SAN DIEGO, CA – May 8, 2024 – LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop that has been shown to improve near vision in people with presbyopia, today reported financial results and operational highlights for the first quarter ended March 31, 2024.

Announced positive topline data from Phase 3 CLARITY study and selected LNZ100 as lead candidate: In April 2024, LENZ reported positive topline data from its Phase 3 CLARITY study for the treatment of presbyopia. Lead product candidate LNZ100 (1.75% aceclidine) achieved all primary and secondary near vision improvement endpoints with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one-line or more in distance visual acuity, demonstrating in all cases p<0.0001.

•Rapid onset: at 30 minutes, for CLARITY 2, 71% and 91% of participants achieved three- and two-lines or greater improvement, respectively, and for CLARITY 1, 72% and 87% of participants achieved three- and two-lines or greater improvement, respectively.

•At 3 hours (primary endpoint for three-lines): for CLARITY 2, 71% and 91% of participants achieved three- and two-lines or greater improvement, respectively, and for CLARITY 1, 64% and 83% of participants achieved three- and two-lines or greater improvement, respectively.

•Long duration: at 10 hours, for CLARITY 2, 40% and 69% of participants achieved three- and two-lines or greater improvement, respectively, and for CLARITY 1, 27% and 61% of participants achieved three- and two-lines or greater improvement, respectively.

Commercial potential was further confirmed by participant surveys with 90% of participants noticing an improvement in near vision and 75% of the participants indicating they would continue to use LNZ100 after the study. The study's broad inclusion criteria of presbyopes ranging from ages 45 to 75 years old represents the vast majority of the 128 million presbyopes in the United States and positions LNZ100 well for the estimated $3B+ potential market opportunity.

On track to submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for LNZ100 as a treatment for presbyopia in mid-2024. The CLARITY Phase 3 study was designed in close alignment with the FDA and the positive topline data generated from the study, concludes the clinical development program for LNZ100. LENZ plans to submit an NDA for the program to the FDA in mid-2024.

Commercial launch preparedness well underway. In February 2024, LENZ launched its unbranded “Eye Am...” campaign to educate and excite eye care professionals about future presbyopia solutions. Over 40 key opinion leaders are involved in the campaign and are featured at EyeAmSelective.com where eye care professionals can learn about ideal pupil size, iris muscle selectivity and expected early adopters of presbyopia eye drops. Continuing on that momentum, to support the projected launch following potential FDA approval, LENZ is actively building out its U.S. commercial capabilities, highlighted by completion of third-party logistics contracting in the first quarter of 2024 and the addition of key commercial expertise in direct-to-consumer and influencer marketing.

Completed merger with Graphite Bio and concurrent private placement. In March 2024, LENZ Therapeutics announced completion of its merger with Graphite Bio, Inc. and the concurrent $53.5 million private placement, commencing trading on the Nasdaq Global Select Market under the ticker symbol “LENZ” on March 21, 2024. LENZ ended the first quarter of 2024 with approximately $213.3 million in cash, cash equivalents and marketable securities, which is anticipated to fund operations to post-launch positive operating cash flow.

Strengthened company leadership team with new appointments to the Board of Directors and management team: Simultaneous with the close of the merger, LENZ appointed life science industry veterans Jeff George as Chairman of the Board of Directors and Dan Chevallard as Chief Financial Officer.

Anticipated Upcoming Corporate Event: Capstone data from Phase 3 CLARITY study to be presented at a Key Opinion Leader event planned for June 18, 2024 in New York City. The event will highlight real-world insights by lead investigators and other key opinion leaders on the current treatment landscape for presbyopia and their perspectives on LNZ100 data from Phase 3 CLARITY study.

Cash Position: Cash, cash equivalents and marketable securities were $213.3 million as of March 31, 2024, including proceeds from the $53.5 million private placement, which is anticipated to fund operations to post-launch positive operating cash flow.

Research and Development (R&D) Expenses: R&D expenses were $10.5 million for the three months ended March 31, 2024, which was materially consistent with $10.3 million during the same period in 2023. Substantially all research and development expenses incurred for the comparative periods related to the clinical development of LNZ100 and LNZ101, both evaluated in the Phase 2 INSIGHT and Phase 3 CLARITY studies.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $5.6 million for the three months ended March 31, 2024, compared to $2.3 million during the same period in 2023. The increase in Q1 2024 was primarily driven by an increase in pre-launch commercial expenses, legal and other professional services, and an increase in personnel costs driven by an increase in headcount, including a one-time, non-cash stock-based compensation charge associated with the merger.

Net Loss: Net loss for the three months ended March 31, 2024, was $16.6 million, or $3.53 per share (basic and diluted), compared to a net loss of $12.7 million, or $6.50 per share (basic and diluted) during the same period in 2023.

LENZ Therapeutics is a late clinical-stage biopharmaceutical company focused on the development and commercialization of the first aceclidine-based eye drop to improve vision in patients diagnosed with presbyopia. LENZ’s product candidate, LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day.” LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com.

LENZ Therapeutics
IR@LENZ-Tx.com