Quince Therapeutics Shares Business Update & 2024 Financial Results
Quince Therapeutics, Inc., a late-stage biotechnology company focused on leveraging a patient’s own biology to treat rare diseases, has provided an update on its development pipeline and released financial results for the fiscal year ending December 31, 2024.
Clinical and Pipeline Developments
Phase 3 NEAT Clinical Trial Progress
Quince Therapeutics’s pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T) clinical trial has now exceeded 50% enrollment, with 71 participants screened and 61 randomized. The trial is evaluating eDSP (previously EryDex) in patients with Ataxia-Telangiectasia (A-T), including 54 participants in the six to nine-year-old primary analysis population.
Key updates:
- 24 participants have transitioned into the NEAT open-label extension study.
- Screening and randomization are expected to accelerate with the activation of new sites across multiple geographic regions.
- The trial aims to enroll approximately 86 patients aged six to nine and around 20 patients aged 10 or older.
- Conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
- Topline results expected in Q4 2025, with an anticipated NDA submission to the FDA and an MAA submission to the EMA in 2026.
The NEAT trial is a randomized, double-blind, placebo-controlled study assessing the neurological effects of eDSP, a dexamethasone sodium phosphate (DSP) formulation encapsulated in autologous red blood cells. Patients receive six infusions over 21 to 30 days, with efficacy measured using the rescored modified International Cooperative Ataxia Rating Scale (RmICARS).
Expansion into Duchenne Muscular Dystrophy (DMD)
Quince is preparing for a Phase 2 trial evaluating eDSP in Duchenne muscular dystrophy (DMD), expected to launch in 2025. The study will employ capital-efficient strategies and seek funding through grants and partnerships.
Scientific and Regulatory Milestones
- January 2025: Published long-term safety data on eDSP in A-T patients in Frontiers in Neurology.
- February 2025: Received a Notice of Allowance from the USPTO, extending patent protection for eDSP treatment in A-T to 2036.
- February 2025: Hosted an investor webinar featuring Dr. Mary Kay Koenig, discussing unmet needs in A-T and the competitive landscape.
- Strengthened the Scientific Advisory Board with the appointment of Dr. William Whitehouse, a leading pediatric neurologist.
Fiscal Year 2024 Financial Highlights
- Cash Position: $40.8 million as of December 31, 2024, sufficient to fund operations through NEAT topline results and into 2026.
- R&D Expenses: $18.6 million, primarily for NEAT trial activities and manufacturing.
- G&A Expenses: $17.6 million, covering personnel, stock-based compensation, and commercial planning.
- Net Loss: $56.8 million, or $1.31 per share, with 43.3 million weighted average shares outstanding.
- Operating Cash Flow: $31.9 million used in operations, offset by a $5.0 million milestone payment to EryDel shareholders following NEAT’s first patient enrollment in Q2 2024.
Future Outlook
Quince remains focused on advancing the NEAT trial while expanding its pipeline into additional indications like DMD. The company anticipates key milestones in 2025, including:
- Continued acceleration of NEAT trial enrollment.
- Launch of the DMD Phase 2 trial.
- Regulatory interactions to support NDA and MAA submissions in 2026.
With strong clinical progress and a solid financial position, Quince Therapeutics is well-positioned to drive meaningful advancements in rare disease treatment.
