atai Life Sciences Reports Q2 2024 Financial Results

LOS ANGELES- atai Life Sciences, a biopharmaceutical company focused on transforming mental health treatment, announced its financial results for the second quarter of 2024 along with updates on its clinical pipeline. The company highlighted significant progress in advancing its VLS-01 and EMP-01 programs, which target treatment-resistant depression (TRD) and social anxiety disorder (SAD), respectively.

Dr. Srinivas Rao, Co-Chief Executive Officer and Co-founder of atai, emphasized the importance of recent developments. “Our positive Phase 1b results for VLS-01 underscore its potential as a best-in-class oral treatment for patients suffering from treatment-resistant depression,” he stated. The company plans to initiate a Phase 2 study of VLS-01 by year-end.

Clinical Program Updates:

VLS-01 (DMT for Treatment-Resistant Depression):
VLS-01 is a proprietary oral transmucosal film formulation of N,N-dimethyltryptamine (DMT) applied to the buccal surface, designed for a two-hour in-clinic treatment. Positive topline results from the Phase 1b trial showed that VLS-01 reached peak plasma concentration within 30-45 minutes and produced a brief psychedelic experience, with effects subsiding within 90-120 minutes. The study demonstrated a favorable safety profile with mild to moderate adverse events, all of which resolved quickly and were unrelated to cardiovascular risks.

The Phase 2 study, set to begin late 2024, will be a randomized, double-blind, placebo-controlled trial to assess the safety, efficacy, and durability of VLS-01 in patients with TRD.

EMP-01 (MDMA Derivative for Social Anxiety Disorder):
atai is advancing clinical development plans for EMP-01, with a Phase 2 study in SAD scheduled to start around year-end. The decision follows encouraging Phase 1 results where EMP-01 showed a unique subjective profile compared to traditional MDMA and psychedelics. The program aims to address the unmet need for novel treatments in SAD, a condition without new therapeutic options in over 20 years.

Looking Ahead:

The company remains focused on delivering key data readouts and initiating new studies in the latter half of 2024. atai continues to position itself as a leader in mental health innovation with a robust pipeline of high-potential programs targeting critical unmet needs in mental health treatment.