AI Earnings Predictions for ATAI Life Sciences N.V. (ATAI)

EX-99.1

2 ef20072731_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

AtaiBeckley Reports First Quarter 2026 Financial Results and Provides Program and Business Update

•

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

NEW YORK, UNITED STATES – May 12, 2026 – AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today reported financial results for the first quarter ended March 31, 2026, and provided a business update across its clinical pipeline.

First Quarter 2026 Highlights

•

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.

Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley, said: “Our $209.9 million in cash is expected to provide a runway through our anticipated Phase 3 topline readouts for BPL-003, as we advance toward the late-stage execution phase. Our near-term priority is initiating the Phase 3 ReConnection program for BPL-003 this quarter, while VLS-01 continues to progress toward anticipated Phase 2 topline results later this year. The positive Phase 2a data for EMP-01 further demonstrated its potential in Social Anxiety Disorder. Collectively, our capital position, pipeline breadth, and multiple near- and mid-term clinical catalysts position us well as we seek to build sustained clinical and shareholder value.”

Program Updates

BPL-003: mebufotenin benzoate nasal spray for treatment-resistant depression (TRD)

•

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.

VLS-01: dimethyltryptamine (DMT) buccal film for TRD

•

Elumina Phase 2 study progressing as planned, with topline results anticipated in Q4 2026

EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD)

•

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.

Business Updates

•

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.

Anticipated Upcoming Milestones

•

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

Consolidated Financial Results

Cash, cash equivalents, and short-term securities (primarily US treasuries): As of March 31, 2026, the Company had cash, cash equivalents and short-term securities of $209.9 million compared to $220.7 million as of December 31, 2025. The $10.8 million decrease is primarily attributable to $21.1 million used in operations, partially offset by $9.5 million in proceeds from sale of equity holdings. The Company expects its cash, cash equivalents, short-term in

EX-99.1

2 ef20066741_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

AtaiBeckley Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business and Clinical Update

•

Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression remains on track for Q2 2026 following successful End‑of‑Phase 2 meeting with the U.S. Food and Drug Administration

•

On-track for VLS-01 Phase 2 Elumina trial topline data readout anticipated in H2 2026

•

Exploratory Phase 2a trial of EMP-01 in Social Anxiety Disorder met its primary safety and tolerability objective and demonstrated clinically meaningful improvements across key efficacy measures

•

Cash runway through the planned early-2029 topline readouts from both Phase 3 pivotal studies

•

Virtual Investor Day scheduled for March 6, 2026

NEW YORK, UNITED STATES - MARCH 6, 2026 –

AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today announced fourth quarter and full year 2025 financial results and provided key regulatory, clinical and business updates.

“Following our strategic combination of atai Life Sciences and Beckley Psytech, and U.S. redomiciliation, we have entered a pivotal execution phase,” said Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of AtaiBeckley. “We received constructive feedback from the FDA on the Phase 3 development plan for BPL-003 in treatment-resistant depression, positioning us to initiate our pivotal program in the second quarter of 2026. We also reported positive topline results from our exploratory Phase 2a study of EMP-01 in Social Anxiety Disorder, which met its primary safety objective and demonstrated clinically meaningful improvements across key efficacy measures after just two administrations and without adjunct psychotherapy. With multiple clinical catalysts ahead and capital expected to fund operations into 2029, we believe AtaiBeckley is well positioned to advance a differentiated portfolio of rapid-acting mental health therapies.”

Program Updates and Anticipated Milestones

BPL-003: mebufotenin benzoate nasal spray for TRD

•

In March 2026, the Company announced a successful End‑of‑Phase 2 meeting with the FDA regarding the development of BPL‑003 for treatment‑resistant depression (TRD), a debilitating and chronic condition affecting millions of people around the world but with limited rapid-acting treatment options.

•

The FDA indicated support for advancement into Phase 3 studies in adults with TRD and provided constructive feedback on the overall design and requirements for a potential NDA package for this indication.

•

The Phase 3 program is designed to include two pivotal studies, ReConnection-1 and ReConnection-2, each consisting of a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension (OLE):

o

ReConnection-1:

■

Approximately 350 participants

■

Single-dose of BPL-003 across three treatment arms - 8 mg, 4 mg, and placebo (randomized 2:1:2)

■

Designed to replicate and extend Phase 2b treatment response and further characterize dose–response relationship for BPL-003

o

ReConnection-2:

■

Approximately 300 participants

■

Two-dose design (Day 1 and Day 15) across two arms - 8 mg BPL-003 and placebo (randomized 1:1)

■

Designed to evaluate if a two-dose induction model increases magnitude and durability of initial response

•

The primary endpoint in both pivotal trials will be the change from baseline in the MADRS total score at Week 4.

•

Both trials include a 52-week OLE allowing individualized 8 mg BPL-003 retreatment at 8- or 12-week intervals with the aim of maintaining remission.

•

Phase 3 program initiation remains on track for Q2 2026.

•

Topline data from the core studies of both ReConnection-1 and –2 anticipated by early 2029.

•

First patient dosed in the Part 4 cohort of the open-label Phase 2a study, evaluating a two-dose induction regimen (8 mg + 8 mg) of BPL-003 in TRD patients receiving defined antidepressants. Initial data expected in Q4 2026.

VLS-01: dimethyltryptamine (DMT) buccal film for 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.

•

Phase 2 Elumina study topline data readout is anticipated in H2 2026.

EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD)

•

In February 2026, the Company reported topline results from the exploratory, randomized, double‑blind, placebo‑controlled Phase 2a trial of EMP‑01 in SAD:

o

Key findings:

■

Met primary safety and tolerability objective with a generally favorable and manageable profile

■

Clinically meaningful placebo-adjusted least squares me

false000184090400-000000000018409042025-11-122025-11-12

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): November 12, 2025

Atai Beckley 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.)

Prof. J.H. Bavincklaan 7

1183 AT Amstelveen

The Netherlands

(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)

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)

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 November 12, 2025, Atai Beckley N.V. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2025 and provided corporate and clinical updates. 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

99.1*

Press Release of Atai Beckley N.V., dated November 12, 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 Beckley N.V.

Date:   November 12, 2025

By:

/s/ Srinivas Rao

Name:

Srinivas Rao

Title:

Chief Executive Officer