atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage
biopharmaceutical company aiming to transform the treatment of
mental health disorders, today launched Invyxis, a new, wholly
owned platform company committed to developing new chemical
entities (NCEs) and to further pioneering next-generation mental
health treatments. Invyxis will bring proven medicinal chemistry
tools and comprehensive biological screening approaches to atai’s
growing enterprise of drug discovery and design.
The launch of Invyxis is a further step-up in atai’s growth and
commitment to innovation in the treatment of mental health
disorders. The new atai platform company has entered into a
strategic collaboration with Dalriada Drug Discovery, specialists
in the discovery of small molecule therapeutics. Invyxis will
harness a broad array of methods including structure-based design,
synthetic chemistry, high-throughput screening, and in vivo
characterization.
Invyxis’ goal will be to discover new agents with potential in
treating mental health disorders, generating NCEs to progress into
atai’s research & development pipeline of psychedelic and
non-psychedelic compounds. The platform company will initially
focus on agonists at the 5-HT2A receptor, recognizing the
importance of this key serotonin receptor system in treating a
range of mental health disorders.
Expanding intellectual property (IP) has been essential to
atai’s strategy since inception, with key investments made to
unlock NCEs. In 2019, atai launched EntheogeniX to pursue novel
compounds using machine learning-based drug discovery, and the
recent launch of TryptageniX added biosynthetic capabilities to
atai’s discovery efforts.1,2 atai has already made substantial
progress in its drug discovery efforts to date, synthesizing and
screening approximately 300 compounds and identifying novel
scaffolds that display potential in targeting mental health
disorders.
“The global mental health crisis continues to escalate at an
alarming rate and many patients do not find sufficient relief from
currently available treatments. We urgently need newer, better
options and innovative drug discovery is integral to this,” said
Florian Brand, Chief Executive Officer and Co-Founder of atai Life
Sciences. “With the addition of Invyxis, atai is now even more
equipped to bring forward revolutionary new treatments and optimize
next-generation therapies to better meet patient needs.”
“Expanding IP and growing our library of NCEs has been essential
to our strategy since our inception,” said Srinivas Rao, Chief
Scientific Officer and Co-Founder of atai Life Sciences. “By
establishing differentiated potential treatments, with near,
middle, and long-term developmental timelines, we add value and
sustainability to our extensive pipeline of novel compounds with
potential in targeting mental health indications. We are uniquely
positioned, as a leading developer of psychedelic therapeutics,
with the resources necessary to commit to and deliver this
forward-looking strategy.”
“The use of psychedelic compounds to create improved
next-generation mental health therapies is a highly promising and
emerging field,” said Diana Kraskouskaya, Dalriada Chief Executive
and Co-Founder. “We’re delighted to be partnering with atai to make
an impact in this area. This creation of Invyxis brings together
Dalriada’s ability to provide a rapid set-up and advancement of NCE
discovery pipelines and atai’s expertise in the preclinical and
clinical development of psychedelic therapeutics.”
Mental health disorders impact over 1 billion people around the
world, representing a growing global crisis, but medical innovation
has failed to offer recent novel solutions.3 Only 7 treatments have
been approved by the FDA for psychiatry disorders since 2015; a
time in which approximately 100 have been advanced in oncology.4
atai Life Sciences is proud to be a driving force in mental health
innovation and to make Invyxis the latest addition to its
diversified platform, to develop new therapeutic options in key
areas of patient unmet need.
References:
- ATAI Life Sciences and Cyclica
Launch Joint Venture to Revolutionize Drug Development for Mental
Health Disorders. [Press Release]
https://www.businesswire.com/news/home/20191111005299/en/ATAI-Life-Sciences-and-Cyclica-Launch-Joint-Venture-to-Revolutionize-Drug-Development-for-Mental-Health-Disorders.
Published November 11, 2019. Accessed January 18, 2022.
- atai Life Sciences launches
TryptageniX to further expand atai’s robust intellectual property
portfolio and strengthen atai's supply chain. [Press release]
https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-launches-tryptagenix-further-expand-atais.
Published December 9, 2021. Accessed January 18, 2022.
- Rehm J, Shield KD. Global Burden of
Disease and the Impact of Mental and Addictive Disorders. Curr
Psychiatry Rep. 2019;21(2):10.
- U.S. Food and Drug Administration.
New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic
Biological Products. Accessed January 5, 2022.
https://www.fda.gov/drugs/development-approval-process-drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products.
About atai Life Sciencesatai is a
clinical-stage biopharmaceutical company aiming to transform the
treatment of mental health disorders. atai was founded in 2018 as a
response to the significant unmet need and lack of innovation in
the mental health treatment landscape. atai is dedicated to
acquiring, incubating and efficiently developing innovative
therapeutics to treat depression, anxiety, addiction, and other
mental health disorders.
atai's business model combines funding, technology, scientific
and regulatory expertise with a focus on psychedelic therapy and
other drugs with differentiated safety profiles and therapeutic
potential. By pooling resources and best practices, atai aims to
responsibly accelerate the development of new medicines across its
companies, seeking to effectively treat and ultimately heal mental
health disorders.
atai's vision is to heal mental health disorders so that
everyone, everywhere can live a more fulfilled life. atai has
offices in New York, London, and Berlin. For more information,
please visit www.atai.life.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended. The
words “believe,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “expect,” “initiate,” “could,” “would,”
“project,” “plan,” “potentially,” “preliminary,” “likely,” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these words. Forward-looking statements include express or implied
statements relating to, among other things: statements regarding
Invyxis and NCE development, the success, cost and timing of
development of our product candidates, including the progress of
preclinical and clinical trials and related milestones; our
business strategy and plans; potential acquisitions; and the plans
and objectives of management for future operations and capital
expenditures. The forward-looking statements in this press release
are neither promises nor guarantees, and you should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties, and other factors, many of
which are beyond our control and which could cause actual results,
levels of activity, performance or achievements to differ
materially from those expressed or implied by these forward-looking
statements.
We have based these forward-looking statements largely on our
current expectations and projections about future events and trends
that we believe may affect our financial condition, results of
operations, business strategy, short-term and long-term business
operations and objectives, and financial needs. These
forward-looking statements are subject to a number of risks,
uncertainties, and assumptions, including without limitation: we
are a clinical-stage biopharmaceutical company and have incurred
significant losses since our inception, and we anticipate that we
will continue to incur significant losses for the foreseeable
future; we will require substantial additional funding to achieve
our business goals, and if we are unable to obtain this funding
when needed and on acceptable terms, we could be forced to delay,
limit or terminate our product development efforts; our limited
operating history may make it difficult to evaluate the success of
our business and to assess our future viability; we have never
generated revenue and may never be profitable; our product
candidates contain controlled substances, the use of which may
generate public controversy; clinical and preclinical development
is uncertain, and our preclinical programs may experience delays or
may never advance to clinical trials; we rely on third parties to
assist in conducting our clinical trials and some aspects of our
research and preclinical testing, and those clinical trials,
including progress and related milestones, may be impacted by
several factors including the failure by such third parties to meet
deadlines for the completion of such trials, research, or testing,
changes to trial sites and other circumstances; we currently rely
on qualified therapists working at third-party clinical trial sites
to administer certain of our product candidates in our clinical
trials and we expect this to continue upon approval, if any, of our
current or future product candidates; if third-party sites fail to
recruit and retain a sufficient number of therapists or effectively
manage their therapists, our business, financial condition and
results of operations would be materially harmed; we cannot give
any assurance that any of our product candidates will receive
regulatory approval, which is necessary before they can be
commercialized; research and development of drugs targeting the
central nervous system, or CNS, is particularly difficult, and it
can be difficult to predict and understand why a drug has a
positive effect on some patients but not others; we face
significant competition in an environment of rapid technological
and scientific change; third parties may claim that we are
infringing, misappropriating or otherwise violating their
intellectual property rights, the outcome of which would be
uncertain and may prevent or delay our development and
commercialization efforts; a change in our effective place of
management may increase our aggregate tax burden; we identified
material weaknesses in connection with our internal control over
financial reporting; and a pandemic, epidemic, or outbreak of an
infectious disease, such as the COVID-19 pandemic, may materially
and adversely affect our business, including our preclinical
studies, clinical trials, third parties on whom we rely, our supply
chain, our ability to raise capital, our ability to conduct regular
business and our financial results. Other risk factors include the
important factors described in the section titled “Risk Factors” in
our final prospectus, dated June 17, 2021, filed with the
Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b)
under the Securities Act, and in our other filings with the SEC,
that may cause our actual results, performance or achievements to
differ materially and adversely from those expressed or implied by
the forward-looking statements.
Any forward-looking statements made herein speak only as of the
date of this press release, and you should not rely on
forward-looking statements as predictions of future events.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee that
the future results, performance, or achievements reflected in the
forward-looking statements will be achieved or will occur. Except
as required by applicable law, we undertake no obligation to update
any of these forward-looking statements for any reason after the
date of this press release or to conform these statements to actual
results or revised expectations.
Contact Information
Media Contact:Camilla DormerVP, CommunicationsEmail:
camilla@atai.lifeInvestor Contact:Chad MesserVP, Investor
RelationsEmail: chad@atai.life
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