Quantum Biopharma Announces Signing of an Agreement with a Global Pharmaceutical Contract Research Organization to Prepare an IND (Investigational New Drug) Application Package for Lucid-21-302 (Lucid-MS), A First-In-Class Treatment for Multiple Sclerosis

Rhea-AI Summary

Quantum BioPharma (NASDAQ: QNTM) has signed an agreement with a global pharmaceutical contract research organization to prepare an Investigational New Drug (IND) application for Lucid-21-302 (Lucid-MS), targeting submission to the FDA in Q4 2025. The successful IND application will enable the company to proceed with Phase 2 trials for multiple sclerosis treatment.

Lucid-21-302 is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action. This patented New Chemical Entity has demonstrated ability in preclinical models to prevent demyelination, a known cause of MS and other neurodegenerative diseases affecting the myelin sheath around nerve fibers.

Positive

• Development of a first-in-class treatment for multiple sclerosis with unique mechanism of action
• Preclinical success in preventing demyelination
• Planned FDA submission in Q4 2025 for Phase 2 trial advancement

Negative

• Still in early stages with only preclinical data available
• No guarantee of FDA approval for IND application
• Significant time and resources required before potential commercialization

News Market Reaction – QNTM

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Data tracked by StockTitan Argus on the day of publication.

TORONTO, May 20, 2025 (GLOBE NEWSWIRE) -- 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 that it has signed an agreement with a global pharmaceutical contract research organization to prepare an IND (Investigational New Drug) application package for Lucid-21-302 (Lucid-MS) with the US FDA. A successful IND application will allow Quantum Biopharma to move forward with a Phase 2 trial of Lucid-21-302 in people with multiple sclerosis (MS).

Lucid-21-302 is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action for the treatment of MS. It is a patented New Chemical Entity (NCE) that has been shown in preclinical models to prevent demyelination, a known cause of MS and other neurogenerative diseases characterized by damage to the myelin sheath surrounding nerve fibers.

“We are pleased to announce that we have signed this agreement to prepare the IND application package, which we hope to submit to the FDA in Q4 2025. This agreement takes us a step closer to initiating the phase 2 trial of Lucid-21-302, a first-in-class treatment for MS,” said Zeeshan Saeed, CEO of Quantum BioPharma.

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”), led by industry veterans. Quantum BioPharma retains ownership of 20.11% (as of March 31, 2025) of Celly Nutrition at www.unbuzzd.com. 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. 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 on Quantum BioPharma, please visit www.quantumbiopharma.com.

Forward-Looking Information

Certain information in this news release constitutes forward-looking statements under applicable securities laws. Any statements that are contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are often identified by terms such as "may", "should", "anticipate", "expect", "potential", "believe", "intend" or the negative of these terms and similar expressions. Forward-looking statements in this news release include statements related to such.

Forward-looking information in this press release are based on certain assumptions and expected future events.

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 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 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.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this press 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.

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 is Quantum BioPharma's (QNTM) new multiple sclerosis drug candidate?

Lucid-21-302 (Lucid-MS) is a first-in-class, non-immunomodulatory, neuroprotective compound designed to prevent demyelination in multiple sclerosis patients.

When will Quantum BioPharma (QNTM) submit its IND application for Lucid-MS?

Quantum BioPharma plans to submit the IND application to the FDA in Q4 2025.

What stage of development is Quantum BioPharma's (QNTM) Lucid-21-302?

Lucid-21-302 has completed preclinical studies and is preparing for Phase 2 trials, pending FDA approval of its IND application.

How does Quantum BioPharma's (QNTM) Lucid-21-302 work for MS treatment?

Lucid-21-302 is a neuroprotective compound that works by preventing demyelination, the damage to the myelin sheath surrounding nerve fibers that causes MS symptoms.

What makes Quantum BioPharma's (QNTM) Lucid-21-302 unique for MS treatment?

Lucid-21-302 is a first-in-class, non-immunomodulatory treatment with a unique mechanism of action, different from existing MS therapies.