ATAI Life Sciences Files 8-K Report

TL;DR

ATAI Life Sciences filed an 8-K on 9/23/25 for disclosures and exhibits.

AI Summary

On September 23, 2025, ATAI Life Sciences N.V. filed an 8-K report. The filing indicates that the company is providing information related to Regulation FD disclosures, other events, and financial statements and exhibits. No specific financial figures or new material events were detailed in the provided excerpt.

Why It Matters

This 8-K filing serves as a public disclosure mechanism for ATAI Life Sciences N.V., informing stakeholders about significant company events or regulatory matters.

Risk Assessment

Risk Level: low — The filing is a routine disclosure and does not appear to contain any immediately alarming or negative information.

Key Players & Entities

• ATAI Life Sciences N.V. (company) — Registrant
• September 23, 2025 (date) — Date of report

FAQ

Filing Documents

• ef20055927_8k.htm (8-K) — 44KB
• ef20055927_ex99-1.htm (EX-99.1) — 35KB
• image00005.jpg (GRAPHIC) — 176KB
• image00006.jpg (GRAPHIC) — 3KB
• image00007.jpg (GRAPHIC) — 3KB
• 0001140361-25-035777.txt ( ) — 473KB
• atai-20250923.xsd (EX-101.SCH) — 4KB
• atai-20250923_lab.xml (EX-101.LAB) — 22KB
• atai-20250923_pre.xml (EX-101.PRE) — 16KB
• ef20055927_8k_htm.xml (XML) — 4KB

01

Item 7.01. Regulation FD Disclosure On September 23, 2025, ATAI Life Sciences N.V. (atai or the "Company") and Beckley Psytech Limited ("Beckley Psytech") issued a press titled "atai Life Sciences and Beckley Psytech Report Positive Phase 2a Data Demonstrating Improved Outcomes with a Two-Dose Induction Regimen of BPL-003 in Patients with Treatment-Resistant Depression". A copy of the press release is being furnished to the Securities and Exchange Commission (the "SEC") as Exhibit 99.1 to this Current Report on Form 8-K ("Form 8-K"). The information in this Item 7.01 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.

01

Item 8.01. Other Events On September 23, 2025, the Company and Beckley Psytech publicly announced positive data from a proof-of-concept study investigating a two-dose induction regimen of BPL-003 (intranasal mebufotenin benzoate), in patients with treatment resistant depression (TRD). The open-label Phase 2a study ( NCT05660642 ) enrolled 13 patients with TRD who were not on concurrent antidepressants, and 12 met the criteria for per-protocol analysis. Patients were given an 8 mg dose of BPL-003 followed by a 12 mg dose two weeks later. Safety, tolerability and efficacy assessments were conducted at various timepoints for 12 weeks following the initial dose using multiple validated depression rating scales including the MADRS (Montgomery-Asberg Depression Rating Scale). Key findings include: (1) following the first (8 mg) dose, patients experienced a mean MADRS reduction of 13.3 points from baseline at Day 2 and a mean MADRS reduction of 12.9 at Day 8; one week after the second dose (12 mg), there was a further decrease in MADRS score to a total of a 19.0 point reduction from baseline, with sustained antidepressant effects observed through Week 12 (13.7 points from baseline); (2) the second dose of BPL-003 increased the proportion of patients meeting response and remission criteria for depression; remitter rates one week after the initial 8mg dose were 25%, with rates doubling to 50% at Week 8, 6 weeks after the second dose administration, and 42% at Week 12; (3) BPL-003 was shown to be generally well-tolerated, with all adverse events classified as mild to moderate, and there were no severe or serious drug-related adverse events reported; and (4) patients met discharge readiness criteria within two hours after dosing for both doses, reinforcing the potential for BPL-003 to be integrated into the established interventional psychiatric treatment paradigm. Doses for the study are the same as the active doses used in the core, blinded stage of Beckley Psytech's Phas

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1* Press Release of ATAI Life Sciences N.V., dated September 23, 2025. 104 Cover Page Interactive Data File (embedded within the inline XBRL document). * Furnished herewith

Forward-looking Statements

Forward-looking Statements This Current Report on Form 8-K 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, 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: expectations regarding the closing of the acquisition of Beckley Psytech Limited (the "Proposed Transactions"), including timing and approvals; progress on and results of Beckley Psytech's BPL-003 trials and related data readouts, including Phase 2a data, the expected timing of Phase 2b data, and the timing of regulatory discussions with respect to Phase 3 trial design for BPL-003; and the potential benefits of BPL-003 for patients with TRD. 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, (i) the Proposed Transaction may not be completed in a timely manner or at all, including the risk that any required shareholder approvals are not obtained; (ii) the failure to realize the anticipated benefits of the Proposed Transaction; (iii) the possibility that any or all of the various conditions to the consummation of the Proposed Transaction may not be satisfied or waived; (iv) the occurrence of any event, change or other circumstance that cou

SIGNATURES

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: September 23, 2025 By: /s/ Srinivas Rao Name: Srinivas Rao Title: Chief Executive Officer

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