Business
Quince Therapeutics Provides Business Update and Reports Fourth Quarter and Fiscal 2023 Financial Results
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug
About this update from Quince Therapeutics, Inc.
[{"type":"text","content":" SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nQuince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today provided an update on the company’s development pipeline and reported financial results for the fourth quarter and fiscal year ended December 31, 2023.\n\n\n“With the acquisition of EryDel S.p.A. in October last year, we have successfully shifted our strategic focus to become a Phase 3 biotechnology company dedicated to securing regulatory approval for our lead product, EryDex, for the treatment of patients with Ataxia-Telangiectasia (A-T),” said Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer. “With $75.1 million cash on hand, we expect to have sufficient funding to complete our Phase 3 clinical trial, in addition to supporting the expansion of EryDex into other indications and our Autologous Intracellular Drug Encapsulation (AIDE) technology platform into new products. By pioneering the delivery of drugs encapsulated in a patient’s own red blood cells, we are working to redefine the standard of care, first for chronic corticosteroid therapy, and later for other drugs, that will meaningfully improve the quality of life for rare disease patients.”\n\n\nPivotal Phase 3 NEAT Clinical Trial\n\n\n\nCompleted the majority of study start up activities related to the company’s pivotal Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T; IEDAT-04-2022/NCT06193200) clinical trial.\n\n\n\n\nNEAT is an international, multi-center, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of the company’s lead asset, EryDex (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells), in patients with A-T.\n\n\n\n\nOn track to meet expectations to begin enrollment in the NEAT study during the second quarter of 2024.\n\n\n\n\nPivotal Phase 3 NEAT clinical trial will be conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food & Drug Administration (FDA).\n\n\n\n\nPlan to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients with A-T ages 10 years or older.\n\n\n\n\nParticipants will be randomized...