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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 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.
atai Life Sciences (Nasdaq: ATAI) has announced the formation of PsyProtix, a new platform focused on precision psychiatry for treatment-resistant depression (TRD) and other mental health conditions. This collaboration with Duke University aims to develop therapeutics that account for patient variability in genes and lifestyle instead of a traditional trial-and-error approach. Over 300 million individuals suffer from major depressive disorder, with TRD presenting significantly higher medical costs. PsyProtix seeks to customize treatments based on metabolomic mechanisms to improve therapeutic outcomes.
DemeRx IB, a platform company of atai Life Sciences (Nasdaq: ATAI), has initiated a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002) for opioid use disorder. The trial has begun dosing with recreational drug users and healthy volunteers in the UK, focusing on safety, tolerability, pharmacokinetics, and efficacy. Previous studies indicate ibogaine's potential for rapid and sustained efficacy in treating opioid dependence. Safety data is expected by early 2022. The trial aims to contribute to existing literature on ibogaine as a treatment option amidst the ongoing opioid crisis.
atai Life Sciences (Nasdaq: ATAI) has amended its loan agreement with IntelGenx Technologies Corp., increasing its loan commitment from US$2.5 million to US$8.5 million to support IntelGenx' graduation to the Toronto Stock Exchange. The additional US$6 million will be allocated in two phases of US$3 million each in January 2022 and January 2023. This move is based on promising early data from ongoing studies. The loan, which matures in January 2024, bears an 8% interest rate, while IntelGenx focuses on developing innovative treatments for mental health disorders.
Perception Neuroscience, a subsidiary of atai, has initiated a Phase 2a clinical study to assess the safety and efficacy of PCN-101 (R-ketamine) for Treatment Resistant Depression (TRD). The trial will enroll 93 patients across 3 arms, with doses of either placebo, 30 mg, or 60 mg of R-ketamine. Patients will be monitored for depressive symptoms over 14 days, with topline data expected by the end of 2022. The study aims to provide insight into R-ketamine's potential as a rapidly-acting antidepressant, addressing the needs of nearly 100 million people affected by TRD.
atai Life Sciences (Nasdaq: ATAI) announces a usability study of its Introspect Digital Therapeutics app, aimed at enhancing ketamine therapy for treatment-resistant depression (TRD), affecting 100 million globally. Conducted in collaboration with Kadima Neuropsychiatry, the study will assess user acceptability, therapeutic content introduction, and treatment settings across three cohorts. Atai believes this digital integration could improve access to mental health care, aligning with its mission to innovate psychiatric treatments and address the substantial unmet need in mental health.
atai Life Sciences (Nasdaq: ATAI) is set to participate in multiple investor conferences this September, focusing on mental health treatments.
Key events include:
- Citi 16th Annual BioPharma Conference on September 8, 2021, at 2:20 p.m. ET (Panel Discussion).
- H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 9:00 a.m. ET (Presentation).
- Baader Investment Conference on September 21, 2021, at 11:30 a.m. ET (Presentation).
- Cantor Fitzgerald Global Healthcare Conference on September 27, 2021, at 10:00 a.m. ET (Fireside Chat).
Archived webcasts will be available on the company's website.
atai Life Sciences (Nasdaq: ATAI) successfully completed its IPO, raising $258.8 million in gross proceeds. The company received $20 million from Otsuka for a collaborative effort in developing R-ketamine. It has advanced 11 therapeutic programs, with notable trials such as Recognify's Phase 2 and GABA's Phase 1 commencing. The company's cash position stands at $453.6 million, positioning it well for upcoming milestones, including 18 catalysts anticipated over the next 18 months.
atai Life Sciences (Nasdaq: ATAI) plans to host a conference call on August 16, 2021, at 8:30 a.m. ET to discuss its financial results for the second quarter ended June 30, 2021, and provide a business update.
The conference call can be accessed at 877-407-3982 in the U.S. and +1 (201) 493-6780 internationally, using conference ID: 13721888. A live and archived webcast will be available on the company's website.
atai Life Sciences N.V. (Nasdaq: ATAI) will participate in the virtual 41st Annual Canaccord Genuity Growth Conference from August 10-12, 2021. The company will conduct a fireside chat on August 10 at 2:30 p.m. ET. Interested parties can access the webcast here.
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