ATAI Life Sciences Files 8-K Report

TL;DR

ATAI Life Sciences filed an 8-K on Oct 16, 2025. Details pending.

AI Summary

On October 16, 2025, ATAI Life Sciences N.V. filed an 8-K report. The filing primarily concerns Regulation FD Disclosure and Other Events, along with Financial Statements and Exhibits. No specific financial figures or material events were detailed in the provided header information.

Why It Matters

This 8-K filing indicates that ATAI Life Sciences N.V. has made a regulatory disclosure or reported other events, which could contain material information for investors.

Risk Assessment

Risk Level: low — The provided text is a standard 8-K filing header and does not contain specific financial or operational details that would indicate a high-risk event.

Key Players & Entities

• ATAI Life Sciences N.V. (company) — Registrant
• October 16, 2025 (date) — Date of report

FAQ

Filing Documents

• ny20057248x2_8k.htm (8-K) — 36KB
• ny20057248x2_ex99-1.htm (EX-99.1) — 19KB
• ny20057248x2_ex99-1img01.jpg (GRAPHIC) — 26KB
• ny20057248x2_ex99-1img02.jpg (GRAPHIC) — 3KB
• 0001140361-25-038319.txt ( ) — 232KB
• atai-20251016.xsd (EX-101.SCH) — 4KB
• atai-20251016_lab.xml (EX-101.LAB) — 22KB
• atai-20251016_pre.xml (EX-101.PRE) — 16KB
• ny20057248x2_8k_htm.xml (XML) — 4KB

01

Item 7.01. Regulation FD Disclosure On October 16, 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 Announce U.S. FDA Breakthrough Therapy Designation Granted to BPL-003, Underscoring its Potential in 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 (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

01

Item 8.01. Other Events On October 16, 2025, the Company and Beckley Psytech announced that the U.S. Food and Drug Administration (the "FDA") granted Breakthrough Therapy designation ("BTD") to BPL-003 (intranasal mebufotenin benzoate) for adult patients with treatment-resistant depression ("TRD"). BTD is granted to drugs targeting serious or life-threatening conditions where preliminary clinical evidence suggests that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over existing therapies. BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose with a short therapeutic experience. The designation follows positive topline results from Beckley Psytech's Phase 2b core, blinded study of BPL-003 in TRD which showed that a single administration of 8 mg or 12 mg of BPL-003 led to clinically meaningful and statistically significant reductions in depressive symptoms within 24 hours, with effects sustained through the eight-week trial period. Notably, most patients were deemed ready for discharge at the 90-minute post-dose assessment, underscoring the potential scalability of the BPL-003 treatment model and its potential to fit into the established two-hour, in-clinic interventional psychiatry treatment paradigm.

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1* Press Release of ATAI Life Sciences N.V., dated October 16, 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 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 potential benefits of the Breakthrough Therapy Designation; progress on and results of Beckley Psytech's BPL-003 trials, and the timing of development and regulatory review of 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 contemplated acquisition of Beckley Psytech and related transactions (collectively, the "Proposed Transactions") 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 Transactions; (iii) the possibility that any or all of the various conditions to the consummation of the Proposed Transactions may not be satisfied or waived; (iv) the occurrence of any event, change or other circumstance that could give rise to the termination of the share purchase agreement governing the Proposed Transactions; and (v) the effect of the anno

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: October 16, 2025 By: /s/ Srinivas Rao Name: Srinivas Rao Title: Chief Executive Officer

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View this 8-K filing on SEC EDGAR