of directors approved a revised operating plan and budget for the remainder of 2024 and related restructuring of the organization to lower operating expenses while focusing on supporting Shionogi’s regulatory and commercialization activities. The Company’s workforce will be reduced by approximately 46% including an elimination of the Company’s marketing and medical affairs teams. In conjunction with this restructuring, the Company has substantially reduced promotional activity for its EndeavorRx and EndeavorOTC products, but plans to continue to support current users of its products and make its products available for purchase. Additionally, the Company plans to continue to pursue marketing authorization from the U.S. Food and Drug Administration (the “FDA”) of the Company’s EndeavorOTC product, which remains under review, in parallel with exploration of broader strategic options.

Finally, Akili plans to report first quarter 2024 financial results and a business update via press release on Tuesday, May 14, 2024 after the market closes. The Company will not be hosting an earnings conference call for that release.

EndeavorOTC Indication and Overview

EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to improve attention function in children ages 8—17. EndeavorOTC is available under the FDA’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 FDA for any indications. It is recommended that patients speak to their health care provider before starting EndeavorOTC treatment. No serious adverse events have been reported in any of our clinical studies. To learn more, visit EndeavorOTC.com.

EndeavorRx Indication and Overview

EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-17 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. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication. 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. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider. To learn more about EndeavorRx, please visit EndeavorRx.com.

About Akili

Akili is pioneering the development of cognitive treatments through game-changing technologies. 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. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. 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. For more information, please visit www.akiliinteractive.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains 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,” “evaluate,” “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 press release related to: the benefits expected from the amendment of the Company’s agreement with its partner, Shionogi; the Company’s shift in corporate strategy; the Company and Board’s exploration of

strategic alternatives; and the Company’s revised operating plan and budget for the remainder of 2024 and related restructuring including a significant workforce reduction; the Company’s plans to focus on supporting the Shionogi partnership and to eliminate the Company’s marketing and medical affairs teams; the Company’s expectations regarding its ability to lower operating expenses; and the Company’s expectations that EndeavorOTC and EndeavorRx will remain on the market while the Company continue to pursue regulatory approval from the FDA for EndeavorOTC in parallel with exploration of broader strategic options. 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: the Company’s ability to successfully support and generate revenue from its EndeavorOTC and EndeavorRx products and its partnerships; the Company’s ability to successfully perform its obligations and achieve the milestones under the amended agreement with Shionogi and Shionogi’s ability to successfully obtain regulatory approval of the SDT-001 product; the Company’s ability to complete the evaluation of potential strategic alternatives and to identify, pursue, and complete a transaction on terms that are in the best interests of and favorable to the Company and its stockholders, if at all; the Company’s ability to manage its business as a result of the workforce reduction; the Company’s ability to successfully obtain approval from the FDA for EndeavorOTC; the Company’s 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 Company’s 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 landscape in the highly competitive industry in which the Company operates; the timing and results expected from the Company’s and its partners’ clinical trials and its reliance on third parties for certain aspects of its business; the Company’s ability to accurately estimate expenses, capital requirements, and needs for additional financing; and other risks identified in the Company’s current filings and any subsequent filings made with the Securities and Exchange Commission. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof and should not be relied upon as representing the Company’s views as of any subsequent date. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

# # #

Investor and Media Contact:

Matt Franklin

President and Chief Executive Officer

InvestorRelations@akiliinteractive.com or PR@akiliinteractive.com

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