Quince Therapeutics (QNCX) investor relations material

Technology and Platform Overview

• Developed a proprietary autologous intracellular drug encapsulation (AID) platform using a mobile, automated machine to load drugs into a patient's own red blood cells for reinfusion, enabling chronic delivery of corticosteroids while minimizing toxicity.

• Lead program is encapsulated dexamethasone sodium phosphate (EDSP/eDSP), designed for monthly dosing to maintain therapeutic levels and avoid toxic plasma concentrations associated with conventional steroids.

• Over 425 participants have received at least one dose of EDSP/eDSP, with more than 7,800 infusions administered, supporting a strong safety and efficacy profile.

• The technology is CE marked in Europe, has undergone rigorous regulatory review, and is protected by a robust patent portfolio and proprietary device components.

• 20+ years of R&D and $100 million investment in AIDE technology underpin the platform.

Clinical Development and Data

• Pivotal Phase III NEAT trial in ataxia telangiectasia (A-T) has completed enrollment, focusing on children aged 6–9, with top-line results expected in Q1 2026.

• Previous ATTEST Phase III trial showed a 24% difference versus placebo in the target age group, with no major safety concerns and strong efficacy signals in posture and gait endpoints.

• RNA sequencing from the ATTEST trial revealed that EDSP/eDSP downregulates interferon-stimulated and pro-inflammatory genes, reduces inflammation, and upregulates neuroprotective and mitochondrial genes, supporting a disease-modifying mechanism.

• NEAT trial conducted under FDA Special Protocol Assessment, with high data integrity and compliance, and primary endpoint focused on clinically meaningful outcomes.

• A pediatric study required by the EMA will enroll 12 children aged 2–6 to assess PK and safety, using wearable devices to explore new functional endpoints.

Regulatory and Commercial Strategy

• Orphan drug and Fast Track designations granted in the US and EU, providing market exclusivity (7 years US, 10 years EU) and regulatory advantages.

• NDA submission for eDSP in A-T planned for the second half of 2026, with a request for Priority Review and the US following a 505(b)(2) pathway leveraging existing dexamethasone data.

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

• Market opportunity for A-T estimated at $1B+ in the US alone, with potential to expand as awareness and diagnosis increase.

• Strong patent protection until at least 2036, with additional technology barriers to generic competition.