Quince Therapeutics (QNCX) Investor Day 2025 summary

Technology and Platform Overview

• AIDE technology enables encapsulation of drugs into a patient's own red blood cells for reinfusion, allowing chronic administration of corticosteroids while minimizing toxicity.

• The Red Cell Loader device and EryKit consumables are fully automated, CE marked, and designed for ease of use and safety.

• Over 7,800 eDSP infusions have been administered, supporting a strong safety and efficacy profile.

• The platform is adaptable for other rare and non-rare diseases, with Duchenne Muscular Dystrophy (DMD) prioritized next.

• eDSP leverages over 20 years of R&D and $100 million investment in AIDE technology.

Clinical Development and Data

• The lead program, eDSP (encapsulated dexamethasone sodium phosphate), is in phase III for ataxia-telangiectasia (AT), with completed enrollment in the pivotal NEAT trial.

• The NEAT phase III trial targets children aged 6–9 with AT, focusing on the FDA-mandated RMICARS endpoint for posture and gait.

• Previous ATTeST/ATTEST phase III trial showed eDSP slowed neurological decline in 6–9-year-olds, with a 24% difference versus placebo and no major safety concerns.

• RNA sequencing from ATTeST revealed eDSP downregulates interferon-stimulated genes, reduces inflammation, and upregulates neuroprotective pathways.

• The pediatric study required by EMA will enroll 12 patients aged 2–6, focusing on PK and safety, with exploratory wearable device endpoints.

Regulatory and Commercial Strategy

• Orphan drug and fast-track designations granted in the US and EU, providing market exclusivity and expedited review.

• NDA submission planned for H2 2026, with top-line NEAT data expected in Q1 2026.

• Commercial launch preparations include a partnership with Option Care Health, enabling broad US infusion center coverage.

• Market opportunity estimated at over $1 billion for AT alone, with potential expansion into DMD and other rare diseases.

• Strong patent portfolio and technology barriers extend exclusivity to at least 2036, with additional extensions possible.