Quince Therapeutics(QNCX) - 2025 Q3 - Quarterly Report

Financial Performance - The company reported a net loss of $13.4 million for the three months ended September 30, 2025, compared to a net loss of $5.5 million for the same period in 2024, representing a 145% increase in net loss [176]. - The company recorded a net loss of $44.5 million for the nine months ended September 30, 2025, compared to a net loss of $44.4 million for the same period in 2024 [188]. - The accumulated deficit as of September 30, 2025, was $421.0 million, with net losses incurred since inception [202]. - The company has not generated any revenue and has financed operations primarily through the issuance of securities, raising approximately $320.1 million to date [201]. Research and Development - Research and development expenses increased to $8.1 million for the three months ended September 30, 2025, up from $4.9 million in the same period in 2024, marking a 64% increase [178]. - The development costs for eDSP rose by $3.0 million compared to the prior year, primarily due to increased clinical trial costs associated with the Phase 3 NEAT clinical trial [179]. - Research and development expenses increased by 78% to $22.8 million for the nine months ended September 30, 2025, compared to $12.8 million for the same period in 2024 [188]. - The costs for eDSP development rose by $8.2 million, primarily due to increased clinical trial costs of $7.2 million [190]. - The company completed enrollment of 105 participants in the Phase 3 NEAT clinical trial, with 83 participants in the primary analysis population, achieving approximately 90% power for statistical significance [156]. - The company expects to report topline results from the Phase 3 NEAT clinical trial in Q1 2026 and plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026, assuming positive results [157]. - The company plans to expand its development pipeline to include additional indications for eDSP, with Duchenne Muscular Dystrophy (DMD) identified as the second targeted indication [161]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $13.4 million, a 129% increase from $5.9 million in the same period in 2024 [176]. - General and administrative expenses decreased by $0.3 million to $3.3 million for the three months ended September 30, 2025, compared to $3.6 million in 2024, reflecting a 10% decrease [181]. - General and administrative expenses decreased by 14% to $11.4 million for the nine months ended September 30, 2025, down from $13.3 million in 2024 [193]. - The company recorded accrued expenses of approximately $5.1 million for clinical trial and operational services as of September 30, 2025 [225]. Cash and Financing Activities - The company has $26.3 million in cash, cash equivalents, and short-term investments as of September 30, 2025, expected to fund operations into Q2 2026 [162]. - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of $26.3 million, which may not be sufficient to fund operations for the next twelve months [203]. - The company utilized its ATM program to raise net proceeds of approximately $4.3 million by issuing 3,637,334 shares of common stock during the nine months ended September 30, 2025 [212]. - The company raised approximately $11.5 million in a private placement by issuing 6,671,928 shares of common stock and warrants [213]. - Cash provided by financing activities totaled $15.9 million for the nine months ended September 30, 2025, including $11.4 million from the June 2025 private placement [222]. Debt and Contingent Considerations - As of September 30, 2025, the company has an outstanding principal of €10.0 million ($11.7 million) on the EIB Loan, classified as current debt [215]. - The EIB Loan has a maximum borrowing capacity of €30.0 million, with tranches A and B drawn as of the reporting date [214]. - The fair value of the EIB Loan is $17.5 million, classified as current debt on the balance sheet [225]. - The fair value of long-term contingent consideration related to the EryDel acquisition is $61.2 million as of September 30, 2025 [225]. - A fair value adjustment for contingent consideration resulted in a $4.7 million increase for the three months ended September 30, 2025, primarily due to the passage of time [182]. - A fair value adjustment for contingent consideration resulted in a $2.4 million charge for the nine months ended September 30, 2025 [195]. Cash Flow Activities - Net cash used in operating activities increased by $6.6 million to $30.9 million for the nine months ended September 30, 2025, primarily due to higher clinical development costs [219]. - Cash provided by investing activities was $15.2 million for the nine months ended September 30, 2025, mainly from short-term investment maturities [221]. - The company has approximately $22.9 million in cancellable future operating expense commitments based on existing contracts as of September 30, 2025 [225].