LENZ Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Highlights

About this update from Lenz Therapeutics, Inc.

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 15 th.” 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 globally and 128 million people in the United States . The Company previously announced the submission of its NDA in August 2024 . The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100, and noted it is not planning to hold an Advisory Committee Meeting to discuss this application. In January 2025 , the mid-cycle review meeting and communications were completed, noting no significant review issues. In the mid-cycle review communications, the FDA reiterated it had no plans to request an Advisory Committee Meeting. The NDA submission for the treatment of presbyopia is supported by positive data from the pivotal Phase 3 CLARITY study. Aceclidine is a new chemical entity in the United States and is not approved for the treatment of presbyopia in any country. Pre-launch U.S. commercial planning advanced in preparation for potential August 2025 approval. The Commercial team advanced its commercial readiness for LNZ100 for the treatment of presbyopia as the Company progressed towards the August 8, 2025 PDUFA target action date. Now approaching its first anniversary date of the EYEAMSELECTIVE unbranded campaign, the awareness of the Eye Care Professional (ECP) community on the importance of a pupil-selective and ciliary-body sparing miotic continued to grow, with over 2 million digital campaign impressions targeting over 30,000 ECPs. In the fourth quarter 2024 and recent period, the Company further expanded its commercial infrastructure and hired key sales force leadership including Regional Sales Directors and all District Managers, adding substantial commercial eye care and pharmaceutical sales experience. CORXEL and LENZ Therapeutics announced positive topline data from Phase 3 study in China for the treatment of presbyopia. In October 2024 , CORXEL and the Company announced topline data from the Phase 3 safety and efficacy study in China . In the Phase 3 study, LNZ100 (1.75% Aceclidine) achieved the primary endpoint and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one-line or more in distance visual acuity. The primary endpoint was met with 74% of patients dosed with LNZ100 achieving three-lines or greater improvement at 3 hours. The difference in efficacy was statistically significant in the LNZ100 treatment group compared to the vehicle-controlled group (p

View stock analysis, news, and events for Lenz Therapeutics, Inc.