Lead product candidate will be advanced to late IND-enabling studies to prepare for clinical trials for evaluation in the treatment of solid tumors Discovery of unique combination of cytokines in multi-functional fusion protein molecule that exhibits ability to expand TPEX cells without cytokine storm in preclinical studies Definitive data from preclinical studies shared at Scientific Seminar Series held at Nova Southeastern University on September 12, 2025, in Fort Lauderdale, Florida MIRAMAR, Fla., Sept. ...

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].