Financial 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].

FDA Approval and Product Launch - VIZZ (aceclidine ophthalmic solution) 1.44% received FDA approval for presbyopia treatment, impacting approximately 128 million adults in the U.S.[2] - Over 2,500 Eye Care Professionals (ECPs) have prescribed VIZZ, with 40% prescribing multiple times, resulting in over 5,000 prescriptions filled through October 2025[1][9] - A partnership with Sarah Jessica Parker as a direct-to-consumer campaign spokesperson is set to launch in Q1 2026[1][9] Financial Performance - Net loss for Q3 2025 was $16.7 million, or $0.59 per share, compared to a net loss of $10.2 million, or $0.38 per share, in Q3 2024[7] - Total revenue for Q3 2025 was $12.5 million, with license revenue contributing $12.5 million, compared to no revenue in Q3 2024[22] - Total operating expenses for the nine months ended September 30, 2025, were $70.2 million, compared to $43.4 million during the same period in 2024[22] Expenses Overview - Selling, General and Administrative (SG&A) expenses increased to $27.6 million for Q3 2025, compared to $6.5 million in Q3 2024, primarily due to increased personnel-related expenses[5] - Research and Development (R&D) expenses decreased to $3.8 million for Q3 2025, down from $6.5 million in Q3 2024, driven by reduced clinical trial-related expenses[6] Cash Position and Funding - Pro forma cash, cash equivalents, and marketable securities were approximately $324.0 million as of September 30, 2025, anticipated to fund operations to post-launch positive cash flow[4] - The company achieved $10 million in milestone payments under its agreement with CORXEL Pharmaceuticals in China, including NDA submission for LNZ100[9]

Product 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]

Regulatory and Approval Updates - NDA for LNZ100 for presbyopia treatment is on track with a PDUFA target action date of August 8, 2025[1] - The NDA submission for LNZ100 in China has triggered a milestone payment under the agreement with CORXEL, with potential for up to $95 million in regulatory and sales milestones[8] Financial Performance - Net loss for Q2 2025 was $14.9 million, or $0.53 per share, compared to a net loss of $10.3 million, or $0.40 per share in Q2 2024[12] - Total revenue for Q2 2025 was $5 million, with license revenue contributing $5 million, compared to no revenue in Q2 2024[20] Sales and Marketing Initiatives - The company has hired an 88-member sales force ready to initiate marketing activities upon FDA approval[4] Licensing and Partnerships - LENZ executed international licensing agreements for LNZ100, securing over $195 million in upfront and milestone payments, plus double-digit royalties on net sales[5] Cash and Expenses - Cash, cash equivalents, and marketable securities totaled $209.6 million as of June 30, 2025, expected to fund operations to post-launch positive cash flow[9] - The company anticipates a cash balance exceeding $205 million by the PDUFA target action date[9] - R&D expenses increased to $9.1 million for Q2 2025, up from $6.9 million in Q2 2024, driven by pre-approval manufacturing activities[10] - SG&A expenses rose to $12.8 million for Q2 2025, compared to $7.4 million in Q2 2024, due to increased personnel and marketing expenses[11]

PART I - FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Presents LENZ Therapeutics, Inc.'s unaudited condensed consolidated financial statements as of March 31, 2025 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$201.3 million** by March 31, 2025, primarily from reduced marketable securities, affecting equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $23,042 | $20,158 | | Marketable securities | $170,934 | $188,872 | | **Total assets** | **$201,252** | **$215,304** | | Total current liabilities | $8,569 | $10,406 | | **Total liabilities** | **$9,242** | **$11,220** | | Accumulated deficit | ($159,633) | ($145,014) | | **Total stockholders' equity** | **$192,010** | **$204,084** | [Condensed Consolidated Statements of Operations And Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20Of%20Operations%20And%20Comprehensive%20Loss) Net loss decreased to **$14.6 million** in Q1 2025, primarily due to lower R&D expenses and higher interest income, despite increased SG&A Condensed Consolidated Statements of Operations (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $5,818 | $10,537 | | Selling, general and administrative | $11,113 | $5,551 | | **Loss from operations** | **($16,931)** | **($16,088)** | | Interest income | $2,323 | $788 | | **Net loss** | **($14,619)** | **($16,648)** | | **Net loss per share, basic and diluted** | **($0.53)** | **($3.53)** | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased to **$16.0 million** in Q1 2025, with investing activities providing **$18.9 million** Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($16,049) | ($23,937) | | Net cash provided by investing activities | $18,889 | $18,000 | | Net cash provided by financing activities | $44 | $171,268 | | **Net increase in cash, cash equivalents, and restricted cash** | **$2,884** | **$165,331** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, reverse merger, liquidity, fair value, commitments, equity, and the CORXEL license - The company is a pre-commercial biopharmaceutical firm focused on therapies to improve vision, having completed a reverse merger with Graphite Bio, Inc. on March 21, 2024, with LENZ OpCo as the accounting acquirer[32](index=32&type=chunk)[33](index=33&type=chunk) - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of **$194.1 million** and believes these funds are sufficient to support operations for at least the next 12 months[35](index=35&type=chunk) - In April 2022, the company entered an exclusive license agreement with CORXEL for Greater China, receiving a **$15.0 million** upfront payment and eligibility for up to **$95.0 million** in milestones plus royalties[106](index=106&type=chunk)[108](index=108&type=chunk) - In April 2025, the company entered an "at the market" (ATM) offering agreement to sell up to **$150 million** of its common stock, subsequently selling 600,500 shares for net proceeds of **$16.3 million**[98](index=98&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, LNZ100 development, Q1 2025 results, liquidity, and capital resources, anticipating R&D decrease and SG&A increase for launch - The company is a pre-commercial biopharmaceutical firm focused on developing LNZ100, a once-daily eye drop for presbyopia, with an estimated U.S. market opportunity exceeding **$3 billion**[116](index=116&type=chunk) - An NDA for LNZ100 was submitted to the FDA in August 2024, with a PDUFA target action date of August 8, 2025, and a commercial launch planned immediately following potential approval[119](index=119&type=chunk)[129](index=129&type=chunk) - Management believes existing cash of **$194.1 million** (as of March 31, 2025) is sufficient to fund the company to positive operating cash flow following the commercial launch of LNZ100, if approved[120](index=120&type=chunk)[144](index=144&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Q1 2025 R&D expenses decreased **45%** to **$5.8 million**, while SG&A increased **100%** to **$11.1 million** due to pre-commercial activities Comparison of Operating Results (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $5,818 | $10,537 | $(4,719) | (45)% | | Selling, general and administrative | $11,113 | $5,551 | $5,562 | 100% | - The **$4.7 million** decrease in R&D expenses was primarily due to a **$4.8 million** reduction in contract research expenses as Phase 3 CLARITY trials were substantially completed in March 2024[138](index=138&type=chunk) - The **$5.6 million** increase in SG&A expenses was driven by a **$2.7 million** rise in employee-related costs from higher headcount, **$1.8 million** in pre-commercial marketing and sales infrastructure expenses, and **$0.7 million** in public company corporate costs[139](index=139&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$194.1 million** in cash and marketable securities, believed sufficient to fund operations to positive cash flow post-LNZ100 launch - As of March 31, 2025, the company had **$194.1 million** in cash, cash equivalents, restricted cash, and marketable securities, with an accumulated deficit of **$159.6 million**[141](index=141&type=chunk) - In April 2025, the company initiated an "at the market" (ATM) offering and sold 600,500 shares for gross proceeds of **$16.5 million** (**$16.3 million** net)[143](index=143&type=chunk) - Management believes that its cash position as of March 31, 2025, is sufficient to fund the company to positive operating cash flow after the commercial launch of LNZ100, if it is approved[144](index=144&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, LENZ Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[169](index=169&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2025[170](index=170&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[171](index=171&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to materially adversely affect its business or financial condition - The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business[175](index=175&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section details risks including limited operating history, LNZ100 dependence, regulatory approval, market acceptance, competition, third-party reliance, intellectual property, and common stock - The company is a pre-commercial entity with a history of significant losses and its business depends entirely on the successful development and commercialization of its single lead product candidate, LNZ100[177](index=177&type=chunk) - The company faces risks related to obtaining regulatory approval from the FDA and other authorities, potential failure to achieve market acceptance, and significant competition from existing and future therapies[177](index=177&type=chunk) - There are substantial risks related to the company's reliance on third parties for manufacturing and clinical trials, as well as its ability to obtain and maintain sufficient intellectual property protection for its products[180](index=180&type=chunk) [Risks Related to Limited Operating History, Development and Commercialization](index=34&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History%2C%20Development%20and%20Commercialization%20of%20Our%20Product%20Candidates) Risks include limited operating history, net losses, LNZ100 dependence, clinical trial uncertainties, market acceptance challenges, and intense competition - The company is a pre-commercial entity with a limited operating history, has incurred significant net losses (**$159.6 million** accumulated deficit as of March 31, 2025), and has no products approved for sale[178](index=178&type=chunk)[179](index=179&type=chunk) - The business is entirely dependent on the successful development and commercialization of LNZ100, with no assurance of approval despite an NDA PDUFA target action date of August 8, 2025[182](index=182&type=chunk) - Even if approved, LNZ100 may fail to gain market acceptance due to competition from over-the-counter reading glasses, other pharmacological options like Qlosi, and potential reluctance from ECPs and patients who had negative experiences with Vuity[201](index=201&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk) - The company faces significant competition from major pharmaceutical companies like AbbVie, Bausch & Lomb, and Johnson & Johnson, which have substantially greater resources[212](index=212&type=chunk)[216](index=216&type=chunk) [Risks Related to Intellectual Property](index=43&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Risks include obtaining and maintaining LNZ100 patent protection, prosecution uncertainty, limited patent terms, infringement claims, and trade secret protection challenges - The company's success depends on its ability to obtain and maintain patent protection for LNZ100, with no guarantee that pending applications will issue as patents or that issued patents will provide sufficient protection[228](index=228&type=chunk)[229](index=229&type=chunk)[230](index=230&type=chunk) - Patent terms are limited and may expire before or shortly after commercialization, opening the door to generic competition, and patent term extensions are not guaranteed[242](index=242&type=chunk)[243](index=243&type=chunk)[245](index=245&type=chunk) - The company may face expensive litigation if third parties claim infringement of their patents, which could block the ability to commercialize LNZ100 or require substantial royalty payments[253](index=253&type=chunk)[258](index=258&type=chunk) - Protecting trade secrets is critical but difficult, especially when sharing information with third-party manufacturers and collaborators, as unauthorized disclosure could impair the company's competitive position[276](index=276&type=chunk)[277](index=277&type=chunk) [Risks Related to Regulatory Approval and Other Legal Compliance Matters](index=58&type=section&id=Risks%20Related%20to%20Our%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) Risks include unpredictable FDA approval, ongoing regulatory compliance, potential side effects, healthcare reform impacts, and adherence to fraud, abuse, data privacy, and anti-corruption laws - The FDA regulatory approval process is lengthy and unpredictable, and the company's NDA for LNZ100 could be delayed or rejected for numerous reasons, including disagreements over clinical trial design or data interpretation[299](index=299&type=chunk)[303](index=303&type=chunk) - Even if approved, LNZ100 will be subject to ongoing regulatory requirements, including for manufacturing (cGMP), labeling, and promotion, with failure to comply resulting in significant penalties, including product withdrawal[317](index=317&type=chunk)[322](index=322&type=chunk) - Healthcare legislative changes, such as the Inflation Reduction Act (IRA), could indirectly impact the company's business by affecting competitor pricing, even though LNZ100 is targeted for the cash-pay market[331](index=331&type=chunk)[333](index=333&type=chunk) - The company is subject to complex data privacy laws like GDPR in Europe and CCPA in California, as well as federal and state anti-kickback and false claims laws, which carry risks of significant penalties for non-compliance[341](index=341&type=chunk)[350](index=350&type=chunk)[352](index=352&type=chunk) [Risks Related to Reliance on Third Parties](index=69&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) Risks include reliance on third-party manufacturers for supply and quality, dependence on CROs for clinical trials, and limited control over the CORXEL collaboration in Greater China - The company does not have its own manufacturing capabilities and relies on third-party manufacturers for clinical and future commercial supply of LNZ100, creating risks related to supply disruption, quality control, and cGMP compliance[355](index=355&type=chunk)[356](index=356&type=chunk) - The company relies on CROs and independent investigators to conduct clinical trials, and their failure to perform duties, comply with GCPs, or meet deadlines could delay or prevent regulatory approval[360](index=360&type=chunk)[361](index=361&type=chunk)[362](index=362&type=chunk) - The company is dependent on its partner, CORXEL, for the development and commercialization of LNZ products in Greater China, with limited control over CORXEL's resources and strategy, potentially impacting future milestone and royalty revenues[366](index=366&type=chunk)[367](index=367&type=chunk) [Risks Related to Business Operations](index=72&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations) Operational risks include dependence on key personnel, organizational growth challenges, potential securities litigation, and vulnerability to cybersecurity breaches - The company is highly dependent on its ability to attract and retain key management and scientific personnel in a competitive industry[369](index=369&type=chunk) - The company expects to significantly expand its organization and may encounter difficulties managing this growth, particularly in building out commercial and public company infrastructure[374](index=374&type=chunk) - Internal computer systems and those of third-party partners are vulnerable to cybersecurity breaches, which could result in material disruption, loss of confidential data, and significant liabilities[376](index=376&type=chunk)[378](index=378&type=chunk)[379](index=379&type=chunk) [Risks Related to Our Common Stock](index=75&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Risks for common stock investors include price volatility, dilution from future issuances, reduced disclosure as an emerging growth/smaller reporting company, and anti-takeover provisions - The market price of the company's common stock is expected to be volatile and could be influenced by clinical trial results, regulatory decisions, and competitor announcements[385](index=385&type=chunk) - Sales of a substantial number of shares, including from recent PIPE financings and a new shelf registration, could cause the stock price to decline[387](index=387&type=chunk)[389](index=389&type=chunk)[393](index=393&type=chunk) - The company is an "emerging growth company" and a "smaller reporting company," allowing it to rely on reduced disclosure exemptions, which may make its stock less attractive to some investors[396](index=396&type=chunk)[398](index=398&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards of **$72.9 million** (federal) and other tax attributes is subject to limitation due to an ownership change that occurred as a result of the Merger[416](index=416&type=chunk)[417](index=417&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=81&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during Q1 2025 that were not previously disclosed in Form 8-K reports - There were no unregistered sales of equity securities during the quarter ended March 31, 2025, that had not been previously reported on a Form 8-K[419](index=419&type=chunk) [Other Information](index=82&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the last fiscal quarter - No directors or officers adopted or terminated a Rule 10b5-1 trading plan or other non-Rule 10b5-1 trading arrangement during the last fiscal quarter[422](index=422&type=chunk) [Exhibits](index=82&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including corporate documents, a sales agreement, and CEO/CFO certifications [Signatures](index=83&type=section&id=Signatures) The report is signed by the Chief Executive Officer and Chief Financial Officer on May 7, 2025

Drug Development - The New Drug Application (NDA) for LNZ100 for the treatment of presbyopia is on track for a PDUFA target action date of August 8, 2025[1]. - The FDA has confirmed that LNZ100 will be duty-free in the U.S., clarifying tariff exposure for the product[5]. Financial Performance - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities of $194.1 million, with an anticipated cash balance exceeding $185.0 million by the PDUFA date[8]. - The net loss for Q1 2025 was $14.6 million, or $0.53 per share, an improvement from a net loss of $16.6 million, or $3.53 per share, in Q1 2024[11]. - Total operating expenses for Q1 2025 were $16.9 million, compared to $16.1 million in Q1 2024[19]. Research and Development - Research and Development (R&D) expenses decreased to $5.8 million for Q1 2025, down from $10.5 million in Q1 2024, due to the conclusion of the Phase 3 CLARITY study[9]. Sales and Marketing - Selling, General and Administrative (SG&A) expenses increased to $11.1 million in Q1 2025, compared to $5.6 million in Q1 2024, driven by personnel-related expenses and pre-commercial marketing[10]. - The company is actively hiring 88 sales representatives, with a target completion date of July 1, 2025, as part of its pre-launch commercial planning[7]. - The company hosted a Commercial Day on April 15, 2025, to share updates on commercialization strategy and supply chain readiness[6]. Cash Management - The company anticipates a cash runway that extends to post-launch positive operating cash flow[8].

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 has not yet realized product revenue and continues to focus on research and development for its product candidate LNZ100[574] - The company expects to incur additional losses as it advances its product candidate through clinical development and seeks regulatory approval[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] - The company incurred an accumulated deficit of $145 million as of December 31, 2024, primarily from 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 company expects to continue incurring significant expenses and operating losses as it seeks approval and pursues the potential commercialization of LNZ100[515] - For the year ended December 31, 2024, the net loss was $49.769 million, an improvement from a net loss of $69.968 million in 2023, representing a 29% reduction in losses[570] Expenses - 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-out of a commercial team[509] - Total operating expenses were $58.61 million, a decrease from $72.43 million in 2023, primarily driven by reduced research and development expenses of $27.91 million compared to $59.06 million in the prior year[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 $79.513 million from the issuance of common stock in 2024, contributing to a net cash provided by financing activities of $199.002 million[570] Shareholder Equity - The company reported total stockholders' equity of $204.1 million in 2024, compared to a deficit of $92.7 million in 2023[558] - The weighted-average common shares outstanding increased to 21.3 million in 2024 from 2.0 million in 2023[561] - The total common stock outstanding increased to 27,518,439 shares, with an additional paid-in capital of $348,901 million[567] Mergers and Acquisitions - The merger with LENZ OpCo was completed on March 21, 2024, with Graphite changing its name to LENZ Therapeutics, Inc.[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] - The merger resulted in the issuance of 15,409,102 shares of Graphite common stock to LENZ OpCo stockholders, with a conversion ratio of 0.2022 shares of Graphite for each share of LENZ OpCo[623] Tax and Deferred Assets - The company recorded a valuation allowance against its net deferred tax assets due to uncertainty regarding their realization, reflecting cautious tax planning[608] - The total deferred tax assets increased significantly to $53.8 million in 2024 from $26.8 million in 2023, primarily due to net operating loss carryforwards of $15.5 million and research and development credit carryforwards of $8.2 million[670] - The valuation allowance against deferred tax assets rose by $26.5 million during 2024, totaling $53.2 million at year-end, indicating uncertainty in realizing these assets[673] License Agreements - The CORXEL License Agreement includes $15 million in upfront payments and potential milestone payments up to $95 million, plus royalties of 5% to 15% on net sales in Greater China[498] - The Company recognized $15.0 million as revenue from the CORXEL License upon completion of the transfer in 2022, with no contractual milestones met in 2024 or 2023[681]

Financial Performance - LENZ Therapeutics reported cash, cash equivalents, and marketable securities of $209.1 million as of December 31, 2024, expected to fund operations until post-launch positive operating cash flow[9]. - The net loss for Q4 2024 was $12.7 million, or $0.46 per share, compared to a net loss of $23.7 million, or $12.04 per share in Q4 2023[12]. - Total operating expenses for the year ended December 31, 2024, were $58.6 million, down from $72.4 million in 2023[21]. - The company’s total assets as of December 31, 2024, were $215.3 million, compared to $70.4 million in 2023[19]. Research and Development - Research and Development (R&D) expenses decreased to $5.9 million for Q4 2024, down from $19.5 million in Q4 2023, and totaled $29.8 million for the year, compared to $59.5 million in 2023[10]. Selling, General and Administrative Expenses - Selling, General and Administrative (SG&A) expenses increased to $9.4 million for Q4 2024, up from $5.5 million in Q4 2023, and totaled $28.8 million for the year, compared to $12.9 million in 2023[11]. Regulatory and Clinical Developments - The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025, for the New Drug Application (NDA) of LNZ100 for presbyopia[4]. - In the pivotal Phase 3 CLARITY study, 74% of patients treated with LNZ100 achieved a statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near[7]. Commercialization Efforts - The company has advanced its commercial planning for LNZ100, with over 2 million digital campaign impressions targeting more than 30,000 Eye Care Professionals (ECPs)[5]. - LENZ Therapeutics plans to host a Commercial Day on April 15, 2025, to discuss commercialization strategies and progress towards the potential approval of LNZ100[8].

Product Development - LENZ's lead product candidate LNZ100 demonstrated a robust product profile with 71% and 91% of participants achieving three- and two-lines or greater improvement in near vision at 30 minutes in the Phase 3 CLARITY study[98] - The FDA assigned a PDUFA target action date of August 8, 2025, for LNZ100, with a potential commercial launch as early as Q4 2025 if approved[104] - LNZ100 achieved statistically significant improvements in distance vision, with 41% of participants achieving at least one line of improvement[100] - LNZ100 has patent protection until at least 2039 in the United States, supported by a robust intellectual property portfolio[98] - The CORXEL License Agreement includes potential milestone payments of up to $95.0 million and tiered royalties ranging from 5% to 15% on net sales of LNZ100 in Greater China[102] Financial Performance - The company incurred an accumulated deficit of $132.4 million as of September 30, 2024, primarily from research and development and administrative costs[100] - The company incurred net losses of $10.2 million and $18.9 million for Q3 2024 and 2023, respectively, and $37.1 million and $46.3 million for the nine months ended September 30, 2024 and 2023, respectively[118] - Cash used in operating activities for the nine months ended September 30, 2024 was $50.3 million, compared to $39.4 million for the same period in 2023[123] - Cash provided by financing activities for the nine months ended September 30, 2024 was $198.9 million, compared to $82.6 million for the same period in 2023[125] - Other income, net for Q3 2024 was $2.7 million, compared to $1.0 million for Q3 2023, driven by an increase in interest income of $1.7 million[112] - Other income, net for the nine months ended September 30, 2024 was $6.3 million, compared to $1.2 million for the same period in 2023, primarily due to an increase in interest income of $4.6 million[116] Research and Development Expenses - Research and development costs decreased during the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to reduced contract manufacturing and clinical research expenses[103] - Research and development expenses decreased by $10.6 million, or 62%, to $6.5 million for Q3 2024 compared to $17.0 million for Q3 2023[111] - For the nine months ended September 30, 2024, research and development expenses decreased by $16.0 million, or 40%, to $23.9 million compared to $40.0 million for the same period in 2023[114] Selling, General and Administrative Expenses - Selling, general and administrative expenses are expected to increase in 2024 as the company builds its commercial infrastructure in preparation for the potential launch of LNZ100[103] - Selling, general and administrative expenses increased by $3.6 million, or 127%, to $6.5 million for Q3 2024 compared to $2.9 million for Q3 2023[112] - Selling, general and administrative expenses for the nine months ended September 30, 2024 increased by $12.0 million, or 160%, to $19.5 million compared to $7.5 million for the same period in 2023[115] Cash Position - As of September 30, 2024, LENZ had $217.2 million in cash, cash equivalents, restricted cash, and marketable securities, which is expected to fund operations until positive operating cash flow post-commercial launch[100] - As of September 30, 2024, the company had $217.2 million in cash, cash equivalents, restricted cash, and marketable securities[118] Company Classification and Future Outlook - The company is classified as an emerging growth company under the JOBS Act and may remain so until December 31, 2026[135] - The company has total annual gross revenue of less than $100 million for the fiscal year ended December 31, 2023[135] - The market value of the company's stock held by non-affiliates was less than $700 million as of June 30, 2024[135] - The company intends to rely on exemptions from various public company disclosure and reporting requirements while remaining an emerging growth company[135] - The company has not historically paid dividends, except for a special dividend prior to the Merger, and does not anticipate future dividends[134] Equity Awards and Valuation - The fair value of equity awards is estimated using the Black-Scholes option pricing model, which is influenced by several assumptions[132] - The expected volatility for equity awards is derived from the average historical volatilities of comparable publicly traded companies[134] - The company uses the simplified method to calculate the expected term for options granted to employees due to insufficient historical exercise data[134] - The Series A Warrants became exercisable into shares of common stock upon completion of the Merger and are no longer remeasured at each reporting date[131] - The company has historically not experienced material changes to its condensed consolidated financial statements due to revisions in estimates[130]

Drug Development and Approval - The New Drug Application (NDA) for LNZ100 for the treatment of presbyopia has been accepted by the FDA, with a PDUFA target action date of August 8, 2025[3]. - LNZ100 demonstrated a statistically significant improvement, with 74% of patients achieving three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near in the Phase 3 study in China[4]. - The company is preparing for a US commercial launch of LNZ100, with a full commercial leadership team established[5]. - Market research indicated that 82% of surveyed Eye Care Professionals (ECPs) would be likely to prescribe LNZ100 based on its clinical data profile[6]. Financial Performance - Cash, cash equivalents, and marketable securities totaled $217.2 million as of September 30, 2024, expected to fund operations until post-launch positive operating cash flow[7]. - Research and Development (R&D) expenses decreased to $6.5 million for Q3 2024, down from $17.0 million in Q3 2023, reflecting a 62% reduction[8]. - Selling, General and Administrative (SG&A) expenses increased to $6.5 million for Q3 2024, compared to $2.9 million in Q3 2023, marking a 124% increase[9]. - The net loss for Q3 2024 was $10.2 million, or $0.38 per share, compared to a net loss of $18.9 million, or $9.62 per share, in Q3 2023[10]. - The company completed a $30 million private placement financing in July 2024 to support its operations[6]. Market Overview - The presbyopia market is significant, with an estimated 128 million people in the United States and 400 million in China affected by the condition[2].