atai Life Sciences (Nasdaq: ATAI) ("atai"), a clinical-stage
biopharmaceutical company aiming to transform the treatment of
mental health disorders, today announced that it has increased
its ownership interest in COMPASS Pathways ("COMPASS"), from 19.4%
to 20.8%.
This equity stake increase is a demonstration of atai’s
confidence in COMPASS Pathways and in the potential of COMP360 in
mental health care, following the recent COMP360 data in
treatment-resistant depression (TRD). This solidifies atai’s
position as COMPASS’ largest shareholder.
“We’ve supported COMPASS Pathways since the early days, when
they were our very first psychedelic initiative, as part of our
quest for more effective solutions for mental health patients. We
believe this month’s Phase 2b data was a true milestone for
innovation in mental health and COMP360 shows strong potential as a
future treatment for patients with TRD,” said Florian Brand,
Co-Founder and Chief Executive Officer of atai Life Sciences. “This
further confirms our belief in COMPASS’ psilocybin-assisted
psychotherapy as a valued part of our diversified approach to
develop novel solutions for patients with unmet needs in mental
health.”
“Today’s announcement underscores our belief in the potential of
COMPASS and COMP360 in the future of mental health care. In my
personal opinion, the market doesn’t seem to appreciate the full
upside potential given these impressive COMP360 data, the size of
the unmet patient need and the potential of COMPASS’ broad patent
portfolio,” said Christian Angermayer, Founder and Chairman of atai
Life Sciences.
Over 300 million people worldwide live with depression and, of
these, a third struggle with TRD that cannot be managed by
currently available options.1,2
COMPASS’s Phase 2b trial of COMP360 psilocybin in TRD is the
largest and most robust trial ever to be conducted with psilocybin.
Participants in this COMPASS trial had previously failed on two to
four antidepressants. The 233-patient, 22-site, randomized,
controlled, double-blind dose-controlled trial with COMP360
reported rapid and durable results in reducing depression, when
combined with psychological support, and was generally well
tolerated. A single 25mg dose achieved a 6.6 point reduction (vs
1mg), from baseline to week three, on the Montgomery-Åsberg
Depression Rating Scale (MADRS) (p<0.001), successfully meeting
the primary endpoint.
Most standard selective serotonin reuptake inhibitor (SSRI)
antidepressants were approved on just a 2-3 MADRS point reduction
in a general major depressive disorder patient population, and
several weeks are typically required to show a significant benefit.
Another comparable, intranasal esketamine has demonstrated only a 4
MADRS point reduction at 28 days vs. placebo in TRD (in third party
studies), thus highlighting the potential of COMP360 in this
challenging patient population.3-5
Despite the mounting problem of mental health in recent years,
further compounded by the pandemic, innovation has been sorely
lacking; only seven new treatments have been approved by the FDA
for psychiatric disorders since 2015.6,7
In 2018, COMP360 received Breakthrough Therapy Designation from
the U.S. Food and Drug Administration (FDA) for TRD.8 COMPASS has
recently expanded the indications of interest to
post-traumatic stress disorder and initiated an additional Phase 2
study. COMPASS also reported positive signals from an open-label
investigator-initiated study in the U.S. of COMP360 for depression
in cancer.9,10 COMPASS’ Phase 3 study of psilocybin in TRD is
anticipated to launch in 2022. Furthermore, COMPASS is exploring
the potential of COMP360 towards several further potential
indications including type 2 bipolar disorder depression, anorexia
nervosa, body dysmorphia, suicidal ideation and autism.
As we ultimately believe there is no one-size-fits-all solution
in the treatment of mental health conditions, atai is progressing a
pharmacologically-diverse array of programs, spanning psychedelics,
non-psychedelics, and is developing innovative digital therapeutics
to address the areas of highest unmet need in mental health. By
developing COMP360 and other novel 5-HT2a agonists, COMPASS is
highly complementary to our diversified platform and fully aligns
with our vision to heal mental health disorders, so that everyone,
everywhere can live a more fulfilled life.
References
1. World Health Organization. Depression.
Published September 13, 2021. Accessed November 24, 2021.
https://www.who.int/news-room/fact-sheets/detail/depression. 2.
Pandarakalam JP. Challenges of Treatment-resistant Depression.
Psychiatr Danub. 2018;30(3):273-284.3. Kennedy SH, Andersen HF, Lam
RW. Efficacy of escitalopram in the treatment of major depressive
disorder compared with conventional selective serotonin reuptake
inhibitors and venlafaxine XR: a meta-analysis [published
correction appears in J Psychiatry Neurosci. 2006 Jul;31(4):228]. J
Psychiatry Neurosci. 2006;31(2):122-131.4. Mayo Clinic. Selective
serotonin reuptake inhibitors (SSRIs). September 17, 2019. Accessed
November 24, 2021.
https://www.mayoclinic.org/diseases-conditions/depression/in-depth/ssris/art-20044825.5.
SPRAVATO (esketamine) nasal spray [Prescribing Information].
Titusville, NJ. Janssen Pharmaceuticals, Inc.6. Abbott A. COVID's
mental-health toll: how scientists are tracking a surge in
depression. Nature. 2021;590(7845):194-195. 7. EvaluatePharma (as
of March 19, 2021). New drugs include new molecular entities or new
active ingredients.8. COMPASS Pathways receives FDA Breakthrough
Therapy designation for psilocybin therapy for treatment-resistant
depression. [Press Release]
https://ir.compasspathways.com/news-events/news-releases. Published
October 23, 2018. Accessed November 24, 2021. 9. COMPASS Pathways
to launch phase II trial of COMP360 psilocybin therapy for
post-traumatic stress disorder. [Press release]
https://ir.compasspathways.com/news-releases/news-release-details/compass-pathways-launch-phase-ii-trial-comp360-psilocybin.
Published November 3, 2021. Accessed November 24, 2021.10.
Open-label study of COMP360 psilocybin therapy for depression in
cancer patients demonstrates feasibility of simultaneous psilocybin
administration in small groups. [Press Release]
https://ir.compasspathways.com/news-releases/news-release-details/open-label-study-comp360-psilocybin-therapy-depression-cancer.
Published October 20, 2021. Accessed November 24, 2021.
About atai Life Sciences
atai 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 mission is to bridge the gap between what the mental
healthcare system currently provides and what patients need. atai
has offices in New York, London, and Berlin. For more information,
please visit www.atai.life.
Forward-Looking Statements
This 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: the success, cost and
timing of development of our product candidates and COMPASS
Pathways’ COMP360, 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
For atai:
Media Contact:Camilla DormerVP, Communications, atai Life
SciencesEmail: camilla@atai.life
Investor Contact:Chad MesserVP, Investor Relations, atai Life
SciencesEmail: chad@atai.life
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