Quantum Biopharma Announces Completion of Dosing in 180-Day Repeated Dose Oral 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

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

Market Reality Check

$7.01 Last Close

Volume Volume 393,348 is about 2.18x the 20-day average of 180,374, indicating elevated trading interest ahead of the Lucid-MS update. high

Technical Shares at $10.69 are trading below the 200-day MA of $13.88 and remain 72.05% under the 52-week high.

Peers on Argus

QNTM’s 20.25% move contrasted with mixed biotech peers: ABVC up 5.38%, PMVP up 1.63%, while MNOV and DTIL declined 2.8% and 3.56%. This points to a stock-specific reaction to the Lucid-MS toxicity study milestone rather than a broad sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 10	Private placement	Neutral	-0.2%	Small related-party private placement and ATM termination with minimal price impact.
Dec 01	Litigation media coverage	Negative	-11.7%	Final W5 segment on USD $700M manipulation lawsuit followed by double-digit decline.
Nov 28	Litigation media coverage	Negative	-15.0%	Repeat airing of W5 Part 2 on alleged stock manipulation coincided with steep drop.
Nov 27	Litigation media coverage	Negative	-15.0%	W5 Part 2 broadcast on manipulation allegations and banks linked to sharp decline.
Nov 26	Litigation announcement	Negative	+41.9%	Initial focus on USD $700M manipulation lawsuit coincided with a strong price gain.

Pattern Detected

News tied to the USD $700 million manipulation lawsuit produced large, volatile swings, including one major divergence where shares rose sharply on litigation headlines.

Recent Company History

Over the last month, Quantum BioPharma’s news flow centered on a USD $700 million stock-manipulation lawsuit and related media coverage, which drove sharp moves including a 41.92% gain on Nov 26 and double-digit declines on later W5 segments. A Dec 10 private placement and ATM termination saw little price impact at -0.19%. Against this backdrop of legal and financing headlines, today’s Lucid-MS toxicity and toxicokinetic completion marks a shift back toward core drug development progress.

Market Pulse Summary

The stock dropped -11.5% in the session following this news. A negative reaction despite the milestone would fit the stock’s history of volatility around major headlines, such as the USD $700 million lawsuit coverage that saw moves from +41.92% to nearly -15%. While completion of 180-day toxicity and toxicokinetic work advances Lucid-MS toward an IND and Phase 2 trial, the pre-news price of $10.69 remained well below the $38.25 52-week high, leaving room for sentiment to swing sharply on any perceived risk or profit-taking.

Key Terms

investigational new drug (IND) regulatory

"Studies Will Support Investigational New Drug Application (IND) with the US FDA"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

toxicokinetic medical

"dosing of Lucid-21-302 (Lucid-MS) is complete in both the 180-day toxicity and toxicokinetic studies"

Toxicokinetic describes how a chemical or drug that can cause harm is absorbed, spread, changed, and removed by the body—essentially tracking the journey and concentration of a potentially toxic substance over time. Investors care because these results shape a product’s safety profile, dosing rules and regulatory odds; strong toxicokinetic data reduces surprise risks much like tracking a package reduces the chance it gets lost or damaged.

multiple sclerosis medical

"Phase 2 trial of Lucid-MS in people with multiple sclerosis (MS)"

A chronic neurological disease in which the immune system damages the protective coating (like insulation on electrical wires) around nerves, disrupting signals between the brain and body and causing symptoms such as numbness, weakness, vision problems, fatigue and mobility issues. It matters to investors because the unpredictability and long-term nature of the condition drive ongoing demand for treatments, influence the value of companies developing therapies, affect healthcare costs and shape regulatory and reimbursement decisions.

phase 2 trial medical

"including the design of a Phase 2 trial of Lucid-MS in people with multiple sclerosis"

A phase 2 trial is an intermediate-stage clinical study that tests whether a new treatment works and is reasonably safe in a group of patients who have the condition it targets. Think of it as a field test of a prototype product: it checks real-world effectiveness and side effects on a modest number of users to decide whether the treatment should move to larger, definitive testing. Investors watch phase 2 results because positive outcomes can sharply increase the likelihood of regulatory approval and future sales, while failures often halt development.

AI-generated analysis. 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 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: Zsaeed@quantumbiopharma.com  
Telephone: (833) 571-1811

Investor Relations
Investor Relations: IR@QuantumBioPharma.com
General Inquiries: info@QuantumBioPharma.com    

FAQ

What studies did Quantum BioPharma complete for Lucid-21-302 (QNTM) on Dec 23, 2025?

Quantum completed oral dosing in both 180-day repeated-dose toxicity and toxicokinetic studies for Lucid-21-302 (Lucid-MS).

How do the completed 180-day studies affect QNTM's IND plans for Lucid-MS?

The studies are intended to support an IND application with the US FDA and help design a Phase 2 trial.

Does the Dec 23, 2025 announcement state when Lucid-MS Phase 2 will start for QNTM?

No specific Phase 2 start date was provided; the company said study completion brings it closer to initiating Phase 2.

What condition is Lucid-21-302 (Lucid-MS) being developed to treat for QNTM (QNTM)?

Lucid-MS is being developed to treat multiple sclerosis (MS), aiming to prevent disease progression and inhibit demyelination.

Did Quantum BioPharma report clinical efficacy results for Lucid-MS in this announcement?

No; the announcement reports completion of toxicity and toxicokinetic dosing but does not report efficacy data.

What regulatory step is required before QNTM can begin a Phase 2 trial for Lucid-MS?

An IND submission and FDA review/clearance are required before initiating a Phase 2 trial.