Atai Life Sciences (NASDAQ: ATAI) has announced key leadership appointments aimed at accelerating the development of its pipeline of novel psychedelic therapeutics for mental health disorders. These changes come as the company advances VLS-01 and EMP-01 into Phase 2 clinical trials. Srinivas Rao M.D., Ph.D., has been appointed as the sole Chief Executive Officer (CEO), effective January 1, 2025.
Leadership Appointments
In addition to Dr. Rao's appointment, Kevin Craig, M.D., has been promoted to Chief Medical Officer (CMO), and Glenn Short, Ph.D., has been promoted to Chief Scientific Officer (CSO). Gerd Kochendoerfer, Ph.D., joins the company as Chief Operating Officer (COO). According to Dr. Rao, these appointments strengthen the leadership team at a crucial time, enhancing capabilities in clinical development, scientific innovation, and operational excellence.
Focus on Clinical Trials
The strengthened leadership team will focus on executing Phase 2 clinical trials for VLS-01, which is currently screening patients. The company also anticipates Phase 2b data readout for Beckley Psytech's BPL-003 in mid-year, marking a significant milestone in developing commercially scalable short-duration psychedelic therapies for treatment-resistant depression.
VLS-01: Buccal Film DMT for Treatment-Resistant Depression
VLS-01 is a proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) designed for individuals with treatment-resistant depression (TRD). DMT acts as a partial agonist of the 5-HT1A/2A/2C receptors, inducing a short psychedelic effect. Clinical evidence suggests that intravenous DMT administration can produce rapid and lasting antidepressant effects in patients with major depressive disorder. The buccal film formulation aims to eliminate the need for IV administration, improve pharmacokinetics, and fit within a two-hour in-clinic treatment paradigm. Atai is currently conducting a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial (NCT06524830) to evaluate the efficacy, safety, and tolerability of multiple doses of VLS-01 in TRD patients, with topline data expected in the first quarter of 2026.
EMP-01: R-MDMA for Social Anxiety Disorder
EMP-01 is an oral formulation of the R-enantiomer of 3,4-Methylenedioxymethamphetamine (MDMA) under development for treating social anxiety disorder (SAD). EMP-01 selectively targets the serotonergic system, reducing activation of other biological targets associated with racemic MDMA side effects. Phase 1 clinical trials have shown that EMP-01 is well-tolerated and produces subjective experiences similar to classic psychedelics, including introspective experiences, emotional breakthroughs, and increased self-compassion. Atai plans to initiate an exploratory Phase 2a placebo-controlled clinical trial in the first quarter of 2025 to assess the safety and efficacy of two doses of EMP-01 in adults with SAD, with topline data also anticipated in the first quarter of 2026.
New Leadership Roles
- Kevin Craig, M.D., CMO: Dr. Craig will head clinical development for VLS-01 and EMP-01, bringing over 20 years of clinical experience, including his previous role as Head of Early Clinical Development at Jazz Pharmaceuticals.
- Glenn Short, Ph.D., CSO: Dr. Short will lead research programs, including discovery, nonclinical pharmacology, and preclinical development, to advance novel 5-HT2AR agonists with non-hallucinogenic potential. He has over 20 years of industry and research experience.
- Gerd Kochendoerfer, Ph.D., COO: Dr. Kochendoerfer will focus on strategic alignment and operational excellence, leveraging his 25 years of experience in leadership roles across the pharmaceutical and biotech sectors.
