Summary of the Conference Call Company and Industry - The conference call discusses **LNZ100**, a treatment for **presbyopia**, a condition affecting near vision, developed by a **biotech company**. The FDA action date for LNZ100 is set for **August 8** of the current year, with a planned launch in **Q4**. Core Points and Arguments - **FDA Approval Confidence**: The company expresses strong confidence in the FDA approval timeline, stating that interactions with the FDA are frequent and productive, with the review team fully in place [3][4][6]. - **Commercial Readiness**: The company is actively preparing for the product launch, including hiring sales representatives and producing commercial-scale product batches. Final packaging awaits FDA approval [5][12][15]. - **Market Dynamics**: The presbyopia market is described as **promotion-sensitive**, with a significant number of potential patients (approximately **40 million**) presenting themselves to optometrists monthly. The company plans to implement direct-to-consumer (DTC) marketing strategies to double patient engagement [30][32][34]. - **Product Differentiation**: LNZ100 is positioned as a superior product compared to competitors like **Vuity**, with claims of better efficacy and longer duration of effect. The company emphasizes its unique mechanism of action that avoids negative impacts on distance vision [24][29][75]. - **Pricing Strategy**: The anticipated price for LNZ100 is around **$80 per month**, similar to other cash-pay products, which allows for flexible promotional strategies [37][70]. - **Long-term Market Potential**: The total addressable market (TAM) for LNZ100 is estimated at **$3 billion** in the U.S. alone, with a focus on targeting specific patient segments, including contact lens wearers and those who have undergone LASIK [42][66]. - **Intellectual Property**: The company holds a robust patent portfolio with protections extending to **2034** and beyond, ensuring a long product lifecycle without traditional generic competition [76][78]. Other Important Content - **Sales Strategy**: The sales force will primarily target optometrists (80%) rather than ophthalmologists, which is a shift from competitors' strategies. The company plans to leverage a strong sales team with significant eye care experience [58][85]. - **Patient Engagement**: The company has already engaged with optometrists and patients in clinical trials, generating positive testimonials that are expected to drive word-of-mouth marketing [39][41]. - **Economic Resilience**: The company believes it will be insulated from economic downturns, as consumers prioritize products that enhance their quality of life, similar to contact lenses and aesthetic treatments [70][72]. - **Future R&D Focus**: While the immediate focus is on the launch of LNZ100, the company envisions expanding its portfolio through mergers and acquisitions in the ophthalmology space once it achieves cash flow breakeven [82]. This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic approach to launching LNZ100 and its positioning within the presbyopia treatment market.

Core Points - LENZ Therapeutics and Lotus Pharmaceutical have entered into an exclusive licensing and commercialization agreement for LNZ100, aimed at treating presbyopia in South Korea and select Southeast Asian countries [1][2] - The agreement includes up to $125 million in upfront and milestone payments to LENZ, along with tiered, double-digit royalties on future net sales [2] - Lotus will have exclusive rights for the development, manufacturing, registration, and commercialization of LNZ100 in the specified regions [2] Company Overview - LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on developing the first aceclidine-based eye drop for presbyopia, a condition affecting approximately 1.8 billion people globally [4] - LNZ100 is a preservative-free, single-use, once-daily eye drop that has undergone a Phase 3 study for registration [4] - The FDA has set a target action date of August 8, 2025, for LNZ100's New Drug Application (NDA) [4] Lotus Pharmaceutical - Founded in 1966, Lotus is an international pharmaceutical company with a strong focus on both novel and generic pharmaceuticals [5] - The company has a robust R&D and manufacturing platform in Asia, certified by major regulatory authorities including the US FDA and EU EMA [5] - Lotus is actively developing over 100 pharmaceutical projects and has a diverse portfolio that includes oncology, complex generics, and biosimilars [6]

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]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q _________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number 001-40532 _________________________ LENZ THERAPEUTICS, INC. (Exact n ...

Exhibit 99.1 LENZ Therapeutics Reports First Quarter 2025 Financial Results and Recent Corporate Highlights New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025 hiring actively underway for 88 sales representatives, targeted for completion by July 1, 2025. A replay of the Commercial Day presentations is available in the Events section of the Investor Relations page on the LENZ Therapeutics website at www.LENZ-tx.com. Cash, cash equivalents ...

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 aimed at improving near vision in individuals with presbyopia [3] - The product candidate, LNZ100, is a preservative-free, single-use, once-daily eye drop containing aceclidine [3] - Presbyopia affects an estimated 1.8 billion people globally and 128 million people in the United States [3] Upcoming Events - Company management will participate in a fireside chat and one-on-one meetings at the BofA Securities 2025 Health Care Conference from May 13-15, 2025, in Las Vegas, NV [1] - The presentation is scheduled for May 13, 2025, at 9:20 am PDT / 12:20 pm EDT [2] - A live audio webcast of the conference presentation will be available on the LENZ Therapeutics website, with a replay accessible for 12 months post-event [2] 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] - The company is committed to commercializing an ideal pharmaceutical solution for presbyopia that enhances vision for "all eyes, all day" [3]

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]

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