Drug Development - Submitted New Drug Application (NDA) to the U.S. FDA for LNZ100 for the treatment of presbyopia, supported by positive data from the Phase 3 CLARITY study[2] - LNZ100 achieved statistically significant improvement in near vision, with 71% of participants achieving three-lines or greater improvement at 3 hours post-administration[4] - 84% of participants achieved at least 4 lines of near vision improvement with LNZ100, demonstrating its robust product profile[4] - The company is targeting a market of approximately 128 million individuals living with presbyopia in the United States[2] - The company plans to engage with key opinion leaders and eye care professionals for the commercialization of LNZ100, pending FDA approval[12] Financial Performance - Pro forma cash, cash equivalents, and marketable securities were $226.2 million as of June 30, 2024, following a $30 million private placement from Ridgeback Capital[1] - R&D expenses decreased to $6.9 million for Q2 2024, down from $12.6 million in Q2 2023, primarily due to reduced clinical trial-related expenses[7] - SG&A expenses increased to $7.4 million for Q2 2024, compared to $2.3 million in Q2 2023, driven by personnel-related expenses and pre-commercial planning[8] - Net loss for Q2 2024 was $10.3 million, or $0.40 per share, compared to a net loss of $14.7 million, or $7.53 per share in Q2 2023[9] - Total assets as of June 30, 2024, were $202.6 million, compared to $70.4 million as of December 31, 2023[13]
Graphite Bio(GRPH) - 2024 Q2 - Quarterly Results