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atai Life Sciences to Participate in Upcoming February Investor Conference

atai Life Sciences to Participate in Upcoming February Investor Conference

NEW YORK, Feb. 15, 2022 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, will participate in the following upcoming investor conference in February.

Presentation details can be found below:

  • Aegis Conference
    Format: Virtual
    Date and Time: Thursday, February 24, 2022, 11:30 a.m. ET
    Webcast Link: https://bit.ly/3JuuKmV 

The presentations and archived webcasts will also be accessible in the Events section of atai’s website.

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 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 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. 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. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

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IntelGenx Receives Third Loan Tranche from atai

IntelGenx Receives Third Loan Tranche from atai

SAINT LAURENT, Quebec, Feb. 01, 2022 (GLOBE NEWSWIRE) — Further to its press release dated September 15, 2021, IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company”) today announced that its wholly-owned subsidiary, IntelGenx Corp. (“IntelGenx”) has received a third term loan (the “Third Loan”) in the amount of U.S.$3 million pursuant to its amended and restated secured loan agreement with atai Life Sciences (“atai”).

The obligations under the Third Loan are guaranteed by the Company.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

Forward Looking Statements:

This document may contain forward-looking information about IntelGenx’s operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

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atai Life Sciences Launches Invyxis to Accelerate Discovery of Next-Generation Mental Health Treatments

Invyxis will add proven medicinal chemistry and comprehensive biological evaluation capabilities to grow atai’s portfolio of new chemical entities (NCEs)

Early focus will be on designing unique, novel compounds aimed at the serotonin 5-HT2A receptor with other central nervous system (CNS) targets to follow

This new platform company is a further step-up in atai’s commitment to next-generation treatments, complementing its machine learning-powered computational chemistry with EntheogeniX and biosynthesis-based drug discovery approaches with TryptageniX

NEW YORK and BERLIN, Jan. 27, 2022 (GLOBE NEWSWIRE) — 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:

  1. 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.
  2. 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.
  3. Rehm J, Shield KD. Global Burden of Disease and the Impact of Mental and Addictive Disorders. Curr Psychiatry Rep. 2019;21(2):10.
  4. 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 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 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 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: 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 Dormer
VP, Communications
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations
Email: chad@atai.life

Posted on

atai Life Sciences Launches Invyxis to Accelerate Discovery of Next-Generation Mental Health Treatments

atai Life Sciences Launches Invyxis to Accelerate Discovery of Next-Generation Mental Health Treatments

Invyxis will add proven medicinal chemistry and comprehensive biological evaluation capabilities to grow atai’s portfolio of new chemical entities (NCEs)

Early focus will be on designing unique, novel compounds aimed at the serotonin 5-HT2A receptor with other central nervous system (CNS) targets to follow

This new platform company is a further step-up in atai’s commitment to next-generation treatments, complementing its machine learning-powered computational chemistry with EntheogeniX and biosynthesis-based drug discovery approaches with TryptageniX

NEW YORK and BERLIN, Jan. 27, 2022 (GLOBE NEWSWIRE) — 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:

  1. 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.
  2. 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.
  3. Rehm J, Shield KD. Global Burden of Disease and the Impact of Mental and Addictive Disorders. Curr Psychiatry Rep. 2019;21(2):10.
  4. 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 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 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 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: 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 Dormer
VP, Communications
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations
Email: chad@atai.life

Posted on

atai Life Sciences announces FDA Investigational New Drug (IND) Clearance for PCN-101 R-ketamine Program

•  Enables expansion of PCN-101 clinical development to the U.S.

•  atai plans to initiate clinical drug-drug interaction (DDI) study in early 2022 to assess pharmacokinetics of PCN-101 when used concurrently with other drugs

•  DDI trial will complement existing Phase 2a trial in treatment-resistant depression (TRD) recently initiated in Europe

NEW YORK, Jan. 12, 2022 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced the U.S. Food and Drug Administration (FDA) has given Investigational New Drug (IND) clearance to conduct a clinical DDI study of PCN-101 (R-ketamine). atai plans to initiate the study early this year through its platform company Perception Neuroscience.

The unique properties of PCN-101 could offer a differentiated profile to currently available antidepressants and address key patient needs, including the potential of rapid action and anti-suicidal effect. Rapid onset of action is particularly important in this patient population, but frontline selective serotonin reuptake inhibitors (SSRIs) can take up to 12 weeks before providing maximal benefit, while suicidality affects as much as 30% of treatment-resistant depression (TRD) patients at least once during their lifetime.1-3

In preclinical animal models of depressive behavior, R-ketamine has demonstrated the potential to offer longer durability and a potentially more favorable safety and tolerability profile than S-ketamine, which could enable the potential for at-home use.4,5 In addition, a third-party, open-label study observed a rapid, durable antidepressant response and limited dissociative side effects in patients with TRD after a single intravenous dose of another formulation of R-ketamine.6

“We see great promise in PCN-101 as a potentially rapid-acting anti-depressant with a more favorable safety and tolerability profile than S-ketamine, which could enable at-home use,” said Florian Brand, CEO and Co-Founder of atai Life Sciences. “With today’s IND clearance, we are excited to continue assessing the therapeutic potential of PCN-101 in the U.S., where, like elsewhere in the world, many patients struggle with treatment-resistant depression and desperately need innovative therapeutic options.”

“TRD represents a large percentage of people with severe, difficult to treat depression who have failed to sufficiently respond to at least two different antidepressant treatments,” explained Terence Kelly, PhD, CEO of Perception Neuroscience, the atai Life Sciences platform company conducting the trials. “We believe that PCN-101 has the potential to offer a differentiated therapeutic effect, in terms of both efficacy and ease of administration, for clinicians and patients, as a potentially rapid-acting antidepressant. We look forward to progressing its clinical development.”

An estimated 100 million people live with TRD globally, representing a third of people with depression, who are undertreated or unresponsive to available treatment options.7,8 In addition to its impact on patients, families, and caregivers, TRD severely impacts healthcare systems and payers. Direct medical costs for TRD patients are estimated to be two times higher than for non-TRD major depressive disorder (MDD) patients, with an average of twice the number of inpatient visits and hospital stays that are over one-third longer.9,10

This clinical DDI trial will advance alongside an existing Phase 2a proof-of-concept trial in TRD, recently initiated in Europe.11 Additionally, atai anticipates running a bioavailability study in 2022, which is designed to bridge the IV formulation to a subcutaneous formulation of PCN-101, supporting the potential for self-administration.

About the clinical DDI study
The clinical study is an open-label, 2-cohort, fixed-sequence, drug-drug interaction study to evaluate the effects of CYP450 inhibition on the pharmacokinetics of PCN-101 in healthy adult subjects. atai will use the results of this study in conjunction with clinical pharmacokinetic data to advance the development of PCN-101 in TRD.

About PCN-101
Perception Neuroscience is developing PCN-101 (R-ketamine) for the treatment of TRD. PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid acting antidepressant (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Nonclinical depression model studies in rodents suggest that R-ketamine could possess more durable effects and favorable safety and tolerability profile. Further supporting the potential of R-ketamine, an open-label clinical study has demonstrated rapid, durable response and limited dissociative side effects in TRD patients after a single intravenous dose.

About Perception Neuroscience, Inc
Perception Neuroscience is a New York City-based biopharmaceutical company committed to developing therapies for neuropsychiatric diseases. Perception’s mission is to provide substantially more effective treatment solutions to serious psychiatric disorders. The company is a majority-owned subsidiary of atai Life Sciences.

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 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.

References:

  1. Tew JD Jr, Mulsant BH, Houck PR, et al. Impact of prior treatment exposure on response to antidepressant treatment in late life. Am J Geriatr Psychiatry. 2006;14(11):957-965.
  2. Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D. Treatment-resistant depression and suicidality. J Affect Disord. 2018;235:362-367.
  3. Dong M, Lu L, Zhang L, et al. Prevalence of suicide attempts in bipolar disorder: a systematic review and meta-analysis of observational studies. Epidemiol Psychiatr Sci. 2019;29:e63.
  4. Zanos P, Moaddel R, Morris PJ, et al. NMDAR inhibition-independent antidepressant actions of ketamine metabolites. Nature. 2016;533(7604):481-486.
  5. Yang C, Shirayama Y, Zhang JC, et al. R-ketamine: a rapid-onset and sustained antidepressant without psychotomimetic side effects [published correction appears in Transl Psychiatry. 2020 Aug 21;10(1):295]. Transl Psychiatry. 2015;5(9):e632.
  6. Leal GC, Bandeira ID, Correia-Melo FS, et al. Intravenous arketamine for treatment-resistant depression: open-label pilot study. Eur Arch Psychiatry Clin Neurosci. 2021;271(3):577-582.
  7. Pandarakalam JP. Challenges of Treatment-resistant Depression. Psychiatr Danub. 2018;30(3):273-284.
  8. World Health Organization. Depression. https://www.who.int/news-room/fact-sheets/detail/depression. Published September 13, 2021. Accessed January 10, 2022.
  9. Ivanova JI, Birnbaum HG, Kidolezi Y, Subramanian G, Khan SA, Stensland MD. Direct and indirect costs of employees with treatment-resistant and non-treatment-resistant major depressive disorder. Curr Med Res Opin. 2010;26(10):2475-2484.
  10. Amos TB, Tandon N, Lefebvre P, et al. Direct and Indirect Cost Burden and Change of Employment Status in Treatment-Resistant Depression: A Matched-Cohort Study Using a US Commercial Claims Database. J Clin Psychiatry. 2018;79(2):17m11725.
  11. Perception Neuroscience initiates Phase 2a study of PCN-101 (R-ketamine) for treatment resistant depression. [Press release] https://ir.atai.life/news-releases/news-release-details/perception-neuroscience-initiates-phase-2a-study-pcn-101-r. Published September 14, 2021. Accessed January 10, 2022.

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: statements regarding the trials by Perception and future activities thereunder, the potential of PCN-101 (R-ketamine), 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

For atai:

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

Posted on

atai Life Sciences to Participate in Upcoming January Investor Conference

atai Life Sciences to Participate in Upcoming January Investor Conference

NEW YORK, Jan. 10, 2022 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, will participate in the following upcoming investor conference today:

  • H.C. Wainwright BioConnect Conference (Virtual)
    Format: Fireside Chat
    Date and Time: Monday, January 10th, 2022, 2:00 p.m. ET
    Webcast Link: URL

The presentations and archived webcasts will also be accessible in the Events section of atai’s website.

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 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 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. 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. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life 

Posted on

atai Life Sciences to Participate in Upcoming January Investor Conference

NEW YORK, Jan. 10, 2022 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, will participate in the following upcoming investor conference today:

  • H.C. Wainwright BioConnect Conference (Virtual)
    Format: Fireside Chat
    Date and Time: Monday, January 10th, 2022, 2:00 p.m. ET
    Webcast Link: URL

The presentations and archived webcasts will also be accessible in the Events section of atai’s website.

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 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 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. 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. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life 

Posted on

atai Impact Establishes the atai Fellowship Fund in Psychedelic Neuroscience with Massachusetts General Hospital’s Center for the Neuroscience of Psychedelics

atai Impact Establishes the atai Fellowship Fund in Psychedelic Neuroscience with Massachusetts General Hospital’s Center for the Neuroscience of Psychedelics

atai Impact’s first major initiative will support promising academics in researching the therapeutic potential of psychedelic compounds to address unmet needs in mental health

The Fund aims to help unlock the mysteries of the brain, improve the treatment of mental health conditions and positively change the future of brain health through psychedelic research

Fellows will be selected with a focus on diversity, equity and inclusion and mentored by leading scientists from across this world-class teaching hospital

NEW YORK and BERLIN, Dec. 16, 2021 (GLOBE NEWSWIRE) — atai Impact, the recently launched philanthropic program of atai Life Sciences (Nasdaq: ATAI) (“atai”), today announced its first major initiative, the establishment of the atai Fellowship Fund in Psychedelic Neuroscience (“atai Fellowship Fund”) in collaboration with Massachusetts General Hospital’s (MGH) Center for the Neuroscience of Psychedelics.

atai Impact was launched in October 2021 by atai Life Sciences, a clinical-stage biopharmaceutical company, to harness the power of innovative mental health approaches for positive social change. atai Impact is committed to advancing education, expanding access, and supporting the wider ecosystem of mental health care, with an initial focus on psychedelics.

The $2 million atai Fellowship Fund will facilitate further research into the potential of psychedelics to address unmet patient needs in mental health and support promising graduate students in furthering their professional careers in this emerging field.

Massachusetts General Hospital was selected as the ideal partner for the atai Fellowship Fund due to its global reputation as a leading academic medical center and position as the largest teaching hospital of Harvard Medical School. This Fellowship builds on existing collaborations between atai Life Sciences and the Center for Neuroscience of Psychedelics, announced in January 2021, to accelerate discovery of the mechanisms underlying the therapeutic effects of psychedelic agents.1

Fellows will have access to MGH’s cutting-edge resources and expertise in neuroimaging technologies, cognitive neuroscience, cellular and molecular neurobiology, and clinical trial design. The Fund will enable them to pursue the discovery, optimization, and translation of novel experimental psychedelic neurotherapeutics. The ultimate objective of the Fund will be to investigate and unlock the potential of psychedelics to improve brain health and reduce the burden of mental health conditions, which affect over a billion people worldwide.2

Fellows will be selected with a focus on diversity, equity and inclusion and mentored by leading scientists from across key departments of Massachusetts General Hospital, including Neurology, Psychiatry and Radiology. Fellows will be equipped to explore a variety of therapies and neurotherapeutics, and their potential to address key mental health needs, in a world-class educational environment.

“We are very proud to kick off the atai Impact initiatives with such an important contribution to drive robust psychedelic medicine research and to do so with the eminent team at Massachusetts General Hospital,” said Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences.

“Through the atai Impact Fellowship Fund, we are excited to be fostering the next generation of neuro-innovators. We look forward to the future findings of their research, and its important contribution to the emerging psychedelic renaissance and the future of global mental health care.”

“The current development of psychedelics as psychiatric therapeutics is the beginning, not the end of the story,” said Jerrold F. Rosenbaum, MD, Director, Center for the Neuroscience of Psychedelics at Massachusetts General Hospital.

“These agents are forerunners to a future of novel compounds that will depend on the advance of science to lead to deeper understanding of the underlying neuroscience to deliver enhanced and more precise treatments. For this we need a new generation of scientists and for this goal, the atai Fellowship will be an essential contribution.”

About atai Impact

atai Impact was launched by atai Life Sciences, in October 2021, to harness the power of innovative mental health approaches for positive social change.

The key pillars of atai Impact’s activities are: advancing education, expanding access, and supporting the wider ecosystem of mental health care. atai Impact has an initial focus on the psychedelics sector, given its emerging potential in tackling the growing mental health crisis.

The establishment of atai Impact is based on atai Life Sciences’ position that harmonization across commercial and non-profit entities represents the best path forward to address all aspects of the escalating global mental crisis.

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 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.

References:

  1. atai Life Sciences to Collaborate with Massachusetts General Hospital to Accelerate Discovery of Mechanisms Underlying Therapeutic Effects of Psychedelic Agents. [Press Release] https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-collaborate-massachusetts-general-hospital. Published January 26, 2021. Accessed November 12, 2021.
  2. Rehm J, Shield KD. Global Burden of Disease and the Impact of Mental and Addictive Disorders. Curr Psychiatry Rep. 2019;21(2):10. 

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 (including without limitation, the atai Impact program and any other future philanthropic endeavors by atai) that are not statements of historical fact may be deemed to be forward-looking statements. 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, and in atai’s other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information

For atai Impact:
Email: Impact@atai.life

For atai:
Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life