eDSP and A-T Treatment - Quince Therapeutics is developing eDSP, a red blood cell encapsulated dexamethasone sodium phosphate, for treating rare diseases, with a focus on Ataxia-Telangiectasia (A-T)[12] - The Phase 3 NEAT clinical trial for A-T has completed enrollment with 105 participants, including 83 in the primary analysis population aged 6-9 years, and topline data is expected in the first quarter of 2026[14, 74, 76] - A-T affects an estimated 10,000 patients in the U S, UK, and EU4 countries, and there are currently no approved treatments[50, 124] - The company estimates a $1+ billion global peak commercial opportunity for eDSP in the A-T indication[14, 33, 34, 124, 125] - The company has $34.7 million in cash, providing funding through topline results in Q1 2026 and potentially into the second half of 2026 if warrants are exercised[14] eDSP Technology and Mechanism - Over 20 years of R&D and $100 million have been invested in the Autologous Intracellular Drug Encapsulation (AIDE) technology used in eDSP[17, 36] - eDSP is designed to deliver corticosteroids in a patient's own red blood cells, aiming to provide efficacy without the toxicity associated with traditional corticosteroid use[17, 18] - RNA sequencing analysis of ATTeST trial samples revealed that eDSP demonstrates a classic glucocorticoid gene signature, including suppression of interferon-stimulated genes and downregulation of inflammation[105, 107, 108] Commercial and Regulatory Strategy - Quince has entered a strategic partnership with Option Care Health, the largest independent provider of home and outpatient infusion services in the U S, for eDSP administration[14] - The eDSP system has secured CE mark in Europe for clinical trial use, and the company has an active Investigational New Drug (IND) application for over 10 years[45] - The Phase 3 NEAT trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA, and the company plans to submit a New Drug Application (NDA) in the second half of 2026, seeking Priority Review[73, 121] Pipeline Expansion - Duchenne muscular dystrophy (DMD) has been selected as the second targeted indication for eDSP, with plans to initiate a Phase 2 clinical study in 2026[14, 33, 163]
Quince Therapeutics (NasdaqGS:QNCX) 2025 Earnings Call Presentation