Quince Therapeutics (QNCX) Company Report

Quince Therapeutics announced that its pivotal Phase 3 NEAT clinical trial for eDSP in Ataxia-Telangiectasia (A-T) did not achieve statistical significance for its primary and key secondary endpoints.
The primary endpoint, measuring change from baseline to month six using RmICARS, showed a mean change of 0.94 in the active arm compared to 2.24 in the placebo arm, with a p-value of 0.0851.
As a result, the company intends to cease clinical development of eDSP and will explore available options to preserve cash.
eDSP was generally well tolerated, with no clinically meaningful safety concerns identified.

4 days ago

Press Release

Quince Therapeutics Provides Update on NEAT Study and Commercial Strategy

QNCX

New Projects/Investments

Product Launch

Quince Therapeutics expects pivotal data from its Phase 3 NEAT study for Ataxia-telangiectasia (A-T) in February 2026 (Q1 2026). The study focuses on patients aged 6-9, a population where a previous trial demonstrated significant benefit, and has a Special Protocol Assessment (SPA) with the FDA.
The NEAT study is powered to show a difference of approximately 2.5 points on the 29-point RmICARS scale, with a statistically significant change defined as 1.5 points.
The company anticipates filing the New Drug Application (NDA) through the 505(b)(2) pathway in the second half of 2026, likely between Q3 and Q4.
The estimated U.S. patient population for A-T is 5,000-6,000 patients, and the projected annual price point for the therapy is between $500,000 and $700,000.
Quince Therapeutics plans to launch the therapy using an outpatient infusion network, aiming to cover 85% of patients within a 90-minute drive of a treatment center.

Dec 3, 2025, 3:30 PM

Transcript

Quince Therapeutics Discusses Upcoming Pivotal Study Readout and Commercialization Strategy for Ataxia Telangiectasia Therapy

QNCX

New Projects/Investments

Product Launch

Quince Therapeutics is developing a drug-device combination therapy for ataxia telangiectasia (AT), a rare pediatric genetic disease, which encapsulates dexamethasone in red blood cells to allow chronic, efficacious dosing without toxicity.
The pivotal Phase 3 NEAT study, focused on AT patients aged six to nine, is expected to read out in February 2026. The FDA has granted a Special Protocol Assessment (SPA), indicating that a successful trial could be sufficient for approval.
The company plans to file the NDA in the second half of 2026, with the estimated U.S. patient population for AT being approximately 5,000 children and a potential therapy price point of $500,000-$700,000 per year.
Quince Therapeutics has a commercial strategy that includes a partnership with Option Care Health to establish outpatient infusion centers, aiming to make the therapy accessible to 85% of patients within a 90-minute drive.

Dec 3, 2025, 3:30 PM

Transcript

Quince Therapeutics Discusses Pivotal AT Study Readout and Commercial Strategy

QNCX

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Quince Therapeutics is developing a drug-device combination technology that encapsulates dexamethasone in red blood cells to treat Ataxia Telangiectasia (AT), a rare pediatric genetic disease, aiming for efficacious dosing without toxicity.
The company's pivotal Phase 3 NEAT study, targeting 6-9 year old AT patients, is expected to read out in February 2026 (Q1 2026). The study has a Special Protocol Assessment (SPA) agreement with the FDA, and its primary endpoint is the RMICARS, powered to show a difference of about 2.5 points out of 29.
The Safety Data Monitoring Committee (DSMB) has concluded no safety signals and approved the continuation of the NEAT study.
Quince anticipates filing the NDA in the second half of 2026, likely between Q3 and Q4, for an estimated U.S. patient population of 5,000.
The therapy's orphan pricing is projected to be in the $500,000-$700,000 per year range, with a commercial launch strategy involving 50 outpatient infusion sites to reach 85% of patients.

Dec 3, 2025, 3:30 PM

Transcript

Quince Therapeutics Reports Q3 2025 Financial Results and Provides Business Update

QNCX

Earnings

Guidance Update

New Projects/Investments

Quince Therapeutics reported a net loss of $13.3 million, or $0.25 per basic and diluted share, for the third quarter ended September 30, 2025. The company held $26.3 million in cash, cash equivalents, and short-term investments as of September 30, 2025, and anticipates its existing cash runway will fund operations through Phase 3 NEAT topline results into the second quarter of 2026, with potential extension into the second half of 2026 if warrants are fully exercised.
The pivotal Phase 3 NEAT clinical trial for eDSP in Ataxia-Telangiectasia (A-T) completed enrollment in July 2025. Topline results are expected in the first quarter of 2026, and a New Drug Application (NDA) submission to the FDA is planned for the second half of 2026, assuming positive study results. An independent data and safety monitoring board (iDSMB) recommended the study continue without modifications.
The company is advancing Duchenne muscular dystrophy (DMD) as its second targeted eDSP indication, with a Phase 2 clinical study planned for 2026. Additionally, Quince Therapeutics amended its European Investment Bank (EIB) debt agreement in September 2025, reducing the required minimum cash balance to €5.0 million for the period from January 1, 2026, to March 31, 2026.

Nov 12, 2025, 9:05 PM

8-K

Quince Therapeutics Reports Q3 2025 Financial Results and Provides Business Update

QNCX

Earnings

Guidance Update

New Projects/Investments

Quince Therapeutics reported $26.3 million in cash, cash equivalents, and short-term investments as of September 30, 2025, with an expected cash runway into the second quarter of 2026, potentially extending into the second half of 2026 if warrants are fully exercised. For the third quarter ended September 30, 2025, the company reported a net loss of $13.3 million (or $0.25 per basic and diluted share), $8.1 million in research and development expenses, and $3.3 million in general and administrative expenses.
The pivotal Phase 3 NEAT clinical trial, evaluating its lead asset eDSP for Ataxia-Telangiectasia (A-T), remains on track, with topline results expected in the first quarter of 2026. The trial completed enrollment in July 2025 with 105 participants and is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
Assuming positive study results, Quince plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026. The company also received FDA Fast Track designation for eDSP and is preparing for a Phase 2 clinical study in 2026 to evaluate Duchenne muscular dystrophy (DMD) as a second targeted eDSP indication.

Nov 12, 2025, 9:05 PM

Press Release

Quell Therapeutics to Unveil Promising QEL-005 Pre-Clinical Data

QNCX

New Projects/Investments

Product Launch

Quell Therapeutics will present promising pre-clinical data for QEL-005, a novel CAR-Treg cell therapy, at ACR Convergence 2025.
QEL-005 demonstrates immunomodulatory activity across multiple immune cell lineages, including B cells, T cells, and inflammatory macrophages, for complex autoimmune inflammation.
Its broad mechanism of action offers a potentially safer and better tolerated therapeutic option compared to existing CAR-T and B-cell depletion approaches.
The company is completing CTA regulatory applications in Q4 and plans to initiate the CHILL clinical study in H1 2026 for Rheumatoid Arthritis and Systemic Sclerosis.

Oct 25, 2025, 3:00 PM

Press Release

Quince Therapeutics Provides Update on Phase III AT Trial and Commercial Strategy

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New Projects/Investments

Guidance Update

Product Launch

Quince Therapeutics anticipates top-line results in Q1 2026 from its pivotal Phase III NEAT trial for encapsulated dexamethasone (eDSP) in ataxia-telangiectasia (AT), a pediatric disease with no currently approved therapies.
The company plans to submit its U.S. NDA for eDSP in AT in the second half of 2026, assuming positive Phase III data, leveraging Orphan Drug and Fast-Track designations from the U.S. FDA.
Quince estimates the U.S. AT market at approximately 5,000 patients, with a potential for a billion-dollar-plus market. The company has secured a partnership with Option Care Health for commercial outpatient infusion services and plans to pursue Duchenne Muscular Dystrophy (DMD) as its next indication, with studies starting in 2026.
The company reported approximately $35 million in cash at the end of Q2, providing a financial runway through the Phase III data readout and into Q2 2026.

Oct 2, 2025, 2:00 PM

Transcript

Quince Therapeutics Completes Enrollment for Pivotal Phase 3 AT Trial, Anticipates Q1 2026 Results

QNCX

New Projects/Investments

Guidance Update

Product Launch

Quince Therapeutics has completed enrollment for its pivotal Phase 3 NEAT trial for ataxia-telangiectasia (AT), with top-line results anticipated in Q1 2026. The trial is under a Special Protocol Assessment (SPA) with the FDA, allowing it to serve as a single pivotal trial for approval.
The company estimates a U.S. market of approximately 5,000 AT patients, representing a potential billion-dollar-plus opportunity for its encapsulated dexamethasone (EDSP) therapy, which holds Orphan Drug Designation and patents until 2036.
Quince Therapeutics reported approximately $35 million in cash at the end of Q2, providing a financial runway through the Phase 3 data readout and into Q2 2026.
A commercial partnership with Option Care Health, an outpatient infusion network, has been established to support the potential launch of EDSP.
Following AT, the company plans to pursue Duchenne muscular dystrophy (DMD) as its second indication, with studies expected to begin next year, leveraging EDSP's potential as a potent yet safe steroid.

Oct 2, 2025, 2:00 PM

Transcript

Quince Therapeutics Provides Update on Phase 3 Trial and Commercial Strategy at Investor Day

QNCX

New Projects/Investments

Guidance Update

Revenue Acceleration/Inflection

Quince Therapeutics announced completed enrollment of 105 patients in its pivotal Phase 3 NEAT trial for Ataxia Telangiectasia (AT), with top-line results expected in Q1 2026.
The NEAT trial is under a Special Protocol Assessment (SPA) with the FDA, positioning a positive outcome as a potential single pivotal trial for approval of EDSP, which has Orphan Drug and Fast Track Designations.
The company estimates a U.S. market of approximately 5,000 AT patients, projecting a $1 billion+ commercial opportunity for EDSP as a potential first-to-market therapy.
Quince Therapeutics reported a cash balance of approximately $35 million at the end of Q2, extending its financial runway through Phase 3 data and into 2026.