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(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
|
Trading
Symbol(s)
|
Name of each exchange
on which registered
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||
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|
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(Nasdaq Global Market)
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| Item 2.02. |
Results of Operations and Financial Condition.
|
| Item 9.01. |
Financial Statements and Exhibits.
|
| (d) |
Exhibits
|
|
Exhibit
No.
|
Description
|
|
|
Press Release of AtaiBeckley Inc., dated May 12, 2026.
|
||
|
104
|
Cover Page Interactive Data File (embedded within the inline XBRL document).
|
|
|
*
|
Furnished herewith
|
| ATAIBECKLEY INC. | ||
|
Date: May 12, 2026
|
By: | /s/ Srinivas Rao |
| Name: |
Srinivas Rao
|
|
| Title: |
Chief Executive Officer
|
|
| • |
Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression on track for Q2 2026
|
| • |
VLS-01 Phase 2 Elumina topline results anticipated in Q4 2026
|
| • |
Consistent, convergent improvements demonstrated in EMP-01 Phase 2a trial across independent clinician-rated and patient-reported outcomes in Social Anxiety Disorder
|
| • |
Cash and cash equivalents expected to fund operations through anticipated BPL-003 Phase 3 topline readouts, with runway into 2029
|
| • |
BPL-003 (TRD): Phase 3 pivotal ReConnection program on track to initiate in Q2 2026.
|
| • |
VLS-01 (TRD): Elumina Phase 2 topline results anticipated in Q4 2026.
|
| • |
EMP-01 (SAD): Phase 2a data provided validation of EMP-01’s potential in Social Anxiety Disorder.
|
| • |
Corporate: Inclusion during Q1 2026 in the S&P Biotechnology Select Industry Index and CRSP U.S. indices, which are tracked by a
broad range of institutional and passive investor exposure.
|
| • |
Cash position: Cash and cash equivalents as of March 31, 2026 expected to fund operations through anticipated BPL-003 Phase 3 topline readouts, with runway into 2029.
|
| • |
On track to initiate Phase 3 program in Q2 2026, following a successful End-of-Phase 2 meeting with the FDA and incorporating regulatory
feedback into a registrational Phase 3 design.
|
| • |
Phase 3 program consists of two pivotal studies:
|
| o |
ReConnection‑1 (~350 patients)
|
| o |
ReConnection‑2 (~230 patients)
|
| • |
Primary endpoint: change from baseline in MADRS total score at Week 4.
|
| • |
Both studies include a 52‑week open‑label extension (OLE), allowing individualized 8mg
BPL-003 retreatment at 8-week or 12-week intervals with the aim of maintaining remission and evaluating durability and longer‑term safety.
|
| • |
Phase 2a Part 4 (two‑dose induction + SSRIs) cohort initial data on track for Q4 2026.
|
| • |
Elumina Phase 2 study progressing as planned, with topline results anticipated in Q4 2026
|
| • |
Phase 2a results demonstrated clinically meaningful and consistent improvements across clinician-rated symptoms, patient-reported experience,
and real-world behavioral outcomes, providing further evidence of EMP-01’s therapeutic potential in SAD.
|
| • |
Index inclusions: During the first quarter of 2026, AtaiBeckley was added to the S&P Biotechnology Select Industry Index and multiple CRSP U.S.
equity indices, expanding eligibility for index‑tracking and passive investment vehicles.
|
| • |
In February 2026, AtaiBeckley appointed Michael Faerm as Chief Financial Officer, effective March 9, 2026, bringing more than 25 years
of life sciences and capital markets experience, to lead the Company’s financial strategy as BPL-003 advances toward Phase 3.
|
| • |
Q2 2026: Initiation of BPL-003 Phase 3 ReConnection program
|
| • |
Q4 2026: VLS-01 Elumina Phase 2 topline results
|
| • |
Q4 2026: BPL-003 Phase 2a Part 4 initial data
|
| • |
Early 2029: BPL-003 Phase 3 topline readouts
|
|
Three Months Ended
|
||||||||
|
March 31,
|
||||||||
|
2026
|
2025
|
|||||||
|
(unaudited)
|
||||||||
|
Revenue
|
$
|
954
|
$
|
1,555
|
||||
|
Operating expenses:
|
||||||||
|
Research and development
|
17,414
|
11,328
|
||||||
|
General and administrative
|
14,441
|
10,597
|
||||||
|
Total operating expenses
|
31,855
|
21,925
|
||||||
|
Loss from operations
|
(30,901
|
)
|
(20,370
|
)
|
||||
|
Other income (expense), net
|
1,119
|
(5,939
|
)
|
|||||
|
Net loss before income taxes
|
(29,782
|
)
|
(26,309
|
)
|
||||
|
Provision for income taxes
|
(20
|
)
|
(156
|
)
|
||||
|
Net loss
|
(29,802
|
)
|
(26,465
|
)
|
||||
|
Net loss attributable to noncontrolling interests
|
(20
|
)
|
(34
|
)
|
||||
|
Net loss attributable to AtaiBeckley Inc. stockholders
|
$
|
(29,782
|
)
|
$
|
(26,431
|
)
|
||
|
Net loss per share attributable to AtaiBeckley Inc. stockholders — basic and diluted
|
$
|
(0.08
|
)
|
$
|
(0.15
|
)
|
||
|
Weighted average shares of common stock outstanding attributable to AtaiBeckley Inc. stockholders — basic and
diluted
|
357,421,528
|
176,271,176
|
||||||
|
March 31,
|
December 31,
|
|||||||
|
|
2026
|
2025
|
||||||
|
Assets
|
(unaudited)
|
|||||||
|
Cash and cash equivalents
|
$
|
43,102
|
$
|
85,300
|
||||
|
Securities carried at fair value
|
166,756
|
135,351
|
||||||
|
Other current investments held at fair value
|
20,909
|
35,389
|
||||||
|
Prepaid expenses and other current assets
|
19,299
|
19,644
|
||||||
|
Property and equipment, net
|
2,086
|
2,166
|
||||||
|
Operating lease right-of-use assets, net
|
1,774
|
1,846
|
||||||
|
Intangible assets, net
|
2,763
|
2,851
|
||||||
|
Goodwill
|
331
|
331
|
||||||
|
Digital assets
|
6,765
|
8,735
|
||||||
|
Other assets
|
1,092
|
1,110
|
||||||
|
Total assets
|
$
|
264,877
|
$
|
292,723
|
||||
|
Liabilities and Stockholders’ Equity
|
||||||||
|
Accounts payable
|
$
|
10,785
|
$
|
4,906
|
||||
|
Accrued liabilities
|
9,847
|
14,168
|
||||||
|
Current portion of lease liabilities
|
310
|
271
|
||||||
|
Deferred revenue
|
1,480
|
1,524
|
||||||
|
Other current liabilities
|
2,542
|
2,610
|
||||||
|
Contingent consideration liability - related party
|
104
|
104
|
||||||
|
Contingent consideration liabilities
|
205
|
205
|
||||||
|
Noncurrent portion of lease liabilities
|
1,690
|
1,801
|
||||||
|
Pre-funded warrant liabilities
|
38,397
|
44,379
|
||||||
|
Other liabilities
|
738
|
754
|
||||||
|
Total stockholders’ equity attributable to AtaiBeckley Inc. stockholders
|
198,683
|
221,874
|
||||||
|
Noncontrolling interests
|
96
|
127
|
||||||
|
Total liabilities and stockholders’ equity
|
$
|
264,877
|
$
|
292,723
|
||||