ATAI Life Sciences N.V. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

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SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): October 16, 2025

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ATAI LIFE SCIENCES N.V.

(Exact name of registrant as specified in its charter)

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(Address of principal executive offices) (Zip Code)

+31 20 793 2536

(Registrant’s telephone number, including area code)

N/A

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

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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:

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

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. ☐

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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.

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.

(d) Exhibits

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 announcement or pendency of the Proposed Transactions on atai’s ability to retain and hire key personnel, or its operating results and business generally and other 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”) and our Proxy Statement on Schedule 14A (the “Proxy Statement”) that was filed with the SEC on September 24, 2025, in each case, 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 herein, other than to the extent required by applicable law.

Additional Information and Where to Find It

This Current Report on Form 8-K is being made in respect of the Proposed Transactions. This communication is not a substitute for the Proxy Statement or any other document which the Company has or may file with the SEC. INVESTORS ARE URGED TO READ IN THEIR ENTIRETY THE PROXY STATEMENT REGARDING THE PROPOSED TRANSACTIONS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE THEY CONTAIN IMPORTANT INFORMATION.

A free copy of the Proxy Statement, as well as other filings containing information about the Company, may be obtained at the SEC’s website (http://www.sec.gov).

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.

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