COSCIENS Biopharma Inc. Provides Corporate Update and Highlights Pipeline Prioritization
COSCIENS Biopharma Inc. Provides Corporate Update and Highlights Pipeline Prioritization
Company leveraging core competencies to develop and commercialize
natural-based products to improve health and wellness
公司利用核心竞争力开发和商业化
基于天然的产品以改善健康和福祉
Streamlined efficiencies and cost cutting measures taken to refine operations and development pathway forward
采取精简效率和削减成本措施来优化运营和未来发展路径
New corporate presentation outlining key development areas to be available in January 2025
新的企业演示文稿将于2025年1月提供,概述关键发展领域
TORONTO, ONTARIO, Dec. 23, 2024 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) ("COSCIENS" or the "Company"), a specialty biopharmaceutical company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products, today provided a corporate update and reiterated its pipeline prioritization.
加拿大安大略省,多伦多,2024年12月23日(全球新闻网) -- COSCIENS Biopharma Inc. (纳斯达克: CSCI) (TSX: CSCI)("COSCIENS"或"公司"),是一家开发和商业化多样化护肤药品、营养补充剂和药品产品的专门生物制药公司,今天提供了企业更新并重申了其管道优先级。
"Over the course of the last several months following the merger, we have taken strategic and deliberate steps to evaluate and prioritize our combined pipeline of products and programs. Through this effort, we have thoroughly evaluated the potential of our assets and prioritized the areas that we believe are high-value opportunities, and we plan to move forward focusing our resources on advancing a pipeline of natural-based products leveraging our core technologies. We believe that this focus, spanning cosmeceuticals, nutraceuticals and pharmaceuticals, positions us with near and long-term life science growth drivers and the potential to become a global leader in natural-based products for health and wellness," stated Gilles Gagnon, M.Sc., MBA, President and CEO of COSCIENS. "In addition, we have continued to make progress driving revenues and growing our active ingredients base business. We are looking to kick off 2025 with a clear line of sight towards execution of our business plan and believe we are well-positioned for a transformational year."
“在过去几个月的合并后,我们采取了战略性和谨慎的步骤,评估并优先考虑我们合并后的产品和项目管道。通过这一努力,我们彻底评估了我们的资产潜力,并优先关注我们认为具备高价值机会的领域,我们计划在自然基础产品的管道上,利用我们的核心技术,集中资源向前推进。我们相信这一专注涵盖美容药品、营养保健品和药品,使我们具备了近期和长期的生命科学增长驱动因素,有潜力成为全球健康和保健领域自然基础产品的领导者,”COSCIENS总裁兼首席执行官Gilles Gagnon万.Sc.,MBA表示。“此外,我们还持续推动收入增长,扩大活性成分基础业务。我们希望在2025年初以清晰的执行计划开启,认为我们在转型的一年中处于良好位置。”
Development Projects Update
开发项目更新
Pharmaceuticals:
药品:
-
Avenanthramides Tablets (Avs) in Development as an Anti-Inflammatory: The Phase 1-2a clinical trial being conducted at the Montreal Heart Institute has fully completed the Phase 1 part of the study with 72 subjects tested. No significant side effects have been observed from ascending doses ranging from 30 mg to 960 mg. The Company expects the Phase 2a efficacy study will be initiated in Q1 2025, with expected completion in Q3 2025.
- 阿维纳那米德片(Avs)作为抗炎药正在开发中:在蒙特利尔心脏研究所进行的1-2期临床试验已完全完成研究的第1阶段,测试了72名受试者。从30毫克到960毫克的递增剂量未观察到显著的副作用。公司预计将于2025年第一季度启动第2a期有效性研究,预计在2025年第三季度完成。
Cosmeceuticals:
药妆:
-
Enriched Oat Flour with High Concentration of Avenanthramides: We have successfully produced and sold small batches for inclusion in cream formulations.
-
JuventeDC Product Line: New website, juventedc.com, was launched on December 19, 2024.
- 高浓度阿维纳那米德的富硒燕麦粉:我们成功生产并销售了小批量用于霜剂配方的产品。
- JuventeDC产品线:新网站juventedc.com于2024年12月19日上线。
Nutraceuticals:
营养补充剂:
-
Yeast Beta Glucan (YBG) Powder - Immune Booster: Our YBG product has been successfully manufactured as part of our PGX scale up project in Edmonton, Alberta. Our YBG product is being finalized in capsule form with the goal to commercialize it as an immune booster in Q2 2025.
-
Oat Beta Glucan (OBG) Chewable Bar – Cholesterol Reduction: We have successfully developed a unique, standardized formulation for a healthy confection which includes a high concentration of OBG with daily dosage according to approved claims in 10 developed countries. The substantive claims include reduction of LDL cholesterol, supporting cardiovascular health reduction of Type 2 diabetes risks, source of fiber for the maintenance of general good health and support of a healthy digestive system. COSCIENS' team anticipates the official commercial launch of its chewable bar OBG natural health product in Q1 2025, marking an important chapter in the Company's journey toward promoting wellness while expanding its business model.
- 酵母β-葡聚糖(YBG)粉末 - 免疫增强剂:我们的YBG产品已成功制造,作为我们在艾德蒙顿(阿尔伯塔)推进的PGX项目的一部分。我们的YBG产品正在以胶囊形式最终定型,目标是于2025年第二季度将其商业化作为免疫增强剂。
- 燕麦β-葡聚糖(OBG)可嚼棒 - 降胆固醇:我们成功开发了一种独特的标准化配方,制作出一种健康的糖果,其中包含高浓度的OBG,每日剂量符合在10个已开发国家批准的声明。实质性声明包括降低LDL胆固醇,支持心血管健康,降低2型糖尿病风险,作为维持一般健康的纤维来源以及支持健康的消化系统。COSCIENS团队预计将在2025年第一季度正式推出其可嚼的OBG自然健康产品,标志着公司在推广健康的同时扩展其业务模型的重要篇章。
Macimorelin:
麦可睦林:
- On August 27, 2024, the Company announced that the Phase 3 safety and efficacy study AEZS-130-P02 (the "DETECT-trial") evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency ("CGHD") had failed to meet its primary endpoints according to the definitions in the study protocol. Based on the results of the study, we are prioritizing our pipeline moving forward and repositioning the Company as a pure play Life Science's business offering natural-based products. Therefore, while maintaining the current commercial indication for the use of macimorelin for the diagnosis of Adult Growth Hormone Deficiency ("AGHD"), the Company has decided to not make any future investments in macimorelin for the diagnosis of CGHD. Consequently, in order to further ensure the streamlining of operations and reduce costs, the roles of some additional members of management have been terminated, including Dr. Nicola Ammer, Chief Medical Officer, which will be ending on March 31, 2025.
- 2024年8月27日,公司宣布Phase 3安全性和有效性研究 AEZS-130-P02("DETEC试验")评估麦可睦林用于诊断儿童期生长激素缺乏("CGHD")未能满足研究方案中的主要指标。根据研究结果,我们正在优先推进我们的管线,并将公司重新定位为提供基于天然产品的纯生命科学业务。因此,在维持麦可睦林用于诊断成人生长激素缺乏("AGHD")的当前商业指示的同时,公司决定不再对麦可睦林用于诊断CGHD进行任何未来投资。因此,为了进一步确保运营效率并降低成本,一些额外管理人员的角色已被终止,包括首席医疗官Nicola Ammer博士,该职位将于2025年3月31日结束。
"On behalf of the entire Board and Company, we are grateful to the members of the team for their years of dedicated service. Nicola has been a long-standing, valued member of our team and provided years of expertise for the development of macimorelin (Macrilen; Ghryvelin), the first and only U.S. FDA and European Medicines Agency approved oral test indicated for the diagnosis of adult growth hormone deficiency. We are thankful to each member of our team and sincerely thank them for the key roles they played," concluded Mr. Gagnon.
“代表整个董事会和公司,我们对团队成员多年来的奉献服务表示感谢。尼古拉是一位长期以来受到重视的团队成员,为macimorelin(Macrilen;Ghyrvelin)的开发提供了多年的专业知识,这是美国FDA和欧洲药品管理局批准的首个也是唯一的口服测试,用于诊断成人生长激素缺乏症。我们感谢团队的每一位成员,并衷心感谢他们所发挥的关键角色。”加戈农先生总结道。
The Company plans to release a new corporate presentation outlining key development areas and upcoming milestones in January 2025.
公司计划在2025年1月发布一份新的企业演示文稿,概述关键开发领域和即将到来的里程碑。
About COSCIENS Biopharma Inc.
关于COSCIENS生物制药公司。
COSCIENS is a specialty biopharmaceutical company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products. Our technology includes proprietary extraction technology, which is applied to the production of active ingredients from renewable plant resources currently used in cosmeceutical products (i.e., oat beta glucan and avenanthramides which are found in leading skincare product brands like Aveeno and Burt's Bees formulations) and being developed as potential nutraceuticals and/or pharmaceuticals. Our consolidated portfolio also includes macimorelin (Macrilen; Ghryvelin), the first and only U.S. FDA and European Medicines Agency approved oral test indicated for the diagnosis of adult growth hormone deficiency ("AGHD").
COSCIENS是一家专业生物制药公司,开发和商业化多样化的美容药品、营养保健品和药品组合。我们的技术包括专有提取技术,可用于从可再生植物资源中生产活性成分,目前这些成分用于美容药品(例如,燕麦β-葡聚糖和在领先护肤品牌如Aveeno和Burt's Bees配方中发现的阿维那氨酸),同时正在开发潜在营养保健品和/或药品。我们的整合组合还包括macimorelin(Macrilen; Ghryvelin),这是美国FDA和欧洲药品管理局批准的首个也是唯一的口服检测,旨在诊断成人生长激素缺乏症("AGHD")。
The Company is listed on the NASDAQ Capital Market and the Toronto Stock Exchange, and trades on both exchanges under the ticker symbol "CSCI". For more information, please visit COSCIENS' website at .
本公司在纳斯达克资本市场和多伦多证券交易所上市,并在两个交易所以逐笔明细"CSCI"进行交易。有关更多信息,请访问COSCIENS的网站。
Forward-Looking Statements
前瞻性声明
Certain statements in this news release, referred to herein as "forward-looking statements", constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended, and "forward-looking information" under the provisions of Canadian securities laws. All statements, other than statements of historical fact, that address circumstances, events, activities, or developments that could or may or will occur are forward-looking statements. When used in this news release, words such as "anticipate", "assume", "believe", "could", "expect", "forecast", "future", "goal", "guidance", "intend", "likely", "may", "would" or the negative or comparable terminology as well as terms usually used in the future and the conditional are generally intended to identify forward-looking statements, although not all forward-looking statements include such words. Forward-looking statements in this news release include, but are not limited to, statements relating to: our goals and expectations regarding our plans related to the development, manufacture or commercialization of our products, our plans to drive revenues from our products, our expectation we have the potential to become a global leader in natural-based products for health and wellness.
本新闻稿中的某些声明,以下称为"前瞻性声明",构成1995年美国私人证券诉讼改革法案所定义的"前瞻性声明",以及根据加拿大证券法的规定的"前瞻性信息"。所有声明,除历史事实声明外,涉及可能发生或将发生的情况、事件、活动或发展均为前瞻性声明。当在本新闻稿中使用时,像"预期"、"假设"、"相信"、"可能"、"期望"、"预测"、"未来"、"目标"、"指导"、"打算"、"很可能"、"可能"、"将"或否定词或类似术语以及通常在未来和条件下使用的术语一般用于标识前瞻性声明,尽管并非所有前瞻性声明都包含这些词。本新闻稿中的前瞻性声明包括但不限于与我们的目标和期望相关的声明,涉及我们关于开发、制造或商业化我们产品的计划,我们推动产品营业收入的计划,我们预计有潜力成为全球基于自然的健康和保健产品的领导者。
Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by the Company as of the date of such statements, are inherently subject to significant business, economic, operational and other risks, uncertainties, contingencies and other factors, including those described below, which could cause actual results, performance or achievements of the combined Company to be materially different from results, performance or achievements expressed or implied by such forward-looking statements and, as such, undue reliance must not be placed on them.
前瞻性声明必然基于许多因素和假设,这些假设虽然在该声明日期被公司认为是合理的,但本质上受到重大业务、经济、运营以及其他风险、不确定性、意外情况和其他因素的影响,包括下面描述的因素,这可能导致合并公司的实际结果、表现或成就与这些前瞻性声明所表达或暗示的结果、表现或成就存在重大差异,因此不应对其过度依赖。
Forward-looking statements involve known and unknown risks and uncertainties which include, among others: the combined Company's present and future business strategies; operations and performance within expected ranges; anticipated future cash flows; local and global economic conditions and the environment in which the combined Company operates; anticipated capital and operating costs; uncertainty in our revenue generation from our marketed products, product development and related clinical trials and validation studies; results from our products under development may not be successful or may not support advancing the product; the failure of the DETECT-trial to achieve its primary endpoint in CGHD may impact the market for macimorelin (Macrilen; Ghryvelin) in AGHD and the existing relationships we have for that product; ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence on sales by and revenue from our main distributor of our legacy Ceapro products and its customers, the continued availability of funds and resources to successfully commercialize our products; the ability to secure strategic partners for late stage development, marketing, and distribution of our products; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our ability to protect and enforce our patent portfolio and intellectual property; and our ability to continue to list our common shares on the NASDAQ Capital Market.
前瞻性声明涉及已知和未知的风险和不确定性,这些风险和不确定性包括但不限于:合并公司当前和未来的商业战略;在预期范围内的运营和表现;未来现金流的预期;合并公司运营的地方和全球经济条件及环境;预期的资本和运营成本;我们对已上市产品、产品开发及相关临床试验和验证研究的收入生成的不确定性;正在开发的产品的结果可能不成功或可能不支持推进该产品;DETECT试验未能达到其在CGHD中的主要终点可能影响macimorelin(Macrilen;Ghryvelin)在AGHD市场的表现,以及我们与该产品的现有关系;为继续我们目前计划的运营而筹集资金和获得融资的能力;我们目前对主要分销商及其客户销售和收入的重度依赖,继续获得资金和资源以成功商业化我们的产品的能力;为晚期开发、营销和分销我们的产品而确保战略合作伙伴的能力;与其他制药公司签订外许可、开发、制造、营销和分销协议的能力,以及保持这些协议的有效性;保护和执行我们的专利组合和知识产权的能力;以及我们继续在纳斯达克资本市场上市的普通股的能力。
Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those discussed in our Annual Report on Form 20-F and MD&A filed under the Company's profile on SEDAR+ at and on EDGAR at www.sec.gov. We disclaim any obligation to update any such risks or uncertainties or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.
投资者应咨询我们与加拿大和美国证券委员会提交的季度和年度文件,以获取有关风险和不确定性的更多信息,包括我们在表格20-F和MD&A中的年度报告,并在SEDAR+及www.sec.gov的公司资料中提交。我们对此类风险或不确定性更新的任何义务,以及公开宣布对本文件中包含的任何前瞻性声明的修订以反映未来结果、事件或发展的义务,概不负责,除非政府机构或适用法律要求这样做。
No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this news release.
没有任何证券监管机构批准或不批准本新闻稿的内容。多伦多证券交易所对本新闻稿的充分性或准确性不承担任何责任。
Issuer:
发行方:
Gilles R. Gagnon
President & CEO
+1 (780) 421-4555
E: ggagnon@cosciensbio.com
吉尔·R·加农
总裁兼首席执行官
+1 (780) 421-4555
E: ggagnon@cosciensbio.com
Investor Contact:
Jenene Thomas
JTC Team
T (US): +1 (908) 824-0775
E: csci@jtcir.com
投资者联系人:
珍妮·托马斯
JTC团队
t (美国): +1 (908) 824-0775
E: csci@jtcir.com