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
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240430639511/en/
Investor and Media Contact: Matt Franklin President and
Chief Executive Officer InvestorRelations@akiliinteractive.com or
PR@akiliinteractive.com
Akili (NASDAQ:AKLI)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Akili (NASDAQ:AKLI)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024