LENZ 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• eligible to receive up to $120.0 million of regulatory and commercial milestone payments, as well as tiered, escalating royalties in the range of 10% to 20% on future net sales in Southeast Asia.

• On July 7, 2025, we entered into a license and commercialization agreement providing an exclusive license (the “Théa License”) to register and commercialize VIZZ for the treatment of presbyopia in Canada. Under the terms of the Théa License, we received a $2.5 million nonrefundable, non-creditable u…

• On January 2, 2026, we entered into a distribution agreement appointing an exclusive distributor for VIZZ in the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Qatar, Bahrain, Oman, Jordan, Lebanon, and Iraq (collectively, the “Middle East”) (the “Lunatus License”). Under the terms of the Lu…

• Submission of Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency

• On April 20, 2026, we announced the submission of a Marketing Authorization Application (“MAA”) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) for the review and approval of VIZZ. The submission of the MAA in the United Kingdom represented the sixth ex-U.S. regu…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• On October 27, 2024, CORXEL and the Company announced positive topline data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. In this China Phase 3 safety and efficacy trial, LNZ100 achieved the primary endpoint and key secondary endpoints, with statistically si…

• On July 7, 2025, we entered into a license and commercialization agreement providing an exclusive license (the “Théa License”) to register and commercialize LNZ100 for the treatment of presbyopia in Canada. Under the terms of the Théa License, we received a $2.5 million nonrefundable, non-creditable…

• 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 marke…

• 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.

• 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 understandin…

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• clinical benefits to ECPs or patients to justify a higher price compared to using glasses, which are potentially just a one-time purchase, and/or to offset the impact of side effects that patients may experience when using VIZZ. Some ECPs may also be deterred by the potential loss of revenue from th…

• specific to us and VIZZ and used the results of these studies to help assess our market opportunity. If any of our assumptions or estimates, or these publications, research, surveys or studies prove to be inaccurate, then the actual market for VIZZ may be smaller than we expect, and as a result our …

• We have devoted and plan to continue to devote a significant portion of our existing cash, cash equivalents, and marketable securities, to continue to build, expand and maintain the sales and marketing infrastructure required to successfully commercialize VIZZ. We have launched commercialization wit…

• Establishing and building out an internal sales and marketing team with technical expertise and supporting distribution capabilities to commercialize VIZZ has been and will continue to be expensive and time-consuming and will require

• VIZZ is based on an active pharmaceutical ingredient (“API”), aceclidine, that has been previously approved and marketed outside of the U.S., which exposes us to additional risks.

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• •We have relied, and expect to continue to rely on third parties, including independent clinical investigators and CROs, to conduct, supervise and monitor certain aspects of our clinical trials and any future preclinical studies. If these third parties do not successfully carry out their contractual…

• We have devoted and plan to continue to devote a significant portion of our existing cash, cash equivalents, and marketable securities, to continue to build, expand and maintain the sales and marketing infrastructure required to successfully commercialize VIZZ. We have launched commercialization wit…

• in parallel, a highly targeted consumer strategy. In order to achieve these commercialization goals for VIZZ we must build marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services for each of the territories in …

• if we were to obtain funding, there can be no assurance that it will be available on terms acceptable to us or our stockholders.

• VIZZ is based on an active pharmaceutical ingredient (“API”), aceclidine, that has been previously approved and marketed outside of the United States, which exposes us to additional risks.

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• On August 12, 2025, Shawn Olsson, Chief Commercial Officer of the Company, entered into a 10b5-1 trading plan intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. This 10b5-1 trading plan provides for the sale of 66,891 shares of the Company’s common stock related to…