Executive Summary / Key Takeaways

• Category-Defining Potential: LENZ Therapeutics is on the cusp of transforming the presbyopia market with VIZZ (formerly LNZ100), an aceclidine-based, once-daily eye drop, recently approved by the FDA. Its pupil-selective mechanism and robust clinical data (rapid onset, up to 10-hour duration, high responder rates) directly address the shortcomings of prior pilocarpine-based treatments, positioning VIZZ as a potential "category of one."
• Strategic Commercial Launch: With FDA approval secured on July 31, 2025, LENZ is executing a meticulously planned U.S. commercial launch, targeting product availability in Q4 2025. This includes a fully staffed sales force, extensive rep-delivered sampling, and a phased direct-to-consumer (DTC) campaign set for early 2026, leveraging e-pharmacy partnerships for seamless patient access and refills.
• Strong Financial Foundation: The company maintains a robust liquidity position, with $209.6 million in cash, cash equivalents, and marketable securities as of June 30, 2025. Management projects this capital will fund operations to positive operating cash flow post-launch, supported by recent financing activities and a disciplined approach to SG&A spend.
• Global Expansion & IP Moat: LENZ is strategically expanding VIZZ's reach internationally through licensing agreements, including recent deals for Greater China, Southeast Asia, and Canada, unlocking significant ex-U.S. market opportunities. A strong intellectual property portfolio, with patents extending to at least 2044 and expected NCE exclusivity, provides a durable competitive moat.
• Significant Market Opportunity: Presbyopia affects an estimated 128 million Americans, representing a $3 billion-plus market opportunity. LENZ's focus on a consumer-driven, quality-of-life product, coupled with its differentiated profile, aims to capture a substantial share by converting patients currently relying on reading glasses or dissatisfied with existing solutions.

The Unmet Need in Near Vision: A Vast Market Awaits Innovation

Presbyopia, the inevitable age-related loss of near vision, impacts nearly all individuals over the age of 45. This pervasive condition affects an estimated 128 million Americans, a population incidence nearly four times larger than dry eye and six times larger than Demodex blepharitis. The sheer scale of this market, estimated to exceed $3 billion, underscores a significant unmet need, particularly as many presbyopes currently self-manage with over-the-counter reading glasses or are dissatisfied with existing prescription options. LENZ Therapeutics is poised to address this challenge with VIZZ, its recently FDA-approved, aceclidine-based eye drop, aiming to redefine the standard of care for blurry near vision.

The company's journey to this pivotal moment has been marked by strategic evolution and disciplined execution. Originating as Presbyopia Therapies, LLC in 2013, the company underwent a reverse merger with Graphite Bio, Inc. in March 2024, becoming LENZ Therapeutics, Inc. This transaction not only transformed LENZ into a publicly traded entity but also significantly bolstered its financial foundation with approximately $112.6 million in net cash. This strategic move signaled a clear transition from a late-stage clinical development company to a pre-commercial entity, fully focused on the impending launch of VIZZ.

VIZZ: A Technological Leap in Presbyopia Treatment

At the core of LENZ's investment thesis is VIZZ's differentiated technology. VIZZ is a preservative-free, single-use, once-daily eye drop containing aceclidine, a predominantly pupil-selective miotic. Unlike other miotics that can cause undesirable side effects by stimulating the ciliary muscle, aceclidine primarily interacts with the iris. This unique mechanism induces a "pinhole effect" by contracting the iris sphincter muscle, achieving a sub-2mm pupil that extends the depth of focus to significantly improve near vision without causing a myopic shift or blurry distance vision. This technological distinction is critical, as it directly addresses the limitations and patient dissatisfaction experienced with previous treatments.

The tangible benefits of VIZZ's technology were robustly demonstrated in its Phase 3 CLARITY trials, which included CLARITY 1, CLARITY 2, and the 6-month safety study CLARITY 3. The capstone data highlighted a compelling product profile:

• Rapid Onset: VIZZ achieved a rapid onset of effect, with 71% of participants in CLARITY 2 gaining three lines or more of near vision improvement at just 30 minutes on the very first day of use. An impressive 91% achieved at least two lines of improvement at this early time point.
• Sustained Duration: At the primary endpoint of 3 hours, 71% of participants in CLARITY 2 still showed three lines or more of near vision improvement. Crucially, this effect was maintained throughout the full workday, with 40% of participants achieving three lines or more and 69% achieving two lines or more of near vision improvement at 10 hours, the last time point measured in the efficacy trials.
• Universal Response & Broad Applicability: The trials showed a near-universal response, with 95% of participants achieving at least two lines of near vision improvement, considered clinically meaningful for most presbyopes. The product also demonstrated efficacy across a broad age and refractive range, with data indicating that the worse a patient's presbyopia, the more lines of vision improvement they gained.
• Favorable Safety Profile: VIZZ was well-tolerated, with no serious treatment-related adverse events observed across over 30,000 patient treatment days. The most common adverse reactions were mild, transient, and self-resolving, including instillation site irritation (20%), dim vision (16%), and headache (13%).

The "so what" for investors is clear: VIZZ's differentiated mechanism and superior clinical profile provide a strong competitive moat. By offering a once-daily, rapid-onset, and long-duration solution that avoids the common side effects of pilocarpine, LENZ aims to capture significant market share and drive sustained patient adherence. This technological edge is foundational to the company's strategy for achieving its $3 billion-plus market potential.

Competitive Landscape: Breaking the Mold

The presbyopia market, while vast, has seen its challenges. The first FDA-approved pharmacologic option, AbbVie 's Vuity (pilocarpine-based), initially saw strong consumer desire with up to 6,000 new scripts per week. However, long-term usage lagged, with ECPs reporting that for most patients, Vuity "did not work or did not work long enough," with 66% of patients not seeing duration past four hours. A second pilocarpine-based product, Qlosi (Orasis), launched in April 2025, but its clinical profile appears similar to Vuity's.

LENZ directly addresses these shortcomings. Management emphasizes that VIZZ is "not pilocarpine based," which is a "key factor" for ECPs. The company believes VIZZ's ability to achieve a sub-2mm pupil size and provide seamless near vision for the full workday positions it as a "category of one." While larger pharmaceutical companies like AbbVie and Johnson & Johnson possess significantly greater financial resources, established distribution networks, and diversified portfolios (AbbVie (ABBV)'s TTM Net Profit Margin: 0.08, Johnson & Johnson (JNJ)'s TTM Net Profit Margin: 0.16, compared to LENZ's TTM Net Loss), LENZ's focused innovation and differentiated technology provide a crucial competitive advantage. Smaller, specialized players like Ocuphire Pharma (OCUP) also compete, but LENZ's unique aceclidine profile aims to offer superior performance.

LENZ's commercial strategy is designed to overcome past market failures and capitalize on its differentiated product. It targets approximately 15,000 high-decile ECPs who historically represented over 85% of Vuity prescriptions. The company's market research indicates strong ECP interest, with over 80% likely to prescribe and sample VIZZ if approved. The strategy is built on three pillars: enabling doctors to recommend, empowering patients to request by name, and ensuring seamless access.

Operational Readiness and Strategic Initiatives

LENZ has meticulously prepared for the U.S. commercial launch of VIZZ. The New Drug Application (NDA) for LNZ100 was submitted to the FDA in August 2024, accepted in October 2024, and received a PDUFA target action date of August 8, 2025. The FDA's decision not to hold an advisory committee meeting and the ongoing, uninterrupted clinical trial site inspections underscore the positive regulatory trajectory. On July 31, 2025, LENZ announced the US FDA approval of VIZZ, a transformative milestone.

Commercial readiness is in full swing. The sales force build-out is nearing completion, with over 40% of the field sales team having accepted offers by Q1 2025, and the full team targeted to be in place by July 1, 2025. These hires bring significant eye care and pharma experience, averaging over 10 years of sales experience. Manufacturing of commercial product and sample inventory commenced in February 2025, with final packaging to occur post-approval, ensuring product availability in Q4 2025.

A key element of the commercial strategy is extensive sampling. Five-day sample packs will be rep-delivered to ECPs, leveraging VIZZ's "immediate response and wow effect" (95% of patients showed at least two lines of improvement on hour one, day one) to drive trial and conversion. E-pharmacy partnerships are being established to provide convenient home delivery and auto-refill options, creating a "closed system" for adherence. Direct-to-consumer (DTC) advertising, featuring influencers and celebrities, is strategically planned for early 2026, after ECPs are well-educated and comfortable with the product, focusing on platforms like Facebook, Instagram, YouTube, and Pinterest.

Beyond the U.S., LENZ is pursuing a global commercialization strategy through out-licensing. The company has already secured agreements for Greater China (with CORXEL Pharmaceuticals, which submitted its NDA in July 2025), Southeast Asia (with Lotus Pharmaceutical Co., LTD., yielding a $5 million upfront payment in May 2025), and Canada (with Laboratoires Théa, signed July 7, 2025, with potential for up to $70 million in milestones). These partnerships unlock significant ex-U.S. market opportunities and provide additional revenue streams.

LENZ's intellectual property portfolio provides a robust competitive moat. The company holds seven granted U.S. patents extending to 2039, with an additional 10 patents under review aiming to extend protection to at least 2044. VIZZ is expected to be eligible for five years of New Chemical Entity (NCE) exclusivity in the U.S. Furthermore, the self-pay nature of the product is anticipated to prevent traditional generic switches, ensuring a strong and long-lasting product lifecycle. U.S. Customs and Border Protection rulings have also confirmed VIZZ's "made in the USA" designation and duty-free status, mitigating potential tariff risks.

Financial Performance and Liquidity

As a pre-commercial biopharmaceutical company, LENZ has incurred net losses since its inception, with an accumulated deficit of $174.5 million as of June 30, 2025. The net loss for the three months ended June 30, 2025, was $14.91 million. The company's revenue primarily stems from licensing agreements, with $5 million recognized in the three and six months ended June 30, 2025, from the Lotus License. Product sales revenue is not expected until regulatory approval and commercial launch.

Operating expenses reflect the company's transition to commercial readiness. Research and Development (R&D) expenses for the three months ended June 30, 2025, increased to $9.061 million from $6.945 million in the prior year, driven by a ramp-up in pre-approval manufacturing and CMC activities ($2.5 million increase). However, for the six months ended June 30, 2025, R&D decreased to $14.879 million from $17.482 million in the prior year, primarily due to the substantial completion of Phase 3 CLARITY trials. Management expects R&D costs to continue decreasing in 2025 compared to 2024.

Selling, General and Administrative (SG&A) expenses are on a clear upward trajectory, reflecting the commercial build-out. SG&A increased to $12.796 million for the three months ended June 30, 2025, from $7.407 million in the prior year, primarily due to a $3.9 million increase in employee salaries (including sales specialists) and a $1.4 million increase in pre-commercial marketing and sales infrastructure. This trend is expected to continue as the company scales its commercial team.

Despite these expenses, LENZ maintains a robust liquidity position. As of June 30, 2025, the company held $209.6 million in cash, cash equivalents, and marketable securities. This figure was bolstered by $26.1 million in net proceeds from at-the-market (ATM) offerings during the three and six months ended June 30, 2025, with $123.5 million of ATM capacity remaining. Following a block trade subsequent to Q1 2025, projected cash at PDUFA was revised upward to over $185 million from over $170 million. Management confidently states that existing capital is "anticipated to fund the company's cash runway to post-launch positive operating cash flow," a critical assumption for investors.

Risks and Outlook

While the outlook for LENZ is highly promising, investors should consider several key risks. The company's business is currently entirely dependent on the successful commercialization of VIZZ, with no other product candidates in the immediate pipeline. Market acceptance by ECPs and patients remains crucial, particularly given the mixed reception of prior presbyopia eye drops. Although LENZ's differentiated profile aims to mitigate this, the shift from self-managed reading glasses to a prescription eye drop requires significant patient and physician education. Reliance on third parties for manufacturing and clinical trials also introduces supply chain and regulatory compliance risks.

Furthermore, the broader regulatory and economic landscape presents potential challenges. Changes in FDA policies, such as the U.S. Supreme Court's overruling of the Chevron doctrine, could lead to increased litigation and potential disruptions in regulatory processes. Government initiatives aimed at controlling prescription drug prices could impact VIZZ's pricing strategy, although its out-of-pocket, cash-pay market positioning may offer some insulation. While management believes the medical aesthetics category (a proxy for VIZZ's consumer-driven nature) is relatively insulated from recessions, a severe economic downturn could still affect discretionary spending.

Despite these risks, LENZ's strategic positioning, robust clinical data, and meticulous commercial planning paint a compelling picture. The company's focus on a truly differentiated product, combined with a strong financial runway and a disciplined commercial build-out, positions it for significant growth. The recent FDA approval of VIZZ and the ongoing international licensing efforts further de-risk the investment thesis and expand the total addressable market.

Conclusion

LENZ Therapeutics stands at a pivotal juncture, transitioning from a clinical-stage entity to a commercial biopharmaceutical company with the FDA approval of VIZZ. The core investment thesis is firmly rooted in VIZZ's superior aceclidine-based technology, which offers a compelling solution to the widespread and underserved market of presbyopia. By delivering rapid, long-lasting, and well-tolerated near vision improvement, VIZZ is poised to overcome the limitations of previous market entrants and establish itself as a leading therapeutic option.

The company's strategic commercialization plan, backed by a strong financial foundation and a seasoned team, is designed for a successful U.S. launch in Q4 2025, with a phased marketing approach and robust sampling strategy. Coupled with expanding international partnerships and a fortified intellectual property portfolio, LENZ is building a durable competitive advantage. While challenges inherent in commercialization and a dynamic regulatory environment persist, LENZ's technological leadership and focused execution suggest a clear path to capturing a significant share of the multi-billion dollar presbyopia market, making it a compelling consideration for discerning investors.