LENZ Therapeutics, Inc.(US:LENZ)2025-11-05 21:10Financial Performance - LENZ is focused on the commercialization of VIZZ™ (aceclidine ophthalmic solution) 1.44%, the first FDA-approved treatment for presbyopia, targeting a U.S. market opportunity exceeding $3 billion[143]. - The company reported an accumulated deficit of $191.2 million as of September 30, 2025, primarily due to research and development costs and selling, general, and administrative expenses[147]. - License revenue for the three months ended September 30, 2025, was $12.5 million, a significant increase from $0 in the same period of 2024[166][167]. - For the nine months ended September 30, 2025, license revenue was $17.5 million, compared to $0 in the same period of 2024[173][174]. - Other income, net for the nine months ended September 30, 2025, was $6.9 million, an increase from $6.3 million in the same period of 2024[178]. Cash and Investments - As of September 30, 2025, LENZ had $202.2 million in cash, cash equivalents, restricted cash, and marketable securities, which is expected to fund operations until positive operating cash flow is achieved[146]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $36.1 million, compared to $50.3 million in 2024[186][188]. - Cash provided by investing activities for the nine months ended September 30, 2025, was $14.1 million, driven by $162.6 million in proceeds from maturities of marketable securities[190]. - Cash used in investing activities for the nine months ended September 30, 2024, was $142.6 million, primarily due to $195.3 million of purchases of marketable securities[191]. - Cash provided by financing activities for the nine months ended September 30, 2025, was primarily driven by $26.1 million in net proceeds from common stock sold under the Sales Agreement[192]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $198.9 million, including $117.8 million in cash and cash equivalents acquired in the Merger[193]. Expenses - The company expects selling, general, and administrative expenses to continue increasing in 2025 as it builds a commercial team and supports the launch of VIZZ[158]. - Selling, general and administrative expenses rose by $21.1 million, or 325%, to $27.6 million for the three months ended September 30, 2025, compared to $6.5 million in 2024[168]. - Selling, general and administrative expenses increased by $32.1 million, or 165%, to $51.5 million for the nine months ended September 30, 2025, compared to $19.5 million in 2024[175]. - Research and development expenses decreased by $2.7 million, or 41%, to $3.8 million for the three months ended September 30, 2025, down from $6.5 million in 2024[170]. - Research and development expenses for the nine months ended September 30, 2025, decreased by $5.3 million, or 22%, to $18.7 million from $23.9 million in 2024[177]. Product Development and Licensing - LENZ achieved FDA approval for VIZZ on July 31, 2025, and launched the product in the U.S. in August 2025, with broader retail availability anticipated by mid-Q4 2025[145][156]. - License revenue increased due to upfront payments from the Lotus and Théa Licenses and two regulatory milestones under the CORXEL License, with no product sales revenue recorded yet[158]. - LENZ entered into a License and Collaboration Agreement with CORXEL, receiving $15.0 million in upfront payments and potential additional payments of up to $85.0 million in milestones[150]. - The Lotus License agreement provided a $5.0 million upfront payment and potential milestone payments of up to $120.0 million for commercialization in Southeast Asia[153]. - The Théa License agreement included a $2.5 million upfront payment and potential milestone payments of up to $67.5 million for commercialization in Canada[154]. Company Status and Compliance - The company is classified as an emerging growth company under the JOBS Act and may remain so until December 31, 2026[203]. - The company is also a "smaller reporting company" with a market value of stock held by non-affiliates less than $700 million as of June 30, 2025[205]. - The company does not have any off-balance sheet arrangements as defined by SEC rules[196]. - Recent accounting pronouncements are discussed in Note 2 of the condensed consolidated financial statements included in the Quarterly Report[206]. Operational Developments - The company entered into a lease for 9,795 square feet of office space in Solana Beach, California, with a term of thirty-nine months starting July 1, 2024, ending September 30, 2027[194]. - The company has contracts with various suppliers for the active pharmaceutical ingredient used in VIZZ, which can be modified or cancelled upon written notice[195].