Drug Development and Approval - The U.S. FDA accepted the New Drug Application (NDA) for LNZ100 for presbyopia treatment, with a PDUFA target action date of August 8, 2025[3]. - LNZ100 demonstrated a statistically significant improvement, with 74% of patients achieving three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near in the Phase 3 study in China[4]. Financial Performance - Cash, cash equivalents, and marketable securities totaled 217.2 million as of September 30, 2024, expected to fund operations to post-launch positive operating cash flow[7]. - Research and Development (R&D) expenses decreased to 6.5 million for Q3 2024, down from 17.0 million in Q3 2023, primarily due to the conclusion of the Phase 3 CLARITY study[8]. - Selling, General and Administrative (SG&A) expenses increased to 6.5 million for Q3 2024, compared to 10.2 million, or 18.9 million, or 30 million private placement financing in July 2024 to support its operations[6]. Market Insights and Commercial Strategy - Market research indicated that 82% of surveyed Eye Care Professionals (ECPs) would be likely to prescribe LNZ100 based on its clinical data profile[6]. - The company is preparing for a U.S. commercial launch of LNZ100, with a full commercial leadership team established[5]. - The presbyopia market is significant, with an estimated 128 million people in the U.S. and 400 million in China affected by the condition[2].
LENZ Therapeutics, Inc.(LENZ) - 2024 Q3 - Quarterly Results