LENZ THERAPEUTICS INC Stock Price, News & Analysis

LENZ Therapeutics reported Q3 2024 financial results with key highlights including FDA acceptance of their New Drug Application for LNZ100 for presbyopia treatment, with a PDUFA date of August 8, 2025. The company announced positive Phase 3 study results in China, with 74% of patients achieving significant vision improvement. Cash position stands at $217.2 million as of September 30, 2024. Q3 financial results showed R&D expenses decreased to $6.5 million from $17.0 million year-over-year, while SG&A expenses increased to $6.5 million from $2.9 million. Net loss was $10.2 million or $0.38 per share.

LENZ Therapeutics (Nasdaq: LENZ), a pre-commercial stage biopharmaceutical company developing aceclidine-based eye drops for presbyopia, has scheduled its third quarter 2024 financial results and business update webcast for November 6, 2024, at 8:00 a.m. EST. The company will host a conference call accessible via phone and webcast, with a replay available on their website for 30 days following the event.

CORXEL and LENZ Therapeutics announced positive topline data from China Phase 3 trial of LNZ100 for presbyopia treatment. The primary endpoint was met with 74% of participants achieving three-lines or greater improvement at 3 hours post-treatment while maintaining optimal distance visual acuity. The trial showed rapid onset with 69% effectiveness at 30 minutes and 30% at 10 hours. The study involved 300 participants aged 45-75 years. LNZ100 was well-tolerated with no serious treatment-related adverse events. The FDA has recently accepted the New Drug Application for LNZ100 in the United States.

Lucy Therapeutics (LucyTx) has appointed Kim Drapkin as Board Chair to guide the company's strategic direction as it enters clinical trial development. Drapkin brings over 25 years of experience in biotech and pharma, most recently serving as President and CEO of Graphite Bio. LucyTx, which develops small molecule therapies for complex neurological diseases, recently secured $12.5 million in additional funding, bringing its total to $37 million.

The company's approach involves analyzing various disease drivers, including mitochondrial, environmental, and genetic factors, to create detailed knowledge maps and identify unique drug targets. LucyTx currently has three drug discovery programs in its pipeline, with Investigational New Drug (IND) studies planned for next year, focusing on treatments for Rett syndrome, Parkinson's, and Alzheimer's disease.

LENZ Therapeutics (Nasdaq: LENZ), a late clinical-stage biopharmaceutical company, announced upcoming presentations featuring LNZ100, their aceclidine-based eye drop for presbyopia treatment, at major ophthalmology and optometry conferences. Presentations include:

1. Eyecelerator at AAO 2024 (October 17, 2024): CLARITY Phase 3 study data of LNZ100

2. Academy 2024 Indianapolis (November 7, 2024): Analysis of pupil size impact on vision improvement with aceclidine

3. Academy 2024 Indianapolis (November 7, 2024): Poster presentation on positive Phase 3 presbyopia trial data

LENZ has submitted a New Drug Application (NDA) to the FDA for LNZ100, a preservative-free, single-use, once-daily eye drop containing aceclidine. The product achieved all primary and secondary endpoints in the Phase 3 CLARITY study for presbyopia treatment.

LENZ Therapeutics (Nasdaq: LENZ), a late clinical-stage biopharmaceutical company developing an aceclidine-based eye drop for presbyopia, has announced its participation in several upcoming investor conferences. These include:

• Morgan Stanley 22nd Annual Global Healthcare Conference (New York, NY) on September 4, 2024
• Wells Fargo Securities 2024 Healthcare Conference (Boston, MA) on September 5, 2024
• H.C. Wainwright 26th Annual Global Investment Conference (New York, NY) on September 10, 2024
• Cantor Global Healthcare Conference (New York, NY) on September 18, 2024

Management will engage in one-on-one meetings at all events and deliver corporate presentations at the H.C. Wainwright and Cantor conferences. A live audio webcast of the Cantor presentation will be available on the LENZ website for 90 days, with a 30-day replay option.

LENZ Therapeutics (Nasdaq: LENZ) reported Q2 2024 financial results and operational highlights. Key developments include:

• Submission of New Drug Application (NDA) to FDA for LNZ100 to treat presbyopia
• Positive topline and capstone data from Phase 3 CLARITY study
• $30 million private placement from Ridgeback Capital
• Pro forma cash position of $226.2 million as of June 30, 2024

Financial results: R&D expenses decreased to $6.9 million, while SG&A expenses increased to $7.4 million. Net loss was $10.3 million ($0.40 per share). The company anticipates its cash runway to extend to post-launch positive operating cash flow.

LENZ Therapeutics (Nasdaq: LENZ) has submitted a New Drug Application (NDA) to the FDA for LNZ100, an aceclidine-based eye drop designed to improve near vision in people with presbyopia. The submission is supported by positive data from the pivotal Phase 3 CLARITY study, which demonstrated statistically significant improvements in near vision without compromising distance vision.

Key highlights:

• Presbyopia affects an estimated 1.8 billion people globally and 128 million in the US
• LNZ100 achieved all primary and secondary near vision improvement endpoints
• The treatment was well-tolerated with no serious treatment-related adverse events
• The FDA has a 60-day filing review period to determine if the NDA is complete and acceptable for review

LENZ Therapeutics (Nasdaq: LENZ), a late clinical-stage biopharmaceutical company, has announced it will report its second quarter 2024 financial results on August 14, 2024. The company, which is developing the first aceclidine-based eye drop for presbyopia, will host a webcast at 4:30 p.m. ET to present the results and provide a business update. Investors and interested parties can access the live webcast through the company's website, where a replay will be available for 30 days following the event.