Product Development - LENZ's lead product candidate LNZ100 is a once-daily eye drop targeting presbyopia, with a U.S. market opportunity exceeding $3 billion[487] - In the Phase 3 CLARITY study, LNZ100 demonstrated that 71% of participants achieved three-lines or greater improvement in near vision at 3 hours post-application[489] - The FDA assigned a PDUFA target action date of August 8, 2025, for LNZ100, with a potential commercial launch in Q4 2025 if approved[491] - LNZ100 has patent protection until at least 2039 in the U.S., supported by a robust intellectual property portfolio[488] - The company plans to continue its research and development efforts, including advancing its product candidate LNZ100 through clinical development[574] Financial Performance - As of December 31, 2024, LENZ had $209.1 million in cash and marketable securities, sufficient to support operations until positive cash flow post-commercial launch[492] - Research and development expenses decreased by 50% from $59.5 million in 2023 to $29.8 million in 2024 due to the completion of Phase 3 trials[509] - Selling, general and administrative expenses increased by 123% from $12.9 million in 2023 to $28.8 million in 2024, reflecting the build-up of a commercial team[509] - The company incurred an accumulated deficit of $145 million as of December 31, 2024, primarily due to research and development costs[492] - Net losses were $49.8 million for the year ended December 31, 2024, compared to $70.0 million for 2023[515] - The net loss for 2024 was $49.8 million, compared to a net loss of $70.0 million in 2023, reflecting an improvement of 29%[561] - Total operating expenses for 2024 were $58.610 million, down from $72.429 million in 2023, indicating a 19% reduction[616] Cash Flow and Financing - Cash used in operating activities was $59.4 million for the year ended December 31, 2024, resulting from a net loss of $49.8 million[523] - Cash provided by financing activities was $199.0 million for the year ended December 31, 2024, including $117.8 million from the Merger[528] - Cash used in investing activities was $154.5 million for the year ended December 31, 2024, primarily due to $241.9 million in purchases of marketable securities[525] - The company raised $79.51 million from the issuance of common stock in 2024, contributing to a net cash provided by financing activities of $199.00 million[570] Assets and Liabilities - Total current assets increased to $211.9 million in 2024 from $67.2 million in 2023, representing a growth of 214%[557] - Total liabilities decreased to $11.2 million in 2024 from $19.7 million in 2023, a decline of 43%[557] - The company's cash and cash equivalents decreased to $20.2 million in 2024 from $35.1 million in 2023, a decrease of 43%[557] - The marketable securities increased significantly to $188.9 million in 2024 from $30.7 million in 2023, a growth of 516%[557] Shareholder Equity - The weighted-average common shares outstanding increased to 21.3 million in 2024 from 2.0 million in 2023, an increase of 965%[561] - The total common stock outstanding increased to 27,518,439 shares, with an additional paid-in capital of $348,901,000[567] - The company issued 28,019,181 shares of Series B Convertible Preferred Stock, raising $82,976,000, net of issuance costs[567] Merger and Acquisitions - The merger with LENZ OpCo was completed on March 21, 2024, with the transaction accounted for as a reverse recapitalization[573] - Following the merger, former LENZ OpCo stockholders owned approximately 56% of the combined company, while Graphite stockholders and PIPE investors owned 31% and 13%, respectively[624] - LENZ OpCo received $112.6 million in cash and cash equivalents, net of transaction costs, and incurred transaction costs of approximately $5.1 million[625] Tax and Regulatory Matters - The Company has federal net operating losses (NOL) of $72.899 million that do not expire, and state NOLs of $3.908 million expiring between 2040 and 2044[673] - The total deferred tax assets increased to $53.794 million in 2024 from $26.810 million in 2023, primarily due to an increase in net operating loss carryforwards[670] Other Financial Metrics - Other income, net for the year ended December 31, 2024, was $8.8 million, up from $2.3 million in 2023, primarily due to increased interest income[514] - The Company recognized interest income of $8.553 million in 2024, compared to $2.189 million in 2023, marking a 290% increase[616]
LENZ Therapeutics, Inc.(LENZ) - 2024 Q4 - Annual Report