Quince Therapeutics(QNCX) - 2024 Q1 - Quarterly Report

Product Development - Quince Therapeutics is focused on developing EryDex, a treatment for A-T, with a global market opportunity exceeding $1 billion [145]. - The Phase 3 NEAT clinical trial for EryDex is expected to begin enrollment in Q2 2024, targeting approximately 86 patients aged 6 to 9 and 20 patients aged 10 and older [161]. - EryDex has received orphan drug designation from the U.S. FDA and EU EC for the treatment of A-T [163]. - The previous ATTeST Phase 3 trial involved 176 patients and evaluated two doses of EryDex, with a primary efficacy endpoint based on neurological symptoms measured by mICARS [166]. - The company plans to submit a New Drug Application (NDA) to the FDA in 2026, contingent on positive NEAT trial results [162]. - EryDex is designed to improve the pharmacokinetics and biodistribution of DSP, a corticosteroid, to enhance safety and efficacy [156]. - The company aims to explore additional indications for EryDex in rare diseases where corticosteroid treatment is standard but limited by safety concerns [154]. - The NEAT trial will be conducted under a Special Protocol Assessment (SPA) agreement with the FDA, facilitating NDA submission post-trial [162]. Financial Performance - Research and development expenses increased by 14.6% to $3.7 million for the three months ended March 31, 2024, compared to $3.2 million for the same period in 2023 [185]. - EryDex development costs rose by $2.7 million due to Phase 3 NEAT clinical trial start-up costs, primarily from a $2.4 million increase in clinical trial costs [186]. - General and administrative expenses increased by 29.9% to $5.0 million for the three months ended March 31, 2024, from $3.8 million for the same period in 2023 [190]. - A fair value adjustment for contingent consideration resulted in a $2.5 million charge for the three months ended March 31, 2024, related to the EryDel acquisition [191]. - Interest income increased by 26.7% to $0.887 million for the three months ended March 31, 2024, compared to $0.700 million for the same period in 2023 [185]. - The net loss for the three months ended March 31, 2024, was $11.149 million, a decrease of 9.0% from a net loss of $12.254 million for the same period in 2023 [185]. - No intangible asset impairment charges were recognized during the three months ended March 31, 2024, compared to a $5.9 million charge in the same period of 2023 [193]. - The company anticipates a significant increase in research and development expenses as it prepares to begin enrollment for the Phase 3 NEAT clinical trial [177]. - Personnel-related costs decreased by $0.4 million during the three months ended March 31, 2024, compared to the same period in 2023 [188]. - As of March 31, 2024, the company had an accumulated deficit of $330.8 million and incurred a net loss of $11.1 million for the three months ended March 31, 2024 [198]. Funding and Cash Flow - The company has financed operations through the issuance of convertible promissory notes and redeemable convertible preferred stock, receiving net proceeds of approximately $303.9 million since inception [199]. - Cash, cash equivalents, and short-term investments were $67.8 million as of March 31, 2024, down from $75.1 million as of December 31, 2023 [200]. - The company believes existing capital resources will fund operations into at least 2026, excluding costs associated with in-licensing activities [201]. - Substantial additional funding will be needed to support ongoing operations and development strategies, with potential reliance on equity or debt financing [202]. - Net cash used in operating activities was $8.4 million for the three months ended March 31, 2024, primarily due to the net loss [209]. - Cash provided by investing activities was $8.9 million for the three months ended March 31, 2024, mainly from maturities of short-term investments [211]. - Cash provided by financing activities was $0.2 million for the three months ended March 31, 2024, from the exercise of stock options [212]. - The fair value of long-term contingent consideration related to the EryDel acquisition is $60.3 million, with a short-term portion of $4.7 million as of March 31, 2024 [214]. - The company has approximately $14.3 million in cancellable future operating expense commitments based on existing contracts as of March 31, 2024 [214].