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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



FORM 8-K


CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 17, 2025



ATAI LIFE SCIENCES N.V.
(Exact name of registrant as specified in its charter)



The Netherlands 001-40493
Not Applicable
(State or other jurisdiction of incorporation or organization)
(Commission File Number)
(I.R.S. Employer Identification No.)

Wallstraße 16
10179 Berlin, Germany
(Address of principal executive offices) (Zip Code)

+49 89 2153 9035
(Registrant’s telephone number, including area code)

N/A
(Former Name or Former Address, if Changed Since Last Report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


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))

Securities registered pursuant to Section 12(b) of the Act

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)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐



Item 2.02.
Results of Operations and Financial Condition.
 
On March 17, 2025, ATAI Life Sciences N.V. (the “Company”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2024 and provided a corporate and clinical update. A copy of the press release is being furnished to the Securities and Exchange Commission as Exhibit 99.1 to this Current Report on Form 8-K (“Form 8-K”).
 
The information in this Item 2.02 of this Form 8-K (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01.
Financial Statements and Exhibits.
 
(d) Exhibits

Exhibit
No.
 
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).

*
Furnished herewith


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
ATAI LIFE SCIENCES N.V.
Date:   March 17, 2025
By:
/s/ Srinivas Rao
 
Name: 
Srinivas Rao
 
Title:
Chief Executive Officer



EX-99.1 2 ef20045600_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1


atai Life Sciences Reports Fourth Quarter and Full Year 2024 Financial Results
and Recent Corporate Highlights

-
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

NEW YORK and BERLIN, March 17, 2025 – atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, today announced fourth quarter and full year 2024 financial results and provided corporate updates.

“We are beginning the year in a strong financial position, thanks to the recent capital raise, which extends our runway into 2027, beyond when we expect the topline data readouts from the Phase 2 clinical trials of our two core programs, VLS-01 and EMP-01, in Q1’26” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai. “Our team is focused on executing these trials rigorously and efficiently to drive forward our mission to transform patient outcomes in mental health. We also look forward to several key milestones this year, notably Beckley Psytech’s BPL-003 Phase 2b topline results in patients with treatment-resistant depression as well as RL-007 in patients with cognitive impairment associated with schizophrenia, both expected mid-2025.”

Recent Clinical Highlights and Upcoming Milestones
VLS-01: N,N-dimethyltryptamine (DMT) for treatment-resistant depression (TRD)

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: R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD)

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: 5-Methoxy N,N-dimethyltryptamine (mebufotenin) benzoate for TRD and alcohol use disorder (AUD) (strategic investment in Beckley Psytech)

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: Pro-cognitive neuromodulator for cognitive impairment associated with schizophrenia (CIAS) (strategic investment in Recognify Life Sciences)

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.

Consolidated Financial Results
Cash, cash equivalents, and short-term securities: As of December 31, 2024, the Company had cash, cash equivalents, restricted cash and short-term securities of $72.3 million compared to $154.2 million as of December 31, 2023. The decrease of $81.9 million was primarily driven by $82.4 million net cash used in operating activities, $15.0 million for the Beckley Psytech investment, and $7.7 million of additional investments to advance our programs; partially offset by $16.1 million in proceeds from the partial sale of our ADS holdings in Compass Pathways, and $5.0 million in proceeds from our committed term loan with Hercules Capital, Inc. In February 2025, the Company completed an equity offering with net proceeds of $59.2 million and now expects its cash, short-term securities, and public equity holdings to be sufficient to fund operations into 2027.

Research and development (R&D) expenses: R&D expenses were $18.9 million and $55.5 million for the three and twelve months ended December 31, 2024, respectively, as compared to $14.2 million and $62.2 million for the comparable prior year periods. The year-over-year full-year decrease of $6.7 million was primarily attributable to a $5.5 million decrease in R&D personnel-related expenses and a $1.4 million decrease in program-specific expenses. The overall decrease in program-specific spend relates to the wind-down of certain programs, offset by the increase in on-going clinical trials and our non-hallucinogenic discovery program. The Company is anticipating R&D spend to increase as its R&D programs progress into later stage clinical trials.





General and administrative (G&A) expenses: G&A expenses for the three and twelve months ended December 31, 2024 were $11.3 million and $47.5 million, respectively, as compared to $19.4 million and $63.6 million for the comparable prior year periods. The year-over-year full-year decrease of $16.0 million was primarily attributable to a $16.2 million decrease in personnel-related expenses and professional services. The Company expects the reduction in G&A spend over prior years to continue.

Net income (loss): Net loss attributable to shareholders for the three and twelve months ended December 31, 2024 was $39.0 million and $149.3 million, respectively, as compared to $18.3 million and $40.2 million for the comparable prior year periods. Net loss attributable to shareholders for the twelve months ended December 31, 2024 includes $48.9 million of non-cash decrease in fair value of assets and liabilities, net and $25.5 million of non-cash share-based compensation. Net loss attributable to shareholders for the twelve months ended December 31, 2023 includes $86.6 million of non-cash increase in fair value of assets and liabilities, net, of which $69.0 million relates to a one-time accounting change, and $33.0 million of non-cash share-based compensation.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes. Our pipeline of psychedelic-based therapies includes VLS-01 (buccal film DMT) for treatment-resistant depression (TRD) and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. We are also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD. These programs aim to address the complex nature of mental health providing commercially scalable interventional psychology therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about our mission, visit www.atai.com or follow us on LinkedIn.

Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans;  the potential, success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; expectations regarding our strategic investment in Beckley Psytech and other investments; expectations regarding our cash runway; and the plans and objectives of management for future operations, research and development and capital expenditures.





Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in atai's other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information
Investor Contact:
IR@atai.com

Media Contact:
PR@atai.com


-- Financial Statements Attached --





ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)

   
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
 





ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)

   
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