1. NEW YORK, Sept. 21, 2021 (GLOBE NEWSWIRE) -- DemeRx IB, Inc. ("DemeRx"), an atai Life Sciences (NASDAQ:ATAI) ("atai") platform company focused on developing ibogaine for the treatment of opioid use disorder (OUD), today announced that the first subjects have been dosed in a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002). The trial has commenced enrollment and dosing of recreational drug users and healthy volunteers in the Phase 1 segment of the study at the Manchester clinical unit of MAC Clinical Research (MAC) in the UK, one of Europe's largest clinical development organizations.

    DMX-1002 is an oral formulation of ibogaine, a naturally occurring psychedelic product isolated from a West African shrub. In previously published non-controlled…

    NEW YORK, Sept. 21, 2021 (GLOBE NEWSWIRE) -- DemeRx IB, Inc. ("DemeRx"), an atai Life Sciences (NASDAQ:ATAI) ("atai") platform company focused on developing ibogaine for the treatment of opioid use disorder (OUD), today announced that the first subjects have been dosed in a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002). The trial has commenced enrollment and dosing of recreational drug users and healthy volunteers in the Phase 1 segment of the study at the Manchester clinical unit of MAC Clinical Research (MAC) in the UK, one of Europe's largest clinical development organizations.

    DMX-1002 is an oral formulation of ibogaine, a naturally occurring psychedelic product isolated from a West African shrub. In previously published non-controlled studies, ibogaine has demonstrated rapid and sustained efficacy in treating OUD and has the potential to be a disease modifying treatment for this vulnerable patient population seeking to end their intractable cycle of drug dependence.

    The Phase 1/2a trial is designed to assess safety, tolerability, pharmacokinetics, and efficacy, and the results will inform future studies in patients with opioid use disorder. We expect to obtain safety data from the phase 1 segment of this trial in early 2022.

    "By launching the Phase1/2a trial, we look forward to bringing important data from carefully designed, controlled studies to the existing literature on ibogaine, a compound with substantial history," said Dr. Deborah Mash, CEO and President of DemeRx. "We are hopeful that this early trial can begin to establish a safe and efficacious profile for Ibogaine, so that we can potentially offer a new option for patients seeking to break free from OUD who have far too few options."

    "The opioid crisis has ravaged the U.S. for over 20 years with little sign of letting up. The COVID-19 pandemic revealed the tragic vulnerability of people addicted to drugs as the CDC tallied 93,000 drug overdose deaths in 2020, a 30% increase, 70,000 of which involved opioids," added Srinivas Rao, Chief Scientific Officer and Co-founder of atai Life Sciences. "Launching our Phase 1/2a trial of ibogaine with assent of regulators, we believe is a major step towards reversing the trend of the opioid crisis."

    "We strive for bold innovation to address the global crisis of mental health," said Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences. "By launching this Phase 1/2a trial, we are grateful for the work of our dedicated teams at DemeRx and atai who are committed to this ethos, striving to bring transformative treatments through rigorous testing."

    About DemeRx, Inc. & DMX-1002

    DemeRx, Inc. is a Miami-based clinical stage pharmaceutical company focused on developing ibogaine and noribogaine for the treatment of OUD. DemeRx's mission is to advance the development of potential treatments for OUD in order to prevent patient suffering, provide better treatment retention, and decrease illegal opioid use.

    DemeRx is developing DMX-1002 for the treatment of OUD. DMX-1002 is a GMP drug product manufactured for human use.

    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. 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 initiation of the Phase 1/2a clinical trial of ibogaine HCl and future activities thereunder, the potential of DMX-1002, 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.

    Contact Information

    For atai:

    Investor Contact:

    Greg Weaver

    atai – Chief Financial Officer

    Email: greg.weaver@atai.life 

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com 

    For DemeRx:

    Company Contacts:

    Deborah C Mash PhD

    CEO & Founder, DemeRx Inc.

    Phone: +1(305)753-2175

    Email: dmash@demerx.com 

    Matthias Luz MD

    Executive Vice President & Chief Medical Officer

    Email: mluz@demerx.com 



    Primary Logo

    View Full Article Hide Full Article
  2. NEW YORK, Sept. 15, 2021 /PRNewswire/ -- The damage done by the opioid epidemic has caused families grief and loss, but recent developments in the case against Purdue Pharma will see some restitution for the family. A potential $10 billion will be going toward fighting the opioid crisis that killed upward of 500,000 Americans in the past two decades. The Sackler family that owns Purdue Pharma will forfeit ownership of Purdue Pharma and pay $4.5 billion for the damage done by opioids like its best-selling Oxycontin. Fortunately, a new flock of companies is upending the traditional view of medicine by providing psychedelic treatments into their research and opening clinics to treat patients. Companies like Revitalist Lifestyle and Wellness Ltd.

    NEW YORK, Sept. 15, 2021 /PRNewswire/ -- The damage done by the opioid epidemic has caused families grief and loss, but recent developments in the case against Purdue Pharma will see some restitution for the family. A potential $10 billion will be going toward fighting the opioid crisis that killed upward of 500,000 Americans in the past two decades. The Sackler family that owns Purdue Pharma will forfeit ownership of Purdue Pharma and pay $4.5 billion for the damage done by opioids like its best-selling Oxycontin. Fortunately, a new flock of companies is upending the traditional view of medicine by providing psychedelic treatments into their research and opening clinics to treat patients. Companies like Revitalist Lifestyle and Wellness Ltd. (CSE:CALM), Atai Life Sciences N.V. (NASDAQ:ATAI), Cybin (NYSE:CYBN), Seelos Therapeutics, Inc. (NASDAQ:SEEL) and Tonix Pharmaceuticals (NASDAQ:TNXP) are researching, developing, and bringing to market new treatments in order to avoid the mistakes of the past.

    Revitalist Lifestyle and Wellness Ltd. (CSE:CALM) has just announced it has opened its fifth clinic in Raleigh, North Carolina. The city of Raleigh was chosen for its leading scholarly institutions and healthcare industry. With 14 treatment rooms, the clinic will have the ability to treat over 14,500 patients annually. The clinic will participate in advocacy programs working with Veterans Affairs and assisting veterans struggling with Post Traumatic Stress Disorder, Pain Syndromes, Major Depressive Disorder, and Suicidal Ideations gain greater access to care and is expected to generate approximately $7.1 million in revenue at full capacity.

    Revitalist will aim to bring its unique blend of comprehensive care and future-centric treatments provided by medical professionals, mental health experts, and chronic pain specialists. As the state ranks 21st in the country for the prevalence of mental illness, Revitalist's clinic is well-placed to serve the people of Raleigh and the surrounding communities in a more holistic and natural way.

    Revitalist now has a total of five clinics since opening the first in 2018. The company operates across the United States and will continue the expansion across the US is advancing its mission of bringing new, comprehensive care solutions to patients in both mental health care and pain management.   If you'd like to learn more about Revitalist Lifestyle and Wellness Ltd. (CSE:CALM), click here.

    Companies Taking a New Approach to Treatment and Avoiding the MIstakes of the Past

    Seelos Therapeutics, Inc. (NASDAQ:SEEL) is a clinical-stage biopharmaceutical company developing therapies for many central nervous system disorders and rare diseases. It is also advancing its mission and announced on January 27 that it had been selected as one of the 17 companies to be included in the world's first psychedelic Exchange Traded Fund (ETF). The fund has begun trading on the NEO exchange under the symbol PSYK. This opens the avenues for investors to gain exposure to the growing psychedelic market.

    Cybin (NYSE:CYBN) is the first for the sector to list on the NYSE, and is a validation for both the company and the industry. Cybin is currently developing a pipeline of psychedelic molecules for treating mental health conditions, including a proprietary formulation of psilocybin. This formulation is currently in phase 2 clinical trials.

    Atai Life Sciences (NASDAQ:ATAI) has a revolutionary digital therapeutic platform called Itrospect Digital Therapeutics. The company has announced it will begin a usability study of the app for support of standard of care ketamine therapy for patients with treatment-resistant depression. With digital health services growing in popularity and need, Atai is hoping to bring its app to more users to help treat mental illness in a more productive way without the need for addictive medications.

    Clinical-stage biopharmaceutical company Tonix Pharmaceuticals (NASDAQ:TNXP) has a large pipeline of innovative and proprietary therapeutics to address the needs of patients. The company also takes an approach that focuses on less addictive treatment. The company's portfolio includes small molecules and biologics to treat pain, neurologic, and psychiatric disorders, along with addiction disorders. The company will be a presenter at the H.C. Wainwright Global Investment Conference from September 13-15, and aims to bring investors awareness to the company through the conference.

    Companies are taking a good, long look at the damage done by companies like Purdue Pharma, and developing new treatments using psychedelics to provide better care for patients. Revitalist Lifestyle and Wellness Ltd. continues to move toward that goal by opening more clinics and bringing its services to more people across the country.

    DISCLAIMER: Microsmallcap.com (MSC) is the source of the Article and content set forth above.  References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. FN Media Group (FNM) is a third-party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated with MSC or any company mentioned herein. The commentary, views and opinions expressed in this release by MSC are solely those of MSC and are not shared by and do not reflect in any manner the views or opinions of FNM. Readers of this Article and content agree that they cannot and will not seek to hold liable MSC and FNM for any investment decisions by their readers or subscribers. MSC and FNM and their respective affiliated companies are a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.

     

     The Article and content related to the profiled company represent the personal and subjective views of the Author (MSC), and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author (MSC) has not independently verified or otherwise investigated all such information. None of the Author, MSC, FNM, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer's filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer's securities, including, but not limited to, the complete loss of your investment. FNM was not compensated by any public company mentioned herein to disseminate this press release but was compensated twenty five hundred dollars by MSC, a non-affiliated third party to distribute this release on behalf of Revitalist Lifestyle and Wellness Ltd.

     

     FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

     

     This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MSC and FNM undertake no obligation to update such statements.

     

     Media Contact:

     FN Media Group, LLC

     info@financialnews.com

     +1(561)325-8757

    Cision View original content:https://www.prnewswire.com/news-releases/10-billion-sackler-opioid-settlement-closes-chapter-psychedelic-chapter-begins-301377161.html

    SOURCE Microsmallcap.com

    View Full Article Hide Full Article
  3. NEW YORK, Sept. 15, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced it has entered into an amended and restated loan agreement ("Loan Agreement") with strategic partner IntelGenx Technologies Corp. ("IntelGenx") to support IntelGenx's conditionally approved graduation from the TSX Venture Exchange to the Toronto Stock Exchange ("TSX"). Completion of the uplisting and the commencement of trading of IntelGenx's common shares, 8% convertible debentures with a maturity date of June 30, 2022, and share purchase warrants expiring on February 11, 2023 is subject to the satisfaction by IntelGenx of all of the…

    NEW YORK, Sept. 15, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced it has entered into an amended and restated loan agreement ("Loan Agreement") with strategic partner IntelGenx Technologies Corp. ("IntelGenx") to support IntelGenx's conditionally approved graduation from the TSX Venture Exchange to the Toronto Stock Exchange ("TSX"). Completion of the uplisting and the commencement of trading of IntelGenx's common shares, 8% convertible debentures with a maturity date of June 30, 2022, and share purchase warrants expiring on February 11, 2023 is subject to the satisfaction by IntelGenx of all of the final conditions of listing.

    atai has agreed to increase the principal amount of its outstanding US$2,500,000 loan to IntelGenx by an additional US$6,000,000, with US$3,000,000 to become available to IntelGenx in each of January 2022 and January 2023, subject to customary conditions. The loan is in addition to atai's previously announced initial equity investment of an approximately 25% interest in IntelGenx. The loan bears interest at a rate of 8% per annum, payable at maturity, and matures in January 2024. The borrower under the secured loan is IntelGenx's wholly-owned subsidiary, IntelGenx Corp., and the loan is guaranteed by IntelGenx.

    As part of the strategic partnership, IntelGenx partnered exclusively with atai to develop formulations of compounds for the prevention or treatment of mental health diseases or disorders, including compounds that have psychedelic, entactogenic and/or oneirophrenic properties (such as DMT and psilocybin, among others). atai agreed to increase the loan principal in part on the basis of early data generated from its ongoing feasibility studies conducted with IntelGenx.

    "We are proud to deepen our relationship with atai, while strengthening our positions of leadership and boldly innovating novel psychedelic therapies," said Dr. Horst G. Zerbe, CEO of IntelGenx. "I'm excited about our companies' mutual efforts to advance our robust pipelines, while finding synergistic ways to work together to develop better compounds and modes of delivery to benefit patients."

    "This transaction illustrates our confidence in IntelGenx's film technology and the potential it has in the development of product candidates to treat mental health disorders," said Florian Brand, CEO of atai. "We look forward to collaborating to transition this innovative film delivery technology into the clinic."

    About atai

    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 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 Information

    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," "anticipate," "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 uplisting of IntelGenx to the TSX and continued strategic cooperation between atai and IntelGenx. 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 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, filed with the Securities and Exchange Commission ("SEC") on June 21, 2021 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 Life Sciences:

    Investor Contact:

    Greg Weaver

    ATAI – Chief Financial Officer

    Email: greg.weaver@atai.life

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com

    For IntelGenx:

    Stephen Kilmer

    Investor Relations

    (514) 331-7440 ext 232

    stephen@intelgenx.com

    Or

    Andre Godin, CPA, CA

    President and CFO

    IntelGenx Technologies Corp.

    (514) 331-7440 ext 203

    andre@intelgenx.com

     



    Primary Logo

    View Full Article Hide Full Article
  4. NEW YORK and BERLIN, Sept. 14, 2021 (GLOBE NEWSWIRE) -- Perception Neuroscience (Perception), an atai Life Sciences (atai) biopharmaceutical company focused on developing innovative therapies in neuropsychiatric diseases, today announced the initiation of a Phase 2a clinical study to evaluate the safety and efficacy of PCN-101 (R-ketamine). R-ketamine is a stereoisomer of ketamine being developed for therapeutic treatment of psychiatric disorders such as Treatment Resistant Depression (TRD). The Phase 2a clinical trial has received the necessary regulatory and ethics approvals to initiate the study.

    The Phase 2a trial is a double blind, placebo-controlled study in patients with TRD. Each of the 3 parallel arms will enroll 31 patients at multiple…

    NEW YORK and BERLIN, Sept. 14, 2021 (GLOBE NEWSWIRE) -- Perception Neuroscience (Perception), an atai Life Sciences (atai) biopharmaceutical company focused on developing innovative therapies in neuropsychiatric diseases, today announced the initiation of a Phase 2a clinical study to evaluate the safety and efficacy of PCN-101 (R-ketamine). R-ketamine is a stereoisomer of ketamine being developed for therapeutic treatment of psychiatric disorders such as Treatment Resistant Depression (TRD). The Phase 2a clinical trial has received the necessary regulatory and ethics approvals to initiate the study.

    The Phase 2a trial is a double blind, placebo-controlled study in patients with TRD. Each of the 3 parallel arms will enroll 31 patients at multiple locations. Patients will receive either placebo, a 30 mg dose, or a 60 mg dose of R-ketamine intravenously.

    Patients will be assessed for depressive symptomology over the subsequent 14 days using the Montgomery-Asberg Depression Rate Scale, or MADRS. Topline data from the study is expected to be reported at the end of 2022.

    "We're excited to take the next key step with this clinical trial to show the potential of PCN-101 for people living with TRD," said Terence Kelly, PhD, CEO of Perception Neuroscience. "TRD impacts nearly 100 million people around the world, making up a third of patients living with depression; currently they are either undertreated or unresponsive to existing treatment options. We believe PCN-101 holds promise in helping such treatment-resistant patients, as a potential rapidly-acting antidepressant which can be administered at home."

    "We believe insight into the molecular properties of the single isomer, R-ketamine, has the potential to offer a highly differentiated profile from current treatment options," added Florian Brand, CEO & Co-founder of atai Life Sciences. "Initiating this Phase 2 clinical study is a major step for our teams at Perception and atai and is a great achievement. We believe this work has the potential to deliver a novel option with diversified delivery capabilities that could decrease overall healthcare utilization, which may help us move toward our greater mission to improve care for patients who suffer from TRD."

    About PCN-101

    Perception Neuroscience is developing PCN-101 (R-ketamine) for the treatment of Treatment Resistant Depression. 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 and potent effects than S-ketamine despite a lower affinity to the NDMA receptor and potentially a more favorable safety and tolerability profile.

    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 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. 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 initiation of the Phase 2a trial by Perception and future activities thereunder, the potential of PCN-101, 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: greg.weaver@atai.life

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com



    Primary Logo

    View Full Article Hide Full Article
  5. 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…

    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: greg.weaver@atai.life

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com



    Primary Logo

    View Full Article Hide Full Article
  6. BERLIN, Sept. 03, 2021 (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 that it will participate in in the following upcoming investor conferences in September:

    Presentation details can be found below:

    • H.C. Wainwright 23rd Annual Global Investment Conference
      Format: Presentation
      Date and Time: Monday, September 13th, 2021, 9:00 a.m. ET
    • Baader Investment Conference (BIC)
      Format: Presentation…

    BERLIN, Sept. 03, 2021 (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 that it will participate in in the following upcoming investor conferences in September:

    Presentation details can be found below:

    • H.C. Wainwright 23rd Annual Global Investment Conference

      Format: Presentation

      Date and Time: Monday, September 13th, 2021, 9:00 a.m. ET
    • Baader Investment Conference (BIC)

      Format: Presentation

      Date and Time: Tuesday, September 21st, 2021, 11:30 a.m. ET

    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 mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. 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.

    Investor Contact:

    Greg Weaver

    atai – Chief Financial Officer

    Email: greg.weaver@atai.life 

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com 



    Primary Logo

    View Full Article Hide Full Article
  7. -Successfully completed Initial Public Offering on Nasdaq raising $258.8 million in gross proceeds, including the underwriters' over-allotment-

    -Received $20 million upfront payment from Otsuka as part of the first major collaboration between a biopharmaceutical company developing psychedelics and large pharma-

    -Advancement of 11 therapeutic programs, including initiation of Recognify's Phase 2 and GABA's Phase 1 trials-

    -18 significant catalysts across atai's platform anticipated over next 18 months including two clinical trials to be completed and four clinical trials to be initiated in 2021-

    -Solidified leadership position with strong cash position of $453.6 million to advance our current programs and incubate, acquire and invest in

    -Successfully completed Initial Public Offering on Nasdaq raising $258.8 million in gross proceeds, including the underwriters' over-allotment-

    -Received $20 million upfront payment from Otsuka as part of the first major collaboration between a biopharmaceutical company developing psychedelics and large pharma-

    -Advancement of 11 therapeutic programs, including initiation of Recognify's Phase 2 and GABA's Phase 1 trials-

    -18 significant catalysts across atai's platform anticipated over next 18 months including two clinical trials to be completed and four clinical trials to be initiated in 2021-

    -Solidified leadership position with strong cash position of $453.6 million to advance our current programs and incubate, acquire and invest in new programs-

    -Company to host a webcast and conference call today at 08:30am EDT-

    BERLIN and NEW YORK, Aug. 16, 2021 (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 reported its financial results for the second quarter ended June 30, 2021 and provided a corporate update.

    "In the second quarter of 2021, we made significant advancements to build our business and successfully completed an initial public offering on Nasdaq, raising approximately US$258.8 million in gross proceeds," said Florian Brand, CEO and co-founder of atai. "We have the financial resources to maximize the value of our decentralized drug development platform for improved probability of clinical success and leverage the value of our transformative pipeline. 2021 continues to be a pivotal year for atai with multiple upcoming catalysts across our expanding pipeline."

    Q2 Corporate Updates

    • Received $20 million as part of Perception's collaboration with Otsuka for the development of R-ketamine, the first major collaboration between a biopharmaceutical company developing psychedelics and large pharma.
    • Entered a strategic partnership with IntelGenx, a leader in pharmaceutical films. As part of the strategic partnership, IntelGenx will exclusively partner with atai to develop compounds for the prevention or treatment of mental health diseases or disorders.
    • Announced InnarisBio in partnership with UniQuest, Australia's leading university technology transfer company commercializing the research of The University of Queensland (UQ), to develop a novel sol-gel-based intranasal drug delivery technology to improve treatments for mental health disorders.

    Recent Advancements and Upcoming Milestones for atai's Core Value Drivers

    Perception Neuroscience:

    Program Details: PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic modulator being developed as a rapid-acting antidepressant, with the potential to be an at-home non-dissociative alternative to S-ketamine (marketed as SPRAVATO).

    Upcoming Milestones

    • Phase 2 randomized, double blind, placebo-controlled trial in patients with treatment-resistant depression (TRD) to be initiated in the third quarter and expected to run through late 2022.
    • The trial will assess efficacy and safety, dose response and duration of action in patients with TRD.

    Recognify Life Sciences:

    Program Details:

    • RL-007, a cholinergic, glutamatergic and GABA-B receptor modulator, is an orally available compound that is thought to alter the excitatory/inhibitory balance in the brain to produce pro-cognitive effects.
    • atai is developing this compound for the treatment of cognitive impairments associated with schizophrenia.

    Q2 Advancements

    • In April 2021, Recognify initiated a Phase 2a study for RL-007, after receiving IND clearance from the U.S. Food and Drug Administration to commence clinical trials for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS).
    • The study is designed to evaluate the effects of RL-007 on safety, tolerability, electroencephalogram-based biomarkers, and cognition. 

    Upcoming Milestones: Topline results from the Phase 2a single-arm, multiple dose trial in patients with CIAS expected in late 2021.

    GABA:

    Program Details

    • GRX-917 is an oral formulation of a deuterated version of etifoxine, a compound that has a long history of prescription use in France for treating anxiety disorders.
    • GRX-917 is designed to provide rapid anxiolytic activity with improved tolerability compared to current treatments for anxiety in the United States.

    Q2 Advancements

    • In June 2021, GABA initiated a randomized, double blind, placebo-controlled Phase 1 trial.
    • The study will evaluate safety, tolerability, pharmacokinetics, as well as pharmacodynamics using qEEG.

    Upcoming Milestones: Topline results from the Phase 1 single ascending dose/multiple ascending dose program expected early in 2022.

    DemeRx:

    Program Details: DMX-1002 is an oral formulation of ibogaine, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of opioid use disorder.

    Q2 Advancements: DemeRx received approval from the UK Medicines and Healthcare products Regulatory Agency to commence subject enrollment in our proposed Phase 1/2 clinical trial.

    Upcoming Milestones

    • Phase 1 component of Phase 1/2 trial of DMX-1002 in recreational drug users and healthy volunteers to be initiated in Q3 2021 and is expected to read out safety data in early 2022.
    • The trial is designed to assess safety, tolerability, pharmacokinetics, and efficacy, and the results will inform future studies in patients with opioid use disorder.

    COMPASS Pathways:

    Program Details: COMP360 is a proprietary formulation of synthetic psilocybin, a 5-HT2A-R agonist being developed as an oral, rapid-acting antidepressant.

    Q2 Advancements

    • In June 2021, COMPASS completed dosing in the Phase 2b clinical trial of COMP360 psilocybin therapy for treatment-resistant depression.
    • The randomized, double-blind, dose-ranging study investigated the safety and efficacy of psilocybin therapy in 233 patients, making it the largest clinical trial with psilocybin to date.

    Upcoming Milestones: Phase 2b trial results are expected in late 2021.

    Second Quarter 2021 Financial Results

    Cash and Cash Equivalents

    Cash and cash equivalents totaled $453.6 million as of June 30, 2021, compared to $97.2 million as of December 31, 2020. The six month increase of $356.4 million is attributed to net proceeds of $231.6 million from our Initial Public Offering, net proceeds of $168.6 million from Series C and Series D common stock issuances, $20.0 million of license revenue proceeds, and $4.0 million proceeds from the sale of investments and conversion of convertible notes. Offsetting were cash payments of $32.0 million for investments in platform companies, and $35.8 million in net operating expenses.

    Revenues

    License revenue in the first half 2021 of $19.9 million was related to proceeds received from Perception's License and Collaboration Agreement with Otsuka.

    Operating Costs and Expenses

    Research and development expenses were $16.0 million and $21.6 million for the three and six months ended June 30, 2021, as compared to $2.9 million and $5.0 million for the same prior year periods. The increase of $13.1 million and $16.6 million, respectively, were attributable to personnel costs, including stock-based compensation expense, and increased CRO expenses related to advancements in our R&D programs.

    We recorded acquisition of in-process research and development expense of $8.0 million and $9.0 million for the three and six months ended June 30, 2021, relating to our investments in Neuronasal and InnarisBio.

    General and administrative expenses for the three and six months ended June 30, 2021 were $37.3 million and $46.6 million, as compared to $2.9 million and $4.4 million in the same prior year periods. The increases of $34.4 million and $42.2 million, respectively, were attributable to personnel costs, including stock-based compensation expense, professional fees, and other costs related to support of our platform growth and public company requirements.

    Total stock-based compensation expense for the three and six months ended June 30, 2021 was $37.5 million and $37.7 million, respectively, as compared to $41,000 and $82,000 for the comparable prior year periods, reflecting the recognition of expense related to the achievement of IPO performance-based partial vesting conditions.

    Net loss attributable to atai stockholders for the three and six months ended June 30, 2021 was $48.5 million and $47.8 million, respectively, as compared to $16.4 million and $0.1 million for the comparable prior year periods.

    Conference Call Information

    atai will host a conference call and live audio webcast today at 08:30am ET to discuss its financial results and provide a corporate update. To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13721888. The live and archived webcast of this call will be available in the "Events" section of the atai Life Sciences website at ir.atai.life. An archived copy of the webcast will be available on the atai website for at least 30 days after the conference call.

    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 is headquartered in Berlin, with offices in New York and London. 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," "anticipate," "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, our future operating results and financial position; the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials; the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue; the timing of and our ability to obtain and maintain regulatory approvals; 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 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, filed with the Securities and Exchange Commission ("SEC") on June 21, 2021 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.

    Investor Contact:

    Greg Weaver

    atai – Chief Financial Officer

    Email: greg.weaver@atai.life

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@kcsa.com





    ATAI LIFE SCIENCES N.V. 
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 
    (Amounts in thousands, except share and per share amounts) 
    (unaudited) 
                    
            Three Months Ended Six Months Ended 
            June 30,  June 30, 
             2021   2020   2021   2020  
    License revenue $-  $-  $19,880  $-  
    Operating expenses:         
    Research and development  16,026   2,854   21,611   4,998  
    Acquisition of in-process research and development  7,962   120   8,934   120  
    General and administrative  37,331   2,851   46,604   4,421  
    Total operating expenses  61,319   5,825   77,149   9,539  
    Loss from operations  (61,319)  (5,825)  (57,269)  (9,539) 
    Other income (expense), net  (5,982)  (1,321)  (4,279)  20,294  
    Net loss before income taxes  (67,301)  (7,146)  (61,548)  10,755  
    Provision for income taxes  (58)  -   (64)  -  
    Gain on investment dilution  16,923   -   16,923   -  
    Losses from investments in equity method investees, net of tax  (2,937)  (9,811)  (4,640)  (11,831) 
    Net loss    (53,373)  (16,957)  (49,329)  (1,076) 
    Net loss attributable to redeemable noncontrolling         
    interests and noncontrolling interests  (4,912)  (600)  (1,556)  (1,022) 
    Net loss attributable to ATAI Life Sciences N.V. stockholders $(48,461) $(16,357) $(47,773) $(54) 
    Net loss per share attributable to ATAI Life Sciences N.V. stockholders-- basic and diluted       $(0.37) $(0.18) $(0.38) $(0.00) 
    Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted        
     132,265,075   90,709,312   125,797,732   90,709,312  
                    





    ATAI LIFE SCIENCES N.V.
    CONDENSED CONSOLIDATED BALANCE SHEET
    (Amounts in thousands)
           
        June 30, December 31,
         2021  2020 
        (unaudited)  (1)
    Assets    
    Cash and cash equivalents $453,622 $97,246 
    Prepaid expenses and other current assets  3,964  2,076 
    Short term notes receivable - related party  -  226 
    Property and equipment, net  331  71 
    Deferred offering costs  -  1,575 
    Equity method investments  19,780  - 
    Other investments held at fair value  6,886  - 
    Other investments  16,107  8,044 
    Long term notes receivable  1,388  911 
    Long term notes receivable - related parties  3,194  1,060 
    Other assets  689  339 
    Total assets $505,961 $111,548 
    Liabilities and Stockholders' Equity    
    Accounts payable $6,202 $3,083 
    Accrued liabilities  7,824  9,215 
    Deferred revenue  120  - 
    Short-term notes payable  39  - 
    Contingent consideration liability - related parties  2,466  1,705 
    Convertible promissory notes - related parties, net of discounts and deferred issuance costs    1,176  1,199 
    Convertible promissory notes and derivative liability  -  978 
    Other liabilities  3,239  - 
    Total stockholders' equity attributable to ATAI Life Sciences N.V. stockholders  474,850  90,822 
    Noncontrolling interests  10,045  4,546 
    Total liabilities and stockholders' equity $505,961 $111,548 
           
    (1)The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.


    Primary Logo

    View Full Article Hide Full Article
  8. BERLIN, Aug. 12, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced the launch of Revixia Life Sciences (Revixia), a wholly owned subsidiary developing Salvinorin A (SalA) to treat a variety of mental health disorders.

    Derived from Salvia divinorum, SalA is a unique non-nitrogenous agonist of the kappa-opioid receptor (KOR) with potential use in treatment-resistant depression (TRD), substance use disorder (SUD) and pain. Traditionally, Salvia divinorum has been used by the Mazatec people in Oaxaca, Mexico for a variety of illnesses, such as diarrhoea, headaches and rheumatism, as well as for palliative care.

    BERLIN, Aug. 12, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced the launch of Revixia Life Sciences (Revixia), a wholly owned subsidiary developing Salvinorin A (SalA) to treat a variety of mental health disorders.

    Derived from Salvia divinorum, SalA is a unique non-nitrogenous agonist of the kappa-opioid receptor (KOR) with potential use in treatment-resistant depression (TRD), substance use disorder (SUD) and pain. Traditionally, Salvia divinorum has been used by the Mazatec people in Oaxaca, Mexico for a variety of illnesses, such as diarrhoea, headaches and rheumatism, as well as for palliative care.

    SalA is an atypical KOR agonist with a complex pharmacological profile. Its mechanism of action (MoA) shows no interaction at the 5-HT2A serotonin receptor, which is the main molecular target for the classical hallucinogens such as psilocybin and DMT. Instead, it is hypothesised that SalA indirectly influences the cannabinoid system, as well as being an allosteric modulator of the µ opioid receptor.

    Clinically, there are published reports of the potential benefits of Salvia divinorum in the treatment of TRD. Karl Hanes reported on 7 patients with TRD who described relief from depressive symptoms with continued oral consumption of salvia leaves three times a week. Most of these patients reported lasting benefits from their use of the herb with significantly reduced scores on quantitative measures of depression and several reported benefits such as mood enhancement, increased feelings of relaxation and increased self-awareness. Additionally, a recent study in rhesus monkeys demonstrated that SalA can decrease oxycodone self-administration in rhesus monkeys in a dose-dependent manner, suggesting that combinations of oxycodone and the KOR agonists should be further investigated as potential analgesics with reduced abuse liability.

    "Due to SalA's short psychedelic effect, it will be an attractive option for those who would like psychedelic treatment but are unwilling or unable to participate in longer sessions," said Glenn Short, CEO of Revixia. "The shorter experience will allow for more practical administration and monitoring, which may even make it possible to attend psychotherapy sessions on the same day."

    "While SalA has until now been understudied, its unique MoA may allow for combination with SSRIs, potentially giving patients a better chance in beating depression," said Srinivas Rao, CSO and co-founder of atai Life Sciences. "We're thrilled to be pursuing SalA and progressing research, as we strive for new treatments."

    Importantly, Revixia's product will be paired with a digital therapeutic being developed by atai company Introspect Digital Therapeutics, with the aim of streamlining preparation, integration, and continued patient engagement.

    "In exploring SalA, Revixia aims to develop a product with a differentiated pharmacological and treatment effect. Considering the significance of prior evidence in humans in parallel with the substantial unmet need in TRD, we believe Revixia has high commercial potential and an increased probability of success in the clinic," said Florian Brand, CEO and co-founder of atai Life Sciences. "SalA is a great product candidate that magnificently matches the criteria we strive for, with recognized synergies across the atai platform."

    Development is underway with clinical trials expected to begin in the second half of 2022.

    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 is headquartered in Berlin, with offices in New York and London. 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.

    Investor Contact:

    Greg Weaver

    atai – Chief Financial Officer

    Email: greg.weaver@atai.life

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com



    Primary Logo

    View Full Article Hide Full Article
  9. BERLIN, Aug. 09, 2021 (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 that it plans to host a conference call on Monday, August 16, 2021 at 8:30 a.m. ET to discuss its financial results for the quarter ended June 30, 2021 and provide a business update.

    To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13721888. The live and archived webcast of this call will be available in the "Events" section of the atai Life Sciences website at ir.atai.life.

    About atai Life Sciences

    atai is a clinical-stage biopharmaceutical…

    BERLIN, Aug. 09, 2021 (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 that it plans to host a conference call on Monday, August 16, 2021 at 8:30 a.m. ET to discuss its financial results for the quarter ended June 30, 2021 and provide a business update.

    To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13721888. The live and archived webcast of this call will be available in the "Events" section of the atai Life Sciences website at ir.atai.life.

    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 is headquartered in Berlin, with offices in New York and London. 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, including without limitation statements regarding atai's participation in upcoming conferences and presentations 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

    atai – Chief Financial Officer

    Email: greg.weaver@atai.life

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com



    Primary Logo

    View Full Article Hide Full Article
  10. BERLIN, Aug. 06, 2021 (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 that it will participate in a fireside chat and one-on-one investor meetings at the Canaccord Genuity Growth Conference, to be held virtually from August 10-12, 2021.

    Presentation details can be found below:

    41st Annual Canaccord Genuity Growth Conference
    Format: Fireside chat
    Date and Time: Tuesday, August 10th, 2:30 p.m. ET
    Webcast link: https://wsw.com/webcast/canaccord60/atai/2419868

    About atai Life Sciences

    atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was…

    BERLIN, Aug. 06, 2021 (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 that it will participate in a fireside chat and one-on-one investor meetings at the Canaccord Genuity Growth Conference, to be held virtually from August 10-12, 2021.

    Presentation details can be found below:

    41st Annual Canaccord Genuity Growth Conference

    Format: Fireside chat

    Date and Time: Tuesday, August 10th, 2:30 p.m. ET

    Webcast link: https://wsw.com/webcast/canaccord60/atai/2419868

    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 is headquartered in Berlin, with offices in New York and London. 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.

    Investor Contact:

    Greg Weaver

    atai – Chief Financial Officer

    Email: greg.weaver@atai.life

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com



    Primary Logo

    View Full Article Hide Full Article
  11. BERLIN and BRISBANE, Australia, July 28, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences ("atai" or the "Company") (NASDAQ:ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, and UniQuest, Australia's leading university technology transfer company commercializing the research of The University of Queensland (UQ), today announced the launch of InnarisBio Inc. (InnarisBio), to develop a novel sol-gel intranasal drug delivery technology to improve treatments for mental health disorders.

    InnarisBio aims to commercialize the sol-gel intranasal drug delivery platform technology developed in the laboratory of UQ researcher Dr. Harendra (Harry) Parekh at the School of Pharmacy in the Faculty…

    BERLIN and BRISBANE, Australia, July 28, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences ("atai" or the "Company") (NASDAQ:ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, and UniQuest, Australia's leading university technology transfer company commercializing the research of The University of Queensland (UQ), today announced the launch of InnarisBio Inc. (InnarisBio), to develop a novel sol-gel intranasal drug delivery technology to improve treatments for mental health disorders.

    InnarisBio aims to commercialize the sol-gel intranasal drug delivery platform technology developed in the laboratory of UQ researcher Dr. Harendra (Harry) Parekh at the School of Pharmacy in the Faculty of Health and Behavioural Sciences. The platform technology, which also includes a patent filing, was licensed to InnarisBio by UniQuest. Under the terms of the license, InnarisBio will receive exclusive rights in their desired fields.

    The sol-gel technology is designed to deliver pharmaceutical compounds as a liquid at room temperature which becomes a gel at body temperature. The platform technology has been successfully utilized with both water soluble and insoluble compounds and extracts.

    Traditional drug delivery methods can be problematic in the treatment of central nervous system (CNS) disorders due to the blood–brain barrier that restricts the CNS entry of therapeutic agents, thereby decreasing drug efficacy. A potential solution is direct nose-to-brain delivery. It has the potential to be a painless and non-invasive administration route and may offer additional advantages such as increased patient compliance, lower dose requirements than oral administration, rapid onset of action and minimized systemic exposure, which may reduce the risk of peripheral toxicity.

    "InnarisBio aims to be a revolutionary technology company for intranasal drug delivery in the treatment of CNS disorders. Dr Parekh and his team at The University of Queensland have worked diligently to develop a platform technology that may mitigate many of the drawbacks typically associated with traditional drug delivery in the CNS space," said Florian Brand, CEO and co-founder of atai Life Sciences. "This novel technology has the potential to be superior to other intranasal drug delivery methods available by improving absolute uptake and duration of uptake through muco-adhesion in the nose, reducing dose administered and dosing frequency. We plan to explore the potential use of this technology for a variety of psychedelic and non-psychedelic compounds across atai's platform."

    "We are excited by the role that UQ's licensed technology may potentially play in solving one of the world's most complex health problems," said Dr. Dean Moss, CEO of UniQuest. "This innovative UQ technology could play a role in helping to tackle the scourge of mental illness; it is an exciting development for the sol-gel technology developed here at UQ and is another terrific example of the power of UQ research to create meaningful change."

    Under the terms of the license, InnarisBio will receive exclusive rights in their desired fields and UniQuest will receive equity in InnarisBio along with the potential to receive future development and commercial milestone payments and a royalty on product sales.

    InnarisBio will collaborate with UniQuest, UQ's Dr Parekh and his research team to formulate and develop bespoke sol-gel formulations for several psychedelic and non-psychedelic compounds nominated by InnarisBio.

    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 is headquartered in Berlin, with offices in New York and London. For more information, please visit www.atai.life.

    About UniQuest

    UniQuest is a leading university-based commercialisation company, managing the intellectual property (IP) of The University of Queensland (UQ). UniQuest has facilitated more than 100 start-up companies built on UQ IP, a milestone unsurpassed by any other Australian university. These companies have gone on to raise more than $794M to take UQ technologies to market. The Queensland Emory Drug Discovery Initiative (QEDDI), a division of UniQuest, is a small molecule drug discovery and development facility translating The University of Queensland and collaborator's biomedical research into new medicines to deliver faster health benefits. UniQuest is a partner on the MRFF Biomedical Translation Bridge (BTB) Program with MTPConnect.

    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 launch of InnarisBio and future activities thereunder, the potential of sol-gel 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.

    atai – Investor Contact:

    Greg Weaver

    Chief Financial Officer

    Email: greg.weaver@atai.life

    atai – Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com

    UniQuest – Media Contact:

    Brooke Baskin

    Manager, Media and Communications

    Phone: +61 7 3365 7480

    Mobile: +61 409 767 199

    Email: b.baskin@uniquest.com.au



    Primary Logo

    View Full Article Hide Full Article
  12. CHICAGO, July 15, 2021 /PRNewswire/ -- Palo Santo, the leading U.S.-based psychedelic investment fund, announced its launch with an initial $35 million in capital raised and an active portfolio of 20 companies. The diversified venture fund is focused on tackling the growing global mental health crisis by investing in innovative psychedelic-based and adjacent therapies that are poised to shape the future of psychiatry and fields beyond.

    Innovative psychedelic-based and adjacent therapies are poised to shape the future of psychiatry and fields beyond.

    In 2020, founders Daniel Goldberg, Tim Schlidt and Tony Eisenberg partnered to form Palo Santo, and formally launched the venture capital fund in 2021. Having seen the enormous therapeutic potential of psychedelic medicines years ago, the partners have been active as early participants and investors in the emerging industry.

    Supported by a rapidly growing body of evidence and strong FDA support, psychedelic-assisted treatments represent a paradigm shift in mental healthcare. Yet, the emerging ecosystem of business opportunities is highly fragmented, and with a lack of institutional capital available, Palo Santo is targeting early-stage, high-growth opportunities within biopharma, drug development, digital therapeutics, healthcare services and tech enabled solutions. These businesses are positioned to have a profound impact on treating a wide range of conditions such as depression, PTSD, anxiety, OCD, addiction, chronic or neuropathic pain, neurodegenerative diseases and a range of inflammatory-related illnesses.

    To date, Palo Santo has partnered with and funded more than 20 portfolio companies with notable investments such as atai Life Sciences ((ATAI), Reset Pharma, Field Trip Health, Tactogen, Eleusis, Bexson Biomedical, Ksana Health, neuroCare, Bright Minds, Diamond Therapeutics and Gilgamesh, among others.

    With a track record of success in backing early-stage enterprises, Palo Santo's team of investment professionals brings together decades of venture capital, private equity, and healthcare-focused experience. The team is further supported by scientific advisors Charles Nichols, one of the world's leading psychedelic pharmacologists; Julie Holland, renowned psychiatrist, psychopharmacologist and author; David Sherman, a medicinal chemist and head of the University of Michigan psychedelic collective; and John Greden, chair emeritus, University of Michigan Department of Psychiatry and the founder of the University of Michigan Depression Center. Collectively, the team applies a diligent, in-depth scientific approach to portfolio company selection, evaluation and monitoring.

    "We could not be more excited about how our portfolio has shaped up, as well as its trajectory," said Palo Santo Co-Founder Daniel Goldberg. "This is a moment of validation for our model, and we will continue to support our thesis by backing talented founders who are creating innovative approaches to mental health and addiction treatment. At my first psychedelics conference years ago, it felt as if only the leading researchers and those 'in the know' were aware that psychedelics were poised to change psychiatry forever. That's all changing now, and with these compounds being destigmatized, medicalized, and legalized, I couldn't think of a more impactful investment for our society."

    Palo Santo Co-Founder Tim Schlidt, added, "Psychedelics represent a paradigm shift in treating a range of illnesses, but a sense of scientific rigor and thoroughness is still required in investing across this ecosystem. Palo Santo applies a meticulous and selective approach to investing and heavily leverages its network of scientific advisors and academicians to evaluate opportunities. We must remember that much of the investment opportunity-set is within biotech, and therefore requires a deep focus on the science, mechanisms of action, and review of the appropriate assays or human data at each phase of drug development. With our background in healthcare and deep network in the space, Palo Santo is well-positioned as a diligent, validating investor. In addition to this, Palo Santo is providing more than just capital. We actively work to support and synergize our portfolio by connecting founders, advisers, and key opinion leaders with a collaborative ethos in mind."

    About Palo Santo

    Palo Santo  is the leading U.S.-based psychedelic investment fund focused on increasing the supply of clinically effective and accessible mental health and addiction treatment solutions needed in today's world. The firm targets a diverse range of companies offering innovative solutions across biopharma, drug development, digital therapeutics, healthcare services, and tech-enabled solutions to address the growing global mental health crisis. From cutting-edge science to commercial application, Palo Santo's portfolio includes more than 20 companies focused on advancing the field of psychedelic medicines and expanding patient access and affordability. For more information, please visit https://palosanto.vc/ or https://twitter.com/PaloSantoFund.

    Media Contact:

    Ellen Mellody

    MATTIO Communications

    570-209-2947

    ellen@mattio.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/leading-us-based-psychedelic-healthcare-vc-fund-launches-with-35-million-raised-to-tackle-the-growing-global-mental-health-crisis-301334228.html

    SOURCE Palo Santo

    View Full Article Hide Full Article
  13. BERLIN, Germany, July 07, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company developing psychedelic and non-psychedelic compounds for various mental health indications, today announced that it will present and participate in one-on-one investor meetings at the Cowen Psychedelics & Novel Mechanisms in Neuropsychiatry Summit on July 13, 2021.

    Presentation details can be found below.

    Date:Tuesday, July 13, 2021
    Time:10:50 AM ET
    Webcast link:https://wsw.com/webcast/cowen86/atai/1936406

    A replay of the presentation will be available in the "Events" section of the atai Life Sciences website at ir.atai.life.

    About atai Life Sciences
    atai is a clinical-stage biopharmaceutical company…

    BERLIN, Germany, July 07, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company developing psychedelic and non-psychedelic compounds for various mental health indications, today announced that it will present and participate in one-on-one investor meetings at the Cowen Psychedelics & Novel Mechanisms in Neuropsychiatry Summit on July 13, 2021.

    Presentation details can be found below.

    Date:Tuesday, July 13, 2021
    Time:10:50 AM ET
    Webcast link:https://wsw.com/webcast/cowen86/atai/1936406

    A replay of the presentation will be available in the "Events" section of the atai Life Sciences website at ir.atai.life.

    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 is headquartered in Berlin, with offices in New York. 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, including without limitation statements regarding atai's participation in upcoming conferences and presentations 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

    atai – Chief Financial Officer

    Email: greg.weaver@atai.life

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com 



    Primary Logo

    View Full Article Hide Full Article
  14. BERLIN, June 17, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences B.V. (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced the pricing of its upsized initial public offering in the United States of 15,000,000 common shares at a price to the public of $15.00 per share. All common shares are being offered by atai. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by atai, are expected to be $225.0 million. In addition, atai has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 common shares at the initial public offering price, less underwriting…

    BERLIN, June 17, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences B.V. (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced the pricing of its upsized initial public offering in the United States of 15,000,000 common shares at a price to the public of $15.00 per share. All common shares are being offered by atai. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by atai, are expected to be $225.0 million. In addition, atai has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 common shares at the initial public offering price, less underwriting discounts and commissions. The offering is expected to close on June 22, 2021, subject to customary closing conditions.

    atai's common shares are expected to begin trading on the Nasdaq Global Market on June 18, 2021 under the ticker symbol "ATAI."

    Credit Suisse, Citigroup, Cowen, and Berenberg are acting as book-running managers for the proposed offering. Cantor, RBC Capital Markets and Canaccord Genuity are also acting as book-running managers for the proposed offering.

    This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, by contacting: Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, or by telephone at (800) 221-1037 or by email at usa.prospectus@credit-suisse.com; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146 or by email at prospectus@citi.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attention: Prospectus Department, or by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; or, Berenberg Capital Markets LLC, Attention: Investment Banking, 1251 Avenue of the Americas, 53rd Floor, New York, New York 10020, or by telephone at +1 (646) 949-9000, or by e-mail at prospectusrequests@berenberg-us.com.

    A registration statement relating to the securities being sold in the offering has been declared effective by the U.S. Securities and Exchange Commission (the "SEC") on June 17, 2021. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    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, as well as the emergence of therapies that previously may have been overlooked or underused, including psychedelic compounds and digital therapeutics. atai is headquartered in Berlin, with offices in New York and London.

    Investor Contact:

    Greg Weaver

    atai – Chief Financial Officer

    Email: greg.weaver@atai.life

    Media Contact:

    Anne Donohoe

    KCSA Strategic Communications

    Phone: +1 (212) 896-1265

    Email: atai@KCSA.com



    Primary Logo

    View Full Article Hide Full Article