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The Markets
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Pharma & Biotech

atai Life Sciences prepares for data readouts from key clinical trials, extends operational runway

atai Life Sciences (NASDAQ:ATAI, ETR:9VC) said it saw significant progress in 2024 with key advancements in its clinical trials as it strengthened its financial position.

The company successfully dosed its first patient in the Phase 2 Elumina trial for VLS-01, a buccal film formulation of DMT designed to treat treatment-resistant depression.

atai also initiated a Phase 2 study of EMP-01, an oral formulation of R-MDMA for social anxiety disorder.

Beckley Psytech, a private biotech firm in which atai is invested, completed patient enrollment in the Phase 2b trial of BPL-003, an intranasal mebufotenin benzoate formulation aimed at treating treatment-resistant depression.

Beckley Psytech’s recent positive results in a Phase 2a study for alcohol use disorder highlight the potential of BPL-003 in addressing a broader range of mental health conditions, atai said.

Financial highlights

atai exited 2024 with $72.3 million in cash, cash equivalents, and short-term securities.

Further, atai has raised $59.2 million in a recent equity offering, extending its operational runway into 2027.

Research and development expenses decreased year-over-year by $6.7 million to $55.5 million for 2024, largely due to a reduction in personnel and program-specific costs, with a focus on advancing ongoing clinical trials.

General and administrative expenses also decreased by $16 million to $47.5 million for the year, reflecting cost-saving initiatives.

“We are beginning the year in a strong financial position, thanks to the recent capital raise, which extends our runway into 2027, beyond when we expect the topline data readouts from the Phase 2 clinical trials of our two core programs, VLS-01 and EMP-01, in Q1 2026,” atai Life Sciences Dr Srinivas Rao said in a statement.

“Our team is focused on executing these trials rigorously and efficiently to drive forward our mission to transform patient outcomes in mental health.”

Rao added that the company was looking forward to several key milestones this year, notably Beckley Psytech’s BPL-003 Phase 2b topline results in patients with treatment-resistant depression as well as RL-007 in patients with cognitive impairment associated with schizophrenia.

The company’s net loss for 2024 was $149.3 million, compared to a net loss of $40.2 million for 2023.

This increase in the net loss was largely driven by non-cash items, including a $48.9 million decrease in the fair value of assets and liabilities and $25.5 million in non-cash share-based compensation.

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