Announcement • Aug 10

Quantum Biopharma Ltd. Receives United States Fda Clearance to Proceed with Lucid-Ms Phase 2 Trial in Progressive Multiple Sclerosis

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 Quantum BioPharma to immediately advance its patented, first-in-class multiple sclerosis program into Phase 2 clinical development. 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. This strategic 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 is working with a 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, and the Company expects to initiate patient enrollment and drug administration as quickly as possible. 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. According to market research, 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 overall global MS therapeutics market is anticipated to reach approximately USD 38.62 billion by 2030, growing at a compound annual growth rate (CAGR) of 5.93%. Despite the availability of disease-modifying therapies (DMTs), a substantial proportion of patients with progressive MS remain untreated or continue to experience disability progression, highlighting the critical need for innovative treatments that not only modulate the immune response but also promote remyelination and neuroprotection. Lucid-MS is a patented, new chemical entity investigational drug candidate designed to provide neuroprotection through the inhibition of demyelination, a key contributor to disability progression in multiple sclerosis. Unlike most existing therapies that focus primarily on modulating the immune system, Lucid-MS represents a differentiated approach targeting the underlying neurodegeneration—a novel mechanism with the potential to address the root cause of disease advancement in progressive MS. 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 a commitment to generating meaningful clinical data that can support a clear path toward regulatory submission and potential future approval. Lucid-MS is designed to provide neuroprotection through the inhibition of demyelination—a key driver of disease progression in MS. This innovative mechanism represents a differentiated therapeutic approach in the global MS market, where most existing therapies focus primarily on modulating the immune response rather than addressing the underlying neurodegeneration. By targeting protein arginine deiminase 2 (PAD2), a key enzyme implicated in myelin degradation, Lucid-MS has demonstrated in preclinical models the ability to prevent and reverse myelin breakdown—offering the potential for a truly disease-modifying therapy in an indication with limited options. The Phase 2 clinical trial will evaluate the efficacy, safety, and tolerability of Lucid-MS in people with MS. In prior Phase 1 clinical trials, Lucid-MS demonstrated a favorable safety profile and was well-tolerated in healthy participants, providing a strong foundation for continued development. The successful completion of Phase 1 supports advancement into this next pivotal study, which is designed to generate meaningful clinical data across both clinical and radiological endpoints. Quantum BioPharma is partnering with a globally recognized clinical research organization, to support the implementation of the Lucid-MS Phase 2 clinical trial. This strategic collaboration is designed to ensure efficient patient enrollment, rigorous data collection, and regulatory compliance throughout the study. Site selection is currently underway, with patient enrollment and drug administration to begin as quickly as possible. The Company's decision to engage a global leading CRO with experience in neurodegenerative diseases, reflects its commitment to operational excellence and rapid advancement of its clinical programs. This partnership approach mirrors industry best practices, as demonstrated by other biotech companies advancing pivotal programs in neurodegenerative diseases. Quantum BioPharma maintains a strong balance sheet to support its clinical development programs. The Company reported cash, digital assets and liquid investments totaling over USD 10 million as of March 31, 2026. The announcement comes amid a period of renewed investor confidence in neurology-focused biotech stocks. The BioWorld Neurological Diseases Index (BNDI) finished 2025 up 6.33%, recovering from a midyear slump. In April 2026, several NASDAQ-listed biotechnology companies specializing in neurology and MS have experienced notable spikes in trading volume, driven by significant corporate developments and clinical advancements. Lucid-MS is positioned as a first-in-class, non-immunomodulatory agent with the potential to address the underlying cause of disease progression – demyelination. The Company's lead molecule, Lucid-MS, is a patented, new chemical entity that has demonstrated excellent efficacy in various preclinical animal models over many years, accelerating functional recovery of mouse models of MS, preserving myelin, and reducing axonal degradation. Lucid-MS does not suppress the immune system unlike most current therapies for MS today, offering potential oral administration with an easy dosing regimen—a significant advantage for patient compliance and quality of life.

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Quantum BioPharma Ltd. Receives FDA Clearance To Begin Phase 2 Trial Of Lucid-MS For Multiple Sclerosis

Quantum BioPharma Ltd., Annual General Meeting, Nov 10, 2026

Quantum Biopharma Ltd. Receives United States Fda Clearance to Proceed with Lucid-Ms Phase 2 Trial in Progressive Multiple Sclerosis

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