Business
LENZ Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Highlights
New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025 Upon FDA approval, commercial launch
About this update from Lenz Therapeutics, Inc.
[{"type":"text","content":"New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025 Upon FDA approval, commercial launch activities to commence immediately with LNZ100 product availability anticipated in the fourth quarter of 2025 Cash, cash equivalents and marketable securities of $209.1 million as of December 31, 2024; cash runway anticipated to extend to post-launch positive operating cash flow Company to host a conference call today at 4:30 p.m. EST SAN DIEGO, March 19, 2025 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today reported financial results for the fourth quarter and full year ended December 31, 2024, and recent corporate highlights. “This year has been an extremely successful year for LENZ, and we have continued to make progress in the fourth quarter and recent period as we move closer to the potential approval and launch of LNZ100 in the United States,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “I am very pleased with the advancements made by our regulatory team with the FDA, having recently completed our mid-cycle review, which led to our manufacturing operations team initiating production to support our potential commercial launch. Importantly, the recent period has been highlighted by the focus and execution of our medical affairs team, continuing to educate the ECP community on the benefits of a pupil-selective, ciliary-body sparing miotic for the treatment of presbyopia, in addition to impressive pre-commercial planning efforts as we near completion of our full commercial infrastructure and finalized our branding creative. We look forward to highlighting much of this recent progress and more at our upcoming Commercial Day on April 15th.” Fourth Quarter 2024 and Recent Corporate Highlights Announced New Drug Application (NDA) acceptance by the U.S. Food and Drug Administration (FDA) for LNZ100 as a treatment for presbyopia. In October 2024, the Company announced that the FDA accepted the NDA for LNZ100 for the treatment of presbyopia, a condition that impacts an estimated 1.8 billion people glo...