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LENZ Therapeutics, Inc.(LENZ) - 2024 Q4 - Annual Report
LENZLENZ Therapeutics, Inc.(LENZ)2025-03-19 20:38
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Product Development - LENZ's lead product candidate LNZ100 is a once-daily eye drop targeting presbyopia, with a U.S. market opportunity exceeding 3billion[487]−InthePhase3CLARITYstudy,LNZ100demonstratedthat713 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 59.5millionin2023to59.5 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 12.9millionin2023to12.9 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 145millionasofDecember31,2024,primarilyduetoresearchanddevelopmentcosts[492]−Netlosseswere145 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 70.0millionfor2023[515]−Thenetlossfor2024was70.0 million for 2023[515] - The net loss for 2024 was 49.8 million, compared to a net loss of 70.0millionin2023,reflectinganimprovementof2970.0 million in 2023, reflecting an improvement of 29%[561] - Total operating expenses for 2024 were 58.610 million, down from 72.429millionin2023,indicatinga1972.429 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 49.8million[523]−Cashprovidedbyfinancingactivitieswas49.8 million[523] - Cash provided by financing activities was 199.0 million for the year ended December 31, 2024, including 117.8millionfromtheMerger[528]−Cashusedininvestingactivitieswas117.8 million from the Merger[528] - Cash used in investing activities was 154.5 million for the year ended December 31, 2024, primarily due to 241.9millioninpurchasesofmarketablesecurities[525]−Thecompanyraised241.9 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 199.00million[570]AssetsandLiabilities−Totalcurrentassetsincreasedto199.00 million[570] Assets and Liabilities - Total current assets increased to 211.9 million in 2024 from 67.2millionin2023,representingagrowthof21467.2 million in 2023, representing a growth of 214%[557] - Total liabilities decreased to 11.2 million in 2024 from 19.7millionin2023,adeclineof4319.7 million in 2023, a decline of 43%[557] - The company's cash and cash equivalents decreased to 20.2 million in 2024 from 35.1millionin2023,adecreaseof4335.1 million in 2023, a decrease of 43%[557] - The marketable securities increased significantly to 188.9 million in 2024 from 30.7millionin2023,agrowthof51630.7 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,netofissuancecosts[567]MergerandAcquisitions−ThemergerwithLENZOpCowascompletedonMarch21,2024,withthetransactionaccountedforasareverserecapitalization[573]−Followingthemerger,formerLENZOpCostockholdersownedapproximately5682,976,000, 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 5.1million[625]TaxandRegulatoryMatters−TheCompanyhasfederalnetoperatinglosses(NOL)of5.1 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 3.908millionexpiringbetween2040and2044[673]−Thetotaldeferredtaxassetsincreasedto3.908 million expiring between 2040 and 2044[673] - The total deferred tax assets increased to 53.794 million in 2024 from 26.810millionin2023,primarilyduetoanincreaseinnetoperatinglosscarryforwards[670]OtherFinancialMetrics−Otherincome,netfortheyearendedDecember31,2024,was26.810 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 2.3millionin2023,primarilyduetoincreasedinterestincome[514]−TheCompanyrecognizedinterestincomeof2.3 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]