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ATAI Life Sciences N.V. (NASDAQ: ATAI) is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of mental health disorders. Based in the United States and Germany, ATAI leverages a decentralized, technology- and data-driven platform to serve millions suffering from mental health challenges. The company’s mission is to develop innovative treatments that address significant unmet medical needs, leading to paradigm shifts in mental health care.
ATAI's product pipeline includes promising candidates such as COMP360/Psilocybin therapy, PCN-101/R-ketamine, RL-007/Compound, DMX-1002/Ibogaine, GRX-917/Deuterated etifoxine, VLS-01/DMT, EMP-01/MDMA derivative, RLS-01/Salvinorin A, KUR-101/Deuterated Mitragynine, and DMX-1001/Noribogaine. These candidates are designed to treat conditions such as depression, anxiety, addiction, and other mental health disorders.
Recently, ATAI announced positive results from its Phase 1 study of EMP-01, the R-enantiomer of MDMA. The study aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01. Involving 32 healthy participants, the study showed that EMP-01 was well-tolerated with no severe adverse events. The PK profile was dose-proportional, and PD measures indicated significant, consistent, and dose-dependent changes. These promising results might pave the way for EMP-01’s further clinical development.
ATAI Life Sciences is committed to efficient drug development by pooling resources, expertise, and best practices across its portfolio. This approach helps mitigate risks and accelerates the development of impactful, evidence-based treatments. The company’s vision is to heal mental health disorders, enabling everyone to live a more fulfilled life.
For more information, visit their official website at www.atai.life.
atai Life Sciences has launched the atai Fellowship Fund in Psychedelic Neuroscience, a $2 million initiative aimed at advancing research on the therapeutic potential of psychedelics for mental health. In collaboration with Massachusetts General Hospital, this fellowship will support graduate students focused on diversity, equity, and inclusion. The program aims to unlock new treatments for mental health disorders affecting over a billion people globally, while fostering a new generation of neuro-innovators.
atai Life Sciences (Nasdaq: ATAI) announced voluntary lock-up agreements by key shareholders, including Apeiron Investment Group, extending trading restrictions for 24 months. This represents over 30% of atai’s outstanding shares, indicating strong investor confidence in its innovative platform to address mental health issues. The renewed commitments signal a long-term belief in atai's mission to transform mental health treatment. The company's focus is on developing new therapies for mental health disorders, leveraging its unique business model to accelerate drug development.
atai Life Sciences announced positive topline data from its Phase 2a study of RL-007 for Cognitive Impairment Associated with Schizophrenia (CIAS). The 32-patient trial demonstrated a clinically meaningful pro-cognitive profile and changes in quantitative electroencephalogram (qEEG) consistent with prior results. Notably, dose-related improvements were observed in cognitive endpoints, including the Symbol Coding Test. The findings support advancing RL-007 to a double-blind, placebo-controlled Phase 2 trial, addressing the significant unmet need for CIAS treatments, which currently lack approved options.
atai Life Sciences N.V. (Nasdaq: ATAI) announced its inclusion in the Nasdaq Biotechnology Index (NBI), effective December 20, 2021. This prestigious index comprises Nasdaq-listed companies in the biotechnology and pharmaceuticals sectors. The NBI is critical for investment managers and institutional investors, providing benchmarks for index funds. With the average market capitalization of NBI companies at $5.7 billion, atai aims to leverage this inclusion to enhance visibility and reach new audiences to further its mission of addressing mental health disorders.
atai Life Sciences has launched TryptageniX, a joint venture with CB Therapeutics, aimed at developing new chemical entities (NCEs) for mental health treatment through bioprospecting and biosynthesis. This initiative is designed to enhance atai's drug development pipeline and expand its intellectual property in both psychedelic and non-psychedelic compounds. TryptageniX will also focus on sustainable manufacturing methods to address the growing mental health crisis. The collaboration is expected to yield innovative solutions for patients while minimizing ecological impacts.
atai Life Sciences (Nasdaq: ATAI) announced an increase in its ownership in COMPASS Pathways from 19.4% to 20.8%, reinforcing its position as the largest shareholder. This move reflects atai's confidence in COMPASS’ recent Phase 2b trial data for COMP360, which showed promising results for treatment-resistant depression (TRD). The trial reported a significant reduction in depression symptoms, indicating potential for COMP360 as a future treatment option. atai emphasizes the importance of COMPASS’ innovative approach in addressing unmet mental health needs.
atai Life Sciences reported positive progress in its therapeutic programs, including encouraging topline results from COMP360’s Phase 2b study for treatment-resistant depression. With cash and equivalents totaling $430.3 million as of September 30, 2021, the company shows strong financial backing after its IPO. Upcoming milestones include Phase 2a data for RL-007 in cognitive impairment expected by the end of Q4 2021. The company's focus on mental health, combined with the recent launch of the atai Impact philanthropic program, positions it for potential growth.
atai Life Sciences N.V. (Nasdaq: ATAI) will host a conference call on November 15, 2021, at 8:30 a.m. ET to discuss its Q3 2021 financial results and provide a business update. Attendees can access the call via dial-in numbers and a dedicated conference ID. Founded in 2018, atai focuses on developing innovative treatments for mental health disorders, including depression and anxiety. The company leverages funding, technology, and regulatory expertise to advance psychedelic therapies and improve treatment options in mental healthcare.
atai Life Sciences N.V. (Nasdaq: ATAI) announced its participation in key investor conferences in November 2021 aimed at transforming mental health treatment. Notable events include the Berenberg US CEO Conference on November 9-10, and the Credit Suisse 30th Annual Healthcare Conference on November 11 at 9:40 a.m. ET, featuring a fireside chat format. The 12th Annual Jefferies London Healthcare Conference is set for November 18, also featuring a fireside chat at 8:00 a.m. ET. Archived webcasts will be available on the company's website.
atai Life Sciences announced promising interim data from its Phase 2a trial of RL-007, which targets Cognitive Impairment Associated with Schizophrenia (CIAS). The results from the initial 8-patient cohort indicate potential cognitive benefits, leading the company to accelerate its development timeline. The trial showcased positive changes in two biomarkers, suggesting improved cognition. The full results are anticipated by year-end 2021. The financial support will expedite planning for the next clinical trial before completing the current one.
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