Major Estimate Revision • May 18
Consensus revenue estimates fall by 23% The consensus outlook for revenues in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from US$24.9m to US$19.0m. Forecast losses increased from -US$3.99 to -US$4.50 per share. Pharmaceuticals industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$39.57 to US$32.00. Share price fell 27% to US$7.34 over the past week. Price Target Changed • May 12
Price target decreased by 18% to US$33.71 Down from US$41.14, the current price target is an average from 7 analysts. New target price is 326% above last closing price of US$7.91. Stock is down 73% over the past year. The company is forecast to post a net loss per share of US$4.47 next year compared to a net loss per share of US$2.85 last year. Tillkännagivande • May 04
LENZ Therapeutics, Inc. to Report Q1, 2026 Results on May 11, 2026 LENZ Therapeutics, Inc. announced that they will report Q1, 2026 results on May 11, 2026 Tillkännagivande • Apr 30
LENZ Therapeutics, Inc., Annual General Meeting, Jun 12, 2026 LENZ Therapeutics, Inc., Annual General Meeting, Jun 12, 2026. Major Estimate Revision • Apr 23
Consensus revenue estimates fall by 12% The consensus outlook for revenues in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from US$28.3m to US$24.9m. Forecast losses increased from -US$3.75 to -US$3.99 per share. Pharmaceuticals industry in the US expected to see average net income decline 14% next year. Consensus price target down from US$41.14 to US$39.57. Share price fell 5.1% to US$9.15 over the past week. Tillkännagivande • Apr 21
Lenz Therapeutics Submits Marketing Authorization Application for Vizz for Treatment of Presbyopia in United Kingdom LENZ Therapeutics, Inc. had submitted a Marketing Authorization Application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for the review and approval of VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only aceclidine-based eye drop for the treatment of presbyopia in adults. Since receiving U.S. Food and Drug Administration (FDA) approval in July 2025, LENZ has moved rapidly to expand global access to VIZZ, with submission of the MAA in the United Kingdom representing the sixth ex-U.S. regulatory submission for VIZZ. The MAA submission is supported by positive data from three randomized, double-masked, controlled Phase 3 studies (CLARITY trials) conducted in the United States, in which VIZZ achieved all primary and secondary endpoints, demonstrating the ability to improve near vision within 30 minutes and last up to 10 hours. VIZZ was well tolerated with no serious treatment-related adverse events observed in over 30,000 treatment days across all three CLARITY trials. VIZZ (aceclidine ophthalmic solution) 1.44% is a once-daily eye drop developed to restore clear near vision for up to 10 hours. Aceclidine is the sole active ingredient in VIZZ and provides rapid and durable near vision improvement. VIZZ is preservative-free and provided in single-dose vials. VIZZ is a predominantly pupil selective miotic that interacts with the iris with minimal ciliary muscle stimulation. VIZZ causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision. VIZZ (aceclidine ophthalmic solution) 1.44% is a prescription eye drop used to treat age-related blurry near vision (presbyopia) in adults. Do not use VIZZ if allergic to any of the ingredients. To help avoid potential eye injury or contamination of the product, do not allow the vial tip to touch the eye or any surfaces. Discard the opened vial immediately after use. Contact lenses should be removed before using VIZZ. After dosing, contact lenses can be reinserted after 10 minutes. If using more than one topical eye medication, the medicines should be administered at least 5 minutes apart. Temporary dim or dark vision may be experienced after using VIZZ. Do not drive or operate machinery if vision is not clear. Seek immediate medical care if sudden onset of flashing lights, floaters, or vision loss is experienced. The most common reported adverse reactions of participants were instillation site irritation (20%), dim vision (16%), and headache (13%). Adverse reactions reported in >5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were mild, transient, and self-resolving. Recent Insider Transactions • Mar 31
President recently bought US$251k worth of stock On the 27th of March, Evert Schimmelpennink bought around 28k shares on-market at roughly US$8.95 per share. This transaction amounted to 57% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Evert's only on-market trade for the last 12 months. Breakeven Date Change • Mar 29
No longer forecast to breakeven The 7 analysts covering LENZ Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$43.2m in 2028. New consensus forecast suggests the company will make a loss of US$10.1m in 2028. Price Target Changed • Mar 25
Price target decreased by 13% to US$44.43 Down from US$51.29, the current price target is an average from 7 analysts. New target price is 390% above last closing price of US$9.07. Stock is down 65% over the past year. The company is forecast to post a net loss per share of US$3.62 next year compared to a net loss per share of US$2.85 last year. Tillkännagivande • Mar 18
LENZ Therapeutics, Inc. to Report Q4, 2025 Results on Mar 24, 2026 LENZ Therapeutics, Inc. announced that they will report Q4, 2025 results Pre-Market on Mar 24, 2026 Tillkännagivande • Mar 10
LENZ Therapeutics Submits Marketing Authorization Application to European Medicines Agency for VIZZ for the Treatment of Presbyopia LENZ Therapeutics, Inc. had submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the review and approval of VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only aceclidine-based eye drop for the treatment of presbyopia in adults. The submission of the MAA in Europe represents the fifth ex-U.S. regulatory submission for VIZZ. The MAA submission is supported by positive data from three randomized, double-masked, controlled Phase 3 studies (CLARITY trials) conducted in the United States, in which VIZZ achieved all primary and secondary endpoints, demonstrating the ability to improve near vision within 30 minutes and last up to 10 hours. VIZZ was well tolerated with no serious treatment-related adverse events observed in over 30,000 treatment days across all three CLARITY trials. VIZZ was approved by the U.S. Food and Drug Administration (FDA) in July 2025 and is commercially available in the United States. The EMA submission marks the fifth ex-US submission and represents a significant milestone in LENZ’s international expansion strategy to establish VIZZ as a global brand. Presbyopia affects an estimated 1.8 billion people globally, and Europe represents one of the largest markets for vision correction products. LENZ intends to pursue commercialization in Europe through strategic partnerships, complementing partnerships already in place for Greater China, the Republic of Korea and Southeast Asia, Canada, and the Middle East region, and expects to provide further updates as the regulatory review progresses. Presbyopia is the inevitable loss of near vision associated with aging, impacting the daily lives of nearly all people over the age of 45. As people age, the crystalline lens in their eyes gradually hardens and becomes less able to change shape. This loss of elasticity of the lens reduces the ability of the lens to focus incoming light from near objects onto the retina. Adults over 50 years of age lose, on average, 1.5 lines of near vision every six years. Although the progression of presbyopia is gradual, presbyopes often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s, when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work. Presbyopia is typically self-diagnosed and self-managed with over-the-counter reading glasses, or managed, after evaluation by an ECP, with prescription reading or bifocal glasses or multifocal contact lenses. VIZZ (aceclidine ophthalmic solution) 1.44% is a once-daily eye drop developed to restore clear near vision for up to 10 hours. Aceclidine is the sole active ingredient in VIZZ and provides rapid and durable near vision improvement. VIZZ is preservative-free and provided in single-dose vials. VIZZ is a predominantly pupil selective miotic that interacts with the iris with minimal ciliary muscle stimulation. VIZZ causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision. VIZZ (aceclidine ophthalmic solution) 1.44% is a prescription eye drop used to treat age-related blurry near vision (presbyopia) in adults. Do not use VIZZ if allergic to any of the ingredients. To help avoid potential eye injury or contamination of the product, do not allow the vial tip to touch the eye or any surfaces. Discard the opened vial immediately after use. Contact lenses should be removed before using VIZZ. After dosing, contact lenses can be reinserted after 10 minutes. If using more than one topical eye medication, the medicines should be administered at least 5 minutes apart. Temporary dim or dark vision may be experienced after using VIZZ. Do not drive or operate machinery if vision is not clear. Seek immediate medical care if sudden onset of flashing lights, floaters, or vision loss is experienced. The most common reported adverse reactions of participants were instillation site irritation (20%), dim vision (16%), and headache (13%). Adverse reactions reported in >5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were mild, transient, and self-resolving. Breakeven Date Change • Dec 31
Forecast to breakeven in 2028 The 7 analysts covering LENZ Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$45.8m in 2028. Average annual earnings growth of 56% is required to achieve expected profit on schedule. Recent Insider Transactions Derivative • Nov 19
Chief Commercial Officer notifies of intention to sell stock Shawn Olsson intends to sell 40k shares in the next 90 days after lodging an Intent To Sell Form on the 17th of November. If the sale is conducted around the recent share price of US$25.60, it would amount to US$1.0m. Since December 2024, Shawn's direct individual holding has increased from 3.33k shares to 4.73k. Company insiders have collectively bought US$304k more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions • Nov 11
Co-Founder & Director recently bought US$239k worth of stock On the 7th of November, James McCollum bought around 11k shares on-market at roughly US$22.79 per share. This transaction amounted to 1.7% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was James' only on-market trade for the last 12 months. Tillkännagivande • Oct 29
LENZ Therapeutics, Inc. to Report Q3, 2025 Results on Nov 05, 2025 LENZ Therapeutics, Inc. announced that they will report Q3, 2025 results on Nov 05, 2025 Tillkännagivande • Sep 30
LENZ Therapeutics Announces Commercial Product Availability of VIZZ in the United States LENZ Therapeutics, Inc. announced VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults, is now available. Professional product sample distribution by the sales force to optometrists and ophthalmologists has been initiated nationwide. Commercial product shipments will be initiated to consumers in October through ePharmacy partner and is anticipated to be broadly available, including via retail pharmacies, by mid-Q4 2025. VIZZ is powered by aceclidine, differentiated by its mechanism of action as a predominantly pupil-selectiveiotic that interacts with the iris, with minimal ciliary muscle stimulation. VIZZ contracts the iris sphincter muscle, resulting in a pinhole effect and uniquely achieves a sub-2mm pupil that extends depth of focus to significantly improve near vision without causing a myopic shift. In the CLARITY Phase 3 clinical trial, 93% of participants achieved 20/40 or better near vision within 30 minutes and lasted up to 10 hours. This level of near vision can restore the ability to read a phone screen and other everyday fine print without the assistance of reading glasses. Presbyopia is the inevitable loss of near vision associated with aging. It impacts the daily lives of nearly all people over the age of 45. seek immediate medical care if sudden onset of flashing lights, floaters, or vision loss is experienced. ADVERSE REACTIONS The most common reported adverse reactions of participants were instillation site irritation (20%), dim vision (16%), and headache (13%). Adverse reactions reported in >5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were mild, transient, and self-resolving. Price Target Changed • Aug 01
Price target increased by 7.8% to US$48.50 Up from US$45.00, the current price target is an average from 8 analysts. New target price is 62% above last closing price of US$29.96. Stock is up 25% over the past year. The company is forecast to post a net loss per share of US$2.62 next year compared to a net loss per share of US$2.34 last year. Tillkännagivande • Aug 01
Lenz Therapeutics, Inc. Announces Us Fda Approval of Vizz for the Treatment of Presbyopia LENZ Therapeutics, Inc. announced the US Food and Drug Administration ("FDA") approved VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025. Direct-to-eye care professional sales and marketing activities to be initiated immediately. VIZZ is powered by aceclidine, highlighted by its differentiated mechanism of action as a predominantly pupil-selective miotic that interacts with the iris, with minimal ciliary muscle stimulation. VIZZ contracts the iris sphincter muscle resulting in a pinhole effect and uniquely achieves a sub-2mm pupil that extends depth of focus to significantly improve near vision without causing a myopic shift.ceclidine, the sole active ingredient in VIZZ, is a new chemical entity in the United States and its FDA approval marks a global first in the treatment of presbyopia. The FDA approval of VIZZ was based upon results from three randomized, double-masked, controlled Phase 3 studies. CLARITY 1 and CLARITY 2 were designed to evaluate the safety and efficacy of VIZZ in 466 participants dosed once daily for 42 days. CLARITY 3 evaluated 217 participants for long term safety over a 6-month duration of once daily dosing. In both CLARity 1 and CLARITY 2, VIZZ achieved all primary and secondary near vision improvement endpoints, demonstrating the ability to improve near vision within 30 minutes and last up to 10 hours. Near vision improvement was reproducible and consistent across both CLARITY 1 and 2. ADVERSE REACTIONS The most common reported adverse reactions of participants were instillation site irritation (20%), dim vision (16%), and headache (13%). Adverse reactions reported in >5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were mild, transient, and self-resolving. Major Estimate Revision • Jul 30
Consensus revenue estimates increase by 13% The consensus outlook for revenues in fiscal year 2025 has improved. 2025 revenue forecast increased from US$8.50m to US$9.57m. Forecast losses expected to reduce from -US$2.74 to -US$2.54 per share. Pharmaceuticals industry in the US expected to see average net income growth of 3.6% next year. Consensus price target up from US$45.00 to US$46.25. Share price fell 6.9% to US$30.76 over the past week. Tillkännagivande • Jul 29
LENZ Therapeutics Announces NMPA Submission of New Drug Application for LNZ100 in China for the Treatment of Presbyopia LENZ Therapeutics, Inc. announced that CORXEL Pharmaceuticals has submitted the New Drug Application (NDA) for LNZ100 to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China (PRC). LENZ licensed the Greater China rights to CORXEL for the development and commercialization of LNZ100 in April 2022. The NDA submission was supported by positive data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. In this Phase 3 safety and efficacy trial, LNZ100 (1.75% aceclidine HCl) achieved the primary endpoint and secondary 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. The submission of the NDA for LNZ100 results in the achievement of the first milestone under the License and Collaboration Agreement with CORXEL (the "License"). Under the terms of the License, LENZ is eligible to receive up to $95.0 million of regulatory and sales milestones, as well as tiered mid single-digit to low double-digit royalties on net sales in Greater China. New Risk • Jun 11
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$8.4m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Tillkännagivande • May 01
LENZ Therapeutics, Inc. to Report Q1, 2025 Results on May 07, 2025 LENZ Therapeutics, Inc. announced that they will report Q1, 2025 results on May 07, 2025 Tillkännagivande • Apr 29
LENZ Therapeutics, Inc., Annual General Meeting, Jun 10, 2025 LENZ Therapeutics, Inc., Annual General Meeting, Jun 10, 2025. Tillkännagivande • Apr 06
LENZ Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $150 million. LENZ Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $150 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Tillkännagivande • Mar 11
LENZ Therapeutics, Inc. to Report Q4, 2024 Results on Mar 19, 2025 LENZ Therapeutics, Inc. announced that they will report Q4, 2024 results at 12:30 PM, US Eastern Standard Time on Mar 19, 2025 New Risk • Nov 04
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 9.7% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$36m net loss in 3 years). Share price has been volatile over the past 3 months (9.7% average weekly change). Tillkännagivande • Oct 30
LENZ Therapeutics, Inc. to Report Q3, 2024 Results on Nov 06, 2024 LENZ Therapeutics, Inc. announced that they will report Q3, 2024 results on Nov 06, 2024 Tillkännagivande • Oct 28
Corxel Pharmaceuticals and LENZ Therapeutics Announce Positive Topline Data from China Phase 3 Presbyopia Trial of LNZ100 Corxel Pharmaceuticals and LENZ Therapeutics announced positive topline data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. CORXEL is a leading biotech company committed to bringing innovative science and medicines to underserved patients with serious and life-threatening diseases. LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on developing the first and only aceclidine-based eye drop to improve near vision in people with presbyopia. In this China Phase 3 safety and efficacy trial, LNZ100 (1.75% aceclidine HCl) achieved the primary endpoint and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, and maintaining their optimal distance visual acuity (i.e., not losing 5 or more letters). More results showed (all p<0.0001): Rapid onset: 84% and 69% achieved two-lines and three-lines or greater improvement at 30 minutes respectively. 3 hours post treatment: 88% and 74% achieved two-lines and three-lines or greater improvement at 3 hours respectively,and maintained their optimal distance visual acuity (i.e., not losing 5 or more letters). Long duration: 61% and 30% achieved two-lines and three-lines or greater improvement at 10 hours respectively. LNZ100 was well-tolerated with no serious treatment-related adverse events observed in the trial. The study was a Phase 3, multicenter, randomized, double-blind, vehicle-controlled study, including a 4-week efficacy study followed by a 5-month extension safety study, designed to evaluate the efficacy and safety of LNZ100 (an aceclidine-based ophthalmic solution) in participants with presbyopia. The objectives were to assess the potential of LNZ100 to improve near vision among Chinese presbyopia patients and to evaluate the efficacy and safety profiles. ?The trial has enrolled 300 participants, with a broad enrollment criteria of between 45 and 75 years of age with a refractive range of -4.0D SE to +1.0D SE, including those who had undergone laser-assisted cornea refractive surgery/monofocal IOL implantation. Presbyopia is a physiological phenomenon associated with aging that results in a progressively worsening ability to see nearby objects clearly. It is caused by the gradual hardening of the lens. This results in a decline of the eye's adjustment function, and the inability to focus the image of nearby objects on the retina, leading to a decline in near vision. Studies have shown that the onset of presbyopia typically occurs around the age of 38, reaching a prevalence rate of nearly 100% at the age of 52 in China. It is estimated that more than 400 million people in China suffer from presbyopia. Currently, the treatment options for presbyopia are very limited. Wearing glasses requires frequent removal and insertion, causing many inconveniences in work and life. Surgery, as an irreversible invasive operation, has a very limited acceptance. There are no approved drugs for the treatment of presbyopia in China and the medical need for non-invasive, safe, efficient and reversible treatments for presbyopia remains unsolved. LNZ100 (aceclidine) eye drops are being developed by LENZ Therapeutics and CORXEL acquired the Greater China rights for the development and commercialization in April 2022. LNZ100 is formulated with aceclidine, a miotic, and designed to achieve optimal pupil diameter without impacting distance vision, a key limitation of other miotics. Miotics are compounds that cause pupil constriction, or miosis, creating a pinhole effect that enables better focus of incoming light from near objects onto the retina. Research has shown that a pupil diameter below two millimeters (2 mm) is optimal for presbyopia treatment and results in clinically meaningful improvement in near vision. Unlike other miotics such as pilocarpine and carbachol, aceclidine’s mechanism of action is pupil-selective, meaning it can activate the iris sphincter muscle and cause miosis of the pupil to a diameter below 2 mm without overstimulating the ciliary muscles that can cause a myopic shift and impair distance vision. As a result, aceclidine does not require any remaining accommodation to improve near vision, broadening its benefits to older presbyopes whose lens has lost this capacity. Therefore, the company expected that users may be able to benefit from treatment even as they age from mid-40s to well into their mid-70s and across a broad range of refractive errors, as demonstrated in clinical testing to date. Tillkännagivande • Aug 13
LENZ Therapeutics, Inc. Announces Submission of New Drug Application to U.S. Food and Drug Administration for Lnz100 for the Treatment of Presbyopia LENZ Therapeutics, Inc. announced that the Company has submitted a New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for LNZ100 (an aceclidine-based ophthalmic solution) for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The NDA submission is supported by positive data from the pivotal Phase 3 CLARITY study of LNZ100 for the treatment of presbyopia. In the Phase 3 CLARITY study LNZ100 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 LNZ100 was well tolerated with no serious treatment-related adverse events observed in the over 30,000 treatment days monitored in the CLARITY study. The FDA has a 60-day filing review period to determine whether the NDA submission is complete and acceptable for review. Tillkännagivande • Aug 08
LENZ Therapeutics, Inc. to Report Q2, 2024 Results on Aug 14, 2024 LENZ Therapeutics, Inc. announced that they will report Q2, 2024 results on Aug 14, 2024 Tillkännagivande • Jul 15
LENZ Therapeutics, Inc. announced that it expects to receive $30 million in funding LENZ Therapeutics, Inc announced it has entered into a stock purchase agreement with new investor, Ridgeback Capital Investments L.P. for gross proceeds $30,000,000 on July 15, 2024. Recent Insider Transactions • May 16
Co-Founder & Director recently bought US$501k worth of stock On the 13th of May, James McCollum bought around 31k shares on-market at roughly US$15.99 per share. This transaction amounted to 5.3% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was James' only on-market trade for the last 12 months. Tillkännagivande • May 03
LENZ Therapeutics, Inc. to Report Q1, 2024 Results on May 08, 2024 LENZ Therapeutics, Inc. announced that they will report Q1, 2024 results on May 08, 2024 Tillkännagivande • Apr 03
LENZ Therapeutics, Inc. Announces Positive Topline Data from Phase 3 CLARITY Presbyopia Trials LENZ Therapeutics, Inc. announced positive topline results from its Phase 3 CLARITY study of two investigational formulations of aceclidine, LNZ100 and LNZ101, for the treatment of presbyopia, the inevitable loss of near vision that impacts the daily lives of nearly all people over 45. In Phase 3 safety and efficacy trials (CLARITY 1 and 2), lead product candidate LNZ100 (1.75% aceclidine) achieved the primary endpoints and key secondary 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. LNZ101 showed similar results, including achieving primary and secondary endpoints in both CLARITY 1 and 2, but did not show superiority to LNZ100. Based on these results, LENZ selected LNZ100 as its lead product candidate, for which it plans to submit a New Drug Application (NDA) in mid-2024. The high responder rate, rapid onset and long duration across a broad range of presbyopes ranging from 45 to 75 years of age and having a refractive range from -4.0 to +1.0D SE are consistent with features that patients are expecting from an effective treatment option. Based on these highly encouraging data, LENZ will direct towards NDA submission in mid-2024 for LNZ100, and preparations for commercialization in second half of 2025 upon FDA approval, with the goal of moving closer to helping many of the 128 million people experiencing symptoms of presbyopia in the United States. Board Change • Mar 25
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. No independent directors (7 non-independent directors). Director Fred Guerard was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment.