Clinical Program & Pipeline

Our clinical pipeline is anchored by two proprietary platforms targeting serious diseases with significant unmet medical need. FS2, our lead candidate, is in Phase 2b/3 clinical development as a topical therapy for scar prevention and treatment of burn patients requiring skin grafts. In addition, FS2 is being advanced as a systemic treatment for organ fibrosis, starting with idiopathic pulmonary fibrosis (IPF), which is a rare, incurable, and deadly lung disease for which FS2 has received FDA Orphan Drug Designation. In earlier clinical testing, FS2 was well tolerated with no serious adverse effects.

AI-001, our regenerative cell-based platform, is designed to treat autoimmune conditions at their source, with preclinical studies demonstrating reversal of disease in gold-standard animal models of type 1 diabetes and alopecia areata. Together, these programs reflect our commitment to developing transformative therapies for patients with limited treatment options.