Graphite Bio(US:GRPH)2025-07-30 20:03Product Development - LENZ's lead product candidate LNZ100 is a once-daily eye drop aimed at treating presbyopia, with a U.S. market opportunity exceeding $3 billion[128] - In the Phase 3 CLARITY study, LNZ100 demonstrated that 71% and 91% of participants achieved three- and two-lines or greater improvement in near vision at 30 minutes, respectively[130] - The FDA assigned a PDUFA target action date of August 8, 2025, for LNZ100's New Drug Application, with a potential commercial launch in Q4 2025 if approved[131] Financial Position - As of June 30, 2025, LENZ had $209.6 million in cash and equivalents, sufficient to support operations until positive cash flow post-commercial launch[132] - LENZ incurred an accumulated deficit of $174.5 million as of June 30, 2025, primarily due to research and development costs[132] Financing Activities - The company completed a PIPE financing of 3,559,565 shares for $53.5 million concurrent with the Merger on March 21, 2024[133] - LENZ entered into a License and Collaboration Agreement with CORXEL, receiving $15.0 million upfront and potential milestone payments up to $95.0 million[137] - The company executed a license agreement with Lotus Pharmaceutical for LNZ100 in Southeast Asia, receiving a $5.0 million upfront payment and potential milestones up to $120.0 million[140] Revenue Generation - LENZ has not generated any revenue from product sales to date, relying on license and collaboration agreements for revenue generation[147] - License revenue for the three months ended June 30, 2025, was $5 million, an increase from $0 in the same period in 2024[153][154] - For the six months ended June 30, 2025, license revenue was $5 million, with no revenue recorded in the same period in 2024[160][161] Expenses - Research and development expenses increased by $2.1 million, or 30%, to $9.1 million for the three months ended June 30, 2025, compared to $6.9 million in 2024[156] - Selling, general and administrative expenses rose by $5.4 million, or 73%, to $12.8 million for the three months ended June 30, 2025, compared to $7.4 million in 2024[157] - Research and development expenses decreased by $2.6 million, or 15%, to $14.9 million for the six months ended June 30, 2025, compared to $17.5 million in 2024[163] - Selling, general and administrative expenses increased by $11 million, or 85%, to $23.9 million for the six months ended June 30, 2025, compared to $13 million in 2024[164] Income and Losses - Other income, net decreased by 40% to $2.4 million for the three months ended June 30, 2025, down from $4.1 million in 2024[159] - Other income, net increased by 34% to $4.8 million for the six months ended June 30, 2025, compared to $3.5 million in 2024[165] - The company incurred net losses of $14.9 million and $29.5 million for the three and six months ended June 30, 2025, respectively[166] Cash Flow - For the six months ended June 30, 2024, cash used in operating activities was $39.7 million, resulting from a net loss of $26.9 million and a $13.4 million cash outflow related to accounts payable and accrued liabilities[175] - Cash provided by financing activities for the six months ended June 30, 2024, was $169.1 million, including $117.8 million in cash from the Merger and $53.5 million from PIPE Financing[180] - Cash used in investing activities for the six months ended June 30, 2024, was $80.4 million, primarily due to $111.3 million in purchases of marketable securities[177] - Cash provided by investing activities for the six months ended June 30, 2025, was $18.5 million, mainly from $110.2 million in proceeds from maturities of marketable securities[176] - Cash provided by financing activities for the six months ended June 30, 2025, was driven by $26.1 million in net proceeds from common stock sold under the Sales Agreement[178] Company Operations - The company has 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[181] - The company has contracts with various organizations for research and development activities, including clinical trials and manufacturing[182] - The company is classified as a smaller reporting company, with the market value of stock held by non-affiliates being less than $700 million as of June 30, 2025[192] - The company intends to rely on exemptions from various public company disclosure and reporting requirements as an emerging growth company until December 31, 2026[190] - The company has no off-balance sheet arrangements as defined by SEC rules[183]