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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 appointed Dr. Kirpekar as Chief Business Officer, effective immediately. Previously, Dr. Kirpekar served as Head of Business Development at Otsuka Pharmaceutical, where he was involved in transactions over USD 2.7 billion. In his new role, he will guide atai's pipeline strategy and global business development efforts. Dr. Kirpekar's extensive experience in CNS and digital health, along with his background in bringing therapies to market, positions him to strengthen atai's initiatives in mental health treatment.
atai Life Sciences (NASDAQ: ATAI) has launched a clinical study in collaboration with Massachusetts General Hospital (MGH) focusing on treatment-resistant depression (TRD). The study aims to identify neuroplasticity biomarkers using neuroimaging techniques during IV ketamine treatment. By assessing brain changes, the research seeks to advance understanding of treatment responses and efficacy. Given that treatment-resistant patients account for a significant portion of annual mental healthcare spending in the U.S., the findings could be pivotal for personalized mental health treatments based on neuroplasticity.
atai Life Sciences announced significant advancements in its clinical trials for mental health therapies. The Phase 2a trial of PCN-101 for treatment-resistant depression (TRD) has completed dosing, with topline results expected by year-end 2022. Positive preliminary results were reported for GRX-917 in generalized anxiety disorder and KUR-101 for opioid use disorder. The company ended Q3 2022 with a cash position of $304 million, providing a runway into 2025, despite a net loss of $33.9 million for the quarter. Future trials and potential market impact were highlighted.
The Women in Psychedelics Network (WIPN) announced atai Life Sciences (NASDAQ: ATAI) as a platinum sponsor through atai Impact. This partnership emphasizes mutual support for women's leadership in the psychedelic industry and mental health advancements. WIPN aims to enhance women’s roles via educational events, mentorship, and funding opportunities. Rae Richman from atai highlighted their commitment to diversity and inclusion while Sarah Popham emphasized the importance of WIPN's work for women in psychedelics. The collaboration aligns with atai's mission to address mental health challenges.
atai Life Sciences (Nasdaq: ATAI) will participate in several investor events and healthcare conferences in November 2022. Key events include:
- Financial Times Pharma and Biotech Summit on November 9, 2022, 9:55 a.m. ET
- Credit Suisse Annual Healthcare Conference on November 9, 2022, 4:35 p.m. ET
- HLTH in Las Vegas on November 14, 2022, 7:20 p.m. ET
- Jefferies Healthcare Conference on November 16, 2022, 8:00 a.m. GMT
- CNS Summit in Boca Raton on November 19, 2022, 12:00 p.m. ET
Archived webcasts will be available on the company's website for 90 days.
atai Life Sciences (Nasdaq: ATAI) will announce its Q3 2022 financial results and provide a business update on November 10, 2022. The announcement comes as atai continues its mission to innovate treatments for mental health disorders. A management interview will be accessible at 8:30 a.m. ET, providing insights into the company's progress and future outlook. Founded in 2018, atai is focused on developing therapeutics for depression, anxiety, and addiction.
atai Life Sciences (NASDAQ: ATAI) has completed enrollment for its Phase 2a clinical trial evaluating PCN-101 (R-ketamine) for treatment-resistant depression (TRD). Targeting around 100 patients who have not responded to previous antidepressants, the randomized, double-blind study is expected to yield topline results by year-end 2022. This trial is significant as PCN-101 may provide rapid-acting treatment options for TRD, allowing for at-home patient administration. The completion of enrollment marks a critical milestone in developing innovative therapeutic solutions for mental health disorders.
atai Life Sciences (NASDAQ: ATAI) announced its upcoming virtual R&D Day scheduled for October 25, 2022, aimed at reviewing its mental health pipeline. The event will showcase updates on various initiatives, including Phase 2a topline results for PCN-101 (R-ketamine) in treatment-resistant depression. Leadership will discuss the clinical and regulatory landscape, along with several programs including COMP360, VLS-01, RL-007, GRX-917, and KUR-101. This meeting emphasizes atai's commitment to addressing mental health disorders through innovative therapeutics.
atai Life Sciences has launched a Phase 1 proof-of-concept clinical trial for INB-01, an innovative intranasal drug-delivery technology. This trial aims to evaluate its safety, tolerability, and brain delivery efficacy. INB-01 could facilitate direct-to-brain delivery, enhancing patient compliance and minimizing systemic exposure. Topline results are anticipated in H1 2023. The technology has shown promising outcomes in animal studies, suggesting its potential effectiveness in humans. ATAI aims to transform mental health disorder treatment through innovative therapeutics.
atai Life Sciences announced positive initial results from the Phase 1 clinical trial of KUR-101, an oral formulation of deuterated mitragynine aimed at treating opioid use disorder (OUD). The trial showed KUR-101 is safe, well-tolerated, and produces dose-dependent analgesia without severe adverse effects. Topline results comparing KUR-101 to oxycodone are anticipated by the end of 2022. OUD affects approximately 3 million Americans, with high relapse rates. KUR-101 could offer a safer alternative in the growing global OUD market, projected to reach $4.81 billion by 2028.
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