TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced a positive End-of-Phase 2 meeting with the FDA for CYB003, its deuterated psilocybin analog for the adjunctive treatment of Major Depressive Disorder (“MDD”)..

多伦多--（商业新闻短讯）--Cybin Inc.（纽约证券交易所美国代码：CYBN）（Cboe CA代码：CYBN）（“Cybin”或“公司”）是一家临床阶段的生物制药公司，致力于通过开发新的和创新的下一代迷幻药治疗方案来彻底改变精神保健，今天宣布与FDA就CYB003举行的第二阶段会议正式结束，它的氘化裸盖菇素类似物用于辅助治疗重度抑郁症（“MDD”）。。

This program will be the first ever adjunctive Phase 3 deuterated psilocybin analog depression study globally and follows the successful completion of the Company’s Phase 2 study in MDD completed at the end of 2023. The Company has received minutes from its End-of-Phase-2 meeting with the FDA and reached alignment on its Phase 3 program design.

该项目将是全球有史以来第一个辅助性3期氘代裸盖菇素类似物抑郁症研究，此前该公司于2023年底成功完成了MDD的2期研究。该公司已收到与FDA第二阶段会议结束的会议记录，并就其第三阶段计划设计达成一致。

The Company intends to commence enrollment for the multinational, multisite Phase 3 program in mid-year 2024. Fifteen U.S. study sites have been targeted, all of which have experience running psychedelic clinical trials and are DEA Schedule I licensed. The preliminary targeting of specific study sites will serve to expedite site initiation.

该公司计划于2024年年中开始注册跨国、多地点第三阶段项目。15个美国研究地点已成为目标，所有这些地点都有开展迷幻药临床试验的经验，并获得了DEA附表I的许可。特定研究地点的初步目标将有助于加快地点启动。

The Company intends to add approximately 8 additional sites in Europe..

该公司打算在欧洲再增加大约8个营业点。。

The Company has engaged Worldwide Clinical Trials (“Worldwide”), a global, full-service contract research organization with deep expertise managing clinical trials for mental health conditions, including major depressive disorder. Worldwide has a track record of successful patient recruitment for psychedelic trials and global relationships with best-in-class investigative sites.

该公司参与了全球临床试验（Worldwide Clinical Trials），这是一家全球性、全方位的合同研究组织，拥有管理包括重度抑郁症在内的心理健康状况临床试验的深厚专业知识。Worldwide有成功招募迷幻药试验患者的记录，并与一流的调查网站建立了全球关系。

Worldwide has recent experience managing psychedelic studies in psychiatric populations, including clinical trials conducted in the U.S., Canada, United Kingdom, and other European countries, across a range of psychedelic compounds and treatment models..

全球范围内最近有管理精神病人群迷幻剂研究的经验，包括在美国，加拿大，英国和其他欧洲国家进行的一系列迷幻剂化合物和治疗模型的临床试验。。

“We are very pleased with the results of our End-of-Phase 2 meeting with the FDA and appreciate the agency’s thoroughness and guidance during the process. Having aligned on key features of the pivotal program, we look forward to initiating a multisite, multinational Phase 3 program around mid-year,” said Doug Drysdale, Chief Executive Officer of Cybin.

Cybin首席执行官道格·德赖斯代尔（DougDrysdale）表示：“我们对与FDA第二阶段会议结束后的结果感到非常满意，并感谢FDA在这一过程中的彻底性和指导。在与关键项目的关键特征保持一致后，我们期待着在年中左右启动一个多地点、多国的第三阶段项目。”。

“The strength of CYB003’s clinical profile to date, which showed that at four months after dosing, across the two doses, 60% of patients receiving 12mg and 75% of patients receiving 16mg of CYB003 achieved remission from depression symptoms. With positive durability data demonstrating sustained effects up to at least four months, BTD, and alignment with the FDA on our Phase 3 plan, we are positioned to move quickly to progress the program and bring relief and treatment alternatives to people who are desperately waiting,” concluded Drysdale..

“迄今为止，CYB003的临床表现显示，在给药后四个月，在两种剂量中，接受12mg CYB003的患者中有60%和接受16mg CYB003的患者中有75%的患者缓解了抑郁症状。积极的耐久性数据表明，至少四个月的持续作用，BTD，以及与FDA在我们的第三阶段计划中的一致性，我们是正确的我决定尽快推进这项计划，为绝望等待的人们带来救济和治疗替代品，”Drysdale总结道。。

CYB003 Phase 3 Pivotal Program Outline

CYB003三期关键项目大纲

The Phase 3 pivotal program will comprise two adequate and well controlled studies and a long-term extension, designed as follows:

第三阶段关键计划将包括两项充分且控制良好的研究和一项长期扩展，设计如下：

CYB003-002 (n=220): Fixed repeat dose study of 16mg CYB003, with two doses 3 weeks apart compared to two doses of placebo. The trial is designed to replicate the treatment response seen in the Company’s Phase 2 study.

CYB003-002（n=220）：16mg CYB003的固定重复剂量研究，与两剂安慰剂相比，两剂间隔3周。该试验旨在复制该公司第二阶段研究中所见的治疗反应。

CYB003-003 (n=330): Three-arm fixed repeat dose study of CYB003 (16mg or 8mg), with two doses 3 weeks apart. Each active arm will be compared to two doses of placebo.

CYB003-003（n=330）：CYB003（16mg或8mg）的三臂固定重复剂量研究，两次剂量间隔3周。将每个活动臂与两剂安慰剂进行比较。

The primary endpoint of both studies is the change in MADRS total score from baseline at Week 6, with a secondary endpoint at Week 12, each compared to placebo.

两项研究的主要终点是MADRS总分从第6周的基线变化，第12周的次要终点分别与安慰剂相比。

Patients from each of these Phase 3 trials will enroll in a one-year extension study, during which time non-responders and relapsing patients will receive one full cycle of CYB003 16mg (two doses, three weeks apart).

这些3期临床试验的患者将参加为期一年的延长研究，在此期间，无反应者和复发患者将接受一个完整周期的CYB003 16mg（两剂，间隔三周）。

Moderate to severe MDD patients enrolled in both studies (MADRS >/=24) will be on stable doses of background antidepressant medication, positioning CYB003 as a convenient, adjunctive treatment option.

参加两项研究（MADRS>/=24）的中度至重度MDD患者将服用稳定剂量的背景抗抑郁药物，将CYB003定位为一种方便的辅助治疗选择。

CYB003-002 is anticipated to begin around mid-year 2024, with CYB003-003 anticipated to initiate a few months later. Each study is expected to run for approximately 18-24 months.

CYB003-002预计在2024年年中左右开始，CYB003-003预计在几个月后启动。每项研究预计将持续约18-24个月。

Patient recruitment for the Phase 3 program will include a broad MDD population including only patients that are currently on antidepressants. Importantly, patients will not be required to titrate off their background antidepressants which will reduce some of the inherent recruitment challenges seen in other depression studies..

第三阶段计划的患者招募将包括广泛的MDD人群，仅包括目前正在服用抗抑郁药的患者。重要的是，患者不需要滴定背景抗抑郁药，这将减少其他抑郁症研究中固有的一些招募挑战。。

Summary of Positive Four-Month Efficacy Data for CYB003

CYB003阳性四个月疗效数据汇总

Robust and sustained improvements in symptoms of depression four months after two doses of 12mg or 16mg of CYB003:

服用两剂12mg或16mg CYB003四个月后，抑郁症症状得到了强有力的持续改善：

Mean reduction from baseline in the MADRS total score was approximately 22 points from baseline in both dosing cohorts.

在两个剂量组中，MADRS总分从基线的平均降低约为22分。

Approximately 75% of the patients were responders (>/= 50% improvement in MADRS scores) following two doses of 16mg.

在两剂16mg后，大约75%的患者是应答者（MADRS评分改善>50%）。

60% of patients on 12mg and 75% on 16mg were in remission from depression following 2 doses (MADRS score </= 10).

服用12mg的患者中有60%和服用16mg的患者中有75%在服用2剂后抑郁症缓解（MADRS评分</=10）。

Safety and tolerability:

安全性和耐受性：

CYB003 was well tolerated with no drug-related serious adverse events.

CYB003耐受性良好，无药物相关严重不良事件。

All adverse events were mild or moderate in intensity.

所有不良事件的强度均为轻度或中度。

No incidents of suicidal ideation or behavior.

没有自杀念头或行为的事件。

No discontinuations due to adverse events.

没有因不良事件而中断。

Earlier this week, Cybin announced the granting of BTD for CYB003 by the FDA. If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.

本周早些时候，Cybin宣布FDA批准CYB003的BTD。如果获得FDA的批准，CYB003将是第一个已知的用于治疗MDD的辅助迷幻药。

BTD provides an expedited review pathway, as well as increased access to FDA guidance on trial design, with the potential to reduce drug development timelines. It is reserved for drug candidates that target serious conditions and demonstrate substantial improvement on a clinically significant endpoint over available therapies.

BTD提供了一个快速的审查途径，以及更多地获得FDA关于试验设计的指导，有可能缩短药物开发时间表。它是为针对严重疾病的候选药物保留的，并且与现有疗法相比，在临床显着终点上表现出显着改善。

The designation includes all “fast track” program features, as well as more intensive FDA guidance and discussion of the CYB003 development program, including planned clinical trials and plans for expediting the manufacturing development strategy. CYB003 is eligible for Priority Review and Accelerated Approval..

该名称包括所有“快速通道”计划功能，以及更深入的FDA指导和CYB003开发计划的讨论，包括计划的临床试验和加速制造业发展战略的计划。CYB003有资格进行优先审查和加速批准。。

The designation of CYB003 as a breakthrough therapy acknowledges the significant unmet medical need for more effective treatments of MDD and supports CYB003’s potential for significant improvements over existing therapies.

将CYB003指定为突破性疗法承认了对MDD更有效治疗的重大未满足医疗需求，并支持CYB003对现有疗法进行重大改进的潜力。

About Cybin

关于Cybin

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin是一家临床阶段的生物制药公司，其使命是创建安全有效的迷幻药治疗药物，以满足患有心理健康状况的人对新的创新治疗方案的大量未满足需求。

Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds..

Cybin革新精神保健的目标得到了世界级合作伙伴和国际公认科学家网络的支持，该网络旨在推进专有药物发现平台，创新药物输送系统以及新颖的配方方法和治疗方案。该公司目前正在开发CYB003，一种用于治疗重度抑郁症的专有氘代裸盖菇素类似物和CYB004，一种用于广泛性焦虑症的专有氘代DMT分子，并拥有一个基于迷幻药的研究化合物的研究管道。。

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.

Cybin总部位于加拿大，成立于2019年，目前在加拿大、美国、英国、荷兰和爱尔兰运营。有关Cybin的公司更新和更多信息，请访问www.Cybin.com或在X、LinkedIn、YouTube和Instagram上关注团队。

Cautionary Notes and Forward-Looking Statements

注意事项和前瞻性声明

Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are 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.

本新闻稿中有关公司的某些声明是前瞻性声明，具有前瞻性。前瞻性陈述并非基于历史事实，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，可能导致实际结果与前瞻性陈述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 “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s planned clinical trials and program strategy for CYB003; plans for additional European study sites; the potential for CYB003 to provide significant improvement over existing therapies; the advancement of CYB003 towards a Phase 3 trial in mid-2024; the potential reduction in drug development timelines afforded by BTD; and the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders..

这些陈述通常可以通过使用前瞻性词语来识别，例如“可能”、“应该”、“可能”、“打算”、“估计”、“计划”、“预期”、“期望”、“相信”或“继续”，或其负面或类似的变化。本新闻稿中的前瞻性声明包括有关公司计划的CYB003临床试验和计划策略的声明；其他欧洲研究地点的计划；CYB003有可能比现有疗法提供显着改善；CYB003在2024年年中进入3期试验；BTD提供的药物开发时间表的潜在减少；以及该公司专有的药物发现平台，创新的药物输送系统，新颖的配方方法和精神健康障碍的治疗方案。。

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements.

这些前瞻性陈述是基于做出此类陈述时公司管理层的合理假设和估计。由于前瞻性陈述涉及已知和未知的风险、不确定性和其他因素，可能导致公司的实际结果、业绩或成就与此类前瞻性陈述中明示或暗示的任何未来结果、业绩或成就存在重大差异，因此未来的实际结果可能会产生重大差异。

Such factors, among other things, include: implications of the spread of COVID-19 on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in each of the Company's management's discussion and analysis for the three and nine month periods ended December 31, 2023, and the Company’s annual information form for the year ended March 31, 2023, which are available under the Company's profile on www.sedarplus.ca and with the U.S.

除其他因素外，这些因素包括：新型冠状病毒传播对公司运营的影响；总体宏观经济状况的波动；证券市场波动；对迷幻药市场规模的期望；公司成功实现其业务目标的能力；增长计划；政治、社会和环境不确定性；员工关系；存在可能对公司经营所在市场施加限制的法律法规；以及公司管理层在截至2023年12月31日的三个月和九个月期间的讨论和分析中列出的风险因素，以及截至2023年3月31日的公司年度信息表，这些信息可在www.sedarplus.ca上的公司简介和美国。

Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or inte.

证券交易委员会关于EDGAR的网站：www.sec.gov。虽然本新闻稿中的前瞻性陈述是基于公司管理层认为或当时认为是合理的假设，但公司无法向股东保证实际结果与此类前瞻性陈述一致，因为可能还有其他因素导致结果不符合预期、估计或不一致。

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds.

Cybin没有就Cybin的拟议产品提出任何医疗、治疗或健康福利要求。美国食品和药物管理局、加拿大卫生部或其他类似监管机构尚未评估有关裸盖菇素、迷幻色胺、色胺衍生物或其他迷幻化合物的索赔。

The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed.

此类产品的功效尚未得到批准研究的证实。不能保证使用裸盖菇素、迷幻色胺、色胺衍生物或其他迷幻化合物可以诊断、治疗、治愈或预防任何疾病或病症。需要严格的科学研究和临床试验。

Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations..

Cybin尚未对其拟议产品的使用进行临床试验。提及潜在产品的质量，一致性，有效性和安全性并不意味着Cybin在临床试验中验证了这一点，也不意味着Cybin将完成此类试验。如果Cybin无法获得商业化业务所需的批准或研究，可能会对Cybin的业绩和运营产生重大不利影响。。

Neither the Cboe Canada nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

加拿大芝加哥期权交易所（Cboe Canada）和纽约证券交易所（NYSE American LLC stock exchange）均未批准或不批准本新闻稿的内容，对本新闻稿内容的充分性和准确性概不负责。