Summary of LENS Therapeutics Corporate Update Conference Call Company Overview - **Company**: LENS Therapeutics - **Product**: LNZ100, now known as VIS, an FDA-approved eye drop for presbyopia treatment Key Industry Insights - **Market Size**: Presbyopia affects approximately 128 million adults in the U.S., significantly larger than other eye conditions like dry eye and glaucoma combined [22][23] - **Unmet Need**: Current treatments (reading glasses, progressive lenses) are seen as inconvenient, highlighting the demand for effective alternatives [6][22] Core Product Insights - **FDA Approval**: LNZ100 is the first and only ecyclin-based eye drop for presbyopia, with clinically proven near vision improvement lasting up to 10 hours [4][15] - **Mechanism of Action**: The product is a predominantly pupil-selective meiotic that interacts with the iris with minimal ciliary muscle stimulation, providing a unique solution for presbyopia [7][16] - **Clinical Trials**: Approval based on three phase three trials demonstrating significant near vision improvement within 30 minutes of dosing [14][15] Commercial Strategy - **Sales Force**: An 88-member sales team has been fully trained and deployed, targeting 15,000 eye care professionals [8][10] - **Marketing Campaigns**: Direct-to-eye care professional marketing campaign initiated, with a consumer campaign expected to launch in 2026 [11][28] - **Product Availability**: Samples expected in October, with full commercial availability by mid-Q4 [12][29] - **Pricing**: $79 for a box of 25 vials, with a three-month supply available for $198 [12][29] Financial Position - **Cash Reserves**: Over $205 million in cash available to support commercial operations, significantly higher than previous guidance [31][32] - **Commercial Spend**: Estimated annual commercial spend of $80 to $100 million starting in 2026 [33][88] Launch Metrics and Expectations - **Initial Focus**: Early metrics will include unique eye care professionals prescribing the product and total new patient starts [34] - **Sampling Strategy**: Emphasis on ensuring samples are well-stocked and utilized in doctors' offices to drive early adoption [78] Additional Considerations - **Consumer Education**: The brand "VIS" is designed to resonate with consumers, being one of only nine single-syllable brand names approved by the FDA in the past 15 years [11][27] - **Safety Profile**: The product has shown no serious treatment-related adverse events across over 30,000 treatment days, with mild and transient reactions [16][46] Potential Risks and Challenges - **Market Competition**: While LENS acknowledges competition, the focus remains on the unique benefits of VIS compared to existing treatments [72][73] - **Consumer Adoption**: The timing of the direct-to-consumer campaign is strategically planned to ensure eye care professionals are prepared before consumer outreach begins [95] Conclusion LENS Therapeutics is poised for a significant market entry with VIS, addressing a substantial unmet need in presbyopia treatment. The company's robust commercial strategy, strong financial position, and innovative product profile position it well for future growth and success in the ophthalmic market.

PART I - FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) The company's pre-commercial financial statements show a $29.5 million net loss for the six months ended June 30, 2025, driven by R&D and SG&A, with strong liquidity and initial license revenue [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, the company reported total assets of $217.3 million, a slight increase from $215.3 million at December 31, 2024, with cash, cash equivalents, and marketable securities dominating the asset base Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $37,608 | $20,158 | | Marketable securities | $171,911 | $188,872 | | Total current assets | $213,602 | $211,917 | | Total assets | $217,332 | $215,304 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $10,398 | $10,406 | | Total liabilities | $10,967 | $11,220 | | Total stockholders' equity | $206,365 | $204,084 | | Total liabilities and stockholders' equity | $217,332 | $215,304 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20And%20Comprehensive%20Loss) For the six months ended June 30, 2025, the company reported its first license revenue of $5.0 million, with increased operating expenses leading to a net loss of $29.5 million Statement of Operations Highlights (in thousands, except per share data) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | License Revenue | $5,000 | $0 | | Research and development | $14,879 | $17,482 | | Selling, general and administrative | $23,909 | $12,958 | | Loss from operations | ($33,788) | ($30,440) | | Net loss | ($29,531) | ($26,902) | | Net loss per share, basic and diluted | ($1.06) | ($1.77) | - The company recognized **$5.0 million in license revenue** in the second quarter and first half of 2025, a new development compared to zero revenue in the prior year periods[21](index=21&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20Preferred%20and%20Common%20Stock%20and%20Stockholders'%20Equity) Stockholders' equity increased to $206.4 million by June 30, 2025, primarily due to $26.1 million from an ATM offering, offset by net loss, reflecting significant recapitalization from the 2024 reverse merger - In the second quarter of 2025, the company issued **920,500 shares** through its at-the-market (ATM) offering, generating net proceeds of **$26.1 million**[24](index=24&type=chunk) - The accumulated deficit grew to **$174.5 million** as of June 30, 2025, from **$145.0 million** at the end of 2024, reflecting ongoing net losses[24](index=24&type=chunk) - The 2024 statement shows the significant recapitalization from the merger, including the conversion of preferred stock and issuance of common stock to Graphite stockholders and private placement investors[27](index=27&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operations was $27.6 million, with investing activities providing $18.5 million and financing activities providing $26.5 million, resulting in a $17.5 million net cash increase Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($27,557) | ($39,732) | | Net cash provided by (used in) investing activities | $18,475 | ($80,390) | | Net cash provided by financing activities | $26,532 | $169,131 | | **Net increase in cash, cash equivalents, and restricted cash** | **$17,450** | **$49,009** | - Financing activities in H1 2025 were driven by **$26.1 million** in net proceeds from the ATM offering, whereas H1 2024 was dominated by **$117.8 million** in cash acquired from the merger and **$49.8 million** from a PIPE financing[30](index=30&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, liquidity, license agreements, and equity transactions, including the March 2024 reverse merger and a new ATM program, confirming sufficient cash for at least 12 months of operations - The company believes its existing cash, cash equivalents, and marketable securities of **$209.6 million** as of June 30, 2025, are sufficient to support operations for at least the next 12 months[36](index=36&type=chunk) - The March 21, 2024 merger with Graphite Bio was accounted for as a reverse recapitalization, with LENZ OpCo as the accounting acquirer, bringing in **$112.6 million** of net cash and cash equivalents[34](index=34&type=chunk)[81](index=81&type=chunk)[85](index=85&type=chunk) - In May 2025, the company entered into a license agreement with Lotus Pharmaceutical, receiving a **$5.0 million** upfront payment, which was recognized as revenue in Q2 2025[119](index=119&type=chunk)[121](index=121&type=chunk) - A subsequent event in July 2025 was a license and commercialization agreement with Laboratoires Théa for Canada, with eligibility for up to **$70.0 million** in various payments and royalties[124](index=124&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses LNZ100's progress, including positive Phase 3 data and NDA submission, affirming sufficient cash to fund operations to positive cash flow post-launch, with increased SG&A for pre-commercial activities and new license revenue [Overview and Recent Developments](index=27&type=section&id=Overview%20and%20Recent%20Developments) LENZ, a pre-commercial biopharmaceutical company, focuses on LNZ100 for presbyopia, with an FDA PDUFA date of August 8, 2025, and recent developments including robust Phase 3 data, sales force hiring, and new licensing agreements - The company's lead product candidate, LNZ100, is under FDA review with a PDUFA target action date of **August 8, 2025**, for the treatment of presbyopia[132](index=132&type=chunk) - Phase 3 CLARITY study data for LNZ100 showed rapid onset (**71% achieved ≥3 lines improvement at 30 mins**) and long duration (**40% achieved ≥3 lines at 10 hours**)[131](index=131&type=chunk)[136](index=136&type=chunk) - In Q2 2025, the company hired **eighty-eight sales specialists** to target approximately **15,000 eye care professionals** for the potential commercial launch of LNZ100[144](index=144&type=chunk) - The company recently executed two new licensing agreements for LNZ100, potentially bringing in up to **$195 million** in upfront, regulatory, and commercial milestone payments plus royalties[145](index=145&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) The company's operating results reflect its transition towards commercialization, with $5.0 million in license revenue, increased R&D due to pre-approval manufacturing, and significantly higher SG&A expenses driven by sales force hiring and pre-commercial marketing Comparison of Operating Results (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | License revenue | $5,000 | $0 | $5,000 | $0 | | Research and development | $9,061 | $6,945 | $14,879 | $17,482 | | Selling, general and administrative | $12,796 | $7,407 | $23,909 | $12,958 | - The increase in SG&A expenses was primarily driven by a **$3.9 million increase** in employee salaries and related costs from hiring eighty-eight sales specialists and a **$1.4 million increase** in pre-commercial marketing and sales infrastructure expenses in Q2 2025[158](index=158&type=chunk) - The decrease in R&D expenses for the six-month period was mainly due to a **$6.1 million reduction** in clinical research costs following the substantial completion of the Phase 3 CLARITY trials in March 2024[164](index=164&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $209.6 million in cash, cash equivalents, and marketable securities, which management believes are sufficient to support the commercial launch of LNZ100 and fund the company to positive operating cash flow - The company had **$209.6 million** in cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2025[167](index=167&type=chunk) - Management believes existing cash will fund the company to **positive operating cash flow** subsequent to the commercial launch of LNZ100, if approved[170](index=170&type=chunk) - During Q2 2025, the company sold **920,500 shares** of common stock under its ATM Sales Agreement, resulting in net proceeds of **$26.1 million**, with **$123.5 million** of capacity remaining under the agreement[169](index=169&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($27,557) | ($39,732) | | Net cash provided by (used in) investing activities | $18,475 | ($80,390) | | Net cash provided by financing activities | $26,532 | $169,131 | [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company as defined by the SEC and is therefore not required to provide the information for this item - As a smaller reporting company, LENZ Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[195](index=195&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025[196](index=196&type=chunk) - No material changes to the company's internal control over financial reporting were identified during the second quarter of 2025[197](index=197&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company states it is not currently a party to any legal proceedings that would have a material adverse effect on its business, financial condition, or results of operations - As of the report date, the company is not involved in any material legal proceedings[200](index=200&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) The company outlines numerous risks, emphasizing its pre-commercial status and complete dependence on the successful commercialization of its sole product candidate, LNZ100, alongside market acceptance, competition, third-party reliance, and intellectual property concerns - The company's business depends entirely on the successful development and commercialization of its single lead product candidate, LNZ100[202](index=202&type=chunk)[207](index=207&type=chunk) - Even if approved, LNZ100 may fail to gain market acceptance from eye care professionals and patients, and faces competition from established treatments like glasses and other pharmaceuticals such as Vuity and Qlosi[202](index=202&type=chunk)[223](index=223&type=chunk)[224](index=224&type=chunk) - The company relies on third-party contract manufacturers for its product supply and CROs for clinical trials, which introduces risks related to supply sufficiency, quality control (cGMP compliance), and trial execution[205](index=205&type=chunk)[375](index=375&type=chunk)[379](index=379&type=chunk) - The company faces significant intellectual property risks, including the ability to obtain and maintain patent protection, the potential for infringement claims from third parties, and the need to protect trade secrets[205](index=205&type=chunk)[251](index=251&type=chunk)[277](index=277&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=87&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the quarter ended June 30, 2025, that were not already disclosed in previous Form 8-K filings - No unregistered sales of equity securities occurred in Q2 2025 that had not been previously reported[439](index=439&type=chunk) [Defaults Upon Senior Securities](index=87&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that there have been no defaults upon senior securities - None[440](index=440&type=chunk) [Mine Safety Disclosures](index=87&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[441](index=441&type=chunk) [Other Information](index=87&type=section&id=Item%205.%20Other%20Information) The company discloses that none of its directors or officers adopted or terminated a Rule 10b5-1 trading plan or a non-Rule 10b5-1 trading arrangement during the last fiscal quarter - During the last fiscal quarter, no directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement[442](index=442&type=chunk) [Exhibits](index=87&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the company's amended certificate of incorporation and bylaws, the sales agreement for the ATM offering, and certifications by the CEO and CFO - The report includes a list of filed exhibits, such as corporate governance documents, material contracts (e.g., Sales Agreement with TD Securities), and required officer certifications[444](index=444&type=chunk)

Corporate Highlights and Business Updates LENZ Therapeutics is advancing LNZ100's FDA review towards an August 8, 2025 PDUFA date, while preparing for U.S. launch and expanding globally through licensing agreements worth over $195 million [LNZ100 U.S. Regulatory and Commercial Readiness](index=1&type=section&id=LNZ100%20U.S.%20Regulatory%20and%20Commercial%20Readiness) The LNZ100 NDA is on track for an August 8, 2025 PDUFA date with no significant FDA issues, and an 88-member sales force is ready for immediate U.S. launch upon approval - The FDA has set a PDUFA target action date of **August 8, 2025**, for LNZ100 and does not plan to hold an Advisory Committee Meeting[1](index=1&type=chunk)[3](index=3&type=chunk) - The late-cycle review meeting in May 2025 concluded with no significant review issues noted[3](index=3&type=chunk) - A full **88-member** sales force has been hired and trained, prepared to initiate sales and marketing activities immediately upon potential U.S. approval[1](index=1&type=chunk)[4](index=4&type=chunk) - If approved, LNZ100 would be the first aceclidine-based eye drop for presbyopia in the United States and globally[3](index=3&type=chunk) [International Expansion and Licensing Agreements](index=1&type=section&id=International%20Expansion%20and%20Licensing%20Agreements) LENZ secured international LNZ100 partnerships with Lotus Pharmaceutical, Laboratoires Théa, and CORXEL, totaling over $195 million in potential milestones and royalties, with CORXEL submitting an NDA in China - Executed multiple international license agreements for LNZ100, securing rights to over **$195 million** in combined upfront and milestone payments, plus double-digit royalties on net sales[1](index=1&type=chunk)[5](index=5&type=chunk) International Licensing Agreements | Partner | Region(s) | Potential Payments (USD) | Royalties (%) | | :--- | :--- | :--- | :--- | | Lotus Pharmaceutical | South Korea & Southeast Asia | Up to $125 million | Tiered, double-digit | | Laboratoires Théa | Canada | Over $70 million | Tiered, double-digit | | CORXEL Pharmaceuticals | Greater China | Up to $95 million | Tiered, mid single-digit to low double-digit | - Partner CORXEL submitted the New Drug Application (NDA) for LNZ100 in China, achieving the first milestone under their licensing agreement[8](index=8&type=chunk) Q2 2025 Financial Results LENZ Therapeutics reported a Q2 2025 net loss of **$14.9 million**, primarily due to increased SG&A for LNZ100 pre-commercialization, while maintaining a strong **$209.6 million** cash position expected to fund post-launch operations [Financial Performance Analysis](index=2&type=section&id=Financial%20Performance%20Analysis) Q2 2025 saw R&D expenses rise to **$9.1 million** and SG&A to **$12.8 million**, leading to a net loss of **$14.9 million** ($0.53/share) compared to **$10.3 million** ($0.40/share) in Q2 2024 Q2 Financial Performance Summary | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | | :--- | :--- | :--- | | R&D Expenses | $9.1M | $6.9M | | SG&A Expenses | $12.8M | $7.4M | | Net Loss | $14.9M | $10.3M | | Net Loss per Share | $0.53 | $0.40 | - The increase in Q2 R&D expenses was driven by pre-approval and contingent product manufacturing activities for LNZ100[10](index=10&type=chunk) - The increase in SG&A expenses was primarily due to personnel costs from a growth in headcount, including **88 sales specialists**, and pre-commercial marketing expenses[11](index=11&type=chunk) [Financial Position](index=2&type=section&id=Financial%20Position) As of June 30, 2025, the company held **$209.6 million** in cash, cash equivalents, and marketable securities, expected to fund operations to post-launch positive cash flow - Cash, cash equivalents, and marketable securities totaled **$209.6 million** as of June 30, 2025[1](index=1&type=chunk)[9](index=9&type=chunk) - The company anticipates its cash balance will be sufficient to fund operations to post-launch positive cash flow[9](index=9&type=chunk) - The company expects to have a cash balance exceeding **$205.0 million** as of its PDUFA target action date on **August 8, 2025**[9](index=9&type=chunk) Financial Statements Unaudited financial statements for June 30, 2025, show total assets of **$217.3 million**, **$5.0 million** in license revenue, and net losses of **$14.9 million** (quarter) and **$29.5 million** (six months) [Selected Balance Sheet Highlights](index=5&type=section&id=Selected%20Balance%20Sheet%20Highlights) As of June 30, 2025, LENZ reported total assets of **$217.3 million** (vs. **$215.3 million** at year-end 2024), **$206.4 million** in stockholders' equity, with **$37.6 million** cash and **$171.9 million** marketable securities Selected Balance Sheet Highlights | Account (in thousands) | June 30, 2025 (unaudited, USD thousands) | December 31, 2024 (USD thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $37,608 | $20,158 | | Marketable securities | $171,911 | $188,872 | | **Total assets** | **$217,332** | **$215,304** | | Total liabilities | $10,967 | $11,220 | | **Total stockholders' equity** | **$206,365** | **$204,084** | [Condensed Consolidated Statement of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2025, the company reported **$5.0 million** in license revenue, **$21.9 million** in operating expenses, a **$16.9 million** loss from operations, and a **$14.9 million** net loss, with a six-month net loss of **$29.5 million** Condensed Consolidated Statement of Operations and Comprehensive Loss | (in thousands, except per share data) | Three Months Ended June 30, 2025 (USD thousands) | Six Months Ended June 30, 2025 (USD thousands) | | :--- | :--- | :--- | | License revenue | $5,000 | $5,000 | | Total operating expenses | $21,857 | $38,788 | | Loss from operations | $(16,857) | $(33,788) | | **Net loss** | **$(14,912)** | **$(29,531)** | | Net loss per share, basic and diluted | $(0.53) | $(1.06) |

Company Overview - LENZ Therapeutics, Inc. currently holds a Momentum Style Score of A, indicating strong momentum characteristics [3] - The company has a Zacks Rank of 2 (Buy), suggesting a favorable outlook for investors [4] Performance Metrics - Over the past week, LENZ shares have increased by 6.64%, outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 2.16% [6] - In a longer time frame, LENZ's monthly price change is 13.09%, compared to the industry's 3.31% [6] - Over the past quarter, LENZ shares have surged by 26.99%, and over the last year, they have gained 49.13%, while the S&P 500 has only increased by 16.04% and 12.11%, respectively [7] Trading Volume - The average 20-day trading volume for LENZ is 330,002 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - In the past two months, one earnings estimate for LENZ has been revised upward, while none have been revised downward, leading to an increase in the consensus estimate from -$2.85 to -$2.81 [10] - For the next fiscal year, one estimate has also moved upwards with no downward revisions during the same period [10] Conclusion - Given the strong performance metrics and positive earnings outlook, LENZ Therapeutics, Inc. is positioned as a promising investment opportunity with a Momentum Score of A [12]

Group 1 - LENZ Therapeutics, Inc. (LENZ) shares have increased by 17% over the past four weeks, closing at $33.73, with a mean price target of $44.14 indicating a potential upside of 30.9% [1] - The average price targets from analysts range from a low of $36.00 to a high of $60.00, with a standard deviation of $8.63, suggesting variability in estimates [2] - Analysts show a consensus that LENZ will report better earnings than previously estimated, which is a positive indicator for potential stock upside [4][11] Group 2 - The Zacks Consensus Estimate for LENZ's current year earnings has increased by 1.5% over the last 30 days, with one estimate moving higher and no negative revisions [12] - LENZ holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating strong potential for near-term upside [13] - While the consensus price target may not be a reliable indicator of the extent of gains, it does suggest a positive direction for price movement [14]

LNZ100 Product & Clinical Trial Highlights - LNZ100 is positioned for leadership in the $3 billion+ presbyopia market with potential launch in Q4 2025[3,5] - Clinical trials showed 71% of participants achieved ≥3-line improvement at 3 hours and 40% at 10 hours[3] - 84% of participants achieved a 4-line gain at some point during the efficacy studies, and 52% achieved a 5-line gain[36] - 41% of participants achieved at least 1 line of distance vision improvement[44] Commercial Opportunity & Market Landscape - Phase 3 patient surveys indicate 75% interest for continued use of LNZ100[3] - ECPs see an average of 215 presbyopic patients per month, representing 61% of their total patient visits[52] - The presbyopia market impacts approximately 128 million people in the US[3,5] - At a conservative 6% adoption rate, the market represents a $3 billion+ opportunity[59] Financial Position & Exclusivity - The company ended Q1 2025 with $194.1 million in cash and anticipates >$190 million at PDUFA[3] - The company has broad IP portfolio and potential new chemical entity (NCE) status for market exclusivity[3]

Group 1 - LENZ Therapeutics, Inc. has a market capitalization of $825 million and holds $190 million in cash [1] - The company has a PDUFA date set for August 8, 2025, for its drug aceclidine (1.75%), which is aimed at treating presbyopia [1] - Presbyopia currently affects 128 million individuals in the U.S. [1]

Summary of the Conference Call Company Overview - The conference focused on LENS Therapeutics, discussing their upcoming regulatory update and product launch plans for LENS100, a treatment for presbyopia [1][2]. Regulatory Updates - The PDUFA date for LENS100 is set for August 8, with positive feedback from the FDA during a recent late cycle review [2][4]. - No major or minor observations were noted by the FDA, indicating a smooth regulatory path towards approval [3][4]. Product Differentiation - LENS100 is the only presbyopia treatment utilizing aceclidine, which effectively creates a small pinhole pupil below two millimeters, enhancing near vision without significant side effects [5][6][8]. - In clinical trials, 71% of participants experienced at least three lines of near vision improvement, significantly outperforming competitors like Vuity [10][12]. - The product's efficacy profile shows a sustained effect, with 40% of participants maintaining improvement at ten hours post-application, compared to only 10% for Vuity [10][12]. Market Potential - The presbyopia market is estimated to exceed $3 billion, with 128 million presbyopes in the U.S. and 4 million new cases annually [13][14]. - The company anticipates a 6% penetration rate among presbyopes, leading to approximately 8 million long-term users [16][20]. - The pricing strategy is expected to be around $79 per prescription, similar to Vuity, which had a successful launch with 150,000 scripts sold [19][20]. Commercial Strategy - A sales force of 88 representatives has been established, primarily targeting optometrists, as they account for 80% of script sales in the presbyopia market [22][24]. - The marketing strategy will focus on digital channels, with a budget of $75 to $80 million for direct-to-consumer (DTC) advertising in the first year [39][67]. - The company plans to sample the product heavily to ensure consumer experience and retention, aiming for a higher refill rate than competitors [49][51]. Financial Outlook - LENS Therapeutics is well-funded, with expectations of reaching cash flow positivity by the PDUFA date, bolstered by a strong balance sheet and non-dilutive cash from licensing deals [65][66]. - The projected commercial spend post-launch is approximately $100 million, with a focus on maintaining a lean operational structure [67][68]. Intellectual Property and Supply Chain - The product is protected by a robust IP portfolio, including five years of data exclusivity upon approval and multiple granted patents [61][62]. - The supply chain is designed to be efficient, with API production in the U.S. and fill-finish operations in Germany, ensuring a duty-free status [55][56]. Future Growth and Licensing - The company is exploring opportunities for expansion through mergers and acquisitions, aiming to build a broader portfolio around LENS100 [70][71]. - Licensing agreements are already in place for markets in China and Southeast Asia, with plans to expand into Europe and other regions through partnerships [73][74]. Conclusion - LENS Therapeutics is positioned for a successful product launch with a strong regulatory outlook, differentiated product offering, and a comprehensive commercial strategy aimed at capturing a significant share of the presbyopia market [1][20][70].

LNZ100 Product & Clinical Trial Highlights - LNZ100, an aceclidine eye drop, aims to provide seamless vision for the majority of 128 million US presbyopes, with a potential launch in Q4 2025[3],[5],[48] - Clinical trials showed 71% of participants achieved ≥3-line improvement at 0.5 hours and 40% at 10 hours[3] - 84% of participants achieved a 4-line gain at some point during the efficacy studies, and 52% achieved a 5-line gain[36] - 41% of participants achieved at least 1 line of distance vision improvement[44] Market Opportunity & Commercial Readiness - The presbyopia market is estimated to be a $3B+ market[3],[5],[59] - Phase 3 patient surveys indicated 75% interest for continued use of LNZ100[3],[49] - ECPs survey indicated that 61% (~215) of their ~350 monthly patients are presbyopic[51],[52] - At a conservative 6% adoption rate or ~8 million users and a 42% refill rate, LNZ100 has blockbuster potential[59] Financial Position & Exclusivity - The company ended Q1 2025 with $194.1M in cash and anticipates >$190M at PDUFA, with cash to positive cash flow[3] - The product has market exclusivity based on a broad IP portfolio and potential new chemical entity (NCE) status[3] - The company has 8 granted patents (Exp 2034-2044) and 7 patents under review (Exp 2034-2044) in the US[64]

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 several investor conferences, including: - William Blair 45 Annual Growth Stock Conference on June 3, 2025, in Chicago, IL, with a management presentation at 1:40pm EDT [1] - Jefferies Global Healthcare Conference on June 4-5, 2025, in New York City, NY, with a management presentation at 9:55am EDT [2] - Goldman Sachs 46 Annual Global Healthcare Conference on June 9, 2025, in Miami Beach, FL, featuring a fireside chat at 4:00pm EDT [2] - Live audio webcasts of the presentations will be available on the LENZ Therapeutics website, with replays accessible for 12 months following the events [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 effective pharmaceutical solution for presbyopia that enhances vision for "all eyes, all day" [3]