Quince Therapeutics: High-Potential Turnaround With Phase 3 Asset EryDex

Company Overview - Quince Therapeutics (NASDAQ:QNCX) is a biotech company focused on developing treatments for rare diseases, with a primary asset being EryDex, a drug delivery platform for Ataxia-Telangiectasia [2][3] - The company aims to expand its development pipeline through in-licensing and acquisition of clinical-stage assets, following a strategic shift after previous setbacks in Alzheimer's disease [3] EryDex and AIDE Technology - EryDex utilizes the AIDE technology platform, which allows for the encapsulation of drugs into a patient's red blood cells, enabling continuous delivery of dexamethasone sodium phosphate over a month without toxicity [2][4] - The treatment involves harvesting about 50 ml of the patient's blood, loading it with dexamethasone, and reinfusing it back into the patient [4] Ataxia-Telangiectasia - Ataxia-Telangiectasia is a genetic disorder with approximately 10,000 diagnosed patients in the U.S., U.K., and Big 4 EU countries, and no approved treatment currently exists [2][6] - The disease is characterized by poor coordination and dilated blood vessels, leading to severe disability and a median lifespan of 25-30 years [6] Clinical Trials and Results - Quince is conducting a pivotal Phase 3 trial (NEAT) for EryDex, targeting patients aged 6-9, with topline data expected in Q4 2025 [2][15] - Previous Phase 3 trials (ATTeST) showed statistically significant efficacy in the 6-9 year old subgroup, with a notable 4.8-point improvement on the mICARS rating scale compared to placebo [10][11] Market Potential - The peak commercial potential for EryDex in treating Ataxia-Telangiectasia is estimated to exceed $1 billion, assuming a treatment price similar to other orphan drugs [21][22] - The company anticipates a market entry as early as 2027, with potential for high market penetration due to the lack of competing treatments [22][28] Financials - As of June 2024, Quince had$59 million in cash, expected to fund operations into 2026, with a net loss of $27.7 million reported for the last quarter [24] - The company is currently trading below its cash value, indicating a potentially undervalued position in the market [23][27] Leadership - Quince's leadership team has extensive experience, with CEO Dirk Thye having a successful track record in founding and selling companies, as well as obtaining FDA approvals [20] - Insider buying activity has been noted, with significant purchases by leadership, indicating confidence in the company's future [20]