atai Life Sciences has announced significant progress in its clinical pipeline of psychedelic-based therapies for mental health conditions, alongside financial results for the fourth quarter and full year 2024.
The clinical-stage biopharmaceutical company, focused on developing mental health treatments, has reached several important milestones in its development programs while strengthening its financial position through a successful capital raise.
Clinical Pipeline Advances
atai has dosed the first patient in its Phase 2 Elumina trial, evaluating VLS-01 for treatment-resistant depression (TRD). VLS-01 is a proprietary oral transmucosal film formulation of N,N-dimethyltryptamine (DMT) applied to the buccal surface. The multicenter, double-blind, randomized, placebo-controlled trial will assess the safety and efficacy of repeated doses of VLS-01, with topline data anticipated in the first quarter of 2026.
Simultaneously, the company has initiated a Phase 2 clinical trial of EMP-01, an oral formulation of R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA), for patients with social anxiety disorder (SAD). This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and efficacy of EMP-01, with results also expected in Q1 2026.
"Our team is focused on executing these trials rigorously and efficiently to drive forward our mission to transform patient outcomes in mental health," stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai.
Strategic Investments Show Progress
Through its strategic investment in Beckley Psytech, atai is advancing BPL-003, an intranasal transmucosal formulation of mebufotenin benzoate (5-Methoxy N,N-dimethyltryptamine). In March 2025, Beckley Psytech completed patient enrollment in its global Phase 2b clinical trial of BPL-003 in 196 patients with TRD. Topline results from this study are expected in mid-2025.
Earlier in January 2025, Beckley Psytech announced positive topline data from an open-label Phase 2a study of BPL-003 in patients with moderate-to-severe alcohol use disorder (AUD). Initial data showed that a single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months.
Additionally, Recognify Life Sciences, another strategic investment, is conducting a Phase 2b proof-of-concept study of RL-007 in 234 patients with cognitive impairment associated with schizophrenia (CIAS). RL-007 is an orally bioavailable compound that has demonstrated pro-cognitive effects in multiple pre-clinical and clinical studies. Topline results from this trial are expected in mid-2025.
Financial Position Strengthened
In February 2025, atai completed an equity offering with net proceeds of $59.2 million, extending its operational runway into 2027. This timeline extends beyond the expected topline data readouts from the Phase 2 clinical trials of the company's two core programs, VLS-01 and EMP-01.
"We are beginning the year in a strong financial position, thanks to the recent capital raise," Dr. Rao noted.
As of December 31, 2024, the company reported cash, cash equivalents, restricted cash, and short-term securities of $72.3 million, compared to $154.2 million as of December 31, 2023. The decrease was primarily driven by $82.4 million net cash used in operating activities, $15.0 million for the Beckley Psytech investment, and $7.7 million of additional investments to advance programs.
Financial Results
For the three months ended December 31, 2024, atai reported a net loss attributable to shareholders of $39.0 million, compared to $18.3 million for the same period in 2023. Research and development expenses were $18.9 million for Q4 2024, up from $14.2 million in the comparable prior year period, reflecting increased investment in clinical trials.
General and administrative expenses for Q4 2024 were $11.3 million, down from $19.4 million for the comparable prior year period, demonstrating the company's focus on operational efficiency.
For the full year 2024, the company reported a net loss attributable to shareholders of $149.3 million, compared to $40.2 million for 2023. The full-year net loss includes $48.9 million of non-cash decrease in fair value of assets and liabilities and $25.5 million of non-cash share-based compensation.
Future Outlook
With its strengthened financial position and advancing clinical pipeline, atai is positioned to reach several key milestones in 2025 and 2026. The company anticipates R&D spending to increase as its programs progress into later-stage clinical trials, while continuing to maintain reduced G&A expenses compared to prior years.
atai's pipeline includes not only the advancing clinical programs but also a drug discovery initiative to identify novel, non-hallucinogenic 5-HT2AR agonists for treatment-resistant depression, further expanding its potential therapeutic offerings in mental health.
The company's focus remains on developing commercially scalable interventional psychology therapies that can integrate into healthcare systems, addressing the complex nature of mental health conditions with innovative approaches.
