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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))
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|
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 Global Market)
|
| Item 2.02. |
Results of Operations and Financial Condition.
|
| Item 9.01. |
Financial Statements and Exhibits.
|
|
Exhibit
No.
|
Description
|
|
|
Press Release of ATAI Life Sciences N.V., dated May 14, 2025.
|
||
|
104
|
Cover Page Interactive Data File (embedded within the inline XBRL document).
|
|
|
*
|
Furnished herewith
|
|
|
ATAI LIFE SCIENCES N.V.
|
||
|
Date: May 14, 2025
|
By:
|
/s/ Srinivas Rao
|
|
Name:
|
Srinivas Rao
|
|
|
Title:
|
Chief Executive Officer
|
|
|
|
• |
Anticipate topline data midyear from the Phase 2b clinical trial of BPL-003 in patients with treatment-resistant depression (TRD) - the largest controlled trial of mebufotenin and
the first and only such trial to investigate mebufotenin in the U.S.
|
|
|
• |
Dosed the first patient in the exploratory Phase 2 study of EMP-01 (oral R-MDMA) for the treatment of social anxiety; topline data anticipated in Q1’26
|
|
|
• |
Continued enrollment in Elumina, a Phase 2 study of VLS-01 (buccal film DMT) in patients with TRD; topline data are anticipated in Q1’26
|
|
|
• |
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.
|
|
|
• |
Continued to enroll patients 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 ~142 patients with
TRD. Topline data are anticipated in the first quarter of 2026.
|
|
|
• |
Presented data from the Phase 1 study of VLS-01 at the Society of Biological Psychiatry (SOBP) annual meeting.
|
|
|
• |
EMP-01 is an oral formulation of R-MDMA that demonstrated unique, dose-dependent subjective effects in a Phase 1 trial that was generally found to be more similar to classical
psychedelics than to racemic MDMA.
|
|
|
• |
Dosed the first patient in the exploratory, randomized, double-blind, placebo-controlled Phase 2 study of EMP-01 to assess the safety, tolerability and efficacy in ~60 adults with SAD. Topline data
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.
|
|
|
• |
Beckley Psytech remains on track to report topline results in mid-year 2025 from the eight-week core phase of the randomized, quadruple-masked, global Phase 2b clinical study of BPL-003 in 196
patients with TRD.
|
|
|
• |
Beckley Psytech also remains on track to report topline data from Part 2 of its Phase 2a study of BPL-003 in combination with selective serotonin reuptake inhibitors (SSRIs) for TRD in the second
quarter of 2025.
|
|
|
• |
Beckley Psytech presented data from Part 1 of its open-label Phase 2a trial in patients with TRD at SOBP 2025.
|
|
|
• |
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.
|
|
|
• |
Presented a poster on the Identification of Lead 5-HT2A Receptor Agonists for use in Treatment Resistant Depression with Non-hallucinogenic Potential and Low Valvulopathy Liability at the International Festival of Neuroscience BNA 2025.
|
|
|
• |
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 remains on track to report topline data in mid-2025 from the Phase 2b proof-of-concept study of RL-007 in 234 patients living with CIAS.
|
|
|
• |
Recognify Life Sciences presented RL-007 preclinical data at SOBP 2025.
|
|
|
• |
On May 2, 2025, the Company repaid in full the outstanding indebtedness of $21.8 million and terminated all commitments and obligations under the Hercules Loan Agreement. The early prepayment saved
atai approximately $2.1 million of interest otherwise due under the full amortization payment schedule.
|
|
Three Months Ended
March 31,
|
||||||||
|
2025
|
2024
|
|||||||
|
(unaudited)
|
||||||||
|
Revenue
|
$
|
1,555
|
$
|
—
|
||||
|
Operating expenses:
|
||||||||
|
Research and development
|
11,328
|
11,530
|
||||||
|
General and administrative
|
10,597
|
12,555
|
||||||
|
Total operating expenses
|
21,925
|
24,085
|
||||||
|
Loss from operations
|
(20,370
|
)
|
(24,085
|
)
|
||||
|
Other expense, net
|
(5,939
|
)
|
(1,596
|
)
|
||||
|
Net loss before income taxes
|
(26,309
|
)
|
(25,681
|
)
|
||||
|
Benefit from (provision for) income taxes
|
(156
|
)
|
4
|
|||||
|
Losses from investments in equity method investees, net of tax
|
—
|
(1,701
|
)
|
|||||
|
Net loss
|
(26,465
|
)
|
(27,378
|
)
|
||||
|
Net loss attributable to noncontrolling interests
|
(34
|
)
|
(665
|
)
|
||||
|
Net loss attributable to ATAI Life Sciences N.V. stockholders
|
$
|
(26,431
|
)
|
$
|
(26,713
|
)
|
||
|
Net loss per share attributable to ATAI Life Sciences N.V. stockholders — basic and diluted
|
$
|
(0.15
|
)
|
$
|
(0.17
|
)
|
||
|
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic
and diluted
|
176,271,176
|
158,891,067
|
||||||
|
March 31,
2025 |
December 31,
2024 |
|||||||
|
(unaudited)
|
||||||||
|
Assets
|
||||||||
|
Cash and cash equivalents
|
$
|
48,287
|
$
|
17,505
|
||||
|
Securities carried at fair value
|
49,917
|
44,825
|
||||||
|
Short-term restricted cash for other investments
|
10,000
|
10,000
|
||||||
|
Prepaid expenses and other current assets
|
7,774
|
7,795
|
||||||
|
Property and equipment, net
|
2,682
|
2,535
|
||||||
|
Operating lease right-of-use assets, net
|
2,905
|
1,334
|
||||||
|
Other investments held at fair value
|
23,053
|
28,887
|
||||||
|
Other investments
|
42,079
|
42,079
|
||||||
|
Intangible assets, net
|
3,157
|
3,246
|
||||||
|
Goodwill
|
331
|
331
|
||||||
|
Digital assets
|
4,788
|
-
|
||||||
|
Other assets
|
810
|
850
|
||||||
|
Total assets
|
$
|
195,783
|
$
|
159,387
|
||||
|
Liabilities and Stockholders' Equity
|
||||||||
|
Accounts payable
|
$
|
2,705
|
$
|
2,616
|
||||
|
Accrued liabilities
|
8,680
|
9,847
|
||||||
|
Current portion of lease liabilities
|
287
|
477
|
||||||
|
Short-term convertible promissory notes and derivative liability - related party
|
1,205
|
1,150
|
||||||
|
Short-term convertible promissory notes and derivative liability
|
1,923
|
1,840
|
||||||
|
Current portion of long-term debt
|
11,366
|
6,374
|
||||||
|
Other current liabilities
|
2,335
|
2,647
|
||||||
|
Contingent consideration liabilities - related parties
|
110
|
110
|
||||||
|
Contingent consideration liabilities
|
212
|
212
|
||||||
|
Noncurrent portion of lease liabilities
|
2,587
|
732
|
||||||
|
Long-term debt, net
|
9,300
|
14,133
|
||||||
|
Other liabilities
|
2,799
|
2,695
|
||||||
|
Total stockholders' equity attributable to ATAI Life Sciences N.V. stockholders
|
152,053
|
116,297
|
||||||
|
Noncontrolling interests
|
221
|
257
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
195,783
|
$
|
159,387
|
||||