atai Life Sciences N.V. (NASDAQ: ATAI)

atai Life Sciences N.V. (NASDAQ: ATAI) is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai is redefining how the world approaches mental health treatment. As a biopharmaceutical company that leverages a decentralized platform approach, atai incubates and accelerates the development of highly effective mental health treatments that address the unmet needs of patients. atai was founded in 2018 as a response to that 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, schizophrenia and other mental health disorders, as well as Traumatic Brain Injury. Its product candidates include 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.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. The company’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai Life Sciences is proud to be a driving force in mental health innovation and to develop new therapeutic options in key areas of unmet patient need. atai is headquartered in Berlin and has offices in New York and London.

Technology and Product Candidates

atai recently launched Invyxis, a new, wholly owned platform company committed to developing new chemical entities (NCEs) and to further pioneering next-generation mental health treatments. Invyxis will bring proven medicinal chemistry tools and comprehensive biological screening approaches to atai’s growing enterprise of drug discovery and design. The launch of Invyxis is a further step-up in atai’s growth and commitment to innovation in the treatment of mental health disorders. Invyxis’ goal will be to discover new agents with potential in treating mental health disorders.

In January 2022, the U.S. Food and Drug Administration gave Investigational New Drug (IND) clearance to conduct a clinical DDI study of PCN-101 (R-ketamine). atai plans to initiate the study early in 2022. The unique properties of PCN-101 could offer a differentiated profile to currently available antidepressants and address key patient needs, including the potential of rapid action and anti-suicidal effect. Rapid onset of action is particularly important in this patient population, but frontline selective serotonin reuptake inhibitors (SSRIs) can take up to 12 weeks before providing maximal benefit.

atai in December 2021 announced positive topline data from its Phase 2a study of RL-007 for cognitive impairment associated with schizophrenia (CIAS). The 32-patient, single-arm, single-blind study demonstrated a clinically meaningful pro-cognitive profile for RL-007, based on analysis of general cognition and episodic memory. Following these promising findings, atai has committed to initiating a randomized, double-blind, placebo-controlled, proof-of-concept Phase 2 study of RL-007.

Market Overview

Mental health disorders impact over 1 billion people around the world, representing a growing global crisis, but medical innovation has failed to offer recent novel solutions. Only seven treatments have been approved by the FDA for psychiatry disorders since 2015, a time during which approximately 100 have been advanced in oncology. In the U.S., an estimated 1.7 million people sustain a traumatic brain injury annually, while more than 20 million live with a substance use disorder. It is estimated that schizophrenia affects over 21 million people globally and approximately 3 million in the U.S. Anxiety disorders are considered to be the most common mental illness in the U.S., affecting approximately 40 million adults. Depression is one of the most prevalent psychiatric disorders and a leading cause of disability worldwide, affecting an estimated 300 million people globally. Approximately one-third of patients with major depressive disorder are diagnosed with treatment-resistant depression.

According to a report from ResearchAndMarkets, the global psychedelic drugs market is expected to grow from $3.21 billion in 2021 to a value of $6.33 billion in 2026, a CAGR of 14.5% during the forecast period. Market growth is due to a large unmet need for mental health treatment driving the adoption of psychedelic drugs. North America accounts for half of the revenue in the global psychedelic drugs market and should be worth $3.184 billion by the end of the forecast period.

Management Team

Christian Angermayer is co-founder and chairman at atai. In 2000, he co-founded Ribopharma (original patents for RNAi technology), which merged with stock market-listed U.S. SPAC Alnylam in 2003 and has a $13 billion market cap today. Since then, Mr. Angermayer has created, co-founded and invested in numerous successful companies and has been involved in more than 50 successful IPOs and M&A transactions.

Florian Brand is the co-founder and CEO of atai. He previously was the managing director of Springlane, Germany’s leading online kitchen appliance retailer. He suffered from anxiety in his youth and achieved remission through cognitive behavioral therapy and meditation practice. Seeing others failed by the mental health system inspired him to help those unable to find relief in currently available therapies.

Dr. Srinivas Rao is co-founder and chief scientific officer at atai. Prior to atai, he held the titles of chief scientific, medical, or CEO at companies from startups to publicly traded pharmaceutical companies. He completed his internship in Internal Medicine at Yale-New Haven Hospital. He received his Ph.D. in neurobiology from Yale Graduate School and his M.D. from Yale School of Medicine.

Greg Weaver is CFO at atai. He joined the company as consulting CFO and assumed the position permanently in September 2020. He has over 25 years of CFO and board director experience in the biotech industry. Prior to joining atai, he was CFO at several successful companies, including SIRNA Therapeutics, ILEX Oncology, Oryzon, Prometic and Eloxx Pharmaceuticals.