- Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression remains on track for Q2 2026 following successful End-of-Phase 2 meeting with the
U.S. Food and Drug Administration - On-track for VLS-01 Phase 2 Elumina trial topline data readout anticipated in H2 2026
- Exploratory Phase 2a trial of EMP-01 in Social Anxiety Disorder met its primary safety and tolerability objective and demonstrated clinically meaningful improvements across key efficacy measures
- Cash runway through the planned early-2029 topline readouts from both Phase 3 pivotal studies
- Virtual Investor Day scheduled for
March 6, 2026
“Following our strategic combination of
Program Updates and Anticipated Milestones
BPL-003: mebufotenin benzoate nasal spray for TRD
- In
March 2026 , the Company announced a successful End-of-Phase 2 meeting with the FDA regarding the development of BPL-003 for treatment-resistant depression (TRD), a debilitating and chronic condition affecting millions of people around the world but with limited rapid-acting treatment options. - The FDA indicated support for advancement into Phase 3 studies in adults with TRD and provided constructive feedback on the overall design and requirements for a potential NDA package for this indication.
- The Phase 3 program is designed to include two pivotal studies, ReConnection-1 and ReConnection-2, each consisting of a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension (OLE):
- ReConnection-1:
- Approximately 350 participants
- Single-dose of BPL-003 across three treatment arms - 8 mg, 4 mg, and placebo (randomized 2:1:2)
- Designed to replicate and extend Phase 2b treatment response and further characterize dose–response relationship for BPL-003
- ReConnection-2:
- Approximately 300 participants
- Two-dose design (Day 1 and Day 15) across two arms - 8 mg BPL-003 and placebo (randomized 1:1)
- Designed to evaluate if a two-dose induction model increases magnitude and durability of initial response
- ReConnection-1:
- The primary endpoint in both pivotal trials will be the change from baseline in the MADRS total score at Week 4.
- Both trials include a 52-week OLE allowing individualized 8 mg BPL-003 retreatment at 8- or 12-week intervals with the aim of maintaining remission.
- Phase 3 program initiation remains on track for Q2 2026.
- Topline data from the core studies of both ReConnection-1 and –2 anticipated by early 2029.
- First patient dosed in the Part 4 cohort of the open-label Phase 2a study, evaluating a two-dose induction regimen (8 mg + 8 mg) of BPL-003 in TRD patients receiving defined antidepressants. Initial data expected in Q4 2026.
VLS-01: dimethyltryptamine (DMT) buccal film for TRD
- VLS-01 is an investigational proprietary oral transmucosal film formulation of DMT applied to the buccal surface, designed to fit within the established two-hour interventional psychiatry treatment paradigm.
- Phase 2 Elumina study topline data readout is anticipated in H2 2026.
EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD)
- In
February 2026 , the Company reported topline results from the exploratory, randomized, double-blind, placebo-controlled Phase 2a trial of EMP-01 in SAD:- Key findings:
- Met primary safety and tolerability objective with a generally favorable and manageable profile
- Clinically meaningful placebo-adjusted least squares mean reduction of 11.85 points on the Liebowitz Social Anxiety Scale (LSAS) at Day 43 (Hedges’ g = 0.45; p-value = 0.036, one-tailed)
- 49% responder rate on Clinician Global Impression–Improvement (CGI-I) vs. 15% for placebo, corresponding to a Number Needed to Treat (NNT) of 2.95
- Demonstrated improvements across Fear and Avoidance sub-domains of LSAS
- Key findings:
- In
December 2025 , the Company was granted a newU.S. patent covering the EMP-01 drug substance, extending expected exclusivity through 2043. - More detailed analyses of the data will be described in upcoming scientific venues and are expected to inform next development steps.
Business Highlights
- Completed the strategic combination in
November 2025 betweenatai Life Sciences N.V. andBeckley Psytech Limited , creating AtaiBeckley, a global leader in transformative mental health therapies. - Completed the redomiciliation to
the United States inDecember 2025 as a Delaware-incorporated company with headquarters inNew York, NY . AtaiBeckley Inc. was added to the NASDAQ Biotechnology Index (NBI) inDecember 2025 .- The Company will host a Virtual Investor Day on
March 6, 2026 , centered on BPL-003 and the Phase 3 development strategy. - The Virtual Investor Day will feature:
- Detailed overview of the BPL-003 Phase 3 program
- Discussion of the commercial opportunity in treatment-resistant depression
- Key opinion leader roundtable discussing the evolving psychedelic therapeutic landscape and operational considerations in interventional psychiatry
Upcoming Anticipated Milestones and Events
March 6, 2026 : Virtual Investor Day- Q2 2026: Initiation of BPL-003 Phase 3 ReConnection-1 and ReConnection-2 trials
- H2 2026: Topline data from VLS-01 Elumina Phase 2 study
- Q4 2026: Initial data from Phase 2a BPL-003 Part 4 cohort
Consolidated Financial Results
Cash, cash equivalents, and short-term securities (primarily US treasuries): As of
Research and development (R&D) expenses: R&D expenses were
We recorded non-cash acquisition of in-process R&D expenses of
General and administrative (G&A) expenses: G&A expenses for the three and twelve months ended
Net income (loss): Net loss attributable to stockholders for the three and twelve months ended
About
AtaiBeckley is a clinical-stage biotechnology company with a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (DMT buccal film) for TRD and EMP-01 (oral R-MDMA) for social anxiety disorder. BPL-003 is in Phase 3 planning, VLS-01 and EMP-01 are in Phase 2 clinical development. The Company is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create new breakthroughs in mental health by providing transformative interventional psychiatry therapies that can integrate seamlessly into healthcare systems.
For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; the potential, success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones and the outcome of related regulatory discussions; expectations regarding our intellectual property portfolio; expectations regarding our cash runway; and the plans and objectives of management for future operations, research and development and capital expenditures.
Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) or Quarterly Reports on Form 10-Q filed with the
Contact Information:
Investors:
VP, Investor Relations
IR@ataibeckley.com
Media:
Associate Director, Communications
PR@ataibeckley.com
-- Financial Statements Attached –
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (Amounts in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (unaudited) | ||||||||||||||||
| Revenue | $ | 1,066 | $ | (5 | ) | $ | 4,089 | $ | 308 | |||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 18,962 | 18,942 | 53,062 | 55,455 | ||||||||||||
| Acquisition of in-process research and development | 527,000 | — | 530,000 | — | ||||||||||||
| General and administrative | 25,086 | 11,318 | 65,088 | 47,544 | ||||||||||||
| Total operating expenses | 571,048 | 30,260 | 648,150 | 102,999 | ||||||||||||
| Loss from operations | (569,982 | ) | (30,265 | ) | (644,061 | ) | (102,691 | ) | ||||||||
| Other income (expense), net | 25,062 | (8,919 | ) | (15,788 | ) | (45,714 | ) | |||||||||
| Net loss before income taxes | (544,920 | ) | (39,184 | ) | (659,849 | ) | (148,405 | ) | ||||||||
| Benefit from (provision for) income taxes | 82 | 193 | (298 | ) | 356 | |||||||||||
| Losses from investments in equity method investees, net of tax | — | — | — | (2,000 | ) | |||||||||||
| Net loss | (544,838 | ) | (38,991 | ) | (660,147 | ) | (150,049 | ) | ||||||||
| Net loss attributable to noncontrolling interests | (25 | ) | (33 | ) | (100 | ) | (780 | ) | ||||||||
| Net loss attributable to | $ | (544,813 | ) | $ | (38,958 | ) | $ | (660,047 | ) | $ | (149,269 | ) | ||||
| Net loss per share attributable to | $ | (1.73 | ) | $ | (0.24 | ) | $ | (2.91 | ) | $ | (0.93 | ) | ||||
| Weighted average common shares outstanding attributable to | 314,276,378 | 160,711,543 | 226,532,786 | 160,159,983 | ||||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEET | ||||||||
| (Amounts in thousands) | ||||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 85,300 | $ | 17,505 | ||||
| Securities carried at fair value | 135,351 | 44,825 | ||||||
| Short-term restricted cash for other investments | — | 10,000 | ||||||
| Other current investments held at fair value | 35,389 | — | ||||||
| Prepaid expenses and other current assets | 19,644 | 7,795 | ||||||
| Property and equipment, net | 2,166 | 2,535 | ||||||
| Operating lease right-of-use assets, net | 1,846 | 1,334 | ||||||
| Other investments held at fair value | — | 28,887 | ||||||
| Other investments | — | 42,079 | ||||||
| Intangible assets, net | 2,851 | 3,246 | ||||||
| 331 | 331 | |||||||
| Digital assets | 8,735 | — | ||||||
| Other assets | 1,110 | 850 | ||||||
| Total assets | $ | 292,723 | $ | 159,387 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Accounts payable | $ | 4,906 | $ | 2,616 | ||||
| Accrued liabilities | 14,168 | 9,847 | ||||||
| Current portion of lease liabilities | 271 | 477 | ||||||
| Short-term convertible promissory notes and derivative liability - related party | — | 1,150 | ||||||
| Short-term convertible promissory notes and derivative liability | — | 1,840 | ||||||
| Current portion of long-term debt | — | 6,374 | ||||||
| Deferred revenue | 1,524 | 721 | ||||||
| Other current liabilities | 2,610 | 1,926 | ||||||
| Contingent consideration liability - related party | 104 | 110 | ||||||
| Contingent consideration liabilities | 205 | 212 | ||||||
| Noncurrent portion of lease liabilities | 1,801 | 732 | ||||||
| Pre-funded warrant liabilities | 44,379 | — | ||||||
| Long-term debt, net | — | 14,133 | ||||||
| Other liabilities | 754 | 2,695 | ||||||
| Total stockholders’ equity attributable to | 221,874 | 116,297 | ||||||
| Noncontrolling interests | 127 | 257 | ||||||
| Total liabilities and stockholders' equity | $ | 292,723 | $ | 159,387 | ||||
