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LENZ Therapeutics Inc. (LENZ-9.72%) has submitted its 10-K filing for the fiscal year ended December 31, 2024.
The filing outlines the company's focus on developing and commercializing innovative therapies to improve vision, with a primary emphasis on treating presbyopia. The company's lead product candidate, LNZ100, is a once-daily eye drop containing aceclidine, which aims to improve near vision without the need for reading glasses.
LENZ reported a net loss of $49.8 million for the year ended December 31, 2024, compared to a net loss of $70.0 million in the previous year. The decrease in net loss is attributed to reduced research and development expenses following the completion of its Phase 3 CLARITY trials.
Research and development expenses decreased to $29.8 million in 2024 from $59.5 million in 2023, primarily due to the completion of clinical trials. Selling, general, and administrative expenses increased to $28.8 million from $12.9 million, driven by pre-commercial marketing and sales infrastructure expenses in preparation for a potential commercial launch.
The company reported $209.1 million in cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2024. LENZ believes these funds will allow it to continue building infrastructure and commercialize LNZ100, subject to FDA approval.
LENZ's NDA for LNZ100 was submitted in August 2024, and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025. If approved, commercial launch is anticipated in the fourth quarter of 2025.
LENZ's market opportunity for LNZ100 is estimated to exceed $3 billion in the United States, targeting the 128 million presbyopes in the country. The company continues to build a commercial strategy and infrastructure to support the potential launch.
The filing also details the company's financial position, including its funding history and future capital requirements. LENZ plans to evaluate financing opportunities as needed to support its operations and growth.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the LENZ Therapeutics Inc. annual 10-K report dated March 19, 2025. To report an error, please email earnings@qz.com.