Quantum BioPharma Submits its Candidate Breakthrough Patented Drug for Multiple Sclerosis for Fast-Track Program in the United Kingdom

Rhea-AI Summary

Quantum BioPharma (NASDAQ: QNTM) has submitted its patented drug candidate Lucid-21-302 (Lucid-MS) to the UK's Innovative Licensing and Access Pathway (ILAP) Passport program. The drug represents a first-in-class treatment for multiple sclerosis, specifically targeting demyelination.

The ILAP program is designed to accelerate the development and approval process of innovative medicines through collaboration between medicine developers, the MHRA, health assessment bodies, NHS, and patients. This submission marks the first step in potentially fast-tracking the drug's development and approval process in the UK.

Positive

• First-in-class treatment targeting demyelination in Multiple Sclerosis
• Potential accelerated development and approval through UK's ILAP program
• Strategic global regulatory approach for efficient clinical development

Negative

• Drug is still in early development stages with no clinical data presented
• No guarantee of ILAP Passport approval or eventual drug success

Insights

Biotechnology Research Scientist

Quantum BioPharma's MS drug enters UK's fast-track pathway, potentially accelerating development of first-in-class treatment targeting demyelination.

Quantum BioPharma has submitted Lucid-21-302 (Lucid-MS) to the UK's Innovative Licensing and Access Pathway (ILAP) Passport program, marking an important early regulatory step for their multiple sclerosis candidate. This submission represents the first stage in the UK's accelerated approval process designed to expedite promising treatments to patients.

What makes this development particularly noteworthy is that Lucid-21-302 is positioned as a first-in-class treatment specifically targeting demyelination in MS. The demyelination process—where the protective coating around nerve fibers degrades—is central to MS pathology, and novel approaches targeting this mechanism could potentially address unmet needs in current treatment paradigms.

The ILAP program itself is significant as it creates a coordinated pathway between regulators, health assessment bodies, the NHS, and patients. This integrated approach could substantially reduce development timelines compared to traditional regulatory routes. For a biopharmaceutical company like Quantum, this represents an opportunity to potentially reduce both time and costs in bringing their treatment to market in the UK.

However, it's important to recognize this submission represents an early regulatory step. The company has not yet disclosed clinical data demonstrating efficacy or safety profiles. The ILAP Passport is essentially an entry point into the accelerated pathway rather than a validation of the treatment's effectiveness. Quantum will still need to progress through clinical trials and generate compelling data to advance through subsequent regulatory stages.

TORONTO, July 08, 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 through its subsidiary, Huge Biopharma Australia Pty Ltd., the submission of its patented candidate breakthrough drug, Lucid-21-302 (Lucid-MS), to the Innovative Licensing and Access Pathway (ILAP) Passport program in the United Kingdom (UK). The ILAP Passport application was submitted for Lucid-21-302 as a new, first-in-class treatment for multiple sclerosis (MS).

The ILAP Passport is the first step in the UK’s Innovative Licensing and Access Pathway (ILAP) – a program designed to accelerate the pace at which groundbreaking new medicines and treatments reach patients. ILAP brings together all key partners, including medicine developers, the Medicines and Healthcare Products Regulatory Agency (MHRA), health assessment bodies, the National Health System (NHS), and patients themselves. By working together through a single, streamlined platform, ILAP aims to reduce the time it takes to develop, review, approve, and deliver new treatments to patients. This highly coordinated and collaborative approach helps ensure that patients get the earliest possible access to the latest medical innovations, while also supporting the NHS and boosting the UK economy.

“We are excited to complete this submission for an ILAP Passport as this Program will help accelerate the clinical development of Lucid-21-302 as a new treatment for Multiple Sclerosis. Lucid-21-302 represents a new, patented, first-in-class treatment for MS targeting demyelination. We are excited about the possibility that the ILAP Program could accelerate drug development, regulatory approval and, most importantly, patient access to this exciting, new potential MS treatment in the UK,” said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma.

Dr. Lakshmi P. Kotra, a Director at Quantum Biopharma, commented that “our goal has always been to bring innovative drugs to patients as quickly as possible, and programs such as this in the UK are ideal avenues. At Quantum, we carefully and deliberately follow a well-thought-out global regulatory strategy to advance our clinical development efficiently, and as such we welcome partnerships with all stakeholders for better healthcare.”

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, Unbuzzd Wellness Inc. (formerly Celly Nutrition Corp.), led by industry veterans. Quantum BioPharma retains ownership of 20.11% (as of March 31, 2025) of Unbuzzd Wellness Inc. 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 on Quantum BioPharma, please visit www.quantumbiopharma.com.

Forward-Looking Information

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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 new drug candidate for Multiple Sclerosis?

Quantum BioPharma's drug candidate is Lucid-21-302 (Lucid-MS), a first-in-class treatment targeting demyelination in Multiple Sclerosis patients.

What is the UK ILAP Passport program that QNTM has applied for?

The ILAP Passport program is the first step in the UK's Innovative Licensing and Access Pathway, designed to accelerate the development and approval of innovative medicines through collaboration between developers, regulators, and healthcare bodies.

How would the ILAP program benefit Quantum BioPharma's MS drug development?

The ILAP program could accelerate drug development, regulatory approval, and patient access to Lucid-21-302 in the UK through a streamlined, collaborative approach with key healthcare stakeholders.

What stage of development is QNTM's Multiple Sclerosis drug currently in?

The press release indicates the drug is in early development stages, with the company seeking fast-track designation through the ILAP Passport program to accelerate its clinical development process.

What makes Lucid-21-302 different from other Multiple Sclerosis treatments?

Lucid-21-302 is described as a new, patented, first-in-class treatment specifically targeting demyelination in Multiple Sclerosis patients.