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,安大略省 / ACCESSWIRE / 2024年10月29日 / 量子生物製藥有限公司(NASDAQ:QNTM)(CSE:QNTM)(FRA:0K91)("量子生物製藥"或"公司"),一家專注於構建創新資產和生物技術解決方案組合的生物製藥公司,今天宣佈,其子公司澳大利亞HUGE生物製藥有限公司宣佈,哨兵劑量試驗已開始,題爲"一項第1期、隨機分組、雙盲、安慰劑對照、多升劑研究,旨在評估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.
"我們非常高興看到警戒參與者接受了Lucid-21-302的第一劑。這標誌着在推進Lucid-21-302臨床開發計劃方面邁出了重要一步在多發性硬化症中,"Quantum Biopharma的科學與臨床事務副總裁Andrzej Chruscinski博士說。
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期療效臨床試驗階段時,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
公司更新。
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.
量子生物製藥已聘用AGORA互聯網關係公司("Agoracom")、Independent Trading Group("ITG")、Buyins,Inc.("Buyins")和Stockjock.com有限合夥公司("Stockjock")來協助公司增強市場認知度,並促進與股東和其他市場參與者之間富有成效的、持續的對話。經過對手頭資本的徹底審查,管理層已做出這一決定,並將這些資源分配給下列公司,這些公司已被委託代表其進行投資者關係活動(定義見加拿大證券交易所規定)。
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.
位於加拿大北約克消費者路505號的Agoracom已被委託,在最初的3個月內,以25,000加元的價格進行合作,雙方有權在提前30天通知後終止合作。
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股票,以維持市場秩序,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加拿大元的費用,最短期限爲3個月。在最初的3個月期限過後,公司可以隨時提前30天書面通知終止協議。公司和ITG是不相關的實體。ITG目前對公司或其證券沒有直接或間接的利益。協議中沒有業績指標,ITG不會收到股票或期權作爲報酬。ITG是加拿大投資業監管組織的成員。因此,ITG可以訪問所有加拿大證券交易所和另類交易系統。
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是一家專注於爲治療挑戰性神經退行性疾病、代謝性疾病和酒精濫用疾病建立創新資產組合和生物技術解決方案的生物製藥公司,其藥物候選品處於不同開發階段。通過其全資子公司Lucid Psycheceuticals Inc.(「Lucid」),Quantum BioPharma專注於主力藥物Lucid-MS的研究與開發。根據預臨床模型,Lucid-MS爲防止和逆轉髓鞘降解,即多發性硬化的潛在機制的專利新化合物。Quantum BioPharma發明了UNBUZZD並將其OTC版本拆分給了一家由行業資深人士領導的公司Celly Nutrition Corp.(「Celly Nutrition」)。Quantum BioPharma截至2024年6月30日持有Celly Nutrition 25.71%的所有權。與Celly Nutrition的協議還包括自無醉的銷售額中支付7%的版稅款項,直至支付給Quantum BioPharma總額達到25000萬美元。一旦達到25000萬美元,版稅永久性下降至3%。此外,Quantum BioPharma持有大約13000萬加元的大額稅務虧損結轉,並可能在未來用於抵消未來利潤產生的應納稅款。Quantum BioPharma保留了100%的權利,用於開發類似產品或特定用於製藥和醫用的替代配方。Quantum BioPharma通過其全資子公司FSD Strategic Investments Inc.保留了一攬子戰略投資組合,這些投資由住宅或商業物業擔保。
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.
本新聞發佈包含特定"前瞻性聲明",符合適用的加拿大證券法。任何表達或涉及對預測、期望、信念、計劃、投影、目標、假設或未來事件或績效討論的聲明(通常但並非總是通過"相信"、"預計"、"期待"、"預期"、"安排"、"估計"、"待處理"、"打算"、"預測"、"目標"或"期望"等詞語或短語識別,或陳述某些行動、事件或結果"可能"、"可能"、"將會"、"應該"、"可能"、"將被採取"或"發生"等表達)不屬於歷史事實陳述,可能屬於前瞻性聲明。本前瞻性信息和前瞻性聲明包括但不限於以下聲明:公司專注於研發Lucid-MS以防止和逆轉髓鞘降解;公司Lucid-21-302臨床開發計劃在多發性硬化症領域朝着人體2期功效試驗前進;公司打算利用其大額稅損抵銷未來的應納稅款;公司打算保留100%的開發藥品用於藥品和醫療用途的權利;公司打算通過FSD Strategic Investments Inc.維持一系列戰略投資組合;公司相信其股價不影響其當前財務狀況和最近的運營改善,強勁的現金及現金等價物爲其運營和潛在增長機會提供了堅實基礎;Agoracom、ITG、Buyins和Stockjock在幫助公司提高市場認知度和促進與股東和其他市場參與者的富有成效和持續對話方面發揮關鍵作用;Agoracom受公司委託爲期三個月;ITG在CSE上交易公司股票以維持市場秩序、提高公司股票流動性,併爲公司提供市場情報;Buyins被公司委託爲期一個月;Stockjock受公司委託爲三個活動。
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.
本新聞稿中的前瞻性信息基於某些假設和未來預期事件,即:公司對市場條件的評估、公司獲得市場份額的能力以及它可能具有的競爭優勢是準確的;公司將有能力實施其關於新創新和產品的計劃,包括進行Lucid-MS的研發能力;公司的多發性硬化症臨床開發項目Lucid-21-302將朝着人類2期有效性試驗前進;公司將保留開發類似產品或專門用於藥品和醫藥用途的替代配方100%的權利;公司將尋求新的業務機會;公司將提高其流程和合作夥伴關係的效率;公司將有能力實現其其他目標和目標;公司準確地認爲其股價未反映當前的財務狀況和最近的運營改善;強大的現金及現金等價物將爲公司的運營和潛在增長機會提供堅實基礎;Agoracom、ITG、Buyins和Stockjock將在幫助公司提高市場意識並促進與股東和其他市場參與者之間富有成效的持續對話中發揮重要作用;Agoracom公司將爲期三個月與公司合作;ITG將在CSE交易公司股票,以維持市場秩序,提高公司股票的流動性,併爲公司提供市場情報;Buyins將與公司合作一個月;Stockjock將爲公司舉辦三次活動。
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、不確定性和其他因素,可能導致實際結果、表現或成就與這些聲明所表達或暗示的結果有實質不同,包括但不限於:公司在認爲其股價未反映當前財務狀況和最近運營改善方面的準確性;強大的現金及現金等價物將無法爲公司的運營和潛在增長機會提供堅實基礎;公司無法實施其關於新創新和產品的計劃;公司無法利用其稅務損失;公司無法保留開發藥品或醫藥用途產品的100%權利;公司無法提升其產品開發能力和/或保持一系列戰略投資組合;公司的多發性硬化症臨床開發項目Lucid-21-302未朝着人類2期有效性試驗前進;Agoracom、ITG、Buyins和Stockjock未能在幫助公司提高市場意識並促進與股東和其他市場參與者之間富有成效的持續對話中發揮關鍵作用;Agoracom未得到公司爲期三個月的合作;ITG未在CSE交易公司股票以維持市場秩序、提高公司股票的流動性或爲公司提供市場情報;Buyins未獲公司一個月的合作;Stockjock未獲公司爲三次活動的合作;以及公司2023年12月31日止財年的年度報告20-F、2023年12月22日最終短表基準招股書和包含基準招股書的Form F-3註冊聲明中討論的風險,標題爲"風險因素"。這些因素應該仔細考慮,讀者不應過於依賴前瞻性聲明。讀者被警告說,前述清單並非窮盡。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,但公司不能保證實際結果與這些前瞻性聲明一致。本新聞稿中的前瞻性聲明受到本警示性聲明的明確限制,並反映了公司截至本日期的預期,並且在此後可能會發生變化。公司不承諾更新或修訂任何前瞻性聲明,無論是基於新信息、估計或意見、未來事件或結果還是其他方面,也無需解釋後續實際事件與此類前瞻性信息之間的任何重大差異,除非法律有要求。
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.
敬請讀者查閱有關Quantum BioPharma的更多信息,包括其年度信息表,可在SEDAR+網站和美國證券交易委員會(SEC)的EDGAR部分網站www.sec.gov找到,以獲取對這些風險因素及其潛在影響更全面的討論。
Contacts:
聯繫人:
Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: Zsaeed@quantumbiopharma.com
Telephone: (416) 854-8884
Quantum BioPharma有限公司。
Zeeshan Saeed,創始人,首席執行官兼執行董事會聯席主席
郵箱:Zsaeed@quantumbiopharma.com
電話:(416) 854-8884
Investor Relations
Email: ir@quantumbiopharma.com, info@quantumbiopharma.com
投資者關係
郵箱:ir@quantumbiopharma.com, info@quantumbiopharma.com
SOURCE: Quantum BioPharma Ltd.
資訊: 量子生物製藥有限公司。
譯文內容由第三人軟體翻譯。