Financial Data and Key Metrics Changes - The company ended Q1 2025 with approximately $194.1 million in cash, cash equivalents, and marketable securities, which has been upwardly revised from over $170 million to over $185 million projected cash at PDUFA [27][28] - Total Q1 2025 operating expenses increased to $16.9 million, an 11% increase over Q4, with a net cash burn of $15 million [28][29] - Net loss per share was $0.53 in Q1 2025, compared to $3.53 in Q1 2024, reflecting a significant improvement in financial performance [30][31] Business Line Data and Key Metrics Changes - The company is focused on the launch of LNZ100, a treatment for presbyopia, with a strong emphasis on commercial readiness and engagement with eye care professionals [5][6] - The unbranded campaign has reached over 12,000 eye care professionals (ECPs) and delivered more than 2 million online impressions [9][10] - The sales force has expanded, with over 40% of the field sales team already hired, and 97% of new team members have prior eye care or pharmaceutical experience [19][20] Market Data and Key Metrics Changes - Presbyopia affects an estimated 128 million people in the U.S., presenting a substantial market opportunity [14][15] - The company aims to capture a significant share of the $3 billion market for presbyopia treatments, with a focus on a once-daily eye drop solution [16][67] Company Strategy and Development Direction - The company is preparing for the launch of LNZ100 with a three-pillar commercial strategy: enabling doctors to recommend the product, empowering patients to request it, and ensuring seamless access [10][25] - The company has established a strong intellectual property position with seven granted patents and additional patents under review, ensuring long-term protection for LNZ100 [82][83] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver effective treatments for presbyopia, emphasizing the importance of sampling and patient experience in driving adoption [32][44] - The company is monitoring economic conditions, noting that historical data suggests medical aesthetics products may be less impacted by recessions compared to elective procedures [88][90] Other Important Information - The company has received positive feedback from eye care professionals regarding the clinical potential of LNZ100, which is expected to enhance patient care [7][8] - The FDA has shown a high level of engagement, with the late cycle review meeting scheduled for later this month, keeping the company on track for the August 8 PDUFA date [11][12] Q&A Session Summary Question: Infrastructure for sample distribution post-launch - The company has contracted a sampling distributor and is coordinating systems to ensure seamless delivery of samples to ECPs immediately after approval [35][36] Question: Preparation for continued use and refills of LNZ100 - The sales team is undergoing training to ensure they can effectively communicate product benefits and drive patient adherence post-sampling [38][43] Question: Metrics to disclose for patient demand - The company plans to provide metrics on new script rates and refill rates, focusing on IQVIA data for tracking [41][42] Question: Management of sample distribution and expected conversion rates - Samples will be managed through a monthly shipment to reps, with tracking to ensure they reach high-potential prescribers [48][51] Question: E-pharmacy partnership mechanics - The e-pharmacy partner is integrated within the eye care professional ecosystem, ensuring a seamless prescription process and strong patient follow-up [55][84] Question: Impact of potential recession on call points - The company believes its product will be less affected by economic downturns due to its focus on quality of life improvements [88][91] Question: Additional patent protection for LNZ100 - The company has a strong patent estate with seven granted patents and additional patents under review, ensuring robust protection for the product [82][83] Question: Potential competition from other approved eye drops - Management believes that the effectiveness of LNZ100 will differentiate it from competitors, emphasizing the importance of initial patient experience [96][97]

Financial Data and Key Metrics Changes - The company ended Q1 2025 with approximately $194.1 million in cash, cash equivalents, and marketable securities, which has been upwardly revised from over $170 million to over $185 million projected cash at PDUFA [26][27] - Total Q1 2025 operating expenses increased to $16.9 million, an 11% increase over Q4 2024, with a net cash burn of $15 million [27][28] - The net loss per share was $0.53 in Q1 2025, compared to $3.53 in Q1 2024, reflecting a significant improvement in financial performance [29] Business Line Data and Key Metrics Changes - The company is focused on the launch of LNZ100, a treatment for presbyopia, with a strong emphasis on commercial readiness and engagement with eye care professionals [5][6] - The unbranded campaign has reached over 12,000 eye care professionals (ECPs) and delivered more than 2 million online impressions [9][10] - The sales force is being expanded, with over 40% of the field sales team already hired, and 97% of new team members having prior eye care or pharmaceutical experience [18][19] Market Data and Key Metrics Changes - Presbyopia affects approximately 128 million Americans, presenting a substantial market opportunity for LNZ100 [8][14] - The initial launch of LNZ100 is expected to tap into a market that is significantly larger than those affected by other eye conditions [14] Company Strategy and Development Direction - The company aims to establish LNZ100 as a category-defining treatment for presbyopia, with a commercial strategy structured around enabling doctors to recommend the product, empowering patients to request it, and ensuring seamless access [10][22] - The company is preparing for a potential August 8 PDUFA date, with a focus on building brand awareness and a strong product access strategy [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver effective treatments for presbyopia, highlighting the strong engagement with the FDA and the positive feedback from eye care professionals [11][30] - The company is aware of potential economic challenges but believes that its product will be viewed as essential, potentially insulating it from significant downside risks during a recession [85][86] Other Important Information - The company has received definitive rulings confirming that LNZ100 will be duty-free, enhancing its competitive position [12] - The company has a strong patent estate, with seven granted patents and additional patents under review, ensuring robust protection for LNZ100 [79][80] Q&A Session Summary Question: Infrastructure for sample distribution post-launch - The company has contracted a sampling distributor and is coordinating systems to ensure seamless distribution of samples to ECPs immediately after approval [35] Question: Preparation for continued use and refills of LNZ100 - The sales team is undergoing training to ensure they can effectively communicate product benefits and drive patient adherence post-sampling [37][42] Question: Metrics to disclose for patient demand - The company plans to provide metrics on new script rates and refill rates, focusing on IQVIA data for tracking [39][40] Question: Sample distribution management - Samples will be managed through a vendor, with reps tracking distribution and ensuring accountability [47][50] Question: E-pharmacy partnership mechanics - The e-pharmacy will streamline the prescription process, allowing for easy patient access and auto-refill options [53][54] Question: Marketing plans and influencer engagement - The influencer campaign will begin in early 2026, after ensuring ECPs are well-informed about the product [60][62] Question: Additional patent protection for LNZ100 - The company has a strong patent estate with several patents under review, ensuring long-term protection for the product [79][80] Question: Impact of potential recession on consumer sentiment - Historical data suggests that the medical aesthetics category is somewhat insulated from recession risks, and the company is focused on major metropolitan markets [85][88] Question: Competition from alternative products - The company believes that the effectiveness of LNZ100 will differentiate it from competitors, emphasizing the importance of sampling [92][93]

Core Viewpoint - LENZ Therapeutics is progressing towards the potential launch of LNZ100, an aceclidine-based eye drop for presbyopia, with a PDUFA target action date set for August 8, 2025, and has reported a strong financial position to support its operations leading up to and post-launch [1][3][11]. Financial Highlights - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $194.1 million, with an anticipated cash balance exceeding $185.0 million by the PDUFA date [1][6][7]. - Research and Development (R&D) expenses decreased to $5.8 million for Q1 2025, down from $10.5 million in Q1 2024, primarily due to the completion of the Phase 3 CLARITY study [7][17]. - Selling, General and Administrative (SG&A) expenses increased to $11.1 million in Q1 2025 from $5.6 million in Q1 2024, driven by personnel-related costs and pre-commercial marketing expenses [8][17]. - The net loss for Q1 2025 was $14.6 million, or $0.53 per share, compared to a net loss of $16.6 million, or $3.53 per share, in the same period of 2024 [9][17]. Regulatory and Development Updates - The NDA for LNZ100 has been accepted by the FDA, with no significant review issues reported, and the review process remains on track [2][3]. - The FDA has confirmed that it will not hold an Advisory Committee Meeting regarding the NDA for LNZ100, indicating a smooth review process [3][4]. - The company received definitive rulings from the U.S. Department of Customs and Border Protection, confirming LNZ100 as duty-free and of U.S. origin [4]. Commercialization Efforts - The company is actively preparing for the U.S. commercial launch of LNZ100, with a full commercial and sales force infrastructure in place and plans to hire 88 sales representatives by July 1, 2025 [5][11]. - A successful Commercial Day event was held on April 15, 2025, where management shared updates on commercialization strategy and insights from key opinion leaders [5].

Company Overview - LENZ Therapeutics, Inc. is a pre-commercial biopharmaceutical company focused on developing and commercializing the first and only aceclidine-based eye drop to improve near vision in people with presbyopia [3] - The product candidate, LNZ100, is a preservative-free, single-use, once-daily eye drop containing aceclidine [3] - The company is headquartered in San Diego, California [3] Market Potential - Presbyopia affects an estimated 1.8 billion people globally and 128 million people in the United States [3] - LENZ Therapeutics aims to provide an ideal pharmaceutical solution for presbyopia that enhances vision for "all eyes, all day" [3] Regulatory Milestones - The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025, for LNZ100 [3] Upcoming Events - The company will host a webcast on May 7th, 2025, at 4:30 p.m. EDT to report its first quarter 2025 financial results and recent corporate highlights [1]

Financial Data and Key Metrics Changes - The company ended 2024 with approximately $209.1 million in cash, cash equivalents, and marketable securities, which is expected to fund operations until post-launch positive cash flow [27] - Total operating expenses for Q4 2024 were approximately $15.2 million, a decrease from $25 million in the same period in 2023, primarily due to the completion of the Phase three CLARITY study [28] - The net loss per share for Q4 2024 was $0.46, compared to a net loss per share of $12.04 in Q4 2023, reflecting a significant reduction in losses as the company transitioned to a pre-commercial stage [31] Business Line Data and Key Metrics Changes - Sales, general, and administrative expenses increased to $9.4 million in Q4 2024 from $5.5 million in Q4 2023, driven by an increase in commercial headcount and pre-launch activities [28] - Research and development expenses decreased to $5.9 million in Q4 2024 from $19.5 million in the same period last year, indicating a shift in focus towards commercial readiness [30] Market Data and Key Metrics Changes - The presbyopia treatment market is estimated to impact approximately 128 million people in the U.S., representing a significant opportunity for the company [17] - The commercial potential of LNZ100 is validated by Phase three CLARITY study results, with 90% of participants noticing vision improvement [19] Company Strategy and Development Direction - The company aims to emerge as a commercial entity in 2025, focusing on the potential approval and launch of LNZ100 [6] - Key areas of focus include regulatory progress, manufacturing readiness, medical affairs, intellectual property, and pre-launch commercial planning [9] - The company is preparing for a high-volume launch, with manufacturing operations already initiated for potential commercial products [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the FDA's review process, indicating no significant issues noted during the mid-cycle review [10] - The company anticipates a potential on-time approval in August 2025, followed by commercial launch activities in Q4 2025 [10] - Management emphasized the importance of a well-prepared sales force and marketing strategy to ensure successful product adoption [21] Other Important Information - The company has strengthened its patent portfolio with seven granted patents in the U.S. and additional patents under review, aiming for extended protection for LNZ100 [12] - The sales force hiring is in its final stages, with a focus on attracting candidates with significant eye care experience [14] Q&A Session Summary Question: How is the sales force targeting the 15,000 ECPs? - The sales force is focusing on high prescribers of existing treatments, representing over 85% of all beauty scripts, while broader awareness is driven through unbranded promotions [36] Question: What is the current awareness level of the "I'm selective" campaign? - The campaign has generated over 2 million digital impressions, significantly increasing awareness among targeted ECPs [66] Question: What factors contribute to the timing of product availability post-PDUFA? - The timeline is influenced by the need for final labeling discussions and packaging after FDA approval, with sales force training occurring beforehand [40] Question: How will sampling be utilized in the launch strategy? - The product is designed for effective sampling, allowing patients to experience the product before purchase, with a five-day sample pack being developed [46] Question: What is the competitive landscape for LNZ100 compared to other products? - The company views LNZ100 as a category of one, emphasizing its unique pupil-selective mechanism and superior efficacy compared to competitors [54] Question: How does the company plan to address potential economic sensitivity in demand? - The company targets a demographic less affected by economic downturns, projecting strong demand regardless of macroeconomic conditions [100]

LENZ Therapeutics (LENZ) Q4 2024 Earnings Call March 19, 2025 04:30 PM ET Company Participants Dan Chevallard - CFOEvert Schimmelpennink - President, CEO, Secretary & DirectorShawn Olsson - Chief Commercial OfficerYigal Nochomovitz - DirectorMarc Goodman - Senior MD - NeuroscienceDenis Reznik - Senior Equity Research Associate Conference Call Participants Joseph Catanzaro - Director & Senior Equity AnalystStacy Ku - AnalystJason Gerberry - AnalystLachlan Hanbury-Brown - Biotech Equity Research AnalystMatthe ...

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 ...

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 ...

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 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 Nu ...

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) (I.R.S. Employer Identification Number) 445 Marine View Ave., Ste. #320 Del Mar, ...