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)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the 'Company' or 'MindMed'), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that the first patient has been dosed in Panorama, its second Phase 3 study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment generalized anxiety disorder (GAD).

)--Mind Medicine（MindMed）Inc.（纳斯达克：MNMD），“公司”或“MindMed”）是一家开发新型候选产品治疗大脑健康障碍的晚期临床生物制药公司，今天宣布，第一名患者已在Panorama中服用，Panorama是其第二项评估MM120 ODT的3期研究，MM120 ODT是一种专有的，药物优化的LSD形式，用于治疗广泛性焦虑症（GAD）。

The Panorama study will evaluate the efficacy and safety of MM120 ODT versus placebo, will be conducted in the United States and Europe, and is expected to enroll approximately 250 participants..

Panorama研究将评估MM120 ODT与安慰剂的疗效和安全性，将在美国和欧洲进行，预计将招募约250名参与者。。

“This is an incredible time for MindMed, and we are optimistic about what lies ahead as we embark on our second Phase 3 study for MM120 ODT in GAD only weeks after the successful launch of our first Phase 3 study, Voyage,” said Dan Karlin, M.D., M.A., Chief Medical Officer of MindMed. “MM120 ODT represents a potentially life-changing treatment for people living with GAD, and if our Phase 3 development program is successful, it could offer a differentiated and compelling option for one of the most significant unmet needs in psychiatry.

MindMed首席医学官Dan Karlin医学博士说：“这对MindMed来说是一个难以置信的时刻，我们对未来的前景感到乐观，因为我们在成功启动第一个第三阶段研究“航行”几周后，就在GAD开始了MM120 ODT的第二个第三阶段研究。”。“MM120 ODT代表了一种潜在的改变GAD患者生活的治疗方法，如果我们的第三阶段开发计划成功，它可以为精神病学中最重要的未满足需求之一提供一种有区别和引人注目的选择。

We aspire to deliver a truly transformational treatment that we believe has the potential to change the trajectory of the ongoing brain health epidemic.”.

我们渴望提供一种真正的变革性治疗，我们认为这种治疗有可能改变正在进行的大脑健康流行病的轨迹。”。

The clinical trial design of the 52-week Panorama study is aligned to Voyage and will be conducted in two parts: Part A, a 12-week, randomized, double-blind, placebo-controlled, parallel-group period; and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT based on symptom severity.

52周Panorama研究的临床试验设计与VOAIGE一致，将分两部分进行：A部分，12周，随机，双盲，安慰剂对照，平行组期；B部分是40周的延长期，在此期间，参与者将有资格根据症状严重程度接受MM120 ODT的开放标签治疗。

Participants will be randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg, or placebo. The 50 µg arm serves to confound participants’ ability to accurately assess the dose condition to which they have been randomized. This approach builds on the MM120 Phase 2b study, which the Company believes demonstrated that the clinical activity of MM120 was not attributable to functional unblinding and aligns with FDA guidance regarding the use of complementary designs across our Phase 2 and 3 studies.

参与者将以2:1:2的比例随机接受MM120 ODT 100µg，MM120 ODT 50µg或安慰剂。50µg组的作用是混淆参与者准确评估随机剂量条件的能力。这种方法建立在MM120 2b期研究的基础上，该公司认为该研究表明MM120的临床活性不归因于功能性揭盲，并且与FDA关于在我们的2期和3期研究中使用补充设计的指导一致。

The primary endpoint of Panorama will measure the change from baseline in HAM-A at Week 12 between MM120 ODT 100 µg and placebo, which is consistent with the durable clinical effect observed in the MM120 Phase 2b study..

Panorama的主要终点将测量MM120 ODT 100µg和安慰剂在第12周时HAM-A的基线变化，这与MM120 2b期研究中观察到的持久临床效果一致。。

“GAD is a common and debilitating disorder, as we have shown that it impairs various cognitive abilities, and many patients are not sufficiently helped by currently available treatments.

“GAD是一种常见且使人衰弱的疾病，因为我们已经证明它会损害各种认知能力，目前可用的治疗方法对许多患者没有足够的帮助。

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There is an urgent need for different approaches. The Panorama study builds on the results of MindMed’s Phase 2b study, which showed a rapid and sustained response to a single dose of MM120, demonstrating its potential as a promising treatment for GAD,” said Philip Gorwood, M.D., Ph.D., Professor of Psychiatry at Sainte-Anne Hospital and Paris Cité University, France.

迫切需要采取不同的方法。Panorama研究以MindMed的2b期研究结果为基础，该研究显示对单剂量MM120有快速持续的反应，证明其作为GAD有希望的治疗方法的潜力，”法国圣安妮医院和巴黎城市大学精神病学教授Philip Gorwood博士说。

“Panorama, which is consistent with the design of the Phase 2b study, has the potential to be a transformative change in the way we understand and treat brain health disorders, offering acute but also lasting benefits to patients who have long been frustrated with current standards of care.”.

“Panorama与2b期研究的设计一致，有可能成为我们理解和治疗大脑健康障碍方式的变革性改变，为长期以来对当前护理标准感到失望的患者提供急性但持久的益处。”。

About Generalized Anxiety Disorder (GAD)

关于广泛性焦虑症（GAD）

GAD is a common disorder associated with significant impairment that adversely affects millions of people. GAD results in fear, continuing anxiety, and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S.

GAD是一种与严重损害相关的常见疾病，对数百万人产生不利影响。GAD导致恐惧，持续焦虑和持续的不知所措感。它的特点是对日常事物过度、执着和不切实际的担忧。大约占美国的10%。

adults, representing around 20 million people.

成年人，代表大约2000万人。

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, currently suffer from GAD. This underdiagnosed and underserved mental health disorder is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007..

，目前患有GAD。这种诊断不足和服务不足的心理健康障碍与严重受损，工作成就降低和劳动力参与减少有关。尽管GAD带来了巨大的个人和社会负担，但在过去的几十年中，GAD的治疗几乎没有创新，最近一次新药批准发生在2007年。。

About MM120 Orally Disintegrating Tablet (ODT)

关于MM120口腔崩解片（ODT）

MM120 ODT (lysergide D-tartrate or LSD) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics which acts as a partial agonist at human serotonin-2A (5-HT2A) receptors. MM120 ODT is MindMed’s proprietary and pharmaceutically optimized form of LSD. MM120 ODT is an advanced formulation incorporating Catalent’s Zydis® ODT fast-dissolve technology which has a unique clinical profile with more rapid absorption, improved bioavailability and reduced gastrointestinal side effects..

MM120 ODT（麦角苷D-酒石酸盐或LSD）是一种合成麦角胺，属于经典或5-羟色胺能迷幻药组，可作为人类5-羟色胺2A（5-HT2A）受体的部分激动剂。MM120 ODT是MindMed的专有和药物优化形式的LSD。MM120 ODT是一种先进的配方，结合了Catalent的Zydis®ODT快速溶解技术，具有独特的临床特征，具有更快的吸收，改善的生物利用度和减少的胃肠道副作用。。

The MM120 ODT Phase 3 clinical development program includes the Voyage and Panaroma studies in generalized anxiety disorder (GAD) and the Emerge study in major depressive disorder (MDD). Additional clinical indications are under consideration. MindMed’s Phase 2b study, MMED008, met its primary and key secondary endpoints and demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety Rating Scale (HAM-A) at Week 4 and Week 12, with a 65% clinical response rate and 48% clinical remission rate sustained to Week 12 in the MM120 100 µg cohort.

MM120 ODT 3期临床开发计划包括广泛性焦虑症（GAD）的VOAIGE和Panaroma研究以及重度抑郁症（MDD）的Emerge研究。其他临床适应症正在考虑中。。

MM120 was generally well-tolerated in this study, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day and being consistent with the expected acute effects of the trial drug..

在这项研究中，MM120的耐受性通常良好，大多数不良事件被评为轻度至中度，短暂性，并且在给药当天发生，并且与试验药物的预期急性作用一致。。

Based on the significant unmet medical need in the treatment of GAD along with the initial clinical data from the Phase 2b study and other research conducted by MindMed, the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for the MM120 program in GAD. MindMed has also been granted an Innovation Passport for the potential treatment of GAD under the United Kingdom Innovative Licensing and Access Pathway (ILAP) by the U.K.

基于GAD治疗中显着未满足的医疗需求以及MindMed进行的2b期研究和其他研究的初步临床数据，美国食品和药物管理局已授予GAD MM120计划突破性治疗指定。MindMed还获得了英国创新许可和准入途径（ILAP）下GAD潜在治疗的创新护照。

Medicines and Healthcare products Regulatory Agency. The Innovation Passport is the entry point to the ILAP, which aims to accelerate time to market and facilitate patient access to medicines in the U.K..

药品和保健品管理局。创新护照是ILAP的切入点，ILAP旨在加快上市时间并促进患者在英国获得药物。。

About MindMed

关于MindMed

MindMed is a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.

MindMed是一家晚期临床生物制药公司，开发用于治疗大脑健康疾病的新型候选产品。我们的使命是成为开发和提供治疗的全球领导者，为改善患者预后提供新的机会。我们正在开发一系列创新产品候选产品，有或没有急性知觉效应，针对在大脑健康中起关键作用的神经递质途径。

MindMed trades on NASDAQ under the symbol MNMD..

MindMed在纳斯达克交易，代码为MNMD。。

Forward-Looking Statements

前瞻性声明

Certain statements in this news release related to the Company constitute 'forward-looking information' within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements.

本新闻稿中与公司有关的某些声明构成适用证券法意义上的“前瞻性信息”，具有前瞻性。前瞻性信息并非基于历史事实，而是基于当前对未来事件的预期和预测，因此存在风险和不确定性，这可能导致实际结果与前瞻性声明所表达或暗示的未来结果存在重大差异。

These statements generally can be identified by the use of forward-looking words such as 'will', 'may', 'should', 'could', 'intend', 'estimate', 'plan', 'anticipate', 'expect', 'believe', 'potential' or 'continue', or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding the Company’s anticipated topline readout for the Panorama study (Part A results) in the second half of 2026; the Company’s expectation to enroll approximately 250 participants in the Panorama study; the Company’s beliefs regarding potential benefits of its product candidates; anticipated upcoming milestones, trials and studies; and potential additional indications for MM120 ODT.

这些陈述通常可以通过使用前瞻性词语来识别，例如“意志”、“可能”、“应该”、“可能”、“打算”、“估计”、“计划”、“预期”、“期望”、“相信”、“潜在”或“继续”，或其负面或类似的变化。本新闻稿中的前瞻性信息包括但不限于有关公司2026年下半年全景研究（A部分结果）预期底线读数的声明；该公司预计将招收大约250名参与者参加全景研究；公司对候选产品潜在利益的信念；预期即将到来的里程碑，试验和研究；以及MM120 ODT的潜在其他适应症。

There are numerous risks and uncertainties that could cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial r.

存在许多风险和不确定性，可能导致实际结果以及公司的计划和目标与前瞻性信息（包括负现金流的历史）中表达的计划和目标存在重大差异；有限的运营历史；未来损失的发生；额外资本的可用性；遵守法律法规；与研发相关的困难；与临床试验或研究相关的风险；加强监管审查；早期产品开发；临床试验r。

www.sedarplus.ca

塞达尔普鲁斯

and with the U.S. Securities and Exchange Commission on EDGAR at

以及美国证券交易委员会关于EDGAR的

www.sec.gov

www.sec.gov

. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.

。

References:

参考文献：

Baussay A, Di Lodovico, Poupon D, Doublet M, Ramoz N, Duriez P, Gorwood P (2024) The capacity of cognitive tests to detect generalized anxiety disorder (GAD), a pilot study. J Psychiatr Res, Jun; 174: 94-100.

Baussay A，Di Lodovico，Poupon D，Doublet M，Ramoz N，Duriez P，Gorwood P（2024）认知测试检测广泛性焦虑症（GAD）的能力，一项初步研究。J Psychiatric Res，Jun；174分：94-100分。

Ringeisen, H., Edlund, M. J., Guyer, H., Geiger, P., Stambaugh, L. F., Dever, J. A., Liao, D., Carr, C. M., Peytchev, A., Reed, W., McDaniel, K., & Smith, T. K. (2023).

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Mental and Substance Use Disorders Prevalence Study: Findings report

精神和物质使用障碍患病率研究：结果报告

. RTI International.

。