atai Life Sciences and Introspect Digital Therapeutics to test novel digital therapeutic approach in patients receiving ketamine for treatment resistant depression

BERLIN and SAN DIEGO, Sept. 09, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, and its digital therapeutic platform Introspect Digital Therapeutics, Inc. (“Introspect”), today announced a usability study of Introspect’s digital therapeutic (DTx) app technology in support of standard of care ketamine therapy for patients with treatment resistant depression (TRD) in collaboration with Kadima Neuropsychiatry. TRD impacts 100 million people globally, close to a third of the 300 million diagnosed with depression, many of whom are geographically restricted in their ability to access in-person psychological care.

Introspect’s DTx app approach to supported treatment in mental health will be integrated across 3 cohorts, with Cohort 1 focusing on user acceptability, Cohort 2 examining the introduction of therapeutic content via the app, and Cohort 3 assessing set and setting of treatment.

“We’re thrilled to be working with Kadima to test our digital therapeutic approach in a clinical setting with patients receiving with standard of care ketamine therapy,” said David Keene, CEO of Introspect. “Our goal is to show that our novel DTx app can be used alongside a drug; that it is useful, usable and intuitive to patients and providers.”

“The integration of Introspect’s digital therapeutic in a clinical environment is a pivotal step towards developing potentially scalable care,” said Florian Brand, Co-Founder and CEO of atai. “In our mission to improve the lives of millions living with mental health disorders, technology will be instrumental, ensuring that our pipeline of novel compounds can benefit patients everywhere.”

Introspect believes that high-quality digital combination therapies have the potential to improve the safety and effectiveness of many mental health treatments. In addition, Introspect considers DTx to be vital to the mission of providing personalized and scalable treatment to those who might not otherwise be able to access high-quality psychological care.

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.

About Introspect Digital Therapeutics

Introspect is a wholly-owned enabling platform company providing tightly integrated DTx on a shared architecture across all of atai’s platform companies. Incorporating a DTx strategy from the very beginning of drug development, Introspect is dedicated to providing more comprehensive, personalized care management with potential to secure stronger IP protection. Introspect aims to develop digital biomarkers, which clinicians will be able monitor to predict patients’ recovery pathways, limiting trial and error while simultaneously streamlining therapeutic impact. A key goal for Introspect is to provide great precision psychiatry and personalization to assist therapists in making the best decisions for their patients.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding the support of clinical trials by Introspect Digital Therapeutics and future activities thereunder, the potential Introspect’s digital therapeutics technology, and similar statements of a future or forward-looking nature. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Investor Contact:

Greg Weaver

Chief Financial Officer

Email: [email protected]

Media Contact:

Anne Donohoe

KCSA Strategic Communications

Phone: +1 (212) 896-1265

Email: [email protected]

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About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.