Core Insights - Quantum BioPharma Ltd. is making significant advancements in its clinical pipeline, particularly with its FSD202 program targeting nociplastic pain in patients with Idiopathic Mast Cell Activation Syndrome (MCAS) and its Lucid-MS program for progressive Multiple Sclerosis [2][3] Clinical Development Milestones - The FSD202 program has received HREC approval for a Phase 2 clinical trial, enrolling 60 patients to assess pain reduction over 28 days [2] - The Lucid-MS program is expected to file an IND application with the U.S. FDA in Q4 2025, which would allow progression to Phase 2 trials [3] Strategic Business Developments - The subsidiary Celly Nutrition has rebranded to Unbuzzd Wellness Inc. and is preparing for a potential IPO to enhance capital for marketing its alcohol metabolism product [4] - Quantum BioPharma holds a 20.11% stake in Unbuzzd Wellness, positioning it to benefit from the subsidiary's growth [4] Financial Performance - For Q1 2025, Quantum BioPharma reported no revenues, with general and administrative expenses down 31% to $1.32 million, while R&D expenses rose to $1.65 million [6][7] - The company maintained cash and cash equivalents of $3.5 million as of March 31, 2025, ensuring liquidity through Q1 2027 [7] Pipeline Overview - The company's pipeline includes Lucid-MS for progressive Multiple Sclerosis, FSD202 for MCAS and inflammatory diseases, and unbuzzd™ for alcohol metabolism [8] Investment Strategy - Quantum BioPharma has diversified its treasury holdings towards Bitcoin, with total investments reaching $5 million [5] - The company plans to issue special dividends linked to potential litigation proceeds exceeding $700 million related to alleged stock manipulation [5]

Core Viewpoint - Quantum BioPharma Ltd. has received approval for a Phase 2 clinical trial of FSD202, aimed at assessing its safety and efficacy in treating chronic widespread musculoskeletal nociplastic pain associated with idiopathic Mast Cell Activation Syndrome (MCAS) [1][4]. Group 1: Clinical Trial Details - The trial will enroll 60 patients with idiopathic MCAS, where participants will receive either FSD202 or a placebo twice daily for 56 days [1]. - The primary outcome will measure the decrease in average daily pain intensity from baseline to Day 28 [1]. - Secondary outcomes will also be evaluated during the trial [1]. Group 2: Drug Information - FSD202 contains ultra-micronized palmitoylethanolamide (PEA) and has potential applications for a variety of inflammatory diseases beyond MCAS [2]. - Chronic inflammatory diseases are a leading cause of death globally, with the World Health Organization identifying chronic disease as a significant health threat [2]. Group 3: Company Insights - Quantum BioPharma is focused on developing innovative biopharmaceutical solutions for neurodegenerative and metabolic disorders, as well as alcohol misuse disorders [4]. - The company retains a 20.11% ownership stake in Celly Nutrition, which is involved in the development of the OTC product unbuzzd™ [4]. - Quantum BioPharma has a royalty agreement with Celly Nutrition, receiving 7% of sales until total payments reach $250 million, after which the royalty rate will drop to 3% indefinitely [4].