424B3 1 d340279d424b3.htm 424B3 424B3

Filed pursuant to Rule 424(b)(3)

Registration Statement No. 333-267031

Prospectus Supplement No. 1

(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 November 10, 2022, 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 November 9, 2022, the closing price of our common stock was $1.74.

 

 

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 November 10, 2022


 

 

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):

November 10, 2022 (November 10, 2022)

 

 

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 2.02

Results of Operations and Financial Condition.

On November 10, 2022, Akili, Inc. (the “Company”) reported its financial results for the quarter ended September 30, 2022. A copy of the press release issued in connection with the report is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. This Exhibit 99.1 is deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is incorporated by reference in all appropriate filings under the Securities Act of 1933, as amended, except for the first three paragraphs of the exhibit, each of which shall be “furnished” and not “filed”.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

No.

   Description of Exhibit
99.1    Press Release issued by Akili, Inc. on November 10, 2022.
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.

 

Akili, Inc.
By:  

/s/ Santosh Shanbhag

Name:   Santosh Shanbhag
Title:   Chief Financial Officer

Date: November 10, 2022


Exhibit 99.1

 

LOGO

Akili Reports Third Quarter 2022 Financial Results and Company Update

EndeavorRx®, the world’s first FDA-authorized video game treatment, saw quarter over quarter growth

in number of prescribers and volume of prescriptions; Initiated commercial launch in Q3

Raised more than $164 million in gross proceeds with business combination; Akili, Inc. now trading as Nasdaq: AKLI

BOSTON, Mass. – November 10, 2022 – Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today reported its financial results for the quarter ended September 30, 2022, and provided an update on business progress.

“We achieved two important milestones this quarter on our path to bring digital treatments to mainstream medicine—we began trading on Nasdaq and raised funds to support our first product launch and advance our pipeline, and we transitioned from pre-launch to launch of EndeavorRx,” said Eddie Martucci, chief executive officer of Akili. “With a solid foundation and experienced team in place, Akili is well-positioned to advance our vision of EndeavorRx becoming part of routine medical care for children with ADHD.” (See below for EndeavorRx full indication and safety information.)

“Prescriptions for EndeavorRx have been written across all 50 states, and market uptake continues to grow,” said Matt Franklin, president and chief operating officer of Akili. “We have now executed the first phase of our commercial launch of EndeavorRx, hiring, training and deploying our initial sales force into priority territories to help us accelerate adoption.”

Recent Business Updates

 

   

Akili deployed the first wave of its EndeavorRx go-to-market sales force in the third quarter of 2022 in 14 priority territories across the U.S. with a focus on Integrated Behavioral Health Centers and pediatric providers. Akili plans to scale to additional territories over the next 18 months.

 

   

More than 1,300 prescriptions for EndeavorRx were written in the third quarter, representing a 71% increase over the second quarter of 2022 and a 146% increase over the third quarter of 2021. In the third quarter of 2022, 789 physicians prescribed EndeavorRx, including more than 500 new prescribers, representing a 91% gain in new prescribers over the second quarter of 2022 and a 110% increase over the third quarter of 2021. From FDA authorization through the third quarter of 2022, over 2,000 physicians prescribed EndeavorRx to patients, with prescriptions now written in every state in the U.S.


   

Akili launched the EndeavorRx Expedition product registry to obtain feedback from patients receiving the digital therapeutic, and their caregivers. This fully remote, direct-to-patient registry is open to any patient who has been prescribed EndeavorRx and is designed to provide insights into patient characteristics, usage patterns, and collection of real-world evidence. The company plans to use the data to expand the real-world evidence base for physicians, payers, and caregivers.

 

   

A phase 3 randomized, controlled study of Akili’s SDT-001 product candidate (the same core technology behind EndeavorRx, localized for Japanese language and culture for distribution in Japan) designed to improve measures of attention in children with ADHD was initiated in Japan. The study is being conducted by Akili’s partner, the global pharmaceutical company Shionogi & Co., Ltd.

 

   

In August, Akili completed its business combination with Social Capital Suvretta Holdings Corp. I and began trading on The Nasdaq Capital Market (“Nasdaq”) under the new ticker symbol “AKLI.” Akili raised more than $164 million from the transaction, before deducting transaction expenses and advisory fees, and established its new public company board of directors.

Third Quarter 2022 Financial Highlights

 

   

Cash position: As of September 30, 2022, Akili had $156.4 million in cash, cash equivalents, and short-term investments, compared to $45.6 million at June 30, 2022. The cash position is expected to be sufficient to fund current and planned operations until mid-2024.

 

   

Revenues: EndeavorRx revenues for the third quarter 2022 were $82 thousand compared to $64 thousand for the quarter ended June 30, 2022.

 

   

Total Operating Expenses: GAAP total operating expenses were $24.5 million for the third quarter, compared to $22.3 million for the quarter ended June 30, 2022. The increase was driven by transaction related costs allocated to earnout shares and stock-based compensation related expenses, partially offset by the timing of discretionary marketing expenditures associated with the commercialization of EndeavorRx. Non-GAAP total operating expenses were $18.3 million for the third quarter, compared to $20.3 million for the quarter ended June 30, 2022. The decrease was primarily due to lower clinical trials related expenses and timing of discretionary marketing expenditures associated with the commercialization of EndeavorRx.

 

   

R&D Expenses: GAAP research and development expenses were $7.6 million for the third quarter, compared to $7.4 million for the quarter ended June 30, 2022. The increase was primarily due to stock-based compensation related expenses. Non-GAAP research and development expenses were $6.2 million for the third quarter, compared to $6.5 million for the quarter ended June 30, 2022. The decrease was primarily due to lower clinical trials related expenses.


   

SG&A Expenses: GAAP selling, general, and administrative expenses were $16.9 million for the third quarter, compared to $14.9 million for the quarter ended June 30, 2022. The increase was driven by transaction related costs allocated to earnout shares and stock-based compensation related expenses, partially offset by the timing of discretionary marketing expenditures associated with the commercialization of EndeavorRx. Non-GAAP selling, general, and administrative expenses were $12.0 million for the third quarter, compared to $13.8 million for the quarter ended June 30, 2022. The decrease was driven primarily by the timing of discretionary marketing expenditures associated with the commercialization of EndeavorRx.

 

   

Net income (loss): GAAP net income was $53.2 million in the third quarter compared to a net loss of $22.5 million for the quarter ended June 30, 2022. The change in profitability was primarily due to the reduction of liabilities relating to the company’s earnout shares. Non-GAAP net loss was $18.5 million in the third quarter compared to a net loss of $20.5 million for the quarter ended June 30, 2022.

For additional information, please see the tables below, which include a reconciliation of the non-GAAP financial measures to GAAP financial measures.

Webcast and Conference Call

Akili will host a conference call and webcast today, Thursday, November 10, 2022, at 4:30 p.m. ET. A live audio webcast of the conference call and presentation will be available at www.akiliinteractive.com under Investor Relations, Events & Presentations. An archived version of the webcast will be available on the company’s website following the event.

To access the call, dial 877-405-1224 (toll-free) or 201-389-0848 (international) and reference “Akili Q3 Results.” International toll-free numbers are available here.

Non-GAAP Financial Measures

In addition to financial information prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), this press release includes the following non-GAAP financial measures: non-GAAP total operating expenses on a historical basis, non-GAAP R&D expenses on a historical basis, non-GAAP SG&A expenses on a historical basis, and non-GAAP net loss on a historical basis. Akili derives these non-GAAP financial measures by excluding certain expenses and other items from the respective GAAP financial measure that is most directly comparable to each non-GAAP financial measure. Specifically, the non-GAAP total operating expenses, non-GAAP R&D expenses, and non-GAAP SG&A expenses exclude stock-based compensation expense and transaction costs allocated to earnout shares, and non-GAAP net loss excludes stock-based compensation expense, transaction costs allocated to earnout shares, and the change in estimated fair value of earn-out


liabilities. Akili’s management believes that these non-GAAP financial measures are useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies. A reconciliation of the non-GAAP financial measures to GAAP financial measures is included in the attached financial tables.

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 vision for EndeavorRx; the commercial launch of EndeavorRx and our plans to scale our commercialization efforts and personnel; the anticipated acceleration of market uptake and insurance coverage of EndeavorRx; the development and advancement of our pipeline of digital therapeutics product candidates for other patient populations; our plans to use data from patients and caregivers to expand the real-world evidence base; and our expectation that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our current and planned operations until mid-2024. 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: our ability to successfully commercialize EndeavorRx; our 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; our ability to obtain and maintain adequate coverage and reimbursement for our digital therapeutics; our ability to continue to advance our clinical development pipeline; our ability to defend our intellectual property and satisfy various FDA and other regulatory requirements in and outside of the United States; the impact of the COVID-19 pandemic on our business; the risk of downturns and a changing regulatory landscape in the highly competitive industry in which we operate; 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.


Akili, Inc.

Unaudited Condensed Consolidated Balance Sheets

 

     September 30,     June 30,     December 31,  
     2022     2022     2021  

Assets

      

Current assets:

      

Cash and cash equivalents

   $ 89,661     $ 40,638     $ 76,899  

Restricted cash

     305       305       305  

Short-term investments

     66,696       4,987       —    

Accounts receivable

     30       17       29  

Prepaid expenses and other current assets

     4,586       5,328       2,500  
  

 

 

   

 

 

   

 

 

 

Total current assets

     161,278       51,275       79,733  

Property and equipment, net

     996       1,054       1,193  

Operating lease right-of-use asset

     2,760       2,686       —    

Prepaid expenses and other long-term assets

     —         —         11  
  

 

 

   

 

 

   

 

 

 

Total assets

   $ 165,034     $ 55,015     $ 80,937  
  

 

 

   

 

 

   

 

 

 

Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)

      

Current liabilities:

      

Accounts payable

   $ 3,486     $ 4,309     $ 2,345  

Accrued expenses and other current liabilities

     6,240       5,044       5,477  

Deferred revenue

     109       109       96  

Deferred rent, short term

     2       9       123  

Operating lease liability

     803       625       —    

Note payable, short term

     2,500       625       —    
  

 

 

   

 

 

   

 

 

 

Total current liabilities

     13,140       10,721       8,041  

Note payable, long term

     12,436       14,213       4,784  

Operating lease liability, net of current portion

     2,701       2,832       —    

Corporate bond, net of bond discount

     1,785       1,735       1,638  

Earn-out liabilities

     11,100       —         —    

Deferred rent, long term

     —         —         712  
  

 

 

   

 

 

   

 

 

 

Total liabilities

     41,162       29,501       15,175  
  

 

 

   

 

 

   

 

 

 

Commitments and contingencies

      

Redeemable convertible preferred stock

     —         300,554       291,876  

Stockholders’ equity (deficit)

      

Common stock

     8       —         —    

Additional paid-in capital

     347,330       —         —    

Accumulated deficit

     (223,473     (275,033     (226,114

Accumulated other comprehensive gain (loss)

     7       (7     —    
  

 

 

   

 

 

   

 

 

 

Total stockholders’ equity (deficit)

     123,872       (275,040     (226,114
  

 

 

   

 

 

   

 

 

 

Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)

   $ 165,034     $ 55,015     $ 80,937  
  

 

 

   

 

 

   

 

 

 


Akili, Inc.

Unaudited Condensed Consolidated Statements of Operations

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
    Three Months
Ended
June 30,
 
     2022     2021     2022     2021     2022  

Revenues

   $ 82     $ 155     $ 212     $ 377     $ 64  

Cost of revenues

     123       83       316       243       97  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit (loss)

     (41     72       (104     134       (33

Operating expenses:

          

Research and development

     7,554       4,756       21,216       12,739       7,358  

Selling, general and administrative

     16,911       13,292       47,250       28,675       14,948  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     24,465       18,048       68,466       41,414       22,306  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (24,506     (17,976     (68,570     (41,280     (22,339
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense), net

     77,742       (161     77,421       (457     (154
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 53,236     $ (18,137   $ 8,851     $ (41,737   $ (22,493
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 


Akili, Inc.

GAAP to Non-GAAP Reconciliation

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
    Three Months Ended
June 30
 
     2022     2021     2022     2021     2022  

R&D Expenses

   $ 7,554     $ 4,756     $ 21,216     $ 12,739     $ 7,358  

Less Stock-Based Compensation

     (1,312     (408     (2,762     (920     (845
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP R&D Expenses

     6,242       4,348       18,454       11,819       6,513  

SG&A Expenses

     16,911       13,292       47,250       28,675       14,948  

Less Transaction costs allocated to earnout shares

     (3,046     —         (3,046     —         —    

Less Stock-Based Compensation

     (1,841     (1,340     (4,430     (2,628     (1,124
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP SG&A Expenses

     12,024       11,952       39,774       26,047       13,824  

Total Operating Expenses

     24,465       18,048       68,466       41,414       22,306  

Less Transaction costs allocated to earnout shares

     (3,046     —         (3,046     —         —    

Less Stock-Based Compensation

     (3,153     (1,748     (7,192     (3,548     (1,969
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Total Operating Expenses

     18,266       16,300       58,228       37,866       20,337  

Operating Loss

     (24,506     (17,976     (68,570     (41,280     (22,339

Less Transaction costs allocated to earnout shares

     3,046       —         3,046       —         —    

Less Stock-Based Compensation

     3,153       1,748       7,192       3,548       1,969  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Operating Loss

     (18,307     (16,228     (58,332     (37,732     (20,370

Other income (expense), net

     77,742       (161     77,421       (457     (154

Less Change in estimated fair value for earn-out liabilities

     (77,892     —         (77,892     —         —    
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Other income (expense), net

     (150     (161     (471     (457     (154

Net Income (Loss)

     53,236       (18,137     8,851       (41,737     (22,493

Less Transaction costs allocated to earnout shares

     3,046       —         3,046       —         —    

Less Stock-Based Compensation

     3,153       1,748       7,192       3,548       1,969  

Less Change in estimated fair value for earn-out liabilities

     (77,892     —         (77,892     —         —    
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Net Loss

   $ (18,457   $ (16,389   $ (58,803   $ (38,189   $ (20,524
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 


###

Investor Contact:

Joshua Young

VP, Investor Relations

jyoung@akiliinteractive.com

Media Contact:

Julie DiCarlo

SVP, Communications

julie@akiliinteractive.com