LENZ Therapeutics Announces Completion of Merger with Graphite Bio and Provides Update on Recent Clinical and Corporate Progress
– LENZ Therapeutics to debut on Nasdaq under the ticker symbol “LENZ” as a publicly traded company advancing late clinical-stage assets for the treatment of presbyopia –
– Topline data from registration-enabling Phase 3 CLARITY trials for lead assets LNZ100 and LNZ101 expected in
– Strong balance sheet with approximately
“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
Topline Data from Pivotal Phase 3 CLARITY Trials for LNZ100 and LNZ101 Expected in
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 positive Phase 2 INSIGHT trial (NCT05294328), both LZN100 and LNZ101 achieved their primary endpoint of three-lines or greater near vision improvement without losing one or more lines in distance vision at one 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 three-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 three-lines or greater improvement in near vision, but at three hours post-treatment rather than one 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 six-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
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
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
LENZ intends to launch either LNZ100 or LNZ101 in
Upcoming Milestones
Based on its progress to date, LENZ anticipates the following near-term milestones in 2024:
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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
Summary of the Merger Transaction, Reverse Stock Split, Special Cash Dividend and Private Placement
In connection with the closing of the merger, Graphite Bio effected a 1 for 7 reverse split of its common stock and issued a special cash dividend of
Concurrent with the closing of the merger, Graphite Bio completed a private placement of
Immediately following the merger and the private placement of
Leadership Team and Board of Directors Updates
The combined company will be led by Eef Schimmelpennink as President and Chief Executive Officer of LENZ. In addition to Mr. Schimmelpennink, the LENZ leadership team includes current members of management
In addition, LENZ appointed
The Board of Directors of LENZ will be composed of Eef Schimmelpennink,
Advisors
About Presbyopia
Presbyopia is the inevitable loss of near vision associated with aging and impacts the daily lives of nearly all people over 45. In
About LENZ Therapeutics
LENZ is a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop to improve vision in patients diagnosed with presbyopia. LENZ’s product candidates, LNZ100 and LNZ101, are preservative-free, single-use, once-daily eye drops containing aceclidine and aceclidine plus brimonidine, respectively. LNZ100 and LNZ101 are under clinical evaluation in the registration-enabling Phase 3 CLARITY trials as potential therapies for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. You can identify forward-looking statements by words such as “may,” “will,” “could,” “can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “poised,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the timing, progress and results of LENZ’s clinical trials for LENZ’s current products, including statements regarding the timing of completion of trials, and the reporting of data from LENZ’s current trials; LENZ’s plans relating to the clinical development of LENZ’s product candidates; the size of the market opportunity for LENZ’s product candidates; LENZ’s plans relating to commercializing LENZ’s product candidates, if approved; the beneficial characteristics of LENZ’s product candidates; the timing of regulatory filings and approvals for LENZ’s product candidates; LENZ’s ability to obtain and maintain regulatory approval for LENZ’s product candidates; the expected potential benefits of strategic collaborations with third parties and LENZ’s ability to attract collaborators with development, regulatory and commercialization expertise; and the period over which LENZ estimates LENZ’s existing cash and cash equivalents will be sufficient to fund LENZ’s future operating expenses and capital expenditure requirements. These statements are based on numerous assumptions concerning the development of LENZ’s products and target markets and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements, including those risk factors described in the section titled “Risk Factors” in Graphite Bio’s Annual Report on Form 10-K for the year ended
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LENZ Therapeutics
IR@LENZ-Tx.com
Stern Investor Relations, Inc.
janhavi.mohite@sternir.com
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