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COSCIENS Biopharma Inc. Provides Corporate Update and Highlights Pipeline Prioritization

COSCIENS Biopharma Inc. Provides Corporate Update and Highlights Pipeline Prioritization

COSCIENS生物製藥公司提供公司更新並強調管線優先級
GlobeNewswire ·  12/23 20:45

Company leveraging core competencies to develop and commercialize
natural-based products to improve health and wellness

公司利用核心競爭力開發和商業化
基於天然的產品以改善健康和福祉

Streamlined efficiencies and cost cutting measures taken to refine operations and development pathway forward

採取精簡效率和削減成本措施來優化運營和未來發展路徑

New corporate presentation outlining key development areas to be available in January 2025

新的企業演示文稿將於2025年1月提供,概述關鍵發展領域

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,多倫多,2024年12月23日(全球新聞網) -- COSCIENS Biopharma Inc. (納斯達克: CSCI) (TSX: CSCI)("COSCIENS"或"公司"),是一家開發和商業化多樣化護膚藥品、營養補充劑和藥品產品的專門生物製藥公司,今天提供了企業更新並重申了其管道優先級。

"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."

「在過去幾個月的合併後,我們採取了戰略性和謹慎的步驟,評估並優先考慮我們合併後的產品和項目管道。通過這一努力,我們徹底評估了我們的資產潛力,並優先關注我們認爲具備高價值機會的領域,我們計劃在自然基礎產品的管道上,利用我們的核心技術,集中資源向前推進。我們相信這一專注涵蓋美容藥品、營養保健品和藥品,使我們具備了近期和長期的生命科學增長驅動因素,有潛力成爲全球健康和保健領域自然基礎產品的領導者,」COSCIENS總裁兼首席執行官Gilles Gagnon萬.Sc.,MBA表示。「此外,我們還持續推動收入增長,擴大活性成分基礎業務。我們希望在2025年初以清晰的執行計劃開啓,認爲我們在轉型的一年中處於良好位置。」

Development Projects Update

開發項目更新

Pharmaceuticals:

藥品:

  • 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.
  • 阿維納那米德片(Avs)作爲抗炎藥正在開發中:在蒙特利爾心臟研究所進行的1-2期臨牀試驗已完全完成研究的第1階段,測試了72名受試者。從30毫克到960毫克的遞增劑量未觀察到顯著的副作用。公司預計將於2025年第一季度啓動第2a期有效性研究,預計在2025年第三季度完成。

Cosmeceuticals:

藥妝:

  • 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.
  • 高濃度阿維納那米德的富硒燕麥粉:我們成功生產並銷售了小批量用於霜劑配方的產品。
  • JuventeDC產品線:新網站juventedc.com於2024年12月19日上線。

Nutraceuticals:

營養補充劑:

  • 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 - 免疫增強劑:我們的YBG產品已成功製造,作爲我們在艾德蒙頓(阿爾伯塔)推進的PGX項目的一部分。我們的YBG產品正在以膠囊形式最終定型,目標是於2025年第二季度將其商業化作爲免疫增強劑。
  • 燕麥β-葡聚糖(OBG)可嚼棒 - 降膽固醇:我們成功開發了一種獨特的標準化配方,製作出一種健康的糖果,其中包含高濃度的OBG,每日劑量符合在10個已開發國家批准的聲明。實質性聲明包括降低LDL膽固醇,支持心血管健康,降低2型糖尿病風險,作爲維持一般健康的纖維來源以及支持健康的消化系統。COSCIENS團隊預計將在2025年第一季度正式推出其可嚼的OBG自然健康產品,標誌着公司在推廣健康的同時擴展其業務模型的重要篇章。

Macimorelin:

麥可睦林:

  • 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,公司宣佈Phase 3安全性和有效性研究 AEZS-130-P02("DETEC試驗")評估麥可睦林用於診斷兒童期生長激素缺乏("CGHD")未能滿足研究方案中的主要指標。根據研究結果,我們正在優先推進我們的管線,並將公司重新定位爲提供基於天然產品的純生命科學業務。因此,在維持麥可睦林用於診斷成人生長激素缺乏("AGHD")的當前商業指示的同時,公司決定不再對麥可睦林用於診斷CGHD進行任何未來投資。因此,爲了進一步確保運營效率並降低成本,一些額外管理人員的角色已被終止,包括首席醫療官Nicola Ammer博士,該職位將於2025年3月31日結束。

"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.

「代表整個董事會和公司,我們對團隊成員多年來的奉獻服務表示感謝。尼古拉是一位長期以來受到重視的團隊成員,爲macimorelin(Macrilen;Ghyrvelin)的開發提供了多年的專業知識,這是美國FDA和歐洲藥品管理局批准的首個也是唯一的口服測試,用於診斷成人生長激素缺乏症。我們感謝團隊的每一位成員,並衷心感謝他們所發揮的關鍵角色。」加戈農先生總結道。

The Company plans to release a new corporate presentation outlining key development areas and upcoming milestones in January 2025.

公司計劃在2025年1月發佈一份新的企業演示文稿,概述關鍵開發領域和即將到來的里程碑。

About COSCIENS Biopharma Inc.

關於COSCIENS生物製藥公司。

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是一家專業生物製藥公司,開發和商業化多樣化的美容藥品、營養保健品和藥品組合。我們的技術包括專有提取技術,可用於從可再生植物資源中生產活性成分,目前這些成分用於美容藥品(例如,燕麥β-葡聚糖和在領先護膚品牌如Aveeno和Burt's Bees配方中發現的阿維那氨酸),同時正在開發潛在營養保健品和/或藥品。我們的整合組合還包括macimorelin(Macrilen; Ghryvelin),這是美國FDA和歐洲藥品管理局批准的首個也是唯一的口服檢測,旨在診斷成人生長激素缺乏症("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 .

本公司在納斯達克資本市場和多倫多證券交易所上市,並在兩個交易所以逐筆明細"CSCI"進行交易。有關更多信息,請訪問COSCIENS的網站。

Forward-Looking Statements

前瞻性聲明

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.

本新聞稿中的某些聲明,以下稱爲"前瞻性聲明",構成1995年美國私人證券訴訟改革法案所定義的"前瞻性聲明",以及根據加拿大證券法的規定的"前瞻性信息"。所有聲明,除歷史事實聲明外,涉及可能發生或將發生的情況、事件、活動或發展均爲前瞻性聲明。當在本新聞稿中使用時,像"預期"、"假設"、"相信"、"可能"、"期望"、"預測"、"未來"、"目標"、"指導"、"打算"、"很可能"、"可能"、"將"或否定詞或類似術語以及通常在未來和條件下使用的術語一般用於標識前瞻性聲明,儘管並非所有前瞻性聲明都包含這些詞。本新聞稿中的前瞻性聲明包括但不限於與我們的目標和期望相關的聲明,涉及我們關於開發、製造或商業化我們產品的計劃,我們推動產品營業收入的計劃,我們預計有潛力成爲全球基於自然的健康和保健產品的領導者。

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.

前瞻性聲明必然基於許多因素和假設,這些假設雖然在該聲明日期被公司認爲是合理的,但本質上受到重大業務、經濟、運營以及其他風險、不確定性、意外情況和其他因素的影響,包括下面描述的因素,這可能導致合併公司的實際結果、表現或成就與這些前瞻性聲明所表達或暗示的結果、表現或成就存在重大差異,因此不應對其過度依賴。

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.

前瞻性聲明涉及已知和未知的風險和不確定性,這些風險和不確定性包括但不限於:合併公司當前和未來的商業戰略;在預期範圍內的運營和表現;未來現金流的預期;合併公司運營的地方和全球經濟條件及環境;預期的資本和運營成本;我們對已上市產品、產品開發及相關臨牀試驗和驗證研究的收入生成的不確定性;正在開發的產品的結果可能不成功或可能不支持推進該產品;DETECT試驗未能達到其在CGHD中的主要終點可能影響macimorelin(Macrilen;Ghryvelin)在AGHD市場的表現,以及我們與該產品的現有關係;爲繼續我們目前計劃的運營而籌集資金和獲得融資的能力;我們目前對主要分銷商及其客戶銷售和收入的重度依賴,繼續獲得資金和資源以成功商業化我們的產品的能力;爲晚期開發、營銷和分銷我們的產品而確保戰略合作伙伴的能力;與其他製藥公司簽訂外許可、開發、製造、營銷和分銷協議的能力,以及保持這些協議的有效性;保護和執行我們的專利組合和知識產權的能力;以及我們繼續在納斯達克資本市場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.

投資者應諮詢我們與加拿大和美國證券委員會提交的季度和年度文件,以獲取有關風險和不確定性的更多信息,包括我們在表格20-F和MD&A中的年度報告,並在SEDAR+及www.sec.gov的公司資料中提交。我們對此類風險或不確定性更新的任何義務,以及公開宣佈對本文件中包含的任何前瞻性聲明的修訂以反映未來結果、事件或發展的義務,概不負責,除非政府機構或適用法律要求這樣做。

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.

沒有任何證券監管機構批准或不批准本新聞稿的內容。多倫多證券交易所對本新聞稿的充分性或準確性不承擔任何責任。

Issuer:

發行方:

Gilles R. Gagnon
President & CEO
+1 (780) 421-4555
E: ggagnon@cosciensbio.com

吉爾·R·加農
總裁兼首席執行官
+1 (780) 421-4555
E: ggagnon@cosciensbio.com

Investor Contact:
Jenene Thomas
JTC Team
T (US): +1 (908) 824-0775
E: csci@jtcir.com

投資者聯繫人:
珍妮·托馬斯
JTC團隊
t (美國): +1 (908) 824-0775
E: csci@jtcir.com


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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