Quantum BioPharma completes dosing of Lucid-MS in toxicology studies, advancing towards FDA IND application for multiple sclerosis treatment.
Quiver AI Summary
Quantum BioPharma Ltd. announced the completion of oral dosing for its drug candidate Lucid-21-302 (Lucid-MS) in 180-day toxicity and toxicokinetic studies, which are essential for submitting an Investigational New Drug (IND) application to the US FDA. This marks a significant milestone in the development of Lucid-MS, aimed at treating multiple sclerosis. Dr. Andrzej Chruscinski, the company's Vice-President of Scientific and Clinical Affairs, emphasized the importance of these studies for advancing the drug development program, while co-chairman Anthony Durkacz expressed excitement about the potential of Lucid-MS to progress treatments for MS. Additionally, Quantum BioPharma maintains involvement in other ventures, including a stake in Unbuzzd Wellness Inc. and strategic investments through FSD Strategic Investments Inc.
Potential Positives
- The completion of oral dosing for the Lucid-MS drug candidate marks a significant milestone in regulatory advancement, supporting the Investigational New Drug (IND) application with the US FDA.
- The successful conclusion of 180-day toxicity studies brings the company closer to initiating a Phase 2 trial in multiple sclerosis patients, highlighting the potential therapeutic advancements of Lucid-MS.
- Lucid-MS is identified as a patented new chemical entity with preclinical evidence suggesting it could prevent and reverse myelin degradation, addressing a critical mechanism in multiple sclerosis.
- The company retains a significant ownership stake and future royalty payments from its spin-off company, Unbuzzd Wellness Inc., which could contribute to long-term revenue streams.
Potential Negatives
- Forward-looking statements indicate potential risks and uncertainties, including ongoing litigation against major financial institutions, which could adversely affect the company's reputation and financial standing.
- The press release implies reliance on litigation funding and whistleblower disclosures, raising concerns about the company's financial stability and future operational success.
- Completion of toxicity studies does not guarantee approval for the IND application, indicating that the company's future drug development may face delays or setbacks.
FAQ
What is the latest news from Quantum BioPharma?
Quantum BioPharma has completed oral dosing of Lucid-21-302 (Lucid-MS) in 180-day toxicity and toxicokinetic studies.
What are the implications of Lucid-MS studies?
The studies support the IND application to the US FDA and the design of a Phase 2 trial for multiple sclerosis patients.
Who commented on the completion of the studies?
Dr. Andrzej Chruscinski and Anthony Durkacz provided insights on the significance of the studies for advancing Lucid-MS development.
What is Lucid-MS's target condition?
Lucid-MS is being developed for the treatment of multiple sclerosis, aiming to prevent disease progression and demyelination.
What is Quantum BioPharma's business focus?
Quantum BioPharma specializes in innovative treatments for neurodegenerative, metabolic disorders, and alcohol misuse disorders.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
TORONTO, Dec. 23, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) (“ Quantum BioPharma ” or the “ Company ”), 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, today announces that oral dosing of Lucid-21-302 (Lucid-MS) is complete in both the 180-day toxicity and toxicokinetic studies. These studies will support the Investigational New Drug (IND) application with the US FDA, including the design of a Phase 2 trial of Lucid-MS in people with multiple sclerosis (MS).
“We are very pleased that dosing is now complete in both 180-day chronic toxicity studies. These studies allow us to advance the Lucid-MS drug development program as they are critical components to the IND application with the FDA”, said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma.
Anthony Durkacz, Founder and executive co-chairman of Quantum BioPharma added, “By completing these 180-day toxicity studies, we are now two important steps closer to initiating the Phase 2 trial of Lucid-MS in people with multiple sclerosis. We are very excited about the potential of this new, first-in-class treatment to prevent disease progression and inhibit demyelination in MS.”
About Quantum BioPharma Ltd.
Quantum BioPharma (NASDAQ: QNTM) 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 ”), now Unbuzzd Wellness Inc., led by industry veterans. Quantum BioPharma retains ownership of 19.86% as of September 30, 2025 of Unbuzzd Wellness Inc. at www.unbuzzd.com . The agreement with Unbuzzd Wellness Inc. 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. Quantum BioPharma retains 100% of the rights to develop similar products 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. For more information visit www.quantumbiopharma.com .
Forward-Looking Information
This press release contains certain "forward-looking statements" within the meaning of applicable securities law. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, identified by words or phrases such as “believes”, “hopes”, “alleges”, “pending”, “further”, or variations of such words and phrases or statements that certain actions events or results “may”, “could”, “which”, or “will” and similar expressions) are not statements of historical fact and may be forward-looking statements. Forward-looking information herein includes, but is not limited to, statements regarding: the Company’s ongoing litigation against major financial institutions; the potential outcome or judgment value; expectations regarding whistleblower submissions and related rewards; continued market integrity initiatives; future business performance and possible acquisitions.
In making the forward-looking statements in this news release, the Company has applied several material assumptions, including without limitation: the ability to obtain and validate whistleblower evidence; the timing and outcome of legal proceedings; resolution of ongoing litigation on favourable terms, availability and sufficiency of litigation funding; continued regulatory compliance and market stability for the Company’s operations.
The Company cautions that forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made, and they involve a number of risks and uncertainties. Consequently, there can be no assurances that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The above lists of forward-looking statements and assumptions are not exhaustive. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated or implied by such forward-looking statements due to a number of factors and risks. These include: the adverse outcome of legal actions; the receipt and credibility of whistleblower disclosures; changes in applicable laws and regulations; the actions of third parties involved in alleged manipulation; evolving market dynamics; the sufficiency of future litigation proceeds to fund the Company’s whistleblower reward; the continued ability to obtain sufficient litigation funding; limited future growth opportunities, and reliance on key personnel.
Except to the extent required by applicable securities laws and the policies of the Canadian Securities Exchange, the Company undertakes no obligation to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors, should change.
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 www.sedarplus.ca and on the EDGAR section of the SEC's website at www.sec.gov for a more complete discussion of such risk factors and their potential effects.
Contacts:
Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email:
[email protected]
Telephone: (833) 571-1811
Investor Relations
Investor Relations:
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General Inquiries:
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