-- BPL-003 (mebufotenin benzoate nasal spray) granted Breakthrough Therapy
designation by the U.S. Food and Drug Administration (FDA) for
treatment-resistant depression (TRD)
-- Reported positive topline data from the Phase 2b open-label extension
(OLE) study of BPL-003 showing the potential added and sustained
antidepressant effects following a second dose in patients with TRD
-- Reported positive open-label Phase 2a data demonstrating improved
outcomes with a two-dose induction regimen of BPL-003 in patients with
TRD
-- An End-of-Phase 2 meeting is scheduled with the FDA for BPL-003,
anticipate providing guidance on the Phase 3 clinical program in the
first quarter of 2026
-- Completed enrollment in the exploratory Phase 2a trial of EMP-01 (oral
R-MDMA) for patients with social anxiety disorder (SAD)
-- Awarded a grant by the National Institute on Drug Abuse (NIDA) to fund
the optimization and early-stage development of novel 5-HT2A/2C receptor
agonists with non-hallucinogenic potential for opioid use disorder
-- Closed an approximate $150 million public offering and expect cash, cash
equivalents, short-term investments and other liquid assets to fund
operations into 2029, through anticipated topline data from the first
Phase 3 trial of BPL-003
NEW YORK and AMSTERDAM, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Atai Beckley N.V. $(ATAI)$ ("AtaiBeckley" or "Company"), a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today announced third quarter 2025 financial results and provided corporate updates.
"This has been a transformational quarter, highlighted by the establishment of AtaiBeckley, which solidifies our position as a global leader in developing transformative mental health therapies with short psychedelic duration," stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai. "The FDA's Breakthrough Therapy designation for BPL-003 represents a major milestone, reinforcing its potential to address the significant unmet need in treatment-resistant depression. Alongside positive Phase 2a and Phase 2b data for BPL-003, we believe we are well positioned to advance BPL-003 into pivotal development pending discussions with the FDA at the upcoming End of Phase 2 Meeting. Beyond BPL-003, we advanced our pipeline by completing enrollment in the Phase 2a study of EMP-01 for social anxiety disorder, expanding clinical trial sites for VLS-01 and securing a NIDA grant to support innovation of 5-HT2A/2C receptor agonists for opioid use disorder. Supported by our recent financing, we remain steadfast in our mission to redefine mental health treatment for patients in need."
"The progress this quarter marks a defining moment for atai," commented Christian Angermayer, Founder and Chairman of atai. "With the creation of AtaiBeckley, the Breakthrough Therapy designation for BPL-003, and a strengthened balance sheet, we are demonstrating the commercial scalability and scientific leadership needed to transform the mental health treatment landscape. Our strategy has been delivering by advancing multiple programs, expanding our innovation engine through grants, and maintaining financial discipline with funding secured well beyond our next major value inflection points. I'm incredibly proud of the team's execution and remain confident that we are building one of the most impactful mental health companies in the world."
Recent Clinical Highlights and Upcoming Milestones
BPL-003: Mebufotenin (5-MeO-DMT) benzoate nasal spray for treatment-resistant depression (TRD) and alcohol use disorder
-- BPL-003 granted Breakthrough Therapy designation by the FDA, recognizing
the potential of BPL-003 to deliver substantial improvement over existing
therapies for patients with TRD.
-- Reported positive topline results from the eight-week OLE study of the
randomized, quadruple-masked, global Phase 2b clinical trial of BPL-003
in patients with TRD demonstrating that a 12 mg dose of BPL-003,
administered eight weeks after an initial dose, was generally
well-tolerated, and produced additional clinically meaningful
antidepressant effects, which were sustained for up to two months.
-- Reported positive open-label Phase 2a data demonstrating improved
antidepressant effects with a two-dose induction regimen of BPL-003 in
patients with TRD.
-- Scheduled an End-of-Phase 2 meeting with the FDA to align on clinical
trial designs and other aspects of the Phase 3 development program.
-- Anticipate providing guidance on the BPL-003 Phase 3 clinical program in
the first quarter 2026 with Phase 3 trial initiation in the second
quarter of 2026, pending the outcome of the FDA meeting.
VLS-01: Buccal film dimethyltryptamine (DMT) for TRD
-- Continued enrollment in the US and expanded clinical sites into Australia
and the United Kingdom for Elumina, the Phase 2, multicenter,
double-blind, randomized, placebo-controlled trial of repeated doses of
VLS-01 in patients with TRD.
-- Anticipate topline data from Elumina in the second half of 2026.
EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD)
-- Completed patient enrollment in the exploratory, randomized, double-blind,
placebo-controlled Phase 2a study of EMP-01 to assess the safety,
tolerability and efficacy in approximately 70 adults with SAD.
-- Anticipate topline results from the exploratory Phase 2a study in the
first quarter of 2026.
Novel 5-HT2A Receptor Agonists (including the discovery of non-hallucinogenic neuroplastogens)
-- Novel 5-HT2A receptor agonists were discovered that maintain
non-hallucinogenic potential based on their inability to fully-substitute
for a traditional psychedelic in rodent drug discrimination studies.
These differentiated 5-HT2A receptor agonists are being further optimized
and studied in a series of animal models to assess therapeutic potential.
-- Awarded a multi-year, milestone-driven grant worth up to $11.4 million by
the National Institute on Drug Abuse (NIDA), part of the National
Institutes of Health (NIH), to fund the optimization and early-stage
development of novel 5-HT2A/2C receptor agonists with non-hallucinogenic
potential for opioid use disorder (OUD).
Corporate Updates
-- Completed the strategic combination between atai Life Science N.V. and
Beckley Psytech Limited, creating AtaiBeckley, a global leader in
transformative mental health therapies.
-- atai Life Sciences shareholders ratified the move of the AtaiBeckley
corporate domiciliation to the U.S., assuming satisfaction of applicable
closing conditions, the corporate redomiciliation is expected around year
end 2025.
-- Appointed Board Member, Scott Braunstein, M.D., as Vice Chairman and Lead
Independent Director. Dr. Braunstein is Chair of AtaiBeckley's Scientific
and Technology Committee and a member of the Audit Committee. Dr.
Braunstein brings extensive leadership experience as well as strategic
expertise across the biopharmaceutical industry, spanning clinical
development, operations, and capital markets.
-- In October, the Company closed a public offering of common shares.
Aggregate gross proceeds from the offering, including the exercise of the
underwriters' option to purchase additional shares, were approximately
$150 million, before deducting underwriting discounts and commissions and
other offering expenses payable by atai.
Consolidated Financial Results
Cash, cash equivalents, and short-term securities: As of September 30, 2025, the Company had cash, cash equivalents and short-term securities of $114.6 million compared to $72.3 million of cash, cash equivalents, restricted cash and short-term securities as of December 31, 2024. The $42.3 million increase is primarily attributable to $148.8 million in net proceeds from equity related issuances and $3.9 million in proceeds from sale of equity holdings, partially offset by $55.2 million used in operations, $21.8 million payoff of Hercules debt facility, $20.0 million in payments relating to the Beckley investment, and $10.0 million investment in digital assets. Including the proceeds from the October public offering, the Company expects its cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029.
Research and development (R&D) expenses: R&D expenses were $14.7 million for the three months ended September 30, 2025, as compared to $12.4 million for the same prior year period. The year-over-year increase of $2.3 million is primarily attributable to higher costs associated with its clinical programs, partially offset by decreases in personnel-related expenses and consulting services.
General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2025 were $14.5 million as compared to $10.3 million in the same prior year period. The year-over-year increase of $4.2 million is largely attributable to increased legal and professional service expenses in connection with the Beckley Psytech strategic combination and the process to move its corporate domicile to the U.S., partially offset by decreases in personnel-related expenses.
Net loss: Net loss attributable to stockholders for the three months ended September 30, 2025 was $61.1 million, as compared to $26.3 million for the three months ended September 30, 2024. The net loss for the three months ended September 30, 2025 includes a $32.6 million non-cash expense related to changes in the fair value of certain assets and liabilities.
About AtaiBeckley N.V.
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