LENZ Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to Lens Therapeutics' first quarter 2024 financial results and business update. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the star 1. Thank you. I would now like to turn the conference over to Dan Chevalard. Please go ahead, sir.

Thank you. Good afternoon, everyone, and thank you for joining us today to discuss LENS' first quarter 2024 financial results and business updates. My name is Dan Chevalard, Chief Financial Officer of LENS Therapeutics. We are joined today by Abe Schimelpinnick, our President and Chief Executive Officer, who will provide our business update, as well as Dr. Mark Odrich, Chief Medical Officer, and Sean Olson, Chief Commercial Officer, both of whom will join us for Q&A. Before we begin, I would like to remind you that this call will contain forward-looking statements regarding LINDA's future expectations, plans, prospects, corporate strategy, cash runway projections, and performance which constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our filings with the FCC. In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. With that, I will now turn the call over to Ace.

Thank you, Dan, and thank you, everyone, for joining us today. Let me start by saying that the first quarter of 2024 and the weeks following have been transformative for Lens. In March, we completed our merger with GraphiteBio and a concurrent $53.5 million pipe financing. And as a result, we became a public company trading on NASDAQ under the ticker Lens. These transactions led us to be well capitalized with around $213 million of cash and cash equivalents at the end of the quarter on our balance sheet. Importantly, we anticipate this cash balance to be sufficient to fund our operations to post-launch positive operating cash flow. I want to acknowledge the hard work that went into this and thank the teams at both Lens and Graphite, as well as advisors on both sides that got us to this strong position. Only a few weeks after our public debut, we announced our positive Clarity Phase III data and selected LNZ100, a single agent, a cycling product, as our commercial candidate to treat presbyopia. As a reminder, presbyopia is the inevitable loss of near vision that impacts the daily lives of nearly all people over the age of 45. As the crystalline lens in our eyes hardens with age, the eye is less able to accommodate and focus the incoming light for near vision on the retina, resulting in blurry near vision. Although the progression of presbyopia is gradual, presbyopes often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s, when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work. To address the daily challenges faced by presbyopes, we are developing a once-daily pharmacological eyedrop that has been shown to be capable of improving near vision throughout the full workday without the need for reading glasses. Before I give a brief summary of the positive clarity top line data, I want to highlight that throughout the development of LNZ100, our objective has always been to commercialize a product that we believe will most effectively meet the needs of the widest range of presbyopes. and best create loyalty and value based on an all eyes, all day brand mission. That means that we're not only aiming for high efficacy with a rapid onset and long duration, but also that the product candidate has to deliver that consistently across the majority of the presbyopic population. This is why we made sure that the close to 1,100 participants in our clarity studies represented the majority of the 128 million presbyopes in the U.S. alone. We included participants aged 45 to 75 with a mean age of 55. We also made sure to include people that had a wide range of refractive errors. Think of this as including people that need to wear contact lenses or glasses to correct their distance vision, but also people that have never had to wear any distance vision or correction in their life. We made sure to also include people that had previously undergone LASIK or cataract surgery. And importantly, we included participants with a wide range of presbyopia to make sure that we have a product that can appeal to mild, moderate, and severe presbyopes. By doing so, we feel confident that the results that we generated truly reflect the potential benefits that LNZ100 can bring to the vast majority of the close to two billion presbyopes globally. On that note, let's talk about the key outcomes of the CLARITY Phase III study, in which MNZ100, a single agent, a cycling product candidate, continued to show strong performance and best-in-class potential. Consistent with previous trials, and for the moment focusing on the results for the CLARITY II trial, as this is the direct vehicle control trial, LNZ100 showed a rapid onset with 71 percent of participants achieving three lines or more of near vision improvement without losing one line or more of distance vision at 30 minutes on the very first day of use of the product. At the primary endpoint of three hours, we also observed a three line or more responder rate of 71 percent. LNZ100 also maintains high levels of near vision improvement with 40% of participants achieving three lines or more of near vision improvement at 10 hours, the last time point measured in our efficacy trials. All results were highly statistically significant with p-values at each time point of less than .0001. We also saw a very impressive near universal response to LNG100. with 95% of participants achieving at least two lines of near vision improvement. This is an important measure because it is seen as clinically meaningful and significant for most presbyopes. Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing. In both efficacy trials, clarity one and two, The participants used their assigned treatment agent every day for 42 days. We saw similarly high response rates for LNG100 across both trials at the various days we brought participants in for measurements. In terms of safety, LNG100 was seen to be well-tolerated with no treatment-related series of adverse events observed in the over 30,000 treatment days across all three CLARITY trials. Of all reported non-serious adverse events, 95% were classified as mild, believed to be transient, and consistent with those observed in previous trials. Commercial potential was further confirmed by participant surveys, with 90% of participants noticing an improvement in near vision and 75% of them indicating that they would continue to use MMZ100 after the study. Together with the broad inclusion criteria we mentioned earlier, we believe this positions MMZ100 well for the estimated over $3 billion potential market opportunity. We recently received the full data sets of the three clarity trials and are currently analyzing them for additional insights. While that work is still ongoing, I can share that some of the early new data that is coming out is exciting and continues to show nearly universal high efficacy of LNG100. For example, looking at pooled data across both of our efficacy trials, Clarity 1 and 2, we see that not only did 97 percent of participants achieve at least a three-line improvement at some point, but an impressive 84 percent improved their near vision by at least four or more lines. We believe that these results indicate that the vast majority of people that, if approved, sample the product would notice a rapid and meaningful improvement in their near vision. This is something that will play a key role in our future commercialization strategy and could serve as a very strong differentiator from the VOD launch. As mentioned, we are conducting analysis of the full data set for phase three results beyond the already shared top line results. We're excited to announce that we're planning a phase three capstone KOL event on June 18th, 2024 in New York City. With this event, we will share additional data and importantly, we will have distinguished and respected KOLs and lead investigators from our study share their views on our data expectations for the clinical practice and market, and first-hand experiences with LNZ100. We look forward to providing additional information on this event in the weeks ahead. Turning to our upcoming NDA submission, I am pleased to share that the CLARITY Phase 3 study was designed in close alignment with the FDA, and the positive top-line data generated concludes the clinical development program for LNZ100. The team is now fully focused on the execution of the filing, and we are well on track to submit our NDA for LNZ100 to the FDA in mid-2024. In parallel to working towards our NDA submission, our commercial launch preparedness is also well underway. In February 2024, Lens launched its unbranded IAM campaign to educate and excite eye care professionals about future presbyopia solution. Over 40 key opinion leaders are involved in the campaign and are featured at IAmSelected.com. That is IAmSelected.com, where eye care professionals can learn about ideal pupil size, iris muscle selectivity, and expected early adopters of presbyopia eye drops. Continuing on that momentum and to support the projected launch following potential FDA approval, lenses actively building out its U.S. commercial capabilities, highlighted by completion of third-party logistics contracting in the first quarter of 2024 and the addition of key commercial expertise in direct-to-consumer and influencer marketing, all in preparation for a potential launch of LNG100 as early as the second half of 2025. In summary, we are very pleased with the progress the team has made on all fronts. The recent period has been and promises to continue to be a very exciting time at Lens. With that, I'll hand it over to Dan, our CFO, for an update on our financial results.