Spruce Biosciences, Inc.

The company is a biopharmaceutical company that develops and sells new treatments for neurological disorders where current medical options are insufficient. Founded in April 2016, the company's management team has experience in developing and commercializing innovative therapies. The company's strategy includes seeking regulatory approval and maximizing the U.S. commercial potential of TA-ERT for treating Mucopolysaccharidosis Type IIIB (MPS IIIB). They plan to seek U.S. accelerated approval for tralesinidase alfa enzyme replacement therapy ("TA-ERT") for MPS IIIB using existing non-clinical and clinical data. As a condition for a biologics license application ("BLA") from the U.S. Food and Drug Administration ("FDA"), a confirmatory trial will be initiated. If the BLA is approved, the company intends to build a specialized commercial and medical affairs organization to support TA-ERT's commercialization. TA-ERT has received Rare Pediatric Disease Designation, Fast Track Designation, Breakthrough Therapy Designation, and Orphan Drug Designation in the United States and European Union ("EU"). The company aims to commercialize TA-ERT and its other investigational products globally, including North America, the EU, the United Kingdom, Latin America, Turkey, Asia, and other international markets. They plan to establish their own commercial organization in the United States, EU, and the United Kingdom, and seek regional strategic collaborations and third-party distributors in other international markets. The company focuses on serious diseases with significant unmet medical need and clear, well-understood biology.