Round TWO on ATAI!!
After alerting this one to you at $1.40 on March 29th, ATAI ran to a HIGH of $1.95 yesterday morning!
Now it took a pull back but could we see an even BIGGER Run Starting TODAY?
If you haven't read our report on ATAI yet, check it out below and make sure you are watching it for the LONG TERM!
Trading at around $1.75 ATAI may be the most promising biotech company hiding in the market!
Greetings All,
Wall Street's eyes have been shifting widely to biotech companies that are aiming to reinvent mental healthcare treatments.
This puts the spotlight on Atai Life Sciences (NASDAQ: ATAI)
After seeing a close friend struggle with mental health issues before self-treating successfully with psychedelics, ATAI CEO and Founder Florian Brand realized that patients across the world were underserved!
Mental health conditions are increasing worldwide. In fact, 90% of US adults say the United States is experiencing a mental health crisis according to a CNN/KFF poll. More than half identified mental health issues among children and teenagers as a crisis, as well as severe mental illness in adults.
"The Covid-19 pandemic exacerbated numerous social stressors that we know can increase the risk of both substance use and mental illness," said Dr. Nora Volkow, director of the National Institute on Drug Abuse.
"Perhaps one of the only benefits of the pandemic and the shift that our country has been going through is the increase in our willingness to acknowledge and talk about when we might be struggling or in need of support," said Sarah Brummett, director of the National Action Alliance for Suicide Prevention's executive committee.
Every year a staggering 13 million to 14 million Americans have major depression. Of those who seek treatment, 30% to 40% will not get better or fully recover with standard antidepressants. Sadly, this puts them at greater risk of alcohol and drug abuse, hospitalization, and suicide attempts.
ATAI is now trying to flip the narrative on the failing mental health treatment space and is zooming in on the promising potential of psychedelics!
The potential of the psychedelics industry has never been bigger. Long-stigmatized drugs like esketemine, MDMA and psilocybin are advancing rapidly through clinical trials for treatments of a range of mental health conditions.
ATAI Life Sciences is embarking on the study of these drugs and others for their potential to treat mental health issues. Proponents of the treatments suggest positive impacts on mood, emotional processing, and overall brain health.
According to ATAI's website, the company's mission is to "Pioneer the development of highly effective mental health treatments that address the unmet needs of patients."
The company's pipeline includes drugs to treat anxiety, depression, schizophrenia, substance use disorder, and traumatic brain injury. These are some of the most significant markets for mental health treatments.
"Watching my best friend and business partner suffer, being let down by existing treatments and finally finding comfort in psychedelic therapies, was all the inspiration I needed to commit my life to this cause." - Florian Brand ATAI CEO.
With prominent backing from venture capitalists, including billionaire Peter Thiel, Atai Life Sciences is considered one of the biggest biotech stocks focused on psychedelic drugs today!
https://atai.life/
NASDAQ: ATAI
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, the company is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
By pooling resources and best practices, 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 Perception Neuroscience unit teamed up with Japanese drugmaker Otsuka to develop R-ketamine in treating depression. This is the first major collaboration between a psychedelic-focused biotech and a big pharma company!
The company announced some exciting corporate highlights recently:
- 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
"The dosing of the first patient in the phase 2b study of RL-007 in CIAS earlier this quarter exemplifies the execution capabilities of our team as we advance our programs into later-stage clinical studies," said Florian Brand, CEO and Co-Founder of atai. "Along these lines, we are excited to announce the updated clinical strategy for GRX-917. The compound will progress directly into a phase 2 study in patients living with an anxiety disorder to accelerate development and generate the robust clinical data needed to inform a potential future registration."
Clinical Programs
ATAI has 8 clinical stage drug development programs with a focus on compound classes with prior evidence in humans; portfolio approach to avoid binary risk and to optimize likelihood of success. The company expects to deliver several R&D milestones anticipated across key clinical programs through 2024.
PCN-101 / R-ketamine - Treatment-Resistant Depression - Phase 2
- In January 2023, in conjunction with the phase 2a study results of PCN-101, atai announced it would further evaluate the data and work with its subsidiary Perception Neuroscience ("Perception") to determine next steps for the program.
- atai will continue to support Perception's development of PCN-101 through the IV-to-subcutaneous bridging study, which is currently on-track to be completed in the middle of 2023. In parallel, atai continues to work with Perception Neuroscience to explore strategic partnership options.
- 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 activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Both depression model studies in rodents and clinical data suggest that R-ketamine could possess more durable effects than S-ketamine despite a lower affinity to the NMDA receptor and potentially a more favorable safety and tolerability profile.
Perception Neuroscience - RL-007 / Compound2 - Cognitive Impairment Associated With Schizophrenia - Phase 2
- The first patient was recently dosed in the phase 2b study of RL-007 in patients with CIAS. Initial results from this study are expected in the 2nd half of 2024.
- The phase 2b study is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 20mg and 40mg of RL-007 vs placebo in approximately 230 patients with CIAS. The primary endpoint of the US-based study is the MATRICS Consensus Cognitive Battery neurocognitive composite score at 6-weeks.
- 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.
"The dosing of the first patient in the phase 2b study of RL-007 in CIAS earlier this quarter exemplifies the execution capabilities of our team as we advance our programs into later-stage clinical studies. Along these lines, we are excited to announce the updated clinical strategy for GRX-917. The compound will progress directly into a phase 2 study in patients living with an anxiety disorder to accelerate development and generate the robust clinical data needed to inform a potential future registration."
- Florian Brand, CEO and Co-Founder of atai
Recognify Life Sciences - GRX-917 / Deuterated etifoxine - Generalized Anxiety Disorder - Phase 1
- The clinical development plan has been updated to now proceed with a phase 2 study in patients. The updated plan is anticipated to generate the robust clinical data needed to best support potential registration. More details on the clinical development plan will be provided upon initiation of the study.
- The updated plan follows the positive results from the phase 1 single and multiple ascending dose study of GRX-917. In this trial, 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.
- 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 leading benzodiazepines, like alprazolam and lorazepam, which are currently considered standard of care. In contrast to these benzodiazepines, however, and based on more than 40 years of the use of etifoxine in clinical practice, etifoxine appears to be non-addictive and does not seem to have the same sedation and other common adverse events. It is believed that etifoxine achieves its anxiolytic activity by increasing endogenous production of brain neurosteroids like allopregnanolone.
A Major Market
Nearly one billion people worldwide suffer from some form of mental disorder, according to latest U.N. data. These disorders do NOT discriminate. They can impact anyone at anytime and anywhere.
In its largest review of mental health since the turn of the century, the World Health Organization has urged more countries to get to grips with worsening conditions.
Depression is one of the most prevalent psychiatric disorders and a leading cause of disability worldwide, affecting an estimated 300 million people globally. Anxiety disorders are considered to be the most common mental illness in the United States, affecting approximately 40 million adults, or 18% of the population. Within the United States, generalized anxiety disorder affects almost seven million adults.
It is estimated that schizophrenia affects over 21 million people globally and approximately 2.4 million people in the United States. Approximately 300,000 new cases are diagnosed each year in the United States. And over 20m people live with a substance use disorder (SUD) in the U.S., and since the drug epidemic started in 1999, there have been over 900,000 overdose fatalities.
The growing body of evidence shows that several psychedelic compounds hold strong therapeutic potential for a wide array of mental health conditions. Although once dismissed as dangerous, today these compounds are gaining mainstream acceptance.
Listen to CEO and co-Founder Florian Brand discuss the potential of psychedelics for the treatment of mental health here:
Link to video: atai Life Sciences on Twitter: "🔊 Sound on 🔊 Listen to our CEO and CO-Founder @flobrand discuss the potential of psychedelics for the treatment of mental health with @MStothard https://t.co/V0VzYBZOf2" / Twitter
In Summary
ATAI expects to deliver several R&D milestones anticipated across key clinical programs through 2024.
This is a company with a strong cash position that could be positioned to becoming a leader in mental health care treatments. ATAI had approximately $304M (as of September 30th, 2022) and access to up to an additional $160m from term loan facility with Hercules2 lead to anticipated cash runway into H1'26.
The company also has a strong market validation. Validation of the company's operating model and ability to capture value include the IPO of COMPASS Pathways in 2020 and a licensing deal between Otsuka and its subsidiary Perception Neuroscience in 2021.
ATAI is a little-known biotech company that could become a pioneer in mental health disorders and is one to keep high on the radar!
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