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."
多倫多, ON / ACCESSWIRE / 2024年10月29日 / Quantum BioPharma有限公司 (納斯達克:QNTM)(CSE:QNTM)(FRA:0K91) ("Quantum BioPharma"或"公司"), 一家致力於建立創新資產和生物技術解決方案投資組合的生物製藥公司, 今天通過其子公司HUGE Biopharma Australia Pty Ltd.宣佈, Sentinel劑量已開始試驗, 標題爲"一項1期、隨機、雙盲、安慰劑對照、多重上升劑量研究以評估Lucid-21-302在健康成年參與者中的安全性和藥代動力學."
"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.
"我們很高興哨兵參與者已經接種了第一劑Lucid-21-302。這標誌着在多發性硬化症中推進Lucid-21-302臨牀開發計劃的重要一步,"Quantum BioPharma科學與臨牀事務副總裁安德烈·克魯辛斯基博士說道。
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.
Lakshmi Kotra教授表示:"這讓我們離Lucid-21-302的人體2期療效試驗又近了一步,這是一個重要的一步。我們堅信,當它進入治療多發性硬化症的2期療效臨牀試驗階段時,它將證明具有潛在的治療效果。"Kotra教授是Quantum BioPharma董事會成員,也是Lucid-21-302的發現者。
Corporate Update
公司動態
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已聘請AGORAInternet Plus-related關係公司("Agoracom"),獨立交易集團("ITG"),Buyins, Inc.("Buyins")和Stockjock.com LP("Stockjock")的服務,他們將各自扮演關鍵角色,幫助公司提升市場知名度,並與股東和其他市場參與者進行富有成效的持續對話。管理層在徹底審核手頭的資本後做出了這一決定,並將這些資源分配給了以下公司,以代表公司開展投資者關係活動(根據加拿大證券交易所的政策定義)。
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.
Agoracom,總部位於加拿大北約克消費者路505號,已與公司簽訂初始爲期3個月的合同,費用爲25,000加元,任何一方均有權在提前30天通知的情況下終止該協議。
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將在加拿大證券交易所交易公司的股票,以維護市場秩序,提高公司股票的流動性,併爲公司提供市場情報。根據協議條款,ITG將每月收取7500加元的費用,最低期限爲3個月。在初始的3個月期滿後,公司可以在任何時候通過提前30天書面通知終止協議。公司與ITG不是關聯實體。ITG目前對公司或其證券沒有直接或間接的利益。協議中沒有績效因素,ITG不會獲得股票或期權作爲報酬。ITG是加拿大投資行業監管組織的成員。因此,ITG可以訪問所有加拿大證券交易所和其他交易系統。
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.
Buyins位於加州Corona del Mar,Orchid Avenue 417號,已與一方達成協議,爲期1個月,金額爲15000美元,任何一方有權在提前10天通知後終止協議。
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.
Stockjock位於加州Calabasas,Mullholland Hwy. 22287號,已與一方達成協議,共進行了3次活動,金額爲15000美元,任何一方有權在提前10天通知後終止協議。
About Quantum BioPharma Ltd.
關於Quantum BioPharma Ltd.
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是一家生物製藥公司,致力於建立一個創新資產和生物技術解決方案的投資組合,以治療具有挑戰性的神經退行性疾病、代謝障礙和酗酒障礙,其藥物候選者處於不同的發展階段。通過其全資子公司Lucid Psycheceuticals Inc.("Lucid"),Quantum BioPharma專注於其主要成分Lucid-MS的研究和開發。Lucid-MS是一種專利的新化學實體,已在臨牀前模型中顯示可防止和逆轉髓鞘降解,這也是多發性硬化症的基本機制。Quantum BioPharma發明了UNBUZZD並將其場外交易版本拆分給一家由行業資深人士領導的公司Celly Nutrition CORP.("Celly Nutrition")。Quantum BioPharma在Celly Nutrition中的持股比例爲25.71%(截至2024年6月30日)。與Celly Nutrition的協議還包括從unbuzzd銷售中支付7%的版權費,直到支付給Quantum BioPharma的總額達到25000萬。一旦達到25000萬,版權費將永久降低到3%。此外,Quantum BioPharma保留約13000萬加元的大量稅收虧損結轉,可以在未來用於抵消應繳稅款。Quantum BioPharma保留100%的權利,以開發類似產品或專爲藥品和醫療用途制定的替代配方。Quantum BioPharma通過其全資子公司FSD Strategic Investments Inc.維護一系列戰略投資,代表以住宅或商業地產擔保的貸款。
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.
本新聞稿包含依據適用的加拿大證券法定義的某些「前瞻性聲明」。任何表達或涉及對預測、期望、信念、計劃、展望、目標、假設或未來事件或表現的討論的聲明(通常,但不總是以「認爲」、「預期」、「期待」、「預計」、「計劃」、「估計」、「待定」、「打算」、「計劃」、「預測」、「目標」或「希望」等詞或短語標識,或這些詞和短語的變體,或者某些行動、事件或結果「可能」、「能夠」、「會」、「將」、「應該」、「也許」、「會採取」或「發生」等類似表達)並非歷史事實聲明,可能是前瞻性聲明。此處包含的前瞻性信息和前瞻性聲明包括但不限於對以下內容的聲明:公司專注於Lucid-MS的研究與開發,以防止和逆轉髓鞘降解;公司Lucid-21-302臨牀開發計劃在多發性硬化症方面推進至人體階段2有效性試驗;公司意圖利用其大額稅務虧損以抵消未來應付稅款與未來利潤的義務;公司意圖保留100%的藥品和醫療用途開發產品的權利;公司意圖通過FSD戰略投資公司維護戰略投資組合;公司相信其股價不影響其當前財務狀況和近期運營改善,以及充足的現金及現金等價物爲運營和潛在增長機會提供堅實基礎;聲網、ITG、Buyins和Stockjock在幫助公司提升市場認知度和促進與股東及其他市場參與者的持續對話中發揮重要作用;聲網被公司聘用爲期三個月;ITG在CSE交易公司的股份以維持市場秩序,改善公司股份的流動性,併爲公司提供市場情報;Buyins被公司聘用爲期一個月;以及Stockjock被公司聘用爲三項活動。
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.
本新聞稿中前瞻性信息基於某些假設和預期的未來事件,具體包括:公司對市場狀況的評估,其在市場份額方面的獲取能力,以及其潛在的競爭優勢是準確的;公司將有能力執行其關於新創新和產品的計劃,包括其進行Lucid-MS研究與開發的能力;公司的Lucid-21-302多發性硬化症臨牀開發項目將推進到人類二期療效試驗;公司將保留100%的權利,以發展類似產品或專門用於藥品和醫療用途的替代配方;公司將尋求新的業務機會;公司將在其流程和合作關係中提高效率;公司將有能力實現其其他目標和工作;公司準確地認爲其股價並不反映當前的財務狀況和近期的運營改進;強勁的現金及現金等價物將爲運營和潛在增長機會提供堅實的基礎;聲網、ITG、Buyins和Stockjock將在幫助公司增強市場認知度和促進與股東及其他市場參與者之間的有效對話方面發揮關鍵作用;聲網將受公司委託爲期三個月;ITG將在CSE上交易公司的股份,以維護市場秩序,提高公司股份的流動性,併爲公司提供市場情報;Buyins將受公司委託爲期一個月;而Stockjock將受公司委託舉辦三場活動。
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.
這些聲明涉及已知和未知的風險、不確定性及其他因素,這些因素可能導致實際結果、表現或成就與這些聲明中表達或暗示的結果有重大差異,包括但不限於:公司對其股價並不反映當前財務狀況和近期運營改進的信念不準確;強勁的現金及現金等價物未能爲運營和潛在增長機會提供堅實的基礎;公司無法執行其關於新創新和產品的計劃;公司無法利用其稅務虧損;公司無法保留100%的權利,以開發藥品或醫療用途的產品;公司無法增強其產品開發能力和/或維持戰略投資組合;公司的Lucid-21-302多發性硬化症臨牀開發項目未能推進到人類二期療效試驗;聲網、ITG、Buyins和Stockjock未能在幫助公司增強市場認知度和促進與股東及其他市場參與者之間的有效對話方面發揮關鍵作用;聲網未能被公司委託爲期三個月;ITG未能在CSE上交易公司的股份,以維持市場秩序、提高公司股份的流動性,或爲公司提供市場情報;Buyins未能被公司委託爲期一個月;Stockjock未能被公司委託舉辦三場活動;及公司在2023財年12月31日結束的Form 20-F年度報告、2023年12月22日的最終簡短基本架構招股說明書及含有基本架構招股說明書的Form F-3註冊聲明中討論的風險,這些均在"風險因素"標題下。應仔細考慮這些因素,讀者不應對前瞻性聲明過度依賴。讀者被警告,前述清單並不詳盡。儘管本新聞稿中包含的前瞻性聲明基於管理層認爲合理的假設,但公司不能向讀者保證實際結果將與這些前瞻性聲明一致。本新聞稿中包含的前瞻性聲明明確受此警告聲明的限制,並反映公司截至本日期的期望,且此後可能會發生變化。公司沒有義務更新或修訂任何前瞻性聲明,無論是由於新信息、估計或意見、未來事件,或結果或其他原因,或解釋後續實際事件和上述前瞻性信息之間的任何重大差異,除非適用法律要求。
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.
讀者被敦促參考與量子生物製藥相關的其他信息,包括其年報信息表,這些信息可在SEDAR+網站上找到,同時也可以在美國證券交易委員會的網站www.sec.gov的EDGAR部分找到,以獲得更完整的風險因素及其潛在影響的討論。
Contacts:
聯繫方式:
Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: Zsaeed@quantumbiopharma.com
Telephone: (416) 854-8884
量子生物藥品有限公司。
Zeeshan Saeed,創始人,首席執行官及董事會執行共同主席
電子郵件:Zsaeed@quantumbiopharma.com
電話:(416)854-8884
Investor Relations
Email: ir@quantumbiopharma.com, info@quantumbiopharma.com
投資者關係
電子郵件:ir@quantumbiopharma.com, info@quantumbiopharma.com
SOURCE: Quantum BioPharma Ltd.
來源:量子生物製藥有限公司。