LENZ Therapeutics, Inc.(US:LENZ)2025-05-07 20:09Drug 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][4]. - The FDA has confirmed that LNZ100 will be duty-free as the country of origin is the United States, providing clarity on potential tariff exposure[5]. - The company is preparing for a successful launch of LNZ100, with ongoing engagement with the FDA and no significant review issues reported[3][4]. 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 of over $185.0 million by the PDUFA date[1][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]. - The total operating expenses for Q1 2025 were $16.9 million, slightly higher than $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 for Q1 2025, compared to $5.6 million in Q1 2024, driven by personnel-related expenses and pre-commercial marketing efforts[10]. - The company is actively hiring 88 sales representatives, with a target completion date of July 1, 2025, to support the commercial launch of LNZ100[7][6]. Capital Raising - The company has completed a block trade in April 2025, raising $16.3 million in net proceeds through an at-the-market offering[8].