New NASDAQ Alert [Inside]

AwesomeStocks Hello! New Alert: Atai Life Sciences N.V. (NASDAQ: ATAI) ATAI has been trending higher over the past few weeks and has experienced some increased upside volatility. Last week, ATAI rallied from 1.29 to a high of 1.93, experiencing gains of more than 49%. Since this rally, ATAI has consolidated some of those gains, closing yesterday at 1.68. In the event that ATAI continues to close above its 50 day moving average of 1.60, it could present increased upside potential. ATAI has a 200 day moving average of 2.97, +76% above yesterday’s close. ATAI is one of the companies that is solving a growing global problem. ATAI is a “clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders”. Millions of people in the U.S. are affected by mental illness each year. According to the National Alliance of Mental Illness “1 in 5 U.S. adults experience mental illness each year”, while “1 in 20 U.S. adults experience serious mental illness each year”. Sadly, mental health problems have skyrocketed globally over the past few years. “Depression is a leading cause of disability worldwide”. The ripple effect that this disease has on people, families, and whole communities is just too devastating. By some estimates, “Depression and anxiety disorders cost the global economy $1 trillion in lost productivity each year”. To make matters even worse, “Depression, anxiety, dementia and similar conditions often are [early symptoms] to more serious neurodegenerative diseases, such as Multiple sclerosis, Alzheimer's disease and Parkinson's disease.” Effective treatments for mental health and related diseases are more needed today than ever before. 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 “aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients”. The company’s “vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life”. Here are some of the company’s “Clinical Pipeline Highlights”: - “RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS))” - “RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in 10 clinical studies with over 500 unique participants dosed to-date and in which it was well tolerated at all doses tested.” - “Notably, in four clinical studies that assessed cognition, including one in patients with CIAS, the compound consistently demonstrated pro-cognitive effects. In atai’s previous Phase 2a proof-of-mechanism study in CIAS of RL-007, the compound showed a large effect size on Symbol Coding, a sub-component of the MCCB that correlates with the overall composite.” - “GRX-917 (Deuterated Etifoxine for Anxiety Disorders)” - “GRX-917 is a deuterated version of etifoxine, a drug used for anxiety and first approved in France in 1979. Etifoxine has a rapid onset and efficacy comparable to benzodiazepines, which are currently considered standard of care. In contrast to benzodiazepines, etifoxine appears to be non-addictive, less sedating, and better tolerated. It is believed that etifoxine achieves its anxiolytic activity by increasing the endogenous production of brain neurosteroids like allopregnanolone.” - “In January 2022, positive results were announced from the phase 1 single and multiple ascending dose study of GRX-917. In this study, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG.” - “COMP360 (Psilocybin Therapy for Treatment-Resistant Depression (TRD))” - “COMP360 is a proprietary formulation of synthetic psilocybin that is administered in conjunction with psychological support. Previously, COMPASS completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support.” - “VLS-01 (N,N-dimethyltryptamine (DMT) for TRD)” - “VLS-01 is an OTF formulation of DMT. DMT is a partial agonist of the 5-HT 1A/2A/2C receptors, characterized by an intrinsically short duration of psychedelic effect, with a serum half-life estimated at less than 10 minutes. DMT results in rapid-acting antidepressant effects when administered via IV infusion in patients with major depressive disorder (MDD). VLS-01 is formulated for oral delivery, potentially eliminating the need for IV infusion.” - “DMX-1002 (Ibogaine for Opioid Use Disorder)” - “In the third quarter of 2022, the first subject was dosed in a phase 1/2 study of Ibogaine. Initial results from the Phase 1 portion of the study are expected in the 1st half of 2023.” - “EMP-01 (MDMA Derivative for PTSD)” - “In the third quarter of 2022, a phase 1 study of EMP-01 was initiated. Initial results from this study are expected in the 2nd half of 2023.” As the company explains: “Cognitive impairment associated with Schizophrenia (CIAS) & Schizophrenia often lead to individuals making choices they feel are out of their control” In addition, sadly, “there are currently no FDA-approved medications for CIAS, a major cause of disability in 80% of patients with schizophrenia”. ATAI has announced multiple developments recently. In December, the company announced: - “The atai Fellowship Fund in Psychedelic Neuroscience Announces its First Cohort at Massachusetts General Hospital” - “atai Life Sciences Initiates Phase 2b proof-of-concept trial of RL-007 for Cognitive Impairment Associated with Schizophrenia” In January, the company announced: - “atai Life Sciences Announces Results from Phase 2a Trial of PCN-101 (R-ketamine) for Treatment-Resistant Depression” - “atai Life Sciences Company GABA Therapeutics Announces Positive Final Results from Phase 1 Single and Multiple Ascending Dose Trial of GRX-917” In March, the company announced: “atai Life Sciences Announces Key Clinical Pipeline and Corporate Updates” - “RL-007: First patient dosed in the on-going phase 2b study in cognitive impairment associated with schizophrenia” - “GRX-917: Intention to progress GRX-917 into a phase 2 study in an anxiety disorder as the next step in clinical development” - “COMP360: Recently announced acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program, with top line data now expected in the summer of 2024” - “Corporate: As a result of our recent restructuring and pipeline updates, the company has extended its cash runway, which is now expected into 1H 2026” In addition, most recently, the company announced: “atai Life Sciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Pipeline Highlights” Here are the highlights from this press release: - “atai’s development candidates, such as RL-007 and GRX-917, all represent significant opportunities to address unmet medical needs of patients living with mental health conditions” - “Continued operational progress on robust clinical pipeline, with multiple phase 1 and phase 2 proof-of-concept datasets expected in the next two years” - “$273 million in cash, cash equivalents and short-term investments at end of 2022 and access to a term loan facility of up to an additional $160 million provide anticipated runway into the first half of 2026” ATAI could be presenting an opportunity for increased growth potential. Make sure to do your own due diligence. Sources: [NAMI]( [Hopkins]( [Presentation]( [PR1]( [PR2]( [PR3]( [PR4]( [PR5]( [PR6]( [PR7]( [PR8]( [Website]( [Chart]( Happy Trading! AwesomeStocks Note: We encourage all traders and investors to develop personal trading rules that you can follow and that work for you. Always protect your downside and note that we alert extremely volatile short-term opportunities. Before investing in securities, you should always consult with your financial, tax and legal advisor and never invest money you cannot afford to lose. DISCLAIMER You should read and understand this disclaimer in its entirety before joining the website or email/blog list of AwesomeStocks.com (the “Publisher”). The information (collectively the “Advertisement”) disseminated by email, text or other method by the Publisher including this publication is a paid commercial advertisement and should not be relied upon for making an investment decision or any other purpose. 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