- Akili’s leading digital therapeutic platform combines science
and technology to address cognitive impairments in patients,
reimagining how central nervous system medicines are designed,
developed, and delivered
- Transaction will support commercial launch of EndeavorRx®, a
first-of-its-kind, FDA-cleared and CE-marked prescription digital
therapeutic for pediatric ADHD, as well as advance clinical
development pipeline across multiple neuropsychiatric diseases,
including expanded ADHD populations, multiple sclerosis, autism,
and depression
- Transaction values the combined company at an equity value
post-money of up to approximately $1 billion and is expected to
provide up to $412 million in gross cash proceeds
- Fully committed PIPE of $162 million led by $100 million from
Social Capital with remaining $62 million from new and existing
investors including: Suvretta Capital Management’s Averill
strategy, Apeiron Investment Group, Temasek, co-founder PureTech
Health, Polaris Partners, Evidity Health Capital, JAZZ Venture
Partners and Omidyar Technology Ventures
- Chamath Palihapitiya expected to become Chair of Akili’s Board
of Directors upon transaction close
Akili Interactive (“Akili” or the “Company”), a leading digital
medicine company developing cognitive treatments through
game-changing technologies, has entered into a definitive agreement
to become publicly traded via a merger with Social Capital Suvretta
Holdings Corp. I (“SCS”) (Nasdaq: DNAA), a special purpose
acquisition company. The transaction is expected to close in
mid-2022, after which Akili will be listed on the Nasdaq stock
market under the new ticker symbol “AKLI.” As a public company with
world-class backing and strong financial flexibility, Akili will be
positioned to pioneer a new class of digital medicines for millions
of people living with cognitive impairment.
New Digital Approach to Cognitive Medicine
The Akili software platform was built on the belief that
directly engaging brain function is the next frontier of science
and medicine. Cognitive impairments – including poor concentration,
memory loss, difficulties learning new skills, and difficulties
with decision making – are in aggregate among the largest unmet
medical needs, and are increasingly recognized as contributing to
or associated with dozens of chronic diseases and acute illnesses,
including attention-deficit/hyperactivity disorder (ADHD), major
depressive disorder (MDD), multiple sclerosis (MS), and autism
spectrum disorder (ASD), as well as postoperative cognitive
dysfunction and COVID-19 “brain fog.”
Despite the rapidly growing prevalence of these conditions, the
acute exacerbation of these issues by the pandemic’s impact, and
the chronic, escalating cognitive overload from the proliferation
of on-demand attention-capturing technology, there has been limited
innovation of novel treatment options. Specifically, current
treatment options are designed to focus on symptoms and coping
strategies instead of directly targeting cognitive functioning.
These therapeutic shortfalls are especially concerning for younger
populations who are potentially facing a lifetime of managing these
conditions.
Akili’s First-of-Its-Kind, Clinically Validated
Therapeutic
By harnessing advances in cognitive neuroscience and consumer
technology, Akili is changing the neuropsychiatric treatment
paradigm. Akili’s patented and clinically validated technology
platform represents a new category of software-based medicine:
advanced and proprietary digital therapeutics that are designed to
directly target neural physiology to better serve the needs of
patients and their families.
Akili’s core therapeutic engine, the Selective Stimulus
Management Engine (SSMETM), is specifically designed to target and
activate neural systems involved in attentional control. This core
platform has the potential to be applied across a diverse set of
indications within psychiatry and neurology. Backed by robust
clinical research, Akili’s treatments are delivered to patients
through engaging interactive mobile games, personalized to each
individual and built to feel like high-end entertainment
products.
The SSMETM technology has already demonstrated proof-of-concept
in controlled trials targeting attention and cognitive dysfunction
in ADHD, ASD, MS, and MDD. Built on the SSMETM technology, Akili
developed EndeavorRx®, the first-ever FDA-cleared prescription
video game and the first-ever FDA-cleared commercial product
indicated to improve attention function in children between the
ages of 8 to 12 years with primarily inattentive or combined-type
ADHD (see full indication below).
Key Investment Highlights:
- Patented and clinically validated technology platform.
Developed with the collaboration of cognitive neuroscientists and
mobile game developers, Akili’s proprietary technology is designed
to target key neural systems underlying specific cognitive
functions through adaptable, personalized closed-loop algorithms.
The technology is clinically validated, using recognized endpoints,
and delivered through smartphones or other mobile devices.
- First-and-only FDA-cleared video game-based digital
therapeutic. Anticipated to launch in the second half of 2022,
EndeavorRx® is the first and only prescription video game treatment
with FDA clearance and a CE mark (designating it has met European
health, safety, performance, and environmental requirements) in
pediatric ADHD. EndeavorRx® has been validated through multiple
clinical trials, including large randomized, controlled trials
demonstrating improved patient outcomes.
- Large and growing market opportunity. Tens of millions
of people worldwide live with cognitive health issues, and many are
actively searching for better solutions. With EndeavorRx®, Akili is
initially targeting the approximately $10 billion U.S. ADHD market.
EndeavorRx® will first launch for the FDA-cleared 8 to 12-year-old
pediatric population. Akili is also seeking to expand into other
U.S. ADHD populations, including younger children (3 to 7 years
old), teens, and adults, while simultaneously working with a
partner to gain approval as a treatment for pediatric ADHD in
Japan.
- Strong clinical rigor. Akili has completed 20 clinical
trials across 2,900 patients and nine disease populations. In
addition, Akili’s clinical studies and data have been published in
16 leading peer-reviewed journals.
- Robust research and clinical pipeline. Akili has a
strong development pipeline, initially focused on treatments for
cognitive impairments across nine patient populations. In addition,
Akili is progressing early discovery for two new platform
technologies to address additional cognitive impairments and
facilitate broader reach across disease spectrums. Akili is poised
to begin pivotal studies in multiple indications where
proof-of-concept has been achieved, including additional ADHD
populations, ASD, MS, and MDD.
Management Comments
Eddie Martucci, Chief Executive Officer of Akili, said:
“This transaction represents the next step in our journey to become
the world’s leading digital medicine company directly targeting
neurological function. Over the past 10 years, we have created a
platform representing a new era of cognitive medicine, driven by
our fundamental focus on patients, advanced science and proprietary
technology, and the mission-driven hard work of our entire team. We
believe medicine now can be both effective and engaging. Social
Capital Suvretta shares our vision for the future, and we look
forward to applying our combined experience as we drive the
commercialization of our platform and advance our deep pipeline of
prescription digital therapeutics to help people living with
cognitive impairments across the globe.”
Chamath Palihapitiya, Founder and CEO of Social Capital and
Chairman and CEO of SCS, commented: “Akili is taking a new
approach to cognitive science – using software to target our
underlying cognitive function and creating an entirely new class of
medicine as a byproduct. With its first-ever, clinically validated
digital therapeutic (EndeavorRx®), Akili has the unique opportunity
to change how we treat pediatric ADHD. They have also laid the
groundwork to treat a wide range of other cognitive issues
affecting tens of millions of people around the world.”
Kishen Mehta, Portfolio Manager of the Averill strategy at
Suvretta Capital Management and President of SCS, said: “Akili
has created a unique disease-agnostic technology platform with an
advanced pipeline of product candidates across multiple indications
where proof-of-concept has already been achieved. The Company is
leading the advancement of digital cognitive therapies with an
FDA-cleared product already on the market, and we believe Akili has
only just scratched the surface of this new and exciting field of
medicine. We look forward to working with Akili to accelerate the
Company’s growth and allow it to continue developing treatment
options for the hundreds of millions of people living with
cognitive impairments.”
Transaction Overview
The transaction implies a post-money equity value of the
combined company of up to approximately $1 billion and is expected
to deliver up to $412 million in gross cash proceeds to the
Company, including the contribution of up to $250 million of cash
held in SCS’s trust account and $162 million from PIPE investors at
$10 per share. All references to available cash from the trust
account and retained transaction proceeds are subject to any
redemptions by the public shareholders of SCS and payment of
transaction expenses. Akili plans to use the net proceeds to help
fund the Company’s go-to-market strategy, to further advance its
pipeline of prescription digital therapeutics targeting a range of
chronic and acute cognitive disorders, and for other general
corporate purposes.
Existing Akili shareholders will roll 100% of their equity into
the combined company and will be eligible to receive additional SCS
shares pursuant to an earnout based on the combined company’s
future stock performance.
Chamath Palihapitiya is expected to join Akili’s board of
directors as chair, upon the close of the transaction.
The proposed business combination, which has been unanimously
approved by the boards of directors of both Akili and SCS, is
expected to close in mid-2022, subject to approval by SCS’s and
Akili’s shareholders, regulatory approvals, and other customary
closing conditions.
Advisors
Morgan Stanley & Co. LLC (“Morgan Stanley”) and Cowen and
Company, LLC (“Cowen”) are serving as financial advisors to Akili.
Morgan Stanley, Credit Suisse, and Cowen are serving as
co-placement agents to SCS with respect to the portion of the PIPE
financing raised from non-insider qualified institutional buyers
and institutional accredited investors. Morgan Stanley, Credit
Suisse, and Cowen are not acting as agents or participating in any
role with respect to, and will not earn any fees from, the portion
of the PIPE financing raised from insiders and individual
investors. Credit Suisse and Cowen are serving as capital markets
advisors to Akili. BofA Securities, Inc. is acting as capital
markets advisor to SCS.
Goodwin Procter LLP is serving as legal counsel to Akili.
Wachtell, Lipton, Rosen & Katz is serving as legal counsel to
SCS. Skadden, Arps, Slate, Meagher & Flom LLP is serving as
legal advisor to the PIPE placement agents.
Conference Call Information
A presentation made by the management teams each of Akili and
SCS regarding the transaction will be available at
https://event.on24.com/wcc/r/3621898/2B6B29D03ADCC3D4AD26E9082AE8ADA1
at 8:00 AM ET.
Additional information about the proposed transaction, including
an investor presentation, will be provided in a Current Report on
Form 8-K to be filed by SCS with the Securities and Exchange
Commission and available at www.sec.gov.
EndeavorRx® Indication and Overview
EndeavorRx® is the first-and-only FDA-cleared 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 trial 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 game-changing
technologies to usher in a new era of cognitive medicine. Focused
on delivering cutting-edge digital diagnostics, treatments and
monitors for cognitive impairments across disease and disorders,
Akili is combining scientific and clinical rigor with the ingenuity
of the tech and entertainment industries and challenging the status
quo of medicine. Akili’s treatments are designed to directly
activate the networks in the brain responsible for cognitive
function and have been rigorously tested in extensive clinical
studies, including prospective randomized, controlled trials.
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.
About Social Capital
At Social Capital, we make big bets on transformational ideas,
technology, and people. We strategically invest in smart,
profit-minded opportunities and forward-thinking social investments
that have the potential to shape a better future. We do this from a
balance sheet of permanent capital to support entrepreneurship at
all stages. This allows us more flexibility to double down on our
convictions, without the limitations of traditional fund
structures, and gives founders the runway and resources necessary
to succeed. We believe in the outsized potential of for-profit
businesses to drive impact in the world. We aim to set a new
standard for what capitalism can be. To learn more about Social
Capital, visit https://www.socialcapital.com/.
About Social Capital Suvretta Holdings Corp I
Social Capital Suvretta Holdings Corp. I is led by Chamath
Palihapitiya and Kishen Mehta and is a blank check company formed
for the purpose of effecting a merger, amalgamation, share
exchange, asset acquisition, share purchase, reorganization or
similar business combination with one or more businesses. The
company is focused on businesses operating in the biotechnology
industry and within the neurology subsector. To learn more about
Social Capital Suvretta Holdings, visit
https://www.socialcapitalsuvrettaholdings.com/.
Additional Information and Where to Find It
In connection with the proposed transaction, SCS intends to file
a registration statement on Form S-4 (as amended, the “Registration Statement”) with the SEC, which will
include a preliminary prospectus and proxy statement of SCS,
referred to as a proxy statement/prospectus. Such documents are not
currently available. When available, a final proxy
statement/prospectus will be sent to all SCS shareholders. SCS will
also file other documents regarding the proposed transaction with
the SEC. SHAREHOLDERS OF SCS ARE ADVISED TO READ, WHEN AVAILABLE,
THE REGISTRATION STATEMENT, THE PROXY STATEMENT/PROSPECTUS AND ALL
OTHER RELEVANT DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC
IN CONNECTION WITH THE PROPOSED TRANSACTION AS THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.
Shareholders will be able to obtain free copies of the Registration
Statement, the proxy statement/prospectus and all other relevant
documents filed or that will be filed with the SEC by SCS (when
available) through the website maintained by the SEC at
http://www.sec.gov.
The documents filed by SCS with the SEC also may be obtained
free of charge at SCS’s website at
https://socialcapitalsuvrettaholdings.com/dnaa or upon written
request to 2850 W. Horizon Ridge Parkway, Suite 200, Henderson, NV
89052.
Participants in the Solicitation
SCS and Akili and their respective directors and executive
officers may be deemed to be participants in the solicitation of
proxies from SCS’s shareholders in connection with the proposed
transaction. A list of the names of such directors and executive
officers and information regarding their interests in the proposed
transaction between Akili and SCS will be contained in the proxy
statement/prospectus when available. You may obtain free copies of
these documents as described in the preceding paragraph.
No Offer or Solicitation
This communication shall not constitute a solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the proposed transaction. This communication shall
not constitute an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any states or jurisdictions in which such offer, solicitation or
sale would be unlawful prior to registration or qualification under
the securities laws of such state or jurisdiction. No offering of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act or an
exemption therefrom. This press release may be deemed to be
solicitation material in respect of the proposed transactions
contemplated by the proposed business combination between Akili and
SCS.
Forward-Looking Statements
This communication may contain certain forward-looking
statements within the meaning of the federal securities laws with
respect to the proposed transaction between Akili and SCS. 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. Many factors could
cause actual future events to differ materially from the
forward-looking statements in this communication, including but not
limited to: (i) the risk that the proposed transaction may not be
completed in a timely manner or at all, which may adversely affect
the price of SCS’s securities, (ii) the risk that the proposed
transaction may not be completed by SCS’s business combination
deadline and the potential failure to obtain an extension of the
business combination deadline if sought by SCS, (iii) the failure
to satisfy the conditions to the consummation of the proposed
transaction, including the adoption of the Merger Agreement by the
shareholders of SCS and the satisfaction of the minimum cash
condition, (iv) the lack of a third party valuation in determining
whether or not to pursue the proposed transaction, (v) the
inability to complete the PIPE Investment, (vi) the occurrence of
any event, change or other circumstance that could give rise to the
termination of the Merger Agreement, (vii) the effect of the
announcement or pendency of the transaction on Akili’s business
relationships, operating results, and business generally, (viii)
risks that the proposed transaction disrupts current plans and
operations of Akili or diverts management’s attention from Akili’s
ongoing business operations and potential difficulties in Akili
employee retention as a result of the announcement and consummation
of the proposed transaction, (ix) the outcome of any legal
proceedings that may be instituted against Akili or against SCS
related to the Merger Agreement or the proposed transaction, (x)
the ability to maintain the listing of SCS’s securities on a
national securities exchange, (xi) the price of SCS’s securities
may be volatile due to a variety of factors, including changes in
the competitive and highly regulated industries in which SCS plans
to operate or Akili operates, variations in operating performance
across competitors, changes in laws and regulations affecting SCS’s
or Akili’s business, and changes in the combined capital structure,
(xii) the ability to implement business plans, forecasts, and other
expectations after the completion of the proposed transaction, and
identify and realize additional opportunities, (xiii) the ability
of Akili to successfully commercialize EndeavorRx® and continue to
advance its clinical development pipeline, (xiv) the ability to
recognize the anticipated benefits of the proposed transaction,
which may be affected by, among other things, competition, the
ability of the combined company to grow and manage growth
profitably, maintain relationships with customers and suppliers and
retain its management and key employees, (xv) the evolution of the
markets in which Akili competes, (xvi) the ability of Akili to
defend its intellectual property and satisfy regulatory
requirements, (xvii) the costs related to the proposed transaction,
(xviii) the impact of the COVID-19 pandemic on Akili’s business,
(xix) Akili’s expectations regarding its market opportunities and
(xx) the risk of downturns and a changing regulatory landscape in
the highly competitive industry in which Akili operates. The
foregoing list of factors is not exhaustive. You should carefully
consider the foregoing factors and the other risks and
uncertainties described in the “Risk Factors” section of SCS’s
registration on Form S-1 (File Nos. 333-256723 and 333-257543),
SCS’s quarterly report on Form 10-Q for the quarter ended September
30, 2021 filed with the SEC on November 15, 2021, the Registration
Statement on Form S-4 when available, including those under “Risk
Factors” therein, and other documents filed by SCS from time to
time with the SEC. These filings identify and address other
important risks and uncertainties that could cause actual events
and results to differ materially from those contained in the
forward-looking statements. Forward-looking statements speak only
as of the date they are made. Readers are cautioned not to put
undue reliance on forward-looking statements, and Akili and SCS
assume no obligation and do not intend to update or revise these
forward-looking statements, whether as a result of new information,
future events, or otherwise. Neither Akili nor SCS gives any
assurance that either Akili or SCS, or the combined company, will
achieve its expectations.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220126005508/en/
Akili: Media Julie DiCarlo Akili Interactive
julie@akiliinteractive.com Sard Verbinnen & Co
akili-svc@sardverb.com Social Capital Suvretta: Media Reze
Wong reze@socialcapital.com Kerry Golds / Kala Krishnan
kerry.golds@fgh.com / kala.krishnan@fgh.com scs-us@fgh.com
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