Quince Therapeutics Announces Major Clinical and Corporate Milestones Alongside Q2 2025 Financial Results
Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to harnessing a patient’s own biology for the treatment of rare and underserved diseases, has delivered a comprehensive update on its clinical pipeline progress and financial performance for the second quarter ended June 30, 2025.
The quarter was marked by a series of strategic and operational achievements that the company believes will position it strongly for the next stage of growth, including the completion of enrollment in its pivotal Phase 3 NEAT trial, new financing to extend its operating runway, and expanded commercial readiness through a key industry partnership.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, framed the quarter as one of transformative progress.
“We achieved many critical milestones over the last quarter that significantly advance our research programs and strengthen our business model. Specifically, we completed enrollment in our pivotal Phase 3 NEAT clinical trial, secured additional financing to extend our operating runway sufficiently beyond topline results, and solidified our commercial development planning through our strategic partnership with Option Care Health. Quince remains confident in our ability to deliver topline results in the first quarter of 2026 and subsequent NDA submission in the second half of 2026, assuming positive study results,” Thye said.
Advancing the Pivotal Phase 3 NEAT Trial
The company’s most notable R&D milestone during the quarter was the successful completion of patient enrollment in the NEAT (Neurological Effects of eDSP on Subjects with A-T) study, a global Phase 3 trial designed to evaluate Quince’s lead investigational therapy, eDSP (dexamethasone sodium phosphate encapsulated in autologous red blood cells), in patients with ataxia-telangiectasia (A-T) — a rare and devastating genetic neurodegenerative disease.
The trial enrolled a total of 105 participants, split into two cohorts:
- Primary analysis group: 83 children aged six to nine years.
- Secondary cohort: 22 patients aged 10 years and older.
This enrollment structure reflects a study power of approximately 90% to detect statistical significance on the primary endpoint.
Quince anticipates reporting topline Phase 3 NEAT results in Q1 2026. If outcomes are positive, the company intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the second half of 2026.
The NEAT trial benefits from several regulatory advantages:
- Special Protocol Assessment (SPA) agreement with the FDA, ensuring regulatory alignment on the trial design and primary endpoints.
- Fast Track designation for eDSP, recognizing the therapy’s potential to address a serious, unmet medical need.
The trial’s design is robust: an international, multicenter, randomized, double-blind, placebo-controlled structure in which participants receive six infusions (either eDSP or placebo) over a treatment period, with each infusion spaced 21 to 30 days apart. The primary endpoint is the change from baseline in the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) score at the last efficacy visit.
Notably, patient retention has been strong:
- All 50 participants who have completed the treatment phase have chosen to transition into the open-label extension (OLE) study, where all patients receive active treatment.
Pipeline and Corporate Progress
Beyond NEAT, Quince made strides in broadening its R&D scope and strengthening commercial pathways.
Strategic Partnership with Option Care Health
In a move designed to accelerate the commercial rollout of eDSP in the U.S., Quince entered into a strategic relationship with Option Care Health, Inc. (Nasdaq: OPCH), the nation’s largest independent provider of home and ambulatory infusion services.
Through this partnership, Quince plans to leverage Option Care’s extensive network of specialty pharmacies and infusion centers to provide patients with greater geographic flexibility for receiving treatment, ensuring a more patient-centric delivery model when eDSP becomes available.
Strengthened Balance Sheet through Private Placement
In June 2025, Quince completed a private placement of common stock and accompanying warrants, led by healthcare-focused institutional investor Nantahala Capital and joined by existing stockholders ADAR1 Capital Management, Legend Capital Partners, and Lagfin S.C.A., as well as new investor Second Line Capital.
The financing, priced at a premium of over 10% to Quince’s market price, generated:
- $11.5 million in upfront proceeds.
- Potential $10.4 million in additional capital if warrants are exercised in full.
These funds will extend Quince’s operating runway past the NEAT topline readout and potentially into late 2026.
Advancing eDSP for Duchenne Muscular Dystrophy (DMD)
The company finalized Phase 2 trial designs to evaluate eDSP for Duchenne muscular dystrophy, a severe genetic disorder characterized by progressive muscle degeneration. Quince plans to use capital-efficient approaches, including potential investigator-initiated trials (IITs), to explore DMD as a second major indication for its lead platform.
Pediatric Encapsulated Dexamethasone Study
Quince initiated Study #3 in its EU pediatric investigational plan (PIP) — the PeD Study — to evaluate the safety and pharmacokinetics of eDSP in younger patients with A-T weighing between 9 and 15 kilograms.
Scientific Engagement and Advisory Board Expansion
The company maintained strong ties with the scientific community:
- Participated in the 2025 A-T Clinical Research Conference organized by the U.K.-based A-T Society.
- Shared post hoc analyses from its earlier Phase 3 ATTeST trial.
- Expanded its Scientific Advisory Board with the appointment of Dr. Hassan Abolhassani, a leading expert in clinical immunology from the Karolinska Institutet in Sweden. Dr. Abolhassani became the ninth SAB member, joining a multidisciplinary team of specialists in neurology, immunology, hematology, pharmacology, genetics, and clinical practice.
Financial Performance – Q2 2025
Cash Position
- $34.7 million in cash, cash equivalents, and short-term investments as of June 30, 2025.
- Existing capital is expected to fund operations into Q2 2026, with potential runway extension into late 2026 if all warrants from the June financing are exercised for cash.
Operating Expenses
- R&D expenses: $6.6 million, primarily for NEAT trial costs and related manufacturing activities.
- G&A expenses: $3.3 million, driven by personnel, stock-based compensation, commercial planning, and professional services.
Net Loss
- Net loss: $16.1 million, or $0.34 per share (basic and diluted).
- Weighted average shares outstanding: 46.7 million.
Cash Flow
- Net cash used in operating activities for the first six months of 2025: $21.0 million.
- The net loss of $31.1 million for the period was partially offset by $9.9 million in non-cash adjustments, including:
- $4.5 million change in fair value of warrants.
- $2.7 million stock-based compensation.
- $2.5 million change in contingent consideration liabilities.
- $0.8 million change in the fair value of a European Investment Bank loan.
- Additional working capital changes included a $0.5 million decrease in operating assets and a $0.3 million increase in accounts payable and accrued expenses.
Quince is now in a critical pre-commercialization phase for eDSP, with multiple catalysts on the horizon:
- Q1 2026: Topline NEAT trial data readout.
- 2H 2026: Anticipated NDA submission to the FDA, assuming positive data.
- Continued advancement of DMD program with Phase 2 initiation.
- Potential expansion into pediatric patient populations through the PeD study.
The company’s approach — combining rigorous clinical execution, strategic partnerships, and disciplined financial management — positions it to address unmet needs in A-T and potentially other neuromuscular diseases.
Dr. Thye concluded:
“We are building a company with the discipline to deliver for both patients and shareholders. Our team is unified around the goal of bringing eDSP to patients with A-T as quickly and efficiently as possible, while also exploring new indications where our technology can make a difference.”
About Quince Therapeutics
Quince Therapeutics, Inc. is a late-stage biotechnology company developing therapies that leverage a patient’s own biology to treat rare diseases. Its lead asset, eDSP, is being evaluated in a pivotal Phase 3 trial for ataxia-telangiectasia and is also under development for Duchenne muscular dystrophy.
