Singular Research Reports on Quantum BioPharma Ltd.'s Strategic Advances and Pipeline Progress

Clinical Development Milestones

Quantum BioPharma has achieved significant progress with its FSD202 program, receiving human ethics review committee (HREC) approval for a Phase 2 clinical trial targeting nociplastic pain in patients with Idiopathic Mast Cell Activation Syndrome (MCAS). The randomized, double-blind trial will enroll 60 patients who will receive FSD202 or placebo twice daily for 56 consecutive days, with the primary outcome measuring decrease in average daily pain intensity from baseline to Day 28. This advancement addresses a significant unmet medical need, as no cure currently exists for MCAS, and FSD202 has potential applications across a wide range of inflammatory diseases.

The Company continues to advance its flagship Lucid-MS program, expecting to file an IND application package for Lucid-21-302 with the U.S. FDA in Q4 2025. A successful IND filing would represent a critical validation milestone and enable advancement to Phase 2 trials for this proprietary compound designed to treat progressive Multiple Sclerosis through a non-immunomodulatory approach. To support this development, Quantum BioPharma has initiated a joint study with Massachusetts General Hospital using PET imaging to evaluate Lucid-MS efficacy, with the first patient already scanned using this technique as a potential biomarker.

Strategic Business Developments

The Company's subsidiary Celly Nutrition has changed its name to Unbuzzd Wellness Inc. and engaged leading audit firm MNP LLP to conduct PCAOB audits in preparation for a potential initial public offering. This IPO preparation will provide access to capital for enhanced marketing and distribution of the unbuzzd™ formulation, a natural product designed to expedite alcohol metabolism and reduce Blood Alcohol Content. Quantum BioPharma maintains a 20.11% stake in Unbuzzd Wellness, positioning the Company to benefit from the subsidiary's growth trajectory.