Quantum BioPharma Receives FDA Clearance to Proceed with Lucid-MS Phase 2 Trial in Progressive Multiple Sclerosis

NASDAQ: QNTM | CSE: QNTM | FRA: 0K91

Overview

Quantum BioPharma Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application for Lucid-MS (Lucid-21-302), enabling the company to advance its patented, first-in-class multiple sclerosis program into Phase 2 clinical development. According to the company, this will be the first time in history patients with MS consume the unique Lucid-MS new chemical entity molecule with a goal of reversing some or all of their loss of bodily control or mobility.

The company stated that this milestone clears a pivotal regulatory pathway, enabling Quantum BioPharma to begin its planned Phase 2 clinical trial of Lucid-MS in individuals with progressive multiple sclerosis (MS). The company said it is working with a leading global clinical research organization with significant experience in neurodegenerative studies to support implementation of the planned disease-modifying Phase 2 study. Trial start-up activities, including site selection, are already underway, according to the company, and the company expects to initiate patient enrollment and drug administration as quickly as possible.

Key Highlights

• The FDA approved Quantum BioPharma's IND application for Lucid-MS (Lucid-21-302), clearing the company to proceed with a Phase 2 clinical trial in progressive multiple sclerosis.
• The planned trial is a randomized, double-blind, placebo-controlled Phase 2 study, according to the company.
• The company stated the IND submitted was approximately 15,000 pages long.
• Lucid-MS is a patented, first-in-class new chemical entity designed to provide neuroprotection through the inhibition of demyelination, targeting protein arginine deiminase 2 (PAD2), a key enzyme implicated in myelin degradation, according to the company.
• In prior Phase 1 clinical trials, the company stated Lucid-MS demonstrated a favorable safety profile and was well-tolerated in healthy participants.
• The company reported cash, digital assets and liquid investments totaling over USD $10 million as of March 31, 2026.
• Site selection is underway, with patient enrollment and drug administration to begin as quickly as possible, according to the company.

Strategic/Operational Context

According to the company, progressive forms of MS, including primary progressive MS (PPMS) and secondary progressive MS (SPMS), represent an area of substantial unmet medical need worldwide, with limited therapeutic options currently available. The company cited market research indicating the Primary Progressive Multiple Sclerosis (PPMS) Treatment Market is projected to expand from USD $1.16 billion in 2025 to USD $1.31 billion by 2026, reflecting a CAGR of 13.7% (The Business Research Company, 2026), and that the global MS therapeutics market is anticipated to reach approximately USD $38.62 billion by 2030, growing at a CAGR of 5.93% (Grand View Research, 2026).

"The IND submitted was approximately 15,000 pages long and the approval from the FDA for Lucid-MS permits Quantum BioPharma to proceed with the Phase 2 clinical trial. This Phase 2 trial marks an important strategic milestone for Quantum BioPharma and advances our unique Lucid-MS program into the next stage of development," said Zeeshan Saeed, Founder, Chief Executive Officer, and Executive Co-Chairman of the Board of Quantum BioPharma. Mr. Saeed added, "Lucid-MS represents a unique patented first-in-class, disease-modifying therapeutic opportunity in multiple sclerosis by targeting demyelination, particularly in progressive forms of the disease where unmet medical needs remain today. Our strong balance sheet and disciplined capital allocation provide a runway for meaningful clinical data generation, and we look forward to delivering results that could transform outcomes for millions of patients worldwide who currently have no effective treatment alternatives. This is not just a regulatory checkpoint, it is a breakthrough moment to try to demonstrate, possibly for the first time, that neuroprotection is achievable."

"This strategic milestone supports advancement of a first-in-class program evaluating a novel neuroprotective strategy in progressive multiple sclerosis," said Andrzej Chruscinski, M.D., Ph.D., Vice-President, Scientific and Clinical Affairs at Quantum BioPharma. "The randomized, double-blind, placebo-controlled Phase 2 trial is intended to evaluate efficacy using clinical and radiological measures relevant to disability progression and disease biology, while also assessing safety and tolerability. This rigorous trial design meets the highest FDA standards and reflects our commitment to generating meaningful clinical data that can support a clear path toward regulatory submission and potential future approval." Dr. Chruscinski continued, "Progressive MS has long been an area of frustration for neurologists and patients alike, given the paucity of effective interventions. Lucid-MS offers a differentiated approach, it does not suppress the immune system but instead works to preserve myelin integrity and neuronal function. We believe this novel mechanism could fundamentally change how clinicians approach progressive MS, and we are excited to move into this pivotal phase of development."

According to the company, unlike most existing therapies that focus primarily on modulating the immune system, Lucid-MS represents a differentiated approach targeting the underlying neurodegeneration. The company stated that its lead molecule has demonstrated in preclinical animal models the ability to accelerate functional recovery in mouse models of MS, preserve myelin, and reduce axonal degradation, and that Lucid-MS does not suppress the immune system unlike most current MS therapies, offering potential oral administration with an easy dosing regimen.

Resources and Financials

• Cash, digital assets and liquid investments: over USD $10 million as of March 31, 2026, according to the company.
• IND submission length: approximately 15,000 pages, according to the company.
• Ownership retained in Unbuzzd Wellness Inc.: 19.84% as of March 31, 2026, according to the company.

What to Watch Next

• Initiation of patient enrollment and drug administration in the Phase 2 trial, which the company expects to begin as quickly as possible.
• Continued site selection and trial start-up activities for the Phase 2 study, according to the company.
• Progress of the randomized, double-blind, placebo-controlled Phase 2 trial evaluating efficacy, safety, and tolerability of Lucid-MS.

About Quantum BioPharma Ltd.

Quantum BioPharma Ltd. 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 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 invented UNBUZZD™ and spun out its OTC version to a company, Unbuzzd Wellness Inc. ("Unbuzzd") (formerly, Celly Nutrition Corp.), led by industry veterans. Quantum retains ownership of 19.84% (as of March 31, 2026) of Unbuzzd at www.unbuzzd.com. The agreement with Unbuzzd also includes royalty payments of 7% of sales from unbuzzd™ until payments to Quantum total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses.

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