LENZ Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Lens Therapeutics Third Quarter 2024 conference call. At this time, all participants are in a listen-only mode. Following prepared remarks from the 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 morning and thank you for joining us today to discuss Lens' third quarter 2024 financial results and recent highlights. My name is Dan Chevalard, Chief Financial Officer of Lens Therapeutics. We are joined today by Abe Schimmelpennig, our President and Chief Executive Officer, and Sean Olson, our Chief Commercial Officer, as well as Dr. Mark Odrich, Chief Medical Officer, who 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 Security 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 third quarter 2024 Form 10-Q, which was filed this morning. With that, I will now turn the call over to Abe.

Thank you, Dan, and good morning, everyone. The third quarter of 2024 has been highlighted by multiple significant corporate achievements. They reflect the consistent pattern of execution by the LEMS team as we continue to build momentum on our path towards the potential approval and launch of LNG 100. I'd like to take a moment to summarize our recent milestones. and signal a clear and important transition in the profile of LENS as we move from a late-stage clinical development by a pharmaceutical company to a pre-commercial company, fully focused on what we believe is to come in 2025. The recent period has been pivotal in our advancement, with significant achievements, most notably the acceptance by the FDA of our MDA for LNG100 for the treatment of presbyopia. and importantly, receipt of a PDUFA target action date of August 8th, 2025. With that, I'd like to provide a brief refresher on the widespread and inevitable problem we are able to solve. As we know, presbyopia is a loss of near vision that impacts the daily lives of nearly all people over the age of 45. As the crystalline lens in our eye partners with age, the eye is less able to accommodate and focus the incoming life for near vision on the retina, resulting in blurry near vision. Although the progression of presbyopia is gradual, presbyopes often experience a 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 advancing the first and only a psychogen-based one daily eyedrop that in our Phase III clarity trials has shown to be capable of improving near vision throughout the full workday without the need for reading glasses. We are extremely excited about the LNG100 product profile, which we believe has best-in-class potential. The profile of LNG100 includes a rapid onset of response, with 71% achieving three lines or greater of near vision improvement at 30 minutes, and also 71% achieving three lines or greater of near-vision improvement at three hours, which was our primary endpoint. An unprecedented, long-lasting response rate measured out to at least 10 hours, with 40% achieving three lines or greater near-vision improvement, which was the last time but measured in our efficacy trials. And a very impressive near-universal response to LNG100 with 95% of participants achieving at least two lines of near vision improvements. This is an important measure because it's 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 addition, we observed a statistically significant at least one line of distance vision improvement across the population. And importantly, in terms of safety, LNG-100 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 in the rare cases of headache, appeared to be tachycolectic, and for most, no longer appearing with prolonged use of LNG-100. Returning now to our recent news, an exciting regulatory milestone announced a few weeks ago. We were pleased to receive our Day 74 letter, which signifies the official acknowledgement of acceptance by the FDA of our MDA for LNZ100 for the treatment of presbyopia. Importantly, including our PDUPA target action date of August 8th, 2025. As I mentioned on our second quarter call, Our NDA is the culmination of a development program that along the way incorporated valuable feedback and guidance from the FDA, and we believe that we've compiled a dossier with strong clinical manufacturing and quality data. We look forward to continuing to collaborate with the agency as they review our submission, all of which we believe could result in a potential approval by the FDA in August of next year and a commercial launch in the United States as early as the fourth quarter of 2025. Before we transition to a commercial discussion, I would like to also take a moment to highlight the exciting results from Coexcel, previously known as Yijing, our development and commercial licensing partner in China, which we jointly announced last week. We were very pleased with the top-line data from the Phase III study performed by Coexcel. It was a well-executed study as evidenced by the strong p-values of at least of less than 0001. We believe it's important to emphasize the relative strength and consistency of that data with that of the CLARITY study, as the JX07001 clinical study was performed by a different company in a different country, and importantly, with a patient population that was predominantly of a different ethnicity. We believe this further highlights the potential LNZ100 has as a global therapy. starting with potentially providing access to the estimated 400 million presbyopes in China. We believe this to be an illustration of an ex-US partnership that has an opportunity to create meaningful shareholder value. As the balance of the global rights around G100 ex-China remain unpartnered, we believe opportunities to further partner globally could provide significant additional upside to our shareholders. As I mentioned in my opening remarks, these recent milestones signal an important transition in the focus and profile of LENS, as we have moved from a late-stage clinical development by a pharmaceutical company to a pre-commercial company. With that, we would like to highlight a few key observations from a recent primary market research survey commissioned by LENS of approximately 430 eye care professionals, comprised of approximately 80% optometrists. and 20% ophthalmologists. We believe the results will help illuminate some very interesting insights about the potential treatment of presbyopia with LNZ100, if approved. I will now hand the call over to Sean Olson, our Chief Commercial Officer, to step us through the results of this analysis. Sean?