|
The Netherlands
|
001-40493
|
Not Applicable
|
|
(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
|
||
|
Common shares, €0.10 par value per share
|
ATAI
|
The Nasdaq Stock Market LLC
(NASDAQ)
|
| Item 2.02. |
Results of Operations and Financial Condition.
|
| Item 9.01. |
Financial Statements and Exhibits.
|
|
Exhibit
No.
|
Description
|
|
|
Press Release of Atai Beckley N.V., dated November 12, 2025.
|
||
|
104
|
Cover Page Interactive Data File (embedded within the inline XBRL document).
|
|
|
*
|
Furnished herewith
|
|
|
Atai Beckley N.V.
|
||
|
Date: November 12, 2025
|
By:
|
/s/ Srinivas Rao
|
|
Name:
|
Srinivas Rao
|
|
|
Title:
|
Chief Executive Officer
|
|
|
|
• |
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 for opioid use disorder
(OUD)
|
|
|
• |
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
|
|
|
• |
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 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.
|
|
|
• |
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.
|
|
|
• |
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 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 for opioid use disorder (OUD).
|
|
|
• |
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 US, assuming satisfaction of applicable closing conditions, the corporate redomiciliation is
expected around yearend 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.
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
|
2025
|
2024
|
2025
|
2024
|
|||||||||||||
|
(unaudited)
|
(unaudited)
|
|||||||||||||||
|
Revenue
|
$
|
749
|
$
|
40
|
$
|
3,023
|
$
|
313
|
||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development
|
14,680
|
12,377
|
37,100
|
36,513
|
||||||||||||
|
General and administrative
|
14,505
|
10,265
|
40,002
|
36,226
|
||||||||||||
|
Total operating expenses
|
29,185
|
22,642
|
77,102
|
72,739
|
||||||||||||
|
Loss from operations
|
(28,436
|
)
|
(22,602
|
)
|
(74,079
|
)
|
(72,426
|
)
|
||||||||
|
Other expense, net
|
(32,531
|
)
|
(3,861
|
)
|
(40,850
|
)
|
(36,795
|
)
|
||||||||
|
Net loss before income taxes
|
(60,967
|
)
|
(26,463
|
)
|
(114,929
|
)
|
(109,221
|
)
|
||||||||
|
Benefit from (provision for) income taxes
|
(131
|
)
|
178
|
(380
|
)
|
163
|
||||||||||
|
Losses from investments in equity method investees, net of tax
|
—
|
(26
|
)
|
—
|
(2,000
|
)
|
||||||||||
|
Net loss
|
(61,098
|
)
|
(26,311
|
)
|
(115,309
|
)
|
(111,058
|
)
|
||||||||
|
Net loss attributable to noncontrolling interests
|
(24
|
)
|
(25
|
)
|
(75
|
)
|
(747
|
)
|
||||||||
|
Net loss attributable to Atai Beckley N.V. stockholders
|
$
|
(61,074
|
)
|
$
|
(26,286
|
)
|
$
|
(115,234
|
)
|
$
|
(110,311
|
)
|
||||
|
Net loss per share attributable to Atai Beckley N.V. stockholders — basic and diluted
|
$
|
(0.28
|
)
|
$
|
(0.16
|
)
|
$
|
(0.59
|
)
|
$
|
(0.69
|
)
|
||||
|
Weighted average common shares outstanding attributable to Atai Beckley N.V. stockholders — basic and diluted
|
217,601,496
|
160,621,817
|
196,963,517
|
159,973,201
|
||||||||||||
|
September 30,
2025 |
December 31,
2024
|
|||||||
|
Assets
|
(unaudited)
|
|||||||
|
Cash and cash equivalents
|
$
|
30,402
|
$
|
17,505
|
||||
|
Securities carried at fair value
|
84,204
|
44,825
|
||||||
|
Short-term restricted cash for other investments
|
-
|
10,000
|
||||||
|
Prepaid expenses and other current assets
|
5,896
|
7,795
|
||||||
|
Short-term notes receivable - related party, net
|
10,164
|
-
|
||||||
|
Property and equipment, net
|
3,010
|
2,535
|
||||||
|
Operating lease right-of-use assets, net
|
2,662
|
1,334
|
||||||
|
Other investments held at fair value
|
34,413
|
28,887
|
||||||
|
Other investments
|
53,947
|
42,079
|
||||||
|
Intangible assets, net
|
3,026
|
3,246
|
||||||
|
Goodwill
|
331
|
331
|
||||||
|
Digital assets
|
11,383
|
-
|
||||||
|
Other assets
|
382
|
850
|
||||||
|
Total assets
|
$
|
239,820
|
$
|
159,387
|
||||
|
Liabilities and Stockholders' Equity
|
||||||||
|
Accounts payable
|
$
|
5,370
|
$
|
2,616
|
||||
|
Accrued liabilities
|
10,464
|
9,847
|
||||||
|
Current portion of lease liabilities
|
532
|
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
|
||||||
|
Other current liabilities
|
178
|
2,647
|
||||||
|
Contingent consideration liability - related party
|
110
|
110
|
||||||
|
Contingent consideration liabilities
|
212
|
212
|
||||||
|
Noncurrent portion of lease liabilities
|
2,426
|
732
|
||||||
|
Pre-funded warrant liabilities
|
57,432
|
-
|
||||||
|
Long-term debt, net
|
-
|
14,133
|
||||||
|
Other liabilities
|
3,188
|
2,695
|
||||||
|
Total stockholders’ equity attributable to Atai Beckley N.V. stockholders
|
159,751
|
116,297
|
||||||
|
Noncontrolling interests
|
157
|
257
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
239,820
|
$
|
159,387
|
||||