Methylenedioxymetamfetamine

AtaiBeckley solidifies position as a global leader in transformative mental health therapies with a short psychedelic durationBPL-003 (mebufotenin benzoate nasal spray) granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for treatment-resistant depression (TRD) Reported positive topline data from the Phase 2b open-label extension (OLE) study of BPL-003 showing the potential added and sustained antidepressant effects following a second dose in patients with TRD Reported positive open-label Phase 2a data demonstrating improved outcomes with a two-dose induction regimen of BPL-003 in patients with TRDAn End-of-Phase 2 meeting is scheduled with the FDA for BPL-003, anticipate providing guidance on the Phase 3 clinical program in the first quarter of 2026Completed enrollment in the exploratory Phase 2a trial of EMP-01 (oral R-MDMA) for patients with social anxiety disorder (SAD)Awarded a grant by the National Institute on Drug Abuse (NIDA) to fund the optimization and early-stage development of novel 5-HT2A/2C receptor agonists with non-hallucinogenic potential for opioid use disorderClosed an approximate $150 million public offering and expect cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029, through anticipated topline data from the first Phase 3 trial of BPL-003 NEW YORK and AMSTERDAM, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Atai Beckley N.V. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today announced third quarter 2025 financial results and provided corporate updates. “This has been a transformational quarter, highlighted by the establishment of AtaiBeckley, which solidifies our position as a global leader in developing transformative mental health therapies with short psychedelic duration,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai. “The FDA’s Breakthrough Therapy designation for BPL-003 represents a major milestone, reinforcing its potential to address the significant unmet need in treatment-resistant depression. Alongside positive Phase 2a and Phase 2b data for BPL-003, we believe we are well positioned to advance BPL-003 into pivotal development pending discussions with the FDA at the upcoming End of Phase 2 Meeting. Beyond BPL-003, we advanced our pipeline by completing enrollment in the Phase 2a study of EMP-01 for social anxiety disorder, expanding clinical trial sites for VLS-01 and securing a NIDA grant to support innovation of 5-HT2A/2C receptor agonists for opioid use disorder. Supported by our recent financing, we remain steadfast in our mission to redefine mental health treatment for patients in need." “The progress this quarter marks a defining moment for atai,” commented Christian Angermayer, Founder and Chairman of atai. “With the creation of AtaiBeckley, the Breakthrough Therapy designation for BPL-003, and a strengthened balance sheet, we are demonstrating the commercial scalability and scientific leadership needed to transform the mental health treatment landscape. Our strategy has been delivering by advancing multiple programs, expanding our innovation engine through grants, and maintaining financial discipline with funding secured well beyond our next major value inflection points. I’m incredibly proud of the team’s execution and remain confident that we are building one of the most impactful mental health companies in the world.” Recent Clinical Highlights and Upcoming MilestonesBPL-003: Mebufotenin (5-MeO-DMT) benzoate nasal spray for treatment-resistant depression (TRD) and alcohol use disorder BPL-003 granted Breakthrough Therapy designation by the FDA, recognizing the potential of BPL-003 to deliver substantial improvement over existing therapies for patients with TRD.Reported positive topline results from the eight-week OLE study of the randomized, quadruple-masked, global Phase 2b clinical trial of BPL-003 in patients with TRD demonstrating that a 12 mg dose of BPL-003, administered eight weeks after an initial dose, was generally well-tolerated, and produced additional clinically meaningful antidepressant effects, which were sustained for up to two months.Reported positive open-label Phase 2a data demonstrating improved antidepressant effects with a two-dose induction regimen of BPL-003 in patients with TRD.Scheduled an End-of-Phase 2 meeting with the FDA to align on clinical trial designs and other aspects of the Phase 3 development program.Anticipate providing guidance on the BPL-003 Phase 3 clinical program in the first quarter 2026 with Phase 3 trial initiation in the second quarter of 2026, pending the outcome of the FDA meeting. VLS-01: Buccal film dimethyltryptamine (DMT) for TRD Continued enrollment in the US and expanded clinical sites into Australia and the United Kingdom for Elumina, the Phase 2, multicenter, double-blind, randomized, placebo-controlled trial of repeated doses of VLS-01 in patients with TRD.Anticipate topline data from Elumina in the second half of 2026. EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD) Completed patient enrollment in the exploratory, randomized, double-blind, placebo-controlled Phase 2a study of EMP-01 to assess the safety, tolerability and efficacy in approximately 70 adults with SAD.Anticipate topline results from the exploratory Phase 2a study in the first quarter of 2026. Novel 5-HT2A Receptor Agonists (including the discovery of non-hallucinogenic neuroplastogens) Novel 5-HT2A receptor agonists were discovered that maintain non-hallucinogenic potential based on their inability to fully-substitute for a traditional psychedelic in rodent drug discrimination studies. These differentiated 5-HT2A receptor agonists are being further optimized and studied in a series of animal models to assess therapeutic potential.Awarded a multi-year, milestone-driven grant worth up to $11.4 million by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to fund the optimization and early-stage development of novel 5-HT2A/2C receptor agonists with non-hallucinogenic potential for opioid use disorder (OUD). Corporate Updates Completed the strategic combination between atai Life Science N.V. and Beckley Psytech Limited, creating AtaiBeckley, a global leader in transformative mental health therapies.atai Life Sciences shareholders ratified the move of the AtaiBeckley corporate domiciliation to the U.S., assuming satisfaction of applicable closing conditions, the corporate redomiciliation is expected around year end 2025.Appointed Board Member, Scott Braunstein, M.D., as Vice Chairman and Lead Independent Director. Dr. Braunstein is Chair of AtaiBeckley’s Scientific and Technology Committee and a member of the Audit Committee. Dr. Braunstein brings extensive leadership experience as well as strategic expertise across the biopharmaceutical industry, spanning clinical development, operations, and capital markets.In October, the Company closed a public offering of common shares. Aggregate gross proceeds from the offering, including the exercise of the underwriters’ option to purchase additional shares, were approximately $150 million, before deducting underwriting discounts and commissions and other offering expenses payable by atai. Consolidated Financial ResultsCash, cash equivalents, and short-term securities: As of September 30, 2025, the Company had cash, cash equivalents and short-term securities of $114.6 million compared to $72.3 million of cash, cash equivalents, restricted cash and short-term securities as of December 31, 2024. The $42.3 million increase is primarily attributable to $148.8 million in net proceeds from equity related issuances and $3.9 million in proceeds from sale of equity holdings, partially offset by $55.2 million used in operations, $21.8 million payoff of Hercules debt facility, $20.0 million in payments relating to the Beckley investment, and $10.0 million investment in digital assets. Including the proceeds from the October public offering, the Company expects its cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029. Research and development (R&D) expenses: R&D expenses were $14.7 million for the three months ended September 30, 2025, as compared to $12.4 million for the same prior year period. The year-over-year increase of $2.3 million is primarily attributable to higher costs associated with its clinical programs, partially offset by decreases in personnel-related expenses and consulting services. General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2025 were $14.5 million as compared to $10.3 million in the same prior year period. The year-over-year increase of $4.2 million is largely attributable to increased legal and professional service expenses in connection with the Beckley Psytech strategic combination and the process to move its corporate domicile to the U.S., partially offset by decreases in personnel-related expenses. Net loss: Net loss attributable to stockholders for the three months ended September 30, 2025 was $61.1 million, as compared to $26.3 million for the three months ended September 30, 2024. The net loss for the three months ended September 30, 2025 includes a $32.6 million non-cash expense related to changes in the fair value of certain assets and liabilities. About AtaiBeckley N.V.AtaiBeckley is a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments. It was formed through the strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited in November 2025. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (buccal film DMT) for TRD and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. It is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create new possibilities in mental health by providing effective, commercially scalable and convenient interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X. 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 studies and clinical trials and related milestones and regulatory processes; risks related to the integration of Beckley Psytech Limited or the corporate redomiciliation; 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 our other filings with the SEC. The Company 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 InformationInvestor Contact:IR@ataibeckley.com Media Contact:PR@ataibeckley.com -- Financial Statements Attached -- ATAI BECKLEY N.V.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Amounts in thousands, except share and per share amounts)(unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2025 2024 2025 2024 (unaudited) (unaudited) Revenue $749 $40 $3,023 $313 Operating expenses: Research and development 14,680 12,377 37,100 36,513 General and administrative 14,505 10,265 40,002 36,226 Total operating expenses 29,185 22,642 77,102 72,739 Loss from operations (28,436) (22,602) (74,079) (72,426)Other expense, net (32,531) (3,861) (40,850) (36,795)Net loss before income taxes (60,967) (26,463) (114,929) (109,221)Benefit from (provision for) income taxes (131) 178 (380) 163 Losses from investments in equity method investees, net of tax — (26) — (2,000)Net loss (61,098) (26,311) (115,309) (111,058)Net loss attributable to noncontrolling interests (24) (25) (75) (747)Net loss attributable to Atai Beckley N.V. stockholders $(61,074) $(26,286) $(115,234) $(110,311)Net loss per share attributable to Atai Beckley N.V. stockholders — basic and diluted $(0.28) $(0.16) $(0.59) $(0.69)Weighted average common shares outstanding attributable to Atai Beckley N.V. stockholders — basic and diluted 217,601,496 160,621,817 196,963,517 159,973,201 ATAI BECKLEY N.V. CONDENSED CONSOLIDATED BALANCE SHEET (Amounts in thousands) September 30, December 31, 2025 2024 Assets (unaudited) Cash and cash equivalents $30,402 $17,505 Securities carried at fair value 84,204 44,825 Short-term restricted cash for other investments - 10,000 Prepaid expenses and other current assets 5,896 7,795 Short-term notes receivable - related party, net 10,164 - Property and equipment, net 3,010 2,535 Operating lease right-of-use assets, net 2,662 1,334 Other investments held at fair value 34,413 28,887 Other investments 53,947 42,079 Intangible assets, net 3,026 3,246 Goodwill 331 331 Digital assets 11,383 - Other assets 382 850 Total assets $239,820 $159,387 Liabilities and Stockholders' Equity Accounts payable $5,370 $2,616 Accrued liabilities 10,464 9,847 Current portion of lease liabilities 532 477 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 178 2,647 Contingent consideration liability - related party 110 110 Contingent consideration liabilities 212 212 Noncurrent portion of lease liabilities 2,426 732 Pre-funded warrant liabilities 57,432 - Long-term debt, net - 14,133 Other liabilities 3,188 2,695 Total stockholders’ equity attributable to Atai Beckley N.V. stockholders 159,751 116,297 Noncontrolling interests 157 257 Total liabilities and stockholders' equity $239,820 $159,387