LENZ Therapeutics, Inc. (NASDAQ:LENZ) saw its stock rise 6.1% in premarket trading following the release of its second-quarter financial report and confirmation that the FDA’s decision on its New Drug Application (NDA) for LNZ100 remains on track for August 8, 2025.
The biopharmaceutical company, currently in the pre-commercial phase, posted a second-quarter loss of $0.53 per share as it prepares for the possible market launch of its aceclidine-based eye drop designed to treat presbyopia. LENZ has completed hiring and training its 88-member sales team, positioning itself to commercialize immediately upon FDA approval. The company ended the quarter with a strong cash balance of $209.6 million, which it expects will support operations until positive cash flow is achieved post-launch.
“As our PDUFA target action date is rapidly approaching, we are encouraged by our ongoing engagement with the FDA and are confident that the review of our NDA for LNZ100 is on track,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics.
LENZ has secured several international licensing deals for LNZ100, including agreements with Lotus Pharmaceutical covering South Korea and parts of Southeast Asia, and with Laboratoires Théa for the Canadian market. These partnerships could generate more than $195 million in upfront and milestone payments, along with double-digit royalties on net sales. Additionally, LENZ’s partner CORXEL has filed an NDA for LNZ100 in China.
Research and development expenses rose to $9.1 million for the quarter, up from $6.9 million in the same period last year, primarily due to manufacturing activities ahead of approval. Selling, general, and administrative costs increased to $12.8 million from $7.4 million, reflecting the company’s preparations for commercialization.
If approved, LNZ100 would become the first aceclidine-based eye drop available worldwide to treat presbyopia.
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