Graphite Bio(US:GRPH)2025-11-05 21:10Financial Performance - As of September 30, 2025, LENZ reported $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][147]. - The company has incurred net losses since inception, with an accumulated deficit of $191.2 million as of September 30, 2025, primarily due to R&D and SG&A 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 [167]. - For the nine months ended September 30, 2025, license revenue was $17.5 million, compared to $0 in the same period of 2024 [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]. - 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 [188]. Expenses - Selling, general and administrative expenses are expected to rise in 2025 as LENZ builds a commercial team and infrastructure to support VIZZ's launch [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, from $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 compared to $23.9 million in 2024 [177]. Funding and Capital - LENZ completed a private placement of 3,559,565 shares for $53.5 million concurrent with the Merger on March 21, 2024, and a subsequent placement of 1,578,947 shares for $30.0 million on July 17, 2024 [148]. - The company sold 920,500 shares of common stock at a weighted-average price of $28.75 under the Sales Agreement, resulting in net proceeds of $26.1 million during the nine months ended September 30, 2025 [182]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $26.1 million from net proceeds of common stock sold under the Sales Agreement [192]. - For the nine months ended September 30, 2024, cash provided by financing activities was $198.9 million, including $117.8 million from cash and cash equivalents acquired in the Merger [193]. Product Development - LENZ's VIZZ™ (aceclidine ophthalmic solution) is the first FDA-approved treatment for presbyopia, targeting a market opportunity exceeding $3 billion in the U.S. [143]. - The FDA approved VIZZ on July 31, 2025, granting it five years of New Chemical Entity (NCE) exclusivity in the U.S., expiring in July 2030 [145][156]. - Research and development costs decreased in 2025 compared to 2024, primarily due to the FDA approval of VIZZ and the completion of Phase 3 CLARITY trials [158]. - The company anticipates generating revenue from VIZZ sales starting in the fourth quarter of 2025, alongside potential future revenue from additional licensing agreements [160]. Licensing Agreements - LENZ has entered into multiple licensing agreements, including a $15.0 million upfront payment from CORXEL for rights in Greater China and a $5.0 million upfront payment from Lotus for Southeast Asia [150][153]. - 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]. Operational Aspects - 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 suppliers for the active pharmaceutical ingredient used in VIZZ, which can be modified or cancelled with written notice [195]. - The company does not have any off-balance sheet arrangements as defined by SEC rules [196]. Company Classification - 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]. - Recent accounting pronouncements are discussed in Note 2 of the condensed consolidated financial statements [206].