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].

As filed with the Securities and Exchange Commission on September 11, 2024 Registration No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 LENZ THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 84-4867570 (I.R.S. Employer Identification Number) 201 Lomas Santa Fe ...

Market Opportunity - The estimated addressable population suffering from presbyopia in the U.S. is 128 million, representing a market opportunity exceeding $3 billion[85]. Clinical Trial Results - LNZ100 achieved a statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity at near, with 71% of participants showing improvement at 3 hours in the CLARITY 2 trial[85]. - LNZ100 was well-tolerated in clinical trials, with no serious treatment-related adverse events reported in over 30,000 treatment days[93]. Financial Position - As of June 30, 2024, the company had $196.1 million in cash, cash equivalents, and marketable securities, sufficient to fund operations until positive operating cash flow post-commercial launch[88]. - The company incurred an accumulated deficit of $122.1 million as of June 30, 2024, primarily due to research and development costs[88]. - The company had $196.1 million in cash, cash equivalents, and marketable securities as of June 30, 2024, with an accumulated deficit of $122.1 million[110]. Financing Activities - The company completed a PIPE Financing in July 2024, raising $30.0 million by selling 1,578,947 shares at $19.00 per share[95]. - Cash provided by financing activities for the six months ended June 30, 2024, was $169.1 million, significantly higher than $83.2 million in the same period in 2023[117]. Research and Development Expenses - The company expects research and development costs to decrease in 2024 due to the completion of the Phase 3 CLARITY trials[92]. - Research and development expenses decreased by $5.7 million, or 45%, from $12.6 million in Q2 2023 to $6.9 million in Q2 2024, primarily due to a $9.2 million decrease in contract research expenses[102]. - For the six months ended June 30, 2024, research and development expenses totaled $17.5 million, down 24% from $22.9 million in the same period in 2023[106]. Selling, General, and Administrative Expenses - Selling, general, and administrative expenses are anticipated to increase in 2024 as the company prepares for a potential commercial launch of LNZ100[92]. - Selling, general and administrative expenses increased by $5.1 million, or 219%, from $2.3 million in Q2 2023 to $7.4 million in Q2 2024, driven by increased employee salaries and marketing expenses[103]. - Selling, general and administrative expenses for the six months ended June 30, 2024, rose to $13.0 million, an increase of 181% from $4.6 million in the same period in 2023[107]. Future Capital Requirements - Future capital requirements will depend on various factors, including manufacturing costs and regulatory review outcomes for LNZ100[111]. - The company expects to continue incurring significant expenses as it seeks approval and pursues the potential commercialization of LNZ100[110]. Licensing and Royalties - The Ji Xing License Agreement includes potential milestone payments of up to $95.0 million and tiered royalties ranging from 5% to 15% on net sales in Greater China[89]. Company Classification and Dividends - The company is classified as an emerging growth company under the JOBS Act and may remain so until December 31, 2026[125]. - The company has historically paid no dividends, except for a special dividend prior to the Merger, and does not anticipate paying dividends in the future[124]. Stock Valuation and Options - The fair value of the company's common stock prior to the Merger was determined by the board of directors based on various factors, including clinical milestones and capital market conditions[124]. - The company uses the Black-Scholes option pricing model to estimate the fair value of equity awards, which is influenced by assumptions such as risk-free interest rate and expected stock price volatility[123]. - The Series A Warrants were revalued at each balance sheet date, with changes recognized in other income (expense) until they became exercisable into common stock upon completion of the Merger[122]. - The company has limited historical stock price volatility data and derives expected volatility from comparable publicly traded companies[124]. - The company does not have sufficient historical exercise data to estimate the expected term for options granted to employees, using the simplified method instead[124]. - The company has not experienced material changes to its financial statements due to revisions in estimates historically[121].

Drug Development - Submitted New Drug Application (NDA) to the U.S. FDA for LNZ100 for the treatment of presbyopia, supported by positive data from the Phase 3 CLARITY study[2] - LNZ100 achieved statistically significant improvement in near vision, with 71% of participants achieving three-lines or greater improvement at 3 hours post-administration[4] - 84% of participants achieved at least 4 lines of near vision improvement with LNZ100, demonstrating its robust product profile[4] - The company is targeting a market of approximately 128 million individuals living with presbyopia in the United States[2] - The company plans to engage with key opinion leaders and eye care professionals for the commercialization of LNZ100, pending FDA approval[12] Financial Performance - Pro forma cash, cash equivalents, and marketable securities were $226.2 million as of June 30, 2024, following a $30 million private placement from Ridgeback Capital[1] - R&D expenses decreased to $6.9 million for Q2 2024, down from $12.6 million in Q2 2023, primarily due to reduced clinical trial-related expenses[7] - SG&A expenses increased to $7.4 million for Q2 2024, compared to $2.3 million in Q2 2023, driven by personnel-related expenses and pre-commercial planning[8] - Net loss for Q2 2024 was $10.3 million, or $0.40 per share, compared to a net loss of $14.7 million, or $7.53 per share in Q2 2023[9] - Total assets as of June 30, 2024, were $202.6 million, compared to $70.4 million as of December 31, 2023[13]

Product Development and Regulatory Approval - LENZ's lead product candidate LNZ100 achieved statistically significant results in Phase 3 trials, with 71% of participants showing a three-lines or greater improvement in near vision at 3 hours post-application [124]. - The company plans to submit a New Drug Application (NDA) for LNZ100 to the FDA in mid-2024, targeting a commercial launch in the second half of 2025 [126]. - LNZ100 has patent protection until at least 2039 in the United States, supported by a robust intellectual property portfolio [123]. - The company anticipates continued significant expenses and operating losses as it seeks regulatory approval and prepares for the potential commercial launch of LNZ100 [127]. - The company expects to incur significant expenses related to the regulatory approval process for LNZ100 and preparation for its potential commercial launch [150]. Financial Performance - Research and development expenses for the three months ended March 31, 2024, were $10.5 million, a slight increase of 2% compared to $10.3 million in the same period in 2023 [144]. - Selling, general and administrative expenses surged by 142% to $5.6 million in Q1 2024, up from $2.3 million in Q1 2023, reflecting increased operational activities [144]. - Net losses for Q1 2024 were $16.6 million, compared to $12.7 million in Q1 2023, reflecting ongoing costs related to research and development and administrative expenses [150]. - Total other income (expense), net for Q1 2024 was $(560,000), a significant increase in expense compared to $(54,000) in Q1 2023, reflecting a 937% change [144]. - Cash used in operating activities for Q1 2024 was $23.9 million, resulting from a net loss and changes in working capital [157]. - As of March 31, 2024, the company had $213.3 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $111.9 million [150]. Mergers and Financing - The merger with Graphite was completed on March 21, 2024, resulting in LENZ OpCo securityholders owning approximately 65% of the combined company's common stock [136]. - Cash provided by financing activities in Q1 2024 was $171.3 million, including $117.8 million from the Merger and $53.5 million from PIPE Financing [161]. - The company received $15 million in upfront payments from Ji Xing Pharmaceuticals as part of a licensing agreement for LNZ100 and LNZ101 in Greater China [131]. Future Outlook and Expenses - Future capital requirements will depend on clinical trial results, manufacturing costs, and the ability to generate positive operating cash flow from LNZ100 sales [153]. - The company anticipates increased rent expenses due to a new lease for office space in Solana Beach, California, starting July 1, 2024 [164]. Company Classification and Reporting - Graphite is classified as an emerging growth company and may remain so until December 31, 2026 [175]. - As of June 30, 2023, the market value of Graphite's stock held by non-affiliates was less than $700 million, qualifying it as a smaller reporting company [178]. - Graphite's annual revenue for the fiscal year ended December 31, 2023, was less than $100 million [178]. - The company can delay adopting new accounting standards until it meets certain revenue or market value thresholds [176]. - Graphite's total annual gross revenue must reach at least $1.235 billion to cease being an emerging growth company [177]. - The company has the option to present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K [178]. - Graphite is exempt from certain public company disclosure and reporting requirements under the JOBS Act [175]. - The company intends to rely on exemptions related to executive compensation disclosures as a smaller reporting company [178]. - Graphite has not issued more than $1.0 billion in non-convertible debt during the prior three-year period [177]. - The company is not required to provide certain market risk disclosures due to its smaller reporting company status [180].

Financial Performance - The net loss for Q1 2024 was $16.6 million, or $3.53 per share, compared to a net loss of $12.7 million, or $6.50 per share, in Q1 2023[16]. - Research and Development (R&D) expenses for Q1 2024 were $10.5 million, consistent with $10.3 million in the same period of 2023[14]. - Selling, General and Administrative (SG&A) expenses increased to $5.6 million in Q1 2024 from $2.3 million in Q1 2023, primarily due to pre-launch commercial expenses and increased personnel costs[15]. Mergers and Acquisitions - The company completed a merger with Graphite Bio and a concurrent private placement of $53.5 million, ending Q1 2024 with approximately $213.3 million in cash, cash equivalents, and marketable securities[9][12]. Product Development and Market Opportunity - LENZ Therapeutics reported positive topline data from the Phase 3 CLARITY study for presbyopia, with 84% of participants achieving at least four lines of near vision improvement[3]. - The Phase 3 CLARITY study achieved statistically significant improvements in near vision, with p<0.0001 for all primary and secondary endpoints[4]. - The estimated U.S. market opportunity for LNZ100 is over $3 billion, targeting the 128 million presbyopes in the United States[6][3]. - The company plans to submit a New Drug Application (NDA) for LNZ100 in mid-2024, with a potential commercial launch as early as the second half of 2025[7][3]. Commercial Strategy - The company is actively building its U.S. commercial capabilities in preparation for the projected launch following potential FDA approval[8]. - Capstone data from the Phase 3 CLARITY study will be presented at a Key Opinion Leader event on June 18, 2024[11].

As filed with the Securities and Exchange Commission on April 8, 2024 Registration No. 333-278393 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 84-4867570 (I.R.S. Employer Identification Number) 445 Marine View Ave., Ste. #320 Del Mar, California 92014 (858) 925-7000 (Address, including zip code, and ...

As filed with the Securities and Exchange Commission on March 29, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 LENZ THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) Delaware 2834 84-4867570 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (Address, including zip code, and telephone number, including area code, of Regi ...

Merger and Corporate Restructuring - The company announced a merger agreement with LENZ Therapeutics, Inc. on November 14, 2023, which is subject to stockholder approval and customary closing conditions[26]. - The merger with LENZ is critical for future operations, and there are no assurances that it will be successfully consummated[27]. - The merger agreement was unanimously approved by the company's board of directors, which resolved to recommend approval to stockholders[26]. - The company is restrained from soliciting other acquisition proposals during the merger's pendency, which may affect its strategic options[13]. - In February 2023, the company announced a corporate restructuring resulting in approximately 78.1% reduction in workforce[23]. Financial Performance and Expectations - The company has incurred significant losses since inception and expects to continue incurring losses for the foreseeable future, with no revenue generated from product sales to date[21]. - The company has never generated revenue from product sales and may never become profitable, indicating a need for substantial additional funding[5]. - The company is considered a "shell company" under federal securities laws due to the sale and write-off of certain operating assets, leading to more stringent reporting requirements[21]. Development Programs and Product Candidates - The company has no remaining ongoing development programs after transferring its pre-clinical non-genotoxic conditioning program to Maro Bio, Inc.[24]. - The company announced a voluntary pause of its Phase 1/2 CEDAR study for its lead product candidate nula-cel due to a serious adverse event in January 2023, leading to the decision to discontinue its development in February 2023[32]. - The company has terminated the development of its lead product candidate, nula-cel, and other related programs due to a serious adverse event and strategic review[32][34][35]. - GPH102 for beta-thalassemia and GPH201 for XSCID, both leveraging the same gene editing platform as nula-cel, have also been terminated due to similar technical limitations[33][34]. Intellectual Property and Licensing Agreements - The company continues to hold and maintain technology and intellectual property related to its nula-cel program, despite discontinuing its development[24]. - As of December 31, 2023, the company in-licensed two issued U.S. patents and two pending U.S. patent applications from Stanford, with expected expiration in 2036[40]. - The company has paid an upfront license fee of $50,000 to Stanford and issued approximately 0.6 million shares of common stock as part of its exclusive license agreement[45]. - The annual license maintenance fee to Stanford will increase from $5,000 to $50,000 over the first seven anniversaries, and $200,000 after the first commercial sale of a licensed product[46]. - The company is obligated to pay Stanford up to $12.8 million upon achieving certain development, regulatory, and commercial milestones for each licensed product[49]. - The company has granted Kamau an option to acquire certain technology and intellectual property related to the nula-cel program and related preclinical platform assets[42][53]. Regulatory Environment and Compliance - The FDA requires a Biologics License Application (BLA) for marketing biological products in the U.S., which includes extensive data from preclinical and clinical studies[83]. - An Investigational New Drug (IND) application must be submitted and becomes effective 30 days after receipt by the FDA unless safety concerns arise[83]. - Clinical trials are conducted in three phases, with Phase 3 requiring two adequate and well-controlled trials for BLA approval[94]. - The FDA aims to review standard BLAs within ten months and priority reviews within six months after acceptance for filing[97]. - Regulatory approval may come with specific indications and limitations on marketing, including the requirement for a Risk Evaluation and Mitigation Strategy (REMS)[100]. - The FDA may require post-marketing studies to monitor the safety and effectiveness of approved products[100]. - Compliance with Good Manufacturing Practices (cGMP) is mandatory for manufacturing facilities before BLA approval[98]. Market and Competitive Landscape - The company faces competition from several firms in gene editing and gene therapy, including Beam Therapeutics, bluebird bio, and CRISPR Therapeutics, among others[37]. - The competitive landscape includes several companies advancing gene editing and gene therapy programs, posing significant risks to the company's market position[37][38]. - The marketability of product candidates may suffer if government and third-party payors do not provide adequate coverage and reimbursement[144]. - In the U.S., third-party payors are increasingly challenging drug prices and may limit coverage to specific approved drug products[141]. Employment and Workforce - As of December 31, 2023, the company had six full-time employees, with no representation by labor unions[159]. - The company plans to attract and retain employees through stock-based compensation awards[160]. Legislative and Policy Environment - Legislative measures at the state level are increasingly aimed at controlling pharmaceutical pricing, which may impact the company's market strategies[158]. - The Biden administration has proposed measures to control drug costs, including a prescription drug pricing model to incentivize manufacturers[156].

Financial Performance - The net loss for the three months ended September 30, 2023, was $22.485 million, compared to a net loss of $24.682 million for the same period in 2022, showing an improvement of about 8.8%[17] - The net loss for the nine months ended September 30, 2023, was $101,733,000, compared to a net loss of $76,453,000 for the same period in 2022, representing an increase of approximately 33%[25] - Comprehensive loss for the nine months ended September 30, 2023, was $100.780 million, compared to $78.049 million for the same period in 2022, indicating a decline of approximately 28.9%[17] Cash and Cash Equivalents - As of September 30, 2023, cash and cash equivalents increased to $182.988 million from $47.730 million as of December 31, 2022, representing a significant growth[15] - Cash, cash equivalents, and restricted cash at the end of the period were $184,704,000, a significant increase from $58,107,000 at the end of the same period in 2022[25] - The company had cash, cash equivalents, and marketable securities totaling $234.0 million as of September 30, 2023, sufficient to fund operations for at least the next 12 months[32] Assets and Liabilities - Total current assets decreased to $238.783 million from $275.365 million as of December 31, 2022, indicating a reduction of approximately 13.3%[15] - Total liabilities increased to $62.209 million from $25.611 million as of December 31, 2022, reflecting a rise of approximately 143.5%[15] - The accumulated deficit increased to $344.136 million as of September 30, 2023, from $242.403 million as of December 31, 2022[15] Research and Development - Research and development expenses for the three months ended September 30, 2023, were $2.384 million, a decrease from $18.302 million in the same period of 2022[17] - The Company recognized $1.1 million in research and development expenses related to the LCGM MSA for the nine months ended September 30, 2023, compared to $4.5 million for the same period in 2022[68] - The Company has not recognized any research and development expenses in connection with the IDT License Agreement for the three and nine months ended September 30, 2023[73] Restructuring and Workforce Changes - The Company announced a restructuring plan in February 2023, resulting in a total reduction in force of 78.1% by August 2023[29] - The company incurred approximately $3.4 million in employee termination benefits expense related to the First Restructuring Plan, which eliminated about 50% of its workforce[126][127] - The Second Restructuring Plan, approved in August 2023, eliminated an additional 33.1% of the workforce, totaling 78.1% overall[128] Stock and Equity - The weighted-average shares used in computing net loss per share for the three months ended September 30, 2023, were 57,257,241, compared to 55,206,139 for the same period in 2022[17] - The company had a total of 57,971,910 shares outstanding as of September 30, 2023, compared to 58,149,317 shares as of September 30, 2022[22] - The company reserved a total of 17,465,405 shares for future issuance, up from 13,893,161 shares as of December 31, 2022, reflecting an increase of 25.0%[99] Impairment and Asset Sales - The company reported a significant impairment of assets amounting to $43,276,000 during the nine months ended September 30, 2023[25] - The company recorded impairment charges and loss on disposal of assets of $5.3 million and $6.8 million for the three and nine months ended, respectively[131] - The company sold certain assets related to its non-genotoxic conditioning technology for upfront consideration of $0.5 million, with potential additional payments of up to $1.0 million[133] Lease Agreements - The company entered into a lease agreement for 85,165 square feet of office and laboratory space with a total right-of-use asset of $32.0 million recognized upon lease commencement[88] - As of September 30, 2023, the Company had total operating lease liabilities of $53.1 million[90] - The Company entered into a sublease agreement for approximately 15,212 square feet of space in South San Francisco, California[141] Strategic Initiatives - The company paused its Phase 1/2 CEDAR study of its lead product candidate, nula-cel, in January 2023 due to a serious adverse event[27] - The Company continues to explore strategic alternatives following the discontinuation of the nula-cel development[30] - The Company has primarily relied on private equity and convertible debt financings to fund operations since inception[32]