Quantum BioPharma Advances Lead MS Drug as Key Toxicity Studies Conclude, Paving Way for Phase 2 IND Filing

New updates have been reported about Quantum.

Quantum BioPharma has completed 180‑day oral dosing in both chronic toxicity and toxicokinetic studies for its lead multiple sclerosis candidate Lucid-21-302 (Lucid-MS), clearing a major preclinical milestone required for a Phase 2 program in MS. The data from these long‑term studies will form core components of the company’s planned Investigational New Drug (IND) submission to the U.S. FDA and will inform Phase 2 trial design in people with multiple sclerosis. Management emphasized that the completion of dosing materially advances the Lucid-MS development timeline, moving the first‑in‑class compound closer to mid-stage clinical evaluation aimed at preventing disease progression and inhibiting demyelination. Lucid-MS, developed through Quantum’s wholly owned subsidiary Lucid Psycheceuticals, is a patented new chemical entity that has shown the ability in preclinical models to prevent and reverse myelin degradation, the underlying pathology in MS, positioning it as a potentially differentiated asset in a large, established therapeutic market.

Beyond Lucid-MS, Quantum BioPharma maintains optionality and diversified exposure through its strategic portfolio and royalty-bearing consumer asset. The company invented unbuzzd™, an over-the-counter formulation addressing alcohol misuse, and has spun out the OTC business to Unbuzzd Wellness Inc. while retaining a 19.86% equity interest as of September 30, 2025 and a tiered royalty structure: 7% of sales until cumulative payments reach $250 million, then 3% in perpetuity, with full retention of rights to develop pharmaceutical or medical formulations. Quantum also manages a portfolio of secured loans via its wholly owned subsidiary FSD Strategic Investments Inc., providing non-correlated cash flow potential. Management cautions that forward‑looking outcomes for Lucid-MS, the royalty stream from unbuzzd™, and returns from litigation- and whistleblower-related initiatives remain subject to regulatory, legal, funding, and market risks as disclosed in its Canadian and U.S. securities filings, but the latest preclinical milestone strengthens the company’s position as it transitions its MS program toward Phase 2 readiness and potential value inflection.