Company: LENZ
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001815776-25-000071
Chunk: 311

Company: LENZ Therapeutics, Inc.
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 1
Chunk 311
---
2024 and the prospective classifications noted above. We expect our research and development costs will continue to decrease over the remainder of 2025, relative to 2024, given the completion of the CLARITY trials, the subsequent reduction of clinical activities over 2024 and the FDA approval of VIZZ.

Recent Developments

FDA Approval and Commercial Launch of VIZZ

On July 31, 2025, the FDA approved VIZZ, the first and only aceclidine-based product approved by the FDA. VIZZ has five years of NCE exclusivity in the United States, expiring in July 2030. We commercially launched VIZZ in the U.S. in August 2025, with direct-to-eye care professional sales and marketing activities initiated immediately upon approval. Professional product sample distribution by the sales force to optometrists and ophthalmologists and commercial product shipments to customers via our e-pharmacy partner were initiated in October 2025, and we anticipate product will be broadly available in retail pharmacies in the middle of the fourth quarter of 2025.

CORXEL New Drug Application Submission

In July 2025, a regulatory milestone was achieved upon the submission of the NDA for LNZ100 to the NMPA in Greater China for the treatment of presbyopia.

26

Basis of Presentation

The following discussion highlights our results of operations and the principal factors that have affected our financial condition as well as our liquidity and capital resources for the periods described and provides information that management believes is relevant for an assessment and understanding of the unaudited condensed consolidated balance sheets and statements of operations and comprehensive loss presented herein. The following discussion and analysis are based on our unaudited condensed consolidated financial statements and related notes thereto, which we have prepared in accordance with U.S. GAAP. You should read the discussion and analysis together with such unaudited condensed consolidated financial statements and the related notes thereto.

Components of Statements of Operations and Comprehensive Loss

Revenue

We have not generated any revenue from product sales through September 30, 2025, however, we expect to generate revenue from sales of VIZZ beginning in the fourth quarter of 2025. We have generated revenue related to various license and collaboration agreements, and in the future may generate revenue from payments received under additional licenses or collaboration agreements we may enter into with respect to VIZZ.

Operating Expenses

Selling, General and Administrative

Selling, general and administrative expenses consist primarily of salaries and related benefits