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AtaiBeckley Reports Wider FY25 Loss, Highlights Progress Across Mental Health Pipeline, Stock Down

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

AtaiBeckley Inc. (ATAI) reported fourth quarter and full year 2025 financial results, alongside updates across its clinical-stage mental health portfolio.

The company said it has entered a "pivotal execution phase" following the strategic combination of Atai Life Sciences and Beckley Psytech and its U.S. redomiciliation.

For the fourth quarter of 2025, AtaiBeckley posted a net loss of $544.8 million, compared with $39.0 million in the same quarter of 2024.

For the full year, net loss of widened to $660.0 million, up from $149.3 million in 2024, largely driven by $530 million in non-cash in-process R&D charges related to the Beckley Psytech combination.

The company ended 2025 with $220.7 million in cash, cash equivalents, restricted cash and short-term securities. AtaiBeckley expects its cash runway to extend into 2029.
The company's pipeline includes BPL-003, VLS-01 and EMP-01, all advancing across late and mid-stage development.

BPL-003, a mebufotenin benzoate nasal spray for treatment-resistant depression, is moving into Phase 3 following a successful End-of-Phase 2 meeting with the FDA. The pivotal program will include two studies, ReConnection-1 and ReConnection-2, evaluating single-dose and two-dose induction regimens. Both trials feature 12-week randomized core studies with 52-week open-label extensions. Phase 3 initiation remains on track for Q2 2026, with topline data expected by early 2029. Initial data from the ongoing Phase 2a Part 4 cohort are expected in Q4 2026.

VLS-01, an oral transmucosal DMT buccal film also being developed for treatment-resistant depression, continues in the Phase 2 Elumina study. A topline readout is anticipated in H2 2026, evaluating whether the formulation can deliver a rapid-acting psychedelic intervention within a two-hour treatment window.

EMP-01, an oral E-MDMA candidate for social anxiety disorder, recently completed a Phase 2a trial that met its primary safety and tolerability objectives. The study demonstrated an 11.85 points placebo-adjusted reduction on the Liebowitz Social Anxiety Scale at Day 43 and a 49% responder rate versus 15% for placebo. A U.S. patent granted in December 2025 extended exclusivity to 2043, and additional analyses will guide next-phase development.

ATAI has traded between $1.15 and $6.75 over the past year. The stock closed yesterday's trading at $3.54, down 4.07%. The stock is currently trading in the pre-market at $3.35, down 5.35%.

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