Quantum Biopharma Announces Completion of Dosing in 180-Day Repeated Dose Oral Toxicity and Toxicokinetic Studies for Lucid-21-302 (Lucid-MS)
Quantum BioPharma (NASDAQ: QNTM) announced completion of oral dosing in both 180-day repeated-dose toxicity and toxicokinetic studies for Lucid-21-302 (Lucid-MS).
Rhea-AI Summary
Quantum BioPharma (NASDAQ: QNTM) announced completion of oral dosing in both 180-day repeated-dose toxicity and toxicokinetic studies for Lucid-21-302 (Lucid-MS). These chronic studies are described as supporting an Investigational New Drug (IND) application with the US FDA and informing the design of a Phase 2 trial in people with multiple sclerosis (MS). Company executives said study completion advances the Lucid-MS development program and moves the program closer to initiating a Phase 2 trial targeting prevention of disease progression and inhibition of demyelination in MS.
Positive
- Completed 180-day repeated-dose oral toxicity studies
- Completed 180-day toxicokinetic studies
- Studies intended to support IND submission and Phase 2 design
Negative
- No clinical efficacy or Phase 2 results reported
- IND submission and FDA review required before Phase 2 can begin
Details
News Market Reaction – QNTM
In the Dec 23 session, QNTM declined 11.51%, reflecting a significant negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
- Toxicity study duration
- 180-day repeated dose
- Oral toxicity and toxicokinetic studies for Lucid-21-302 (Lucid-MS)
- Planned trial phase
- Phase 2 trial
- Planned Phase 2 study of Lucid-MS in people with multiple sclerosis
- Lawsuit size
- USD $700 million
- Alleged stock market manipulation lawsuit highlighted in W5 coverage
- ATM offering size
- US$21,225,000
- Primary at-the-market offering of Class B Subordinate Voting Shares
- Sales agent commission
- 3.0%
- Commission on gross proceeds under the ATM Sales Agreement
- Public float
- US$67,723,261
- Public float disclosed for Form F-3 eligibility in 424B5
- I.B.5 capacity
- US$21,248,272
- Capacity to sell under General Instruction I.B.5 with float below US$75M
- Private placement proceeds
- $750
- 30 Class A multiple voting shares at $25 per share on Dec 10, 2025
Historical Context
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Small related-party private placement and ATM termination with minimal price impact.
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Final W5 segment on USD $700M manipulation lawsuit followed by double-digit decline.
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Repeat airing of W5 Part 2 on alleged stock manipulation coincided with steep drop.
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W5 Part 2 broadcast on manipulation allegations and banks linked to sharp decline.
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Initial focus on USD $700M manipulation lawsuit coincided with a strong price gain.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
investigational new drug (IND) regulatory
toxicokinetic medical
multiple sclerosis medical
phase 2 trial medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Studies Will Support Investigational New Drug Application (IND) with the US FDA, Including Design of Phase 2 Trial
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
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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