Graphite Bio(US:GRPH)2024-05-08 20:05Financial Performance - The net loss for Q1 2024 was $16.6 million, or $3.53 per share, compared to a net loss of $12.7 million, or $6.50 per share, in Q1 2023[16]. - Research and Development (R&D) expenses for Q1 2024 were $10.5 million, consistent with $10.3 million in the same period of 2023[14]. - Selling, General and Administrative (SG&A) expenses increased to $5.6 million in Q1 2024 from $2.3 million in Q1 2023, primarily due to pre-launch commercial expenses and increased personnel costs[15]. Mergers and Acquisitions - The company completed a merger with Graphite Bio and a concurrent private placement of $53.5 million, ending Q1 2024 with approximately $213.3 million in cash, cash equivalents, and marketable securities[9][12]. Product Development and Market Opportunity - LENZ Therapeutics reported positive topline data from the Phase 3 CLARITY study for presbyopia, with 84% of participants achieving at least four lines of near vision improvement[3]. - The Phase 3 CLARITY study achieved statistically significant improvements in near vision, with p<0.0001 for all primary and secondary endpoints[4]. - The estimated U.S. market opportunity for LNZ100 is over $3 billion, targeting the 128 million presbyopes in the United States[6][3]. - The company plans to submit a New Drug Application (NDA) for LNZ100 in mid-2024, with a potential commercial launch as early as the second half of 2025[7][3]. Commercial Strategy - The company is actively building its U.S. commercial capabilities in preparation for the projected launch following potential FDA approval[8]. - Capstone data from the Phase 3 CLARITY study will be presented at a Key Opinion Leader event on June 18, 2024[11].