LENZ Therapeutics Nears FDA Decision

By Philip Seaworth • Wednesday, July 30 15:33 • Permanent Link

Lenz Therapeutics, Inc. has reported its financial results for the second quarter ended June 30, 2025, and recent corporate highlights. The company's new drug application (NDA) for LNZ100, aimed at treating presbyopia, is on track for the Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025. The NDA submission is supported by positive data from the pivotal Phase 3 Clarity study.

The company has hired an 88-member sales force and completed their pre-approval training, preparing them to initiate sales and marketing activities immediately upon approval in the United States. Lenz has also executed multiple international license and commercialization agreements for LNZ100, including over $195 million in upfront and milestone payments together with double-digit royalties on net sales.

As of June 30, 2025, the company's cash, cash equivalents, and marketable securities totaled $209.6 million. This is expected to fund operations to post-launch positive cash flow, with an anticipated cash balance in excess of $205.0 million as of the PDUFA target action date.

In terms of financial results, research and development (R&D) expenses increased to $9.1 million for the three months ended June 30, 2025, compared to $6.9 million during the same period in 2024. Selling, general, and administrative (SG&A) expenses also saw an increase, reaching $12.8 million and $23.9 million for the three and six months ended June 30, 2025, respectively, compared to $7.4 million and $13.0 million during the same periods in 2024.

The net loss for the three and six months ended June 30, 2025, was $14.9 million and $29.5 million, respectively, or $0.53 and $1.06 per share (basic and diluted), compared to a net loss of $10.3 million and $26.9 million, or $0.40 and $1.77 per share (basic and diluted) during the same periods in 2024.

Lenz Therapeutics remains committed to commercializing LNZ100, a preservative-free, single-use, once-daily eye drop containing aceclidine, to improve near vision in patients with presbyopia. The company is headquartered in San Diego, California. As a result of these announcements, the company's shares have moved 0.63% on the market, and are now trading at a price of $31.87. For more information, read the company's full 8-K submission here.

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