Quantum BioPharma Receives Final Reports for Two Key Studies of its Potential Breakthrough Drug for Multiple Sclerosis, Moving Closer to Phase 2 Clinical Trial
Rhea-AI Summary
Quantum BioPharma (NASDAQ: QNTM) has reached a significant milestone in the development of Lucid-21-302 (Lucid-MS), its potential breakthrough drug for Multiple Sclerosis. The company received final reports for two critical studies: the 90-day oral toxicity study and the toxicokinetic study.
These reports will support Quantum's Investigational New Drug (IND) application to the US FDA for a planned Phase 2 clinical trial. Lucid-MS is being developed as a first-in-class treatment targeting demyelination in Multiple Sclerosis patients.
Positive
- Receipt of final toxicity study reports marks progress toward IND application
- Potential first-in-class treatment targeting MS demyelination
- Advancing to Phase 2 clinical trial preparation phase
Negative
- Drug is still in early development stages with no efficacy data yet
- FDA approval for Phase 2 trials not yet secured
- Multiple regulatory hurdles remain before commercialization
News Market Reaction
On the day this news was published, QNTM gained 9.50%, reflecting a notable positive market reaction. Argus tracked a peak move of +11.4% during that session. Our momentum scanner triggered 27 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $6M to the company's valuation, bringing the market cap to $74M at that time.
Data tracked by StockTitan Argus on the day of publication.
TORONTO, Oct. 02, 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, is pleased to announce today that it has received two key final reports related to its potential breakthrough drug for Multiple Sclerosis: the 90-day oral toxicity study report and the toxicokinetic study report for Lucid-21-302 (“Lucid-MS”). These studies were commissioned to provide key data to support an Investigational New Drug (IND) application with the US FDA for a phase-2 clinical trial in Multiple Sclerosis.
“We are pleased that we now have the final reports for these toxicity studies, as this represents an important milestone,” said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma. “These reports will be used to support Quantum’s IND application to the US FDA, further advancing the Lucid-MS drug development program.”
Anthony Durkacz, Executive Co-Chairman of Quantum BioPharma added, “We are very excited about the potential of Lucid-MS as a first-in-class treatment for MS targeting demyelination. With these final reports, we move significantly closer to initiating our Phase 2 trial of Lucid-MS in people with Multiple Sclerosis.”
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
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: Zsaeed@quantumbiopharma.com
Telephone: (833) 571-1811
Investor Relations
Investor Relations: IR@QuantumBioPharma.com
General Inquiries: info@QuantumBioPharma.com
FAQ
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