Filed pursuant to Rule 424(b)(3)

Registration Statement No. 333-267031

Prospectus Supplement No. 3

(To Prospectus dated October 17, 2022)

43,414,721 SHARES OF COMMON STOCK

OF

AKILI, INC.

 

 

This prospectus supplement updates, amends and supplements the prospectus dated October 17, 2022 (as supplemented or amended from time to time, the “Prospectus”), which forms a part of our Registration Statement on Form S-1 (Registration No. 333-267031). Capitalized terms used in this prospectus supplement and not otherwise defined herein have the meanings specified in the Prospectus.

This prospectus supplement is being filed to update, amend and supplement the information included in the Prospectus with specified information contained or incorporated by reference in our Current Report on Form 8-K filed with the Securities and Exchange Commission on January 5, 2023, which is set forth below.

This prospectus supplement is not complete without the Prospectus. This prospectus supplement should be read in conjunction with the Prospectus, which is to be delivered with this prospectus supplement, and is qualified by reference thereto, except to the extent that the information in this prospectus supplement updates or supersedes the information contained in the Prospectus. Please keep this prospectus supplement with your Prospectus for future reference.

Akili, Inc.’s common stock is quoted on the Nasdaq Capital Market under the symbol “AKLI.” On January 4, 2023, the closing price of our common stock was $1.08.

 

 

INVESTING IN OUR SECURITIES INVOLVES CERTAIN RISKS. SEE “RISK FACTORS” BEGINNING ON PAGE 17 OF THE PROSPECTUS.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if the Prospectus or this prospectus supplement is truthful or complete. Any representation to the contrary is a criminal offense.

 

 

The date of this prospectus supplement is January 5, 2023

 

 

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):

January 5, 2023 (January 5, 2023)

 

 

Akili, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware		001-40558		98-1586159
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

125 Broad Street, Fifth Floor, Boston MA		02110
(Address of Principal Executive Offices)		(Zip Code)

(617) 456-0597

(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 8.01

Other Events.

On January 5, 2023, Akili, Inc. issued a press release titled “Pivotal Trial of EndeavorRx^® in Adolescents with ADHD Shows Robust Improvements in Attention and Broader Clinical Outcomes”. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

No.		Description of Exhibit
99.1		Press Release issued by Akili, Inc. on January 5, 2023.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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.

 

Date: January 5, 2023

Exhibit 99.1

 

Pivotal Trial of EndeavorRx^® in Adolescents with ADHD Shows Robust Improvements in Attention and Broader Clinical Outcomes

 

●

Attention improvements were nearly three times as large as those in the pivotal trial that served as the basis for EndeavorRx’s FDA authorization for children with ADHD ages 8-12

 

●

Study data will be used to file for EndeavorRx label expansion with FDA in 2023

 

●

Akili has stopped recruitment in separate adult ADHD trial to allow for earlier data analysis

BOSTON, Mass. – January 5, 2023 – Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today announced topline results of the STARS-ADHD-Adolescents label expansion study evaluating the efficacy and safety of EndeavorRx^® (AKL-T01) in adolescents ages 13-17 with attention-deficit/hyperactivity disorder (ADHD). The pivotal study achieved its predefined primary efficacy outcome, showing statistically significant improvement in attentional functioning after four weeks of treatment. Consistent improvements were also seen in a range of secondary measures of ADHD-related inattention symptoms and functioning. EndeavorRx treatment was generally well-tolerated, with no serious device-related adverse events reported.

“The results of this study extend the already substantial evidence base to support the efficacy of EndeavorRx for improving attentional functioning in patients with ADHD, and most importantly show the ability of this safe treatment to help teenagers, who have been significantly impacted by the current mental health crisis,” said Scott Kollins, Ph.D., chief medical officer of Akili.

The multi-center open-label study enrolled 162 adolescents ages 13-17 with inattentive or combined-type ADHD. In the study, EndeavorRx demonstrated a statistically significant improvement in the Test of Variables of Attention (TOVA^®)-Attention Comparison Score (ACS) of sustained and selective attention from baseline after one month of treatment (p<0.0001), the study’s predefined primary efficacy outcome. The change from baseline on the TOVA ACS was nearly three times as large as the changes seen in STARS-ADHD, a large randomized controlled trial of children with ADHD ages 8-12 that served as the basis for EndeavorRx’s U.S. Food and Drug Administration (FDA) authorization in that age group. In the STARS-ADHD-Adolescents study, nearly two-thirds (66%) of adolescents met the prespecified definition of clinical response on the TOVA-ACS and nearly a quarter (24.7%) moved into the non-clinical, or normative, range. TOVA is a computerized test cleared by FDA to assess attention deficits and evaluate the effects of interventions in ADHD.

Adolescents using EndeavorRx also saw significant improvement in ADHD symptoms, as measured by the Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS) inattention subscale and total scale scores. ADHD-RS is a clinician-administered questionnaire based on information collected from the child’s caregiver. Following treatment, participants in the study showed significant improvement

on both the inattention subscale and total score of the ADHD-RS (p<0.0001 for both). A prespecified responder analysis also showed that 27.1% of all participants in the study demonstrated at least a 30% reduction in total scores on the ADHD-RS, a finding similar to the STARS-ADHD trial in children with ADHD (24%). Statistically significant improvements were also observed for parent and child ratings of attention improvement, as well as parent ratings of function across a number of domains, including peer relationships, academic functioning, behavioral functioning, homework functioning, and self-esteem. Overall, 4 (2.5%) participants experienced a treatment-emergent adverse device event (3 decreased frustration tolerance, 1 headache; all mild or moderate). There were no serious adverse device events.

Akili plans to present full data from the STARS-ADHD-Adolescents study at a future medical meeting, and the company will file for EndeavorRx label expansion with FDA in 2023. As part of Akili’s label expansion strategy for EndeavorRx, in addition to the study in adolescents, the company has been conducting a separate pivotal trial of EndeavorRx in adults with ADHD. As was previously noted during the company’s last earnings call, recruiting for that adult study has been slower than projected. Based on this strong clinical data in adolescents and the desire to maximize capital efficiency, Akili has stopped recruitment of the adult study with 224 patients enrolled in order to analyze the trial data ahead of schedule.

EndeavorRx Indication and Overview

EndeavorRx is the first-and-only FDA-authorized treatment delivered through a video game experience. EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8 to 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. 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,” “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: our expectations with respect to timing of a regulatory submission to FDA for EndeavorRx (AKL-T01) and our aim to expand the EndeavorRx label; our clinical development plans, including the timing of enrollment for and analysis of data from clinical trials as well as the release of additional clinical data; and the likelihood that data from clinical trials will be positive and support further clinical development and regulatory approval of AKL-T01. 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 risk that prior results, such as signals of efficacy or safety observed from clinical trials of AKL-T01 will not continue or be repeated in our ongoing or planned clinical trials of AKL-T01, will be insufficient to support regulatory submissions or support or maintain marketing approval in the United States or other jurisdictions, or that long-term adverse safety findings may be discovered; the risk that AKL-T01 will not be further developed or commercialized successfully; the timing and results expected from our and our partners’ clinical trials and our reliance on third parties for certain aspects of our business; our ability to accurately estimate expenses, capital requirements, and needs for additional financing; and other risks identified in our current filings and any subsequent filings made with the Securities and Exchange Commission (SEC). We caution 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. We disclaim 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.

###

Contact:

Julie DiCarlo

pr@akiliinteractive.com