LENZ Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Lens Therapeutics year-end 2024 financial results conference call. This time, all participants are in a listen-only mode. Following prepared remarks from the management, we will conduct a question-and-answer session with instructions we'll 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 for joining us today. My name is Dan Chevalard, Chief Financial Officer of Lenz Therapeutics. We are joined today by Eif Schimelpennig, 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 LENZ'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, which can also be found on our website. In addition, any forward-looking statements represent only our views as of the day 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 2024 Form 10-K, which is being filed today. With that, I will now turn the call over to Abe.

Thank you, Dan, and good afternoon, everyone. 2024 has been a highly successful year for Lens, and I'm extremely proud of all we have accomplished. We are truly building something special, and I strongly believe we have put ourselves in a position to have an even greater and transformational year in 2025, as we aim to emerge as a commercial company. On previous calls, I've mentioned the consistent pattern of execution by the team, and I would like to take a moment and acknowledge their efforts. We are a team that are the best when we are together. We go fast on purpose, we relish ingenuity, and we are relentless. On the back of these core values, we had a tremendous year in 2024, highlighted by our emergence as a public company in March and completion of our phase three clarity study and announcement of stellar data for LNG 100 in April. This was followed by the execution of a 30 million pipe financing with Richback Capital in July, submission of our NDA in August, and its acceptance in October. all contributing to significant progress and momentum as we work towards the potential approval and launch of L&Z 100. With all of the exciting progress we've made over 2024, the fourth quarter and most recent period has been a critical time as we have completely transitioned to a pre-commercial company and have entered 2025 in a position of financial strength, ending 2024 with over $209 million in cash. I'd now like to take a few minutes to highlight five key areas of corporate focus where we've seen excellent progress in recent months. Regulatory, manufacturing readiness, medical affairs, intellectual property, and prelaunch commercial planning. First, on the regulatory front, in what has been a very constructive and highly engaged process thus far, we continue to make encouraging progress with the FDA on our NDA review. In January of this year, we completed our mid-cycle review, which is a key milestone in the agency's review progress. But we were very pleased that the agency noted no significant review issues and that they reiterated that no plans to request an advisory committee meeting. Importantly, in light of the recent developments around federally funded agencies, FDA inspections on our clinical trial sites are now underway. And we are pleased to report that we have confidence that our MDA review has been uninterrupted and is making great progress. As such, we continue to believe that we are well positioned for a potential on-time approval in August 2025, which, if granted, will be immediately followed by commercial launch activities in the United States with products anticipated to be available in the market in the fourth quarter of 2025. Second, on manufacturing readiness, I am particularly pleased with the progress the manufacturing operations team has made in recent months. Importantly, and signifying an important milestone, in February, we initiated the manufacturing of potential commercial products. The team, together with our manufacturing partners, has been working tirelessly to enable the achievement of this important landmark and will continue to focus over the coming months on manufacturing adequate commercial sample, and product inventory to support a successful launch. For the time being, this product will be kept in bulk and, following label discussions and potential approval of our MDA, undergo final packaging. As a result, and following FDA approval, we expect to have commercial products available in the market in Q4 of this year. Third, I'm very excited to highlight key progress from our medical affairs team. We are seeing noteworthy eye care professional engagement nationwide, led by meaningful interactions by our all optometrists medical science liaison team who have been very active at state and national medical conferences, educating the ECP community on the importance of being pupil selected and the differentiation of a psyched in ciliary body sparing mechanism of action, as well as on the data from the phase three clarity study. Just a few weeks ago, the medical team held a fantastic event at SECO in Atlanta, where we hosted over 100 ECPs at the College Football Hall of Fame. And since the beginning of Q4, we've had meaningful medical interactions with more than 1,000 individual ECPs. Our intent is to have our MSL team engage with the majority of our key target ECPs ahead of our PDUFA date. Next. A foundational area of focus and recent progress has been on intellectual property, more specifically our domestic and international patent estate for L&Z 100. We have continued to strengthen our patent ticket and currently have seven granted patents in the United States that go out to 2039. There are additional 10 patents under review that aim to extend our patent protection to at least 2044. Together with the expected five years of NCE exclusivity, we believe our product is extremely well protected and set up for longevity. In addition, we continue to extend our patent portfolio, XUS, to support the significant commercial opportunity we believe exists there. And lastly, I'll turn to pre-launch commercial planning. The commercial team has been hard at work, and before I turn it over to Sean to step through in more detail, I would like to highlight a few key items. First, the hiring of a sales force is in its final stage. Both of our regional directors were hired in Q4, and we now have hired all 10 of our district managers. We've been extremely pleased with the excellent quality of candidates we are attracting, the significant eye care experiences across the board. As you may have seen, last week we launched a hiring campaign for our 88 territory sales force. our last sales hires, and as an indication of the anticipation we believe exists in the market, received over 1,300 applications within the first 24 hours of posting the job profiles. We're looking forward to hiring only the best and most talented candidates to Lens and have them fully onboarded ahead of our Purdue for dates. This will ensure that they can be in the field promoting our products immediately after potential approval. and get one or more cold cycles in ahead of product being available in the market. Second, we're very much looking forward to our upcoming commercial day on April 15th. We will have the opportunity to elaborate on our commercial strategy and pre-launch preparations, as well as bring forward additional key opinion leader and ECP perspectives as we approach the potential approval and launch of LNZ100. something Sean will touch on in more detail shortly. As I mentioned in my opening remarks, 2024 has been a highly successful year, and the recent period has continued to be extremely productive as we prepare for the potential approval of LNG 100. I will now hand the call over to Sean Olson, our Chief Commercial Officer, to provide additional comments on our pre-commercial planning efforts. Sean?