Graphite Bio(GRPH) - 2025 Q1 - Quarterly Results

Drug Development - The New Drug Application (NDA) for LNZ100 for the treatment of presbyopia is on track for a PDUFA target action date of August 8, 2025[1]. - The FDA has confirmed that LNZ100 will be duty-free in the U.S., clarifying tariff exposure for the product[5]. Financial Performance - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities of $194.1 million, with an anticipated cash balance exceeding $185.0 million by the PDUFA date[8]. - The net loss for Q1 2025 was $14.6 million, or $0.53 per share, an improvement from a net loss of $16.6 million, or $3.53 per share, in Q1 2024[11]. - Total operating expenses for Q1 2025 were $16.9 million, compared to $16.1 million in Q1 2024[19]. Research and Development - Research and Development (R&D) expenses decreased to $5.8 million for Q1 2025, down from $10.5 million in Q1 2024, due to the conclusion of the Phase 3 CLARITY study[9]. Sales and Marketing - Selling, General and Administrative (SG&A) expenses increased to $11.1 million in Q1 2025, compared to $5.6 million in Q1 2024, driven by personnel-related expenses and pre-commercial marketing[10]. - The company is actively hiring 88 sales representatives, with a target completion date of July 1, 2025, as part of its pre-launch commercial planning[7]. - The company hosted a Commercial Day on April 15, 2025, to share updates on commercialization strategy and supply chain readiness[6]. Cash Management - The company anticipates a cash runway that extends to post-launch positive operating cash flow[8].