Graphite Bio(GRPH) - 2024 Q4 - Annual Results

Financial Performance - LENZ Therapeutics reported cash, cash equivalents, and marketable securities of $209.1 million as of December 31, 2024, expected to fund operations until post-launch positive operating cash flow[9]. - The net loss for Q4 2024 was $12.7 million, or $0.46 per share, compared to a net loss of $23.7 million, or $12.04 per share in Q4 2023[12]. - Total operating expenses for the year ended December 31, 2024, were $58.6 million, down from $72.4 million in 2023[21]. - The company’s total assets as of December 31, 2024, were $215.3 million, compared to $70.4 million in 2023[19]. Research and Development - Research and Development (R&D) expenses decreased to $5.9 million for Q4 2024, down from $19.5 million in Q4 2023, and totaled $29.8 million for the year, compared to $59.5 million in 2023[10]. Selling, General and Administrative Expenses - Selling, General and Administrative (SG&A) expenses increased to $9.4 million for Q4 2024, up from $5.5 million in Q4 2023, and totaled $28.8 million for the year, compared to $12.9 million in 2023[11]. Regulatory and Clinical Developments - The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025, for the New Drug Application (NDA) of LNZ100 for presbyopia[4]. - In the pivotal Phase 3 CLARITY study, 74% of patients treated with LNZ100 achieved a statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near[7]. Commercialization Efforts - The company has advanced its commercial planning for LNZ100, with over 2 million digital campaign impressions targeting more than 30,000 Eye Care Professionals (ECPs)[5]. - LENZ Therapeutics plans to host a Commercial Day on April 15, 2025, to discuss commercialization strategies and progress towards the potential approval of LNZ100[8].