Quantum Biopharma Announces That Sentinel Dosing Has Started for the Phase-1 Multiple Ascending Dose Clinical Trial for Lucid-21-302 (Lucid-Ms) in Australia
Quantum Biopharma Announces That Sentinel Dosing Has Started for the Phase-1 Multiple Ascending Dose Clinical Trial for Lucid-21-302 (Lucid-Ms) in Australia
TORONTO, ON / ACCESSWIRE / October 29, 2024 / Quantum BioPharma Ltd. (NASDAQ:QNTM)(CSE:QNTM)(FRA:0K91) ("Quantum BioPharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, HUGE Biopharma Australia Pty Ltd., that sentinel dosing has started its trial entitled "A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants."
安大略省多伦多/ACCESSWIRE/2024年10月29日/致力于建立创新资产和生物技术解决方案组合的生物制药公司量子生物制药有限公司(纳斯达克股票代码:QNTM)(FRA: 0K91)(“Quantum BioPharma” 或 “公司”)今天通过其子公司HUGE Biopharma Australia Pty Ltd.(CSE: QNTM)(FRA: 0K91)(“量子生物制药” 或 “公司”)今天通过其子公司HUGE Biopharma Australia Pty Ltd. sing已经开始了名为 “评估Lucid-21-302在健康成年参与者中的安全性和药代动力学的1期、随机、双盲、安慰剂对照、多次递增剂量研究” 的试验。
"We are thrilled that sentinel participants have received their first doses of Lucid-21-302. This marks an important step in advancing the Lucid-21-302 clinical development program in multiple sclerosis," said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma.
“我们很高兴哨兵参与者收到了第一剂Lucid-21-302。这标志着推进多发性硬化症Lucid-21-302临床开发计划的重要一步。” 量子生物制药公司科学与临床事务副总裁安德烈·赫鲁辛斯基博士说。
Prof. Lakshmi Kotra said, "This brings us one step closer to the human phase-2 efficacy trials with Lucid-21-302 and is an important one. We strongly believe it will prove to be a potentially promising therapeutic when it advances into phase-2 efficacy clinical trials for the treatment of degenerative condition in multiple sclerosis". Prof. Kotra serves on the board of Quantum BioPharma and discovered Lucid-21-302.
拉克希米·科特拉教授说:“这使我们离Lucid-21-302的人体2期疗效试验又近了一步,而且是一项重要的试验。我们坚信,当它进入治疗多发性硬化症退行性疾病的第二阶段疗效临床试验时,它将被证明是一种潜在的有前途的治疗方法”。科特拉教授在 Quantum BioPharma 的董事会任职,他发现了 Lucid-21-302。
Corporate Update
企业最新动态
Quantum BioPharma has retained the services of AGORA Internet Relations Corp. ("Agoracom"), Independent Trading Group ("ITG"), Buyins, Inc. ("Buyins") and Stockjock.com LP ("Stockjock") who will each play a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants. Management has made this decision following a thorough review of capital on hand and allocated these resources to the following companies it has engaged to conduct Investor Relations Activities (as defined in the policies of the Canadian Securities Exchange) on its behalf.
Quantum Biopharma保留了AGORA互联网关系公司(“Agoracom”)、独立交易集团(“ITG”)、Buyins, Inc.(“Buyins”)和Stockjock.com LP(“Stockjock”)的服务,他们将在协助公司提高市场知名度以及促进与股东和其他市场参与者的富有成效的持续对话方面发挥关键作用。管理层是在对手头资本进行全面审查后做出这一决定的,并将这些资源分配给了其委托代表其开展投资者关系活动(定义见加拿大证券交易所的政策)的以下公司。
Agoracom, based at 505 Consumers Rd, North York, Canada has been engaged for an initial period of 3 months, for C$25,000, with either party having the right to terminate the engagement upon providing 30-days' notice.
总部位于加拿大北约克消费者路505号的Agoracom已开始为期3个月,价格为25,000加元,任何一方都有权在提前30天通知后终止合约。
ITG will trade shares of the Company on the Canadian Securities Exchange to maintain an orderly market, improve the liquidity of the Company's shares and provide the Company with market intelligence. Under the terms of the agreement, ITG will receive a fee of C$7,500 per month for a minimum period of 3 months. After the initial 3 month period, the agreement may be terminated by the Company at any time upon 30 days written notice. The Company and ITG are unrelated entities. ITG has no present, direct or indirect interest in the Company or its securities. There are no performance factors in the agreement, and ITG will not receive shares or options as compensation. ITG is a member of the Investment Industry Regulatory Organization of Canada. Accordingly, ITG can access all Canadian Stock Exchanges and Alternative Trading Systems.
ITG将在加拿大证券交易所交易公司的股票,以维持市场秩序,改善公司股票的流动性并为公司提供市场情报。根据协议条款,ITG每月将获得至少3个月的7,500加元的费用。在最初的3个月期限过后,公司可以在收到30天书面通知后随时终止该协议。该公司和ITG是无关的实体。ITG在公司或其证券中没有现有、直接或间接的权益。协议中没有绩效因素,ITG不会获得股票或期权作为补偿。ITG 是加拿大投资行业监管组织的成员。因此,ITG可以访问所有加拿大证券交易所和另类交易系统。
Buyins based at 417 Orchid Avenue, Corona del Mar, CA has been engaged for a period of 1 month, for USD$15,000, with either party having the right to terminate the engagement upon providing 10-days notice.
总部位于加利福尼亚州科罗纳德尔玛兰花大道417号的Buyins已签订了为期1个月的合同,价格为15,000美元,任何一方都有权在发出10天通知后终止合约。
Stockjock based at 22287 Mullholland Hwy., Calabasas, CA has been engaged for 3 events, for USD$15,000, with either party having the right to terminate the engagement upon providing 10-days notice.
总部位于加利福尼亚州卡拉巴萨斯穆赫兰高速公路22287号的Stockjock已参与了3场活动,费用为15,000美元,任何一方都有权在发出10天通知后终止活动。
About Quantum BioPharma Ltd.
关于量子生物制药有限公司
Quantum BioPharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. ("Lucid"), Quantum BioPharma is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum BioPharma invented UNBUZZD and spun out its OTC version to a company, Celly Nutrition Corp. ("Celly Nutrition"), led by industry veterans. Quantum BioPharma retains ownership of 25.71% (as of June 30, 2024) of Celly Nutrition at . The agreement with Celly Nutrition also includes royalty payments of 7% of sales from unbuzzd until payments to Quantum BioPharma total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Additionally, Quantum BioPharma retains a large tax loss carry forward of approximately C$130 million and could be utilized in the future to offset tax payable obligations against future profits. Quantum BioPharma retains 100% of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses. Quantum BioPharma maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property.
Quantum BioPharma是一家生物制药公司,致力于建立创新资产和生物技术解决方案组合,使用处于不同开发阶段的候选药物治疗具有挑战性的神经退行性和代谢性疾病以及酒精滥用障碍。量子生物制药通过其全资子公司Lucid Psycheeceuticals Inc.(“Lucid”)专注于其主要化合物Lucid-MS的研发。Lucid-MS 是一种获得专利的新化学实体,在临床前模型中被证明可以预防和逆转髓磷脂降解,这是多发性硬化的潜在机制。Quantum BioPharma发明了UNBUZZD,并将其非处方药版本分拆给了一家由业内资深人士领导的名为Celly Nutrition Corp.(“Celly Nutrition”)的公司。Quantum BioPharma保留了Celly Nutrition公司25.71%(截至2024年6月30日)的所有权。与Celly Nutrition的协议还包括从unbuzzd到向Quantum BioPharma支付总额为2.5亿美元的销售额的7%的特许权使用费。一旦达到2.5亿美元,特许权使用费将永久降至3%。此外,Quantum BioPharma保留了约1.3亿加元的巨额税收亏损结转,将来可用于抵消未来利润的应纳税义务。Quantum BioPharma保留开发专门用于制药和医疗用途的类似产品或替代配方的100%权利。Quantum BioPharma通过其全资子公司FSD Strategic Investments Inc. 维持战略投资组合,该公司代表以住宅或商业地产为担保的贷款。
Forward-Looking Information
前瞻性信息
This press release contains certain "forward-looking statements" within the meaning of applicable Canadian securities law. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, identified by words or phrases such as "believes", "anticipates", "expects", "is expected", "scheduled", "estimates", "pending", "intends", "plans", "forecasts", "targets", or "hopes", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "would", "will", "should" "might", "will be taken", or "occur" and similar expressions) are not statements of historical fact and may be forward-looking statements. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the Company's focus on the research and development of Lucid-MS to prevent and reverse myelin degradation; the Company's Lucid-21-302 clinical development program in multiple sclerosis advancing towards human phase-2 efficacy trials; the Company's intention to utilize its large tax loss to offset future tax payable obligations against future profits; the Company's intention to retain 100% of the rights to develop products for pharmaceutical and medical uses; the Company's intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; the Company's belief that its share price does not affect its current financial position and recent operational improvements and that a strong cash and cash equivalents provide a solid foundation for operations and potential growth opportunities; Agoracom, ITG, Buyins, and Stockjock playing a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants; Agoracom being engaged by the Company for a period of three months; ITG trading shares of the Company on the CSE to maintain an orderly market, improve the liquidity of the Company's shares, and providing the company with market intelligence; Buyins being engaged by the company for a period of one month; and Stockjock being engaged by the Company for three events.
本新闻稿包含适用的加拿大证券法所指的某些 “前瞻性陈述”。任何表达或涉及有关预测、期望、信念、计划、预测、目标、假设或未来事件或绩效的讨论的陈述(通常,但并非总是如此)以 “相信”、“预期”、“预期”、“预期”、“预期”、“预期”、“预期”、“估计”、“待定”、“打算”、“计划”、“预测”、“目标” 或 “希望” 或变体等词语或短语来识别某些行动、事件或结果 “可能”、“将”、“将”、“应该”、“可能采取” 或 “发生” 的措辞、短语或陈述,以及类似的表达)不是历史事实的陈述,可能是前瞻性陈述。此处包含的前瞻性信息和前瞻性陈述包括但不限于以下方面的陈述:公司专注于Lucid-MS的研究和开发,以防止和逆转髓磷脂降解;公司在多发性硬化症方面的Lucid-21-302临床开发计划推进人体2期疗效试验;公司打算利用其巨额税收损失来抵消未来的应纳税义务;公司打算保留100%的权利为以下对象开发产品药品和医疗用途;公司打算通过FSD Strategic Investments Inc. 维持战略投资组合;公司认为其股价不会影响其当前财务状况和最近的运营改善,强劲的现金和现金等价物为运营和潜在的增长机会提供了坚实的基础;Agoracom、ITG、Buyins和Stockjock在协助公司提高市场知名度和提高生产率方面发挥了关键作用,继续与股东对话和其他市场参与者;公司聘请Agoracom为期三个月;ITG在CSE上交易公司的股票,以维持市场秩序,改善公司股票的流动性并向公司提供市场情报;该公司聘请Buyins为期一个月;公司聘请Stockjock参加三次活动。
Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company's assessment of market conditions, its ability to gain market share, and its potential competitive edge are accurate; the Company will have the ability to carry out its plans with respect to its new innovation and offerings, including its ability to conduct research and development of Lucid-MS; the Company's Lucid-21-302 clinical development program in multiple sclerosis will advance towards human phase-2 efficacy trials; the Company will retain 100% of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses; the Company will seek new business opportunities; the Company will increase efficiency in its processes and partnerships; the Company will have the ability to carry out its other goals and objectives; the Company is accurate in its belief that its share price does not current financial position and recent operational improvements; that a strong cash and cash equivalents will provide a solid foundation for operations and potential growth opportunities; Agoracom, ITG, Buyins, and Stockjock will play a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants; Agoracom will be engaged by the Company for a period of three months; ITG will be trading shares of the Company on the CSE to maintain an orderly market, improve the liquidity of the Company's shares, and provide the company with market intelligence; Buyins will be engaged by the company for a period of one month; and Stockjock will be engaged by the Company for three events.
本新闻稿中的前瞻性信息基于某些假设和预期的未来事件,即:公司对市场状况、获得市场份额的能力和潜在竞争优势的评估是准确的;公司将有能力执行有关其新创新和产品的计划,包括进行Lucid-MS研发的能力;公司的多发性硬化症Lucid-21-302临床开发计划将进入人类第二阶段功效试验;公司将保留开发专门用于制药和医疗用途的类似产品或替代配方的100%权利;公司将寻求新的商机;公司将提高其流程和合作伙伴关系的效率;公司将有能力实现其其他宗旨和目标;公司准确地认为其股价不是当前的财务状况和最近的运营改善;强劲的现金和现金等价物将为运营和潜力提供坚实的基础增长机会;Agoracom、ITG、Buyins和Stockjock将在协助公司提高市场知名度、促进与股东和其他市场参与者的富有成效的持续对话方面发挥关键作用;公司将聘请Agoracom为期三个月;ITG将在CSE上交易公司股票,以维持市场秩序,改善公司股票的流动性,为公司提供市场情报;该公司将聘请Buyins为期一个月;Stockjock将聘用受公司聘请参加三场活动。
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the Company being inaccurate in its belief that its share price does not current financial position and recent operational improvements; and that a strong cash and cash equivalents will not provide a solid foundation for operations and potential growth opportunities; the Company's inability to carry out its plans with respect to its new innovation and offerings; the Company's inability to utilize its tax loss; the Company's inability to retain 100% of the rights to develop products for pharmaceutical or medical uses; the Company's inability to enhance its product development capabilities and/or maintain a portfolio of strategic investments; the Company's Lucid-21-302 clinical development program in multiple sclerosis not advancing towards human phase-2 efficacy trials; Agoracom, ITG, Buyins, and Stockjock not playing a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants; Agoracom not being engaged by the Company for a period of three months; ITG not trading shares of the Company on the CSE to maintain an orderly market, improve the liquidity of the Company's shares, or provide the company with market intelligence; Buyins not being engaged by the company for a period of one month; Stockjock not being engaged by the Company for three events; and the risks discussed in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2023, final short form base shelf prospectus dated December 22, 2023 and registration statement on Form F-3 containing a base shelf prospectus, each under the heading "Risk Factors". These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Readers are cautioned that the foregoing list is not exhaustive. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company's expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events, or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.
这些陈述涉及已知和未知的风险、不确定性和其他因素,可能导致实际业绩、业绩或成就与此类陈述所表达或暗示的结果存在重大差异,包括但不限于:公司认为其股价不符合当前财务状况和近期的运营改善;强劲的现金和现金等价物不会为运营和潜在增长机会提供坚实的基础;公司无法通过以下方式执行其计划:尊重其新的创新和产品;公司无法利用其税收损失;公司无法保留开发药品或医疗用途产品的100%权利;公司无法增强其产品开发能力和/或维持战略投资组合;公司的多发性硬化症Lucid-21-302临床开发计划未进入人体2期疗效试验;Agoracom、ITG、Buyins和Stockjock未推进在协助公司扩大市场方面发挥关键作用提高认识并促进与股东和其他市场参与者的富有成效的持续对话;公司在三个月内没有聘请Agoracom;ITG没有在CSE上交易公司的股票,以维持市场秩序、改善公司股票的流动性或向公司提供市场情报;公司在一个月内没有聘请买入;公司在三次活动中没有聘请Stockjock;以及公司本财年20-F表年度报告中讨论的风险截至2023年12月31日的截止日期为2023年12月22日的最终简式基本货架招股说明书以及包含基本货架招股说明书的F-3表格注册声明,每份招股说明书的标题均为 “风险因素”。应仔细考虑这些因素,读者不应过分依赖前瞻性陈述。请读者注意,上述清单并不详尽。尽管本新闻稿中包含的前瞻性陈述基于管理层认为的合理假设,但公司无法向读者保证实际业绩将与这些前瞻性陈述一致。本新闻稿中包含的前瞻性陈述受本警示声明的明确限制,反映了公司截至本新闻稿发布之日的预期,此后可能会发生变化。除非适用法律要求,否则公司没有义务更新或修改任何前瞻性陈述,无论是由于新的信息、估计或观点、未来事件或业绩还是其他原因,也没有义务解释后续实际事件与此类前瞻性信息之间的任何实质性区别。
The reader is urged to refer to additional information relating to Quantum BioPharma, including its annual information form, can be located on the SEDAR+ website at and on the EDGAR section of the United States Securities and Exchange Commission's website at www.sec.gov for a more complete discussion of such risk factors and their potential effects.
我们敦促读者参考与Quantum BioPharma相关的其他信息,包括其年度信息表,可在SEDAR+网站以及美国证券交易委员会网站www.sec.gov的EDGAR部分找到,以更全面地讨论此类风险因素及其潜在影响。
Contacts:
联系人:
Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: Zsaeed@quantumbiopharma.com
Telephone: (416) 854-8884
量子生物制药有限公司
Zeeshan Saeed,创始人、首席执行官兼董事会执行联席主席
电子邮件:Zsaeed@quantumbiopharma.com
电话:(416) 854-8884
Investor Relations
Email: ir@quantumbiopharma.com, info@quantumbiopharma.com
投资者关系
电子邮件:ir@quantumbiopharma.com,info@quantumbiopharma.com
SOURCE: Quantum BioPharma Ltd.
来源:量子生物制药有限公司
译文内容由第三方软件翻译。