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||
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(State or other jurisdiction of incorporation or organization)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.)
|
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
|
Title of each class
|
|
Trading
Symbol(s)
|
|
Name of each exchange
on which registered
|
|
|
|
|
(Nasdaq Global Market)
|
| Item 2.02. |
Results of Operations and Financial Condition.
|
|
Item 7.01.
|
Regulation FD Disclosure.
|
|
Item 9.01.
|
Financial Statements and Exhibits.
|
|
Exhibit
No. |
|
Description
|
| 99.1* |
Press Release of AtaiBeckley Inc., dated March 6, 2026.
|
|
|
|
Presentation of AtaiBeckley Inc., dated March 6, 2026.
|
|
|
104
|
Cover Page Interactive Data File (embedded within the inline XBRL document).
|
|
|
*
|
Furnished herewith
|
|
|
ATAIBECKLEY INC.
|
||
|
Date: March 6, 2026
|
By:
|
/s/ Srinivas Rao |
|
Name:
|
Srinivas Rao
|
|
|
Title:
|
Chief Executive Officer
|
|

| • |
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
|
| • |
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):
|

| o |
ReConnection-1:
|
| ■ |
Approximately 350 participants
|
| ■ |
Single-dose of BPL-003 across three treatment arms - 8 mg, 4 mg, and placebo (randomized 2:1:2)
|
| ■ |
| o |
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)
|
| ■ |
| • |
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.
|
| • |
| • |
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.
|
| • |
In February 2026, the Company reported topline results from the exploratory, randomized, double‑blind, placebo‑controlled Phase 2a trial of EMP‑01 in SAD:
|
| o |
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
|
| • |
In December 2025, the Company was granted a new U.S. patent covering the EMP‑01 drug substance, extending expected exclusivity through 2043.
|
| • |

| • |
Completed the strategic combination in November 2025 between atai Life Sciences N.V. and Beckley Psytech Limited, creating AtaiBeckley, a global leader in transformative mental health therapies.
|
| • |
Completed the redomiciliation to the United States in December 2025 as a Delaware‑incorporated company with headquarters in New York, NY.
|
| • |
AtaiBeckley Inc. was added to the NASDAQ Biotechnology Index (NBI) in December 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:
|
| o |
Detailed overview of the BPL-003 Phase 3 program
|
| o |
Discussion of the commercial opportunity in treatment-resistant depression
|
| o |
Key opinion leader roundtable discussing the evolving psychedelic therapeutic landscape and operational considerations in interventional psychiatry
|
| • |
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
|


|
Three Months Ended
|
Twelve Months Ended
|
|||||||||||||||
|
December 31,
|
December 31,
|
|||||||||||||||
|
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 AtaiBeckley Inc. stockholders
|
$
|
(544,813
|
)
|
$
|
(38,958
|
)
|
$
|
(660,047
|
)
|
$
|
(149,269
|
)
|
||||
|
Net loss per share attributable to AtaiBeckley Inc. stockholders — basic and diluted
|
$
|
(1.73
|
)
|
$
|
(0.24
|
)
|
$
|
(2.91
|
)
|
$
|
(0.93
|
)
|
||||
|
Weighted average common shares outstanding attributable to AtaiBeckley Inc. stockholders — basic and diluted
|
314,276,378
|
160,711,543
|
226,532,786
|
160,159,983
|
||||||||||||

|
December 31,
|
December 31,
|
|||||||
|
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
|
||||||
|
Goodwill
|
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 AtaiBeckley Inc. stockholders
|
221,874
|
116,297
|
||||||
|
Noncontrolling interests
|
127
|
257
|
||||||
|
Total liabilities and stockholders’ equity
|
$
|
292,723
|
$
|
159,387
|
||||