LENZ Therapeutics, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Lens Therapeutics second quarter 2024 conference call. At this time, all participants are in a listen-only mode. Following prepared remarks from management, we will conduct a question and answer session and instructions will follow at that time. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevalard, Chief Financial Officer. Please go ahead.

Thank you. Good afternoon, and thank you to everyone for joining us today to discuss LENDS' second quarter 2024 financial results and recent highlights. My name is Dan Chevalard, Chief Financial Officer of LENDS Therapeutics. We are joined today by Abe Schimmelpennig, our President and Chief Executive Officer, and Shawn Olson, our Chief Commercial Officer. In addition, Dr. Mark Odrich, our Chief Medical Officer, will join us for the question and answer session. Before we begin, I would like to remind you that this call will contain forward-looking statements regarding LINZ's future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations, cash runway projections, and performance. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors and risks, including those discussed in our filings with the Securities and Exchange Commission and which can also be found on our website. 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. The company encourages you to consult the risk factors contained in our SEC filings for additional detail including in our second quarter 2024 410Q, which was filed today. With that, I will now turn the call over to Abe.

Thank you, Dan, and good afternoon, everyone. The first half of 2024 and recent period has been transformational for Lance. In short succession, we made our debut on our public markets with a strong investor base and balance sheet, delivered the results of our phase three clarity trials, which we believe support LNG100 as the potential best-in-class treatment for presbyopia, concluded a $30 million pipe financing, and importantly, submitted our NDA to the FDA. I am incredibly proud of the continued excellent execution across the organization and highly confident that we are well on our way to deliver the first and only a cyclin-based eye drop for the improvement in their vision in people with presbyopia. Looking ahead, and in line with our previous guidance, we continue to work towards a potential approval by the FDA in mid-2025, and if approved, US launch as early as second half of 2025. Before I review our key achievements in more detail, and as a quick 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 eye drop that in our clarity trials has shown to be capable of improving their vision throughout the full workday without the need for reading glasses. More specifically, in April, we reported positive Phase III data, which we complemented with capstone data in June, in which LNG100, our Cycadine-based product candidate, continued to show strong performance and best-in-class potential. Highlighting some of the key results of the trial, and for the moment focusing on the results of Clarity 2, as this is the direct vehicle control trial, we saw a rapid onset effect with 71% of participants achieving three lines or more of near vision improvement at 30 minutes on the very first day of use of the product. At three hours, our primary endpoint, we also observed a three line or more responder rate of 71%. And we maintained these high levels for the full workday with 40% of participants still achieving three lines or more of near vision improvement at 10 hours, the last time point measured in our efficacy trials. And these three-line gains turned out to be only the beginning. Eighty-four percent of participants achieved at least a four-line gain during the study and a staggering 52% at least five lines. 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. Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing. Interestingly, we also observed a statistically significant at least one line of distance vision improvement across the population. In terms of safety, LMZ100 was seen to be well tolerated with no treatment-related serious adverse events observed in the over 30,000 treatment days across all three clarity trials. Of all reported adverse events, 95% were classified as mild, believed to be transient, and consistent with those observed in previous trials. We also saw that in the rare cases, more specifically 7.6% placebo corrected, that participant noticed a mostly mild and transient headache following installation of the drop. This appears to be tachyphallactic and for most no longer appearing with prolonged use of LNG100. These strong clinical results and the promise they bring for 128 million presbyopes in the U.S. alone allowed us to further strengthen our balance sheet with a $30 million investment from Ridgeback Capital in July. We appreciate the significant support and confidence shown by the Ridgeback team and are pleased to add this additional capital as we aim to make LNZ100 the best in class, if not only in class, therapeutic option for the treatment of presbyopia. Lastly, I'm very excited to highlight that we have submitted our NDA for LNZ100 to the FDA, marking a key milestone for the company. Our NDA is a culmination of a development program that along the way incorporated valuable feedback and guidance from the FDA. We believe that we have compiled a dossier with strong clinical manufacturing and quality data, and we look forward to working with the agency as they review our submission. The first step in this, and following a positive initial review, would be the formal acceptance of our NDA within 60 days of submission. Once the FDA accepts our NDA, the agency must complete their review within 10 months. The date at the end of this period is referred to as the PDUPA date, and once the FDA has provided us with it, we will communicate this with you. As mentioned earlier, and in line with previous guidance, We believe that this PDUFA date can be in the middle of next year and, if our submission needs approval, could lead to launch of LNG100 in the US in the second half of 2025. To highlight some of the key areas of focus as we begin to prepare for our potential launch, I will now hand the call over to Sean Olson, Chief Commercial Officer.