Quantum BioPharma Ltd.

Quantum BioPharma Ltd. has reached a significant clinical milestone by submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lucid-MS (Lucid-21-302), its lead drug candidate for the treatment of multiple sclerosis (MS). This regulatory filing supports the Company's planned Phase 2 clinical trial, which is anticipated to begin in Q2 2026 subject to FDA clearance. The submission includes data from nonclinical pharmacology and toxicology studies, as well as manufacturing and quality information. Lucid-MS represents a first-in-class therapeutic approach designed to provide neuroprotection through the inhibition of demyelination, a key driver of disease progression in MS. This mechanism differentiates Lucid-MS from many existing therapies that primarily focus on immune system modulation rather than addressing underlying neurodegeneration. The IND submission is supported by prior Phase 1 clinical trials in which Lucid-MS demonstrated a favorable safety profile and was well-tolerated in healthy participants. Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs, stated that the comprehensive preclinical research package characterizes the safety profile and supports evaluation in patients. The Company projects interim data from the Phase 2 trial in Q4 2026. The global MS therapeutic market is projected to exceed $38 billion by 2030, representing a substantial opportunity for innovative treatments targeting unmet patient needs.