5-MeO-DMT

atai Life Sciences’ shareholders voted to approve the strategic combination with Beckley Psytech Limited and the corporate redomiciliation at the Extraordinary General Meeting of Shareholders on November 4, 2025, with approximately 98% of the votes cast at the Extraordinary General Meeting in favor of the transactionsAtaiBeckley has an industry-leading pipeline of investigational treatments, led by BPL-003 (mebufotenin benzoate nasal spray), a Phase 3-ready asset Diversified portfolio also includes Phase 2 assets VLS-01 (DMT buccal film) and EMP-01 (oral R-MDMA), as well as a portfolio of novel 5-HT2A receptor agonists, including non-hallucinogenic neuroplastogens, in preclinical developmentDr. Srinivas Rao, CEO and Co-Founder of atai, to lead experienced team of executives from atai and Beckley Psytech; Cosmo Feilding Mellen, CEO and Co-Founder of Beckley Psytech, to serve on the Board of Directors Board of Directors to be led by Founder and Chairman of atai, Christian Angermayer, and newly appointed Vice Chairman, Scott Braunstein, M.D. All members of the atai Board will remain on the AtaiBeckley Board and, in addition to Cosmo Feilding Mellen, will be joined by Beckley Psytech Board Member Robert Hershberg, M.D., Ph.D. Cash, cash equivalents, short-term investments and other liquid assets are expected to fund operations into 2029, through anticipated topline data from the first Phase 3 trial of BPL-003 NEW YORK and AMSTERDAM, Nov. 05, 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 the successful completion of the strategic combination between atai Life Sciences (“atai”) and Beckley Psytech Limited (“Beckley Psytech”) in an all-share transaction. The combined company brings together world-class science and clinical expertise with a pipeline of investigational psychedelic-based neuroplastogens designed to address some of the most urgent unmet needs in mental health. Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of AtaiBeckley, said “We are bringing together the assets, expertise and vision of atai Life Sciences and Beckley Psytech to transform patient outcomes. Around the world, too many people continue to suffer without effective treatments and AtaiBeckley is taking a decisive step toward changing this. We are a well-financed, Phase 3-ready company with a strong team in place to execute on our mission and I am excited by what we can achieve together, with our team fully committed to creating breakthroughs in mental health.” Cosmo Feilding Mellen, Director and Co-Founder of AtaiBeckley, said “I believe AtaiBeckley is uniquely positioned to deliver commercially scalable psychedelic-based therapies that could transform the treatment landscape for people living with serious mental health conditions. This is an exciting moment for patients and the mental health sector more widely, and I am deeply proud to be a part of it.” Industry-Leading PipelineAtaiBeckley’s lead program is BPL-003, an investigational, novel mebufotenin benzoate nasal spray designed to produce rapid and durable antidepressive effects from a single dose and with a short psychedelic duration. BPL-003 is currently being investigated as a potential treatment for patients with treatment-resistant depression (TRD) and was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in recognition of its potential to deliver substantial improvement over existing therapies for TRD. The Company is scheduled to meet with the FDA for an End-of-Phase 2 meeting to discuss the design of a Phase 3 clinical program for BPL-003 in the coming months, with initiation of Phase 3 studies expected in the second quarter of 2026. AtaiBeckley’s diversified pipeline also includes VLS-01 (DMT buccal film), currently being evaluated in a Phase 2 clinical trial for patients with TRD, with topline data expected in the second half of 2026; EMP-01 (R-MDMA), currently in an exploratory Phase 2a study for adults with social anxiety disorder, with topline results anticipated in the first quarter of 2026; and a portfolio of novel 5-HT2A receptor agonists, including non-hallucinogenic neuroplastogens, in earlier stages of development. Experienced Leadership TeamAtaiBeckley will be led by CEO and Co-Founder Dr. Rao. He will be joined by an executive team with deep expertise in neuroscience, psychiatry, and drug development including: Anne Johnson, CPA as Chief Financial Officer, Rob Conley, M.D. as Chief Research & Development Officer, Gerd Kochendoerfer, Ph.D. as Chief Operating Officer, Kevin Craig, M.D. as Chief Medical Officer, Glenn Short, Ph.D. as Chief Scientific Officer and Ryan Barrett as Chief Legal and Business Officer. Accomplished Board of DirectorsAtaiBeckley’s Board of Directors comprises a diverse group of accomplished leaders with significant experience across biotechnology, pharmaceuticals, healthcare investment, and company building. Christian Angermayer, Founder of atai, will continue to serve as Chairman, and Scott Braunstein, M.D., has been appointed Vice Chairman and designated Lead Independent Director. All members of the atai Board will remain on the AtaiBeckley Board and they will be joined by Beckley Psytech Board Members Cosmo Feilding Mellen and Robert Hershberg, M.D., Ph.D. Strong Cash PositionIn October 2025, atai closed a public offering of common shares with leading healthcare-focused institutional investors. 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. With the proceeds from this public offering, the Company expects its cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029, through the anticipated topline data from the first Phase 3 trial of BPL-003. Shareholder VoteIn addition to approving the strategic combination, atai’s shareholders also approved the proposed redomiciliation to Delaware, United States. Assuming satisfaction of applicable closing conditions, the corporate redomiciliaton is expected to be completed around year end. Transaction TermsIn connection with the AtaiBeckley transaction, Beckley’s shareholders (other than atai), certain Beckley equity award holders and certain Beckley consultants will be issued approximately 105 million new AtaiBeckley shares or replacement awards covering AtaiBeckley shares. The newly issued shares equate to approximately 28% of shares outstanding of the combined company. Subject to certain limited exceptions, these new issuances are subject to a lock-up wherein, following the completion of the lock-up period, 1/12 of the shares are released every month. Additionally, Apeiron Investment Group, the family office of Mr. Angermayer, voluntarily entered into a similar lock-up agreement covering all of its shares in AtaiBeckley. 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 and Beckley Psytech Limited in November 2025. AtaiBeckley’s pipeline of novel investigational 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 (SAD), 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 breakthroughs in mental health by providing innovative 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 StatementsThis 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, 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 anticipated benefits of the acquisition of Beckley Psytech Limited or the redomiciliation transaction (the “Proposed Redomiciliation Transaction”), including timing for completion of the Proposed Redomiciliation Transaction; expectations regarding operations of AtaiBeckley, including strategic value of the clinical development programs for patients and shareholders as well as expectations regarding financial synergies; progress on and results of BPL-003 trials and related data readouts, including the timing of regulatory discussions with respect to Phase 3 trial design for BPL-003; the potential benefits of BPL-003 for patients with TRD; our business strategy and plans; the potential, success, cost and timing of development of our product candidates, and the product candidates of those companies we invest in; and potential future changes to jurisdiction of tax residency or jurisdiction of incorporation and the effects of those changes on us. 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 Redomiciliation Transaction may not be completed in a timely manner or at all; (ii) the failure to realize the anticipated benefits of the Proposed Redomiciliation Transaction; (iii) the possibility that any or all of the various conditions to the consummation of the Proposed Redomiciliation Transaction may not be satisfied or waived; (iv) the effect of the pendency of the Proposed Redomiciliation Transaction on our ability to retain and hire key personnel, or its operating results and business generally and (v) the effects of the Proposed Redomiciliation Transaction on trading, liquidity and the price of our securities and other important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, our subsequent Quarterly Reports on Form 10-Q filed with the SEC and the registration statement on Form S-4 that was filed with the SEC on September 22, 2025 (the “Registration Statement”), as such factors may be updated from time to time in our other filings with the SEC. We disclaim 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

1. 外侧缰核星形胶质细胞抗抑郁机制研究1.1 外侧缰核神经解剖与功能特性 外侧缰核（LHb）是情绪调节的 "反奖赏中心"，连接前脑边缘系统与中脑单胺核团，编码负性情绪信号。其输出至 VTA、SNc 等单胺能中心，输入来自边缘系统及基底神经节结构。抑郁症模型中 LHb 代谢活动增强，人类功能成像亦显示抑郁患者 LHb 过度活跃，与无助感、快感缺失相关。1.2 星形胶质细胞在外侧缰核中的作用机制 星形胶质细胞是中枢神经系统主要胶质细胞，其 Kir4.1 钾通道是抑郁症关键调节因子 —— 紧密包绕 LHb 神经元，调节胞外钾平衡，改变神经元发放特性，导致 LHb 过度活跃。此外，星形胶质细胞还通过调节单胺递质、谷氨酸循环等参与抑郁发生，为治疗提供新视角。1.3 快速抗抑郁作用的分子通路 核心机制为基于 Kir4.1 的神经 - 胶质相互作用：抑郁模型中 LHb 星形胶质细胞 Kir4.1 上调，增强胞外 K + 清除，使神经元超极化，激活 T-VSCCs 引发 NMDAR 依赖性簇状放电，抑制下游单胺能中心。氯胺酮可升高星形胶质细胞 cAMP、重分布膜胆固醇、减少 Kir4.1 表面密度，阻断 LHb 神经元簇状放电，实现快速抗抑郁。1.4 与传统抗抑郁机制的对比优势 优势维度 传统抗抑郁药（SSRIs/SNRIs） 外侧缰核星形胶质细胞机制 起效速度 数周至数月 1-4 小时（如氯胺酮 / Lys05） 作用机制 调节单胺递质浓度 调节神经元放电模式与神经 - 胶质相互作用 靶点特异性 作用于全脑单胺系统 精准靶向 LHb"反奖赏中心" 持续时间 依赖长期用药 氯胺酮 "滞留" 受体实现长效，Lys05 效果持久 安全性 响应率低、有副作用 LHb 特异性调节，Lys05 无明显毒副反应2. 药物研发现状与进展分析2.1 主要研究机构与研发团队 浙江大学胡海岚团队：2018 年 Nature 揭示 LHb 在氯胺酮抗抑郁中作用；2023 年 Nature 阐明氯胺酮 "超长待机" 机制；2024 年 Science 揭示 LHb 为氯胺酮首要靶向脑区的神经基础。 中国科学院上海药物研究所高召兵课题组：2024 年联合郭江涛团队在 Nature Chemical Biology 发表 Kir4.1 为快速抗抑郁靶点的研究，开发 Lys05。 国际团队：斯洛文尼亚 Matjaž Stenovec 团队研究氯胺酮对星形胶质细胞功能可塑性的影响。2.2 候选化合物与临床试验进展核心候选化合物：Lys05 首个 Kir4.1 特异性小分子抑制剂，IC50=0.22μM，选择性优异。 动物实验：单剂量 1 小时内缓解抑郁表型，疗效媲美 S - 氯胺酮，优于需连续给药 5 天的丙咪嗪。 机制：结合于 Kir4.1 中央孔区阻断钾离子流动，E158/I159/T128 为关键残基。其他快速抗抑郁药物进展 药物 研发机构 机制 临床进展 Spravato（艾司氯胺酮） 强生 靶向谷氨酸 2025 年 FDA 批准为难治性抑郁单药疗法，77 国获批 BPL-003（5-MeO-DMT 衍生物） Atai 作用 5-HT 受体 2a 期：单次 10mg 次日响应率 55%，12 周维持 SPN-820（mTORC1 调节剂） Supernus 增加突触功能 2a 期：4 小时 MADRS 改善 - 16.6，10 天缓解率 63.2% LY03021（三重再摄取抑制剂） 绿叶制药 调节 5 - 羟色胺等 中国获批临床2.3 专利布局与知识产权分析 Kir4.1 相关：WO2018205927A1（全球多区域保护）、CN115025224A（T-VSCC 抑制剂用途）。 氯胺酮相关：胡海岚团队围绕 LHb 特异性作用机制申请专利。 企业布局：Cybin 拥有 80 + 授权专利、230 + 待审申请，CYB 003 独占期至 2041 年。2.4 2024-2025 年最新研发动态 机制突破：胡海岚团队证实 LHb 神经元 NR1 敲除可产生抗抑郁表型；高召兵团队解析 Lys05-Kir4.1 复合物结构。 临床前进展：Lys05 完成药效 / 药代 / 毒理学评估，新型 Kir4.1 抑制剂筛选中。 产业动态：强生 146 亿收购 Intra-Cellular 获 Caplyta；绿叶若欣林 2024 年销售 7.5 亿（+200%）；Autobahn 获 1 亿 C 轮、Reunion 获 1.03 亿 A 轮融资。3. 市场规模与竞争格局评估3.1 全球抑郁症流行病学与市场需求 全球数据：WHO 2024 年显示，全球超 10 亿人有精神障碍，5% 成年人患抑郁（女性 6.9%/ 男性 4.6%），仅 1/3 高收入国家患者获治疗。 中国数据：抑郁患病率 6.9%（较五年前 + 32%），2024 年公立医疗机构抗抑郁化药销售额超 91 亿元。3.2 快速抗抑郁药物市场规模分析 市场维度 规模数据 增长预测 全球抗抑郁药市场 2024 年 187 亿美元 2025-2034 年 CAGR 7.5%，2034 年达 379 亿 氯胺酮 / 艾司氯胺酮市场 2024 年分别为 43.3 亿 / 17.3 亿美元 艾司氯胺酮 2025-2034 年 CAGR 16%，2034 年达 78.6 亿 鼻内抗抑郁药市场 2024 年 7.8 亿美元 2025-2032 年 CAGR 6.88%，2032 年达 13.28 亿 中国抗抑郁药市场 2024 年 187-391 亿元 SNRIs 类 2024 年 108.72 亿（+14.6%）3.3 主要竞争者与产品分析传统制药巨头 强生：Spravato 覆盖 77 国，2025 年获批难治性抑郁单药，收购 Intra-Cellular 获 Caplyta，精神药物市占 15-18%。 辉瑞 / 礼来：分别占 15-30%/11-25% 抗抑郁市场，礼来百优解中国市占 43.2%。 其他：葛兰素史克、赛诺菲（20%）、阿斯利康（15%）等有布局。新兴生物公司 Supernus：SPN-820 口服制剂，2a 期自杀意念从 12.5% 降至 2.6%。 Atai：BPL-003 鼻内给药，12 周缓解率 45%。 绿叶制药：若欣林 2024 年市占从 0.8% 升至 2.5%，LY03021 进入临床。3.4 技术路径竞争优势对比 技术路径 代表药物 优势 劣势 LHb-Kir4.1 调节 Lys05 靶点特异、起效快、安全窗好 暂处临床前 mTORC1 调节 SPN-820 口服便利、突触功能改善 机制复杂 5-HT 受体激动 BPL-003 效果持久 致幻风险、需医疗监督 传统单胺调节 LY03021 机制明确、口服方便 起效慢 GABA 调节 Zuranolone 获批产后抑郁 适应症窄4. 投资机会与风险评估4.1 投资价值与回报预期 需求驱动：全球 2.8 亿抑郁患者，快速抗抑郁市场增速超传统品类。 科学基础：机制明确（顶级期刊验证）、靶点充分验证、专利保护完善。 回报预测：若占 10% 快速抗抑郁市场，2034 年潜在销售额 7.86 亿美元；参考强生收购案例，并购价值高。4.2 融资案例与估值参考重大融资案例 案例 时间 金额 / 动作 核心资产 / 意义 强生收购 Intra-Cellular 2025.1 146 亿美元 获 Caplyta（双相抑郁药物） Autobahn C 轮 2024.7 1 亿美元 ABX-002（甲状腺激素受体 β 激动剂） Reunion A 轮 2024.5 1.03 亿美元 迷幻疗法（产后抑郁） 绿叶若欣林 2024 销售 7.5 亿元 中国首个抗抑郁化药 1 类创新药估值参考 上市企业：强生收购估值基于 Caplyta 首创地位；私有公司：临床前 / 早期临床企业估值 5-10 亿美元。 收入倍数：绿叶若欣林高增长支撑高估值倍数。4.3 技术风险与应对策略 风险类型 风险描述 应对策略 靶点验证风险 动物 - 人体种属差异 分阶段验证（动物→人体药理→临床） 药物设计挑战 血脑屏障穿透、特异性 开发纳米载体 / 前药；基于结构设计 安全性风险 长期抑制 Kir4.1 副作用 全面毒理评估；开发可逆抑制剂 制剂技术风险 起效与副作用平衡 缓释 / 智能制剂；新型给药途径4.4 市场风险与监管考量市场风险 竞争加剧：巨头与新兴企业涌入；医保支付：高价药物报销受限；患者接受度：对新型机制顾虑。监管应对 早期沟通：与监管机构对接研发计划；渐进申报：先在宽松市场上市；风险管理：制定 REMS 类方案；合规体系：全流程质量管控。5. 技术转化与产业化路径5.1 从基础研究到临床应用的转化路径 阶段 时间 核心任务 基础研究 3-5 年 靶点发现（已完成）、机制深化、动物模型建立 药物发现 3-4 年 化合物筛选、先导优化、确定临床前候选物 临床前研究 2-3 年 药效 / 药代 / 毒理学研究、制剂开发 临床试验 5-7 年 I 期（安全耐受）→II 期（有效性）→III 期（确证）→IV 期（上市后监测）5.2 产业化过程中的关键挑战 技术挑战：血脑屏障穿透（纳米载体 / 结构优化）、靶点特异性（结构设计）、制剂开发（缓释 / 新型给药）。 生产挑战：合成工艺复杂（与 CDMO 合作）、质量控制（全程追溯）、供应链（多元供应商）。 商业化挑战：市场准入（分阶段布局）、教育推广（医学教育 / 患者支持）、定价（差异化策略）。5.3 知识产权布局与保护策略 专利布局：核心专利（靶点 / 化合物 / 用途）、外围专利（制剂 / 工艺）、国际布局（PCT 覆盖主要市场）。 组合管理：构建完整专利链、差异化维护、专利预警。 秘密保护：核心工艺 / 质控方法保密、商业秘密管理、员工培训。5.4 商业化前景与成功案例借鉴成功案例经验 强生 Spravato：定位难治性抑郁、REMS 管控、专业渠道建设。 绿叶若欣林：中国首创定位、快速抢占市场、高增长策略。商业化路径 分阶段上市：先澳加→再美欧→后新兴市场。 商业模式：药品销售 + 技术授权 + 合作开发 + 并购退出。 长期规划：扩展适应症、技术平台化、全球化布局、构建 "药物 + 诊断 + 服务" 生态。6. 结论与发展建议6.1 关键发现总结 科学价值：LHb-Kir4.1 为全新靶点，起效快、机制明确、安全窗好。 市场前景：全球 2.8 亿患者，快速抗抑郁市场 CAGR 16%，中国市场规模超百亿。 技术成熟度：基础研究扎实、候选物验证完成、专利保护完善、转化路径清晰。6.2 发展战略建议 研发机构：加速 Lys05 临床、拓展适应症、建技术平台、国际合作。 投资机构：把握临床转化时机、组合投资分散风险、关注技术 / 团队 / 专利、长期导向。 制药企业：并购获技术、合作开发、纳入产品线、全球化布局。 政策制定者：优化审批流程、医保支持、创新激励、国际协调。6.3 未来展望 技术趋势：精准医疗（生物标志物）、联合治疗、新型制剂、多靶点协同。 市场预测：2030 年占抗抑郁重要份额，年销售额数十亿美元，竞争趋烈但先发者占优。 社会影响：改善患者生活、减轻医疗负担、提升社会认知、带动相关产业。