Graphite Bio(US:GRPH)2024-11-06 12:26Drug Development and Approval - The New Drug Application (NDA) for LNZ100 for the treatment of presbyopia has been accepted by the FDA, 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]. - The company is preparing for a US commercial launch of LNZ100, with a full commercial leadership team established[5]. - Market research indicated that 82% of surveyed Eye Care Professionals (ECPs) would be likely to prescribe LNZ100 based on its clinical data profile[6]. Financial Performance - Cash, cash equivalents, and marketable securities totaled $217.2 million as of September 30, 2024, expected to fund operations until 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, reflecting a 62% reduction[8]. - Selling, General and Administrative (SG&A) expenses increased to $6.5 million for Q3 2024, compared to $2.9 million in Q3 2023, marking a 124% increase[9]. - The net loss for Q3 2024 was $10.2 million, or $0.38 per share, compared to a net loss of $18.9 million, or $9.62 per share, in Q3 2023[10]. - The company completed a $30 million private placement financing in July 2024 to support its operations[6]. Market Overview - The presbyopia market is significant, with an estimated 128 million people in the United States and 400 million in China affected by the condition[2].