Quantum BioPharma Announces Completion of Dosing in 90-Day Repeated Dose Oral Toxicity and Toxicokinetic Studies for Lucid-MS for Multiple Sclerosis

Rhea-AI Summary

Quantum BioPharma (NASDAQ: QNTM) has completed the dosing phase of 90-day oral toxicity and toxicokinetic studies for its Multiple Sclerosis drug candidate Lucid-21-302 (Lucid-MS). These studies are crucial for supporting an upcoming Investigational New Drug (IND) application with the US FDA, which the company aims to submit by the end of 2025. The completion of these toxicity studies marks a significant step toward initiating a Phase 2 trial for Lucid-MS, which is being developed as a first-in-class treatment for Multiple Sclerosis patients.

Positive

• Successful completion of 90-day toxicity studies, advancing the drug development program
• Plans to submit IND application by end of 2025, showing clear regulatory pathway
• Advancing towards Phase 2 trials, indicating promising development progress
• Potential first-in-class treatment for Multiple Sclerosis, suggesting competitive advantage

Negative

• Still in pre-clinical stage, requiring significant development time before potential commercialization
• No efficacy data or trial results shared in the announcement
• IND approval not guaranteed, presenting regulatory risk

TORONTO, May 12, 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 announced that dosing of drug has completed in 90-day oral toxicity and toxicokinetic studies for Lucid-21-302 (Lucid-MS) for Multiple Sclerosis (“MS”). These studies were commissioned to provide data to support an IND application with the US FDA.

“We are very pleased to have completed dosing in these toxicity studies as this advances the Lucid-21-302 drug development program,” said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma. “Reports from these studies will support an IND application, which we hope to submit before the end of the year.”

Zeeshan Saeed, CEO of Quantum BioPharma added, “We are excited about potential of Lucid-21-302 as a new first-in-class treatment for Multiple Sclerosis. By completing these toxicity studies, we are now closer to initiating a Phase 2 trial of Lucid-21-302 in people with 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”), led by industry veterans. Quantum BioPharma retains ownership of 22.95% (as of December 31, 2024) 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

This press release contains certain “forward-looking statements” within the meaning of applicable Canadian securities law. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, identified by words or phrases such as “believes”, “anticipates”, “expects”, “is expected”, “scheduled”, “estimates”, “pending”, “intends”, “plans”, “forecasts”, “targets”, or “hopes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “will”, “should” “might”, “will be taken”, or “occur” and similar expressions) are not statements of historical fact and may be forward-looking statements. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the Company’s focus on the research and development of Lucid-MS to prevent and reverse myelin degradation; the Company’s Lucid-21-302 clinical development program in multiple sclerosis advancing towards human phase-2 efficacy trials; Lucid-21-302 having an initial indication in multiple sclerosis; the Company’s intention to retain 100% of the rights to develop products for pharmaceutical and medical uses; the Company’s intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; the Company’s approach to treatments in brain disorders and alcohol health representing a tremendous revenue potential; the Company’s belief that its share price does not current financial position and recent operational improvements; that certain amounts can be collected by the Company from the bond when all appeals of Dr. Bokhari are exhausted; and that a strong cash and cash equivalents provide a solid foundation for operations and potential growth opportunities.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s assessment of market conditions, its ability to gain market share, and its potential competitive edge are accurate; the Company will have the ability to carry out its plans with respect to its new innovation and offerings, including its ability to conduct research and development of Lucid-MS; the Company’s Lucid-21-302 clinical development program in multiple sclerosis will advance towards human phase-2 efficacy trials; Lucid-21-302 having an initial indication in multiple sclerosis; the Company will retain 100% of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses; the Company will seek new business opportunities; the Company will increase efficiency in its processes and partnerships; the Company will have the ability to carry out its other goals and objectives the Company’s intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; the Company’s approach to treatments in brain disorders and alcohol health will have a tremendous revenue potential;

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: the Company’s inability to retain 100% of the rights to develop products for pharmaceutical or medical uses; the Company’s inability to enhance its product development capabilities and/or maintain a portfolio of strategic investments; the Company’s Lucid-21-302 clinical development program in multiple sclerosis will not advance towards human phase-2 efficacy trials; Lucid-21-302 not having an initial indication in multiple sclerosis; the Company will not have the ability to carry out its other goals and objectives the Company’s intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; the Company’s approach to treatments in brain disorders and alcohol health will not have a tremendous revenue potential; and the risks discussed in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2024, final short form base shelf prospectus dated December 22, 2023 and registration statement on Form F-3 containing a base shelf prospectus, each under the heading “Risk Factors”. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Readers are cautioned that the foregoing list is not exhaustive. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. Forward-looking statements contained in this news 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.

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 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.

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 milestone did Quantum BioPharma (QNTM) achieve for its Multiple Sclerosis drug?

Quantum BioPharma completed the dosing phase of 90-day oral toxicity and toxicokinetic studies for Lucid-21-302 (Lucid-MS), their Multiple Sclerosis drug candidate.

When does Quantum BioPharma plan to submit the IND application for Lucid-MS?

Quantum BioPharma plans to submit the IND application to the US FDA before the end of 2025.

What is the current development stage of Quantum BioPharma's Lucid-MS?

Lucid-MS is in pre-clinical development, with the company preparing to advance to Phase 2 trials following IND approval.

What makes Quantum BioPharma's Lucid-MS unique in the Multiple Sclerosis market?

Lucid-MS is being developed as a first-in-class treatment for Multiple Sclerosis, suggesting a novel therapeutic approach.

What is the significance of completing the toxicity studies for QNTM's Multiple Sclerosis drug?

The completion of toxicity studies is crucial as it provides necessary safety data to support the IND application, which is required before beginning human clinical trials.