The Netherlands | 001-40493 |
Not Applicable |
(State or other jurisdiction of incorporation or organization)
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(Commission File Number) |
(I.R.S. Employer Identification No.)
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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||
Common shares, €0.10 par value per share
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ATAI
|
The Nasdaq Stock Market LLC
(Nasdaq Global Market)
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Item 2.02. |
Results of Operations and Financial Condition.
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Item 9.01. |
Financial Statements and Exhibits.
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Exhibit
No.
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Description
|
|
Press Release of ATAI Life Sciences N.V., dated March 17, 2025.
|
||
104
|
Cover Page Interactive Data File (embedded within the inline XBRL document).
|
*
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Furnished herewith
|
ATAI LIFE SCIENCES N.V.
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||
Date: March 17, 2025
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By:
|
/s/ Srinivas Rao
|
Name:
|
Srinivas Rao
|
|
Title:
|
Chief Executive Officer
|
-
|
Dosed the first patient in the Phase 2 Elumina trial of VLS-01 (buccal film DMT) for patients with treatment-resistant depression; topline data anticipated in Q1’26
|
-
|
Initiated a Phase 2 clinical trial of EMP-01 (oral R-MDMA) for patients with social anxiety; topline data anticipated in Q1’26
|
-
|
Beckley Psytech completed enrollment in the Phase 2b study of BPL-003 (mebufotenin benzoate) in patients with treatment-resistant depression; topline
data anticipated in mid-25
|
-
|
Completed an equity offering with net proceeds of $59.2 million extending operational runway into 2027
|
|
• |
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.
|
|
• |
Dosed first patient in Elumina, a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of repeated doses of VLS-01 in patients with TRD.
|
|
• |
Topline data from the Phase 2 Elumina trial of VLS-01 are anticipated in the first quarter of 2026.
|
|
• |
EMP-01 is an oral formulation of R-MDMA that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to
classical psychedelics than to racemic MDMA.
|
|
• |
Initiated a Phase 2 exploratory, randomized, double-blind, placebo-controlled trial to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD.
|
|
• |
Topline data from the Phase 2 study of EMP-01 are anticipated in the first quarter of 2026.
|
|
• |
BPL-003 is an intranasal transmucosal formulation of mebufotenin benzoate designed to fit within the established two-hour interventional psychiatry treatment paradigm.
|
|
• |
In March 2025, Beckley Psytech completed patient enrollment in its eight-week, core, randomized, quadruple-masked, global Phase 2b study of BPL-003 in 196 patients with
TRD. Topline results from the core phase of the study are expected in mid-2025.
|
|
• |
In January 2025, Beckley Psytech announced positive topline data from its open-label Phase 2a study of BPL-003 in 12 patients with moderate-to-severe AUD. Initial data
demonstrated that a single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months and was
well-tolerated with no serious adverse events reported.
|
|
• |
RL-007 is an orally bioavailable compound that has demonstrated pro-cognitive effects in multiple pre-clinical and clinical studies, including two Phase 1 and two Phase 2
trials.
|
|
• |
Recognify Life Sciences is running a Phase 2b proof-of-concept study in 234 patients living with CIAS. Topline results are expected in mid-2025.
|
Three Months Ended
|
Twelve Months Ended
|
|||||||||||||||
December 31,
|
December 31,
|
|||||||||||||||
2024
|
2023
|
2024
|
2023
|
|||||||||||||
(unaudited)
|
||||||||||||||||
License revenue
|
$
|
(5
|
)
|
$
|
18
|
$
|
308
|
$
|
314
|
|||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
18,942
|
14,156
|
55,455
|
62,203
|
||||||||||||
General and administrative
|
11,318
|
19,423
|
47,544
|
63,582
|
||||||||||||
Total operating expenses
|
30,260
|
33,579
|
102,999
|
125,785
|
||||||||||||
Loss from operations
|
(30,265
|
)
|
(33,561
|
)
|
(102,691
|
)
|
(125,471
|
)
|
||||||||
Other income (expense), net
|
(8,919
|
)
|
15,241
|
(45,714
|
)
|
86,185
|
||||||||||
Net loss before income taxes
|
(39,184
|
)
|
(18,320
|
)
|
(148,405
|
)
|
(39,286
|
)
|
||||||||
Benefit from (provision for) income taxes
|
193
|
(428
|
)
|
356
|
(1,016
|
)
|
||||||||||
Losses from investments in equity method investees, net of tax
|
—
|
(394
|
)
|
(2,000
|
)
|
(3,593
|
)
|
|||||||||
Net loss
|
(38,991
|
)
|
(19,142
|
)
|
(150,049
|
)
|
(43,895
|
)
|
||||||||
Net loss attributable to noncontrolling interests
|
(33
|
)
|
(850
|
)
|
(780
|
)
|
(3,671
|
)
|
||||||||
Net loss attributable to ATAI Life Sciences N.V. stockholders
|
$
|
(38,958
|
)
|
$
|
(18,292
|
)
|
$
|
(149,269
|
)
|
$
|
(40,224
|
)
|
||||
Net loss per share attributable to ATAI Life Sciences N.V. stockholders — basic and diluted
|
$
|
(0.24
|
)
|
$
|
(0.12
|
)
|
$
|
(0.93
|
)
|
$
|
(0.25
|
)
|
||||
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic
and diluted
|
160,711,543
|
158,842,995
|
160,159,983
|
158,833,785
|
December 31,
|
December 31,
|
|||||||
2024
|
2023
|
|||||||
Assets
|
||||||||
Cash and cash equivalents
|
$
|
17,505
|
$
|
45,034
|
||||
Securities carried at fair value
|
44,825
|
109,223
|
||||||
Short-term restricted cash for other investments
|
10,000
|
-
|
||||||
Committed investment funds
|
-
|
25,000
|
||||||
Prepaid expenses and other current assets
|
7,795
|
5,830
|
||||||
Short-term notes receivable - related party, net
|
-
|
505
|
||||||
Property and equipment, net
|
2,535
|
981
|
||||||
Operating lease right-of-use assets, net
|
1,334
|
1,223
|
||||||
Other investments held at fair value
|
28,887
|
89,825
|
||||||
Other investments
|
42,079
|
1,838
|
||||||
Intangible assets, net
|
3,246
|
1,772
|
||||||
Goodwill
|
331
|
-
|
||||||
Long-term notes receivable - related party, net
|
-
|
97
|
||||||
Convertible notes receivable - related party
|
-
|
11,202
|
||||||
Other assets
|
850
|
948
|
||||||
Total assets
|
$
|
159,387
|
$
|
293,478
|
||||
Liabilities and Stockholders' Equity
|
||||||||
Accounts payable
|
$ |
2,616
|
$ |
4,589
|
||||
Accrued liabilities
|
9,847
|
15,256
|
||||||
Current portion of lease liabilities
|
477
|
275
|
||||||
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
|
2,647
|
-
|
||||||
Contingent consideration liability - related party
|
110
|
620
|
||||||
Contingent consideration liabilities
|
212
|
1,637
|
||||||
Noncurrent portion of lease liabilities
|
732
|
990
|
||||||
Convertible promissory notes and derivative liability - related party
|
-
|
164
|
||||||
Convertible promissory notes and derivative liability
|
-
|
2,666
|
||||||
Long-term debt, net
|
14,133
|
15,047
|
||||||
Other liabilities
|
2,695
|
7,918
|
||||||
Total stockholders' equity attributable to ATAI Life Sciences N.V. stockholders
|
116,297
|
242,962
|
||||||
Noncontrolling interests
|
257
|
1,354
|
||||||
Total liabilities and stockholders' equity
|
$
|
159,387
|
$
|
293,478
|