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Quince Therapeutics Inc. (QNCX+2.00%) has submitted its 10-K filing for the fiscal year ended December 31, 2024.
The filing details Quince's focus on developing its proprietary AIDE technology platform and its lead asset, eDSP, for the treatment of Ataxia-Telangiectasia (A-T).
The company is conducting a Phase 3 NEAT clinical trial for eDSP in patients with A-T, with 61 participants enrolled as of March 24, 2025. The trial is expected to complete enrollment by the second quarter of 2025, with topline results anticipated in the fourth quarter of 2025.
Quince reported a net loss of $56.8 million for the year ended December 31, 2024, compared to a net loss of $31.4 million in 2023. The company had an accumulated deficit of $376.5 million as of December 31, 2024.
The company's cash, cash equivalents, and short-term investments totaled $40.8 million as of December 31, 2024. Quince acknowledges substantial doubt about its ability to continue as a going concern without additional funding.
Quince is exploring strategic partnerships to support the development and commercialization of eDSP and other drug candidates. The company also plans to expand its development pipeline to include additional indications for eDSP, such as Duchenne muscular dystrophy (DMD).
The company has received orphan drug designation for eDSP for the treatment of A-T from both the FDA and the European Commission. eDSP has also been granted Fast Track designation by the FDA.
Quince's intellectual property portfolio includes patents covering its eDSP System and AIDE technology in the United States and other jurisdictions. The company continues to pursue additional patent protection for its technologies.
The filing outlines various risks, including the potential need for substantial additional funding, dependence on the success of eDSP, and challenges related to regulatory approvals and commercialization.
Quince's operations are subject to extensive regulation by the FDA and other regulatory authorities. The company must comply with various regulatory requirements to maintain approvals for its drug candidates.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Quince Therapeutics Inc. annual 10-K report dated March 24, 2025. To report an error, please email earnings@qz.com.