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Quince Therapeutics (QNCX) investor relations material

Quince Therapeutics Investor Day 2025 summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Investor Day 2025 summary2 Oct, 2025

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.

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Frequently asked questions

Quince Therapeutics Inc is a U.S.-based biopharmaceutical company focused on the development and commercialization of targeted therapeutics for debilitating and rare diseases. The company’s pipeline includes treatments designed to improve drug delivery and tissue targeting for enhanced efficacy and safety. Quince Therapeutics leverages proprietary platforms and collaborates with partners to advance its clinical and preclinical programs. The company is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ.

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