Quince Therapeutics, Inc.

Company overview

Formerly Cortexyme, Inc.; renamed August 1, 2022.
Core focus: development of the Autologous Intracellular Drug Encapsulation (AIDE) platform, which encapsulates drugs into a patient’s own red blood cells (RBCs) using a CE‑marked automated device (the RCL) and a sterile single‑use treatment kit.
Platform objectives: use autologous RBCs to improve safety, tissue biodistribution, pharmacokinetics/pharmacodynamics, and reduce immunogenicity for drugs limited by toxicity, poor biodistribution, or immune-related constraints. The platform is intended to enable chronic administration of such drugs.
Device and process: a point‑of‑care workflow of about two hours that collects 50 mL of patient blood, loads it into the RCL with the treatment kit, performs hypotonic loading to encapsulate drug, reseals with hypertonic solution, washes, and re‑infuses the treated RBCs.

Lead asset: eDSP (encapsulated dexamethasone sodium phosphate) for Ataxia‑Telangiectasia (A‑T).
NEAT Phase 3 trial (A‑T): completed January 2026. The primary endpoint (change on the Rescored international cooperative ataxia rating scale, RmICARS) did not reach statistical significance. The key secondary endpoint (CGI‑S) also did not meet significance. Based on NEAT results, eDSP did not demonstrate efficacy for A‑T.
Safety: eDSP was generally well tolerated; most common adverse events were pruritis and pyrexia.
Other development: a Phase 2 program targeting Duchenne muscular dystrophy (DMD) to evaluate eDSP’s potential to deliver corticosteroids with an improved safety profile.
Strategic implication: the company indicates it will not continue development of eDSP for A‑T or other indications and is evaluating strategic alternatives.

EryDel acquisition completed October 20, 2023: Quince acquired EryDel, the private company that developed the AIDE technology and eDSP. EryDel is a variable interest entity; Quince is the primary beneficiary and sole shareholder.
Milestone structure tied to EryDel: up to $485 million in potential cash payments for development, regulatory, and sales milestones. Examples include:
- $5 million for first patient dosed in NEAT (achieved)
- $25 million at NDA acceptance
- Up to $60 million on regulatory milestones
- Up to $395 million on sales milestones
As of the date provided, there are no ongoing royalty payments to EryDel.

Manufacturing footprint: one facility in Medolla, Italy, authorized for design/development, production, distribution, and servicing of RCL machines and treatment kits. The facility is ISO 13485 certified and CE‑marked for medical device manufacturing.
External manufacturing: several third‑party manufacturers are used for key components and final assembly of the RCL and treatment kits.
International operations: clinical and operational activities include sites in Italy and other EU locations in addition to the United States.

Patent portfolio: six published patent families related to eDSP and the AIDE technology.
Key patent families:
- Family covering the RCL and treatment kit (U.S. patent 9,089,640 and foreign counterparts); U.S. expiry 2031 (excluding potential extension).
- Family covering the second swelling step in the loading process and methods for treating A‑T (U.S. patent 10,849,858 and continuation US 17/083,771); expiry around 2035–2036 (subject to patent term adjustments/extensions).
- Additional families cover therapeutic use of drug‑loaded erythrocytes and planned operation methods of the eDSP system.
Patent term and extensions: U.S. patent term is generally 20 years from earliest non‑provisional filing, with potential extensions under applicable rules. Foreign terms vary by jurisdiction.
Protection strategy: patents complemented by trade secrets, know‑how, trademarks, and confidentiality agreements.

Revenue: $0; no approved or commercial products generating revenue.
Net loss: $84.0 million for the year ended December 31, 2025; $56.8 million for the year ended December 31, 2024.
Cash, cash equivalents, and short‑term investments: $17.8 million as of December 31, 2025.
Financing activity (post‑2025): issued approximately 105.3 million shares under an ATM program, net proceeds of about $20.4 million; approximately $47.5 million remaining available under the ATM as reported.
Working capital and liquidity: the company reported substantial doubt about its ability to continue as a going concern and intends to pursue strategic alternatives and additional financing.

Headcount: 38 employees as of December 31, 2025 (25 in R&D; 13 in general and administrative).
Locations: South San Francisco, CA; Medolla and Bresso, Italy.

Listing: shares trade on the Nasdaq Global Select Market.
Compliance matters: March 2026 Nasdaq notices for non‑compliance with minimum bid price ($1.00) and minimum market value of listed securities ($50 million); a 180‑day period was provided to regain compliance.
Risk considerations: potential delisting or failure to execute a strategic transaction could impair liquidity and the ability to raise capital.

Strategic advisor: LifeSci Capital engaged on February 9, 2026, as exclusive financial advisor to assist with restructuring and evaluating strategic alternatives, including a possible reverse merger.
Financing plan: the company intends to pursue additional funding through public equity (including the ATM program) or other debt/equity financing to support strategic activities; success is not guaranteed.
Operational posture: no ongoing clinical development expected to produce near‑term revenue; the company is preserving cash while evaluating strategic alternatives, including potential reverse merger or asset dispositions.

Addressable patient populations referenced:
- A‑T in the U.S.: approximately 4,600 patients
- A‑T in the U.K. and EU4: approximately 5,000 patients
- DMD in the U.S.: approximately 15,000 patients

The company has no approved products generating revenue, reported ongoing liquidity concerns, and is pursuing strategic transactions and financing to support future value creation. Operational, regulatory, and financing risks exist across its international operations and device‑drug platform.