Lenz Therapeutics Completes Merger with Graphite Bio; Debuts on Nasdaq

Lenz Therapeutics announced the completion of its previously announced merger with Graphite Bio. The new combined company will operate under the name Lenz Therapeutics and will commence trading on Nasdaq under the ticker symbol “LENZ” on March 22, 2024.

“Following the close of this transaction, we believe we are well-positioned to bring the opportunity of a once-daily pharmacological eye drop intended to improve near vision throughout the full workday closer to the 128 million people in the United States who are impacted by presbyopia,” Eef Schimmelpennink, President and CEO of Lenz Therapeutics, said in a company news release. “With clinical activities completed in each of the three phase 3 CLARITY trials evaluating LNZ100 and LNZ101, we look forward to reporting topline results from these trials in April 2024 and, subject to successful completion of such trials, submitting an NDA to the FDA by mid-year. Backed by a strong balance sheet and supported by a proven management team and top-tier investors, we believe it is an exciting time for Lenz as we prepare to execute in a catalyst-rich year and, if approved by the FDA, potentially deliver the first aceclidine-based therapy intended to treat presbyopia.”

Topline Data from Phase 3 CLARITY Trials for LNZ100 and LNZ101 Expected in April 2024

Lenz’s product candidates, LNZ100 and LNZ101, are preservative-free, single-use, once-daily eye drops containing aceclidine and aceclidine plus brimonidine, respectively.

Previously, both LNZ100 and LNZ101 have demonstrated rapid onset and long duration of near vision improvement as well as an ability to be used across a wide age range of presbyopes with a broad refractive range while avoiding blurry distance vision. In the phase 2 INSIGHT trial (NCT05294328), both LZN100 and LNZ101 achieved their primary endpoint of 3-lines or greater near vision improvement without losing one or more lines in distance vision at 1 hour post-treatment, with 71% (P<0.0001) and 56% (P<0.0001) of treated patients achieving this endpoint, respectively, compared to 6% for vehicle. After 10 hours, 37% and 48% of patients treated with LNZ100 and LNZ101, respectively, maintained 3-lines or greater improvement compared to vehicle. Both product candidates had a well-tolerated safety profile with no serious drug-related adverse events.

Following the completion of the INSIGHT trial, Lenz initiated three pivotal phase 3 CLARITY trials for LNZ100 and LNZ101. Similar to the INSIGHT trial, the primary efficacy endpoint in the CLARITY-1 and CLARITY-2 trials is the percentage of participants who achieve 3-lines or greater improvement in near vision, but at 3 hours post-treatment rather than 1 hour post-treatment, comparing to brimonidine and vehicle, respectively. The objective of the CLARITY-3 trial is to confirm the long-term safety profile of LNZ100 and LNZ101 over a 6-month period. Participants in the CLARITY trials range in age from 45 to 75 years old, the same age range used in the INSIGHT trial, with a refractive range of -4.0 diopters (D) spherical equivalent (SE) to +1.0D SE.

The last visits of the last patients in each CLARITY trial have been completed as of the first quarter of 2024, and Lenz expects to report phase 3 topline results from the CLARITY trials in April 2024.

Planned Approach to Commercialization of LNZ100 or LNZ101

Based on the data generated from the CLARITY trials, Lenz plans to submit a new drug application (NDA) to the FDA in mid-2024.

Lenz's objective is to commercialize the product that the company believes will most effectively meet the needs of the widest range of presbyopes tested and has the potential to provide the best value based on an “all eyes, all day” brand mission, and expects to share the selected product candidate for NDA submission as part of the topline results in April 2024.

Lenz intends to launch either LNZ100 or LNZ101 in the United States with its own commercial organization. To support the projected launch following potential FDA approval, Lenz is actively building out its US commercial capabilities and plans to share additional updates related to its commercialization planning in due course. In addition, Lenz is developing regulatory strategies and intends to opportunistically seek partnerships for Europe, Canada, and other markets to maximize the value of its product candidates. Lenz has already entered into a license and collaboration agreement with Ji Xing for the development and commercialization of LNZ100 and LNZ101 for the treatment of presbyopia in Greater China.

Upcoming Milestones

Based on its progress to date, Lenz anticipates the following near-term milestones in 2024:

• Announce topline results from the phase 3 CLARITY trials and product candidate selection for NDA submission in April 2024
• Submit an NDA for the selected product candidate in mid-2024 to seek FDA marketing approval